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Sample records for suspension formulation developing

  1. Formulation development and rheological studies of palatable cefetamet pivoxil hydrochloride dry powder suspension

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    G Divakar

    2011-05-01

    Full Text Available Background and the purpose of the study: Because of its intense bitter taste and susceptibility to moisture Cefetamet Pivoxil (CPH is presently available only in the form of tablet. The aim of this study was to develop taste masked CPH dry powder suspension. Methods: Methods employed for formulations were: a Film coating of CPH using Eudragit E100 and subsequent adsorption on different carriers such as spray-dried lactose, sodium starch glycolate and spry-dried mannitol and b Complexation of CPH with three different ion exchange resins viz; indion 234, amberlite IRP64 and amberlite IRP69. Results: Taste evaluation as recognized by volunteers revealed that coating with eudragit E100 and subsequent adsorption on different carriers do not mask the bitter taste of the drug. Suspensions prepared using amberlite IRP64 and amberlite IRP69 were extremely palatable with no bitter after taste. They showed pseudoplastic flow behavior and were too viscous even after shearing for sufficient duration of time and exhibited poor pourability. The suspension made with indion 234 was palatable with slight or no bitter after taste. It demonstrated plastic flow with negligible thixotropy. It had moderate viscosity at rest and could be poured after a reasonable amount of shaking. CPH dry powder suspensions were very unstable under different conditions except under refrigeration. A 5% degradation of drug was occurred in reconstituted suspension in 4 days period when stored at room temperature. Conclusion: Dry powder suspension prepared with indion 234 with 5% overages was stable even after 4th day of reconstitution and palatable with slight or no bitter after taste

  2. Characterizing viscoelasticity of unhydrolyzed chicken sternal cartilage extract suspensions: Towards development of injectable therapeutics formulations.

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    Hama, Brian; Mahajan, Gautam; Kothapalli, Chandrasekhar

    2017-08-01

    Exogenous delivery of cartilage extract is being explored as a promising candidate for knee arthritis treatment as it biomimics native cartilage tissue characteristics. In this study, we report on the rheological characterization of aqueous suspensions constituted from a powdered form of unhydrolyzed chicken sternum extract. The effect of particle size (as-received vs. milled), suspension fluid (water vs. PBS), and temperature (37°C vs. 4°C), on the viscoelastic properties of the sternum extract based particulate suspensions were evaluated. Results showed that these suspensions exhibit shear-thinning characteristics as shear rate (γ̇) increases, while viscosity (η), storage (G'), and loss (G″) moduli of the suspensions increased with increasing particulate loading (ϕ: 2.5-10wt%). Reducing the as-received particle size by milling decreased G', G, and η of the suspensions and increased the influence of ϕ on these properties, possibly due to improved particle packing. Replacing water with PBS had no significant effect on the rheological properties, but temperature reduction from 37°C to 4°C increased G', G", and η of the suspensions and lowered the impact of powder loading on viscoelastic properties. The suspension's time-dependent response was typical of viscoelastic materials, characterized by an asymptotical approach to a final stress (stress relaxation) or strain (creep). Results were fit to a power-law model for creep, a general relaxation model for exponential decay in stress, Carreau-Yasuda models for flow curves, and a two-parameter Liu model to identify the maximum powder loading (ϕ m ). Among the various forces involved in particle-particle interactions within these suspensions, electrostatic forces appeared to dominate the most. Such characterization of the viscoelastic nature of these suspensions would help in formulating stable injectable cartilage extract based therapeutics for in vivo applications. Copyright © 2017 Elsevier Ltd. All

  3. Evaluating Suspension Formulations of Theophylline Cocrystals With Artificial Sweeteners.

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    Aitipamula, Srinivasulu; Wong, Annie B H; Kanaujia, Parijat

    2018-02-01

    Pharmaceutical cocrystals have garnered significant interest as potential solids to address issues associated with formulation development of drug substances. However, studies concerning the understanding of formulation behavior of cocrystals are still at the nascent stage. We present results of our attempts to evaluate suspension formulations of cocrystals of an antiasthmatic drug, theophylline, with 2 artificial sweeteners. Stability, solubility, drug release, and taste of the suspension formulations were evaluated. Suspension that contained cocrystal with acesulfame showed higher drug release rate, while a cocrystal with saccharin showed a significant reduction in drug release rate. The cocrystal with saccharin was found stable in suspension for over 9 weeks at accelerated test condition; in contrast, the cocrystal with acesulfame was found unstable. Taste analysis using an electronic taste-sensing system revealed improved sweetness of the suspension formulations with cocrystals. Theophylline has a narrow therapeutic index with a short half-life which necessitates frequent dosing. This adversely impacts patient compliance and enhances risk of gastrointestinal and cardiovascular adverse effects. The greater thermodynamic stability, sweetness, and sustained drug release of the suspension formulation of theophylline-saccharin could offer an alternative solution to the short half-life of theophylline and make it a promising formulation for treating asthmatic pediatric and geriatric patients. Copyright © 2018 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.

  4. Influence of crystal habit on trimethoprim suspension formulation.

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    Tiwary, A K; Panpalia, G M

    1999-02-01

    The role of crystal habit in influencing the physical stability and pharmacokinetics of trimethoprim suspensions was examined. Different habits for trimethoprim (TMP) were obtained by recrystallizing the commercial sample (PD) utilizing solvent-change precipitation method. Four distinct habits (microscopic observation) belonging to the same polymorphic state (DSC studies) were selected for studies. Preformulation and formulation studies were carried out on suspension dosage forms containing these crystals. The freshly prepared suspensions were also evaluated for their pharmacokinetic behaviour on healthy human volunteers using a cross over study. Variation of crystallization conditions produces different habits of TMP. Among the different crystal habits exhibiting same polymorphic state, the most anisometric crystal showed best physical stability in terms of sedimentation volume and redispersibility. However, habit did not significantly affect the extent of TMP excreted in urine. Modification of surface morphology without significantly altering the polymorphic state can be utilized for improving physical stability of TMP suspensions. However, the pharmacokinetic profile remains unaltered.

  5. A study of the effect of certain formulation variables on the mucoadhesive properties of per oral sucralfate suspensions

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    Dobrozsi, Douglas Joseph

    1999-10-01

    agglomerates into primary colloidal particles had little effect on suspension properties or rheologic synergism. Factorial experiments were conducted to determine effects of the primary formulation variables on mucosal coating and retention on esophagus. Ex vivo mucosal coating increased with increasing sucralfate gel concentration, and increasing glycerin concentration, but was not effected by pH adjustment or addition of KCl. Ex vivo mucosal retention was increased by increasing sucralfate gel concentration, decreased by addition of glycerin or salt, and not effected by pH adjustment. The factorial model developed predicted that a sucralfate suspension consisting of sucralfate gel in water at 22.8% w/v might be expected to provide the best mucosal coating and retention. Evaluation of mucoretention in a large animal or human model is needed to test the prediction and establish the predictiveness of the in vitro and ex vivo models.

  6. Formulation of cefuroxime axetil oral suspension and investigation of its pharmaceutical properties

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    Valizadeh, Hadi; Farajnia, Aynoor; Zakeri-Milani, Parvin

    2011-01-01

    Purpose: Cefuroxime is the second generation cephalosporin, which its intravenous and oral dosage forms are available. Oral route is the selective method for administration of most of the drugs. The aim of this study was formulating ‘for oral’ cefuroxime axetil suspensions. Methods: Minitab (ver.15) was used to design the formulations containing 125 mg of cefuroxime in 5 ml vehicle. After selecting the acceptable preparations, physical stability tests and other tests such as dissolution rate,...

  7. Formulation design of oral pediatric Acetazolamide suspension: dose uniformity and physico-chemical stability study.

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    Santoveña, Ana; Suárez-González, Javier; Martín-Rodríguez, Cristina; Fariña, José B

    2017-03-01

    The formulation of an active pharmaceutical ingredient (API) as oral solution or suspension in pediatrics is a habitual practice, due to the non-existence of many commercialized medicines in pediatric doses. It is also the simplest way to prepare and administer them to this vulnerable population. The design of a formulation that assures the dose and the system stability depends on the physico-chemical properties of the API. In this study, we formulate a class IV API, Acetazolamide (AZM) as suspension for oral administration to pediatric population. The suspension must comply attributes of quality, safety and efficacy for this route of administration. We use simple compounding procedures, as well as fewer pure excipients, as recommended for children. Mass and uniformity content assays and physical and chemical stability studies were performed. To quantify the API an UPLC method was used. We verified the physico-chemical stability of the suspensions and that they passed the mass test of the European Pharmacopeia (EP), but not the dose uniformity test. This reveals that AZM must be formulated as liquid forms with a more complex system of excipients (not usually indicated in pediatrics), or otherwise solid forms capable of assuring uniformity of mass and dose for every dosage unit.

  8. Formulation of cefuroxime axetil oral suspension and investigation of its pharmaceutical properties

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    Hadi Valizadeh

    2011-12-01

    Full Text Available Purpose: Cefuroxime is the second generation cephalosporin, which its intravenous and oral dosage forms are available. Oral route is the selective method for administration of most of the drugs. The aim of this study was formulating ‘for oral’ cefuroxime axetil suspensions. Methods: Minitab (ver.15 was used to design the formulations containing 125 mg of cefuroxime in 5 ml vehicle.After selecting the acceptable preparations, physical stability tests and other tests such as dissolution rate, pH, zeta potential and viscosity measurement of formulations were performed. Results: From all 33 formulations, only 9 were selected to further investigation. Considering no sedimentation, the sedimentation volume was determined to be 1. The degrees of flocculation were also equal to 1. All selected formulations released the drug between 81-100% in 30 minutes which was acceptable according to the USP32 criteria. The results of assay test also proved that all formulations contain the drug in acceptable range (91-106%. The viscosity curves showed that the systems were pseudo plastic and thixotrop. Conclusion: Designed cefuroxime axetil formulations had good qualities and could be added as a new product to Iran drug marketing.

  9. A new formulation for orally disintegrating tablets using a suspension spray-coating method.

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    Okuda, Y; Irisawa, Y; Okimoto, K; Osawa, T; Yamashita, S

    2009-12-01

    The aim of this study was to design a new orally disintegrating tablet (ODT) that has high tablet hardness and a fast oral disintegration rate using a new preparation method. To obtain rapid disintegration granules (RDGs), a saccharide, such as trehalose, mannitol, or lactose, was spray-coated with a suspension of corn starch using a fluidized-bed granulator (suspension method). As an additional disintegrant, crospovidone, light anhydrous silicic acid, or hydroxypropyl starch was also included in the suspension. The RDGs obtained possessed extremely large surface areas, narrow particle size distribution, and numerous micro-pores. When tabletting these RDGs, it was found that the RDGs increased tablet hardness by decreasing plastic deformation and increasing the contact frequency between granules. In all tablets, a linear relationship was observed between tablet hardness and oral disintegration time. From each linear correlation line, a slope (D/H value) and an intercept (D/H(0) value) were calculated. Tablets with small D/H and D/H(0) values could disintegrate immediately in the oral cavity regardless of the tablet hardness and were considered to be appropriate for ODTs. Therefore, these values were used as key parameters to select better ODTs. Of all the RDGs prepared in this study, mannitol spray-coated with a suspension of corn starch and crospovidone (2.5:1 w/w ratio) showed most appropriate properties for ODTs; fast in vivo oral disintegration time, and high tablet hardness. In conclusion, this simple method to prepare superior formulations for new ODTs was established by spray-coating mannitol with a suspension of appropriate disintegrants.

  10. Formulation and Validation of an Efficient Computational Model for a Dilute, Settling Suspension Undergoing Rotational Mixing

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    Sprague, Michael A.; Stickel, Jonathan J.; Sitaraman, Hariswaran; Crawford, Nathan C.; Fischer, Paul F.

    2017-04-11

    Designing processing equipment for the mixing of settling suspensions is a challenging problem. Achieving low-cost mixing is especially difficult for the application of slowly reacting suspended solids because the cost of impeller power consumption becomes quite high due to the long reaction times (batch mode) or due to large-volume reactors (continuous mode). Further, the usual scale-up metrics for mixing, e.g., constant tip speed and constant power per volume, do not apply well for mixing of suspensions. As an alternative, computational fluid dynamics (CFD) can be useful for analyzing mixing at multiple scales and determining appropriate mixer designs and operating parameters. We developed a mixture model to describe the hydrodynamics of a settling cellulose suspension. The suspension motion is represented as a single velocity field in a computationally efficient Eulerian framework. The solids are represented by a scalar volume-fraction field that undergoes transport due to particle diffusion, settling, fluid advection, and shear stress. A settling model and a viscosity model, both functions of volume fraction, were selected to fit experimental settling and viscosity data, respectively. Simulations were performed with the open-source Nek5000 CFD program, which is based on the high-order spectral-finite-element method. Simulations were performed for the cellulose suspension undergoing mixing in a laboratory-scale vane mixer. The settled-bed heights predicted by the simulations were in semi-quantitative agreement with experimental observations. Further, the simulation results were in quantitative agreement with experimentally obtained torque and mixing-rate data, including a characteristic torque bifurcation. In future work, we plan to couple this CFD model with a reaction-kinetics model for the enzymatic digestion of cellulose, allowing us to predict enzymatic digestion performance for various mixing intensities and novel reactor designs.

  11. Food effect on the bioavailability of two distinct formulations of megestrol acetate oral suspension

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    Benoit Deschamps

    2009-09-01

    Full Text Available Benoit Deschamps1, Naomi Musaji2, John A Gillespie21SFBC Anapharm, Montreal, Canada; 2Strativa Pharmaceuticals, a division of Par Pharmaceutical, Inc., Woodcliff Lake, NJ, USAObjective: Megestrol acetate oral suspension (MAOS is an appetite stimulant indicated for cachexia in patients with AIDS. It is available in its original formulation, Megace® (MAOS, and as a nanocrystal dispersion, Megace® ES (MA-ES. Three studies were conducted to evaluate the pharmacokinetic properties of these formulations under fed and fasting conditions.Methods: An open-label, crossover trial was conducted in 24 healthy males randomized to MA-ES 625 mg/5 mL given with a high-calorie, high-fat meal, or after an overnight fast. Blood samples were drawn at multiple time points and pharmacokinetic parameters were determined. Two separate, open-label reference studies evaluated MAOS 800 mg/20 mL in 40 fed or 40 fasting healthy male volunteers.Results: In fasting MA-ES subjects, the average maximum concentration (Cmax was 30% less than the fed Cmax value. For MAOS, fasting Cmax was 86% less than fed Cmax. In fasting subjects, the area under the curve was 12,095 ng⋅h/mL for MA-ES, and 8,942 ng⋅h/mL for MAOS. In fed subjects, the absorption of the two formulations was comparable.Conclusion: Bioavailability and absorption are greater for MA-ES than MAOS in fasting subjects. MA-ES may be a preferred formulation of megestrol acetate when managing cachectic patients whose caloric intake is reduced.Keywords: megestrol acetate, bioavailability, cachexia, nanocrystal technology, appetite stimulant

  12. Formulation development for PREPP concreted waste forms

    International Nuclear Information System (INIS)

    Neilson, R.M. Jr.; Welch, J.M.

    1984-05-01

    Analysis of variance and logistic regression techniques have been used to develop models describing the effects of formulation variables and their interactions on compressive strength, solidification, free-standing water, and workability of hydraulic cement grouts incorporating simulated Process Experimental Pilot Plant (PREPP) wastes. These models provide the basis for specifications of grout formulations to solidify these wastes. The experimental test matrix, formulation preparation, and test methods employed are described. The development of analytical models for formulation behavior and the conclusions drawn regarding appropriate formulation variable ranges are discussed. 13 references, 9 figures, 15 tables

  13. Application of UV Imaging in Formulation Development

    DEFF Research Database (Denmark)

    Sun, Yu; Østergaard, Jesper

    2017-01-01

    defining formulation behavior after exposure to the aqueous environments and pharmaceutical performance is critical in pharmaceutical development, manufacturing and quality control of drugs. UV imaging has been explored as a tool for qualitative and quantitative characterization of drug dissolution...... related to the structural properties of the drug substance or formulation can be monitored. UV imaging is a non-intrusive and simple-to-operate analytical technique which holds potential for providing a mechanistic foundation for formulation development. This review aims to cover applications of UV...

  14. MMB4 DMS nanoparticle suspension formulation with enhanced stability for the treatment of nerve agent intoxication.

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    Dixon, Hong; Clark, Andrew P-Z; Cabell, Larry A; McDonough, Joe A

    2013-01-01

    Various oximes are currently fielded or under investigation in the United States and other countries as a component of autoinjector emergency treatment systems for organophosphate nerve agent chemical weapons. Bis-pyridinium oximes in general have greater efficacy against a broad spectrum of nerve agents, but they have poor stability due to hydrolytic degradation at elevated temperatures. 1,1'-Methylenebis-4-[(hydroxyimino)methyl]pyridinium dimethanesulfonate (MMB4 DMS) is a leading candidate for next-generation nerve agent treatment systems, because it is more stable than other bis-pyridinium oximes, but it still degrades quickly at temperatures often encountered during storage and field use. The primary goal is to increase the stability and shelf life of MMB4 while maintaining the desirable pharmacokinetic (PK) properties of the aqueous formulation. We have developed a formulation to be used in a phase 1 clinical trial consisting of MMB4 micro/nanoparticles suspended in cottonseed oil, a biocompatible vegetable oil. Through various milling techniques, the average particle size can be controlled from approximately 200 to 6000 nm to produce non-Newtonian formulations that are viscous enough to resist rapid particle sedimentation while remaining injectable at a range of concentrations from 5 to 400 mg/mL. The preliminary accelerated stability test shows that MMB4 in these formulations is stable for at least 2 years at temperatures up to 80°C. Preliminary preclinical in vivo studies have demonstrated that all concentrations and particle sizes have desirable PK properties, including high bioavailability and rapid absorption, which is critical to combat potent and fast-acting nerve agents.

  15. Development of A New Automotive Active Suspension System

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    Yousef Abdulhammed, Eng.; Eng. Hisham Elsherif, Dr, Prof.

    2017-12-01

    The main objective was to develop a smart new vehicle suspension system that minimizes the road irregularities impact on the driver, also to increase performance and stability of the vehicle at high speeds. The central idea is based on modifying the normal passive suspension system into a computer controller hydraulic actuated active suspension system simply by adding a new component such as a hydraulic cylinder on a normal passive system. The new suspension system is economical to be wildly used in consumer’s cars with low prices. The new added components was analytically tested and modeled according to different parameters. A new test rig was implemented to simulate a real quarter suspension system. The new suspension model was controlled by feedback controller according to the road conditions; the controller output controls the cylinder actuator to compensate the road oscillations and increases the vehicle stability for the passenger. Finally, to maximize the aerodynamics coefficients of the vehicle during high speeds by controlling the vehicle clearance level from the ground to achieve full stability, steering and fuel economy.

  16. Development of the Nissan hydraulic active suspension. Nissan yuatsu active suspension no kaihatsu

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    Kawarasaki, y.; Fukunaga, Y.; Hasegawa, S.; Okuyama, Y.; Omura, I.; Takahashi, K.; Abe, S.; Tsuruta, E. (Nissan Motor Co. Ltd., Tokyo (Japan))

    1989-12-25

    A hydraulic active suspension system, Nissan original product, was developed and mass produced for the first time in the world. The system incorporates a sufficient power source, a high accuracy sensor and a high response device for continuous and intended vehicle control and at the same time delivers high levels of ride comfort and driving performance. The suspension system has four innovative features: skyhook damping, active roll and pitching control, a frequency-dependent damping mechanism, and active steering characteristics control. Under all road and operating conditions, the system actively suppresses vehicle attitude changes and unnecessary movement, and also gently absorbs inputs from the road. This epoch-making system provides a dramatic improvement in vehicle performance, and has been adopted in the Infiniti Q45 luxury sedan. 2 refs., 20 figs., 4 tabs.

  17. Application of UV Imaging in Formulation Development.

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    Sun, Yu; Østergaard, Jesper

    2017-05-01

    Efficient drug delivery is dependent on the drug substance dissolving in the body fluids, being released from dosage forms and transported to the site of action. A fundamental understanding of the interplay between the physicochemical properties of the active compound and pharmaceutical excipients defining formulation behavior after exposure to the aqueous environments and pharmaceutical performance is critical in pharmaceutical development, manufacturing and quality control of drugs. UV imaging has been explored as a tool for qualitative and quantitative characterization of drug dissolution and release with the characteristic feature of providing real-time visualization of the solution phase drug transport in the vicinity of the formulation. Events occurring during drug dissolution and release, such as polymer swelling, drug precipitation/recrystallization, or solvent-mediated phase transitions related to the structural properties of the drug substance or formulation can be monitored. UV imaging is a non-intrusive and simple-to-operate analytical technique which holds potential for providing a mechanistic foundation for formulation development. This review aims to cover applications of UV imaging in the early and late phase pharmaceutical development with a special focus on the relation between structural properties and performance. Potential areas of future advancement and application are also discussed.

  18. Development of an Air Pneumatic Suspension System for Transtibial Prostheses

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    Gholamhossein Pirouzi

    2014-09-01

    Full Text Available The suspension system and socket fitting of artificial limbs have major roles and vital effects on the comfort, mobility, and satisfaction of amputees. This paper introduces a new pneumatic suspension system that overcomes the drawbacks of current suspension systems in donning and doffing, change in volume during daily activities, and pressure distribution in the socket-stump interface. An air pneumatic suspension system (APSS for total-contact sockets was designed and developed. Pistoning and pressure distribution in the socket-stump interface were tested for the new APSS. More than 95% of the area between each prosthetic socket and liner was measured using a Tekscan F-Scan pressure measurement which has developed matrix-based pressure sensing systems. The variance in pressure around the stump was 8.76 kPa. APSS exhibits less pressure concentration around the stump, improved pressure distribution, easy donning and doffing, adjustability to remain fitted to the socket during daily activities, and more adaptability to the changes in stump volume. The volume changes were adjusted by utility of air pressure sensor. The vertical displacement point and reliability of suspension were assessed using a photographic method. The optimum pressure in every level of loading weight was 55 kPa, and the maximum displacement was 6 mm when 90 N of weight was loaded.

  19. Desarrollo de la formulación de la suspensión oral de ibuprofeno 100 mg/5 mL para uso pediátrico Development of formulation for oral suspension Ibuprofen 100 mg/5mL for pediatric use

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    Nilia de la Paz Martín-Viaña

    2009-08-01

    Full Text Available Se empleó el método de prueba y error para el desarrollo de la formulación de la suspensión oral de ibuprofeno 100 mg/5 mL para uso pediátrico; se estudió su estabilidad químico-física por el método acelerado y de vida de estante; se envasó en frasco de vidrio ámbar por 120 mL y se almacenó a temperatura ambiente. Se realizó el estudio reológico y la determinación de la viscosidad aparente, además, se efectuó el estudio microbiológico a través de la prueba de efectividad de preservativo antimicrobiano y el conteo microbiano; se comprobó la seguridad del producto mediante el estudio toxicológico. Todos los resultados cumplieron con los límites de calidad establecidos en la literatura científica, USP 30, para este tipo de forma farmacéutica. Se concluye que el medicamento desarrollado está correctamente formulado, desde el punto de vista galénico con un tiempo de vida útil de 24 meses bajo las condiciones estudiadas.Authors used the test and error method to develop the formulation of Ibuprofen oral suspension (100 mg/5 mL for pediatric use. Its chemical-physic stability was studied through accelerated method and shelf life. It was bottled in amber glass small bottles by 120 mL, and it was stored at room temperature. A rheology study and assessment of apparent viscosity was made as well as a microbiologic one by test of effectiveness of antimicrobial preservative and the microbial count. Product safe was verified by toxicology study. All results fulfilled quality limits established in scientific literature, USP 30, for this type of pharmaceutical method. We conclude that drug developed is correctly formulated, from the doctoral point of view with a time of useful life of 24 months under study conditions.

  20. Development of formulation device for periodontal disease.

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    Sato, Yasuhiko; Oba, Takuma; Watanabe, Norio; Danjo, Kazumi

    2012-01-01

    In addition to providing standard surgical treatment that removes the plaque and infected tissues, medications that can regenerate periodontal tissue are also required in the treatment of periodontal disease. As a form of regenerative medication, various growth factors are expected to be used while treating periodontal disease. A protein-like growth factor is often developed as a lyophilized product with dissolution liquid, considering its instability in the solution state. We have clarified that the formulation for periodontal disease needs to be viscous. When the lyophilized product was dissolved using a sticky solution, various problems were encountered, difficulty in dissolving and air bubbles, for example, and some efforts were needed to prepare the formulation. In this research, to identify the problem of preparing a viscous formulation, a lyophilized product (placebo) and sticky liquid were prepared by using vial and ampoule as the conventional containers. Based on these problems, a prototype administration device was developed, and its functionality was confirmed. As a result, it was suggested that the device with a useful mixing system that could shorten the preparation time was developed.

  1. Development of Prototype HTS Components for Magnetic Suspension Applications

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    Haldar, P.; Hoehn, J., Jr.; Selvamanickam, V.; Farrell, R. A.; Balachandran, U.; Iyer, A. N.; Peterson, E.; Salazar, K.

    1996-01-01

    We have concentrated on developing prototype lengths of bismuth and thallium based silver sheathed superconductors by the powder-in-tube approach to fabricate high temperature superconducting (HTS) components for magnetic suspension applications. Long lengths of mono and multi filament tapes are presently being fabricated with critical current densities useful for maglev and many other applications. We have recently demonstrated the prototype manufacture of lengths exceeding 1 km of Bi-2223 multi filament conductor. Long lengths of thallium based multi-filament conductor have also been fabricated with practical levels of critical current density and improved field dependence behavior. Test coils and magnets have been built from these lengths and characterized over a range of temperatures and background fields to determine their performance. Work is in progress to develop, fabricate and test HTS windings that will be suitable for magnetic suspension, levitation and other electric power related applications.

  2. Development of curcumin liposome formulations using polyol dilution method

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    Lalana Kongkaneramit

    2016-12-01

    Full Text Available This study was aimed to formulate curcumin liposomes (CLs by using polyol dilution method which is advantageous for no residue of organic solvent. CLs were the mixture of hydrogenated phosphatidylcholine (PC and cholesterol (CH at the molar ratio of 9:1. Propylene glycol (PG, glycerin, and polyethylene glycol 400 (PEG-400 were used as polyol solvent. Extrusion was applied after the suspension formed. The amount of polyol and curcumin and preparing temperature were investigated. The obtained suspensions were observed for appearance, size, size distribution, zeta potential, morphology, and percentage of entrapment. The results showed that type and amount of polyol had an impact on both liposomal size and the amount of entrapped curcumin, while preparing temperature was also an important factor. However, the solubility of lipids and drug in a given polyol should be considered because of loading efficiency in the formulation.

  3. FORMULATION OF INDONESIAN PUBLIC HEALTH DEVELOPMENT INDEX

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    Puti Sari Hidayangsih

    2012-11-01

    Full Text Available The objective of formulation the Indonesian Public Health Development Index (IPHDI was to describe the successful development of public health based on composite several community-based health indicators. Cross sectional study design.The data analyzed was a combination of a nationwide survey covering Baseline Health Research (Riskesdas 2007, National Social Economic Survey (Susenas 2007 and the Village Potential (Podes in 2008. Selection of appropriate indicators included in IPHDI associated with LE at birth, selected on the basis of consensus expert team. When the indicator has the RSE (relative standard error value of less than 30% and the value was held for more than 75% of districts. then the indicator is a candidate in the calculation IPHDI. The team doing the analysis on 22 models of the combination of indicators. The number of indicators chat involved between 18 to 24. These models have been made and tested for correlation weighting of life expectancy each district. Results of correlation ranged from 0.314 to 0.512 and all models have a significance value p< 0.001. The model was chosen considering the variables that are considered priorities and values of correlation. IPHDI Highest value is 0.708959 (Magelang City, Central Java and the lowest is 0.247059 (Pegunungan Bintang district, Papua. Conclusion. IPHDI utilization is to know district who has severe health problems, resulting in enhancement programs that have intervened, resulting in focusing the target location, and became one of the parameters for the calculation of aid allocations fairly from center to the region. Key words: health indicators, Indonesian public health development index, life expectancy

  4. Developing a new formulation of sodium phenylbutyrate.

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    Guffon, Nathalie; Kibleur, Yves; Copalu, William; Tissen, C; Breitkreutz, Joerg

    2012-12-01

    Sodium phenylbutyrate (NaPB) is used as a treatment for urea cycle disorders (UCD). However, the available, licensed granule form has an extremely bad taste, which can compromise compliance and metabolic control. A new, taste-masked, coated-granule formulation (Luc 01) under development was characterised for its in vitro taste characteristics, dissolution profiles and bioequivalence compared with the commercial product. Taste, safety and tolerability were also compared in healthy adult volunteers. The in vitro taste profile of NaPB indicated a highly salty and bitter tasting molecule, but Luc 01 released NaPB only after a lag time of ∼10 s followed by a slow release over a few minutes. In contrast, the licensed granules released NaPB immediately. The pharmacokinetic study demonstrated the bioequivalence of a single 5 g dose of the two products in 13 healthy adult volunteers. No statistical difference was seen either for maximal plasma concentration (C(max)) or for area under the plasma concentration-time curve (AUC). CI for C(max) and AUC(0-inf) of NaPB were included in the bioequivalence range of 0.80-1.25. One withdrawal for vomiting and five reports of loss of taste perception (ageusia) were related to the licensed product. Acceptability, bitterness and saltiness assessed immediately after administration indicated a significant preference for Luc 01 (p<0.01), confirming the results of the taste prediction derived from in vitro measurements. In vitro dissolution, in vitro and in vivo taste profiles support the view that the newly developed granules can be swallowed before release of the bitter active substance, thus avoiding stimulation of taste receptors. Moreover, Luc 01 was shown to be bioequivalent to the licensed product. The availability of a taste-masked form should improve compliance which is critical to the efficacy of NaPB treatment in patients with UCD.

  5. STRATEGY FORMULATION FOR DEVELOPING BATIK TULIS

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    Indah Eko Suryani

    2015-01-01

    Full Text Available The objective of this study was to formulate a development strategy in order to maintain the existence of Batik Tulis Rolla Junior. The study used a case study approach with Rumah Batik Tulis Rolla Junior as the research object. The data were analyzed by a value chain approach to determine the internal and external conditions influencing the existence of the Batik Tulis Rolla Junior. Furthermore, this study also used the analysis of Internal Factor Evaluation (IFE, External Factor Evaluation (EFE, Internal-External (IE Matrix, SWOT, dan Quantitative Strategic Planning Matrix (QSPM to create the development strategy. The results show that the strategies that can be recommended to Rolla Junior include 1 increasing the capital by Kredit Usaha Rakyat (KUR program, 2 conductiong expansions to other regencies, 3 creating a website/blog  to promote and perform business transactions, 4 increasing the frequency in joining exhibitions or EXPO both in regional and national levels, 5 conducting researches to solve the problem of coloring which requires sun rays, 6 conducting cooperations with raw material suppliers (backward integration, and 7 finding alternative suppliers of raw materials especially from the areas closer to Jember district.Keywords: development strategy, batik tulis Rolla Junior, SWOT, QSPMABSTRAKPenelitian ini bertujuan merumuskan strategi pengembangan sehingga dapat menjaga eksistensi Batik Tulis Rolla Junior. Penelitian menggunakan pendekatan studi kasus dengan Rolla Junior sebagai objek penelitiannya. Data dianalisis dengan pendekatan rantai nilai untuk mengetahui kondisi internal dan eksternal yang berpengaruh terhadap Batik Tulis kemudian menggunakan analisis Internal Factor Evaluation (IFE, External Factor Evaluation (EFE, Internal-External (IE Matrix, SWOT, dan Quantitative Strategic Planning Matrix (QSPM untuk menyusun strategi pengembangan Batik Tulis Rolla Junior. Hasil penelitian menunjukkan bahwa strategi-straegi prioritas

  6. Development and Evaluation of Topical Gabapentin Formulations

    Directory of Open Access Journals (Sweden)

    Christopher J. Martin

    2017-08-01

    Full Text Available Topical delivery of gabapentin is desirable to treat peripheral neuropathic pain conditions whilst avoiding systemic side effects. To date, reports of topical gabapentin delivery in vitro have been variable and dependent on the skin model employed, primarily involving rodent and porcine models. In this study a variety of topical gabapentin formulations were investigated, including Carbopol® hydrogels containing various permeation enhancers, and a range of proprietary bases including a compounded Lipoderm® formulation; furthermore microneedle facilitated delivery was used as a positive control. Critically, permeation of gabapentin across a human epidermal membrane in vitro was assessed using Franz-type diffusion cells. Subsequently this data was contextualised within the wider scope of the literature. Although reports of topical gabapentin delivery have been shown to vary, largely dependent upon the skin model used, this study demonstrated that 6% (w/w gabapentin 0.75% (w/w Carbopol® hydrogels containing 5% (w/w DMSO or 70% (w/w ethanol and a compounded 10% (w/w gabapentin Lipoderm® formulation were able to facilitate permeation of the molecule across human skin. Further pre-clinical and clinical studies are required to investigate the topical delivery performance and pharmacodynamic actions of prospective formulations.

  7. Development and Evaluation of Topical Gabapentin Formulations

    Science.gov (United States)

    Alcock, Natalie; Hiom, Sarah; Birchall, James C.

    2017-01-01

    Topical delivery of gabapentin is desirable to treat peripheral neuropathic pain conditions whilst avoiding systemic side effects. To date, reports of topical gabapentin delivery in vitro have been variable and dependent on the skin model employed, primarily involving rodent and porcine models. In this study a variety of topical gabapentin formulations were investigated, including Carbopol® hydrogels containing various permeation enhancers, and a range of proprietary bases including a compounded Lipoderm® formulation; furthermore microneedle facilitated delivery was used as a positive control. Critically, permeation of gabapentin across a human epidermal membrane in vitro was assessed using Franz-type diffusion cells. Subsequently this data was contextualised within the wider scope of the literature. Although reports of topical gabapentin delivery have been shown to vary, largely dependent upon the skin model used, this study demonstrated that 6% (w/w) gabapentin 0.75% (w/w) Carbopol® hydrogels containing 5% (w/w) DMSO or 70% (w/w) ethanol and a compounded 10% (w/w) gabapentin Lipoderm® formulation were able to facilitate permeation of the molecule across human skin. Further pre-clinical and clinical studies are required to investigate the topical delivery performance and pharmacodynamic actions of prospective formulations. PMID:28867811

  8. Prednisone raw material characterization and formulation development

    OpenAIRE

    Leonardo Henrique Toehwé; Livia Deris Prado; Helvécio Vinícius Antunes Rocha

    2018-01-01

    ABSTRACT Solid dosage forms for oral use, particularly tablets, are the most highly used dosage forms in therapy because they are easily administered, have high productivity and relatively low cost and provide a more stable drug to form a semi-solid net. Numerous parameters influence the quality of the final dosage form. In this study, the dissolution profile of 20-mg prednisone tablets bioequivalent to the reference product and three test formulations were evaluated using stability testing. ...

  9. Dermal miconazole nitrate nanocrystals - formulation development, increased antifungal efficacy & skin penetration.

    Science.gov (United States)

    Pyo, Sung Min; Hespeler, David; Keck, Cornelia M; Müller, Rainer H

    2017-10-05

    Miconazole nitrate nanosuspension was developed to increase its antifungal activity and dermal penetration. In addition, the nanosuspension was combined with the synergistic additive chlorhexidine digluconate. The production was performed by wet bead milling and both production and formulation parameters were optimized. A stabilizer screening revealed poloxamer 407 and Tween 80 both at 0.15% as the most effective stabilizers for miconazole nanosuspensions at 1.0%. The nanocrystals were incorporated into a hydroxypropyl cellulose gel base. Short-term stability (3months) of the nanocrystal bulk population could be shown at room temperature and fridge. Besides the stable bulk nanocrystals, some longitudinal crystal growth to needle like crystals occurred. The addition of ionic compounds as the chlorhexidine digluconate often destabilizes suspensions. Surprisingly here, the addition minimized the crystal growth. An underlying mechanism is proposed. An inhibition zone assay was performed using Candida albicans (ATCC ® 10231™). When comparing the nanocrystals in suspension and in gel to μm-sized miconazole nitrate formulations and two market products, the increase in inhibition zone diameter for the nanosuspension formulations was most pronounced in the chlorhexidine digluconate free formulations. These nanocrystal formulations were closely or similarly effective as the microsuspensions and the market products containing the synergistic chlorhexidine digluconate, showing the potential of the nanosuspension formulation. Nanosuspension performance was even further increased when chlorhexidine digluconate was added. Ex-vivo skin penetration studies on porcine ears revealed distinctly less remaining miconazole nitrate on the skin surface for nanocrystals (e.g., 76-86%) compared to market products (e.g. 94%). Also, penetration was increased e.g. in skin depth of 5-10μm from <1.0/1.7% to e.g. 3.3-6.2% for nanocrystals. Copyright © 2017 Elsevier B.V. All rights reserved.

  10. Development and validation of an HPLC method to quantify camptothecin in polymeric nanocapsule suspensions.

    Science.gov (United States)

    Granada, Andréa; Murakami, Fabio S; Sartori, Tatiane; Lemos-Senna, Elenara; Silva, Marcos A S

    2008-01-01

    A simple, rapid, and sensitive reversed-phase column high-performance liquid chromatographic method was developed and validated to quantify camptothecin (CPT) in polymeric nanocapsule suspensions. The chromatographic separation was performed on a Supelcosil LC-18 column (15 cm x 4.6 mm id, 5 microm) using a mobile phase consisting of methanol-10 mM KH2PO4 (60 + 40, v/v; pH 2.8) at a flow rate of 1.0 mL/min and ultraviolet detection at 254 nm. The calibration graph was linear from 0.5 to 3.0 microg/mL with a correlation coefficient of 0.9979, and the limit of quantitation was 0.35 microg/mL. The assay recovery ranged from 97.3 to 105.0%. The intraday and interday relative standard deviation values were entrapment efficiency and drug content in polymeric nanocapsule suspensions during the early stage of formulation development.

  11. Investigating high-concentration monoclonal antibody powder suspension in nonaqueous suspension vehicles for subcutaneous injection.

    Science.gov (United States)

    Bowen, Mayumi; Armstrong, Nick; Maa, Yuh-Fun

    2012-12-01

    Developing high-concentration monoclonal antibody (mAb) liquid formulations for subcutaneous (s.c.) administration is challenging because increased viscosity makes injection difficult. To overcome this obstacle, we investigated a nonaqueous powder suspension approach. Three IgG1 mAbs were spray dried and suspended at different concentrations in Miglyol® 840, benzyl benzoate, or ethyl lactate. Suspensions were characterized for viscosity, particle size, and syringeability; physical stability was visually inspected. Suspensions generally outperformed liquid solutions for injectability despite higher viscosity at the same mAb concentrations. Powder formulations and properties had little effect on viscosity or injectability. Ethyl lactate suspensions had lowest viscosity (Miglyol® 840 improved overall performance in high mAb concentration suspensions. This study demonstrated the viability of high mAb concentration (>300 mg/mL) in suspension formulations for s.c. administration. Copyright © 2012 Wiley Periodicals, Inc.

  12. Recent Developments in Suspension Plasma Sprayed Titanium Oxide and Hydroxyapatite Coatings

    Science.gov (United States)

    Jaworski, R.; Pawlowski, L.; Pierlot, C.; Roudet, F.; Kozerski, S.; Petit, F.

    2010-01-01

    The paper aims at reviewing of the recent studies related to the development of suspension plasma sprayed TiO2 and Ca5(PO4)3OH (hydroxyapatite, HA) coatings as well as their multilayer composites obtained onto stainless steel, titanium and aluminum substrates. The total thickness of the coatings was in the range 10 to 150 μm. The suspensions on the base of distilled water, ethanol and their mixtures were formulated with the use of fine commercial TiO2 pigment crystallized as rutile and HA milled from commercial spray-dried powder or synthesized from calcium nitrate and ammonium phosphate in an optimized reaction. The powder was crystallized as hydroxyapatite. Pneumatic and peristaltic pump liquid feeders were applied. The injection of suspension to the plasma jet was studied carefully with the use of an atomizer injector or a continuous stream one. The injectors were placed outside or inside of the anode-nozzle of the SG-100 plasma torch. The stream of liquid was tested under angle right or slightly backwards with regard to the torch axis. The sprayed deposits were submitted to the phase analysis by the use of x-ray diffraction. The content of anatase and rutile was calculated in the titanium oxide deposits as well as the content of the decomposition phases in the hydroxyapatite ones. The micro-Raman spectroscopy was used to visualize the area of appearance of some phases. Scratch test enabled to characterize the adhesion of the deposits, their microhardness and friction coefficient. The electric properties including electron emission, impedance spectroscopy, and dielectric properties of some coatings were equally tested.

  13. Prednisone raw material characterization and formulation development

    Directory of Open Access Journals (Sweden)

    Leonardo Henrique Toehwé

    2018-01-01

    Full Text Available ABSTRACT Solid dosage forms for oral use, particularly tablets, are the most highly used dosage forms in therapy because they are easily administered, have high productivity and relatively low cost and provide a more stable drug to form a semi-solid net. Numerous parameters influence the quality of the final dosage form. In this study, the dissolution profile of 20-mg prednisone tablets bioequivalent to the reference product and three test formulations were evaluated using stability testing. During the study, prednisone tablets and the active pharmaceutical ingredient (API prednisone from two different manufacturers were characterized with respect to their physical and physicochemical properties. The results showed that the dissolution profiles of the test batches and the reference product did not retain pharmaceutical equivalence throughout all the stability study. Notably, both samples of API prednisone were of the same crystal form, and any phase transition that occurred during the study could not be attributed to dissolution variation during stability.

  14. Eudragit nanoparticles containing genistein: formulation, development, and bioavailability assessment

    Directory of Open Access Journals (Sweden)

    Tang J

    2011-10-01

    Full Text Available Jingling Tang2, Na Xu1,2, Hongyu Ji1, Hongmei Liu1, Zhiyong Wang1, Linhua Wu1,2 1Department of Pharmacy, the Second Affiliated Hospital of Harbin Medical University, Key Laboratory of College in Heilongjiang Province; 2Department of Pharmaceutics, School of Pharmacy, Harbin Medical University, Harbin, China Background: Genistein, one of the major isoflavones, has received great attention as a phytoestrogen and potential cancer chemoprevention agent. However, the dissolution and bioavailability of genistein from solid oral preparations is low due to its poor water solubility. Methods: In order to improve the oral bioavailability of genistein, genistein nanoparticles were prepared by the nanoprecipitation technique using Eudragit® E100 as carriers and an optimized formulation of mass ratio (genistein:Eudragit E100, 1:10. The mean particle size of genistein nanoparticles was approximately 120 nm when diluted 100 times with distilled water. The drug-loaded nanoparticles were spherical on observation by transmission electric microscopy. Results: Encapsulation efficiency and drug loading of the genistein nanoparticles were approximately 50.61% and 5.02%, respectively. Release of drug from the genistein nanoparticles was two times greater than that from the conventional capsules. After administration of genistein suspension or genistein nanoparticles at a single dose of 100 mg/kg to fasted rats, the relative bioavailability of genistein from the nanoparticles compared with the reference suspension was 241.8%. Conclusion: These results suggested that a nanoparticle system is a potentially promising formulation for the efficient delivery of poorly water-soluble drugs by oral administration. Keywords: bioavailability, dissolution, genistein, nanoparticles, nanoprecipitation technique

  15. Nano-formulations of drugs: Recent developments, impact and challenges.

    Science.gov (United States)

    Jeevanandam, Jaison; Chan, Yen San; Danquah, Michael K

    2016-01-01

    Nano-formulations of medicinal drugs have attracted the interest of many researchers for drug delivery applications. These nano-formulations enhance the properties of conventional drugs and are specific to the targeted delivery site. Dendrimers, polymeric nanoparticles, liposomes, nano-emulsions and micelles are some of the nano-formulations that are gaining prominence in pharmaceutical industry for enhanced drug formulation. Wide varieties of synthesis methods are available for the preparation of nano-formulations to deliver drugs in biological system. The choice of synthesis methods depend on the size and shape of particulate formulation, biochemical properties of drug, and the targeted site. This article discusses recent developments in nano-formulation and the progressive impact on pharmaceutical research and industries. Additionally, process challenges relating to consistent generation of nano-formulations for drug delivery are discussed. Copyright © 2016 Elsevier B.V. and Société Française de Biochimie et Biologie Moléculaire (SFBBM). All rights reserved.

  16. Preparation and evaluation of a timolol maleate drug-resin ophthalmic suspension as a sustained-release formulation in vitro and in vivo.

    Science.gov (United States)

    Qin, Fuhong; Zeng, Li; Zhu, Yongtao; Cao, Jingjing; Wang, Xiaohui; Liu, Wei

    2016-01-01

    The aim of this work was to assess the performance of resin as an ocular delivery system. Timolol maleate (TM) was chosen as the model drug and an ion exchange resin (IER) as the carrier. The drug-resin complex was prepared using an oscillation method and then characterized regarding particle size, zeta potential, morphology, and drug content. After in vitro drug release study and corneal permeation study were performed, in vivo studies were performed in New Zealand albino rabbits using a suspension with particles sized 4.8 ± 1.2 μm and drug loading at 43.00 ± 0.09%. The results indicate that drug released from the drug-resin ophthalmic suspension permeated the cornea and displayed a sustained-release behavior. Drug levels in the ocular tissues after administration of the drug-resin ophthalmic suspension were significantly higher than after treatment with an eye drop formulation but were lower in body tissues and in the plasma. In conclusion, resins have great potential as effective ocular drug delivery carriers to increase ocular bioavailability of timolol while simultaneously reducing systemic drug absorption.

  17. Dissolution Model Development: Formulation Effects and Filter Complications

    DEFF Research Database (Denmark)

    Berthelsen, Ragna; Holm, Rene; Jacobsen, Jette

    2016-01-01

    This study describes various complications related to sample preparation (filtration) during development of a dissolution method intended to discriminate among different fenofibrate immediate-release formulations. Several dissolution apparatus and sample preparation techniques were tested. The fl....... With the tested drug–formulation combination, the best in vivo–in vitro correlation was found after filtration of the dissolution samples through 0.45-μm hydrophobic PTFE membrane filters....

  18. Curcumin phytosomal softgel formulation: Development, optimization and physicochemical characterization.

    Science.gov (United States)

    Allam, Ahmed N; Komeil, Ibrahim A; Abdallah, Ossama Y

    2015-09-01

    Curcumin, a naturally occurring lipophilic molecule can exert multiple and diverse bioactivities. However, its limited aqueous solubility and extensive presystemic metabolism restrict its bioavailability. Curcumin phytosomes were prepared by a simple solvent evaporation method where free flowing powder was obtained in addition to a newly developed semisolid formulation to increase curcumin content in softgels. Phytosomal powder was characterized in terms of drug content and zeta potential. Thirteen different softgel formulations were developed using oils such as Miglyol 812, castor oil and oleic acid, a hydrophilic vehicle such as PEG 400 and bioactive surfactants such as Cremophor EL and KLS P 124. Selected formulations were characterized in terms of curcumin in vitro dissolution. TEM analysis revealed good stability and a spherical, self-closed structure of curcumin phytosomes in complex formulations. Stability studies of chosen formulations prepared using the hydrophilic vehicle revealed a stable curcumin dissolution pattern. In contrast, a dramatic decrease in curcumin dissolution was observed in case of phytosomes formulated in oily vehicles.

  19. Curcumin phytosomal softgel formulation: Development, optimization and physicochemical characterization

    Directory of Open Access Journals (Sweden)

    Allam Ahmed N.

    2015-09-01

    Full Text Available Curcumin, a naturally occurring lipophilic molecule can exert multiple and diverse bioactivities. However, its limited aqueous solubility and extensive presystemic metabolism restrict its bioavailability. Curcumin phytosomes were prepared by a simple solvent evaporation method where free flowing powder was obtained in addition to a newly developed semisolid formulation to increase curcumin content in softgels. Phytosomal powder was characterized in terms of drug content and zeta potential. Thirteen different softgel formulations were developed using oils such as Miglyol 812, castor oil and oleic acid, a hydrophilic vehicle such as PEG 400 and bioactive surfactants such as Cremophor EL and KLS P 124. Selected formulations were characterized in terms of curcumin in vitro dissolution. TEM analysis revealed good stability and a spherical, self-closed structure of curcumin phytosomes in complex formulations. Stability studies of chosen formulations prepared using the hydrophilic vehicle revealed a stable curcumin dissolution pattern. In contrast, a dramatic decrease in curcumin dissolution was observed in case of phytosomes formulated in oily vehicles.

  20. Do rice suspension-cultured cells treated with abscisic acid mimic developing seeds?

    Science.gov (United States)

    Matsuno, Koya; Fujimura, Tatsuhito

    2015-08-01

    Starch synthesis is activated in the endosperm during seed development and also in rice suspension cells cultured with abscisic acid. In the anticipation that the mechanisms of starch synthesis are similar between the endosperm and the suspension cells cultured with abscisic acid, expression of genes involved in starch synthesis was evaluated in the suspension cells after abscisic acid treatment. However, it was found that the regulatory mechanism of starch synthesis in the suspension cells cultured with abscisic acid was different from that in developing seeds. Expression analyses of genes involved in oil bodies, which accumulate in the embryo and aleurone layer, and seed storage proteins, which accumulate mainly in the endosperm, showed that the former were activated in the suspension cells cultured with abscisic acid, but the latter were not. Master regulators for embryogenesis, OsVP1 (homologue of AtABI3) and OsLFL1 (homologue of AtFUS3 or AtLFL2), were expressed in the suspension cells at levels comparable to those in the embryo. From these results, it is suggested that interactions between regulators and abscisic acid control the synthesis of phytic acid and oil bodies in the cultured cells and embryo. We suggest that the system of suspension cells cultured with abscisic acid helps to reveal the mechanisms of phytic acid and oil body synthesis in embryo.

  1. Formulation, development and evaluation of colon-specific ketorolac ...

    African Journals Online (AJOL)

    The major intention to formulate and develop colon targeted tablets is to improve the therapeutic efficacy by increasing therapeutic drug concentrations in colon. The present study was aimed to develop guar gum compression coated tablets ketorolac tromethamine to achieve the colon-specific drug release. In this study ...

  2. Development and evaluation of a novel microemulsion formulation of elacridar to improve its bioavailability

    Science.gov (United States)

    Sane, Ramola; Mittapalli, Rajendar K.; Elmquist, William F.

    2014-01-01

    The study objective was to develop a formulation of elacridar to overcome its dissolution-rate limited bioavailability. Elacridar is a P-gp and BCRP inhibitor that has been used to improve the brain distribution of drugs that are substrates of P-gp and BCRP. The chronic use of elacridar is restricted due to poor solubility leading to poor oral bioavailability. A microemulsion formulation using Cremophor EL, Carbitol and Captex 355 (6:3:1) was developed. The elacridar microemulsion was effective in the inhibition of P-gp and Bcrp in MDCKII-transfected cells. FVBn mice were used to determine the bioavailability of elacridar after a 10 mg/kg dose of elacridar in the microemulsion, intraperitoneally and orally; and the absolute bioavailability was determined to be 1.3 and 0.47, respectively. Co-administration of elacridar microemulsion intraperitoneally with oral erlotinib in FVBn mice improved the erlotinib brain penetration three-fold. The current study shows that a microemulsion formulation of elacridar is effective in improving the bioavailability of elacridar and is an effective inhibitor of P-gp and Bcrp; in-vitro and in-vivo. It offers an alternative to the suspension and allows a decrease in the dose required to achieve a significant inhibitory effect at the blood-brain barrier. PMID:23334925

  3. Improved oral bioavailability for lutein by nanocrystal technology: formulation development, in vitro and in vivo evaluation.

    Science.gov (United States)

    Chang, Daoxiao; Ma, Yanni; Cao, Guoyu; Wang, Jianhuan; Zhang, Xia; Feng, Jun; Wang, Wenping

    2018-08-01

    Lutein is a kind of natural carotenoids possessing many pharmacological effects. The application of lutein was limited mainly due to its low oral bioavailability caused by poor aqueous solubility. Nanocrystal formulation of lutein was developed to improve the oral bioavailability in this study. The nanosuspension was prepared by the anti-solvent precipitation-ultrasonication method and optimized by Box-Behnken design, followed by freeze-drying to obtain lutein nanocrystals. The nanocrystals were characterized on their physical properties, in vitro dissolution and in vivo absorption performance. Lutein nanocrystals showed as tiny spheres with an average particle size of 110.7 nm. The result of diffractograms indicated that the percent crystallinity of lutein was 89.4% in coarse powder and then declined in nanocrystal formulation. The saturated solubility of lutein in water increased from 7.3 μg/ml for coarse powder up to 215.7 μg/ml for lutein nanocrystals. The dissolution rate of lutein nanocrystals was significantly higher than that of coarse powder or the physical mixture. The C max and AUC 0-24 h of lutein nanocrystals after oral administration in rats was 3.24 and 2.28 times higher than those of lutein suspension, respectively. These results indicated that the nanocrystal formulation could significantly enhance the dissolution and absorption of lutein and might be a promising approach for improving its oral bioavailability.

  4. Formulation and development of colon-targeted mucopenetrating ...

    African Journals Online (AJOL)

    Purpose: To formulation and develop colon-targeted mucopenetrating metronidazole nanoparticles. Methods: Metronidazole-loaded chitosan nanoparticles with a pH-sensitive polymer, hydroxyl propyl methyl cellulose phthalate (HPMCP), were prepared by ionic gelation technique and then coated with Eudragit S100 by ...

  5. Dissolution stability studies of suspensions of prolonged-release diclofenac microcapsules prepared by the Wurster process: I. Eudragit-based formulation and possible drug-excipient interaction.

    Science.gov (United States)

    Adeyeye, M C; Mwangi, E; Katondo, B; Jain, A; Ichikawa, H; Fukumori, Y

    2005-06-01

    The aim was to evaluate possible interaction in solid and liquid state of the drug with formulation excipients consequent to very fast drug release of diclofenac-Eudragit prolonged release microcapsules. The microcapsules were prepared by drug layering on calcium carbonate cores and coated with Eudragit RS 30D and L30D-55 as previously reported. Suspension of the microcapsules was prepared using microcrystalline cellulose/sodium carboxymethyl cellulose (Avicel CL-611) as medium. In vitro dissolution testing of the suspension was done, and, based on the dissolution results, possible interaction between diclofenac and Eudragit and Avicel in the medium was studied. Powder X-ray diffraction (PXRD) and differential scanning calorimetry (DSC) analyses were performed using 1:1 binary, 1:1:1 ternary mixtures and a ratio equivalent to that in the formulation. The mixtures were prepared by mixing the dispersions--Eudragit RS 30D or L30D-55 with the drug or other components, followed by drying at 60 degrees C for 48 h. Dry mixing was done using the powder equivalents of the polymers, Eudragit RS PO and L100-55, Avicel and calcium carbonate. In vitro dissolution of the suspended microcapsules showed a very fast release after 48 h (T50 = microcapsules (T50 = 6 h). DSC curves of the formulation components or microcapsules did not show the characteristic endothermic peak of diclofenac at 287 degrees C. Powder X-ray diffraction of the binary or ternary mixtures of diclofenac and Eudragit polymers indicated reduction, shift or modification of the crystalline peaks of the drug or excipients at 2theta of 12 degrees and 18 degrees , suggestive of interaction. Some changes in drug peak characteristics at 18 degrees and 23 degrees were observed for Avicel/drug mixture, though not significant. The DSC curves of the binary mixture of diclofenac co-dried with liquid forms of Eudragit (i.e. RS 30D or L30D-55) revealed greater interaction compared to the curves of drug and powdered forms of

  6. Development of a Fabrication Process Using Suspension Plasma Spray for Titanium Oxide Photovoltaic Device

    Directory of Open Access Journals (Sweden)

    Hsian Sagr Hadi A

    2017-03-01

    Full Text Available In order to reduce the high costs of conventional materials, and to reduce the power necessary for the deposition of titanium dioxide, titanium tetrabutoxide has been developed in the form of a suspension of TiO2 using water instead of expensive ethanol. To avoid sedimentation of hydroxide particles in the suspension, mechanical milling of the suspension was conducted in order to create diffusion in colloidal suspension before using it as feedstock. Consequently, through the creation of a colloidal suspension, coating deposition was able to be conducted without sedimentation of the hydroxide particles in the suspension during the deposition process. Though an amorphous as-deposited coating was able to be deposited, through post heat treatment at 630 °C for 60 min, the chemical structure became anatase rich. In addition, it was confirmed that the post heat treated anatase rich coating had enough photo-catalytic activity to decolor methylene-blue droplets. From these results, this technique was found to have high potential in the low cost photo-catalytic titanium coating production process.

  7. Preformulation and formulation development of a bioactive nitroaromatic compound

    Science.gov (United States)

    Sena, Camila F. A.; Apolinário, Lívia S.; Duarte, Jaqueline A.; dos Santos, Giovanna C.; Monteiro, Liziane O. F.; de Oliveira, Mônica C.; Leite, Elaine A.; de Oliveira, Renata B.

    2017-11-01

    The N-(butanoyloxyethyl)-4-(chloromethyl)-3-nitrobenzamide (BNB) is a nitroaromatic derivative with significant antitumor activity. Preformulation, forced degradation (distilled water, acid and base hydrolysis, oxidation, and light), and formulation studies were performed to investigate the chemical behavior of the molecule, the physicochemical properties, and the impact of formulation variables. Pharmacokinetic properties for BNB were estimated in silico. Solid lipid nanoparticles (SLN) and nanostructured lipid carriers (NLC) containing BNB were developed by a hot melt homogenization method for parenteral administration. Degradation studies demonstrated that this compound is sensitive to hydrolysis. BNB was predicted to have a favorable absorption, distribution, metabolism, and excretion profile. The nanocarriers developed were characterized for particle size (PS = 61 to 85 nm), polydispersity index (PI moderate cytotoxicity against breast cancer cell line. Blank formulations did not induce cytotoxicity and BNB-loaded SLN was able to potentiate the action of BNB (lC50 12.4 μM). BNB is a promising antitumor agent and it is possible to modulate its activity based on the particle size of the formulation.

  8. Otic drug delivery systems: formulation principles and recent developments.

    Science.gov (United States)

    Liu, Xu; Li, Mingshuang; Smyth, Hugh; Zhang, Feng

    2018-04-25

    Disorders of the ear severely impact the quality of life of millions of people, but the treatment of these disorders is an ongoing, but often overlooked challenge particularly in terms of formulation design and product development. The prevalence of ear disorders has spurred significant efforts to develop new therapeutic agents, but perhaps less innovation has been applied to new drug delivery systems to improve the efficacy of ear disease treatments. This review provides a brief overview of physiology, major diseases, and current therapies used via the otic route of administration. The primary focuses are on the various administration routes and their formulation principles. The article also presents recent advances in otic drug deliveries as well as potential limitations. Otic drug delivery technology will likely evolve in the next decade and more efficient or specific treatments for ear disease will arise from the development of less invasive drug delivery methods, safe and highly controlled drug delivery systems, and biotechnology targeting therapies.

  9. Development and Application of Binary Suspensions in the Ternary System Cr2O3-TiO2-Al2O3 for S-HVOF Spraying

    Science.gov (United States)

    Potthoff, Annegret; Kratzsch, Robert; Barbosa, Maria; Kulissa, Nick; Kunze, Oliver; Toma, Filofteia-Laura

    2018-04-01

    Compositions in the system Cr2O3-TiO2-Al2O3 are among the most used ceramic materials for thermally sprayed coating solutions. Cr2O3 coatings present good sliding wear resistance; Al2O3 coatings show excellent insulation behavior and TiO2 striking corrosion properties. In order to combine these properties, coatings containing more than one oxide are highly interesting. The conventional spraying process is limited to the availability of binary feedstock powders with defined compositions. The use of suspensions offers the opportunity for tailor-made chemical compositions: within the triangle of Cr2O3-TiO2-Al2O3, each mixture of oxides can be created. Criteria for the selection of raw materials as well as the relevant aspects for the development of binary suspensions in the Cr2O3-TiO2-Al2O3 system to be used as feedstock for thermal spraying are presented. This formulation of binary suspensions required the development of water-based single-oxide suspensions with suitable behavior; otherwise, the interaction between the particles while mixing could lead up to a formation of agglomerates, which affect both the stability of the spray process and the coating properties. For the validation of this formulation procedure, binary Cr2O3-TiO2 and Al2O3-TiO2 suspensions were developed and sprayed using the S-HVOF process. The binary coatings were characterized and discussed in terms of microstructure and microhardness.

  10. Development and Application of Binary Suspensions in the Ternary System Cr2O3-TiO2-Al2O3 for S-HVOF Spraying

    Science.gov (United States)

    Potthoff, Annegret; Kratzsch, Robert; Barbosa, Maria; Kulissa, Nick; Kunze, Oliver; Toma, Filofteia-Laura

    2018-03-01

    Compositions in the system Cr2O3-TiO2-Al2O3 are among the most used ceramic materials for thermally sprayed coating solutions. Cr2O3 coatings present good sliding wear resistance; Al2O3 coatings show excellent insulation behavior and TiO2 striking corrosion properties. In order to combine these properties, coatings containing more than one oxide are highly interesting. The conventional spraying process is limited to the availability of binary feedstock powders with defined compositions. The use of suspensions offers the opportunity for tailor-made chemical compositions: within the triangle of Cr2O3-TiO2-Al2O3, each mixture of oxides can be created. Criteria for the selection of raw materials as well as the relevant aspects for the development of binary suspensions in the Cr2O3-TiO2-Al2O3 system to be used as feedstock for thermal spraying are presented. This formulation of binary suspensions required the development of water-based single-oxide suspensions with suitable behavior; otherwise, the interaction between the particles while mixing could lead up to a formation of agglomerates, which affect both the stability of the spray process and the coating properties. For the validation of this formulation procedure, binary Cr2O3-TiO2 and Al2O3-TiO2 suspensions were developed and sprayed using the S-HVOF process. The binary coatings were characterized and discussed in terms of microstructure and microhardness.

  11. Development of a simulation model of semi-active suspension for monorail

    Science.gov (United States)

    Hasnan, K.; Didane, D. H.; Kamarudin, M. A.; Bakhsh, Qadir; Abdulmalik, R. E.

    2016-11-01

    The new Kuala Lumpur Monorail Fleet Expansion Project (KLMFEP) uses semiactive technology in its suspension system. It is recognized that the suspension system influences the ride quality. Thus, among the way to further improve the ride quality is by fine- tuning the semi-active suspension system on the new KL Monorail. The semi-active suspension for the monorail specifically in terms of improving ride quality could be exploited further. Hence a simulation model which will act as a platform to test the design of a complete suspension system particularly to investigate the ride comfort performance is required. MSC Adams software was considered as the tool to develop the simulation platform, where all parameters and data are represented by mathematical equations; whereas the new KL Monorail being the reference model. In the simulation, the model went through step disturbance on the guideway for stability and ride comfort analysis. The model has shown positive results where the monorail is in stable condition as an outcome from stability analysis. The model also scores a Rating 1 classification in ISO 2631 Ride Comfort performance which is very comfortable as an overall outcome from ride comfort analysis. The model is also adjustable, flexibile and understandable by the engineers within the field for the purpose of further development.

  12. Development of Oral Flexible Tablet (OFT) Formulation for Pediatric and Geriatric Patients: a Novel Age-Appropriate Formulation Platform.

    Science.gov (United States)

    Chandrasekaran, Prabagaran; Kandasamy, Ruckmani

    2017-08-01

    Development of palatable formulations for pediatric and geriatric patients involves various challenges. However, an innovative development with beneficial characteristics of marketed formulations in a single formulation platform was attempted. The goal of this research was to develop solid oral flexible tablets (OFTs) as a platform for pediatrics and geriatrics as oral delivery is the most convenient and widely used mode of drug administration. For this purpose, a flexible tablet formulation using cetirizine hydrochloride as model stability labile class 1 and 3 drug as per the Biopharmaceutical Classification System was developed. Betadex, Eudragit E100, and polacrilex resin were evaluated as taste masking agents. Development work focused on excipient selection, formulation processing, characterization methods, stability, and palatability testing. Formulation with a cetirizine-to-polacrilex ratio of 1:2 to 1:3 showed robust physical strength with friability of 0.1% (w/w), rapid in vitro dispersion within 30 s in 2-6 ml of water, and 0.2% of total organic and elemental impurities. Polacrilex resin formulation shows immediate drug release within 30 min in gastric media, better taste masking, and acceptable stability. Hence, it is concluded that ion exchange resins can be appropriately used to develop taste-masked, rapidly dispersible, and stable tablet formulations with tailored drug release suitable for pediatrics and geriatrics. Flexible formulations can be consumed as swallowable, orally disintegrating, chewable, and as dispersible tablets. Flexibility in dose administration would improve compliance in pediatrics and geriatrics. This drug development approach using ion exchange resins can be a platform for formulating solid oral flexible drug products with low to medium doses.

  13. 78 FR 32696 - China Properties Developments, Inc.; Order of Suspension of Trading

    Science.gov (United States)

    2013-05-31

    ... SECURITIES AND EXCHANGE COMMISSION [File No. 500-1] China Properties Developments, Inc.; Order of Suspension of Trading May 29, 2013. It appears to the Securities and Exchange Commission that there is a lack of current and accurate information concerning the securities of China Properties Developments, Inc...

  14. Skin decontamination cream for radiological contaminants: Formulation development and evaluation.

    Science.gov (United States)

    Khan, Abdul Wadood; Kotta, Sabna; Rana, Sudha; Ansari, Shahid Husain; Sharma, Rakesh Kumar; Ali, Javed

    2013-01-01

    Increased use of the radioactive materials in the field of research, medical, nuclear power plant, and industry has increased the risk of accidental exposure. Intentional use of the radioisotopes by terrorist organizations could cause exposure/contamination of a number of the population. In view of the accidental contamination, there is a need to develop self-usable decontamination formulations that could be used immediately after contamination is suspected. Present work was planned to optimize and develop self-usable radiation decontamination cream formulation. Various pharmaceutical parameters were characterized. (99m)Tc-sodium pertechnetate was used as radiocontaminant. Static counts were recorded before and after decontamination using single photon emission computed tomography. Decontamination efficacy of the cream was found to be 42% ± 3% at 0-0.5 h after the exposure. Primary skin irritancy test was satisfactory as no erythema or edema was observed visually after 2 weeks of the formulation application. The decontamination studies proved the potential of EDTA to remove the radiological contaminants effectively.

  15. Development of a scalable suspension culture for cardiac differentiation from human pluripotent stem cells

    Directory of Open Access Journals (Sweden)

    Vincent C. Chen

    2015-09-01

    Full Text Available To meet the need of a large quantity of hPSC-derived cardiomyocytes (CM for pre-clinical and clinical studies, a robust and scalable differentiation system for CM production is essential. With a human pluripotent stem cells (hPSC aggregate suspension culture system we established previously, we developed a matrix-free, scalable, and GMP-compliant process for directing hPSC differentiation to CM in suspension culture by modulating Wnt pathways with small molecules. By optimizing critical process parameters including: cell aggregate size, small molecule concentrations, induction timing, and agitation rate, we were able to consistently differentiate hPSCs to >90% CM purity with an average yield of 1.5 to 2 × 109 CM/L at scales up to 1 L spinner flasks. CM generated from the suspension culture displayed typical genetic, morphological, and electrophysiological cardiac cell characteristics. This suspension culture system allows seamless transition from hPSC expansion to CM differentiation in a continuous suspension culture. It not only provides a cost and labor effective scalable process for large scale CM production, but also provides a bioreactor prototype for automation of cell manufacturing, which will accelerate the advance of hPSC research towards therapeutic applications.

  16. Vigostsky's formulations on ZDP - Zone of Proximal Development

    Directory of Open Access Journals (Sweden)

    José Moysés Alves

    2005-06-01

    Full Text Available The zone of proximal development (ZPD is, probably, the most known concept from Vygotsky's theory. And has been much discussed recently. Hoping to contribute for the understanding of this contemporary debate, we focus on recurrent themes in Vygotsky's writings. We read ten texts of his where he constructed the concept of ZPD. We have through the reading summarized his formulations about the following topics: criticism to the traditional diagnostic; explicit definitions of ZPD's concept; redefinition of imitation's concept; ZPD and pretend play; ZPD and the interaction between development and learning; ZPD and the interaction among daily and scientific concepts; practical value and theoretical value of ZPD's concept

  17. DEVELOPMENT OF A CAST STONE FORMULATION FOR HANFORD TANK WASTES

    International Nuclear Information System (INIS)

    COOKE; ATTERIDGE; AVILA

    2005-01-01

    The U.S. Department of Energy (DOE) Hanford Site, the location of plutonium production for the US. nuclear weapons program, is the focal point of a broad range of waste remediation efforts. This presentation will describe a test program to develop a ''cast stoney'' formulation for the stabilization of certain Hanford tank wastes (Lockrem 2005). The program consisted of (1) a short series of tests with nonradioactive simulant to select preferred dry reagent formulations (DRF) and determine allowable liquid addition levels, (2) waste form performance testing on cast stone made from the DRF formulations using low-activity waste (LAW) simulant, (3) waste form performance testing on cast stone made from the preferred DRF using LAW, (4) waste form validation testing on a selected nominal cast stone formulation using the preferred DRF and LAW simulant, and (5) technetium ''getter'' testing with cast stone made with LAW simulant and with LAW. In addition, nitrate leaching observations were drawn from nitrate leachability data obtained in the course of waste form performance testing. The nitrate leachability index results are presented along with data on other performance criteria The results of this study led to the selection of a specific DRF. The key attributes of the DRF/waste loading combination considered were presence of ''bleed'' (or free) water, volume change on curing, compressive strength, maximum curing temperature, toxicity characteristic leaching testing, ANSYANS-16.1 (Measurement of the Leachability of Solidified Low-Level Radioactive Wastes by a Short-Term Test Procedure) leachability, and hydraulic conductivity. Important considerations included that the monoliths could be produced using readily available, low-cost reagents. The key results from each of these testing and evaluation activity categories will be summarized

  18. Pharmacogenomics and its potential impact on drug and formulation development.

    Science.gov (United States)

    Regnstrom, Karin; Burgess, Diane J

    2005-01-01

    Recent advances in genomic research have provided the basis for new insights into the importance of genetic and genomic markers during the different stages of drug development. A new field of research, pharmacogenomics, which studies the relationship between drug effects and the genome, has emerged. Structural pharmacogenomics maps the complete DNA sequences of whole genomes (genotypes) including individual variations, and functional pharmacogenomics assesses the expression levels of thousands of genes in one single experiment. Together, these two areas of pharmacogenomics have generated massive databases, which have become a challenge for the research field of informatics and have fostered a new branch of research, bioinformatics. If skillfully used, the databases generated by pharmacogenomics together with data mining on the Web promise to improve the drug development process in a variety of areas: identification of drug targets, evaluation of toxicity, classification of diseases, evaluation of formulations, assessment of drug response and treatment, post-marketing applications, and development of personalized medicines.

  19. Triptans and migraine: advances in use, administration, formulation, and development.

    Science.gov (United States)

    Macone, Amanda E; Perloff, Michael D

    2017-03-01

    Recent triptan development has focused on new administration methods and formulations, triptan combination therapies, treatment in menstrually related migraines, and novel serotonin receptor subtype agonists (5HTf). Areas covered: Clinical triptan research related to migraine was reviewed, analyzing EMBASE and PUBMED data bases from 01/01/2011 to 06/29/2016, with a focus on clinical trials of class 1 or 2 level of evidence. There have been advances in drug combination therapies, as well as administration devices that aid in ease of use, increase efficacy, and decrease adverse reactions. Some new agents and devices have similar or less efficacy compared to previous generic triptan formulations. New agents have action at the 5HTf receptor subtype, and avoid vascular side effects of classic 5Ht1b/d agonists, however adverse reactions may limit their clinic use. Long half-life triptans, frovatriptan and naratriptan, do appear to have good benefit in menstral related migraine. Expert opinion: Recent advances in triptan development can offer some advantages to migraine therapy and patient preferences, but have a much higher cost compared to individual generic triptan agents. In the coming years, triptan advances with high efficacy, limiting ADRs and cost are welcomed, in this regard the 5HT1b/d triptans are already well established.

  20. Recent progress at NASA in LISA formulation and technology development

    International Nuclear Information System (INIS)

    Stebbins, R T

    2008-01-01

    Over the last year, the NASA half of the joint LISA project has focused its efforts on responding to a major review, and advancing the formulation and technology development of the mission. The NAS/NRC Beyond Einstein program assessment review will be described, including the outcome. The basis of the LISA science requirements has changed from detection determined by integrated signal-to-noise ratio to observation determined by uncertainty in the estimation of astrophysical source parameters. The NASA team has further defined the spacecraft bus design, participated in many design trade studies and advanced the requirements flow down and the associated current best estimates of performance. Recent progress in technology development is also summarized

  1. Etodolac Containing Topical Niosomal Gel: Formulation Development and Evaluation

    Directory of Open Access Journals (Sweden)

    Gyati Shilakari Asthana

    2016-01-01

    Full Text Available The present study aimed to investigate the delivery potential of Etodolac (ETD containing topical niosomal gel. Niosomal formulations were prepared by thin film hydration method at various ratios of cholesterol and Span 60 and were evaluated with respect to particle size, shape, entrapment efficiency, and in vitro characteristics. Dicetyl phosphate (DCP was also added in the niosomal formulation. Mean particle size of niosomal formulation was found to be in the range of 2 μm to 4 μm. Niosomal formulation N2 (1 : 1 ratio of cholesterol and surfactant displayed good entrapment efficiency (96.72%. TEM analyses showed that niosomal formulation was spherical in shape. Niosomal formulation (N2 displayed high percentage of drug release after 24 h (94.91 at (1 : 1 ratio of cholesterol : surfactant. Further selected niosomal formulation was used to formulate topical gel and was characterized with respect to its various parameters such as pH, viscosity, spreadability, ex vivo study, and in vivo potential permeation. Ex vivo study showed that niosomal gel possessed better skin permeation study than the plain topical gel. Further in vivo study revealed good inhibition of inflammation in case of topical niosomal gel than plain gel and niosomal formulation. The present study suggested that topical niosomal gel formulations provide sustained and prolonged delivery of drug.

  2. Development and validation of a dissolution method using HPLC for diclofenac potassium in oral suspension

    Directory of Open Access Journals (Sweden)

    Alexandre Machado Rubim

    2014-04-01

    Full Text Available The present study describes the development and validation of an in vitro dissolution method for evaluation to release diclofenac potassium in oral suspension. The dissolution test was developed and validated according to international guidelines. Parameters like linearity, specificity, precision and accuracy were evaluated, as well as the influence of rotation speed and surfactant concentration on the medium. After selecting the best conditions, the method was validated using apparatus 2 (paddle, 50-rpm rotation speed, 900 mL of water with 0.3% sodium lauryl sulfate (SLS as dissolution medium at 37.0 ± 0.5°C. Samples were analyzed using the HPLC-UV (PDA method. The results obtained were satisfactory for the parameters evaluated. The method developed may be useful in routine quality control for pharmaceutical industries that produce oral suspensions containing diclofenac potassium.

