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

    Science.gov (United States)

    Sateesha, SB.; Rajamma, AJ.; Shekar, HS.; Divakar, G.

    2011-01-01

    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 spray-dried mannitol and b) Complexation of CPH with three different ion exchange resins indion 234 amberlite IRP64 and amberlite IRP69. Results Taste viz 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 having 5% overages was stable even after 4th day of reconstitution and palatable with slight or no bitter after taste. PMID:22615648

  3. [Formulation and stability of suspensions for preclinical study].

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    Burgalassi, S; Perini, G; Giannaccini, B; Saettone, M F; Lodi, A

    1997-11-01

    In preclinical studies, poorly soluble drugs are usually administered orally to experimental animals as suspensions. The present study was aimed at providing data allowing predictive estimations of the stability of such suspensions. To this purpose aqueous suspensions of three drugs (griseofulvin, ibuprofen and indomethacin) were prepared at different concentrations using four different suspending agents: sodium carboxymethylcellulose (CMC), microcrystalline cellulose/carboxymethylcellulose (MC/CMC), hydroxypropylmethylcellulose (HPMC) and jota carragenaan (CJ). The physical and physico-chemical characteristics of the drugs, the rheological properties of the suspending media and of the corresponding drug suspensions, and the physical and chemical stability of the suspensions was then evaluated. The type of suspending agent, rather than the physical characteristics of the drug, appeared to exert the main influence on the physical stability of suspensions. The most stable formulations were produced by suspending agents with low-temperature gelation characteristics (CJ) or with thixotropic flux (MC/CMC).

  4. Flywheel Magnetic Suspension Developments

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    Palazzolo, Alan; Kenny, Andrew; Sifford, Curtiss; Thomas, Erwin; Bhuiyan, Mohammad; Provenza, Andrew; Kascak, Albert; Montague, Gerald; Lei, Shuliang; Kim, Yeonkyu; hide

    2002-01-01

    The paper provides an overview of many areas of the flywheel magnetic suspension (MS) R&D being performed at the Texas A&M Vibration Control and Electromechanics Lab (TAMU-VCEL). This includes system response prediction, actuator optimization and redundancy, controller realizations and stages, sensor enhancements and backup bearing reliability.

  5. Formulation and Evaluation of Hydrotropic Solublization Based Suspensions of Griseofulvin

    OpenAIRE

    A. S. Shete,; Yadav, A. V.; A.P. Dabke; Sakhare, S. S.

    2010-01-01

    Purpose: Hydrotropes increases the solubility of organics in water. Objective of present investigation was to enhance the solubility of griseofulvin using the technique of hydrotropic solubilization technique and convert them into suitable oral liquid dosage form (suspension) useful for enhancement of bioavailability. Methods: 0.5M, 1M, 2M of the hydrotropes (tri sodium citrate, urea, sodium acetate, sodium benzoate and sodium salicylates) were used to study the saturation solubility. Solubil...

  6. 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.

  7. Formulation and Evaluation of Pharmaceutically Equivalent Parenteral Depot Suspension of Methyl Prednisolone Acetate

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    Alam, A.; Ahuja, Alka; Baboota, Sanjula; Gidwani, S. K.; Ali, J.

    2009-01-01

    The aim of the present study was to formulate and evaluate pharmaceutically equivalent injectable aqueous suspension for parenteral depot of methyl prednisolone acetate. Various aqueous suspensions were prepared by rapid stirring and colloid milling method. The prepared aqueous suspensions were subjected to particle size determination, sedimentation study, in vitro release studies (pH dependent dissolution study), and stability studies. The optimized formulation consisted of 4% w/w of methyl prednisolone acetate, 2.91% w/w of PEG-3350, 0.19% w/v of injection grade Tween-80, 0.68% w/w of monobasic sodium phosphate, 0.15% w/w of di-basic sodium phosphate, 0.91% w/v of benzyl alcohol, 0.32% w/w sodium meta bisulphate. The f2 value was calculated for innovator (DepoMedrol®, Batch No. MPH-0254) and optimized formulation at pH 6.8 and pH 7.4 phosphate buffers. The f2 values of 62.94 and 54.37 were obtained at pH 6.8 and pH 7.4 phosphate buffers respectively. The particle size ranged 23-27 μm at D value of 0.9 for both test and innovator product. PMID:20177452

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

    OpenAIRE

    Pirouzi, Gholamhossein; Osman, Noor Azuan Abu; Oshkour, Azim; Ali, Sadeeq; Gholizadeh, Hossein; Abas, Wan Wan

    2014-01-01

    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 a...

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

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    Deschamps, Benoit; Musaji, Naomi; Gillespie, John A

    2009-01-01

    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. 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. In fasting MA-ES subjects, the average maximum concentration (C(max)) was 30% less than the fed C(max) value. For MAOS, fasting C(max) was 86% less than fed C(max). 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. 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.

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

    Energy Technology Data Exchange (ETDEWEB)

    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. Development of sludge based stable aqueous Bacillus thuringiensis formulations.

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    Brar, S K; Verma, M; Tyagi, R D; Valéro, J R; Surampalli, R Y; Banerji, S K

    2004-01-01

    This study focuses on development of aqueous flowable (suspension) formulations for Bacillus thuringiensis (Bt) based biopesticides from wastewater sludge. Different inerts like sorbitol, sodium monophosphate, sodium metabisulphite, sorbic acid, propionic acid, Tween-80, Triton X-100 and glycerol were tested for formulations. Five different formulations for non-hydrolyzed (NH) secondary sludges were tried and the best combination selected on the basis of various physical parameters like viscosity, particle size, suspendibility, entomotoxicity, and microbiological purity tests. F5 formulations (for secondary sludge) comprising sorbitol, sodium monophosphate and sodium metabisulphite gave better physical and biological characteristics with a small effect on entomotoxicity and spore concentration after 120 days at pH 6, 6.5 and temperatures 40 and 50 degrees C and viscosity change at 40 and 50 degrees C. The formulations were more stable at pH 4.0 to 5.0 and temperatures 4 to 30 degrees C whereas at pH 6.0 and 6.5 and temperatures 40 and 50 degrees C, there was degeneration of the product. Lower proteolytic activity and physical factors like ionic strength and surface group changes at pH 6 and 6.5 were responsible for the instability of the formulation.

  12. Bioequivalence study with lapatinib powder for oral suspension and the original tablet formulation in cancer patients.

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    Koch, Kevin M; Ferron-Brady, Geraldine; Lemmon, Colleen; Cartee, Leanne; Hollyfield, Hedy; D'Amelio, Anthony M; Piepszak, Alexandra; Swaby, Ramona F; Curran, David; Arya, Niki

    2015-01-01

    Lapatinib is approved for use in various therapeutic combinations for treating metastatic breast cancers that over-express HER2. To deliver the approved doses, up to six large tablets need to be ingested with the current 250-mg tablets. For ease of ingestion, a powder for oral suspension was developed. This study was an open-label, randomized, adaptive design, two-period crossover bioequivalence study of the powder for suspension relative to the commercial tablet at steady state following once daily dosing for 7 days in patients with advanced cancer. To minimize the number of cancer patients required for a pivotal bioequivalence study (144 in this case), a four-stage adaptive group sequential design with interim analyses after every 36 subjects was implemented to allow for early termination. Bioequivalence for the oral suspension relative to the commercial tablet was demonstrated in both the first (and only) interim analysis and the final analysis, as the 90% confidence intervals for the treatment comparison ratios for both AUC0-24 and Cmax were contained within the acceptance criteria (0.80, 1.25). Additionally, there was no statistical difference in tlag or tmax , suggesting no difference in the absorption rate between treatments. There were no unexpected safety findings during this study. © 2014, The American College of Clinical Pharmacology.

  13. Development and optimization of the activated charcoal suspension composition based on a mixture design approach.

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    Ronowicz, Joanna; Kupcewicz, Bogumiła; Pałkowski, Łukasz; Krysiński, Jerzy

    2015-03-01

    In this study, a new drug product containing activated charcoal was designed and developed. The excipient levels in the pharmaceutical formulation were optimized using a mixture design approach. The adsorption power of the activated charcoal suspension was selected as the critical quality attribute influencing the efficacy of medical treatment. Significant prognostic models (p<0.05) were obtained to describe in detail the interrelations between excipient levels and the adsorption power of the formulation. Liquid flavour had a critical impact on the adsorption power of the suspension. Formulations containing the largest amount of liquid flavour showed the lowest adsorption power. Sorbitol was not adsorbed onto activated charcoal so strongly as liquid flavour. A slight increase in the content of carboxymethylcellulose sodium led to a marked decrease in adsorption power. The obtained mathematical models and response surface allowed selection of the optimal composition of excipients in a final drug product.

  14. Influence of Formulation Factors on the Aerosol Performance of Suspension and Solution Metered Dose Inhalers: A Systematic Approach.

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    Sheth, Poonam; Sandell, Dennis; Conti, Denise S; Holt, Jay T; Hickey, Anthony J; Saluja, Bhawana

    2017-09-01

    Metered dose inhalers (MDIs) are complex drug-device combination products widely used to treat pulmonary disorders. The efficacy, driven by aerosol performance of the products, depends on a multitude of factors including, but not limited to, the physicochemical properties of drug and nature and amount of excipient(s). Under the quality by design (QbD) paradigm, systematic investigations are necessary to understand how changes in critical quality attributes (CQAs) of formulation, device, and manufacturing process influence key product performance parameters, such as delivered dose (DD) and fine particle dose (FPD). The purpose of this work is to provide a better understanding of the effects of different levels of excipients and drug particle size distribution on the aerosol performance of MDI products, while using two fundamentally different MDI products as relevant model systems, Proventil® HFA (albuterol sulfate suspension) and Qvar® (beclomethasone dipropionate solution). These MDI products, as model systems, provided mid-points around which a design of experiments (DOE), consisting of 22 suspension and 9 solution MDI formulations, were defined and manufactured. The DOE included formulations factors with varying ethanol (2 to 20% w/w and 7 to 9% w/w for the suspension and solution, respectively) and oleic acid concentrations (0.005 to 0.25% w/w and 0 to 2% w/w for the suspension and solution, respectively) and drug volumetric median particle size distribution (PSD D50, 1.4 to 2.5 μm for the suspension). The MDI formulations were analyzed using compendial methods to elucidate the effect of these formulation variables (ethanol, oleic acid, and PSD D50) on DD and FPD. The outcomes of this study allowed defining design spaces for the formulation factors, such that DD and FPD would remain within specific pre-defined requirements. The systematic approach utilized in this work can contribute as a QbD tool to evaluate the extent to which the formulation factors

  15. Capillary suspensions as beneficial formulation concept for high energy density Li-ion battery electrodes

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    Bitsch, Boris; Gallasch, Tobias; Schroeder, Melanie; Börner, Markus; Winter, Martin; Willenbacher, Norbert

    2016-10-01

    We introduce a novel formulation concept to prepare high capacity graphite electrodes for lithium ion batteries. The concept is based on the capillary suspension phenomenon: graphite and conductive agent are dispersed in an aqueous binder solution and the organic solvent octanol is added as immiscible, secondary fluid providing the formation of a sample-spanning network resulting in unique stability and coating properties. No additional processing steps compared to conventional slurry preparation are required. The resulting ultra-thick electrodes comprise mass loadings of about 16.5 mg cm-2, uniform layer thickness, and superior edge contours. The adjustment of mechanical energy input ensures uniform distribution of the conductive agent and sufficient electronic conductivity of the final dry composite electrode. The resulting pore structure is due to the stable network provided by the secondary fluid which evaporates residue-free during drying. Constant current-constant potential (CC-CP) cycling clearly indicates that the corresponding microstructure significantly improves the kinetics of reversible Li+ (de-) intercalation. A double layer electrode combining a conventionally prepared layer coated directly onto the Cu current collector with an upper layer stabilized with octanol was prepared applying wet-on-wet coating. CC-CP cycling data confirms that staged porosity within the electrode cross section results in superior electrochemical performance.

  16. 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.

  17. Influence of formulation pH and suspension state on freezing-induced agglomeration of aluminum adjuvants.

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    Salnikova, Maya S; Davis, Harrison; Mensch, Christopher; Celano, Lauren; Thiriot, David S

    2012-03-01

    Freezing and thawing of vaccines containing aluminum adjuvants can lead to formation of aggregates and loss in vaccine potency. We sought to understand whether and to what extent the freeze-thaw damage to aluminum adjuvants would differ based on suspension state (flocculation and settlement) at the time of freezing. As flocculation and settlement characteristics of aluminum adjuvants are driven largely by the electrostatic charges on the adjuvant particles, which, in turn, are strongly influenced by the pH of the suspension, we conducted freeze-thaw studies on both Adjuphos and Alhydrogel™ samples at three pH levels (4, 6.5, and 7.2) in buffer solutions with 9% sucrose. Significantly less aggregation occurred in the buffered sucrose solutions at the pH furthest from the aluminum adjuvant point of zero charge during slow freezing at -20°C. The freezing-induced aggregation for the samples with 9% sucrose at each pH was minimal during fast freezing at -70°C and -115°C. Suspensions that were flocculated and settled to a greater extent experienced the most freeze-thaw aggregation, whereas suspensions that were frozen before significant flocculation and settlement occurred showed little or no aggregation. Because pH of formulation can affect flocculation and settling time, it indirectly affects the extent of freeze-thaw aggregation. Copyright © 2011 Wiley Periodicals, Inc.

  18. 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.

  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

    Directory of Open Access Journals (Sweden)

    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 novel solid-phase protein formulations

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    Montalvo Ortiz, Brenda Liz

    profiles and activity during in vitro release. These findings demonstrate that protein particle size is a crucial parameter for protein encapsulation in PLGA devices. Consequently, we developed a simple and effective method to obtain very small protein particles to further improve protein stability in PLGA microspheres. Protein nanoparticles of approximately 200 rim size were obtained by co-lyophilization of HRP with methyl-beta-cyclodextrin (MbetaCD), followed by suspension in ethyl acetate and sonication. We proved that protein integrity was maintained after the nanoparticle formulation. Finally, we encapsulated these protein nanospheres in PLGA microspheres by the s/o/w encapsulation method. The results showed that protein activity was improved when the HRP nanoparticle formulation was encapsulated in PLGA microspheres. In addition, we obtained a reduced initial protein release when the protein was encapsulated as nanoparticles and a linear release profile for more than 30 days. Furthermore, protein activity was maintained for prolonged times during release when compared to the lyophilized HRP formulation. Such improvements were attributed to the decrease in protein particle size. In general, these studies made a contribution in the protein-solid state formulation area. We demonstrate that protein dehydration could be done by a simple method and that particle size could be controlled to obtain the desired protein particle size. Moreover, with the nanoparticle formulation we obtained superior protein stability during encapsulation and release from PLGA microspheres. These new approaches will further increase the use of sustained delivery systems in clinical applications.

  1. Development of an air pneumatic suspension system for transtibial prostheses.

    Science.gov (United States)

    Pirouzi, Gholamhossein; Abu Osman, Noor Azuan; Oshkour, Azim Ataollahi; Ali, Sadeeq; Gholizadeh, Hossein; Abas, Wan A B Wan

    2014-09-09

    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.

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

    Directory of Open Access Journals (Sweden)

    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.

  3. Nanonized itraconazole powders for extemporary oral suspensions: Role of formulation components studied by a mixture design.

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    Foglio Bonda, Andrea; Rinaldi, Maurizio; Segale, Lorena; Palugan, Luca; Cerea, Matteo; Vecchio, Carlo; Pattarino, Franco

    2016-02-15

    Itraconazole (ITZ) nanocrystal-containing powders were prepared through the combined use of high pressure homogenization (HPH) and spray drying (SD). These powders were intended as base materials for the preparation of extemporary oral suspensions of the drug. The role and the effect of stabilizers on the size of re-dispersed particles were studied using a mixture design and a Scheffé model relating the dried nanosuspension composition to the mean particle diameters. The homogenization process required a surface active agent (Tween 20) to obtain the efficient comminution of itraconazole micronized powder. SD was carried out on ITZ nanosuspensions after addition of a cellulose derivative (Methocel(®) E5) that allowed the prompt re-dispersion of nanoparticles under "in use" conditions. The powders obtained by drying of homogenized systems showed in vitro dissolution profile faster than that of the micronized drug, suggesting a potential ameliorated GI absorption of itraconazole released from the nanosuspensions. Copyright © 2015 Elsevier B.V. All rights reserved.

  4. Development and Evaluation of Topical Gabapentin Formulations

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    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

  5. 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.

  6. 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.

  7. Antimicrobial effect of Anacardium Occidentale extract and cosmetic formulation development

    OpenAIRE

    Gisele Mara Silva Gonçalves; Juliana Gobbo

    2012-01-01

    The objective of this work was to assess the activity of the extract of Anacardium occidentale Staphylococcus epidermidis and S. aureus and then to develop cosmetic formulations from those extracts. These formulations were stable in relation to their pH and rheological behavior, but were gradually darkened when stored for assessment at temperatures between 40 and 60ºC. Thus, even though the extract appeared a promising raw material for use in cosmetic formulations, those compounds might still...

  8. Development of an MR seat suspension with self-powered generation capability

    Science.gov (United States)

    Sun, S. S.; Ning, D. H.; Yang, J.; Du, H.; Zhang, S. W.; Li, W. H.; Nakano, M.

    2017-08-01

    This paper proposes a self-powered magnetorheological (MR) seat suspension on the basis of a rotary MR damper and an electromagnetic induction device. By applying the self-powering component to the MR seat suspension, the operation cost of the semi-active seat is much cheaper because no external energy is required to control the MR damper. In this paper, the structure, design and analysis of the seat suspension were presented following the introduction section. The property tests of the self-powered seat suspension were conducted using an MTS machine. A robust control algorithm was developed to control the self-powered MR seat suspension and the vibration attenuation performance of the seat suspension was tested under two different vibration excitations, i.e. harmonic excitation and random excitation. The testing result verifies that the self-powered MR seat suspension under proper control can improve the ride comfort for passengers and drivers.

  9. Development of extended-release formulation of domperidone using ...

    African Journals Online (AJOL)

    Purpose: To develop an extended-release formulation of domperidone using a blend of Raphia hookeri gum and hydroxypropyl methylcellulose as tablet matrix. Methods: Tablets (400 mg) containing 30 mg domperidone (DPD) were formulated using binary mixtures of hydroxypropyl methylcellulose (HPMC) and Raphia ...

  10. Development of kineto-dynamic quarter-car model for synthesis of a double wishbone suspension

    Science.gov (United States)

    Balike, K. P.; Rakheja, S.; Stiharu, I.

    2011-02-01

    Linear or nonlinear 2-degrees of freedom (DOF) quarter-car models have been widely used to study the conflicting dynamic performances of a vehicle suspension such as ride quality, road holding and rattle space requirements. Such models, however, cannot account for contributions due to suspension kinematics. Considering the proven simplicity and effectiveness of a quarter-car model for such analyses, this article presents the formulation of a comprehensive kineto-dynamic quarter-car model to study the kinematic and dynamic properties of a linkage suspension, and influences of linkage geometry on selected performance measures. An in-plane 2-DOF model was formulated incorporating the kinematics of a double wishbone suspension comprising an upper control arm, a lower control arm and a strut mounted on the lower control arm. The equivalent suspension and damping rates of the suspension model are analytically derived that could be employed in a conventional quarter-car model. The dynamic responses of the proposed model were evaluated under harmonic and bump/pothole excitations, idealised by positive/negative rounded pulse displacement and compared with those of the linear quarter-car model to illustrate the contributions due to suspension kinematics. The kineto-dynamic model revealed considerable variations in the wheel and damping rates, camber and wheel-track. Owing to the asymmetric kinematic behaviour of the suspension system, the dynamic responses of the kineto-dynamic model were observed to be considerably asymmetric about the equilibrium. The proposed kineto-dynamic model was subsequently applied to study the influences of links geometry in an attempt to seek reduced suspension lateral packaging space without compromising the kinematic and dynamic performances.

  11. Accelerating Vaccine Formulation Development Using Design of Experiment Stability Studies.

    Science.gov (United States)

    Ahl, Patrick L; Mensch, Christopher; Hu, Binghua; Pixley, Heidi; Zhang, Lan; Dieter, Lance; Russell, Ryann; Smith, William J; Przysiecki, Craig; Kosinski, Mike; Blue, Jeffrey T

    2016-10-01

    Vaccine drug product thermal stability often depends on formulation input factors and how they interact. Scientific understanding and professional experience typically allows vaccine formulators to accurately predict the thermal stability output based on formulation input factors such as pH, ionic strength, and excipients. Thermal stability predictions, however, are not enough for regulators. Stability claims must be supported by experimental data. The Quality by Design approach of Design of Experiment (DoE) is well suited to describe formulation outputs such as thermal stability in terms of formulation input factors. A DoE approach particularly at elevated temperatures that induce accelerated degradation can provide empirical understanding of how vaccine formulation input factors and interactions affect vaccine stability output performance. This is possible even when clear scientific understanding of particular formulation stability mechanisms are lacking. A DoE approach was used in an accelerated 37(°)C stability study of an aluminum adjuvant Neisseria meningitidis serogroup B vaccine. Formulation stability differences were identified after only 15 days into the study. We believe this study demonstrates the power of combining DoE methodology with accelerated stress stability studies to accelerate and improve vaccine formulation development programs particularly during the preformulation stage. Copyright © 2016 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.

  12. Formulation development of carvedilol compression coated tablet.

    Science.gov (United States)

    Shah, Ritesh; Patel, Sachin; Patel, Hetal; Pandey, Sonia; Shah, Shailesh; Shah, Dinesh

    2013-01-01

    The aim of present research was to produce carvedilol compression coated tablet to provide biphasic drug release. A compressed coated tablet made of a sustained release core tablet and an immediate release coat tablet. Both the core and the coat contained carvedilol. The sustained release effect was achieved with polymers (HPMC K4M and PEO WSR 205) to modulate the release of the drug. The powder blends for core and coat tablets were evaluated for angle of repose, bulk density, compressibility index, and drug content. Compressed coated tablets were evaluated for thickness, diameter, weight variation test, drug content, hardness, friability, disintegration and in vitro release studies. The powder blends showed satisfactory flow properties, compressibility, drug content and all the tablet formulations showed acceptable pharmaco-technical properties. Carvedilol contained in the fast releasing component was released within 3 min, whereas the drug in the core tablet was released at different times up to 24 h, depending on the composition of the matrix tablet. The mechanism of drug release was fickian diffusion or anomalous behavior. Batch F7, containing 10 mg PEO WSR 205 and 5 mg HPMC K4M, showed maximum similarity with theoretical profile and zero order drug release kinetic.

  13. 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.

  14. Formule.

    Directory of Open Access Journals (Sweden)

    Le Comité de Rédaction d' EspacesTemps.net

    2004-09-01

    Full Text Available Vous découvrez aujourd’hui la nouvelle formule d’EspacesTemps. net. Ce basculement repose sur des changements techniques d’une certaine ampleur et nous vous demandons d’être indulgents si quelques imperfections subsistent dans les prochains jours. Il s’agit d’abord de la substitution du dispositif de mise en ligne : à partir de maintenant, nous utilisons le logiciel Lodel. Dans l’esprit de l’association Revues.org, à laquelle EspacesTemps adhère, l’unification du ...

  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. The surface characterisation and comparison of two potential sub-micron, sugar bulking excipients for use in low-dose, suspension formulations in metered dose inhalers.

    Science.gov (United States)

    James, Jeff; Crean, Barry; Davies, Martyn; Toon, Richard; Jinks, Phil; Roberts, Clive J

    2008-09-01

    analysis (SCA). The Young's modulus for each sub-micron excipient and parent material was also determined using AFM. Finally, the adhesive interactions were determined between each sub-micron bulking excipient and five APIs (formoterol fumarate, salmeterol xinafoate, salbutamol sulphate, mometasone furoate and salmon calcitonin). Both sub-micron sucrose and anhydrous sub-micron alpha-lactose exhibited a lower surface free energy than their respective parent materials/intermediates. In addition, both AFM and CA surface energy measurements also showed that sub-micron sucrose has a higher surface energy than anhydrous sub-micron alpha-lactose. Theoretical work of adhesion values between anhydrous sub-micron alpha-lactose and each API are considerably lower than those observed between micronised alpha-lactose monohydrate and each API. Corresponding theoretical work of adhesion values between sub-micron sucrose and each API were almost identical to those observed between silk grade sucrose and each API. Young's modulus determination revealed that sub-micron sucrose has a greater crystal hardness/elasticity ratio than anhydrous sub-micron alpha-lactose. With the exception of salmon calcitonin, sub-micron sucrose showed larger adhesive interactions to the selected APIs than anhydrous sub-micron alpha-lactose. Anhydrous sub-micron alpha-lactose has been found to have lower adhesive interactions with a range of chosen, low-dose APIs compared to sub-micron sucrose. This could be related to the lower surface energy for anhydrous sub-micron alpha-lactose. Knowledge of the surface free energy and mechanical properties of potential sub-micron bulking excipients and API materials could provide useful information regarding the selection of suitable API-submicron bulking excipient combinations during the development and optimisation stages of suspension pMDI formulations.

  17. Formulation development of the deleterious rhizobacterium Pseudomonas trivialis X33d for biocontrol of brome (Bromus diandrus) in durum wheat.

    Science.gov (United States)

    Mejri, D; Gamalero, E; Souissi, T

    2013-01-01

    To develop an appropriate formulation of the deleterious rhizobacterium Pseudomonas trivialis X33d and to evaluate its effectiveness to reduce brome growth. Two formulations of Ps. trivialis X33d, a semolina-kaolin granular formulation (Pesta) and talc-kaolin powder, were prepared and their effectiveness in reducing brome growth was evaluated. Both brome suppression and cell viability of X33d were higher in Pesta granular formulation than in talc-kaolin powder one. The impact of storage temperature and the addition of adjuvants (sucrose and oil) to the granular formulation of X33d were assessed in order to improve the shelf life of the formulation. The longest viability was found in formulated product supplemented with adjuvants and stored at 4°C. The effect of Pesta granules supplemented with adjuvants and stored for 6 months at 4°C on brome and wheat growth under controlled and greenhouse conditions was evaluated. The X33d formulation in Pesta increased the growth of wheat and reduced brome growth. Our results indicate that Ps. trivialis X33d formulated in Pesta has potential as a bioherbicide to control brome. Because of the impracticality of applying bacterial cell suspension on a large scale, the use of Pesta granules of X33d against brome could help in achieving a sustainable agriculture application of a bioherbicide. © 2012 The Society for Applied Microbiology.

  18. Research on Suspension with Novel Dampers Based on Developed FOA-LQG Control Algorithm

    Directory of Open Access Journals (Sweden)

    Xiao Ping

    2017-01-01

    Full Text Available To enhance working-performance robustness of suspension, a vehicle suspension with permanent-magnet magnetic-valve magnetorheological damper (PMMVMD was studied. Firstly, mechanical structure of traditional magnetorheological damper (MD used in vehicle suspensions was redesigned through introducing a permanent magnet and a magnetic valve. Based on theories of electromagnetics and Bingham model, prediction model of damping force was built. On this basis, two-degree-of-freedom vehicle suspension model was established. In addition, fruit fly optimization algorithm- (FOA- line quadratic Gaussian (LQG control algorithm suitable for PMMVMD suspensions was designed on the basis of developing normal FOA. Finally, comparison simulation experiments and bench tests were conducted by taking white noise and a sine wave as the road surface input and the results indicated that working performance of PMMVMD suspension based on FOA-LQG control algorithm was good.

  19. 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 flow...... the mini paddle dissolution method demonstrates that sample preparation influenced the results. The investigations show that excipients from the formulations directly affected the drug–filter interaction, thereby affecting the dissolution profiles and the ability to predict the in vivo data....... 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....

  20. Development of a chitosan-derivative micellar formulation to improve celecoxib solubility and bioavailability.

    Science.gov (United States)

    Mennini, Natascia; Furlanetto, Sandra; Bragagni, Marco; Ghelardini, Carla; Di Cesare Mannelli, Lorenzo; Mura, Paola

    2014-11-01

    Celecoxib is an anti-inflammatory drug, specific inhibitor of COX-2, classified as a BCS class II compound due to its very low aqueous solubility (3 μg/mL) and good permeability. An innovative micellar formulation of celecoxib has been developed to increase its solubility and, consequently, its oral bioavailability. Quaternary-ammonium-palmitoyl-glycol-chitosan (GCPQ) was selected as carrier, due to its micelle-forming ability joined to its solubilizing and enhancer properties towards hydrophobic drugs. A Doehlert design was applied to optimize the drug solubilizing efficiency of the micellar formulation. Tested factors were GCPQ concentration and time and power of probe sonication during micelles formation; the response to maximize was the celecoxib solubility. The response-surface study allowed a thorough investigation of the effect of factors variations on the response over the considered experimental domain and identification of the best variable combination in order to maximize the desired improvement in drug solubility. The optimized micellar formulation (GCPQ 4.5 mg/mL; 25 min at 60% power of probe sonication) enabled an about 60-fold increase in celecoxib aqueous solubility. The optimized formulation, tested in vivo in mice by the writhing test, allowed a statistically significant shortening (p < 0.05) of the pain alleviation onset and a more intense effect (p < 0.05) with respect to the celecoxib aqueous suspension obtained by the commercial formulation. The results proved that the developed GCPQ micellar formulation is a valuable approach for improving the therapeutic effectiveness of celecoxib.

  1. Development of a Parenteral Formulation of NTS-Polyplex Nanoparticles for Clinical Purpose

    Directory of Open Access Journals (Sweden)

    María E. Aranda-Barradas

    2018-01-01

    Full Text Available Neurotensin (NTS-polyplex is a nanoparticle system for targeted gene delivery that holds great promise for treatment of Parkinson’s disease and various types of cancer. However, the high instability in aqueous suspension of NTS-polyplex nanoparticles is a major limitation for their widespread clinical use. To overcome this obstacle, we developed a clinical formulation and a lyophilization process for NTS-polyplex nanoparticles. The reconstituted samples were compared with fresh preparations by using transmission electron microscopy, dynamic light scattering, electrophoretic mobility, circular dichroism and transfection assays in vitro and in vivo. Our formulation was able to confer lyoprotection and stability to these nanoparticles. In addition, transmission electron microscopy (TEM and size exclusion-high performance liquid chromatography (SEC-HPLC using a radioactive tag revealed that the interaction of reconstituted nanoparticles with fetal bovine or human serum did not alter their biophysical features. Furthermore, the formulation and the lyophilization procedure guaranteed functional NTS-polyplex nanoparticles for at least six months of storage at 25 °C and 60% relative humidity. Our results offer a pharmaceutical guide for formulation and long-term storage of NTS-polyplex nanoparticles that could be applied to other polyplexes.

  2. 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.

  3. 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 ...

  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. Support Tools in Formulation Development for Poorly Soluble Drugs.

    Science.gov (United States)

    Fridgeirsdottir, Gudrun A; Harris, Robert; Fischer, Peter M; Roberts, Clive J

    2016-08-01

    The need for solubility enhancement through formulation is a well-known but still problematic issue because of the numbers of poorly water-soluble drugs in development. There are several possible routes that can be taken to increase the bioavailability of drugs intended for immediate-release oral formulation. The best formulation strategy for any given drug will depend on numerous factors, including required dose, shelf life, manufacturability, and the properties of the active pharmaceutical ingredient (API). Choosing an optimal formulation and manufacturing route for a new API is therefore not a straightforward process. Currently, there are several approaches that are used in the pharmaceutical industry to select the best formulation strategy. These differ in complexity and efficiency, but most try to predict which route will best suit the API based on selected molecular parameters such as molecular weight, lipophilicity (logP), and solubility. These methods range from using no tools, trial and error methods through a variety of complex tools from small in vitro or in vivo experiments or high throughput screening, guidance maps, and decision trees to the most complex methods based on computational modelling tools. This review aims to list available support tools and explain how they are used. Copyright © 2016 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.

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

    Science.gov (United States)

    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

    2017-02-01

    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 drug use are associated with a greater risk for harm than on-label drug use, a range of global initiatives have been developed to realize "better" medicines for children. This review describes the challenges and achievements of the European Union to realize this goal, with a focus on paediatric drug development and formulation design. In 2007, a European Paediatric Regulation was installed enforcing companies to consider children in the early development of drugs with a new drug substance, for a new indication or with a new route of administration. The Regulation, e.g. requires companies to develop a paediatric investigation plan discussing the proposed clinical trials in children of different ages and the formulations for future marketing. Since 2013, the pharmaceutical design of any newly marketed paediatric drug should comply with the "Guideline on the Pharmaceutical Development of Medicines for Paediatric Use." Companies should, e.g. justify the route of administration, dosage form, formulation characteristics, safety of excipients, dosing frequency, container closure system, administration device, patient acceptability and user information. In this review, the guideline's key aspects are discussed with a focus on novel formulations such as mini-tablets and orodispersible films, excipients with a potential risk for harm such as azo dyes and adequate user instructions.

  7. Development of Stable Influenza Vaccine Powder Formulations: Challenges and Possibilities

    Science.gov (United States)

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

    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 into the dry state using suitable excipients, stabilizers and drying processes. The resulting stable influenza vaccine powder is independent of cold-chain facilities. This can be attractive for the integration of the vaccine logistics with general drug distribution in Western as well as developing countries. In addition, a stockpile of stable vaccine formulations of potential vaccines against pandemic viruses can provide an immediate availability and simple distribution of vaccine in a pandemic outbreak. Finally, in the development of new needle-free dosage forms, dry and stable influenza vaccine powder formulations can facilitate new or improved targeting strategies for the vaccine compound. This review represents the current status of dry stable inactivated influenza vaccine development. Attention is given to the different influenza vaccine types (i.e. whole inactivated virus, split, subunit or virosomal vaccine), the rationale and need for stabilized influenza vaccines, drying methods by which influenza vaccines can be stabilized (i.e. lyophilization, spray drying, spray-freeze drying, vacuum drying or supercritical fluid drying), the current status of dry influenza vaccine development and the challenges for ultimate market introduction of a stable and effective dry-powder influenza vaccine. PMID:18338241

  8. BCS class IV drugs: Highly notorious candidates for formulation development.

    Science.gov (United States)

    Ghadi, Rohan; Dand, Neha

    2017-02-28

    BCS class IV drugs (e.g., amphotericin B, furosemide, acetazolamide, ritonavir, paclitaxel) exhibit many characteristics that are problematic for effective oral and per oral delivery. Some of the problems associated include low aqueous solubility, poor permeability, erratic and poor absorption, inter and intra subject variability and significant positive food effect which leads to low and variable bioavailability. Also, most of the class IV drugs are substrate for P-glycoprotein (low permeability) and substrate for CYP3A4 (extensive pre systemic metabolism) which further potentiates the problem of poor therapeutic potential of these drugs. A decade back, extreme examples of class IV compounds were an exception rather than the rule, yet today many drug candidates under development pipeline fall into this category. Formulation and development of an efficacious delivery system for BCS class IV drugs are herculean tasks for any formulator. The inherent hurdles posed by these drugs hamper their translation to actual market. The importance of the formulation composition and design to successful drug development is especially illustrated by the BCS class IV case. To be clinically effective these drugs require the development of a proper delivery system for both oral and per oral delivery. Ideal oral dosage forms should produce both a reasonably high bioavailability and low inter and intra subject variability in absorption. Also, ideal systems for BCS class IV should produce a therapeutic concentration of the drug at reasonable dose volumes for intravenous administration. This article highlights the various techniques and upcoming strategies which can be employed for the development of highly notorious BCS class IV drugs. Some of the techniques employed are lipid based delivery systems, polymer based nanocarriers, crystal engineering (nanocrystals and co-crystals), liquisolid technology, self-emulsifying solid dispersions and miscellaneous techniques addressing the P

  9. Development and validation of a fluorimetric method to determine curcumin in lipid and polymeric nanocapsule suspensions

    Directory of Open Access Journals (Sweden)

    Letícia Mazzarino

    2010-06-01

    Full Text Available A simple, rapid, and sensitive fluorimetric method was developed and validated to quantify curcumin in lipid and polymeric nanocapsule suspensions, using acetonitrile as a solvent. The excitation and emission wavelengths were set at 397 nm and 508 nm, respectively. The calibration graph was linear from 0.1 to 0.6 µg/mL with a correlation coefficient of 0.9982. The detection and quantitation limits were 0.03 and 0.10 µg/mL, respectively. The validation results confirmed that the developed method is specific, linear, accurate, and precise for its intended use. The current method was successfully applied to the evaluation of curcumin content in lipid and polymeric nanocapsule suspensions during the early stage of formulation development.Um método fluorimétrico simples, rápido e sensível foi desenvolvido e validado para quantificação da curcumina em suspensões de nanocápsulas lipídicas e poliméricas, usando acetonitrila como solvente. Os comprimentos de onda de excitação e emissão foram 397 nm e 508 nm, respectivamente. Nas condições testadas, a curva de calibração demonstrou-se linear na faixa de 0,1 a 0,6 µg/mL, exibindo coeficiente de correlação de 0,9982. Os limites de detecção e quantificação foram 0,03 e 0,10 µg/mL, respectivamente. Os resultados da validação confirmaram que o método desenvolvido é específico, linear, exato e preciso para o uso proposto. O presente método foi aplicado com sucesso para a avaliação do teor de curcumina nas suspensões de nanocápsulas lipídicas e poliméricas durante o estágio inicial do desenvolvimento da formulação.

  10. Development of liposomal salbutamol sulfate dry powder inhaler formulation.

    Science.gov (United States)

    Huang, Wen-Hua; Yang, Zhi-Jun; Wu, Heng; Wong, Yuen-Fan; Zhao, Zhong-Zhen; Liu, Liang

    2010-01-01

    The purpose of our study was to develop a formulation of liposomal salbutamol sulfate (SBS) dry powder inhaler (DPI) for the treatment of asthma. Liposomes of high encapsulation efficiency (more than 80%) were prepared by a vesicular phospholipid gel (VPG) technique. SBS VPG liposomes were subjected to lyophilization using different kinds of cryoprotectants in various mass ratios. Coarse lactose (63-106 microm) in different mass ratios was used as a carrier. Magnesium stearate (0.5%) was added as a lubricator. The dry liposomal powders were then crushed by ball milling and sieved through a 400-mesh sieve to control the mean particle size at about 10 microm. The effects of different kinds of cryoprotectants and the amount of lactose carrier on the fine particle fraction (FPF) of SBS were investigated. The results showed that the developed formulation of liposomal dry powder inhaler was obtained using lactose as a cryoprotectant with a mass ratio of lyophilized powder to carrier lactose at 1 : 5; 0.5% magnesium stearate was used as a lubricator. The value of FPF for SBS was 41.51+/-2.22% for this formulation. Sustained release of SBS from the VPG liposomes was found in the in vitro release study. The study results offer the promising possibility of localized pulmonary liposomal SBS delivery in the anhydrous state.

  11. 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

  12. Glass Formulation Development for INEEL Sodium-Bearing Waste

    Energy Technology Data Exchange (ETDEWEB)

    Vienna, John D.; Buchmiller, William C.; Crum, Jarrod V.; Graham, Dennis D.; Kim, Dong-Sang; Macisaac, Brett D.; Schweiger, Michael J.; Peeler, David K.; Edwards, Tommy B.; Reamer, Irene A.; Workman, R. J.

    2002-08-01

    Studies were performed to develop and test a glass formulation for immobilization of sodium-bearing waste (SBW). SBW is a high soda, acid high activity waste stored at the INEEL in 10 underground tanks. It was determined in previous studies that SBW?s sulfur content dictates the its loading in borosilicate glasses to be melted by currently assumed processes. If the sulfur content (which is ~4.5 mass% SO3 on a non-volatile oxide basis in SBW) of the melter feed is too high then a molten alkali sulfate containing salt phase accumulates on the melt surface. The avoidance of salt accumulation during the melter process and the maximization of sulfur incorporation into the glass melt were the main focus of this development work. A glass was developed for 20 mass% SBW (on a non-volatile oxide basis), which contained 0.91 mass% SO3, that met all the processing and product quality constraint determined for SBW vitrification at a planned INEEL treatment plant?SBW-22-20. This report summarizes the formulation efforts and presents the data developed on a series of glasses with simulated SBW. Summary

  13. Some physicochemical properties of acetaminophen pediatric suspensions formulated with okra gums obtained from different extraction processes as suspending agent

    OpenAIRE

    Ikoni Ogaji

    2011-01-01

    The purpose of this work was to evaluate the effect of the extraction process and the potential of okra gum as a suspending agent in pharmaceutical oral formulations containing acetaminophen as a model drug. Clarified mucilage of dried okra was either extracted directly with ethanol 96% (F1) or was first treated with base (F2), acid (F3) or heating in the presence of salt (F4) before extraction with ethanol 96%. The samples were used at 0.5% w/v as suspending agents in ac...

  14. Development of friable embryogenic callus and embryogenic suspension culture systems in cassava (Manihot esculenta Crantz)

    Science.gov (United States)

    Taylor, N J; Edwards, M; Kiernan, R J; Davey, C D; Blakesley, D; Henshaw, G G

    1996-06-01

    Procedures for the production of a new and highly prolific embryogenic culture system have been developed in cassava. The importance of the basal salts and type of auxin in controlling the development of cassava embryogenic tissues has been demonstrated, with culture on Gresshoff and Doy basal medium in the presence of 4-amino-3,5,6,trichloro-picolinic acid (picloram) inducing the formation of friable embryogenic callus from which highly totipotent embryogenic suspension cultures could be established. Plants have been regenerated from these cultures. The availability of embryogenic suspension cultures is considered to have important implications for the application of genetic transformation and other biotechnologies in the agronomic improvement of cassava.

  15. 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.

  16. The use of morphogenic suspension cultures for the development of a protoplast regeneration system in lily

    NARCIS (Netherlands)

    Famelaer, L.; Bordas, M.; Baliu', E.; Ennik, E.; Meijer, H.; Tuyl, van J.M.; Creemers-Molenaar, J.

    1997-01-01

    The present study reports data on the development of a protoplast regeneration procedure in lily. Established morphogenic suspension cultures were obtained from callus cultures induced on mature embryos from crosses between cultivars of L. longiflorum. The effect on the frequency of protoplast

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

    Science.gov (United States)

    Shilakari Asthana, Gyati; Asthana, Abhay; Singh, Davinder; Sharma, Parveen Kumar

    2016-01-01

    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.

  18. 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.

  19. 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.

  20. 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

  1. Sunscreen creams containing naringenin nanoparticles: Formulation development and in vitro and in vivo evaluations.

    Science.gov (United States)

    Joshi, Haritima; Hegde, Aswathi R; Shetty, Pallavi K; Gollavilli, Hemanth; Managuli, Renuka S; Kalthur, Guruprasad; Mutalik, Srinivas

    2018-01-01

    The aim of this study was to develop sunscreen creams containing polymeric nanoparticles (NPs) of naringenin for photoprotective and antioxidant effects. Polymeric NPs of naringenin were prepared and optimized. The NPs were incorporated into sunscreen creams and evaluated for in vitro and in vivo skin retention. The optimized naringenin NPs showed a size of 131.2 nm, zeta potential -25.4 mV, and entrapment efficiency 32.45%. The absence of drug-excipient interaction was confirmed by Fourier transform infrared spectroscopy and differential scanning calorimetry. X-Ray diffraction analysis demonstrated the amorphization of naringenin in nanoparticles. Transmission electron microscopy showed the sphericity of the NPs with the size of creams (SC1-SC5) containing plain naringenin or NPs with/without nano-zinc oxide and nano-titanium dioxide were prepared and evaluated. Optimized cream (SC5) containing naringenin NPs showed highest SPF value and enhanced skin retention of naringenin in comparison with NPs in suspension form and other cream formulations. Optimized nanoparticulate sunscreen cream exhibited highest skin retention and negligible skin permeation of naringenin besides showing excellent SPF value. © 2017 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  2. Formulation development and evaluation of metronidazole magnetic nanosuspension as a magnetic-targeted and polymeric-controlled drug delivery system

    Energy Technology Data Exchange (ETDEWEB)

    Latha, Subbiah [Department of Pharmaceutical Technology, Anna University Tiruchirappalli, Tiruchirappalli 620 024, Tamil Nadu (India)], E-mail: lathasuba@yahoo.co.in; Selvamani, Palanisamy; Kumar, Chelladurai Senthil; Sharavanan, Palaniappan; Suganya, Govindan [Department of Pharmaceutical Technology, Anna University Tiruchirappalli, Tiruchirappalli 620 024, Tamil Nadu (India); Beniwal, Vijender Singh; Rao, Poduri Rama [Centre for Pharmaceutical Nanotechnology, National Institute of Pharmaceutical Education and Research (NIPER), Mohali 160 062, Punjab (India)

    2009-05-15

    A nanosuspension of magnetically tagged metronidazole was developed by the solvent displacement method coupled with ultrasonication and was evaluated for its physicochemical properties. The drug release from metronidazole magnetic nanosuspension at pH 1.2 and 7.0 shows maximum correlation coefficient for zero order and Higuchi model, respectively. The anthelmintic activity of the formulated metronidazole magnetic nanosuspension was evaluated on Indian earthworms (Pheretima poi). Metronidazole magnetic nanosuspension at a dose of 10 and 50 mg/ml shortened by 31% and 34%, respectively, the mean time to death of the earthworms when compared against a non-magnetic metronidazole suspension. Thus, the developed metronidazole magnetic nanosuspension showed potent, controlled and targeted drug action and might be a good therapeutic avenue in combating infectious GI disorders.

  3. Bioavailability of two oral suspension and two oral tablet formulations of acyclovir 400 mg: two single-dose, open-label, randomized, two-period crossover comparisons in healthy Mexican adult subjects.

