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Sample records for lyophilized orally disintegrating

  1. ORALLY DISINTEGRATING TABLETS: A REVIEW

    Directory of Open Access Journals (Sweden)

    Mudgal Vinod Kumar

    2011-04-01

    Full Text Available Orally disintegrating tablets (ODTs are gaining prominence as new drug delivery systems and emerged as one of the popular and widely accepted dosage forms, especially for the pediatric and geriatric patients. To obviate the problem of dysphagia and to improve patient compliance, ODTs have gained considerable attention as preferred alternatives to conventional tablet and capsule formulations. Various scientific techniques including freeze drying, moulding, spray drying, sublimation, direct compression, cotton candy process, mass extrusion, melt granulation etc. have been employed for the development of ODTs. These techniques render the disintegration of tablet rapidly and dissolve in mouth without chewing or additional water intake. The current article is focused on ideal characteristics, significant features, patented technologies, formulation aspects including the use of superdisintegrants. Various marketed preparations along with numerous scientific advancements made so far in this avenue have also been discussed.

  2. Lyophilized Oral Sustained Release Polymeric Nanoparticles of Nateglinide

    National Research Council Canada - National Science Library

    Kaleemuddin, Mohammad; Srinivas, Prathima

    2013-01-01

    The objective of this study is to formulate lyophilized oral sustained release polymeric nanoparticles of nateglinide in order to decrease dosing frequency, minimize side effects, and increase bioavailability...

  3. Comprehensive review on oral disintegrating films.

    Science.gov (United States)

    Nagaraju, T; Gowthami, R; Rajashekar, M; Sandeep, S; Mallesham, M; Sathish, D; Kumar, Y Shravan

    2013-02-01

    Fast-dissolving drug-delivery systems were first developed in the late 1970s as an alternative to tablets, capsules, and syrups for pediatric and geriatric patients who experience difficulties swallowing traditional oral solid dosage forms. In response to this need, a variety of orally disintegrating tablet (ODT) formats were commercialized, which disintegrate within 1 min when placed in the mouth without drinking water or chewing. Oral drug delivery technology has improved from conventional dosage forms to modified release dosage forms to ODT to the recent oral disintegrating films (ODF). Oral disintegrating film or strip that employs a water dissolving polymer which allows the dosage form to quickly hydrate by saliva, adhere to mucosa, and disintegrate within a few seconds, dissolve and releases medication for oromucosal absorption when placed on the tongue or oral cavity. Oral strip technology provides an alternate route for drugs with first pass metabolism. This review give details of materials used in ODF, manufacturing aspects, technologies, evaluation tests and marketed products.

  4. A dual strategy to improve psychotic patients’ compliance using sustained release quetiapine oral disintegrating tablets

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    Refaat Ahmed

    2016-12-01

    Full Text Available Quetiapine (QT is a short acting atypical antipsychotic drug effective in schizophrenia and bipolar disorder. This study aims at designing a novel dosage form of sustained release taste-masked QT orally disintegrating tablets (ODTs based on solid lipid micro-pellets (SLMPs. QT SLMPs were prepared using the hot melt extrusion technique and utilizing three lipid carriers: Compritol, Precirol and white beeswax either alone or in mixtures. They showed sustained QT release and a taste masking effect. The selected QT SLMP was further blended with an aqueous solution containing polyvinylpyrollidone (2.5 %, croscarmellose sodium (2 % and mannitol (50 %; it was then lyophilized into ODT in a mass ratio of 1:2, respectively. ODTs containing QT SLMPs showed: average wetting time (40.92 s, average oral disintegration time (21.49 s, average hardness (16.85 N and also imparted suitable viscosity to suspend pellets during the lyophilization process. In conclusion, lyophilization is a promising technique for the formulation of multiparticulate systems into ODTs.

  5. Design and evaluation of microwave-treated orally disintegrating tablets containing polymeric disintegrant and mannitol.

    Science.gov (United States)

    Sano, Syusuke; Iwao, Yasunori; Noguchi, Shuji; Kimura, Susumu; Itai, Shigeru

    2013-05-01

    Microwave (MW) treatment was used to develop a formulation process for the preparation of wet molded orally disintegrating tablets (ODTs) consisting of mannitol and polymeric disintegrant with improved hardness and disintegration properties. The wet molded tablets were prepared in accordance with the conventional methods and subsequently heated by MW irradiation to induce the swelling of the tablet. Croscarmellose sodium, crospovidone, and low-substituted hydroxypropylcellulose (L-HPC) were evaluated for their use with this technology. NBD-020, which is a grade of L-HPC, provided the better hardness and disintegration results. In addition, the crystalline forms of mannitol impacted on hardness and disintegration properties of the ODT upon MW irradiation. The effects of the disintegrant ratio, δ and β crystalline mannitol ratio, amount of water, and compression force on the ODT properties were evaluated using the design of experiment method. MW-induced swelling was enhanced by an increase in the disintegrant ratio. Although the hardness of the tablet increased following MW treatment, the disintegration time became less than that of the MW-untreated tablets as the β-mannitol ratios increased. Taken together, the results indicated that the polymeric disintegrant greatly improved the properties of the molded tablets in combination with MW treatment. Copyright © 2013 Elsevier B.V. All rights reserved.