  3. Advances in Nanotechnology for Efficacious and Stable Formulation Development

    Science.gov (United States)

    Putcha, Lakshimi

    2012-01-01

    Current operational medical kits aboard the International Space Station (ISS) include an array of medications intended for the treatment of minor ambulatory care symptoms, first aid, and basic life support. All medications contained in the flight kits are commercially available off-the-shelf formulations used for treatment of illnesses on Earth. However, transport and stowage of supplies including medications for space missions are exposed to adverse environmental conditions and extended shelf-life demands. Proposed missions to Mars and near-Earth objects such as asteroid 1999 AO10 will present crew health risk that is different both quantitatively and qualitatively from those encountered on ISS missions. Few drug options are available at the present time for mitigation of crew health risk of planned space exploration missions. Alternatives to standard oral formulations that include sustained and targeted delivery technologies for preventive healthcare in space will be a welcome addition to the space formulary and may include controlled release topical, sub-cutaneous, intranasal and inhalation dosage forms. An example of such a technology development endeavor can be nanotechnology-based multi-stage drug cocktail and vaccine delivery systems. Nanostructures also have the ability to protect drugs encapsulated within them from physiologic degradation, target their delivery with sustained release and are suitable for per oral routes of administration. The use of nanostructures such as polymeric nanoparticles offers a non-invasive approach for penetrating the blood brain barrier. Finally, nanotechnology offers great potential for the development of safe and efficacious drug delivery systems for preventive health care in space and on Earth.

  4. Update on taxane development: new analogs and new formulations

    Directory of Open Access Journals (Sweden)

    Yared JA

    2012-12-01

    Full Text Available Jean A Yared, Katherine HR TkaczukUniversity of Maryland School of Medicine, Marlene and Stewart Greenebaum Cancer Center, Baltimore, MD, USAAbstract: The taxanes (paclitaxel and docetaxel represent an important class of antineoplastic agents that interfere with microtubule function leading to altered mitosis and cellular death. Paclitaxel (Taxol® was originally extracted from a yew tree (Taxus spp., Taxaceae a small slow-growing evergreen, coniferous tree. Due to the initial scarcity of paclitaxel, docetaxel (Taxotere® a semisynthetic analog of paclitaxel produced from the needles of European yew tree, Taxus baccata was developed. Docetaxel differs from paclitaxel in two positions in its chemical structure and this small alteration makes it more water soluble. Today, paclitaxel and docetaxel are widely prescribed antineoplastic agents for a broad range of malignancies including lung cancer, breast cancer, prostate cancer, Kaposi’s sarcoma, squamous cell carcinoma of the head and neck, gastric cancer, esophageal cancer, bladder cancer, and other carcinomas. Although very active clinically, paclitaxel and docetaxel have several clinical problems including poor drug solubility, serious dose-limiting toxicities such as myelosuppression, peripheral sensory neuropathy, allergic reactions, and eventual development of drug resistance. A number of these side effects have been associated with the solvents used for dilution of these antineoplastic agents: Cremophor EL for paclitaxel and polysorbate 80 for docetaxel. In addition, reports have linked these solvents to the alterations in paclitaxel and docetaxel pharmacokinetic profiles. In this review, we provide preclinical and clinical data on several novel taxanes formulations and analogs which are currently US Food and Drug Administration (FDA-approved or in clinical development in various solid tumor malignancies. Of the new taxanes nab-paclitaxel and cabazitaxel have enjoyed clinical success and

  5. Formulation and Development of Metered Dose Inhalations of Salbutamol in Solution Form

    Science.gov (United States)

    Khale, Anubha; Bajaj, Amrita

    2011-01-01

    In the present study attempts were made to prepare metered dose inhalation of salbutamol in solution form and compared it with the marketed metered dose inhalation in suspension form. Solution form of the drug was found better than marketed suspension formulation with respect to homogeneity and content uniformity. Propellant blend P-11 and P-12 in the proportion 30:70 was selected as it gave optimum vapour pressure. Surfactant oleic acid in concentration 10 mg per can was selected as it gave best results with clarity, spray pattern, vapour pressure, content per spray and rate of evaporation. Ethyl alcohol 2 ml per can was used as a cosolvent to give a clear solution, optimum vapour pressure, maximum content per spray and fair rate of evaporation. The selected formulation was subjected to the physico-chemical evaluation tests as per the standard pharmacopoeial procedures and the characteristics of the formulations were further compared with a conventional marketed formulation. In vitro study reveled the net respirable fraction was better than marketed preparation. PMID:22923867

  6. Development and evaluation of exemestane-loaded lyotropic liquid crystalline gel formulations

    OpenAIRE

    Musa, Muhammad Nuh; David, Sheba Rani; Zulkipli, Ihsan Nazurah; Mahadi, Abdul Hanif; Chakravarthi, Srikumar; Rajabalaya, Rajan

    2017-01-01

    Introduction: The use of liquid crystalline (LC) gel formulations for drug delivery has considerably improved the current delivery methods in terms of bioavailability and efficacy. The purpose of this study was to develop and evaluate LC gel formulations to deliver the anti-cancer drug exemestane through transdermal route. Methods: Two LC gel formulations were prepared by phase separation coacervation method using glyceryl monooleate (GMO), Tween 80 and Pluronic® F127 (F127). The formulations...

  7. Development and Evaluation of Herbal Formulations for Hair Growth

    Directory of Open Access Journals (Sweden)

    Lipi Purwal

    2008-01-01

    Full Text Available Hair formulation of Emblica officinalis (Euphorbiaceae, Bacopa, monnieri (Scrophulariaceae, Trigonella foenumgraecum (Leguminosae, Murraya koenigii (Rutaceae in various concentrations in the form of herbal oil were studied for their hair growth activity. Each drug was tested for their hair growth activity in a concentration range for 1-10% separately. Based on these results mixture of crude drugs Murraya koeniigi, leaf (Rutaceae, Bacopa monnieri, leaf (Scrophulariaceae, Trigonella foenumgraecum (Leguminosae, Murraya koenigii (Rutaceae were prepared in varying concentration in the form of herbal hair oil by three different oils preparation techniques and were tested for hair growth activity. The result revealed that the hair growth activity of each drug was found proportional to the concentration range tested. Similarly higher concentrations of drug in the formulation were found to have higher hair growth activities. But looking towards the formulation viscosity the maximum concentration of combined drug was found to be 30% at their maximum level. The formulation containing 7.5% of each drug used for the study and showed excellent hair growth activity with standard (2% minoxidil ethanolic solution by an enlargement of follicular size and prolongation of the anagen phase. It holds the promise of potent herbal alternative for minoxidil. Excellent results of hair growth were seen in formulation prepared by cloth pouch decoction method of oils preparation technique.

  8. Application of the aqueous coating suspension for the protection of Gas Turbine Engine parts from corrosion

    Directory of Open Access Journals (Sweden)

    E. G. Ivanov

    2015-01-01

    Full Text Available The article considers the physical nature of receiving diffusion coatings from aqueous suspensions of various alloys for various conditions and their further exploitation. Structure of coatings, advantages and features of the production of coatings from aqueous suspensions are shown. Based on the analysis of thermodynamic reactions in the systems of elements formulations of aqueous suspensions were developed and practical recommendations for their application to the parts of gas turbine engine were given.

  9. Salt formation improved the properties of a candidate drug during early formulation development.

    Science.gov (United States)

    Sigfridsson, Kalle; Ahlqvist, Matti; Lindsjö, Martin; Paulsson, Stefan

    2018-07-30

    The purpose of this study was to investigate if AZD5329, a dual neurokinin NK1/2 receptor antagonist, is a suitable candidate for further development as an oral immediate release (IR) solid dosage form as a final product. The neutral form of AZD5329 has only been isolated as amorphous material. In order to search for a solid material with improved physical and chemical stability and more suitable solid-state properties, a salt screen was performed. Crystalline material of a maleic acid salt and a fumaric acid salt of AZD5329 were obtained. X-ray powder diffractiometry, thermogravimetric analysis, differential scanning calorimetry and dynamic vapor sorption were used to investigate the physicochemical characteristics of the two salts. The fumarate salt of AZD5329 is anhydrous, the crystallization is reproducible and the hygroscopicity is acceptable. Early polymorphism assessment work using slurry technique did not reveal any better crystal modification or crystallinity for the fumarate salt. For the maleate salt, the form isolated originally was found to be a solvate, but an anhydrous form was found in later experiments; by suspension in water or acetone, by drying of the solvate to 100-120 °C or by subjecting the solvate form to conditions of 40 °C/75%RH for 3 months. The dissolution behavior and the chemical stability (in aqueous solutions, formulations and solid-state) of both salts were also studied and found to be satisfactory. The compound displays sensitivity to low pH, and the salt of the maleic acid, which is the stronger acid, shows more degradation during stability studies, in line with this observation. The presented data indicate that the substance fulfils basic requirements for further development of an IR dosage form, based on the characterization on crystalline salts of AZD5329. Copyright © 2018 Elsevier B.V. All rights reserved.

  10. Development of stable influenza vaccine powder formulations : Challenges and possibilities

    NARCIS (Netherlands)

    Amorij, J-P; Huckriede, A; Wilschut, J; Frijlink, H W; Hinrichs, W L J

    2008-01-01

    Influenza vaccination represents the cornerstone of influenza prevention. However, today all influenza vaccines are formulated as liquids that are unstable at ambient temperatures and have to be stored and distributed under refrigeration. In order to stabilize influenza vaccines, they can be brought

  11. Developments in the formulation and delivery of spray dried vaccines

    NARCIS (Netherlands)

    Kanojia, Gaurav; Have, Rimko Ten; Soema, Peter C; Frijlink, Henderik; Amorij, Jean-Pierre; Kersten, Gideon

    2017-01-01

    Spray drying is a promising method for the stabilization of vaccines, which are usually formulated as liquids. Usually, vaccine stability is improved by spray drying in the presence of a range of excipients. Unlike freeze drying, there is no freezing step involved, thus the damage related to this

  12. Development and evaluation of ibuprofen transdermal gel formulations

    African Journals Online (AJOL)

    A commercial ibuprofen gel product (Ibutop®) was used as a reference. Results: The formulations containing 5 % of either menthol or glycerol as permeation enhancers gave drug release patterns comparable to that of the reference product. Propanol increased the apparent viscosity of the test gels to the same extent as that ...

  13. Paediatric Drug Development and Formulation Design-a European Perspective

    NARCIS (Netherlands)

    Nales, D.A.; Kozarewicz, Piotr; Aylward, Brian; de Vries, Rutger; Egberts, Toine C G; Rademaker, Carin M A; Schobben, Alfred F A M

    The availability of licensed paediatric drugs is lagging behind those for adults, and there is a lack of safe formulations in suitable doses that children are able and willing to take. As a consequence, children are commonly treated with off-label or unlicensed drugs. As off-label and unlicensed

  14. Paediatric Drug Development and Formulation Design—a European Perspective

    NARCIS (Netherlands)

    van Riet-Nales, Diana A.; Kozarewicz, Piotr; Aylward, Brian; de Vries, Rutger; Egberts, Toine C G; Rademaker, Carin M A; Schobben, Alfred F A M

    The availability of licensed paediatric drugs is lagging behind those for adults, and there is a lack of safe formulations in suitable doses that children are able and willing to take. As a consequence, children are commonly treated with off-label or unlicensed drugs. As off-label and unlicensed

  15. Development of fi lm forming formulation and technology of polymeric fi lm coating on Indotril tablets

    Directory of Open Access Journals (Sweden)

    L. I. Kucherenko

    2013-09-01

    Full Text Available Introduction. In previous researches we grounded expedience of «Indotril» tablets development; formulation and technology of "Indotril" tablet cores were developed. Received tablet cores should be covered by protective polymeric film with the purpose of unpleasant taste elimination, increase of tablets expiration date. Objective. The aim of our investigation was to develop the film forming composition and technology of polymeric film coating on «Indotril» tablets in pseudo-fluidized layer. Materials and Methods. As “Indotril” tablets cores should be covered by protective polymeric film we performed research designed to select efficient film forming solution. Thus modern filming agents were studied, besides such factors were investigated: concentration of film forming suspension, increase of tablet coat in mass, air temperature under gas distribution grid. Obtained tablets were checked according to pharmacopeia methods. Results and discussion. First we studied tablet compression force influence on main parameters of «Indotril» cores tablets: on crushing strength, abrasion in pseudo-fluidized layer unit and disintegration. Then for further investigation we chose «Indotril» cores tablets with crushing strength near 70 H, abrasion - up to 0,5% and disintegration time - not more than 10 minutes. We performed research to select film forming solution for covering “Indotril” tablets in pseudo-fluidized layer unit. As filming agents we used different samples of hydroxypropyl methylcellulose (HPMC by Japan company Shin-Etsu Chemical Co and English company Colorcon. Water HPMC solutions were prepared which contained plasticizer (propylene glycol, pigment (titanium IV dioxide and dye (tartrazine. Coating process of “Indotril” tablets was performed in laboratory pseudo-fluidized layer unit with the air temperature 75ºC under gas distribution grid. Variance analysis of experimental data on quality of coat surface showed insignificance as

  16. Development and evaluation of suspension plasma sprayed yttria stabilized zirconia coatings as thermal barriers

    Science.gov (United States)

    van Every, Kent J.

    The insulating effects from thermal barrier coatings (TBCs) in gas turbine engines allow for increased operational efficiencies and longer service lifetimes. Consequently, improving TBCs can lead to enhanced gas turbine engine performance. This study was conducted to investigate if yttria-stabilized zirconia (YSZ) coatings, the standard industrial choice for TBCs, produced from nano-sized powder could provide better thermal insulation than current commericial YSZ coatings generated using micron-sized powders. The coatings for this research were made via the recently developed suspension plasma spraying (SPS) process. With SPS, powders are suspended in a solvent containing dispersing agents; the suspension is then injected directly into a plasma flow that evaporates the solvent and melts the powder while transporting it to the substrate. Although related to the industrial TBC production method of air plasma spraying (APS), SPS has two important differences---the ability to spray sub-micron diameter ceramic particles, and the ability to alloy the particles with chemicals dissolved in the solvent. These aspects of SPS were employed to generate a series of coatings from suspensions containing ˜100 nm diameter YSZ powder particles, some of which were alloyed with neodymium and ytterbium ions from the solvent. The SPS coatings contained columnar structures not observed in APS TBCs; thus, a theory was developed to explain the formation of these features. The thermal conductivity of the coatings was tested to evaluate the effects of these unique microstructures and the effects of the alloying process. The results for samples in the as-sprayed and heat-treated conditions were compared to conventional YSZ TBCs. This comparison showed that, relative to APS YSZ coatings, the unalloyed SPS samples typically exhibited higher as-sprayed and lower heat-treated thermal conductivities. All thermal conductivity values for the alloyed samples were lower than conventional YSZ TBCs

  17. Research on magnetorheological damper suspension with permanent magnet and magnetic valve based on developed FOA-optimal control algorithm

    Energy Technology Data Exchange (ETDEWEB)

    Xiao, Ping; Gao, Hong [Anhui Polytechnic University, Wuhu (China); Niu, Limin [Anhui University of Technology, Maanshan (China)

    2017-07-15

    Due to the fail safe problem, it was difficult for the existing Magnetorheological damper (MD) to be widely applied in automotive suspensions. Therefore, permanent magnets and magnetic valves were introduced to existing MDs so that fail safe problem could be solved by the magnets and damping force could be adjusted easily by the magnetic valve. Thus, a new Magnetorheological damper with permanent magnet and magnetic valve (MDPMMV) was developed and MDPMMV suspension was studied. First of all, mechanical structure of existing magnetorheological damper applied in automobile suspensions was redesigned, comprising a permanent magnet and a magnetic valve. In addition, prediction model of damping force was built based on electromagnetics theory and Bingham model. Experimental research was onducted on the newly designed damper and goodness of fit between experiment results and simulated ones by models was high. On this basis, a quarter suspension model was built. Then, fruit Fly optimization algorithm (FOA)-optimal control algorithm suitable for automobile suspension was designed based on developing normal FOA. Finally, simulation experiments and bench tests with input surface of pulse road and B road were carried out and the results indicated that working erformance of MDPMMV suspension based on FOA-optimal control algorithm was good.

  18. Glass Formulation Development for INEEL Sodium-Bearing Waste

    International Nuclear Information System (INIS)

    Vienna, J.D.; Schweiger, M.J.; Smith, D.E.; Smith, H.D.; Crum, J.V.; Peeler, D.K.; Reamer, I.A.; Musick, C.A.; Tillotson, R.D.

    1999-01-01

    For about four decades, radioactive wastes have been collected and calcined from nuclear fuels reprocessing at the Idaho Nuclear Technology and Engineering Center (INTEC), formerly Idaho Chemical Processing Plant (ICPP). Over this time span, secondary radioactive wastes have also been collected and stored as liquid from decontamination, laboratory activities, and fuel-storage activities. These liquid wastes are collectively called sodium-bearing wastes (SBW). About 5.7 million liters of these wastes are temporarily stored in stainless steel tanks at the Idaho National Engineering and Environmental Laboratory (INEEL). Vitrification is being considered as an immobilization step for SBW with a number of treatment and disposal options. A systematic study was undertaken to develop a glass composition to demonstrate direct vitrification of INEEL's SBW. The objectives of this study were to show the feasibility of SBW vitrification, not a development of an optimum formulation. The waste composition is relatively high in sodium, aluminum, and sulfur. A specific composition and glass property restrictions, discussed in Section 2, were used as a basis for the development. Calculations based on first-order expansions of selected glass properties in composition and some general tenets of glass chemistry led to an additive (fit) composition (68.69 mass % SiO 2 , 14.26 mass% B 2 O 3 , 11.31 mass% Fe 2 O 3 , 3.08 mass% TiO 2 , and 2.67 mass % Li 2 O) that meets all property restrictions when melted with 35 mass % of SBW on an oxide basis, The glass was prepared using oxides, carbonates, and boric acid and tested to confirm the acceptability of its properties. Glass was then made using waste simulant at three facilities, and limited testing was performed to test and optimize processing-related properties and confirm results of glass property testing. The measured glass properties are given in Section 4. The viscosity at 1150 C, 5 Pa·s, is nearly ideal for waste-glass processing in

  19. Developments in the formulation and delivery of spray dried vaccines.

    Science.gov (United States)

    Kanojia, Gaurav; Have, Rimko Ten; Soema, Peter C; Frijlink, Henderik; Amorij, Jean-Pierre; Kersten, Gideon

    2017-10-03

    Spray drying is a promising method for the stabilization of vaccines, which are usually formulated as liquids. Usually, vaccine stability is improved by spray drying in the presence of a range of excipients. Unlike freeze drying, there is no freezing step involved, thus the damage related to this step is avoided. The edge of spray drying resides in its ability for particles to be engineered to desired requirements, which can be used in various vaccine delivery methods and routes. Although several spray dried vaccines have shown encouraging preclinical results, the number of vaccines that have been tested in clinical trials is limited, indicating a relatively new area of vaccine stabilization and delivery. This article reviews the current status of spray dried vaccine formulations and delivery methods. In particular it discusses the impact of process stresses on vaccine integrity, the application of excipients in spray drying of vaccines, process and formulation optimization strategies based on Design of Experiment approaches as well as opportunities for future application of spray dried vaccine powders for vaccine delivery.

  20. Developments in the formulation and delivery of spray dried vaccines

    Science.gov (United States)

    Kanojia, Gaurav; Have, Rimko ten; Soema, Peter C.; Frijlink, Henderik; Amorij, Jean-Pierre; Kersten, Gideon

    2017-01-01

    ABSTRACT Spray drying is a promising method for the stabilization of vaccines, which are usually formulated as liquids. Usually, vaccine stability is improved by spray drying in the presence of a range of excipients. Unlike freeze drying, there is no freezing step involved, thus the damage related to this step is avoided. The edge of spray drying resides in its ability for particles to be engineered to desired requirements, which can be used in various vaccine delivery methods and routes. Although several spray dried vaccines have shown encouraging preclinical results, the number of vaccines that have been tested in clinical trials is limited, indicating a relatively new area of vaccine stabilization and delivery. This article reviews the current status of spray dried vaccine formulations and delivery methods. In particular it discusses the impact of process stresses on vaccine integrity, the application of excipients in spray drying of vaccines, process and formulation optimization strategies based on Design of Experiment approaches as well as opportunities for future application of spray dried vaccine powders for vaccine delivery. PMID:28925794

  1. Development of grout formulations for 106-AN waste: Mixture-experiment results and analysis

    International Nuclear Information System (INIS)

    Spence, R.D.; McDaniel, E.W.; Anderson, C.M.; Lokken, R.O.; Piepel, G.F.

    1993-09-01

    Twenty potential ingredients were identified for use in developing a 106-AN grout formulation, and 18 were subsequently obtained and tested. Four ingredients-Type II-LA (moderate heat of hydration) Portland cement, Class F fly ash, attapulgite 150 drilling clay, and ground air-cooled blast-furnace slag (GABFS) were selected for developing the 106-AN grout formulations. A mixture experiment was designed and conducted around the following formulation: 2.5 lb of cement per gallon, 1.2 lb of fly ash per gallon, 0.8 lb of attapulgite per gallon, and 3.5 lb of GABFS per gallon. Reduced empirical models were generated from the results of the mixture experiment. These models were used to recommend several grout formulations for 106-AN. Westinghouse Hanford Company selected one of these formulations to be verified for use with 106-AN and a backup formulation in case problems arise with the first choice

  2. Nanoparticles containing curcuminoids (Curcuma longa: development of topical delivery formulation

    Directory of Open Access Journals (Sweden)

    Cristina M. Zamarioli

    Full Text Available Solid lipid nanoparticles incorporating Curcuma longa L., Zingiberaceae, curcuminoids were produced by the hot melt emulsion method. A Box–Behnken factorial design was adopted to study the nanoparticles production at different levels of factors such as the percentage of curcuminoids, time of homogenization and surfactant ratio. The optimized nanoparticles were incorporated into hydrogels for stability, drug release and skin permeation tests. The average nanoparticle sizes were 210.4 nm; the zeta potential of −30.40 ± 4.16; the polydispersivity was 0.222 ± 0.125. The average encapsulation efficiency of curcumin and curcuminoids was 52.92 ± 5.41% and 48.39 ± 6.62%, respectively. Solid lipid nanocapsules were obtained with curcumin load varying from 14.2 to 33.6% and total curcuminoids load as high as 47.7%. The topical formulation containing SLN-Curcuminoids showed good spreadability and stability when subjected to mechanical stress test remained with characteristic color, showed no phase separation and no significant change in pH. As a result of slow release, the nanoparticles were able to avoid permeation or penetration in the pig ear epidermis/dermis during 18 h. The topical formulation is stable and can be used in further in vivo studies for the treatment of inflammatory reactions, in special for radiodermitis.

  3. Newly developed controlled release subcutaneous formulation for tramadol hydrochloride

    Directory of Open Access Journals (Sweden)

    Mostafa Mabrouk

    2018-05-01

    Full Text Available This study presents a drug delivery system of poly (Ɛ-caprolactone (PCL ribbons to optimize the pharmaceutical action of tramadol for the first time according to our knowledge. PCL ribbons were fabricated and loaded with tramadol HCl. Ribbons were prepared by slip casting technique and coated with dipping technique with β-cyclodextrin. The chemical integrity and surface morphology of the ribbons were confirmed using FTIR and SEM coupled with EDX. In addition, thermodynamic behavior of the fabricated ribbons was investigated using DSC/TGA. Tramadol loading into PCL ribbons, biodegradation of ribbons and tramadol release kinetics were studied in PBS.The results revealed that the formulated composition did not affect the chemical integrity of the drug. Furthermore, SEM/EDX confirmed the inclusion of tramadol into the PCL matrix in homogenous distribution pattern without any observation of porous structure. The particle size of loaded tramadol was found to be in the range of (2–4 nm. The formulated composition did not affect the chemical integrity of the drug and should be further investigated for bioavailability. Tramadol exhibited controlled release behavior from PCL ribbons up to 45 days governed mainly by diffusion mechanism. The fabricated ribbons have a great potentiality to be implemented in the long term subcutaneous delivery of tramadol. Keywords: Tramadol, Polycaprolcatone, Subcutaneous membrane, Ribbons, β-Cyclodextrin, Controlled release

  4. 75 FR 26822 - In the Matter of: Universal Property Development & Acquisition Corp.; Order of Suspension of Trading

    Science.gov (United States)

    2010-05-12

    ... Universal Property Development & Acquisition Corp. (``Universal Property'') because it has not filed any... SECURITIES AND EXCHANGE COMMISSION [File No. 500-1] In the Matter of: Universal Property Development & Acquisition Corp.; Order of Suspension of Trading May 10, 2010. It appears to the Securities and...

  5. Development of Matlab Simulink model for dynamics analysis of passive suspension system for lightweight vehicle

    Science.gov (United States)

    Jamali, M. S.; Ismail, K. A.; Taha, Z.; Aiman, M. F.

    2017-10-01

    In designing suitable isolators to reduce unwanted vibration in vehicles, the response from a mathematical model which characterizes the transmissibility ratio of the input and output of the vehicle is required. In this study, a Matlab Simulink model is developed to study the dynamic behaviour performance of passive suspension system for a lightweight electric vehicle. The Simulink model is based on the two degrees of freedom system quarter car model. The model is compared to the theoretical plots of the transmissibility ratios between the amplitudes of the displacements and accelerations of the sprung and unsprung masses to the amplitudes of the ground, against the frequencies at different damping values. It was found that the frequency responses obtained from the theoretical calculations and from the Simulink simulation is comparable to each other. Hence, the model may be extended to a full vehicle model.

  6. Development of a new formulation combining calcipotriol and betamethasone dipropionate in an ointment vehicle

    DEFF Research Database (Denmark)

    Simonsen, Lene; Høy, Gert; Didriksen, Erik

    2004-01-01

    was to develop a formulation which combines calcipotriol and betamethasone dipropionate in a single vehicle hereby achieving optimal delivery of both substances into the skin. As the two substances are incompatible in aqueous and alcoholic medias, different non-aqueous formulations were prepared. Skin permeation...

  7. Downstream Processing, Formulation Development and Antithrombotic Evaluation of Microbial Nattokinase.

    Science.gov (United States)

    Kapoor, Rohit; Harde, Harshad; Jain, Sanyog; Panda, Amulya Kumar; Panda, Bibhu Prasad

    2015-07-01

    The present research work describes the downstreaming of nattokinase (NK) produced by Bacillus subtilis under solid state fermentation; and the role of efficient oral formulation of purified NK in the management of thrombotic disorders. Molecular weight of purified NK was estimated to be 28 kDa with specific activity of 504.4 FU/mg. Acid stable nattokinase loaded chitosan nanoparticles (sNLCN) were fabricated for oral delivery of this enzyme. Box-Behnken design (BBD) was employed to investigate and validate the effect of process (independent) variables on the quality attributes (dependent variables) of nanoparticles. The integrity, conformational stability and preservation of fibrinolytic activity of NK (in both free and sNLCN forms) were established by SDS-PAGE, CD analysis and in vitro clot lytic examination, respectively. A 'tail thrombosis model' demonstrated significant decrease in frequency of thrombosis in Wistar rats upon peroral administration of sNLCN in comparison with negative control and free NK group. Furthermore, coagulation analysis, namely the measurement of prothrombin and activated partial thromboplastin time illustrated that sNLCN showed significantly (p < 0.001) higher anti-thrombotic potential in comparison to the free NK. Further, sNLCN showed anti-thrombotic profile similar to warfarin. This study signifies the potential of sNLCN in oral delivery of NK for the management of thrombotic disorders.

  8. Development and assessment of countermeasure formulations for treatment of lung injury induced by chlorine inhalation

    Energy Technology Data Exchange (ETDEWEB)

    Hoyle, Gary W., E-mail: Gary.Hoyle@louisville.edu [Department of Environmental and Occupational Health Sciences, School of Public Health and Information Sciences, University of Louisville, Louisville, KY (United States); Chen, Jing; Schlueter, Connie F.; Mo, Yiqun; Humphrey, David M. [Department of Environmental and Occupational Health Sciences, School of Public Health and Information Sciences, University of Louisville, Louisville, KY (United States); Rawson, Greg; Niño, Joe A.; Carson, Kenneth H. [Microencapsulation and Nanomaterials Department, Chemistry and Chemical Engineering Division, Southwest Research Institute, San Antonio, TX (United States)

    2016-05-01

    Chlorine is a commonly used, reactive compound to which humans can be exposed via accidental or intentional release resulting in acute lung injury. Formulations of rolipram (a phosphodiesterase inhibitor), triptolide (a natural plant product with anti-inflammatory properties), and budesonide (a corticosteroid), either neat or in conjunction with poly(lactic:glycolic acid) (PLGA), were developed for treatment of chlorine-induced acute lung injury by intramuscular injection. Formulations were produced by spray-drying, which generated generally spherical microparticles that were suitable for intramuscular injection. Multiple parameters were varied to produce formulations with a wide range of in vitro release kinetics. Testing of selected formulations in chlorine-exposed mice demonstrated efficacy against key aspects of acute lung injury. The results show the feasibility of developing microencapsulated formulations that could be used to treat chlorine-induced acute lung injury by intramuscular injection, which represents a preferred route of administration in a mass casualty situation. - Highlights: • Chlorine causes lung injury when inhaled and is considered a chemical threat agent. • Countermeasures for treatment of chlorine-induced acute lung injury are needed. • Formulations containing rolipram, triptolide, or budesonide were produced. • Formulations with a wide range of release properties were developed. • Countermeasure formulations inhibited chlorine-induced lung injury in mice.

  9. Pharmacokinetic comparison of different flubendazole formulations in pigs: A further contribution to its development as a macrofilaricide molecule

    Directory of Open Access Journals (Sweden)

    L. Ceballos

    2015-12-01

    Full Text Available Despite the well established ivermectin activity against microfilaria, the success of human filariasis control programmes requires the use of a macrofilaricide compound. Different in vivo trials suggest that flubendazole (FLBZ, an anthelmintic benzimidazole compound, is a highly efficacious and potent macrofilaricide. However, since serious injection site reactions were reported in humans after the subcutaneous FLBZ administration, the search for alternative pharmaceutical strategies to improve the systemic availability of FLBZ has acquired special relevance both in human and veterinary medicine. The goal of the current experimental work was to compare the pharmacokinetic plasma behavior of FLBZ, and its metabolites, formulated as either an aqueous hydroxypropyl- β -cyclodextrin-solution (HPBCD, an aqueous carboxymethyl cellulose-suspension (CMC or a Tween 80-based formulation, in pigs. Animals were allocated into three groups and treated (2 mg/kg with FLBZ formulated as either a HPBCD-solution (oral, CMC-suspension (oral or Tween 80-based formulation (subcutaneous. Only trace amounts of FLBZ parent drug and its reduced metabolite were measured after administration of the different FLBZ formulations in pigs. The hydrolyzed FLBZ (H-FLBZ metabolite was the main analyte recovered in the bloodstream in pigs treated with the three experimental FLBZ formulations. The oral administration of the HPBCD-solution accounted for significantly higher (P < 0.05 Cmax and AUC (23.1 ± 4.4 μg h/mL values for the main metabolite (H-FLBZ, compared with those observed for the oral CMC-suspension (AUC = 3.5 ± 1.0 μg h/mL and injectable Tween 80-based formulation (AUC: 7.5 ± 1.7 μg h/mL. The oral administration of the HPBCD-solution significantly improved the poor absorption pattern (indirectly assessed as the H-FLBZ plasma concentrations observed after the oral administration of the FLBZ-CMC suspension or the subcutaneous injection of the

  10. PNL vitrification technology development project glass formulation strategy for LLW vitrification

    International Nuclear Information System (INIS)

    Kim, D.; Hrma, P.R.; Westsik, J.H. Jr.

    1996-03-01

    This Glass Formulation Strategy describes development approaches to optimize glass compositions for Hanford's low-level waste vitrification between now and the projected low-level waste facility start-up in 2005. The objectives of the glass formulation task are to develop optimized glass compositions with satisfactory long-term durability, acceptable processing characteristics, adequate flexibility to handle waste variations, maximize waste loading to practical limits, and to develop methodology to respond to further waste variations

  11. Development of cosmetic formulations containing glucan polymer of Cassava (Manihot esculenta: stability and sensory analysis

    Directory of Open Access Journals (Sweden)

    Luisa M. Manço

    2014-12-01

    Full Text Available The aim of this study was the development, rheological behaviour determination, and sensory analysis of cosmetic formulations containing glucan biopolymer (Manihot esculenta, a tensor agent that was proposed to produce an immediate lifting and smoothing effect. For this purpose, formulations were developed and supplemented or not with 4 % of hydrolysed Manihot esculenta tuber extract and submitted to preliminary stability tests. These formulations were evaluated in terms of rheological behaviour over 90 days. Sensory analysis was carried out through a research with 20 cosmetic consumers who answered a questionnaire regarding their perception to the cosmetic qualities. The formulations presented pseudoplastic behavior and were considered stable in the physical stability studies, with the exception of the gel formulation based on Ammonium Acryloyldimethyltaurate/VP Copolymer. The formulations were well evaluated in the sensory parameters. The gel formulations based on Polyacrylamide, C13- 14 Isoparaffin, and Laureth-7 were stable and presented the best sensory profile in some evaluated parameters, such as spreadability, smoothness and skin moisturizing, and can be considered an appropriate vehicle for formulations containing hydrolysed Manihot esculenta tuber extract.

  12. Final Technical Progress Report: Development of Low-Cost Suspension Heliostat; December 7, 2011 - December 6, 2012

    Energy Technology Data Exchange (ETDEWEB)

    Bender, W.

    2013-01-01

    Final technical progress report of SunShot Incubator Solaflect Energy. The project succeeded in demonstrating that the Solaflect Suspension Heliostat design is viable for large-scale CSP installations. Canting accuracy is acceptable and is continually improving as Solaflect improves its understanding of this design. Cost reduction initiatives were successful, and there are still many opportunities for further development and further cost reduction.

  13. Preparation and evaluation of tilmicosin-loaded hydrogenated castor oil nanoparticle suspensions of different particle sizes.

    Science.gov (United States)

    Chen, Xiaojin; Wang, Ting; Lu, Mengmeng; Zhu, Luyan; Wang, Yan; Zhou, WenZhong

    2014-01-01

    Three tilmicosin-loaded hydrogenated castor oil nanoparticle (TMS-HCO-NP) suspensions of different particle sizes were prepared with different polyvinyl alcohol surfactant concentrations using a hot homogenization and ultrasonic technique. The in vitro release, in vitro antibacterial activity, mammalian cytotoxicity, acute toxicity in mice, and stability study were conducted to evaluate the characteristics of the suspensions. The in vitro tilmicosin release rate, antibacterial activity, mammalian cytotoxicity, acute toxicity in mice, and stability of the suspensions were evaluated. When prepared with polyvinyl alcohol concentrations of 0.2%, 1%, and 5%, the mean diameters of the nanoparticles in the three suspensions were 920±35 nm, 452±10 nm, and 151±4 nm, respectively. The three suspensions displayed biphasic release profiles similar to that of freeze-dried TMS-HCO-NP powders, with the exception of having a faster initial release. Moreover, suspensions of smaller-sized particles showed faster initial release, and lower minimum inhibitory concentrations and minimum bactericidal concentrations. Time-kill curves showed that within 12 hours, the suspension with the 151 nm particles had the most potent bactericidal activity, but later, the suspensions with larger-sized particles showed increased antibacterial activity. None of the three suspensions were cytotoxic at clinical dosage levels. At higher drug concentrations, all three suspensions showed similar concentration-dependent cytotoxicity. The suspension with the smallest-sized particle showed significantly more acute toxicity in mice, perhaps due to faster drug release. All three suspensions exhibited good stability at 4°C and at room temperature for at least 6 months. These results demonstrate that TMS-HCO-NP suspensions can be a promising formulation for tilmicosin, and that nanoparticle size can be an important consideration for formulation development.

  14. Economic Growth of a Rapidly Developing Economy: Theoretical Formulation

    Directory of Open Access Journals (Sweden)

    Oleg Sergeyevich Sukharev

    2016-06-01

    Full Text Available The subject matter of the article is the description of economic growth. Modern economy is characterized by a high rate of changes. These changes are the limiting parameters of modern development, which requires a modification of the basic models of growth, the substantiation of the expediency and necessity of a rapid development strategy. In a simple mathematical form, the statement of the problem of economic growth in the “green economy” is examined, in which the costs of environmental measures are not considered a priori as hampering economic development (as it is common for a number of modern neoclassical and neo-Keynesian growth models. The methodological basis of the article are the econometric approach and modelling method. The article has a theoretical character. The main hypothesis supposes that the rapid development strategy cannot make an adequate development strategy under certain conditions, but may be acceptable in other its specific conditions. In this sense, the important growth conditions are the availability of resources, the effectiveness of institutions and the current economic structure, the technological effectiveness of economy, as well as the conditions of technological development (“green economy” and the path of such development. In the article, on the theoretical level of analysis, the substantiation of the adequacy of the rapid development strategy for an economic system is given, whose goal is to achieve the standard of living of the countryleader. Based on the assumptions introduced, the period for which the rapid development strategy might be implemented and the economic lag of the country might be reduced from the country-leader is determined. The conditions that ensure the impact of innovations on the rate of economic development are summarized. The introduced range of dependencies and relations can be useful for the elaboration of the theory of innovation development and for the formation of a new

  15. TRX Suspension Training: A New Functional Training Approach for Older Adults - Development, Training Control and Feasibility.

    Science.gov (United States)

    Gaedtke, Angus; Morat, Tobias

    Because of its proximity to daily activities functional training becomes more important for older adults. Sling training, a form of functional training, was primarily developed for therapy and rehabilitation. Due to its effects (core muscle activation, strength and balance improvements), sling training may be relevant for older adults. However, to our knowledge no recent sling training program for healthy older adults included a detailed training control which is indeed an essential component in designing and implementing this type of training to reach positive effects. The purpose of this study was to develop a TRX Suspension Training for healthy older adults (TRX-OldAge) and to evaluate its feasibility. Eleven participants finished the 12 week intervention study. All participants trained in the TRX-OldAge whole-body workout which consists of seven exercises including 3-4 progressively advancing stages of difficulty for every exercise. At each stage, intensity could be increased through changes in position. Feasibility data was evaluated in terms of training compliance and a self-developed questionnaire for rating TRX-OldAge. The training compliance was 85 %. After study period, 91 % of the participants were motivated to continue with the program. The training intensity, duration and frequency were rated as optimal. All participants noted positive effects whereas strength gains were the most. On the basis of the detailed information about training control, TRX-OldAge can be individually adapted for each older adult appropriate to its precondition, demands and preference.

  16. Development ethics - Why? What? How? A formulation of the field

    NARCIS (Netherlands)

    D.R. Gasper (Des)

    2012-01-01

    textabstractThe paper assesses the rationale, contributions, structure, and challenges of the field of development ethics. Processes of social and economic transformation involve great risks and costs and great opportunities for gain, but the benefits, costs, and risks are typically hugely unevenly

  17. Development of a non-piston MR suspension rod for variable mass systems

    Science.gov (United States)

    Deng, Huaxia; Han, Guanghui; Zhang, Jin; Wang, Mingxian; Ma, Mengchao; Zhong, Xiang; Yu, Liandong

    2018-06-01

    The semi-active suspension systems for variable mass systems require long work stroke and variable damping, while the currently piston structure limits the work stroke for the magnetorheological (MR) dampers. The main work of this paper is to design a semi-active non-piston MR (NPMR) suspension rod for the reduction of the vibration of an automatic impeller washing machine, which is a typical variable mass system. The designed suspension rod locates in the suspension system that links the internal tub to the washing machine cabinet. The NPMR suspension rod includes a MR part and a air part. The MR part can provide low initial damping force and the unlimited work stroke compared with the piston MR damper. The hysteretic response tests and vibration performance evaluation with different loadings are conducted to verify the dynamic performance for the designed rod. The measured damping force of the MR part varies from 5 to 20 N. Studies of dehydration mode experiments of the washing machine indicate that its vibration acceleration with the NPMR suspension rods can reduce to half of the original passive ones in certain conditions.

  18. Need for appropriate formulations for children: the national institute of child health and human development-pediatric formulations initiative, part 1.

    Science.gov (United States)

    Giacoia, George P; Taylor-Zapata, Perdita; Mattison, Donald

    2007-01-01

    The development and compounding of pharmacotherapeutic formulations that are suitable for infants and young children can be a challenging problem. This problem results from the lack of knowledge on the acceptability of different dosage forms and formulations in children in relation to age and developmental status, as well as the lack of reliable documentation of formulations used in pediatric clinical trials. As part of its mandate under the Best Pharmaceuticals for Children Act to improve pediatric therapeutics, the National Institute of Child Health and Human Development has sponsored the Pediatric Formulation Initiative. The goal of this ongoing initiative is to address the issues and concnerns associated with pediatric therapeutics by convening groups of researchers and experts in pediatric formulations from academia, pharmaceutical companies, the National Institutes of Health, and the U.S. Food and Drug Administration.

  19. Linear programming: an alternative approach for developing formulations for emergency food products.

    Science.gov (United States)

    Sheibani, Ershad; Dabbagh Moghaddam, Arasb; Sharifan, Anousheh; Afshari, Zahra

    2018-03-01

    To minimize the mortality rates of individuals affected by disasters, providing high-quality food relief during the initial stages of an emergency is crucial. The goal of this study was to develop a formulation for a high-energy, nutrient-dense prototype using linear programming (LP) model as a novel method for developing formulations for food products. The model consisted of the objective function and the decision variables, which were the formulation costs and weights of the selected commodities, respectively. The LP constraints were the Institute of Medicine and the World Health Organization specifications of the content of nutrients in the product. Other constraints related to the product's sensory properties were also introduced to the model. Nonlinear constraints for energy ratios of nutrients were linearized to allow their use in the LP. Three focus group studies were conducted to evaluate the palatability and other aspects of the optimized formulation. New constraints were introduced to the LP model based on the focus group evaluations to improve the formulation. LP is an appropriate tool for designing formulations of food products to meet a set of nutritional requirements. This method is an excellent alternative to the traditional 'trial and error' method in designing formulations. © 2017 Society of Chemical Industry. © 2017 Society of Chemical Industry.

  20. Characterization, thermal stability studies, and analytical method development of Paromomycin for formulation development.

    Science.gov (United States)

    Khan, Wahid; Kumar, Neeraj

    2011-06-01

    Paromomycin (PM) is an aminoglycoside antibiotic, first isolated in the 1950s, and approved in 2006 for treatment of visceral leishmaniasis. Although isolated six decades back, sufficient information essential for development of pharmaceutical formulation is not available for PM. The purpose of this paper was to determine thermal stability and development of new analytical method for formulation development of PM. PM was characterized by thermoanalytical (DSC, TGA, and HSM) and by spectroscopic (FTIR) techniques and these techniques were used to establish thermal stability of PM after heating PM at 100, 110, 120, and 130 °C for 24 h. Biological activity of these heated samples was also determined by microbiological assay. Subsequently, a simple, rapid and sensitive RP-HPLC method for quantitative determination of PM was developed using pre-column derivatization with 9-fluorenylmethyl chloroformate. The developed method was applied to estimate PM quantitatively in two parenteral dosage forms. PM was successfully characterized by various stated techniques. These techniques indicated stability of PM for heating up to 120 °C for 24 h, but when heated at 130 °C, PM is liable to degradation. This degradation is also observed in microbiological assay where PM lost ∼30% of its biological activity when heated at 130 °C for 24 h. New analytical method was developed for PM in the concentration range of 25-200 ng/ml with intra-day and inter-day variability of stability of PM was determined successfully. Developed analytical method was found sensitive, accurate, and precise for quantification of PM. Copyright © 2010 John Wiley & Sons, Ltd. Copyright © 2010 John Wiley & Sons, Ltd.

  1. Development and Optimization of Silver Nanoparticle Formulation for Fabrication

    Science.gov (United States)

    2015-08-14

    steady increase in multi - drug resistant organisms. Therefore , the development of next generation antimicrobial compounds , such as silver...information. Publication Clearance Request (CPP- 1) Version 9.3: 10.2014 D Animal Use Research Protocol No.: List the IACUC that approved the...nanoparticles, is a priority. However , due to the inconsistencies in current fabrication and processing methods , it is unclear whether the antimicrobial

  2. Secondary Waste Simulant Development for Cast Stone Formulation Testing

    Energy Technology Data Exchange (ETDEWEB)

    Russell, Renee L. [Pacific Northwest National Lab. (PNNL), Richland, WA (United States); Westsik, Joseph H. [Pacific Northwest National Lab. (PNNL), Richland, WA (United States); Rinehart, Donald E. [Pacific Northwest National Lab. (PNNL), Richland, WA (United States); Swanberg, David J. [Washington River Protection Solutions, Richland, WA (United States); Mahoney, J. [Washington River Protection Solutions, Richland, WA (United States)

    2015-04-01

    Washington River Protection Solutions, LLC (WRPS) funded Pacific Northwest National Laboratory (PNNL) to conduct a waste form testing program to implement aspects of the Secondary Liquid Waste Treatment Cast Stone Technology Development Plan (Ashley 2012) and the Hanford Site Secondary Waste Roadmap (PNNL 2009) related to the development and qualification of Cast Stone as a potential waste form for the solidification of aqueous wastes from the Hanford Site after the aqueous wastes are treated at the Effluent Treatment Facility (ETF). The current baseline is that the resultant Cast Stone (or grout) solid waste forms would be disposed at the Integrated Disposal Facility (IDF). Data and results of this testing program will be used in the upcoming performance assessment of the IDF and in the design and operation of a solidification treatment unit planned to be added to the ETF. The purpose of the work described in this report is to 1) develop simulants for the waste streams that are currently being fed and future WTP secondary waste streams also to be fed into the ETF and 2) prepare simulants to use for preparation of grout or Cast Stone solid waste forms for testing.

  3. Formulation, Development and Evaluation of delayed release capsules of Duloxetine Hydrochloride made of different Enteric Polymers

    OpenAIRE

    Pallavi Yerramsetty; J. Vijaya Ratna; Venkata Ramana Reddy; Praveen Kumar

    2012-01-01

    Delayed release systems have acquired a centre stage in the arena of pharmaceutical research and development. The present study involves formulation and evaluation of Duloxetine Hydrochloride delayed release capsules. Duloxetine Hydrochloride is an acid labile drug. It degrades in the acidic environment of the stomach thus leading to therapeutic inefficacy. Therefore it is necessary to bypass the acidic pH of the stomach which can be achieved by formulating delayed release dosage form by usin...

  4. Development and preventative effect against pine wilt disease of a novel liquid formulation of emamectin benzoate.

    Science.gov (United States)

    Takai, Kazuya; Suzuki, Toshio; Kawazu, Kazuyoshi

    2003-03-01

    Injection of the poorly water-soluble emamectin benzoate (EB) into pine trunks required the development of an efficient liquid formulation. For injection into big trees in forests a good rate of injection and a high active content were required. Tests on the viscosity and EB-solubilizing ability of 14 various solubilizers in diethylene glycol monobutyl ether (DGMBE) led to the selection of Sorpol SM-100PM as the solubilizer of the formulation. Relationships between the solubilizing ability and amounts of Sorpol SM-100PM and DGMBE relative to that of EB, and between the concentration of the latter and the viscosity or the injection rate of the formulation led to a novel 40 g litre(-1) emamectin benzoate formulation (Shot Wan Liquid Formulation), which was composed of EB (40), Sorpol SM-100PM (120), DGMBE (160) and distilled water (50 g litre(-1)) in methanol. Injection of this formulation at a dose of 10 g EB per unit volume of pine tree prevented over 90% of the trees from wilting caused by pine wood nematode, and this preventative effect continued for 3 years. Neither discolouration of the leaves nor injury around the injection hole on the trees was observed after injection of the formulation.

  5. Development of the novel coating formulations for skin vaccination using stainless steel microneedle.

    Science.gov (United States)

    Kim, Seong-Jin; Shin, Ju-Hyung; Noh, Jin-Yong; Song, Chang-Seon; Kim, Yeu-Chun

    2016-10-01

    This study focused on the development of novel coating formulations for stainless steel microneedles against influenza A virus. With in vitro studies, various viscosity enhancers and stabilizers were screened based on the hemagglutination activity of the vaccine, which was coated and dried onto a stainless steel chip at room temperature for 1 day. Following the long-term storage test, the hemagglutination activity and particle size of the vaccine, which was formulated with conventional or methylcellulose or hydroxyethyl cellulose and dried onto the microneedle, were monitored. Next, to evaluate the in vivo immunogenicity and protection effect of each dried vaccine formulation, mice were immunized by the antigen-coated microneedle, which had either the conventional or the proposed formulation. Two novel formulations were chosen in the preliminary screening, and in further evaluations, they exhibited a 20 % higher HA activity during storage for 3 months, and no aggregation was observed during storage after drying. In a mouse model, the microneedle with the novel formulation elicited a higher level of IgG and IgG2a was more prevalent in the IgG isotype profile. In addition, mice immunized with the HEC-coated microneedle survived with small weight loss (>90 %) against lethal challenge infection. Overall, the novel formulation hydroxyethyl cellulose preserved significantly higher HA activity during the production and storage of the microneedle as well as improved the in vivo immunogenicity of the vaccine.

  6. Soluble organic additive effects on stress development during drying of calcium carbonate suspensions.

    Science.gov (United States)

    Wedin, Pär; Lewis, Jennifer A; Bergström, Lennart

    2005-10-01

    The effect of polymer, plasticizer, and surfactant additives on stress development during drying of calcium carbonate particulate coatings was studied using a controlled-environment apparatus that simultaneously monitors drying stress, weight loss, and relative humidity. We found that the calcium carbonate coatings display a drying stress evolution typical of granular films, which is characterized by a sharp capillary-induced stress rise followed by a rapid stress relaxation. The addition of a soluble polymer to the CaCO3 suspension resulted in a two-stage stress evolution process. The initial stress rise stems from capillary-pressure-induced stresses within the film, while the second, larger stress rise occurs due to solidification and shrinkage of the polymeric species. Measurements on the corresponding pure polymer solutions established a clear correlation between the magnitude of residual stress in both the polymer and CaCO3-polymer films to the physical properties of the polymer phase, i.e. its glass transition temperature, T(g), and Young's modulus. The addition of small organic molecules can reduce the residual stress observed in the CaCO3-polymer films; e.g., glycerol, which acts as a plasticizer, reduces the drying stress by lowering T(g), while surfactant additions reduce the surface tension of the liquid phase, and, hence, the magnitude of the capillary pressure within the film.

  7. Development of grout formulations for 106-AN waste: Mixture-experiment results and analysis

    International Nuclear Information System (INIS)

    Spence, R.D.; McDaniel, E.W.; Anderson, C.M.; Lokken, R.O.; Piepel, G.F.

    1993-09-01

    Twenty potential ingredients were identified for use in developing a 106-AN grout formulation, and 18 were subsequently obtained and tested. Four ingredients: Type II-LA (moderate heat of hydration) Portland cement, Class F fly ash, attapulgite 150 drilling clay, and ground air-cooled blast-furnace slag (GABFS) -- were selected for developing the 106-AN grout formulations. A mixture experiment was designed and conducted around the following formulation: 2.5 lb of cement per gallon, 1.2 lb of fly ash per gallon, 0.8 lb of attapulgite per gallon, and 3.5 lb of GABFS per gallon. Reduced empirical models were generated from the results of the mixture experiment. These models were used to recommend several grout formulations for 106-AN. Westinghouse Hanford Company selected one of these formulations to be verified for use with 106-AN and a backup formulation in case problems arise with the first choice. This report presents the mixture-experimental results and leach data

  8. Limitations of polyethylene glycol-induced precipitation as predictive tool for protein solubility during formulation development.

    Science.gov (United States)

    Hofmann, Melanie; Winzer, Matthias; Weber, Christian; Gieseler, Henning

    2018-05-01

    Polyethylene glycol (PEG)-induced protein precipitation is often used to extrapolate apparent protein solubility at specific formulation compositions. The procedure was used for several fields of application such as protein crystal growth but also protein formulation development. Nevertheless, most studies focused on applicability in protein crystal growth. In contrast, this study focuses on applicability of PEG-induced precipitation during high-concentration protein formulation development. In this study, solubility of three different model proteins was investigated over a broad range of pH. Solubility values predicted by PEG-induced precipitation were compared to real solubility behaviour determined by either turbidity or content measurements. Predicted solubility by PEG-induced precipitation was confirmed for an Fc fusion protein and a monoclonal antibody. In contrast, PEG-induced precipitation failed to predict solubility of a single-domain antibody construct. Applicability of PEG-induced precipitation as indicator of protein solubility during formulation development was found to be not valid for one of three model molecules. Under certain conditions, PEG-induced protein precipitation is not valid for prediction of real protein solubility behaviour. The procedure should be used carefully as tool for formulation development, and the results obtained should be validated by additional investigations. © 2017 Royal Pharmaceutical Society.

  9. Development and Stability Evaluation of Liquid Crystal-Based Formulations Containing Glycolic Plant Extracts and Nano-Actives

    Directory of Open Access Journals (Sweden)

    Andreza Rodrigues Ueoka

    2018-03-01

    Full Text Available Emulsions are of great use in cosmetic formulations due to their stability. The aim of this work was to develop and assess organoleptic, physicochemical, and microscopic properties of four auto-emulsifiable oil-in-water formulations. Such formulations were developed containing 4.0% cetearyl alcohol, dicetyl phosphate, and ceteth-10 phosphate (Formulation A, nano-actives obtained from safflower, coconut, and clove oils (Formulation B; a mixture of glycolic extracts from Centella asiatica leaves, Aesculus hippocastanum seeds, and Hamamelis virginiana leaves (Formulation C; association between the nano-actives and glycolic extracts described above (Formulation D. The formulations were trialed for 90 days under the normal stability test. The developed formulations were considered all stable and homogeneous, with liquid crystals possibly being formed. Organoleptic parameters and pH of Formulations A and B remained unchanged, but the color of Formulations C and D changed due to the natural color of the glycolic extracts used. It can be concluded that the formation of liquid crystals increased the stability of the formulations, and future tests should be carried out in order to assess the rheological properties and hydration potential of the developed formulations.

  10. Development of a standardized Intranet database of formulation records for nonsterile compounding, Part 2.

    Science.gov (United States)

    Haile, Michael; Anderson, Kim; Evans, Alex; Crawford, Angela

    2012-01-01

    In part 1 of this series, we outlined the rationale behind the development of a centralized electronic database used to maintain nonsterile compounding formulation records in the Mission Health System, which is a union of several independent hospitals and satellite and regional pharmacies that form the cornerstone of advanced medical care in several areas of western North Carolina. Hospital providers in many healthcare systems require compounded formulations to meet the needs of their patients (in particular, pediatric patients). Before a centralized electronic compounding database was implemented in the Mission Health System, each satellite or regional pharmacy affiliated with that system had a specific set of formulation records, but no standardized format for those records existed. In this article, we describe the quality control, database platform selection, description, implementation, and execution of our intranet database system, which is designed to maintain, manage, and disseminate nonsterile compounding formulation records in the hospitals and affiliated pharmacies of the Mission Health System. The objectives of that project were to standardize nonsterile compounding formulation records, create a centralized computerized database that would increase healthcare staff members' access to formulation records, establish beyond-use dates based on published stability studies, improve quality control, reduce the potential for medication errors related to compounding medications, and (ultimately) improve patient safety.

  11. Development of poloxamer gel formulations via hot-melt extrusion technology.

    Science.gov (United States)

    Mendonsa, Nicole S; Murthy, S Narasimha; Hashemnejad, Seyed Meysam; Kundu, Santanu; Zhang, Feng; Repka, Michael A

    2018-02-15

    Poloxamer gels are conventionally prepared by the "hot" or the "cold" process. But these techniques have some disadvantages such as high energy consumption, requires expensive equipment and often have scale up issues. Therefore, the objective of this work was to develop poloxamer gels by hot-melt extrusion technology. The model drug selected was ketoprofen. The formulations developed were 30% and 40% poloxamer gels. Of these formulations, the 30% poloxamer gels were selected as ideal gels. DSC and XRD studies showed an amorphous nature of the drug after extrusion. It was observed from the permeation studies that with increasing poloxamer concentration, a decrease in drug permeation was obtained. Other studies conducted for the formulations included in-vitro release studies, texture analysis, rheological studies and pH measurements. In conclusion, the hot-melt extrusion technology could be successfully employed to develop poloxamer gels by overcoming the drawbacks associated with the conventional techniques. Published by Elsevier B.V.

  12. Information technology in developing countries: a study to guide policy formulation

    NARCIS (Netherlands)

    de Boer, S.J.; Walbeek, M.M.

    1999-01-01

    This article discusses the information gap between industrialised and developing countries. In view of this gap, the Dutch Ministry of Development Co-operation decided to finance research aimed at formulating policy recommendations on the removal of bottlenecks preventing or slowing down the growth

  13. On the Methodology of Formulation and Assessment of Implementing Strategies and Indicative Plans for Regional Development

    Directory of Open Access Journals (Sweden)

    Suspitsyn S. A.

    2009-06-01

    Full Text Available Issues of the content and tools for formulating strategic documents for regional socio-economic development are studied. The research findings in the area of indicative planning and medium-term forecasting of development of multilayer regional systems by the example of the Siberian Federal District, Novosibirsk Region and the city of Novosibirsk are given

  14. Formulation and development of bicontinuous nanostructured liquid crystalline particles of efavirenz.

    Science.gov (United States)

    Avachat, Amelia M; Parpani, Shreekrishna S

    2015-02-01

    Efavirenz is a lipophilic non-nucleoside reverse transcriptase inhibitor used in the first-line pediatric therapeutic cocktail. Due to its high lipophilicity (logP = 5.4) and poor aqueous solubility (intrinsic water solubility = 8.3 μg/mL) efavirenz has low bioavailability. A 30 mg/mL solution in a medium-chain triglyceride vehicle is the only pediatric formulation available with an oral bioavailability 20% lower than the solid form. The current work was aimed at formulating and characterizing liquid crystal nanoparticles for oral delivery of efavirenz to improve oral bioavailability, provide sustained release, minimize side effects and drug resistance. Formulation of cubosomes was done by two methods; sonication and spray drying. Sonication gave highest entrapment efficiency and least particle size. Further, monoolein was substituted with phytantriol as monoolein gets degraded in the presence of lipase when administered orally with consequent loss of liquid crystalline structure. It was confirmed that there was no difference in particle size, entrapment efficiency and nature of product formed by using monoolein or phytantriol. The best formulation was found to be F9, having particle size 104.19 ± 0.21 nm and entrapment efficiency 91.40 ± 0.10%. In vitro release at the end of 12h was found to be 56.45% and zeta potential to be -23.14 mV which stabilized the cubic phase dispersions. It was further characterized for TEM, small angle X-ray scattering (SAXS), DSC and stability studies. SAXS revealed Pn3m space group, indicating a diamond cubic phase which was further confirmed by TEM. Pharmacokinetics of EFV was studied in male Wistar rats. EFV-loaded cubosome dispersions exhibited 1.93 and 1.62-fold increase in peak plasma concentration (Cmax) and 1.48 and 1.42-fold increase in AUC in comparison to that of a suspension prepared with the contents of EFV capsules suspended in 1.5% carboxymethylcellulose PBS solution (pH 5.0), and an EFV solution in medium

  15. Development of human impact on suspension-feeding bivalves in coastal soft-bottom ecosystems

    NARCIS (Netherlands)

    Wolff, Wim J.; Dame, RF; Olenin, S

    2005-01-01

    Suspension-feeding bivalves often may occur in large concentrations ('beds') on tidal flats. This makes them attractive for human consumers and the archaeological record shows collection of bivalves by coastal populations already tens of thousands of years ago. In modem time human interference with

  16. Development and stability studies of sunscreen cream formulations containing three photo-protective filters

    Directory of Open Access Journals (Sweden)

    Slim Smaoui

    2017-02-01

    Full Text Available The present study aimed to formulate and subsequently evaluate sunscreen cream (W/O/W emulsion containing three photo-protective filters: benzophenone-3, ethylhexyl methoxycinnamate and titanium dioxide at different percentages. Formulations were stored at 8, 25 and 40 °C for four weeks to investigate their stability. Color, centrifugation, liquefaction, phase separation, pH and Sun Protection Factor (SPF of sunscreen cream formulations were determined. The microbiological stability of the creams was also evaluated and the organoleptic quality was carried out for 28 days. Interestingly, the combination of 7% Benzophenone-3, 7% Ethylhexyl methoxycinnamate and 6% Titanium dioxide preserved physicochemical properties of the product and was efficient against the development of different spoilage microorganisms as well as aerobic plate counts, Pseudomonas aeruginosa, Staphylococcus aureus, and yeast and mold counts. Furthermore, a good stability was observed for all formulations throughout the experimental period. The newly formulated sunscreen cream was proved to exhibit a number of promising properties and attributes that might open new opportunities for the development of more efficient, safe, and cost-effective skin-care, cosmetic, and pharmaceutical products.

  17. Need for appropriate formulations for children: the national institute of child health and human development-pediatric formulations initiative, part 2.

    Science.gov (United States)

    Giacoia, George P; Taylor-Zapata, Perdita; Mattison, Donald

    2007-01-01

    The development and compounding of pharmacotherapeutic formulations that are suitable for infants and young children can be a challenging problem. This problem results from the lack of knowledge on the acceptability of different dosage forms and formulations to children in relation to age and developmental status, as well as the lack of reliable documentation of formulations used in pediatric clinical trials. As part of its mandate under the Best Pharmaceuticals for Children Act to improve pediatric therapeutics, the National Institute of Child Health and Human Development has sponsored the Pediatric Formulations Initiative. The goal of this ongoing initiative is to address the issues and concerns associated with pediatric therapeutics by convening groups of researchers and experts in pediatric formulations from academia, pharmaceutical companies, the National Institutes of Health, and the U.S. Food and Drug Administration. In this second part of a two-part article, the activities of the various groups that constitute the Pediatric Formulations Initiative are discussed, in addition the Initiative's future activities and plans are outlined.

  18. Development and evaluation of exemestane-loaded lyotropic liquid crystalline gel formulations.

    Science.gov (United States)

    Musa, Muhammad Nuh; David, Sheba Rani; Zulkipli, Ihsan Nazurah; Mahadi, Abdul Hanif; Chakravarthi, Srikumar; Rajabalaya, Rajan

    2017-01-01

    Introduction: The use of liquid crystalline (LC) gel formulations for drug delivery has considerably improved the current delivery methods in terms of bioavailability and efficacy. The purpose of this study was to develop and evaluate LC gel formulations to deliver the anti-cancer drug exemestane through transdermal route. Methods: Two LC gel formulations were prepared by phase separation coacervation method using glyceryl monooleate (GMO), Tween 80 and Pluronic® F127 (F127). The formulations were characterized with regard to encapsulation efficiency (EE), vesicle size, Fourier transform infrared (FTIR) spectroscopy, surface morphology (using light and fluorescence microscopy), in vitro release, ex vivo permeation, in vitro effectiveness test on MDA-MB231 cancer cell lines and histopathological analysis. Results: Results exhibited that the EE was 85%-92%, vesicle size was 119.9-466.2 nm while morphology showed spherical vesicles after hydration. An FTIR result also revealed that there was no significant shift in peaks corresponding to Exemestane and excipients. LC formulations release the drug from cellulose acetate and Strat-MTM membrane from 15%-88.95%, whereas ex vivo permeation ranges from 37.09-63%. The in vitro effectiveness study indicated that even at low exemestane concentrations (12.5 and 25 μg/mL) the formulations were able to induce cancer cell death, regardless of the surfactant used. Histopathological analysis thinning of the epidermis as the formulations penetrate into the intercellular regions of squamous cells. Conclusion: The results conjectured that exemestane could be incorporated into LC gels for the transdermal delivery system and further preclinical studies such as pharmacokinetic and pharmacodynamic studies will be carried out with suitable animal models.

  19. Formulation of price strategies in the software sector: outsourcing of development and maintenance software product case

    Directory of Open Access Journals (Sweden)

    Antonio Cezar Bornia

    2008-07-01

    Full Text Available The main goal of this article is to discuss the formulation of price strategies in the software sector. In the intention of reaching the proposed goal, strategies models of prices are introduced along with the procedure to the formulation of price strategies, composed by five stages: external and internal analyses, consolidation, positioning, price strategy formalization and market attendance. As for the methodology, the study is classified as qualitative, exploratory, descriptive, documental, of field and case study, according to the approach of Vergara (1998. In the case study, the model to the formulation of price strategies is applied in a company’s software sector, being analyzed the outsourcing of development and maintenance software product. As main contributions, it is highlighted the price procedure application that emphasizes strategic price logic and prices strategies formulations, with base in the analysis of five main factors: quality, comparison with the competition, company life cycle, product life cycle and characteristics of the segment-objective. Based on the analyzed factors, a possible strategy to be adopted considering the characteristics of the product and the company is the price strategy and superior value. Key-words: Pricing Strategies. Price Formulation. Software Enterprises.

  20. Development of Novel Formulations to Enhance in Vivo Transdermal Permeation of Tocopherol

    Directory of Open Access Journals (Sweden)

    Nada Aly H.

    2014-09-01

    Full Text Available Tocopherol represents a big challenge for transdermal permeation owing to its extreme hydrophobicity and large molecular mass. The aim of the present study was to develop alpha-tocopherol (T topical formulations and evaluate their ex vivo and in vivo permeation. Franz diffusion cells were used for ex vivo permeation, and neonatal rats were used for in vivo permeation. Seven gel formulations and 21 liquid formulations were investigated for physical stability, viscosity and permeation of T. Analysis of T was performed by a validated HPLC method using a UV detector. The ex vivo permeation from gel and emulsion formulations was very poor (0.001-0.015 %. Highest permeation was observed from monophasic liquid formulations containing dimethyl sulfoxide (DMSO, tocopheryl polyethylene glycols (TPGs, propylene glycol, ethanol and 9.5 % T. The in vivo results demonstrated higher retention in the epidermis compared to subcutaneous tissues, 1377 and 1.13 μg g-1, respectively. Increasing T concentration from 4.8 to 9.5 % did not increase the amount permeated or % of T retained. It was concluded that simple solutions of T in the presence of DMSO and TPGs were more promising systems for effective transdermal permeation compared to gel, emulsion or oleaginous systems.

  1. Mixture experiment methods in the development and optimization of microemulsion formulations.

    Science.gov (United States)

    Furlanetto, S; Cirri, M; Piepel, G; Mennini, N; Mura, P

    2011-06-25

    Microemulsion formulations represent an interesting delivery vehicle for lipophilic drugs, allowing for improving their solubility and dissolution properties. This work developed effective microemulsion formulations using glyburide (a very poorly-water-soluble hypoglycaemic agent) as a model drug. First, the area of stable microemulsion (ME) formations was identified using a new approach based on mixture experiment methods. A 13-run mixture design was carried out in an experimental region defined by constraints on three components: aqueous, oil and surfactant/cosurfactant. The transmittance percentage (at 550 nm) of ME formulations (indicative of their transparency and thus of their stability) was chosen as the response variable. The results obtained using the mixture experiment approach corresponded well with those obtained using the traditional approach based on pseudo-ternary phase diagrams. However, the mixture experiment approach required far less experimental effort than the traditional approach. A subsequent 13-run mixture experiment, in the region of stable MEs, was then performed to identify the optimal formulation (i.e., having the best glyburide dissolution properties). Percent drug dissolved and dissolution efficiency were selected as the responses to be maximized. The ME formulation optimized via the mixture experiment approach consisted of 78% surfactant/cosurfacant (a mixture of Tween 20 and Transcutol, 1:1, v/v), 5% oil (Labrafac Hydro) and 17% aqueous phase (water). The stable region of MEs was identified using mixture experiment methods for the first time. Copyright © 2011 Elsevier B.V. All rights reserved.

  2. Effects of Cosmetic Formulations Containing Hydroxyacids on Sun-Exposed Skin: Current Applications and Future Developments

    Directory of Open Access Journals (Sweden)

    Andrija Kornhauser

    2012-01-01

    Full Text Available This paper describes recent data on the effects of various skin formulations containing hydroxyacids (HAs and related products on sun-exposed skin. The most frequently used classes of these products, such as α- and β-hydroxyacids, polyhydroxy acids, and bionic acids, are reviewed, and their application in cosmetic formulations is described. Special emphasis is devoted to the safety evaluation of these formulations, particularly on the effects of their prolonged use on sun-exposed skin. We also discuss the important contribution of cosmetic vehicles in these types of studies. Data on the effects of HAs on melanogenesis and tanning are also included. Up-to-date methods and techniques used in those explorations, as well as selected future developments in the cosmetic area, are presented.

  3. Development of suspension plasma sprayed alumina coatings with high enthalpy plasma torch

    Czech Academy of Sciences Publication Activity Database

    Tesař, Tomáš; Mušálek, Radek; Medřický, Jan; Kotlan, Jiří; Lukáč, František; Pala, Zdeněk; Ctibor, Pavel; Chráska, Tomáš; Houdková, Š.; Rimal, V.; Curry, N.

    2017-01-01

    Roč. 325, September (2017), s. 277-288 ISSN 0257-8972 R&D Projects: GA ČR GA15-12145S Institutional support: RVO:61389021 Keywords : Suspension plasma spraying * Aluminium oxide * Mechanical properties * Hardness * Adhesion * Wear resistance Subject RIV: JK - Corrosion ; Surface Treatment of Materials OBOR OECD: Coating and films Impact factor: 2.589, year: 2016 http://www.sciencedirect.com/science/article/pii/S0257897217306424

  4. An efficient sensitivity analysis method for modified geometry of Macpherson suspension based on Pearson correlation coefficient

    Science.gov (United States)

    Shojaeefard, Mohammad Hasan; Khalkhali, Abolfazl; Yarmohammadisatri, Sadegh

    2017-06-01

    The main purpose of this paper is to propose a new method for designing Macpherson suspension, based on the Sobol indices in terms of Pearson correlation which determines the importance of each member on the behaviour of vehicle suspension. The formulation of dynamic analysis of Macpherson suspension system is developed using the suspension members as the modified links in order to achieve the desired kinematic behaviour. The mechanical system is replaced with an equivalent constrained links and then kinematic laws are utilised to obtain a new modified geometry of Macpherson suspension. The equivalent mechanism of Macpherson suspension increased the speed of analysis and reduced its complexity. The ADAMS/CAR software is utilised to simulate a full vehicle, Renault Logan car, in order to analyse the accuracy of modified geometry model. An experimental 4-poster test rig is considered for validating both ADAMS/CAR simulation and analytical geometry model. Pearson correlation coefficient is applied to analyse the sensitivity of each suspension member according to vehicle objective functions such as sprung mass acceleration, etc. Besides this matter, the estimation of Pearson correlation coefficient between variables is analysed in this method. It is understood that the Pearson correlation coefficient is an efficient method for analysing the vehicle suspension which leads to a better design of Macpherson suspension system.

  5. Development of polyisocyanurate pour foam formulation for space shuttle external tank thermal protection system

    Science.gov (United States)

    Harvey, James A.; Butler, John M.; Chartoff, Richard P.

    1988-01-01

    Four commercially available polyisocyanurate polyurethane spray-foam insulation formulations are used to coat the external tank of the space shuttle. There are several problems associated with these formulations. For example, some do not perform well as pourable closeout/repair systems. Some do not perform well at cryogenic temperatures (poor adhesion to aluminum at liquid nitrogen temperatures). Their thermal stability at elevated temperatures is not adequate. A major defect in all the systems is the lack of detailed chemical information. The formulations are simply supplied to NASA and Martin Marietta, the primary contractor, as components; Part A (isocyanate) and Part B (poly(s) and additives). Because of the lack of chemical information the performance behavior data for the current system, NASA sought the development of a non-proprietary room temperature curable foam insulation. Requirements for the developed system were that it should exhibit equal or better thermal stability both at elevated and cryogenic temperatures with better adhesion to aluminum as compared to the current system. Several formulations were developed that met these requirements, i.e., thermal stability, good pourability, and good bonding to aluminum.

  6. Conception and development of an optical methodology applied to long-distance measurement of suspension bridges dynamic displacement

    International Nuclear Information System (INIS)

    Martins, L Lages; Ribeiro, A Silva; Rebordão, J M

    2013-01-01

    This paper describes the conception and development of an optical system applied to suspension bridge structural monitoring, aiming real-time and long-distance measurement of dynamical three-dimensional displacement, namely, in the central section of the main span. The main innovative issues related to this optical approach are described and a comparison with other optical and non-optical measurement systems is performed. Moreover, a computational simulator tool developed for the optical system design and validation of the implemented image processing and calculation algorithms is also presented

  7. Development of a lyophilized formulation for preparing the radiopharmaceutical 177Lu-DOTA-Anti-CD20

    International Nuclear Information System (INIS)

    Serrano E, L. A.

    2015-01-01

    The radiolabeled proteins are molecules of interest in nuclear medicine for their diagnostic and therapeutic application in cancer. Antibodies, such as chimeric monoclonal antibody Anti-CD20 rituximab, have established themselves as suitable vectors of radionuclides (e.g. 177 Lu) , introducing high affinity by the surface antigens over- expressed and widely distributed in cells involved in certain diseases. The aim of this work was to design, optimize and document the production process of radiopharmaceutical 177 Lu-DOTA-Anti-CD20 for sanitary registration request to the Comision Federal para la Proteccion contra Riesgos Sanitarios (COFEPRIS). First, a raw material analysis using the Ft-Mir technique and gamma spectrometry was performed. Then, was carried out the development of the lyophilized formulation for the preparation of 177 Lu-DOTA-Anti-CD20, in which an ANOVA was performed where the dependent variable was the radiochemical purity. The optimal pharmaceutical formulation was: 5 mg DOTA-CD20 and 80 mg Mannitol to be reconstituted with 1 m L of acetate buffer 0.25 M, ph 7, with an incubation time of 15 min at 37 degrees Celsius in a dry bath. Once completed the development of the lyophilized formulation, we proceeded to the optimization of the production process, development and validation of the analytical method. Three batches were prepared under protocols of Good Manufacturing Practice, which met pre-established specifications as sterile and endotoxin-free of bacterial formulations, with greater that 95% of radiochemical purity. Currently, is conducting the study of shelf stability. Upon completion of the stability studies, the legal record of 177 Lu-DOTA-Anti-CD20 will be integrated with documented evidence of the quality and stability of the formulation of this radiopharmaceutical. (Author)

  8. The Development of a Parenteral Pharmaceutical Formulation of a New Class of Compounds of Nitrosourea.

    Science.gov (United States)

    Nikolaeva, Ludmila; Oborotova, Natalia; Bunyatyan, Natalia; Zhang, Xi; Sanarova, Ekaterina; Lantsova, Anna; Orlova, Olga; Polozkova, Alevtina

    2016-11-01

    Despite the rapid development of medical technologies, chemotherapy treatment still occupies an important place in clinical oncology. In this regard, the current research in this area focuses on the synthesis of new highly effective antitumor substances that have minimal side effects and the development of stable pharmaceutical formulations (PF) on their basis. In order to solve this problem, the I. Ya. Postovsky Institute of Organic Synthesis of the Ural Branch of the Russian Academy of Sciences actively sought for original substances, namely, nitrosourea (NU) derivatives, one of the most promising classes of anticancer drugs. As a result of this research, a novel NU derivative was synthesized, namely ormustine, which showed high antitumor activity in preliminary preclinical trials. It is now crucial to develop an ormustine pharmaceutical formulation. Conducted technological studies showed that the most suitable solvent for the drug substance is 0.1 M hydrochloric acid, which ensures its rapid dissolution by ultrasonic treatment. A significant reduction in the concentration of the active ingredient during the storage of the solution required the development of a technique of its lyophilization and the selection of a shaper such as a Kollidon 17 PF. Upon completion of the development of a pharmaceutical formulation of ormustine, its stability after lyophilization was demonstrated, and a sufficient amount of the drug has been acquired for preclinical research.