    Science.gov (United States)

    Palma-Aguirre, Jose Antonio; Absalón-Reyes, Jose Antonio; Novoa-Heckel, Germán; de Lago, Alberto; Oliva, Iván; Rodríguez, Zulema; González-de la Parra, Mario; Burke-Fraga, Victoria; Namur, Salvador

    2007-06-01

    Acyclovir is an important antiviral drug, used extensively for treatment of herpes simplex and varicella zoster. Six oral generic formulations of acyclovir are available in Mexico; however, a literature search failed to identify data information concerning the bioavailability of these formulations in the Mexican population. The aim of these 2 studies was to compare the bioavailability of 4 oral formulations of acyclovir 400 mg--2 tablet formulations and 2 suspension formulations--with their corresponding listed drug references in Mexico (a list issued by Mexican Health Authorities). Two separate, single-dose, open-label, randomized, 2-period crossover studies were conducted at the Centro de Estudios Científicos y Clínicos Pharma, S.A. de C.V. (clinical unit), Mexico City, Mexico. For each study, a different set of eligible subjects were selected. They included healthy Mexican volunteers of either sex. For each study, subjects were randomly assigned to receive 1 test formulation of acyclovir 400 mg followed by the reference formulation, or vice versa, with a 1-week washout period between doses. After a 12-hour (overnight) fast, subjects received a single 400-mg dose (tablet or 10-mL suspension) of the corresponding formulation. For the analysis of pharmacokinetic properties, including C(max), AUC from time 0 (baseline) to time t (AUC(0-t)), and AUC from baseline to infinity (AUC(0-infinity)), blood samples were drawn at baseline, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12, and 24 hours after dosing. The formulations were considered bioequivalent if the natural logarithm (ln)-transformed ratios of Cmax and AUC were within the predetermined equivalence range of 80% to 125% and if P healthy subjects, single, 400-mg doses of the test brand of acyclovir administered either in tablet or suspension form, appeared to be bioequivalent to the reference brand based on the rate and extent of absorption in accordance with the definition of the US Food and Drug

  4. 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.

  5. Pharmacokinetic and bioequivalence comparison of a single 100-mg dose of cefteram pivoxil powder suspension and tablet formulations: a randomized-sequence, open-label, two-period crossover study in healthy Chinese adult male volunteers.

    Science.gov (United States)

    Zou, Jianjun; Di, Bin; Wu, Chun Yong; Hu, Qin; Li, Jian Hua; Zhu, Yubing; Fan, Hongwei; Xiao, DaWei; Wang, Guang Ji

    2008-04-01

    Cefteram pivoxil (CFTM-PI) is an oral antibiotic available in powder suspension and tablet formulations indicated in China for the treatment of bacterial infections. Although these 2 formulations are marketed in China, published information regarding their pharmacokinetics and bioequivalence in the Chinese population is not available. The aim of this study was to compare the pharmacokinetics and bioequivalence of the powder suspension (test) and tablet (reference) formulations of CFTM-PI 100 mg available in China. This single-dose, randomized-sequence, open-label, 2-period crossover study was performed at the Nanjing First Hospital of Nanjing Medical University. Eligible subjects were healthy male volunteers who were randomly assigned at a 1:1 ratio to receive a single 100-mg dose of the test or reference formulation, followed by a 1-week washout period and administration of the alternate formulation. The study drugs were administered after a 12-hour overnight fast. Plasma was assayed using a high-performance liquid chromatography method. For analysis of pharmacokinetic properties, including C(max), AUC from time 0 (baseline) to 6 hours (AUC(0-6)), and AUC from baseline to infinity (AUC(0-infinity)), blood samples were obtained at intervals over the 6-hour period after study drug administration. The formulations were considered bioequivalent if the log-transformed ratios of C(max) and AUC were within the predetermined equivalence range (80%-125%) as established by the US Food and Drug Administration (FDA). Tolerability was assessed by monitoring vital signs and laboratory tests (hematology, blood biochemistry, hepatic function, and urinalysis), and by questioning subjects about adverse events (AEs). Twenty-four Chinese male subjects (mean [range] age,24.2 [23-32] years;weight,64.3 [58-67] kg; height, 172 [167-185] cm) enrolled; all completed the study. No period or sequence effect was observed. The 90% CIs for the log-transformed ratios of C(max), AUC(0-6;), and

  6. Development of YSZ Thermal Barrier Coatings Using Axial Suspension Plasma Spraying

    Directory of Open Access Journals (Sweden)

    Dapeng Zhou

    2017-08-01

    Full Text Available The axial injection of the suspension in the atmospheric plasma spraying process (here called axial suspension plasma spraying is an attractive and advanced thermal spraying technology especially for the deposition of thermal barrier coatings (TBCs. It enables the growth of columnar-like structures and, hence, combines advantages of electron beam-physical vapor deposition (EB-PVD technology with the considerably cheaper atmospheric plasma spraying (APS. In the first part of this study, the effects of spraying conditions on the microstructure of yttria partially-stabilized zirconia (YSZ top coats and the deposition efficiency were investigated. YSZ coatings deposited on as-sprayed bond coats with 5 wt % solid content suspension appeared to have nicely-developed columnar structures. Based on the preliminary results, the nicely developed columnar coatings with variations of the stand-off distances and yttria content were subjected to thermal cycling tests in a gas burner rig. In these tests, all columnar structured TBCs showed relatively short lifetimes compared with porous APS coatings. Indentation measurements for Young’s modulus and fracture toughness on the columns of the SPS coatings indicated a correlation between mechanical properties and lifetime for the SPS samples. A simplified model is presented which correlates mechanical properties and lifetime of SPS coatings.

  7. Establishing "abuse-deterrence equivalence" for generic abuse-deterrent opioid formulations: A proposed development framework.

    Science.gov (United States)

    Setnik, Beatrice; Cone, Edward J

    2016-01-01

    Abuse-deterrent formulations are one strategy for mitigating the epidemic of prescription opioid abuse. Regulatory guidance documents describe the requirements for developing abuse-deterrent formulations of novel drugs and formulations; however, they do not address "abuse-deterrence equivalence" for generic formulations. As generics may be produced with different excipients and formulations compared to reference drugs, differences in their properties may impact their abuse-deterrent features. Currently, it is unclear what specific studies are needed to support generic abuse-deterrence claims. This commentary outlines several recommendations on the in vitro and in vivo testing required, including the conditions for conducting a human abuse potential study.

  8. Development and evaluation of ibuprofen transdermal gel formulations

    African Journals Online (AJOL)

    Carrageenan-induced rat paw oedema model was used for the evaluation of their analgesic and anti-inflammatory activities. 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 ...

  9. Development of New Formulation for Mouth Disintegrating Tablets of ...

    African Journals Online (AJOL)

    The main purpose of the present research work was to mask the bitter taste of the active drug and to formulate the MD tablets by sublimation method. Metoclopramide HCl tablets were prepared by masking the bitter taste with the help of Eudragit E-100, then preparing the tablets by using subliming agents i.e. camphor and ...

  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 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

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

    OpenAIRE

    Luisa M. Manço; Daiane G. Mercurio; Maísa O. Melo; Patrícia M. B. G. Maia Campos

    2014-01-01

    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 behav...

  14. Treatment of anisotropic damage development within a scalar damage formulation

    Science.gov (United States)

    Chan, K. S.; Bodner, S. R.; Munson, D. E.

    This paper is concerned with describing a damage mechanics formulation which provides for non-isotropic effects using a scalar damage variable. An investigation has been in progress for establishing the constitutive behavior of rock salt at long times and low to moderate confining pressures in relation to the possible use of excavated rooms in rock salt formations as repositories for nuclear waste. An important consideration is the effect of damage manifested principally by the formation of shear induced wing cracks which have a stress dependent orientation. The analytical formulation utilizes a scalar damage parameter, but is capable of indicating the non-isotropic dependence of inelastic straining on the stress state and the confining pressure. Also, the equations indicate the possibility of volumetric expansions leading to the onset of tertiary creep and eventually rupture if the damage variable reaches a critical value.

  15. Glass Formulation Development for INEEL Sodium-Bearing Waste

    Energy Technology Data Exchange (ETDEWEB)

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

    1999-08-03

    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{sub 2}, 14.26 mass% B{sub 2}O{sub 3}, 11.31 mass% Fe{sub 2}O{sub 3}, 3.08 mass% TiO{sub 2}, and 2.67 mass % Li{sub 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{center_dot}s, is

  16. 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.

  17. Formulation, development and optimization of raloxifene-loaded chitosan nanoparticles for treatment of osteoporosis.

    Science.gov (United States)

    Saini, Deepa; Fazil, Mohammad; Ali, Mushir M; Baboota, Sanjula; Ali, Javed

    2015-01-01

    Osteoporosis (OP) is a disease of skeletal system and is associated with fragility fracture at the hip, spine and wrist. Various drugs have been used to treat OP. One of them is raloxifene hydrochloride (RLX), a second-generation selective estrogen receptor modulator (SERM) approved by the USFDA. RLX possesses only 2% absolute bioavailability (BA) by oral route due to its extensive first-pass metabolism. The purpose of the current research work was to develop and evaluate RLX-loaded chitosan nanoparticles (CS-NPs) for treatment of OP with enhanced BA. The RLX-loaded CS-NPs were prepared by gelation of CS with tripolyphosphate (TPP) by ionic cross-linking. Formulation was optimized and in vitro drug release and in vivo study were performed. CS-NPs were formed by the ionic gelation method. The particle size, entrapment efficiency and loading efficiency varied from 216.65 to 1890 nm, 32.84 to 97.78% and 23.89 to 62.46%, respectively. Release kinetics showed diffusion-controlled and Fickian release pattern. In vivo study indicated higher plasma drug concentration with NPs administered intranasally as compared to drug suspension administered through oral route (p < 0.05). A significantly higher drug concentration in plasma was achieved in 10 min after nasal administration with respect to oral administration. The results suggest that RLX-loaded CS-NPs have better BA and would be a promising approach for intranasal (i.n.) delivery of RLX for the treatment of OP.

  18. [Psychoanalysis and epistemology: mental development and formulation of theories].

    Science.gov (United States)

    Zysman, Samuel

    2004-01-01

    This paper aims at studying from a psychoanalytical perspective the relationship between the acquisition of knowledge, the formulation of theories based on the generalization of such knowledge, and, what we consider to be an antecedent, the infantile sexual theories (IST). Psychoanalysis is also a psychology of normal psychic processes, among them creative activity which includes scientific thought. This is of interest to psychoanalysts and to epistemologists and paves the way to necessary interdisciplinary endeavors.

  19. Bioprocess development for mass production of size-controlled human pluripotent stem cell aggregates in stirred suspension bioreactor.

    Science.gov (United States)

    Abbasalizadeh, Saeed; Larijani, Mehran Rezaei; Samadian, Azam; Baharvand, Hossein

    2012-11-01

    Current protocols for the scalable suspension culture of human pluripotent stem cells (hPSCs) are limited by multiple biological and technical challenges that need to be addressed before their use in clinical trials. To overcome these challenges, we have developed a novel bioprocess platform for large-scale expansion of human embryonic and induced pluripotent stem cell lines as three-dimensional size-controlled aggregates. This novel bioprocess utilizes the stepwise optimization of both static and dynamic suspension culture conditions. After screening eight xeno-free media in static suspension culture and optimizing single-cell passaging in dynamic conditions, the scale-up from a static to a dynamic suspension culture in the stirred bioreactor resulted in a two- to threefold improvement in expansion rates, as measured by cell counts and metabolic activity. We successfully produced size-specific aggregates through optimization of bioreactor hydrodynamic conditions by using combinations of different agitation rates and shear protectant concentrations. The expansion rates were further improved by controlling oxygen concentration at normoxic conditions, and reached a maximum eightfold increase for both types of hPSCs. Subsequently, we demonstrated a simple and rapid scale-up strategy that produced clinically relevant numbers of hPSCs (∼2×10(9) cells) over a 1-month period by the direct transfer of "suspension-adapted frozen cells" to a stirred suspension bioreactor. We omitted the required preadaptation passages in the static suspension culture. The cells underwent proliferation over multiple passages in the demonstrated xeno-free dynamic suspension culture while maintaining their self-renewal capabilities, as determined by marker expressions and in vitro spontaneous differentiation. In conclusion, suspension culture protocols of hPSCs could be used to mass produce homogenous and pluripotent undifferentiated cells by identification and optimization of key bioprocess

  20. Development of a Refined Rollover Model That Recognizes the Effects of Suspension and Tire Deformation

    Directory of Open Access Journals (Sweden)

    Xiaowen Song

    2013-01-01

    Full Text Available Vehicle rollover represents one of the most dangerous traffic accidents in the world. To improve the antirollover capability of a vehicle, we established an improved rollover model with a particular focus on the effects of independent suspensions and the lateral deformation of the tire. Based on this model, we further developed a new method to mitigate the rollover occurrence by adjusting the stiffness of the spring and the damping coefficient of the damper. Through simulation tests with a brand of SUV, we demonstrated that these adjustments improved the mitigation control as evidenced by better confined steady value and decreased overshoot of the roll angle.

  1. 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.

  2. 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.

  3. Hair care formulations containing argan oil: development, stability and texture profile

    Directory of Open Access Journals (Sweden)

    Stefânia Duz Delsin

    2015-12-01

    Full Text Available The aim of this study was to develop hair care cosmetic formulations containing argan oil to evaluate the stability and texture profile of these formulations. Shampoos, conditioners and leave-in formulations were developed with or without (vehicle argan oil in concentrations of 0.1, 2.0 and 2.0% (w/w respectively. The formulations were stored at room temperature (25°C, 37°C and 45°C for a period of 28 days and submitted to spreadability and texture tests using the Texture Analyser. For this purpose, work of shear and consistency parameters were determined. The results have shown that all formulations were stable and the argan oil-based formulations had a better spreadability when compared with the vehicle. This is a desirable effect, once cosmetic formulations which presents a lower values of work of shear are better accepted by cosmetic sensory panels. In addition, no difference was found between conditioners with or without argan oil in terms of texture profile, and leave-informulation with argan oil showed an increased consistency when compared with the vehicle. Finally, formulations with argan oil showed better the texture profile, therefore, it is a potential ingredient for use in hair care formulations.

  4. Development of formulation multicomponent protein-fat emulsion

    Directory of Open Access Journals (Sweden)

    Y. Kotlyar

    2016-12-01

    Full Text Available The article is based on research of the protein components of different nature analysis. The possibility of their use as components of protein and fat emulsions for the purpose of modeling their optimal formulations for use in the composition of meat pates was proved. Rational individuals’ emulsification process parameters, which guarantee high-quality homogeneous emulsions, were found. The samples of protein and fat emulsions using protein drugs and partial replacement of animal fats fortified blend of vegetable oils, determined by their biological value, rheological, functional and technological properties were investigated. Organoleptic analysis model of meat pates masses were analyzed and recommended percentage of protein and fat emulsions on recipes meat pates are shown.

  5. 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...

  6. Formulation and process development of (recombinant human) deoxyribonuclease I as a powder for inhalation

    NARCIS (Netherlands)

    Zijlstra, Gerrit S; Ponsioen, Bart J; Hummel, Sylvia A; Sanders, Niek; Hinrichs, Wouter L J; de Boer, Anne H; Frijlink, Henderik W

    2009-01-01

    A formulation and process development study was performed to formulate recombinant human deoxyribonuclease I as a powder for inhalation. First, excipient compatibility (with bovine DNase as a model substance) was examined with a stability study at stressed conditions (60 and 85 degrees C) while

  7. Development and Assessment of Countermeasure Formulations for Treatment of Lung Injury Induced by Chlorine Inhalation

    Science.gov (United States)

    Hoyle, Gary W.; Chen, Jing; Schlueter, Connie F.; Mo, Yiqun; Humphrey, David M.; Rawson, Greg; Niño, Joe A.; Carson, Kenneth H.

    2016-01-01

    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. PMID:26952014

  8. 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.

  9. Formulation development of metoprolol succinate and hydrochlorothiazide compression coated tablets.

    Science.gov (United States)

    Shah, Ritesh; Parmar, Swatil; Patel, Hetal; Pandey, Sonia; Shah, Dinesh

    2013-12-01

    The purpose of present research work was to design and optimize compression coated tablet to provide an immediate release of hydrochlorothiazide in stomach and extended release of metoprolol succinate in intestine. Compression coated tablet was prepared by direct compression method which consisted of metoprolol succinate extended release core tablet and hydrochlorothiazide immediate release coat layer. Barrier coating of Hydroxy Propyl Methyl Cellulose (HPMC) E15LV was applied onto the core tablets to prevent burst release of metoprolol succinate in acidic medium. A 32 full factorial design was employed for optimization of the amount of polymers required to achieve extended release of drug. The percentage drug release at given time Q3, Q6, Q10, Q22; were selected as dependent variables. Core and compression coated tablets were evaluated for pharmaco-technical parameters. In vitro drug release of optimized batch was found to comply with Pharmacopoeial specifications. Desired release of metoprolol succinate was obtained by suitable combination of HPMC having high gelling capacity and polyethylene oxide having quick gelling capacity. The mechanism of release of metoprolol succinate from all batches was anomalous diffusion. Optimised batch was stable at accelerated conditions up to 3 months. Thus, compression coated tablet of metoprolol succinate and hydrochlorothiazide was successfully formulated.

  10. Formulation Development and Evaluation of Lyophilized Nasal Inserts for Migraine Treatment.

    Science.gov (United States)

    Harshada, Sarode D; Mundada, Atishkumar S

    2017-01-01

    Nasal inserts are novel, solid, bioadhesive dosage forms administered via nasal route for prolonged systemic drug delivery. The principle of the dosage form is that, after administration nasal inserts imbibe nasal fluid from the mucosa and form a gel in the nasal cavity in order to avoid foreign body sensation. The objective of this investigation was the development of chitosan/xanthan gum based bioadhesive nasal inserts of antimigraine drug. Lyophilization is more usual technique for the preparation of nasal inserts and it is one of the applied methods for drying of solids either in the form of aqueous solution or rarely in the form of aqueous suspension by using freeze dryers. The recent patents on Biocompatible polymer (US20140301972A1), High molecular weight polymers (US20050048121A1), Migraine treatment (WO2009080764A3) helped in selecting the drug and polymers. A 32 factorial design was used to investigate the combined effect of two independent variables such as concentration of Xanthan gum (X1) and the concentration of Chitosan (X2), onto the water uptake, bioadhesion potential and drug release which were the dependent variables. Nine batches of the nasal inserts were developed and evaluated for water uptake at three different pH, bioadhesion potential and drug release. The optimized nasal inserts batch was also characterized by DSC, PXRD and SEM. The results showed that the water uptake ability of nasal insert was strongly influenced by pH of the medium and by polycation/polyanion concentration. This investigation verifies the formation of complexes between chitosan and xanthan gum and confirms the potential of these complexes, in achieving the sustained antimigraine drug delivery in the nasal cavity. The best nasal inserts formulation containing chitosan and xanthan gum in the ratio 0.5:0.5, showed desirable % drug release as well as bioadhesion which may result in an increase in the nasal residence time. Copyright© Bentham Science Publishers

  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. Developing methods to compare tablet formulations of atorvastatin

    Directory of Open Access Journals (Sweden)

    Marcelo Antonio de Oliveira

    2012-12-01

    Full Text Available Atorvastatin (ATV is an antilipemic drug of great interest to the pharmaceutical industry. ATV does not appear in the monographs of Brazilian pharmacopoeia, and analytical methodologies for its determination have been validated. The chromatographic conditions used included: RP-18 column-octadecylsilane (250 x 4.6 mm, 5 mm, detection at 238 nm, mobile phase containing 0.1% phosphoric acid and acetonitrile (35:65% v/v, flow at 1.5 mL min-1, oven temperature at 30ºC, and injection volume of 10 mL. ATV is classified as a class II product, according to the biopharmaceutical classification system. As such, a dissolution test was proposed to evaluate pharmaceutical formulations on the market today, under the following conditions: water as a dissolution medium, 1000 mL as a volume, paddle apparatus at a rotation speed of 50 rpm, 80% (Q in 15 minutes with UV spectrophotometer readings at 238 nm. In the pattern condition proposed as the ideal dissolution test, which appropriately differentiates amongst formulations, the generic product was not considered pharmaceutically equivalent; however, in other less differential dissolution methods, which also fall within appropriate legal parameters, this product could come to be regarded as generic.Atorvastatina (ATV é um fármaco antilipêmico de grande interesse para a indústria farmacêutica. ATV não apresenta monografia na Farmacopéia Brasileira e metodologias analíticas para sua determinação foram validadas. As condições cromatográficas utilizadas foram: coluna RP-18-octadecilsilano (250 x 4.6 mm, 5 mm, detecção em 238 nm, fase móvel contendo ácido fosfórico 0,1% e acetonitrila (35:65% v/v, fluxo de 1,5 mL min-1, temperatura do forno de 30 ºC e volume de injeção de 10 mL. ATV é classificada como um fármaco de classe II, de acordo com o sistema de classificação biofarmacêutica (SCB. Como tal, um teste de dissolução foi proposto para avaliar as formulações farmacêuticas do mercado

  13. Formulation development for the orexin receptor antagonist almorexant: assessment in two clinical studies

    Directory of Open Access Journals (Sweden)

    Dingemanse J

    2014-04-01

    Full Text Available Jasper Dingemanse, Martine Gehin, Hans Gabriel Cruz, Petra HoeverDepartment of Clinical Pharmacology, Actelion Pharmaceuticals Ltd, Allschwil, SwitzerlandAbstract: Almorexant, a dual orexin receptor antagonist, was investigated for the treatment of insomnia. The following observations initiated further formulation development: the active pharmaceutical ingredient (API was sticking to the apparatus used during tablet compression; almorexant has an absolute bioavailability of 11.2%; and almorexant modestly decreased the latency to persistent sleep by 10.4 minutes in patients. Two randomized crossover studies were performed to investigate the pharmacokinetics of several new formulations in healthy subjects. In study I, the old “sticky” tablet was compared to two new formulations developed to prevent sticking: a qualitatively similar tablet but with a larger API crystal size and a tablet with 30% more excipients as well as a larger API crystal size. This latter formulation was available in two strengths. The geometric mean ratios and 90% confidence interval of the area under the curve (AUC were within the bioequivalence range of 0.80–1.25 for the different comparisons between formulations. In study II, 100 mg of the reference tablet was compared to 25 and 50 mg of a liquid-filled hard gelatin capsule developed to increase the bioavailability of almorexant. The geometric mean ratios of the maximum concentration and AUC comparing the new 25 and 50 mg capsule formulations to the reference tablet did not exceed 0.25 and 0.50, respectively, indicating that the new capsule formulation did not increase the maximum concentration of or the total exposure to almorexant. In conclusion, a new tablet was developed but formulation development aimed at increasing the bioavailability of almorexant failed.Keywords: almorexant, orexin receptor antagonist, pharmacokinetics, formulation development, healthy subjects

  14. 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

  15. 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

  16. 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.

  17. Development of a novel parenteral formulation for tetrazepam using a lipid emulsion.

    Science.gov (United States)

    Jumaa, M; Müller, B W

    2001-11-01

    A novel parenteral formulation for tetrazepam (10 mg/ml) was developed using lipid emulsions. This formulation utilized a new lipid emulsion formulation, which was developed by changing the polarity of the oil phase. It was found that increasing the polarity of the oil phase resulted in enhanced solubility of tetrazepam. Tetrazepam showed higher solubility in a mixture of castor oil and middle-chain triglycerides (MCTs) (1:1) than in any other oil investigated. This mixture resulted in low interfacial tension and moderate viscosity, which seemed to be the optimum oil phase. In addition, to increase the concentration of tetrazepam, an emulsion formulation containing 30% oil phase was produced and optimized. The drug-free emulsion formulation showed fine particle sizes with an imperceptible change in physicochemical properties after more than 2 years on the shelf. As a result, it was possible to produce a parenteral emulsion formulation containing 10 mg/ml tetrazepam. No change in the physicochemical properties of the emulsion was observed after the addition of tetrazepam. The tetrazepam emulsion showed stable behavior during the autoclaving process and good shelf stability for at least 10 months as well. Tetrazepam itself also displayed good stability during the autoclaving process and also showed good shelf stability in this emulsion formulation.

  18. 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

    2017-08-04

    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.

  19. Formulation and Development of Dendrimer-Based Transdermal ...

    African Journals Online (AJOL)

    Purpose: To develop transdermal patches of meloxicam (MLX) using chitosan and hydroxypropyl methylcellulose (HPMC) and polyvinyl alcohol (PVA) as hydrophilic polymers, polyamido amine (PAMAM) dendrimer as a permeation enhancer, and dibutyl pthalate as a plasticizer. Methods: The patches were prepared by ...

  20. 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

  1. Drug nanocrystals: four basic prerequisites for formulation development and scale-up.

    Science.gov (United States)

    Srivalli, Kale Mohana Raghava; Mishra, Brahmeshwar

    2015-01-01

    Drug nanocrystals have been studied since the 1990s and there are already six therapeutic nanocrystal products on market and many more in clinical trials. Nanocrystals are encapsulating-carrier free nanoparticles wherein 100% drug loading could be achieved. This signifies that nanocrystals, among other nanoparticulate products, could be more easily manufactured even at the initial formulation development stages to evaluate the effect of size reduction on the bioavailability of drugs. Additionally, a drug nanocrystal is considered not as a generic product but as a "new drug" by FDA. Process characterization, equipment choice, robust formulation and stability are discussed as four basic prerequisites for formulation development and scale-up of drug nanocrystals. The fast growing and relatively superior market profile of nanocrystals amongst other nanoparticle systems is due to their rational formulation design and production simplicity. In this emerging scenario, keeping an eye on the four basic prerequisites can further improve the success of drug nanocrystals.

  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. Aspects of suspension design for the development of advanced gravitational wave detectors

    Science.gov (United States)

    Kumar, Rahul

    The Institute for Gravitational Research in the University of Glasgow in collaboration with the Albert Einstein Institute in Hannover, Golm and the University of Cardiff has been actively involved in the research for the development of instruments and data analysis techniques to detect gravitational waves. This includes construction of a long ground based interferometer in Germany called GEO 600 (upgraded to GEO-HF) having an arm length 600 m and strong involvement in the larger detectors of the LIGO (Laser interferometer gravitational wave observatory) project in USA having arm lengths of 4 km (Operated by MIT, Boston and CALTECH, Pasadena). An upgrade to LIGO called Advanced LIGO (aLIGO) is currently under construction with significant input from the University of Glasgow. Thermal noise is one of the most significant noise sources affecting the sensitivity of the detector at a range of frequencies. Thermal noise arises due to the random fluctuations of atoms and molecules in the materials of the test mass mirrors and suspension elements, and is related to mechanical loss in these materials. The work presented in chapter 3 of this thesis is devoted to the analysis of aspects of mechanical loss and thermal noise in the final stages of the GEO suspension. The work in chapter 4 focuses on the theory of photoelasticty and birefringence techniques. A study of mechanical and thermal stress induced in fused silica has been discussed in chapter 5 of this thesis. To understand the working of photoelastic techniques learned in chapter 4, a study of mechanical stress was undertaken by applying a load on the sample to induce temporary birefringence. A study of thermal stress in fused silica welds has also been presented in chapter 5.

  4. FORMULATION DEVELOPMENT AND EVALUATION OF TERBUTALINE SULPHATE MUCOADHESIVE BUCCAL TABLETS

    OpenAIRE

    Gururaj S.Kulkarni; N.G RaghavendraRao; D.Narasimhareddy

    2013-01-01

    The main objective of developing any new dosage form is reduce the side effects and increase the therapeutic effect of drug in existing dose of dosage form. Mucoadhesive drug delivery system is oral dosage form, where the tablet, gel or patch is attached to the buccal region for direct absorption of drug into blood circulation. This route can prevent the metabolism of drug in G.I tract or liver and side effects of metabolites avoided. In this study, the attempt was made to prepare mucoadhesiv...

  5. 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.

  6. Gastroretentive particles formulated with thiomers: development and in vitro evaluation.

    Science.gov (United States)

    Senyigit, Zeynep Ay; Vetter, Anja; Guneri, Tamer; Bernkop-Schnürch, Andreas

    2010-06-01

    The objective of this study is to develop and evaluate gastroretentive particulate delivery systems using Riboflavin-5'-monophosphate sodium salt dihydrate (RF5'PNa) as model drug. Poly(acrylic acid)-cysteine and chitosan-4-thiobuthylamidine were evaluated and compared as anionic and cationic polymers for gastroretentive particles. Permeation studies were performed with freshly excised stomach mucosa from rats. Polymers and combination with glutathione were evaluated for permeation enhancing properties. Furthermore, particles were prepared by air jet milling and characterized. Permeation studies showed that the apparent permeability coefficients for RF5'PNa with thiomers and glutathione are 1.511-fold and 2.354-fold higher than control, respectively. It can be seen from the results glutathione in combination with thiomers has a significant influence for increasing permeation. Poly(acrylic acid)-cysteine and chitosan-4-thiobuthylamidine particles demonstrated a mean diameter of 336.5 +/- 16.5 and 396.3 +/- 17.0 nm and zeta potential of -19.98 +/- 1.015 and 27.15 +/- 0.500 mV, respectively. The drug loading of Poly(acrylic acid) particles was significantly higher than chitosan particles. The release rate of RF5'PNa from the thiolated particles was slower compared with unmodified particles. Moreover, thiolated particles showed higher mucoadhesive properties compared to unmodified particles. Overall, thiolated particles of both anionic and cationic polymers had improved mucoadhesive and controlled release properties. Therefore, they could be promising for gastroretentive delivery systems.

  7. Recent advances and novel strategies in pre-clinical formulation development: an overview.

    Science.gov (United States)

    Shah, Amit K; Agnihotri, Sunil A

    2011-12-20

    Preclinical profiling for a New Chemical Entity (NCE), if carried out carefully, can be a good predictor of human clinical outcome. Along with the pre-clinical study design a thorough understanding of the physico-chemical properties of the drug candidate and a careful selection of the formulation development strategy are of high importance. The study scientist can experience various challenges in executing a pre-clinical study. This review article provides an overview of the significance of pre-formulation study parameters and their relevance to preclinical studies. Various physico-chemical properties such as solubility, partition co-efficient, and permeability are attributes critical to the performance of the drug substance. This article presents unique formulation development strategies for the successful completion of pre-clinical studies. Formulation development approach for a pre-clinical study involves taking into consideration various important factors such as duration of the study, Biopharmaceutics Classification System (BCS) of the drug, intended duration of action and the desired route of administration. These parameters play key role in the selection of solubilizers, surfactants, co-solvents and optimum pH for the formulation. Two most common routes of administration in the early screening of pharmaceuticals viz., oral and intravenous are emphasized. The article also describes recent advances in preclinical formulation development including selected examples of in vivo preclinical models for anti-cancer, anti-viral, anti-diabetic and anti-hypertensive drugs. Adherence to the regulatory requirement is also the key to successful completion of the preclinical development. An overview of preclinical formulation development along with basic concepts and the recent studies conducted in the past decade are presented in this review. Copyright © 2011 Elsevier B.V. All rights reserved.

  8. Antidepressant-like activity of liposomal formulation containing nimodipine treatment in the tail suspension test, forced swim test and MAOB activity in mice.

    Science.gov (United States)

    Moreno, Lina Clara Gayoso E Almendra Ibiapina; Rolim, Hercília Maria Lins; Freitas, Rivelilson Mendes; Santos-Magalhães, Nereide Stela

    2016-09-01

    Previous studies have shown that intracellular calcium ion dysfunction may be an etiological factor in affective illness. Nimodipine (NMD) is a Ca(2+) channel blocker that has been extensively investigated for therapy of central nervous system (CNS) disorders. In this work, we have evaluated the antidepressant-like activity of nimodipine encapsulated into liposomes (NMD-Lipo) in mice through tail suspension and forced swim assays, as well as MAOB activity. During the tail suspension test, the administration of NMD-Lipo at 0.1, 1 and 10mg/kg was able to promote a reduction in the immobility time of animals greater than the positive control (imipramine). In the forced swim test, the immobility time of mice treated with NMD-Lipo was reduced. This reduction was significantly greater than that found in the animals treated with imipramine and paroxetine. This may suggest that NMD-Lipo provides more antidepressant-like activity than in positive controls. The groups that received a combination of liposomal NMD and antidepressant drugs showed lower immobility time than the groups, which were treated only with imipramine or paroxetine. The mice treated with the combination of NMD-Lipo and reserpine presented an increase in the time of immobility compared with animals treated only with NMD-Lipo. There was a significant decrease in MAOB activity in animals treated with NMD-Lipo compared with untreated animals. The results of the tail suspension test, forced swim test and MAOB activity suggested that the antidepressant activity of NMD-Lipo may be related to an increase in the cerebral monoamine concentrations. Copyright © 2016 Elsevier B.V. All rights reserved.

  9. 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.

  10. 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.

  11. Development and evaluation of matrix material formulations for potential integration into immunodiagnostic biosensors

    Science.gov (United States)

    Aminayi, Payam

    This study supports the development, characterization and optimization of biosensor material formulations for immunodiagnostic applications based on experimental findings and hypotheses by Wang and Wu [1, 2], and using a test-plate apparatus and thin-film design developed by Young [3]. (Abstract shortened by ProQuest.).

  12. Development of a particle-settling tolerant transmission Raman scheme for analysis of suspension samples.

    Science.gov (United States)

    Shin, Kayeong; Duy, Pham Khac; Park, Sijun; Woo, Young-Ah; Chung, Hoeil

    2014-06-07

    We have demonstrated a simple and effective strategy, the so-called axial illumination scheme, that is able to obtain representative Raman spectra of suspension samples with minimal influence from internal particle settling. In a partially settled suspension sample, since particle concentrations at given points throughout the sample differ, the acquisition of Raman spectra representative of the entire sample composition is critically important for accurate quantitative analysis. The proposed scheme used axially irradiated laser radiation in the same or opposite direction of settling, thus allowing laser photons to migrate through the settling-induced particle-density gradient formed in the suspension and to widely interact with particles regardless of their settled locations. Therefore, transmitted Raman signals gathered opposite to the illumination could be more representative of the overall suspension composition even with partial settling. In this study, the performance of axial illumination schemes (TB (Top-to-Bottom) and BT (Bottom-to-Top) illumination) was evaluated for the determination of the aceclofenac (a non-steroidal anti-inflammatory drug) concentration in suspensions. Although the spectral features exhibited minute variations during settling, settling did not significantly degrade the accuracy of the concentration determination, thereby indicating effective acquisition of settling-tolerant Raman spectra. In addition, the characteristics of photon migration in a partially settled suspension sample were studied using a simulation based on Monte-Carlo method.

  13. Highly efficient miniaturized coprecipitation screening (MiCoS) for amorphous solid dispersion formulation development.

    Science.gov (United States)

    Hu, Qingyan; Choi, Duk Soon; Chokshi, Hitesh; Shah, Navnit; Sandhu, Harpreet

    2013-06-25

    Microprecipitated bulk powder (MBP) is a novel solid dispersion technology to manufacture amorphous formulations of poorly soluble compounds that cannot be processed by spray drying or melt extrusion. An efficient high-throughput screening method has been developed to aid the selection of polymer type, drug loading and antisolvent to solvent ratio for MBP formulation development. With a 96-well platform, the miniaturized coprecipitation screening (MiCoS) includes mixing of drug and polymer in dimethylacetamide, controlled precipitation to generate MBP, filtration/washing, drying and high throughput characterization. The integrated MiCoS approach has been demonstrated with a model compound, glybenclamide. Based on the solid state stability and kinetic solubility of the MBP, hydroxypropylmethylcellulose acetate succinate polymer with 40% or lower drug loading, and antisolvent (0.01 N HCl) to solvent (dimethylacetamide) ratio of 5:1 or higher were selected to make glybenclamide MBP. MiCoS can be applied to both early and late stage formulation processing. In early stage research programs, the system can be used to enable efficacy, pharmacokinetics or mini-toxicology studies for poorly water soluble molecules using minimal amount of drug substance (2-10mg). In late stage development programs, MiCoS can be used to optimize MBP formulation by expanding the experimental design space to include additional formulation variants. Copyright © 2013 Elsevier B.V. All rights reserved.

  14. Development and validation of HPLC analytical method for nepafenac in ophthalmic dosage form (suspension).

    Science.gov (United States)

    Usman, Shahnaz; Akram, Muhammad; Aziz, Asif; Ramesh, Venkat; Sarheed, Omar Abdulraheem

    2014-09-01

    The aim of the present study was to develop and validate an analytical method for the estimation of nepafenac as a raw material as well as in dosage form (suspension) by using reverse phase high performance liquid chromatographic (RP-HPLC). The target was to obtain an easy, rapid, reproducible as well as a rugged method. The HPLC system that was used in the proposed study was LC-20AD liquid chromatograph equipped with SPD-20A UV-VIS detector. The separation was performed on C18 column which was attached with loop 20 β l. Elution was done at ambient temperature with a mobile phase consisting of acetonitrile: Water (40: 60v/v) at a flow rate of 1ml/min and at a wavelength of 254 nm. The proposed method was validated as per the ICH guidelines. The retention time for nepafenac was 7.49 minutes (% CV=0.0076). The percentage coefficient variation (CV) of six consecutive peak areas of injections was 0.34% with tailing factor 1.76. The peak area responses were linear within the concentration range of 0.078-20.0 βg/ml (R(2)=0.9993). The sensitivity of the method could be evaluated by limits of detection (LOD) (0.0195 β g/ml) and limits of quantitation (LOQ) (0.039 β g/ml). Nepafenac drug is s in its diluent that could see by intra-day (% CV =0.45-1.96) and inter-day variation (%CV=0.173-1.898%). The accuracy and recovery results of 80%, 100% and 120% were 97.40% to 102.10% with % CV of 0.3201% to 1.3496%. The robustness and ruggedness of the method are significantly broader and is reproducible. It could be used as a more convenient, efficient, easy and time saving method for the analysis of drug in raw material as well as in dosage form (ophthalmic suspension).

  15. 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.

  16. Formulation development and evaluation of lamivudine controlled release tablets using cross-linked sago starch.

    Science.gov (United States)

    Singh, Akhilesh Vikram; Nath, Lila Kanta

    2013-02-01

    Modified starches based polymeric substances find utmost applicability in pharmaceutical formulation development. Cross-linked starches showed very promising results in drug delivery application. The present investigation concerns with the development of controlled release tablets of lamivudine using cross-linked sago starch. The cross-linked derivative was synthesized with phosphorous oxychloride and native sago starch in basic pH medium. The cross-linked sago starch was tested for acute toxicity and drug-excipient compatibility study. The formulated tablets were evaluated for various physical characteristics, in vitro dissolution release study and in vivo pharmacokinetic study in rabbit model. In vitro release study showed that the optimized formulation exhibited highest correlation (R) in case of zero order kinetic model and the release mechanism followed a combination of diffusion and erosion process. There was a significant difference in the pharmacokinetic parameters (T(max), C(max), AUC, V(d), T(1/2), and MDT) of the optimized formulation as compared to the marketed conventional tablet Lamivir®. The cross-linked starch showed promising results in terms of controlling the release behavior of the active drug from the matrix. The hydrophilic matrix synthesized by cross-linking could be used with a variety of active pharmaceutical ingredients for making their controlled/sustained release formulations.

  17. Formulation and Development of a Validated UV-Spectrophotometric Analytical Method of Rutin Tablet

    Directory of Open Access Journals (Sweden)

    Murad N. Abualhasan

    2017-01-01

    Full Text Available Rutin is available in some foods, fruits, and vegetables. It has various beneficial medical effects making it useful in the treatment of various diseases. Rutin is available in different oral dosage forms such as tablets or capsules, widely available in the market. Rutin and many herbal medicines lack quality control due to unavailability of analytical methods. In this study, we formulated rutin tablet and studied its stability using a simple developed analytical method. The dissolution profile of our formulated tablet was also inspected. The results showed that our developed method was linear (R2=0.999, precise (% RSD = 0.026, and accurate (% recovery = 98.55–103.34. The formulated rutin tablet was stable under accelerated conditions as well as room temperature for 150 days (% assay > 91.69. The dissolution profile over 45 minutes of our formulated tablet showed a better dissolution (26.5% compared with the internationally marketed Rutin® tablet (18.5%. This study can serve as a guideline to companies that manufacture herbal products to improve their formulated herbs and apply validated analytical methods to check the quality of their product.

  18. Development and Evaluation of Stability of a Gel Formulation Containing the Monoterpene Borneol

    Directory of Open Access Journals (Sweden)

    Milla Gabriela Belarmino Dantas

    2016-01-01

    Full Text Available Borneol is a bicyclic monoterpenoid alcohol commonly used in traditional Chinese and Indian medicine. It is extracted from the essential oil of various medicinal plants. It has antibacterial, analgesic, and anti-inflammatory action proven in studies that used oral and intraperitoneal applications of this monoterpene in mice. The current study was designed to develop a topical gel formulation containing the monoterpene borneol using carbopol as gel base and to evaluate its stability. The prepared formulation was subjected to physical characterization and physical-chemistry assessment. The gel was prepared from carbopol and 5% of borneol. The prepared gel was subjected to pharmacotechnical tests such as its pH, viscosity, conductivity, spreadability, centrifugation, and accelerated stability with freezing-thaw cycle. The borneol was successfully incorporated into the carbopol formulation. Borneol gel (BG5 showed good stability after eight months of its development and after 12 days in the freeze-thaw cycle, not showing statistical difference in pH value, conductivity, and viscosity before and after test. Furthermore, the formulation showed a good spreadability. Therefore, it was concluded that the formulation could be very promising alternative for the topical or transdermal treatment of skin diseases.

  19. Cryonic Suspension and the Law.

    Science.gov (United States)

    Smith, George P.; Hall, Clare

    1987-01-01

    Analyzes three central problems which adversely affect use, development, and perfection of cryonic suspension of individuals: the extent to which a physician may be guilty of malpractice in assisting with a suspension; the need for a recognition of suspension; and the present effect of the law's anachronistic treatment of estate devolution upon a…

  20. Development of Solid Self-Emulsifying Formulation for Improving the Oral Bioavailability of Erlotinib.

    Science.gov (United States)

    Truong, Duy Hieu; Tran, Tuan Hiep; Ramasamy, Thiruganesh; Choi, Ju Yeon; Lee, Hee Hyun; Moon, Cheol; Choi, Han-Gon; Yong, Chul Soon; Kim, Jong Oh

    2016-04-01

    To improve the solubility and oral bioavailability of erlotinib, a poorly water-soluble anticancer drug, solid self-emulsifying drug delivery system (SEDDS) was developed using solid inert carriers such as dextran 40 and Aerosil® 200 (colloidal silica). The preliminary solubility of erlotinib in various oils, surfactants, and co-surfactants was determined. Labrafil M2125CS, Labrasol, and Transcutol HP were chosen as the oil, surfactant, and co-surfactant, respectively, for preparation of the SEDDS formulations. The ternary phase diagram was evaluated to show the self-emulsifying area. The formulations were optimized using the droplet size and polydispersity index (PDI) of the resultant emulsions. Then, the optimized formulation containing 5% Labrafil M2125CS, 65% Labrasol, and 30% Transcutol was spray dried with dextran or Aerosil® and characterized for surface morphology, crystallinity, and pharmacokinetics in rats. Powder X-ray diffraction (PXRD) and differential scanning calorimetry (DSC) exhibited the amorphous form or molecular dispersion of erlotinib in the formulations. The pharmacokinetic parameters of the optimized formulations showed that the maximum concentration (C max) and area under the curve (AUC) of erlotinib were significantly increased, compared to erlotinib powder (p < 0.05). Thus, this SEDDS could be a promising method for enhancing the oral bioavailability of erlotinib.

  1. 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.

  2. 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.

  3. Development and formulation of metformin (Antidiabetic) effervescent Granules: to increase patient compliance and its stability study.

    Science.gov (United States)

    Nazir, Saeedur Rashid; Ambreen, Ghazala; Irfan, Hafiz Muhammad; Bashir, Sajid; Rauf, Asim

    2014-07-01

    Convenience of administration and patient compliance are gaining importance in the formulation of dosage forms. Many patients, like elderly people and person with dysphagia find difficulty to swallow the tablets and thus do not comply with prescriptions. So the present study was conducted to develop and formulate metformin effervescent granules. The stability study was carried out for 24 weeks (168 days) at temperatures of 4°C, Room temperature, 40°C & 60°C and at the end, the %age of drug remaining in the formulation was determined. The results showed that the formulation of metformin effervescent granules were remained best stable at 4°C in refrigerator, as the %age of drug remaining is not decreased more than 5% and the formulation stored at room temperature, was also found to be very close to the standard at the end of 24 weeks. It is concluded from the study that granules may be another dosage form to use as antidiabetic pharmaceutical product.

  4. 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.

  5. Development and validation of a microbial counting method for mebendazole oral suspension

    Directory of Open Access Journals (Sweden)

    Polyana Araújo de Assis

    2011-09-01

    Full Text Available Mebendazole is an important medicine used to treat helminth infections. These infections affect more than two billion people worldwide. The LAFEPE® (Recife-PE, Brazil produces the drug mebendazole oral suspension that contains the preservatives methylparaben and propylparaben in its formulation. Drugs that have antimicrobial properties due to preservatives must undergo neutralization of these compounds to allow microbial count testing according to recommendations by the official compendia. In order to obtain a validated method for microbial counting and to ensure its safety and reliability within the pharmaceutical industry, validation of preservative neutralization and of the method for microbial counting was performed according to the USP 30 and PDA Technical Report No. 33. The method used ATCC Gram positive and Gram negative microorganisms, yeasts, most and culture media Tryptic Soy Agar and Sabouraud dextrose agar. The neutralizers were polysorbate 80 and lecithin. Recovery levels of over 70% of the microorganisms used in the test indicated the neutralization of antimicrobial activity and proved the absence of toxicity of neutralizers. The microbial counting method validated proved accurate, precise, robust and linear and can be safely used in routine operations.O mebendazol é um importante medicamento utilizado no tratamento de infecções por helmintos. Essas infecções afetam mais de dois bilhões de pessoas em todo o mundo. O LAFEPE (Recife-PE, Brasil produz o medicamento mebendazol suspensão oral, que possui em sua formulação os conservantes metilparabeno e propilparabeno. Em medicamentos que possuem propriedades antimicrobianas em decorrência dos conservantes faz-se necessária a neutralização da ação desses compostos para a realização do teste de contagem microbiana segundo preconizado pelos compêndios oficiais. A fim de obter um método de contagem microbiana validado e que garanta sua segurança e reprodutibilidade

  6. The effect of severe stress on early brain development, attachment, and emotions: a psychoanatomical formulation.

    Science.gov (United States)

    Vela, Ricardo M

    2014-12-01

    Child abuse is the most extreme form of stress in childhood and adolescence, and has severe effects on the child's development. Limbic nuclei and circuitry development are especially vulnerable to child abuse and neglect during the first year of life. Development at the neuronal level can be severely disturbed by trauma during early infancy, resulting in maladaptive synaptic formation, impeding experience-expectant brain development. Development of basic emotions may favor the development of negative instead of positive emotions. The new concept of psychoanatomical formulation is introduced. A case vignette is presented and analyzed, based on the disturbed neuroanatomy underlying symptom expression. Copyright © 2014 Elsevier Inc. All rights reserved.