  6. Characterization of Oral Disintegrating Film Containing Donepezil for Alzheimer Disease

    OpenAIRE

    2011-01-01

    The aim of this study was to develop a taste-masked oral disintegrating film (ODF) containing donepezil, with fast disintegration time and suitable mechanical strength, for the treatment of Alzheimer’s disease. Hydroxypropyl methylcellulose, corn starch, polyethylene glycol, lactose monohydrate and crosspovidone served as the hydrophilic polymeric bases of the ODF. The uniformity, in vitro disintegration time, drug release and the folding endurance of the ODF were examined. The in vitro resul...

  7. Orally disintegrating films: A modern expansion in drug delivery system

    Directory of Open Access Journals (Sweden)

    Muhammad Irfan

    2016-09-01

    Full Text Available Over the past few decades, tendency toward innovative drug delivery systems has majorly increased attempts to ensure efficacy, safety and patient acceptability. As discovery and development of new chemical agents is a complex, expensive and time consuming process, so recent trends are shifting toward designing and developing innovative drug delivery systems for existing drugs. Out of those, drug delivery system being very eminent among pediatrics and geriatrics is orally disintegrating films (ODFs. These fast disintegrating films have superiority over fast disintegrating tablets as the latter are associated with the risks of choking and friability. This drug delivery system has numerous advantages over conventional fast disintegrating tablets as they can be used for dysphasic and schizophrenic patients and are taken without water due to their ability to disintegrate within a few seconds releasing medication in mouth. Various approaches are employed for formulating ODFs and among which solvent casting and spraying methods are frequently used. Generally, hydrophilic polymers along with other excipients are used for preparing ODFs which allow films to disintegrate quickly releasing incorporated active pharmaceutical ingredient (API within seconds. Orally disintegrating films have potential for business and market exploitation because of their myriad of benefits over orally disintegrating tablets. This present review attempts to focus on benefits, composition, approaches for formulation and evaluation of ODFs. Additionally, the market prospect of this innovative dosage form is also targeted.

  8. Further improvement of orally disintegrating tablets using micronized ethylcellulose.

    Science.gov (United States)

    Okuda, Yutaka; Irisawa, Yosuke; Okimoto, Kazuto; Osawa, Takashi; Yamashita, Shinji

    2012-02-28

    The aim of this study is to design a new orally disintegrating tablet (ODT) containing micronized ethylcellulose (MEC). The new ODT was prepared by physical mixing of rapidly disintegrating granules (RDGs) with MEC. To obtain RDGs, mannitol was spray-coated with a suspension of corn starch and crospovidone (9:1, w/w ratio) using a fluidized-bed granulator (suspension spray-coating method). The new ODTs were evaluated for their hardness, friability, thickness, internal structure (X-ray-CT scanning), in vivo disintegration time, and water absorption rate. Since MEC increases tablet hardness by increasing the contact frequency between the granules, the new ODTs could obtain high hardness (>50 N) and low friability (disintegration in vivo (film coating, matrix, and microcapsule).

  9. Preparation and evaluation of diclofenac sodium orally disintegrating tablets

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    Iancu Valeriu

    2016-06-01

    Full Text Available Orally disintegrating tablets (ODTs are dosage forms which disintegrate in mouth within seconds without need of water. This type of quality in dosage form can be attained by addition of different varieties of excipients. Pharmaburst™ 500 is a co-processed excipient system which allows rapid disintegration and low adhesion to punches. The aim of the present study was to develop and evaluate 25 mg diclofenac sodium ODTs (orodispersible tablets batches by direct compression method at different compression forces 10 kN (F1 and 20 kN (F2 and directly compressible excipients used in different ratio (Avicel PH 102, magnesium stearate and coprocessed excipient Pharmaburst™ 500, 70% and 80% w/w. The obtained batches were analyzed for appearance, tablet thickness, uniformity of weight, hardness, friability, disintegration time, and non-compendial methods (wetting time. Co-processed Pharmaburst™ 500 excipient 70% used for sodium diclofenac ODT obtaining determined good results for quality control tests evaluation.

  10. Formulation and Characterization of Acetaminophen Nanoparticles in Orally Disintegrating Films

    Science.gov (United States)

    AI-Nemrawi, Nusaiba K.