  9. Design and development of a MLS based compact active suspension system, featuring air spring and energy harvesting capabilities

    DEFF Research Database (Denmark)

    Berg, Nick Ilsø; Holm, Rasmus Koldborg; Rasmussen, Peter Omand

    2016-01-01

    This paper describes the design and development of an novel Magnetic Lead Screw based active suspension system for passenger vehicles, using a new MLS topology. The design is based on performance specifications found from ISO road profiles, with a maximum harvested energy approach. By integrating...... the PMSM motor with the MLS, it possible to construct a very compact design with an integrated air spring. The prototype is build and frictional losses and efficiency for the MLS damper unit are measured. Additional the stall force and stall torque are measured for the build prototype to validate...

  10. Formulation development and comparative in vitro study of metoprolol tartrate (IR) tablets.

    Science.gov (United States)

    Husain, Tazeen; Shoaib, Muhammad Harris; Yousuf, Rabia Ismail; Maboos, Madiha; Khan, Madeeha; Bashir, Lubna; Naz, Shazia

    2016-05-01

    The objective of the present work was to develop Immediate Release (IR) tablets of Metoprolol Tartrate (MT) and to compare trial formulations to a reference product. Six formulations (F1-F6) were designed using central composite method and compared to a reference brand (A). Two marketed products (brands B and C) were also evaluated. F1-F6 were prepared with Avicel PH101 (filler), Crospovidone (disintegrant) and Magnesium Stearate (lubricant) by direct compression. Pharmacopoeial and non-pharmacopoeial methods were used to assess their quality. Furthermore, drug profiles were characterized using model dependent and independent (f(2)) approaches. Brands B and C and F5 and F6 did not qualify the tests for content uniformity. Moreover, brand B did not meet weight variation criteria and brand C did not satisfy requirements for single point dissolution test. Of the trial formulations, F2 failed the test for uniformity in thickness while F4 did not disintegrate within time limit. Only F1 and F3 met all quality parameters and were subjected to accelerated stability testing without significant alterations in their physicochemical characteristics. Based on AIC and r(2)(adjusted) values obtained by applying various kinetic models, drug release was determined to most closely follow Hixson-Crowell cube root law. F1 was determined to be the optimized formulation.

  11. The development of basic glass formulations for solidifying HLW from nuclear fuel reprocessing plant

    International Nuclear Information System (INIS)

    Jiang Yaozhong; Tang Baolong; Zhang Baoshan; Zhou Hui

    1995-01-01

    Basic glass formulations 90U/19, 90U/20, 90Nd/7 and 90Nd/10 applied in electric melting process are developed by using the mathematical model of the viscosity and electric resistance of waste glass. The yellow phase does not occur for basic glass formulations 90U/19 and 90U/20 solidifying HLW from nuclear fuel reprocessing plant when the waste loading is 20%. Under the waste loading is 16%, the process and product properties of glass 90U/19 and 90U/20 come up to or surpass the properties of the same kind of foreign waste glasses, and other properties are about the same to them of foreign waste glasses. The process and product properties of basic glass formulations 90Nd/7 and 90Nd/10 used for the solidification of 'U replaced by Nd' liquid waste are almost similar to them of 90U/19 and 90U/20. These properties fairly meet the requirements of 'joint test' (performed at KfK-INE, Germany). Among these formulations, 90Nd/7 is applied in cold engineering scale electric melting test performed at KfK-INE in Germany. The main process properties of cold test is similar to laboratory results

  12. Development and evaluation of a microemulsion formulation for transdermal delivery of terbinafine.

    Science.gov (United States)

    Baboota, S; Al-Azaki, A; Kohli, K; Ali, J; Dixit, N; Shakeel, F

    2007-01-01

    The aim of the present study is to develop and evaluate microemulsion formulations for Terbinafine (TB) with a view to enhance its permeability through the skin and provide release for 24 h. Various o/w microemulsions were prepared by the spontaneous emulsification method. Oleic acid was chosen as the oil phase, Caprylo caproyl macrogol-8- glyceride (Labrasol S) and purified diethylene glycol monoethyl ether (Transcutol P) were used as surfactant and cosurfactant, respectively, on the basis of solubility studies. Pseudoternary phase diagrams were constructed to obtain the concentration range of oil, surfactant, cosurfactant, and water for microemulsion formulation. The optimized microemulsion consisted of 2% w/w TB, 8% w/w oleic acid, 31% w/w labrasol S, 31% w/w transcutol P, and 30% w/w distilled water. Permeability parameters like Jss and Kp were found to be significantly higher for formulation F4 as compared to other formulations (P activity against Candida albicans and Aspergillus flavus as compared to marketed product (P < 0.05).

  13. HPTLC Method Development and Validation of Zolpidem Tartrate in Bulk and Marketed Formulation

    OpenAIRE

    Abhay R. Shirode; Bharti G. Jadhav; Vilasrao J. Kadam

    2015-01-01

    High performance thin layer chromatography (HPTLC) offers many advantages over HPLC. It reduces the cost of analysis as compare to HPLC. The mobile phase consumption per sample is extremely low in HPTLC, hence reducing the acquisition and disposal cost. Considering the cost and suitability of analysis for estimation of zolpidem tartrate in bulk and its marketed formulation, HPTLC method was developed and validated. The Camag HPTLC system, employed with software winCATS (ver.1.4.1.8) was used ...

  14. Field evaluation of the biolarvicide, spinosad 20 per cent emulsifiable concentrate in comparison to its 12 per cent suspension concentrate formulation against Culex quinquefasciatus, the vector of bancroftian filariasis in India.

    Science.gov (United States)

    Sadanandane, Candasamy; Gunasekaran, Kasinathan; Boopathi Doss, Ponnusamy Sivagnana; Jambulingam, Purushothaman

    2018-01-01

    Biolarvicides may offer alternatives to chemical larvicides as these are known to be safe to environment and selective against the target species. However, only a limited number of biolarvicides have been approved for mosquito larval control. In the current study, a new formulation of spinosad, 20 per cent emulsifiable concentrate (EC) was tested for its efficacy against Culex quinquefasciatus, in comparison to its 12 per cent suspension concentrate (SC). Spinosad 20 per cent EC was tested against Cx. quinquefasciatus immature at 25, 50, 100 and 150 mg active ingredient (ai)/m [2] in cesspits, drains and abandoned wells in comparison with spinosad 12 per cent SC at the optimum field application dosage of 50 mg ai/m [2] . The 20 per cent EC caused 90-100 per cent reduction of pupal density for 7-14 days in cesspits, 10-17 days in drains and 14-30 days in abandoned wells at all dosages tested. At lower dosages of 25 and 50 mg ai/m [2] , >90 per cent reduction of pupal density was observed for one week in cesspits and street drains and for two weeks in abandoned wells. The effective duration of control provided by the higher dosages, 100 and 150 mg ai/m [2] was 1.4 to 2 times greater than the lower dosages, 25 and 50 mg ai/m [2] . The findings showed that the spinosad 20 per cent EC can be used for larval control against Cx. quinquefasciatus, at the dosage of 25 mg ai/m [2] at weekly interval in cesspits and drains and at fortnightly interval in abandoned wells. Spinosad 20 per cent EC could be one of the options to be considered for larval control under integrated vector management.

  15. Synovial and systemic pharmacokinetics (PK) of triamcinolone acetonide (TA) following intra-articular (IA) injection of an extended-release microsphere-based formulation (FX006) or standard crystalline suspension in patients with knee osteoarthritis (OA).

    Science.gov (United States)

    Kraus, V B; Conaghan, P G; Aazami, H A; Mehra, P; Kivitz, A J; Lufkin, J; Hauben, J; Johnson, J R; Bodick, N

    2018-01-01

    Intra-articular (IA) corticosteroids relieve osteoarthritis (OA) pain, but rapid absorption into systemic circulation may limit efficacy and produce untoward effects. We compared the pharmacokinetics (PK) of IA triamcinolone acetonide (TA) delivered as an extended-release, microsphere-based formulation (FX006) vs a crystalline suspension (TAcs) in knee OA patients. This Phase 2 open-label study sequentially enrolled 81 patients who received a single IA injection of FX006 (5 mL, 32 mg delivered dose, N = 63) or TAcs (1 mL, 40 mg, N = 18). Synovial fluid (SF) aspiration was attempted in each patient at baseline and one post-IA-injection visit (FX006: Week 1, Week 6, Week 12, Week 16 or Week 20; TAcs: Week 6). Blood was collected at baseline and multiple post-injection times. TA concentrations (validated LC-MS/MS, geometric means (GMs)), PK (non-compartmental analysis models), and adverse events (AEs) were assessed. SF TA concentrations following FX006 were quantifiable through Week 12 (pg/mL: 231,328.9 at Week 1; 3590.0 at Week 6; 290.6 at Week 12); post-TAcs, only two of eight patients had quantifiable SF TA at Week 6 (7.7 pg/mL). Following FX006, plasma TA gradually increased to peak (836.4 pg/mL) over 24 h and slowly declined to IA injection prolonged SF joint residency, diminished peak plasma levels, and thus reduced systemic TA exposure relative to TAcs. Copyright © 2017 The Authors. Published by Elsevier Ltd.. All rights reserved.

  16. [Development of Inhalable Dry Powder Formulations Loaded with Nanoparticles Maintaining Their Original Physical Properties and Functions].

    Science.gov (United States)

    Okuda, Tomoyuki

    2017-01-01

     Functional nanoparticles, such as liposomes and polymeric micelles, are attractive drug delivery systems for solubilization, stabilization, sustained release, prolonged tissue retention, and tissue targeting of various encapsulated drugs. For their clinical application in therapy for pulmonary diseases, the development of dry powder inhalation (DPI) formulations is considered practical due to such advantages as: (1) it is noninvasive and can be directly delivered into the lungs; (2) there are few biocomponents in the lungs that interact with nanoparticles; and (3) it shows high storage stability in the solid state against aggregation or precipitation of nanoparticles in water. However, in order to produce effective nanoparticle-loaded dry powders for inhalation, it is essential to pursue an innovative and comprehensive formulation strategy in relation to composition and powderization which can achieve (1) the particle design of dry powders with physical properties suitable for pulmonary delivery through inhalation, and (2) the effective reconstitution of nanoparticles that will maintain their original physical properties and functions after dissolution of the powders. Spray-freeze drying (SFD) is a relatively new powderization technique combining atomization and lyophilization, which can easily produce highly porous dry powders from an aqueous sample solution. Previously, we advanced the optimization of components and process conditions for the production of SFD powders suitable to DPI application. This review describes our recent results in the development of novel DPI formulations effectively loaded with various nanoparticles (electrostatic nanocomplexes for gene therapy, liposomes, and self-assembled lipid nanoparticles), based on SFD.

  17. Challenges and strategies to facilitate formulation development of pediatric drug products: Safety qualification of excipients.

    Science.gov (United States)

    Buckley, Lorrene A; Salunke, Smita; Thompson, Karen; Baer, Gerri; Fegley, Darren; Turner, Mark A

    2018-02-05

    A public workshop entitled "Challenges and strategies to facilitate formulation development of pediatric drug products" focused on current status and gaps as well as recommendations for risk-based strategies to support the development of pediatric age-appropriate drug products. Representatives from industry, academia, and regulatory agencies discussed the issues within plenary, panel, and case-study breakout sessions. By enabling practical and meaningful discussion between scientists representing the diversity of involved disciplines (formulators, nonclinical scientists, clinicians, and regulators) and geographies (eg, US, EU), the Excipients Safety workshop session was successful in providing specific and key recommendations for defining paths forward. Leveraging orthogonal sources of data (eg. food industry, agro science), collaborative data sharing, and increased awareness of the existing sources such as the Safety and Toxicity of Excipients for Paediatrics (STEP) database will be important to address the gap in excipients knowledge needed for risk assessment. The importance of defining risk-based approaches to safety assessments for excipients vital to pediatric formulations was emphasized, as was the need for meaningful stakeholder (eg, patient, caregiver) engagement. Copyright © 2017 Elsevier B.V. All rights reserved.

  18. Development and characterization of ice cream enriched with different formulations flour jabuticaba bark (Myrciaria cauliflora

    Directory of Open Access Journals (Sweden)

    Marina Leopoldina Lamounier

    2015-09-01

    Full Text Available The aim was to perform the physicochemical characterization of the flour from the bark of jabuticaba, as well as developing three ice cream formulations (enriched with 0, 5 and 10% of this flour and evaluate the physicochemical and sensory characteristics. Fruits were pulped, the peels were dehydrated, dried, crushed and sieved to obtain the flour that was analyzed for physicochemical levels. Then, three ice cream formulations were developed (with 0%, 5% and 10% flour from the bark of jabuticaba, considering the physicochemical and sensorial characteristics. The results showed that the flour from the bark of jabuticaba showed high ash and fiber. The ice creams showed differences (p < 0.05 for pH, titratable acidity, moisture and ash due to the incorporation of flour from the bark of jabuticaba. The only attribute that did not differ (p > 0.05 was soluble solid. The overrun was ecreasing with increasing addition of flour. In the sensory evaluation, only attributes that differ (p < 0.05 were flavor, texture and overall appearance of the formulation with 10% flour from the bark of jabuticaba, which represents that incorporation of 5% flour from the bark of jabuticaba did not affect the cceptability of ice creams. It can be concluded that the enrichment of blemish bark flour provides edible ice increase in nutritional value without affecting the sensory characteristics at the level of 5% added.

  19. Development of chemical cleaning formulation for service water system of FBTR

    International Nuclear Information System (INIS)

    Velmurugan, S.; Narasimhan, S.V.; Das, P.C.; Mathur, P.K.

    1995-01-01

    Service water system of Fast Breeder Test Reactor (FBTR) was found to be corroded and at few locations, the corrosion product oxides were choking the smaller diameter pipelines. An attempt was made to develop a chemical cleaning formulation to chemically remove the oxides using a surface conditioner and chelating agents. Of the several complexants tested, hydroxyethylethylene diamine tetraacetic acid (HEDTA) was found to be better than other complexants from the point of view of oxide dissolution efficiency, solubility etc. A two stage chemical cleaning process involving conditioning of the oxide layer with 0.1% tannic acid followed by exposure of the conditioned oxide layer with a formulation containing 1% HEDTA + 0.5% Sodium Gluconate +0.2% hexamine was recommended to remove the corrosion product oxide present in the service water system. (author). 4 refs., 2 tabs

  20. Crystallization Formulation Lab

    Data.gov (United States)

    Federal Laboratory Consortium — The Crystallization Formulation Lab fills a critical need in the process development and optimization of current and new explosives and energetic formulations. The...

  1. Development of polyherbal antidiabetic formulation encapsulated in the phospholipids vesicle system

    Directory of Open Access Journals (Sweden)

    Vinod Kumar Gauttam

    2013-01-01

    Full Text Available Multifactorial metabolic diseases, for instance diabetes develop several complications like hyperlipidemia, hepatic toxicity, immunodeficiency etc., Hence, instead of mono-drug therapy the management of the disease requires the combination of herbs. Marketed herbal drugs comprise of irrational combinations, which makes their quality control more difficult. Phytoconstituents, despite having excellent bioactivity in vitro demonstrate less or no in vivo actions due to their poor lipid solubility, resulting in high therapeutic dose regimen; phospholipids encapsulation can overcome this problem. Hence, present study was designed to develop a phospholipids encapsulated polyherbal anti-diabetic formulation. In the present study, polyherbal formulation comprises of lyophilized hydro-alcoholic (50% v/v extracts of Momordica charantia, Trigonella foenum-graecum and Withania somnifera 2:2:1, respectively, named HA, optimized based on oral glucose tolerance test model in normal Wistar rats. The optimized formulation (HA entrapped in the phosphatidylcholine and cholesterol (8:2 vesicle system is named HA lipids (HAL. The vesicles were characterized for shape, morphology, entrapment efficiency, polar-dispersity index and release profile in the gastric pH. The antidiabetic potential of HA, marketed polyherbal formulation (D-fit and HAL was compared in streptozotocin-induced diabetic rat model of 21 days study. The parameters evaluated were behavioral changes, body weight, serum glucose level, lipid profile and oxidative stress. The antidiabetic potential of HA (1000 mg/kg was at par with the D-fit (1000 mg/kg. However, the potential was enhanced by phospholipids encapsulation; as HAL (500 mg/kg has shown more significant (P < 0.05 potential in comparison to HA (1000 mg/kg and at par with metformin (500 mg/kg.

  2. Formulation development and characterization of cellulose acetate nitrate based propellants for improved insensitive munitions properties

    Directory of Open Access Journals (Sweden)

    Thelma Manning

    2014-06-01

    Full Text Available Cellulose acetate nitrate (CAN was used as an insensitive energetic binder to improve the insensitive munitions (IM properties of gun propellants to replace the M1 propellant used in 105 mm artillery charges. CAN contains the energetic nitro groups found in nitrocellulose (NC, but also acetyl functionalities, which lowered the polymer's sensitivity to heat and shock, and therefore improved its IM properties relative to NC. The formulation, development and small-scale characterization testing of several CAN-based propellants were done. The formulations, using insensitive energetic solid fillers and high-nitrogen modifiers in place of nitramine were completed. The small scale characterization testing, such as closed bomb testing, small scale sensitivity, thermal stability, and chemical compatibility were done. The mechanical response of the propellants under high-rate uni-axial compression at, hot, cold, and ambient temperatures were also completed. Critical diameter testing, hot fragment conductive ignition (HFCI tests were done to evaluate the propellants' responses to thermal and shock stimuli. Utilizing the propellant chemical composition, theoretical predictions of erosivity were completed. All the small scale test results were utilized to down-select the promising CAN based formulations for large scale demonstration testing such as the ballistic performance and fragment impact testing in the 105 mm M67 artillery charge configurations. The test results completed in the small and large scale testing are discussed.

  3. Development of formulation Q1As method for quadrupole noise prediction around a submerged cylinder

    Directory of Open Access Journals (Sweden)

    Yo-Seb Choi

    2017-09-01

    Full Text Available Recent research has shown that quadrupole noise has a significant influence on the overall characteristics of flow-induced noise and on the performance of underwater appendages such as sonar domes. However, advanced research generally uses the Ffowcs Williams–Hawkings analogy without considering the quadrupole source to reduce computational cost. In this study, flow-induced noise is predicted by using an LES turbulence model and a developed formulation, called the formulation Q1As method to properly take into account the quadrupole source. The noise around a circular cylinder in an underwater environment is examined for two cases with different velocities. The results from the method are compared to those obtained from the experiments and the permeable FW–H method. The results are in good agreement with the experimental data, with a difference of less than 1 dB, which indicates that the formulation Q1As method is suitable for use in predicting quadrupole noise around underwater appendages.

  4. Development of sustained and dual drug release co-extrusion formulations for individual dosing.

    Science.gov (United States)

    Laukamp, Eva Julia; Vynckier, An-Katrien; Voorspoels, Jody; Thommes, Markus; Breitkreutz, Joerg

    2015-01-01

    In personalized medicine and patient-centered medical treatment individual dosing of medicines is crucial. The Solid Dosage Pen (SDP) allows for an individual dosing of solid drug carriers by cutting them into tablet-like slices. The aim of the present study was the development of sustained release and dual release formulations with carbamazepine (CBZ) via hot-melt co-extrusion for the use in the SDP. The selection of appropriate coat- and core-formulations was performed by adapting the mechanical properties (like tensile strength and E-modulus) for example. By using different excipients (polyethyleneglycols, poloxamers, white wax, stearic acid, and carnauba wax) and drug loadings (30-50%) tailored dissolution kinetics was achieved showing cube root or zero order release mechanisms. Besides a biphasic drug release, the dose-dependent dissolution characteristics of sustained release formulations were minimized by a co-extruded wax-coated formulation. The dissolution profiles of the co-extrudates were confirmed during short term stability study (six months at 21.0 ± 0.2 °C, 45%r.h.). Due to a good layer adhesion of core and coat and adequate mechanical properties (maximum cutting force of 35.8 ± 2.0 N and 26.4 ± 2.8 N and E-modulus of 118.1 ± 8.4 and 33.9 ± 4.5 MPa for the dual drug release and the wax-coated co-extrudates, respectively) cutting off doses via the SDP was precise. While differences of the process parameters (like the barrel temperature) between the core- and the coat-layer resulted in unsatisfying content uniformities for the wax-coated co-extrudates, the content uniformity of the dual drug release co-extrudates was found to be in compliance with pharmacopoeial specification. Copyright © 2015 Elsevier B.V. All rights reserved.

  5. Development of a new esomeprazole delayed release gastro-resistant pellet formulation with improved storage stability.

    Science.gov (United States)

    Barmpalexis, Panagiotis; Grypioti, Agni

    2018-06-01

    This study describes the development of a new esomeprazole (ESO) delayed release gastro-resistant formulation with improved storage stability. A three-step (drug-, sub(seal)- and enteric-) coating process was employed with the aid of a fluid bed coater. Several formulation factors (namely, size and quantity of starting non-pareil sugar spheres, binder quantity during drug-layering, sub(seal)-coating polymer type, and quantity and enteric coating quantity) were evaluated and the whole process was modeled with the aid of feed-forward back-propagation artificial neural networks (ANNs). Results showed that the selection of small-sized starting spheres (45/60 mesh size) leads to pellet agglomeration, while as sub(seal)-coating weight gain increases a reduction in ESO dissolution rate is observed. The enteric-coating applied (Eudragit L30D-55) showed good gastro-resistant performance in both 0.1 N HCl and pH 4.5 media, while immediate release profiles with more than 85% of ESO being released in less than 30 min were obtained. The effect of cellulose-based sub(seal)-coating polymers, (namely, hydroxypropyl cellulose and hydroxypropylmethyl cellulose) on formulation's storage stability at 40 ± 2 °C/75 ± 5%RH indicated that only hydroxypropylmethyl cellulose was able to stabilize ESO delayed-release formulations in terms of assay, dissolution, impurities, and gastro-resistance performance. Finally, scanning electron microscopy (SEM) analysis revealed smooth and homogeneous external surface/coating layers in all three levels (drug-, sub(seal)-, and enteric- coating), while x-ray diffraction showed no polymorphic transformations.

  6. Dispersible formulation of artemether/lumefantrine: specifically developed for infants and young children

    Directory of Open Access Journals (Sweden)

    Sagara Issaka

    2009-10-01

    Full Text Available Abstract Infants and children under five years of age are the most vulnerable to malaria with over 1,700 deaths per day from malaria in this group. However, until recently, there were no WHO-endorsed paediatric anti-malarial formulations available. Artemisinin-based combination therapy is the current standard of care for patients with uncomplicated falciparum malaria in Africa. Artemether/lumefantrine (AL meets WHO pre-qualification criteria for efficacy, safety and quality. Coartem®, a fixed dose combination of artemether and lumefantrine, has consistently achieved cure rates of >95% in clinical trials. However, AL tablets are inconvenient for caregivers to administer as they need to be crushed and mixed with water or food for infants and young children. Further, in common with other anti-malarials, they have a bitter taste, which may result in children spitting the medicine out and not receiving the full therapeutic dose. There was a clear unmet medical need for a formulation of AL specifically designed for children. Ahead of a call from WHO for child-friendly medicines, Novartis, working in partnership with Medicines for Malaria Venture (MMV, started the development of a new formulation of AL for infants and young children: Coartem® Dispersible. The excellent efficacy, safety and tolerability already demonstrated by AL tablets were confirmed with dispersible AL in a large trial comparing the crushed tablets with dispersible tablets in 899 African children with falciparum malaria. In the evaluable population, 28-day PCR-corrected cure rates of >96% were achieved. Further, its sweet taste means that it is palatable for children, and the dispersible formulation makes it easier for caregivers to administer than bitter crushed tablets. Easing administration may foster compliance, hence improving therapeutic outcomes in infants and young children and helping to preserve the efficacy of ACT.

  7. Bottlenecks in the development of topical analgesics: molecule, formulation, dose-finding, and phase III design

    Directory of Open Access Journals (Sweden)

    Keppel Hesselink JM

    2017-03-01

    Full Text Available Jan M Keppel Hesselink,1 David J Kopsky,2 Stephen M Stahl3 1Institute Neuropathic Pain, Bosch en Duin, the Netherlands; 2Institute Neuropathic Pain, Amsterdam, the Netherlands; 3University of California San Diego, La Jolla, CA, USA Abstract: Topical analgesics can be defined as topical formulations containing analgesics or co-analgesics. Since 2000, interest in such formulations has been on the rise. There are, however, four critical issues in the research and development phases of topical analgesics: 1 The selection of the active pharmaceutical ingredient. Analgesics and co-analgesics differ greatly in their mechanism of action, and it is required to find the most optimal fit between such mechanisms of action and the pathogenesis of the targeted (neuropathic pain. 2 Issues concerning the optimized formulation. For relevant clinical efficacy, specific characteristics for the selected vehicle (eg, cream base or gel base are required, depending on the physicochemical characteristics of the active pharmaceutical ingredient(s to be delivered. 3 Well-designed phase II dose-finding studies are required, and, unfortunately, such trials are missing. In fact, we will demonstrate that underdosing is one of the major hurdles to detect meaningful and statistically relevant clinical effects of topical analgesics. 4 Selection of clinical end points and innovatively designed phase III trials. End point selection can make or break a trial. For instance, to include numbness together with tingling as a composite end point for neuropathic pain seems stretching the therapeutic impact of an analgesic too far. Given the fast onset of action of topical analgesics (usually within 30 minutes, enrichment designs might enhance the chances for success, as the placebo response might decrease. Topical analgesics may become promising inroads for the treatment of neuropathic pain, once sufficient attention is given to these four key aspects. Keywords: topical, analgesics

  8. Formulation development of retrocyclin 1 analog RC-101 as an anti-HIV vaginal microbicide product.

    Science.gov (United States)

    Sassi, A B; Cost, M R; Cole, A L; Cole, A M; Patton, D L; Gupta, P; Rohan, L C

    2011-05-01

    RC-101 is a synthetic microbicide analog of retrocyclin, which has shown in vitro activity against X4 and R5 HIV-1. In an effort to develop a safe and effective RC-101 vaginal microbicide product, we assessed safety in ex vivo macaque and human models and efficacy using in vitro and ex vivo models. A polyvinyl-alcohol vaginal film containing RC-101 (100 μg/film) was developed. Formulation assessment was conducted by evaluating disintegration, drug content, mechanical properties, and stability. Efficacy was evaluated by in vitro peripheral blood mononuclear cells (PBMC) assay and ex vivo human ectocervical tissue explant model. Ex vivo safety studies were conducted by exposing RC-101 to an excised monkey reproductive tract and excised human ectocervical tissue. RC-101 100 μg films were shown to be safe to human and monkey tissue and effective against HIV-1 in vitro and ex vivo in human ectocervical tissue. The 90% inhibitory concentration (IC90) for RC-101 films at 2,000 μg (IC90=57.5 μM) using an ex vivo model was 10-fold higher than the IC90 observed using an in vitro model (IC90=5.0 μM). RC-101 films were stable for 1 month at 25°C, with in vitro bioactivity maintained for up to 6 months. RC-101 was developed in a quick-dissolve film formulation that was shown to be safe in an ex vivo model and effective in in vitro and ex vivo models. RC-101 film formulations were shown to maintain bioactivity for a period of 6 months. Findings from the present study contribute to the development of a safe and effective topical microbicide product.

  9. Development of gellan gum containing formulations for transdermal drug delivery: Component evaluation and controlled drug release using temperature responsive nanogels.

    Science.gov (United States)

    Carmona-Moran, Carlos A; Zavgorodnya, Oleksandra; Penman, Andrew D; Kharlampieva, Eugenia; Bridges, S Louis; Hergenrother, Robert W; Singh, Jasvinder A; Wick, Timothy M

    2016-07-25

    Enhancing skin permeation is important for development of new transdermal drug delivery formulations. This is particularly relevant for non-steroidal anti-inflammatory drugs (NSAIDs). To address this, semisolid gel and solid hydrogel film formulations containing gellan gum as a gelling agent were developed and the effects of penetration enhancers (dimethyl sulfoxide, isopropyl alcohol and propylene glycol) on transport of the NSAID diclofenac sodium was quantified. A transwell diffusion system was used to accelerate formulation development. After 4h, diclofenac flux from a superior formulation of the semisolid gel or the solid hydrogel film was 130±11μg/cm(2)h and 108±7μg/cm(2)h, respectively, and significantly greater than that measured for a currently available diclofenac sodium topical gel (30±4μg/cm(2)h, ptransdermal drug formulations with adjustable drug transport kinetics. Copyright © 2016 Elsevier B.V. All rights reserved.

  10. Development and application of a biorelevant dissolution method using USP apparatus 4 in early phase formulation development.

    Science.gov (United States)

    Fang, Jiang B; Robertson, Vivian K; Rawat, Archana; Flick, Tawnya; Tang, Zhe J; Cauchon, Nina S; McElvain, James S

    2010-10-04

    Dissolution testing is frequently used to determine the rate and extent at which a drug is released from a dosage form, and it plays many important roles throughout drug product development. However, the traditional dissolution approach often emphasizes its application in quality control testing and usually strives to obtain 100% drug release. As a result, dissolution methods are not necessarily biorelevant and meaningful application of traditional dissolution methods in the early phases of drug product development can be very limited. This article will describe the development of a biorelevant in vitro dissolution method using USP apparatus 4, biorelevant media, and real-time online UV analysis. Several case studies in the areas of formulation selection, lot-to-lot variability, and food effect will be presented to demonstrate the application of this method in early phase formulation development. This biorelevant dissolution method using USP apparatus 4 provides a valuable tool to predict certain aspects of the in vivo drug release. It can be used to facilitate the formulation development/selection for pharmacokinetic (PK) and clinical studies. It may also potentially be used to minimize the number of PK studies, and to aid in the design of more efficient PK and clinical studies.

  11. Characterising lipid lipolysis and its implication in lipid-based formulation development

    DEFF Research Database (Denmark)

    Thomas, Nicky; Holm, Rene; Rades, Thomas

    2012-01-01

    the last decades and several successfully marketed products have shown the potential for LBDDS. However, there exists a discrepancy between the clear need for innovative delivery forms and their rational design. In the case of LBDDS, this can be attributed to the complexity of LBDDS after administration....... Unlike conventional formulations, LBDDS are susceptible to digestion in the gastrointestinal tract, the interplay of delivery system, drug and physiology ultimately effecting drug disposition. In vitro lipolysis has become an important technique to mimic the enzymatic degradation. For the better...... that the increasing knowledge about LBDDS will foster their rationale development thereby increasing their broader application....

  12. Investigations into, and development of, a lyophilized and formulated recombinant human factor IX produced from CHO cells.

    Science.gov (United States)

    Almeida, Aline G; Pinto, Rodrigo C V; Smales, C Mark; Castilho, Leda R

    2017-08-01

    To develop a recombinant human factor IX (rFIX) formulation equivalent to commercially available products in terms of cake appearance, residual moisture, proportion of soluble aggregates and activity maintenance for 3 months at 4-8 °C. NaCl and low bulking agent/cryoprotectant mass ratio had a negative impact on cake quality upon lyophilisation for a wide range of formulations tested. Particular devised formulations maintained rFIX activity after lyophilization with a similar performance when compared with the rFIX formulated using the excipients reported for a commercially available FIX formulation (Benefix). rFIX remained active after 3 months when stored at 4 °C, though this was not the case with samples stored at 40 °C. Interestingly, particular formulations had an increase in residual moisture after 3 months storage, but not above a 3% threshold. All four formulations tested were equivalent to the Benefix formulation in terms of particle size distribution and cake appearance. Three specific formulations, consisting of surfactant polysorbate-80, sucrose or trehalose as cryoprotectant, mannitol or glycine as bulking agent, L-histidine as buffering agent, and NaCl added in the reconstitution liquid at 0.234% (w/v) were suitable for use with a CHO cell-derived recombinant FIX.

  13. Formulation Development, Optimization, and In vitro - In vivo Characterization of Natamycin Loaded PEGylated Nano-lipid Carriers for Ocular Applications.

    Science.gov (United States)

    Patil, Akash; Lakhani, Prit; Taskar, Pranjal; Wu, Kai-Wei; Sweeney, Corinne; Avula, Bharathi; Wang, Yan-Hong; Khan, Ikhlas A; Majumdar, Soumyajit

    2018-04-23

    Current study aimed at formulating and optimizing natamycin (NT) loaded PEGylated NLCs (NT-PEG-NLCs) using Box-Behnken Design and investigating their potential in ocular applications. Response surface methodology (RSM) computations and plots for optimization were performed using Design Expert ® software, to obtain optimum values for response variables based on the criteria of desirability. Optimized NT-PEG-NLCs had predicted values for the dependent variables not significantly different from the experimental values. NT-PEG-NLCs were characterized for their physicochemical parameters; NT's rate of permeation and flux across rabbit cornea was evaluated, in vitro; ocular tissue distribution was assessed in rabbits, in vivo. NT-PEG-NLCs were found to have optimum particle size (< 300 nm) narrow PDI, high NT entrapment and NT content. In vitro transcorneal permeability and flux of NT from NT-PEG-NLCs was significantly higher than Natacyn ® . NT-PEG-NLC (0.3%) showed improved delivery of NT across the intact cornea and provided concentrations statistically similar to the marketed suspension (5%) in inner ocular tissues, in vivo, indicating that it could be a potential alternative to the conventional suspension during the course of fungal keratitis therapy. Copyright © 2018. Published by Elsevier Inc.

  14. In situ monitoring of cocrystals in formulation development using low-frequency Raman spectroscopy.

    Science.gov (United States)

    Otaki, Takashi; Tanabe, Yuta; Kojima, Takashi; Miura, Masaru; Ikeda, Yukihiro; Koide, Tatsuo; Fukami, Toshiro

    2018-05-05

    In recent years, to guarantee a quality-by-design approach to the development of pharmaceutical products, it is important to identify properties of raw materials and excipients in order to determine critical process parameters and critical quality attributes. Feedback obtained from real-time analyses using various process analytical technology (PAT) tools has been actively investigated. In this study, in situ monitoring using low-frequency (LF) Raman spectroscopy (10-200 cm -1 ), which may have higher discriminative ability among polymorphs than near-infrared spectroscopy and conventional Raman spectroscopy (200-1800 cm -1 ), was investigated as a possible application to PAT. This is because LF-Raman spectroscopy obtains information about intermolecular and/or lattice vibrations in the solid state. The monitoring results obtained from Furosemide/Nicotinamide cocrystal indicate that LF-Raman spectroscopy is applicable to in situ monitoring of suspension and fluidized bed granulation processes, and is an effective technique as a PAT tool to detect the conversion risk of cocrystals. LF-Raman spectroscopy is also used as a PAT tool to monitor reactions, crystallizations, and manufacturing processes of drug substances and products. In addition, a sequence of conversion behaviors of Furosemide/Nicotinamide cocrystals was determined by performing in situ monitoring for the first time. Copyright © 2018 Elsevier B.V. All rights reserved.

  15. EDITORIAL: Colloidal suspensions Colloidal suspensions

    Science.gov (United States)

    Petukhov, Andrei; Kegel, Willem; van Duijneveldt, Jeroen

    2011-05-01

    fluid-fluid interface [2]. Together with Remco Tuinier, Henk has recently completed a book in this area which is to appear later this year. A major theme in Henk's research is that of phase transitions in lyotropic liquid crystals. Henk, together with Daan Frenkel and Alain Stroobants, realized in the 1980s that a smectic phase in dispersions of rod-like particles can be stable without the presence of attractive interactions, similar to nematic ordering as predicted earlier by Onsager [3]. Together with Gert-Jan Vroege he wrote a seminal review in this area [4]. Henk once said that 'one can only truly develop one colloidal model system in one's career' and in his case this must be that of gibbsite platelets. Initially Henk's group pursued another polymorph of aluminium hydroxide, boehmite, which forms rod-like particles [5], which already displayed nematic liquid crystal phases. The real breakthrough came when the same precursors treated the produced gibbsite platelets slightly differently. These reliably form a discotic nematic phase [6] and, despite the polydispersity in their diameter, a columnar phase [7]. A theme encompassing a wide range of soft matter systems is that of colloidal dynamics and phase transition kinetics. Many colloidal systems have a tendency to get stuck in metastable states, such as gels or glasses. This is a nuisance if one wishes to study phase transitions, but it is of great practical significance. Such issues feature in many of Henk's publications, and with Valerie Anderson he wrote a highly cited review in this area [8]. Henk Lekkerkerker has also invested significant effort into the promotion of synchrotron radiation studies of colloidal suspensions. He was one of the great supporters of the Dutch-Belgian beamline 'DUBBLE' project at the ESRF [9]. He attended one of the very first experiments in Grenoble in 1999, which led to a Nature publication [7]. He was strongly involved in many other experiments which followed and also has been a

  16. Development of methodologies for dimethylaminoethanol glycolate assay in association with sunscreens in dermocosmetic formulation

    Directory of Open Access Journals (Sweden)

    Daniela Soares Deccache

    2010-12-01

    Full Text Available DMAE glycolate (DG and sunscreens have been used associated in anti-aging dermocosmetic formulations. Despite extensive use of these substances, methods for quantification of DG as raw material and in cosmetic formulations, especially when associated, are not described in the literature. RP-HPLC and non-aqueous titration methods, with determination potentiometric end-point (PT, were developed and validated for rapid assay of DG as raw material and in a topic emulsion in association with sunscreens. Both methods are simple, selective, linear, accurate and precise. The PT method was chosen for stability study of DG in the formulation developed. The proposed formulation presented good stability performance as regards aspect, pH, apparent viscosity, and SPF, with less than 5% of DG degradation compared to initial conditions.Glicolato de DMAE (DG e protetores solares têm sido utilizados associados em formulações dermocosméticas antiidade. Apesar da ampla utilização dessas substâncias, métodos de quantificação para DG matéria-prima e em formulações cosméticas, especialmente quando associados, não estão descritos na literatura. Neste trabalho foram desenvolvidas e validadas metodologias por CLAE-FR e titulação em meio não-aquoso, com determinação do ponto final por potenciométrica (TP, para a rápida análise de DG matéria-prima e em emulsão tópica em associação com fotoprotetores. Ambos os métodos são simples, seletivos, lineares, exatos e precisos. O método TP foi escolhido para o estudo da estabilidade do DG na formulação desenvolvida. A formulação proposta apresentou um bom desempenho no que se refere a estabilidade, aspecto, pH, viscosidade aparente e SPF, com menos de 5% degradação do DG comparado as condições iniciais.

  17. Applicability of low-melting-point microcrystalline wax to develop temperature-sensitive formulations.

    Science.gov (United States)

    Matsumoto, Kohei; Kimura, Shin-Ichiro; Iwao, Yasunori; Itai, Shigeru

    2017-10-30

    Low-melting-point substances are widely used to develop temperature-sensitive formulations. In this study, we focused on microcrystalline wax (MCW) as a low-melting-point substance. We evaluated the drug release behavior of wax matrix (WM) particles using various MCW under various temperature conditions. WM particles containing acetaminophen were prepared using a spray congealing technique. In the dissolution test at 37°C, WM particles containing low-melting-point MCWs whose melting was starting at approx. 40°C (Hi-Mic-1045 or 1070) released the drug initially followed by the release of only a small amount. On the other hand, in the dissolution test at 20 and 25°C for WM particles containing Hi-Mic-1045 and at 20, 25, and 30°C for that containing Hi-Mic-1070, both WM particles showed faster drug release than at 37°C. The characteristic drug release suppression of WM particles containing low-melting-point MCWs at 37°C was thought attributable to MCW melting, as evidenced by differential scanning calorimetry analysis and powder X-ray diffraction analysis. Taken together, low-melting-point MCWs may be applicable to develop implantable temperature-sensitive formulations that drug release is accelerated by cooling at administered site. Copyright © 2017 Elsevier B.V. All rights reserved.

  18. Development and comparison of new high-efficiency dry powder inhalers for carrier-free formulations.

    Science.gov (United States)

    Behara, Srinivas R B; Longest, P Worth; Farkas, Dale R; Hindle, Michael

    2014-02-01

    High-efficiency dry powder inhalers (DPIs) were developed and tested for use with carrier-free formulations across a range of different inhalation flow rates. Performance of a previously reported DPI was compared with two new designs in terms of emitted dose (ED) and aerosolization characteristics using in vitro experiments. The two new designs oriented the capsule chamber (CC) at different angles to the main flow passage, which contained a three-dimensional (3D) rod array for aerosol deaggregation. Computational fluid dynamics simulations of a previously developed deaggregation parameter, the nondimensional specific dissipation (NDSD), were used to explain device performance. Orienting the CC at 90° to the mouthpiece, the CC90 -3D inhaler provided the best performance with an ED = 73.4%, fine particle fractions (FPFs) less than 5 and 1 μm of 95.1% and 31.4%, respectively, and a mass median aerodynamic diameter (MMAD) = 1.5 μm. For the carrier-free formulation, deaggregation was primarily influenced by capsule aperture position and the NDSD parameter. The new CC-3D inhalers reduced the percent difference in FPF and MMAD between low and high flows by 1-2 orders of magnitude compared with current commercial devices. In conclusion, the new CC-3D inhalers produced extremely high-quality aerosols with little sensitivity to flow rate and are expected to deliver approximately 95% of the ED to the lungs. © 2013 Wiley Periodicals, Inc. and the American Pharmacists Association.

  19. Development of Probiotic Formulation for the Treatment of Iron Deficiency Anemia.

    Science.gov (United States)

    Korčok, Davor Jovan; Tršić-Milanović, Nada Aleksandar; Ivanović, Nevena Djuro; Đorđević, Brižita Ivan

    2018-04-01

    Probiotics are increasingly more present both as functional foods, and in pharmaceutical preparations with multiple levels of action that contribute to human health. Probiotics realize their positive effects with a proper dose, and by maintaining a declared number of probiotics cells by the expiration date. Important precondition for developing a probiotic product is the right choice of clinically proven probiotic strain, the choice of other active components, as well as, the optimization of the quantity of active component of probiotic per product dose. This scientific paper describes the optimization of the number of probiotics cells in the formulation of dietary supplement that contains probiotic culture Lactobacillus plantarum 299v, iron and vitamin C. Variations of the quantity of active component were analyzed in development batches of the encapsulated probiotic product categorized as dietary supplement with the following ingredients: probiotic culture, sucrosomal form of iron and vitamin C. Optimal quantity of active component L. plantarum of 50 mg, was selected. The purpose of this scientific paper is to select the optimal formulation of probiotic culture in a dietary supplement that contains iron and vitamin C, and to also determine its expiration date by the analysis of the number of viable probiotic cells.

  20. Development of a new formulation of interferons (HEBERPAG for BCC treatment

    Directory of Open Access Journals (Sweden)

    Bello-Rivero I

    2013-12-01

    Full Text Available Purpose: This work is aimed to show briefly, the clinical development of a new pharmaceutical formulation of interferons for the treatment of basal cell carcinoma. Methods: A rationale design of the combination of IFN-α2b and -γ based in their anti-proliferative synergism on several tumors cell lines identified adequate proportions to be combined to obtain the best clinical results. The potential mechanism of antitumoral effect was studied by qPCR mRNA quantification. HEBERPAG (anti-proliferative synergistic combination of co-formulated recombinant interferons-α2b and –γ was used in clinical trials in adult patients with non-melanoma skin cancer. Trials were conducted after approval by the ethics review boards of the institutions participating in trials; and the patients gave their written informed consent to be enrolled in the studies and receive HEBERPAG. Results: HEBERPAG inhibits the proliferation of several tumor cell lines in vitro and in vivo. The combination has improved pharmacodinamic properties. Several clinical trials have demonstrated the efficacy of HEBERPAG in BCC, with excellent cosmetic effect and well tolerable, mild side effects. HEBERPAG was approved by State Control Center for Drug, Medical Equipment and Devises in Cuba, for the treatment of basal cell carcinoma of any subtype, size and localization, and adjuvant to other treatments, surgical or not. After 3-year follow-up, a recurrence rate of 0.03% was detected in treated patients. Conclusions: HEBERPAG is a novel formulation of IFNs, more potent than separated IFNs for the treatment of basal cell carcinoma, with more rapid and prolonged clinical effect and excellent cosmetic effect and safety profile.

  1. Dermal quercetin smartCrystals®: Formulation development, antioxidant activity and cellular safety.

    Science.gov (United States)

    Hatahet, T; Morille, M; Hommoss, A; Dorandeu, C; Müller, R H; Bégu, S

    2016-05-01

    Flavonoids are natural plant pigments, which possess high antioxidative and antiradical activities. However, their poor water solubility led to a limited bioavailability. To overcome this major hurdle, quercetin nanocrystals were produced implementing smartCrystals® technology. This process combines bead milling and subsequent high-pressure homogenization at relatively low pressure (300bar). To test the possibility to develop a dermal formulation from quercetin smartCrystals®, quercetin nanosuspensions were admixed to Lutrol® F127 and hydroxythylcellulose nonionic gels. The physicochemical properties (morphology, size and charge), saturation solubility, dissolution velocity and the antioxidant properties (DPPH assay) as well as the cellular interaction of the produced quercetin smartCrystals® were studied and compared to crude quercetin powder. Quercetin smartCrystals® showed a strong increase in the saturation solubility and the dissolution velocity (7.6 fold). SmartCrystals® loaded or not into gels proved to be physically stable over a period of three months at 25°C. Interestingly, in vitro DPPH assay confirmed the preservation of quercetin antioxidative properties after nanonization. In parallel, the nanocrystalline form did not display cellular toxicity, even at high concentration (50μg/ml), as assayed on an epithelial cell line (VERO cells). In addition, the nanocrystalline form confirmed a protective activity for VERO cells against hydrogen peroxide induced toxicity in vitro. This new formulation presents a promising approach to deliver quercetin efficiently to skin in well-tolerated formulations. Copyright © 2016 Elsevier B.V. All rights reserved.

  2. Development of an Alternative Glass Formulation for Vitrification of Excess Plutonium

    International Nuclear Information System (INIS)

    MARRA, JAMES

    2006-01-01

    The Department of Energy Office of Environmental Management (DOE/EM) plans to conduct the Plutonium Disposition Project at the Savannah River Site (SRS) to disposition excess weapons-usable plutonium. A plutonium glass waste form is a leading candidate for immobilization of the plutonium for subsequent disposition in a geologic repository. A reference glass composition (Lanthanide Borosilicate (La 2 O 3 -B 2 O 3 -SiO 2 (LaBS))-Frit B) was developed and testing with the LaBS Frit B composition is underway to provide data to support the Yucca Mountain License Application process. The objective of this task was to investigate alternative frit compositions and/or processing conditions that may improve the performance of the reference Frit B-LaBS glass in the repository. The current LaBS Frit B composition was used as the baseline for alternative glass formulation development efforts. A review of the literature and past high actinide concentration glass development efforts was conducted to formulate candidate compositions for testing. Glass science principles were also utilized to determine candidate frit components that may meet task objectives. Additionally, glass processing methods (e.g. slow cooling or induced heat treatment) were investigated as potential means to improve the glass durability and/or minimize fissile material and neutron absorber separation. Based on these analyses, a series of candidate surrogate glasses were fabricated and analyzed. One composition was then selected for fabrication with PuO 2 and subsequently analyzed. A phase equilibrium approach, developed from the assessment of previous high lanthanide glass formulations, was used to recommend modifications to the SRNL Frit B composition. A specific recommendation to increase Ln 2 O 3 content with concurrent reduction of Al 2 O 3 and SiO 2 content proved to be successful in improving the melting behavior and component solubility of the glass. This change moved the formulation from a

  3. Development and characterization of nanoparticulate formulation of a water soluble prodrug of dexamethasone by HIP complexation.

    Science.gov (United States)

    Gaudana, Ripal; Parenky, Ashwin; Vaishya, Ravi; Samanta, Swapan K; Mitra, Ashim K

    2011-01-01

    The objective of this study was to develop and characterize a nanoparticulate-based sustained release formulation of a water soluble dipeptide prodrug of dexamethasone, valine-valine-dexamethasone (VVD). Being hydrophilic in nature, it readily leaches out in the external aqueous medium and hence partitions poorly into the polymeric matrix resulting in minimal entrapment in nanoparticles. Hence, hydrophobic ion pairing (HIP) complexation of the prodrug was employed with dextran sulphate as a complexing polymer. A novel, solid in oil in water emulsion method was employed to encapsulate the prodrug in HIP complex form in poly(lactic-co-glycolic acid) matrix. Nanoparticles were characterized with respect to size, zeta potential, crystallinity of entrapped drug and surface morphology. A significant enhancement in the entrapment of the prodrug in nanoparticles was achieved. Finally, a simple yet novel method was developed which can also be applicable to encapsulate other charged hydrophilic molecules, such as peptides and proteins.

  4. Producing a lycopene nanodispersion: Formulation development and the effects of high pressure homogenization.

    Science.gov (United States)

    Shariffa, Y N; Tan, T B; Uthumporn, U; Abas, F; Mirhosseini, H; Nehdi, I A; Wang, Y-H; Tan, C P

    2017-11-01

    The aim of this study was to develop formulations to produce lycopene nanodispersions and to investigate the effects of the homogenization pressure on the physicochemical properties of the lycopene nanodispersion. The samples were prepared by using emulsification-evaporation technique. The best formulation was achieved by dispersing an organic phase (0.3% w/v lycopene dissolved in dichloromethane) in an aqueous phase (0.3% w/v Tween 20 dissolved in deionized water) at a ratio of 1:9 by using homogenization process. The increased level of homogenization pressure to 500bar reduced the particle size and lycopene concentration significantly (phomogenization pressure (700-900bar) resulted in large particle sizes with high dispersibility. The zeta potential and turbidity of the lycopene nanodispersion were significantly influenced by the homogenization pressure. The results from this study provided useful information for producing small-sized lycopene nanodispersions with a narrow PDI and good stability for application in beverage products. Copyright © 2017 Elsevier Ltd. All rights reserved.

  5. Development of a Topical Resveratrol Formulation for Commercial Applications Using Dendrimer Nanotechnology.

    Science.gov (United States)

    Pentek, Tyler; Newenhouse, Eric; O'Brien, Brennin; Chauhan, Abhay Singh

    2017-01-14

    Resveratrol (RSV) is well known for its anti-oxidant and anti-aging properties. However, resveratrol is insoluble in water and has stability issues. Recently, efforts were placed to prepare a resveratrol-based advanced anti-aging topical product but it contains harsh organic solvents and oils that could be harmful to the human body and the environment. Hence, we propose the use of a multifunctional dendrimer to solve the solubility and stability issues of resveratrol. A dendrimer-resveratrol complex was prepared, optimized and tested for solubility enhancement, stability in solution and cream dosage forms. We have also developed a high performance liquid chromatography method to measure the resveratrol within the final product. PAMAM dendrimers increased the solubility and stability of resveratrol in water and semisolid dosage forms. Therefore, this product would be water based 'green' formulation devoid of harsh organic solvents and oils and can be safely applied to the skin. Additionally, we have shown that the dendrimer helped to increase overall RSV loading and skin penetration of resveratrol. The dendrimer-RSV formulation was successfully scaled up towards commercialization. Dendrimer with RSV has led to an innovation in anti-aging cream and solutions that could be commercially marketed. Dendrimer-RSV complex could also be added to other product forms for additional purposes and applications.

  6. Formulation and development of a self-nanoemulsifying drug delivery system of irbesartan

    Directory of Open Access Journals (Sweden)

    Jaydeep Patel

    2011-01-01

    Full Text Available Irbesartan (IRB is an angiotensin II receptor blocker antihypertensive agent. The aim of the present investigation was to develop a self-nanoemulsifying drug delivery system (SNEDDS to enhance the oral bioavailability of poorly water-soluble IRB. The solubility of IRB in various oils was determined to identify the oil phase of SNEDDS. Various surfactants and co-surfactants were screened for their ability to emulsify the selected oil. Pseudoternary phase diagrams were constructed to identify the efficient self-emulsifying region. The optimized SNEDDS formulation contained IRB (75 mg, Cremophor® EL (43.33%, Carbitol® (21.67% and Capryol® 90 (32%. SNEDDS was further evaluated for its percentage transmittance, emulsification time, drug content, phase separation, dilution, droplet size and zeta potential. The optimized formulation of IRB-loaded SNEDDS exhibited complete in vitro drug release in 15 min as compared with the plain drug, which had a limited dissolution rate. It was also compared with the pure drug solution by oral administration in male Wister rats. The in vivo study exhibited a 7.5-fold increase in the oral bioavailability of IRB from SNEDDS compared with the pure drug solution. These results suggest the potential use of SNEDDS to improve dissolution and oral bioavailability of poorly water-soluble IRB.

  7. Development of UV Curable Overprint Varnishes (OPV) Formulation from Epoxidized Palm Olein Acrylated (EPOLA)

    International Nuclear Information System (INIS)

    Nurul Huda Mudri; Nik Ghazali Nik Salleh; Mek Zah Salleh

    2014-01-01

    The synthesis procedure of Epoxidized Palm Olein Acrylated (EPOLA) has been established by Radiation Curing and Synthesis Group. The quality control test such as acid value, oxirane oxygen content and Fourier- Transform Infra Red (FTIR) were done to monitor the synthesis process. The completion of synthesis process was observed via FTIR with the presence of hydroxyl (-OH) absorption between 3440-3480 cm -1 and an absorption of acrylate groups at 819 cm -1 . The EPOLA was then coated on glass plate and irradiated with UV light. It was found that EPOLA is curable under exposure of UV light and has potential in the application of Overprint Varnishes (OPV). Several formulations have been developed which basically consist of oligomer, monomer, photo initiator EPOLA and additives. The formulations were then coated on black and white paper and irradiated under UV light. The speed of the conveyer was set at 5 m/ min and 20 m/ min during irradiation and the number of passes for the coated substrate to be cured is recorded. The physical characterization such as adhesion and curing rate were observed compared with desirable finished products. (author)

  8. Cream formulation impact on topical administration of engineered colloidal nanoparticles.

    Directory of Open Access Journals (Sweden)

    Benedetta Santini

    Full Text Available In order to minimize the impact of systemic toxicity of drugs in the treatment of local acute and chronic inflammatory reactions, the achievement of reliable and efficient delivery of therapeutics in/through the skin is highly recommended. While the use of nanoparticles is now an established practice for drug intravenous targeted delivery, their transdermal penetration is still poorly understood and this important administration route remains almost unexplored. In the present study, we have synthesized magnetic (iron oxide nanoparticles (MNP coated with an amphiphilic polymer, developed a water-in-oil emulsion formulation for their topical administration and compared the skin penetration routes with the same nanoparticles deposited as a colloidal suspension. Transmission and scanning electron microscopies provided ultrastructural evidence that the amphiphilic nanoparticles (PMNP cream formulation allowed the efficient penetration through all the skin layers with a controllable kinetics compared to suspension formulation. In addition to the preferential follicular pathway, also the intracellular and intercellular routes were involved. PMNP that crossed all skin layers were quantified by inductively coupled plasma mass spectrometry. The obtained data suggests that combining PMNP amphiphilic character with cream formulation improves the intradermal penetration of nanoparticles. While PMNP administration in living mice via aqueous suspension resulted in preferential nanoparticle capture by phagocytes and migration to draining lymph nodes, cream formulation favored uptake by all the analyzed dermis cell types, including hematopoietic and non-hematopoietic. Unlike aqueous suspension, cream formulation also favored the maintenance of nanoparticles in the dermal architecture avoiding their dispersion and migration to draining lymph nodes via afferent lymphatics.

  9. The economics of pediatric formulation development for off-patent drugs.

    Science.gov (United States)

    Milne, Christopher-Paul; Bruss, Jon B

    2008-11-01

    Many drugs currently used in children have never been adequately studied in rigorous scientific trials. Although these medications can still be prescribed in the pediatric setting, they are considered "off-label" because they are not specifically approved for use in children. The role of the Economics Working Group (EWG) within the Pediatric Formulation Initiative (PFI) of the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) is to identify economic barriers and to propose possible mechanisms to create cost-effective and appropriately formulated products for off-patent pediatric drugs and to ensure their distribution and availability. The purpose of this article was to briefly outline the EWG's considerations and recommendations on these topics. Information for this article was gathered from the proceedings of a PFI workshop sponsored by the NICHD, held December 6 and 7, 2005, in Bethesda, Maryland. Other information was based on: the authors' unpublished and published research as well as personal communication with members of the EWG; a comprehensive search of Web sites, publications, and publicly accessible databases of the European Medicines Agency, the US Food and Drug Administration, the Agency for Healthcare Research and Quality, and the NICHD; and the databases and publications available from the Louis Lasagna Library of the Tufts Center for the Study of Drug Development (Boston, Massachusetts). The US Congress has attempted to remedy the lack of incentives to develop pediatric drugs by passing 2 key pieces of legislation. After >10 years, this US pediatric initiative has stimulated a great deal of pediatric drug research, and similar initiatives have been emulated in Europe and proposed in Japan. Although the initiative is generally considered successful in the United States, an incentive gap exists that still hinders pediatric drug development. It results from a series of factors, including: (1) a relatively small

  10. Separation of pigment formulations by high-performance thin-layer chromatography with automated multiple development.

    Science.gov (United States)

    Stiefel, Constanze; Dietzel, Sylvia; Endress, Marc; Morlock, Gertrud E

    2016-09-02

    Food packaging is designed to provide sufficient protection for the respective filling, legally binding information for the consumers like nutritional facts or filling information, and an attractive appearance to promote the sale. For quality and safety of the package, a regular quality control of the used printing materials is necessary to get consistently good print results, to avoid migration of undesired ink components into the food and to identify potentially faulty ink batches. Analytical approaches, however, have hardly been considered for quality assurance so far due to the lack of robust, suitable methods for the analysis of rarely soluble pigment formulations. Thus, a simple and generic high-performance thin-layer chromatography (HPTLC) method for the separation of different colored pigment formulations was developed on HPTLC plates silica gel 60 by automated multiple development. The gradient system provided a sharp resolution for differently soluble pigment constituents like additives and coating materials. The results of multi-detection allowed a first assignment of the differently detectable bands to particular chemical substance classes (e.g., lipophilic components), enabled the comparison of different commercially available pigment batches and revealed substantial variations in the composition of the batches. Hyphenation of HPTLC with high resolution mass spectrometry and infrared spectroscopy allowed the characterization of single unknown pigment constituents, which may partly be responsible for known quality problems during printing. The newly developed, precise and selective HPTLC method can be used as part of routine quality control for both, incoming pigment batches and monitoring of internal pigment production processes, to secure a consistent pigment composition resulting in consistent ink quality, a faultless print image and safe products. Hyphenation of HPTLC with the A. fischeri bioassay gave first information on the bioactivity or rather

  11. Development of corotational formulated FEM for application to 30m class large deployable reflector

    International Nuclear Information System (INIS)

    Ozawa, Satoru; Fujiwara, Yuuichi; Tsujihata, Akio

    2010-01-01

    JAXA, Japan Aerospace Exploration Agency, is now developing a corotational formulated finite element analysis method and its software 'Origami/ETS' for the development of 30m class large deployable reflectors. For the reason that the deployable reflector is composed of beams, cables and mesh, this analysis method is generalized for finite elements with multiple nodes, which are commonly used in linear finite element analyses. The large displacement and rotation are taken into account by the corotational formulation. The tangent stiffness matrix for finite elements with multiple nodes is obtained as follows; the geometric stiffness matrix of two node elements is derived by taking variation of the element's corotational matrix from the virtual work of finite elements with large displacement; similarly the geometric stiffness matrix for three node elements is derived; as the extension of two and three node element theories, the geometric stiffness matrix for multiple node elements is derived; with the geometric stiffness matrix for multiple node elements, the tangent stiffness matrix is obtained. The analysis method is applied for the deployment analysis and static structural analysis of the 30m class large deployable reflector. In the deployment analysis, it is confirmed that this method stably analyzes the deployment motion from the deployment configuration to the stowed configuration of the reflector. In the static analysis, it is confirmed that the mesh structure is analyzed successfully. The 30m class large deployable reflector is now still being developed and is about to undergo several tests with its prototypes. This analysis method will be used in the tests and verifications of the reflector.

  12. Adaptive tracking control for active suspension systems with non-ideal actuators

    Science.gov (United States)

    Pan, Huihui; Sun, Weichao; Jing, Xingjian; Gao, Huijun; Yao, Jianyong

    2017-07-01

    As a critical component of transportation vehicles, active suspension systems are instrumental in the improvement of ride comfort and maneuverability. However, practical active suspensions commonly suffer from parameter uncertainties (e.g., the variations of payload mass and suspension component parameters), external disturbances and especially the unknown non-ideal actuators (i.e., dead-zone and hysteresis nonlinearities), which always significantly deteriorate the control performance in practice. To overcome these issues, this paper synthesizes an adaptive tracking control strategy for vehicle suspension systems to achieve suspension performance improvements. The proposed control algorithm is formulated by developing a unified framework of non-ideal actuators rather than a separate way, which is a simple yet effective approach to remove the unexpected nonlinear effects. From the perspective of practical implementation, the advantages of the presented controller for active suspensions include that the assumptions on the measurable actuator outputs, the prior knowledge of nonlinear actuator parameters and the uncertain parameters within a known compact set are not required. Furthermore, the stability of the closed-loop suspension system is theoretically guaranteed by rigorous mathematical analysis. Finally, the effectiveness of the presented adaptive control scheme is confirmed using comparative numerical simulation validations.

  13. Development and stability studies of sunscreen cream formulations containing three photo-protective filters

    OpenAIRE

    Smaoui, Slim; Ben Hlima, Hajer; Ben Chobba, Ines; Kadri, Adel

    2013-01-01

    The present study aimed to formulate and subsequently evaluate sunscreen cream (W/O/W emulsion) containing three photo-protective filters: benzophenone-3, ethylhexyl methoxycinnamate and titanium dioxide at different percentages. Formulations were stored at 8, 25 and 40 °C for four weeks to investigate their stability. Color, centrifugation, liquefaction, phase separation, pH and Sun Protection Factor (SPF) of sunscreen cream formulations were determined. The microbiological stability of the ...

  14. Development of a falling ball rheometer with applications to opaque systems: measurements of the rheology of suspensions of rods

    International Nuclear Information System (INIS)

    Powell, R.L.; Mondy, L.A.; Stoker, G.G.; Milliken, W.J.; Graham, A.L.

    1989-01-01

    With falling ball rheometry, we have measured the apparent relative viscosity of suspensions of large, neutrally buoyant, rigid rods in a viscous Newtonian fluid, while approximately maintaining the rods in a randomly oriented configuration. A new technique for measuring the time of flight of a ball between two positions is used. This computerized technique, based upon an eddy current detector, enables us to determine the position of a metallic (nonmagnetic) ball falling through an opaque suspension, with high accuracy (less than 1.5% error). The rods for the suspensions had a nominal aspect ratio of 10 and experiments were carried out at a single volume fraction, 0.05. Two populations of rods were used to having nominal diameters of 1.5875 mm and 3.175 mm. To within the errors of these experiments, suspensions from both populations had the same relative viscosity, with the overall average being 1.457. This viscosity was significantly different from that of a similar suspension (volume fraction=0.05) of rods of nominal aspect ratio 20 and it agreed well with theoretical results for the viscosity of a dilute suspension of randomly oriented rods

  15. Development of a nanoparticulate formulation of diminazene to treat African trypanosomiasis

    Energy Technology Data Exchange (ETDEWEB)

    Kroubi, Maya; Betbeder, Didier [EA 4483, IFR 114 IMPRT, Faculte de Medecine, Pole recherche, Departement de Physiologie, 1 place de Verdun, 59045 Lille Cedex (France); Daulouede, Sylvie; Mossalayi, Djavad; Vincendeau, Philippe [Laboratoire de Parasitologie, Universite Victor Segalen Bordeaux 2, 146 rue Leo Saignat, 33076 Bordeaux Cedex (France); Karembe, Hamadi [CEVA Sante Animale, ZI la Ballastiere, BP 126, 33501 Libourne (France); Jallouli, Youssef [Faculte de Pharmacie, Universite de Lille 2, 3 rue du Professeur Laguesse, 59006 Lille (France); Howsam, Mike, E-mail: dbetbeder@aol.com [Centre Universitaire de Mesure et d' Analyse, Faculte de Pharmacie, Universite de Lille 2, 3 rue du Professeur Laguesse, 59006 Lille (France)

    2010-12-17

    There is a real need to develop new therapeutic strategies for African trypanosomiasis infections. In our study, we developed a new drug delivery system of diminazene (DMZ), a trypanocidal drug registered for veterinary use. This drug candidate presents a limited efficacy, a poor affinity for brain tissue and instability. The development of colloidal formulations based on a porous cationic nanoparticle with an oily core ({sub 70}DGNP{sup +}), has potentially two advantages: stabilization of the drug and potential targeting of the parasite. We analyzed two processes of drug loading: in process (DMZ was added during the preparation of {sub 70}DGNP{sup +} at 80 deg. C) and post-loading (DMZ was mixed with a {sub 70}DGNP{sup +} solution at room temperature). Poor stability of the drug was observed using the in process technique. When using the post-loading technique over 80% drug entrapment efficiency was obtained at a ratio of DMZ:phospholipids (wt:wt) < 5%. Moreover, DMZ loaded into {sub 70}DGNP{sup +} was found to be protected against oxidation and was stable for at least six months at 4 deg. C. Finally, in vitro tests on T.b. brucei showed an increased efficacy of DMZ loaded in {sub 70}DGNP{sup +}.

  16. Application of two component biodegradable carriers in a particle-fixed biofilm airlift suspension reactor: development and structure of biofilms.

    Science.gov (United States)

    Hille, Andrea; He, Mei; Ochmann, Clemens; Neu, Thomas R; Horn, Harald

    2009-01-01

    Two component biodegradable carriers for biofilm airlift suspension (BAS) reactors were investigated with respect to development of biofilm structure and oxygen transport inside the biofilm. The carriers were composed of PHB (polyhydroxybutyrate), which is easily degradable and PCL (caprolactone), which is less easily degradable by heterotrophic microorganisms. Cryosectioning combined with classical light microscopy and CLSM was used to identify the surface structure of the carrier material over a period of 250 days of biofilm cultivation in an airlift reactor. Pores of 50 to several hundred micrometers depth are formed due to the preferred degradation of PHB. Furthermore, microelectrode studies show the transport mechanism for different types of biofilm structures, which were generated under different substrate conditions. At high loading rates, the growth of a rather loosely structured biofilm with high penetration depths of oxygen was found. Strong changes of substrate concentration during fed-batch mode operation of the reactor enhance the growth of filamentous biofilms on the carriers. Mass transport in the outer regions of such biofilms was mainly driven by advection.

  17. Stabilized Polymer Micelles for the Development of IT-147, an Epothilone D Drug-Loaded Formulation

    Directory of Open Access Journals (Sweden)

    Adam Carie

    2016-01-01

    Full Text Available Epothilones have demonstrated promising potential for oncology applications but suffer from a narrow therapeutic window. Epothilone D stabilizes microtubules leading to apoptosis, is active against multidrug-resistant cells, and is efficacious in animal tumor models despite lack of stability in rodent plasma. Clinical development was terminated in phase II due to dose limiting toxicities near the efficacious dose. Taken together, this made epothilone D attractive for encapsulation in a stabilized polymer micelle for improved safety and efficacy. We have designed a library of triblock copolymers to develop IT-147, a lead formulation of epothilone D that extends plasma circulation for accumulation in the tumor environment, and potentially decrease systemic exposure to reduce dose limiting toxicities. The drug loading efficiency for IT-147 exceeds 90%, is 75 nm in diameter, and demonstrates pH-dependent release of epothilone D without chemical conjugation or enzymatic activation. Administration of IT-147 at 20 mg/kg increases exposure of epothilone D to the plasma compartment over 6-fold compared to free drug. At the same dose, 20 mg/kg epothilone D from IT-147 is considered the no observed adverse effect level (NOAEL but is the maximum tolerated dose for free drug. Consequently, IT-147 is positioned to be a safer, more effective means to deliver epothilone D.

  18. Study on Mixed Solvency Concept in Formulation Development of Aqueous Injection of Poorly Water Soluble Drug

    Directory of Open Access Journals (Sweden)

    Shailendra Singh Solanki

    2013-01-01

    Full Text Available In the present investigation, mixed-solvency approach has been applied for the enhancement of aqueous solubility of a poorly water- soluble drug, zaltoprofen (selected as a model drug, by making blends (keeping total concentrations 40% w/v, constant of selected water-soluble substances from among the hydrotropes (urea, sodium benzoate, sodium citrate, nicotinamide; water-soluble solids (PEG-4000, PEG-6000; and co-solvents (propylene glycol, glycerine, PEG-200, PEG-400, PEG-600. Aqueous solubility of drug in case of selected blends (12 blends ranged from 9.091 ± 0.011 mg/ml–43.055 ± 0.14 mg/ml (as compared to the solubility in distilled water 0.072 ± 0.012 mg/ml. The enhancement in the solubility of drug in a mixed solvent containing 10% sodium citrate, 5% sodium benzoate and 25 % S cosolvent (25% S cosolvent contains PEG200, PEG 400, PEG600, Glycerine and Propylene glycol was more than 600 fold. This proved a synergistic enhancement in solubility of a poorly water-soluble drug due to mixed cosolvent effect. Each solubilized product was characterized by ultraviolet and infrared techniques. Various properties of solution such as pH, viscosity, specific gravity and surface tension were studied. The developed formulation was studied for physical and chemical stability. This mixed solvency shall prove definitely a boon for pharmaceutical industries for the development of dosage form of poorly water soluble drugs.

  19. Development and validation of Ketorolac Tromethamine in eye drop formulation by RP-HPLC method

    Directory of Open Access Journals (Sweden)

    G. Sunil

    2017-02-01

    Full Text Available A simple, precise and accurate method was developed and validated for analysis of Ketorolac Tromethamine in eye drop formulation. An isocratic HPLC analysis was performed on Kromosil C18 column (150 cm × 4.6 mm × 5 μm. The compound was separated with the mixture of methanol and ammonium dihydrogen phosphate buffer in the ratio of 55:45 V/V, pH 3.0 was adjusted with O-phosphoric acid as the mobile phase at flow of 1.5 mL min−1. UV detection was performed at 314 nm using photo diode array detection. The retention time was found to be 6.01 min. The system suitability parameters such as theoretical plate count, tailing and percentage RSD between six standard injections were within the limit. The method was validated according to ICH guidelines. Calibrations were linear over the concentration range of 50–150 μg mL−1 as indicated by correlation coefficient (r of 0.999. The robustness of the method was evaluated by deliberately altering the chromatographic conditions. The developed method can be applicable for routine quantitative analysis.

  20. Formulation of an aloe-based product according to Iranian traditional medicine and development of its analysis method.

    Science.gov (United States)

    Moein, Elham; Hajimehdipoor, Homa; Toliyat, Tayebeh; Choopani, Rasool; Hamzeloo-Moghadam, Maryam

    2017-08-29

    Currently, people are more interested to traditional medicine. The traditional formulations should be converted to modern drug delivery systems to be more acceptable for the patients. In the present investigation, a poly herbal medicine "Ayarij-e-Faiqra" (AF) based on Iranian traditional medicine (ITM) has been formulated and its quality control parameters have been developed. The main ingredients of AF including barks of Cinnamomum zeylanicum Blume and Cinnamomum cassia J. Presl, the rhizomes of Nardostachys jatamansi DC., the fruits of Piper cubeba L.f., the flowers of Rosa damascena Herrm., the oleo gum resin of Pistacia terebinthus L. and Aloe spp. dried juice were powdered and used for preparing seven tablet formulations of the herbal mixture. Flowability of the different formulated powders was examined and the best formulations were selected (F6&F7). The tablets were prepared from the selected formulations compared according to the physical characteristics and finally, F7 was selected and coated. Physicochemical characters of core and coated AF tablets were determined and the HPLC method for quantitation of aloin as a marker of tablets was selected and verified according to selectivity, linearity, precision, recovery, LOD and LOQ. The results showed that core and coated AF tablets were in agreement with USP requirements for herbal drugs. They had acceptable appearance, disintegration time, friability, hardness, dissolution behavior, weight variation and content uniformity. The amount of aloin in tablets was found 123.1 mg/tab. The HPLC method for aloin determination in AF tablets was verified according to selectivity, linearity (5-500 μg/ml, r 2 :0.9999), precision (RSD: 1.62%), recovery (108.0%), LOD & LOQ (0.0053 & 0.0161 μg/ml). The formulated tablets could be a good substitute for powder and capsules of AF in ITM clinics with a feasible and precise method for its quality control. Ayarij-e-Faiqra formulation.