  7. Formulation, development and validation of insulin loaded particulate systems for their oral administration

    OpenAIRE

    Diop, Mouhamadou

    2015-01-01

    Insulinotherapy helps diabetics to regulate their glycaemia. This thesis is part of the ORAIL Bis project which aims to develop an oral insulin delivery system based on the double encapsulation of insulin. The developed vector is composed of a capsule containing insulin loaded particles (NPs) formulated with chitosan (CS) by complex coacervation or poly (lactic-co-glycolic) acid (PLGA) by double emulsion solvent evaporation. The objectives of the thesis are to stabilize chitosan NPs by crossl...

  8. Eunice Kennedy Shriver National Institute of Child Health and Human Development Pediatrics Formulation Initiative: proceedings from the Second Workshop on Pediatric Formulations.

    Science.gov (United States)

    Giacoia, George P; Taylor-Zapata, Perdita; Zajicek, Anne

    2012-11-01

    The Eunice Kennedy Shriver National Institute of Child Health and Human Development of the National Institutes of Health (NIH) organized a workshop held in November 2011 to address knowledge gaps that limit the availability of adequate pediatric formulations. This workshop was used as a means to identify the types of research innovations needed and to stimulate research efforts designed to improve the availability of pediatric formulations and the technologies required to make these formulations. Information for this article was gathered from the proceedings of the Second US PFI Workshop sponsored by the Eunice Kennedy Shriver National Institute of Child Health and Human Development in Bethesda, Maryland, on November 1 and 2, 2011, as well as from post-workshop discussions. The workshop preparation began with formation of 4 working groups: Biopharmaceutics, Biopharmaceutics Classification System (BCS), New Technology and Drug Delivery Systems, and Taste and Flavor. The recommendations of the 4 working groups will form the basis for the development of a blueprint to guide future research efforts. The pediatric-specific problems identified include the heterogeneity of the population, the small size of the pediatric drug market, the limited number of new formulations for the large number of off-patent and unlabeled drugs, and the lack of universal agreement on how to define appropriate formulations for different ages and stages of development. There was consensus on the need to develop a universal technology platform for flexible pediatric dosage forms, transforming an empirical process into a science-based platform. A number of problems affect the availability of drugs in the developing world. Age-appropriate solid oral pediatric medicines for common diseases can have a global impact. Success on a global scale depends on the commitment of policy makers, regulators, scientists, pharmaceutical companies, sponsors, government, and research foundations to address gaps in

  9. Efinaconazole topical solution, 10%: formulation development program of a new topical treatment of toenail onychomycosis.

    Science.gov (United States)

    Bhatt, V; Pillai, R

    2015-07-01

    Transungual drug delivery of antifungals is considered highly desirable to treat common nail disorders such as onychomycosis, due to localized effects, and improved adherence resulting from minimal systemic adverse events. However, the development of effective topical therapies has been hampered by poor nail penetration. An effective topical antifungal must permeate through, and under the dense keratinized nail plate to the site of infection in the nail bed and nail matrix. We present here the formulation development program to provide effective transungual and subungual delivery of efinaconazole, the first topical broad spectrum triazole specifically developed for onychomycosis treatment. We discuss the important aspects encompassing the formulation development program for efinaconazole topical solution, 10%, focusing on its solubility in a number of solvents, in vitro penetration through the nail, and in vivo efficacy. Efinaconazole topical solution, 10% is a stable, non-lacquer, antifungal with a unique combination of ingredients added to an alcohol-based formulation to provide low surface tension and good wetting properties. This low surface tension is believed to affect effective transungual delivery of efinaconazole and believed to provide a dual mode of delivery by accessing the nail bed by wicking into the space between the nail and nail plate. © 2015 Wiley Periodicals, Inc. and the American Pharmacists Association.

  10. Formulating Assessment Indices and Strategies for the Transition to Local Industrial Development in Taoyuan City, Taiwan

    Directory of Open Access Journals (Sweden)

    Yung-Cheng Pan

    2017-03-01

    Full Text Available Local industries are crucial for enhancing urban competitiveness and are closely related to national economic performance. To sustainably develop local industries, a set of assessment indices should be formulated in addition to factors such as geographical environments, cultural history, development processes, and industrial structures for governments to promote development policies while satisfying the goal of sustainable industrial development. This study first adopted the fuzzy Delphi method to construct the indices for assessing local industrial development, referred to the action plans for the six key industries formulated by the Executive Yuan of Taiwan, and subsequently integrated the analytic hierarchy process and analytic network process to determine the order of priority for policies facilitating local industrial development for future reference. The results indicated that infrastructure, innovative research and development, and government policies are crucial bases for local industrial development. Furthermore, this study adopted Taoyuan to verify these indices and compiled expert suggestions to indicate that the government should prioritize the development of the biotechnology, green energy, and medical care industries. When developing local industries in the future, a set of assessment standards and policy analyses should be established for the government to enhance local industrial development and thus increase international competitive advantages by fully ascertaining the factors for industrial success and the characteristics of local advantages.

  11. 24 CFR 21.670 - Suspension.

    Science.gov (United States)

    2010-04-01

    ... 24 Housing and Urban Development 1 2010-04-01 2010-04-01 false Suspension. 21.670 Section 21.670... GOVERNMENTWIDE REQUIREMENTS FOR DRUG-FREE WORKPLACE (GRANTS) Definitions § 21.670 Suspension. Suspension means an... CFR part 9, subpart 9.4) and the common rule, Government-wide Debarment and Suspension (Nonprocurement...

  12. Periodate salts as pyrotechnic oxidizers: development of barium- and perchlorate-free incendiary formulations.

    Science.gov (United States)

    Moretti, Jared D; Sabatini, Jesse J; Chen, Gary

    2012-07-09

    In a flash: pyrotechnic incendiary formulations with good stabilities toward various ignition stimuli have been developed without the need for barium or perchlorate oxidizers. KIO(4) and NaIO(4) were introduced as pyrotechnic oxidizers and exhibited excellent pyrotechnic performance. The periodate salts may garner widespread use in military and civilian fireworks because of their low hygroscopicities and high chemical reactivities. Copyright © 2012 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

  13. Diffuse reflectance near infrared-chemometric methods development and validation of amoxicillin capsule formulations

    Directory of Open Access Journals (Sweden)

    Ahmed Nawaz Khan

    2016-01-01

    Full Text Available Objective: The aim of present study was to establish near infrared-chemometric methods that could be effectively used for quality profiling through identification and quantification of amoxicillin (AMOX in formulated capsule which were similar to commercial products. In order to evaluate a large number of market products easily and quickly, these methods were modeled. Materials and Methods: Thermo Scientific Antaris II near infrared analyzer with TQ Analyst Chemometric Software were used for the development and validation of the identification and quantification models. Several AMOX formulations were composed with four excipients microcrystalline cellulose, magnesium stearate, croscarmellose sodium and colloidal silicon dioxide. Development includes quadratic mixture formulation design, near infrared spectrum acquisition, spectral pretreatment and outlier detection. According to prescribed guidelines by International Conference on Harmonization (ICH and European Medicine Agency (EMA developed methods were validated in terms of specificity, accuracy, precision, linearity, and robustness. Results: On diffuse reflectance mode, an identification model based on discriminant analysis was successfully processed with 76 formulations; and same samples were also used for quantitative analysis using partial least square algorithm with four latent variables and 0.9937 correlation of coefficient followed by 2.17% root mean square error of calibration (RMSEC, 2.38% root mean square error of prediction (RMSEP, 2.43% root mean square error of cross-validation (RMSECV. Conclusion: Proposed model established a good relationship between the spectral information and AMOX identity as well as content. Resulted values show the performance of the proposed models which offers alternate choice for AMOX capsule evaluation, relative to that of well-established high-performance liquid chromatography method. Ultimately three commercial products were successfully evaluated

  14. Diffuse reflectance near infrared-chemometric methods development and validation of amoxicillin capsule formulations.

    Science.gov (United States)

    Khan, Ahmed Nawaz; Khar, Roop Krishen; Ajayakumar, P V

    2016-01-01

    The aim of present study was to establish near infrared-chemometric methods that could be effectively used for quality profiling through identification and quantification of amoxicillin (AMOX) in formulated capsule which were similar to commercial products. In order to evaluate a large number of market products easily and quickly, these methods were modeled. Thermo Scientific Antaris II near infrared analyzer with TQ Analyst Chemometric Software were used for the development and validation of the identification and quantification models. Several AMOX formulations were composed with four excipients microcrystalline cellulose, magnesium stearate, croscarmellose sodium and colloidal silicon dioxide. Development includes quadratic mixture formulation design, near infrared spectrum acquisition, spectral pretreatment and outlier detection. According to prescribed guidelines by International Conference on Harmonization (ICH) and European Medicine Agency (EMA) developed methods were validated in terms of specificity, accuracy, precision, linearity, and robustness. On diffuse reflectance mode, an identification model based on discriminant analysis was successfully processed with 76 formulations; and same samples were also used for quantitative analysis using partial least square algorithm with four latent variables and 0.9937 correlation of coefficient followed by 2.17% root mean square error of calibration (RMSEC), 2.38% root mean square error of prediction (RMSEP), 2.43% root mean square error of cross-validation (RMSECV). Proposed model established a good relationship between the spectral information and AMOX identity as well as content. Resulted values show the performance of the proposed models which offers alternate choice for AMOX capsule evaluation, relative to that of well-established high-performance liquid chromatography method. Ultimately three commercial products were successfully evaluated using developed methods.

  15. Evaluation of the suspending properties of two local Opuntia spp. mucilages on paracetamol suspension.

    Science.gov (United States)

    Gebresamuel, Naod; Gebre-Mariam, Tsige

    2013-01-01

    Some excipients are currently available for the formulation of pharmaceutical suspensions. The purpose of this study is to develop cheap and effective natural excipient that can be used as an effective alternative for the formulation of pharmaceutical suspensions. The suspending properties of Opuntia ficus-indica and Opuntia stricta mucilages (family Cactaceae) were evaluated comparatively with that of NaCMC at concentration range of 2-6% (w/v) in Paracetamol suspension. Sedimentation volume (%) (with and without electrolyte), rheology, redispersibility, and dissolution rate of the suspensions were employed as evaluation parameters. The values obtained were used as basis for comparison of the suspending agents. The apparent viscosities of the suspensions in all the suspending agents concentration levels and applied shear rates were in the order of NaCMC>OS>OFI with non-Newtonian flow and accordingly the flow rates of the suspensions were in the order of OFI > OS > NaCMC. The sedimentation volumes (%) of the suspensions in all the suspending agent concentration levels were higher for OS followed by OFI and then NaCMC. The high sedimentation volumes (%) of suspensions, in turn, were accompanied by ease of redispersibility of that order. The effect of electrolyte on sedimentation volume (%) had dual effect. It was only the suspensions that had NaCMC that showed increase in sedimentation volume (%) in all molar NaCl concentration. However, in suspensions that had mucilages of OS and OFI, an initial increase in sediment volumes (%) were accompanied by decrease after 1x10(-3)M and 1x10(-2)M of NaCl, respectively. Dissolution of the suspensions which had mucilages attained the acceptable ranges (> 80% drug release in 30 min) in 5 min. Similarly, except A6 formulations A2, A3, A4 and A5 have attained the limit but the release was not as quick as the previous formulations. Hence, it can be concluded that mucilages of Opuntia spp. (Opuntia ficus-indica and Opuntia stricta

  16. Developing Emotion-Based Case Formulations: A Research-Informed Method.

    Science.gov (United States)

    Pascual-Leone, Antonio; Kramer, Ueli

    2017-01-01

    New research-informed methods for case conceptualization that cut across traditional therapy approaches are increasingly popular. This paper presents a trans-theoretical approach to case formulation based on the research observations of emotion. The sequential model of emotional processing (Pascual-Leone & Greenberg, 2007) is a process research model that provides concrete markers for therapists to observe the emerging emotional development of their clients. We illustrate how this model can be used by clinicians to track change and provides a 'clinical map,' by which therapist may orient themselves in-session and plan treatment interventions. Emotional processing offers as a trans-theoretical framework for therapists who wish to conduct emotion-based case formulations. First, we present criteria for why this research model translates well into practice. Second, two contrasting case studies are presented to demonstrate the method. The model bridges research with practice by using client emotion as an axis of integration. Key Practitioner Message Process research on emotion can offer a template for therapists to make case formulations while using a range of treatment approaches. The sequential model of emotional processing provides a 'process map' of concrete markers for therapists to (1) observe the emerging emotional development of their clients, and (2) help therapists develop a treatment plan. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

  17. Design and development of a stable polyherbal formulation based on the results of compatibility studies

    Science.gov (United States)

    Bhope, Shrinivas G.; Nagore, Dheeraj H.; Kuber, Vinod V.; Gupta, Pankaj K.; Patil, Manohar J.

    2011-01-01

    Introduction: Ayurvedic and herbal medicinal products contain a combination of botanicals; each of these contains a number of chemical compounds that may give the anticipated activity in combination. Therefore, it is very important to analyze and evaluate the compatibility of various active constituents and markers from different medicinal plants for their possible chemical interactions with various excipients at different storage conditions during the development of a stable polyherbal formulation. Objective: To study chemical stability of kalmegh (Andrographis paniculata) and kutki (Picrorhiza kurroa) extract for their active markers andrographolide, kutkoside and picroside-I and to develop stable polyherbal formulation based on the incompatibility studies. Materials and Methods: The compatibility study was carried out on individual ethanolic extracts of these two plants along with the commonly used excipients in the ratio of 1:1 at 40 ± 2°C and 75 ± 5% relative humidity and at a refrigeration temperature of 5 ± 1°C for initial, 7-, 15- and 30-day intervals. The analysis was carried out using the validated reverse phase–high-performance liquid chromatography methods. A stable tablet dosage form was developed based on the results of these studies. Result: The study suggested that the active markers of kutki (kutkoside and picroside-I) were found to be degraded in the presence of the kalmegh extract. However, the active marker of the kalmegh extract (andrographolide) was found to be stable. Both the extracts showed excellent compatibility with all the excipients used in making this formulation. No significant decrease in the kutkoside and picroside-I content from the formulation was observed. Conclusion: By separate granulation process the exposure of both the extracts can be minimized thus avoiding the degradation of active markers. PMID:21772756

  18. Development and characterization of gastroretentive sustained-release formulation by combination of swelling and mucoadhesive approach: a mechanistic study.

    Science.gov (United States)

    Sankar, R; Jain, Subheet Kumar

    2013-01-01

    Acyclovir has pharmacokinetic limitations, including poor oral bioavailability of 15%-30%, high variability, and short elimination half-life of 2.3 hours. These limitations necessitate frequent administration of acyclovir, up to five times daily, leading to poor patient compliance, which in turn leads to a reduction in therapeutic efficacy and development of resistance. A gastroretentive sustained-release (GR) formulation of acyclovir, based on a combination of swelling and mucoadhesive mechanisms, has been developed. Composition has been optimized after evaluation of different polymers, carbomer, polyethylene oxide, and sodium alginate alone and/or in combination. GR formulations were characterized for in-process quality-control tests, drug release and release rate kinetics, similarity factor analysis, swelling index, and matrix erosion. A formulation containing a combination of carbomer and polyethylene oxide had the highest similarity of drug release compared with a target drug-release profile obtained by pharmacokinetic simulations. The measurement of mucoadhesive strength, carried out with a texture analyzer, showed that the mucoadhesive strength of the GR formulation was significantly higher than that of the immediate-release (IR) tablet. The optimized GR formulation was found to be retained in the upper part of the gastrointestinal tract for 480 minutes; the IR tablet was retained for only 90 minutes as measured using a gastrointestinal retention study in albino rabbits. The GR formulation was also found to maintain more sustained plasma concentrations than the IR tablet. Mean residence time of the GR formulation was 7 hours versus 3.3 hours for the IR formulation. The relative bioavailability of the GR formulation was 261% of the IR formulation. The GR formulation of acyclovir, based on swelling and mucoadhesive mechanisms, has prolonged retention in the upper gastrointestinal tract, sustained in vitro drug release, prolonged in vivo absorption, and better

  19. [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.

  20. 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.

  1. Effect of hydroxypropyl-β-cyclodextrin on the stability of cisapride in oral suspensions

    Directory of Open Access Journals (Sweden)

    Jutima Boonleang

    2010-12-01

    Full Text Available Cisapride (CIS is a gastrointestinal prokinetic agent. It has been associated with rare, but serious cardiac side effects.However, it does not affect psychomotor functions or induce central depressant adverse effects. As liquid formulations arerequired in a number of cases, an oral suspension of CIS was developed from CIS tablets. The objective of this study was toinvestigate the effect of hydroxypropyl--cyclodextrin (HP--CD on the stability of CIS in oral suspension with an ultimateaim to formulate a more stable CIS oral suspension. Six batches of CIS oral suspensions, namely, 0 (control, 0.3, 1.6, and 3%HP--CD containing formulations were prepared. They were stored at 5°C and 30°C. The amounts of CIS in the suspensionswere determined by a validated stability-indicating HPLC-DAD method. The stability was assessed based on the 90%remaining. The changes in the amounts of CIS over time were statistically analyzed by ANOVA and ANCOVA. At 5°C, HP--CD had no significant effect on the stability of CIS. CIS in all four formulations was stable for at least 12.5 months. At 30°C,HP--CD affected the stability of CIS. CIS was most stable in 0.3% HP--CD containing formulation with the observed t90 ofapproximately 11 months as compared to 7 months in control formulation.

  2. 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...

  3. 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.

  4. 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...

  5. Development and evaluation of liposomal formulation containing nimodipine on anxiolytic activity in mice.

    Science.gov (United States)

    Moreno, Lina Clara Gayoso E Almendra Ibiapina; da Silva Oliveira, Giselle Zayra; Cavalcanti, Isabella Macário Ferro; Santos-Magalhães, Nereide Stela; Rolim, Hercília Maria Lins; de Freitas, Rivelilson Mendes

    2014-01-01

    Nimodipine has been investigated in the treatment of anxiety. Its administration, however, presents a number of limitations, particularly by low bioavailability, low aqueous solubility and photosensitivity. These difficulties can be resolved by the use of nanometer-scale pharmaceutical carriers. The goal of the present study was thus to develop a liposomal formulation containing nimodipine (NMD-Lipo) and evaluate anxiolytic activity using models of anxiety (open-field, light and dark and elevated plus-maze test). The results suggest that administration of NMD-Lipo has no sedative or muscle relaxant effect in animals, since there was no reduction in the number of crossings, grooming and rearings. The increased residence time of the animals treated with NMD-Lipo in the bright field is a reflection of the anxiolytic-like activity of the formulation. Furthermore, the reduction in residence time of rodents treated with the combination of flumazenil and NMD-Lipo in the illuminated box suggests that NMD-Lipo acts on benzodiazepine receptors. The increase in the number of entries and length of stay in the open arms of mice treated with NMD-Lipo suggests that anxiolytic activity of formulation and reduction in number of entries and length of stay in open arms of rodents treated with a combination of flumazenil and NMD-Lipo suggest that NMD-Lipo act on benzodiazepine receptors. © 2013.

  6. 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.

  7. 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.

  8. 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.

  9. 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

  10. Development of Vitrification Process and Glass Formulation for Nuclear Waste Conditioning

    Energy Technology Data Exchange (ETDEWEB)

    Petitjean, V.; Fillet, C.; Boen, R.; Veyer, C.; Flament, T.

    2002-02-26

    The vitrification of high-level waste is the internationally recognized standard to minimize the impact to the environment resulting from waste disposal as well as to minimize the volume of conditioned waste to be disposed of. COGEMA has been vitrifying high-level waste industrially for over 20 years and is currently operating three commercial vitrification facilities based on a hot metal crucible technology, with outstanding records of safety, reliability and product quality. To further increase the performance of vitrification facilities, CEA and COGEMA have been developing the cold crucible melter technology since the beginning of the 1980s. This type of melter is characterized by a virtually unlimited equipment service life and a great flexibility in dealing with various types of waste and allowing development of high temperature matrices. In complement of and in parallel with the vitrification process, a glass formulation methodology has been developed by the CEA in order to tailor matrices for the wastes to be conditioned while providing the best adaptation to the processing technology. The development of a glass formulation is a trade-off between material properties and qualities, technical feasibility, and disposal safety criteria. It involves non-radioactive and radioactive laboratories in order to achieve a comprehensive matrix qualification. Several glasses and glass ceramics have thus been studied by the CEA to be compliant with industrial needs and waste characteristics: glasses or other matrices for a large spectrum of fission products, or for high contents of specifics elements such as sodium, phosphate, iron, molybdenum, or actinides. New glasses or glass-ceramics designed to minimize the final wasteform volume for solutions produced during the reprocessing of high burnup fuels or to treat legacy wastes are now under development and take benefit from the latest CEA hot-laboratories and technology development. The paper presents the CEA state

  11. Histology of embryoid development in oil palm (Elaeis guineensis Jacq. cell suspension culture

    Directory of Open Access Journals (Sweden)

    Songrat Tinnongjig

    2001-11-01

    Full Text Available Embryos of oil palm (Elaeis guineensis Jacq. variety tenera were cultured on Eeuwens or Y3 (1976; 1978 medium supplemented with 2 mg/l 2,4-D. Calluses were initiated from these embryos. The eight-weekold calluses derived from embryos were transferred to modified Y3 liquid medium devoid of 2,4-D and supplemented with NAA, BA and coconut water to establish cell suspension culture. After a period of culture,these cells were then subcultured to the same medium without plant growth regulators to induce embryoid formation. The calluses and embryoids were harvested at various times, fixed, sectioned, stained and examined microscopically. Histological study revealed that embryoid occurred from meristematic cells with dense cytoplasm along the callus clumps.

  12. Development and evaluation of a new alcohol-based surgical hand scrub formulation with persistent antimicrobial characteristics and brushless application.

    Science.gov (United States)

    Hobson, D W; Woller, W; Anderson, L; Guthery, E

    1998-10-01

    Since the introduction in the 1970s of surgical hand scrub formulations that contain 4% chlorhexidine gluconate (CHG), new surgical scrub formulations that have improved efficacy, persistence, or significantly improved use characteristics have not been forthcoming. In addition, the manufacturer's labeling for popular hand scrub products generally requires scrub times in excess of 6 minutes, whereas current practical needs call for products with substantially shorter scrub times. A new alcohol-based surgical scrub formulation, which has ingredients that provide emollient, surfactant, and antimicrobial persistence characteristics to complement the rapid and broad-spectrum antiseptic qualities of alcohol, has been developed in an effort to address these current practical needs. The relative efficacy of a new alcohol-based surgical scrub formulation that contains ingredients that provide surfactant and antimicrobial persistence characteristics was compared with that of commercial 4% CHG and 7.5% povidone iodine (PVPI) formulations with use of human subjects. Hand antimicrobial count sampling was performed by using standardized "glove juice" methodology. The efficacy and persistence results of the new formulation showed statistically significant improvement over both CHG and PVPI at a substantially lessened scrub time (3 minutes). In addition, use of the new formulation without a scrub brush produced results statistically similar to 3-minute applications with either a brush or a sponge. The new alcohol-based formulation demonstrates promise as a new surgical hand scrub formulation with antimicrobial and use characteristics that are significantly improved over current CHG and PVPI formulations. These studies demonstrate the suitability of this formulation for use as a surgical hand scrub and for brushless application.

  13. Striking the Optimal Solubility-Permeability Balance in Oral Formulation Development for Lipophilic Drugs: Maximizing Carbamazepine Blood Levels.

    Science.gov (United States)

    Beig, Avital; Miller, Jonathan M; Lindley, David; Dahan, Arik

    2017-01-03

    The purpose of this research was to investigate the performance of cosolvent based solubility-enabling formulations in oral delivery of lipophilic drugs, accounting for the gastrointestinal tract (GIT) luminal solubilization processes, the solubility-permeability interplay, and the overall in vivo systemic absorption. The poorly soluble antiepileptic agent carbamazepine was formulated in three cosolvent-based formulations: 20%, 60%, and 100% PEG-400, and the apparent solubility and rat permeability of the drug in these formulations were evaluated. The performance of the formulations in the dynamic GIT environment was assessed utilizing the biorelevant pH-dilution method. Then, the overall in vivo drug exposure was investigated following oral administration to rats. The three formulations showed dramatic solubility and permeability differences; the 100% PEG-400 provided the highest solubility enhancement and the 20% the poorest, while the exact opposite was evident from the permeability point of view. The dissolution results indicated that the 20% PEG-400 formulation crashes quickly following oral administration, but both the 60% and the 100% PEG-400 formulations allowed full solubilization of the dose throughout the entire GIT-like journey. The best in vivo performing formulation was the 60% PEG-400 (F sys > 90%), followed by the 100% PEG-400 (F sys = 76%), and the 20% PEG-400 formulation (F sys ≈ 60%). In conclusion, this work demonstrates the in vivo solubility-permeability trade-off in oral delivery of lipophilic drugs; when a solubility-enabling formulation is developed, minimal threshold solubility should be targeted, that is just enough to allow solubilization of the drug dose throughout the GIT, while excess solubilizer should be avoided.

  14. 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.

  15. Microsponge based drug delivery system for augmented gastroparesis therapy: Formulation development and evaluation

    Directory of Open Access Journals (Sweden)

    Riyaz Ali M. Osmani

    2015-10-01

    Full Text Available The intention behind the present work was to develop a microsponge based novel dosage form for sustained delivery of domperidone. Quasi-emulsion solvent diffusion method was employed using Eudragit RS-100 with various drug–polymer ratios for the preparation of microsponges. For optimization purposes, several factors which affect microparticles' physical properties were investigated. Characterization techniques followed for the formed microsponges were DSC, FTIR, SEM, XRD and particle size analysis, along with morphology, drug loading and in vitro drug release. It was found that there were no chemical interactions between drugs and polymers used as per DSC and FTIR results. The drug–polymer ratio showed remarkable impact on drug content, encapsulation efficiency and particle size. SEM micrographs revealed that microsponges were spherical in shape with porous surface, and had 104 ± 0.22 µm mean particle size. The microsponges were then loaded in capsules followed by in vitro drug release study; which depicted that microsponges with drug–polymer ratio of 1:2 were more proficient to give extended drug release of 76.38% at the end of 8 h, superior in contrast to conventional marketed formulation Domstal®, which got exhausted incredibly earlier by releasing 82.57% drug at the end of ½ h only. Hence, the developed microsponge based formulation of domperidone would be an expectant, promising substitute to conventional therapy of gastroparesis, emesis and alike gastric ailments.

  16. 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.

  17. 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

    2013-01-01

    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 3D rod array for aerosol deaggregation. Computational fluid dynamics simulations of a previously developed deaggregation parameter, the 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 (FPF) less than 5µm and 1µm of 95.1% and 31.4%, respectively, and a MMAD=1.5µm. 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. PMID:24307605

  18. Development of ultraviolet spectroscopic method for the estimation of metronidazole benzoate from pharmaceutical formulation.

    Science.gov (United States)

    Mishra, Arun K; Kumar, Arvind; Mishra, Amrita; Mishra, Hari V

    2014-07-01

    The present study was undertaken with an objective to develop a simple, accurate, cost-effective and reproducible ultraviolet spectrophotometric method for the estimation of metronidazole benzoate (MB) from pharmaceutical formulations. The analysis was performed on λmax 268 nm by using 0.1 NHCl as diluents. The proposed method was validated on International Conference Harmonization guideline including the parameters viz., accuracy, linearity, precision, specificity and reproducibility. The proposed method was also used to access the content of MB in two commercial brands of Indian market. Beer's law was obeyed in the concentration range of 1-10 μg/ml having regression equation y = 0.078 x-0.012. The accuracy value for 4 μg/ml and 5 μg/ml concentration of MB was found to be 99.37% and 98.9% respectively. The relative standard deviation of interday and intraday was lesser than 1%. The developed method was applied on two different marketed brands and contents of MB were found to be 98.62% and 98.59% incompliance with labeled claim. The results were under the limit of acceptance statistically. It was concluded that the proposed method can be used for routine analysis of MB in bulk and commercial formulations.

  19. 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.

  20. Megestrol acetate NCD oral suspension--Par Pharmaceutical: megestrol acetate nanocrystal dispersion oral suspension, PAR 100.2, PAR-100.2.

    Science.gov (United States)

    2007-01-01

    Par Pharmaceutical has developed megestrol acetate (Megace ES) oral suspension for the treatment of anorexia, cachexia and a significant weight loss associated with AIDS. Par Pharmaceutical used Elan Corporation's NanoCrystal Dispersion (NCD) technology to develop an advanced, concentrated formulation of megestrol acetate with improved bioavailability, more rapid onset of action, more convenient dosing and a lower dosing regimen compared with the original marketed formulation of megestrol acetate oral suspension. Patients are administered a teaspoon (5mL) of the new NCD formulation once daily, compared with a daily 20mL dosage cup of the original formulation. The new megestrol acetate NCD formulation represents a line-extension of Par's megestrol acetate oral suspension (800mg/20mL, Megace O/S) that has been marketed for anorexia, cachexia and AIDS-related weight loss since July 2001. Par's megestrol acetate is the generic version of Bristol-Myers Squibb's Megace Oral Suspension. NanoCrystal Dispersion (NCD) is a trademark of Elan Corporation. Par Pharmaceutical will market megestol acetate NCD oral suspension under the Megace brand name. The company licensed the Megace name from Bristol-Myers Squib in August 2003. The US FDA approved megestrol acetate oral suspension (625 mg/mL) in July 2005 for the treatment of anorexia, cachexia or a significant, unexplained weight loss in patients with AIDS. The NDA for the product was accepted for review by the agency in September 2004, following its submission in June of that year.Par Pharmaceutical commenced the first of two phase III clinical trials of megestrol acetate oral suspension (PAR 100.2) in cancer-induced anorexia in the first quarter of 2006. However, this trial was discontinued in September 2006 because of slow patient enrolment. The company intends to discuss future development options in this indication with the FDA.New formulations or dosage forms of megestrol acetate concentrated suspension are also in

  1. Development of new formulations of Bacillus subtilis for management of tomato damping-off caused by Pythium aphanidermatum

    Energy Technology Data Exchange (ETDEWEB)

    Jayaraj, J.; Radhakrishnan, N.V.; Kannan, R.; Sakthivel, K.; Suganya, D.; Venkatesan, S.; Velazhahan, R. [Simon Fraser University, Burnaby, B (Canada). Dept. of Biological Science

    2005-02-15

    Formulations of a strain of Bacillus subtilis AUBS-1 inhibitory to the growth of the damping-off pathogen, Pythium aphanidermatum, were developed for seed treatment. The formulations included a talc-based powder, lignite-based powder, lignite + fly ash-based powder, wettable powder, bentonite-paste, polyethylene glycol (PEG) paste and a water-dispersible tablet. Formulations were stored at room temperature for 2 years and frequently sampled to test their shelf life. Populations of bacteria in the formulations were stable for up to 2 years storage at room temperature (28{degree}C). Viability of propagules in lignite, lignite + fly ash, bentonite paste, wettable powder and water dispersible tablet formulations was 100% for up to 1 year. However, the viability of propagules was significantly reduced in talc, wettable powder, PEG paste and tablet formulations beyond 1 year of storage. Seed treatment of tomato with these formulations resulted in effective control of damping-off caused by P. aphanidermatum, and also enhanced plant biomass under glasshouse and field conditions. Active rhizosphere colonization by the bacterium was observed on tomato plants grown from seeds treated with the above formulations.

  2. 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

  3. Systematic Approach to Formulate PSS Development Project Proposals in the Fuzzy Front End

    DEFF Research Database (Denmark)

    Barquet, Ana Paula B.; Pigosso, Daniela Cristina Antelmi; Rozenfeld, Henrique

    2013-01-01

    be considered by companies during this definition. The systematization of PSS attributes may help increase the knowledge about different PSS projects that can emerge in the front end, thus leading to the discovery of opportunities that are not apparent in the existing business models and give rise to new ideas......Product-service systems (PSS) adoption has increased over the last years due to its potential for innovative value creation. However, the identification of ideas and opportunities in the innovation planning and the structuring of PSS projects are still incipient in organizations, following the same...... patterns adopted for product development. Currently, there is not a systematic approach that can be followed for the formulation of PSS proposals in the fuzzy front end. Therefore, the aim of this research is to develop a method for defining PSS project proposals based on attributes that should...

  4. Glass Formulation Development for INEEL Sodium -Bearing Waste (FY2001 WM-180)

    Energy Technology Data Exchange (ETDEWEB)

    Peeler, D.K.

    2001-09-21

    A systematic study was undertaken to develop a glass composition to demonstrate the vitrification flowsheet of the Idaho National Engineering and Environmental Laboratory's sodium bearing waste (SBW) using the latest WM-180 tank composition. Although the previous study did not restrict waste loadings (WLs) based on the potential to form a segregated salt layer, avoiding its development in a melter is beneficial and was the primary focus from the glass-formulation perspective. The testing results described in this report were aimed at providing a candidate glass composition for use in a scaled melter demonstration of direct vitrification of WM-180 in the Research Scale Melter (RSM) at Pacific Northwest National Laboratory and the EV-16 melter at the Clemson Environmental Technology Laboratory.

  5. Development of a Bacillus sphaericus tablet formulation and its evaluation as a larvicide in the biological control of Culex quinquefasciatus

    Directory of Open Access Journals (Sweden)

    Flávia P Morais de Medeiros

    2005-07-01

    Full Text Available This study aimed to analyze the final fermentation culture of Bacillus sphaericus 2362, standardize it and develop an active tablet formulation for use in urban mosquito breeding sites. It was performed in three phases: analysis and standardization of a B. sphaericus fermented culture; physical, chemical, and biological analysis of the active powder (solubility, residual humidity, particle size, resting angle, flowing off time, compacted density, and biological activity against Culex quinquefasciatus larvae; and the development of fast-disintegrating tablets. Five formulations with differing compositions were developed and a UV protector was added to the selected formulation. The formulation products with or without UV protector, as well as the active powder caused 100% larval mortality from 1 day to 2 months after a single treatment under simulated field conditions. These results show that the UV protector does not affect the initial larvicide activity of B. sphaericus, nor its persistence over a period of two months.

  6. Development of a process using electron beam for a terminal sterilization for parenteral formulations of pharmaceuticals

    Science.gov (United States)

    Matagne, D.; Delbar, N.; Hartmann, H.-J.; Gray, M.; Stickelmeyer, M.

    2004-09-01

    As pharmaceutical technology advances and sensitive drug formulations demand ever-greater stability, radiation processing is likely the only alternative that can be used to terminally sterilize thermo-labile pharmaceutical products intended for parenteral administration. To this end, a radiation process using e-beam technology has been developed. A key feature of this process is the elucidation of defined conditions of radiation processing in order to achieve the homogeneity of the absorbed dose inside a single vial and throughout a tray containing several vials. Results of several dosimetry studies, using e-beam technology, demonstrate the beneficial effects of the use of aluminum or stainless-steel plates to scatter the beam and therefore to obtain an excellent Dmax/ Dmin across all dose-monitoring positions within the vial and throughout a tray containing 260 vials filled with a dry powder or a tray containing approximately 30 vials filled with an aqueous solution. This ionizing radiation process can be directly applicable, at a manufacturing level, for a terminal sterilization of parenteral formulations of pharmaceuticals.

  7. Development of a process using electron beam for a terminal sterilization for parenteral formulations of pharmaceuticals

    Energy Technology Data Exchange (ETDEWEB)

    Matagne, D. E-mail: matagne_daniel_m@lilly.com; Delbar, N.; Hartmann, H.-J.; Gray, M.; Stickelmeyer, M

    2004-10-01

    As pharmaceutical technology advances and sensitive drug formulations demand ever-greater stability, radiation processing is likely the only alternative that can be used to terminally sterilize thermo-labile pharmaceutical products intended for parenteral administration. To this end, a radiation process using e-beam technology has been developed. A key feature of this process is the elucidation of defined conditions of radiation processing in order to achieve the homogeneity of the absorbed dose inside a single vial and throughout a tray containing several vials. Results of several dosimetry studies, using e-beam technology, demonstrate the beneficial effects of the use of aluminum or stainless-steel plates to scatter the beam and therefore to obtain an excellent D{sub max}/D{sub min} across all dose-monitoring positions within the vial and throughout a tray containing 260 vials filled with a dry powder or a tray containing approximately 30 vials filled with an aqueous solution. This ionizing radiation process can be directly applicable, at a manufacturing level, for a terminal sterilization of parenteral formulations of pharmaceuticals.

  8. 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.

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

    Directory of Open Access Journals (Sweden)

    Tyler Pentek

    2017-01-01

    Full Text Available 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.

  10. Development, characterization and in vivo localization study of topical 5-fluorouracil gels: a comparative study with conventional formulation.

    Science.gov (United States)

    Jain, Subheet Kumar; Puri, Richa

    2014-01-01

    5-Fluorouracil (5-FU) is one of the most effective antineoplastic agents used for the treatment of skin cancers and actinic keratosis (AK). Currently commercial formulation for topical 5-FU administration is available in the form of solution or cream. Commercial topical formulations are associated with the limitation of very short retention time at the administration site resulting in very poor skin permeation and deposition of drug. In the present study attempt was made for the preparation, optimization and characterization of bioadhesive gel formulations for localized delivery of 5-FU. Four bioadhesive gel formers, Carbopol 934, Carbopol 980, Methylcellulose (MC) and Poloxamer 188 were selected for the preparation of 5-FU bioadhesive gel formulations. The formulations were characterized for characteristic parameters including bioadhesive strength, skin deposition and interaction study. Carbopol 934 based bioadhesive gel formulation at the concentration of 1.5% w/w showed the best physicochemical properties such as viscosity (2670±12.2 cP), which was similar to the value obtained with the marketed cream (2870±14.4 cP), highest skin deposition (1290±56.4μg) and bioadhesive strength (18.62 gf). Cutaneous irritation of optimized bioadhesive gel formulations was also tested using the Draize test and only very slight erythema and no oedema was observed. In comparison, marketed formulation showed well defined erythema along with oedema formation. The result of the present study demonstrated that formulation of Carbopol 934 based 5-FU bioadhesive gel is a better alternative to the traditional cream base for enhanced topical delivery of 5-FU. The developed formulation will have the ease of application, better skin deposition and sustained release characteristic with reduced skin toxicity.

  11. Independent suspension

    National Research Council Canada - National Science Library

    Chaikin, Don

    1992-01-01

    ... independent suspension. INDEPENDENCE! An independent system is simply one in which each of the vehicle's wheels is free to react totally separate from any of the other wheels. If the right rear wheel hits a bump, the left rear wheel is undisturbed. Since the whole car does not bounce and shake every time one of the wheels hits a potho...

  12. Development and characterization of gastroretentive sustained-release formulation by combination of swelling and mucoadhesive approach: a mechanistic study

    Directory of Open Access Journals (Sweden)

    Sankar R

    2013-12-01

    Full Text Available R Sankar,1 Subheet Kumar Jain1,2 1Department of Pharmaceutical Sciences and Drug Research, Punjabi University, Patiala, Punjab, India; 2Department of Pharmaceutical Sciences, Guru Nanak Dev University, Amritsar, Punjab, India Background: Acyclovir has pharmacokinetic limitations, including poor oral bioavailability of 15%–30%, high variability, and short elimination half-life of 2.3 hours. These limitations necessitate frequent administration of acyclovir, up to five times daily, leading to poor patient compliance, which in turn leads to a reduction in therapeutic efficacy and development of resistance. Methods: A gastroretentive sustained-release (GR formulation of acyclovir, based on a combination of swelling and mucoadhesive mechanisms, has been developed. Composition has been optimized after evaluation of different polymers, carbomer, polyethylene oxide, and sodium alginate alone and/or in combination. GR formulations were characterized for in-process quality-control tests, drug release and release rate kinetics, similarity factor analysis, swelling index, and matrix erosion. Results: A formulation containing a combination of carbomer and polyethylene oxide had the highest similarity of drug release compared with a target drug-release profile obtained by pharmacokinetic simulations. The measurement of mucoadhesive strength, carried out with a texture analyzer, showed that the mucoadhesive strength of the GR formulation was significantly higher than that of the immediate-release (IR tablet. The optimized GR formulation was found to be retained in the upper part of the gastrointestinal tract for 480 minutes; the IR tablet was retained for only 90 minutes as measured using a gastrointestinal retention study in albino rabbits. The GR formulation was also found to maintain more sustained plasma concentrations than the IR tablet. Mean residence time of the GR formulation was 7 hours versus 3.3 hours for the IR formulation. The relative

  13. Use of Curcuma longa in cosmetics: extraction of curcuminoid pigments, development of formulations, and in vitro skin permeation studies

    Directory of Open Access Journals (Sweden)

    Gisele Mara Silva Gonçalves

    2014-12-01

    Full Text Available Curcuma longais a ginger family aromatic herb (Zingiberaceae whose rhizomes contain curcuminoid pigments, including curcumin, a compound known for its anti-inflammatory effects. The objective of this study was to obtain curcuminoid-rich extracts, develop topical formulations thereof, and assess the stability and skin permeation of these formulations. Curcuma longa extracts were obtained and used to develop formulations. Skin permeation studies were conducted in a modified Franz diffusion cell system, and skin retention of curcuminoid pigments was quantified in pig ear membrane. Prepared urea-containing gel-cream formulations were unstable, whereas all others had satisfactory stability and pseudoplastic rheological behavior. The amount of curcuminoid pigments recovered from the receptor solution was negligible. The skin concentration of curcuminoid pigments retained was positive (>20 µg/g of skin, mostly in the stratum corneum, considering the low skin permeability of curcumin. We conclude that development of topical formulations containing curcumin or Curcuma longaextract is feasible, as long as adjuvants are added to improve preservation and durability. The formulations developed in this study enabled penetration of curcumin limited to the superficial layers of the skin and then possibly without a risk of systemic action, thus permitting local use as a topical anti-inflammatory.

  14. 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.

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

    Science.gov (United States)

    Santini, Benedetta; Zanoni, Ivan; Marzi, Roberta; Cigni, Clara; Bedoni, Marzia; Gramatica, Furio; Palugan, Luca; Corsi, Fabio; Granucci, Francesca; Colombo, Miriam

    2015-01-01

    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.

  16. Development of nutraceutical formulations based on the mycelium of Pleurotus ostreatus and Agaricus bisporus.

    Science.gov (United States)

    Cardoso, Rossana V C; Fernandes, Ângela; Oliveira, M Beatriz P P; Calhelha, Ricardo C; Barros, Lillian; Martins, Anabela; Ferreira, Isabel C F R

    2017-06-21

    The present work is aimed at developing nutraceutical formulations based on the mycelium of Agaricus bisporus and Pleurotus ostreatus, highlighting the potential of in vitro culture as a tool to improve the production of bioactive compounds, namely phenolic acids and ergosterol. The mycelia of both species were cultured in different solid and liquid media in order to compare the growth rate and yielded biomass. Fruiting bodies, mycelia and culture media were compared regarding the antioxidant activity, anti-inflammatory effects in RAW264.7 cells and cytotoxicity in human tumor cell lines and non-tumor porcine liver cells. P. ostreatus mycelia showed higher contents of ergosterol and phenolic compounds, and stronger antioxidant activity than the corresponding fruiting body. P. ostreatus and A. bisporus did not show anti-inflammatory activity, and P. ostreatus was the only one showing cytotoxicity in tumor cell lines. The results show that these mushrooms provide compounds with antioxidant and cytotoxic capacities, with variations among species.

  17. Design and development of a workflow for microbial spray formulations including decision criteria.

    Science.gov (United States)

    Bejarano, Ana; Sauer, Ursula; Preininger, Claudia

    2017-10-01

    Herein, we present a workflow for the development of talc-based microbial inoculants for foliar spray consisting of four steps. These include together with decision-making criteria (1) the selection of additives based on their capability to wet juvenile maize leaves, (2) their adhesion on the plant, (3) their interaction with the biological systems, and (4) the choice of thickener for good dispersion stability. In total, 29 additives including polysaccharides and proteins, polyols, glycosides, oils, waxes, and surfactants (e.g., chitosan, gelatin, glycerol, saponin, castor oil, polyethylene, rhamnolipid) were evaluated. Contact angle and spreading index measurements revealed that the use of 5% Geloil, 1% rhamnolipid, or suitable combinations of Geloil + rhamnolipid and Nurture Yield S 2002 + rhamnolipid enhanced wetting of hydrophobic maize leaves and adherence, similarly to the commercial wetting agents recommended for plant protection 1% Prev B2 and 1% Trifolio S Forte. Interaction of additives with biological systems was based on biocompatibility and phytotoxicity assays, and cell viability monitoring using the endophytic Gram-negative bacterium Paraburkholderia phytofirmans PsJN. Results from biocompatibility assays indicated that in contrast to rhamnolipid and Prev B2 Geloil, Nurture Yield S 2002 and Trifolio S Forte fully supported bacterial growth within a concentration range of 1 to 5%. Dose-dependent phytotoxicity was observed in plants treated with rhamnolipid. Most efficient formulation was composed of PsJN, talc, xanthan, and Geloil. Beyond that, the proposed workflow is expected to generally provide guidance for the development of spray formulations and help other researchers to optimize their choices in this area.

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

    OpenAIRE

    Kornhauser, Andrija; Coelho, Sergio G.; Hearing, Vincent J.

    2012-01-01

    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 ...