  1. Development of a Highly Biocompatible Antituberculosis Nanodelivery Formulation Based on Para-Aminosalicylic Acid—Zinc Layered Hydroxide Nanocomposites

    Science.gov (United States)

    Arulselvan, Palanisamy; El Zowalaty, Mohamed Ezzat; Fakurazi, Sharida; Webster, Thomas J.; Geilich, Benjamin; Hussein, Mohd Zobir

    2014-01-01

    Tuberculosis is a lethal epidemic, difficult to control disease, claiming thousands of lives every year. We have developed a nanodelivery formulation based on para-aminosalicylic acid (PAS) and zinc layered hydroxide using zinc nitrate salt as a precursor. The developed formulation has a fourfold higher efficacy of PAS against mycobacterium tuberculosis with a minimum inhibitory concentration (MIC) found to be at 1.40 μg/mL compared to the free drug PAS with a MIC of 5.0 μg/mL. The newly developed formulation was also found active against Gram-positive bacteria, Gram-negative bacteria, and Candida albicans. The formulation was also found to be biocompatible with human normal lung cells MRC-5 and mouse fibroblast cells-3T3. The in vitro release of PAS from the formulation was found to be sustained in a human body simulated phosphate buffer saline (PBS) solution at pH values of 7.4 and 4.8. Most importantly the nanocomposite prepared using zinc nitrate salt was advantageous in terms of yield and free from toxic zinc oxide contamination and had higher biocompatibility compared to one prepared using a zinc oxide precursor. In summary, these promising in vitro results are highly encouraging for the continued investigation of para-aminosalicylic acid and zinc layered hydroxide nanocomposites in vivo and eventual preclinical studies. PMID:25050392

  2. Development of a second generation torsion balance based on a spherical superconducting suspension

    Science.gov (United States)

    Hammond, Giles D.; Speake, Clive C.; Matthews, Anthony J.; Rocco, Emanuele; Peña-Arellano, Fabian

    2008-02-01

    This paper describes the development of a second generation superconducting torsion balance to be used for a precision measurement of the Casimir force and a short range test of the inverse square law of gravity at 4.2K. The instrument utilizes niobium (Nb) as the superconducting element and employs passive damping of the parasitic modes of oscillation. Any contact potential difference between the torsion balance and its surroundings is nulled to within ≈50mV by applying known DC biases and fitting the resulting parabolic relationship between the measured torque and the applied voltage. A digital proportional-integral-derivative servo system has been developed and characterized in order to control the azimuthal position of the instrument. The angular acceleration and displacement noise are currently limited by the capacitive sensor at the level 3×10-8rads-2/√Hz and 30nm/√Hz at 100mHz. The possibility of lossy dielectric coatings on the surface of the torsion balance test masses is also investigated. Our measurements show that the loss angles δ are (1.5±2.3)×10-4 and (2.0±2.2)×10-4 at frequencies of 5 and 10mHz, respectively. These values of loss are not significant sources of error for measurements of the Casimir force using this experimental setup.

  3. Challenges Involved in the Development and Delivery of Abuse-deterrent Formulations of Opioid Analgesics.

    Science.gov (United States)

    Cohen, Joshua P; Mendoza, Mario; Roland, Carl

    2018-02-01

    This commentary examines the development, regulatory, and reimbursement challenges facing abuse-deterrent formulation (ADF) products. In January 2017, the Tufts Center for the Study of Drug Development convened a roundtable to explore clinical development, regulatory, and reimbursement challenges with respect to ADFs of opioid analgesics. Roundtable participants, who included a range of pharmaceutical industry and other experts, discussed multiple challenges. First, several key clinical development challenges were identified and discussed. These challenges pertain to prodrug development and development of deterrents against oral abuse. Second, experts suggested that more clarity is needed from regulatory authorities regarding standards for proving ADF labeling claims and for being rewarded with 3-year data exclusivity. Similarly, given the substantial burdens associated with the development of postapproval evidence generation, experts raised the need for a consistent regulatory policy related to postapproval evidence generation for all ADFs (branded and generic). Third, despite the public health benefits of certain ADF products, current coverage and access policies impede patient access. Payer justification for restrictive policies appears to be based more on budget impact considerations than cost-effectiveness. Fourth, there remains a need to further expand the evidence base regarding clinical and cost-effectiveness as well as abuse deterrence in a real-world setting for all ADF products. Clinical development challenges need to be overcome with respect to novel ADF technologies, such as prodrugs and deterrents against oral abuse. More clarity is needed from regulatory authorities on labeling claims and data exclusivity eligibility with respect to ADFs. Ensuring prescriber training and awareness of various options for treating pain, including ADF products, is an important step, as is educating payers about the public health benefits of ADFs in appropriate

  4. Formulation development of the biocontrol agent Bacillus subtilis strain CPA-8 by spray-drying.

    Science.gov (United States)

    Yánez-Mendizábal, V; Viñas, I; Usall, J; Torres, R; Solsona, C; Abadias, M; Teixidó, N

    2012-05-01

    To prepare commercially acceptable formulations of Bacillus subtilis CPA-8 by spray-drying with long storage life and retained efficacy to control peach and nectarine brown rot caused by Monilinia spp. CPA-8 24-h- and 72-h-old cultures were spray dried using 10% skimmed milk, 10% skimmed milk plus 10% MgSO(4) , 10% MgSO(4) and 20% MgSO(4) as carriers/protectants. All carriers/protectants gave good percentages of powder recovery (28-38%) and moisture content (7-13%). CPA-8 survival varied considerably among spray-dried 24-h- and 72-h-old cultures. Seventy-two hours culture spray dried formulations showed the highest survival (28-32%) with final concentration products of 1·6-3·3 × 10(9) CFU g(-1) , while viability of 24-h-old formulations was lower than 1%. Spray-dried 72-h-old formulations were selected to subsequent evaluation. Rehydration of cells with water provided a good recovery of CPA-8 dried cells, similar to other complex rehydration media tested. Spray-dried formulations stored at 4 ± 1 and 20 ± 1°C showed good shelf life during 6 months, and viability was maintained or slightly decreased by 0·2-0·3-log. CPA-8 formulations after 4- and 6 months storage were effective in controlling brown rot caused by Monilinia spp. on nectarines and peaches resulting in a 90-100% reduction in disease incidence. Stable and effective formulations of biocontrol agent B. subtilis CPA-8 could be obtained by spray-drying. New shelf-stable and effective formulations of a biocontrol agent have been obtained by spray-drying to control brown rot on peach. © 2012 The Authors. Journal of Applied Microbiology © 2012 The Society for Applied Microbiology.

  5. Topical Formulation Comprising Fatty Acid Extract from Cod Liver Oil: Development, Evaluation and Stability Studies.

    Science.gov (United States)

    Ilievska, Biljana; Loftsson, Thorsteinn; Hjalmarsdottir, Martha Asdis; Asgrimsdottir, Gudrun Marta

    2016-06-01

    The purpose of this study was to develop a pharmaceutical formulation containing fatty acid extract rich in free omega-3 fatty acids such as eicosapentaenoic acid and docosahexaenoic acid for topical use. Although the health benefits of cod liver oil and other fish oils taken orally as a dietary supplement have been acknowledged and exploited, it is clear that their use can be extended further to cover their antibacterial properties. In vitro evaluation showed that 20% (v/v) fatty acid extract exhibits good activity against strains of the Gram-positive bacteria Staphylococcus aureus, Enterococcus faecalis, Streptoccoccus pyogenes and Streptoccoccus pneumonia. Therefore, free polyunsaturated fatty acids from cod liver oil or other fish oils can be used as safe and natural antibacterial agents. In this study, ointment compositions containing free fatty acids as active antibacterial agents were prepared by using various natural waxes and characterized. The effects of different waxes, such as carnauba wax, ozokerite wax, laurel wax, beeswax, rice bran wax, candelilla wax and microcrystalline wax, in the concentration range of 1% to 5% (w/w) on the ointment texture, consistency and stability were evaluated. The results showed significant variations in texture, sensory and rheological profiles. This was attributed to the wax's nature and chain composition. Microcrystalline wax gave the best results but laurel wax, beeswax and rice bran wax exhibited excellent texturing, similar sensory profiles and well-balanced rheological properties.

  6. Topical Formulation Comprising Fatty Acid Extract from Cod Liver Oil: Development, Evaluation and Stability Studies

    Directory of Open Access Journals (Sweden)

    Biljana Ilievska

    2016-06-01

    Full Text Available The purpose of this study was to develop a pharmaceutical formulation containing fatty acid extract rich in free omega-3 fatty acids such as eicosapentaenoic acid and docosahexaenoic acid for topical use. Although the health benefits of cod liver oil and other fish oils taken orally as a dietary supplement have been acknowledged and exploited, it is clear that their use can be extended further to cover their antibacterial properties. In vitro evaluation showed that 20% (v/v fatty acid extract exhibits good activity against strains of the Gram-positive bacteria Staphylococcus aureus, Enterococcus faecalis, Streptoccoccus pyogenes and Streptoccoccus pneumonia. Therefore, free polyunsaturated fatty acids from cod liver oil or other fish oils can be used as safe and natural antibacterial agents. In this study, ointment compositions containing free fatty acids as active antibacterial agents were prepared by using various natural waxes and characterized. The effects of different waxes, such as carnauba wax, ozokerite wax, laurel wax, beeswax, rice bran wax, candelilla wax and microcrystalline wax, in the concentration range of 1% to 5% (w/w on the ointment texture, consistency and stability were evaluated. The results showed significant variations in texture, sensory and rheological profiles. This was attributed to the wax’s nature and chain composition. Microcrystalline wax gave the best results but laurel wax, beeswax and rice bran wax exhibited excellent texturing, similar sensory profiles and well-balanced rheological properties.

  7. Overview of Development and Formulation of ¹⁷⁷Lu-DOTA-TATE for PRRT.

    Science.gov (United States)

    Breeman, Wouter A P; Chan, Ho Sze; de Zanger, Rory M S; Konijnenberg, Mark K; de Blois, Erik

    2016-01-01

    Peptide receptor radionuclide therapy (PRRT) using radiolabeled somatostatin analogs has become an established procedure for the treatment of patients suffering from inoperable neuroendocrine cancers over-expressing somatostatin receptors. Success of PRRT depends on the availability of the radiolabeled peptide with adequately high specific activity, so that required therapeutic efficacy can be achieved without saturating the limited number of receptors available on the target lesions. Specific activity of the radionuclide and the radiolabeled somatostatin analog are therefore an important parameters. Although these analogs have been investigated and improved, and successfully applied for PRRT for more than 15 years, there are still many possibilities for further improvements that fully exploit PRRT with 177Lu-DOTA-TATE. The here summarized data presented herein on increased knowledge of the components of 177Lu-DOTA-TATE (especially the purity of 177Lu and specific activity of 177Lu) and the reaction kinetics during labeling 177Lu-DOTA-TATE clearly show that the peptide dose and dose in GBq can be varied. Here we present an overview of the development, formulation and optimisation of 177Lu-DOTA-TATE, mainly addressing radiochemical parameters.

  8. Development of formulations and processes to incorporate wax oleogels in ice cream.

    Science.gov (United States)

    Zulim Botega, Daniele C; Marangoni, Alejandro G; Smith, Alexandra K; Goff, H Douglas

    2013-12-01

    The objective of this study was to investigate the influence of emulsifiers, waxes, fat concentration, and processing conditions on the application of wax oleogel to replace solid fat content and create optimal fat structure in ice cream. Ice creams with 10% or 15% fat were formulated with rice bran wax (RBW), candelilla wax (CDW), or carnauba wax (CBW) oleogels, containing 10% wax and 90% high-oleic sunflower oil. The ice creams were produced using batch or continuous freezing processes. Transmission electron microscopy (TEM) and cryo-scanning electron microscopy were used to evaluate the microstructure of ice cream and the ultrastructure of oleogel droplets in ice cream mixes. Among the wax oleogels, RBW oleogel had the ability to form and sustain structure in 15% fat ice creams when glycerol monooleate (GMO) was used as the emulsifier. TEM images revealed that the high degree of fat structuring observed in GMO samples was associated with the RBW crystal morphology within the fat droplet, which was characterized by the growth of crystals at the outer edge of the droplet. Continuous freezing improved fat structuring compared to batch freezing. RBW oleogels established better structure compared to CDW or CBW oleogels. These results demonstrate that RBW oleogel has the potential to develop fat structure in ice cream in the presence of GMO and sufficiently high concentrations of oleogel. © 2013 Institute of Food Technologists®

  9. Role of In Vitro Release Methods in Liposomal Formulation Development: Challenges and Regulatory Perspective.

    Science.gov (United States)

    Solomon, Deepak; Gupta, Nilesh; Mulla, Nihal S; Shukla, Snehal; Guerrero, Yadir A; Gupta, Vivek

    2017-11-01

    In the past few years, measurement of drug release from pharmaceutical dosage forms has been a focus of extensive research because the release profile obtained in vitro can give an indication of the drug's performance in vivo. Currently, there are no compendial in vitro release methods designed for liposomes owing to a range of experimental challenges, which has created a major hurdle for both development and regulatory acceptance of liposome-based drug products. In this paper, we review the current techniques that are most often used to assess in vitro drug release from liposomal products; these include the membrane diffusion techniques (dialysis, reverse dialysis, fractional dialysis, and microdialysis), the sample-and-separate approach, the in situ method, the continuous flow, and the modified United States Pharmacopeia methods (USP I and USP IV). We discuss the principles behind each of the methods and the criteria that assist in choosing the most appropriate method for studying drug release from a liposomal formulation. Also, we have included information concerning the current regulatory requirements for liposomal drug products in the United States and in Europe. In light of increasing costs of preclinical and clinical trials, applying a reliable in vitro release method could serve as a proxy to expensive in vivo bioavailability studies. Graphical Abstract Appropriate in-vitro drug release test from liposomal products is important to predict the in-vivo performance.

  10. Increasing Possibilities of Nano suspension

    International Nuclear Information System (INIS)

    Sutradhar, K.B.; Khatun, S.; Luna, I.P.

    2013-01-01

    Nowadays, a very large proportion of new drug candidates emerging from drug discovery programmes are water insoluble and thus poorly bioavailable. To avoid this problem, nano technology for drug delivery has gained much interest as a way to improve the solubility problems. Nano refers to particles size range of 1-1000 nm. The reduction of drug particles into the submicron range leads to a significant increase in the dissolution rate and therefore enhances bioavailability. Nanosuspensions are part of nano technology. This interacts with the body at subcellular (i.e., molecular) scales with a high degree of specificity and can be potentially translated into targeted cellular and tissue-specific clinical applications designed to achieve maximal therapeutic efficacy with minimal side effects. Production of drugs as nanosuspensions can be developed for drug delivery systems as an oral formulation and no noral administration. Here, this review describes the methods of pharmaceutical nano suspension production including advantages and disadvantages, potential benefits, characterization tests, and pharmaceutical applications in drug delivery

  11. Self-emulsifying drug delivery systems (SEDDS): formulation development, characterization, and applications.

    Science.gov (United States)

    Singh, Bhupinder; Bandopadhyay, Shantanu; Kapil, Rishi; Singh, Ramandeep; Katare, O

    2009-01-01

    Self-emulsifying drug delivery systems (SEDDS) possess unparalleled potential in improving oral bioavailability of poorly water-soluble drugs. Following their oral administration, these systems rapidly disperse in gastrointestinal fluids, yielding micro- or nanoemulsions containing the solubilized drug. Owing to its miniscule globule size, the micro/nanoemulsifed drug can easily be absorbed through lymphatic pathways, bypassing the hepatic first-pass effect. We present an exhaustive and updated account of numerous literature reports and patents on diverse types of self-emulsifying drug formulations, with emphasis on their formulation, characterization, and systematic optimization strategies. Recent advancements in various methodologies employed to characterize their globule size and shape, ability to encapsulate the drug, gastrointestinal and thermodynamic stability, rheological characteristics, and so forth, are discussed comprehensively to guide the formula-tor in preparing an effective and robust SEDDS formulation. Also, this exhaustive review offers an explicit discussion on vital applications of the SEDDS in bioavailability enhancement of various drugs, outlining an overview on myriad in vitro, in situ, and ex vivo techniques to assess the absorption and/ or permeation potential of drugs incorporated in the SEDDS in animal and cell line models, and the subsequent absorption pathways followed by them. In short, the current article furnishes an updated compilation of wide-ranging information on all the requisite vistas of the self-emulsifying formulations, thus paving the way for accelerated progress into the SEDDS application in pharmaceutical research.

  12. Novel technology to prepare oral formulations for preclinical safety studies.

    Science.gov (United States)

    Niwa, Toshiyuki; Hashimoto, Naofumi

    2008-02-28

    A novel method to prepare oral formulations, normally suspended dosage form, for preclinical safety studies in animals has been developed using a rotation/revolution mixer. Small hard balls made of zirconia were added to the mixing process to evaluate effectiveness in making a high quality suspension. The driving with balls loaded in the cylindrical container (vessel) of the mixer was quite efficient in dispersing and milling the particles of the active pharmaceutical ingredient (API) in an aqueous medium. The API powder and a small amount of oral aqueous medium (vehicle) were successfully mixed by the spinning motion of the balls in the vessel as though the paste-like suspension was kneaded with a mortar and pestle. It was found that the milled suspension with the mean size of 10-20microm could be prepared, in addition finer milling of less than 10microm could be achieved by selecting the material of vessel. Optimum driving conditions including mixing time, size and quantity of balls, and the standard operational procedure was established using compounds varying in physicochemical properties. The particle size and quantitative analysis by HPLC showed that the resultant suspension was well-milled and highly homogeneous with the nearly intended concentration of API. The proposed method established by this experiment could be applied to the actual safety studies in the real preparation scale of oral suspension.

  13. Development of a New Aprepitant Liquisolid Formulation with the Aid of Artificial Neural Networks and Genetic Programming.

    Science.gov (United States)

    Barmpalexis, Panagiotis; Grypioti, Agni; Eleftheriadis, Georgios K; Fatouros, Dimitris G

    2018-02-01

    In the present study, liquisolid formulations were developed for improving dissolution profile of aprepitant (APT) in a solid dosage form. Experimental studies were complemented with artificial neural networks and genetic programming. Specifically, the type and concentration of liquid vehicle was evaluated through saturation-solubility studies, while the effect of the amount of viscosity increasing agent (HPMC), the type of wetting (Soluplus® vs. PVP) and solubilizing (Poloxamer®407 vs. Kolliphor®ELP) agents, and the ratio of solid coating (microcrystalline cellulose) to carrier (colloidal silicon dioxide) were evaluated based on in vitro drug release studies. The optimum liquisolid formulation exhibited improved dissolution characteristics compared to the marketed product Emend®. X-ray diffraction (XRD), scanning electron microscopy (SEM) and a novel method combining particle size analysis by dynamic light scattering (DLS) and HPLC, revealed that the increase in dissolution rate of APT in the optimum liquisolid formulation was due to the formation of stable APT nanocrystals. Differential scanning calorimetry (DSC) and attenuated total reflection FTIR spectroscopy (ATR-FTIR) revealed the presence of intermolecular interactions between APT and liquisolid formulation excipients. Multilinear regression analysis (MLR), artificial neural networks (ANNs), and genetic programming (GP) were used to correlate several formulation variables with dissolution profile parameters (Y 15min and Y 30min ) using a full factorial experimental design. Results showed increased correlation efficacy for ANNs and GP (RMSE of 0.151 and 0.273, respectively) compared to MLR (RMSE = 0.413).

  14. Pharmaceutical development of an amorphous solid dispersion formulation of elacridar hydrochloride for proof-of-concept clinical studies

    NARCIS (Netherlands)

    Sawicki, E.; Schellens, J. H M; Beijnen, J. H.; Nuijen, B.

    2017-01-01

    Objective: A novel tablet formulation containing an amorphous solid dispersion (ASD) of elacridar hydrochloride was developed with the purpose to resolve the drug’s low solubility in water and to conduct proof-of-concept clinical studies. Significance: Elacridar is highly demanded for

  15. [Development of a paté formulation basis on rainbow trout discards].

    Science.gov (United States)

    Villarroel, Mario; Hazbun, Julia; Morales, Pamela

    2010-06-01

    An optimized formulation of pate was developed using rainbow trout discard with the employment ofTaguchi methodology, taking into account that the health-promoting benefits of this resource makes it a viable alternative as a functional foods to help consumers to get a healthy lifestyle. The optimization process utilizing Taguchi methodology was carried out in two phases. First, an orthogonal array L(8)2(7) with seven independent variables was chosen to select the control factors with a significant effect on the sensory quality (SQ). As a result, the following independent variables were selected: merkén pepper, sodium chloride, vegetal lard and margarine. In the second stage the L(9)3(4) orthogonal array was used. Data were analysed using differences between average values of factors according working levels, and also ANOVA, summing up that merken pepper, sodium chloride and margarine showed a significant effect (p > 0.05) on the SQ. Best combination turned to be: merkén 0.7%, sodium chloride 1.3%, vegetal lard 5.2% and margarine 5.2%. Among the chemical characteristics highlighted protein 13.8%, lipid 10.21%, caloric density 175 Kcal/100 g and cholesterol 46 mg/100 g. Shelf life study during a period of time of 6 weeks at 5 degrees C expressed as mesophyl aerobic count (MAC) and peroxide index were 1.6E+0.4 ufc/g and 8.44 meg O2/Kg respectively, both characteristics lower than the maximum limits allowed for chilean regulations. Concerning to the acceptability of the optimized product the hedonic test showed 91% approval and also 87% of consumers would be well disposed to buy this product.

  16. Development and Validation of Chronopotentiometric Method for Imidacloprid Determination in Pesticide Formulations and River Water Samples

    Directory of Open Access Journals (Sweden)

    Ana Đurović

    2016-01-01

    Full Text Available A new electrochemical method for determination of imidacloprid using chronopotentiometry on thin film mercury and glassy carbon electrode was presented. The most important experimental parameters of chronopotentiometry were examined and optimized with respect to imidacloprid analytical signal. Imidacloprid provided well-defined reduction peak in Britton-Robinson buffer on thin film mercury electrode at −1.0 V (versus Ag/AgCl (KCl, 3.5 mol/L and on glassy carbon electrode at −1.2 V (versus Ag/AgCl (KCl, 3.5 mol/L. The reduction time was linearly proportional to concentrations from 0.8 to 30.0 mg/L on thin film mercury electrode and from 7.0 to 70.0 mg/L on glassy carbon electrode. The detection limits were 0.17 mg/L and 0.93 mg/L for thin film mercury and glassy carbon electrode, respectively. The estimation of method precision as a function of repeatability and reproducibility showed relative standard deviations values lower than 3.73%. Recovery values from 97.3 to 98.1% confirmed the accuracy of the proposed method, while the constancy of the transition time with deliberated small changes in the experimental parameters indicated a very good robustness. A minor influence of possible interfering compounds proved good selectivity of the method. Developed method was applied for imidacloprid determination in commercial pesticide formulations and river water samples.

  17. Development of a formulation for the preparation of 99m Tc-Ida-bis-Biotin complex

    International Nuclear Information System (INIS)

    Gutierrez B, L.C.

    2000-01-01

    The radiopharmaceuticals of diagnostic use incorporate the radioisotope to an organic or inorganic molecule which goes selectively to the interest organ, to an a physiologic or metabolic process of the body with a simple and quantitatively interpretable kinetics. The 99m Tc occupies 80% from total of the studies realized in the world by the optimum combination of physical half-life (6 h), radionuclide quantity (ng) and high energy emission which allows to obtain results with the greatest information. Actually, in Nuclear Medicine, the research strategies are directed to the use of 'premarkers systems' based in the antibody administration, separated from radionuclide through the use of the avidin/biotin system. According to these considerations it was developed the 99m Tc-IDA-bis-Biotine complex as a new radiopharmaceutical which improves the diagnostic image of infectious core and tumorals. The IDA-biotin compound was synthesised and characterized by its melting point, IR spectroscopy, NMR, MS, UV and High-resolution liquid chromatography (HRLC). With base in an experimental factorial design those variables were established which influence in the radiochemical purity of the radiopharmaceutical which allowed to determine the reaction conditions, pH 9 at environmental temperature (22 Celsius degrees) and the optimum concentrations of the formulation components. IDA-biotine 1.0 mg, stannous chloride 0.1 mg and gluconate 15 mg as weak binding linking were realized to the lyophilized product quality control tests like: stability and radiochemical purity. The analytical techniques used UV spectrophotometry and HRLC were validated. The studies of biodistribution of the 99m Tc-Ida-bis-biotin complex were realized in healthy laboratory animals, showing stability 'In vivo' with renal purification. (Author)

  18. [Development of an optimized formulation of damask marmalade with low energy level using Taguchi methodology].

    Science.gov (United States)

    Villarroel, Mario; Castro, Ruth; Junod, Julio

    2003-06-01

    The goal of this present study was the development of an optimized formula of damask marmalade low in calories applying Taguchi methodology to improve the quality of this product. The selection of this methodology lies on the fact that in real life conditions the result of an experiment frequently depends on the influence of several variables, therefore, one expedite way to solve this problem is utilizing factorial desings. The influence of acid, thickener, sweetener and aroma additives, as well as time of cooking, and possible interactions among some of them, were studied trying to get the best combination of these factors to optimize the sensorial quality of an experimental formulation of dietetic damask marmalade. An orthogonal array L8 (2(7)) was applied in this experience, as well as level average analysis was carried out according Taguchi methodology to determine the suitable working levels of the design factors previously choiced, to achieve a desirable product quality. A sensory trained panel was utilized to analyze the marmalade samples using a composite scoring test with a descriptive acuantitative scale ranging from 1 = Bad, 5 = Good. It was demonstrated that the design factors sugar/aspartame, pectin and damask aroma had a significant effect (p < 0.05) on the sensory quality of the marmalade with 82% of contribution on the response. The optimal combination result to be: citric acid 0.2%; pectin 1%; 30 g sugar/16 mg aspartame/100 g, damask aroma 0.5 ml/100 g, time of cooking 5 minutes. Regarding chemical composition, the most important results turned out to be the decrease in carbohydrate content compaired with traditional marmalade with a reduction of 56% in coloric value and also the amount of dietary fiber greater than similar commercial products. Assays of storage stability were carried out on marmalade samples submitted to different temperatures held in plastic bags of different density. Non percetible sensorial, microbiological and chemical changes

  19. Applications of quantitative time lapse holographic imaging to the development of complex pharmaceutical nano formulations

    Science.gov (United States)

    Luther, Ed; Mendes, Livia; Pan, Jiayi; Costa, Daniel; Sarisozen, Can; Torchilin, Vladimir

    2018-02-01

    We rely on in vitro cellular cultures to evaluate the effects of the components of multifunctional nano-based formulations under development. We employ an incubator-adapted, label-free holographic imaging cytometer HoloMonitor M4® (Phase Holographic Imaging, Lund, Sweden) to obtain multi-day time-lapse sequences at 5- minute intervals. An automated stage allows hand-free acquisition of multiple fields of view. Our system is based on the Mach-Zehnder interferometry principle to create interference patterns which are deconvolved to produce images of the optical thickness of the field of view. These images are automatically segmented resulting in a full complement of quantitative morphological features, such as optical volume, thickness, and area amongst many others. Precise XY cell locations and the time of acquisition are also recorded. Visualization is best achieved by novel 4-Dimensional plots, where XY position is plotted overtime time (Z-directions) and cell-thickness is coded as color or gray scale brightness. Fundamental events of interest, i.e., cells undergoing mitosis or mitotic dysfunction, cell death, cell-to-cell interactions, motility are discernable. We use both 2D and 3D models of the tumor microenvironment. We report our new analysis method to track feature changes over time based on a 4-sample version of the Kolmogorov-Smirnov test. Feature A is compared to Control A, and Feature B is compared to Control B to give a 2D probability plot of the feature changes over time. As a result, we efficiently obtain vectors quantifying feature changes over time in various sample conditions, i.e., changing compound concentrations or multi-compound combinations.

  20. FORMULATION AND TECHNOLOGY DEVELOPMENT OF HERBAL PHENOLIC BIOPOLYMER-CONTAINING FILMS FOR BURN TREATMENT.

    Science.gov (United States)

    Gokadze, S; Barbakadze, V; Mulkijanyan, K; Bakuridze, A; Bakuridze, L

    2017-06-01

    Application of phytofilms based on biosolublepolymers is considered as a prospectivemethod for burn treatment . Herbal remedies contain biologically active substances, that are relatively less toxic, do not cause skin irritation or allergic reactions and, importantly, affectstrains of the microorganisms and viruses resistant to antibiotics and synthetic drugs. Nowadays, the advantages are given to such burn healing drugs, which along with high specific efficacy, have analgesic, anti-inflammatory and antimicrobial effects, and don't irritate the tissues. The mentioned peculiarities are characteristic for a new herbal phenolic biopolymer poly[3-(3,4-dihydroxyphenyl) glyceric acid](PDGA), isolated from the roots and stems of different comfrey species . The aim of the study was the development of the formulation and technology of biosoluble films for burn treatment on the basis of PDGA. The optimal content of phytofilm for burn healing was selected on the basis of the biopharmaceutical study results. The impact of the film-former on the quality, adhesion and moisture absorption of the phytofilmhas been studied. The optimal degree of the phytofilm moisture, determining its high adhesive properties,was established. The film prepared on the basis of sodium alginate, with 30.4% humidity, demonstrated the greatest adhesion strength. After investigation of the PDGA release it was found, that the hydrophilic bases such as: sodium carboxymethyl-cellulose (69.2%) andsodium alginate (78,65%) appeared to be optimal among the others. At the same time, taking into consideration the disadvantages of sodium carboxymethyl-cellulose (tautening effect on burnt surface, relatively low stability), a film based on sodium alginate has been chosen. The manufacturing technology for obtaining PDGA-containing phytofilm by casting is proposed. Theshelf-lifeofproposedPDGA-containingphytofilmis 2 years.

  1. Development and Evaluation of Taste Masked Granular Formulation of Satranidazole by Melt Granulation Technique

    Directory of Open Access Journals (Sweden)

    Harshal Ashok Pawar

    2014-01-01

    Full Text Available Drugs from nitroimidazole category are generally bitter in taste. Oral formulation with bitter taste is not palatable. Geriatrics and pediatrics patients usually suffer from swallowing difficulties. Many other patients in some disease conditions avoid swallowing tablets. Satranidazole is a new nitro-imidazole derivative with bitter taste and is available in market as film coated tablet. The purpose of this research was to mask the bitter taste of Satranidazole by coating complexation with low melting point wax and Eudragit EPO. Different types of wax (glyceryl monostearate, stearic acid and cetyl alcohol were tried for taste masking. The drug to stearic acid ratio 1 : 2 was found to be optimum on the basis of taste evaluation and in vitro release. The formulated granules were found to possess good flow property. FTIR studies confirmed that there was no interaction between drug and excipients. Scanning Electron Microscopy of drug and the optimized batch of granules was performed. The in vitro release of drug from granules was compared with marketed tablet formulation. The taste masked granules of optimized batch showed 87.65% release of drug in 1 hr which is comparable to that of marketed tablet formulation.

  2. Development and characterization of an atorvastatin solid dispersion formulation using skimmed milk for improved oral bioavailability

    Directory of Open Access Journals (Sweden)

    Ankush Choudhary

    2012-08-01

    Full Text Available Atorvastatin has low aqueous solubility resulting in low oral bioavailability (12% and thus presents a challenge in formulating a suitable dosage form. To improve the aqueous solubility, a solid dispersion formulation of atorvastatin was prepared by lyophilization utilising skimmed milk as a carrier. Six different formulations were prepared with varying ratios of drug and carrier and the corresponding physical mixtures were also prepared. The formation of a solid dispersion formulation was confirmed by differential scanning calorimetry and X-ray diffraction studies. The optimum drug-to-carrier ratio of 1:9 enhanced solubility nearly 33-fold as compared to pure drug. In vitro drug release studies exhibited a cumulative release of 83.69% as compared to 22.7% for the pure drug. Additionally, scanning electron microscopy studies suggested the conversion of crystalline atorvastatin to an amorphous form. In a Triton-induced hyperlipidemia model, a 3-fold increase in the lipid lowering potential was obtained with the reformulated drug as compared to pure drug. These results suggest that solid dispersion of atorvastatin using skimmed milk as carrier is a promising approach for oral delivery of atorvastatin.

  3. Relative bioavailability of three newly developed albendazole formulations : a randomized crossover study with healthy volunteers

    NARCIS (Netherlands)

    Rigter, I M; Schipper, H G; Koopmans, R P; van Kan, H J M; Frijlink, H W; Kager, P A; Guchelaar, H-J

    2004-01-01

    This study of healthy volunteers shows that the relative bioavailability of albendazole formulations that use arachis oil-polysorbate 80 or hydroxypropyl-beta-cyclodextrin as an excipient was enhanced 4.3- and 9.7-fold compared to the results seen with commercial tablets. Administration of macrogol

  4. Relative bioavailability of three newly developed albendazole formulations: a randomized crossover study with healthy volunteers

    NARCIS (Netherlands)

    Rigter, I. M.; Schipper, H. G.; Koopmans, R. P.; van Kan, H. J. M.; Frijlink, H. W.; Kager, P. A.; Guchelaar, H.-J.

    2004-01-01

    This study of healthy volunteers shows that the relative bioavailability of albendazole formulations that use arachis oil-polysorbate 80 or hydroxypropyl-beta-cyclodextrin as an excipient was enhanced 4.3- and 9.7-fold compared to the results seen with commercial tablets. Administration of macrogol

  5. Eunice Kennedy Shriver National Institute of Child Health and Human Development Pediatric Formulation Initiative: selected reports from working groups.

    Science.gov (United States)

    Giacoia, George P; Taylor-Zapata, Perdita; Mattison, Donald

    2008-11-01

    The Pediatric Formulation Initiative (PFI) is a project of the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). The PFI was established to address the issue of the lack of appropriate formulations in children and to use this activity as a means to improve pediatric formulations, as mandated by the Best Pharmaceuticals for Children Act of 2002 and 2007. The PFI began in 2005 with the formation of 3 working groups-Scientific, Economics, and Taste and Flavor. These groups began the process of identifying issues, gathering needed information, and considering possible ways to overcome barriers to the development of pediatric drug formulations. The purpose of this supplement was to provide details of the working groups' activities through presentation of full-length articles. Also presented is an article that discusses the 2007 European Union (EU) regulation on medicinal products for pediatric use. Information for this article was gathered from the proceedings of a PFI workshop, sponsored by the NICHD, that was held in Bethesda, Maryland, on December 6 and 7, 2005, as well as postworkshop discussions of the different working groups. The increased awareness that the majority of medications used today have not been labeled for use in children, and have not been tested to define safety, efficacy, and appropriate dosing, has led to the passage of legislation in the United States and in the EU to create incentives to stimulate the testing of drugs in this special population. It is imperative that the problems associated with the compounding and use of extemporaneous formulations as described in this supplement be addressed. Regulatory barriers to the availability of commercially developed pediatric formulations in different countries will need to be minimized or removed. New drug delivery systems will need to be tested and made available to pediatric patients. Further research in the mediators of bitter taste and study of taste blockers

  6. Development of a stability-indicating high performance liquid chromatography method for assay of erythromycin ethylsuccinate in powder for oral suspension dosage form

    Directory of Open Access Journals (Sweden)

    Fahimeh Kamarei

    2014-12-01

    Full Text Available In this study an effective method was developed to assay erythromycin ethylsuccinate for an oral suspension dosage form. The chromatographic separation was achieved on an X-Terra™ C18 analytical column. A mixture of acetonitrile–ammonium dihydrogen phosphate buffer (0.025 mol L-1 (60:40, V/V (pH 7.0 was used as the mobile phase, effluent flow rate monitored at 1.0 mL min−1, and UV detection at 205 nm. In forced degradation studies, the effects of acid, base, oxidation, UV light and temperature were investigated showing no interference in the peak of drug. The proposed method was validated in terms of specificity, linearity, robustness, precision and accuracy. The method was linear at concentrations ranging from 400 to 600 μg mL−1, precise (intra- and inter-day relative standard deviations <0.65, accurate (mean recovery; 99.5%. The impurities and degradation products of erythromycin ethylsuccinate were selectively determined with good resolution in both the raw material and the final suspension forms. The method could be useful for both routine analytical and quality control assays of erythromycin ethylsuccinate in commercial powder for an oral suspension dosage form and it could be a very powerful tool to investigate the chemical stability of erythromycin ethylsuccinate.

  7. Pulmonary Delivery of an Ultra-Fine Oxytocin Dry Powder Formulation: Potential for Treatment of Postpartum Haemorrhage in Developing Countries

    OpenAIRE

    Prankerd, Richard J.; Nguyen, Tri-Hung; Ibrahim, Jibriil P.; Bischof, Robert J.; Nassta, Gemma C.; Olerile, Livesey D.; Russell, Adrian S.; Meiser, Felix; Parkington, Helena C.; Coleman, Harold A.; Morton, David A. V.; McIntosh, Michelle P.

    2013-01-01

    Oxytocin is recommended by the World Health Organisation as the most effective uterotonic for the prevention and treatment of postpartum haemorrhage. The requirement for parenteral administration by trained healthcare providers and the need for the drug solution to be maintained under cold-chain storage limit the use of oxytocin in the developing world. In this study, a spray-dried ultrafine formulation of oxytocin was developed with an optimal particle size diameter (1-5 µm) to facilitate ae...

  8. Formulation Development and Evaluation of Hybrid Nanocarrier for Cancer Therapy: Taguchi Orthogonal Array Based Design

    Directory of Open Access Journals (Sweden)

    Rakesh K. Tekade

    2013-01-01

    Full Text Available Taguchi orthogonal array design is a statistical approach that helps to overcome limitations associated with time consuming full factorial experimental design. In this study, the Taguchi orthogonal array design was applied to establish the optimum conditions for bovine serum albumin (BSA nanocarrier (ANC preparation. Taguchi method with L9 type of robust orthogonal array design was adopted to optimize the experimental conditions. Three key dependent factors namely, BSA concentration (% w/v, volume of BSA solution to total ethanol ratio (v : v, and concentration of diluted ethanolic aqueous solution (% v/v, were studied at three levels 3%, 4%, and 5% w/v; 1 : 0.75, 1 : 0.90, and 1 : 1.05 v/v; 40%, 70%, and 100% v/v, respectively. The ethanolic aqueous solution was used to impart less harsh condition for desolvation and attain controlled nanoparticle formation. The interaction plot studies inferred the ethanolic aqueous solution concentration to be the most influential parameter that affects the particle size of nanoformulation. This method (BSA, 4% w/v; volume of BSA solution to total ethanol ratio, 1 : 0.90 v/v; concentration of diluted ethanolic solution, 70% v/v was able to successfully develop Gemcitabine (G loaded modified albumin nanocarrier (M-ANC-G of size 25.07±2.81 nm (ζ=-23.03±1.015 mV as against to 78.01±4.99 nm (ζ=-24.88±1.37 mV using conventional method albumin nanocarrier (C-ANC-G. Hybrid nanocarriers were generated by chitosan layering (solvent gelation technique of respective ANC to form C-HNC-G and M-HNC-G of sizes 125.29±5.62 nm (ζ=12.01±0.51 mV and 46.28±2.21 nm (ζ=15.05±0.39 mV, respectively. Zeta potential, entrapment, in vitro release, and pH-based stability studies were investigated and influence of formulation parameters are discussed. Cell-line-based cytotoxicity assay (A549 and H460 cells and cell internalization assay (H460 cell line were performed to assess the

  9. Use of a continuous twin screw granulation and drying system during formulation development and process optimization.

    Science.gov (United States)

    Vercruysse, J; Peeters, E; Fonteyne, M; Cappuyns, P; Delaet, U; Van Assche, I; De Beer, T; Remon, J P; Vervaet, C

    2015-01-01

    Since small scale is key for successful introduction of continuous techniques in the pharmaceutical industry to allow its use during formulation development and process optimization, it is essential to determine whether the product quality is similar when small quantities of materials are processed compared to the continuous processing of larger quantities. Therefore, the aim of this study was to investigate whether material processed in a single cell of the six-segmented fluid bed dryer of the ConsiGma™-25 system (a continuous twin screw granulation and drying system introduced by GEA Pharma Systems, Collette™, Wommelgem, Belgium) is predictive of granule and tablet quality during full-scale manufacturing when all drying cells are filled. Furthermore, the performance of the ConsiGma™-1 system (a mobile laboratory unit) was evaluated and compared to the ConsiGma™-25 system. A premix of two active ingredients, powdered cellulose, maize starch, pregelatinized starch and sodium starch glycolate was granulated with distilled water. After drying and milling (1000 μm, 800 rpm), granules were blended with magnesium stearate and compressed using a Modul™ P tablet press (tablet weight: 430 mg, main compression force: 12 kN). Single cell experiments using the ConsiGma™-25 system and ConsiGma™-1 system were performed in triplicate. Additionally, a 1h continuous run using the ConsiGma™-25 system was executed. Process outcomes (torque, barrel wall temperature, product temperature during drying) and granule (residual moisture content, particle size distribution, bulk and tapped density, hausner ratio, friability) as well as tablet (hardness, friability, disintegration time and dissolution) quality attributes were evaluated. By performing a 1h continuous run, it was detected that a stabilization period was needed for torque and barrel wall temperature due to initial layering of the screws and the screw chamber walls with material. Consequently, slightly deviating

  10. Development of paracetamol-caffeine co-crystals to improve compressional, formulation and in vivo performance.

    Science.gov (United States)

    Latif, Sumera; Abbas, Nasir; Hussain, Amjad; Arshad, Muhammad Sohail; Bukhari, Nadeem Irfan; Afzal, Hafsa; Riffat, Sualeha; Ahmad, Zeeshan

    2018-07-01

    Paracetamol, a frequently used antipyretic and analgesic drug, has poor compression moldability owing to its low plasticity. In this study, new co-crystals of paracetamol (PCM) with caffeine (as a co-former) were prepared and delineated. Co-crystals exhibited improved compaction and mechanical behavior. A screening study was performed by utilizing a number of methods namely dry grinding, liquid assisted grinding (LAG), solvent evaporation (SE), and anti-solvent addition using various weight ratios of starting materials. LAG and SE were found successful in the screening study. Powders at 1:1 and 2:1 weight ratio of PCM/CAF by LAG and SE, respectively, resulted in the formation of co-crystals. Samples were characterized by PXRD, DSC, and ATR-FTIR techniques. Compressional properties of PCM and developed co-crystals were analyzed by in-die heckle model. Mean yield pressure (Py), an inverse measure of plasticity, obtained from the heckle plots decreased significantly (p < .05) for co-crystals than pure drug. Intrinsic dissolution profile of co-crystals showed up to 2.84-fold faster dissolution than PCM and physical mixtures in phosphate buffer pH 6.8 at 37 °C. In addition, co-crystals formulated into tablets by direct compression method showed better mechanical properties like hardness and tensile strength. In vitro dissolution studies on tablets also showed enhanced dissolution profiles (∼90-97%) in comparison to the tablets of PCM prepared by direct compression (∼55%) and wet granulation (∼85%) methods. In a single dose sheep model study, co-crystals showed up to twofold increase in AUC and C max . A significant (p < .05) decrease in clearance as compared to pure drug was also recorded. In conclusion, new co-crystals of PCM were successfully prepared with improved tabletability in vitro and in vivo profile. Enhancement in AUC and C max of PCM by co-crystallization might suggest the dose reduction and avoidance of side effects.

  11. Forecasting of development of acute poisonings in agricultural workers while using combined formulations based on difenoconazole

    Directory of Open Access Journals (Sweden)

    Stavnichenko P.V.

    2017-10-01

    Full Text Available In the general structure of occupational diseases, a large proportion belongs to acute poisoning with pesticides (mainly group cases. However, today it is impossible to drop the use of pesticides in agriculture. Their application ensures high biological and economic efficiency of the latter, reduces losses of the yield. The purpose of the work was to predict the possibility of acute toxic effects in agricultural workers when working with combined formulations based on difenoconazole. Materials and methods. To assess the influence on the organism of the workers of the above-mentioned substances and formulations on their basis, the coefficient of inhalation poisoning possibility (CIPP, the coefficient of selective action of the pesticide in inhalation effect (CSAing and the selective action of the pesticide in the dermal effect (CSAderm were calculated. Results. Calculated values of CSAing (103.4-4701.2 and CSAderm (237.4-12345.7 for all investigated active substances were more than 100, this indicates to a rather high selectivity of their action. By the CSAing value formulations Celeste Top, Celeste Trio, Dinali, Cydeli Top belong to pesticides with a relatively low selectivity of action when they are inhaled by workers in the process of crops treating, the remaining formulations have a sufficient selectivity of action in inhalation intake. In addition, it should be noted that in general, for all combined preparations CSA values are significantly lower than for separate active ingredients, in addition to the above assumption, can be explained by the presence of other formulants in the preparation that may have not significant but toxic effect on the body of workers. All investigated substances in the probability of occurrence of acute poisoning with the use of combined preparations on their basis are related to the 4th grade of danger according to State Standards 8.8.1.002-98. There was proved relative safety in case of penetration into the

  12. Compounded Apixaban Suspensions for Enteral Feeding Tubes.

    Science.gov (United States)

    Caraballo, Maria L; Donmez, Seda; Nathan, Kobi; Zhao, Fang

    2017-07-01

    Objective: There is limited information on compounded apixaban formulations for administration via enteral feeding tubes. This study was designed to identify a suitable apixaban suspension formulation that is easy to prepare in a pharmacy setting, is compatible with commonly used feeding tubes, and has a beyond-use date of 7 days. Methods: Apixaban suspensions were prepared from commercially available 5-mg Eliquis tablets. Several vehicles and compounding methods were screened for ease of preparation, dosage accuracy, and tube compatibility. Two tubing types, polyurethane and polyvinyl chloride, with varying lengths and diameters, were included in the study. They were mounted on a peg board during evaluation to mimic the patient body position. A 7-day stability study of the selected formulation was also conducted. Results: Vehicles containing 40% to 60% Ora-Plus in water all exhibited satisfactory flowability through the tubes. The mortar/pestle compounding method was found to produce more accurate and consistent apixaban suspensions than the pill crusher or crushing syringe method. The selected formulation, 0.25 mg/mL apixaban in 50:50 Ora-Plus:water, was compatible with both tubing types, retaining >98% drug in posttube samples. The stability study also confirmed that this formulation was stable physically and chemically over 7 days of storage at room temperature. Conclusions: A suitable apixaban suspension formulation was identified for administration via enteral feeding tubes. The formulation consisted of 0.25 mg/mL apixaban in 50:50 Ora-Plus:water. The stability study results supported a beyond-use date of 7 days at room temperature.

  13. Qualitative analysis of controlled release ciprofloxacin/carbopol 934 mucoadhesive suspension

    Directory of Open Access Journals (Sweden)

    Subhashree Sahoo

    2011-01-01

    Full Text Available Mucoadhesive polymeric (carbopol 934 suspension of ciprofloxacin was prepared by ultrasonication and optimized with the aim of developing an oral controlled release gastro-retentive dosage form. The qualitative analysis of the formulation was performed by fourier transform infrared spectroscopy (FTIR, Raman spectroscopy, X-ray powder diffraction (XRD, and scanning electron microscopy (SEM analyses. FTIR (400 cm-1 to 4000 cm-1 region and Raman (140 to 2400 cm-1 region Spectroscopic studies were carried out and the spectra were used for interpretation. XRD data of pure drug, polymer and the formulation were obtained using a powder diffractometer scanned from a Bragg′s angle (2q of 10° to 70°. The dispersion of the particle was observed using SEM techniques. The particle size distribution and aspect ratio of particles in the polymeric suspension were obtained from SEM image analysis. The results from FTIR and Raman spectroscopic analyses suggested that, in formulation, the carboxylic groups of ciprofloxacin and hydroxyl groups of C934 undergo a chemical interaction leading to esterification and hydrogen bonding. The XRD data suggested that the retention of crystalline nature of ciprofloxacin in the formulation would lead to increase in stability and drug loading; decrease in solubility; and delay in release of the drug from polymeric suspension with better bioavailability and penetration capacity. The SEM image analysis indicated that, in the formulation maximum particles were having aspect ratio from 2 to 4 and standard deviation was very less which provided supporting evidences for homogeneous, uniformly dispersed, stable controlled release ciprofloxacin suspension which would be pharmaceutically acceptable.

  14. Colon Targeted Guar Gum Compression Coated Tablets of Flurbiprofen: Formulation, Development, and Pharmacokinetics

    Directory of Open Access Journals (Sweden)

    Sateesh Kumar Vemula

    2013-01-01

    Full Text Available The rationale of the present study is to formulate flurbiprofen colon targeted compression coated tablets using guar gum to improve the therapeutic efficacy by increasing drug levels in colon, and also to reduce the side effects in upper gastrointestinal tract. Direct compression method was used to prepare flurbiprofen core tablets, and they were compression coated with guar gum. Then the tablets were optimized with the support of in vitro dissolution studies, and further it was proved by pharmacokinetic studies. The optimized formulation (F4 showed almost complete drug release in the colon (99.86% within 24 h without drug loss in the initial lag period of 5 h (only 6.84% drug release was observed during this period. The pharmacokinetic estimations proved the capability of guar gum compression coated tablets to achieve colon targeting. The Cmax of colon targeted tablets was 11956.15 ng/mL at Tmax of 10 h whereas it was 15677.52 ng/mL at 3 h in case of immediate release tablets. The area under the curve for the immediate release and compression coated tablets was 40385.78 and 78214.50 ng-h/mL and the mean resident time was 3.49 and 10.78 h, respectively. In conclusion, formulation of guar gum compression coated tablets was appropriate for colon targeting of flurbiprofen.

  15. Colon Targeted Guar Gum Compression Coated Tablets of Flurbiprofen: Formulation, Development, and Pharmacokinetics

    Science.gov (United States)

    Bontha, Vijaya Kumar

    2013-01-01

    The rationale of the present study is to formulate flurbiprofen colon targeted compression coated tablets using guar gum to improve the therapeutic efficacy by increasing drug levels in colon, and also to reduce the side effects in upper gastrointestinal tract. Direct compression method was used to prepare flurbiprofen core tablets, and they were compression coated with guar gum. Then the tablets were optimized with the support of in vitro dissolution studies, and further it was proved by pharmacokinetic studies. The optimized formulation (F4) showed almost complete drug release in the colon (99.86%) within 24 h without drug loss in the initial lag period of 5 h (only 6.84% drug release was observed during this period). The pharmacokinetic estimations proved the capability of guar gum compression coated tablets to achieve colon targeting. The C max of colon targeted tablets was 11956.15 ng/mL at T max of 10 h whereas it was 15677.52 ng/mL at 3 h in case of immediate release tablets. The area under the curve for the immediate release and compression coated tablets was 40385.78 and 78214.50 ng-h/mL and the mean resident time was 3.49 and 10.78 h, respectively. In conclusion, formulation of guar gum compression coated tablets was appropriate for colon targeting of flurbiprofen. PMID:24260738

  16. Development of parenteral formulations and evaluation of the biological activity of the trypanocide drug benznidazole.

    Science.gov (United States)

    Lamas, María C; Villaggi, Luciano; Nocito, Isabel; Bassani, Georgina; Leonardi, Darío; Pascutti, Fernanda; Serra, Esteban; Salomón, Claudio J

    2006-01-13

    Chagas disease, caused by Trypanosoma cruzi, is a major public health problem in Latin America. According to the World Health Organization, around 20 million people are infected and another 40 million are at risk of acquiring the disease. One of the drugs most frequently used for the treatment of Chagas disease is benznidazole (BZL). It is practically insoluble in water (0.4 mg/ml), which precludes the preparation of liquid dosage forms, in particular, parenteral formulations. Thus, the aim of this work was to investigate the solubilization of BZL at two pH values using various cosolvents such as ethyl alcohol, propylene glycol, polyethylene glycol 400, benzyl alcohol, diethylene glycol monoethyl ether (Transcutol) and surfactants such as polysorbates (Tween) 40 and 80, and sodium dioctyl sulfosuccinate (AOT). Solvent systems based on PEG 400, with the addition ethyl alcohol and/or potassium biphthalate buffer solution, increased the BZL solubility up to 10 mg/ml. These alcoholic vehicles showed no toxicity against parasite when assayed at 1%. Physical and chemical stability studies showed that the formulations were stable for at least 1.5 years. In agreement with the biological activity results, the selected formulations are suitable for further clinical studies. Moreover, increasing the aqueous solubility of BZL reduced the problems in vitro testing techniques and bioassays leading to more reliable results and/or reproducibility.

  17. Development of a microparticle-based dry powder inhalation formulation of ciprofloxacin hydrochloride applying the quality by design approach

    Directory of Open Access Journals (Sweden)

    Karimi K

    2016-10-01

    Full Text Available Keyhaneh Karimi, Edina Pallagi, Piroska Szabó-Révész, Ildikó Csóka, Rita Ambrus Faculty of Pharmacy, Institute of Pharmaceutical Technology and Regulatory Affairs, University of Szeged, Szeged, Hungary Abstract: Pulmonary drug delivery of ciprofloxacin hydrochloride offers effective local antibacterial activity and convenience of easy application. Spray drying is a trustworthy technique for the production of ciprofloxacin hydrochloride microparticles. Quality by design (QbD, an up-to-date regulatory-based quality management method, was used to predict the final quality of the product. According to the QbD-based theoretical preliminary parameter ranking and priority classification, dry powder inhalation formulation tests were successfully performed in practice. When focusing on the critical parameters, the practical development was more effective and was in correlation with our previous findings. Spray drying produced spherical microparticles. The dry powder formulations prepared were examined by particle size analysis, scanning electron microscopy, Fourier-transform infrared spectroscopy, X-ray powder diffraction, differential scanning calorimetry, and in vitro drug release and aerodynamic particle size analyses were also performed. These formulations showed an appropriate particle size ranging between 2 and 4 µm and displayed an enhanced aerosol performance with fine particle fraction up to 80%. Keywords: antibiotic, carrier-free formulation, quality by design, aerodynamic evaluation, dry powder for inhalation

  18. Development and scintigraphic evaluation of submicron sized dry powder inhalation formulation of fluticasone propionate in healthy human volunteers

    International Nuclear Information System (INIS)

    Ali, Sultana S.; Ahmad, F.J.; Khar, R.K.; Rathore, V.P.; Ali, Rashid; Rawat, H.S.; Chopra, M.K.; Mittal, G.; Bhatnagar, A.

    2010-01-01

    Full text: Objective of the present study concerns formulation and evaluation of submicron sized dry powder inhalation formulation of Fluticasone propionate for the treatment of bronchial asthma, COPD and a new life saving treatment option in restrictive lung diseases such as Interstitial Lung Disease (ILD), toxic and non-cardiogenic pulmonary inflammations or pulmonary edema, which have no effective treatment presently. Materials and Methods: The submicron sized particles were prepared by precipitation method using acetone as solvent and water as antisolvent. Poloxamer F127 was used as stabilizer. Both submicronized and micronized particles were characterized using FTIR, XRD, DSC, SEM and TEM. The mass median aerodynamic diameter (MMAD) of the submicronized and micronized API was calculated using Andersen cascade impactor. The prepared particles and micronized Active Pharmaceutical Ingredient (API) were radiolabeled with 99m Tc. Size3 HPMC capsules were filled with the 12.5 mg radiolabeled blend (100μg Fluticasone propionate and 12.4mg inhalable lactose) and given to healthy volunteers to assess the comparative pulmonary deposition. Results: The prepared formulation has shown better lung deposition as compared to micronized API. The MMAD of submicronized particles was in the range of 1 - 5 μm while the MMAD of micronized API was in the range of 5 - 15μm. Conclusion: The developed submicron sized dry powder inhalation formulation has better lung deposition as compared to micron sized API and it will become a better treatment option for the bronchial asthma, COPD and ILDs

  19. Systematic Development of Transethosomal Gel System of Piroxicam: Formulation Optimization, In Vitro Evaluation, and Ex Vivo Assessment.

    Science.gov (United States)

    Garg, Varun; Singh, Harmanpreet; Bhatia, Amit; Raza, Kaisar; Singh, Sachin Kumar; Singh, Bhupinder; Beg, Sarwar

    2017-01-01

    Piroxicam is used in the treatment of rheumatoid arthritis, osteoarthritis, and other inflammatory diseases. Upon oral administration, it is reported to cause ulcerative colitis, gastrointestinal irritation, edema and peptic ulcer. Hence, an alternative delivery system has been designed in the form of transethosome. The present study describes the preparation, optimization, characterization, and ex vivo study of piroxicam-loaded transethosomal gel using the central composite design. On the basis of the prescreening study, the concentration of lipids and ethanol was kept in the range of 2-4% w/v and 0-40% v/v, respectively. Formulation was optimized by measuring drug retention in the skin, drug permeation, entrapment efficiency, and vesicle size. Optimized formulation was incorporated in hydrogel and compared with other analogous vesicular (liposomes, ethosomes, and transfersomes) gels for the aforementioned responses. Among the various lipids used, soya phosphatidylcholine (SPL 70) and ethanol in various percentages were found to affect drug retention in the skin, drug permeation, vesicle size, and entrapment efficiency. The optimized batch of transethosome has shown 392.730 μg cm -2 drug retention in the skin, 44.312 μg cm -2  h -1 drug permeation, 68.434% entrapment efficiency, and 655.369 nm vesicle size, respectively. It was observed that the developed transethosomes were found superior in all the responses as compared to other vesicular formulations with improved stability and highest elasticity. Similar observations were noted with its gel formulation.

  20. Development of an injectable formulation for the preparation of radiopharmaceutical 68Ga-DOTA-Sar gastrin

    International Nuclear Information System (INIS)

    Castillo P, M.

    2015-01-01

    The CCK2 receptor (cholecystokinin) is located in areas of the central and peripheral nervous system and is over expressed in several types of human cancer, as medullar thyroid, lung and ovarian carcinomas. One of the endogenous ligands for the CCK2 receptor is the gastrin, so that radiolabeled peptides analogues to gastrin as Sar gastrin (Gln-Gly-Pro-Trp-Leu-Glu-Glu-Glu-Glu-Glu-Ala-Tyr-Gly-Trp-Nle-Asp-Phe-NH 2 ) have been proposed as potential diagnostic radiopharmaceuticals for obtaining tumors images with CCK2 receptors over expressed. The 68 Ga is an ideal candidate for the peptides radiolabelled and has favorable characteristics to be used for diagnostic purposes by imaging with Positron emission tomography (PET). This work aimed to verify the technical documentation of the production process of radiopharmaceutical 68 Ga-DOTA-Sar gastrin for its sanitary registration before the Comision Federal contra Riesgos Sanitarios (COFEPRIS) in Mexico. For optimization of the production process was assessed a factorial design of two variables with mixed levels (27 combinations), where the dependent variable was the radiochemical purity. The analytical method used for evaluating the content of Sar gastrin peptide in the injectable formulation was also validated by High-performance liquid chromatography. Subsequently the validation of the production process was carried out by manufacturing of lots in single-dose of the optimized injectable formulation of the radiopharmaceutical 68 Ga-DOTA-Sar gastrin and the stability study was conducted at different times to determine the useful life time. The following was established as the optimal pharmaceutical formulation: 185 MBq of 68 Ga, 50 μg de DOTA-Sar gastrin, 14 mg of sodium acetate and 0.5 m L of buffer acetates, 1.0 M, ph 4.22 in 2.5 m L of the vehicle. The analytical method used to determine the radiochemical purity of the formulation satisfied the requirements for the intended analytical application. The lots in

  1. Naratriptan hydrochloride in extemporaneosly compounded oral suspensions.

    Science.gov (United States)

    Zhang, Y P; Trissel, L A; Fox, J L

    2000-01-01

    The purpose of this study was to determine the pharmaceutical acceptability and chemical stability of naratriptan hydrochloride in three extemporaneously compounded suspension formulations. The naratriptan-hydrochloride oral suspensions were prepared from 2.5-mg commercial tablets yielding a nominal naratriptan concentration of 0.5 mg/mL. The suspension vehicles selected for testing were Syrpalta, an equal-parts mixture of Ora-Plus and Ora-Sweet, and an equal-parts mixture of Ora-Plus and Ora-Sweet SF. The tablets were crushed and thoroughly triturated to a fine powder using a porcelain mortar and pestle. The powder was incorporated into a portion of the Syrpalta or Ora-Plus suspension vehicle and mixed until homogeneous. The mixtures were then brought to volume with Syrpalta, Ora-Sweet or Ora-Sweet SF, as appropriate. The suspensions were packaged in amber, plastic, screw-cap prescription bottles and stored at 23 deg C for seven days and 4 deg C for 90 days. An adequate suspension was never achieved in Syrpalta. The crushed-tablet powder did not produce a uniformly dispersed mixture and exhibited clumping and a high rate of sedimentation. A distinct layer of the solid tablet material settled immediately after shaking. Over the next four hours, a densely packed, yellow, caked layer formed at the bottom of the containers, making resuspension difficult. During storage, the caking became worse. Chemical analysis was not performed. The Ora-Plus and Ora-Sweet or Ora-Sweet SF suspensions had a slight greenish cast and were resuspended without difficulty by shaking for approximately ten seconds, yielding easily poured and homogeneous mixtures throughout the study. Visible settling and layering did not begin for four hours with the Ora-Sweet suspension and 24 hours for the Ora-Sweet SF suspension. High pressure liquid chromatographic analysis found that the naratriptan concentration in both suspension-vehicle combinations exhibited little or no loss for seven days at 23

  2. Formulation of disperse systems science and technology

    CERN Document Server

    Tadros, Tharwat F

    2014-01-01

    This book presents comprehensively the science and technology behind the formulation of disperse systems like emulsions, suspensions, foams and others. Starting with a general introduction, the book covers a broad range of topics like the role of different classes of surfactants, stability of disperse systems, formulation of different dispersions, evaluation of formulations and many more. Many examples are included, too. Written by the experienced author and editor Tharwart Tadros, this book is indispensable for every scientist working in the field.

  3. FORMULATION DEVELOPMENT OF MUCOADHESIVE MICROCAPSULES OF METFORMIN HYDROCHLORIDE USING NATURAL AND SYNTHETIC POLYMERS AND IN VITRO CHARACTERIZATION

    OpenAIRE

    Yellanki Shiva Kumar; Deb Sambit kumar; Goranti Sharada; Nerella Naveen kumar

    2010-01-01

    The objective of this work was to develop optimized and systematically evaluate performances of mucoadhesive microcapsules of antihyperglycemic agent drug Metformin. Alginate microcapsules coated with mucoadhesive natural or synthetic polymers were prepared by Orifice-Ionic Gelation technique utilizing calcium chloride as a cross linking agent. The effect of type (natural or synthetic) and concentration of coating polymers and concentration of alginate on formulation was investigated. Prepare...

  4. Pharmacokinetics of a new diclofenac sodium formulation developed for subcutaneous and intramuscular administration.

    Science.gov (United States)

    Zeitlinger, Markus; Rusca, Antonio; Oraha, Alhan Z; Gugliotta, Barbara; Müller, Markus; Ducharme, Murray P

    2012-06-01

    To assess the relative bioavailability of diclofenac sodium hydroxypropyl β-cyclodextrin (HPβCD) administered via the subcutaneous (s.c.) and intramuscular (i.m.) route versus Voltaren® i.m. and to evaluate the dose linearity and pharmacokinetics of the s.c. formulation at three dose levels. Safety and local tolerability were also assessed. One single-dose, randomized, three-way, crossover relative bioavailability study and one linearity single escalating dose, randomized, three-way cross-over pharmacokinetic study were conducted at two different clinical sites. A total of 42 healthy male and female subjects participated in both studies. Subjects received 75 mg/ml diclofenac sodium HPβCD (i.m. and s.c.) and Voltaren® 75 mg/3 ml (i.m.) in Study 1 and 25, 50, or 75 mg/ml diclofenac sodium HPβCD (s.c.) in Study 2. Study 1 demonstrated bioequivalence of the s.c. test formulation with Voltaren® i.m. with respect to Cmax and AUC. Bioequivalence of the test i.m. with Voltaren® i.m. was also demonstrated (except the upper limit of the 90% confidence interval (CI) for Cmax which marginally exceeded the 80 - 125% range (125.78%)). Study 2 demonstrated that after s.c. administration of the test formulation, both Cmax and AUC are linearly related to the tested diclofenac doses. All tested doses were safe and locally well-tolerated with no serious adverse events reported. Bioequivalence of diclofenac HPβCD 75 mg/ml after s.c. and i.m. administration with Voltaren® i.m. was demonstrated, except for the marginal deviation in Cmax when comparing the i.m. test and Voltaren®. Linearity was also demonstrated for the three doses intended for marketing.

  5. Formulation of Hydrocolloid-Agar, Sucrose, and Acidulant on Jam Leather Product Development

    Directory of Open Access Journals (Sweden)

    Wahyu Ramadhan

    2017-04-01

    Full Text Available Tallying agar powder as a texturizer in guava single sheet jam instigate the product more convenience to consumed. The aims of this research were to determine the best concentration of sucrose, citric acid and agar powder to form a good quality guava jam slice. The research method are optimization and formulationof sucrose, citric acid and agar-agar on making guava jam single sheets product. Physochemical and sensory tests were performed to reveal the best formulation of guava jam slice and the Bayes method used to determine the optimization of the selected formula. Based on the results of formulation and analysis, itwas obtained that  the guava jam slice with Acidulant concentration (0.02%, 0.04%, 0.06%, sucrose (70%, 80%, 90%, 100% and agar powder (0.7%, 0.8%, 0.9%, 1.0%, 1.1%, 1.2% had pH 3.63-3.90, sugar content 34.68 g/100 g – 35.76 g/100 g, color intensity L*, a*, b* with ΔE* value was 37,88-53,97, fiber content 1.01%-1.59%, and water activity 0.852-0.893. Rheology properties for texture profile (hardness, cohesiveness, springiness, adhesive force, and gumminess also showed significant value with agar powder formulation. Based on the Bayes test and hedonic test, it was found that the best formula was for guava jam slices with the addition of 90% sucrose, citric acid 0.04% and agar powder 0.9%. From the best formula, it was found the shelf life prediction model of Arrhenius formula was ln k = 20.222-6660.6(1/T and the nutrition facts contribute total energy 45 kcal, fat 0%, carbohydrate 9%, protein 2% and dietary fiber 3%.

  6. Pulmonary delivery of an ultra-fine oxytocin dry powder formulation: potential for treatment of postpartum haemorrhage in developing countries.

    Science.gov (United States)

    Prankerd, Richard J; Nguyen, Tri-Hung; Ibrahim, Jibriil P; Bischof, Robert J; Nassta, Gemma C; Olerile, Livesey D; Russell, Adrian S; Meiser, Felix; Parkington, Helena C; Coleman, Harold A; Morton, David A V; McIntosh, Michelle P

    2013-01-01

    Oxytocin is recommended by the World Health Organisation as the most effective uterotonic for the prevention and treatment of postpartum haemorrhage. The requirement for parenteral administration by trained healthcare providers and the need for the drug solution to be maintained under cold-chain storage limit the use of oxytocin in the developing world. In this study, a spray-dried ultrafine formulation of oxytocin was developed with an optimal particle size diameter (1-5 µm) to facilitate aerosolised delivery via the lungs. A powder formulation of oxytocin, using mannitol, glycine and leucine as carriers, was prepared with a volume-based median particle diameter of 1.9 µm. Oxytocin content in the formulation was assayed using high-performance liquid chromatography-mass spectroscopy and was found to be unchanged after spray-drying. Ex vivo contractility studies utilising human and ovine uterine tissue indicated no difference in the bioactivity of oxytocin before and after spray-drying. Uterine electromyographic (EMG) activity in postpartum ewes following pulmonary (in vivo) administration of oxytocin closely mimicked that observed immediately postpartum (0-12 h following normal vaginal delivery of the lamb). In comparison to the intramuscular injection, pulmonary administration of an oxytocin dry powder formulation to postpartum ewes resulted in generally similar EMG responses, however a more rapid onset of uterine EMG activity was observed following pulmonary administration (129 ± 18 s) than intramuscular injection (275 ± 22 s). This is the first study to demonstrate the potential for oxytocin to elicit uterine activity after systemic absorption as an aerosolised powder from the lungs. Aerosolised oxytocin has the potential to provide a stable and easy to administer delivery system for effective prevention and treatment of postpartum haemorrhage in resource-poor settings in the developing world.

  7. Pulmonary delivery of an ultra-fine oxytocin dry powder formulation: potential for treatment of postpartum haemorrhage in developing countries.

    Directory of Open Access Journals (Sweden)

    Richard J Prankerd

    Full Text Available Oxytocin is recommended by the World Health Organisation as the most effective uterotonic for the prevention and treatment of postpartum haemorrhage. The requirement for parenteral administration by trained healthcare providers and the need for the drug solution to be maintained under cold-chain storage limit the use of oxytocin in the developing world. In this study, a spray-dried ultrafine formulation of oxytocin was developed with an optimal particle size diameter (1-5 µm to facilitate aerosolised delivery via the lungs. A powder formulation of oxytocin, using mannitol, glycine and leucine as carriers, was prepared with a volume-based median particle diameter of 1.9 µm. Oxytocin content in the formulation was assayed using high-performance liquid chromatography-mass spectroscopy and was found to be unchanged after spray-drying. Ex vivo contractility studies utilising human and ovine uterine tissue indicated no difference in the bioactivity of oxytocin before and after spray-drying. Uterine electromyographic (EMG activity in postpartum ewes following pulmonary (in vivo administration of oxytocin closely mimicked that observed immediately postpartum (0-12 h following normal vaginal delivery of the lamb. In comparison to the intramuscular injection, pulmonary administration of an oxytocin dry powder formulation to postpartum ewes resulted in generally similar EMG responses, however a more rapid onset of uterine EMG activity was observed following pulmonary administration (129 ± 18 s than intramuscular injection (275 ± 22 s. This is the first study to demonstrate the potential for oxytocin to elicit uterine activity after systemic absorption as an aerosolised powder from the lungs. Aerosolised oxytocin has the potential to provide a stable and easy to administer delivery system for effective prevention and treatment of postpartum haemorrhage in resource-poor settings in the developing world.

  8. Furosemide Loaded Silica-Lipid Hybrid Microparticles: Formulation Development, in vitro and ex vivo Evaluation.

    Science.gov (United States)

    Sambaraj, Swapna; Ammula, Divya; Nagabandi, Vijaykumar

    2015-09-01

    The main objective of the current research work was to formulate and evaluate furosemide loaded silica lipid hybrid microparticles for improved oral delivery. A novel silica-lipid hybrid microparticulate system is used for enhancing the oral absorption of low solubility and low permeability of (BCS Class IV) drugs. Silica-lipid hybrid microparticles include the drug solubilising effect of dispersed lipids and stabilizing effect of hydrophilic silica particles to increase drug solubilisation, which leads to enhanced oral bioavailability. The slica lipid hybrid (SLH) microparticles were composed of poorly soluble drug (furosemide), dispersion of oil phase (Soya bean oil and miglyol) in lecithin (Phospholipoid 90H), non-ionic surfactant (Polysorbate 80) and adsorbent (Aerosol 380). Saturation solubility studies were performed in different oils and surfactants with increased concentration of drug revealed increased solubility of furosemide. In vitro dissolution studies conducted under simulated gastric medium revealed 2-4 fold increase in dissolution efficiencies for SLH microparticles compared to that of pure drug (furosemide) and marketed formulation Lasix®. Ex vivo studies showed enhanced lipid digestibility, which improved drug permeability. Solid-state characterization of SLH microparticles by X-ray powder diffraction and Fourier transform infrared spectroscopic analysis confirmed non-crystalline nature and more compatibility of furosemide in silica-lipid hybrid microparticles. It can be concluded that the role of lipids and hydrophilic silica based carrier highlighted in enhancing solubility and permeability, and hence the oral bioavailability of poorly soluble drugs.

  9. Formulation development and optimization of palm kernel oil esters-based nanoemulsions containing sodium diclofenac.

    Science.gov (United States)

    Rezaee, Malahat; Basri, Mahiran; Rahman, Raja Noor Zaliha Raja Abdul; Salleh, Abu Bakar; Chaibakhsh, Naz; Karjiban, Roghayeh Abedi

    2014-01-01

    Response surface methodology was employed to study the effect of formulation composition variables, water content (60%-80%, w/w) and oil and surfactant (O/S) ratio (0.17-1.33), as well as high-shear emulsification conditions, mixing rate (300-3,000 rpm) and mixing time (5-30 minutes) on the properties of sodium diclofenac-loaded palm kernel oil esters-nanoemulsions. The two response variables were droplet size and viscosity. Optimization of the conditions according to the four variables was performed for preparation of the nanoemulsions with the minimum values of particle size and viscosity. The results showed that the experimental data could be sufficiently fitted into a third-order polynomial model with multiple regression coefficients (R(2) ) of 0.938 and 0.994 for the particle size and viscosity, respectively. Water content, O/S ratio and mixing time, quadrics of all independent variables, interaction between O/S ratio and mixing rate and between mixing time and rate, as well as cubic term of water content had a significant effect (Pdiclofenac nanoemulsions were predicted to be: 71.36% water content; 0.69 O/S ratio; 950 rpm mixing rate, and 5 minute mixing time. The optimized formulation showed good storage stability in different temperatures.

  10. Development of a formulation lyophilized for the obtention of a antimicrobial peptide Ubiquicidine labelled with 99m Tc

    International Nuclear Information System (INIS)

    Palomares R, P.; Hernandez B, C.A.; Contreras N, G.; Garcia P, M.L.; Pantoja H, I.E.; Ferro F, G.

    2004-01-01

    The 99m Tc-UBI 29-41 are a labelled fragment of the antimicrobial human peptide Ubiquicidine proposed as a new radiopharmaceutical able to differentiate an infectious process of an inflammatory one through the gamma graphic image. It has been demonstrated that the 99m Tc-UBI 29-41 unite to bacteria in vitro and that accumulates in infection sites in human with minimum captivation in inflammation sites. In this work the development of a pharmaceutical lyophilized formulation is presented for the instantaneous marked one of the UBI 29-41 with 99m Tc. The selection of the components of the formulation settled down by means of the employment of an experimental design of 3 factors with mixed levels, evaluating the effect of the diluent type, concentration of tinny chloride and the reaction volume. The obtained formulations showed to be stable until for 6 months, being obtained complexes of the radiolabelled peptide with radiochemical purity > 95 % in sterile form and apirogen. The developed pharmaceutical form, will facilitate the routinary use of this new radiopharmaceutical in the diverse hospital departments of nuclear medicine. (Author)

  11. Development and in vitro testing of liposomal gadolinium-formulations for neutron capture therapy of glioblastoma multiforme

    International Nuclear Information System (INIS)

    Peters, Tanja

    2013-01-01

    For the improvement of current neutron capture therapy, several liposomal formulations of neutron capture agent gadolinium were developed and tested in a glioma cell model. Formulations were analyzed regarding physicochemical and biological parameters, such as size, zeta potential, uptake into cancer cells and performance under neutron irradiation. The neutron and photon dose derived from intracellular as well as extracellular Gd was calculated via Monte Carlo simulations and set in correlation with the reduction of cell survival after irradiation. To investigate the suitability of Gd as a radiosensitizer for photon radiation, cells were also irradiated with synchrotron radiation in addition to clinically used photons generated by linear accelerator. Irradiation with neutrons led to significantly lower survival for Gd-liposome-treated F98 and LN229 cells, compared to irradiated control cells and cells treated with non-liposomal Gd-DTPA. Correlation between Gd-content and -dose and respective cell survival displayed proportional relationship for most of the applied formulations. Photon irradiation experiments showed the proof-of-principle for the radiosensitizer approach, although the photon spectra currently used have to be optimized for higher efficiency of the radiosensitizer. In conclusion, the newly developed Gd-liposomes show great potential for the improvement of radiation treatment options for highly malignant glioblastoma.

  12. Letter Report. Proposed Approach for Development of LAW Glass Formulation Correlation, VSL-04L4460-1, Rev. 2

    Energy Technology Data Exchange (ETDEWEB)

    Muller, Isabelle S. [The Catholic University of America, Washington, DC (United States); Diener, Glenn [The Catholic University of America, Washington, DC (United States); Joseph, Innocent [The Catholic University of America, Washington, DC (United States); Pegg, Ian L. [The Catholic University of America, Washington, DC (United States); Kruger, Albert A. [The Catholic University of America, Washington, DC (United States)

    2015-06-18

    The main objective of the work is to develop a correlation that employs waste composition information to determine the appropriate waste loading, glass composition, and amounts and types of glass formers. In addressing this objective emphasis has been placed on those compositions that have been validated in DM100 and LAW Pilot Melter testing. This is particularly important in view of the essential role that potential for sulfate phase separation in the melter plays in glass formulation selection. A further objective of this work is to select and test glass compositions in order to augment the existing data set and to test the predictions from the correlation. It should be noted that the intent of the correlation is to provide practical, robust glass formulations that exceed all of the contract and processability requirements; it is not intended to provide the "maximum achievable" waste loading such that at least one of those properties is at its respective limit.

  13. Effect of suspension characteristics on in-flight particle properties and coating microstructures achieved by suspension plasma spray

    Science.gov (United States)

    Aubignat, E.; Planche, M. P.; Allimant, A.; Billières, D.; Girardot, L.; Bailly, Y.; Montavon, G.

    2014-11-01

    This paper focuses on the influence of suspension properties on the manufacturing of coatings by suspension plasma spraying (SPS). For this purpose, alumina suspensions were formulated with two different liquid phases: water and ethanol. Suspensions were atomized with a twin-fluid nozzle and injected in an atmospheric plasma jet. Suspension injection was optimized thanks to shadowgraphy observations and drop size distribution measurements performed by laser diffraction. In-flight particle velocities were evaluated by particle image velocimetry. In addition, splats were collected on glass substrates, with the same conditions as the ones used during the spray process. Scanning electron microscopy (SEM) and profilometry analyses were then performed to observe the splat morphology and thus to get information on plasma / suspension interactions, such as particle agglomeration. Finally, coatings were manufactured, characterized by SEM and compared to each other.

  14. Enrichment, development, and assessment of Indian basil oil based antiseptic cream formulation utilizing hydrophilic-lipophilic balance approach.

    Science.gov (United States)

    Yadav, Narayan Prasad; Meher, Jaya Gopal; Pandey, Neelam; Luqman, Suaib; Yadav, Kuldeep Singh; Chanda, Debabrata

    2013-01-01

    The present work was aimed to develop an antiseptic cream formulation of Indian basil oil utilizing hydrophilic-lipophilic balance approach. In order to determine the required-hydrophilic lipophilic balance (rHLB) of basil oil, emulsions of basil oil were prepared by phase inversion temperature technique using water, Tween 80, and Span 80. Formulated emulsions were assessed for creaming (BE9; 9.8, BE10; 10.2), droplet size (BE18; 3.22 ± 0.09 μ m), and turbidity (BE18; 86.12 ± 2.1%). To ensure correctness of the applied methodology, rHLB of light liquid paraffin was also determined. After rHLB determination, basil oil creams were prepared with two different combinations of surfactants, namely, GMS : Tween 80 (1 : 3.45) and SLS : GMS (1 : 3.68), and evaluated for in vitro antimicrobial activity, skin irritation test, viscosity and consistency. The rHLB of basil oil and light liquid paraffin were found to be 13.36 ± 0.36 and 11.5 ± 0.35, respectively. Viscosity, and consistency parameters of cream was found to be consistent over 90 days. Cream formulations showed net zone of growth inhibition in the range of 5.0-11.3 mm against bacteria and 4.3-7.6 mm against fungi. Primary irritation index was found to be between 0.38 and1.05. Conclusively stable, consistent, non-irritant, enriched antiseptic basil oil cream formulations were developed utilizing HLB approach.

  15. Self-powered suspension criterion and energy regeneration implementation scheme of motor-driven active suspension

    Science.gov (United States)

    Yan, Shuai; Sun, Weichao

    2017-09-01

    Active suspension systems have advantages on mitigating the effects of vehicle vibration caused by road roughness, which are one of the most important component parts in influencing the performances of vehicles. However, high amount of energy consumption restricts the application of active suspension systems. From the point of energy saving, this paper presents a self-powered criterion of the active suspension system to judge whether a motor-driven suspension can be self-powered or not, and then a motor parameter condition is developed as a reference to design a self-powered suspension. An energy regeneration implementation scheme is subsequently proposed to make the active suspension which has the potential to be self-powered achieve energy-saving target in the real application. In this implementation scheme, operating electric circuits are designed based on different working status of the actuator and power source and it is realizable to accumulate energy from road vibration and supply energy to the actuator by switching corresponding electric circuits. To apply the self-powered suspension criterion and energy regeneration implementation scheme, an active suspension system is designed with a constrained H∞ controller and calculation results indicate that it has the capability to be self-powered. Simulation results show that the performances of the self-powered active suspension are nearly the same as those of the active suspension with an external energy source and can achieve energy regeneration at the same time.

  16. Study of quality and stability of ursodeoxycholic acid formulations for oral pediatric administration.

    Science.gov (United States)

    Santoveña, A; Sánchez-Negrín, E; Charola, L; Llabrés, M; Fariña, J B

    2014-12-30

    This paper describes a rational method of characterizing the biopharmaceutical stability of two oral suspensions of ursodeoxycholic acid (UDCA) used in pediatrics. Because there is no commercial presentation of UDCA that can administer appropriate doses for infants and children, an active pharmaceutical ingredient (API) formulation is required. Due to its very low solubility and low dose in the formula (1.5%), two different suspensions with minimal use of excipients were studied, avoiding the use of complex additives and those not recommended by the European Medicines Agency (EMA). Adherence to Standard Operating Procedure (SOP) allows the preparation of formulations with appropriately sized and stable particles, and suitable rheological behavior in withdrawing the dose after stirring. Dose uniformity, expressed as mass and content variability, was determined using the criteria of the European and the United States Pharmacopoeia. Additionally, dose content variation of every mass determined was studied. A rational method was developed for determining the dose uniformity of UDCA in suspensions, whether freshly prepared or after storage under different conditions for 30 and 60 days. This method permits detection of differences between doses taken at different heights in the vessel at various times and storage conditions. UDCA was stable under all conditions studied, requiring the presence of glycerol in the formulation to obtain the declared API value after stirring. Storage of UDCA suspensions in a refrigerator increased variability between doses. Copyright © 2014 Elsevier B.V. All rights reserved.

  17. Microencapsulation techniques to develop formulations of insulin for oral delivery: a review.

    Science.gov (United States)

    Cárdenas-Bailón, Fernando; Osorio-Revilla, Guillermo; Gallardo-Velázquez, Tzayhrí

    2013-01-01

    Oral insulin delivery represents one of the most challenging goals for pharmaceutical industry. In general, it is accepted that oral administration of insulin would be more accepted by patients and insulin would be delivered in a more physiological way than the parenteral route. From all strategies to deliverer insulin orally, microencapsulation or nanoencapsulation of insulin are the most promising approaches because these techniques protect insulin from enzymatic degradation in stomach, show a good release profile at intestine pH values, maintain biological activity during formulation and enhance intestinal permeation at certain extent. From different microencapsulation techniques, it seems that complex coacervation, multiple emulsion and internal gelation are the most appropriate techniques to encapsulate insulin due to their relative ease of preparation. Besides that, the use of organic solvents is not required and can be scaled up at low cost; however, relative oral bioavailability still needs to be improved.

  18. Preview based control of suspension systems for commercial vehicles

    NARCIS (Netherlands)

    Muijderman, J.H.E.A.; Kok, J.J.; Huisman, R.G.M.; Veldpaus, F.E.; van Heck, J.G.A.M.

    1999-01-01

    An active suspension with preview is developed for the rear axle of a commercial vehicle. The obtained improvements are promising and justify further investigation of the more feasible semi-active suspensions with preview. The inherent non-linearity of semi-active suspensions with switching shock

  19. Professor Jesse W. Beams and the first practical magnetic suspension

    Science.gov (United States)

    Allaire, P. E.; Humphris, R. R.; Lewis, D. W.

    1992-01-01

    Dr. Jesse W. Beams developed the first practical magnetic suspension for high speed rotating devices. The devices included high speed rotating mirrors, ultracentrifuges, and high speed centrifugal field rotors. A brief biography of Dr. Beams is presented, and the following topics are discussed: (1) early axial magnetic suspension for ultracentrifuges; and (2) magnetic suspension for high centrifugal fields.

  20. Development and Performance of a Highly Sensitive Model Formulation Based on Torasemide to Enhance Hot-Melt Extrusion Process Understanding and Process Development.

    Science.gov (United States)

    Evans, Rachel C; Kyeremateng, Samuel O; Asmus, Lutz; Degenhardt, Matthias; Rosenberg, Joerg; Wagner, Karl G

    2018-02-27

    The aim of this work was to investigate the use of torasemide as a highly sensitive indicator substance and to develop a formulation thereof for establishing quantitative relationships between hot-melt extrusion process conditions and critical quality attributes (CQAs). Using solid-state characterization techniques and a 10 mm lab-scale co-rotating twin-screw extruder, we studied torasemide in a Soluplus® (SOL)-polyethylene glycol 1500 (PEG 1500) matrix, and developed and characterized a formulation which was used as a process indicator to study thermal- and hydrolysis-induced degradation, as well as residual crystallinity. We found that torasemide first dissolved into the matrix and then degraded. Based on this mechanism, extrudates with measurable levels of degradation and residual crystallinity were produced, depending strongly on the main barrel and die temperature and residence time applied. In addition, we found that 10% w/w PEG 1500 as plasticizer resulted in the widest operating space with the widest range of measurable residual crystallinity and degradant levels. Torasemide as an indicator substance behaves like a challenging-to-process API, only with higher sensitivity and more pronounced effects, e.g., degradation and residual crystallinity. Application of a model formulation containing torasemide will enhance the understanding of the dynamic environment inside an extruder and elucidate the cumulative thermal and hydrolysis effects of the extrusion process. The use of such a formulation will also facilitate rational process development and scaling by establishing clear links between process conditions and CQAs.

  1. [Effect of gravitation loading and retabolil on development of atrophy in muscles and bones of rats due to suspension].

    Science.gov (United States)

    KaplanskiI, A S; Il'ina-Kakueva, E I; Durnova, G N; Alekseev, E A; Loginov, V I

    1999-01-01

    In a 3-wk experiment with tail-suspended rats histological and histomorphometric methods were used to determine the effects of graded gravitational loading (GGL) and anabolic steroid retabolil (nortestosterone decanoate) on the course of atrophy in soleus m. (SM), gastrocnemius m. (GM), tibia and humerus, and functioning of somatotrophic hormones (STH) of the pituitary and thyrocytes of the thyroid. Suspension was found to produce atrophy in SM and, to a less degree, in GM, partial transformation of SM slow fibers into the fast ones, suppression of the tibial longitudinal growth, demineralization of the tibial and humeral spongious metaphyses; besides, functional activities of STH-cells and thyrocytes were inhibited. Graded gravitational loading of rats by intermittence of suspension for 2 hrs slowed down atrophy in both muscles and osteopenia in tibia, stimulated the synthetic and secretory functions of STH-cells without any marked effect on thyrocytes or humeral osteopenia. GGL failed to influence the slow-to-fast transformation of SM fibers. Two injections of retabolil at the total dose of 3 mg/kg of the body mass somewhat interfered with the SM atrophy and humoral osteopenia, and were favorable to the synthetic but not secretory activity of STH-cells. Neither SM and tibial atrophies nor thyroid activity of the gland were improved. The prophylactic action of GGL upon the SM and humeral atrophies was significantly higher when combined with retabolil, whereas GM and tibia were not noticeably cured by retabolil. Inhibition of the SM atrophy and humeral osteopenia in rats treated with GGL and retabolil concurred with elevated activities of STH-cells and thyrocytes indirectly suggesting their more intensive production of the growth hormone and thyroid hormones, respectively.

  2. On the Benefits of Semi-Active Suspensions with Inerters

    Directory of Open Access Journals (Sweden)

    Xin-Jie Zhang

    2012-01-01

    Full Text Available Inerters have become a hot topic in recent years especially in vehicle, train, building suspension systems, etc. Eight different layouts of suspensions were analyzed with a quarter-car model in this paper. Dimensionless root mean square (RMS responses of the sprung mass vertical acceleration, the suspension travel, and the tire deflection are derived which were used to evaluate the performance of the quarter-car model. The behaviour of semi-active suspensions with inerters using Groundhook, Skyhook, and Hybrid control has been evaluated and compared to the performance of passive suspensions with inerters. Sensitivity analysis was applied to the development of a high performance semi-active suspension with an inerter. Numerical simulations indicate that a semi-active suspension with an inerter has much better performance than the passive suspension with an inerter, especially with the Hybrid control method, which has the best compromise between comfort and road holding quality.

  3. Formulation Design and Development of a Unani Transdermal Patch for Antiemetic Therapy and Its Pharmaceutical Evaluation

    Directory of Open Access Journals (Sweden)

    Mohd Nauman Saleem

    2016-01-01

    Full Text Available The Transdermal Drug Delivery System (TDDS is one of the novel routes for systemic delivery of drugs through intact skin. A transdermal patch (TP is a medicated patch that is placed on skin for delivery of medication through skin into the blood stream. The aim of present study was to formulate and evaluate a Unani transdermal patch that could be used for antiemetic therapy. The incorporation of Unani ingredients, namely, Khardal (Brassica nigra, Zanjabeel (Zingiber officinale, Podina (Mentha arvensis, and Sirka (Vinegar were envisaged. The TP was prepared by solvent evaporation technique and was evaluated for organoleptic characteristics and other physicochemical properties, such as thickness, weight uniformity, folding endurance, moisture content, drug content, and tolerability and acceptability of patch. The in vitro permeation study of the patch was carried out through Franz diffusion cell using egg shell membrane as barrier membrane. Phosphate buffer pH 7.4 was used as dissolution medium and the temperature was maintained at 37 ± 1°C. The in vitro permeation study of the prepared TP indicated a time dependent increase in drug release throughout the study. The percentage of cumulative drug release was found to be 77.38% in 24 hours. The study shows a new approach to work in Unani pharmaceutics.

  4. Formulation, development and characterization of mucoadhesive film for treatment of vaginal candidiasis.

    Science.gov (United States)

    Mishra, Renuka; Joshi, Priyanka; Mehta, Tejal

    2016-01-01

    The objective of the present investigation was formulation, optimization and characterization of mucoadhesive film of clotrimazole (CT) which is patient-convenient and provides an effective alternative for the treatment of vaginal candidiasis. CT is an antimycotic drug applied locally for the treatment of vaginal candidiasis. Mucoadhesive vaginal films were prepared by solvent casting technique using hydroxyl propylcellulose and sodium alginate as polymers. Propylene glycol and polyethylene glycol-400 were evaluated as plasticizers. The mucoadhesive vaginal films were evaluated for percentage elongation, tensile strength, folding endurance, drug content, in vitro disintegration time, in vitro dissolution study, swelling index, bioadhesive strength, and diffusion study. Among various permeation enhancers used, isopropyl myristate was found to be suitable. To evaluate the role of the concentration of permeation enhancer and concentration of polymers in the optimization of mucoadhesive vaginal film, 3(2) full factorial design was employed. Optimized batch showed in vitro disintegration time, 18 min; drug content, 99.83%; and tensile strength, 502.1 g/mm(2). In vitro diffusion study showed that 77% drug diffusion occurred in 6 h. This batch was further evaluated by scanning electron microscopy indicating uniformity of the film. In vitro Lactobacillus inhibition and in vitro antifungal activity of optimized batch showed an inhibitory effect against Candida albicans and no effect on Lactobacillus, which is a normal component of vaginal flora. Mucoadhesive vaginal film of CT is an effective dosage form for the treatment of vaginal candidiasis.

  5. Desenvolvimento de formulações de biscoitos tipo cookie contendo café Development of cookie formulations containing coffee

    Directory of Open Access Journals (Sweden)

    Melissa de Abreu Andrade Rodrigues

    2007-03-01

    Full Text Available Este trabalho teve como objetivo desenvolver formulações de biscoitos tipo cookie contendo café. Desenvolveram-se três formulações com inserção de café como: bebida tipo expresso, café solúvel e café torrado e moído, utilizando como base uma formulação americana adaptada aos ingredientes brasileiros e à inserção de café. A composição centésimal média (base seca foi: 7% umidade, 70% carboidratos, 8% proteínas, 21% gorduras e 1% minerais, com valor calórico médio de 499 kcal.100 g -1. A composição centesimal e o valor calórico observados foram similares a valores reportados para biscoitos cookie comercialmente disponíveis. A forma de inserção de café afetou as características sensoriais dos produtos, avaliados por metodologia descritiva de perfil de sabor e de textura. A Formulação 1 (bebida tipo expresso apresentou valores inferiores para a intensidade dos atributos referentes à presença de rachaduras, fragmentação, presença de pontos escuros, aroma de café e queimado. A Formulação 2 (café solúvel apresentou notas superiores de intensidade dos atributos de cor marrom, brilho, sabor amargo e de queimado, sabor residual de açúcar mascavo e crocância da borda e inferiores para concavidade. A Formulação 3 (café torrado e moído apresentou valores superiores para a presença de pontos escuros. As três formulações apresentaram notas satisfatórias e equivalentes de aceitação por crianças.The aim of the present study is to develop cookie formulations containing coffee. Three formulations were developed, each with a distinct way of adding coffee: espresso beverage, instant coffee and roasted coffee powder. The average proximate composition (dry basis of the formulations was 7% moisture, 70% carbohydrates, 8% protein, 21% fat and 1% minerals, resulting in an average caloric value of 499 kcal per 100 g product. Both the proximate composition and average caloric value were similar to values reported

  6. Glass formulation development and testing for the vitrification of DWPF HLW sludge coupled with crystalline silicotitanate (CST)

    International Nuclear Information System (INIS)

    Andrews, M.K.; Workman, P.J.

    1997-01-01

    An alternative to the In Tank Precipitation and sodium titanate processes at the Savannah River Site is the removal of cesium, strontium, and plutonium from the tank supernate by ion exchange using crystalline silicotitanate (CST). This inorganic material has been shown to effectively and selectively sorb these elements from supernate. The loaded CST could then be immobilized with High-Level Waste (HLW) sludge during vitrification. Initial efforts on the development of a glass formulation for a coupled waste stream indicate that reasonable loadings of both sludge and CST can be achieved in glass

  7. Mechanistic Oral Absorption Modeling and Simulation for Formulation Development and Bioequivalence Evaluation: Report of an FDA Public Workshop.

    Science.gov (United States)

    Zhang, X; Duan, J; Kesisoglou, F; Novakovic, J; Amidon, G L; Jamei, M; Lukacova, V; Eissing, T; Tsakalozou, E; Zhao, L; Lionberger, R

    2017-08-01

    On May 19, 2016, the US Food and Drug Administration (FDA) hosted a public workshop, entitled "Mechanistic Oral Absorption Modeling and Simulation for Formulation Development and Bioequivalence Evaluation." The topic of mechanistic oral absorption modeling, which is one of the major applications of physiologically based pharmacokinetic (PBPK) modeling and simulation, focuses on predicting oral absorption by mechanistically integrating gastrointestinal transit, dissolution, and permeation processes, incorporating systems, active pharmaceutical ingredient (API), and the drug product information, into a systemic mathematical whole-body framework. © 2017 The Authors CPT: Pharmacometrics & Systems Pharmacology published by Wiley Periodicals, Inc. on behalf of American Society for Clinical Pharmacology and Therapeutics.

  8. Development and Validation of RP-HPLC Method for the Determination of Adefovir Dipivoxil in Bulk and in Pharmaceutical Formulation

    Directory of Open Access Journals (Sweden)

    Zaheer Ahmed

    2009-01-01

    Full Text Available A rapid and sensitive RP-HPLC method with UV detection (262 nm for routine analysis of adefovir dipivoxil in bulk and in pharmaceutical formulation was developed. Chromatography was performed with mobile phase containing a mixture of acetonitrile and phosphate buffer (50:50, v/v with flow rate 1.0 mL min-l. In the range of 5.0-100 µg/mL, the linearity of adefovir dipivoxil shows a correlation co-efficient of 0.9999. The proposed method was validated by determining sensitivity accuracy, precision, robustness stability, specificity, selectivity and system suitability parameters.

  9. Development of transethosomes formulation for dermal fisetin delivery: Box-Behnken design, optimization, in vitro skin penetration, vesicles-skin interaction and dermatokinetic studies.

    Science.gov (United States)

    Moolakkadath, Thasleem; Aqil, Mohd; Ahad, Abdul; Imam, Syed Sarim; Iqbal, Babar; Sultana, Yasmin; Mujeeb, Mohd; Iqbal, Zeenat

    2018-05-07

    The present study was conducted for the optimization of transethosomes formulation for dermal fisetin delivery. The optimization of the formulation was carried out using "Box-Behnken design". The independent variables were Lipoid S 100, ethanol and sodium cholate. The prepared formulations were characterized for vesicle size, entrapment efficiency and in vitro skin penetration study. The vesicles-skin interaction, confocal laser scanning microscopy and dermatokinetic studies were performed with optimized formulation. Results of the present study demonstrated that the optimized formulation presented vesicle size of 74.21 ± 2.65 nm, zeta potential of -11.0 mV, entrapment efficiency of 68.31 ± 1.48% and flux of 4.13 ± 0.17 µg/cm 2 /h. The TEM image of optimized formulation exhibited sealed and spherical shape vesicles. Results of thermoanalytical techniques demonstrated that the prepared transethosomes vesicles formulation had fluidized the rigid membrane of rat's skin for smoother penetration of fisetin transethosomes. The confocal study results presented well distribution and penetration of Rhodamine B loaded transethosomes vesicles formulation up to deeper layers of the rat's skin as compared to the Rhodamine B-hydro alcoholic solution. Present study data revealed that the developed transethosomes vesicles formulation was found to be a potentially useful drug carrier for fisetin dermal delivery.

  10. [Efficient Pharmaceutical Formulation Designs and Their Development Using Mathematical and Statistical Analysis].

    Science.gov (United States)

    Iwao, Yasunori

    2015-01-01

    With the aim of directly predicting the functionality and mechanism of pharmaceutical excipients, we investigated an analysis method based on available surface area (S(t)), which is the surface area of a drug in direct contact with the external solvent during dissolution. First, to study the effect of lubricant concentration on the dissolution rate of acetaminophen (APAP), the dissolution behaviors as well as the change over time in S(t) of APAP tablets were examined. In the dissolution tests, a retarded dissolution of APAP was not observed with new lubricant triglycerin full behenate (TR-FB), whereas magnesium stearate (Mg-St) retarded the dissolution. The S(t) profiles for APAP with Mg-St at>0.5% showed downward curvature indicating a gradual decrease in surface area over time. Conversely, with TR-FB, even when its concentration was increased, the S(t) profile for APAP had a maximum value. The differences between Mg-St and TR-FB could be explained by the differences in extensibility deriving from their morphology. Next, we evaluated the effect of disintegtant concentration using five disintegrants. When disintegrant was added to ethenzamide tablet formulation, an increase in the dissolution rate and S(t) dependent on disintegrant concentration was observed, according to the type of disintegrant. It was found that the water absorption ability of disintegrants had strong correlations with the parameters of S(t). Taken together, this study demonstrates that analysis of S(t) can directly provide useful information, especially about the functionality of pharmaceutical excipients.

  11. Development of an attract-and-kill co-formulation containing Saccharomyces cerevisiae and neem extract attractive towards wireworms.

    Science.gov (United States)

    Humbert, Pascal; Vemmer, Marina; Mävers, Frauke; Schumann, Mario; Vidal, Stefan; Patel, Anant V

    2017-12-27

    Wireworms (Coleoptera: Elateridae) are major insect pests of worldwide relevance. Owing to the progressive phasing-out of chemical insecticides, there is great demand for innovative control options. This study reports on the development of an attract-and-kill co-formulation based on Ca-alginate beads, which release CO 2 and contain neem extract as a bioinsecticidal compound. The objectives of this study were to discover: (1) whether neem extract can be immobilized efficiently, (2) whether CO 2 -releasing Saccharomyces cerevisiae and neem extract are suitable for co-encapsulation, and (3) whether co-encapsulated neem extract affects the attractiveness of CO 2 -releasing beads towards wireworms. Neem extract was co-encapsulated together with S. cerevisiae, starch and amyloglucosidase with a high encapsulation efficiency of 98.6% (based on measurement of azadirachtin A as the main active ingredient). Even at enhanced concentrations, neem extract allowed growth of S. cerevisiae, and beads containing neem extract exhibited CO 2 -emission comparable with beads without neem extract. When applied to the soil, the beads established a CO 2 gradient of >15 cm. The co-formulation containing neem extract showed no repellent effects and was attractive for wireworms within the first 24 h after exposure. Co-encapsulation of S. cerevisiae and neem extract is a promising approach for the development of attract-and-kill formulations for the control of wireworms. This study offers new options for the application of neem extracts in soil. © 2017 Society of Chemical Industry. © 2017 Society of Chemical Industry.

  12. Development of a 186Re-HEDP formulation and radio pharmacokinetics comparison with 153Sm-EDTMP

    International Nuclear Information System (INIS)

    Bribiesca C, A.I.

    1998-01-01

    Because of the growing interest in the use of the beta emitters radiopharmaceuticals applied to therapy in different cancer cases, we developed a formulation of 186 Re-HEDP (hydroxy ethylidene diphosphonate) as a pain palliative in osseous metastases. Besides serving like therapeutic agent, together with the 153 Sm-EDTMP (ethylene diamine tetra methylene phosphonate), which has already been synthesized and proved, labels EHDP could be very useful like a diagnostic agent in the pursuit of the illness. The irradiation conditions for Rhenium-186 were established by ORIGIN 2 codes for TRIGA reactors. A pharmaceutical formulation was developed employing a factorial experimental design obtaining a complex with a radiochemical purity over 90 %. The complexes 186 Re-HEDP 153 Sm-EDTMP were intravenous administered in BALB-C mice sacrifying them in several intervals of time in order to determine the cumulated activity in each organ to perform absorbed dose calculation by MIRD methodology (Medical Internal Radiation Dose). Radio pharmacokinetic data demonstrated that both complexes follow a biexponential kinetic of first order behavior. In the case of the 186 Re-HEDP the value of the α constant was 0.2789 and β 0.0006 with an effective dose of 2.56 (mSv)/MBq , while for the complex 153 Sm-EDTMP the values of α to and β were 0.9012 and and 0.616 respectively and the effective dose was 0.262 (mSv)/MBq. In conclusion, radiopharmaceutical 153 Sm-EDTMP, showed a greater bone uptake and a minor effective dose, for which it is a better radiopharmaceutical, respect to with the formulation of 186 Re-HEDP. (Author)

  13. Suspension trauma; Le traumatisme de suspension

    Energy Technology Data Exchange (ETDEWEB)

    Trudel, S. [Le Centre de sante et de services sociaux du rocher Perce, Chandler, PQ (Canada)

    2010-07-01

    This presentation discussed the precautions that should be taken to avoid falls from wind turbines or transmission towers. Suspension trauma was explained by a medical doctor in terms of physiology and the body's normal circulation and the elements that disturb normal physiology when in suspension. The trauma occurs following a fall, which carries the risk of 1or more disorders, such as massive hemorrhage, high cardiac pulse, and constriction of blood vessels. Nausea, vertigo, cardiac arrhythmia and sweating occur 15 to 20 minutes following the fall. The presentation emphasized the importance of having qualified personnel at the site and wearing proper harnesses and equipment that supports the neck. figs.

  14. Development and gamma scintigraphy evaluation of gastro retentive calcium ion-based oral formulation: an innovative approach for the management of gastro-esophageal reflux disease (GERD).

    Science.gov (United States)

    Sharma, Braj Gaurav; Khanna, Kushagra; Kumar, Neeraj; Nishad, Dhruv K; Basu, Mitra; Bhatnagar, Aseem

    2017-11-01

    Calcium chloride is an essential calcium channel agonist which plays an important role in the contraction of muscles by triggering calcium channel. First time hypothesized about its role in the treatment of GER (gastro-esophageal reflux) and vomiting disorder due to its local action. There are two objectives covered in this study as first, the development and optimization of floating formulation of calcium chloride and another objective was to evaluate optimized formulation through gamma scintigraphy in human subjects. Gastro retentive formulation of calcium chloride was prepared by direct compression method. Thirteen tablet formulations were designed with the help of sodium chloride, HPMC-K4M, and carbopol-934 along with effervescing agent sodium bicarbonate and citric acid. Formulation (F8) fitted best for Korsmeyer-Peppas equation with an R 2 value of 0.993. The optimized formulation was radiolabelled with 99m Tc-99 m pertechnetate for its evaluation by gamma scintigraphy. Gastric retention (6 h) was evaluated by gamma scintigraphy in healthy human subjects and efficacy of present formulation confirmed in GER positive human subjects. Gamma scintigraphy results indicated its usefulness in order to manage GERD. Stability studies of the developed formulation were carried out as per ICH guidelines for region IV and found out to be stable for 24 months.

  15. Study on kinematic and compliance test of suspension

    Science.gov (United States)

    Jing, Lixin; Wu, Liguang; Li, Xuepeng; Zhang, Yu

    2017-09-01

    Chassis performance development is a major difficulty in vehicle research and development, which is the main factor restricting the independent development of vehicles in China. These years, through a large number of studies, chassis engineers have found that the suspension K&C characteristics as a quasi-static characteristic of the suspension provides a technical route for the suspension performance R&D, and the suspension K&C test has become an important means of vehicle benchmarking, optimization and verification. However, the research on suspension K&C test is less in china, and the test conditions and setting requirements vary greatly from OEM to OEM. In this paper, the influence of different settings on the characteristics of the suspension is obtained through experiments, and the causes of the differences are analyzed; in order to fully reflect the suspension characteristics, the author recommends the appropriate test case and settings.

  16. Disintegration mediated controlled release supersaturating solid dispersion formulation of an insoluble drug: design, development, optimization, and in vitro evaluation.

    Science.gov (United States)

    Verma, Sanjay; Rudraraju, Varma S

    2015-02-01

    The objective of this study was to develop a solid dispersion based controlled release system for drug substances that are poorly soluble in water. A wax-based disintegration mediated controlled release system was designed based on the fact that an amorphous drug can crystallize out from hydrophilic matrices. For this study, cilostazol (CIL) was selected as the model drug, as it exhibits poor aqueous solubility. An amorphous solid dispersion was prepared to assist the drug to attain a supersaturated state. Povidone was used as carrier for solid dispersion (spray drying technique), hydrogenated vegetable oil (HVO) as wax matrix former, and sodium carboxymethyl cellulose (NaCMC) as a disintegrant. The extreme vertices mixture design (EVMD) was applied to optimize the designed and developed composition. The optimized formulation provided a dissolution pattern which was equivalent to the predicted curve, ascertaining that the optimal formulation could be accomplished with EVMD. The release profile of CIL was described by the Higuchi's model better than zero-order, first-order, and Hixson-Crowell's model, which indicated that the supersaturation state of CIL dominated to allow drug release by diffusion rather than disintegration regulated release as is generally observed by Hixson-Crowell's model. The optimized composition was evaluated for disintegration, dissolution, XRD, and stability studies. It was found that the amorphous state as well as the dissolution profile of CIL was maintained under the accelerated conditions of 40°C/75% RH for 6 months.

  17. Development of indirect spectrophotometric method for quantification of cephalexin in pure form and commercial formulation using complexation reaction

    International Nuclear Information System (INIS)

    Khan, M.N.; Hussain, R.; Kalsoom, S.; Saadiq, M.

    2016-01-01

    A simple, accurate and indirect spectrophotometric method was developed for the quantification of cephalexin in pure form and pharmaceutical products using complexation reaction. The developed method is based on the oxidation of the cephalexin with Fe/sup 3+/ in acidic medium. Then 1, 10- phenanthroline reacts with Fe/sup 2+/ and a red colored complex was formed. The absorbance of the complex was measured at 510 nm by spectrophotometer. Different experimental parameters affecting the complexation reactions were studied and optimized. Beer law was obeyed in the concentration range 0.4 -10 micro gmL/sup -1/ with a good correlation of 0.992. The limit of detection and limit of quantification were found to be 0.065 micro gmL/sup -1/ and 0.218 micro gmL/sup -1/ , respectively. The method have good reproducibility with a relative standard deviation of 6.26 percent (n = 6). The method was successfully applied for the determination of cephalexin in bulk powder and commercial formulation. Percent recoveries were found to range from 95.47 to 103.87 percent for the pure form and 98.62 to 103.35 percent for commercial formulations. (author)

  18. Quality by design in formulation and process development for a freeze-dried, small molecule parenteral product: a case study.

    Science.gov (United States)

    Mockus, Linas N; Paul, Timothy W; Pease, Nathan A; Harper, Nancy J; Basu, Prabir K; Oslos, Elizabeth A; Sacha, Gregory A; Kuu, Wei Y; Hardwick, Lisa M; Karty, Jacquelyn J; Pikal, Michael J; Hee, Eun; Khan, Mansoor A; Nail, Steven L

    2011-01-01

    A case study has been developed to illustrate one way of incorporating a Quality by Design approach into formulation and process development for a small molecule, freeze-dried parenteral product. Sodium ethacrynate was chosen as the model compound. Principal degradation products of sodium ethacrynate result from hydrolysis of the unsaturated ketone in aqueous solution, and dimer formation from a Diels-Alder condensation in the freeze-dried solid state. When the drug crystallizes in a frozen solution, the eutectic melting temperature is above -5°C. Crystallization in the frozen system is affected by pH in the range of pH 6-8 and buffer concentration in the range of 5-50 mM, where higher pH and lower buffer concentration favor crystallization. Physical state of the drug is critical to solid state stability, given the relative instability of amorphous drug. Stability was shown to vary considerably over the ranges of pH and buffer concentration examined, and vial-to-vial variability in degree of crystallinity is a potential concern. The formulation design space was constructed in terms of pH and drug concentration, and assuming a constant 5 mM concentration of buffer. The process design space is constructed to take into account limitations on the process imposed by the product and by equipment capability.

  19. Development of a new, rapid and sensitive HPTLC method for estimation of Milnacipran in bulk, formulation and compatibility study

    Directory of Open Access Journals (Sweden)

    Gautam Singhvi

    2017-05-01

    Full Text Available A simple, sensitive and rapid high performance thin layer chromatographic (HPTLC method has been developed and validated for quantitative determination of Milnacipran Hydrochloride (MIL in bulk and formulations. The chromatographic development was carried out on HPTLC plates precoated with silica gel 60 F254 using a mixture of acetonitrile, water and ammonia (6:0.6:1.6 (v/v/v as mobile phase. Detection was carried out densitometrically at 220 nm. The Rf value of drug was found to be 0.63 ± 0.02. The method was validated as per ICH guideline with respect to linearity, accuracy, precision, robustness etc. The calibration curve was found to be linear over a range of 100–1000 ng μL−1 with a regression coefficient of 0.999. The accuracy was found to be very high (99.12–100.87%. %RSD values for intra-day and inter-day variation were not more than 1.43. The method has demonstrated high sensitivity and specificity. The method was applied for compatibility studies also. The method is new, simple and economic for routine estimation of MIL in bulk, preformulation studies and pharmaceutical formulation to help the industries as well as researchers for their sensitive determination of MIL rapidly at low cost in routine analysis.

  20. Characterization of new functionalized calcium carbonate-polycaprolactone composite material for application in geometry-constrained drug release formulation development.

    Science.gov (United States)

    Wagner-Hattler, Leonie; Schoelkopf, Joachim; Huwyler, Jörg; Puchkov, Maxim

    2017-10-01

    A new mineral-polymer composite (FCC-PCL) performance was assessed to produce complex geometries to aid in development of controlled release tablet formulations. The mechanical characteristics of a developed material such as compactibility, compressibility and elastoplastic deformation were measured. The results and comparative analysis versus other common excipients suggest efficient formation of a complex, stable and impermeable geometries for constrained drug release modifications under compression. The performance of the proposed composite material has been tested by compacting it into a geometrically altered tablet (Tablet-In-Cup, TIC) and the drug release was compared to commercially available product. The TIC device exhibited a uniform surface, showed high physical stability, and showed absence of friability. FCC-PCL composite had good binding properties and good compactibility. It was possible to reveal an enhanced plasticity characteristic of a new material which was not present in the individual components. The presented FCC-PCL composite mixture has the potential to become a successful tool to formulate controlled-release dosage solid forms.

  1. Human resource development formulation and evaluation in an Iranian Petrochemical Company using ANP and grey relational analysis

    Directory of Open Access Journals (Sweden)

    Ahmad Reza Ghasemi

    2016-07-01

    Full Text Available Today, human capital is considered a key factor of achieving the competitive advantage in different industries. The present study, as an applied and descriptive research, aims at providing formulation and evaluation of human resource development of an Iranian Petrochemical Company (APC. The human resource experts and managers of APC together with university professors of human capital and familiar with local conditions of Khuzestan province, Iran, made up the statistical population of this research. In this connection, first the internal factors (including advantages and disadvantages were identified using human resource excellence indicators. Then, the opportunities and threats of human resource system were found via PESTEL approach. In the next step, the primary strategies were formulated using the strength, weakness, opportunities and threats (SWOT Matrix. The next phases of the study were included evaluation and ranking of human resource development strategies based on analytical network process (ANP multi-criteria decision making method and grey systems theory. According to results of the research, defensive strategies (WT are suggested as the best and most appropriate strategies in human resource area. In other words, the internal and external factors of APC are problematic. Accordingly, APC is expected to adopt WT strategy, minimize the weaknesses, and avoid threats. Subsequent to the above policy, the strategies of WO, ST, and SO are advised to employ.

  2. Development of an Improved Inhalable Powder Formulation of Pirfenidone by Spray-Drying: In Vitro Characterization and Pharmacokinetic Profiling.

    Science.gov (United States)

    Seto, Yoshiki; Suzuki, Gen; Leung, Sharon Shui Yee; Chan, Hak-Kim; Onoue, Satomi

    2016-06-01

    Previously, a respirable powder (RP) formulation of pirfenidone (PFD) was developed for reducing phototoxic risk; however, PFD-RP demonstrated unacceptable in vitro inhalation performance. The present study aimed to develop a new RP system of PFD with favorable inhalation properties by spray-drying method. Spray-dried PFD (SD/PFD) was prepared by spray-drying with L-leucine, and the physicochemical properties and efficacy in an antigen-sensitized airway inflammation model were assessed. A pharmacokinetic study was also conducted after intratracheal and oral administration of PFD formulations. Regarding powder characterization, SD/PFD had dimpled surface with the mean diameter of 1.793 μm. In next generation impactor analysis, SD/PFD demonstrated high in vitro inhalation performance without the need of carrier particles, and the fine particle fraction of SD/PFD was calculated to be 62.4%. Insufflated SD/PFD (0.3 mg-PFD/rat) attenuated antigen-evoked inflammatory events in the lung, including infiltration of inflammatory cells and myeloperoxidase activity. Systemic exposure level of PFD after insufflation of SD/PFD at the pharmacologically effective dose was 600-fold lower than that after oral administration of PFD at the phototoxic dose. SD/PFD would be suitable for inhalation, and the utilization of an RP system with SD/PFD would provide a safer medication compared with oral administration of PFD.

  3. The application of remote sensing to the development and formulation of hydrologic planning models

    Science.gov (United States)

    Fowler, T. R.; Castruccio, P. A.; Loats, H. L., Jr.

    1977-01-01

    The development of a remote sensing model and its efficiency in determining parameters of hydrologic models are reviewed. Procedures for extracting hydrologic data from LANDSAT imagery, and the visual analysis of composite imagery are presented. A hydrologic planning model is developed and applied to determine seasonal variations in watershed conditions. The transfer of this technology to a user community and contract arrangements are discussed.

  4. Evaluating Self-Concept and Ego Development within Erikson's Psychosocial Framework: A Formulation.

    Science.gov (United States)

    Hamachek, Don E.

    1988-01-01

    Suggests criteria developed within context of Erikson's first five psychosocial stages that may help in evaluating self-concept and ego development. To assess strengths and weaknesses in self's growth as it progresses through the stages, five behavioral expressions tables are presented, each illustrating possible behaviors and implicit attitudes…

  5. Development of an optimized tetracycline-inducible expression system to increase the accumulation of interleukin-10 in tobacco BY-2 suspension cells.

    Science.gov (United States)

    Bortesi, Luisa; Rademacher, Thomas; Schiermeyer, Andreas; Schuster, Flora; Pezzotti, Mario; Schillberg, Stefan

    2012-07-11

    Plant cell suspension cultures can be used for the production of valuable pharmaceutical and industrial proteins. When the recombinant protein is secreted into the culture medium, restricting expression to a defined growth phase can improve both the quality and quantity of the recovered product by minimizing proteolytic activity. Temporal restriction is also useful for recombinant proteins whose constitutive expression affects cell growth and viability, such as viral interleukin-10 (vIL-10). We have developed a novel, tetracycline-inducible system suitable for tobacco BY-2 suspension cells which increases the yields of vIL-10. The new system is based on a binary vector that is easier to handle than conventional vectors, contains an enhanced inducible promoter and 5'-UTR to improve yields, and incorporates a constitutively-expressed visible marker gene to allow the rapid and straightforward selection of the most promising transformed clones. Stable transformation of BY-2 cells with this vector, without extensive optimization of the induction conditions, led to a 3.5 fold increase in vIL-10 levels compared to constitutive expression in the same host. We have developed an effective and straightforward molecular farming platform technology that improves both the quality and the quantity of recombinant proteins produced in plant cells, particularly those whose constitutive expression has a negative impact on plant growth and development. Although we tested the platform using vIL-10 produced in BY-2 cells, it can be applied to other host/product combinations and is also useful for basic research requiring strictly controlled transgene expression.

  6. Development and validation of a stability-indicating HPLC-UV method for the determination of triamcinolone acetonide and its degradation products in an ointment formulation

    NARCIS (Netherlands)

    van Heugten, A J P; Boer, W.; de Vries, W S; Markesteijn, C M A; Vromans, H

    2018-01-01

    A stability indicating high performance liquid chromatography method has been developed for the determination of triamcinolone acetonide (TCA) and its main degradation products in ointment formulations. The method, based on extensive stress testing using metal salts, azobisisobutyronitrile, acid,

  7. Stability Prediction of Polymeric Suspensions of some Fluoroquinolones

    OpenAIRE

    Subhashree Sahoo; Chandra Kanti Chakraborti; Pradipta Kumar Behera

    2014-01-01

    Considering the importance of physical stability, zeta potential values, percentage volume of sedimentation and redispersibility of polymeric suspensions of some fluoroquinolones like Ciprofloxacin (Cipro) and Ofloxacin (Oflox) were measured. These formulations were prepared using two grades of Carbopol polymer such as C934 and C940; and Hydroxypropyl methylcellulose (HPMC). Above mentioned values of each suspension was determined by following standard methods. The results of those experiment...

  8. Development of Metarhizium anisopliae and Beauveria bassiana formulations for control of malaria mosquito larvae

    NARCIS (Netherlands)

    Bukhari, S.T.; Takken, W.; Koenraadt, C.J.M.

    2011-01-01

    Background The entomopathogenic fungi Metarhizium anisopliae and Beauveria bassiana have demonstrated effectiveness against anopheline larvae in the laboratory. However, utilising these fungi for the control of anopheline larvae under field conditions, relies on development of effective means of

  9. Oral fast-dissolving films containing lutein nanocrystals for improved bioavailability: formulation development, in vitro and in vivo evaluation.

    Science.gov (United States)

    Liu, Chen; Chang, Daoxiao; Zhang, Xinhui; Sui, Hong; Kong, Yindi; Zhu, Rongyue; Wang, Wenping

    2017-11-01

    Lutein is widely used as diet supplement for prevention of age-related macular degeneration. However, the application and efficacy of lutein in food and nutritional products has been hampered due to its poor solubility and low oral bioavailability. This study aimed to develop and evaluate the formulation of oral fast-dissolving film (OFDF) containing lutein nanocrystals for enhanced bioavailability and compliance. Lutein nanocrystals were prepared by anti-solvent precipitation method and then encapsulated into the films by solvent casting method. The formulation of OFDF was optimized by Box-Behnken Design (BBD) as follows: HPMC 2.05% (w/v), PEG 400 1.03% (w/v), Cremophor EL 0.43% (w/v). The obtained films exhibited uniform thickness of 35.64 ± 1.64 μm and drug content of 0.230 ± 0.003 mg/cm 2 and disintegrated rapidly in 29 ± 8 s. The nanocrystal-loaded films with reconstituted particle size of 377.9 nm showed better folding endurance and faster release rate in vitro than the conventional OFDFs with raw lutein. The microscope images, thermograms, and diffractograms indicated that lutein nanocrystals were highly dispersed into the films. After administrated to SD rats, t max was decreased from 3 h for oral solution formulation to less than 0.8 h for OFDF formulations, and C max increased from 150 ng/mL for solution to 350 ng/mL for conventional OFDF or 830 ng/mL for nanocrystal OFDF. The AUC 0-24h of conventional or nanocrystal OFDF was 1.37 or 2.08-fold higher than that of the oral solution, respectively. These results suggested that drug nanocrystal-loaded OFDF can be applied as a promising approach for enhanced bioavailability of poor soluble drugs like lutein.

  10. Adaptation of the quality by design concept in early pharmaceutical development of an intranasal nanosized formulation.

    Science.gov (United States)

    Pallagi, Edina; Ambrus, Rita; Szabó-Révész, Piroska; Csóka, Ildikó

    2015-08-01

    Regulatory science based pharmaceutical development and product manufacturing is highly recommended by the authorities nowadays. The aim of this study was to adapt regulatory science even in the nano-pharmaceutical early development. Authors applied the quality by design (QbD) concept in the early development phase of nano-systems, where the illustration material was meloxicam. The meloxicam nanoparticles produced by co-grinding method for nasal administration were studied according to the QbD policy and the QbD based risk assessment (RA) was performed. The steps were implemented according to the relevant regulatory guidelines (quality target product profile (QTPP) determination, selection of critical quality attributes (CQAs) and critical process parameters (CPPs)) and a special software (Lean QbD Software(®)) was used for the RA, which represents a novelty in this field. The RA was able to predict and identify theoretically the factors (e.g. sample composition, production method parameters, etc.) which have the highest impact on the desired meloxicam-product quality. The results of the practical research justified the theoretical prediction. This method can improve pharmaceutical nano-developments by achieving shorter development time, lower cost, saving human resource efforts and more effective target-orientation. It makes possible focusing the resources on the selected parameters and area during the practical product development. Copyright © 2015 Elsevier B.V. All rights reserved.

  11. Development of Sensitive and Specific Analysis of Vildagliptin in Pharmaceutical Formulation by Gas Chromatography-Mass Spectrometry

    Directory of Open Access Journals (Sweden)

    Ebru Uçaktürk

    2015-01-01

    Full Text Available A sensitive and selective gas chromatography-mass spectrometry (GC-MS method was developed and fully validated for the determination of vildagliptin (VIL in pharmaceutical formulation. Prior to GC-MS analysis, VIL was efficiently derivatized with MSTFA/NH4I/β-mercaptoethanol at 60°C for 30 min. The obtained O-TMS derivative of VIL was detected by selected ion monitoring mode using the diagnostic ions m/z 223 and 252. Nandrolone was chosen as internal standard. The GC-MS method was fully validated by the following validation parameters: limit of detection (LOD and quantitation (LOQ, linearity, precision, accuracy, specificity, stability, robustness, and ruggedness. LOD and LOQ were found to be 1.5 and 3.5 ng mL−1, respectively. The GC-MS method is linear in the range of 3.5–300 ng mL−1. The intra- and interday precision values were less than ≤3.62%. The intra- and interday accuracy values were found in the range of -0.26–2.06%. Finally, the GC-MS method was successfully applied to determine VIL in pharmaceutical formulation.

  12. Efficacy of Topical Therapy with Newly Developed Terbinafine and Econazole Formulations in the Treatment of Dermatophytosis in Cats.

    Science.gov (United States)

    Ivaskiene, M; Matusevicius, A P; Grigonis, A; Zamokas, G; Babickaite, L

    2016-09-01

    In the field of veterinary dermatology dermatophytosis is one of the most frequently occurring infectious diseases, therefore its treatment should be effective, convenient, safe and inexpensive. The aim of this study was to evaluate the efficacy of newly developed topical formulations in the treatment of cats with dermatophytosis. Evaluation of clinical efficacy and safety of terbinafine and econazole formulations administered topically twice a day was performed in 40 cats. Cats, suffering from the most widely spread Microsporum canis-induced dermatophytosis and treated with terbinafine hydrochloride 1% cream, recovered within 20.3±0.88 days; whereas when treated with econazole nitrate 1% cream, they recovered within 28.4±1.14 days. A positive therapeutic effect was yielded by combined treatment with local application of creams and whole coat spray with enilconazole 0.2% emulsion "Imaverol". Most cats treated with econazole cream revealed redness and irritation of the skin at the site of application. This study demonstrates that terbinafine tended to have superior clinical efficacy (p<0.001) in the treatment of dermatophytosis in cats compared to the azole tested.

  13. Development and validation of a simple spectrophotometric method for the determination of methyldopa in both bulk and marketed dosage formulations

    Directory of Open Access Journals (Sweden)

    Paulo Roberto da Silva Ribeiro

    2014-09-01

    Full Text Available A simple, precise, sensitive, rapid, specific and economical spectrophotometric method was developed to determine methyldopa (MTD content in bulk and pharmaceutical dosage formulations. The proposed method was based on the formation of a colored product from the nitrosation reaction of MTD with sodium nitrite in an acid medium. The resultant nitroso derivative species reacts further with sodium hydroxide and is converted it into a more stable compound. This yellow nitrosation product exhibited an absorption maximum at 430 nm. Beer's Law was obeyed in a concentration range of 6.37 to 82.81 μg mL-1 MTD with an excellent coefficient of determination (R2 = 0.9998. No interference was observed from common excipients in formulations. The results showed the method to be simple, accurate and readily applied for the determination of MTD in pure form and in pharmaceutical preparations. The analytical results obtained for these products using the proposed method are in agreement with those of the Brazilian Pharmacopoeia procedure at a 95% confidence level.

  14. Assessment of drug salt release from solutions, suspensions and in situ suspensions using a rotating dialysis cell

    DEFF Research Database (Denmark)

    Parshad, Henrik; Frydenvang, Karla; Liljefors, Tommy

    2003-01-01

    buffer is used as release media. Generally, the initial release of the drug salt from in situ suspensions occurred faster as compared to conventional suspensions, probably due to incomplete precipitation of the drug salt, and hence formation of supersaturated solutions where the rate of release......A rotating dialysis cell consisting of a small (10 ml) and a large compartment (1000 ml) was used to study the release of drug salt (bupivacaine 9-anthracene carboxylate) from (i). solutions, (ii). suspensions and (iii). in situ formed suspensions. Initial release experiments from suspensions...... indicated that the release of drug salt in deionized water was predominantly limited by the diffusion across the membrane whereas it is essentially dissolution rate controlled in 0.05 M phosphate buffer (pH 7.40). Thus, the in vitro model appears to have a potential in formulation screening when phosphate...

  15. Orodispersible films in individualized pharmacotherapy : The development of a formulation for pharmacy preparations

    NARCIS (Netherlands)

    Visser, Caroline; Woerdenbag, Herman J.; Crediet, Stefan; Gerrits, Edwin; Lesschen, Marjan A.; Hinrichs, Wouter L.J.; Breitkreutz, Jörg; Frijlink, Henderik W.

    2015-01-01

    Orodispersible films (ODFs) are promising drug delivery systems for customized small scale pharmacy preparations. The aim of the present study was to develop a versatile casting solution suitable for the extemporaneous production of ODFs to which active pharmaceutical ingredients (APIs) can be

  16. Morphology development during single droplet drying of mixed component formulations and milk

    NARCIS (Netherlands)

    Both, E.M.; Nuzzo, N.; Millqvist-Fureby, A.; Boom, R.M.; Schutyser, M.A.I.

    2018-01-01

    We report on the influence of selected components and their mixtures on the development of the morphology during drying of single droplets and extend the results to the morphology of whole milk powder particles. Sessile single droplet drying and acoustic levitation methods were employed to study

  17. Policy framework for formulating environmental management strategy for sustainable development of tanneries in India.

    Science.gov (United States)

    Ingle, Kapilkumar N; Harada, Koichi; Wei, Chang Nian; Minamoto, Keiko; Ueda, Atsushi

    2011-03-01

    The leather industry is one of the main examples of industries which play an important role in the Indian economy in terms of exports and employment opportunities, while being blamed for environmental pollution. The objective of this study was to find the advances or improvements in the Japanese leather industry which are not found in typical leather industries in developing countries. We examined the Japanese leather industry in this context because Japan is a developed country in which tanning processes have been a traditional business from ancient times, and also the leather industry has played an important role in the process of economic development of Japan. The study was based both on information collected from various areas related to the leather industry or leather industry stakeholders, and also on a review of published information. Information was collected through site visits, interviews, questionnaires, and detailed discussions with these stakeholders, as well as from their websites. The framework of a typical leather industry is discussed in three sections: pollution prevention, pollution control, and pollution mitigation related to sources, processes, and impact possibilities, respectively. Eleven basic differences were noted between the Japanese and Indian leather industries. The availability of melting centers is the main important feature of the Japanese leather sector. Guidelines are suggested which focus on some changes that are expected to lead to both environmental and economic benefits, with better pollution management, which should lead to continuous improvement of the environmental performance of the industry, and, finally, sustainable development.

  18. Development of novel encapsulated formulations using albumin-chitosan as a polymer matrix for ocular drug delivery

    Science.gov (United States)

    Addo, Richard Tettey

    Designing formulations for ophthalmic drug delivery is one of the most challenging endeavors facing the pharmaceutical scientist due to the unique anatomy, physiology, and biochemistry of the eye. Current treatment protocols for administration of drugs in eye diseases are primarily solution formulations, gels or ointments. However, these modes of delivery have several drawbacks such as short duration of exposure, need for repeated administrations and non-specific toxicity. We hypothesize that development of ocular drugs in microparticles will overcome the deficiencies of the current modalities of treatment. We based the hypothesis on the preliminary studies conducted with encapsulated tetracaine, an anesthetic used for surgical purposes and atropine, a medication used for several ophthalmic indications including mydriatic and cycloplegic effects. However, atropine is well absorbed into the systemic circulation and has been reported to exert severe systemic side effects after ocular administration (Hoefnagel D. 1961, Morton H. G. 1939 and Lang J. C. 1995) and may lead to serious side effects including death in extreme cases with pediatric use. Based on these observations, the focus of this dissertation is to formulate microparticulate drug carrier for treatment of various conditions of the eye. Purpose: To prepare, characterize, study the in vitro and in vivo interaction of albumin-chitosan microparticles (BSA-CSN MS), a novel particulate drug carrier for ocular drug delivery. Method: Microparticle formulations were prepared by method of spray drying. The percentage drug loading and efficiency were assessed using USP (I) dissolution apparatus. Using Malvern Zeta-Sizer, we determined size and surface charge of the fabrication. Surface morphology of the microparticles was examined using Scanning Electron Microscopy. Microparticles were characterized in terms of thermal properties using Differential Scanning Calorimetry. Human corneal epithelial cells (HCET-1) were

  19. Development and application of spectrophotometric method for the determination of cefaclor in pharmaceutical formulations

    Directory of Open Access Journals (Sweden)

    Asad Raza

    2009-01-01

    Full Text Available A simple, fast and sensitive spectrophotometric method for the determination of cefaclor in pharmaceutical raw and dosage forms based on reaction with ninhydrin is developed, optimized and validated. The purple color (Ruhemenn's purple that resulted from the reaction was stabilized and measured at 560 nm. Beer's law is obeyed in the concentration range of 4-80 µg mL-1 with molar absorptivity of 1.42 × 10(5 L mole-1 cm-1. All variables including the reagent concentration, heating time, reaction temperature, color stability period, and cefaclor/ninhydrin ratio were studied in order to optimize the reaction conditions. No interference was observed from common pharmaceutical adjuvant. The developed method is easy to use, accurate and highly cost-effective for routine studies relative to HPLC and other techniques.

  20. Polymeric materials and formulation technologies for modified-release tablet development.

    Science.gov (United States)

    Zarate, J; Igartua, M; Hernández, R M; Pedraz, J L

    2009-11-01

    Over the last years significant advances have been made in the area of drug delivery with the development of modified-release (MR) dosage forms. The present review is divided into two parts, one dealing with technologies for the design of modified-release drug delivery tablets and the other with the use of synthetic and natural polymers that are capable of controlling drug release.

  1. Formulating Human Resources Development Strategies for Nuclear R and D, Safety and Security

    International Nuclear Information System (INIS)

    Min, B. J.; Kim, M. K.; Son, M. Y.

    2010-05-01

    Enforced by the recent launch of the 4th National Power Expansion Plan and the 1st Basic Plan for National Energy Policy with an ambitious goal of achieving 'Low CO2 Emission and Green Growth', a rapid expansion of nuclear technology development has been reemphasized. In addition, the nation, being a potential exporter of nuclear power plants and nuclear technologies strives to explore their exports markets. In response, it is inevitable to set the priority in human resource development (HRD) as nuclear technology development both requires and fosters HRD which in turn, enables to meet the successful implementation of nuclear power expansion. A continuous, consistent and well-managed programme of HRD is crucial to assure continuity over time in the needed capacities, skills and knowledge, and to establish and maintain a cadre of manpower variously trained in different nuclear-related skills and educated in nuclear relevant fields. The objective of the study is to conduct comprehensive quantitative analyses to estimate future human resources requirements, particularly in the field of nuclear R and D, safety and security in order to establish an appropriate long-term nuclear HRD plan

  2. Regional deposition of mometasone furoate nasal spray suspension in humans.

    Science.gov (United States)

    Shah, Samir A; Berger, Robert L; McDermott, John; Gupta, Pranav; Monteith, David; Connor, Alyson; Lin, Wu

    2015-01-01

    Nasal deposition studies can demonstrate whether nasal sprays treating allergic rhinitis and polyposis reach the ciliated posterior nasal cavity, where turbinate inflammation and other pathology occurs. However, quantifying nasal deposition is challenging, because in vitro tests do not correlate to human nasal deposition; gamma scintigraphy studies are thus used. For valid data, the radiolabel must distribute, as the drug, into different-sized droplets, remain associated with the drug in the formulation after administration, and not alter its deposition. Some nasal deposition studies have demonstrated this using homogenous solutions. However, most commercial nasal sprays are heterogeneous suspensions. Using mometasone furoate nasal suspension (MFS), we developed a technique to validate radiolabel deposition as a surrogate for nasal cavity drug deposition and characterized regional deposition and nasal clearance in humans. Mometasone furoate (MF) formulation was spiked with diethylene triamine pentacaetic acid. Both unlabeled and radiolabeled formulations (n = 3) were sprayed into a regionally divided nasal cast. Drug deposition was quantified by high pressure liquid chromatography within each region; radiolabel deposition was determined by gamma camera. Healthy subjects (n = 12) were dosed and imaged for six hours. Scintigraphic images were coregistered with magnetic resonance imaging scans to quantify anterior and posterior nasal cavity deposition and mucociliary clearance. The ratio of radiolabel to unlabeled drug was 1.05 in the nasal cast and regionally appeared to match, indicating that in vivo radiolabel deposition could represent drug deposition. In humans, MFS delivered 86% (9.2) of metered dose to the nasal cavity, approximately 60% (9.1) of metered dose to the posterior nasal cavity. After 15 minutes, mucociliary clearance removed 59% of the initial radiolabel in the nasal cavity, consistent with clearance rates from the ciliated posterior surface. MFS

  3. Robust Tensioned Kevlar Suspension Design

    Science.gov (United States)

    Young, Joseph B.; Naylor, Bret J.; Holmes, Warren A.

    2012-01-01

    One common but challenging problem in cryogenic engineering is to produce a mount that has excellent thermal isolation but is also rigid. Such mounts can be achieved by suspending the load from a network of fibers or strings held in tension. Kevlar fibers are often used for this purpose owing to their high strength and low thermal conductivity. A suite of compact design elements has been developed to improve the reliability of suspension systems made of Kevlar.

  4. Symbolic Algebra Development for Higher-Order Electron Propagator Formulation and Implementation.

    Science.gov (United States)

    Tamayo-Mendoza, Teresa; Flores-Moreno, Roberto

    2014-06-10

    Through the use of symbolic algebra, implemented in a program, the algebraic expression of the elements of the self-energy matrix for the electron propagator to different orders were obtained. In addition, a module for the software package Lowdin was automatically generated. Second- and third-order electron propagator results have been calculated to test the correct operation of the program. It was found that the Fortran 90 modules obtained automatically with our algorithm succeeded in calculating ionization energies with the second- and third-order electron propagator in the diagonal approximation. The strategy for the development of this symbolic algebra program is described in detail. This represents a solid starting point for the automatic derivation and implementation of higher-order electron propagator methods.

  5. Formulating a comprehensive strategy to counter the menace of malnutrition in developing countries

    Directory of Open Access Journals (Sweden)

    Saurabh RamBihariLal Shrivastava

    2014-01-01

    Full Text Available The indispensable role of optimal nutrition in ensuring absolute health status and holistic development of a society is well acknowledged. Malnutrition is considered as a disease of human society that can begin in the womb and eventually lasts till the death. A wide range of socio-cultural and infectious parameters have been determined that can ultimately precipitate malnutrition. Considering the multi-factorial origin of the disease, the strategy to combat malnutrition should also be comprehensive and multi-pronged comprising measures to combat the condition at every level concurrently in the entire nation. The corrective policy essentially requires the coordinated approach of different stakeholders and should be targeted at four different levels - family, community, national, and international. To conclude, diet is a crucial element in the natural history of many public health-related diseases, and owing to the multiple factors that eventually determine the dietary habits, a comprehensive approach is the need of the hour.

  6. Modelling of hybrid energy system - Part I: Problem formulation and model development

    Energy Technology Data Exchange (ETDEWEB)

    Gupta, Ajai; Saini, R.P.; Sharma, M.P. [Alternate Hydro Energy Centre, Indian Institute of Technology Roorkee, Roorkee, Uttarakhand 247667 (India)

    2011-02-15

    A well designed hybrid energy system can be cost effective, has a high reliability and can improve the quality of life in remote rural areas. The economic constraints can be met, if these systems are fundamentally well designed, use appropriate technology and make use effective dispatch control techniques. The first paper of this tri-series paper, presents the analysis and design of a mixed integer linear mathematical programming model (time series) to determine the optimal operation and cost optimization for a hybrid energy generation system consisting of a photovoltaic array, biomass (fuelwood), biogas, small/micro-hydro, a battery bank and a fossil fuel generator. The optimization is aimed at minimizing the cost function based on demand and potential constraints. Further, mathematical models of all other components of hybrid energy system are also developed. This is the generation mix of the remote rural of India; it may be applied to other rural areas also. (author)

  7. Vitamin E TPGS emulsified vinorelbine bitartrate loaded solid lipid nanoparticles (SLN): Formulation development, optimization and in vitro characterization.

    Science.gov (United States)

    Maurya, Lakshmi; Rajamanickam, Vijayakumar Mahalingam; Narayan, Gopeshwar; Singh, Sanjay

    2018-04-08

    Vinorelbine bitartrate (VRL), a semi synthetic vinca alkaloid approved for breast cancer, has been proved to beneficial as first line and subsequent therapies. However, it's hydrophilic and thermo labile nature provides hindrance to oral clinical translation. The current work focused on the application of DOE a modern statistical optimization tool for the development and optimization of a solid lipid nanoparticle (SLN) formulation that can encapsulate hydrophilic and thermolabile Vinorelbine bitartrate (VRL) to a maximum extent without compromising integrity and anticancer activity of the drug. SLNs were prepared by solvent diffusion technique employing Taguchi orthogonal array design with optimized formulation and process variables. The emulsifying nature and low melting point of glyceryl mono-oleate (GMO) were exploited to enhance entrapment and minimizing temperature associated degradation, respectively. Moreover, two types of surfactants, Vitamin E TPGS (TPGS) and Poloxamer-188 were utilized to obtain TPGS-VRL-SLNs and PL-VRL-SLNs, respectively. The SLNs were characterized for various physicochemical properties, in-vitro drug release kinetics and anticancer activity by MTT assay on MCF-7 cancer cell lines. The SLNs were found to be spherical in shape with entrapment efficiency (EE) up to 58 %. In-vitro release studies showed biphasic release pattern following Korsemeyer peppas model with fickian release kinetics. Results of MTT assay revealed that TPGS-VRL-SLNs and PL-VRL-SLNs were 39.5 and 18.5 fold more effective, respectively, compared to the pristine VRL. DOE approach was successfully applied for the development of VRL-SLNs. Enhanced entrapment and anticancer efficacy of TPGS-VRL-SLN can be attributed to emulsifying nature of GMO and inherent cytotoxic nature of TPGS, respectively, which synergizes with VRL. Therefore, TPGS associated SLNs may be potential carrier in cancer chemotherapeutics. Copyright© Bentham Science Publishers; For any queries, please

  8. Rheology of organoclay suspension

    CSIR Research Space (South Africa)

    Hato, MJ

    2011-05-01

    Full Text Available The authors have studied the rheological properties of clay suspensions in silicone oil, where clay surfaces were modified with three different types of surfactants. Dynamic oscillation measurements showed a plateau-like behavior for all...

  9. Hydropneumatic suspension systems

    Energy Technology Data Exchange (ETDEWEB)

    Bauer, Wolfgang

    2011-07-01

    Hydropneumatic suspensions systems combine the excellent properties of gas springs with the favourable damping properties of hydraulic fluids. The advantages of these systems are particularly appropriate for automotive applications, such as passenger cars, trucks and agricultural equipment. In this book, Dr. Bauer provides an extensive overview of hydropneumatic suspension systems. Starting with a comparison of different types of suspension systems, the author subsequently describes the theoretical background associated with spring and damping characteristics of hydropneumatic systems and furthermore explains the design of the most important system components. Additionally he gives an overview of level control systems and various special functions. Finally the technology is illustrated by design examples and the outlook for future hydropneumatic suspensions is discussed. (orig.)

  10. Suspension Trauma / Orthostatic Intolerance

    Science.gov (United States)

    ... Suspension Trauma/Orthostatic Intolerance Safety and Health Information Bulletin SHIB 03-24-2004, updated 2011 This Safety ... the harness, the environmental conditions, and the worker's psychological state all may increase the onset and severity ...

  11. The Mystical Suspension

    Directory of Open Access Journals (Sweden)

    Héctor Santiesteban Oliva

    2016-11-01

    Full Text Available Mistical suspension, silence, time, absolute, ontology, ineffability, aletheiaIn the mystical ecstasy there is a sensorial and intellectual suspension when contemplating the absolute, the ontological Being. Silence is not only significant: it is revealing. The greatest expression of experience inner silence . The word is insufficient when the ontological reality is revealed. Revelation or truth , the Greek concept of aletheia, takes on greater significance in that transcendental experience. It is also suspended phenomenological time and remains eternity open.

  12. Development of modified release diltiazem HCl tablets using composite index to identify optimal formulation.

    Science.gov (United States)

    Gohel, M C; Patel, M M; Amin, A F

    2003-05-01

    This article reports the preparation of tartaric acid treated ispaghula husk powder for the development of modified release tablets of diltiazem HCl by adopting direct compression technique and a 32 full factorial design. The modified ispaghula husk powder showed superior swelling and gelling as compared to untreated powder. Addition of compaction augmenting agent such as dicalcium phosphate was found to be essential for obtaining tablets with adequate crushing strength. In order to improve the crushing strength of diltiazem HCl tablets, to modulate drug release pattern, and to obtain similarity of dissolution profiles in distilled water and simulated gastric fluid (pH 1.2), modified guar gum was used along with modified ispaghula husk powder and tartaric acid. A novel composite index, which considers a positive or a negative deviation from an ideal value, was calculated considering percentage drug release in 60, 300, and 540 min as dependent variables for the selection of a most appropriate batch. Polynomial equation and contour plots are presented. The concept of similarity factor (f2) was used to prove similarity of dissolution in water and simulated gastric fluid (pH 1.2).

  13. Active Electromechanical Suspension System for Planetary Rovers, Phase I

    Data.gov (United States)

    National Aeronautics and Space Administration — Balcones Technologies, LLC proposes to adapt actively controlled suspension technology developed by The University of Texas at Austin Center for Electromechanics...

  14. Community participation in formulating the post-2015 health and development goal agenda: reflections of a multi-country research collaboration.

    Science.gov (United States)

    Brolan, Claire E; Hussain, Sameera; Friedman, Eric A; Ruano, Ana Lorena; Mulumba, Moses; Rusike, Itai; Beiersmann, Claudia; Hill, Peter S

    2014-10-10

    Global discussion on the post-2015 development goals, to replace the Millennium Development Goals when they expire on 31 December 2015, is well underway. While the Millennium Development Goals focused on redressing extreme poverty and its antecedents for people living in developing countries, the post-2015 agenda seeks to redress inequity worldwide, regardless of a country's development status. Furthermore, to rectify the UN's top-down approach toward the Millennium Development Goals' formulation, widespread negotiations are underway that seek to include the voices of people and communities from around the globe to ground each post-2015 development goal. This reflexive commentary, therefore, reports on the early methodological challenges the Go4Health research project experienced in its engagement with communities in nine countries in 2013. Led by four research hubs in Uganda, Bangladesh, Australia and Guatemala, the purpose of this engagement has been to ascertain a 'snapshot' of the health needs and priorities of socially excluded populations particularly from the Global South. This is to inform Go4Health's advice to the European Commission on the post-2015 global goals for health and new governance frameworks. Five methodological challenges were subsequently identified from reflecting on the multidisciplinary, multiregional team's research practices so far: meanings and parameters around qualitative participatory research; representation of marginalization; generalizability of research findings; ethical research in project time frames; and issues related to informed consent. Strategies to overcome these methodological hurdles are also examined. The findings from the consultations represent the extraordinary diversity of marginal human experience requiring contextual analysis for universal framing of the post-2015 agenda. Unsurprisingly, methodological challenges will, and did, arise. We conclude by advocating for a discourse to emerge not only critically

  15. Development of ELISA-based methods to measure the anti-malarial drug chloroquine in plasma and in pharmaceutical formulations

    Directory of Open Access Journals (Sweden)

    Ronn Anita

    2011-08-01

    Full Text Available Abstract Background In Central and South America and Eastern and Southern Africa, Plasmodium vivax infections accounts for 71-81% and 5% of malaria cases, respectively. In these areas, chloroquine (CQ remains the treatment of choice for P. vivax malaria. In addition, CQ has recently proven to be an effective HIV-1 therapeutic agent. There is a dire need to continue monitoring quality of CQ as there is a major influx of substandard and fake formulations into malaria-endemic countries. The use of fake/substandard drugs will result in sub-therapeutic levels endangering the patient and possibly select for parasite resistance. The aim of this study was to develop an inexpensive, simple antibody-based ELISA to measure CQ concentrations in tablets and in plasma. Methods A monoclonal antibody (MAb that reacts with the N-side chain of the CQ molecule was prepared by use of a CQ analogue. A specific and reliable ELISA for detection of CQ was developed. The developed assay was validated by measuring CQ in tablets sold in Denmark, India and Sudan. Furthermore, kinetics of CQ concentrations in plasma of four volunteers, who ingested two tablets of Malarex® containing, 250 mg CQ base, were measured before drug intake, three hours later and thereafter at days 1, 3, 7, 14, 21 and 28. The same plasma samples were simultaneously measured by high performance liquid chromatography (HPLC. Results The ELISA proved an easy-to-handle and very sensitive tool for the detection of CQ with a lower limit of detection at 3.9 ng/ml. ELISA levels of CQ in plasma showed high agreement with the levels obtained by HPLC (r = 0.98. The specificity in the negative control group was 100%. Conclusion The developed ELISA can be used for quality screening of CQ in pharmaceutical formulations and for drug monitoring in malaria and in other infectious diseases, such as HIV, where CQ proved to be an effective therapeutic agent. The methodology has been exploited to develop monoclonal

  16. Development and Validation of Stability Indicating HPTLC and HPLC Methods for Simultaneous Determination of Telmisartan and Atorvastatin in Their Formulations

    Directory of Open Access Journals (Sweden)

    Kaliappan Ilango

    2013-01-01

    Full Text Available The present study describes development and subsequent validation of stability indicating HPLC and HPTLC methods for simultaneous estimation of Telmisartan (TLM and Atorvastatin (ATV in their combined formulation. The proposed RP-HPLC method utilizes a Phenomenex Luna C18 column using acetonitrile: 0.025 M ammonium acetate (38 : 52%, v/v as mobile phase (pH 3.8, flow rate of 1.0 mL/min. Quantification was achieved with UV detection at 281 nm over concentration range of 12 to 72 μg/mL for TLM and 3 to 18 μg/mL for ATV respectively. In HPTLC, separations were performed on silica gel 60 F254 using toluene-methanol-ethyl acetate-acetic acid (5 : 1 : 1 : 0.3, v/v as mobile phase. The compact bands of TLM and ATV at 0.37 ± 0.02 and 0.63 ± 0.01 respectively were scanned at 279 nm. Linear regression analysis revealed linearity in the range of 40 to 240 ng/band for TLM and 10 to 60 ng/band for ATV respectively. For both the methods, dosage form was exposed to thermal, photolytic, acid, alkali and oxidative stress. The methods distinctly separated the drugs and degradation products even in actual samples. In conclusion, the proposed HPLC and HPTLC methods were appropriate for routine quantification of TLM and ATV in tablet formulation.

  17. Antifungal Screening of Bridelia ferruginea Benth (Euphorbiaceae Stem Bark Extract in Mouthwash Formulations

    Directory of Open Access Journals (Sweden)

    Aremu Olusola Isaac

    2017-06-01

    Full Text Available The plant Bridelia ferruginea Benth (Euphorbiaceae has been known for its use in the management of oral thrush ethnomedicinally in various parts of Africa, a practice which has been justified by results of certain scientific studies. The aim of this study was to develop an appropriate dosage formulation, a mouthwash and evaluate the antifungal potential of this dosage formulation against a major causative organism of oral thrush, Candida albicans. Extraction of the stem bark was carried out with boiled distilled water, the extract was formulated into mouthwashes at concentrations of 0.5, 1.0, 1.5, 2.0 and 2.5%w/v. All formulations contained viscosity imparting agent, a sweetener and a preservative. Physical characterisation, viscosity, pH and palatability of the mouthwash formulations were determined. Agar-well diffusion method was used to assess antifungal activity of the formulations against Candida albicans and Nystatin oral suspension was used as reference compound. The results showed that Bridelia ferruginea stem bark extract mouthwash solutions were brown in colour, had agreeable odour and sweet astringent taste. The pH for all concentrations was in the range 5.41-5.63. The viscosity at spindle no 2, 60rpm range between 0.226-0.238 Pa.S for all concentrations studied. The formulations had antifungal activity against Candida albicans. The highest concentration (2.5%w/v gave mean zone of inhibition of 25.50±0.71mm that was comparable with Nystatin oral suspension 28.00±1.41mm, a reference compound. The foregoing suggests that with little modification in the formulation especially the adjustment of the pH, Bridellia ferruginea mouthwash solutions may be developed into commercially useful preparations.