  19. Development and characterization of a novel PRESAGE formulation for radiotherapy applications

    Energy Technology Data Exchange (ETDEWEB)

    Mostaar, A. [Department of Medical Physics and Biomedical Engineering, Shahid Beheshti University of Medical Sciences, Tehran (Iran, Islamic Republic of); Department of Medical Physics, Tarbiat Modares University, Al-Ahmad and Chamran Cross, PO Box 14115151, Tehran 1411713116 (Iran, Islamic Republic of); Hashemi, B., E-mail: bhashemi@modares.ac.ir [Department of Medical Physics, Tarbiat Modares University, Al-Ahmad and Chamran Cross, PO Box 14115151, Tehran 1411713116 (Iran, Islamic Republic of); Zahmatkesh, M.H. [Novin Medical Radiation Institute, Tehran (Iran, Islamic Republic of); Aghamiri, S.M.R. [Department of Radiation Medicine, Shahid Beheshti University, Tehran (Iran, Islamic Republic of); Mahdavi, S.R. [Department of Medical Physics, Tehran University of Medical Sciences, Tehran (Iran, Islamic Republic of)

    2011-10-15

    A novel water equivalent formulation of PRESAGE dosimeter more suitable for radiotherapy applications has been introduced and its radiological water equivalency has been investigated. Furthermore, its radiological properties have been compared with an existing PRESAGE formulation over an energy range from 10 to 20 MeV. Monte Carlo simulation method has been implemented to determine and compare depth dose profiles in both of the PRESAGE formulations at two different photon energies (140 KV{sub P} and 6 MV). The results show that our proposed PRESAGE formulation is more water equivalent than its known formulation especially for low photon energy beams. - Highlights: > A novel PRESAGE formulation is introduced and compared with the common PRESAGE dosimeter. > Mass density calculations indicate that the novel and common PRESAGE formulations both are not a good water equivalent material. > Effective atomic number of the novel PRESAGE formulation is nearly the same as those of muscle and water. > Radiation transport parameters of the novel PRESAGE formulation are very closer to that of water. > Novel PRESAGE dosimeter is a better water equivalent material especially at low photon energies.

  20. 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 <110 pg/mL over Weeks 12-20; following TAcs, plasma TA peaked at 4 h (9628.8 pg/mL), decreased to 4991.1 pg/mL at 24 h, and was 149.4 pg/mL at Week 6, the last post-treatment time point assessed. AEs were similar between groups. In knee OA patients, microsphere-based TA delivery via a single 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.

  1. Design, characterization, and evaluation of meloxicam gel prepared by suspension and solution polymerization using solubility parameter as the basis for development.

    Science.gov (United States)

    Jain, Deepika; Pathak, Kamla

    2010-03-01

    Meloxicam gel was designed based on the matching of the solubility parameter (delta) of the drug with that of the polymer and subsequently with skin for improved dermal delivery of meloxicam. The delta of meloxicam (11.48 (cal/cm(3))(0.5)) determined by solubility measurement was matched statistically to the solubility parameter of monomers, n-vinyl-2-pyrrolidone, polyvinyl alcohol (PVA), hydroxyl ethyl methacrylate, ethylene glycol methacrylate (EGMA) determined by intrinsic viscosity measurement. Consequently gels were formulated by polymerization in selected solvent blend of water/ethyl acetate (20:80) in which the drug showed maximum solubility. Thus, F1-F16 formulations designed were evaluated for physicochemical properties, textural analysis, and in vitro drug release. On the basis of optimum characteristics, F2 (PVA, delta = 16.96 (cal/cm(3))(0.5)) and F8 (EGMA, delta = 18.35 (cal/cm(3))(0.5)) formulated by suspension polymerization were selected and subjected to skin irritation and topical anti-inflammatory studies. The formulation F8 demonstrated significant (p < 0.05) of anti-inflammatory activity in comparison to marketed piroxicam gel and was free from irritation.

  2. 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.

  3. 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.

  4. Formulation Development of Mouth Dissolving Film of Etoricoxib for Pain Management

    Directory of Open Access Journals (Sweden)

    K. Senthilkumar

    2015-01-01

    Full Text Available Etoricoxib is a potent, orally active, and highly selective COX-2 inhibitor that exhibits anti-inflammatory, analgesic, and antipyretic activities. The present research was undertaken to develop mouth dissolving films of etoricoxib to have rapid onset of action. Mouth dissolving film (MDF is a better alternate to oral disintegrating tablets due to its novelty, ease of use, and the consequent patient compliance. Solubility enhancement and taste masking of etoricoxib were the two challenges solved by formulating drug-inclusion complex with beta-cyclodextrin (BCD. MDF prepared by solvent casting etoricoxib-BCD complex along with HPMC as film forming polymer was found to possess desirable physicomechanical properties. In vitro release of etoricoxib from MDF in simulated salivary fluid and 0.1 N HCl was more than 95% within 2 minutes. Taste masking and in vivo disintegration were in acceptable range as assessed by human volunteers. Etoricoxib MDF was further characterized by differential scanning calorimetry, powder X-ray diffraction, and scanning electron microscopy. The index of analgesia shown by etoricoxib MDF was comparable to that of immediate release tablets (100% activity within 40 minutes in animal studies. Conclusively, the present study documents the development of a commercially viable formula for an MDF of etoricoxib with rapidity in pain management.

  5. Mixture design approach for early stage formulation development of a transdermal delivery system.

    Science.gov (United States)

    Michaelis, M; Leopold, C S

    2015-01-01

    Transdermal delivery systems (TDS) consisting of mixtures of adhesives also named multiple polymer adhesive systems are rarely found in the market and research has only been performed on a few of them. Following the principles of ICH Q8, a Design of Experiments (DOE) approach was selected for the formulation development. For evaluation of the statistical method of "mixture design", blends of silicon adhesive, acrylic adhesive, oleyl alcohol as a surfactant and ibuprofen as a model drug were considered to be combined at different concentrations. A randomized design of 16 runs with five replicates and five runs to estimate the lack of fit (LOF) was generated. Samples were tested for adhesion properties, stability of the wet mixes, solubility of the API in the matrix and appearance of the matrix. After performing an ANOVA with the results, response surfaces of tack, shear adhesion, extent of creaming, crystallization behavior, droplet size and droplet size range were derived as contour plots. It could be shown that crystal growth of ibuprofen correlates well with droplet size and droplet size range, where lowest values for crystallization were found with mixtures containing small droplets. However, it was observed that oleyl alcohol showed no positive effect on the miscibility of the polymers and no improvement of the solubility of ibuprofen in the mixtures. With a reasonable number of experiments, the development of a design space for a TDS via mixture design gave valuable information on the product as well as on the interactions of the components.

  6. Application of SeDeM Expert system in formulation development of effervescent tablets by direct compression.

    Science.gov (United States)

    Khan, Amjad; Iqbal, Zafar; Rehman, Zahir; Nasir, Fazli; Khan, Abad; Ismail, M; Roohullah; Mohammad, Akhlaq

    2014-11-01

    The SeDeM expert system is a pre formulation tool applied for the prediction of the suitability of a material for direct compression. This innovative tool provides an index of good compressibility of the material indicating its aptitude to be compressed by direct compression. In the study the SeDeM expert system has been applied for the prediction of the behavior of the material to be used in the formulation of effervescent tablets by direct compression. Different formulations were developed on the basis of the results of the SeDeM expert system. Various parameters for the material as per the SeDeM expert system were determined according to their official and reported methods. Powder blend for different formulations was evaluated for their rheological properties while tablets were evaluated for various official and unofficial tests. Suitability of the material for direct compression was successfully predicted using the SeDeM expert system. Domperidone was found unsuitable for direct compression. During formulation all excipients responded as they were predicted as per the SeDeM expert system. Tablets produced using the resultant formulations were having sufficient mechanical strength, free of premature effervescence and were capable to be scaled up for commercial manufacturing.

  7. Development of carrier-based formulation of root endophyte Piriformospora indica and its evaluation on Phaseolus vulgaris L.

    Science.gov (United States)

    Tripathi, Swati; Das, Aparajita; Chandra, Anil; Varma, Ajit

    2015-02-01

    Endophytic fungi are plant beneficial rhizospheric microorganisms often applied as bioinoculants for enhanced and disease-free crop production. The objectives of the present work were to develop a carrier-based formulation of root endophyte Piriformospora indica as a bioinoculant. Powder formulation of four different carrier materials viz., talcum powder, clay, sawdust and bioboost (organic supplement) were evaluated and a talc-based formulation was optimized for a longer shelf life with respect to microbial concentration, storage temperature and biological activity. Finally the effect of optimized talc formulation on plant productivity was determined. The application dosages were optimized by studies on plant growth parameters of Phaseolus vulgaris L. plants under green house conditions. Five percent formulation (w/w) of talcum powder was observed to be the most stable at 30 °C with 10(8) CFU g(-1) and effective for a storage period of 6 months. The application of this optimized formulation resulted in increase of growth parameters of P. vulgaris L. and better adaptation of plants under green house conditions.

  8. 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.

  9. 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, r2:0.9999), 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.

  10. Development and evaluation of antimicrobial herbal formulations containing the methanolic extract of Samadera indica for skin diseases

    Directory of Open Access Journals (Sweden)

    Vidya Viswanad

    2012-01-01

    Full Text Available Samadera indica Gaetrn (Simaroubaceae is claimed to possess various pharmacological activities like antioxidant, antifungal, antitumor, antiviral, and so on, but its taste is bitter. The aim of the present study is to investigate the toxicity of the methanolic extract and to develop suitable herbal formulations of the methanolic extract of Samadera indica, having efficient antimicrobial activity. The methanolic extract prepared from the dried leaves of Samadera indica by continuous hot percolation, were used to examine the toxicity, according to the OECD 423 guidelines, in Swiss Albino mice. Topical formulations were prepared by incorporating Samadera indica (5% w / w in an emulsifying ointment and a carbopol gel base and evaluated for physical parameters and in-vitro antimicrobial activity (S. aureus, P. aeruginosa and C. albicans. The study reveals that no animals under the study showed any clinical signs of toxicity or mortality when administered a dose of 5 - 2000 mg / kg body weight. Therefore, the maximum tolerated dose of the methanolic extract of Samadera indica was above 2000 mg / kg body weight. The formulated ointment and gel had acceptable physical parameters that showed that they were compatible with the skin, and in addition to this, these formulations passed the short-term stability studies. The in-vitro antimicrobial activity studies showed that the formulated ointment showed significantly strong (p < 0.05 activity against S. aureus, P. aeruginosa and C. albicans than the formulated gel. Thus, the present study concludes that the formulated ointment and gel are safe and efficient antimicrobial formulations for the topical delivery of the methanolic extract of Samadera indica.

  11. Development and evaluation of antimicrobial herbal formulations containing the methanolic extract of Samadera indica for skin diseases.

    Science.gov (United States)

    Viswanad, Vidya; Aleykutty, N A; Jayakar, B; Zacharia, Subin Mary; Thomas, Litha

    2012-04-01

    Samadera indica Gaetrn (Simaroubaceae) is claimed to possess various pharmacological activities like antioxidant, antifungal, antitumor, antiviral, and so on, but its taste is bitter. The aim of the present study is to investigate the toxicity of the methanolic extract and to develop suitable herbal formulations of the methanolic extract of Samadera indica, having efficient antimicrobial activity. The methanolic extract prepared from the dried leaves of Samadera indica by continuous hot percolation, were used to examine the toxicity, according to the OECD 423 guidelines, in Swiss Albino mice. Topical formulations were prepared by incorporating Samadera indica (5% w / w) in an emulsifying ointment and a carbopol gel base and evaluated for physical parameters and in-vitro antimicrobial activity (S. aureus, P. aeruginosa and C. albicans). The study reveals that no animals under the study showed any clinical signs of toxicity or mortality when administered a dose of 5 - 2000 mg / kg body weight. Therefore, the maximum tolerated dose of the methanolic extract of Samadera indica was above 2000 mg / kg body weight. The formulated ointment and gel had acceptable physical parameters that showed that they were compatible with the skin, and in addition to this, these formulations passed the short-term stability studies. The in-vitro antimicrobial activity studies showed that the formulated ointment showed significantly strong (p < 0.05) activity against S. aureus, P. aeruginosa and C. albicans than the formulated gel. Thus, the present study concludes that the formulated ointment and gel are safe and efficient antimicrobial formulations for the topical delivery of the methanolic extract of Samadera indica.

  12. 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

  13. Air permeability of powder: a potential tool for Dry Powder Inhaler formulation development.

    Science.gov (United States)

    Le, V N P; Robins, E; Flament, M P

    2010-11-01

    Dry Powder Inhalers have drawn great attention from pharmaceutical scientists in recent years in particular those consisting of low-dose micronized drug particles associated with larger carrier particles and called interactive mixtures. However, there is little understanding of the relation between bulk powder properties such as powder structure and its aerodynamic dispersion performance. The aim of this work was to develop a simple method to measure the air permeability of interactive mixtures used in Dry Powder Inhalers by using Blaine's apparatus--a compendial permeameter and to relate it to the aerodynamic behaviour. The study was done with fluticasone propionate and terbutaline sulphate as drug models that were blended with several lactoses having different particle size distribution thus containing different percentages of fine particle lactose. The quality of the blends was examined by analysing the drug content uniformity. Aerodynamic evaluation of fine particle fraction was obtained using a Twin Stage Impinger. A linear correlation between a bulk property--air permeability of packed powder bed--and the fine particle fraction of drug was observed for the tested drugs. The air permeability reflects the quantity of the free particle fraction in the interparticulate spaces of powder bed that leads to fine particle fraction during fluidization in air flow. A theoretical approach was developed in order to link the air permeability of powder bed and drag force acting on powders during aerosolization process. The permeability technique developed in this study provides a potential tool for screening Dry Powder Inhaler formulations at the development stage. Copyright © 2010 Elsevier B.V. All rights reserved.

  14. 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®

  15. Development and in vitro evaluation of furosemide transdermal formulations using experimental design techniques.

    Science.gov (United States)

    Agyralides, Gregorios G; Dallas, Paraskevas P; Rekkas, Dimitrios M

    2004-08-20

    The in vitro skin permeation of furosemide, a commonly used loop diuretic, through human epidermis, as a preliminary step towards the development of a transdermal therapeutic system, was examined. A screening study was carried out, in order to estimate the effects of the type, the concentration of enhancer and the concentration of gelling agent on the cumulative amount of furosemide permeated through human epidermis, using a 3(3) factorial design. The type and the concentration of enhancer were further evaluated as they were found to affect significantly furosemide permeation. In order to further increase the amount of the drug permeated, the combination of two enhancers, Azone and oleyl alcohol, at three concentration levels was employed, using an optimization technique. The results indicated that higher amounts of furosemide permeated were observed when Azone was used at 5.0-6.5% (v/v) and oleyl alcohol at 7.5-9% (v/v), in the gels used. These formulations seem to be suitable for possible transdermal delivery of furosemide for pediatric use.

  16. Formulation Development and Optimization of Fast Dissolving Tablets of Aceclofenac Using Natural Superdisintegrant

    OpenAIRE

    Kaur, Lovleen; Bala, Rajni; Kanojia, Neha; Nagpal, Manju; Dhingra, Gitika Arora

    2014-01-01

    The current research work involves preparation of fast dissolving tablets of Aceclofenac by direct compression method using different concentrations of Lepidium sativum mucilage as natural superdisintegrant. A two-factor three-level (32) factorial design is being used to optimize the formulation. Nine formulation batches (D1–D9) were prepared accordingly. Two factors as independent variables (X 1-amount of β-cyclodextrin and X 2-amount of Lepidium sativum mucilage) were taken with three level...

  17. Development of photochemoprotective herbs containing cosmetic formulations for improving skin properties.

    Science.gov (United States)

    Saraf, Swarnlata; Chhabra, Sumit Kour; Kaur, Chanchal Deep; Saraf, Shailendra

    2012-01-01

    Botanical photochemoprotectives are used because they act on various stages to prevent skin cancer and photoaging. The aim of this study was to prepare herbal creams from various photochemoprotective herbs and to perform efficacy studies on them by using physicochemical, microbiological, safety, psychometric, biophysical, and sun protection factor measurements. Herbal creams were prepared by incorporating hydroalcoholic extracts of Curcuma caesia (rhizome), Areca catechu (seeds), Centella asiatica (leaves) Cinnamon zeylanicum (dried bark), and Tamarindus indica (fruit pulp) in varied concentrations (1-5% w/w) in a base cream. The efficacy of all formulations was checked out for four weeks on 60 normal subjects on the volar forearm for evaluation of biophysical properties, and for psychometric evaluations (fragrance, lathery feel, softness, irritation, stickiness, smoothness, and aftereffect on the skin) and safety measurements. In the biophysical characterization, a cutometer for viscoelasticity, a mexameter for melanin content, a corneometer for hydration, and a sebumeter for sebum determination were used. All the cream formulations with 1% and 3% w/w extracts showed positive results and passed physicochemical, microbiological, and safety tests. The SPF values increased as the concentration of extract was increased up to a limit in the formulations. The SPF values were significantly higher (p formulations with 3% herbal extract than with 1% herbal extract. Increased skin hydration, sebum levels, viscoelasticity, and decreased melanin values were obtained. The Cinnamon, Centella, and Tamarindus formulations were found more effective as photoprotectives than the Areca and Curcuma formulations.

  18. Genetic diversity of the O antigens of Proteus species and the development of a suspension array for molecular serotyping.

    Science.gov (United States)

    Yu, Xiang; Torzewska, Agnieszka; Zhang, Xinjie; Yin, Zhiqiu; Drzewiecka, Dominika; Cao, Hengchun; Liu, Bin; Knirel, Yuriy A; Rozalski, Antoni; Wang, Lei

    2017-01-01

    Proteus species are well-known opportunistic pathogens frequently associated with skin wound and urinary tract infections in humans and animals. O antigen diversity is important for bacteria to adapt to different hosts and environments, and has been used to identify serotypes of Proteus isolates. At present, 80 Proteus O-serotypes have been reported. Although the O antigen structures of most Proteus serotypes have been identified, the genetic features of these O antigens have not been well characterized. The O antigen gene clusters of Proteus species are located between the cpxA and secB genes. In this study, we identified 55 O antigen gene clusters of different Proteus serotypes. All clusters contain both the wzx and wzy genes and exhibit a high degree of heterogeneity. Potential functions of O antigen-related genes were proposed based on their similarity to genes in available databases. The O antigen gene clusters and structures were compared, and a number of glycosyltransferases were assigned to glycosidic linkages. In addition, an O serotype-specific suspension array was developed for detecting 31 Proteus serotypes frequently isolated from clinical specimens. To our knowledge, this is the first comprehensive report to describe the genetic features of Proteus O antigens and to develop a molecular technique to identify different Proteus serotypes.

  19. Design and development of insulin emulgel formulation for transdermal drug delivery and its evaluation.

    Science.gov (United States)

    Akram, Muhammad; Naqvi, Syed Baqirshyum; Khan, Ahmad

    2013-03-01

    The objective of the present study was to formulate an insulin emulgel, selection of an optimize formulation through in vitro drug release kinetics and finally evaluate its hypoglycemic activity in animal model. Insulin emulgel was prepared using emu oil as penetration enhancer with the combination of carbomer or hydroxypropyl methylcellulose (HPMC) as gelling agent and polysorbate 80 as emulsifier. The response of gelling agent type (carbomer or HPMC) and concentration of other two variables penetration enhancer and emulsifier were studied using 2(3)factorial design during in vitro drug release through excised rat skin. Biological activity of emulgel formulation was also investigated using Albino rabbits alone and in combination with iontophoresis. The in vivo efficacy of insulin emulgel was assessed by measuring the blood glucose level at start of the experiment and after every 15 minutes interval for 120 minutes. Total eight formulations were studied. F4 formulation showed maximum insulin permeation flux (4.88 ± 0.09 μg/cm(2)/hour) through excised rat skin. Insulin permeation from these formulations was found to follow the Korsmeyer-Peppas model (r(2) =0.975 to 0.998) during 24 hour with non-Fickian mechanism. Formulation F4 was further investigated in Albino rabbits. For the first group (treated with insulin emulgel alone) the blood glucose level decreased from initial value 250±10mg/dl to 185±7mg/dl at 120 minutes and for the second group (treated with insulin emulgel plus iontophoresis) the blood glucose level decreased to 125±5mg/dl in 120 minutes (Ppainless) to injectable insulin subject to further studies on large animals.

  20. Formulation parameters of crystalline nanosuspensions on spray drying processing: a DoE approach.

    Science.gov (United States)

    Kumar, Sumit; Xu, Xiaoming; Gokhale, Rajeev; Burgess, Diane J

    2014-04-10

    Nanocrystalline suspensions offer a promising approach to improve dissolution of BCS class II/IV compounds. Spray drying was utilized as a downstream process to improve the physical and chemical stability of dried nanocrystals. The effect of nanocrystalline suspension formulation variables on spray-drying processing was investigated. Naproxen and indomethacin nanocrystalline formulations were formulated with either Dowfax 2A1 (small molecule) or HPMC E15 (high molecular weight polymer) and spray drying was performed. A DoE approach was utilized to understand the effect of critical formulation variables, i.e. type of stabilizer, type of drug, ratio of drug-to-stabilizer and drug concentration. The powders were analyzed for particle size, moisture content, powder X-ray diffraction and dissolution. A dialysis sac adapter for USP apparatus II was developed which provided good discrimination between aggregated and non-aggregated formulations. Nanocrystal aggregation was dependent on the drug-to-stabilizer ratio. The glass transition temperature and the charge effect played a dominant role on spray-dried powder yield. Those formulations with low drug-to-excipient ratios were less aggregating and showed faster dissolution compared to those formulations with high drug-to-excipient ratios. All stable (less aggregated) formulations were subjected to accelerated storage stability testing. The Flory-Huggins interaction parameter (between drug and excipients) correlated with the spray-dried nanocrystal formulations stability. Published by Elsevier B.V.

  1. Lipid Vesicles for the Skin Delivery of Diclofenac: Cerosomes vs. Other Lipid Suspensions

    Directory of Open Access Journals (Sweden)

    Anahita Fathi-Azarbayjani

    2015-03-01

    Full Text Available Purpose: Lipid suspensions as drug carriers, including conventional liposomes, ethosomes, transferosomes, proniosomes, niosomes, PEG-PPG-PEG niosomes and stratum corneum liposomes (cerosomes, were formulated and compared. Methods: Lipid vesicles were formulated and assessed with regards to enhancement of skin permeation of diclofenac and stability profiles of the formulations. Formulation-induced changes of the biophysical structure of excised human skin were monitored using the Fourier transform infrared spectroscopy. Results: The stability profiles of these suspensions over 12 weeks did not show any significant drug leakage from the vesicles of interest (p > 0.05. FTIR observations indicated that the vesicles increased stratum corneum (SC lipid fluidization and altered protein conformation. Skin permeability experiments showed that the free unencapsulated drug in the cerosomal formulations caused significant increase in drug permeation across the skin (p < 0.01. Low skin permeability of drug from the other lipid suspensions could be due to the entrapment of diclofenac within these vesicles which decreased the solubility of the hydrophilic drug in the skin lipids and the partition coefficient of the drug from these vesicles into the SC. Conclusion: Optimal drug entrapment in vesicles or alteration of the skin structure may not necessarily enhance the permeation of hydrophilic drugs across the human skin. These lipid vesicles may be further developed into carriers of both hydrophilic and hydrophobic drugs for topical and transdermal delivery, respectively.

  2. Discriminative Dissolution Method for Benzoyl Metronidazole Oral Suspension.

    Science.gov (United States)

    da Silva, Aline Santos; da Rosa Silva, Carlos Eduardo; Paula, Fávero Reisdorfer; da Silva, Fabiana Ernestina Barcellos

    2016-06-01

    A dissolution method for benzoyl metronidazole (BMZ) oral suspensions was developed and validated using a high-performance liquid chromatography (HPLC) method. After determination of sink conditions, dissolution profiles were evaluated using different dissolution media and agitation speeds. The sample insertion mode in dissolution media was also evaluated. The best conditions were obtained using a paddle, 50 rpm stirring speed, simulated gastric fluid (without pepsin) as the dissolution medium, and sample insertion by a syringe. These conditions were suitable for providing sink conditions and discriminatory power between different formulations. Through the tested conditions, the results can be considered specific, linear, precise, accurate, and robust. The dissolution profiles of five samples were compared using the similarity factor (f 2) and dissolution efficiency. The dissolution kinetics were evaluated and described by the Weibull model. Whereas there is no monograph for this pharmaceutical formulation, the dissolution method proposed can be considered suitable for quality control and dissolution profile comparison of different commercial formulations.

  3. Implementation of the Cultural Formulation through a newly developed Brief Cultural Interview : Pilot data from the Netherlands

    NARCIS (Netherlands)

    Groen, S.P.N.; Richters, Annemiek; Laban, Cornelis J.; Devillé, W

    2017-01-01

    The Outline for a Cultural Formulation (OCF) has remained underutilized in clinical practice since its publication in the DSM-IV in 1994. In the Netherlands, a Cultural Interview (CI) was developed in 2002 as a tool to facilitate use of the OCF in clinical practice. The time needed to conduct the

  4. 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).

  5. Formulation development of ambroxol hydrochloride soft gel with application of statistical experimental design and response surface methodology.

    Science.gov (United States)

    Dabhi, Mahesh; Gohel, Mukesh; Parikh, Rajesh; Sheth, Navin; Nagori, Stavan

    2011-01-01

    The purpose of present work was to develop ambroxol hydrochloride soft gel formulation with the application of statistical experimental design and response surface methodology (RSM). A two-factor, three-level (3(2)) full factorial design of experiment with RSM was run to evaluate the main and interaction effect of two independent formulation variables that included the amount of low-acetylated gellan gum and sodium citrate. The dependent variables included viscosity (Y(1)), amount of drug release at 10 min (Y(2)) and 30 min (Y(3)), and gelation time (Y(4)). In order to obtain a formulation having the maximum amount of drug release at 10 min and minimum gelation time, RSM optimization was used. The prepared formulations were evaluated for pH, viscosity, rheological properties, gelation time, drug content, in vitro drug release, appearance, and taste. All the formulations showed a gelation time in the range of 6 to 48 min. The drug content in all the formulations was within limit (99.6 ± 1.56%). The viscosity of all the formulations was found in the range of 1872-12,182 cP. Dissolution studies of the formulations showed drug release in the range of 40.56-72.46% within 10 min and 80.2-100.5% within 30 min. Human evaluation tests revealed that all the gels possessed acceptable characteristics. This study showed that the soft gel formulation GA5, containing 0.3% of gellan gum and 0.4% of sodium citrate, has potential use as an immediate release soft gel for oral drug delivery. The objective of this investigation was to develop a new, immediate-release, soft gel dosage form for ambroxol hydrochloride, an oral expectorant and mucolytic agent. This novel soft gel dosage form needs to be suitable for pediatric and geriatric patients as well as patients with dysphagia. A statistical technique was used for optimization of the gel formulation. The methodology, called a design of experiment with response surface methodology, evaluated several independent formulation variables

  6. Development and application of high-throughput techniques for evaluation of photopolymerizable monomer formulations

    Science.gov (United States)

    Johnson, Peter Michael

    Photopolymerization of multicomponent mixtures is widely used in industry to create a wide range of material properties for a variety of applications including microelectronics, contact lenses, dental restorations, adhesives and coatings. Under typical photopolymerization conditions, crosslinking polymerization exhibit non-classical phenomena such as autoacceleration, autodeceleration, incomplete conversion, and reaction diffusion controlled termination. These non-classical behaviors present difficult challenges to predicting network properties over various polymerization conditions. However, the complex photopolymerization reaction that generates these properties is modulated by the variety of conditions that these materials are subjected to both during and after the photopolymerization. A design of experiments approach limits the number of systems that are required for analysis, but a significant fraction of photopolymer analysis techniques are time consuming and the conclusions are limited to the region analyzed. This process creates a large bottleneck in the ability to optimize formulations and understand the effects that develop such advantageous properties. The wide spectrum of monomer chemistries add to this complexity and hinder the efficient optimization of various control parameters to produce a resulting polymer with the suitable material properties. In this work, high-throughput techniques for analyzing photopolymer conversion and modeling copolymerizations were developed. Controllable gradients of significant properties in photopolymerization were employed to produce a two factor system with all available analysis conditions on a single substrate. Gradients of composition, light intensity, exposure time, and temperature were all developed to produce combinatorial samples that were subsequently analyzed for their conversion. This technique allows for the rapid assessment of conversion over the entire substrate, generating a large set of data in a

  7. [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.

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

    Science.gov (United States)

    Đurović, Ana; Stojanović, Zorica; Kravić, Snežana; Grahovac, Nada; Bursić, Vojislava; Vuković, Gorica; Suturović, Zvonimir

    2016-01-01

    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. PMID:27042181

  9. 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.

  10. 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.

  11. 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

    2018-02-15

    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 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.

  12. Formulation development of antibodies using robotic system and high-throughput laboratory (HTL).

    Science.gov (United States)

    Zhao, Hui; Graf, Olivier; Milovic, Nebojsa; Luan, Xiaosong; Bluemel, Markus; Smolny, Markus; Forrer, Kurt

    2010-05-01

    Since each antibody has its unique physical chemical properties, optimal formulation for one antibody is likely not applicable for the others. To rapidly screen multiple antibody formulations, an automated system was constructed to perform sample preparation, testing, and data management. Using the automatic system, up to 500 liquid formulations can be prepared in deep well microplates and further distributed into standard microplates that can be stored under different stress conditions for degradation studies. In addition, the system can also be used to prepare samples in microplates for different analytical measurements such as UV spectroscopy, turbidity, dynamic light scattering (DLS), SEC-HPLC, RP-HPLC and CEX-HPLC, and automated lab-on-a-chip platform (ALP). The data generated using different techniques in the automatic system were comparable to those of the classical approaches.

  13. The development and evaluation of single cell suspension from wheat and barley as a model system; a first step towards functional genomics application

    DEFF Research Database (Denmark)

    Dong, Jing; Bowra, Steve; Vincze, Éva

    2010-01-01

    Background The overall research objective was to develop single cell plant cultures as a model system to facilitate functional genomics of monocots, in particular wheat and barley. The essential first step towards achieving the stated objective was the development of a robust, viable single cell...... suspension culture from both species. Results We established growth conditions to allow routine culturing of somatic cells in 24 well microtiter plate format. Evaluation of the wheat and barley cell suspension as model cell system is a multi step process. As an initial step in the evaluation procedure we...... chose to study the impact of selected abiotic stress elicitors at the physiological, biochemical and molecular level. We report the results of osmotic stress imposed by NaCl and PEG. As proline is an important osmoprotectant of the cereal cells, colorimetric assay for proline detection was developed...

  14. Formulation development of sunscreen lotion containing jackfruit starch and the lotion acceptance evaluation in volunteers

    Directory of Open Access Journals (Sweden)

    Chitropas, P.

    2006-01-01

    Full Text Available In present study, a 23 full factorial design was used for optimization of the sunscreen lotions containing mucilage from jackfruit (JK, sodium carboxymethylcellulose (SCMC and Carbopol 940 as the thickening agents. The optimized sunscreen lotion containing JK, control and benchmark product were tested for acceptance by 44 volunteers using randomized controlled study. To optimize the formulation, the changes of physical properties before and after freeze-thaw cycling of sunscreen lotion, which were pH, conductivity, viscosity as well as stability of emulsions, were investigated. It was found that any formulation containing SCMC was unstable. After undergoing 6 freeze-thaw cycles, pH and conductivity of all formulations had changed but with no significant difference. In addition, the viscosity of all formulations increased after 6 cycles. The formulation containing low and high levels of JK as well as containing JK in combination with Carbopol 940 showed a good signs of emulsion stability. In conclusion, the formulation containing high levels of JK in combination with Carbopol 940 exhibited the greatest physical stability of lotion. Using JK alone in formula gave a stable physical properties and good texture but the viscosity of the lotion was practically low. As a result, in order to obtain the stable lotion and high viscosity, it is important to use in combination with other viscosity-inducing agents. When the lotion containing JK alone was tested for acceptance in volunteers, it was found that the JK lotion texture and odor needed to be improved. However, its penetration, stickiness and moisturizing properties, as well as its feeling after use, were acceptable more or less the same as the benchmark product.

  15. 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

  16. A contemporary approach on design, development, and evaluation of Ayurvedic formulation - Triphala Guggulu.

    Science.gov (United States)

    Muguli, Ganesh; Gowda, Vishakante D; Dutta, Vishnu; Jadhav, Atul N; Mendhe, Bibhilesh B; Paramesh, Rangesh; Babu, U V

    2015-01-01

    Ayurvedic texts describe many formulations for different ailments. Triphala Guggulu (TG) is reputed for treating inflammatory conditions. These formulations have been considered complementary medicine or alternative to conventional medicines across the globe. These complex polyherbal formulations need science-based approach toward manufacturing process and chemical standardization. To evaluate TG tablets to meet modern pharmaceutical approaches and also standardization processes. Shodhana of Guggulu was performed using Triphala Kwatha (decoction) as mentioned in ayurvedic texts. This processed material was dried using spray drying technique, blended with other herbal powders as per formula and using suitable excipients was incorporated for compressing into tablets. Excipients and their concentrations were evaluated for various micromeritic properties and the formula that met the requirements was compressed. The angle of repose was considered fair with a range of 25-30, Carr's index at a range between 17 and 30, and Hausner ratio of 1.21:1.44, which was well within the limits as per the United States Pharmacopeia (USP) and among the three blends tested, blend Triphala Guggulu formulation-3 was found most suitable for tablets compression. Physical properties were well within the limits as per the USP and disintegration time was within 30 min. Modern pharmaceutical processing can very well be adapted for Guggulu preparations.

  17. 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.

  18. Biorelevant Dissolution Models for a Weak Base To Facilitate Formulation Development and Overcome Reduced Bioavailability Caused by Hypochlordyria or Achlorhydria.

    Science.gov (United States)

    Kou, Dawen; Dwaraknath, Sudharsan; Fischer, Yannick; Nguyen, Daniel; Kim, Myeonghui; Yiu, Hiuwing; Patel, Preeti; Ng, Tania; Mao, Chen; Durk, Matthew; Chinn, Leslie; Winter, Helen; Wigman, Larry; Yehl, Peter

    2017-10-02

    In this study, two dissolution models were developed to achieve in vitro-in vivo relationship for immediate release formulations of Compound-A, a poorly soluble weak base with pH-dependent solubility and low bioavailability in hypochlorhydric and achlorhydric patients. The dissolution models were designed to approximate the hypo-/achlorhydric and normal fasted stomach conditions after a glass of water was ingested with the drug. The dissolution data from the two models were predictive of the relative in vivo bioavailability of various formulations under the same gastric condition, hypo-/achlorhydric or normal. Furthermore, the dissolution data were able to estimate the relative performance under hypo-/achlorhydric and normal fasted conditions for the same formulation. Together, these biorelevant dissolution models facilitated formulation development for Compound-A by identifying the right type and amount of key excipient to enhance bioavailability and mitigate the negative effect of hypo-/achlorhydria due to drug-drug interaction with acid-reducing agents. The dissolution models use readily available USP apparatus 2, and their broader utility can be evaluated on other BCS 2B compounds with reduced bioavailability caused by hypo-/achlorhydria.

  19. Development and characterization of fast-dissolving tablet formulations of glyburide based on solid self-microemulsifying systems.

    Science.gov (United States)

    Cirri, Marzia; Roghi, Alessandra; Valleri, Maurizio; Mura, Paola

    2016-07-01

    The aim of this work was to develop effective fast-dissolving tablet formulations of glyburide, endowed with improved dissolution and technological properties, investigating the actual effectiveness of the Solid-Self MicroEmulsifying Drug Delivery System (S-SMEDDS) approach. An initial screening aimed to determine the solubility of the drug in different oils, Surfactants and CoSurfactants allowed the selection of the most suitable components for liquid SMEDDS, whose relative amounts were defined by the construction of pseudo-ternary phase diagrams. The selected liquid SMEDDS formulations (Capyol 90 as oil, Tween 20 as Surfactant and Glycofurol or Transcutol as CoSurfactant) were converted into Solid-SMEDDS, by adsorbing them onto Neusilin (1:1 and 1:0.8w/w S-SMEDDS:carrier), and fully characterized in terms of solid state (DSC and X-ray powder diffraction), morphological (ESEM) and dissolution properties, particle size and reconstitution ability. Finally, the 1:1 S-SMEDDS containing Glycofurol as CoSurfactant, showing the best performance, was selected to prepare two final tablet formulations. The ratio test (t10 min ratio and DE60 ratio) and pair-wise procedures (difference (f1) and similarity (f2) factors) highlighted the similarity of the new developed tablets and the marked difference between their drug dissolution profiles and those of formulations based on the micronized drug. The S-SMEDDS approach allowed to develop fast-dissolving tablets of glyburide, endowed with good technological properties and able to achieve the complete drug dissolution in a time ranging from 10 to 15min, depending on the formulation composition. Copyright © 2016 Elsevier B.V. All rights reserved.

  20. Development of a stable low-dose aglycosylated antibody formulation to minimize protein loss during intravenous administration.

    Science.gov (United States)

    Morar-Mitrica, Sorina; Puri, Manasi; Beumer Sassi, Alexandra; Fuller, Joshua; Hu, Ping; Crotts, George; Nesta, Douglas

    2015-01-01

    The physical and chemical integrity of a biopharmaceutical must be maintained not only during long-term storage but also during administration. Specifically for the intravenous (i.v.) delivery of a protein drug, loss of stability can occur when the protein formulation is compounded with i.v. bag diluents, thus modifying the original composition of the drug product. Here we present the challenges associated with the delivery of a low-dose, highly potent monoclonal antibody (mAb) via the i.v. route. Through parallel in-use stability studies and conventional formulation development, a drug product was developed in which adsorptive losses and critical oxidative degradation pathways were effectively controlled. This development approach enabled the i.v. administration of clinical doses in the range of 0.1 to 0.5 mg total protein, while ensuring liquid drug product storage stability under refrigerated conditions.

  1. Development and optimization of dextromethorphan hydrobromide oral disintegrating tablets: effect of formulation and process variables.

    Science.gov (United States)

    Mostafa, Haitham Fady; Ibrahim, Mohamed Abbas; Sakr, Adel

    2013-01-01

    Orally disintegrating tablets (ODTs), which disintegrate rapidly (croscarmellose sodium (X(2)) concentrations. Disintegration time, hardness and T(50) values for all the formulations varied from 12.5 to 152.6 s, 3.58 to 4.92 kp and 0.8 to 2.8 min, respectively. The results indicated that the selected variables have a strong influence on disintegration time, hardness and T(50) of the ODTs. The manufactured ODTs formula composed of 30% microcrystalline cellulose in combination with 3% croscarmellose sodium was chosen as optimized formula, as it showed the lowest disintegration time (12.5 ± 1.22 s), low T(50) (0.8 min.) and hard tablets (4.92 ± 0.28 kp) amongst other tested ODTs formulations. Hardness of DM ODTs was not affected by changing the type of superdisintegrant and lubricant. The disintegration time was significantly (p croscarmellose sodium.

  2. 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.

  3. Inhibitory activity of the isoflavone biochanin A on intracellular bacteria of genus Chlamydia and initial development of a buccal formulation.

    Directory of Open Access Journals (Sweden)

    Leena Hanski

    Full Text Available Given the established role of Chlamydia spp. as causative agents of both acute and chronic diseases, search for new antimicrobial agents against these intracellular bacteria is required to promote human health. Isoflavones are naturally occurring phytoestrogens, antioxidants and efflux pump inhibitors, but their therapeutic use is limited by poor water-solubility and intense first-pass metabolism. Here, we report on effects of isoflavones against C. pneumoniae and C. trachomatis and describe buccal permeability and initial formulation development for biochanin A. Biochanin A was the most potent Chlamydia growth inhibitor among the studied isoflavones, with an IC50 = 12 µM on C. pneumoniae inclusion counts and 6.5 µM on infectious progeny production, both determined by immunofluorescent staining of infected epithelial cell cultures. Encouraged by the permeation of biochanin A across porcine buccal mucosa without detectable metabolism, oromucosal film formulations were designed and prepared by a solvent casting method. The film formulations showed improved dissolution rate of biochanin A compared to powder or a physical mixture, presumably due to the solubilizing effect of hydrophilic additives and presence of biochanin A in amorphous state. In summary, biochanin A is a potent inhibitor of Chlamydia spp., and the in vitro dissolution results support the use of a buccal formulation to potentially improve its bioavailability in antichlamydial or other pharmaceutical applications.

  4. Solubility parameter-based screening methods for early-stage formulation development of itraconazole amorphous solid dispersions.

    Science.gov (United States)

    Piccinni, Piero; Tian, Yiwei; McNaughton, Alyn; Fraser, Jane; Brown, Stephen; Jones, David S; Li, Shu; Andrews, Gavin P

    2016-05-01

    This article uses conventional and newly extended solubility parameter (δ) methods to identify polymeric materials capable of forming amorphous dispersions with itraconazole (itz). Combinations of itz and Soluplus, Eudragit E PO (EPO), Kollidon 17PF (17PF) or Kollidon VA64 (VA64) were prepared as amorphous solid dispersions using quench cooling and hot melt extrusion. Storage stability was evaluated under a range of conditions using differential scanning calorimetry and powder X-ray diffraction. The rank order of itz miscibility with polymers using both conventional and novel δ-based approaches was 17PF > VA64 > Soluplus > EPO, and the application of the Flory-Huggins lattice model to itz-excipient binary systems corroborated the findings. The solid-state characterisation analyses of the formulations manufactured by melt extrusion correlated well with pre-formulation screening. Long-term storage studies showed that the physical stability of 17PF/vitamin E TPGS-itz was poor compared with Soluplus and VA64 formulations, and for EPO/itz systems variation in stability may be observed depending on the preparation method. Results have demonstrated that although δ-based screening may be useful in predicting the initial state of amorphous solid dispersions, assessment of the physical behaviour of the formulations at relevant temperatures may be more appropriate for the successful development of commercially acceptable amorphous drug products. © 2016 Royal Pharmaceutical Society.

  5. Development of bio-based thermoplastic polyurethanes formulations using corn-derived chain extender for reactive rotational molding

    Directory of Open Access Journals (Sweden)

    K. Prashantha

    2013-10-01

    Full Text Available Partly bio-based segmented thermoplastic polyurethane (TPU formulations were developed to fulfill the requirements of the reactive rotational molding process. They were obtained by one-shot bulk polymerization between an aliphatic diisocyanate (1,6-hexamethylene diisocyanate, a polyether polyol as macrodiol (polyethylene glycol and a biobased corn-derived 1,3-propanediol as chain extender (CE, in presence of a catalyst, at an initial temperature of 45°C. Equivalent TPU formulations with classical petroleum-based 1,3-propanediol were also prepared for a purpose of comparison. TPU with different soft to hard segment (SS/HS ratios were synthesized by varying the macrodiol and CE concentrations in the formulations. For each formulation, the evolution of the reaction temperature as a function of time was monitored and the kinetics of polymerization was studied by Fourier Transform infrared spectroscopy in attenuated total reflection mode (FTIR-ATR. The morphology, thermal properties, solubility in different solvents and tensile properties of the final products were analyzed. All synthesized polyurethanes are 100% linear polymers and the extent of microphase separation, as well as the thermal and mechanical properties highly depends on the HS content, and glass transition temperature and Young modulus can be tuned by adjustment of the SS/HS ratio. All results indicate that petrochemical CE can be replaced by its recently available corn-derived homologue, without sacrificing any use properties of the final polyurethanes.

  6. 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

  7. The establishment of suspension and meristem cultures for the development of a protoplast regeneration and fusion system in Lily

    NARCIS (Netherlands)

    Famelaer, I.; Ennik, E.; Tuyl, van J.M.; Meijer, H.; Creemers-Molenaar, J.

    1996-01-01

    The present results indicate that established morphogenic suspension cultures can be obtained from crosses between cultivars of L. longiflorum and from a cross between Asiatic hybrid 'Orlito' x 'Connecticut King'. Meristem cultures were obtained from L. longiflorum 'Gelria' and Oriental hybrid 'Star

  8. Development and Optimization of a Novel Prolonged Release Formulation to Resist Alcohol-Induced Dose Dumping.

    Science.gov (United States)

    Gujjar, Chaitanya Yogananda; Rallabandi, Balaramesha Chary; Gannu, Ramesh; Deulkar, Vallabh Subashrao

    2016-04-01

    Alcohol-induced dose dumping is a serious concern for the orally administered prolonged release dosage forms. The study was designed to optimize the independent variables, propylene glycol alginate (PGA), Eudragit RS PO (ERS) and coating in mucoadhesive quetiapine prolonged release tablets 200 mg required for preventing the alcohol-induced dose dumping. Optimal design based on response surface methodology was employed for the optimization of the composition. The formulations are evaluated for in vitro drug release in hydrochloric acid alone and with 40% v/v ethanol. The responses, dissolution at 120 min without alcohol (R1) and dissolution at 120 min with alcohol (R2), were statistically evaluated and regression equations are generated. PGA as a hydrophilic polymeric matrix was dumping the dose when dissolutions are carried in 0.1 N hydrochloric acid containing 40% v/v ethanol. ERS addition was giving structural support to the swelling and gelling property of PGA, and thus, was reducing the PGA erosion in dissolution media containing ethanol. Among the formulations, four formulations with diverse composition were meeting the target dissolution (30-40%) in both the conditions. The statistical validity of the mathematical equations was established, and the optimum concentration of the factors was established. Validation of the study with six confirmatory runs indicated high degree of prognostic ability of response surface methodology. Further coating with ReadiLycoat was providing an additional resistance to the alcohol-induced dose dumping. Optimized compositions showed resistance to dose dumping in the presence of alcohol.

  9. Development of a novel dry powder inhalation formulation for the delivery of rivastigmine hydrogen tartrate.

    Science.gov (United States)

    Simon, Alice; Amaro, Maria Inês; Cabral, Lucio Mendes; Healy, Anne Marie; de Sousa, Valeria Pereira

    2016-03-30

    The purpose of this study was to prepare engineered particles of rivastigmine hydrogen tartrate (RHT) and to characterize the physicochemical and aerodynamic properties, in comparison to a lactose carrier formulation (LCF). Microparticles were prepared from ethanol/water solutions containing RHT with and without the incorporation of L-leucine (Leu), using a spray dryer. Dry powder inhaler formulations prepared were characterized by scanning electron microscopy, powder X-ray diffraction, laser diffraction particle sizing, ATR-FTIR, differential scanning calorimetry, bulk and tapped density, dynamic vapour sorption and in vitro aerosol deposition behaviour using a next generation impactor. The smooth-surfaced spherical morphology of the spray dried microparticles was altered by adding Leu, resulting in particles becoming increasingly wrinkled with increasing Leu. Powders presented low densities. The glass transition temperature was sufficiently high (>90 °C) to suggest good stability at room temperature. As Leu content increased, spray dried powders presented lower residual solvent content, lower particle size, higher fine particle fraction (FPFMMAD). The LCF showed a lower FPF and higher MMAD, relative to the spray dried formulations containing more than 10% Leu. Spray dried RHT powders presented better aerodynamic properties, constituting a potential drug delivery system for oral inhalation. Copyright © 2016. Published by Elsevier B.V.