  18. Simple additive manufacturing of an osteoconductive ceramic using suspension melt extrusion

    DEFF Research Database (Denmark)

    Slots, Casper; Bonde Jensen, Martin; Ditzel, Nicholas

    2017-01-01

    /calcium phosphate suspension melt for simple additive manufacturing of ceramic tricalcium phosphate implants. METHODS: A wide variety of non-aqueous liquids were tested to determine the formulation of a storable 3D printable tricalcium phosphate suspension ink, and only fatty acid-based inks were found to work...

  19. Development and validation of a method for the determination of folic acid in different pharmaceutical formulations using derivative spectrophotometry

    Directory of Open Access Journals (Sweden)

    Marcos Vinícius de Moura Ribeiro

    Full Text Available ABSTRACT Folic acid is a B complex water-soluble vitamin that is essential to humans, and its deficiency can cause problems including congenital malformations in the fetus as well as heart disease. Most countries affected by diseases associated with a lack of folic acid now supplement foods with the vitamin. There is therefore a need for the development of new analytical procedures able to determine folic acid present in different matrices. This work describes the development of zero order and first order derivative spectrophotometric methods for the determination of folic acid in different pharmaceutical formulations, using 0.1 mol L-1 NaOH as solvent. The methods are shown to be simple, selective, and robust. Good linearity was achieved, with correction coefficients ≥0.9996 and limits of detection and quantification ranging from 0.64 to 0.75 and from 1.80 to 2.85 mg L-1, respectively. Recoveries of 98-104% were obtained in accuracy tests, and precision (as RSD was between 0.2 and 4.8%. The methods can be used in routine analyses for quality control purposes, offering an alternative to the procedures already reported in the literature.

  20. Development and validation of green method for estimation of clarithromycin in pharmaceutical formulation by transmission fourier transform infrared spectroscopy

    International Nuclear Information System (INIS)

    Mallah, M.A.; Sherazi, S.T.H.; Mahesar, S.A.; Rauf, A.

    2012-01-01

    A rapid, sensitive and environmental friendly analytical method for the direct determination of clarithromycin in tablet formulations through transmission Fourier Transform Infrared (FT-IR) spectroscopy has been successfully developed for routine quality control analysis. This method avoids any sample pretreatment except grinding or use of any solvent as extraction is no more required. Standards and samples were analysed in the form of KBr pellet for recording FT-IR spectra. In the final step, chemometric method was used to filter out unmatched spectral features and the converted and filtered spectra were used to build a calibration model based on partial least square (PLS) using the FT-IR carbonyl region (C=O) from 2965-1662 cm/sup -1/. The excellent correlation coefficient (R2) was achieved (0.9999). This also fulfills the ever increasing demand of pharmaceutical industries for developing sensitive, economical and less time consuming methods for the quantification of Active Pharmaceutical Ingredients (API) while monitoring quality of finished product with total analysis time of less than three minutes. (author)

  1. Flow-induced structure in colloidal suspensions

    Energy Technology Data Exchange (ETDEWEB)

    Vermant, J [Department of Chemical Engineering, K U Leuven, W de Croylaan 46, B-3001 Leuven (Belgium); Solomon, M J [Department of Chemical Engineering, University of Michigan, Ann Arbor, MI 48109-2136 (United States)

    2005-02-02

    We review the sequences of structural states that can be induced in colloidal suspensions by the application of flow. Structure formation during flow is strongly affected by the delicate balance among interparticle forces, Brownian motion and hydrodynamic interactions. The resulting non-equilibrium microstructure is in turn a principal determinant of the suspension rheology. Colloidal suspensions with near hard-sphere interactions develop an anisotropic, amorphous structure at low dimensionless shear rates. At high rates, clustering due to strong hydrodynamic forces leads to shear thickening rheology. Application of steady-shear flow to suspensions with repulsive interactions induces a rich sequence of transitions to one-, two-and three-dimensional order. Oscillatory-shear flow generates metastable ordering in suspensions with equilibrium liquid structure. On the other hand, short-range attractive interactions can lead to a fluid-to-gel transition under quiescent suspensions. Application of flow leads to orientation, breakup, densification and spatial reorganization of aggregates. Using a non-Newtonian suspending medium leads to additional possibilities for organization. We examine the extent to which theory and simulation have yielded mechanistic understanding of the microstructural transitions that have been observed. (topical review)

  2. Development of a spatial planning support system for agricultural policy formulation related to land and water resources in Borkhar & Meymeh district, Iran

    NARCIS (Netherlands)

    Farhadi Bansouleh, B.F.

    2009-01-01

    In this study, a system was developed to support agricultural planners and
    policy makers in land resource analysis, policy formulation, identification of
    possible policy measures and policy impact analysis. The research is part of a
    larger programme, aiming at development of a

  3. Development of a CO2 releasing co-formulation 1 based on starch, Saccharomyces cerevisiae and Beauveria bassiana attractive towards western corn rootworm larvae

    Science.gov (United States)

    CO2 is known as an attractant for many soil-dwelling pests. To implement an attract-and-kill strategy for soil pest control, CO2 emitting formulations need to be developed. This work aimed at the development of a slow release bead system in order to bridge the gap between application and hatching of...

  4. Hybrid superconducting magnetic suspensions

    International Nuclear Information System (INIS)

    Tixador, P.; Hiebel, P.; Brunet, Y.; Chaud, X.; Gautier-Picard, P.

    1996-01-01

    Superconductors, especially high T c ones, are the most attractive materials to design stable and fully passive magnetic suspensions which have to control five degrees of freedom. The hybrid superconducting magnetic suspensions present high performances and a simple cooling mode. They consist of a permanent magnet bearing, stabilized by a suitable magnet-superconductor structure. Several designs are given and compared in terms of forces and stiffnesses. The design of the magnet bearing plays an important part. The superconducting magnetic bearing participates less in levitation but must provide a high stabilizing stiffness. This is achieved by the magnet configuration, a good material in term of critical current density and field cooling. A hybrid superconducting suspension for a flywheel is presented. This system consists of a magnet thrust bearing stabilized by superconductors interacting with an alternating polarity magnet structure. First tests and results are reported. Superconducting materials are magnetically melt-textured YBaCuO

  5. Role of cellular antioxidants (glutathione and ascorbic acid) in the growth and development of wild carrot suspension cultures

    International Nuclear Information System (INIS)

    Earnshaw, B.A.

    1986-01-01

    Determinations of endogenous glutathione (GSH), glutathione disulfide (GSSG), ascorbic acid (AA) and dehydroascorbic acid (DHA) in proliferating and developing wild carrot cultures showed that lower levels of GSH and AA were associated with developing cultures. The GSSG and DHA levels did not account for the changes in the levels of antioxidants between proliferating and developing cultures. Studies were designed to test an observed auxin (2,4-Dichlorophenoxyacetic acid, 2,4-D)-antioxidant association. Two fractions (embryo and less developed) were obtained by screening developed cultures which were previously grown in the presence of 14 C-2, 4-D. The embryo fraction had a lower concentration of 14 C than the less developed fraction, supporting the association, since the two fractions showed this relationship with respect to GSH and AA concentrations. Determinations of GSH and AA levels of cells grown in various concentrations of 2,4-D showed the association, decreases in the 2,4-D concentration correlated with decreases in the GSH and AA concentrations. The existence of a respiratory pathway involving GSSG reductase, DHA reductase, and AA oxidase was investigated to test whether inhibition of AA oxidase by 2,4-D could explain the auxin-antioxidant association; however, AA oxidase activity was not detected

  6. Validated modified Lycopodium spore method development for standardisation of ingredients of an ayurvedic powdered formulation Shatavaryadi churna.

    Science.gov (United States)

    Kumar, Puspendra; Jha, Shivesh; Naved, Tanveer

    2013-01-01

    Validated modified lycopodium spore method has been developed for simple and rapid quantification of herbal powdered drugs. Lycopodium spore method was performed on ingredients of Shatavaryadi churna, an ayurvedic formulation used as immunomodulator, galactagogue, aphrodisiac and rejuvenator. Estimation of diagnostic characters of each ingredient of Shatavaryadi churna individually was carried out. Microscopic determination, counting of identifying number, measurement of area, length and breadth of identifying characters were performed using Leica DMLS-2 microscope. The method was validated for intraday precision, linearity, specificity, repeatability, accuracy and system suitability, respectively. The method is simple, precise, sensitive, and accurate, and can be used for routine standardisation of raw materials of herbal drugs. This method gives the ratio of individual ingredients in the powdered drug so that any adulteration of genuine drug with its adulterant can be found out. The method shows very good linearity value between 0.988-0.999 for number of identifying character and area of identifying character. Percentage purity of the sample drug can be determined by using the linear equation of standard genuine drug.

  7. Development of analytical method for PBDEs and PBDDs/DFs in environmental matrices and some chemical formulations

    Energy Technology Data Exchange (ETDEWEB)

    Hanari, N.; Okazawa, T.; Yamashita, N. [National Institute of Advanced Industrial Science and Technology (AIST), Tsukuba (Japan); Guruge, K. [National Institute of Animal Health (NIAH), Tsukuba (Japan); Falandysz, J. [Gdansk Univ. (Poland)

    2004-09-15

    Brominated flame retardants (BFRs) are environmentally and toxicologically hazardous compounds amongst many of chemicals used to reduce inherent fire hazards in a variety of goods. Polybrominated diphenyl ethers (PBDEs) are widely used flame retardants in textile and plastic materials and their content can be up to 10-30% of the product weight as is found for polyurethane foams. The technical PBDE products become available at the market as pentaBDE, octaBDE and decaBDE formulation. A combustion of the wastes containing PBDEs as well as thermal destruction of other BFR-containing materials may lead to the formation of another and considered to be highly toxic compounds such as polybrominated dibenzo-p-dioxins (PBDDs) and dibenzofurans (PBDFs). Some of PBDE congeners were found to be liable for debromination and photodegradation under a real environmental condition but also during chemical laboratory analysis. Additionally, co-occurrence of PBDDs/DFs and PBDEs can cause interferences during quantitative analysis of PBDFs when using HRGC/HRMS. The objective of this study was to develop a method of perfect separation of PBDDs/DFs from PBDEs and their congener-specific determination using HRGC/HRMS but also to optimize quantification of BDE 209 in environmental samples.

  8. Development and Validation of an HPLC Method for Simultaneous Determination of Rifampicin, Isoniazid, Pyrazinamide, and Ethambutol Hydrochloride in Pharmaceutical Formulations.

    Science.gov (United States)

    Chellini, Paula R; Lages, Eduardo B; Franco, Pedro H C; Nogueira, Fernando H A; César, Isabela C; Pianetti, Gerson A

    2015-01-01

    Tuberculosis treatment consists of a fixed dose combination of rifampicin (RIF), isoniazid (INH), pyrazinamide (PYZ), and ethambutol hydrochloride (EMB). The combined treatment using various drugs is necessary for patient curing, without recrudescence, and for prevention of drug-resistant mutants, which may occur during treatment. An HPLC-diode array detector (DAD) method for the simultaneous determination of RIF, INH, PYZ, and EMB in fixed dose combination tablets was developed and validated. Chromatographic experiments were performed on an Agilent 1200 HPLC system, and the separation was carried out on a Purospher STAR RP18e (250×4.6 mm id, 5 μm, Merck) analytical column. Gradient elution was carried out with a mobile phase of 20 mM monobasic sodium phosphate buffer with 0.2% triethylamine (pH 7.0) and acetonitrile at a flow rate of 1.5 mL/min. The total run time was 12 min, and the re-equilibration time was 5 min. EMB detection was performed at 210 nm, and RIF, INH, and PYZ were detected at 238 nm, using a DAD. The method proved to be specific, linear (r2>0.99), precise (RSD<2%), accurate, and robust and may be applied to the QC analysis of pharmaceutical formulations.

  9. Development and Validation of LC Method for the Determination of Famciclovir in Pharmaceutical Formulation Using an Experimental Design

    Directory of Open Access Journals (Sweden)

    Srinivas Vishnumulaka

    2008-01-01

    Full Text Available A rapid and sensitive RP-HPLC method with UV detection (242 nm for routine analysis of famciclovir in pharmaceutical formulations was developed. Chromatography was performed with mobile phase containing a mixture of methanol and phosphate buffer (50:50, v/v with flow rate 1.0 mL min−1. Quantitation was accomplished with internal standard method. The procedure was validated for linearity (correlation coefficient =0.9999, accuracy, robustness and intermediate precision. Experimental design was used for validation of robustness and intermediate precision. To test robustness, three factors were considered; percentage v/v of methanol in mobile phase, flow rate and pH; flow rate, the percentage of organic modifier and pH have considerable important effect on the response. For intermediate precision measure the variables considered were: analyst, equipment and number of days. The RSD value (0.86%, n=24 indicated an acceptable precision of the analytical method. The proposed method was simple, sensitive, precise, accurate and quick and useful for routine quality control.

  10. Magnetic Suspension Technology Workshop

    International Nuclear Information System (INIS)

    Keckler, C.R.; Groom, N.J.; Britcher, C.P.

    1993-01-01

    In order to identify the state of magnetic suspension technology in such areas as rotating systems, pointing of experiments or subsystems, payload isolation, and superconducting materials, a workshop on Magnetic Suspension Technology was held at the Langley Research Center in Hampton, Virginia, on 2-4 Feb. 1988. The workshop included five technical sessions in which a total of 24 papers were presented. The technical sessions covered the areas of pointing, isolation, and measurement, rotating systems, modeling and control, and superconductors. A list of attendees is provided. Separate abstracts have been prepared for articles from this report

  11. Performance Testing of Suspension Plasma Sprayed Thermal Barrier Coatings Produced with Varied Suspension Parameters

    Directory of Open Access Journals (Sweden)

    Nicholas Curry

    2015-07-01

    Full Text Available Suspension plasma spraying has become an emerging technology for the production of thermal barrier coatings for the gas turbine industry. Presently, though commercial systems for coating production are available, coatings remain in the development stage. Suitable suspension parameters for coating production remain an outstanding question and the influence of suspension properties on the final coatings is not well known. For this study, a number of suspensions were produced with varied solid loadings, powder size distributions and solvents. Suspensions were sprayed onto superalloy substrates coated with high velocity air fuel (HVAF -sprayed bond coats. Plasma spray parameters were selected to generate columnar structures based on previous experiments and were maintained at constant to discover the influence of the suspension behavior on coating microstructures. Testing of the produced thermal barrier coating (TBC systems has included thermal cyclic fatigue testing and thermal conductivity analysis. Pore size distribution has been characterized by mercury infiltration porosimetry. Results show a strong influence of suspension viscosity and surface tension on the microstructure of the produced coatings.

  12. Just add water: reproducible singly dispersed silver nanoparticle suspensions on-demand

    International Nuclear Information System (INIS)

    MacCuspie, Robert I.; Allen, Andrew J.; Martin, Matthew N.; Hackley, Vincent A.

    2013-01-01

    Silver nanoparticles (AgNPs) are of interest due to their antimicrobial attributes, which are derived from their inherent redox instability and subsequent release of silver ions. At the same time, this instability is a substantial challenge for achieving stable long-term storage for on-demand use of AgNPs. In this study, we describe and validate a “just add water” approach for achieving suspensions of principally singly dispersed AgNPs. By lyophilizing (freeze drying) the formulated AgNPs into a solid powder, or cake, water is removed thereby eliminating solution-based chemical changes. Storing under inert gas further reduces surface reactions such as oxidation. An example of how to optimize a lyophilization formulation is presented, as well as example formulations for three AgNP core sizes. This “just add water” approach enables ease of use for the researcher desiring on-demand singly dispersed AgNP suspensions from a single master batch. Implementation of this methodology will enable studies to be performed over long periods of time and across different laboratories using particles that are identical chemically and physically and available on-demand. In addition, the approach of freeze drying and on-demand reconstitution by adding water has enabled the development of AgNP reference materials with the required shelf-life stability, one of the principal objectives of this research

  13. Stability of allopurinol and of five antineoplastics in suspension.

    Science.gov (United States)

    Dressman, J B; Poust, R I

    1983-04-01

    The stability of allopurinol, azathioprine, chlorambucil, melphalan, mercaptopurine, and thioguanine each in an extemporaneously prepared suspension was studied. Tablets of each drug were crushed, mixed with a suspending agent, and brought to a final volume of 10, 15, or 20 ml with a 2:1 mixture of simple syrup and wild cherry syrup. Suspensions were prepared in the following concentrations: allopurinol (20 mg/ml), azathioprine (50 mg/ml), chlorambucil (2 mg/ml), melphalan (2 mg/ml), mercaptopurine (50 mg/ml), and thioguanine (40 mg/ml). Using high-performance liquid chromatography or ultraviolet scans, duplicate assays were performed on each suspension periodically during storage for up to 84 days at ambient room temperature or 5 degrees C. The time required for the suspensions to drop below 90% of labeled strength was used as an indicator of drug stability. Allopurinol and azathioprine were stable for at least 56 days at room temperature and at 5 degrees C. Chlorambucil decomposed rapidly at room temperature but was stable for seven days when stored at 5 degrees C. Melphalan suspensions did not meet the stated criteria for stability even at the time of initial assay. Mercaptopurine and thioguanine were stable for 14 and 84 days, respectively, at room temperature; at 5 degrees C, assay values dropped below those obtained at room temperature. In the suspension formulation tested, allopurinol, azathioprine, mercaptopurine, and thioguanine are stable for at least 14 days at room temperature; chlorambucil suspensions should be refrigerated and discarded after seven days. Melphalan decomposes too rapidly to make this suspension formulation feasible for extemporaneous compounding.

  14. Design of an expert system for the development and formulation of push-pull osmotic pump tablets containing poorly water-soluble drugs.

    Science.gov (United States)

    Zhang, Zhi-hong; Dong, Hong-ye; Peng, Bo; Liu, Hong-fei; Li, Chun-lei; Liang, Min; Pan, Wei-san

    2011-05-30

    The purpose of this article was to build an expert system for the development and formulation of push-pull osmotic pump tablets (PPOP). Hundreds of PPOP formulations were studied according to different poorly water-soluble drugs and pharmaceutical acceptable excipients. The knowledge base including database and rule base was built based on the reported results of hundreds of PPOP formulations containing different poorly water-soluble drugs and pharmaceutical excipients and the experiences available from other researchers. The prediction model of release behavior was built using back propagation (BP) neural network, which is good at nonlinear mapping and learning function. Formulation design model was established based on the prediction model of release behavior, which was the nucleus of the inference engine. Finally, the expert system program was constructed by VB.NET associating with SQL Server. Expert system is one of the most popular aspects in artificial intelligence. To date there is no expert system available for the formulation of controlled release dosage forms yet. Moreover, osmotic pump technology (OPT) is gradually getting consummate all over the world. It is meaningful to apply expert system on OPT. Famotidine, a water insoluble drug was chosen as the model drug to validate the applicability of the developed expert system. Copyright © 2011 Elsevier B.V. All rights reserved.

  15. Capacity Development and Strengthening for Energy Policy formulation and implementation of Sustainable Energy Projects in Indonesia CASINDO. Deliverable No. 19. Development or improvement of infrastructure for knowledge valorisation

    Energy Technology Data Exchange (ETDEWEB)

    Wijnker, M. [Eindhoven University of Technology TUE, Eindhoven (Netherlands)

    2011-11-15

    The overall objective of the CASINDO programme is to establish a self-sustaining and self-developing structure at both the national and regional level to build and strengthen human capacity to enable the provinces of North Sumatra, Yogyakarta, Central Java, West Nusa Tenggara and Papua to formulate sound policies for renewable energy and energy efficiency and to develop and implement sustainable energy projects. All five universities managed to organise workshops visited each by 30-60 participants. At these workshops the relationship and possibilities for co-operation between university, industry, companies, communities etc. were discussed. In total 13-14 workshops have been organised. Most workshops focussed on a specific topic interesting to both local industry and university. Although the contents, audience and (in-depth) discussions were very different at each university, it can be said that ties with local industry in all regions have been improved.

  16. Compressible Fluid Suspension Performance Testing

    National Research Council Canada - National Science Library

    Hoogterp, Francis

    2003-01-01

    ... compressible fluid suspension system that was designed and installed on the vehicle by DTI. The purpose of the tests was to evaluate the possible performance benefits of the compressible fluid suspension system...

  17. Dose uniformity of loteprednol etabonate ophthalmic gel (0.5% compared with branded and generic prednisolone acetate ophthalmic suspension (1%

    Directory of Open Access Journals (Sweden)

    Marlowe ZT

    2013-12-01

    Full Text Available Zora T Marlowe, Stephen R DavioPharmaceutical Product Development, Global Pharmaceutical Research and Development, Bausch and Lomb, Inc, Rochester, NY, USAIntroduction: Loteprednol etabonate (LE ophthalmic gel 0.5% (Lotemax® is a new polycarbophil-based, nonsettling topical ophthalmic formulation. The formulation is a semisolid gel at rest and a shear thinning fluid when expressed through a dropper tip. The present study was undertaken to determine how the nonsettling character of LE ophthalmic gel affects dose uniformity. Prednisolone acetate ophthalmic suspension 1% (Pred Forte® and a generic prednisolone acetate suspension 1% were used as comparators.Methods: Drug concentrations of LE ophthalmic gel, Pred Forte, and a generic prednisolone acetate suspension were determined following simulated dosing – consisting of 2 drops, expressed four times daily for 2 weeks, with bottles that were shaken or not shaken immediately prior to expressing the drops. Drug concentrations were determined using a reverse-phase high-performance liquid chromatography (HPLC method and reported as a percentage of the declared (labeled concentration. Comparative kinetics of drug particle sedimentation were also determined for each formulation, using dispersion analysis under gravity.Results: Mean drug concentrations in drops of all three formulations were within a few percentage points of the declared concentration when the bottles were shaken for 5 seconds prior to dispensing. Only LE ophthalmic gel showed consistent and on-target concentrations when the bottles were unshaken prior to dispensing, with a mean (standard deviation [SD] percent declared concentration of 102% (1.92% over the 2-week dosing regimen. Drug concentrations for the branded and generic prednisolone acetate suspensions following expression from unshaken bottles were highly variable (overall relative SDs of 16.8% and 20.3%, respectively, with mean concentrations for both falling significantly

  18. Multiobjective suspension control problem

    NARCIS (Netherlands)

    Jager, de A.G.

    1995-01-01

    The paper describes a (controller) design problem in the field of suspension systems for transport vehicles. A ten degrees-of-freedom model for a tractor-semitrailer vehicle is presented, using parameters derived from a real vehicle, which should be used for design and verification purposes. Road

  19. Capacity Development and Strengthening for Energy Policy formulation and implementation of Sustainable Energy Projects in Indonesia CASINDO. Deliverable No. 17. Development of Education Programs at Indonesian Universities

    Energy Technology Data Exchange (ETDEWEB)

    Wijnker, M. [Eindhoven University of Technology TUE, Eindhoven (Netherlands)

    2011-08-15

    The overall objective of the CASINDO programme is to establish a self-sustaining and self-developing structure at both the national and regional level to build and strengthen human capacity to enable the provinces of North Sumatra, Yogyakarta, Central Java, West Nusa Tenggara and Papua to formulate sound policies for renewable energy and energy efficiency and to develop and implement sustainable energy projects. All five Indonesian partner universities managed to develop and implement an education program within the timeline of the CASINDO project. UMY (Muhammadiyah University of Yogyakarta, Indonesia), UNRAM (University of Mataram, Mataram, Indonesia) and UNCEN (Cenderawasih University, Jayapura, Papua, Indonesia) have chosen to develop a certificate program. UNDIP (Diponegoro University in Semarang, Java, Indonesia) and USU (University of Sumatra Utara, Medan, Indonesia) have both developed a master program in sustainable energy. UNDIP has already discussed the proposal of their master program with the Ministry of Education and will have to make some improvements. USU will first start the program as a specialisation within the Mechanical Engineering department and in some time continues to make it an independent master program. At all universities both contact persons and lecturers have put a lot of effort in developing the programs and succeeded. Additionally, through CASINDO a network of lecturers between the universities has developed, which will ease future cooperation, after the CASINDO project will have finished.

  20. Formulation development of smart gel periodontal drug delivery system for local delivery of chemotherapeutic agents with application of experimental design.

    Science.gov (United States)

    Dabhi, Mahesh R; Nagori, Stavan A; Gohel, Mukesh C; Parikh, Rajesh K; Sheth, Navin R

    2010-01-01

    Smart gel periodontal drug delivery systems (SGPDDS) containing gellan gum (0.1-0.8% w/v), lutrol F127 (14, 16, and 18% w/v), and ornidazole (1% w/v) were designed for the treatment of periodontal diseases. Each formulation was characterized in terms of in vitro gelling capacity, viscosity, rheology, content uniformity, in vitro drug release, and syringeability. In vitro gelation time and the nature of the gel formed in simulated saliva for prepared formulations showed polymeric concentration dependency. Drug release data from all formulations was fitted to different kinetic models and the Korsemeyer-Peppas model was the best fit model. Drug release was significantly decreased as the concentration of each polymer component was increased. Increasing the concentration of each polymeric component significantly increased viscosity, syringeability, and time for 50%, 70%, and 90% drug release. In conclusion, the formulations described offer a wide range of physical and drug release characteristics. The formulation containing 0.8% w/v of gellan gum and 16% w/v of lutrol F127 exhibited superior physical characteristics.

  1. Development of controlled release formulations of azadirachtin-A employing poly(ethylene glycol) based amphiphilic copolymers.

    Science.gov (United States)

    Kumar, Jitendra; Shakil, Najam A; Singh, Manish K; Singh, Mukesh K; Pandey, Alka; Pandey, Ravi P

    2010-05-01

    Controlled release (CR) formulations of azadirachtin-A, a bioactive constituent derived from the seed of Azadirachta indica A. Juss (Meliaceae), have been prepared using commercially available polyvinyl chloride, polyethylene glycol (PEG) and laboratory synthesized poly ethylene glycol-based amphiphilic copolymers. Copolymers of polyethylene glycol and various dimethyl esters, which self assemble into nano micellar aggregates in aqueous media, have been synthesized. The kinetics of azadirachtin-A, release in water from the different formulations was studied. Release from the commercial polyethylene glycol (PEG) formulation was faster than the other CR formulations. The rate of release of encapsulated azadirachtin-A from nano micellar aggregates is reduced by increasing the molecular weight of PEG. The diffusion exponent (n value) of azadirachtin-A, in water ranged from 0.47 to 1.18 in the tested formulations. The release was diffusion controlled with a half release time (t(1/2)) of 3.05 to 42.80 days in water from different matrices. The results suggest that depending upon the polymer matrix used, the application rate of azadirachtin-A can be optimized to achieve insect control at the desired level and period.

  2. Recent progress towards developing a high field, high-T(sub c) superconducting magnet for magnetic suspension and balance systems

    Science.gov (United States)

    Derochemont, L. Pierre; Oakes, Carlton E.; Squillante, Michael R.; Duan, Hong-Min; Hermann, Allen M.; Andrews, Robert J.; Poeppel, Roger B.; Maroni, Victor A.; Carlberg, Ingrid A.; Kelliher, Warren C.

    1992-01-01

    This paper reviews superconducting magnets and high T(sub c) superconducting oxide ceramic materials technology to identify areas of fundamental impasse to the fabrication of components and devices that tap what are believed to be the true potential of these new materials. High T(sub c) ceramics pose problems in fundamentally different areas which need to be solved unlike low T(sub c) materials. The authors map out an experimental plan designed to research process technologies which, if suitably implemented, should allow these deficiencies to be solved. Finally, assessments are made of where and on what regimes magnetic system designers should focus their attention to advance the practical development of systems based on these new materials.

  3. Enhanced transdermal permeability of Terbinafine through novel nanoemulgel formulation; Development, in vitro and in vivo characterization

    Directory of Open Access Journals (Sweden)

    Maha E. Elmataeeshy

    2018-06-01

    Full Text Available Terbinafine Hcl (TB is a poorly water soluble antifungal drug. Topical nanoemulsion based gel containing TB was prepared with a view to improve its solubility and antifungal activity. In preparation of the nanoemulsion (NE, excipients were selected based on the solubility study. Peceol was optimized as the oil phase. Tween 80 and propanol were optimized as the surfactant and co-solvent respectively, and were mixed (Smix in different weight ratios (1:1, 1:2, 1:3, 1:4, 4:1, 3:1 and 2:1, respectively. Pseudoternary phase diagrams were developed and Pecol and Smix were mixed in different weight ratios ranging from 1:9 to 9:1. Based on the NE region of each diagram, the formulae were selected. The formulated nanoemulsions were characterized and evaluated for in vitro drug release and thermodynamic stability. The optimum nanoemulsion formulae containing 10 or 15% w/w oil, 45% w/w Smix (1:2/1:3 and 45-40% w/w aqueous phase were incorporated into Carbopol 940 gel bases forming three different TB nanoemulsion based emulgel formulae (F1-F3 which were examined for ex vivo drug permeation and in vivo antifungal activity compared to the marketed product; Lamisil® emulgel. The results showed that TB skin permeation from all the prepared nanoemulsion based gel formulae was significantly (p < 0.05 improved in relation to the commercial emulgel. F3 exhibited a superior in vivo antifungal activity over the marketed emulgel for the treatment of Candida infection. Keywords: Terbinafine nanoemulsion, Pseudoternary phase diagrams, Permeation study

  4. Comparison of cortisol exposures and pharmacodynamic adrenal steroid responses to hydrocortisone suspension vs. commercial tablets.

    Science.gov (United States)

    Sarafoglou, Kyriakie; Gonzalez-Bolanos, Maria T; Zimmerman, Cheryl L; Boonstra, Timothy; Yaw Addo, O; Brundage, Richard

    2015-04-01

    The Endocrine Society Clinical Practice Guidelines on congenital adrenal hyperplasia (CAH) recommend against using hydrocortisone suspension based on a study that examined a commercial suspension. Our objective was to examine the absorption of an extemporaneously prepared hydrocortisone suspension and compare it to tablets. Secondary objectives were to evaluate the 17-hydroxyprogesterone and androstenedione adrenal steroid responses. Using a parallel design, 34 children diagnosed with CAH received either suspension (n = 9; median age 1.8 years) or tablets (n = 25; median age 7.5 years). Patients were given their usual morning hydrocortisone formulation and dose; 12 serial blood samples were obtained and the area under the curve (AUC) was calculated. The mg/m(2) dose-normalized cortisol AUCs were no different in the suspension and tablet groups (P = ·06), nor was there a significant difference in the C(max) or T(max) (P = .08 and P = .41, respectively). Although there were no differences in the 17-hydroxyprogesterone change-from-baseline AUCs, baseline concentrations, or the nadir concentrations when comparing suspension and tablet formulations, the androstenedione values were significantly lower as expected in the younger aged suspension group. Our results offer compelling evidence that an extemporaneously prepared hydrocortisone suspension provides comparable cortisol exposures to commercially available tablet formulations in children and can be used to safely and effectively treat CAH. © 2014, The American College of Clinical Pharmacology.

  5. Formulation development and in vitro evaluation of solidified self-microemulsion in the form of tablet containing atorvastatin calcium.

    Science.gov (United States)

    Ali, Kazi Asraf; Mukherjee, Biswajit; Bandyopadhyay, Amal Kumar

    2013-11-01

    The objective of our present study was to prepare solid self-microemulsion in the form of tablet of a poorly water soluble drug, Atorvastatin calcium (ATNC) to increase the solubility, dissolution rate, and minimize the hazards experienced from liquid emulsions. Self-microemulsifying ATNC tablet was formulated mainly by using self-emulsifying base, solidifying agent silicon dioxide and sodium starch glycolate as tablet disintegrant. Self-emulsifying base containing Transcutol P, Gelucire 44/14, and Lutrol F68 with their ratios in the formulation, were best selected by solubility study and ternary phase diagram in different vehicles. Particle size of microemulsion from tablet, physical parameters of the tablet and drug content has been checked. In vitro drug release rate has been carried out in phosphate buffer medium (pH 6.8). Physicochemical characterization of the drug in the optimized formulation has been performed to check drug-excipient incompatibility, if any. Average particle diameter of the emulsions formed from the tablet was found to be below 100 nm in case of formulation F4 and F5, which indicated microemulsions has been formed. In vitro drug release from the formulations F3, F4, and F5 was found to be >90%, indicated the enhancement of solubility of ATNC compared to parent drug. Differential thermal analysis (DTA), Powder X-ray Diffraction (X-RD) and Fourier transform infra red (FTIR) study proved the identity of the drug in the optimized formulation. The tablet form of self-microemulsifying (SME) drug delivery is good for solubility enhancement.

  6. Suspension Hydrogen Reduction of Iron Oxide Concentrates

    Energy Technology Data Exchange (ETDEWEB)

    H.Y. Sohn

    2008-03-31

    The objective of the project is to develop a new ironmaking technology based on hydrogen and fine iron oxide concentrates in a suspension reduction process. The ultimate objective of the new technology is to replace the blast furnace and to drastically reduce CO2 emissions in the steel industry. The goals of this phase of development are; the performance of detailed material and energy balances, thermochemical and equilibrium calculations for sulfur and phosphorus impurities, the determination of the complete kinetics of hydrogen reduction and bench-scale testing of the suspension reduction process using a large laboratory flash reactor.

  7. Intelligent systems of the vehicles’ suspension

    Science.gov (United States)

    Yurlin, D.

    2018-02-01

    The article is devoted to the current condition of car’s active suspension system. It presents the tendencies in development of the active systems of suspension system, adjustable elements incorporated in them and the companies succeeded in designing such systems. It also mirrors the problem of impact of active systems on car’s safety and their importance for the driver. Advantages and disadvantages of the most common types of active elements are being described, analyzed and compared. The author concludes about the perspectives of these systems’ development.

  8. Desarrollo de la formulación Compvit-B® inyectable Development of Compvit-B® injectable formulation

    Directory of Open Access Journals (Sweden)

    Olivia Teresa González Gay

    2012-12-01

    containing a combination of high dose of vitamins B1, B6 and B12 which have known positive effects on the treatment of neuropathies. Methods: comprehensive assessment of eight different variants of injectable formulation, with or without ethylenediaminetetraacetic acid (EDTA and benzyl alcohol, and of the lyophilization process included in the flow of production or not, in line with the technology suggested by the manufacturer. Results: the variant number 8 was selected since it meets the set parameters according to the manufacturer's technology and to the Center for the State Quality Control of Drugs. A Cuban-made injectable and lyophilized pharmaceutical called Compvit-B®, made up of 100 mg B1, 100 mg B6 and 5 000 µg B12, was obtained. It meets the established specifications and the requirements by the regulatory bodies for the manufacture of drugs for human use. Conclusions: the selected variant allowed developing the Compvit-B ® pharmaceutical, which is a pharmacologically stable drug of quality, and the health licensing for the general use and the production of this drug was granted by the Center for the State Quality Control of Drugs (CEDMED

  9. Pharmaceutical development of an oral tablet formulation containing a spray dried amorphous solid dispersion of docetaxel or paclitaxel

    NARCIS (Netherlands)

    Sawicki, Emilia; Beijnen, Jos H|info:eu-repo/dai/nl/071919570; Schellens, Jan H M|info:eu-repo/dai/nl/073926272; Nuijen, Bastiaan

    2016-01-01

    Previously, it was shown in Phase I clinical trials that solubility-limited oral absorption of docetaxel and paclitaxel can be drastically improved with a freeze dried solid dispersion (fdSD). These formulations, however, are unfavorable for further clinical research because of limitations in

  10. Minimally invasive brow suspension for facial paralysis.

    Science.gov (United States)

    Costantino, Peter D; Hiltzik, David H; Moche, Jason; Preminger, Aviva

    2003-01-01

    To report a new technique for unilateral brow suspension for facial paralysis that is minimally invasive, limits supraciliary scar formation, does not require specialized endoscopic equipment or expertise, and has proved to be equal to direct brow suspension in durability and symmetry. Retrospective survey of a case series of 23 patients between January 1997 and December 2000. Metropolitan tertiary care center. Patients with head and neck tumors and brow ptosis caused by facial nerve paralysis. The results of the procedure were determined using the following 3-tier rating system: outstanding (excellent elevation and symmetry); acceptable (good elevation and fair symmetry); and unacceptable (loss of elevation). The results were considered outstanding in 12 patients, acceptable in 9 patients, and unacceptable in only 1 patient. One patient developed a hematoma, and 1 patient required a secondary adjustment. The technique has proved to be superior to standard brow suspension procedures with regard to scar formation and equal with respect to facial symmetry and suspension. These results have caused us to abandon direct brow suspension and to use this minimally invasive method in all cases of brow ptosis due to facial paralysis.

  11. Baseline LAW Glass Formulation Testing

    International Nuclear Information System (INIS)

    Kruger, Albert A.; Mooers, Cavin; Bazemore, Gina; Pegg, Ian L.; Hight, Kenneth; Lai, Shan Tao; Buechele, Andrew; Rielley, Elizabeth; Gan, Hao; Muller, Isabelle S.; Cecil, Richard

    2013-01-01

    The major objective of the baseline glass formulation work was to develop and select glass formulations that are compliant with contractual and processing requirements for each of the LAW waste streams. Other objectives of the work included preparation and characterization of glasses with respect to the properties of interest, optimization of sulfate loading in the glasses, evaluation of ability to achieve waste loading limits, testing to demonstrate compatibility of glass melts with melter materials of construction, development of glass formulations to support ILAW qualification activities, and identification of glass formulation issues with respect to contract specifications and processing requirements

  12. The Evolution of Discipline: Alternative to Suspension Programs.

    Science.gov (United States)

    Streva, Michael A.

    Historically, the chosen method of discipline in United States schools has gone from corporal punishment to an emphasis on suspension. Recently, as principals have become less certain about the extent of their authority to suspend students, many inschool programs have been developed as alternatives to suspension. Among the advantages of such…

  13. 45 CFR 99.4 - Suspension of rules.

    Science.gov (United States)

    2010-10-01

    ... 45 Public Welfare 1 2010-10-01 2010-10-01 false Suspension of rules. 99.4 Section 99.4 Public Welfare DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL ADMINISTRATION PROCEDURE FOR HEARINGS FOR THE CHILD CARE AND DEVELOPMENT FUND General § 99.4 Suspension of rules. With notice to all parties, the...

  14. Tuning a Le Mans Car Suspension in ADAMS

    CSIR Research Space (South Africa)

    Berman, R

    2012-09-01

    Full Text Available An ADAMS model of South Africa’s first ever Le Mans car was developed and used to tune the suspension parameters. Validation of the model is to be done by comparing simulation results to those obtained in track testing. The suspension parameters...

  15. Formulation development and optimization of Lamivudine 300 mg and Tenofovir Disoproxil Fumarate (TDF 300 mg FDC tablets by D-optimal mixture design

    Directory of Open Access Journals (Sweden)

    Prosper Tibalinda

    2016-12-01

    Full Text Available The usage of fixed dose combination (FDC tablets of Lamivudine and Tenofovir Disoproxil Fumarate (TDF is increasing due to increased incidences of HIV/Hepatitis B and HIV/TB co-infections. This is likely to increase the financial crisis due to limited resources for funding procurement of ready-made products from the pharmaceuticals manufacturing leading countries. Therefore, production of local oral tablets containing Lamivudine and TDF FDC is inevitable. Lamivudine 300 mg/TDF 300 mg tablets were developed and optimized by D-optimal mixture design and produced by direct compression technique. Twenty trial formulations with independent variables, including PVP-CL 1–12.00%, PVP-K30 1–10.00%, starch-1500 2.5–12.5% and Avicel-PH102 2–19.25% were prepared by direct compression technique. The formulations were assessed on assay, dissolution, friability, weight variation and disintegration time. It was found that assay ranged from 98.13–101.95% for Lamivudine, 98.25–102.84 for TDF, both were within the in-house assay specification of 95 to 105%. Dissolution at single point was above 80% for Lamivudine 93.96–100.55% and 95.85–103.15% for TDF, disintegration time was between 1.92–66.33 min and friability 0.06–12.56%. Out of twenty formulation trials, eight formulations had all parameters in proven acceptable range. On optimization, one formulation with independent variables, PVP-CL 5.67%, PVP-K30 1.00%, Starch-1500 5.76% was selected. The optimized formulation was comparable to the reference product on the market with similarity factor (f2 and difference factor (f1 within the acceptable range for both Lamivudine and TDF.

  16. Formulation of the endophytic fungus Cladosporium oxysporum Berk.

    Directory of Open Access Journals (Sweden)

    Bensaci Oussama Ali

    2015-01-01

    Full Text Available Two formulations containing culture filtrates and conidial suspensions of the endophytic fungus Cladosporium oxysporum Berk. & M.A. Curtis, isolated previously from stems of Euphorbia bupleuroides subsp. luteola (Kralik Maire, were experimentally tested for their aphicid activity against the black bean aphid Aphis fabae Scop. found in Algeria. It was shown that invert emulsions are more effective against aphids, than using aqueous suspensions. This was especially true for formulations containing culture filtrates. The relatively insignificant mortalities obtained by formulations containing conidial suspensions indicated a low infectious potential towards the aphids. The proteolytic activity seemed to be more important than the chitinolytic activity of the fungus against the black bean aphid A. fabae

  17. Coupling Mechanism and Decoupled Suspension Control Model of a Half Car

    Directory of Open Access Journals (Sweden)

    Hailong Zhang

    2016-01-01

    Full Text Available A structure decoupling control strategy of half-car suspension is proposed to fully decouple the system into independent front and rear quarter-car suspensions in this paper. The coupling mechanism of half-car suspension is firstly revealed and formulated with coupled damping force (CDF in a linear function. Moreover, a novel dual dampers-based controllable quarter-car suspension structure is proposed to realize the independent control of pitch and vertical motions of the half car, in which a newly added controllable damper is suggested to be installed between the lower control arm and connection rod in conventional quarter-car suspension structure. The suggested damper constantly regulates the half-car pitch motion posture in a smooth and steady operation condition meantime achieving the expected completely structure decoupled control of the half-car suspension, by compensating the evolved CDF.

  18. Development and validation of an in vitro–in vivo correlation (IVIVC model for propranolol hydrochloride extended-release matrix formulations

    Directory of Open Access Journals (Sweden)

    Chinhwa Cheng

    2014-06-01

    Full Text Available The objective of this study was to develop an in vitro–in vivo correlation (IVIVC model for hydrophilic matrix extended-release (ER propranolol dosage formulations. The in vitro release characteristics of the drug were determined using USP apparatus I at 100 rpm, in a medium of varying pH (from pH 1.2 to pH 6.8. In vivo plasma concentrations and pharmacokinetic parameters in male beagle dogs were obtained after administering oral, ER formulations and immediate-release (IR commercial products. The similarity factor f2 was used to compare the dissolution data. The IVIVC model was developed using pooled fraction dissolved and fraction absorbed of propranolol ER formulations, ER-F and ER-S, with different release rates. An additional formulation ER-V, with a different release rate of propranolol, was prepared for evaluating the external predictability. The results showed that the percentage prediction error (%PE values of Cmax and AUC0–∞ were 0.86% and 5.95%, respectively, for the external validation study. The observed low prediction errors for Cmax and AUC0–∞ demonstrated that the propranolol IVIVC model was valid.

  19. Capacity Development and Strengthening for Energy Policy formulation and implementation of Sustainable Energy Projects in Indonesia CASINDO. Deliverable No. 38. Pro-poor Energy Strategy in Central Java

    Energy Technology Data Exchange (ETDEWEB)

    Sumardi, R. Rizal Isnanto; Firdausi, Aulia Latifah Insan [Diponegoro University, Semarang (Indonesia)

    2012-01-15

    The overall objective of the CASINDO programme is to establish a self-sustaining and self-developing structure at both the national and regional level to build and strengthen human capacity to enable the provinces of North Sumatra, Yogyakarta, Central Java, West Nusa Tenggara and Papua to formulate sound policies for renewable energy and energy efficiency and to develop and implement sustainable energy projects.

  20. Robustness analysis of bogie suspension components Pareto optimised values

    Science.gov (United States)

    Mousavi Bideleh, Seyed Milad

    2017-08-01

    Bogie suspension system of high speed trains can significantly affect vehicle performance. Multiobjective optimisation problems are often formulated and solved to find the Pareto optimised values of the suspension components and improve cost efficiency in railway operations from different perspectives. Uncertainties in the design parameters of suspension system can negatively influence the dynamics behaviour of railway vehicles. In this regard, robustness analysis of a bogie dynamics response with respect to uncertainties in the suspension design parameters is considered. A one-car railway vehicle model with 50 degrees of freedom and wear/comfort Pareto optimised values of bogie suspension components is chosen for the analysis. Longitudinal and lateral primary stiffnesses, longitudinal and vertical secondary stiffnesses, as well as yaw damping are considered as five design parameters. The effects of parameter uncertainties on wear, ride comfort, track shift force, stability, and risk of derailment are studied by varying the design parameters around their respective Pareto optimised values according to a lognormal distribution with different coefficient of variations (COVs). The robustness analysis is carried out based on the maximum entropy concept. The multiplicative dimensional reduction method is utilised to simplify the calculation of fractional moments and improve the computational efficiency. The results showed that the dynamics response of the vehicle with wear/comfort Pareto optimised values of bogie suspension is robust against uncertainties in the design parameters and the probability of failure is small for parameter uncertainties with COV up to 0.1.

  1. Rheological behavior and stability of ciprofloxacin suspension: Impact of structural vehicles and flocculating agent

    Directory of Open Access Journals (Sweden)

    Eskandar Moghimipour

    2013-01-01

    Full Text Available Ciprofloxacin is a fluoroquinolone and is used against a broad spectrum of gram-negative and gram-positive bacteria. The aim of the study is to investigate the effect of structural vehicles and other formulating factors on physical stability and rheological behavior of ciprofloxacin suspension. To formulate the suspensions, the effect of glycerin and polysorbate 80 as wetting agents was evaluated. Then to achieve controlled flocculation, different concentrations of sodium chloride and calcium chloride were added. After choosing suitable wetting and flocculating agents, structural vehicles such as sodium carboxyl methyl cellulose (NaCMC, hydroxypropylmethylcellulose (HPMC and Veegum were evaluated. Physical stability parameters such as sedimentation volume, the degree of flocculation and the ease of redispersion of the suspensions and growth of crystals were evaluated. After incorporation of structural vehicles, the rheological properties of formulations containing were also studied to find out their rheological behavior. According to the results, suspension containing glycerin (0.2% w/v and sodium chloride (0.05% w/v as wetting agent and flocculating agent, respectively, were the most stable formulations regarding their F and N. Microscopic observations showed the growth of crystals in ciprofloxacin suspension in formulation without excipients and the minimum amount of crystal growth was seen in suspension containing NaCMC (0.25% w/v, Veegum (0.1% w/v and NaCl (0.05% w/v. Rheological studies showed that almost all of the formulations had psuedoplastic behavior with different degree of thixotropy. The formulation containing NaCMC (0.25% w/v, Veegum (0.1% w/v and NaCl (0.05% w/v was the most stable formulation. It may be concluded that by altering the amount ratios of formulation factors, the best rheological behavior and the most proper thixotropy may be achieved.

  2. Rheological behavior and stability of ciprofloxacin suspension: Impact of structural vehicles and flocculating agent.

    Science.gov (United States)

    Moghimipour, Eskandar; Rezaee, Saeed; Salimi, Anayatollah; Asadi, Elham; Handali, Somayeh

    2013-07-01

    Ciprofloxacin is a fluoroquinolone and is used against a broad spectrum of gram-negative and gram-positive bacteria. The aim of the study is to investigate the effect of structural vehicles and other formulating factors on physical stability and rheological behavior of ciprofloxacin suspension. To formulate the suspensions, the effect of glycerin and polysorbate 80 as wetting agents was evaluated. Then to achieve controlled flocculation, different concentrations of sodium chloride and calcium chloride were added. After choosing suitable wetting and flocculating agents, structural vehicles such as sodium carboxyl methyl cellulose (NaCMC), hydroxypropylmethylcellulose (HPMC) and Veegum were evaluated. Physical stability parameters such as sedimentation volume, the degree of flocculation and the ease of redispersion of the suspensions and growth of crystals were evaluated. After incorporation of structural vehicles, the rheological properties of formulations containing were also studied to find out their rheological behavior. According to the results, suspension containing glycerin (0.2% w/v) and sodium chloride (0.05% w/v) as wetting agent and flocculating agent, respectively, were the most stable formulations regarding their F and N. Microscopic observations showed the growth of crystals in ciprofloxacin suspension in formulation without excipients and the minimum amount of crystal growth was seen in suspension containing NaCMC (0.25% w/v), Veegum (0.1% w/v) and NaCl (0.05% w/v). Rheological studies showed that almost all of the formulations had psuedoplastic behavior with different degree of thixotropy. The formulation containing NaCMC (0.25% w/v), Veegum (0.1% w/v) and NaCl (0.05% w/v) was the most stable formulation. It may be concluded that by altering the amount ratios of formulation factors, the best rheological behavior and the most proper thixotropy may be achieved.

  3. Particle interactions in concentrated suspensions

    International Nuclear Information System (INIS)

    Mondy, L.A.; Graham, A.L.; Abbott, J.R.; Brenner, H.

    1993-01-01

    An overview is presented of research that focuses on slow flows of suspensions in which colloidal and inertial effects are negligibly small. The authors describe nuclear magnetic resonance imaging experiments to quantitatively measure particle migration occurring in concentrated suspensions undergoing a flow with a nonuniform shear rate. These experiments address the issue of how the flow field affects the microstructure of suspensions. In order to understand the local viscosity in a suspension with such a flow-induced, spatially varying concentration, one must know how the viscosity of a homogeneous suspension depends on such variables as solids concentration and particle orientation. The authors suggest the technique of falling ball viscometry, using small balls, as a method to determine the effective viscosity of a suspension without affecting the original microstructure significantly. They also describe data from experiments in which the detailed fluctuations of a falling ball's velocity indicate the noncontinuum nature of the suspension and may lead to more insights into the effects of suspension microstructure on macroscopic properties. Finally, they briefly describe other experiments that can be performed in quiescent suspensions (in contrast to the use of conventional shear rotational viscometers) in order to learn more about boundary effects in concentrated suspensions

  4. Next Generation Suspension Dynamics Algorithms

    Energy Technology Data Exchange (ETDEWEB)

    Schunk, Peter Randall [Sandia National Lab. (SNL-NM), Albuquerque, NM (United States); Higdon, Jonathon [Sandia National Lab. (SNL-NM), Albuquerque, NM (United States); Chen, Steven [Sandia National Lab. (SNL-NM), Albuquerque, NM (United States)

    2014-12-01

    This research project has the objective to extend the range of application, improve the efficiency and conduct simulations with the Fast Lubrication Dynamics (FLD) algorithm for concentrated particle suspensions in a Newtonian fluid solvent. The research involves a combination of mathematical development, new computational algorithms, and application to processing flows of relevance in materials processing. The mathematical developments clarify the underlying theory, facilitate verification against classic monographs in the field and provide the framework for a novel parallel implementation optimized for an OpenMP shared memory environment. The project considered application to consolidation flows of major interest in high throughput materials processing and identified hitherto unforeseen challenges in the use of FLD in these applications. Extensions to the algorithm have been developed to improve its accuracy in these applications.

  5. Prototype Scale Development of an Environmentally Benign Yellow Smoke Hand-Held Signal Formulation Based on Solvent Yellow 33

    Science.gov (United States)

    2013-04-15

    safely implemented in several Navy signaling devices.21,22 ■ EXPERIMENTAL SECTION Materials. Potassium chlorate (MIL-P-150D, grade B, Class 7), sugar...the potassium chlorate overnight at 60 °C, formulations were prepared in 300 g batches by blending all ingredients according to their respective...damage. ■ ASSOCIATED CONTENT *S Supporting Information Particle size analyses for potassium chlorate (Table S1 and Figure S1), sugar (Table S2 and

  6. Formulating a preliminary business plan for a business consultancy company : case: CreaNets Business Development and Consultancy

    OpenAIRE

    Korkmaz, Gökhan

    2015-01-01

    The main purpose of this research is to formulate a preliminary business plan for a business consultancy which will operate between Finland and Turkey and be headquartered in Finland. The research focuses on practical information on entrepreneurship, business planning and business models as well as starting up a new business in Finland. During the theoretical framework, information is provided on entrepreneurship and business planning. Hoffren’s Dynamic Business Model and Osterwalder’s Bu...

  7. The solubility-permeability interplay and its implications in formulation design and development for poorly soluble drugs.

    Science.gov (United States)

    Dahan, Arik; Miller, Jonathan M

    2012-06-01

    While each of the two key parameters of oral drug absorption, the solubility and the permeability, has been comprehensively studied separately, the relationship and interplay between the two have been largely ignored. For instance, when formulating a low-solubility drug using various solubilization techniques: what are we doing to the apparent permeability when we increase the solubility? Permeability is equal to the drug's diffusion coefficient through the membrane times the membrane/aqueous partition coefficient divided by the membrane thickness. The direct correlation between the intestinal permeability and the membrane/aqueous partitioning, which in turn is dependent on the drug's apparent solubility in the GI milieu, suggests that the solubility and the permeability are closely associated, exhibiting a certain interplay between them, and the current view of treating the one irrespectively of the other may not be sufficient. In this paper, we describe the research that has been done thus far, and present new data, to shed light on this solubility-permeability interplay. It has been shown that decreased apparent permeability accompanies the solubility increase when using different solubilization methods. Overall, the weight of the evidence indicates that the solubility-permeability interplay cannot be ignored when using solubility-enabling formulations; looking solely at the solubility enhancement that the formulation enables may be misleading with regards to predicting the resulting absorption, and hence, the solubility-permeability interplay must be taken into account to strike the optimal solubility-permeability balance, in order to maximize the overall absorption.

  8. Fast Disintegrating Combination Tablet of Taste Masked Levocetrizine Dihydrochloride and Montelukast Sodium: Formulation Design, Development, and Characterization

    Directory of Open Access Journals (Sweden)

    M. M. Gupta

    2014-01-01

    Full Text Available The aim of this study was to prepare fast disintegrating combination tablet of taste masked Levocetrizine dihydrochloride and Montelukast sodium by using direct compression method. To prevent bitter taste and unacceptable odour of the Levocetrizine dihydrochloride drug, the drug was taste masked with ion exchange resins like Kyron-T-104 and Tulsion-412. Among the two resins, Kyron-T-104 was selected for further studies because of high drug loading capacity, low cost, and better drug release profile. An ion exchange resin complex was prepared by the batch technique and various parameters; namely, resin activation, drug: resin ratio, pH, temperature, and stirring time, and swelling time were optimized to successfully formulate the tasteless drug resin complex (DRC. The tablets were prepared using microcrystalline cellulose (MCC PH 102 as diluent along with crospovidone (CP, croscarmellose sodium (CCM, and sodium starch glycolate (SSG as a superdisintegrants. The tablets were evaluated for weight variation, hardness, friability, wetting time, water absorption ratio, disintegration time (DT, and dissolution study and it was concluded that the tablet formulation prepared with 2% SSG + CCS showed better disintegration time in comparison with other formulation and good drug release. The stability studies were carried out for the optimized batch for three months and it showed acceptable results.

  9. In vitro evaluation of mucoadhesive vaginal tablets of antifungal drugs prepared with thiolated polymer and development of a new dissolution technique for vaginal formulations.

    Science.gov (United States)

    Baloglu, Esra; Ay Senyıgıt, Zeynep; Karavana, Sinem Yaprak; Vetter, Anja; Metın, Dilek Yesim; Hilmioglu Polat, Suleyha; Guneri, Tamer; Bernkop-Schnurch, Andreas

    2011-01-01

    The main objective of this work was to develop antifungal matrix tablet for vaginal applications using mucoadhesive thiolated polymer. Econazole nitrate (EN) and miconazole nitrate (MN) were used as antifungal drugs to prepare the vaginal tablet formulations. Thiolated poly(acrylic acid)-cysteine (PAA-Cys) conjugate was synthesized by the covalent attachment of L-cysteine to PAA with the formation of amide bonds between the primary amino group of L-cysteine and the carboxylic acid group of the polymer. Vaginal mucoadhesive matrix tablets were prepared by direct compression technique. The investigation focused on the influence of modified polymer on water uptake behavior, mucoadhesive property and release rate of drug. Thiolated polymer increased the water uptake ratio and mucoadhesive property of the formulations. A new simple dissolution technique was developed to simulate the vaginal environment for the evaluation of release behavior of vaginal tablets. In this technique, daily production amount and rate of the vaginal fluid was used without any rotational movement. The drug release was found to be slower from PAA-Cys compared to that from PAA formulations. The similarity study results confirmed that the difference in particle size of EN and MN did not affect their release profile. The release process was described by plotting the fraction released drug versus time and n fitting data to the simple exponential model: M(t)/M(∞)=kt(n). The release kinetics were determined as Super Case II for all the formulations prepared with PAA or PAA-Cys. According to these results the mucoadhesive vaginal tablet formulations prepared with PAA-Cys represent good example for delivery systems which prolong the residence time of drugs at the vaginal mucosal surface.

  10. An improved experimental methodology to evaluate the effectiveness of protective gloves against nanoparticles in suspension.

    Science.gov (United States)

    Vinches, Ludwig; Zemzem, Mohamed; Hallé, Stéphane; Peyro, Caroline; Wilkinson, Kevin J; Tufenkji, Nathalie

    2017-07-01

    Recent studies underline the potential health risks associated to the "nano" revolution, particularly for the workers who handle engineered nanoparticles (ENPs) that can be found in the formulation of several commercial products. Although many Health & Safety agencies recommend the use of protective gloves against chemicals, few studies have investigated the effectiveness of these gloves towards nanoparticle suspensions. Moreover, the data that are available are often contradictory. This study was designed to evaluate the effectiveness of protective gloves against nanoparticles in suspension. For this purpose, a new methodology was developed in order to take into account parameters encountered in the workplace such as mechanical deformations (MD) that simulate hand flexion and sweat. The effects of the precise experimental protocol on the concentrations of nanoparticles that were detected in the sampling suspension were assessed. Several samples of nitrile rubber gloves (73 µm thick), taken from different boxes, were brought into contact with gold nanoparticles (5 nm) in water. During their exposure to ENPs, the glove samples submitted systematic mechanical deformations and were placed in contact with a physiological solution simulating human sweat. Under these conditions, results obtained by inductively coupled plasma mass spectrometry (ICPMS) showed that the 5 nm gold nanoparticles passed through the protective gloves. This result was acquired, in spite of the observation of significant losses during the sampling phase that will be important for future experiments evaluating the effectiveness of these materials.

  11. Development and optimization of a new processing approach for manufacturing topical liposomes-in-hydrogel drug formulations by dual asymmetric centrifugation.

    Science.gov (United States)

    Ingebrigtsen, Sveinung G; Škalko-Basnet, Nataša; Holsæter, Ann Mari

    2016-09-01

    The objective of the present study was to utilize dual asymmetric centrifugation (DAC) as a novel processing approach for the production of liposomes-in-hydrogel formulations. Lipid films of phosphatidylcholine, with and without chloramphenicol (CAM), were hydrated and homogenized by DAC to produce liposomes in the form of vesicular phospholipid gels with a diameter in the size range of 200-300 nm suitable for drug delivery to the skin. Different homogenization processing parameters were investigated along with the effect of adding propylene glycol (PG) to the formulations prior to homogenization. The produced liposomes were incorporated into a hydrogel made of 2.5% (v/v) soluble β-1,3/1,6-glucan (SBG) and mixed by DAC to achieve a homogenous liposomes-in-hydrogel-formulation suitable for topical application. CAM-containing liposomes with a vesicle diameter of 282 ± 30 nm and polydispersity index (PI) of 0.13 ± 0.02 were successfully produced by DAC after 50 min centrifugation at 3500 rpm, and homogenously (< 4% content variation) incorporated into the SBG hydrogel. Addition of PG decreased the necessary centrifugation time to 2 min and 55 s, producing liposomes of 230 ± 51 nm and PI of 0.25 ± 0.04. All formulations had an entrapment efficiency of approximately 50%. We managed to develop a relatively fast and reproducible new method for the production of liposomes-in-hydrogel formulations by DAC.

  12. Administrative license suspension: Does length of suspension matter?

    Science.gov (United States)

    Fell, James C; Scherer, Michael

    2017-08-18

    Administrative license revocation (ALR) laws, which provide that the license of a driver with a blood alcohol concentration at or over the illegal limit is subject to an immediate suspension by the state department of motor vehicles, are an example of a traffic law in which the sanction rapidly follows the offense. The power of ALR laws has been attributed to how swiftly the sanction is applied, but does the length of suspension matter? Our objectives were to (a) determine the relationship of the ALR suspension length to the prevalence of drinking drivers relative to sober drivers in fatal crashes and (b) estimate the extent to which the relationship is associated to the general deterrent effect compared to the specific deterrent effect of the law. Data comparing the impact of ALR law implementation and ALR law suspension periods were analyzed using structural equation modeling techniques on the ratio of drinking drivers to nondrinking drivers in fatal crashes from the Fatality Analysis Reporting System (FARS). States with an ALR law with a short suspension period (1-30 days) had a significantly lower drinking driver ratio than states with no ALR law. States with a suspension period of 91-180 days had significantly lower ratios than states with shorter suspension periods, while the three states with suspension lengths of 181 days or longer had significantly lower ratios than states with shorter suspension periods. The implementation of any ALR law was associated with a 13.1% decrease in the drinking/nondrinking driver fatal crash ratio but only a 1.8% decrease in the intoxicated/nonintoxicated fatal crash ratio. The ALR laws and suspension lengths had a significant general deterrent effect, but no specific deterrent effect. States might want to keep (or adopt) ALR laws for their general deterrent effects and pursue alternatives for specific deterrent effects. States with short ALR suspension periods should consider lengthening them to 91 days or longer.

  13. 75 FR 35044 - Notice of Approval of a Supplemental New Animal Drug Application; Penicillin G Procaine Suspension

    Science.gov (United States)

    2010-06-21

    ...] Notice of Approval of a Supplemental New Animal Drug Application; Penicillin G Procaine Suspension AGENCY... Laboratories, Ltd. The supplemental NADA provides for a revised formulation of penicillin G procaine injectable... of NOROCILLIN (penicillin G procaine) Injectable Suspension by intramuscular injection in cattle...

  14. Core–shell hybrid nanocapsules for oral delivery of camptothecin: formulation development, in vitro and in vivo evaluation

    Energy Technology Data Exchange (ETDEWEB)

    Ünal, Hale, E-mail: unalhale@gmail.com [Hacettepe University, Division of Nanotechnology and Nanomedicine, Institute of Pure and Applied Science (Turkey); D’Angelo, Ivana [Second University of Napoli, Di.S.T.A.Bi.F. (Italy); Pagano, Ester; Borrelli, Francesca; Izzo, Angelo; Ungaro, Francesca; Quaglia, Fabiana [University of Naples Federico II, Department of Pharmacy (Italy); Bilensoy, Erem [Hacettepe University, Division of Nanotechnology and Nanomedicine, Institute of Pure and Applied Science (Turkey)

    2015-01-15

    The objective of this study was to design and in vitro–in vivo evaluate oral nanocapsules prepared from amphiphilic cyclodextrins (CDs) or poly-ε-caprolactone (PCL) for the effective oral delivery of an anticancer agent, camptothecin (CPT). CPT-loaded anionic and Chitosan (CS)-coated cationic nanocapsules were prepared and characterized in vitro. Morphological analysis was performed by scanning electron microscope (SEM). CPT release profile was evaluated using dialysis method under sink conditions. To determine the protective effect and drug stability provided by nanocapsules, all the formulations were incubated in simulated gastrointestinal media. Measurement of mucoadhesive tendency of CPT-loaded nanocapsules was realized by turbidimetric method. Penetration of nanocapsules was performed through an artificial mucus model. The permeability of CPT in solution form and bound to nanocapsule formulations were demonstrated across Caco-2 cell line. Finally, the intestinal uptake of nanocapsules was evaluated in vivo, in a mouse model. Both anionic and cationic formulations were in the range of 180–220 nm with a narrow size distribution and desired zeta potential values. CPT-loaded nanocapsules were found to be stable in simulated gastrointestinal media. Turbidimetric measurements confirmed the interaction between nanoparticles and mucin. Penetration of CPT through an artificial mucus gel layer was higher with CS-coated nanocapsules in accordance with the results obtained from permeability studies across Caco-2 cell line. In vivo animal studies confirmed that the intestinal uptake of nanocapsules was significantly higher with cationic nanocapsules. CPT-loaded positively charged CD nanocapsules might be an attractive and promising treatment for oral chemotherapy.

  15. Core–shell hybrid nanocapsules for oral delivery of camptothecin: formulation development, in vitro and in vivo evaluation

    International Nuclear Information System (INIS)

    Ünal, Hale; D’Angelo, Ivana; Pagano, Ester; Borrelli, Francesca; Izzo, Angelo; Ungaro, Francesca; Quaglia, Fabiana; Bilensoy, Erem

    2015-01-01

    The objective of this study was to design and in vitro–in vivo evaluate oral nanocapsules prepared from amphiphilic cyclodextrins (CDs) or poly-ε-caprolactone (PCL) for the effective oral delivery of an anticancer agent, camptothecin (CPT). CPT-loaded anionic and Chitosan (CS)-coated cationic nanocapsules were prepared and characterized in vitro. Morphological analysis was performed by scanning electron microscope (SEM). CPT release profile was evaluated using dialysis method under sink conditions. To determine the protective effect and drug stability provided by nanocapsules, all the formulations were incubated in simulated gastrointestinal media. Measurement of mucoadhesive tendency of CPT-loaded nanocapsules was realized by turbidimetric method. Penetration of nanocapsules was performed through an artificial mucus model. The permeability of CPT in solution form and bound to nanocapsule formulations were demonstrated across Caco-2 cell line. Finally, the intestinal uptake of nanocapsules was evaluated in vivo, in a mouse model. Both anionic and cationic formulations were in the range of 180–220 nm with a narrow size distribution and desired zeta potential values. CPT-loaded nanocapsules were found to be stable in simulated gastrointestinal media. Turbidimetric measurements confirmed the interaction between nanoparticles and mucin. Penetration of CPT through an artificial mucus gel layer was higher with CS-coated nanocapsules in accordance with the results obtained from permeability studies across Caco-2 cell line. In vivo animal studies confirmed that the intestinal uptake of nanocapsules was significantly higher with cationic nanocapsules. CPT-loaded positively charged CD nanocapsules might be an attractive and promising treatment for oral chemotherapy

  16. Development of a versatile high-temperature short-time (HTST) pasteurization device for small-scale processing of cell culture medium formulations.

    Science.gov (United States)

    Floris, Patrick; Curtin, Sean; Kaisermayer, Christian; Lindeberg, Anna; Bones, Jonathan

    2018-07-01

    The compatibility of CHO cell culture medium formulations with all stages of the bioprocess must be evaluated through small-scale studies prior to scale-up for commercial manufacturing operations. Here, we describe the development of a bespoke small-scale device for assessing the compatibility of culture media with a widely implemented upstream viral clearance strategy, high-temperature short-time (HTST) treatment. The thermal stability of undefined medium formulations supplemented with soy hydrolysates was evaluated upon variations in critical HTST processing parameters, namely, holding times and temperatures. Prolonged holding times of 43 s at temperatures of 110 °C did not adversely impact medium quality while significant degradation was observed upon treatment at elevated temperatures (200 °C) for shorter time periods (11 s). The performance of the device was benchmarked against a commercially available mini-pilot HTST system upon treatment of identical formulations on both platforms. Processed medium samples were analyzed by untargeted LC-MS/MS for compositional profiling followed by chemometric evaluation, which confirmed the observed degradation effects caused by elevated holding temperatures but revealed comparable performance of our developed device with the commercial mini-pilot setup. The developed device can assist medium optimization activities by reducing volume requirements relative to commercially available mini-pilot instrumentation and by facilitating fast throughput evaluation of heat-induced effects on multiple medium lots.

  17. Cochrane Qualitative and Implementation Methods Group guidance series-paper 2: methods for question formulation, searching, and protocol development for qualitative evidence synthesis.

    Science.gov (United States)

    Harris, Janet L; Booth, Andrew; Cargo, Margaret; Hannes, Karin; Harden, Angela; Flemming, Kate; Garside, Ruth; Pantoja, Tomas; Thomas, James; Noyes, Jane

    2018-05-01

    This paper updates previous Cochrane guidance on question formulation, searching, and protocol development, reflecting recent developments in methods for conducting qualitative evidence syntheses to inform Cochrane intervention reviews. Examples are used to illustrate how decisions about boundaries for a review are formed via an iterative process of constructing lines of inquiry and mapping the available information to ascertain whether evidence exists to answer questions related to effectiveness, implementation, feasibility, appropriateness, economic evidence, and equity. The process of question formulation allows reviewers to situate the topic in relation to how it informs and explains effectiveness, using the criterion of meaningfulness, appropriateness, feasibility, and implementation. Questions related to complex questions and interventions can be structured by drawing on an increasingly wide range of question frameworks. Logic models and theoretical frameworks are useful tools for conceptually mapping the literature to illustrate the complexity of the phenomenon of interest. Furthermore, protocol development may require iterative question formulation and searching. Consequently, the final protocol may function as a guide rather than a prescriptive route map, particularly in qualitative reviews that ask more exploratory and open-ended questions. Copyright © 2017 Elsevier Inc. All rights reserved.

  18. Recent Developments in the Study of operating and marketing strategy factors in the formulation of strategies of small manufacturers

    Directory of Open Access Journals (Sweden)

    Seyed Mohammad Abdollahi Keyvani

    2011-06-01

    Full Text Available The main purpose of this research is to measure the relative importance of a selected number of primary operating and marketing factors which may be involved in the formulation of strategies of small manufacturers. One hundred manufacturing owner-managers in Iran were investigated. The marketing factors emphasized most often were improvement in product quality and reduction in product cost. However, improvements in customer service and in scheduling appeared to contribute more to actual firm performance. Overall, there seemed to be more emphasis on the production strategy factors than marketing factors as a means to gaining competitive advantage.

  19. Development and validation of RP-HPLC method for analysis of multicomponent cough-cold syrup formulation

    OpenAIRE

    Ivković, Branka; Marković, Bojan; Vladimirov, Sote

    2014-01-01

    In this study a reversed phase HPLC method for rapid and simultaneous identification and quantification of doxylamine succinate, ephedrine sulfate, dextrometorphane hydrobromide, paracetamole and sodium benzoate in cough-cold syrup formulation was described. Separation was carried out on XTerraTM RP 18, Waters (150 mm x 4.6 mm column, 5 μm particle size). For the analysis of investigated substances gradient elution was used employing water, pH adjusted at 2.5 with 85 % ortophosphoric acid as ...

  20. Development of ELISA-based methods to measure the anti-malarial drug chloroquine in plasma and in pharmaceutical formulations

    DEFF Research Database (Denmark)

    Khalil, Insaf F; Alifrangis, Michael; Recke, Camilla

    2011-01-01

    In Central and South America and Eastern and Southern Africa, Plasmodium vivax infections accounts for 71-81% and 5% of malaria cases, respectively. In these areas, chloroquine (CQ) remains the treatment of choice for P. vivax malaria. In addition, CQ has recently proven to be an effective HIV-1...... therapeutic agent. There is a dire need to continue monitoring quality of CQ as there is a major influx of substandard and fake formulations into malaria-endemic countries. The use of fake/substandard drugs will result in sub-therapeutic levels endangering the patient and possibly select for parasite...

  1. The initial pharmaceutical development of an artesunate/amodiaquine oral formulation for the treatment of malaria: a public-private partnership

    Directory of Open Access Journals (Sweden)

    Gaudin Karen

    2011-05-01

    Full Text Available Abstract Background Artemisinin-based combination therapy is currently recommended worldwide for the treatment of uncomplicated malaria. Fixed-dose combinations are preferred as they favour compliance. This paper reports on the initial phases of the pharmaceutical development of an artesunate-amodiaquine (ASAQ bilayer co-formulation tablet, undertaken following pre-formulation studies by a network of scientists and industrials from institutions of both industrialized and low income countries. Methods Pharmaceutical development was performed by a research laboratory at the University Bordeaux Segalen, School of Pharmacy, for feasibility and early stability studies of various drug formulations, further transferred to a company specialized in pharmaceutical development, and then provided to another company for clinical batch manufacturing. The work was conducted by a regional public-private not-for-profit network (TropiVal within a larger Public Private partnership (the FACT project, set up by WHO/TDR, Médecins Sans Frontières and the Drugs for Neglected Disease initiative (DNDi. Results The main pharmaceutical goal was to combine in a solid oral form two incompatible active principles while preventing artesunate degradation under tropical conditions. Several options were attempted and failed to provide satisfactory stability results: incorporating artesunate in the external phase of the tablets, adding a pH regulator, alcoholic wet granulation, dry granulation, addition of an hydrophobic agent, tablet manufacturing in controlled conditions. However, long-term stability could be achieved, in experimental batches under GMP conditions, by physical separation of artesunate and amodiaquine in a bilayer co-formulation tablet in alu-alu blisters. Conduction of the workplan was monitored by DNDi. Conclusions Collaborations between research and industrial groups greatly accelerated the process of development of the bi-layered ASAQ tablet. Lack of public

  2. The initial pharmaceutical development of an artesunate/amodiaquine oral formulation for the treatment of malaria: a public-private partnership.