  10. Formulation development and optimization of fast dissolving tablets of aceclofenac using natural superdisintegrant.

    Science.gov (United States)

    Kaur, Lovleen; Bala, Rajni; Kanojia, Neha; Nagpal, Manju; Dhingra, Gitika Arora

    2014-01-01

    The current research work involves preparation of fast dissolving tablets of Aceclofenac by direct compression method using different concentrations of Lepidium sativum mucilage as natural superdisintegrant. A two-factor three-level (3(2)) factorial design is being used to optimize the formulation. Nine formulation batches (D1-D9) were prepared accordingly. Two factors as independent variables (X 1-amount of β-cyclodextrin and X 2-amount of Lepidium sativum mucilage) were taken with three levels (+1, 0, -1). The levels of two factors were selected on the basis of preliminary experiments conducted and their effect on three dependent variables (disintegration time, wetting time, and in vitro drug release) was studied along with their % prediction error. All the active blends were evaluated for postcompression parameters (angle of repose, Carr's index, Hausner ratio, etc.) and the tablets were evaluated for postcompression parameters (weight variation, hardness, and friability, wetting time, disintegration time, water absorption ratio, and in vitro drug release studies). The optimum batch was further used for SEM and stability studies. Formulation D5 was selected by the Design-Expert software which exhibited DT (15.5 sec), WT (18.94 sec), and in vitro drug release (100%) within 15 minutes.

  11. Suspension flow modelling in particle migration and microfiltration

    NARCIS (Netherlands)

    Vollebregt, H.M.; Sman, van der R.G.M.; Boom, R.M.

    2010-01-01

    We review existing mixture models for shear-induced migration (SIM) in flowing viscous, concentrated particle suspensions via an analysis of the models from the perspective of a two-fluid formulation. Our analysis shows that particle suspensions in strong non-linear shear fields are a prime example

  12. Suspension Properties Of Binary Mixtures Of Tragacanth Gum And ...

    African Journals Online (AJOL)

    In this work the effect of irvingia gum on the suspending properties of tragacanth in zinc oxide suspension has been investigated. The gum of Irvingia gabonensis was extracted by macerated and characterized using standard procedures. Batches of zinc oxide suspension were formulated with varying ratios of tragacanth ...

  13. Development and validation of a HPLC method for the determination of amoxicillin trihydrate, colistin sulphate, nipasol and nipagin in an injectable suspension.

    Directory of Open Access Journals (Sweden)

    Violeta Tauber,

    2016-06-01

    Full Text Available A liquid chromatographic method has been developed and validated for simultaneous determination of amoxicillin trihydrate, colistin sulphate, nipasol and nipagin in injectable suspension. Efficient chromatographic separation was achived on a Hypersil Gold (150mm x 4.6mm, 5.0 µm with mobile phase containing 4.46 g‰, pH 2.5 (adjusted with dilute sulphuric acid in gradient with acetonitrile at a flow rate of 1.0 mL/min. detection of the analyses was performed at different wavelengths using a DAD detector. The elution was a seven step gradient elution program in 42 minutes. The proposed HPLC method was statistically validated with respect to specificity, linearity, limits of detection and quantification, ranges, precision and accuracy. The HPLC method was applied to injectable suspension in which the analyses were successfully quantified with no interfering peaks from excipients.

  14. Formulation of detailed consumables management models for the development (preoperational) period of advanced space transportation system: Executive summary

    Science.gov (United States)

    Torian, J. G.

    1976-01-01

    Formulation of models required for the mission planning and scheduling function and establishment of the relation of those models to prelaunch, onboard, ground support, and postmission functions for the development phase of space transportation systems (STS) was conducted. The preoperational space shuttle is used as the design baseline for the subject model formulations. Analytical models were developed which consist of a mission planning processor with appropriate consumables data base and a method of recognizing potential constraint violations in both the planning and flight operations functions. A flight data file for storage/retrieval of information over an extended period which interfaces with a flight operations processor for monitoring of the actual flights was examined.

  15. Development and evaluation of antimicrobial herbal formulations containing the methanolic extract of Samadera indica for skin diseases

    OpenAIRE

    Vidya Viswanad; Aleykutty, N. A.; B Jayakar; Subin Mary Zacharia; Litha Thomas

    2012-01-01

    Samadera indica Gaetrn (Simaroubaceae) is claimed to possess various pharmacological activities like antioxidant, antifungal, antitumor, antiviral, and so on, but its taste is bitter. The aim of the present study is to investigate the toxicity of the methanolic extract and to develop suitable herbal formulations of the methanolic extract of Samadera indica, having efficient antimicrobial activity. The methanolic extract prepared from the dried leaves of Samadera indica by continuous hot perco...

  16. Development and assessment of stable formulations containing two herbal antimicrobials: Allium sativum L. and Eruca sativa miller seed oils.

    Science.gov (United States)

    Sanad, Rania Abd el Basset; Mabrouk, Mona Ibraheem

    2016-01-01

    Garlic oil and Eruca oil have been reported to have excellent antimicrobial activity. However, the exact knowledge of their required hydrophilic-lipophilic balance (rHLB) values to facilitate their emulsification are still not reported in the literature. The objective of this study is to determine rHLB values of Garlic and Eruca oils to formulate an elegant stable cream formulation enriched with both oils. Emulsions of both oils were prepared by the bottle method using water, Tween 80 and Span 80. Formulated emulsions were evaluated for creaming index (CI), droplet size, and turbidity to determine rHLB. Utilizing determined rHLB, creams were formulated using a combination of two surfactants, Span 60:Brij 58 (1:2.333) at three different concentrations (2, 4, and 6%). rHLB of Garlic oil and Eruca oil was determined to be 7.92 ± 0.27 and 9.76 ± 0.32, respectively. Stable cream (F1) developed with 2% surfactant blend showed elegant rheological properties, the best antimicrobial activity against Staphyococcus aureus ATCC29737, Escherichia coli ATCC25299 S. aureus (MRSA), Malassezia fufur AUMC No. 5173 with no skin irritation. In addition, its texture parameters and pH were found to be consistent over 12 months at 25 ± 1 °C and 60% relative humidity. The lowest CI, smallest droplet size, and highest turbidity were obtained at the optimum surfactant concentration in the prepared emulsions. Increasing surfactant blend concentration in cream formulations leads to increasing viscosity and consequently decreasing antimicrobial activity. Determination of the rHLB of Garlic and Eruca oils allows the ease of preparation of stable, consistent, and non-irritant cream.

  17. Explosive Formulation Pilot Plant

    Data.gov (United States)

    Federal Laboratory Consortium — The Pilot Plant for Explosive Formulation supports the development of new explosives that are comprised of several components. This system is particularly beneficial...

  18. Formulation Development and Evaluation of Fast Disintegrating Tablet of Cetirizine Hydrochloride: A Novel Drug Delivery for Pediatrics and Geriatrics

    Directory of Open Access Journals (Sweden)

    Deepak Sharma

    2014-01-01

    Full Text Available Recent developments in fast disintegrating tablets have brought convenience in dosing to pediatric and elderly patients who have trouble in swallowing tablets. The objective of the present study was to prepare the fast disintegrating tablet of Cetirizine Hydrochloride for allergic and respiratory disorders. As precision of dosing and patient's compliance become important prerequisite for a long-term treatment, there is a need to develop a formulation for this drug which overcomes problems such as difficulty in swallowing, inconvenience in administration while travelling, and patient’s acceptability. Hence, the present investigation was undertaken with a view to develop a fast disintegrating tablet of Cetirizine Hydrochloride which offers a new range of products having desired characteristics and intended benefits. Superdisintegrants such as Sodium Starch Glycolate were optimized. Different binders were optimized along with optimized superdisintegrant concentration. The tablets were prepared by direct compression technique. The tablets were evaluated for hardness, friability, weight variation, wetting time, disintegration time and uniformity of content. Optimized formulation was evaluated by in vitro dissolution test, drug excipient compatibility and accelerated stability study. It was concluded that fast disintegrating tablets of Cetirizine Hydrochloride were formulated successfully with desired characteristics which disintegrated rapidly, provide rapid onset of action, and enhance the patient convenience and compliance.

  19. 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%.

  20. 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.

  1. The role of particle engineering in relation to formulation and de-agglomeration principle in the development of a dry powder formulation for inhalation of cetrorelix

    NARCIS (Netherlands)

    Zijlstra, Gerrit S; Hinrichs, Wouter L J; de Boer, Anne H; Frijlink, Henderik W

    2004-01-01

    We formulated cetrorelix acetate, as an adhesive mixture for use in dry powder inhalation. To achieve the highest possible deposition efficiency we investigated both the influence of different micronization techniques and different inhalers. The Novolizer with an air classifier as the powder

  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. Early pediatric formulation development with new chemical entities: Opportunities of e-tongue besides human taste assessment.

    Science.gov (United States)

    Immohr, Laura Isabell; Dischinger, Angela; Kühl, Peter; Kletzl, Heidemarie; Sturm, Stefan; Günther, Andreas; Pein-Hackelbusch, Miriam

    2017-09-15

    The palatability of a pediatric drug formulation is one of the key prerequisites for therapeutic success. Liquid formulations are often chosen for pediatric drug products, and they require special attention regarding their taste, as they have direct contact to the taste buds and a relatively long residence time in the oral cavity. For ethical reasons, the role of electronic tongues in the development of oral drug formulations with new chemical entities (NCEs) for pediatric use is growing, however, little is known about the strategies how this instrumental taste assessment can be performed. The present study illustrates two possibilities to combine in-vitro and in-vivo data for the characterization of the palatability of the new drug candidates CSE3104 and CSE3165. As a first step, the implementation and suitability of electronic tongue measurements has been demonstrated by comparison of in-vivo and in-vitro data. In alignment with the taste assessment results during a single-center, double-blinded, randomized, placebo-controlled, single ascending dose (SAD) study in healthy subjects, the bitter taste perception of CSE3104 was assessed with e-tongue measurements. Moreover, the sensor response pattern showed comparable results of the e-tongue measurements to the human taste study of CSE3165: With increasing concentration, the bitterness values were increased. In addition, the human taste pattern showed increasing values for sourness due to higher volumes of the citric acid buffer. Results of the hedonic descriptor "unpleasant" within the human taste assessments could be related to bitterness in the instrumental taste assessment. For the second step in electronic tongue guided formulation development two possibilities are depicted in the article focusing on the effect of different excipients on the formulation on the one hand and on the assessment and comparison of two drug formulations on the other hand. Based on these results, the low number of healthy volunteers

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

    Energy Technology Data Exchange (ETDEWEB)

    Peters, Tanja

    2013-10-29

    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.

  5. Novel montelukast sodium-loaded stable oral suspension bioequivalent to the commercial granules in rats.

    Science.gov (United States)

    Kim, Dong Wuk; Kim, Young Hun; Yousaf, Abid Mehmood; Kim, Dong Shik; Kwon, Taek Kwan; Park, Jung Hee; Kim, Yong Il; Park, Jae-Hyun; Jin, Sung Giu; Kim, Kyung Soo; Cho, Kwan Hyung; Li, Dong Xun; Kim, Jong Oh; Yong, Chul Soon; Woo, Jong Soo; Choi, Han-Gon

    2016-04-01

    To develop a montelukast sodium-loaded stable oral suspension bioequivalent to the commercial granules in rats, several montelukast sodium-loaded suspensions were prepared with a suspending agent, stabilizers and anti-aggregation agents, and their stabilities were investigated by visually observing the sedimentation phenomenon and determining the concentration of the degradation product. Moreover, dissolution and pharmacokinetic studies of the optimized formulation were examined in rats compared to commercial montelukast sodium-loaded granules. Avicel RC-591 (Avicel), a suspending agent, prevented the sedimentation of these suspensions at >2.496 (w/v) per cent composition. Amongst the stabilizers tested, fumaric acid provided the lowest concentration of montelukast sulphoxide (a degradation product) in these suspensions at 40 °C, demonstrating its excellent stabilizing activity. Furthermore, as an anti-aggregation agent, glycerin gave lower amounts of degradation product than those with poloxamer 407 and Tween 80. In particular, montelukast-loaded oral suspension, an aqueous suspension containing montelukast sodium/Avicel/fumaric acid/glycerin at a concentration of 312/2496/15.6/62.4 (mg/100 ml), and the commercial granules exhibited similar dissolution profiles in 0.5% (w/v) aqueous solution of sodium lauryl sulphate. Moreover, the pharmacokinetics in rats provided by this suspension was comparable to that of the commercial granules, suggesting that they were bioequivalent. In addition, it was physically and chemically stable at 40 °C for at least 6 months. Thus, this montelukast sodium-loaded oral suspension, with bioequivalence to the commercial granules and excellent stability, could be a prospective dosage form for the treatment of asthma.

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

    Science.gov (United States)

    Sahoo, Subhashree; Chakraborti, Chandra Kanti; Mishra, Subash Chandra

    2011-01-01

    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 (2θ) 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. PMID:22171318

  7. 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.

  8. 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.

  9. 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 μm), 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. PMID:23984361

  10. Enrichment, Development, and Assessment of Indian Basil Oil Based Antiseptic Cream Formulation Utilizing Hydrophilic-Lipophilic Balance Approach

    Directory of Open Access Journals (Sweden)

    Narayan Prasad Yadav

    2013-01-01

    Full Text Available 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 μm, 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.

  11. Stability of extemporaneously prepared rosuvastatin oral suspension.

    Science.gov (United States)

    Zaid, Abdel Naser; Shtayah, Rania; Qadumi, Ayman; Ghanem, Mashour; Qedan, Rawan; Daibes, Marah; Awwad, Somud Abu; Jaradat, Nidal; Kittana, Naim

    2017-10-01

    The stability of an extemporaneously prepared rosuvastatin suspension stored over 30 days under various storage conditions was evaluated. Rosuvastatin suspension was extemporaneously prepared using commercial rosuvastatin tablets as the source of active pharmaceutical ingredient. The organoleptic properties, dissolution profile, and stability of the formulation were investigated. For the stability studies, samples of the suspension were stored under 2 storage conditions, room temperature (25 °C and 60% relative humidity) and accelerated stability chambers (40 °C and 75% relative humidity). Viscosity, pH, organoleptic properties, and microbial contamination were evaluated according to the approved specifications. High-performance liquid chromatography was used for the analysis and quantification of rosuvastatin in selected samples. Microbiological investigations were also conducted. The prepared suspension showed acceptable organoleptic properties. It showed complete release of rosuvastatin within 15 minutes. The pH of the suspension was 9.8, which remained unchanged during the stability studies. The microbiological investigations demonstrated that the preparation was free of any microbial contamination. In addition, the suspension showed stability within at least the period of use of a 100-mL rosuvastatin bottle. Extemporaneously prepared rosuvastatin 20-mg/mL suspension was stable for 30 days when stored at room temperature. Copyright © 2017 by the American Society of Health-System Pharmacists, Inc. All rights reserved.

  12. Development of Subischial Prosthetic Sockets with Vacuum-Assisted Suspension for Highly Active Persons with Transfemoral Amputations

    Science.gov (United States)

    2016-12-01

    limb amputation. Healthcare Quarterly 440 2008;11:117-121. 441 53. Kahle JT, Highsmith MJ. Transfemoral sockets with vacuum-assisted suspension442...in-patients following major lower-limb amputation. Healthcare Quarterly 302 2008;11:117-121. 303 2953. Kahle JT, Highsmith MJ. Transfemoral sockets...velocity is then the speed at which the generator spins . The generated voltage is then calculated by the equation: = "# × # Here, Kg is the

  13. Development and Validation of HPTLC method for the estimation of Sitagliptin Phosphate and Simvastatin in bulk and Marketed Formulation

    OpenAIRE

    Rathod Sonali; Patil Pallavi; Chopade Vittal

    2012-01-01

    Method describes a development and validation of HPTLC method for the estimation of sitagliptin phosphate and simvastatin in bulk and marketed formulation. This employs a precoated silica gel 60 F254 (0.2 mm thickness) on aluminium sheets and mobile phase chloroform: methanol in the ratio of 8:2 v/v, having chamber saturation for 20 min at room temperature. The developing chamber was run up to 8cm. The Rf values were found to be 0.13 and 0.75 for sitagliptin phosphate and simvastatin respecti...

  14. Solid dispersions in the development of a nimodipine floating tablet formulation and optimization by artificial neural networks and genetic programming.

    Science.gov (United States)

    Barmpalexis, Panagiotis; Kachrimanis, Kyriakos; Georgarakis, Emanouil

    2011-01-01

    The present study investigates the use of nimodipine-polyethylene glycol solid dispersions for the development of effervescent controlled release floating tablet formulations. The physical state of the dispersed nimodipine in the polymer matrix was characterized by differential scanning calorimetry, powder X-ray diffraction, FT-IR spectroscopy and polarized light microscopy, and the mixture proportions of polyethylene glycol (PEG), polyvinyl-pyrrolidone (PVP), hydroxypropylmethylcellulose (HPMC), effervescent agents (EFF) and nimodipine were optimized in relation to drug release (% release at 60 min, and time at which the 90% of the drug was dissolved) and floating properties (tablet's floating strength and duration), employing a 25-run D-optimal mixture design combined with artificial neural networks (ANNs) and genetic programming (GP). It was found that nimodipine exists as mod I microcrystals in the solid dispersions and is stable for at least a three-month period. The tablets showed good floating properties and controlled release profiles, with drug release proceeding via the concomitant operation of swelling and erosion of the polymer matrix. ANNs and GP both proved to be efficient tools in the optimization of the tablet formulation, and the global optimum formulation suggested by the GP equations consisted of PEG=9%, PVP=30%, HPMC=36%, EFF=11%, nimodipine=14%. Copyright © 2010 Elsevier B.V. All rights reserved.

  15. Development and characterization of new and scalable topical formulations containing N-acetyl-d-glucosamine-loaded solid lipid nanoparticles.

    Science.gov (United States)

    Marto, Joana; Sangalli, Cecilia; Capra, Priscilla; Perugini, Paola; Ascenso, Andreia; Gonçalves, Lídia; Ribeiro, Helena

    2017-11-01

    N-Acetyl-d-glucosamine (NAG) has been recently considered for topical treatment of hyperpigmentation disorders due to its inhibitory effect on thyrosinase enzymes in melanocytes. NAG is a precursor of hyaluronic acid, increasing its amount in skin, and consequently, preserving the skin hydration and elasticity. It may also act as an emulsion stabilizer. Solid lipid nanoparticles (SLN) are advanced delivery systems successfully used in pharmaceutical and cosmetic formulations for the improvement of active molecules penetration into the skin. Therefore, this work aimed to develop and characterize stable and scalable topical formulations containing NAG-loaded SLN. NAG was incorporated in SLN which were prepared by two high shear homogenizers and characterized regarding its morphology and particle size by transmission electron microscopy and photon correlation spectroscopy, respectively. Oil emulgel and hydrogel were used as carriers of NAG-loaded SLN. Several parameters were evaluated, including the droplet size distribution, rheology, pH and topical delivery by different techniques. It was observed that SLN size was significantly dependent on NAG incorporation and homogenization process. Most tested SLN parameters appeared to be quite suitable, that is, spherical and well-defined SLN with approximately 258 nm and -30 mV. Hereafter, both gels containing SLN presented a pseudoplastic flow. Emulgel formulation containing NAG-loaded SLN allowed a higher NAG permeation through the SC compared to the respective control (about 0.8 μgcm -2  h -1 ). According to the results obtained, it can be suggested that NAG acts as an emulsion stabilizer. This stabilization was also particularly dependent on the homogenizer type which is quite important for scale-up process. This study demonstrated the potential of scalable SLN formulations to improve NAG topical delivery contributing to the improvement of skin properties on several skin disorders.

  16. Formulation, development, and optimization of a novel octyldodecanol-based nanoemulsion for transdermal delivery of ceramide IIIB

    Science.gov (United States)

    Su, Runping; Yang, Li; Wang, Yue; Yu, Shanshan; Guo, Yu; Deng, Jiayu; Zhao, Qianqian; Jin, Xiangqun

    2017-01-01

    This research aimed to develop and optimize a nanoemulsion-based formulation containing ceramide IIIB using phase-inversion composition for transdermal delivery. The effects of ethanol, propylene glycol (PG), and glycerol in octyldodecanol and Tween 80 systems on the size of the nanoemulsion region in the phase diagrams were investigated using water titration. Subsequently, ceramide IIIB loading was kept constant (0.05 wt%), and the proposed formulation and conditions were optimized via preliminary screening and experimental design. Factors such as octyldodecanol/(Tween 80:glycerol) weight ratio, water content, temperature, addition rate, and mixing rate were investigated in the preliminary screening experiment. Response surface methodology was employed to study the effect of water content (30%–70%, w/w), mixing rate (400–720 rpm), temperature (20°C–60°C), and addition rate (0.3–1.8 mL/min) on droplet size and polydispersity index. The mathematical model showed that the optimum formulation and conditions for preparation of ceramide IIIB nanoemulsion with desirable criteria were a temperature of 41.49°C, addition rate of 1.74 mL/min, water content of 55.08 wt%, and mixing rate of 720 rpm. Under optimum formulation conditions, the corresponding predicted response values for droplet size and polydispersity index were 15.51 nm and 0.12, respectively, which showed excellent agreement with the actual values (15.8 nm and 0.108, respectively), with no significant (P>0.05) differences. PMID:28860748

  17. Development of self-lubricating coatings via cold spray process: Feedstock formulation and deformation modeling

    Science.gov (United States)

    Aggarwal, Gaurav

    Because of their low density, high specific strength and high stiffness, titanium alloys are one of the prime candidates for structural application often requiring specific tribological properties. However, their relatively high friction coefficients and low wear resistance are limiting their application over a wider temperature range. Various coatings deposited with technologies like high velocity oxy flame (HVOF), detonation gun (DGun), electron beam physical vapor deposition (EB-PVD), etc., can improve wear performance and decrease corrosion damage. These technologies require high processing temperatures precluding the integration of thermally vulnerable lubricants. This research looks at a relatively new coating process called Cold Spray for self-lubricating coatings on Ti-6Al-4V alloys. Cold Spray can produce coatings without significant heating of the sprayed powder or substrate. The particles are in solid state as they hit the substrate, and the formation of coatings occurs mainly due to the kinetic energy of the particles. Therefore, the impact velocity plays an important role. Below a critical value, the particles can cause densification and abrasion of the substrate. The focus of this study is to design composite coatings for the cold spray process and determination of the critical velocity through finite element modeling. Different powders and feedstock formulation techniques are discussed in order to find an optimum formulation for self-lubricating coatings. A composite powder (Ni coated hBN) was found to be the best candidate for the feedstock. The deformation of composite particles upon impact on the substrate was modeled and compared to the experiments. A number of approaches involving different modeling platforms, particle-substrate geometries, and material models have been tried. This work presents the results of ANSYS (version 10.0) analysis using an axisymmetric model of the particle impact. Stress and strain distributions in the particle

  18. Film flow of a suspension down an inclined plane.

    Science.gov (United States)

    Li, Xiaofan; Pozrikidis, C

    2003-05-15

    A method is developed for simulating the film flow of a suspension of rigid particles with arbitrary shapes down an inclined plane in the limit of vanishing Reynolds number. The problem is formulated in terms of a system of integral equations of the first and second kind for the free-surface velocity and the traction distribution along the particle surfaces involving the a priori unknown particle linear velocity of translation and angular velocity of rotation about designated centres. The problem statement is completed by introducing scalar constraints that specify the force and torque exerted on the individual particles. A boundary-element method is implemented for solving the governing equations for the case of a two-dimensional periodic suspension. The system of linear equations arising from numerical discretization is solved using a preconditioner based on a particle-cluster iterative method recently developed by Pozrikidis (2000 Engng Analysis Bound. Elem. 25, 19-30). Numerical investigations show that the generalized minimal residual (GMRES) method with this preconditioner is significantly more efficient than the plain GMRES method used routinely in boundary-element implementations. Extensive numerical simulations for solitary particles and random suspensions illustrate the effect of the particle shape, size and aspect ratio in semi-finite shear flow, and the effect of free-surface deformability in film flow.

  19. 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

  20. Etude thermique expérimentale des suspensions non newtoniennes ...

    African Journals Online (AJOL)

    Newtonian and pseudoplastic suspensions flowing in a horizontal pipe with variable geometry. These suspensions are composed of large hard spheres in a solution of Tylose. It helped to highlight the limits of the development of the thermal boundary ...

  1. 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

  2. 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.

  3. Development of biomedical 5-fluorouracil nanoplatforms for colon cancer chemotherapy: Influence of process and formulation parameters.

    Science.gov (United States)

    Pretel, Elena; Arias, José L; Cabeza, Laura; Melguizo, Consolación; Prados, José; Mallandrich, Mireia; Suñer, Joaquim; Clares, Beatriz

    2017-09-15

    In the present investigation solvent displacement or nanoprecipitation, and emulsion/solvent evaporation methods were utilized to optimize poly(D,L-lactide-co-glycolide) nanoparticles for the vehiculization of the 5-fluorouracil. Formulation components from both the aqueous and organic phases, as well as, operating conditions were varied. Particles were characterized in terms of particle size and morphology, electrical properties, rheology, drug loading, stability, and drug release. Furthermore, in vitro cytotoxicity on human colon cells and different colon carcinoma cells was evaluated. Four types of nanoparticles were selected for drug loading, revealing differences between variables. Low viscosity values and their Newtonian behavior could assure the suitability of the nanoformulation for the intravenous route of administration. The greatest drug entrapment efficiency and best stability was achieved when the chemotherapeutic agent was incorporated into the internal aqueous phase of particles prepared by double emulsion/solvent evaporation. However, a more sustained drug release at pH 7.4 was possible when 5-fluorouracil was added to the external aqueous phase. These were the nanoformulations reporting the greatest antiproliferative efficacy compared with the free drug. The nanocarrier can optimize the antitumor activity of 5-fluorouracil, thus being a potential nanotool against colon cancer. Copyright © 2017 Elsevier B.V. All rights reserved.

  4. Formulation development, optimization and evaluation of aloe vera gel for wound healing

    Science.gov (United States)

    Khan, Abdul Wadood; Kotta, Sabna; Ansari, Shahid Hussain; Sharma, Rakesh Kumar; Kumar, Amit; Ali, Javed

    2013-01-01

    Purpose: To formulate and optimize a herbal gel of Aloe vera extract containing Carbopol 934 as gelling agent and to investigate the effects of topical application of Carbopol 934 gel containing Aloe vera extract on the healing of skin wounds surgically induced in Wistar rats. Materials and Methods: Different concentrations of viscosity enhancer Carbopol 934 were tried and finally gel that showed good spreadability and consistency was selected for wound healing property of herbal gel of Aloe vera. Excision wound model was used for the study. Results: The optimized gel was evaluated for different physicochemical properties and wound healing property. Differences in wound healing were observed between the various treatments when compared to the control group. Tissue hyperplasia was lower in the control group compared to the other treated groups. In animals group treated with gel, 80.14% healing was observed up to 14th day. While in untreated group I (control) animals showed 52.68% healing of wounds on 14th day. On the other hand, control group animals also showed inflammation and pus formation up to 5th day of study, while treated animals did not showed any observable inflammation and pus formation. Conclusion: Results shows prepared gel has promising effect on the wound healing process. PMID:24143047

  5. 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.

  6. Suspension as an Emergency Power

    National Research Council Canada - National Science Library

    Amanda L. Tyler

    2009-01-01

    ... Legislation B. Suspension During Reconstruction: Putting Down the Klan in South Carolina IV. UNDERSTANDING SUSPENSION AS AN EMERGENCY POWER A. Reading the Suspension Clause in Context B. Giving Meaning to the Suspension Power C. Mapping the Suspension Clause Within the Constitution V. SUSPENSION AND THE SEPARATION OF POWERS CONCLUSION [A] suspensio...

  7. Novel nanocrystal formulation of megestrol acetate has improved bioavailability compared with the conventional micronized formulation in the fasting state.

    Science.gov (United States)

    Jang, Kyungho; Yoon, Seonghae; Kim, Sung-Eun; Cho, Joo-Youn; Yoon, Seo Hyun; Lim, Kyoung Soo; Yu, Kyung-Sang; Jang, In-Jin; Lee, Howard

    2014-01-01

    Megestrol acetate is an effective treatment for improving appetite and increasing body weight in patients with cancer-associated anorexia. However, Megace oral suspension (OS), a micronized formulation of megestrol acetate, has low bioavailability in the fasting state. To overcome this limitation, a nanocrystal formulation has been developed. This study was performed to evaluate the pharmacokinetics and tolerability of the nanocrystal formulation and to compare them with those of Megace OS in the fed and fasting states. A randomized, open-label, two-treatment, two-period, two-sequence, crossover study was performed in three parts in 93 healthy subjects. A single 625 mg/5 mL oral dose of a nanocrystal formulation was administered in the fasting and fed states (part I). In parts II and III, a single 625 mg/5 mL oral dose of the nanocrystal formulation or Megace OS 800 mg/20 mL was given in the fed and fasting states, respectively. Blood samples were collected for up to 120 hours post dose for pharmacokinetic analysis. Tolerability was evaluated throughout the entire study period. The nanocrystal formulation of megestrol acetate was rapidly absorbed in both the fed and fasting states. In the fed state, systemic exposure was comparable between the nanocrystal formulation of megestrol acetate and Megace OS. In the fasting state, however, the peak plasma concentration and area under the plasma concentration-time curve to the last measurable concentration of megestrol acetate was 6.7-fold and 1.9-fold higher, respectively, for the nanocrystal formulation than for Megace OS. No serious adverse events were reported. Systemic exposure to megestrol acetate is less affected by lack of concomitant food intake when it is administered using the nanocrystal formulation. The nanocrystal formulation of megestrol acetate could be more effective in treating patients with cachexia or anorexia.

  8. Current and future development of extended-release, abuse-deterrent opioid formulations in the United States.

    Science.gov (United States)

    Webster, Lynn R; Markman, John; Cone, Edward J; Niebler, Gwendolyn

    2017-01-01

    Prescription opioid misuse and abuse in the United States (US) is epidemic and is a major burden on health-care resources and costs to society. The need to significantly reduce the risks of prescription opioid misuse and abuse must be balanced with the important needs of patients with chronic pain who may benefit from treatment with opioids. The use of abuse-deterrent formulations (ADFs) of prescription opioids is one approach that could reduce the risk of prescription opioid abuse and misuse while maintaining access to opioids. ADF opioids have properties that make their abuse more difficult, less attractive, or less rewarding. In 2015, the US Food and Drug Administration issued final guidance to industry for the development of ADF opioids that recommended specific studies be conducted to demonstrate the abuse-deterrent properties of new opioid formulations. The technologies and the preclinical and clinical development of ADF opioids are rapidly evolving. This review provides an overview of the required testing for product labeling that includes language about the abuse-deterrent features of an ADF opioid. The objective of this review is to inform and help health-care providers understand the unique development of extended-release ADF opioids and their place in the treatment of patients with pain.

  9. Development of new formulation and its evaluation by capillary electrophoresis of tablets containing tramadol hydrochloride and paracetamol.

    Science.gov (United States)

    Ciurba, Adriana; Hancu, Gabriel; Cojocea, Livia-Maria; Sipos, Emese; Todoran, Nicoleta

    2014-11-01

    A quick and efficient method to eliminate pain is combining complementary action and substances with synergic effect. Such an association is the one between tramadol hydrochloride and paracetamol, in which the rapid reaction time of the paracetamol is combined with the long-term effect of the tramadol hydrochloride. Our aim was to develop and characterize alternative tablet formulations containing tramadol hydrochloride 37.5 mg and paracetamol 325 mg with different excipients in different ratio, and also the development of a new electrophoretic method for the quantitative determination of the active substances. The tablets were evaluated for physical characteristics (weight, thickness, diameter, mechanical strength, friability, disintegration time), drug content and dissolution following Ph.Eur.7 and USP 35 guidelines. A new capillary electrophoretic method was developed for the determination of the two active substances. Capillary electrophoresis proved to be an efficient method for the determination of drug content and also for the dissolution profile. The two substances were separated based on the differences between their own electrophoretic mobilities, and determined in UV at two different wavelengths. Tablet formulation proved to be a significant factor in quality of tramadol hydrochloride/paracetamol tablets, as considerable differences between tablets containing different excipients were found; while capillary electrophoresis can be considered a useful alternative for the quantitative determination of tramadol hydrochloride/paracetamol combinations.

  10. 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 world-wide relevance. Due to the progressive phasing-out of chemical insecticides, there is a 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 CO2 and contain neem extract as a bioinsecticidal compound. Our objectives were to figure out, (i) whether neem extract can be efficiently immobilized, (ii) whether CO2 -releasing Saccharomyces cerevisiae and neem extract are suitable for co-encapsulation, and (iii) whether co-encapsulated neem extract affects the attractiveness of CO2 -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 the measurement of azadirachtin A as main active ingredient). Even in enhanced concentrations, neem extract allowed growth of S. cerevisiae and beads containing neem extract exhibited a comparable CO2 -emission as beads without neem extract. When applied into the soil, the beads established a CO2 gradient spanning more than 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. This article is protected by copyright. All rights reserved.

  11. [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.

  12. Lipid Vesicles for the Skin Delivery of Diclofenac: Cerosomes vs. Other Lipid Suspensions

    Science.gov (United States)

    Fathi-Azarbayjani, Anahita; Ng, Kai Xin; Chan, Yew Weng; Chan, Sui Yung

    2015-01-01

    Purpose: Lipid suspensions as drug carriers, including conventional liposomes, ethosomes, transferosomes, proniosomes, niosomes, PEG-PPG-PEG niosomes and stratum corneum liposomes (cerosomes), were formulated and compared. Methods: Lipid vesicles were formulated and assessed with regards to enhancement of skin permeation of diclofenac and stability profiles of the formulations. Formulation-induced changes of the biophysical structure of excised human skin were monitored using the Fourier transform infrared spectroscopy. Results: The stability profiles of these suspensions over 12 weeks did not show any significant drug leakage from the vesicles of interest (p > 0.05). FTIR observations indicated that the vesicles increased stratum corneum (SC) lipid fluidization and altered protein conformation. Skin permeability experiments showed that the free unencapsulated drug in the cerosomal formulations caused significant increase in drug permeation across the skin (p hydrophilic drug in the skin lipids and the partition coefficient of the drug from these vesicles into the SC. Conclusion: Optimal drug entrapment in vesicles or alteration of the skin structure may not necessarily enhance the permeation of hydrophilic drugs across the human skin. These lipid vesicles may be further developed into carriers of both hydrophilic and hydrophobic drugs for topical and transdermal delivery, respectively. PMID:25789216

  13. 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.

  14. 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.

  15. Development of inhalable formulations of anti-inflammatory drugs to potentially treat smoke inhalation injury in burn victims.

    Science.gov (United States)

    Thai, A; Xiao, J; Ammit, A J; Rohanizadeh, R

    2010-04-15

    Injury arising from smoke inhalation is a significant mortality risk in severe burned patients. Inflammatory processes are major contributors to the development of respiratory insufficiency owing to pulmonary oedema, formation of airway fibrin clots and hypoxaemia. Anti-inflammatory and anti-coagulant drugs such as heparin and pentoxifylline are currently systemically administered for the treatment of smoke inhalation. Delivery of these drugs in the form of inhalable particles could be an effective manner to achieve rapid targeted action for acceleration of the treatment. The study developed and characterised a series of spray-dried heparin and pentoxifylline dry powder formulations suitable for inhalation administration. Drug particles were co-spray-dried with leucine in varying ratios. Particle size analysis confirmed all powders (except 2%, w/w, pentoxifylline with 1%, w/w, leucine in spray-drying feed solution) had particle size in the optimal range (heparin surface topography while pentoxifylline formulations were a mixture of elongated needles interspersed with wrinkly particles. Addition of leucine improved fine particle fraction of heparin and pentoxifylline. The study indicated manufacture of inhalable heparin and pentoxifylline was feasible and can potentially be an attractive delivery alternative to the more conventional systemic delivery route. Copyright 2010 Elsevier B.V. All rights reserved.

  16. Quality by Design Empowered Development and Optimisation of Time-Controlled Pulsatile Release Platform Formulation Employing Compression Coating Technology.

    Science.gov (United States)

    Patadia, Riddhish; Vora, Chintan; Mittal, Karan; Mashru, Rajashree C

    2017-05-01

    The research was envisaged for development of time-controlled pulsatile release (PR) platform formulation to facilitate management of early morning chronological attacks. The development was started using prednisone as a model drug wherein core tablets were prepared using direct compression method and subsequently compression-coated with ethylcellulose (EC)-hydroxypropyl methylcellulose (HPMC) excipient blend. Initially, quality target product profile was established and risk assessment was performed using failure mode and effect analysis. In an endeavour to accomplish the objective, central composite design was employed as a design of experiment (DoE) tool. Optimised compression-coated tablet (CCT) exhibited 4-6 h lag time followed by burst release profile under variegated dissolution conditions viz. multi-media, change in apparatus/agitation and biorelevant media. Afterwards, five different drugs, i.e. methylprednisolone, diclofenac sodium, diltiazem hydrochloride, nifedipine and lornoxicam, were one-by-one incorporated into the optimised prednisone formula with replacement of former drug. Change in drug precipitated the issues like poor solubility and flow property which were respectively resolved through formulation of solid dispersion and preparation of active pharmaceutical ingredient (API) granules. Albeit, all drug CCTs exhibited desired release profile similar to prednisone CCTs. In nutshell, tour de force of research epitomised the objective of incorporating diverse drug molecules and penultimately obtaining robust release profile at varying dissolution conditions.

  17. Use of honey as a viscosity modifier in the formulation of ...

    African Journals Online (AJOL)

    Family, Apidae) as a viscosity modifier in conjunction with certain suspending agents in the formulation of cotrimoxazole suspension, to solve the problem of caking associated with most brands in the market. Six formulations including control, with or ...

  18. A critical evaluation of Tm(FTIR) measurements of high-concentration IgG1 antibody formulations as a formulation development tool.

    Science.gov (United States)

    Matheus, Susanne; Mahler, Hanns-Christian; Friess, Wolfgang

    2006-07-01

    Fourier-transform infrared (FTIR) spectroscopy was applied for the determination of protein melting temperature (Tm(FTIR)) and to assess the stability predictability of a 100-mg/mL liquid IgG1 antibody formulation. Tm(FTIR) values of various formulations (different pH, buffers, excipients) were compared to the results of a stability study under accelerated conditions (40 degrees C/75% relative humidity), using size-exclusion high-performance liquid chromatography (SE-HPLC) and sodium dodecyl sulfate-polyacrylamide gel electrophoresis (SDS-PAGE) for the detection of soluble aggregates and covalent modifications. The highest Tm(FTIR) was achieved at pH 5.5, and, similarly, SE-HPLC and SDS-PAGE results suggested a pH optimum between 5.5 and 6.0. Transition temperatures were comparable for all tested buffers. However, the decrease in the monomer fraction upon thermal storage was the lowest for citrate buffers. Whereas sugars and polyols resulted in an increase in Tm(FTIR) and enhanced monomer fraction after storage, amino acids showed a destabilization according to SE-HPLC analysis, albeit no change or even an increase in the melting temperature was observed. All examples gave evidence that Tm(FTIR) values did not necessarily correspond to the storage stability at 40 degrees C analyzed by means of SE-HPLC and SDS-PAGE. Tm values, e.g., determined by FTIR, should only be employed as supportive information to the results from both real-time and accelerated stability studies.

  19. Formulation of consumables management models. Development approach for the mission planning processor working model

    Science.gov (United States)

    Connelly, L. C.

    1977-01-01

    The mission planning processor is a user oriented tool for consumables management and is part of the total consumables subsystem management concept. The approach to be used in developing a working model of the mission planning processor is documented. The approach includes top-down design, structured programming techniques, and application of NASA approved software development standards. This development approach: (1) promotes cost effective software development, (2) enhances the quality and reliability of the working model, (3) encourages the sharing of the working model through a standard approach, and (4) promotes portability of the working model to other computer systems.

  20. Scenario Development as a Basis for Formulating a Research Program on Future Agriculture: A Methodological Approach

    National Research Council Canada - National Science Library

    Ingrid Öborn; Jan Bengtsson; Fredrik Hedenus; Lotta Rydhmer; Maria Stenström; Katarina Vrede; Charles Westin; Ulf Magnusson

    2013-01-01

    ... for future agricultural research. Using a scenario development method known as morphological analysis, scenarios were constructed that took economic, political, technical, and environmental factors into account...

  1. 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.

  2. [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.

  3. 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

  4. 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.

  5. 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.

  6. Development of Denticap, a matrix based sustained release formulation for treatment of toothache, dental infection and other gum problem.

    Science.gov (United States)

    Mukherjee, Biswajit; Roy, Gopa; Ghosh, Soma

    2009-04-01

    Toothache is a serious problem worldwide. To give relief from this intolerable toothache, doctors prescribe painkillers along with antibiotics. Most of the painkillers, if not all, produce hyperacidity and gastric irritation upon oral administration. Oral antibiotics have slow onset of action and undergo hepatic "first-pass" effect. Moreover, available dental formulations are mostly liquid and last only few hours upon application, before being washed out by saliva. To overcome the above-mentioned problems, a soft polymeric mold containing antibiotic and analgesic drugs and having an appropriate consistency to adhere to the tooth, was developed for sustained drug release to provide better relief in dental patients. Eudragit L 100-55, carbopol 971 P, gum karaya powder and ethyl cellulose were used to prepare the mold "Denticaps" containing Lidocaine hydrochloride and Amoxicillin trihydrate individually and in combination, by mixing and solvent evaporation technique. Different physicochemical characterization studies such as mucoadhesion test, water absorption capacity and swelling index were carried out. In vitro drug release studies showed sustained release of Lidocaine hydrochloride and Amoxicillin trihydrate in simulated saliva for 24 h. Further studies are warranted to succeed with these formulations in humans. Upon success, this type of dosage form may open up new avenues towards dentistry.

  7. Development and Validation of an HPLC Method for the Simultaneous Determination of Fipronil, Chlorfenapyr, and Pyriproxyfen in Insecticide Formulations.

    Science.gov (United States)

    Hafeez, Anum; Tawab, Iffat Abdul; Iqbal, Sajid

    2016-09-01

    In this study, the analytical method development and validation of an HPLC assay for simultaneous determination of fipronil, chlorfenapyr, and pyriproxyfen in formulation products is described. On the basis of solubility and chromatographic separation with good resolution, acetonitrile-water (80 + 20) was selected as the mobile phase in isocratic mode with a flow rate of 1 mL/min. Chromatographic separations were performed on a Beckman C18 analytical column (4.6 mm × 15 cm, 5 μm particle size; Musa Jee & Sons, Karachi, Pakistan). The retention times for fipronil, chlorfenapyr, and pyriproxyfen were 3.70, 8.61 and 10.09 min, respectively. Calibration curves of all studied insecticides were linear in the concentration range of 20 to 800 μg/mL, with R(2) > 0.997. The LODs of fipronil, chlorfenapyr, and pyriproxyfen were 15.1, 13.3, and 20.0 μg/mL, respectively, whereas the LOQs were 45.9, 40.3, and 60.6 μg/mL. Interday precision was RSD, % pyriproxyfen in their formulations.

  8. Formulation development of SYN-004 (ribaxamase) oral solid dosage form, a β-lactamase to prevent intravenous antibiotic-associated dysbiosis of the colon.

    Science.gov (United States)

    Bristol, Andrew; Hubert, Steven; Hofmann, Felix; Baer, Hans

    2017-12-20

    SYN-004 (ribaxamase) delayed release drug product is a multi-particulate, hard capsule for oral delivery of a recombinant β-lactamase enzyme designed to degrade β-lactam antibiotics administered intravenously, and thus prevent colon dysbiosis. Here we describe the development of the SYN-004 enteric coated pellet formulation, which has been tested in multiple clinical trials. Since the SYN-004 drug substance is a buffered liquid, several binder excipients in different ratios were tested to facilitate binding of SYN-004 to sugar spheres. The binding systems were evaluated by droplet pre-evaluation and film casting tests. The most promising formulations were produced in small scale fluidized bed application runs and analyzed by dissolution tests and complementary analytical assays. Hydroxypropyl cellulose was selected as the preferred SYN-004 binding excipient. The formulation included a second, outer coat containing the enteric EUDRAGIT® L 30 D-55 polymer-based formulation to achieve gastric protection, and rapid SYN-004 release in the intestinal tract, when the pH rises above 5.5. Additional formulation improvements resulted in an increase in the SYN-004 load compared to a predecessor oral enzyme formulation (Ipsat P1A). Thus, a novel formulation and process for an orally administered enzyme was developed and used to manufacture drug product for clinical trials. Copyright © 2017 The Authors. Published by Elsevier B.V. All rights reserved.

  9. 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

  10. Formulation of consumables management models. Guidelines for the development of consumables subsystem redlines for advanced spacecraft

    Science.gov (United States)

    Zamora, M. A.

    1977-01-01

    Techniques developed for determining the safe operating range or condition of past space programs are inadequate to support requirements of highly repetitive and routine earth orbit operations of advanced spacecraft systems. General concepts are presented for establishing maximum and minimum limits (redlines) for the consumables subsystems of the space shuttle orbiter. Implementation of a redline status subprocessor is recommended as a substitute for methods employed in past programs. The algorithms developed are amenable for use in the Mission Control Center, the launch processing system, and the space shuttle onboard computer.

  11. 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

  12. 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.

  13. Stability of dynamic response of suspension bridges

    Science.gov (United States)

    Capsoni, Antonio; Ardito, Raffaele; Guerrieri, Andrea

    2017-04-01

    The potential occurrence of internal parametric resonance phenomena has been recently indicated as a potential contributory cause of the appearance of critical dynamic states in long-span suspension bridges. At the same time, suspension bridges, in view of their flexibility, are prone to aeroelastic response, such as vortex shedding, torsional divergence and flutter. In this paper, a non-linear dynamic model of a suspension bridge is devised, with the purpose of providing a first attempt toward a unified framework for the study of aeroelastic and internal resonance instabilities. Inspired by the pioneering work of Herrmann and Hauger, the analyses have been based on a linearized formulation that is able to represent the main structural non-linear effects and the coupling given by aerodynamic forces. The results confirm that the interaction between aeroelastic effects and non-linear internal resonance leads to unstable conditions for wind speeds which can be lower than the critical threshold for standard aeroelastic predictions.

  14. 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.

  15. 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.

  16. Development of Solid Self-Emulsifying Formulation for Improving the Oral Bioavailability of Erlotinib

    OpenAIRE

    Truong, Duy Hieu; Tran, Tuan Hiep; Ramasamy, Thiruganesh; Choi, Ju Yeon; Lee, Hee Hyun; Moon, Cheol; Choi, Han-Gon; Yong, Chul Soon; Kim, Jong Oh

    2015-01-01

    To improve the solubility and oral bioavailability of erlotinib, a poorly water-soluble anticancer drug, solid self-emulsifying drug delivery system (SEDDS) was developed using solid inert carriers such as dextran 40 and Aerosil® 200 (colloidal silica). The preliminary solubility of erlotinib in various oils, surfactants, and co-surfactants was determined. Labrafil M2125CS, Labrasol, and Transcutol HP were chosen as the oil, surfactant, and co-surfactant, respectively, for preparation of the ...

  17. Development of a Vorticity-Velocity Navier-Stokes Formulation for the Study of Compressibility Effects on Dynamic Stall

    Science.gov (United States)

    Ghia, K. N.; Ghia, U.

    1996-01-01

    The first major area of this study was to develop a vorticity-velocity formulation and numerical solution algorithms suitable for the analyses of incompressible as well as low-to- moderate-speed compressible flows. Research performed towards contributing to the determination of the appropriate vorticity and dilation creation boundary conditions suggested to temporarily set aside this approach and use a primitive-variable approach other than the pseudo-compressibility approach used. The second major area of study was initiated to comprehensively examine the INS-2D and INS-3D programs from the point of view of boundary conditions. The research carried out was documented in the form of two technical papers which are included in Appendices A and B; the boundary-condition related issues for INS-3D are briefly mentioned.

  18. A formulation approach for development of HPMC-based sustained release tablets for tolterodine tartrate with a low release variation

    DEFF Research Database (Denmark)

    Cao, Qing-Ri; Choi, Jae-Seung; Liu, Yan

    2013-01-01

    Objective: The purpose of this study was to develop hydroxypropylmethylcellulose (HPMC)-based sustained release (SR) tablets for tolterodine tartrate with a low drug release variation. Methods: The SR tablets were prepared by formulating a combination of different grades of HPMC as the gelling...... agents. The comparative dissolution study for the HPMC-based SR tablet as a test and Detrusitol(®) SR capsule as a reference was carried out, and the bioequivalence study of the two products was also conducted in human volunteers. Results: The amount of HPMC, the grade of HPMC and the combination ratio...... of different grades of HPMC had remarkable effects on drug release from the SR tablets. Both the test and reference products had no significant difference in terms of comparative dissolution patterns in four different media (f(2) > 50). Furthermore, the dissolution method and rotation speed showed no effects...

  19. Development of standard operating procedures of Habbe Shifa: A polyherbal Unani formulation

    Directory of Open Access Journals (Sweden)

    Asira Tarannum

    2013-01-01

    Full Text Available Background: Unani medicines are being used since antiquity. However, in spite of their efficacy, they have been widely criticized due to lack of standardization and poor quality presentation. For this reason, application of good manufacturing practices and development of standard operating procedures (SOPs in the manufacture of herbal medicines became an essential tool to assure their quality. Objectives: Therefore, the objective of the study was to develop the SOP of Habbe Shifa (HS regarding the particle size (PS, binder, temperature of drying, and duration of drying. Materials and Methods: In this study, 24 batches of HS were prepared according to the instructions given in formulary to develop SOP. Three particle sizes (i.e., 80, 100, and 120 No. Mesh sieve, were taken for preparation of pills. Water and Samaghe Arabi (Gum Acacia mucilage [GAM] were used as binder for preparing the lubdi (mass in different batches. Different temperature and duration of drying were used to dry the pills in hot air oven to get satisfactory results. All the batches were assessed three times for hardness, friability, and disintegration time and mean regarded as standard parameter value. Results and Conclusion: The batch with 150 mm PS (100 mesh sieve, 5% w/w GAM used as a binder, dried at 90°C for 120 min showed hardness 3.50 ± 0.00 kg/cm, friability 0.02 ± 0.003%, and disintegration time 25.00 ± 0.57 min, which showed most appropriate result among all batches and considered as final batch. Its SOP may be used for future reference which can help in setting up regulatory limit to assure the quality of Unani medicines.

  20. Stability of sunitinib in oral suspension.

    Science.gov (United States)

    Navid, Fariba; Christensen, Robbin; Minkin, Patton; Stewart, Clinton F; Furman, Wayne L; Baker, Sharyn

    2008-07-01

    Sunitinib is a novel, oral, multitargeted tyrosine kinase inhibitor with antiangiogenic and antitumor activity. No liquid formulation of sunitinib malate is commercially available for pediatric administration. To prepare extemporaneously an oral liquid formulation of sunitinib malate from commercially available capsules and study its chemical and physical stability in suspension at room temperature and under refrigeration at 4 degrees C. Six independent samples were prepared by mixing the contents of 3 sunitinib malate capsules (each equivalent to 50 mg of sunitinib) with 15 mL of a 1:1 mixture of Ora-Plus:Ora-Sweet solution to yield a final concentration of 10 mg/mL. Suspensions were stored in amber plastic bottles with child-resistant caps. Three samples were refrigerated at 4 degrees C and 3 were stored at room temperature. Aliquots from each bottle were obtained on days 1, 2, 3, 5, 7, 14, 21, 30, and 60 and diluted to a final concentration of 300 ng/mL with 500 ng/mL of clozapine in 50% acetonitrile. Sunitinib concentrations were then measured by a liquid chromatography-tandem mass spectrometry assay validated in our laboratory. At room temperature and under refrigeration at 4 degrees C, sunitinib in a 10-mg/mL suspension of sunitinib malate with Ora-Plus:Ora-Sweet 1:1 maintained greater than 96% of its initial concentration for 60 days. Visual appearance (color and consistency) and odor of drug suspension remained unchanged during the study. Sunitinib is stable in an oral suspension prepared from commercially available capsules for at least 60 days at room temperature and refrigeration at 4 degrees C. This liquid formulation is better suited for administration to children and adults with cancer who cannot swallow sunitinib capsules.

  1. Electrorheology of nanofiber suspensions

    National Research Council Canada - National Science Library

    Yin, Jianbo; Zhao, Xiaopeng

    2011-01-01

    .... In this review, we especially focus on the recent researches on electrorheology of various nanofiber-based suspensions, including inorganic, organic, and inorganic/organic composite nanofibers...

  2. Quality by design approach for formulation development: a case study of dispersible tablets.

    Science.gov (United States)

    Charoo, Naseem A; Shamsher, Areeg A A; Zidan, Ahmed S; Rahman, Ziyaur

    2012-02-28

    The focus of the current investigations was to apply quality by design (QbD) approach to the development of dispersible tablets. Critical material and process parameters are linked to the critical quality attributes of the product. Variability is reduced by product and process understanding which translates into quality improvement, risk reduction and productivity enhancement. The risk management approach further leads to better understanding of the risks, ways to mitigate them and control strategy is proposed commensurate with the level of the risk. Design space in combination with pharmaceutical quality management system provide for flexible regulatory approaches with opportunity for continuous improvement that benefit patient and manufacturer alike. The development of dispersible tablet was proposed in the current study through a QbD paradigm for a better patient compliance and product quality. The quality target product profile of a model biopharmaceutical class II drug was identified. Initial risk analysis led to the identification of the critical quality attributes. Physicochemical characterization and compatibility studies of the drug with commonly used excipients were performed. Experiments were designed with focus on critical material and process attributes. Design space was identified and risk factors for all the possible failure modes were below critical levels after the implementation of control strategy. Compliance to the design space provides an opportunity to release batches in a real time. In conclusion, QbD tools together with risk and quality management tools provided an effective and efficient paradigm to build the quality into dispersible tablet. Published by Elsevier B.V.

  3. 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.

  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. Formulation development of stronger and quick disintegrating tablets: a crucial effect of chitin.

    Science.gov (United States)

    Goel, Honey; Kaur, Gurpreet; Tiwary, Ashok K; Rana, Vikas

    2010-05-01

    A well known superdisintegrant like croscarmellose sodium or crospovidone loses their quick disintegration property when compressed at more than 4 kg tablet crushing strength (TCS). Therefore, the objective of the present work was to develop a disintegrating system that could be used for preparing fast disintegrating tablets (FDTs) of highly water soluble drug, metoclopramide, without compromising on the mechanical strength, irrespective of the TCS used for compressing the granules. For this purpose disintegrating system consisting of chitosan-alginate (CTN-ALG) complex (1:1): glycine and chitin was developed. The results revealed that when CTN-ALG and glycine were mixed in the ratio of 30:70, the granules exhibited a minimum water sorption time and maximum effective pore radius (R(eff.p)). The addition of chitin (5-10% w/w) into this mixture further enhanced the R(eff.p). Further, increase in the concentration of chitin from 10% to 20% w/w did not produce any significant effect (p>0.05) on the R(eff.p). The FDTs prepared by using CTN-ALG:glycine (30:70) and chitin exhibited increased porosity and lower disintegration time (DT). Further, chitin was found to neutralize the effect of TCS on DT of FDTs. This property of chitin was also observed in FDTs prepared by using croscarmellose sodium (5% w/w) or crospovidone (5% w/w). The reduction in DT of FDTs by chitin was also observed in tablets prepared without the drug. Hence, the effect was not influenced by the solubility component present in the tablets. Overall, the results suggested incorporation of chitin (5-10% w/w) while preparing FDTs of metoclopramide to enhanced the disintegration without compromising their mechanical strength of the tablets.

  6. High-throughput development of amphiphile self-assembly materials: fast-tracking synthesis, characterization, formulation, application, and understanding.

    Science.gov (United States)

    Mulet, Xavier; Conn, Charlotte E; Fong, Celesta; Kennedy, Danielle F; Moghaddam, Minoo J; Drummond, Calum J

    2013-07-16

    Amphiphile self-assembly materials, which contain both a hydrophilic and a hydrophobic domain, have great potential in high-throughput and combinatorial approaches to discovery and development. However, the materials chemistry community has not embraced these ideas to anywhere near the extent that the medicinal chemistry community has. While this situation is beginning to change, extracting the full potential of high-throughput approaches in the development of self-assembling materials will require further development in the synthesis, characterization, formulation, and application domains. One of the key factors that make small molecule amphiphiles prospective building blocks for next generation multifunctional materials is their ability to self-assemble into complex nanostructures through low-energy transformations. Scientists can potentially tune, control, and functionalize these structures, but only after establishing their inherent properties. Because both robotic materials handling and customized rapid characterization equipment are increasingly available, high-throughput solutions are now attainable. These address traditional development bottlenecks associated with self-assembling amphiphile materials, such as their structural characterization and the assessment of end-use functional performance. A high-throughput methodology can help streamline materials development workflows, in accord with existing high-throughput discovery pipelines such as those used by the pharmaceutical industry in drug discovery. Chemists have identified several areas that are amenable to a high-throughput approach for amphiphile self-assembly materials development. These allow an exploration of not only a large potential chemical, compositional, and structural space, but also material properties, formulation, and application variables. These areas of development include materials synthesis and preparation, formulation, characterization, and screening performance for the desired end

  7. Development of Lingzhi or Reishi medicinal mushroom, Ganoderma lucidum (Higher Basidiomycetes) polysaccharides injection formulation.

    Science.gov (United States)

    Jiang, Yuji; He, Anle; Liu, Yanhong; Xie, Baogui; Li, Ye; Deng, Youjin; Liu, Xinrui; Liu, Qichao

    2014-01-01

    Biochemical and pharmacological research has demonstrated that Lingzhi or Reishi medicinal mushroom Ganoderma lucidum polysaccharides (GLPS) have significant anticancer, antitumor, and antioxidant activities. To investigate the effect of injecting GLPS into hosts for clinical studies, aqueous polysaccharide extracts from G. lucidum fruit bodies were purified by deproteinization using the Sevage method, anion-exchange chromatography elution (cellulose DEAE-52 chromatography), dialysis, ethanol precipitation, and active carbon and millipore membrane filtration techniques. The purified GLPS were used for injection in mice. Polysaccharide indexes, protein, tannin, heavy metal, arsenic salt, oxalate, potassium ion, resin, pH, ignition residue measurements, evaluation criterion for allergic reactions, and total solids content of the GLPS injection were all performed using the reference methods in the Chinese Pharmacopoeia. Our results showed that polysaccharide was the key component of injection mixtures. The ignition residue and total solids content in the injection mixture were 1.4% and 2.4%, respectively. The other indices were all within the expected safety ranges. Furthermore, studies from mice functional assays showed that the injection mixture improved the antifatigue capacity of mice without any effect on weight loss/gain. In addition, the injection mixture was safe, which was confirmed by allergy testing in guinea pigs. The development of a GLPS injection offers a novel approach for future medicinal mushroom utilization and holds great commercial promise.

  8. 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

  9. 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

  10. A Novel Approach for Development and Characterization of Effective Mosquito Repellent Cream Formulation Containing Citronella Oil

    Directory of Open Access Journals (Sweden)

    Narayan Prasad Yadav

    2014-01-01

    Full Text Available Citronella essential oil (CEO has been reported as an excellent mosquito repellent; however, mild irritancy and rapid volatility limit its topical application. It was aimed to develop a nonirritant, stable, and consistent cream of CEO with improved residence time on skin using an industrial approach. Phase inversion temperature technique was employed to prepare the cream. It was optimized and characterized based on sensorial evaluation, emulsification, and consistency in terms of softness, greasiness, stickiness, and pH. The optimum batch (B5 was evaluated for viscosity (90249.67 ± 139.95 cP, texture profile with respect to firmness (38.67 ± 0.88 g, spreadability (70.33 ± 0.88 mJ, and extrudability (639.67 ± 8.09 ± 0.1 mJ using texture analyzer along with two most popular marketed products selected as reference standard. Subsequently, B5 was found to be stable for more than 90 days and showed enhanced duration of mosquito repellency as compared to CEO. HS-GC ensured the intactness of CEO in B5. Investigated primary irritation index (PII 0.45 positioned B5 into the category of irritation barely perceptible. The pronounced texture profile and stability of B5 with extended residence time and less PII revealed its potential application in industry and offered a promising alternative to the marketed products of synthetic origin.

  11. TURBISCAN MA 2000: multiple light scattering measurement for concentrated emulsion and suspension instability analysis.

    Science.gov (United States)

    Mengual, O; Meunier, G; Cayré, I; Puech, K; Snabre, P

    1999-09-13

    Emulsion or suspension destabilisation often results from coalescence or particle aggregation (flocculation) leading to particle migration (creaming or sedimentation). Creaming and sedimentation are often considered as reversible, while coalescence and flocculation spell disaster for the formulator. Thus, it is of prime importance to detect coalescence or cluster formation at an early stage to shorten the ageing tests and to improve the formulations. This work mainly concerns the independent and anisotropic scattering of light from an emulsion or suspension in a cylindrical glass measurement cell, in relation with the optical analyser TURBISCAN MA 2000. The propagation of light through a concentrated dispersion can be used to characterise the system physico-chemical stability. Indeed, photons undergo many scattering events in an optically thick dispersion before escaping the medium and entering a receiver aperture. Multiple scattering thus contributes significantly to the transmitted and backscattered flux measured by TURBISCAN MA 2000. We present statistical models and numerical simulations for the radiative transfer in a suspension (plane or cylindrical measurement cells) only involving the photon mean path length, the asymmetry factor and the geometry of the light receivers. We further have developed an imaging method with high grey level resolution for the visualisation and the analysis of the surface flux in the backscattered spot light. We compare the results from physical models and numerical simulations with the experiments performed with the imaging method and the optical analyser TURBISCAN MA 2000 for latex beads suspensions (variable size and particle volume fraction). We then present a few examples of concentrated emulsion and suspension instability analysis with TURBISCAN 2000. It is shown that the instrument is able to characterise particle or aggregate size variation and particle/aggregate migration and to detect these phenomena much more earlier

  12. 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.

  13. 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.

  14. Characterization of Mucoadhesive Norfloxacin suspensions by fourier transform Infrared Spectroscopy

    OpenAIRE

    Subhashree Sahoo; Chandra Kanti Chakraborti; Pradipta Kumar Behera; Subash Chandra Mishra

    2011-01-01

    Till now very few formulations are available from which the drug is absorbed uniformly so that safe and effective blood level of Norfloxacin could be maintained for a prolonged period. To fulfill this requirement a controlled release mucoadhesive suspension was prepared using mucoadhesive polymers. The chemical interaction between Norfloxacin and different polymers in suspensions has been studied to know their compatibility by Fourier Transform Infrared Spectroscopy (FTIR). Ultrasonication me...

  15. An examination of the rheology of flocculated clay suspensions

    Science.gov (United States)

    Spearman, Jeremy

    2017-04-01

    A dense cohesive sediment suspension, sometimes referred to as fluid mud, is a thixotropic fluid with a true yield stress. Current rheological formulations struggle to reconcile the structural dynamics of cohesive sediment suspensions with the equilibrium behaviour of these suspensions across the range of concentrations and shear. This paper is concerned with establishing a rheological framework for the range of sediment concentrations from the yield point to Newtonian flow. The shear stress equation is based on floc fractal theory, put forward by Mills and Snabre (1988). This results in a Casson-like rheology equation. Additional structural dynamics is then added, using a theory on the self-similarity of clay suspensions proposed by Coussot (1995), giving an equation which has the ability to match the equilibrium and time-dependent viscous rheology of a wide range of suspensions of different concentration and mineralogy.

  16. 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.

  17. An extended coupled phase theory for the sound propagation in polydisperse concentrated suspensions of rigid particles.

    Science.gov (United States)

    Baudoin, Michael; Thomas, Jean-Louis; Coulouvrat, François; Lhuillier, Daniel

    2007-06-01

    An extension of the classical coupled phase theory is proposed to account for hydrodynamic interactions between neighboring rigid particles, which are essential to describe properly the sound propagation in concentrated suspensions. Rigorous ensemble-averaged equations are derived for each phase and simplified in the case of acoustical wave propagation. Then, closure is achieved by introducing a self-consistent scheme originally developed by Buyevich and Shchelchkova [Prog. Aerosp. Sci. 18, 121-151 (1978)] for incompressible flows, to model the transfer terms between the two phases. This provides an alternative to the effective medium self-consistent theory developed by Spelt et al. [J. Fluid Mech. 430, 51-86 (2001)] in which the suspension is considered as a whole. Here, a significantly simpler formulation is obtained in the long wavelength regime. Predictions of this self-consistent theory are compared with the classical coupled phase theory and with experimental data measuring the attenuation in concentrated suspensions of silica in water. Our calculation is shown to give a good description of the attenuation variation with volume fraction. This theory is also extended to the case of polydisperse suspensions. Finally, the link between the self-consistent theory and the different orders of the multiple scattering theory is clarified.

  18. Flow induced orientation in carbon nanotube suspensions: Modeling and experiments

    Science.gov (United States)

    Natale, Giovanniantonio

    Due to their unique properties, carbon nanotubes (CNTs) hold remarkable promise for the next generation of materials, with potential applications in organic electronics, reinforced and electrically conducting plastic composites, new alloys, and even new types of biological sensors and devices. Despite these promises and potentialities, carbon nanotube composites and suspensions are inherently difficult to process, and efficient processing schemes are only just starting to be formulated. The success of CNTs, in all potential applications, depends on the understanding and ability to control the microstructure evolution during processing. During flow, CNTs dispersed in a polymeric matrix orient and interact, inducing spatial and orientation correlations. Agglomerates can also break if the hydrodynamic forces are sufficient, increasing the probability of contact between different nanotubes and improving the interactions with the matrix and the flowability of the composite. At rest, the microstructure of the CNT suspension keeps changing due to Brownian motion and van der Waals attractive forces, and the CNTs diffuse in the suspending fluid and eventually form a network of particles. To analyze such a complex system, a low viscosity epoxy was used as the matrix to disperse the multiwall carbon nanotubes (MWCNTs). Nearly Newtonian polymers are particularly useful because they can impart significant shear stress to break the CNT agglomerates and facilitate their dispersion, while their Newtonian behavior does not mask the viscoelastic properties of the overall system. From dilute to concentrated regimes, CNT suspensions were rheologically probed to obtain information ranging from the orientation and transport of individual carbon nanotubes to the viscoelastic properties of dense and isotropic network of rods. Rheology was used to understand the microstructure evolution under flow and in static conditions. The effects of flow history, shearing velocity, rest time and

  19. Roll- and pitch-plane coupled hydro-pneumatic suspension. Part 1: Feasibility analysis and suspension properties

    Science.gov (United States)

    Cao, Dongpu; Rakheja, Subhash; Su, Chun-Yi

    2010-03-01

    Passive fluidically coupled suspensions have been considered to offer a promising alternative solution to the challenging design of a vehicle suspension system. A theoretical foundation, however, has not been established for fluidically coupled suspension to facilitate its broad applications to various vehicles. The first part of this study investigates the fundamental issues related to feasibility and properties of the passive, full-vehicle interconnected, hydro-pneumatic suspension configurations using both analytical and simulation techniques. Layouts of various interconnected suspension configurations are illustrated based on two novel hydro-pneumatic suspension strut designs, both of which provide a compact design with a considerably large effective working area. A simplified measure, vehicle property index, is proposed to permit a preliminary evaluation of different interconnected suspension configurations using qualitative scaling of the bounce-, roll-, pitch- and warp-mode stiffness properties. Analytical formulations for the properties of unconnected and three selected X-coupled suspension configurations are derived, and simulation results are obtained to illustrate their relative stiffness and damping properties in the bounce, roll, pitch and warp modes. The superior design flexibility feature of the interconnected hydro-pneumatic suspension is also discussed through sensitivity analysis of a design parameter, namely the annular piston area of the strut. The results demonstrate that a full-vehicle interconnected hydro-pneumatic suspension could provide enhanced roll- and pitch-mode stiffness and damping, while retaining the soft bounce- and warp-mode properties. Such an interconnected suspension thus offers considerable potential in realising enhanced decoupling among the different suspension modes.

  20. Formulation and pharmaceutical development of quetiapine fumarate sustained release matrix tablets using a QbD approach

    Directory of Open Access Journals (Sweden)

    Gavan Alexandru

    2017-03-01

    Full Text Available The main objective of the present study was to apply QbD methodology in the development of once-a-day sustained release quetiapine tablets. The quality target product profile (QTPP was defined after the pharmaceutical properties and kinetic release of the innovator product, Seroquel XR 200 mg. For the D-optimal experimental design, the level and ratio of matrix forming agents and the type of extragranular diluent were chosen as independent inputs, which represented critical formulation factors. The critical quality attributes (CQAs studied were the cumulative percentages of quetiapine released after certain time intervals. After the analysis of the experimental design, optimal formulas and the design space were defined. Optimal formulas demonstrated zero-order release kinetics and a dissolution profile similar to the innovator product, with f2 values of 74.53 and 83.74. It was concluded that the QbD approach allowed fast development of sustained release tablets with similar dissolution behavior as the innovator product.

  1. Original research paper. Formulation and pharmaceutical development of quetiapine fumarate sustained release matrix tablets using a QbD approach.

    Science.gov (United States)

    Gavan, Alexandru; Porfire, Alina; Marina, Cristina; Tomuta, Ioan

    2017-03-01

    The main objective of the present study was to apply QbD methodology in the development of once-a-day sustained release quetiapine tablets. The quality target product profile (QTPP) was defined after the pharmaceutical properties and kinetic release of the innovator product, Seroquel XR 200 mg. For the D-optimal experimental design, the level and ratio of matrix forming agents and the type of extragranular diluent were chosen as independent inputs, which represented critical formulation factors. The critical quality attributes (CQAs) studied were the cumulative percentages of quetiapine released after certain time intervals. After the analysis of the experimental design, optimal formulas and the design space were defined. Optimal formulas demonstrated zero-order release kinetics and a dissolution profile similar to the innovator product, with f2 values of 74.53 and 83.74. It was concluded that the QbD approach allowed fast development of sustained release tablets with similar dissolution behavior as the innovator product.

  2. 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.

  3. Development of standard operating procedure and standardization of Habb-e-Banafsha Qawi-A Unani polyherbal formulation

    Directory of Open Access Journals (Sweden)

    Athar Ali

    2015-01-01

    Full Text Available Introduction: Herbals drugs became a boon for mankind since ancient times and still are used worldwide for the treatment of various human ailments. The safety of alternative medicinal preparations has been questioned due to reports of unwanted side effects. To maintain the quality and efficacy of these drugs, it is essential to standardize them in order to avoid the use of substandard or adulterated medicines in the market. Unani system of medicine mainly focuses on the treatment by natural drugs. Habb-e-Banafsha Qawi is useful in a cough, catarrah, and coryza. Materials and Methods: Physiochemical constants of Habb-e-Banafsha Qawi were determined through organoleptic characters, macro- and micro-scopic characters, ash value, solubility, pH values. Chromatographic fingerprints were developed using thin layer chromatography method. Aflatoxin (AF contamination, heavy metal, and pesticide residues were also evaluated by standard methods.Objectives: In the present study, an attempt has been made to develop standard operating procedure and physiochemical parameters to monitor the quality of a Unani poly-herbal formulation, Habb-e-Banafsha Qawi. Results: The tablets tasted sweetish bitter with a pleasant odor, water soluble and acidic in nature. Rfvalues were almost same in all the extracts. No AF, heavy metal, and pesticide residues were observed. Conclusions: It may be concluded that the values and chromatographic fingerprints obtained can be used for quality evaluation and to set new pharmacopoeial standards for the preparation of Habb-e-Banafsha Qawi.

  4. A Comparative Study of Newly Developed HPLC-DAD and UHPLC-UV Assays for the Determination of Posaconazole in Bulk Powder and Suspension Dosage Form

    Directory of Open Access Journals (Sweden)

    Dalia A. Hamdy

    2014-01-01

    Full Text Available Objective. To develop and compare HPLC-DAD and UHPLC-UV assays for the quantitation of posaconazole in bulk powder and suspension dosage form. Methods. Posaconazole linearity range was 5–50 μg/mL for both assays. For HPLC-DAD assay, samples were injected through Zorbax SB-C18 (4.6 × 250 mm, 5 μm column. The gradient elution composed of the mobile phase acetonitrile: 15 mM potassium dihydrogen orthophosphate (30 : 70 to 80 : 20, linear over 7 minutes pumped at 1.5 mL/min. For UHPLC-UV assay, samples were injected through Kinetex-C18 (2.1 × 50 mm, 1.3 μm column. The mobile phase composed of acetonitrile: 15 mM potassium dihydrogen orthophosphate (45 : 55 pumped isocratically at 0.4 mL/min. Detection wavelength was 262 nm in both methods. Results. The run time was 11 and 3 minutes for HPLC-DAD and UHPLC-UV assays, respectively. Both assays were linear (r2>0.999 with CV% and % error of the mean <3%. Limits of detection and quantitation were 0.82 and 2.73 μg/mL for HPLC-DAD and 1.04 and 3.16 μg/mL for UHPLC-UV, respectively. The methods quantitated PSZ in suspension dosage form with no observable interferences. Conclusions. Both assays were proven sensitive and selective according to ICH guidelines. UHPLC-UV assay exhibited some economic and chromatographic separation superiority.

  5. 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

    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...

  6. 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 model system to

  7. 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...

  8. Stepwise flow diagram for the development of formulations of non spore-forming bacteria against foliar pathogens: The case of Lysobacter capsici AZ78.

    Science.gov (United States)

    Segarra, Guillem; Puopolo, Gerardo; Giovannini, Oscar; Pertot, Ilaria

    2015-12-20

    The formulation is a significant step in biopesticide development and is an efficient way to obtain consistency in terms of biological control under field conditions. Nonetheless, there is still a lack of information regarding the processes needed to achieve efficient formulation of non spore-forming bacterial biological control agents. In response to this, we propose a flow diagram made up of six steps including selection of growth parameters, checking of minimum shelf life, selection of protective additives, checking that the additives have no adverse effects, validation of the additive mix under field conditions and choosing whether to use additives as co-formulants or tank mix additives. This diagram is intended to provide guidance and decision-making criteria for the formulation of non spore-forming bacterial biological control agents against foliar pathogens. The diagram was then validated by designing an efficient formulation for a Gram-negative bacterium, Lysobacter capsici AZ78, to control grapevine downy mildew caused by Plasmopara viticola. A harvest of 10(10)L. capsici AZ78cellsml(-1) was obtained in a bench top fermenter. The viability of cells decreased by only one order of magnitude after one year of storage at 4°C. The use of a combination of corn steep liquor, lignosulfonate, and polyethyleneglycol in the formulation improved the survival of L. capsici AZ78 cells living on grapevine leaves under field conditions by one order of magnitude. Furthermore, the use of these additives also guaranteed a reduction of 71% in P. viticola attacks. In conclusion, this work presents a straightforward stepwise flow diagram to help researchers develop formulations for biological control agents that are easy to prepare, stable, not phytotoxic and able to protect the microorganims under field conditions. Copyright © 2015 Elsevier B.V. All rights reserved.

  9. Recent Developments in the Study of operating and marketing strategy factors in the formulation of strategies of small manufacturers

    National Research Council Canada - National Science Library

    Seyed Mohammad Abdollahi Keyvani

    2011-01-01

    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...

  10. Microemulsions based on paeonol-menthol eutectic mixture for enhanced transdermal delivery: formulation development and in vitro evaluation.

    Science.gov (United States)

    Wang, Wenping; Cai, Yaqin; Liu, Yanhua; Zhao, Yunsheng; Feng, Jun; Liu, Chen

    2017-09-01

    In this work, microemulsion-based gels were prepared for transdermal delivery of paeonol. Microemulsions containing eutectic mixtures of paeonol and menthol were developed. The obtained microemulsions were evaluated for particle size, viscosity and physical stability. The selected microemulsions were incorporated into Carbopol gels. Drug crystallization behavior during a short-term storage was compared and in vitro permeation and deposition study were conducted on mouse skin. Results showed that the eutectic liquids of paeonol and menthol at all ratio (6:4, 5:5 and 4:6) could form microemulsions but with significantly different physical characteristics. As the ratio of paeonol increased, the prepared microemulsions exhibited larger droplet size, higher viscosity and quicker crystal growth. Microemulsion containing paeonol and menthol at a ratio of 4:6 possessed the smallest size of 27 nm. Accordingly, the related gel showed better physical stability during 10 days of storage, as well as the highest percent of drug deposition (111.8 μg/cm 2 ) and steady-state flux (0.3 μg/cm 2  h). These results suggested that the microemulsion formulation is a preferable approach for enhanced skin permeation, and the microemulsion based on drug-menthol eutectic mixture might be used as a potential transdermal delivery system for better therapeutic efficacy.

  11. 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.

  12. Nanoemulsion as pharmaceutical carrier for dermal and transdermal drug delivery: Formulation development, stability issues, basic considerations and applications.

    Science.gov (United States)

    Rai, Vineet Kumar; Mishra, Nidhi; Yadav, Kuldeep Singh; Yadav, Narayan Prasad

    2017-12-01

    The use of nanoemulsion in augmenting dermal and transdermal effectiveness of drugs has now well established. The development of nanoemulsion based semisolid dosage forms is an active area of present research. However, thickening or liquid-to-semisolid conversion of the nanoemulsions provides opportunities to the formulation scientist to explore novel means of solving instability issues during transformation. Extending knowledge about the explicit role of nature/magnitude of zeta potential, types of emulsifiers and selection of appropriate semisolid bases could place these versatile carriers from laboratory to industrial scale. This article reviews the progressive advancement in the delivery of medicament via nanoemulsion with special reference to the dermal and transdermal administration. It is attempted to explore the most suitable semi solid dosage form for the particular type of nanoemulsion (o/w, w/o and others) and effect of particle size and zeta potential on the delivery of drugs through dermal or transdermal route. Finally, this review also highlights the basic principles and fundamental considerations of nanoemulsion manufacture, application of nanoemulsion based semisolid dosage forms in the dermal/transdermal administration and basic considerations during the nanoemulsion absorption into and through skin. Copyright © 2017 Elsevier B.V. All rights reserved.

  13. Application of a PEG precipitation method for solubility screening: A tool for developing high protein concentration formulations

    Science.gov (United States)

    Li, Li; Kantor, Angela; Warne, Nicholas

    2013-01-01

    Previous publications demonstrated that the extrapolated solubility by polyethylene glycol (PEG) precipitation method (Middaugh et al., J Biol Chem 1979; 254:367–370; Juckes, Biochim Biophys Acta 1971; 229:535–546; Foster et al., Biochim Biophys Acta 1973; 317:505; Mahadevan and Hall, AIChE J 1990; 36:1517–1528; Stevenson and Hageman, Pharm Res 1995; 12:1671–1676) has a strong correlation to experimentally measured solubility of proteins. Here, we explored the utility of extrapolated solubility as a method to compare multiple protein drug candidates when nonideality of a highly soluble protein prohibits accurate quantitative solubility prediction. To achieve high efficiency and reduce the amount of protein required, the method is miniaturized to microwell plate format for high-throughput screening application. In this simplified version of the method, comparative solubility of proteins can be obtained without the need of concentration measurement of the supernatant following the precipitation step in the conventional method. The monoclonal antibodies with the lowest apparent solubilities determined by this method are the most difficult to be concentrated, indicating a good correlation between the prediction and empirical observations. This study also shows that the PEG precipitation method gives results for opalescence prediction that favorably compares to experimentally determined opalescence levels at high concentration. This approach may be useful in detecting proteins with potential solubility and opalescence problems prior to the time-consuming and expensive development process of high concentration formulation. PMID:23740802

  14. Development of novel formulations containing Lysozyme and Lactoferrin and evaluation of antibacterial effects on Mutans Streptococci and Lactobacilli.

    Science.gov (United States)

    Tonguc-Altin, K; Sandalli, N; Duman, G; Selvi-Kuvvetli, S; Topcuoglu, N; Kulekci, G

    2015-05-01

    The aim of this study was to determine the antibacterial effect of different formulations containing Lysozyme and Lactoferrin and drug delivery system as well as poloxamer 407 with the trade name of Pluronic F-127 and/or freeze dried liposome containing DOTAP [freeze dried Liposomal DOTAP] on Streptococcus sobrinus, Streptococcus mutans and Lactobacillus acidophilus in comparison with 0.2% chlorhexidine. The antibacterial effect was assessed by determining the minimum inhibitory concentrations (MIC) for the study and control groups on Streptococcus sobrinus, Streptococcus mutans and Lactobacillus acidophilus. The amounts of biofilm formation accumulation of Mutans Streptococci for 24h on sterile hydroxyapatite discs after application of different formulations were evaluated. The different formulations studied were: (1) Sorensen's Buffer Solution, (2) a gel formulation containing only poloxamer 407, (3) Lysozyme and Lactoferrin dissolved in Sorensen's Buffer Solution, (4) poloxamer 407 combined with the third formulation, (5) Freeze dried Liposomal DOTAP dissolved in Sorensen's Buffer Solution, (6) Freeze dried Liposomal DOTAP combined with poloxamer 407 dispersed in Sorensen's Buffer Solution, (7) Freeze dried Liposomal DOTAP combined with the third formulation, and (8) Lysozyme and Lactoferrin dissolved in Sorensen's Buffer Solution, which was then incorporated into poloxamer 407 and combined with Freeze dried Liposomal DOTAP. The positive and negative control groups were 0.2% chlorhexidine gel and empty hydroxyapatite discs, respectively. Statistical evaluation was carried out with Kruskal-Wallis and Dunn's multiple comparison tests. It was observed that the first, third and fifth groups did not have any antibacterial effects on the tested bacteria. The groups that contained poloxamer 407 had nearly identical antibacterial effects on Mutans Streptococci and L. acidophilus. These formulations also inhibited biofilm formation of the bacteria (pLactoferrin exhibited

  15. Pharmacokinetics of two formulations of omeprazole administered through a gastrostomy tube in patients with severe neurodevelopmental problems

    Science.gov (United States)

    Boussery, Koen; De Smet, Julie; De Cock, Pieter; Vande Velde, Saskia; Mehuys, Els; De Paepe, Peter; Remon, Jean Paul; Van Bocxlaer, Jan F P; Van Winckel, Myriam

    2011-01-01

    AIMS Omeprazole is often administered through a gastrostomy tube as either (i) a Multiple Unit Pellet System (MUPS®) tablet disintegrated in water (MUPS® formulation), or (ii) a suspension in 8.4% sodium bicarbonate (suspension formulation). This bioavailability study evaluates this practice in tube-fed patients with severe neurodevelopmental problems. METHODS Nonblinded, two-phase cross-over trial. RESULTS In seven of 10 patients, bioavailability was higher for the suspension formulation than for the MUPS® formulation. Median (90% confidence interval) area under the plasma concentration–time curve ratio (MUPS® over suspension) was 0.5 (0.06–2.37). CONCLUSIONS In this population, omeprazole MUPS® formulation has no apparent advantage over the more easily administered suspension formulation. PMID:21658093

  16. 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.

  17. 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.

  18. Active Electromechanical Suspension System for Planetary Rovers Project

    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...

  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. Suspension Trauma / Orthostatic Intolerance

    Science.gov (United States)

    ... Emphasis Programs Directives Severe Violators TOPICS By Sector Construction Health Care Agriculture Maritime Oil and Gas Federal ... such fatalities often are referred to as "harnessinduced pathology" or "suspension trauma." Signs & symptoms that may be ...

  1. Urinary incontinence - retropubic suspension

    Science.gov (United States)

    ... your doctor will have you try bladder retraining, Kegel exercises, medicines, or other options. If you tried ... retropubic colposuspension; Needle suspension; Burch colposuspension Patient Instructions Kegel exercises - self-care Self catheterization - female Suprapubic catheter ...

  2. 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...

  3. 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...

  4. Articulated suspension system

    Science.gov (United States)

    Bickler, Donald B. (Inventor)

    1989-01-01

    The invention provides a rough terrain vehicle which maintains a substantially constant weight, and therefore traction, on all wheels, despite one wheel moving considerably higher or lower than the others, while avoiding a very soft spring suspension. The vehicle includes a chassis or body to be supported and a pair of side suspensions at either side of the body. In a six wheel vehicle, each side suspension includes a middle wheel, and front and rear linkages respectively coupling the front and rear wheels to the middle wheel. A body link pivotally connects the front and rear linkages together, with the middle of the body link rising or falling by only a fraction of the rise or fall of any of the three wheels. The body link pivotally supports the middle of the length of the body. A transverse suspension for suspending the end of the body on the side suspensions includes a middle part pivotally connected to the body about a longitudinal axis and opposite ends each pivotally connected to one of the side suspensions along at least a longitudinal axis.

  5. Stability study of oral pediatric idebenone suspensions.

    Science.gov (United States)

    Schlatter, Joël; Bourguignon, Elodie; Majoul, Elyes; Kabiche, Sofiane; Balde, Issa-Bella; Cisternino, Salvatore; Fontan, Jean-Eudes

    2017-03-01

    Adapted forms for administration to infants are limited. The proposed study was performed to propose oral liquid formulations of idebenone in Ora-Plus and either Ora-Sweet or Ora-Sweet SF, Ora-Blend, Ora-Blend SF and Inorpha. Each formulation was stored in 30 ml amber glass bottle at 5 or 25 °C for 90 days. Idebenone contents in these suspensions, determined by a stability-indicating high-performance liquid chromatography method, remained stable at least 90 days in Inorpha when stored at the two temperatures. In Ora-Blend, the stability was estimated at 14 days and in other suspensions at 20 days at the two temperatures. After 90 days storage, the pH of Ora-Plus and Ora-Sweet or Ora-Sweet SF changed between -0.10 and -0.25 units. For others suspensions, the pH changes were not significant (< -0.09 unit). No change was observed in color, odor or visual microbiology. To conclude, we recommended the use of idebenone in Inorpha vehicle stable for at least 90 days at 25 °C.

  6. Volatiles identified from five stages of embryo development separated from a heterogeneous suspension culture of Daucus carota.

    Science.gov (United States)

    Kennedy, A H; Chamberlain, D; Wilson, G; Ryan, M F

    1991-11-01

    Five stages of embryo development were fractionated from a mature culture of Daucus carota (Gelbe Rheinsche), using a series of metal sieves. The composition of the population of embryos in each fraction was determined quantitatively from microscopic investigations. Volatiles from samples of tissue from six stages of development were trapped on activated charcoal cartridges. These volatiles, some of which may play a significant role in the interaction of the plant with the carrot root fly (Psila rosae), were analysed using gas chromatography/mass spectroscopy. The resulting chromatograms are arranged in order of embryo development. The progressive elaboration of the volatile profile reflects the increased biosynthetic capacity of the developing embryo.

  7. Development of square-wave adsorptive stripping voltammetric method for determination of acebutolol in pharmaceutical formulations and biological fluids

    Directory of Open Access Journals (Sweden)

    Al-Ghamdi Ali F

    2012-02-01

    Full Text Available Abstract A validated simple, rapid, sensitive and specific square-wave voltammetric technique is described for the determination of acebutolol (AC following its accumulation onto a hanging mercury drop electrode in a Britton-Robinson universal buffer of pH 7.5. The optimal procedural conditions were: accumulation potential Eacc = - 0.8 V versus Ag/AgCl/KCl, accumulation duration tacc = 30 s, pulse-amplitude = 70 mV, scan rate = 100 mV/s, frequency = 30 Hz, surface area of the working electrode = 0.6 mm2 and the convection rate = 2000 rpm. Under these optimized conditions, the adsorptive stripping voltammetry (AdSV peak current was proportional over the concentration range 5 × 10-7 - 6 × 10-6 M (r = 0.999. Recoveries for acebutolol from human plasma and urine were in the range 97-103% and 96-104% respectively. The method proved to be precise (intra-day precision expressed as %RSD in human plasma ranged from 2.9 - 3.2% and inter-day precision expressed as %RSD ranged from 3.4 - 3.8% and accurate (intra-day accuracies expressed as % error in human urine ranged from -3.3 - 2.8% and inter-day accuracies ranged from -3.3 - 1.7%. The limit of quantitation (LOQ and limit of detection (LOD for acebutolol were 1.7 × 10-7 and 5 × 10-7 M, respectively. Possible interferences by substances usually present in the pharmaceutical formulations were investigated with a mean recovery of 101.6 ± 0.64%. Results of the developed square-wave adsorptive stripping voltammetry (SW-AdSV method were comparable with those obtained by reference analytical method.

  8. Development and Assessment of a Gas Chromatographic Based Method for the Quantification of Thymol from Cream Based Formulation.

    Science.gov (United States)

    Samani, Soliman Mohammadi; Moein, Mahmoodreza; Petramfar, Peyman; Zarshenas, Mohammad M

    2016-01-01

    Herbal medicines have been used for different illnesses. However, standardization of these medicaments should be done before introducing for treatment purposes. Ajwain an essential oil, is traditionally used for neuropathic pain. To develop and assess a gas chromatographic-based method for the quantification of thymol in Ajwain essential oil, current work was performed. Both pure thymol and Ajwain creams were prepared and subjected to hydrodistillation method under temperature-controlled procedure to re-extract the applied essential oil and pure thymol. Previously, Ajwain seeds essential oil composition was analyzed and identified using GC/MS. After re-extraction, GC/FID was applied quantitatively to determine the thymol content in the Ajwain and thymol creams. The parameters represented in International Conference on Harmonization (ICH) guidelines were considered for the determination. Thymol content in a 50 g laminated tube of Ajwain cream was calculated as 2.34 g ± 0.02. Regarding the total thymol content of a 50 g laminated tube of Thymol cream (2.43 g), recovery percent for Ajwain cream was calculated as 96.29 %. Using hydrodistillation for an essential oil- containing cream sample via Clevenger proved to be a simple and convenient method to work up and extract active volatile components of such semisolid formulation. However, the extraction yield was profoundly related to the condenser temperature. The current employed determination method is introduced as a rapid and reliable method and thus, can be suggested for the quality control assessment of phytopharmaceutical semisolid preparations containing thymol and similar volatile constituents.

  9. Cosmetic powder suspensions in compliant, fingerprintlike contacts.

    Science.gov (United States)

    Timm, K; Myant, C; Spikes, H A; Schneider, M; Ladnorg, T; Grunze, M

    2011-09-01

    Cosmetic powders are regularly employed in skin creams and cosmetic formulations to improve performance and enhance skin feel. A previous study investigated the effect of particle concentration and size on the lubricating properties of powder suspensions in smooth, compliant contacts [Timm et al., Tribol. Int. (2011)]. In this paper the tribological properties of cosmetic powder suspensions are investigated in compliant contacts having model fingerprintlike surface topography. Friction coefficients were measured for a series of powder suspensions with varying particle size and concentration in a polydimethylsiloxane (PDMS)/PDMS contact. A commercial tribometer (MTM, PCS Instruments) was employed to measure friction as a function of rubbing time (20 min), under pure sliding (50 mm/s) and low load (0.5 N) conditions. Compared to results using smooth surfaces, it was clear that surface topography has a pronounced affect on the time-dependent tribological behavior of the cosmetic powder suspensions studied. A two-stage friction coefficient versus time curve was observed. By varying the particle size and concentration it was shown that the duration and magnitude of each stage can be controlled.