    Science.gov (United States)

    Lacaze, Catherine; Kauss, Tina; Kiechel, Jean-René; Caminiti, Antonella; Fawaz, Fawaz; Terrassin, Laurent; Cuart, Sylvie; Grislain, Luc; Navaratnam, Visweswaran; Ghezzoul, Bellabes; Gaudin, Karen; White, Nick J; Olliaro, Piero L; Millet, Pascal

    2011-05-23

    Artemisinin-based combination therapy is currently recommended worldwide for the treatment of uncomplicated malaria. Fixed-dose combinations are preferred as they favour compliance. This paper reports on the initial phases of the pharmaceutical development of an artesunate-amodiaquine (ASAQ) bilayer co-formulation tablet, undertaken following pre-formulation studies by a network of scientists and industrials from institutions of both industrialized and low income countries. Pharmaceutical development was performed by a research laboratory at the University Bordeaux Segalen, School of Pharmacy, for feasibility and early stability studies of various drug formulations, further transferred to a company specialized in pharmaceutical development, and then provided to another company for clinical batch manufacturing. The work was conducted by a regional public-private not-for-profit network (TropiVal) within a larger Public Private partnership (the FACT project), set up by WHO/TDR, Médecins Sans Frontières and the Drugs for Neglected Disease initiative (DNDi). The main pharmaceutical goal was to combine in a solid oral form two incompatible active principles while preventing artesunate degradation under tropical conditions. Several options were attempted and failed to provide satisfactory stability results: incorporating artesunate in the external phase of the tablets, adding a pH regulator, alcoholic wet granulation, dry granulation, addition of an hydrophobic agent, tablet manufacturing in controlled conditions. However, long-term stability could be achieved, in experimental batches under GMP conditions, by physical separation of artesunate and amodiaquine in a bilayer co-formulation tablet in alu-alu blisters. Conduction of the workplan was monitored by DNDi. Collaborations between research and industrial groups greatly accelerated the process of development of the bi-layered ASAQ tablet. Lack of public funding was the main obstacle hampering the development process

  3. Development of a novel cell-based assay system EPISSAY for screening epigenetic drugs and liposome formulated decitabine

    International Nuclear Information System (INIS)

    Lim, Sue Ping; Callen, David F; Kumar, Raman; Akkamsetty, Yamini; Wang, Wen; Ho, Kristen; Neilsen, Paul M; Walther, Diego J; Suetani, Rachel J; Prestidge, Clive

    2013-01-01

    Despite the potential of improving the delivery of epigenetic drugs, the subsequent assessment of changes in their epigenetic activity is largely dependent on the availability of a suitable and rapid screening bioassay. Here, we describe a cell-based assay system for screening gene reactivation. A cell-based assay system (EPISSAY) was designed based on a silenced triple-mutated bacterial nitroreductase TMnfsB fused with Red-Fluorescent Protein (RFP) expressed in the non-malignant human breast cell line MCF10A. EPISSAY was validated using the target gene TXNIP, which has previously been shown to respond to epigenetic drugs. The potency of a epigenetic drug model, decitabine, formulated with PEGylated liposomes was also validated using this assay system. Following treatment with DNA methyltransferase (DNMT) and histone deacetylase (HDAC) inhibitors such as decitabine and vorinostat, increases in RFP expression were observed, indicating expression of RFP-TMnfsB. The EPISSAY system was then used to test the potency of decitabine, before and after PEGylated liposomal encapsulation. We observed a 50% higher potency of decitabine when encapsulated in PEGylated liposomes, which is likely to be due to its protection from rapid degradation. The EPISSAY bioassay system provides a novel and rapid system to compare the efficiencies of existing and newly formulated drugs that reactivate gene expression

  4. Development of a nasal adenovirus-based vaccine: Effect of concentration and formulation on adenovirus stability and infectious titer during actuation from two delivery devices.

    Science.gov (United States)

    Renteria, Sandra S; Clemens, Courtney C; Croyle, Maria A

    2010-02-25

    A nasal adenovirus-based vaccine is under development. To determine if aggregation occurs during vaccination, infectious titer (limiting dilution) and capsid integrity (dynamic light scattering) were assessed after extrusion of a model vector from two intranasal delivery devices. Preparations of 2.5x10(12) and 1.25x10(11) virus particles (vp)/ml were studied. Virus aggregated ( approximately 10%) in the multi-dose vessel. Virus titer dropped by one log. Virus in the unit-dose device aggregated ( approximately 1%). Titer remained unchanged. Aggregation was concentration dependent. Formulations prevented aggregation during actuation, freeze-thaw and long-term storage. The device, formulation and dose may significantly influence aggregation and potency of any nasal adenovirus 5-based vaccine. Copyright 2009 Elsevier Ltd. All rights reserved.

  5. Development of Formulations for a-SiC and Manganese CMP and Post-CMP Cleaning of Cobalt

    Science.gov (United States)

    Lagudu, Uma Rames Krishna

    . Furthermore, addition of a low concentration of 250 ppm Brij-35 to this slurry suppressed the RRs of silicon dioxide to zero, while retaining the RRs of a-SiC at ˜2700 nm/h , a combination of RRs that is appropriate for hard mask polishing. The second part of this thesis focuses on the polishing of manganese which was proposed as a "self-forming" barrier material to prevent copper diffusion in advanced generation (22 nm and smaller) Si devices. A major challenge associated with such a self-forming Mn barrier for Cu interconnects in sub-22nm devices is galvanic corrosion that can occur at the Cu-Mn interface during chemical mechanical planarization. In the present work, it was shown that an aqueous solution of sucrose, BTA and potassium periodate reduces the corrosion potential gap between Cu and Mn to ˜ 0.01 V at pH 10 while also lowering the galvanic currents significantly and hence can be an excellent candidate for a polishing slurry. We discuss the role of these reagents and the inhibiting film that can be formed at the interface of the bimetallic system in this solution. Preliminary polishing results for Cu and Mn using a silica-based slurry formulated with this solution are also presented. The third part involves the development of compositions for Post CMP cleaning of cobalt barriers in advanced generation (22 nm and smaller). The thickness of the cobalt films was found to impact the corrosion behavior of the films. Thinner films of cobalt were found be more prone to galvanic corrosion in the presence of copper. The corrosion currents were low for both Cu and Co in all the solutions tested but the galvanic currents varied significantly. It was found that while BTA was not able to suppress the galvanic corrosion between Cu and Co (2000 A) at pH 8, either 60 mM of 3 Amino 1,2,4 triazole or 30 mM of 3 Amino 5 methyl thio 1,2,4 triazole were able to suppress the galvanic corrosion between Cu and Co (2000 A) to < 0.3 micro amperes per square cm at pH 8. These compositions

  6. Stability of extemporaneously prepared rufinamide oral suspensions.

    Science.gov (United States)

    Hutchinson, David J; Liou, Yayin; Best, Robert; Zhao, Fang

    2010-03-01

    Rufinamide is an oral antiepileptic drug indicated for adjunctive therapy in treating generalized seizures associated with Lennox-Gastaut syndrome. Currently, rufinamide is available as 200-mg and 400-mg tablets. A liquid dosage form does not exist at the present time. Lack of a suspension formulation may present an administration problem for many children and adults who are unable to swallow tablets. The availability of a liquid dosage form will provide an easy and accurate way to measure and administer the medication. To determine the stability of both sugar-containing and sugar-free rufinamide suspensions over a 90-day period. A suspension of rufinamide 40 mg/mL was prepared by grinding twelve 400-mg tablets of rufinamide tablets in a glass mortar. Sixty milliliters of Ora-Plus and 60 mL of either Ora-Sweet or Ora-Sweet SF (sugar free) were mixed and added to the powder to make a final volume of 120 mL. Three identical samples of each formulation were prepared and placed in 60-mL amber plastic bottles and were stored at room temperature. A 1-mL sample was withdrawn from each of the 6 bottles with a micropipette immediately after preparation and at 7, 14, 28, 56, and 90 days. After further dilution to an expected concentration of 0.4 mg/mL, the samples were assayed using high-performance liquid chromatography. Stability was defined as the retention of at least 90% of the initial concentration. At least 90% of the initial rufinamide concentration remained throughout the 90-day study period in both preparations. There were no detectable changes in color, odor, taste, and pH and no visible microbial growth. Extemporaneously compounded suspensions of rufinamide 40 mg/mL in a 1:1 mixture of Ora-Plus and Ora-Sweet or Ora-Sweet SF were stable for at least 90 days when stored in 59-mL amber polypropylene plastic bottles at room temperature.

  7. First Steps towards the Pharmaceutical Development of Ovules Containing Lactobacillus Strains: Viability and Antimicrobial Activity as Basic First Parameters in Vaginal Formulations.

    Science.gov (United States)

    Camilletti, A L; Ruíz, F O; Pascual, L M; Barberis, I L

    2018-02-01

    In the majority of Latin-American countries, including Argentina, there is a limited availability of vaginal bioproducts containing probiotics in the market. In addition, the conventional treatments of genital tract infections in women represent a high cost to the public health systems. The future development of this type of bioproducts that employ specific lactobacilli strains would not only have a meaningful impact on women's health but would also represent a significant challenge to the pharmaceutical industry. The aims of the work described in this paper were (i) to study different pharmaceutical formulations of vaginal ovules containing Lactobacillus fermentum L23 and L. rhamnosus L60, to determine in which formulation lactobacilli viability was sustained for longer time and (ii) to evaluate if probiotic strains maintained both the antimicrobial activity and biofilm-producing ability after being recovered from the ovules. In this study, we developed and characterized three pharmaceutical formulations containing different glycerol amounts and specific lactobacilli strains. Three relevant parameters, cell viability, antimicrobial activity, and biofilm production, by lactobacilli recovered from the ovules were tested. Although the viability of L23 and L60 strains was mainly influenced by high ovule's glycerol proportion, they survived at 4 °C during the 180 days. Both lactobacilli's antimicrobial activity and biofilm-producing ability were maintained for all treatments. In conclusion, employing a much reduced number of components, we were able to select the most suitable pharmaceutical formulation which maintained not only lactobacilli viability for a long period of time but also their antimicrobial activity and biofilm-producing ability.

  8. New CeO2 nanoparticles-based topical formulations for the skin protection against organophosphates

    Directory of Open Access Journals (Sweden)

    Arnaud Zenerino

    2015-01-01

    Full Text Available To reinforce skin protection against organophosphates (OPs, the development of new topical skin protectants (TSP has received a great interest. Nanoparticles like cerium dioxide (CeO2 known to adsorb and neutralize OPs are interesting candidates for TSP. However, NPs are difficult to disperse into formulations and they are suspected of toxicological issues. Thus, we want to study: (1 the effect of the addition of CeO2 NPs in formulations for the skin protection (2 the impact of the doping of CeO2 NPs by calcium; (3 the effect of two methods of dispersion of CeO2 NPs: an O/W emulsion or a suspension of a fluorinated thickening polymer (HASE-F grafted with these NPs. As a screening approach we used silicone membranes as a skin equivalent and Franz diffusion cells for permeation tests. The addition of pure CeO2 NPs in both formulations permits the penetration to decrease by a 3–4-fold factor. The O/W emulsion allows is the best approach to obtain a film-forming coating with a good reproducibility of the penetration results; whereas the grafting of NPs to a thickener is the best way to obtain an efficient homogenous suspension of CeO2 NPs with a decreased of toxicological impact but the coating is less film-forming which slightly impacts the reproducibility of the penetration results.

  9. New CeO2 nanoparticles-based topical formulations for the skin protection against organophosphates.

    Science.gov (United States)

    Zenerino, Arnaud; Boutard, Tifenn; Bignon, Cécile; Amigoni, Sonia; Josse, Denis; Devers, Thierry; Guittard, Frédéric

    2015-01-01

    To reinforce skin protection against organophosphates (OPs), the development of new topical skin protectants (TSP) has received a great interest. Nanoparticles like cerium dioxide (CeO 2 ) known to adsorb and neutralize OPs are interesting candidates for TSP. However, NPs are difficult to disperse into formulations and they are suspected of toxicological issues. Thus, we want to study: (1) the effect of the addition of CeO 2 NPs in formulations for the skin protection (2) the impact of the doping of CeO 2 NPs by calcium; (3) the effect of two methods of dispersion of CeO 2 NPs: an O/W emulsion or a suspension of a fluorinated thickening polymer (HASE-F) grafted with these NPs. As a screening approach we used silicone membranes as a skin equivalent and Franz diffusion cells for permeation tests. The addition of pure CeO 2 NPs in both formulations permits the penetration to decrease by a 3-4-fold factor. The O/W emulsion allows is the best approach to obtain a film-forming coating with a good reproducibility of the penetration results; whereas the grafting of NPs to a thickener is the best way to obtain an efficient homogenous suspension of CeO 2 NPs with a decreased of toxicological impact but the coating is less film-forming which slightly impacts the reproducibility of the penetration results.

  10. The Use of D-Optimal Mixture Design in Optimizing Development of Okara Tablet Formulation as a Dietary Supplement

    Science.gov (United States)

    Mohamad Zen, Nur Izzati; Shamsudin, Rosnah

    2015-01-01

    The usage of soy is increasing year by year. It increases the problem of financial crisis due to the limited sources of soybeans. Therefore, production of oral tablets containing the nutritious leftover of soymilk production, called okara, as the main ingredient was investigated. The okara tablets were produced using the direct compression method. The percentage of okara, guar gum, microcrystalline cellulose (Avicel PH-101), and maltodextrin influenced tablets' hardness and friability which are analyzed using a D-optimal mixture design. Composition of Avicel PH-101 had positive effects for both hardness and friability tests of the tablets. Maltodextrin and okara composition had a significant positive effect on tablets' hardness, but not on percentage of friability of tablets. However, guar gum had a negative effect on both physical tests. The optimum tablet formulation was obtained: 47.0% of okara, 2.0% of guar gum, 35.0% of Avicel PH-101, and 14.0% of maltodextrin. PMID:26171418

  11. Development and validation of a new LBM-MRT hybrid model with enthalpy formulation for melting with natural convection

    Energy Technology Data Exchange (ETDEWEB)

    Miranda Fuentes, Johann [Université de Lyon, CNRS, UMR5008, F-69622 Villeurbanne (France); INSA-Lyon, CETHIL, F-69621 Villeurbanne (France); Kuznik, Frédéric, E-mail: frederic.kuznik@insa-lyon.fr [Université de Lyon, CNRS, UMR5008, F-69622 Villeurbanne (France); INSA-Lyon, CETHIL, F-69621 Villeurbanne (France); Johannes, Kévyn; Virgone, Joseph [Université de Lyon, CNRS, UMR5008, F-69622 Villeurbanne (France); Université Lyon 1, CETHIL, F-69622 Villeurbanne (France)

    2014-01-17

    This article presents a new model to simulate melting with natural convection of a phase change material. For the phase change problem, the enthalpy formulation is used. Energy equation is solved by a finite difference method, whereas the fluid flow is solved by the multiple relaxation time (MRT) lattice Boltzmann method. The model is first verified and validated using the data from the literature. Then, the model is applied to a tall brick filled with a fatty acid eutectic mixture and the results are presented. The main results are (1) the spatial convergence rate is of second order, (2) the new model is validated against data from the literature and (3) the natural convection plays an important role in the melting process of the fatty acid mixture considered in our work.

  12. The Use of D-Optimal Mixture Design in Optimizing Development of Okara Tablet Formulation as a Dietary Supplement

    Directory of Open Access Journals (Sweden)

    Nur Izzati Mohamad Zen

    2015-01-01

    Full Text Available The usage of soy is increasing year by year. It increases the problem of financial crisis due to the limited sources of soybeans. Therefore, production of oral tablets containing the nutritious leftover of soymilk production, called okara, as the main ingredient was investigated. The okara tablets were produced using the direct compression method. The percentage of okara, guar gum, microcrystalline cellulose (Avicel PH-101, and maltodextrin influenced tablets’ hardness and friability which are analyzed using a D-optimal mixture design. Composition of Avicel PH-101 had positive effects for both hardness and friability tests of the tablets. Maltodextrin and okara composition had a significant positive effect on tablets’ hardness, but not on percentage of friability of tablets. However, guar gum had a negative effect on both physical tests. The optimum tablet formulation was obtained: 47.0% of okara, 2.0% of guar gum, 35.0% of Avicel PH-101, and 14.0% of maltodextrin.

  13. Capacity Development and Strengthening for Energy Policy formulation and implementation of Sustainable Energy Projects in Indonesia CASINDO. Deliverable No. 4. Inception report

    Energy Technology Data Exchange (ETDEWEB)

    Van der Linden, N.; Smekens, K. [Unit Policy Studies, Energy research Centre of the Netherlands ECN, Petten (Netherlands); Wijnker, M.; Lemmens, L. [Eindhoven University of Technology TUE, Eindhoven (Netherlands); Kamphuis, E. [ETC Nederland, Leusden (Netherlands); Permana, I. [Technical Education Development Centre TEDC, Bandung (Indonesia); Winarno, O.T. [Institute of Technology of Bandung ITB, Bandung (Indonesia)

    2009-10-15

    The overall objective of the CASINDO programme is to establish a self-sustaining and self-developing structure at both the national and regional level to build and strengthen human capacity to enable the provinces of North Sumatra, Yogyakarta, Central Java, West Nusa Tenggara and Papua to formulate sound policies for renewable energy and energy efficiency and to develop and implement sustainable energy projects. This inception report presents the proposed programmes for addressing the identified training needs, the proposed changes to the monitoring framework and other relevant issues discussed during the inception phase.

  14. Stability of three commonly compounded extemporaneous enrofloxacin suspensions for oral administration to exotic animals.

    Science.gov (United States)

    Petritz, Olivia A; Guzman, David Sanchez-Migallon; Wiebe, Valerie J; Papich, Mark G

    2013-07-01

    To evaluate the stability of 3 extemporaneous oral suspensions of enrofloxacin mixed with readily available flavoring vehicles when stored at room temperature (approx 22°C). Evaluation study. 3 commonly compounded oral suspensions of enrofloxacin. On day 0, commercially available enrofloxacin tablets were compounded with a mixture of distilled water and corn syrup (formulation A) or cherry syrup (formulation B) flavoring vehicles to create suspensions with a nominal enrofloxacin concentration of 22.95 mg/mL, and 2.27% enrofloxacin injectable solution was compounded with a liquid sweetener (formulation C) to create a suspension with a nominal enrofloxacin concentration of 11.35 mg/mL. Preparations were stored in amber-colored vials at room temperature for 56 days. For each preparation, the enrofloxacin concentration was evaluated with high-performance liquid chromatography at prespecified intervals during the study. The pH, odor, and consistency for all suspensions were recorded at the start and completion of the study. Relative to the nominal enrofloxacin concentration, the enrofloxacin concentration strength ranged from 95.80% to 100.69% for formulation A, 108.44% to 111.06% for formulation B, and 100.99% to 103.28% for formulation C. A mild pH increase was detected in all 3 suspensions during the study. Results indicated that, when stored in amber-colored vials at room temperature for 56 days, the enrofloxacin concentration strength in all 3 formulations was retained within acceptance criteria of 90% to 110%. Subjectively, cherry syrup flavoring was better at masking the smell and taste of enrofloxacin than were the other mixing vehicles.

  15. Development and validation of stability indicating method for the quantitative determination of venlafaxine hydrochloride in extended release formulation using high performance liquid chromatography

    Directory of Open Access Journals (Sweden)

    Jaspreet Kaur

    2010-01-01

    Full Text Available Objective : Venlafaxine,hydrochloride is a structurally novel phenethyl bicyclic antidepressant, and is usually categorized as a serotonin-norepinephrine reuptake inhibitor (SNRI but it has been referred to as a serotonin-norepinephrine-dopamine reuptake inhibitor. It inhibits the reuptake of dopamine. Venlafaxine HCL is widely prescribed in the form of sustained release formulations. In the current article we are reporting the development and validation of a fast and simple stability indicating, isocratic high performance liquid chromatographic (HPLC method for the determination of venlafaxine hydrochloride in sustained release formulations. Materials and Methods : The quantitative determination of venlafaxine hydrochloride was performed on a Kromasil C18 analytical column (250 x 4.6 mm i.d., 5 μm particle size with 0.01 M phosphate buffer (pH 4.5: methanol (40: 60 as a mobile phase, at a flow rate of 1.0 ml/min. For HPLC methods, UV detection was made at 225 nm. Results : During method validation, parameters such as precision, linearity, accuracy, stability, limit of quantification and detection and specificity were evaluated, which remained within acceptable limits. Conclusions : The method has been successfully applied for the quantification and dissolution profiling of Venlafaxine HCL in sustained release formulation. The method presents a simple and reliable solution for the routine quantitative analysis of Venlafaxine HCL.

  16. Development and in vitro-in vivo evaluation of a water-in-oil microemulsion formulation for the oral delivery of troxerutin.

    Science.gov (United States)

    Xu, Man; Yu, Qing; Zhao, Qianru; Chen, Wei; Lin, Yuanjie; Jin, Yong

    2016-01-01

    The main objective of this study was to develop and evaluate a W/O microemulsion formulation of troxerutin to improve its oral bioavailability. The W/O microemulsion was optimized using a pseudo-ternary phase diagram and evaluated for physical properties. In vitro MDCK cell permeability studies were carried out to evaluate the permeability enhancement effect of microemulsion, and in vivo absorption of troxerutin microemulsion in the intestine was compared with that of solution after single-dose administration (56.7 mg/kg) in male Wistar rats. The optimal formulation consisted of lecithin, ethanol, isopropyl myristate and water (23.30/11.67/52.45/12.59 w/w) was physicochemical stable and the mean droplet size was about 50.20 nm. In vitro study, the troxerutin-loaded microemulsion showed higher intestinal membrane permeability across MDCK monolayer when compared with the control solution. The W/O microemulsion can significantly promote the intestinal absorption of troxerutin in rats in vivo, and the relative bioavailability of the microemulsion was about 205.55% compared to control solution. These results suggest that novel W/O microemulsion could be used as an effective formulation for improving the oral bioavailability of troxerutin.

  17. Formulation and development of ophthalmic in situ gel for the treatment ocular inflammation and infection using application of quality by design concept.

    Science.gov (United States)

    Patel, Nirav; Thakkar, Vaishali; Metalia, Viral; Baldaniya, Lalji; Gandhi, Tejal; Gohel, Mukesh

    2016-09-01

    The conventional liquid ophthalmic delivery systems exhibit short pre-corneal residence time and the relative impermeability to the cornea which leads to poor ocular bioavailability. The aim of this study was to apply quality by design (QbD) for development of dexamethasone sodium phosphate (DSP) and tobramycin sulfate (TS)-loaded thermoresponsive ophthalmic in situ gel containing Poloxamer 407 and hydroxyl propyl methyl cellulose (HPMC) K4M for prolonging the pre-corneal residence time, ocular bioavability and decreases the frequency of administration of dosage form. The material attributes and the critical quality attributes (CQA) of the in situ gel were identified. Central composite design (CCD) was adopted to optimize the formulation. The ophthalmic in situ forming gels were prepared by cold method. Materials attributes were the amount of Poloxamer 407 and HPMC and CQA identified were Gel strength, mucoadhesive index, gelation temperature and % of drug release of both drug. Optimized batch (F*) containing 16.75% poloxamer 407 and 0.54% HPMC K4M were exhibited all results in acceptable limits. Compared with the marketed formulation, optimized in situ gel showed delayed Tmax, improved Cmax and AUC in rabbit aqueous humor, suggesting the sustained drug release and better corneal penetration and absorption. According to the study, it could be concluded that DSP and TS would be successfully formulated as in situ gelling mucoadhesive system for the treatment of steroid responsive eye infections with the properties of sustained drug release, prolonged ocular retention and improved corneal penetration.

  18. A universal suspension test rig for electrohydraulic active and passive automotive suspension system

    Directory of Open Access Journals (Sweden)

    Mahmoud Omar

    2017-12-01

    Full Text Available A fully active electro-hydraulic and passive automotive quarter car suspensions with their experimental test-rigs are designed and implemented. Investigation of the active performance compared against the passive is performed experimentally and numerically utilizing SIMULINK's Simscape library. Both systems are modeled as single-degree-of-freedom in order to simplify the validation process. Economic considerations were considered during the rig's implementation. The rig consists of two identical platforms fixed side by side allowing testing two independent suspensions simultaneously. Position sensors for sprung and unsprung masses on both platforms are installed. The road input is introduced by a cam and a roller follower mechanism driven by 1.12 kW single phase induction motor with speed reduction assembly. The active hydraulic cylinder was the most viable choice due to its high power-to-weight ratio. The active control is of the proportional-integral-differential (PID type. Though this technique is quite simple and not new, yet the emphasis of this paper is the engineering, design and implementation of the experimental setup and controller. A successful validation process is performed. Ride comfort significantly improved with active suspension, as shown by the results; 24.8% sprung mass vibration attenuation is achieved. The details of the developed system with the analytical and experimental results are presented. Keywords: Active suspension, Passive suspension, Servo, Hydraulic, Control, PID

  19. IN VITRO ANTIBACTERIAL ACTIVITIES STUDY OF POLYMERIC CIPROFLOXACIN SUSPENSIONS

    OpenAIRE

    Sahoo Subhashree; Chakraborti Chandra Kanti; Behera Pradipta Kumar

    2012-01-01

    To study the in vitro antibacterial activities of mucoadhesive suspensions containing Ciprofloxacin, three different formulations were prepared by using three polymers, such as Hydroxypropyl methylcellulose (HPMC) (S1), Carbapol934 (S2) and Carbapol940 (S3), along with some common ingredients (bases). For the investigation, agar well diffusion method was performed taking Staphylococcus aureus (ATCC 25923), Bacillus subtilis and Escherichia coli (ATCC 25922). Apart from S. aureus, S1 and Cipro...

  20. Magnetorheological suspension electromagnetic brake

    International Nuclear Information System (INIS)

    Bica, Ioan

    2004-01-01

    The magnetorheological suspension (MRS) brake is of the monoblock type. The main part of the electromagnetic brake is an electromagnet, between whose poles two MRS disks are placed. For distances between disks of 0.65x10 -3 m±10%, revolutions of the electric motor, coupled to the electromagnetic brake, ranging between 200 and 1600 rev/min and braking powers of up to 85 W, there are no differences in revolutions between the disks of the electromagnetic brake. For fixed revolutions of the electric motor, the revolution of the parallel disk can be modified continuously by means of the intensity of the magnetic field. In all cases, the quantity of MRS is of 0.35x10 -3 kg

  1. Degradation theories of concrete and development of a new deviatoric model in incremental tangent formulation: limit analysis applied to case of anchor bolts embedded in concrete

    International Nuclear Information System (INIS)

    Ung Quoc, H.

    2003-12-01

    This research is achieved in the general framework of the study of the concrete behaviour. It has for objective the development of a new behaviour model satisfying to the particular requirements for an industrial exploitation. After the analysis of different existent models, a first development has concerned models based on the smeared crack theory. A new formulation of the theory permitted to overcome the stress locking problem. However, the analysis showed the persistence of some limits inert to this approach in spite of this improvement. Then, an analysis of the physical mechanisms of the concrete degradation has been achieved and permitted to develop the new damage model MODEV. The general formulation of this model is based on the theory of the thermodynamics and applied to the case of the heterogeneous and brittle materials. The MODEV model considers two damage mechanisms: extension and sliding. The model considers also that the relative tangent displacement between microcracks lips is responsible of the strain irreversibility. Thus, the rate of inelastic strain becomes function of the damage and the heterogeneity index of the material. The unilateral effect is taken in account as an elastic hardening or softening process according to re-closing or reopening of cracks. The model is written within the framework of non standard generalised materials in incremental tangent formulation and implemented in the general finite element code SYMPHONIE. The validation of the model has been achieved on the basis of several tests issued from the literature. The second part of this research has concerned the development of the CHEVILAB software. This simulation tool based on the limit analysis approach permit the evaluation of the ultimate load capacity of anchors bolts. The kinematics approach of the limit analysis has been adapted to the problem of anchors while considering several specific failure mechanisms. This approach has been validated then by comparison with the

  2. The global pediatric antiretroviral market: analyses of product availability and utilization reveal challenges for development of pediatric formulations and HIV/AIDS treatment in children

    Directory of Open Access Journals (Sweden)

    Jambert Elodie

    2010-10-01

    Full Text Available Abstract Background Important advances in the development and production of quality-certified pediatric antiretroviral (ARV formulations have recently been made despite significant market disincentives for manufacturers. This progress resulted from lobbying and innovative interventions from HIV/AIDS activists, civil society organizations, and international organizations. Research on uptake and dispersion of these improved products across countries and international organizations has not been conducted but is needed to inform next steps towards improving child health. Methods We used information from the World Health Organization Prequalification Programme and the United States Food and Drug Administration to describe trends in quality-certification of pediatric formulations and used 7,989 donor-funded, pediatric ARV purchase transactions from 2002-2009 to measure uptake and dispersion of new pediatric ARV formulations across countries and programs. Prices for new pediatric ARV formulations were compared to alternative dosage forms. Results Fewer ARV options exist for HIV/AIDS treatment in children than adults. Before 2005, most pediatric ARVs were produced by innovator companies in single-component solid and liquid forms. Five 2-in1 and four 3-in-1 generic pediatric fixed-dose combinations (FDCs in solid and dispersible forms have been quality-certified since 2005. Most (67% of these were produced by one quality-certified manufacturer. Uptake of new pediatric FDCs outside of UNITAID is low. UNITAID accounted for 97-100% of 2008-2009 market volume. In total, 33 and 34 countries reported solid or dispersible FDC purchases in 2008 and 2009, respectively, but most purchases were made through UNITAID. Only three Global Fund country recipients reported purchase of these FDCs in 2008. Prices for pediatric FDCs were considerably lower than liquids but typically higher than half of an adult FDC. Conclusion Pediatric ARV markets are more fragile than

  3. The global pediatric antiretroviral market: analyses of product availability and utilization reveal challenges for development of pediatric formulations and HIV/AIDS treatment in children.

    Science.gov (United States)

    Waning, Brenda; Diedrichsen, Ellen; Jambert, Elodie; Bärnighausen, Till; Li, Yun; Pouw, Mieke; Moon, Suerie

    2010-10-17

    Important advances in the development and production of quality-certified pediatric antiretroviral (ARV) formulations have recently been made despite significant market disincentives for manufacturers. This progress resulted from lobbying and innovative interventions from HIV/AIDS activists, civil society organizations, and international organizations. Research on uptake and dispersion of these improved products across countries and international organizations has not been conducted but is needed to inform next steps towards improving child health. We used information from the World Health Organization Prequalification Programme and the United States Food and Drug Administration to describe trends in quality-certification of pediatric formulations and used 7,989 donor-funded, pediatric ARV purchase transactions from 2002-2009 to measure uptake and dispersion of new pediatric ARV formulations across countries and programs. Prices for new pediatric ARV formulations were compared to alternative dosage forms. Fewer ARV options exist for HIV/AIDS treatment in children than adults. Before 2005, most pediatric ARVs were produced by innovator companies in single-component solid and liquid forms. Five 2-in1 and four 3-in-1 generic pediatric fixed-dose combinations (FDCs) in solid and dispersible forms have been quality-certified since 2005. Most (67%) of these were produced by one quality-certified manufacturer. Uptake of new pediatric FDCs outside of UNITAID is low. UNITAID accounted for 97-100% of 2008-2009 market volume. In total, 33 and 34 countries reported solid or dispersible FDC purchases in 2008 and 2009, respectively, but most purchases were made through UNITAID. Only three Global Fund country recipients reported purchase of these FDCs in 2008. Prices for pediatric FDCs were considerably lower than liquids but typically higher than half of an adult FDC. Pediatric ARV markets are more fragile than adult markets. Ensuring a long-term supply of quality, well

  4. The physical and chemical stability of suspensions of sustained-release diclofenac microspheres.

    Science.gov (United States)

    Lewis, L; Boni, R L; Adeyeye, C M

    1998-01-01

    The major challenge in liquid sustained-release oral suspensions is to minimize drug diffusion into the suspending medium and to retain the original properties of the microparticles during storage. Diclofenac wax microspheres prepared by the hydrophobic congealable disperse phase method were formulated as a sustained release suspension and stored at three different temperatures (25, 37 and 45 degrees C) for 3 months, to evaluate the physical and chemical stability of the suspended microspheres. Suspensions of microspheres stored at ambient temperatures were both physically and chemically stable, but at higher temperatures, up to 45 degrees C, there was a decrease in drug release due to scaling and melting on the microsphere surface as observed by scanning electron microscopy. However, on prolonged storage, up to 90 days, especially at 45 degrees C, temperature became a dominant factor causing an increase in drug release. The suspension of diclofenac microspheres was chemically stable for 3 months, while the plain drug suspension exhibited slight degradation.

  5. Effect of buffer and antioxidant on stability of a mercaptopurine suspension.

    Science.gov (United States)

    Aliabadi, Hamidreza Montazeri; Romanick, Marcel; Desai, Sunil; Lavasanifar, Afsaneh

    2008-03-01

    The stability of standard and modified mercaptopurine suspensions when stored at room temperature and under refrigerated conditions to test the feasibility of increasing shelf life was studied. A 50-mg/mL mercaptopurine suspension was compounded by adding simple syrup, cherry syrup, and sterile water for irrigation to triturated mercaptopurine tablets for the initial reference formulation. Three additional formulations were prepared by adding an antioxidant (ascorbic acid 10 mg), a buffer (sodium phosphate monobasic monohydrate 500 mg), and a combination of antioxidant and buffer to the reference formulation. Each compounded batch was divided into two parts and stored in amber bottles at room temperature (19-23 degrees C) or under refrigerated conditions (4-8 degrees C). Analysis through high-performance liquid chromatography determined mercaptopurine levels after three and seven days and weekly thereafter for at least two weeks after shelf life was reached under specified storage conditions. Solutions with at least 93% of the original mercaptopurine concentration and with no observable sign of aggregation or cake formation were considered stable. The reference suspension of mercaptopurine showed an acceptable physical and chemical stability of up to 5 weeks when stored at room temperature. The addition of ascorbic acid extended the shelf life of the compounded suspension to 11 weeks. However, the addition of sodium phosphate monobasic did not improve the stability of mercaptopurine in the suspension. The results showed a higher stability for all formulations after storage at room temperature compared with those stored in a refrigerator. A standard oral suspension of mercaptopurine contained an acceptable drug concentration for up to 5 weeks when stored at room temperature. The addition of ascorbic acid at a concentration of 0.1% w/v to the standard formulation increased the suspension's shelf life at room temperature to 11 weeks.

  6. Synergistic Interplay of Medicinal Chemistry and Formulation Strategies in Nanotechnology - From Drug Discovery to Nanocarrier Design and Development.

    Science.gov (United States)

    Sunoqrot, Suhair; Hamed, Rania; Abdel-Halim, Heba; Tarawneh, Ola

    2017-01-01

    Over the last few decades, nanotechnology has given rise to promising new therapies and diagnostic tools for a wide range of diseases, especially cancer. The unique properties of nanocarriers such as liposomes, polymeric nanoparticles, micelles, and bioconjugates have mainly been exploited to enhance drug solubility, dissolution, and bioavailability. The most important advantage offered by nanotechnology is the ability to specifically target organs, tissues, and individual cells, which ultimately reduces the systemic side effects and improves the therapeutic index of drug molecules. The contribution of medicinal chemistry to nanotechnology is evident in the abundance of new active molecules that are being discovered but are faced with tremendous delivery challenges by conventional formulation strategies. Additionally, medicinal chemistry plays a crucial role in all the steps involved in the preparation of nanocarriers, where structure-activity relationships of the drug molecule as well as the nanocarrier are harnessed to enhance the design, efficacy, and safety of nanoformulations. The aim of this review is to provide an overview of the contributions of medicinal chemistry to nanotechnology, from supplying drug candidates and inspiring high-throughput nanocarrier design strategies, to structure-activity relationship elucidation and construction of computational models for better understanding of nanocarrier physicochemical properties and biological behavior. These two fields are undoubtedly interconnected and we will continue to see the fruits of that communion for years to come. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

  7. Development of a long-acting injectable formulation with nanoparticles of rilpivirine (TMC278) for HIV treatment.

    Science.gov (United States)

    Baert, Lieven; van 't Klooster, Gerben; Dries, Willy; François, Marc; Wouters, Alfons; Basstanie, Esther; Iterbeke, Koen; Stappers, Fred; Stevens, Paul; Schueller, Laurent; Van Remoortere, Pieter; Kraus, Guenter; Wigerinck, Piet; Rosier, Jan

    2009-08-01

    Long-acting parenteral formulations of antiretrovirals could facilitate maintenance and prophylactic treatment in HIV. Using the poorly water- and oil-soluble non-nucleoside reverse transcriptase inhibitor (NNRTI) TMC278 (rilpivirine) as base or hydrochloride (HCl), nanosuspensions were prepared by wet milling (Elan NanoCrystal technology) in an aqueous carrier. Laser diffraction showed that the average particles size were (1) close to the targeted size proportionality (200-400-800 nm), with increasing distributions the larger the average particle size, and (2) were stable over 6 months. Following single-dose administration, the plasma concentration profiles showed sustained release of TMC278 over 3 months in dogs and 3 weeks in mice. On comparison of intramuscular and subcutaneous injection of 5mg/kg (200 nm) in dogs, the subcutaneous route resulted in the most stable plasma levels (constant at 25 ng/mL for 20 days, after which levels declined slowly to 1-3 ng/mL at 3 months); 200 nm nanosuspensions achieved higher and less variable plasma concentration profiles than 400 and 800 nm nanosuspensions. In mice, the pharmacokinetic profiles after a single 20mg/kg dose (200 nm) were similar with two different surfactants used (poloxamer 338, or d-alpha-tocopheryl polyethylene glycol 1000 succinate). In conclusion, this study provides proof-of-concept that 200-nm sized TMC278 nanosuspensions may act as long-acting injectable.

  8. Development and optimization of solid lipid nanoparticle formulation for ophthalmic delivery of chloramphenicol using a Box-Behnken design

    Science.gov (United States)

    Hao, Jifu; Fang, Xinsheng; Zhou, Yanfang; Wang, Jianzhu; Guo, Fengguang; Li, Fei; Peng, Xinsheng

    2011-01-01

    The purpose of the present study was to optimize a solid lipid nanoparticle (SLN) of chloramphenicol by investigating the relationship between design factors and experimental data using response surface methodology. A Box-Behnken design was constructed using solid lipid (X1), surfactant (X2), and drug/lipid ratio (X3) level as independent factors. SLN was successfully prepared by a modified method of melt-emulsion ultrasonication and low temperature-solidification technique using glyceryl monostearate as the solid lipid, and poloxamer 188 as the surfactant. The dependent variables were entrapment efficiency (EE), drug loading (DL), and turbidity. Properties of SLN such as the morphology, particle size, zeta potential, EE, DL, and drug release behavior were investigated, respectively. As a result, the nanoparticle designed showed nearly spherical particles with a mean particle size of 248 nm. The polydispersity index of particle size was 0.277 ± 0.058 and zeta potential was −8.74 mV. The EE (%) and DL (%) could reach up to 83.29% ± 1.23% and 10.11% ± 2.02%, respectively. In vitro release studies showed a burst release at the initial stage followed by a prolonged release of chloramphenicol from SLN up to 48 hours. The release kinetics of the optimized formulation best fitted the Peppas–Korsmeyer model. These results indicated that the chloramphenicol-loaded SLN could potentially be exploited as a delivery system with improved drug entrapment efficiency and controlled drug release. PMID:21556343

  9. A novel magnetic lead screw active suspension system for vehicles

    DEFF Research Database (Denmark)

    Berg, Nick Ilsø; Holm, Rasmus Koldborg; Rasmussen, Peter Omand

    2014-01-01

    This paper encompasses a detailed study of the redesign of a novel Magnetic Lead Screw (MLS) active suspension system for possible regeneration of the energy dispatched in the suspension system and active control of vehicle body movement. The MLS converts a low speed high force linear motion...... of a translator into a high speed low torque rotational motion of a rotor through helically shaped magnets. The paper describes the drawback of the first MLS prototype v1.0 developed for active suspension system, which lead to a new design of the MLS prototype named v1.5. Furthermore the paper introduces detailed...

  10. Modelling nonlinear viscoelastic behaviours of loudspeaker suspensions-like structures

    Science.gov (United States)

    Maillou, Balbine; Lotton, Pierrick; Novak, Antonin; Simon, Laurent

    2018-03-01

    Mechanical properties of an electrodynamic loudspeaker are mainly determined by its suspensions (surround and spider) that behave nonlinearly and typically exhibit frequency dependent viscoelastic properties such as creep effect. The paper aims at characterizing the mechanical behaviour of electrodynamic loudspeaker suspensions at low frequencies using nonlinear identification techniques developed in recent years. A Generalized Hammerstein based model can take into account both frequency dependency and nonlinear properties. As shown in the paper, the model generalizes existing nonlinear or viscoelastic models commonly used for loudspeaker modelling. It is further experimentally shown that a possible input-dependent law may play a key role in suspension characterization.

  11. Stability of an extemporaneously prepared thalidomide suspension.

    Science.gov (United States)

    Kraft, Shawna; Johnson, Cary E; Tyler, Ryan P

    2012-01-01

    The short-term physical and chemical stability of an oral suspension of thalidomide 20 mg/mL was studied. An oral suspension of thalidomide 20 mg/mL was prepared by emptying the contents of 12 100-mg thalidomide capsules into a glass mortar; 30 mL of Ora-Plus and 30 mL of Ora-Sweet were mixed and added to the thalidomide powder to make a final volume of 60 mL. Three identical samples of the formulation were prepared and placed in 2-oz amber plastic bottles with child-resistant caps and stored under refrigeration (3-5 °C). A 1-mL sample was withdrawn from each of the three samples with a micropipette immediately after preparation and at 7, 14, 21, 28, and 35 days. After further dilution to an expected concentration of 20 μg/mL with acetonitrile-methanol and then dilution with mobile phase, the samples were assayed in duplicate using stability-indicating high-performance liquid chromatography. Stability was determined by evaluating the percentage of the initial concentration remaining at each time point; stability was defined as the retention of at least 90% of the initial concentration of thalidomide. At least 92% of the initial thalidomide concentration remained throughout the 35-day study period. There were no detectable changes in color, odor, or pH and no visible microbial growth in any sample. An extemporaneously prepared suspension of thalidomide 20 mg/mL in a 1:1 mixture of Ora-Plus and Ora-Sweet was stable for at least 35 days when stored in 2-oz amber plastic bottles under refrigeration.

  12. Stability of an extemporaneously prepared tadalafil suspension.

    Science.gov (United States)

    Pettit, Rebecca S; Johnson, Cary E; Caruthers, Regine L

    2012-04-01

    The stability of an extemporaneously prepared tadalafil oral suspension was studied. An oral suspension of tadalafil 5 mg/mL was prepared by thoroughly grinding 15 20-mg tadalafil tablets in a glass mortar. Thirty milliliters of Ora-Plus and 30 mL of Ora-Sweet were mixed and added to the powder to make a final volume of 60 mL. Three identical samples of the formulation were prepared and placed in 2-oz amber plastic bottles with child-resistant caps and stored at room temperature (23-25 °C). A 1-mL sample was withdrawn from each of the three bottles with a micropipette immediately after preparation and at 7, 14, 28, 57, and 91 days. After double dilution (1:10 and 0.1:5 v/v) to an expected concentration of 10 μg/mL with methanol and mobile phase, respectively, the samples were assayed in duplicate using stability-indicating high-performance liquid chromatography. The samples were visually examined for any color change and evaluated for pH changes on each day of analysis. Taste evaluation was performed at the beginning and end of the study. Stability was defined as the retention of at least 90% of the initial concentration. At least 99% of the initial tadalafil concentration remained throughout the 91-day study period. There were no detectable changes in color, odor, taste, and pH, and no visible microbial growth was observed in any sample. An extemporaneously prepared suspension of tadalafil 5 mg/mL in a 1:1 mixture of Ora-Plus and Ora-Sweet was stable for at least 91 days when stored in amber plastic bottles at room temperature.

  13. Stability of extemporaneously prepared moxifloxacin oral suspensions.

    Science.gov (United States)

    Hutchinson, David J; Johnson, Cary E; Klein, Kristin C

    2009-04-01

    The stability of extemporaneously prepared moxifloxacin oral suspensions was studied. An oral suspension of moxifloxacin 20 mg/mL was prepared by thoroughly grinding three 400-mg tablets of moxifloxacin in a glass mortar. Thirty milliliters of Ora-Plus and 30 mL of either Ora-Sweet or Ora-Sweet SF were mixed and added to the powder to make a final volume of 60 mL. Three identical samples of each formulation were prepared and placed in 2-oz amber plastic bottles with child-resistant caps and were stored at room temperature (23-25 degrees C). A 1-mL sample was withdrawn from each of the six bottles with a micropipette immediately after preparation and at 7, 14, 28, 60, and 90 days. After further dilution to an expected concentration of 8 microg/ mL with sample diluent, the samples were assayed in duplicate by stability-indicating high-performance liquid chromatography. Stability was defined as the retention of at least 90% of the initial concentration. At least 99% of the initial moxifloxacin remained throughout the 90-day study period in both preparations. There were no detectable changes in color, odor, taste, and pH and no visible microbial growth in any sample. Extemporaneously compounded suspensions of moxifloxacin 20 mg/mL in a 1:1 mixture of Ora-Plus and Ora-Sweet or Ora-Sweet SF were stable for at least 90 days when stored in 2-oz amber plastic bottles at room temperature.

  14. Stability of extemporaneously prepared glycopyrrolate oral suspensions.

    Science.gov (United States)

    Cober, Mary Petrea; Johnson, Cary E; Sudekum, David; Penprase, Kimberly

    2011-05-01

    The stability of extemporaneously prepared glycopyrrolate 0.5-mg/mL suspensions was evaluated. An oral suspension of glycopyrrolate 0.5 mg/mL was prepared by thoroughly grinding 30 1-mg tablets of glycopyrrolate in a glass mortar. Thirty milliliters of Ora-Plus and 30 mL of either Ora-Sweet or Ora-Sweet SF were mixed and added to the powder to make a final volume of 60 mL. Three identical samples of the formulation were prepared and placed in 2-oz amber plastic bottles with child-resistant caps and stored at room temperature (23-25 °C). A 1-mL sample was withdrawn from each of the three bottles with a micropipette immediately after preparation and 7, 15, 30, 60, and 90 days afterward. After further dilution to an expected concentration of 50 μg/mL with sample diluent, the samples were assayed in duplicate by stability-indicating high-performance liquid chromatography. The samples were visually examined for any color change and evaluated for pH on each day of analysis. Taste evaluations were performed at the beginning and end of the study. Stability was defined as the retention of at least 90% of the initial concentration. At least 95% of the initial glycopyrrolate remained throughout the 90-day study period in both preparations. There were no detectable changes in color, odor, taste, and pH, and no visible microbial growth was observed in any sample. Extemporaneously compounded suspensions of glycopyrrolate 0.5 mg/mL in a 1:1 mixture of Ora-Plus/Ora-Sweet or Ora-Plus/Ora-Sweet SF were stable for at least 90 days when stored in amber plastic bottles at room temperature.

  15. Stability of extemporaneously prepared rifaximin oral suspensions.

    Science.gov (United States)

    Cober, Mary Petrea; Johnson, Cary E; Lee, Jordan; Currie, Kenne

    2010-02-15

    The stability of extemporaneously prepared rifaximin oral suspensions was studied. An oral suspension of rifaximin 20 mg/mL was prepared by thoroughly grinding six 200-mg tablets of rifaximin in a glass mortar. Thirty milliliters of Ora-Plus and 30 mL of either Ora-Sweet or Ora-Sweet SF were mixed and added to the powder to make a final volume of 60 mL. Three identical samples of each formulation were prepared and placed in 2-oz amber plastic bottles with child-resistant caps and were stored at room temperature (23-25 degrees C). A 1-mL sample was withdrawn from each of the six bottles with a micropipette immediately after preparation and at 7, 15, 30, and 60 days. After further dilution to an expected concentration of 20 microg/mL with mobile phase, the samples were assayed in duplicate using stability-indicating high-performance liquid chromatography. The samples were visually examined for any color change and pH was tested on each day of analysis. Stability was determined by evaluating the percentage of the initial concentration remaining at each time point and defined as retention of at least 90% of the initial concentration of rifaximin. At least 99% of the initial rifaximin remained throughout the 60-day study period in both preparations. There were no detectable changes in color, odor, taste, or pH and no visible microbial growth in any sample. Extemporaneously prepared suspensions of rifaximin 20 mg/mL in 1:1 mixtures of Ora-Plus with either Ora-Sweet or Ora-Sweet SF were stable for at least 60 days when stored in 2-oz amber plastic bottles at room temperature.

  16. Development of SCAR (sequence-characterized amplified region) markers as a complementary tool for identification of ginger (Zingiber officinale Roscoe) from crude drugs and multicomponent formulations.

    Science.gov (United States)

    Chavan, Preeti; Warude, Dnyaneshwar; Joshi, Kalpana; Patwardhan, Bhushan

    2008-05-01

    Zingiber officinale Roscoe (common or culinary ginger) is an official drug in Ayurvedic, Indian herbal, Chinese, Japanese, African and British Pharmacopoeias. The objective of the present study was to develop DNA-based markers that can be applied for the identification and differentiation of the commercially important plant Z. officinale Roscoe from the closely related species Zingiber zerumbet (pinecone, bitter or 'shampoo' ginger) and Zingiber cassumunar [cassumunar or plai (Thai) ginger]. The rhizomes of the other two Zingiber species used in the present study are morphologically similar to that of Z. officinale Roscoe and can be used as its adulterants or contaminants. Various methods, including macroscopy, microscopy and chemoprofiling, have been reported for the quality control of crude ginger and its products. These methods are reported to have limitations in distinguishing Z. officinale from closely related species. Hence, newer complementary methods for correct identification of ginger are useful. In the present study, RAPD (random amplification of polymorphic DNA) analysis was used to identify putative species-specific amplicons for Z. officinale. These were further cloned and sequenced to develop SCAR (sequence-characterized amplified region) markers. The developed SCAR markers were tested in several non-Zingiber species commonly used in ginger-containing formulations. One of the markers, P3, was found to be specific for Z. officinale and was successfully applied for detection of Z. officinale from Trikatu, a multicomponent formulation.

  17. Development of a new version of the Liverpool Malaria Model. I. Refining the parameter settings and mathematical formulation of basic processes based on a literature review

    Directory of Open Access Journals (Sweden)

    Jones Anne E

    2011-02-01

    Full Text Available Abstract Background A warm and humid climate triggers several water-associated diseases such as malaria. Climate- or weather-driven malaria models, therefore, allow for a better understanding of malaria transmission dynamics. The Liverpool Malaria Model (LMM is a mathematical-biological model of malaria parasite dynamics using daily temperature and precipitation data. In this study, the parameter settings of the LMM are refined and a new mathematical formulation of key processes related to the growth and size of the vector population are developed. Methods One of the most comprehensive studies to date in terms of gathering entomological and parasitological information from the literature was undertaken for the development of a new version of an existing malaria model. The knowledge was needed to allow the justification of new settings of various model parameters and motivated changes of the mathematical formulation of the LMM. Results The first part of the present study developed an improved set of parameter settings and mathematical formulation of the LMM. Important modules of the original LMM version were enhanced in order to achieve a higher biological and physical accuracy. The oviposition as well as the survival of immature mosquitoes were adjusted to field conditions via the application of a fuzzy distribution model. Key model parameters, including the mature age of mosquitoes, the survival probability of adult mosquitoes, the human blood index, the mosquito-to-human (human-to-mosquito transmission efficiency, the human infectious age, the recovery rate, as well as the gametocyte prevalence, were reassessed by means of entomological and parasitological observations. This paper also revealed that various malaria variables lack information from field studies to be set properly in a malaria modelling approach. Conclusions Due to the multitude of model parameters and the uncertainty involved in the setting of parameters, an extensive

  18. Magnetic suspension - Today's marvel, tomorrow's tool

    Science.gov (United States)

    Lawing, Pierce L.

    1989-01-01

    NASA's Langley facility has through constant advocacy of magnetic suspension systems (MSSs) for wind-tunnel model positioning obtained a technology-development status for the requisite large magnets, computers, automatic control techniques, and apparatus configurations, to contemplate the construction of MSSs for large wind tunnels. Attention is presently given to the prospects for MSSs in wind tunnels employing superfluid helium atmospheres to obtain very high Reynolds numbers, where the MSS can yield substantial enhancements of wind tunnel productivity.

  19. Formulation, Preparation, and Characterization of Polyurethane Foams

    Science.gov (United States)

    Pinto, Moises L.

    2010-01-01

    Preparation of laboratory-scale polyurethane foams is described with formulations that are easy to implement in experiments for undergraduate students. Particular attention is given to formulation aspects that are based on the main chemical reactions occurring in polyurethane production. This allows students to develop alternative formulations to…

  20. A New Approach for Modeling Darrieus-Type Vertical Axis Wind Turbine Rotors Using Electrical Equivalent Circuit Analogy: Basis of Theoretical Formulations and Model Development

    Directory of Open Access Journals (Sweden)

    Pierre Tchakoua

    2015-09-01

    Full Text Available Models are crucial in the engineering design process because they can be used for both the optimization of design parameters and the prediction of performance. Thus, models can significantly reduce design, development and optimization costs. This paper proposes a novel equivalent electrical model for Darrieus-type vertical axis wind turbines (DTVAWTs. The proposed model was built from the mechanical description given by the Paraschivoiu double-multiple streamtube model and is based on the analogy between mechanical and electrical circuits. This work addresses the physical concepts and theoretical formulations underpinning the development of the model. After highlighting the working principle of the DTVAWT, the step-by-step development of the model is presented. For assessment purposes, simulations of aerodynamic characteristics and those of corresponding electrical components are performed and compared.

  1. Controlling active cabin suspensions in commercial vehicles

    NARCIS (Netherlands)

    Evers, W.J.E.; Besselink, I.J.M.; Teerhuis, A.P.; Knaap, van der A.C.M.; Nijmeijer, H.

    2009-01-01

    The field of automotive suspensions is changing. Semi-active and active suspensions are starting to become viable options for vehicle designers. Suspension design for commercial vehicles is especially interesting given its potential. An active cabin suspension for a heavy-duty truck is considered,

  2. Formulation development and optimization of sustained release matrix tablet of Itopride HCl by response surface methodology and its evaluation of release kinetics.

    Science.gov (United States)

    Bose, Anirbandeep; Wong, Tin Wui; Singh, Navjot

    2013-04-01

    The objective of this present investigation was to develop and formulate sustained release (SR) matrix tablets of Itopride HCl, by using different polymer combinations and fillers, to optimize by Central Composite Design response surface methodology for different drug release variables and to evaluate drug release pattern of the optimized product. Sustained release matrix tablets of various combinations were prepared with cellulose-based polymers: hydroxy propyl methyl cellulose (HPMC) and polyvinyl pyrolidine (pvp) and lactose as fillers. Study of pre-compression and post-compression parameters facilitated the screening of a formulation with best characteristics that underwent here optimization study by response surface methodology (Central Composite Design). The optimized tablet was further subjected to scanning electron microscopy to reveal its release pattern. The in vitro study revealed that combining of HPMC K100M (24.65 MG) with pvp(20 mg)and use of LACTOSE as filler sustained the action more than 12 h. The developed sustained release matrix tablet of improved efficacy can perform therapeutically better than a conventional tablet.

  3. "Point de suspension"

    CERN Multimedia

    2004-01-01

    CERN - Globe of Science and Innovation 20 and 21 October Acrobatics, mime, a cappella singing, projections of images, a magical setting... a host of different tools of a grandeur matching that of the Universe they relate. A camera makes a massive zoom out to reveal the multiple dimensions of Nature. Freeze the frame: half way between the infinitesimally small and the infinitesimally large, a man suspends his everyday life (hence the title "Point de Suspension", which refers to the three dots at the end of an uncompleted sentence) to take a glimpse of the place he occupies in the great history of the Universe. An unusual perspective on what it means to be a human being... This wondrous show in the Globe of Science and Innovation, specially created by the Miméscope* company for the official ceremony marking CERN's fiftieth anniversary, is a gift from the Government of the Republic and Canton of Geneva, which also wishes to share this moment of wonder with the local population. There will be three perfo...

  4. "Point de suspension"

    CERN Multimedia

    2004-01-01

    http://www.cern.ch/cern50/ CERN - Globe of Science and Innovation 20 and 21 October Acrobatics, mime, a cappella singing, projections of images, a magical setting... a host of different tools of a grandeur matching that of the Universe they relate. A camera makes a massive zoom out to reveal the multiple dimensions of Nature. Freeze the frame: half way between the infinitesimally small and the infinitesimally large, a man suspends his everyday life (hence the title "Point de Suspension", which refers to the three dots at the end of an uncompleted sentence) to take a glimpse of the place he occupies in the great history of the Universe. An unusual perspective on what it means to be a human being... This wondrous show in the Globe of Science and Innovation, specially created by the Miméscope* company for the official ceremony marking CERN's fiftieth anniversary, is a gift from the Government of the Republic and Canton of Geneva, which also wishes to share this moment of wonder with the local pop...

  5. "Point de suspension"

    CERN Multimedia

    2004-01-01

    CERN - Globe of Science and Innovation 20 and 21 October Acrobatics, mime, a cappella singing, projections of images, a magical setting... a host of different tools of a grandeur matching that of the Universe they relate. A camera makes a massive zoom out to reveal the multiple dimensions of Nature. Freeze the frame: half way between the infinitesimally small and the infinitesimally large, a man suspends his everyday life (hence the title "Point de Suspension", which refers to the three dots at the end of an uncompleted sentence) to take a glimpse of the place he occupies in the great history of the Universe. An unusual perspective on what it means to be a human being... This spectacle in the Globe of Science and Innovation, specially created by the Miméscope* company for the official ceremony marking CERN's fiftieth anniversary, is a gift from the Government of the Republic and Canton of Geneva, which also wishes to share this moment of wonder with the local population. There will be three performances for...

  6. DEVELOPMENT AND VALIDATION OF UPLC METHOD FOR THE SIMULTANEOUS DETERMINATION OF ATORVASTATIN AND EZETIMIBE IN PHARMACEUTICAL FORMULATION

    OpenAIRE

    Sharma Amit Kumar; Dharamsi Abhay

    2012-01-01

    A simple, rapid and accurate UPLC method was developed and validated for estimation of atorvastatin and ezetimibe in combined dosage forms. With the objective of reducing analysis time and maintaining good efficiency in the area of fast chromatographic separations the UPLC has proven to be one of the most promising developments in the area of fast chromatographic separations. In this work a isocratic reverse phase chromatographic method was developed using UPLC for the estimation of atorvasta...

  7. Constraint Embedding for Vehicle Suspension Dynamics

    Directory of Open Access Journals (Sweden)

    Jain Abhinandan

    2016-06-01

    Full Text Available The goal of this research is to achieve close to real-time dynamics performance for allowing auto-pilot in-the-loop testing of unmanned ground vehicles (UGV for urban as well as off-road scenarios. The overall vehicle dynamics performance is governed by the multibody dynamics model for the vehicle, the wheel/terrain interaction dynamics and the onboard control system. The topic of this paper is the development of computationally efficient and accurate dynamics model for ground vehicles with complex suspension dynamics. A challenge is that typical vehicle suspensions involve closed-chain loops which require expensive DAE integration techniques. In this paper, we illustrate the use the alternative constraint embedding technique to reduce the cost and improve the accuracy of the dynamics model for the vehicle.

  8. Submerged cutting characteristics of abrasive suspension jet

    International Nuclear Information System (INIS)

    Shimizu, Seiji; Peng, Guoyi; Oguma, Yasuyuki; Nishikata, Hiroyuki

    2015-01-01

    An abrasive suspension jet (ASJ) formed by propelling abrasive suspension through a nozzle has a greater cutting capability than the conventional abrasive water jet. However the cutting capability of submerged ASJs decreases drastically with increasing the standoff distance and the pressure around the jet. A sheathed nozzle with ventilation for ASJs has been developed as a mean of extending the effective stand-off distance and improving the cutting capabilities under submerged condition. In the present investigation, cutting tests by ASJs in air and under submerged condition are conducted with specimens of aluminum alloy. Air coated ASJs are formed by using a sheathed nozzle with ventilation. The relative cutting depth is defined as the cutting depth under submerged condition divided by the cutting depth in air at the same standoff distance. The relative cutting depth is arranged effectually by the cavitation number based on the cavity pressure measured at the sheath. (author)

  9. Submerged cutting characteristics of abrasive suspension jet

    International Nuclear Information System (INIS)

    Shimizu, Seiji; Peng, Guoyi; Oguma, Yasuyuki; Nishikata, Hiroki

    2015-01-01

    An abrasive suspension jet (ASJ) formed by propelling abrasive suspension through a nozzle has a greater cutting capability than the conventional abrasive water jet. However the cutting capability of submerged ASJs decreases drastically with increasing the standoff distance and the pressure around the jet. A sheathed nozzle nozzle with ventilation for ASJs has been developed as a mean of extending the effective stand-off distance and improving the cutting capabilities under submerged condition. In the present investigation, cutting tests by ASJs in air and under submerged condition are conducted with specimens of aluminum alloy. Air coated ASJs are formed by using a sheathed nozzle with ventilation. The relative cutting depth is defined as the cutting depth is arranged effectually by the cavitation number based on the cavity pressure measured at the sheath. (author)

  10. Vibration Reduction System Using Magnetic Suspension Technology

    Directory of Open Access Journals (Sweden)

    Spychała Jarosław

    2015-01-01

    Full Text Available The article presents considerations concerning the construction of vibration reduction system using magnetic suspension technology. Presents the results of simulation, numerical and experimental the bearingless electric motor, for which successfully used this type of solution. Positive results of research and testing have become the basis for the development of the concept of building this type of active vibration reduction system , at the same time acting as a support for a technical object, which is a jet engine. Bearing failures are manifested by loss or distortion of their mass, which leads to a total destruction of the roller bearing, and thus reflected in the security. The article presents the concept of building active magnetic suspension to eliminate the bearing system of classical rolling bearing and replace it with magnetic bearing.

  11. Development of a lyophilized formulation for preparing the radiopharmaceutical 68Ga-DOTA-Nal3-Octreotide for the diagnosis of tumors of neuroendocrine origin

    International Nuclear Information System (INIS)

    Lorenzo L, G. A.

    2015-01-01

    The present study aimed to develop a radiopharmaceutical consisting of an emitter positrons radionuclide ( 68 Ga) which is used in imaging by positron emission tomography; and a peptide capable of binding to somatostatin receptors subtypes 2, 3 and 5; which together serve as a diagnostic support of tumors of neuroendocrine origin. The peptide characterization DOTA-1-Naphthylalanine 3 -Octreotide (DOTA-NOC) by infrared spectroscopy technique by Fourier transform was performed, in which the principal functional groups belonging to this molecule were identified as well as its identification by UV-Vis spectroscopy. Subsequently, a variance analysis taking into account three different levels of amounts of sodium acetate, and three different levels of amounts of the peptide was performed. These masses were subjected to lyophilization for a period of 21 h; after completion of lyophilization, were labeled with 2 m L of 68 GaCl 3 eluates of a 68 Ge/ 68 Ga ITG generator to determine the percentage of radiochemical purity of the different formulations. It was observed that the ideal formulation must contain 75 μg of peptide and 14 mg of NaOAc, according to studies, was determined that the amount of peptide does not influence the response of radiochemical purity in the same way that the amount of added sodium acetate, which produces different effects on the dependent variable. Finally the radiopharmaceutical formulation was obtained with greater than 95% of radiochemical purity. The validation of the analytical method was performed describing the system accuracy and linearity, specificity and accuracy; linearity and precision of the method, taking into account acceptance criteria based on the guidance of validation of analytical methods published by the National Association of Pharmacists Chemical Biologists of Mexico, A. C.; the parameters evaluated met the specifications given by the guide validation of analytical methods. Uptake and internalization tests of the

  12. Microbial spoilage, instability risk of antacid suspension in the presence of commonly used preservative system.

    Science.gov (United States)

    Khan, Jamshaid Ali; Khan, Imran Ullah; Iqbal, Zafar; Nasir, Fazli; Muhammad, Salar; Hannan, Peer Abdul; Ullah, Irfan

    2015-09-01

    Manifestation of microbial spoilage of any product by bacteria and to assess the effectiveness of the anti-microbial preservatives (parabens) used for the prevention and stability purpose. The aim of the present work is to study the effectiveness of preservatives used in the antacid suspensions and to analyze the effect of microbial growth on the quality of respective antacid suspensions. Samples of various antacid suspensions were randomly collected from local market and Government hospital pharmacies. Three different antacid formulations were prepared in the laboratory. All the formulations were preliminarily evaluated on the basis of organoleptic characteristics, pH, viscosity and assay. Efficacy of the preservative system in suspension formulation was determined by inoculating the samples in its final container, with specific strains of bacteria i.e. Escherichia coli ATCC 8739, Pseudomonas aeruginosa ATCC 9027 and Staphylococcus aureus ATCC 6538, taking samples from the inoculated preparation at specified intervals of time i.e. 0 time, 07 days, 14 days and 28 days, growing it on nutrient agar medium and colony forming units (CFUs) were scored by plate count. At the same time the samples were also subjected to qualitative and quantitative testing. The decrease in CFU and alteration in assay, pH and viscosity was observed in all the formulations except formulation M2 and F3 that showed stability throughout the study period.

  13. Optimal Vibration Control for Tracked Vehicle Suspension Systems

    Directory of Open Access Journals (Sweden)

    Yan-Jun Liang

    2013-01-01

    Full Text Available Technique of optimal vibration control with exponential decay rate and simulation for vehicle active suspension systems is developed. Mechanical model and dynamic system for a class of tracked vehicle suspension vibration control is established and the corresponding system of state space form is described. In order to prolong the working life of suspension system and improve ride comfort, based on the active suspension vibration control devices and using optimal control approach, an optimal vibration controller with exponential decay rate is designed. Numerical simulations are carried out, and the control effects of the ordinary optimal controller and the proposed controller are compared. Numerical simulation results illustrate the effectiveness of the proposed technique.

  14. An integrated, quality by design (QbD) approach for design, development and optimization of orally disintegrating tablet formulation of carbamazepine.

    Science.gov (United States)

    Mishra, Saurabh M; Rohera, Bhagwan D

    2017-11-01

    The objective of the present study was to design and develop a formulation for orally disintegrating tablets (ODTs) of carbamazepine using quality by design principles. The target product profile (TPP) and quality target product profile (QTPP) of ODTs were identified. Risk assessment was carried out by leveraging prior knowledge and experience to define the criticality of factors based on their impact by Ishikawa fishbone diagram and preliminary hazard analysis tool. Box-Behnken response surface methodology was used to study the effect of critical factors on various attributes of ODTs. The independent factors selected were compression pressure (X 1 ), concentration of sublimating agent (volatile material) (X 2 ), disintegrant concentration (X 3 ) and the responses were tablet crushing strength, tablet porosity, disintegration time, water absorption time, tablet friability and drug dissolution. ANOVA and lack of fit test illustrated that selected independent variables had significant effect on the response variables, and excellent correlation was observed between actual and predicted values. Optimization by desirability function indicated that compression pressure, X 1 (1534 lbs), ammonium bicarbonate concentration, X 2 (7.68%) and Kollidon ® CL-SF concentration, X 3 (6%) were optimum to prepare ODT formulation of carbamazepine of desired attributes complying with QTPP. Thus, in the present study, a high level of assurance was established for ODT product quality and performance.

  15. Development and Validation of a Precise Method for Determination of Benzalkonium Chloride (BKC Preservative, in Pharmaceutical Formulation of Latanoprost Eye Drops

    Directory of Open Access Journals (Sweden)

    J. Mehta

    2010-01-01

    Full Text Available A simple and precise reversed phase high performance liquid chromatographic method has been developed and validated for the quantification of benzalkonium chloride (BKC preservative in pharmaceutical formulation of latanoprost eye drops. The analyte was chromatographed on a Waters Spherisorb CN, (4.6×250 mm column packed with particles of 5 μm. The mobile phase, optimized through an experimental design, was a 40:60 (v/v mixture of potassium dihydrogen orthophosphate buffer (pH 5.5 and acetonitrile, pumped at a flow rate of 1.0 mL/min at maintaining column temperature at 30 °C. Maximum UV detection was achieved at 210 nm. The method was validated in terms of linearity, repeatability, intermediate precision and method accuracy. The method was shown to be robust, resisting to small deliberate changes in pH, flow rate and composition (organic ratio of the mobile phase. The method was successfully applied for the determination of BKC in a pharmaceutical formulation of latanoprost ophthalmic solution without any interference from common excipients and drug substance. All the validation parameters were within the acceptance range, concordant to ICH guidelines.

  16. Development and Validation of a Precise and Stability Indicating LC Method for the Determination of Benzalkonium Chloride in Pharmaceutical Formulation Using an Experimental Design

    Directory of Open Access Journals (Sweden)

    Harshal K. Trivedi

    2010-01-01

    Full Text Available A simple, precise, shorter runtime and stability indicating reverse-phase high performance liquid chromatographic method has been developed and validated for the quantification of benzalkonium chloride (BKC preservative in pharmaceutical formulation of sparfloxacin eye drop. The method was successfully applied for determination of benzalkonium chloride in various ophthalmic formulations like latanoprost, timolol, dexametasone, gatifloxacin, norfloxacin, combination of moxifloxacin and dexamethasone, combination of nepthazoline HCl, zinc sulphate and chlorpheniramine maleate, combination of tobaramycin and dexamethasone, combination of phenylephrine HCl, naphazoline HCl, menthol and camphor. The RP-LC separation was achieved on an Purospher Star RP-18e 75 mm × 4.0 mm, 3.0 μ in the isocratic mode using buffer: acetonitrile (35: 65, v/v, as the mobile phase at a flow rate of 1.8 mL/min. The methods were performed at 215 nm; in LC method, quantification was achieved with PDA detection over the concentration range of 50 to 150 μg/mL. The method is effective to separate four homologs with good resolution in presence of excipients, sparfloxacin and degradable compound due to sparfloxacin and BKC within five minutes. The method was validated and the results were compared statistically. They were found to be simple, accurate, precise and specific. The proposed method was validated in terms of specificity, precision, recovery, solution stability, linearity and range. All the validation parameters were within the acceptance range and concordant to ICH guidelines.

  17. Usnea barbata CO2-supercritical extract in alkyl polyglucoside-based emulsion system: contribution of Confocal Raman imaging to the formulation development of a natural product.

    Science.gov (United States)

    Zugic, Ana; Lunter, Dominique Jasmin; Daniels, Rolf; Pantelic, Ivana; Tasic Kostov, Marija; Tadic, Vanja; Misic, Dusan; Arsic, Ivana; Savic, Snezana

    2016-08-01

    Topical treatment of skin infections is often limited by drawbacks related to both antimicrobial agents and their vehicles. In addition, considering the growing promotion of natural therapeutic products, our objective was to develop and evaluate naturally-based emulsion system, as prospective topical formulation for skin infections-treatment. Therefore, alkyl polyglucoside surfactants were used for stabilization of a vehicle serving as potential carrier for supercritical CO2-extract of Usnea barbata, lichen with well-documented antimicrobial activity, incorporated using two protocols and three concentrations. Comprehensive physicochemical characterization suggested possible involvement of extract's particles in stabilization of the investigated system. Raman spectral imaging served as the key method in disclosing extract's particles potential to participate in the microstructure of the tested emulsion system via three mechanisms: (1) particle-particle aggregation, (2) adsorption at the oil-water interface and (3) hydrophobic particle-surfactant interactions. Stated extract-vehicle interaction proved to be correlated to the preparation procedure and extract concentration on one hand and to affect the physicochemical and biopharmaceutical features of investigated system, on the other hand. Thereafter, formulation with the best preliminary stability and liberation profile was selected for further efficiency and in vivo skin irritation potential evaluation, implying pertinent in vitro antimicrobial activity against G+ bacteria and overall satisfying preliminary safety profile.

  18. Neonates need tailored drug formulations.

    Science.gov (United States)

    Allegaert, Karel

    2013-02-08

    Drugs are very strong tools used to improve outcome in neonates. Despite this fact and in contrast to tailored perfusion equipment, incubators or ventilators for neonates, we still commonly use drug formulations initially developed for adults. We would like to make the point that drug formulations given to neonates need to be tailored for this age group. Besides the obvious need to search for active compounds that take the pathophysiology of the newborn into account, this includes the dosage and formulation. The dosage or concentration should facilitate the administration of low amounts and be flexible since clearance is lower in neonates with additional extensive between-individual variability. Formulations need to be tailored for dosage variability in the low ranges and also to the clinical characteristics of neonates. A specific focus of interest during neonatal drug development therefore is a need to quantify and limit excipient exposure based on the available knowledge of their safety or toxicity. Until such tailored vials and formulations become available, compounding practices for drug formulations in neonates should be evaluated to guarantee the correct dosing, product stability and safety.

  19. Drug delivery and formulations.

    Science.gov (United States)

    Breitkreutz, Jörg; Boos, Joachim

    2011-01-01

    Paediatric drug delivery is a major challenge in drug development. Because of the heterogeneous nature of the patient group, ranging from newborns to adolescents, there is a need to use appropriate excipients, drug dosage forms and delivery devices for different age groups. So far, there is a lack of suitable and safe drug formulations for children, especially for the very young and seriously ill patients. The new EU legislation will enforce paediatric clinical trials and drug development. Current advances in paediatric drug delivery include interesting new concepts such as fast-dissolving drug formulations, including orodispersible tablets and oral thin strips (buccal wafers), and multiparticulate dosage forms based on mini-tabletting or pelletization technologies. Parenteral administration is likely to remain the first choice for children in the neonatal period and for emergency cases. Alternative routes of administration include transdermal, pulmonary and nasal drug delivery systems. A few products are already available on the market, but others still need further investigations and clinical proof of concept.

  20. NUMERICAL RESEARCH ON THE THREE-DIMENSIONAL FIBER ORIENTATION DISTRIBUTION IN PLANAR SUSPENSION FLOWS

    Directory of Open Access Journals (Sweden)

    Qihua Zhang

    Full Text Available Abstract To describe flow-induced fiber orientation, the Fokker-Planck equation is widely applied in the processing of composites and fiber suspensions. The analytical solution only exists when the Péclet number is infinite. So developing a numerical method covering a full range of Péclet number is of great significance. To accurately solve the Fokker-Planck equation, a numerical scheme based on the finite volume method is developed. Using spherical symmetry, the boundary is discretized and formulated into a cyclic tridiagonal matrix which is further solved by the CTDMA algorithm. To examine its validity, benchmark tests over a wide range of Péclet number are performed in a simple shear flow. For Pe=∞, the results agree well with the analytical solutions. For the other Pe numbers, the results are compared to results available in the literature. The tests show that this algorithm is accurate, stable, and globally conservative. Furthermore, this algorithm can be extended and used to predict the three-dimensional orientation distribution of complex suspension flows.

  1. Bioequivalence assessment of two formulations of ibuprofen

    KAUST Repository

    Al-Talla, Zeyad

    2011-10-19

    Background: This study assessed the relative bioavailability of two formulations of ibuprofen. The first formulation was Doloraz , produced by Al-Razi Pharmaceutical Company, Amman, Jordan. The second forumulation was Brufen , manufactured by Boots Company, Nottingham, UK. Methods and results: A prestudy validation of ibuprofen demonstrated long-term stability, freeze-thaw stability, precision, and accuracy. Twenty-four healthy volunteers were enrolled in this study. After overnight fasting, the two formulations (test and reference) of ibuprofen (100 mg ibuprofen/5 mL suspension) were administered as a single dose on two treatment days separated by a one-week washout period. After dosing, serial blood samples were drawn for a period of 14 hours. Serum harvested from the blood samples was analyzed for the presence of ibuprofen by high-pressure liquid chromatography with ultraviolet detection. Pharmacokinetic parameters were determined from serum concentrations for both formulations. The 90% confidence intervals of the ln-transformed test/reference treatment ratios for peak plasma concentration and area under the concentration-time curve (AUC) parameters were found to be within the predetermined acceptable interval of 80%-125% set by the US Food and Drug Administration. Conclusion: Analysis of variance for peak plasma concentrations and AUC parameters showed no significant difference between the two formulations and, therefore, Doloraz was considered bioequivalent to Brufen. 2011 Al-Talla et al, publisher and licensee Dove Medical Press Ltd.

  2. DEVELOPMENT OF FORMULATION AND TECHNOLOGY FOR THE POLY[3-(3,4-DIHYDROXYPHENYL)GLYCERIC ACID] GEL.

    Science.gov (United States)

    Gokadze, S; Barbakadze, V; Mulkijanyan, K; Bakuridze, L; Bakuridze, A

    2017-01-01

    One of the most actual problems of pharmacy is the development of medication forms for external application with complex effects on (gel, emplastro, aerosol, etc.) skin wounds, burns and inflammatory factors. The centuries-old practice of using phyto-preparations (herbal remedies) proved that they have fewer side effects in comparison with synthetic drugs. Despite the wide application of herbal preparations, in the literature there is a little information about their application in development of wound and burn healing modern dosage forms. Among the medicinal plants with the mentioned pharmacological actions, comfrey (Symphytum L.) should be distinguished. Phenolic polymer poly[3-(3,4-dihydroxyphenyl)glyceric acid] (PDGA) or poly[oxy-1-carboxy-2-(3,4-dihydroxyphenyl)ethylene], amounting approximately 25% of polysaccharides and 1.5-2.5% of dry plant material, were isolated from the roots and stems of Caucasian comfrey species (S. asperum, S. caucasicum). Contrary to polysaccharides this phenolic polymer of Comfrey appeared to have a high immunomodulatory (anticomplement), antioxidative, antilipoperoxidantive, anti-inflammatory and wound-healing efficacy/activities. The aim of the study was development of the composition and technology of PDGA-containing gel. According to the results of complex biopharmaceutical studies PDGA gel optimal composition has been proved. The technological scheme for preparation of PDGA gel has been developed. PDGA gel stability under normal conditions of storage at +40С was studied. The gel has a shelf life (determined expiration date) of 2 year.

  3. Development of a bone-targeted pH-sensitive liposomal formulation containing doxorubicin: physicochemical characterization, cytotoxicity, and biodistribution evaluation in a mouse model of bone metastasis

    Directory of Open Access Journals (Sweden)

    Ferreira DS

    2016-08-01

    Full Text Available Diêgo dos Santos Ferreira,1,2 Samilla Dornelas Faria,1 Sávia Caldeira de Araújo Lopes,1 Cláudia Salviano Teixeira,1 Angelo Malachias,3 Rogério Magalhães-Paniago,3 José Dias de Souza Filho,4 Bruno Luis de Jesus Pinto Oliveira,2 Alexander Ramos Guimarães,2 Peter Caravan,2 Lucas Antônio Miranda Ferreira,1 Ricardo José Alves,1 Mônica Cristina Oliveira1 1Department of Pharmaceutical Products, Faculty of Pharmacy,Universidade Federal de Minas Gerais, Belo Horizonte, Minas Gerais, Brazil; 2Athinoula A Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA; 3Department of Physics, 4Department of Chemistry, Institute of Exact Sciences, Universidade Federal de Minas Gerais, Belo Horizonte, Brazil Background: Despite recent advances in cancer therapy, the treatment of bone tumors remains a major challenge. A possible underlying hypothesis, limitation, and unmet need may be the inability of therapeutics to penetrate into dense bone mineral, which can lead to poor efficacy and high toxicity, due to drug uptake in healthy organs. The development of nanostructured formulations with high affinity for bone could be an interesting approach to overcome these challenges.Purpose: To develop a liposomal formulation with high affinity for hydroxyapatite and the ability to release doxorubicin (DOX in an acidic environment for future application as a tool for treatment of bone metastases.Materials and methods: Liposomes were prepared by thin-film lipid hydration, followed by extrusion and the sulfate gradient-encapsulation method. Liposomes were characterized by average diameter, ζ-potential, encapsulation percentage, X-ray diffraction, and differential scanning calorimetry. Release studies in buffer (pH 7.4 or 5, plasma, and serum, as well as hydroxyapatite-affinity in vitro analysis were performed. Cytotoxicity was evaluated by MTT assay against the MDA-MB-231 cell line, and biodistribution was

  4. A comprehensive approach to formulation of seaweed-enriched meat products: From technological development to assessment of healthy properties.

    Science.gov (United States)

    Cofrades, S; Benedí, J; Garcimartin, A; Sánchez-Muniz, F J; Jimenez-Colmenero, F

    2017-09-01

    Meat consumption is influenced by various kinds of factors, among them health implications. Different strategies can be effective in developing meat-based functional foods. These basically entail reducing the presence of compounds with negative health implications and enhancing the presence of beneficial compounds. This article reviews a comprehensive model for the development of meat-based functional foods based on a presentation of the research achieved in terms of the design and development of qualitatively and quantitatively modified meat products (frankfurters, patties and restructured steaks). These were reformulated to incorporate nutrients associated with three different seaweeds (wakame-Undaria pinnatifida; nori-Porphyra umbilicalis; and sea spaghetti-Himanthalia elongata) as sources of bioactive substances, while simultaneously reducing sodium and fat and improving fatty acid profiles. Those seaweeds were chosen, because in terms of composition and health implications, abundance on Spanish coasts, relatively widespread consumption, and suitability in terms of flavour and colour they are better suited than others for use as ingredients in new products. It also discusses the consequences of the use of this type of meat-based functional foods (combination of pork meat and 5% of each seaweed with or without hypercholesterolaemic agent included in the diets) on growing animals (Wistar male rats), and their effects on different aspects of lipoprotein metabolism, oxidative stress and liver structure. This article, then, reports a comprehensive approach to the production of seaweed-enriched meat products, considering aspects of technological development aimed at achieving the functional effect. Copyright © 2016 Elsevier Ltd. All rights reserved.

  5. The development of a new process for gentle drying, micronisation and formulation of a high viscous biopoymer

    OpenAIRE

    Reibe, Christian

    2011-01-01

    Biopolymers are characterised by their biodegradable behaviour in certain environments. Especially the development of natural biopolymers from renewable resources is gathering increasing interest in the scientific as well as in the industrial sectors . Since Biopolymers may be tailored to specific requirements, the encapsulation of pharmaceutical compounds or flavours in biopolymers would open wide avenues for the production of controlled- release systems. Most common mechanical pulverisation...

  6. Development of Nano-Liposomal Formulations of Epidermal Growth Factor Receptor Inhibitors and their Pharmacological Interactions on Drug-Sensitive and Drug-Resistant Cancer Cell Lines

    Science.gov (United States)

    Trummer, Brian J.

    A rapidly expanding understanding of molecular derangements in cancer cell function has led to the development of selective, targeted chemotherapeutic agents. Growth factor signal transduction networks are frequently activated in an aberrant fashion, particularly through the activity of receptor tyrosine kinases (RTK). This has spurred an intensive effort to develop receptor tyrosine kinase inhibitors (RTKI) that are targeted to specific receptors, or receptor subfamilies. Chapter 1 reviews the pharmacology, preclinical, and clinical aspects of RTKIs that target the epidermal growth factor receptor (EGFR). EGFR inhibitors demonstrate significant success at inhibiting phosphorylation-based signaling pathways that promote cancer cell proliferation. Additionally RTKIs have physicochemical and structural characteristics that enable them to function as inhibitors of multi-drug resistance transport proteins. Thus EGFR inhibitors and other RTKIs have both on-target and off-target activities that could be beneficial in cancer therapy. However, these agents exert a number of side effects, some of which arise from their hydrophobic nature and large in vivo volume of distribution. Side effects of the EGFR inhibitor gefitinib include skin rash, severe myelotoxicity when combined with certain chemotherapeutic agents, and impairment of the blood brain barrier to xenobiotics. Weighing the preclinical and clinical observations with the EGFR inhibitors, we developed the primary overall hypothesis of this research: that drug-carrier formulations of RTKIs such as the EGFR inhibitors could be developed based on nanoparticulate liposomal carriers. Theoretically, this carrier strategy would ameliorate toxicity and improve the biodistribution and tumor selectivity of these agents. We hypothesized specifically that liposomal formulations could shift the biodistribution of EGFR inhibitors such as gefitinib away from skin, bone marrow, and the blood brain barrier, and toward solid tumors

  7. An observational study of the effect of vibration on the caking of suspensions in oily vehicles.

    Science.gov (United States)

    Jain, Rohit; Bork, Olaf; Alawi, Fadil; Nanjan, Karthigeyan; Tucker, Ian G

    2016-11-30

    An oily suspension of penethamate (PNT) that was physically stable on storage, caked solidly during road/air transport. This paper reports on the caking behaviour of PNT oily suspension formulations exposed to vibrations in a lab-based test designed to simulate road/air transport. The lab-test was used to study the effects of container type (glass v PET) and formulation (oil, surfactant type and concentration) on the physical stability of suspension under vibration. Redispersibility of the sediment was lower at longer vibrations times and at higher intensity of vibration. Caking on vibration was strongly influenced by the type of container (caking in glass but not in PET) possibly due to tribo-charging of particles. Caking on vibration was dependent on the formulation: type and concentration of surfactant; type of oil. The physical stability of oily suspensions, and the effect of vibration are two areas which have been largely neglected in the pharmaceutical literature. This paper discusses some potential mechanisms for the observations but studies using fully characterised materials are required. Finally we conclude that static testing of physical stability of oily suspensions is not sufficient and that a vibrational stress test is required. Copyright © 2016 Elsevier B.V. All rights reserved.

  8. Analysis of Train Suspension System Using MR dampers

    Science.gov (United States)

    RamaSastry, DVA; Ramana, K. V.; Mohan Rao, N.; Siva Kumar, SVR; Priyanka, T. G. L.

    2016-09-01

    This paper deals with introducing MR dampers to the Train Suspension System for improving the ride comfort of the passengers. This type of suspension system comes under Semi-active suspension system which utilizes the properties of MR fluid to damp the vibrations. In case of high speed trains, the coach body is subjected to vibrations due to vertical displacement, yaw and pitch movements. When the body receives these disturbances from the ground,the transmission of vibrations to the passenger increases which affect the ride comfort. In this work, the equations of motion of suspension system are developed for both conventional passive system and semi-active system and are modelled in Matlab/Simulink and analysis has been carried out. The passive suspension system analysis shows that it is taking more time to damp the vibrations and at the same time the transmissibility of vibrations is more.Introducing MR dampers,vertical and angular displacements of the body are computed and compared. The results show that the introduction of MR dampers into the train suspension system improves ride comfort.

  9. Clay-cement suspensions - rheological and functional properties

    Science.gov (United States)

    Wojcik, L.; Izak, P.; Mastalska-Poplawska, J.; Gajek, M.

    2017-01-01

    The piping erosion in soil is highly unexpected in civil engineering. Elimination of such damages is difficult, expensive and time-consuming. One of the possibility is the grouting method. This method is still developed into direction of process automation as well as other useful properties of suspensions. Main way of modernization of the grouting method is connected it with rheology of injection and eventuality of fitting them to specific problems conditions. Very popular and useful became binders based on modified clays (clay-cement suspensions). Important principle of efficiency of the grouting method is using of time-dependent pseudothixotropic properties of the clay-cement suspensions. The pseudo-rheounstability aspect of the suspensions properties should be dedicated and fitted to dynamic changes of soil conditions destructions. Whole process of the modification of the suspension rheology is stimulated by the specific agents. This article contains a description of practical aspects of the rheological parameters managing of the clay-cement suspensions, dedicated to the building damages, hydrotechnic constructions etc.

  10. Formulations development for improving the classification of ceramic tile manufactured in the Sergipe state - part one: mineralogical characterization

    International Nuclear Information System (INIS)

    Goes, J.R.; Azevedo, T.F.; Barreto, L.S.

    2011-01-01

    The ceramic tiles manufactured in Sergipe State are classified in Absorption 'BIIb' Group. Studies have been developed to obtain the classification 'BIIa' Group. This first part is about the mineralogical characterization of raw materials used for ceramics tiles, collected for three different fields. The mineralogical characterization was made with: X-ray Diffraction, Infrared, Thermogravimetric and Differential Thermal Analysis, and was also obtained clays plasticity indices. The samples were heated up to 500 deg C, 900° C and 1100° C. Clays were classified as highly plastics and moderately plastics with a large number of grain with size order smaller than 0,074 mm. The main minerals identified were: kaolinite, illite, montmorillonite, quartz, feldspar and calcite. Two of the three studied fields had high calcite content. The Calcite retards the sintering process causing higher porosity to the ceramic tiles. (author)

  11. Ether formulations of relativity

    International Nuclear Information System (INIS)

    Duffy, M.C.

    1980-01-01

    Contemporary ether theories are surveyed and criticised, especially those formally identical to orthodox Relativity. The historical development of Relativity, Special and General, in terms of an ether, is briefly indicated. Classical interpretations of Generalized Relativity using ether are compared to Euclidean formulations using a background space. The history of a sub-group of theories, formulating a 'new' Relativity involving modified transforms, is outlined. According to the theory with which they agree, recent supposed detections of drift are classified and criticised. Cosmological evidence suggesting an ether is mentioned. Only ether theories formally identical to Relativity have been published in depth. They stand criticised as being contrary to the positivist spirit. The history of mechanical analogues is traced, from Hartley's representing gravitating matter as spherical standing waves, to recent suggestions that vortex-sponge might model electromagnetic, quantum, uncertainty and faster-than-light phenomena. Contemporary theories are particular physical theories, themselves 'second interpretations' of a primary mathematical model. Mechanical analogues are auxiliary, not necessary, to other theory, disclosing relationships between classical and non-classical descriptions of assemblies charging state. The ether-relativity polemic, part of a broader dispute about relativity, is founded on mistaken conceptions of the roles of mathematical and physical models, mechanical analogues; and a distored view of history, which indicates that ether theories have become relativistic. (author)

  12. Development of Tablet Formulation of Amorphous Solid Dispersions Prepared by Hot Melt Extrusion Using Quality by Design Approach.

    Science.gov (United States)

    Agrawal, Anjali; Dudhedia, Mayur; Deng, Weibin; Shepard, Kevin; Zhong, Li; Povilaitis, Edward; Zimny, Ewa

    2016-02-01

    The objective of the study was to identify the extragranular component requirements (level and type of excipients) to develop an immediate release tablet of solid dispersions prepared by hot melt extrusion (HME) process using commonly used HME polymers. Solid dispersions of compound X were prepared using polyvinyl pyrrolidone co-vinyl acetate 64 (PVP VA64), Soluplus, and hypromellose acetate succinate (HPMCAS-LF) polymers in 1:2 ratio by HME through 18 mm extruder. A mixture design was employed to study effect of type of polymer, filler (microcrystalline cellulose (MCC), lactose, and dicalcium phosphate anhydrous (DCPA)), and disintegrant (Crospovidone, croscarmellose sodium, and sodium starch glycolate (SSG)) as well as level of extrudates, filler, and disintegrant on tablet properties such as disintegration time (DT), tensile strength (TS), compactibility, and dissolution. Higher extrudate level resulted in longer DT and lower TS so 60-70% was the maximum amount of acceptable extrudate level in tablets. Fast disintegration was achieved with HPMCAS-containing tablets, whereas Soluplus- and PVP VA64-containing tablets had higher TS. Crospovidone and croscarmellose sodium were more suitable disintegrant than SSG to achieve short DT, and MCC was a suitable filler to prepare tablets with acceptable TS for each studied HME polymer. The influence of extragranular components on dissolution from tablets should be carefully evaluated while finalizing tablet composition, as it varies for each HME polymer. The developed statistical models identified suitable level of fillers and disintegrants for each studied HME polymer to achieve tablets with rapid DT (tablet porosity), and their predictivity was confirmed by conducting internal and external validation studies.

  13. Summary of the National Institute of Child Health and Human Development-best pharmaceuticals for Children Act Pediatric Formulation Initiatives Workshop-Pediatric Biopharmaceutics Classification System Working Group.

    Science.gov (United States)

    Abdel-Rahman, Susan M; Amidon, Gordon L; Kaul, Ajay; Lukacova, Viera; Vinks, Alexander A; Knipp, Gregory T

    2012-11-01

    The Biopharmaceutics Classification System (BCS) allows compounds to be classified based on their in vitro solubility and intestinal permeability. The BCS has found widespread use in the pharmaceutical community to be an enabling guide for the rational selection of compounds, formulation for clinical advancement, and generic biowaivers. The Pediatric Biopharmaceutics Classification System (PBCS) Working Group was convened to consider the possibility of developing an analogous pediatric-based classification system. Because there are distinct developmental differences that can alter intestinal contents, volumes, permeability, and potentially biorelevant solubilities at different ages, the PBCS Working Group focused on identifying age-specific issues that need to be considered in establishing a flexible, yet rigorous PBCS. We summarized the findings of the PBCS Working Group and provided insights into considerations required for the development of a PBCS. Through several meetings conducted both at The Eunice Kennedy Shriver National Institute of Child Health, Human Development-US Pediatric Formulation Initiative Workshop (November 2011) and via teleconferences, the PBCS Working Group considered several high-level questions that were raised to frame the classification system. In addition, the PBCS Working Group identified a number of knowledge gaps that need to be addressed to develop a rigorous PBCS. It was determined that for a PBCS to be truly meaningful, it needs to be broken down into several different age groups that account for developmental changes in intestinal permeability, luminal contents, and gastrointestinal (GI) transit. Several critical knowledge gaps were identified, including (1) a lack of fully understanding the ontogeny of drug metabolizing enzymes and transporters along the GI tract, in the liver, and in the kidney; (2) an incomplete understanding of age-based changes in the GI, liver, and kidney physiology; (3) a clear need to better understand

  14. Capacity Development and Strengthening for Energy Policy formulation and implementation of Sustainable Energy Projects in Indonesia CASINDO. Deliverable No. 27. Biogas Construction Plan in Segoroyoso Village Yogyakarta Region

    Energy Technology Data Exchange (ETDEWEB)

    Lesmana, Surya Budi; Putra, Sri Atmaja [Muhammadiyah University of Yogyakarta, Yogyakarta (Indonesia)

    2011-10-15

    The overall objective of the CASINDO programme is to establish a self-sustaining and self-developing structure at both the national and regional level to build and strengthen human capacity to enable the provinces of North Sumatra, Yogyakarta, Central Java, West Nusa Tenggara (WNT) and Papua to formulate sound policies for renewable energy and energy efficiency and to develop and implement sustainable energy projects. To achieve the CASINDO objective seven Technical Working Groups have been established with the aim to conduct the technical activities under the various work packages and to produce the agreed deliverables. This report presents results from Technical Working Group IV on Renewable Energy project development. Its main aims were: To identify suitable non-hydro RE projects that can be developed in the province; To conduct an energy needs assessment in a selected location; To develop a business plan for a proposed solution to the identified main energy problem of the target community; To identify potential investors; To construct the project.

  15. Development and stability evaluation of water-in-edible oils emulsions formulated with the incorporation of hydrophilic Hibiscus sabdariffa extract.

    Science.gov (United States)

    Pimentel-Moral, Sandra; Rodríguez-Pérez, Celia; Segura-Carretero, Antonio; Martínez-Férez, Antonio

    2018-09-15

    New functional oils (extra virgin olive oil, EVOO and sunflower oil, SO) containing antioxidants from Hibiscus sabdariffa extract were developed by W/O emulsion. Their physical and chemical stability was measured over time. The lowest coalescence rate was obtained with 8 and 12 wt% surfactant amount for EVOO and SO emulsions, respectively. Before the evaluation of the oxidative stability, an optimization of phenolic compounds extraction from emulsions by multi-response surface methodology was performed. EVOO emulsions were chemically more stable over time than SO emulsions in terms of total phenolic content (TPC), antioxidant activity and chemical composition measured by HPLC-ESI.TOF-MS. TPC significantly increased (from 2.02 ± 0.07 to 2.71 ± 0.06 mg Eq GAE/g extract) and the antioxidant activity measured by TEAC remained constant for 1 month of storage. Thus, W/O emulsion technology has proven to be a potential method to vehiculize and stabilize bioactive compounds from H. sabdariffa into edible oils. Copyright © 2018 Elsevier Ltd. All rights reserved.

  16. The development and evaluation of ultrasound for the treatment of bacterial suspensions. A study of frequency, power and sonication time on cultured Bacillus species.

    Science.gov (United States)

    Joyce, E; Phull, S S; Lorimer, J P; Mason, T J

    2003-10-01

    Some species of bacteria produce colonies and spores which agglomerate in spherical clusters (Bacillus subtilis) and this serves as a protection for the organisms inside against biocidal attack. Flocs of fine particles e.g. clay can entrap bacteria which can also protect them against the biocides. It is because of problems such as these that alternative methods of disinfecting water are under active investigation. One such method is the use of power ultrasound, either alone or in combination with other methods. Ultrasound is able to inactivate bacteria and deagglomerate bacterial clusters or flocs through a number of physical, mechanical and chemical effects arising from acoustic cavitation. The aim of this study was to investigate the effect of power ultrasound at different powers and frequencies on Bacillus subtilis. Viable plate count techniques were used as a measure of microbial activity. Results showed a significant increase in percent kill for Bacillus species with increasing duration of exposure and intensity of ultrasound in the low-kilohertz range (20 and 38 kHz). Results obtained at two higher frequencies (512 and 850 kHz) indicated a significant increase in bacteria count suggesting declumping. In assessing the bacterial kill with time under different sonication regimes three types of behaviour were characterized: High power ultrasound (lower frequencies) in low volumes of bacterial suspension results in a continuous reduction in bacterial cell numbers i.e. the kill rate predominates. High power ultrasound (lower frequencies) in larger volumes results in an initial rise in cell numbers suggesting declumping of the bacteria but this initial rise then falls as the declumping finishes and the kill rate becomes more important. Low intensity ultrasound (higher frequencies) gives an initial rise in cell numbers as a result of declumping. The kill rate is low and so there is no significant subsequent decrease in bacterial cell numbers.

  17. Development of a nanostructured lipid carrier formulation for increasing photo-stability and water solubility of Phenylethyl Resorcinol

    International Nuclear Information System (INIS)

    Fan, Hengfeng; Liu, Guoqing; Huang, Yiqing; Li, Yan; Xia, Qiang

    2014-01-01

    The Phenylethyl Resorcinol loaded nanostructured lipid carrier (PR-NLC) was developed by hot high-pressure homogenization method. The freshly prepared PR-NLC showed a spherical morphology under transmission electron microscope, and the particle size was 218.3 ± 9.2 nm. The value of the zeta potential of PR-NLC decreased from −30.2 ± 1.9 mV to −64.9 ± 1.3 mV when the dilution times reach 10. The loading amount of PR encapsulated in NLC was 2.94 ± 0.03%, and the average entrapment efficiencies of PR-NLC determinated by size exclusion chromatography and ultrafiltration were 90.2 ± 0.6% and 98.3 ± 0.3%. Lyophilization was proved feasible for the storage of NLC dispersion. Fourier transform infrared spectra (FTIR) was exploited to investigate the possible drug–lipid complex formation. Advancements in water solubility of PR were demonstrated by NLC using a contact angle measurement. The hemolysis percentage of the NLC was less than 1.3% in a certain range of concentration. In 90 days’ storage, 88.6 ± 2.8% of PR remained unchanged in PR-NLC under natural daylight. In vitro release studies revealed a sustained drug release, and in vitro penetration studies showed an increase of retention amount of PR in the skin, when applying PR-NLC. Therefore, the NLC might be a potential delivery vehicle in cosmetic dermal products.

  18. Euphorbia denticulata Lam.: A promising source of phyto-pharmaceuticals for the development of novel functional formulations.

    Science.gov (United States)

    Zengin, Gokhan; Uysal, Ahmet; Aktumsek, Abdurrahman; Mocan, Andrei; Mollica, Adriano; Locatelli, Marcello; Custodio, Luisa; Neng, Nuno R; Nogueira, José M F; Aumeeruddy-Elalfi, Zaahira; Mahomoodally, M Fawzi

    2017-03-01

    In this study, Methanolic extracts of Euphorbia denticulata parts (flowers, leaf, stem, and mix of aerial parts) were assessed for a panoply of bioactivities. Inhibitory potential against key enzymes involved in diabetes (α-glucosidase and α-amylase), obesity (pancreatic lipase), neurodegenerative diseases (cholinesterases), and hyperpigmentation (tyrosinase) was evaluated. The antioxidant and antibacterial properties were also assessed. The total phenolic, flavonoid, and phytochemical profile were established using HPLC/DAD and molecular modelling studies on specific target compounds were performed in silico. The flower extract was found to be rich in phenolics and flavonoids, (60.11±1.40mgGAE/g and 42.04±0.16mgRE/g respectively), which tend to correlate with the high radical scavenging activity of this extract (120.34±3.33mgTE/g and 165.42±2.16mgTE/g for DPPH and ABTS respectively). Catechin, epicatechin, gallic acid, p-OH-Benzoic acid, rosmarinic acid, and epigallocatechin gallate, found in significant abundance in the extracts were assessed using molecular modelling with the aim to study their docking properties on a set of six enzymes used in this study. The extracts were moderately effective with MIC values ranging between 1.56 to 6.25mg/ml, but potent growth inhibitors of MRSA strains. Results amassed herein can be used as a stimulus for further studies geared towards the development of novel phyto-pharmaceuticals. Copyright © 2016 Elsevier Masson SAS. All rights reserved.

  19. Evaluation of models of particulate suspension for a thorium ore stockpile

    International Nuclear Information System (INIS)

    Smith, W.J.

    1983-01-01

    Fifteen mathematical models of particle saltation, suspension, and resuspension were reviewed and categorized. Appropriate models were applied to the estimation of particulate releases from a hypothetical thorium ore storage pile. An assumed location (near Lemhi Pass, Montana) was used to permit the development of site specific information on ore characteristics and environmental influences. The available models were characterized in terms of suitability for representing aspects of the ore pile, such as rough surface features, wide particle size range, and site specific climate. Five models were selected for detailed study. A computer code for each of these is given. Site specific data for the assumed ore stockpile location were prepared. These data were manipulated to provide the input values required for each of the five models. Representative values and ranges for model variables are tabulated. The response of each model to input data for selected variables was determined. Each model was evaluated in terms of the physical realism of its response of each model to input data for selected variables was determined. Each model was evaluated in terms of the physical realism of its responses and its overall ability to represent the features of an ore stockpile. The two models providing the best representation were a modified version of the dust suspension subroutine TAILPS from the computer code MILDOS, and the dust suspension formulation from the computer code REDIST. Their responses are physically reasonable, although different from each other for two parameters: ore moisture and surface roughness. With the input values judged most representative of an ore pile near Lemhi Pass, the estimate of the release of suspended particulates is on the order of 1 g/m 2 -yr

  20. Optimal design of MR shock absorber and application to vehicle suspension

    International Nuclear Information System (INIS)

    Nguyen, Quoc-Hung; Choi, Seung-Bok

    2009-01-01

    This paper presents an optimal design of a magnetorheological (MR) shock absorber based on finite element analysis. The MR shock absorber is constrained in a specific volume and the optimization problem identifies geometric dimensions of the shock absorber that minimize a multi-objective function. The objective function is proposed by considering the damping force, dynamic range and the inductive time constant of the shock absorber. After describing the configuration of the MR shock absorber, a quasi-static modeling of the shock absorber is performed based on the Bingham model of an MR fluid. The initial geometric dimensions of the shock absorber are then determined based on the assumption of constant magnetic flux density throughout the magnetic circuit. The objective function of the optimization problem is derived based on the solution of the initial shock absorber. An optimization procedure using a golden-section algorithm and a local quadratic fitting technique is constructed via a commercial finite element method parametric design language. Using the developed optimization tool, optimal solutions of the MR shock absorber, which is constrained in a specific cylindrical volume defined by its radius and height, are determined. Subsequently, a quarter-car suspension model with the optimized MR shock absorber is formulated and the vibration control performance of the suspension is evaluated under bump and sinusoidal road conditions

  1. Development of a lyophilized formulation for the preparation of radiopharmaceutical 68Ga-DOTA-E-[c(RGDfK)]2 for the diagnosis of breast cancer tumors

    International Nuclear Information System (INIS)

    Terron A, E. J.

    2015-01-01

    Radiopharmaceuticals of third generation by its design that includes peptides capable of selectively directing the radiation to a specific molecular target are useful in molecular medicine for obtaining molecular images that allow recording in vivo phenomena temporal-space of molecular or cellular processes, with diagnostic or therapeutic applications. Generally, peptides that recognize cellular receptors that are over-expressed in cancer cells of interest are used; such is the case of RGD (arginine-glycine-aspartic acid) a tri-peptide sequence which recognizes to the membrane receptors α(v)β(3) and α(v)β(5) that are involved in metastasis and angiogenic processes as well as in tumor cells of breast glioma. The high affinity and selectivity of RGD peptide with integrin s α(v)β(3) and α(v)β(5) is the basis for designing radiopharmaceuticals for diagnostic of breast cancer and the metastasis and angiogenic processes. In this paper a useful lyophilized formulation was development for obtaining 68 Ga-DOTA-E-[c(RGDfK)] 2 radiopharmaceutical that for its effectiveness, stability and security can be used in humans. The production process of core-equipment DOTA-E-[c(RGDfK] 2 /Buffer sodium acetate 1.0 M was optimized, and the formulation was transferred to the radiopharmaceuticals production plant of the Instituto Nacional de Investigaciones Nucleares (ININ). The optimized formulation of the core-equipment for the 68 Ga-DOTA-E-[c(RGDfK)] 2 radiopharmaceutical preparation is: DOTA-E-[c(RGDfK)] 2 peptide - 75 μg; Mannitol - 50 mg; Sodium acetate - 14 mg; Sodium acetate buffer 1.0 M ph 4.3 - 0.5 m L. The production process was validated and stability studies were carried out to the validation batches in compliance with the validation master plan of the ININ and in adherence to compliance of the applicable national and international regulations. Also the legal dossier was drawn up in order to make the application of sanitary registration before Comision Federal para

  2. Formulation of itraconazole nanococrystals and evaluation of their bioavailability in dogs.

    Science.gov (United States)

    De Smet, Lieselotte; Saerens, Lien; De Beer, Thomas; Carleer, Robert; Adriaensens, Peter; Van Bocxlaer, Jan; Vervaet, Chris; Remon, Jean Paul

    2014-05-01

    The aim of the study is to increase the bioavailability of itraconazole (ITRA) using nanosized cocrystals prepared via wet milling of ITRA in combination with dicarboxylic acids. Wet milling was used in order to create a nanosuspension of ITRA in combination with dicarboxylic acids. After spray-drying and bead layering, solid state was characterized by MDSC, XRD, Raman and FT-IR. The release profiles and bioavailability of the nanococrystalline suspension, the spray-dried and bead layered formulation were evaluated. A monodisperse nanosuspension (549±51nm) of ITRA was developed using adipic acid and Tween®80. Solid state characterization indicated the formation of nanococrystals by hydrogen bounds between the triazole group of ITRA and the carboxyl group of adipic acid. A bioavailability study was performed in dogs. The faster drug release from the nanocrystal-based formulation was reflected in the in vivo results since Tmax of the formulations was obtained 3h after administration, while Tmax of the reference formulation was observed only 6h after administration. This fast release of ITRA was obtained by a dual concept: manufacturing of nanosized cocrystals of ITRA and adipic acid via wet milling. Formation of stable nanosized cocrystals via this approach seems a good alternative for amorphous systems to increase the solubility and obtain a fast drug release of BCS class II drugs. Copyright © 2013 Elsevier B.V. All rights reserved.

  3. The Effect of Polymer Content on the Non-Newtonian Behavior of Acetaminophen Suspension

    Science.gov (United States)

    Moghimipour, Eskandar; Kouchak, Maryam; Salimi, Anayatollah; Bahrampour, Saeed; Handali, Somayeh

    2013-01-01

    Acetaminophen is used as an analgesic and antipyretic agent. The aim of the study was evaluation of the effect of different polymers on rheological behavior of acetaminophen suspension. In order to achieve controlled flocculation, sodium chloride was added. Then structural vehicles such as carboxymethyl cellulose (CMC), polyvinyl pyrrolidone (PVP), tragacanth, and magnesium aluminum silicate (Veegum) were evaluated individually and in combination. Physical stability parameters such as sedimentation volume (F), redispersibility (n), and growth of crystals of the suspensions were determined. Also, the rheological properties of formulations were studied. The results of this study showed that the combination of suspending agents had the most physical stability and pseudoplastic behavior with some degree of thixotropy. Viscosity of suspensions was increased by adding NaCl 0.02%. Presence of PVP is necessary for improving rheological behavior of suspensions by NaCl. This may be related to the cross-linking between the carbonyl group in the PVP segment and Na+ ions. PMID:24109512

  4. Active Control of Suspension Bridges

    DEFF Research Database (Denmark)

    Thoft-Christensen, Palle

    In this paper some recent research on active control of very long suspension bridges, is presented. The presentation is based on research work at Aalborg University, Denmark. The active control system is based on movable flaps attached to the bridge girder. Wind load on bridges with or without...... flaps attached to the girder is briefly presented. A simple active control system is discussed. Results from wind tunnel experiments with a bridge section show that flaps can be used effectively to control bridge girder vibrations. Flutter conditions for suspension bridges with and without flaps...

  5. Capacity Development and Strengthening for Energy Policy formulation and implementation of Sustainable Energy Projects in Indonesia CASINDO. Deliverable No. 38. Pro-poor Energy Strategy In North Sumatra

    Energy Technology Data Exchange (ETDEWEB)

    Soeharwinto [University of Sumatra Utara, Medan (Indonesia)

    2011-12-15

    The overall objective of the CASINDO programme is to establish a self-sustaining and self-developing structure at both the national and regional level to build and strengthen human capacity to enable the provinces of North Sumatra, Yogyakarta, Central Java, West Nusa Tenggara and Papua to formulate sound policies for renewable energy and energy efficiency and to develop and implement sustainable energy projects. A key component of the recent political reforms undertaken in Indonesia is the decentralization and regional autonomy that were implemented in 2001. This process has devolved almost all powers and responsibilities from the central government to the local government, including responsibilities for energy sector development. This means that regional governments are now responsible for formulating their energy policy and, consequently, must reform their institutional structure and strengthen their human capacity to be able to carry out this new responsibility. In Indonesia, people living in urban areas generally have access to efficient and modern energy supplies. However, the rural communities are generally less fortunate and continue to rely on traditional fuels of firewood, because the energy and electricity production system available to them are costly and inefficient. The aim of CASINDO's Technical Working Group V (TWG V) on Identification of Energy Needs and Assessment for Poor Communities was to establish energy-related needs and priorities of poor communities in selected locations in the Province of Central Java. The target location for Casindo TWG V activities was the village of Sruni, in the Boyolali district, because it is a district which produces a great amount of milk from dairy cows (greatest amount in Central Java); and secondly, because it does not receive any funds from other development programs, as well as from other institutions, while other subdistricts do. In order to identify actual energy needs successfully, the Participatory

  6. Post-marketing assessment of content and efficacy of preservatives in artemisinin-derived antimalarial dry suspensions for paediatric use

    Directory of Open Access Journals (Sweden)

    Plaizier-Vercammen Jacqueline

    2007-01-01

    Full Text Available Abstract Background Artemisinin-derivative formulations are now widely used to treat falciparum malaria. However, the dry powder suspensions developed for children are few and/or are of poor quality. In addition to the active compound, the presence of a suitable preservative in these medicines is essential. In this study, an evaluation of the preservative content and efficacy in some dry suspensions available on the Kenyan market was performed. Method UV spectrophotometry was used to identify the preservatives in each sample while HPLC-UV was used for quantification. After reconstitution of the powders in water, the dissolution of the preservatives was followed for 7 days. Antimicrobial efficacy of the preservatives was assessed by conducting a preservative efficacy test (PET following the European pharmacopoeia standards. Results Four different preservatives were identified namely methylparahydroxybenzoate (MP, propylparahydroxybenzoate (PP, benzoic acid and sorbic acid. MP and PP were identified in Artesiane® (artemether 300 mg/100 ml, Alaxin® (dihydroartemisinin 160 mg/80 ml andGvither ® (artemether 300 mg/100 ml respectively. Sorbic acid was presentin Artenam® (artemether 180 mg/60 ml while benzoic acid was identified in Santecxin® (dihydroartemisinin 160 mg/80 ml andArtexin® (dihydroartemisinin 160 mg/80 ml respectively. Cotecxin® (dihydroartemisinin 160 mg/80 ml did not contain any of the above preservatives. After reconstitution in water, preservativesin 50%(3/6 of the products did not completely dissolve and the PET results revealed that only Artenam® and Gvither® met the requirements for antimicrobial efficacy. The other products did not conform. Conclusion These results show that paediatric antimalarial dry powder formulations on the market may contain ineffective or incorrect amounts of preservatives. This is a potential risk to the patient. Studies conducted on the dry powder suspensions should include the analysis of both

  7. Development of Multiple-Unit Floating Drug Delivery System of Clarithromycin: Formulation, in vitro Dissolution by Modified Dissolution Apparatus, in vivo Radiographic Studies in Human Volunteers.

    Science.gov (United States)

    Reddy, Arun B; Reddy, Narendar D

    2017-07-01

    Clarithromycin (CM), a broad spectrum macrolide antibiotic used to eradicate H. pylori in peptic ulcer. Clarithromycin (CM) is well absorbed from the gastrointestinal tract, but has a bioavailability of 50% due to rapid biodegradation. The aim of this investigation was to increase the gastric residence time, and to control the drug release of clarithromycin by formulating into multiple unit floating mini-tablets. Floating tablets were prepared by using direct compression method with HPMC K 4 M and Polyox WSR 1105 as release retarded polymers and sodium bicarbonate as gas generating agent. The prepared mini-tablets were evaluated for thickness, weight variation, friability, hardness, drug content, in vitro buoyancy, swelling studies, in vitro dissolution studies by using modified Rossett-Rice test and in vivo radiographic studies in healthy human volunteers in fasting conditions. DSC analysis revealed that no interaction between drug and excipients. All the physical parameters of the tablets were within the acceptable limits. The optimized formulation (F6) had showed controlled drug release of 99.16±3.22% in 12 h, by zero-order release kinetics, along with floating lag time of 9.5±1.28 s and total floating time of 12±0.14 h. X-ray imaging studies revealed that in vivo gastric residence time of clarithromycin floating mini-tablet in the stomach was about 3.5 h. The results demonstrated that the developed floating mini-tablets of clarithromycin caused significant enhancement in gastric retention time along with sustained effect and increased oral bioavailability. © Georg Thieme Verlag KG Stuttgart · New York.

  8. Development and Characterization of Sodium Hyaluronate Microparticle-Based Sustained Release Formulation of Recombinant Human Growth Hormone Prepared by Spray-Drying.

    Science.gov (United States)

    Kim, Sun J; Kim, Chan W

    2016-02-01

    The purpose of this study was to develop and characterize a sodium hyaluronate microparticle-based sustained release formulation of recombinant human growth hormone (SR-rhGH) prepared by spray-drying. Compared to freeze-drying, spray-dried SR-rhGH showed not only prolonged release profiles but also better particle property and injectability. The results of size-exclusion high-performance liquid chromatography showed that no aggregate was detected, and dimer was just about 2% and also did not increase with increase of inlet temperature up to 150 °C. Meanwhile, the results of reversed-phase high-performance liquid chromatography revealed that related proteins increased slightly from 4.6% at 100 °C to 6.3% at 150 °C. Thermal mapping test proved that product temperature did not become high to cause protein degradation during spray-drying because thermal energy was used for the evaporation of surface moisture of droplets. The structural characterization by peptide mapping, sodium dodecyl sulfate-polyacrylamide gel electrophoresis, and circular dichroism revealed that the primary, secondary, and tertiary structures of rhGH in SR-rhGH were highly comparable to those of reference somatropin materials. The biological characterization by rat weight gain and cell proliferation assays provided that bioactivity of SR-rhGH was equivalent to that of native hGH. These data establish that spray-dried SR-rhGH is highly stable by preserving intact rhGH and hyaluronate microparticle-based formulation by spray-drying can be an alternative delivery system for proteins. Copyright © 2016 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.

  9. Formulation, Development, and In Vitro Evaluation of a CD22 Targeted Liposomal System Containing a Non-Cardiotoxic Anthracycline for B Cell Malignancies

    Directory of Open Access Journals (Sweden)

    Nivesh K. Mittal

    2018-04-01

    Full Text Available Doxorubicin cardiotoxicity has led to the development of superior chemotherapeutic agents such as AD 198. However, depletion of healthy neutrophils and thrombocytes from AD 198 therapy must be limited. This can be done by the development of a targeted drug delivery system that delivers AD 198 to the malignant cells. The current research highlights the development and in vitro analysis of targeted liposomes containing AD 198. The best lipids were identified and optimized for physicochemical effects on the liposomal system. Physiochemical characteristics such as size, ζ-potential, and dissolution were also studied. Active targeting to CD22 positive cells was achieved by conjugating anti-CD22 Fab’ to the liposomal surface. Size and ζ-potential of the liposomes was between 115 and 145 nm, and −8 to−15 mV. 30% drug was released over 72 h. Higher cytotoxicity was observed in CD22+ve Daudi cells compared to CD22−ve Jurkat cells. The route of uptake was a clathrin- and caveolin-independent pathway. Intracellular localization of the liposomes was in the endolysosomes. Upon drug release, apoptotic pathways were activated partly by the regulation of apoptotic and oncoproteins such as caspase-3 and c-myc. It was observed that the CD22 targeted drug delivery system was more potent and specific compared to other untargeted formulations.

  10. Stress degradation studies and development of stability-indicating TLC-densitometry method for determination of prednisolone acetate and chloramphenicol in their individual and combined pharmaceutical formulations

    Directory of Open Access Journals (Sweden)

    Musharraf Syed

    2012-01-01

    Full Text Available Abstract A rapid and reproducible stability indicating TLC method was developed for the determination of prednisolone acetate and chloramphenicol in presence of their degraded products. Uniform degradation conditions were maintained by refluxing sixteen reaction mixtures for two hours at 80°C using parallel synthesizer including acidic, alkaline and neutral hydrolysis, oxidation and wet heating degradation. Oxidation at room temperature, photochemical and dry heating degradation studies were also carried out. Separation was done on TLC glass plates, pre-coated with silica gel 60F-254 using chloroform: methanol (14:1 v/v. Spots at Rf 0.21 ± 0.02 and Rf 0.41 ± 0.03 were recognized as chloramphenicol and prednisolone acetate, respectively. Quantitative analysis was done through densitometric measurements at multiwavelength (243 nm, λmax of prednisolone acetate and 278 nm, λmax of chloramphenicol, simultaneously. The developed method was optimized and validated as per ICH guidelines. Method was found linear over the concentration range of 200-6000 ng/spot with the correlation coefficient (r2 ± S.D. of 0.9976 ± 3.5 and 0.9920 ± 2.5 for prednisolone acetate and chloramphenicol, respectively. The developed TLC method can be applied for routine analysis of prednisolone acetate and chloramphenicol in presence of their degraded products in their individual and combined pharmaceutical formulations.

  11. Aqueous clay suspensions stabilized by alginate fluid gels for coal spontaneous combustion prevention and control.

    Science.gov (United States)

    Qin, Botao; Ma, Dong; Li, Fanglei; Li, Yong

    2017-11-01

    We have developed aqueous clay suspensions stabilized by alginate fluid gels (AFG) for coal spontaneous combustion prevention and control. Specially, this study aimed to characterize the effect of AFG on the microstructure, static and dynamic stability, and coal fire inhibition performances of the prepared AFG-stabilized clay suspensions. Compared with aqueous clay suspensions, the AFG-stabilized clay suspensions manifest high static and dynamic stability, which can be ascribed to the formation of a robust three-dimensional gel network by AFG. The coal acceleration oxidation experimental results show that the prepared AFG-stabilized clay suspensions can improve the coal thermal stability and effectively inhibit the coal spontaneous oxidation process by increasing crossing point temperature (CPT) and reducing CO emission. The prepared low-cost and nontoxic AFG-stabilized clay suspensions, exhibiting excellent coal fire extinguishing performances, indicate great application potentials in coal spontaneous combustion prevention and control.

  12. Formation and composition of adsorbates on hydrophobic carbon surfaces from aqueous laccase-maltodextrin mixture suspension

    Energy Technology Data Exchange (ETDEWEB)

    Corrales Ureña, Yendry Regina, E-mail: yendry386@hotmail.com [UNESP São Paulo State University, Av. Eng. Luiz Edmundo Carrijo Coube, 14-01, Bauru, São Paulo (Brazil); Fraunhofer Institute for Manufacturing Technology and Advanced Materials IFAM, Wiener Strasse 12, 28359 Bremen (Germany); Lisboa-Filho, Paulo Noronha [UNESP São Paulo State University, Av. Eng. Luiz Edmundo Carrijo Coube, 14-01, Bauru, São Paulo (Brazil); Szardenings, Michael [Fraunhofer Institute for Cell Therapy and Immunology IZI, Perlickstrasse 1, 04103 Leipzig (Germany); Gätjen, Linda; Noeske, Paul-Ludwig Michael; Rischka, Klaus [Fraunhofer Institute for Manufacturing Technology and Advanced Materials IFAM, Wiener Strasse 12, 28359 Bremen (Germany)

    2016-11-01

    Highlights: • Less than 10 nm layer formed on carbon based materials composed by laccase and maltodextrin. • Improvement of the wettability of carbon based materials. • A protein-polysaccharide biofilm layer formation at solid liquid interface. • Stable layers formed under buffer and water rinsing. - Abstract: A robust procedure for the surface bio-functionalization of carbon surfaces was developed. It consists on the modification of carbon materials in contact with an aqueous suspension of the enzyme laccase from Trametes versicolor and the lyophilization agent maltodextrin, with the pH value adjusted close to the isoelectric point of the enzyme. We report in-situ investigations applying Quartz Crystal Microbalance with Dissipation (QCM-D) for carbon-coated sensor surfaces and, moreover, ex-situ measurements with static contact angle measurements, X-ray Photoelectron Spectroscopy (XPS) and Scanning Force Microscopy (SFM) for smooth Highly Oriented Pyrolytic Graphite (HOPG) substrates, for contact times between the enzyme formulation and the carbon material surface ranging from 20 s to 24 h. QCM-D studies reveals the formation of rigid layer of biomaterial, a few nanometers thin, which shows a strongly improved wettability of the substrate surface upon contact angle measurements. Following spectroscopic characterization, these layers are composed of mixtures of laccase and maltodextrin. The formation of these adsorbates is attributed to attractive interactions between laccase, the maltodextrin-based lyophilization agent and the hydrophobic carbon surfaces; a short-term contact between the aqueous laccase mixture suspension and HOPG surfaces is shown to merely result in de-wetting patterns influencing the results of contact angle measurements. The new enzyme-based surface modification of carbon-based materials is suggested to be applicable for the improvement of not only the wettability of low energy substrate surfaces with fluid formulations like coatings

  13. Tactile friction of topical formulations.

    Science.gov (United States)

    Skedung, L; Buraczewska-Norin, I; Dawood, N; Rutland, M W; Ringstad, L

    2016-02-01

    The tactile perception is essential for all types of topical formulations (cosmetic, pharmaceutical, medical device) and the possibility to predict the sensorial response by using instrumental methods instead of sensory testing would save time and cost at an early stage product development. Here, we report on an instrumental evaluation method using tactile friction measurements to estimate perceptual attributes of topical formulations. Friction was measured between an index finger and an artificial skin substrate after application of formulations using a force sensor. Both model formulations of liquid crystalline phase structures with significantly different tactile properties, as well as commercial pharmaceutical moisturizing creams being more tactile-similar, were investigated. Friction coefficients were calculated as the ratio of the friction force to the applied load. The structures of the model formulations and phase transitions as a result of water evaporation were identified using optical microscopy. The friction device could distinguish friction coefficients between the phase structures, as well as the commercial creams after spreading and absorption into the substrate. In addition, phase transitions resulting in alterations in the feel of the formulations could be detected. A correlation was established between skin hydration and friction coefficient, where hydrated skin gave rise to higher friction. Also a link between skin smoothening and finger friction was established for the commercial moisturizing creams, although further investigations are needed to analyse this and correlations with other sensorial attributes in more detail. The present investigation shows that tactile friction measurements have potential as an alternative or complement in the evaluation of perception of topical formulations. © 2015 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  14. Four-Wheel Vehicle Suspension System

    Science.gov (United States)

    Bickler, Donald B.

    1990-01-01

    Four-wheel suspension system uses simple system of levers with no compliant components to provide three-point suspension of chassis of vehicle while maintaining four-point contact with uneven terrain. Provides stability against tipping of four-point rectangular base, without rocking contact to which rigid four-wheel frame susceptible. Similar to six-wheel suspension system described in "Articulated Suspension Without Springs" (NPO-17354).

  15. Heavy vehicle pitch dynamics and suspension tuning

    OpenAIRE

    Cao, Dongpu; Rakheja, Subhash; Su, Chun-Yi

    2008-01-01

    The influence of suspension tuning of passenger cars on bounce and pitch ride performance has been explored in a number of studies, while only minimal efforts have been made for establishing similar rules for heavy vehicles. This study aims to explore pitch dynamics and suspension tunings of a two-axle heavy vehicle with unconnected suspension, which could also provide valuable information for heavy vehicles with coupled suspensions. Based on a generalised pitch-plane model of a two-axle heav...

  16. Suspension-Firing of Biomass

    DEFF Research Database (Denmark)

    Shafique Bashir, Muhammad; Jensen, Peter Arendt; Frandsen, Flemming

    2012-01-01

    This paper is the second of two papers, describing probe measurements of deposit buildup and removal (shedding), conducted in a 350 MWth suspension-fired boiler, firing straw and wood. Investigations of deposit buildup and shedding have been made by use of an advanced online deposit probe and a s...

  17. Suspension-Firing of Biomass

    DEFF Research Database (Denmark)

    Bashir, Muhammad Shafique; Jensen, Peter Arendt; Frandsen, Flemming

    2012-01-01

    This paper is Part 1 in a series of two describing probe measurements of deposit build-up and removal (shedding) in a 350 MWth suspension boiler, firing straw and wood. The influence of fuel type (straw share in wood), probe exposure time, probe surface temperature (500, 550, and 600 °C), and flu...

  18. Nonlinear models of suspension bridges

    Czech Academy of Sciences Publication Activity Database

    Malík, Josef

    2006-01-01

    Roč. 321, č. 2 (2006), s. 828-850 ISSN 0022-247X Institutional research plan: CEZ:AV0Z30860518 Keywords : suspension bridges * principle of minimum energy Subject RIV: BA - General Mathematics Impact factor: 0.758, year: 2006

  19. Fracture in Kaolinite clay suspensions

    Science.gov (United States)

    Kosgodagan Acharige, Sebastien; Jerolmack, Douglas J.; Arratia, Paulo E.

    2017-11-01

    Clay minerals are involved in many natural (landslides, river channels) and industrial processes (ceramics, cosmetics, oil recovery). They are plate shaped charged colloids and exhibit different flow properties than simpler colloids when suspended in a liquid such as thixotropy and shear-banding. kaolinite platelets are non-swelling, meaning that the stacks formed by the platelets do not have water layers, and thus the suspension does not have a sol-gel transition. However, it has been shown that kaolinite suspensions possesses a non-zero yield stress even at low concentrations, indicating that the particles arrange themselves in a structure through attractive interactions. Here, we experimentally investigate the sedimentation of kaolinite suspensions in a Hele-Shaw cell. The sedimentation of these dilute suspensions can display solid behavior like fracture, revealed in cross-polarized light, which is linked to the failure of the weakly-bonded structure (typical yield stress 10-2 Pa). By changing the interaction potential of the particles (by sonication or introducing salts), we show through these sedimentation experiments, how the fracture pattern can be avoided. Research was sponsored by the Army Research Laboratory and was accomplished under Grant Number 569074.

  20. Effect of different polymers on in vitro and ex vivo permeability of Ofloxacin from its mucoadhesive suspensions

    OpenAIRE

    Chakraborti, Chandra Kanti; Sahoo, Subhashree; Behera, Pradipta Kumar

    2014-01-01

    Considering the importance of drug permeation from formulations, in vitro and ex vivo drug permeation characteristics of three oral mucoadhesive suspensions of Ofloxacin were designed and compared. Three suspensions of Ofloxacin were prepared by taking two grades of Carbopol polymer such as Carbopol 934 (C934) and Carbopol 940 (C940); and Hydroxypropyl methylcellulose. The permeability study was performed by using a Franz diffusion cell through both synthetic cellulose acetate membrane and ex...

  1. 49 CFR 570.8 - Suspension systems.

    Science.gov (United States)

    2010-10-01

    ... 49 Transportation 6 2010-10-01 2010-10-01 false Suspension systems. 570.8 Section 570.8 Transportation Other Regulations Relating to Transportation (Continued) NATIONAL HIGHWAY TRAFFIC SAFETY... Pounds or Less § 570.8 Suspension systems. (a) Suspension condition. Ball joint seals shall not be cut or...

  2. 49 CFR 570.61 - Suspension system.

    Science.gov (United States)

    2010-10-01

    ... 49 Transportation 6 2010-10-01 2010-10-01 false Suspension system. 570.61 Section 570.61... ADMINISTRATION, DEPARTMENT OF TRANSPORTATION VEHICLE IN USE INSPECTION STANDARDS Vehicles With GVWR of More Than 10,000 Pounds § 570.61 Suspension system. (a) Suspension condition. Ball joint seals shall not be cut...

  3. A microsphere suspension model of metamaterial fluids

    Directory of Open Access Journals (Sweden)

    Qian Duan

    2017-05-01

    Full Text Available Drawing an analogy to the liquid phase of natural materials, we theoretically propose a microsphere suspension model to realize a metamaterial fluid with artificial electromagnetic indexes. By immersing high-ε, micrometer-sized dielectric spheres in a low-ε insulating oil, the structured fluid exhibits liquid-like properties from dispersing phase as well as the isotropic negative electromagnetic parameters caused by Mie resonances from dispersed microspheres. The work presented here will benefit the development of structured fluids toward metamaterials.

  4. Capacity Development and Strengthening for Energy Policy formulation and implementation of Sustainable Energy Projects in Indonesia CASINDO. Deliverable No. 20. Installation of Demonstration Units at the Indonesian Universities

    Energy Technology Data Exchange (ETDEWEB)

    Wijnker, M. [Eindhoven University of Technology TUE, Eindhoven (Netherlands)

    2011-08-15

    The overall objective of the CASINDO programme is to establish a self-sustaining and self-developing structure at both the national and regional level to build and strengthen human capacity to enable the provinces of North Sumatra, Yogyakarta, Central Java, West Nusa Tenggara and Papua to formulate sound policies for renewable energy and energy efficiency and to develop and implement sustainable energy projects. Each of the five Indonesian partner universities has managed to choose, purchase and install demonstration equipment within the timeline of the Casindo project. This equipment will be presented to students, visitors, lecturers, government personnel and staff of other organizations. Next to this, researchers made research proposals in which use of the demonstration equipment is presented according to the research agenda of the university. The procedure of purchasing and installing equipment has been delayed in several ways, but all universities have managed to finalise the procedure and install the equipment. First research results have been presented and more results will follow in the next months.

  5. Development and validation of a liquid chromatography method for the simultaneous determination of eight water-soluble vitamins in multivitamin formulations and human urine.

    Science.gov (United States)

    Patil, Suyog S; Srivastava, Ashwini K

    2013-01-01

    A simple, precise, and rapid RPLC method has been developed without incorporation of any ion-pair reagent for the simultaneous determination of vitamin C (C) and seven B-complex vitamins, viz, thiamine hydrochloride (B1), pyridoxine hydrochloride (B6), nicotinamide (B3), cyanocobalamine (B12), folic acid, riboflavin (B2), and 4-aminobenzoic acid (Bx). Separations were achieved within 12.0 min at 30 degrees C by gradient elution on an RP C18 column using a mobile phase consisting of a mixture of 15 mM ammonium formate buffer and 0.1% triethylamine adjusted to pH 4.0 with formic acid and acetonitrile. Simultaneous UV detection was performed at 275 and 360 nm. The method was validated for system suitability, LOD, LOQ, linearity, precision, accuracy, specificity, and robustness in accordance with International Conference on Harmonization guidelines. The developed method was implemented successfully for determination of the aforementioned vitamins in pharmaceutical formulations containing an individual vitamin, in their multivitamin combinations, and in human urine samples. The calibration curves for all analytes showed good linearity, with coefficients of correlation higher than 0.9998. Accuracy, intraday repeatability (n = 6), and interday repeatability (n = 7) were found to be satisfactory.

  6. Capacity Development and Strengthening for Energy Policy formulation and implementation of Sustainable Energy Projects in Indonesia CASINDO. Deliverable No. 38. Pro-poor Energy Strategy in Yogyakarta

    Energy Technology Data Exchange (ETDEWEB)

    Rosyidi Sri Atmaja P.; Lesmana, Surya Budi Lesmana [Muhammadiyah University of Yogyakarta, Yogyakarta (Indonesia)

    2011-12-15

    The overall objective of the CASINDO programme is to establish a self-sustaining and self-developing structure at both the national and regional level to build and strengthen human capacity to enable the provinces of North Sumatra, Yogyakarta, Central Java, West Nusa Tenggara and Papua to formulate sound policies for renewable energy and energy efficiency and to develop and implement sustainable energy projects. Chapter 2 provides a review of the national, regional and local policy and programs on energy access for poor communities that have been implemented in Yogyakarta region. However, the two villages, i.e., Dusun Srumbung, Segoroyoso village, Pleret District, Bantul Regency and Dusun Wirokerten, Botokenceng Village, Banguntapan District, Bantul Regency, Yogyakarta Region, selected as locations for energy need assessments in this project have not received any support from the energy programs mentioned in this section. Chapter 3 gives the criteria used to select the locations. Chapter 4 provides the results and analysis of the participatory rural appraisal used for the energy needs assessments which have been carried out in the selected locations. Chapter presents the renewable energy potentials in the study area. Chapter 6 gives the results of a stakeholder analysis for implementing the proposed programmes and roadmap. Chapter 7 is the roadmap for RE project implementation for poor community and provincial budget analysis.

  7. Capacity Development and Strengthening for Energy Policy formulation and implementation of Sustainable Energy Projects in Indonesia CASINDO. Deliverable No. 14. Fast-track program at UNDIP and UNCEN

    Energy Technology Data Exchange (ETDEWEB)

    Wijnker, M. (ed.) [Eindhoven University of Technology TUE, Eindhoven (Netherlands)

    2011-01-15

    The overall objective of the CASINDO programme is to establish a self-sustaining and self-developing structure at both the national and regional level to build and strengthen human capacity to enable the provinces of North Sumatra, Yogyakarta, Central Java, West Nusa Tenggara and Papua to formulate sound policies for renewable energy and energy efficiency and to develop and implement sustainable energy projects. The relationship between UNDIP (Diponegoro University in Semarang, Java, Indonesia) and TU/e (Eindhoven University of Technology) has improved because of organising two additional activities together. The chosen topics of the two workshops offered a good opportunity to get to know each other. The level of knowledge in sustainable energy and energy efficiency at UNDIP is already on a high level. The relationship between UNCEN (Cenderawasih University, Jayapura, Papua, Indonesia) and TU/e has also improved much through the organisation of two additional activities. Staff of UNCEN took the opportunity to organise two workshops improving their knowledge in the field of sustainable energy and energy efficiency.

  8. Study and rheological characterization of various bone ash porcelain formulations

    International Nuclear Information System (INIS)

    Carus, L.A.; Bento, L.; Braganca, S.R.

    2012-01-01

    The bone ash porcelain is a widely accepted product on the market because their qualities such as high strength and whiteness, to differ from common table porcelains. Its traditional formulation comes from an English recipe, consisting of 25% of kaolin, 25% of feldspar and 50% of bovine bone ash. In some studies, this proportion is adapted to regional conditions, optimizing the formulation according to the raw materials available. In this study, the rheological behavior of bone porcelain suspensions, in which the flux feldspar is partially substituted by an alternative flux (espudomenio, wollastonite and glass). The results show that the rheological behavior of porcelain is affected by the size, shape, surface area and particle size distribution of particles in suspension

  9. Capacity Development and Strengthening for Energy Policy formulation and implementation of Sustainable Energy Projects in Indonesia CASINDO. Deliverable No. 24. Energy Efficiency in Central Java

    Energy Technology Data Exchange (ETDEWEB)

    Windarto, Joko; Nugroho, Agung; Hastanto, Ari; Mahartoto, Gigih [Diponegoro University, Semarang (Indonesia)

    2012-01-15

    The overall objective of the CASINDO programme is to establish a self-sustaining and self-developing structure at both the national and regional level to build and strengthen human capacity to enable the provinces of North Sumatra, Yogyakarta, Central Java, West Nusa Tenggara and Papua to formulate sound policies for renewable energy and energy efficiency and to develop and implement sustainable energy projects. Energy has a very important role and has become a basic necessity in national sustainable development. Therefore, energy should be used sparingly and in a rational manner so that present and future energy demand can be met. Given the importance of using energy efficiently Government needs to devise a framework regulating the utilization of energy resources through the efficient application of technology and stimulating energy-saving behaviours. The purpose of this technical working group in CASINDO project is to research the steps and policy measures needed to improve the efficiency of electrical energy consumption in the household, industrial, and commercial buildings sector for Central Java. The government's efforts in promoting energy efficiency in Indonesia are still hampered by public awareness factor. This study exists to promote public awareness of energy efficiency by describing the financial benefits and possibilities of savings energies in order to support the government's energy saving program, replacement of old equipment that uses high power consumption with a new low-power one, reduction of unnecessary lighting, appreciation to the people who find and develop energy-efficient power utilization, persuade industries to uses the speed controller driver for production and fan motor to streamline the electrical energy usage.

  10. Suspensions with reduced violin string modes

    International Nuclear Information System (INIS)

    Lee, B H; Ju, L; Blair, D G

    2006-01-01

    We discuss the possibility of significantly reducing the number and Q-factor of violin string modes in the mirror suspension. Simulations of a bar-flexure suspension and an orthogonal ribbon have shown a reduction in the number of violin string modes when compared to a normal ribbon suspension. By calculating the expected suspension thermal noise, we find that the orthogonal ribbon provides a promising suspension alternative. A lower number of violin modes oscillating in the direction of the laser and a reduction in violin mode peak values of at least 23dB can be achieved with a slight increase in thermal noise above 40Hz

  11. Suspensions with reduced violin string modes

    Energy Technology Data Exchange (ETDEWEB)

    Lee, B H; Ju, L; Blair, D G [School of Physics, University of Western Australia, Crawley 6009, WA (Australia)

    2006-03-02

    We discuss the possibility of significantly reducing the number and Q-factor of violin string modes in the mirror suspension. Simulations of a bar-flexure suspension and an orthogonal ribbon have shown a reduction in the number of violin string modes when compared to a normal ribbon suspension. By calculating the expected suspension thermal noise, we find that the orthogonal ribbon provides a promising suspension alternative. A lower number of violin modes oscillating in the direction of the laser and a reduction in violin mode peak values of at least 23dB can be achieved with a slight increase in thermal noise above 40Hz.

  12. Influence of Differing Analgesic Formulations of Aspirin on Pharmacokinetic Parameters

    Directory of Open Access Journals (Sweden)

    Kunal Kanani

    2015-08-01

    Full Text Available Aspirin has been used therapeutically for over 100 years. As the originator and an important marketer of aspirin-containing products, Bayer’s clinical trial database contains numerous reports of the pharmacokinetics of various aspirin formulations. These include evaluations of plain tablets, effervescent tablets, granules, chewable tablets, and fast-release tablets. This publication seeks to expand upon the available pharmacokinetic information concerning aspirin formulations. In the pre-systemic circulation, acetylsalicylic acid (ASA is rapidly converted into its main active metabolite, salicylic acid (SA. Therefore, both substances are measured in plasma and reported in the results. The 500 mg strength of each formulation was chosen for analysis as this is the most commonly used for analgesia. A total of 22 studies were included in the analysis. All formulations of 500 mg aspirin result in comparable plasma exposure to ASA and SA as evidenced by AUC. Tablets and dry granules provide a consistently lower Cmax compared to effervescent, granules in suspension and fast release tablets. Effervescent tablets, fast release tablets, and granules in suspension provide a consistently lower median Tmax compared to dry granules and tablets for both ASA and SA. This report reinforces the importance of formulation differences and their impact on pharmacokinetic parameters.

  13. Development of shampoo, soap and ointment formulated by green synthesised silver nanoparticles functionalised with antimicrobial plants oils in veterinary dermatology: treatment and prevention strategies.

    Science.gov (United States)

    Bansod, Sunita Dashrath; Bawaskar, Manisha Subrashrao; Gade, Aniket Krishnarao; Rai, Mahendra Kumar

    2015-08-01

    Many scientists have focused their research on the role of nanotechnology for the control of human pathogens, but there are also many topical pathogens present in animals, which infect animals and transfer to humans. Topical therapy is extremely important for the management of dermatological condition in animals. Therefore, the present study aims to evaluate the efficacy of biogenic silver nanoparticles (AgNPs) in combination with herbal oils against animal skin infections which may be responsible for causing infections in human beings. Here, the authors synthesised and characterised the AgNPs from Azadirachta indica. The oils were extracted from medicinal plants including Cymbopogon citratus, Cymbopogon martini, Eucalyptus globules, A. indica and Ocimum sanctum and the antifungal and antibacterial activity of plant oils along with AgNPs were evaluated. An excision wound model was used for the study of wound healing activity in rabbits. AgNPs functionalised oil has demonstrated remarkable antimicrobial activity against pathogens present on the skin of animals. The nano-functionalised antimicrobial oils were used in the formulation of shampoo, soap and ointment for veterinary dermatology. Antimicrobial products of plant origin with AgNPs are valuable, safe and have a specific role in controlling diseases. The authors believe that this approach will be a good alternative therapy to solve the continuous antibiotic resistance developed by many bacterial pathogens and will be utilised in various animal contacting areas in medicine.

  14. Development of a Dispersive Liquid–Liquid Microextraction Technique for the Extraction and Spectrofluorimetric Determination of Fluoxetine in Pharmaceutical Formulations and Human Urine

    Directory of Open Access Journals (Sweden)

    Ahad Bavili Tabrizi

    2012-06-01

    Full Text Available Purpose: Fluoxetine is the most prescribed antidepressant drug worldwide. In this work, a new dispersive liquid–liquid microextraction (DLLME method combined with spectrofluorimetry has been developed for the extraction and determination of FLX in pharmaceutical formulations and human urine. Methods: For FLX determination, the pH of a 10 mL of sample solution containing FLX, was adjusted to 11.0. Then, 800 μL of ethanol containing 100 μL of chloroform was injected rapidly into the sample solution. A cloudy solution was formed and FLX extracted into the fine droplets of chloroform. After centrifugation, the extraction solvent was sedimented and supernatant aqueous phase was readily decanted. The remained organic phase was diluted with ethanol and its fluorescence was measured at 292±3 nm after excitation at 234±3 nm. Results: Some important parameters influencing microextraction efficiency were investigated. Under the optimum extraction conditions, a linear calibration curve in the range of 10 to 800 ng/mL with a correlation coefficient of r2 = 0.9993 was obtained. Limit of detection (LOD and limit of quantification (LOQ were found to be 2.78 and 9.28 ng/mL, respectively. The relative standard deviations (RSDs were less than 4%. Average recoveries for spiked samples were 93–104%. Conclusion: The proposed method gives a very rapid, simple, sensitive, wide dynamic range and low–cost procedure for the determination of FLX.

  15. Development and Sequential Analysis of a New Multi-Agent, Anti-Acne Formulation Based on Plant-Derived Antimicrobial and Anti-Inflammatory Compounds

    Directory of Open Access Journals (Sweden)

    Crina Saviuc

    2017-01-01

    Full Text Available The antibacterial and anti-inflammatory potential of natural, plant-derived compounds has been reported in many studies. Emerging evidence indicates that plant-derived essential oils and/or their major compounds may represent a plausible alternative treatment for acne, a prevalent skin disorder in both adolescent and adult populations. Therefore, the purpose of this study was to develop and subsequently analyze the antimicrobial activity of a new multi-agent, synergic formulation based on plant-derived antimicrobial compounds (i.e., eugenol, β-pinene, eucalyptol, and limonene and anti-inflammatory agents for potential use in the topical treatment of acne and other skin infections. The optimal antimicrobial combinations selected in this study were eugenol/β-pinene/salicylic acid and eugenol/β-pinene/2-phenoxyethanol/potassium sorbate. The possible mechanisms of action revealed by flow cytometry were cellular permeabilization and inhibition of efflux pumps activity induced by concentrations corresponding to sub-minimal inhibitory (sub-MIC values. The most active antimicrobial combination represented by salycilic acid/eugenol/β-pinene/2-phenoxyethanol/potassium sorbate was included in a cream base, which demonstrated thermodynamic stability and optimum microbiological characteristics.

  16. Influence of flocculating agents and structural vehicles on the physical stability and rheological behavior of nitrofurantoin suspension.

    Science.gov (United States)

    Moghimipour, Eskandar; Salimi, Anayatollah; Rezaee, Saeed; Balack, Maryam; Handali, Somayeh

    2014-05-01

    Nitrofurantoin is a nitrofuran antibiotic that has been used for treatment of urinary tract against positive and negative bacteria. The aim of this study was to evaluate the effect of structural vehicles and flocculating agents on physical stability and rheological behavior of nitrofurantoin suspension. To formulate the suspensions, the effect of glycerin and polysorbate 80 as wetting agents was evaluated and their particle sizes were determined using the sieve method. Then to achieve controlled flocculation, sodium citrate and aluminum chloride were added. After choosing the suitable wetting and flocculating agents, structural vehicles such as sodium carboxyl methyl cellulose and Veegum were evaluated individually and in combination. In addition, the effect of sorbitol on density of continuous phase and some physical stability parameters such as sedimentation volume, degree of flocculation and ease of redispersion of the suspensions were evaluated. After incorporation of structural vehicles, the rheological properties of formulations were also determined to find their flow behavior. According to the results, glycerin (0.2%) and sodium citrate (0.3%) had the best effect on the suspension stability as wetting and flocculating agents, respectively. Rheological properties of formulations showed pseudoplastic behavior with some degree of thixotropy. In conclusion, the suspension containing Veegum 1%, sodium carboxy methyl cellulose 1%, glycerine 0.2%, sodium citrate 0.3% and sorbitol 20 % was chosen as the most physically stable formulation.

  17. Numerical homogenization on approach for stokesian suspensions.

    Energy Technology Data Exchange (ETDEWEB)

    Haines, B. M.; Berlyand, L. V.; Karpeev, D. A. (Mathematics and Computer Science); (Department of Mathematics, Pennsylvania State Univ.)

    2012-01-20

    In this technical report we investigate efficient methods for numerical simulation of active suspensions. The prototypical system is a suspension of swimming bacteria in a Newtonian fluid. Rheological and other macroscopic properties of such suspensions can differ dramatically from the same properties of the suspending fluid alone or of suspensions of similar but inactive particles. Elongated bacteria, such as E. coli or B. subtilis, swim along their principal axis, propelling themselves with the help of flagella, attached at the anterior of the organism and pushing it forward in the manner of a propeller. They interact hydrodynamically with the surrounding fluid and, because of their asymmetrical shape, have the propensity to align with the local flow. This, along with the dipolar nature of bacteria (the two forces a bacterium exerts on a fluid - one due to self-propulsion and the other opposing drag - have equal magnitude and point in opposite directions), causes nearby bacteria to tend to align, resulting in a intermittent local ordering on the mesoscopic scale, which is between the microscopic scale of an individual bacterium and the macroscopic scale of the suspension (e.g., its container). The local ordering is sometimes called a collective mode or collective swimming. Thanks to self-propulsion, collective modes inject momentum into the fluid in a coherent way. This enhances the local strain rate without changing the macroscopic stress applied at the boundary of the container. The macroscopic effective viscosity of the suspension is defined roughly as the ratio of the applied stress to the bulk strain rate. If local alignment and therefore local strain-rate enhancement, are significant, the effective viscosity can be appreciably lower than that of the corresponding passive suspension or even of the surrounding fluid alone. Indeed, a sevenfold decrease in the effective viscosity was observed in experiments with B. subtilis. More generally, local collective

  18. Audits of radiopharmaceutical formulations

    International Nuclear Information System (INIS)

    Castronovo, F.P. Jr.

    1992-01-01

    A procedure for auditing radiopharmaceutical formulations is described. To meet FDA guidelines regarding the quality of radiopharmaceuticals, institutional radioactive drug research committees perform audits when such drugs are formulated away from an institutional pharmacy. All principal investigators who formulate drugs outside institutional pharmacies must pass these audits before they can obtain a radiopharmaceutical investigation permit. The audit team meets with the individual who performs the formulation at the site of drug preparation to verify that drug formulations meet identity, strength, quality, and purity standards; are uniform and reproducible; and are sterile and pyrogen free. This team must contain an expert knowledgeable in the preparation of radioactive drugs; a radiopharmacist is the most qualified person for this role. Problems that have been identified by audits include lack of sterility and apyrogenicity testing, formulations that are open to the laboratory environment, failure to use pharmaceutical-grade chemicals, inadequate quality control methods or records, inadequate training of the person preparing the drug, and improper unit dose preparation. Investigational radiopharmaceutical formulations, including nonradiolabeled drugs, must be audited before they are administered to humans. A properly trained pharmacist should be a member of the audit team

  19. Multiphase modeling of settling and suspension in anaerobic digester

    International Nuclear Information System (INIS)

    Yu, Liang; Ma, Jingwei; Frear, Craig; Zhao, Quanbao; Dillon, Robert; Li, Xiujin; Chen, Shulin

    2013-01-01

    Highlights: • Develop biowaste fluid dynamics for collision, aggregation and breakup of clusters. • Explore the mechanisms of settling and suspension in anaerobic digester. • Biowaste particles tended to have fluid properties. • Aided with CFD simulation, the scale-up effect was reduced. - Abstract: Effective suspension and settling are critical for controlling biomass retention in a bioreactor. In this paper, a multi-fluid model with kinetic theory of granular flow (KTGF) was established to describe these phenomena in the biowaste particles flow in anaerobic digesters. Solid retention time (SRT) was added as a parameter into anaerobic digestion No.1 (ADM1) model to evaluate its effect on the bio