  10. Development and characterization of chitosan-polycarbophil interpolyelectrolyte complex-based 5-fluorouracil formulations for buccal, vaginal and rectal application

    Directory of Open Access Journals (Sweden)

    Pendekal Mohamed S

    2012-10-01

    Full Text Available Abstract Background of the study The present investigation was designed with the intention to formulate versatile 5-fluorouracil (5-FU matrix tablet that fulfills the therapeutic needs that are lacking in current cancer treatment and aimed at minimizing toxic effect, enhancing efficacy and increasing patient compliance. The manuscript presents the critical issues of 5-FU associate with cancer and surpasses issues by engineering novel 5-FU matrix tablets utilizing chitosan- polycarbophil interpolyelectrolyte complex (IPEC. Methods Precipitation method is employed for preparation of chitosan and polycarbophil interpolyelectrolyte complex (IPEC followed by characterization with Fourier transform infrared spectroscopy (FT-IR, Differential Scanning calorimeter (DSC and X-ray Diffraction (XRD. 5-FU tablets were prepared by direct compression using IPEC. Six formulations were prepared with IPEC alone and in combination with chitosan, polycarbophil and Sodium deoxycholate. The formulations were tested for drug content, hardness, friability, weight variation, thickness, swelling studies, in vitro drug release (buccal, vaginal and rectal pH, ex vivo permeation studies, mucoadhesive strength and in vivo studies. Results FT-IR studies represent the change in spectra for the IPEC than single polymers.DSC study represents the different thermo gram for chitosan, polycarbophil and IPEC whereas in X-ray diffraction, crystal size alteration was observed. Formulations containing IPEC showed pH independent controlled 5-FU without an initial burst release effect in buccal, vaginal and rectal pH. Furthermore, F4 formulations showed controlled release 5-FU with highest bioadhesive property and satisfactory residence in both buccal and vaginal cavity of rabbit. 3% of SDC in formulation F6 exhibited maximum permeation of 5-FU. Conclusion The suitable combination of IPEC, chitosan and polycarbophil demonstrated potential candidate for controlled release of 5-FU in buccal

  11. Development and Characterization of Chitosan-Polycarbophil Interpolyelectrolyte Complex-Based 5-Flurouracil Formulations for Buccal, Vaginal and Rectal Application

    Directory of Open Access Journals (Sweden)

    Mohamed S Pendekal

    2012-10-01

    Full Text Available Background of the study:The present investigation was designed with the intention to formulate versatile 5-flurouracil(5-FU matrix tablet that fulfills the therapeutic needs that are lacking in current cancer treatment and aimed at minimizing toxic effect, enhancing efficacy and increasing patient compliance. The manuscript presents the critical issues of 5-FU associate with cancer andsurpasses issues by engineering novel 5-FU matrix tablets utilizing chitosan- polycarbophil interpolyelectrolyte complex (IPECMethods:Precipitation method is employed for preparation of chitosan and polycarbophil interpolyelectrolyte complex (IPEC followed by characterization with Fourier transform infrared spectroscopy (FT-IR, Differential Scanning calorimeter (DSC and X-ray Diffraction (XRD. 5-FU tablets were prepared by direct compression using IPEC. Six formulations were prepared with IPEC alone and in combination with chitosan, polycarbophil and Sodium deoxycholate. The formulations were tested for drug content, hardness, friability,weight variation, thickness, swelling studies, in vitro drug release (buccal, vaginal and rectal pH, ex vivo permeation studies, mucoadhesive strength and in vivo studies.Results:FT-IR studies represent the change in spectra for the IPEC than single polymers.DSC study represents the different thermo gram for chitosan, polycarbophil and IPEC whereas in X-ray diffraction, crystal size alteration was observed. Formulations containing IPEC showed pH independent controlled 5-FU without an initial burst release effect in buccal, vaginal and rectal pH. Furthermore, F4 formulations showed controlled release 5-FU with highest bioadhesive property and satisfactory residence in both buccal and vaginal cavity of rabbit.3% of SDC in formulation F6 exhibited maximum permeation of 5-FU.Conclusion:The suitable combination of IPEC, chitosan and polycarbophil demonstrated potential candidate for controlled release of 5-FU in buccal, vaginal and

  12. 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

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

    Energy Technology Data Exchange (ETDEWEB)

    MacCuspie, Robert I., E-mail: robert.maccuspie@nist.gov; Allen, Andrew J.; Martin, Matthew N.; Hackley, Vincent A. [National Institute of Standards and Technology, Materials Measurement Science Division (United States)

    2013-07-15

    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.

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

    Science.gov (United States)

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

    2013-07-01

    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.

  15. Formulation, characterization and evaluation of an optimized microemulsion formulation of griseofulvin for topical application.

    Science.gov (United States)

    Aggarwal, Nidhi; Goindi, Shishu; Khurana, Ranjit

    2013-05-01

    The main objective of the study was to develop a microemulsion (ME) formulation of griseofulvin for the treatment of dermatophytosis (Indian Patent Application 208/DEL/2009). The oil phase was selected on the basis of drug solubility whereas the surfactant and cosurfactant were screened on the basis of their oil solubilizing capacity as well as their efficiency to form ME from pseudo-ternary phase diagrams. The influence of surfactant and cosurfactant mass ratio (Smix) on the ME formation and its permeation through male Laca mice skin was studied. The optimized formulation (ME V) consisting of 0.2% (w/w) griseofulvin, 5% (w/w) oleic acid, 40% (w/w) Smix (1:1, Tween 80 and ethanol) possessed globule size of 12.21 nm, polydispersity index of 0.109 and zeta potential value of -0.139 mV. ME V exhibited 7, 5 and almost 3-fold higher drug permeation as compared to aqueous suspension, oily solution and conventional cream respectively. Besides this the formulation was also evaluated for drug content, pH, stability, dermatopharmacokinetics and antifungal activity against Microsporum canis using guinea pig model for dermatophytosis. Treatment of guinea pigs with ME V resulted in a complete clinical and mycological cure in 7 days. The formulation was observed to be non-sensitizing, histopathologically safe, and stable at 5±3°C, 25±2°C and 40±2°C for a period of six months. Copyright © 2013 Elsevier B.V. All rights reserved.

  16. Lipid Vesicles for the Skin Delivery of Diclofenac: Cerosomes vs. Other Lipid Suspensions

    OpenAIRE

    Anahita Fathi-Azarbayjani; Kai Xin Ng; Yew Weng Chan; Sui Yung Chan

    2015-01-01

    Purpose: Lipid suspensions as drug carriers, including conventional liposomes, ethosomes, transferosomes, proniosomes, niosomes, PEG-PPG-PEG niosomes and stratum corneum liposomes (cerosomes), were formulated and compared. Methods: Lipid vesicles were formulated and assessed with regards to enhancement of skin permeation of diclofenac and stability profiles of the formulations. Formulation-induced changes of the biophysical structure of excised human skin were monitored using the Fourier t...

  17. Cytohistological analysis of somatic embryogenesis in cucumber (Cucumis sativus L. I. Comparison of cell suspension containing and lacking natural fluorescence with in vivo developing embryos

    Directory of Open Access Journals (Sweden)

    J. A. Tarkowska

    2014-01-01

    Full Text Available Under in vivo conditions early-globular embryos occur in cucumber on the 9th day after pollination, heart-shaped ones on the 14th, and morphologically mature embryos appear on the 19th day. Single starch grains already appear in the cells of the globular embryo, and in the heart-shaped one they occur within the forming root cap. In the morphologically mature embryo only the precambium is free from starch. Somatic embryogenesis (SE in suspension occurs similarly as in vivo, even though the starch localization is somewhat different and torpedo-like embryos occur, which are not observed in vivo. The histological structure of in vitro embryos is similar to in vivo ones, and the greatest morphological difference are the poorly developed cotyledons and their variable number (1 to 3. Aggregates showing fluorescence were found to be composed of cells which differ in morphology from cells not showing fluorescence and appear to be more capable of attaining the mature stages.

  18. 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

    ammunition , signal flares, and training simulators contain once popular chemicals that are now scrutinized by environmental regulators.1−4 In order to...for each formulation. The top and inner core surfaces of each pellet were coated with a thin layer of thermite -based igniter slurry (composed of 33.0

  19. Development of Mushroom-Based Cosmeceutical Formulations with Anti-Inflammatory, Anti-Tyrosinase, Antioxidant, and Antibacterial Properties.

    Science.gov (United States)

    Taofiq, Oludemi; Heleno, Sandrina A; Calhelha, Ricardo C; Alves, Maria José; Barros, Lillian; Barreiro, Maria Filomena; González-Paramás, Ana M; Ferreira, Isabel C F R

    2016-10-14

    The cosmetic industry is in a constant search for natural compounds or extracts with relevant bioactive properties, which became valuable ingredients to design cosmeceutical formulations. Mushrooms have been markedly studied in terms of nutritional value and medicinal properties. However, there is still slow progress in the biotechnological application of mushroom extracts in cosmetic formulations, either as antioxidants, anti-aging, antimicrobial, and anti-inflammatory agents or as hyperpigmentation correctors. In the present work, the cosmeceutical potential of ethanolic extracts prepared from Agaricus bisporus, Pleurotus ostreatus, and Lentinula edodes was analyzed in terms of anti-inflammatory, anti-tyrosinase, antioxidant, and antibacterial activities. The extracts were characterized in terms of phenolic acids and ergosterol composition, and further incorporated in a base cosmetic cream to achieve the same bioactive purposes. From the results obtained, the final cosmeceutical formulations presented 85%-100% of the phenolic acids and ergosterol levels found in the mushroom extracts, suggesting that there was no significant loss of bioactive compounds. The final cosmeceutical formulation also displayed all the ascribed bioactivities and as such, mushrooms can further be exploited as natural cosmeceutical ingredients.

  20. Development of Mushroom-Based Cosmeceutical Formulations with Anti-Inflammatory, Anti-Tyrosinase, Antioxidant, and Antibacterial Properties

    Directory of Open Access Journals (Sweden)

    Oludemi Taofiq

    2016-10-01

    Full Text Available The cosmetic industry is in a constant search for natural compounds or extracts with relevant bioactive properties, which became valuable ingredients to design cosmeceutical formulations. Mushrooms have been markedly studied in terms of nutritional value and medicinal properties. However, there is still slow progress in the biotechnological application of mushroom extracts in cosmetic formulations, either as antioxidants, anti-aging, antimicrobial, and anti-inflammatory agents or as hyperpigmentation correctors. In the present work, the cosmeceutical potential of ethanolic extracts prepared from Agaricus bisporus, Pleurotus ostreatus, and Lentinula edodes was analyzed in terms of anti-inflammatory, anti-tyrosinase, antioxidant, and antibacterial activities. The extracts were characterized in terms of phenolic acids and ergosterol composition, and further incorporated in a base cosmetic cream to achieve the same bioactive purposes. From the results obtained, the final cosmeceutical formulations presented 85%–100% of the phenolic acids and ergosterol levels found in the mushroom extracts, suggesting that there was no significant loss of bioactive compounds. The final cosmeceutical formulation also displayed all the ascribed bioactivities and as such, mushrooms can further be exploited as natural cosmeceutical ingredients.

  1. 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; Schellens, Jan H M; 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

  2. 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.

  3. Formulation development and optimization of Lamivudine 300 mg and Tenofovir Disoproxil Fumarate (TDF) 300 mg FDC tablets by D-optimal mixture design.

    Science.gov (United States)

    Tibalinda, Prosper; Sempombe, Joseph; Shedafa, Raphael; Masota, Nelson; Pius, Dickson; Temu, Mary; Kaale, Eliangiringa

    2016-12-01

    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.

  4. Ride responses of macpherson suspension systems

    Directory of Open Access Journals (Sweden)

    Yu Cheng-Chi

    2017-01-01

    Full Text Available The main purpose of this study is to obtain more correct vehicle ride responses by using a nonlinear ride model considering the effect of Macpherson suspension geometry. Traditional ride model applied to analysis and controller design uses a two degree of freedom linear model, which includes sprung mass and unsprung mass and a spring and a damper vertically connect them. In fact, suspension components do not vertically position above the tire. The motions of body and tire are not going straight up and down. Therefore, the analysis results obtained by the simple model are often different from the experimental values of the actual vehicle. Because of the difference between simple model and actual vehicle, the control strategy almost cannot apply to actual vehicle. In order to understand the effect of suspension geometry on the vehicle ride responses and design a more practical control strategy, a nonlinear model including the geometric parameters of the suspension is constructed in this study. To estimate the initial equilibrium position of the suspension assembly under load, the static equilibrium analysis and mechanism motion analysis are synchronous implemented at the same time. The nonlinear model describes not only the relative position and velocity but also the force transmission between body and tire. Furthermore, by linearize this nonlinear model the development of control strategy for subsequent (semi active suspension system could be expected.

  5. X-ray Mapping of Dynamic Suspensions

    Science.gov (United States)

    Gholami, Mohammad; Lenoir, Nicolas; Ovarlez, Guillaume; Hormozi, Sarah

    2016-11-01

    Dense non-colloidal suspensions are materials with broad application both in industrial processes and natural phenomena. In most of these applications, the suspensions are either far from equilibrium or strongly non-Newtonian (i.e., non-colloidal particles are suspended in non-Newtonian fluid) meaning that the flow kinetics are not only strain-dependent but also strain-rate dependent. Therefore, experimental techniques must be developed to analyze the flows of these complex suspensions over a wide range of steady and transient shear rates. Techniques such as Nuclear Magnetic Resonance/Imaging (NMR/I) are inapplicable due to low sampling frequency and low image resolution (typically 10 minutes per averaged NMR image of 1x1cm). We introduce a new technique using an X-ray/CT-scan system to study dynamic suspensions. We show our recent results on the application of this technique for the study of shear induced migration of particles in a yield stress matrix fluid in a wide-gap cylindrical Couette cell. This work opens new avenues to study dynamic non-colloidal suspensions and the suspensions with other types of nonlinear suspending fluids such as viscoelastic and shear thickening fluids. NFS(CBET-1554044-CAREER).

  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 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.

  7. Development of a New Type of Prolonged Release Hydrocodone Formulation Based on Egalet® ADPREM Technology Using In Vivo–In Vitro Correlation

    Directory of Open Access Journals (Sweden)

    Jean-Michel Cardot

    2011-03-01

    Full Text Available A novel abuse deterrent, prolonged release tablet formulation of Hydrocodone for once-daily dosing has been developed, based on the novel proprietary Egalet® ADPREM technology. The tablet is an injection molded polymer system consisting of an erodible matrix in which the Active Pharmaceutical Ingredient (API, such as Hydrocodone, is dispersed. The matrix is partly covered with a water-impermeable, non-erodible shell which leaves both ends of the cylindrical tablet exposed to erosion by the gastrointestinal (GI fluid. In vivo–in vitro correlation (IVIVC was initiated and validated with three formulations. A good internal predictability was observed for the three formulations. How the changing conditions in the GI tract influenced in vivo performance of an erosion based product was discussed. The validated IVIVC could be used to optimize the tablet formulation and to obtain a desired profile. In addition, this technique could help to establish the dissolution limits in which a certainty of bioequivalence is calculated. Based on this validated level A IVIVC, dissolution can be used as surrogate of bioequivalence for development, but also scale up post approval changes.

  8. Development of an antidiabetic formulation (ADJ6 and its inhibitory activity against α-amylase and α-glucosidase

    Directory of Open Access Journals (Sweden)

    Anand Duraiswamy

    2016-07-01

    Full Text Available There has recently been much advancement in the diagnosis, treatment, and research of metabolic disorders, especially diabetes. Current research around the world is focused on finding an alternative source of treatment from natural resources for diabetic management, apart from the available synthetic medicines. The present study is a preliminary study of a polyherbal formulation using edible natural resources and an assessment of its antidiabetic activity. The formulation was screened for its phytochemical constituents, total phenols, flavonoids, and vitamin C content. It was also analyzed for its inhibitory effect against the digestive enzymes α-amylase and α-glucosidase, compared with the standard drug acarbose. The formulation showed the presence of major constituents such as steroids, cardiac glycosides, phenols, flavonoids, and saponins. It also had a high level of phenols (340 ± 2.5 mg/g, flavonoids (235.4 ± 8.3 mg/g, and vitamin C (470.8 ± 16.6 mg/g, and showed a half-maximal inhibitory concentration (IC50 value of 0.41 ± 0.03 mg/mL and 0.51 ± 0.01 mg/mL for amylase and glucosidase, respectively. The results showed that ADJ6 had a significant inhibitory activity on α-amylase and α-glucosidase; however, its inhibitory activity was less than that of acarbose. The plants that are formulated in ADJ6 possess potent antidiabetic activity. Thus, we found that ADJ6 is a potent lead for effective diabetic management; however, an evaluation of the formulation must be illustrated using an in vivo model.

  9. Baseline LAW Glass Formulation Testing

    Energy Technology Data Exchange (ETDEWEB)

    Kruger, Albert A. [USDOE Office of River Protection, Richland, WA (United States); Mooers, Cavin [The Catholic University of America, Washington, DC (United States). Vitreous State Lab.; Bazemore, Gina [The Catholic University of America, Washington, DC (United States). Vitreous State Lab; Pegg, Ian L. [The Catholic University of America, Washington, DC (United States). Vitreous State Lab; Hight, Kenneth [The Catholic University of America, Washington, DC (United States). Vitreous State Lab; Lai, Shan Tao [The Catholic University of America, Washington, DC (United States). Vitreous State Lab; Buechele, Andrew [The Catholic University of America, Washington, DC (United States). Vitreous State Lab; Rielley, Elizabeth [The Catholic University of America, Washington, DC (United States). Vitreous State Lab; Gan, Hao [The Catholic University of America, Washington, DC (United States). Vitreous State Lab; Muller, Isabelle S. [The Catholic University of America, Washington, DC (United States). Vitreous State Lab; Cecil, Richard [The Catholic University of America, Washington, DC (United States). Vitreous State Lab

    2013-06-13

    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.

  10. Development of separation technology for the removal of radium-223 from targeted thorium conjugate formulations. Part II: purification of targeted thorium conjugates on cation exchange columns.

    Science.gov (United States)

    Frenvik, Janne Olsen; Dyrstad, Knut; Kristensen, Solveig; Ryan, Olav B

    2017-09-01

    Tumor targeting pharmaceuticals will play a crucial role in future pharma pipelines. The targeted thorium conjugate (TTC) therapeutic platform could provide real benefit to patients, whereby targeting moieties like monoclonal antibodies are radiolabelled with the alpha-emitting radionuclide thorium-227 ((227)Th, t1/2 = 18.7 days). A potential problem could be the accumulation of the long-lived daughter nuclide radium-223 ((223)Ra, t1/2 = 11.4 days) in the drug product during manufacturing and distribution. Therefore, the level of (223)Ra must be standardized before administration to the patient. The focus in this study has been the removal of (223)Ra, as the other progenies will have a very limited stay in the formulation. In this study, the purification of TTCs labeled with decayed (227)Th has been explored. Columns packed with a strong cation exchange resin have been used to sequester (223)Ra. The separation of TTC from (223)Ra has been evaluated as influenced by both formulation and process parameters with a design of experiments (DOE) study; including citrate or acetate buffer, pH, buffer concentration, presence or absence of pABA + EDTA, resin amount and sodium chloride concentration. The aim was to achieve a separation with high sorption of (223)Ra and accompanying low TTC sorption. The results were analyzed by multivariate analysis. Four regression models of TTC and (223)Ra sorption from citrate and acetate buffered formulations were developed. The predictive accuracy of sorption in the four statistical models was given by standard deviations and confidence intervals. The TTC sorption in citrate and acetate buffered formulations was affected by the identical variables and the variation in TTC sorption was comparable for the two models. However, the DOE variables had a significantly stronger impact on the (223)Ra sorption in citrate buffered formulations than the (223)Ra sorption in acetate buffer. An optimal separation with a TTC sorption

  11. Assessment of strategy formulation

    DEFF Research Database (Denmark)

    Acur, Nuran; Englyst, Linda

    2006-01-01

    Purpose – Today, industrial firms need to cope with competitive challenges related to innovation, dynamic responses, knowledge sharing, etc. by means of effective and dynamic strategy formulation. In light of these challenges, the purpose of the paper is to present and evaluate an assessment tool...... for strategy formulation processes that ensures high quality in process and outcome. Design/methodology/approach – A literature review was conducted to identify success criteria for strategy formulation processes. Then, a simple questionnaire and assessment tool was developed and used to test the validity...... of the success criteria through face-to-face interviews with 46 managers, workshops involving 40 managers, and two in-depth case studies. The success criteria have been slightly modified due to the empirical results, to yield the assessment tool. Findings – The resulting assessment tool integrates three generic...

  12. Development of a lyophilization formulation that preserves the biological activity of the platelet-inducing cytokine interleukin-11 at low concentrations.

    Science.gov (United States)

    Page, C; Dawson, P; Woollacott, D; Thorpe, R; Mire-Sluis, A

    2000-01-01

    Recombinant human interleukin-11 (rhIL-11) is a licensed biological therapeutic product in at least one country and is used to combat thrombocytopenia during chemotherapeutic regimens, as well as undergoing clinical trials for a range of other disorders. Following attempts to lyophilize IL-11 at low concentrations, it was clear that a significant loss of recoverable biological activity occurred. Investigation of a variety of factors, including the type of container in which the rhIL-11 was lyophilized, revealed that surface adsorption to glass was a major factor resulting in loss of activity of rhIL-11 in solution (> 40% reduction after 3 h at room temperature), in addition to losses of activity post-lyophilization. To overcome this problem, different formulations containing combinations of human serum albumin (HSA), trehalose and Tween-20 have been investigated. Two formulations were successful in entirely preserving the biological activity of rhIL-11 through lyophilization and subsequent reconstitution (potency estimates of formulated relative to original material being > or =0.97). Accelerated degradation studies, performed at intervals over a six-month period, demonstrated the stability of freeze-dried rhIL-11 using these formulations (predicted annual reduction in potency after storage at -20 degrees C containers, with no loss in potency. These findings should facilitate development of low dose rhIL-11 products and be an indicator of caution to those using this and other material with similar physical properties, without taking appropriate precautions to avoid losses through adsorption.

  13. Use of Crystalline Boron as a Burn Rate Retardant Toward the Development of Green-Colored Handheld Signal Formulations

    Science.gov (United States)

    2011-01-01

    Laminac 4116 was purchased from Ashland Chemical Company (Covington, KY). Lupersol was purchased from Norac (Azusa, CA). Epon 828 and Epikure 3140...a binder system (95% Laminac 4116=5% Lupersol or 80% Epon 828 =20% Epikure 3140), and the mixture was hand-blended for 20min. After hand-mixing...carcinogen, has Table 2 Barium-free M125A1 formulation A Components Weight, % Potassium Nitrate 83 Amorphous Boron 10 Epon 828 =Epikure 3140 7 364 J. J

  14. Recent Developments in the Study of operating and marketing strategy factors in the formulation of strategies of small manufacturers

    OpenAIRE

    Seyed Mohammad Abdollahi Keyvani

    2011-01-01

    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 ...

  15. 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

  16. Fast Disintegrating Combination Tablet of Taste Masked Levocetrizine Dihydrochloride and Montelukast Sodium: Formulation Design, Development, and Characterization

    Science.gov (United States)

    Gupta, M. M.; Gupta, Niraj; Chauhan, Bhupendra S.; Pandey, Shweta

    2014-01-01

    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. PMID:26556198

  17. 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.

  18. Fast Disintegrating Combination Tablet of Taste Masked Levocetrizine Dihydrochloride and Montelukast Sodium: Formulation Design, Development, and Characterization.

    Science.gov (United States)

    Gupta, M M; Gupta, Niraj; Chauhan, Bhupendra S; Pandey, Shweta

    2014-01-01

    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.

  19. Development and evaluation of antimicrobial herbal formulations containing the methanolic extract of Cassia alata for skin diseases

    Directory of Open Access Journals (Sweden)

    Stephen Olaribigbe Majekodunmi

    2014-11-01

    Full Text Available Objective: To explore the antifungal and antibacterial activity of methanolic extract of Cassia alata (C. alata and its formulations for skin diseases. Methods: Sundried leaves of C. alata Linn. were extracted using different solvents as follows: water, methanol, ethanol, n-hexane and lastly with acetone. The crude extract was investigated for antifungal and antibacterial activities using disc diffusion method against Coccidioides immitis, Exophilia dermatitidis, Aspergillus fumigatus and human pathogenic fungi Candida albicans and a group of bacteria, Staphylococcus aureus. The minimum inhibitory concentrations of the methanolic extract were determined using the agar dilution method. Herbal ointments were prepared by incorporating the methanol extract of C. alata into emulsifying ointment to obtain different concentrations of 25, 50, 100, and 200 mg/mL. Results: The methanol extraction gave the maximum extraction. The formulated C. alata ointment when compared with standard drugs nystatin and streptomycin in vitro was more effective against the microorganisms. Conclusions: This study showed that C. alata had antifungal and antibacterial activities when formulated as ointment for topical use and could, therefore, explained its folkloric use for the treatment of dermatitis.

  20. 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.

  1. Development of in vitro-in vivo correlation for extended-release niacin after administration of hypromellose-based matrix formulations to healthy volunteers.

    Science.gov (United States)

    Kesisoglou, Filippos; Rossenu, Stefaan; Farrell, Colm; Van Den Heuvel, Michiel; Prohn, Marita; Fitzpatrick, Shaun; De Kam, Pieter-Jan; Vargo, Ryan

    2014-11-01

    Development of in vitro-in vivo correlations (IVIVCs) for extended-release (ER) products is commonly pursued during pharmaceutical development to increase product understanding, set release specifications, and support biowaivers. This manuscript details the development of Level C and Level A IVIVCs for ER formulations of niacin, a highly variable and extensively metabolized compound. Three ER formulations were screened in a cross-over study against immediate-release niacin. A Multiple Level C IVIVC was established for both niacin and its primary metabolite nicotinuric acid (NUA) as well as total niacin metabolites urinary excretion. For NUA, but not for niacin, Level A IVIVC models with acceptable prediction errors were achievable via a modified IVIVC rather than a traditional deconvolution/convolution approach. Hence, this is in contradiction with current regulatory guidelines that suggest that when a Multiple Level C IVIVC is established, Level A models should also be readily achievable. We demonstrate that for a highly variable, highly metabolized compound such as niacin, development of a Level A IVIVC model fully validated according to agency guidelines may be challenging. However, Multiple Level C models are achievable and could be used to guide release specifications and formulation/manufacturing changes. © 2014 Wiley Periodicals, Inc. and the American Pharmacists Association.

  2. Final Report - Glass Formulation Development and DM10 Melter Testing with ORP LAW Glasses, VSL-09R1510-2, Rev. 0, dated 6/12/09

    Energy Technology Data Exchange (ETDEWEB)

    Kruger, Albert A.; Pegg, I. L.; Matlack, K. S.; Joseph, I.; Muller, I. S.; Gong, W.

    2013-11-13

    The principal objective of the work described in this Final Report is to extend the glass formulation methodology developed in the earlier work by development of acceptable glass compositions for four LAW compositions specified by ORP that cover the range of sulfate to sodium and potassium to sodium ratios expected in Hanford LAW. The glass formulations were designed to exclude titanium and iron as glass former additives, while tin and vanadium as glass former additives were evaluated for beneficial effects in increasing waste loading in the glasses. This was accomplished through a combination of crucible-scale tests and tests on the DM10 melter system. This melter is the most efficient melter platform for screening glass compositions over a wide range of sulfate concentrations and therefore was selected for the present tests. The current tests provide information on melter processing characteristics and off-gas data, including sulfur incorporation and partitioning.

  3. Advances in developing Bacillus thuringiensis-based insecticde formulations Avances en el desarrollo de formulaciones insecticidas a base de Bacillus thuringiensis

    OpenAIRE

    Rosas-García Ninfa María

    2008-01-01

    Developing Bacillus thuringiensis-based formulations is an old technology which has been revived during recent decades. The spore-crystal complex (being the main ingredient in these preparations) has been the main objective of this research, involving the search for new or improved strains. The type of materials used included a wide variety of completely biodegradable ingredients which could have been leaves, stems or fruit which when dried and ground could serve as feeding stimulants, as wel...

  4. 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.

  5. Nano- and micro-particulate formulations of poorly water-soluble drugs by using a novel optimized technique.

    Science.gov (United States)

    Douroumis, D; Fahr, A

    2006-06-01

    A novel technique for the production of nano- and micro-particulate formulations of poorly water-soluble drugs has been developed. This technique involves the use of static mixer elements to provide fast precipitation by continuous turbulent mixing of two liquid flows, an aqueous phase and an organic phase, respectively. The objective of this study was to develop the mixer technique by investigating the influence of the element number on the particle size of the resulting dispersions. Four model active pharmaceutical ingredients (APIs) with a variety of polymers, lipids or surfactants underwent intensive mixing and the final suspensions showed a narrow size distribution. Parameters such as the flow rate and the temperature of the precipitated organic-aqueous phases were also significant in the reduction of particle size. Further development of the mixing technique led to reproducible and stable formulations with minimal excipient amounts. These formulations were spray- or freeze-dried to improve stability.

  6. Viscosity of colloidal suspensions

    Energy Technology Data Exchange (ETDEWEB)

    Cohen, E.G.D. [Rockefeller Univ., New York, NY (United States); Schepper, I.M. de [Delft Univ. of Technology (Netherlands)

    1995-12-31

    Simple expressions are given for the effective Newtonian viscosity as a function of concentration as well as for the effective visco-elastic response as a function of concentration and imposed frequency, of monodisperse neutral colloidal suspensions over the entire fluid range. The basic physical mechanisms underlying these formulae are discussed. The agreement with existing experiments is very good.

  7. 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.

  8. Development, characterization, and optimization of a new suspension chicken-induced pluripotent stem cell line for the production of Newcastle disease vaccine

    Science.gov (United States)

    Traditionally, substrates for production of vaccines have been embryonated eggs or adherent cell culture. The daunting challenge of scaling up these technologies in the face of an outbreak has been a limitation for industrial applicability. Suspension cell lines are better suited in many ways to e...

  9. Development of a zero trans margarine from soybean-based interesterified fats formulated using artificial neural networks

    Directory of Open Access Journals (Sweden)

    Garcia, R. K.A.

    2013-12-01

    Full Text Available The formulation of products with low levels of saturated and trans fatty acids is a new challenge for industries, and alternative raw materials have been studied. Artificial neural networks (ANNs have been used for this process. The objective of the present study was to formulate blends, with the help of an ANN, using soybean-based interesterified fats for the production of a zero trans fat margarine similar to a margarine produced using a specific commercial fat. The software was trained with three raw materials to generate formulations with a solid fat content (SFC and a melting point (MP similar to specific commercial fats. The SFC, MP, fatty acid and triacylglycerol composition were determined for all ANN blends and commercial fats. Margarines were produced in a pilot plant and evaluated for consistency and stability under temperature cyclization. The ANN showed efficiency in to predict SFC and MP of the suggested formulations, although there were differences at low temperatures for the desired SFC. Differences in the consistency of the commercial fats and ANN blends were observed; however, the margarines produced in the pilot plant had a similar consistency. The margarine prepared with ANN formulation had a higher emulsion stability. Overall, the margarine produced with ANN formulation had characteristics very similar to margarine produced with the commercial fat, and the margarine with soybean-based fat contained reduced saturated and trans fat levels.La formulación de productos con bajos niveles de ácidos grasos trans y saturados es el nuevo desafío para la indutria grasa, y nuevas materias primas alternativas están siendo estudiadas. Las redes neuronales artificiales (RNA están siendo usadas para este proceso. El objectivo de este estudio fue formular mezclas para margarinas con la ayuda de una RNA, usando grasas interesterificadas de soja para producir margarinas cero trans con funcionalidad similar a las margarinas producidas

  10. 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

  11. 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.

  12. 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.

  13. Advantages of neurofuzzy logic against conventional experimental design and statistical analysis in studying and developing direct compression formulations.

    Science.gov (United States)

    Landín, Mariana; Rowe, R C; York, P

    2009-11-05

    This study has investigated the utility and potential advantages of an artificial intelligence technology - neurofuzzy logic - as a modeling tool to study direct compression formulations. The modeling performance was compare with traditional statistical analysis. From results it can be stated that the normalized error obtained from neurofuzzy logic was lower. Compared to the multiple regression analysis neurofuzzy logic showed higher accuracy in prediction for the five outputs studied. Rule sets generated by neurofuzzy logic are completely in agreement with the findings based on statistical analysis and advantageously generate understandable and reusable knowledge. Neurofuzzy logic is easy and rapid to apply and outcomes provided knowledge not revealed via statistical analysis.

  14. 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.

  15. Efficacy of natural antimicrobials in toothpaste formulations against oral biofilms in vitro

    NARCIS (Netherlands)

    Verkaik, M.J.; Busscher, H.J.; Jager, D.; Slomp, A.M.; Abbas, F.; Mei, H.C. van der

    Objectives: To evaluate the antimicrobial efficacies of two toothpaste formulations containing natural antimicrobials (herbal extracts and chitosan) against oral biofilms of different composition and maturational status. Methods: Bacteria from a buffer suspension or fresh saliva were adhered for 2 h

  16. Use of hydrophobins in formulation of water insoluble drugs for oral administration

    NARCIS (Netherlands)

    Haas Jimoh Akanbi, Marijke; Post, Eduard; Meter-Arkema, Anita; Rink, Rick; Robillard, George T; Wang, Xiaoqin; Wösten, Han A B; Scholtmeijer, Karin

    2010-01-01

    The poor water solubility of many drugs requires a specific formulation to achieve a sufficient bioavailability after oral administration. Suspensions of small drug particles can be used to improve the bioavailability. We here show that the fungal hydrophobin SC3 can be used to make suspensions of

  17. 22 CFR 213.29 - Suspension-general.

    Science.gov (United States)

    2010-04-01

    ... 22 Foreign Relations 1 2010-04-01 2010-04-01 false Suspension-general. 213.29 Section 213.29 Foreign Relations AGENCY FOR INTERNATIONAL DEVELOPMENT CLAIMS COLLECTION Suspension or Termination of Collection Action § 213.29 Suspension—general. The CFO may suspend or terminate the Agency's collection...

  18. Development of a non-settling gel formulation of 0.5% loteprednol etabonate for anti-inflammatory use as an ophthalmic drop

    Directory of Open Access Journals (Sweden)

    Coffey MJ

    2013-02-01

    Full Text Available Martin J Coffey,1 Heleen H DeCory,2 Stephen S Lane31Pharmaceutical Product Development, Bausch and Lomb, Inc, Rochester, NY, USA; 2Global Medical Affairs, Pharmaceuticals, Bausch and Lomb, Inc, Rochester, NY, USA; 3Associated Eye Care, Stillwater, MN, USAAbstract: The eye has protective barriers (ie, the conjunctival and corneal membranes and defense mechanisms (ie, reflex tearing, blinking, lacrimal drainage which present challenges to topical drug delivery. Topical ocular corticosteroids are commonly used in the treatment of anterior segment diseases and inflammation associated with ocular surgery, and manufacturers continually strive to improve their characteristics. We describe the development of a novel ophthalmic gel formulation of loteprednol etabonate (LE, a C-20 ester-based corticosteroid with an established safety profile, in the treatment of ocular inflammatory conditions. The new LE gel formulation is non-settling, eliminating the need to shake the product to resuspend the drug, has a pH close to that of tears, and a low preservative concentration. The rheological characteristics of LE gel are such that the formulation is instilled as a drop and transitions to a fluid upon instillation in the eye, yet retains sufficient viscosity to prolong ocular surface retention. The new formulation provides consistent, uniform dosing as evidenced by dose extrusion studies, while pharmacokinetic studies in rabbits demonstrated rapid and sustained exposure to LE in ocular tissues following instillation of LE gel. Finally, results from two clinical studies of LE gel in the treatment of postoperative inflammation and pain following cataract surgery indicate that it was safe and effective. Most patients reported no unpleasant drop sensation upon instillation, and reports of blurred vision were rare.Keywords: loteprednol etabonate, gel, drug delivery, clinical trial, ocular surface

  19. Highly conductive, printable pastes from capillary suspensions

    Science.gov (United States)

    Schneider, Monica; Koos, Erin; Willenbacher, Norbert

    2016-08-01

    We have used the capillary suspension phenomenon to design conductive pastes for printed electronic applications, such as front side metallization of solar cells, without non-volatile, organic additives that often deteriorate electrical properties. Adding a small amount of a second, immiscible fluid to a suspension creates a network of liquid bridges between the particles. This capillary force-controlled microstructure allows for tuning the flow behavior in a wide range. Yield stress and low-shear viscosity can be adjusted such that long-term stability is provided by inhibiting sedimentation, and, even more importantly, narrow line widths and high aspect ratios are accessible. These ternary mixtures, called capillary suspensions, exhibit a strong degree of shear thinning that allows for conventional coating or printing equipment to be used. Finally, the secondary fluid, beneficial for stability and processing of the wet paste, completely evaporates during drying and sintering. Thus, we obtained high purity silver and nickel layers with a conductivity two times greater than could be obtained with state-of-the-art, commercial materials. This revolutionary concept can be easily applied to other systems using inorganic or even organic conductive particles and represents a fundamental paradigm change to the formulation of pastes for printed electronics.

  20. Analytical method development for powder characterization: Visualization of the critical drug loading affecting the processability of a formulation for direct compression

    DEFF Research Database (Denmark)

    Hirschberg, Cosima; Sun, Calvin Changquan; Rantanen, Jukka

    2016-01-01

    Characterization of particulate systems (powders) is one of the remaining scientific challenges. Evaluation of powder behaviour is often empirical and the decision-making processes are experience-based. There is a need for development of analytical instrumentation enabling more fundamental...... was investigated using a ring shear tester and tablets were prepared at four different compression pressures using a single punch tablet press. Thereby, a material sparing screening approach was developed to estimate the influence of APIs on behaviour of a given DC formulation. Additionally, this approach...

  1. 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.

  2. An inverse relationship between allelopathic activity and salt tolerance in suspension cultures of three mangrove species, Sonneratia alba, S. caseolaris and S. ovata: development of a bioassay method for allelopathy, the protoplast co-culture method.

    Science.gov (United States)

    Hasegawa, Ai; Oyanagi, Tomoya; Minagawa, Reiko; Fujii, Yoshiharu; Sasamoto, Hamako

    2014-11-01

    A bioassay method for allelopathy, the 'protoplast co-culture method' was developed to study the relationship between salt tolerance and allelopathy of three mangrove species, Sonneratia alba, S. caseolaris, and S. ovata. Plants of S. alba grow in the seaward-side high salinity region and plants of the latter two species grow in upstream-side regions of a mangrove forest, respectively. Effects of five sea salts (NaCl, KCl, MgCl2, MgSO4 and CaCl2) on the growth of the suspension cells of the latter two species were first investigated by a small-scale method using 24-well culture plates. S. ovata cells showed higher tolerance than S. caseolaris cells to NaCl and other salts, but were not as halophilic as S. alba cells. Protoplasts isolated from suspension cells were co-cultured with lettuce protoplasts in Murashige and Skoog's (MS) basal medium containing 1 μM 2,4-dichlorophenoxyacetic acid, 0.1 μM benzyladenine, 3% sucrose and 0.6-0.8 M osmoticum. S. caseolaris protoplasts had a higher inhibitory effect on lettuce protoplast cell divisions than S. alba protoplasts at any lettuce protoplast density, and the effect of S. ovata was intermediate between the two. These results were similar to those obtained from a different in vitro bioassay method for allelopathy, the 'sandwich method' with dried leaves. The inverse relationship between allelopathic activity and salt tolerance in suspension cells of Sonneratia mangroves is discussed.

  3. The Use of D-Optimal Mixture Design in Optimizing Development of Okara Tablet Formulation as a Dietary Supplement.

    Science.gov (United States)

    Zen, Nur Izzati Mohamad; Abd Gani, Siti Salwa; Shamsudin, Rosnah; Masoumi, Hamid Reza Fard

    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.

  4. 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.

  5. 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

  6. Reducing Transmitted Vibration Using Delayed Hysteretic Suspension

    Directory of Open Access Journals (Sweden)

    Lahcen Mokni

    2011-01-01

    Full Text Available Previous numerical and experimental works show that time delay technique is efficient to reduce transmissibility of vibration in a single pneumatic chamber by controlling the pressure in the chamber. The present work develops an analytical study to demonstrate the effectiveness of such a technique in reducing transmitted vibrations. A quarter-car model is considered and delayed hysteretic suspension is introduced in the system. Analytical predictions based on perturbation analysis show that a delayed hysteretic suspension enhances vibration isolation comparing to the case where the nonlinear damping is delay-independent.

  7. Development of oral solid self-emulsifying lipid formulations of risperidone with improved in vitro dissolution and digestion.

    Science.gov (United States)

    Kazi, Mohsin; Al-Qarni, Hassan; Alanazi, Fars K

    2017-05-01

    Liquid adsorption on solid adsorbent carriers is an emerging technique for oral lipid-based drug delivery systems. The purpose of the current study is to convert liquid into solid self-emulsifying lipid formulations (SELFs) using an inorganic adsorbent Neusilin® grade US2 (NUS2) and investigate in vitro dissolution and digestion performance of the model antipsychotic compound risperidone. The liquid SELFs were designed using various oils, nonionic surfactants and converted into solid at various SELF: NUS2 (%m/m) mixing ratios. The characterization of solid SELF powder was performed by using SEM, XRD, FT-IR & DSC to investigate the physical nature of the drug. The in vitro dissolution experiments were conducted to compare the representative formulations with marketed product risperdal®. In vitro digestion experiments were performed using a pH-stat at pH 6.8 for 30mins to predict the fate of risperidone in the GI tract after exposure of the solid SELF to pancreatic enzymes and bile. The results from the characterization studies showed that NUS2 with SELF at 1:1 (%m/m) yield superior flowability of the powder. The SEM revealed that pure risperidone was in irregular crystal shape whereas the drug loaded solid SELFs were in smooth regular shape. The XRD and DSC analyses of pure risperidone also confirmed the intense peaks due to the native crystalline form of the drug. However, the absence of sharp peaks in solid SELFs indicated the amorphous form of the drug. From the dissolution studies it was found that solid SELFs provided significant release profiles (>95%) compared to marketed product risperdal®. The digestion experiments suggested that risperidone was in a supersaturated state which could be maintained in the presence of mixed bile salt micelles. Solid SELF of risperidone with improved dissolution and digestion profile was successfully prepared using Neusilin® US2 as an adsorbent carrier. Copyright © 2017 Elsevier B.V. All rights reserved.

  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. Mechanistic model and analysis of doxorubicin release from liposomal formulations.

    Science.gov (United States)

    Fugit, Kyle D; Xiang, Tian-Xiang; Choi, Du H; Kangarlou, Sogol; Csuhai, Eva; Bummer, Paul M; Anderson, Bradley D

    2015-11-10

    Reliable and predictive models of drug release kinetics in vitro and in vivo are still lacking for liposomal formulations. Developing robust, predictive release models requires systematic, quantitative characterization of these complex drug delivery systems with respect to the physicochemical properties governing the driving force for release. These models must also incorporate changes in release due to the dissolution media and methods employed to monitor release. This paper demonstrates the successful development and application of a mathematical mechanistic model capable of predicting doxorubicin (DXR) release kinetics from liposomal formulations resembling the FDA-approved nanoformulation DOXIL® using dynamic dialysis. The model accounts for DXR equilibria (e.g. self-association, precipitation, ionization), the change in intravesicular pH due to ammonia release, and dialysis membrane transport of DXR. The model was tested using a Box-Behnken experimental design in which release conditions including extravesicular pH, ammonia concentration in the release medium, and the dilution of the formulation (i.e. suspension concentration) were varied. Mechanistic model predictions agreed with observed DXR release up to 19h. The predictions were similar to a computer fit of the release data using an empirical model often employed for analyzing data generated from this type of experimental design. Unlike the empirical model, the mechanistic model was also able to provide reasonable predictions of release outside the tested design space. These results illustrate the usefulness of mechanistic modeling to predict drug release from liposomal formulations in vitro and its potential for future development of in vitro - in vivo correlations for complex nanoformulations. Copyright © 2015 Elsevier B.V. All rights reserved.

  10. Heteropolar Magnetic Suspension

    Science.gov (United States)

    Misovec, Kathleen; Johnson, Bruce; Downer, James; Eisenhaure, David; Hockney, Richard

    1990-01-01

    Compact permanent-magnet/electromagnet actuator has six degrees of freedom. Heteropolar magnetic actuator conceived for use as actively controlled vibration-isolating suspension device. Exerts forces along, and torques about, all three principal coordinate axes to resist all three components of translational vibration and all three components of rotational vibration. Inner cylinder suspended magnetically within outer cylinder. Electro-magnet coils interact with fields of permanent magnets to provide active control of suspending force and torque.

  11. 75 FR 35044 - Notice of Approval of a Supplemental New Animal Drug Application; Penicillin G Procaine Suspension

    Science.gov (United States)

    2010-06-21

    ... Application; Penicillin G Procaine Suspension AGENCY: Food and Drug Administration, HHS. ACTION: Notice... for a revised formulation of penicillin G procaine injectable suspension that includes lecithin as a... 6JP, Northern Ireland, filed a supplement to NADA 065-010 for use of NOROCILLIN (penicillin G procaine...

  12. 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

  13. 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

  14. 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.

  15. Liposomal paclitaxel formulations.

    Science.gov (United States)

    Koudelka, Stěpán; Turánek, Jaroslav

    2012-11-10

    Over the past three decades, taxanes represent one of the most important new classes of drugs approved in oncology. Paclitaxel (PTX), the prototype of this class, is an anti-cancer drug approved for the treatment of breast and ovarian cancer. However, notwithstanding a suitable premedication, present-day chemotherapy employing a commercial preparation of PTX (Taxol®) is associated with serious side effects and hypersensitivity reactions. Liposomes represent advanced and versatile delivery systems for drugs. Generally, both in vivo mice tumor models and human clinical trials demonstrated that liposomal PTX formulations significantly increase a maximum tolerated dose (MTD) of PTX which outperform that for Taxol®. Liposomal PTX formulations are in various stages of clinical trials. LEP-ETU (NeoPharm) and EndoTAG®-1 (Medigene) have reached the phase II of the clinical trials; Lipusu® (Luye Pharma Group) has already been commercialized. Present achievements in the preparation of various liposomal formulations of PTX, the development of targeted liposomal PTX systems and the progress in clinical testing of liposomal PTX are discussed in this review summarizing about 30 years of liposomal PTX development. Copyright © 2012 Elsevier B.V. All rights reserved.

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

    National Research Council Canada - National Science Library

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

    2014-01-01

    .... 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...

  17. Development of a spray-drying method for the formulation of respirable microparticles containing ofloxacin-palladium complex.

    Science.gov (United States)

    Palazzo, Francesco; Giovagnoli, Stefano; Schoubben, Aurelie; Blasi, Paolo; Rossi, Carlo; Ricci, Maurizio

    2013-01-20

    The purpose of this study was to produce low-releasing spray-dried polymeric microparticles (MP) useful to target alveolar macrophages in tuberculosis (TB) inhalation therapy. Ofloxacin (Ofx) was encapsulated as ofloxacin-palladium (Ofx-Pd) complex into poly DL-lactide (PLA) MP by spray-drying. Ofx-Pd was prepared according to a method previously reported. A D-optimal design was employed to optimize drug content (DC), aerodynamic diameter (d(ae)) and span. d(ae) was calculated coupling tap-density to particle size analysis. The MP were characterized by SEM, UV spectrophotometry, and DSC. In vitro drug release was performed in comparison to Ofx loaded PLA MP. The Ofx-Pd complex formed spontaneously with a 1:1 stoichiometry. Inlet temperature, drug loading and polymer concentration resulted the most influential. Optimal MP had span of 0.9, a round shape, d(ae) of 2.5 μm, and DC of 30% (w/w). DSC and SEM analyses correlated with particle size. The optimized MP formulation showed a very low release at pH 7.4 compared to spray-dried Ofx loaded MP, the release increased slightly at lower pHs. Potentially inhalable MP were obtained by an optimized spray-drying process. The very low initial drug release at physiologic pH could be useful to target alveolar macrophages and to avoid systemic exposure. Copyright © 2012 Elsevier B.V. All rights reserved.

  18. 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.

  19. BUDGET IMPACT ANALYSIS OF USING OMEPRAZOLE IMMEDIATE-RELEASE ORAL SUSPENSION IN REPLACE OF INTRAVENOUS PANTOPRAZOLE IN CRITICALLY ILL PATIENTS.

    Science.gov (United States)

    Foroutan, Naghmeh; Fahimi, Fanak; Dabiri, Yasamin; Foroutan, Arash; Habibi, Maryam; Salamzadeh, Jamshid

    2015-12-31

    The aim of the present study was to estimate the financial consequence of using omeprazole immediate-release (IR) oral suspension versus pantoprazole intravenous infusion for preventing stress-related upper gastrointestinal bleeding in critically ill patients from the perspective of the health care system. An Excel-based model was developed to compare the cost of prevention of upper gastrointestinal bleeding early after intensive care admission using the current intravenous (IV) pantoprazole formulation versus omeprazole IR oral suspension. Total costs included the cost of acid suppressive drugs and related clinical outcomes. Inputs were obtained from a local clinical trial, the Ministry of Health database, insurance organizations, hospital and pharmacy registries, the relevant literature, and expert opinion. The robustness of the input data was investigated by one-way sensitivity analysis. The model was developed based on the results of a randomized control trial (RCT), in which experimental and control groups received omeprazole and pantoprazole, respectively. According to the proposed model, the cost of gastrointestinal (GI) bleeding prevention using pantoprazole IV was US$ 950,000 while US$ 750,000 was spent on receiving omeprazole oral suspension. These costs led to the annual cost-saving of almost US$ 200,000 (US$4 per member, per month) for the health care system. In the present study, a budget impact analysis was performed to assess the financial consequences of using omeprazole IR oral suspension in place of pantoprazole IV for prevention of upper gastrointestinal bleeding. The better preventive effect of omeprazole IR oral suspension when compared with conventional therapy using pantoprazole IV was the major reason for the final comparative budgetary savings.

  20. 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.

  1. 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

  2. Clarithromycin and cefaclor suspensions in the treatment of acute otitis media in children.

    Science.gov (United States)

    Gooch, W M; Gan, V N; Corder, W T; Khurana, C M; Andrews, W P

    1993-12-01

    The safety and efficacy of a new oral suspension formulation of clarithromycin were evaluated in this multicenter, Phase III, single blind, comparative trial in 379 children ages 6 months to 12 years with signs or symptoms of acute otitis media. Children were randomized to receive a 10-day course of clarithromycin oral suspension (7.5 mg/kg; maximum, 500 mg) or cefaclor oral suspension (20 mg/kg; maximum, 500 mg) twice daily. Specific clinical response criteria were developed based on pretreatment signs and symptoms and results of tympanometry. Of the 379 enrolled patients 281 (74%) were evaluable (clarithromycin, 150; cefaclor, 131). There were no demographic differences between the two groups. Fifty percent of the patients had 2 to 4 episodes of otitis media (including the current episode) in the past 12 months; 63% of the patients had an infection of moderate severity. Clarithromycin and cefaclor suspensions were similarly effective for the treatment of acute otitis media. Clinical success (cure, cure with effusion or improvement) was achieved in 86% of clarithromycin-treated patients and 90% of cefaclor-treated patients. The majority of bacterial isolates for which susceptibility results were available were fully or moderately susceptible to the study drugs (96% clarithromycin, 92% cefaclor). Both drugs were well-tolerated; adverse events considered probably study drug-related were reported by 30 (15%) of clarithromycin recipients and 31 (17%) of cefaclor recipients. There were no significant differences between the groups in the numbers of patients reporting events that were thought to be related to study medication.(ABSTRACT TRUNCATED AT 250 WORDS)

  3. 31 CFR 10.82 - Expedited suspension.

    Science.gov (United States)

    2010-07-01

    ... 31 Money and Finance: Treasury 1 2010-07-01 2010-07-01 false Expedited suspension. 10.82 Section... INTERNAL REVENUE SERVICE Rules Applicable to Disciplinary Proceedings § 10.82 Expedited suspension. (a... suspension. A suspension under this section will commence on the date that written notice of the suspension...

  4. 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.

  5. 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…

  6. 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.

  7. Preparation, characterisation and antibacterial activity of a florfenicol-loaded solid lipid nanoparticle suspension.

    Science.gov (United States)

    Wang, Ting; Chen, Xiaojin; Lu, Mengmeng; Li, Xihe; Zhou, WenZhong

    2015-12-01

    A florfenicol-loaded solid lipid nanoparticle (FFC-SLN) suspension was prepared by hot homogenisation and ultrasonic technique. The suspension was characterised for its release profile, stability, toxicity, and the physicochemical properties of the nanoparticles. Antibacterial activity of the suspension was evaluated in vitro and in vivo. The results showed that the mean diameter, polydispersity index and zeta potential of the nanoparticles were 253 ± 3 nm, 0.409 ± 0.022 and 47.5 ± 0.21 mV, respectively. In vitro release profile showed the FFC-SLN suspension had sustained release effect. The minimum inhibition concentration values of the FFC-SLN suspension were 6 and 3 µg/mL against Staphylococcus aureus and Escherichia coli respectively, compared with 3.5 and 2 µg/mL of native florfenicol. The suspension was relatively stable at 4°C and less stable at room temperature during 9 months storage. Although the nanoparticle carriers exhibited cytotoxicity in cell cultures, the LD50 of the lyophilised dry power of the suspension was higher than 5 g/kg body weight. Mortality protection against E. coli lethal infection in mice showed that the nanoparticle suspension had much better efficacy (6/10) than native drug (1/10). These results indicate that FFC-SLN suspension could be a promising formulation in veterinary medicine.

  8. Potential Use of Polyvinyl Acetate-Polyvinylpyrrolidone Mixture for the Development of Atenolol Sustained Release Matrix Tablets: Optimization of Formulation through in Vitro-in Vivo Assessment Study.

    Science.gov (United States)

    Owayez, Ali Saeed; Abd El-Ghany, Galal Mahmoud; Abu Hashim, Irhan Ibrahim

    2017-01-01

    The objective of this study was to develop sustained release matrix tablets of atenolol (AT) using different concentrations of polyvinyl acetate-polyvinylpyrrolidone mixture (KSR) (20, 30, or 40%) with various types of fillers such as spray dried lactose (SP.D.L), avicel pH 101 (AV), and emcompress (EMS). The physical characteristics of the prepared tablets were evaluated. Characterization of the optimized formulation was performed using Fourier transform (FT)-IR spectroscopy and differential scanning calorimetry (DSC). Moreover, the in vitro release profiles of AT formulations were investigated in different pH dissolution media. Drug release kinetics and mechanisms were also determined. The results revealed that there was no potential incompatibility of the drug with the polymer. The release profiles of AT were affected by the concentration of KSR, fillers used, and pH of the dissolution media. The drug release kinetic from most of the formulations obeyed Higuchi diffusion model. The selected formulae were investigated for their stability by storage at 30 and 40°C with atmospheric humidity and 75% relative humidity (RH), respectively. The results demonstrated that no change in the physicochemical properties of the tablets stored at 30°C/atmospheric RH in comparison with some changes at 40°C/75% RH. Finally, the in vivo study provided an evidence that the optimized AT tablet containing 40% KSR and SP.D.L exhibited prominent higher oral bioavailability and more efficient sustained-release effect than the drug alone or the commercial tablet product. It is noteworthy that KSR could be considered as a promising useful release retardant for the production of AT sustained release matrix tablets.

  9. Counteractive effect of antacid suspensions on intrinsic dental erosion.

    Science.gov (United States)

    Turssi, Cecilia P; Vianna, Lídia M F F; Hara, Anderson T; do Amaral, Flávia L B; França, Fabiana M G; Basting, Roberta T

    2012-08-01

    This in vitro study aimed to investigate the anti-erosive effect of antacid suspensions applied to enamel after exposure to hydrochloric acid (HCl). Ninety bovine enamel slabs were embedded, flattened, and polished. Reference areas were created and specimens were divided into six groups. They were exposed to 0.01 M HCl (pH 2) for 2 min, followed by immersion for 1 min in one of the following test suspensions: magnesium hydroxide, aluminum hydroxide, magnesium hydroxide/aluminum hydroxide, sodium alginate/sodium bicarbonate/calcium carbonate, or hydrated magnesium aluminate. Artificial saliva was used as a negative control. Specimens were subjected to a total of five cycles of erosion/antacid treatment. Enamel surface loss was measured (in micrometers) by optical profilometry. In addition, baseline and final surface microhardness (SMH) values of enamel were obtained. It was found that antacid suspensions significantly reduced enamel loss, and that similar protection was afforded by all formulations. No differences were observed between the final enamel SMH values among groups. Antacid suspensions counteracted HCl-induced enamel loss, although they were not effective in reducing enamel softening. Mouth rinsing with antacid suspensions after vomiting can potentially represent a promising strategy to counteract enamel loss caused by erosion. © 2012 Eur J Oral Sci.

  10. 48 CFR 209.407 - Suspension.

    Science.gov (United States)

    2010-10-01

    ... 48 Federal Acquisition Regulations System 3 2010-10-01 2010-10-01 false Suspension. 209.407... OF DEFENSE ACQUISITION PLANNING CONTRACTOR QUALIFICATIONS Debarment, Suspension, and Ineligibility 209.407 Suspension. ...

  11. Comparative oral bioavailability advantage from curcumin formulations.

    Science.gov (United States)

    Munjal, Bhushan; Pawar, Yogesh Bapurao; Patel, Sarsvatkumar Babulal; Bansal, Arvind Kumar

    2011-08-01

    The aim of the present study was to study the oral bioavailability of seven different formulations of curcumin (CRM). CRM formulations viz. aqueous suspension, micronized suspension, nanosuspension, amorphous solid dispersion, hydroxypropyl-β-cyclodextrin (HP-β-CD) inclusion complex, combination with piperine, and spray-dried CRM-milk composite were compared for oral bioavailability in male Sprague-Dawley rats at a CRM dose of 250 mg/kg body weight using a validated high-performance liquid chromatography method. Aqueous suspension provided a C max and AUC(0 - t) of 28.9 ng/ml and 26.9 ng h/ml, respectively. In comparison, statistically significant increase in the oral bioavailability was obtained with the nanosuspension, HP-β-CD inclusion complex, and amorphous solid dispersion with 251%, 567%, and 446% increase in terms of AUC(0 - t) and 405%, 415%, and 270% in terms of C max. However, no significant increase in AUC(0 - t) and C max was observed with piperine and micronized suspension. The milk composite reduced the oral bioavailability of CRM (10% and 37% in terms of AUC(0 - t) and C max). A statistically significant increase in the T max was observed with piperine and in HP-β-CD complex, while the T max was reduced for nanosuspension. The results provide interesting insights into the role of solubility enhancement and metabolism inhibition, for improving the oral bioavailability of CRM.

  12. Contact-aware simulations of particulate Stokesian suspensions

    Science.gov (United States)

    Lu, Libin; Rahimian, Abtin; Zorin, Denis

    2017-10-01

    We present an efficient, accurate, and robust method for simulation of dense suspensions of deformable and rigid particles immersed in Stokesian fluid in two dimensions. We use a well-established boundary integral formulation for the problem as the foundation of our approach. This type of formulation, with a high-order spatial discretization and an implicit and adaptive time discretization, have been shown to be able to handle complex interactions between particles with high accuracy. Yet, for dense suspensions, very small time-steps or expensive implicit solves as well as a large number of discretization points are required to avoid non-physical contact and intersections between particles, leading to infinite forces and numerical instability. Our method maintains the accuracy of previous methods at a significantly lower cost for dense suspensions. The key idea is to ensure interference-free configuration by introducing explicit contact constraints into the system. While such constraints are unnecessary in the formulation, in the discrete form of the problem, they make it possible to eliminate catastrophic loss of accuracy by preventing contact explicitly. Introducing contact constraints results in a significant increase in stable time-step size for explicit time-stepping, and a reduction in the number of points adequate for stability.

  13. 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.

  14. Stability indicating method development and validation for simultaneous estimation of atorvastatin calcium and celecoxib in bulk and niosomal formulation by RP-HPLC

    Directory of Open Access Journals (Sweden)

    Priyanka S. Jadhav

    2015-09-01

    Full Text Available The present work describes development and validation of a specific, sensitive, precise and stability-indicating high-performance liquid chromatographic method of analysis of atorvastatin calcium and celecoxib, both as a bulk drug and in niosomal formulation. The analysis has been performed by using Cosmosil-C18 column (4.6 mm´250 mm, 5 m at 25 °C using acetonitrile: ammonium acetate buffer pH 5.0: methanol (50:25:25 v/v/v as mobile phase. The detection was carried out at 277nm with a flow rate of 1.0mL/min. The retention times of Atorvastatin calcium and Celecoxib were 6.195 and 3.989min, respectively. The method was validated according to ICH guidelines, for specificity, precision, linearity, accuracy and robustness. Atorvastatin calcium and Celecoxib were subjected to stress conditions of hydrolysis, oxidation, photolysis and thermal degradation. The degradation was observed in oxidation and acid hydrolysis. The linearity for atorvastatin calcium and celecoxib were in the range of 100-500 µg/mL. The recovery study of atorvastatin and celecoxib were found to be in the range of 98.96 - 99.92% and 98.90-100%, respectively. The proposed method was validated and successfully applied to the estimation of Atorvastatin calcium and Celecoxib in combined in-house niosomal formulation.

  15. Application of design space optimization strategy to the development of LC methods for simultaneous analysis of 18 antiretroviral medicines and 4 major excipients used in various pharmaceutical formulations.

    Science.gov (United States)

    Habyalimana, Védaste; Mbinze, Jérémie Kindenge; Yemoa, Achille Loconon; Waffo, Christelle; Diallo, Tidiane; Tshilombo, Nicodème Kalenda; Ntokamunda, Justin-Léonard Kadima; Lebrun, Pierre; Hubert, Philippe; Marini, Roland Djang'eing'a

    2017-05-30

    As one of the world's most significant public health challenges in low- and middle-income countries, HIV/AIDS deserves to be treated with appropriate medicines, however which are not spared from counterfeiting. For that, we developed screening and specific HPLC methods that can analyze 18 antiretroviral medicines (ARV) and 4 major excipients. Design of experiments and design space methodology were initially applied for 15 ARV and the 4 excipients with prediction thanks to Monte Carlo simulations and focusing on rapidity and affordability thus using short column and low cost organic solvent (methanol) in gradient mode with 10mM buffer solutions of ammonium hydrogen carbonate. Two other specific methods dedicated to ARV in liquid and in solid dosage formulations were also predicted and optimized. We checked the ability of one method for the analysis of a fixed-dose combination composed by emtricitabine/tenofovir/efavirenz in tablet formulations. Satisfying validation results were obtained by applying the total error approach taking into account the accuracy profile as decision tool. Then, the validated method was applied to test two samples coded A and B, and claimed to contain the tested ARV. Assay results were satisfying only for sample B. Copyright © 2017 Elsevier B.V. All rights reserved.

  16. Formulation development of therapeutic monoclonal antibodies using high-throughput fluorescence and static light scattering techniques: role of conformational and colloidal stability.

    Science.gov (United States)

    Goldberg, Deborah S; Bishop, Steven M; Shah, Ambarish U; Sathish, Hasige A

    2011-04-01

    In this work, we describe the application of two different high-throughput screening (HTS) techniques that can be used to determine protein stability during early formulation development. Differential scanning fluorescence (DSF) and differential static light scattering (DSLS) are used to determine the conformational and colloidal stability of therapeutic monoclonal antibodies (mAbs) during thermal denaturation in a high-throughput fashion. DSF utilizes SYPRO Orange, a polarity-sensitive extrinsic fluorescent probe, to monitor protein unfolding. We found that melting temperatures determined by DSF have a linear correlation with melting temperatures of the first domain unfolding determined by differential scanning calorimetry, establishing DSF as a reliable method for measuring thermal stability. The DSLS method employs static light scattering to evaluate protein stability during thermal denaturation in a 384-well format. Overall comparison between mAb aggregation under typical accelerated stress conditions (40°C) and the thermal stability obtained by DSF and DSLS is also presented. Both of these HTS methods are cost effective with high-throughput capability and can be implemented in any laboratory. Combined with other emerging HTS techniques, DSF and DSLS could be powerful tools for mAb formulation optimization. Copyright © 2010 Wiley-Liss, Inc.

  17. Developing a Stable Aqueous Enteric Coating Formulation with Hydroxypropyl methylcellulose acetate succinate (HPMCAS-MF) and Colloidal Silicon Dioxide as Anti-tacking Agent.

    Science.gov (United States)

    Deshpande, Tanvi M; Quadir, Anisul; Obara, Sakae; Ibrahim, Ahmed; Hoag, Stephen W

    2018-02-16

    The purpose of this study was to use statistical design of experiments to develop a stable aqueous enteric coating formulation containing stabilizing excipients, such as polyethylene glycol that can minimize hydroxypropyl methylcellulose acetate succinate aggregation and minimize spray-nozzle clogging at elevated processing temperatures. The mechanisms of stabilization (i.e. charge stabilization and molecular interactions) were studied by performing zeta potential and FTIR studies. Electrostatic stabilization by sodium lauryl sulfate and hydrogen bonding by polyethylene glycol provided dispersion stability and yielded a stable aqueous coating formulation that prevented spray-nozzle clogging. An enteric coated tablet with better gastric resistance was obtained by incorporating fumed silica (Aerosil ® R972) as the anti-tacking agent instead of talc. Dissolution testing on the riboflavin enteric coated tablets showed a good enteric release profile without releasing riboflavin in 0.1 N HCl, and completely disintegrating within 10 min in phosphate buffer (pH 6.8). Copyright © 2018. Published by Elsevier B.V.

  18. Supercritical fluid processing of drug nanoparticles in stable suspension.

    Science.gov (United States)

    Pathak, Pankaj; Meziani, Mohammed J; Desai, Tarang; Foster, Charles; Diaz, Julian A; Sun, Ya-Ping

    2007-07-01

    Significant effort has been directed toward the development of drug formulation and delivery techniques, especially for the drug of no or poor aqueous solubility. Among various strategies to address the solubility issue, the reduction of drug particle sizes to the nanoscale has been identified as a potentially effective and broadly applicable approach. Complementary to traditional methods, supercritical fluid techniques have found unique applications in the production and processing of drug particles. Here we report the application of a newly developed supercritical fluid processing technique, Rapid Expansion of a Supercritical Solution into a Liquid Solvent, to the nanosizing of potent antiparasitic drug Amphotericin B particles. A supercritical carbon dioxide-cosolvent system was used for the solubilization and processing of the drug. The process produced well-dispersed nanoscale Amphotericin B particles suspended in an aqueous solution, and the suspension was intrinsically stable or could be further stabilized in the presence of water-soluble polymers. The properties of the drug nanoparticles were found to be dependent on the type of cosolvent used. The results on the use of dimethyl sulfoxide and methanol as cosolvents and their effects on the properties of nanosized Amphotericin B particles are presented and discussed.

  19. Field evaluations of the efficacy and safety of Emodepside plus toltrazuril (Procox® oral suspension for dogs) against naturally acquired nematode and Isospora spp. infections in dogs.

    Science.gov (United States)

    Altreuther, Gertraut; Gasda, Nadine; Adler, Kerstin; Hellmann, Klaus; Thurieau, Heloise; Schimmel, Annette; Hutchens, Douglas; Krieger, Klemens J

    2011-08-01

    Three controlled, blinded and randomised multicentre field studies evaluated the efficacy and safety of a new formulation containing emodepside plus toltrazuril (Procox® suspension for dogs) against naturally acquired parasite infections in dogs. In two studies dogs positive for gastrointestinal nematodes and/or Isospora spp. were treated with emodepside/toltrazuril suspension (at least 0.45 mg emodepside plus 9 mg toltrazuril per kg body weight) or a reference product containing either milbemycin oxime plus praziquantel (Milbemax®) or sulfadimethoxine (Kokzidiol SD®) at recommended dose rates. The third study investigated efficacy against prepatent natural Isospora spp. infections in comparison to an untreated control group by enrolling Isospora- negative dogs that were at risk to develop a patent infection during the study.No suspected adverse drug reactions were observed in any of the 403 dogs enrolled in the three studies including 234 dogs treated with emodepside/toltrazuril suspension. In dogs treated with emodepside/toltrazuril suspension against nematode infection faecal egg counts were reduced by 100 % (reference product: 99.7 %). Similarly, in the dogs that had been treated against patent Isospora spp. infection, faecal oocyst counts were reduced by 100 % (reference product: 99.0 %). In both studies, statistical analysis demonstrated non-inferiority and even superiority to the reference products (p ≤ 0.009). Dogs treated with emodepside/toltrazuril suspension during suspected prepatent Isospora spp. infection had 98.7 % lower faecal oocyst counts after treatment compared to untreated dogs (p toltrazuril suspension is safe and highly efficacious against nematodes and Isospora spp. under field conditions.

  20. 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.

  1. 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...... resistance. The aim of this study was to develop an inexpensive, simple antibody-based ELISA to measure CQ concentrations in tablets and in plasma....

  2. DEVELOPMENT OF ASSAY METHOD AND FORCED DEGRADATION STUDY OF LEDIPASVIR AND SOFOSBUVIR BY RP-HPLC IN TABLET FORMULATION

    OpenAIRE

    S. Naazneen*, A. Sridevi

    2017-01-01

    Chronic hepatitis C virus (HCV) infection is one of the most common etiologies of liver-related mortality throughout the world. Sofosbuvir and ledipasvir are inhobits HCV NS5B and HCV NS5A polymerase respectively. No published LC-MS/MS and HPLC based methods for simultaneous estimation of ledipasvir and sofosbuvir. Therefore, A stability indicating high performance liquid Chromatographic (HPLC) method was developed and validated for estimation of both drugs. Chromatographic separation was ach...

  3. 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.

  4. Mechanistic theory of margination and flow-induced segregation in confined multicomponent suspensions: Simple shear and Poiseuille flows*

    Science.gov (United States)

    Henríquez Rivera, Rafael G.; Zhang, Xiao; Graham, Michael D.

    2016-10-01

    A mechanistic model, derived from kinetic theory, is developed to describe segregation in confined multicomponent suspensions such as blood. It incorporates the two key phenomena arising in these systems at low Reynolds number: hydrodynamic pair collisions and hydrodynamic migration. Two flow profiles are considered: simple shear flow (plane Couette flow) and plane Poiseuille flow. The theory begins by writing the evolution of the number density of each component in the suspension as a master equation with contributions from migration and collisions. By making judicious approximations for the collisions, this system of integrodifferential equations is reduced to a set of drift-diffusion equations. We focus attention on the case of a binary suspension with a deformable primary component that completely dominates the collision dynamics in the system and a trace component that has no effect on the primary. The model captures the phenomena of depletion layer formation and margination observed in confined multicomponent suspensions of deformable particles. The depletion layer thickness of the primary component is predicted to follow a master curve relating it in a specific way to confinement ratio and volume fraction. Results from various sources (experiments, detailed simulations, master equation solutions) with different parameters (flexibility of different components in the suspension, viscosity ratio, confinement, among others) collapse onto the same curve. For sufficiently dilute suspensions the analytical form predicted by the drift-diffusion theory for this curve is in excellent agreement with results from these other sources with only one adjustable parameter. In a binary suspension, several regimes of segregation arise, depending on the value of a "margination parameter" M . Most importantly, in both Couette and Poiseuille flows there is a critical value of M below which a sharp "drainage transition" occurs: one component is completely depleted from the bulk

  5. Rapid ultraviolet spectrophotometric assay of benzoyl metronidazole in an oral suspension.

    Science.gov (United States)

    Sanyal, A K

    1992-01-01

    A procedure is described for the rapid determination of benzoyl metronidazole in an oral suspension which is based on measurement of the change in absorbance at 276 nm during alkaline hydrolysis of the compound in 2 mol dm-3 NaOH. The change in absorbance follows a linear relationship with concentration in the range 3-18 micrograms ml-1. Results of the determination of benzoyl metronidazole in an oral suspension and of the recovery experiments performed on this formulation, and also on various individual excipients and other additives, confirmed the applicability of the proposed method to complex formulations.

  6. 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.

  7. Investigation of influence of NaOH and NaCl activating solutions on bentonite stabilization in suspension fertilizers

    Science.gov (United States)

    Hoffmann, Krystyna; Hoffmann, Józef; Mikła, Daniel; Huculak-Mä Czka, Marta; Skut, Jakub

    2010-05-01

    1. INTRODUCTION Regular plants growth and their metabolic activity are determined by the macro- (C, H, O, N, P, S, K, Ca, Mg) and micronutrients (Fe, Mn, Zn, Cu, B, Mo, Cl, Ni). The role of these elements is very important, the excess as well as the deficiency have the negative influence on their development [1]. In order to increase yields and quality of crops a mineral, organic and mineral-organic fertilizers are applied. In the last years suspension fertilizers have been of great significance, taking the agricultural benefits into consideration. Suspension fertilizers are products of a new generation on account of higher nutrients concentrations than in the majority of other fertilizers, what makes them more efficient. Suspension fertilizers differ from solid fertilizers in more regular distribution on field. Nutrients are more concentrated what is economically relevant on account of the facilitated transportation. Examinations indicated, that nutrients from suspension fertilizers are more available than from solid fertilizers. The high concentration of nutrients in fertilizer is obtained by introducing a substance which holds them regularly in the suspension. Bentonites are the substances used for stabilization of suspension fertilizers most often [2,3]. Bentonites belong to ore of clay minerals, primarily made from minerals of smectite group, montmorillonite especially [4]. Bentonite loams were formulated as a result of Aluminium Silicate-bearing Rocks weathering and subsequent sedimentation in the aqueous environment. Characteristic features of rocks of the smectite group are their ability to absorb water (swelling), to form thixotrophic suspensions which aren't undergoing sedimentation process for a long time; as well as susceptibility to absorb cations and organic substances [4,5]. Therefore investigations have been carried out in order to evaluate the possibility of application of diverse loamy raw materials as suspension stabilizers for fertilizer

  8. 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 (<15 min) and acceptable TS (≥1 MPa at 10-15% tablet porosity), and their predictivity was confirmed by conducting internal and external validation studies.

  9. Optimisation of the Nonlinear Suspension Characteristics of a Light Commercial Vehicle

    Directory of Open Access Journals (Sweden)

    Dinçer Özcan

    2013-01-01

    Full Text Available The optimum functional characteristics of suspension components, namely, linear/nonlinear spring and nonlinear damper characteristic functions are determined using simple lumped parameter models. A quarter car model is used to represent the front independent suspension, and a half car model is used to represent the rear solid axle suspension of a light commercial vehicle. The functional shapes of the suspension characteristics used in the optimisation process are based on typical shapes supplied by a car manufacturer. The complexity of a nonlinear function optimisation problem is reduced by scaling it up or down from the aforementioned shape in the optimisation process. The nonlinear optimised suspension characteristics are first obtained using lower complexity lumped parameter models. Then, the performance of the optimised suspension units are verified using the higher fidelity and more realistic Carmaker model. An interactive software module is developed to ease the nonlinear suspension optimisation process using the Matlab Graphical User Interface tool.

  10. 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.

  11. Optimization Analysis Model of Self-Anchored Suspension Bridge

    OpenAIRE

    Pengzhen Lu; Jianting Chen; Jingru Zhong; Penglong Lu

    2014-01-01

    The hangers of self-anchored suspension bridge need to be tensioned suitably during construction. In view of this point, a simplified optimization calculation method of cable force for self-anchored suspension bridge has been developed based on optimization theories, such as minimum bending energy method, and internal force balanced method, influence matrix method. Meanwhile, combined with the weak coherence of main cable and the adjacently interaction of hanger forces, a simplified analysis ...

  12. 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

  13. Development of a nanostructured lipid carrier formulation for increasing photo-stability and water solubility of Phenylethyl Resorcinol

    Energy Technology Data Exchange (ETDEWEB)

    Fan, Hengfeng; Liu, Guoqing; Huang, Yiqing; Li, Yan; Xia, Qiang, E-mail: xiaq@seu.edu.cn

    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.

  14. Stability Indicating Liquid Chromatographic Method for Estimation of Trihexyphenidyl Hydrochloride and Risperidone in Tablet Formulation: Development and Validation Consideration

    Directory of Open Access Journals (Sweden)

    Patel Bhaumik

    2014-01-01

    Full Text Available This paper describes validated reverse phase high-performance liquid chromatographic (RP-HPLC method for simultaneous estimation of trihexyphenidyl hydrochloride (THP and risperidone (RSP in the pure powder form and in combined tablet dosage form. The HPLC separation was achieved on a core shell C18 (100 mm length × 4.6 mm, 2.6 μm particle size using methanol : ammonium acetate buffer 1% (85 : 15 v/v; pH-6.5 as mobile phase and delivered at flow rate of 0.8 mL/min. The calibration plot showed good linear relationship with r2 = 0.997 ± 0.001 for THP and r2 = 0.998 ± 0.001 for RSP in concentration range of 50–175 μg/mL and 50–175 μg/mL, respectively. LOD and LOQ were found to be 0.40 and 1.29 μg/mL for THP and 1.24 and 3.92 μg/mL for RSP. Assay of THP and RSP was found to be 100.16 ± 0.03% and 99.83 ± 0.02%, respectively. THP and RSP were subjected to different stress conditions (acidic, basic, oxidative, thermal, and photolytic degradation. The degraded product peaks were well resolved from the pure drug peak. The method was successfully validated as per the ICH guidelines. The developed RP-HPLC method was successfully applied for the estimation of THP and RSP in tablet dosage form.

  15. Development of a nanostructured lipid carrier formulation for increasing photo-stability and water solubility of Phenylethyl Resorcinol

    Science.gov (United States)

    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.

  16. Ether formulations of relativity

    Energy Technology Data Exchange (ETDEWEB)

    Duffy, M.C.

    1980-12-01

    Contemporary ether theories are surveyed and criticized, 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 criticized. Cosmological evidence suggesting an ether is mentioned. Only ether theories formally identical to Relativity have been published in depth. They stand criticized 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. 103 references.

  17. Investigation of friction and perceived skin feel after application of suspensions of various cosmetic powders.

    Science.gov (United States)

    Timm, K; Myant, C; Nuguid, H; Spikes, H A; Grunze, M

    2012-10-01

    The perceived skin feel during and after application of skin care products is highly important to the consumer and therefore to cosmetic formulators. Powder particles are commonly incorporated in cosmetic formulations to improve their sensory properties. Although a large variety of cosmetic powders is available, it is presently uncertain how the particles' properties affect the perceived skin feel. Well-trained panellists usually assess the perceived skin feel; however, these tests are time-consuming and by nature subjective. To address this complexity, the authors have systematically investigated various suspensions of cosmetic powders with regard to the perceived skin feel after application. Furthermore, an in vitro friction measurement set-up was developed which features a tribological contact similar to the mechanical properties and the topography of the contact between finger tip and human skin. A correlation was found between the friction coefficients determined in vitro and the perceived skin feel after sample application (as assessed by a descriptive panel). The results indicate that cosmetic powder particles should be small with a rather irregular shape to better lubricate the tribological contact between finger tip and skin surface, which leads to a more 'powdery' skin feel. It is suggested to carry out further tests with different powder particles or other skin care formulations to fully understand the underlying mechanisms of skin feel improvement and to validate or even partly replace the results of panel testing. © 2012 Society of Cosmetic Scientists and the Société Française de Cosmétologie.

  18. Development and validation of a supercritical fluid chromatography method for the direct determination of enantiomeric purity of provitamin B5 in cosmetic formulations with mass spectrometric detection.

    Science.gov (United States)

    Khater, Syame; West, Caroline

    2015-01-01

    A rapid and efficient chiral supercritical fluid chromatography (SFC) method has been developed for the quantitative determination of panthenol enantiomers in cosmetic formulations (cream, lotion, wipe, and exfoliant). Indeed, the pharmacological effect only depends on the D form (Dexpanthenol) thus accurate measurement of its enantiomeric purity in formulated cosmetic products is of interest. The samples were prepared with liquid-liquid extraction followed by solid-phase extraction on Adsorbex amino cartridges. After testing several enantioselective columns in an attempt at reversing the elution order to have the minor enantiomer eluted first, the best separation of enantiomers and internal standard (N-acetyl-L-alanine) was achieved on a 3 μm-amylose-type immobilized polysaccharide chiral stationary phase (Chiralpak IA) in less than 6 min with a simple mobile phase comprising carbon dioxide and 11% methanol pumped at 2.3 mL/min, 25°C and 150 bar backpressure. Supercritical fluid chromatography coupled to both an optical diode-array detector and a user-friendly single-quadrupole mass spectrometer (Waters QDa) equipped with electrospray ionization source has been used. The on-line coupling ensures the technique to be more informative and improves detection sensitivity, as underivatized panthenol has a poor UV absorption. The limit of quantification (LOQ) achieved with single-ion recording was 0.5 μg/mL. The method was validated in terms of linearity, precision and accuracy and satisfactory results were obtained. Copyright © 2014 Elsevier B.V. All rights reserved.

  19. 49 CFR 238.427 - Suspension system.

    Science.gov (United States)

    2010-10-01

    ... 49 Transportation 4 2010-10-01 2010-10-01 false Suspension system. 238.427 Section 238.427... Equipment § 238.427 Suspension system. (a) General requirements. (1) Suspension systems shall be designed to... equipment. (2) Passenger equipment shall meet the safety performance standards for suspension systems...

  20. 78 FR 57525 - Suspension of Community Eligibility

    Science.gov (United States)

    2013-09-19

    ... SECURITY Federal Emergency Management Agency 44 CFR Part 64 Suspension of Community Eligibility AGENCY...) that are scheduled for suspension on the effective dates listed within this rule because of... measures prior to the effective suspension date given in this rule, the suspension will not occur and a...

  1. 48 CFR 2909.407 - Suspension.

    Science.gov (United States)

    2010-10-01

    ... 48 Federal Acquisition Regulations System 7 2010-10-01 2010-10-01 false Suspension. 2909.407... CONTRACTOR QUALIFICATIONS Debarment, Suspension, and Ineligibility 2909.407 Suspension. (a) The Senior... authorized to make an exception, regarding suspension by another agency suspending official under the...

  2. 14 CFR 1267.670 - Suspension.

    Science.gov (United States)

    2010-01-01

    ... 14 Aeronautics and Space 5 2010-01-01 2010-01-01 false Suspension. 1267.670 Section 1267.670... WORKPLACE (FINANCIAL ASSISTANCE) Definitions § 1267.670 Suspension. Suspension means an action taken by a..., subpart 9.4) and the common rule, Government-wide Debarment and Suspension (Nonprocurement), that...

  3. 22 CFR 1008.670 - Suspension.

    Science.gov (United States)

    2010-04-01

    ... 22 Foreign Relations 2 2010-04-01 2010-04-01 true Suspension. 1008.670 Section 1008.670 Foreign... ASSISTANCE) Definitions § 1008.670 Suspension. Suspension means an action taken by a Federal agency that...-wide Debarment and Suspension (Nonprocurement), that implements Executive Order 12549 and Executive...

  4. 2 CFR 182.670 - Suspension.

    Science.gov (United States)

    2010-01-01

    ... 2 Grants and Agreements 1 2010-01-01 2010-01-01 false Suspension. 182.670 Section 182.670 Grants... Suspension. Suspension means an action taken by a Federal agency that immediately prohibits a recipient from... guidance on nonprocurement debarment and suspension (2 CFR part 180, which implements Executive Orders...

  5. 40 CFR 36.670 - Suspension.

    Science.gov (United States)

    2010-07-01

    ... 40 Protection of Environment 1 2010-07-01 2010-07-01 false Suspension. 36.670 Section 36.670... REQUIREMENTS FOR DRUG-FREE WORKPLACE (FINANCIAL ASSISTANCE) Definitions § 36.670 Suspension. Suspension means... contracts (48 CFR part 9, subpart 9.4) and the common rule, Government-wide Debarment and Suspension...

  6. 78 FR 5734 - Suspension of Community Eligibility

    Science.gov (United States)

    2013-01-28

    ... SECURITY Federal Emergency Management Agency 44 CFR Part 64 Suspension of Community Eligibility AGENCY...) that are scheduled for suspension on the effective dates listed within this rule because of... measures prior to the effective suspension date given in this rule, the suspension will not occur and a...

  7. 77 FR 53775 - Suspension of Community Eligibility

    Science.gov (United States)

    2012-09-04

    ... SECURITY Federal Emergency Management Agency 44 CFR Part 64 Suspension of Community Eligibility AGENCY...) that are scheduled for suspension on the effective dates listed within this rule because of... measures prior to the effective suspension date given in this rule, the suspension will not occur and a...

  8. 29 CFR 94.670 - Suspension.

    Science.gov (United States)

    2010-07-01

    ... 29 Labor 1 2010-07-01 2010-07-01 true Suspension. 94.670 Section 94.670 Labor Office of the... § 94.670 Suspension. Suspension means an action taken by a Federal agency that immediately prohibits a... Debarment and Suspension (Nonprocurement), that implements Executive Order 12549 and Executive Order 12689...

  9. 45 CFR 1173.670 - Suspension.

    Science.gov (United States)

    2010-10-01

    ... 45 Public Welfare 3 2010-10-01 2010-10-01 false Suspension. 1173.670 Section 1173.670 Public... (FINANCIAL ASSISTANCE) Definitions § 1173.670 Suspension. Suspension means an action taken by a Federal..., subpart 9.4) and the common rule, Government-wide Debarment and Suspension (Nonprocurement), that...

  10. 45 CFR 1641.11 - Suspension.

    Science.gov (United States)

    2010-10-01

    ... 45 Public Welfare 4 2010-10-01 2010-10-01 false Suspension. 1641.11 Section 1641.11 Public Welfare Regulations Relating to Public Welfare (Continued) LEGAL SERVICES CORPORATION DEBARMENT, SUSPENSION AND REMOVAL OF RECIPIENT AUDITORS Suspension § 1641.11 Suspension. (a) IPAs suspended from providing audit...

  11. 77 FR 2646 - Suspension of Community Eligibility

    Science.gov (United States)

    2012-01-19

    ... SECURITY Federal Emergency Management Agency 44 CFR Part 64 Suspension of Community Eligibility AGENCY...) that are scheduled for suspension on the effective dates listed within this rule because of... measures prior to the effective suspension date given in this rule, the suspension will not occur and a...

  12. 31 CFR 19.1015 - Suspension.

    Science.gov (United States)

    2010-07-01

    ... 31 Money and Finance: Treasury 1 2010-07-01 2010-07-01 false Suspension. 19.1015 Section 19.1015 Money and Finance: Treasury Office of the Secretary of the Treasury GOVERNMENTWIDE DEBARMENT AND SUSPENSION (NONPROCUREMENT) Definitions § 19.1015 Suspension. Suspension is an action taken by a suspending...

  13. 41 CFR 105-68.1015 - Suspension.

    Science.gov (United States)

    2010-07-01

    ... 41 Public Contracts and Property Management 3 2010-07-01 2010-07-01 false Suspension. 105-68.1015 Section 105-68.1015 Public Contracts and Property Management Federal Property Management Regulations...-GOVERNMENTWIDE DEBARMENT AND SUSPENSION (NONPROCUREMENT) Definitions § 105-68.1015 Suspension. Suspension is an...

  14. 15 CFR 29.670 - Suspension.

    Science.gov (United States)

    2010-01-01

    ... 15 Commerce and Foreign Trade 1 2010-01-01 2010-01-01 false Suspension. 29.670 Section 29.670... WORKPLACE (FINANCIAL ASSISTANCE) Definitions § 29.670 Suspension. Suspension means an action taken by a..., subpart 9.4) and the common rule, Government-wide Debarment and Suspension (Nonprocurement), that...

  15. 13 CFR 147.670 - Suspension.

    Science.gov (United States)

    2010-01-01

    ... 13 Business Credit and Assistance 1 2010-01-01 2010-01-01 false Suspension. 147.670 Section 147...-FREE WORKPLACE (NONPROCUREMENT) Definitions § 147.670 Suspension. Suspension means an action taken by a..., subpart 9.4) and the common rule, Government-wide Debarment and Suspension (Nonprocurement), that...

  16. 78 FR 2622 - Suspension of Community Eligibility

    Science.gov (United States)

    2013-01-14

    ... SECURITY Federal Emergency Management Agency 44 CFR Part 64 Suspension of Community Eligibility AGENCY...) that are scheduled for suspension on the effective dates listed within this rule because of... measures prior to the effective suspension date given in this rule, the suspension will not occur and a...

  17. 10 CFR 607.670 - Suspension.

    Science.gov (United States)

    2010-01-01

    ... 10 Energy 4 2010-01-01 2010-01-01 false Suspension. 607.670 Section 607.670 Energy DEPARTMENT OF... ASSISTANCE) Definitions § 607.670 Suspension. Suspension means an action taken by a Federal agency that...-wide Debarment and Suspension (Nonprocurement), that implements Executive Order 12549 and Executive...

  18. 76 FR 9666 - Suspension of Community Eligibility

    Science.gov (United States)

    2011-02-22

    ... SECURITY Federal Emergency Management Agency 44 CFR Part 64 Suspension of Community Eligibility AGENCY...), that are scheduled for suspension on the effective dates listed within this rule because of... measures prior to the effective suspension date given in this rule, the suspension will not occur and a...

  19. 29 CFR 1471.1015 - Suspension.

    Science.gov (United States)

    2010-07-01

    ... 29 Labor 4 2010-07-01 2010-07-01 false Suspension. 1471.1015 Section 1471.1015 Labor Regulations Relating to Labor (Continued) FEDERAL MEDIATION AND CONCILIATION SERVICE GOVERNMENTWIDE DEBARMENT AND SUSPENSION (NONPROCUREMENT) Definitions § 1471.1015 Suspension. Suspension is an action taken by a suspending...

  20. 22 CFR 133.670 - Suspension.

    Science.gov (United States)

    2010-04-01

    ... 22 Foreign Relations 1 2010-04-01 2010-04-01 false Suspension. 133.670 Section 133.670 Foreign... ASSISTANCE) Definitions § 133.670 Suspension. Suspension means an action taken by a Federal agency that...-wide Debarment and Suspension (Nonprocurement), that implements Executive Order 12549 and Executive...

  1. 43 CFR 43.670 - Suspension.

    Science.gov (United States)

    2010-10-01

    ... 43 Public Lands: Interior 1 2010-10-01 2010-10-01 false Suspension. 43.670 Section 43.670 Public... WORKPLACE (FINANCIAL ASSISTANCE) Definitions § 43.670 Suspension. Suspension means an action taken by a..., subpart 9.4) and 2 CFR part 180. Suspension of a recipient is a distinct and separate action from...

  2. 22 CFR 312.670 - Suspension.

    Science.gov (United States)

    2010-04-01

    ... 22 Foreign Relations 2 2010-04-01 2010-04-01 true Suspension. 312.670 Section 312.670 Foreign... § 312.670 Suspension. Suspension means an action taken by a Federal agency that immediately prohibits a... Debarment and Suspension (Nonprocurement), that implements Executive Order 12549 and Executive Order 12689...

  3. 34 CFR 84.670 - Suspension.

    Science.gov (United States)

    2010-07-01

    ... 34 Education 1 2010-07-01 2010-07-01 false Suspension. 84.670 Section 84.670 Education Office of... ASSISTANCE) Definitions § 84.670 Suspension. Suspension means an action taken by a Federal agency that...-wide Debarment and Suspension (Nonprocurement), that implements Executive Order 12549 and Executive...

  4. 77 FR 7537 - Suspension of Community Eligibility

    Science.gov (United States)

    2012-02-13

    ... SECURITY Federal Emergency Management Agency 44 CFR Part 64 Suspension of Community Eligibility AGENCY...) that are scheduled for suspension on the effective dates listed within this rule because of... measures prior to the effective suspension date given in this rule, the suspension will not occur and a...

  5. 19 CFR 146.82 - Suspension.

    Science.gov (United States)

    2010-04-01

    ... 19 Customs Duties 2 2010-04-01 2010-04-01 false Suspension. 146.82 Section 146.82 Customs Duties U... (CONTINUED) FOREIGN TRADE ZONES Penalties; Suspension; Revocation § 146.82 Suspension. (a) For cause. The... for a period not to exceed 90 days. Upon order of the Board the suspension may be continued. If...

  6. 77 FR 24858 - Suspension of Community Eligibility

    Science.gov (United States)

    2012-04-26

    ... SECURITY Federal Emergency Management Agency 44 CFR Part 64 Suspension of Community Eligibility AGENCY...) that are scheduled for suspension on the effective dates listed within this rule because of... measures prior to the effective suspension date given in this rule, the suspension will not occur and a...

  7. 75 FR 5890 - Suspension of Community Eligibility

    Science.gov (United States)

    2010-02-05

    ... SECURITY Federal Emergency Management Agency 44 CFR Part 64 Suspension of Community Eligibility AGENCY...), that are scheduled for suspension on the effective dates listed within this rule because of... measures prior to the effective suspension date given in this rule, the suspension will not occur and a...

  8. 76 FR 39782 - Suspension of Community Eligibility

    Science.gov (United States)

    2011-07-07

    ... SECURITY Federal Emergency Management Agency 44 CFR Part 64 Suspension of Community Eligibility AGENCY...), that are scheduled for suspension on the effective dates listed within this rule because of... measures prior to the effective suspension date given in this rule, the suspension will not occur and a...