    The purpose of this study is to prepare acetaminophen loaded nanoparticles to be cast directly, while still in the emulsion form, into Orally Disintegrating Films (ODF). By casting the nanoparticles in the films, we expected to keep the particles in a stable form where the nanoparticles would be away from each other to prevent their aggregation. Once the films are applied on the buccal mucosa, they are supposed to dissolve within seconds, releasing the nanoparticles. Then the nanoparticles could be directly absorbed through the mucosa to the blood stream and deliver acetaminophen there. The oral cavity mucosa is one of the most attractive sites for systemic drug delivery due to its high permeability and blood supply. Furthermore, it is robust and shows short recovery times after stress or damage, and the drug bypasses first pass effect and avoids presystemic elimination in the GI tract. Nanoencapsulation increases drug efficacy, specificity, tolerability and therapeutic index. These Nanocapsules have several advantages in the protection of premature degradation and interaction with the biological environment, enhancement of absorption into a selected tissue, bioavailability, retention time and improvement of intracellular penetration. The most important characteristics of nanoparticles are their size, encapsulation efficiency (EE), zeta potential (surface charge), and the drug release profiles. Unfortunately, nanoparticles tend to precipitate or aggregate into larger particles within a short time after preparation or during storage. Some solutions for this problem were mentioned in literature including lyophilization and spray drying. These methods are usually expensive and give partial solutions that might have secondary problems; such as low re-dispersion efficacy of the lyophilized NPs. Furthermore, most of the formulations of NPs are invasive or topical. Few formulas are available to be given orally. Fast disintegrating films (ODFs) are rapidly gaining interest

  11. Characterization of oral disintegrating film containing donepezil for Alzheimer disease.

    Science.gov (United States)

    Liew, Kai Bin; Tan, Yvonne Tze Fung; Peh, Kok Khiang

    2012-03-01

    The aim of this study was to develop a taste-masked oral disintegrating film (ODF) containing donepezil, with fast disintegration time and suitable mechanical strength, for the treatment of Alzheimer's disease. Hydroxypropyl methylcellulose, corn starch, polyethylene glycol, lactose monohydrate and crosspovidone served as the hydrophilic polymeric bases of the ODF. The uniformity, in vitro disintegration time, drug release and the folding endurance of the ODF were examined. The in vitro results showed that 80% of donepezil hydrochloride was released within 5 minutes with mean disintegration time of 44 seconds. The result of the film flexibility test showed that the number of folding time to crack the film was 40 times, an indication of sufficient mechanical property for patient use. A single-dose, fasting, four-period, eight-treatment, double-blind study involving 16 healthy adult volunteers was performed to evaluate the in situ disintegration time and palatability of ODF. Five parameters, namely taste, aftertaste, mouthfeel, ease of handling and acceptance were evaluated. The mean in situ disintegration time of ODF was 49 seconds. ODF containing 7 mg of sucralose were more superior than saccharin and aspartame in terms of taste, aftertaste, mouthfeel and acceptance. Furthermore, the ODF was stable for at least 6 months when stored at 40°C and 75% relative humidity.

  12. Fast disintegrating tablets of nisoldipine for intra-oral administration.

    Science.gov (United States)

    El Maghraby, Gamal M; Elsergany, Ramy N

    2014-09-01

    Nisoldipine is a calcium channel blocker with low and variable oral bioavailability. This was attributed to slow dissolution and presystemic metabolism. Accordingly, the objective of this work was to enhance the dissolution rate of nisoldipine to formulate fast disintegrating tablets with rapid dissolution. Binary solid dispersions (SD) were prepared for the drug with hydroxypropyl methyl cellulose E5 (HPMC), polyvinylpyrrolidone (PVP), Pluronic F68 or polyethylene glycol 6000 (PEG 6000). SD formation increased the dissolution rate compared to pure drug with the corresponding physical mixtures failing to provide the same dissolution enhancement. This indicates that the SD enhanced dissolution is not due to the solubilizing effect of the polymer and can be due to physical change in the drug crystal which was confirmed by thermal analysis. SD with HPMC and PVP were selected for preparation of fast disintegrating tablets as they liberated most of the drug in the first 5 min. HPMC-based tablets disintegrated rapidly and released most of the drug in the first 2 min which correlated with the corresponding SD. In contrast, PVP-based tablets disintegrated slowly with gradual dissolution. This can be attributed to the binding effect of PVP. The study developed fast disintegrating tablet for intra-oral administration.

  13. SUPERDISINTEGRANTS IN THE DEVELOPMENT OF ORALLY DISINTEGRATING TABLETS: A REVIEW

    Directory of Open Access Journals (Sweden)

    Nisha Gupta

    2011-11-01

    Full Text Available The desire of improved palatability in orally administered products has prompted the development of numerous formulations with improved performance and acceptability. Orally disintegrating tablets are an emerging trend in novel drug delivery system and have received ever-increasing demand during the last few decades. The field has become a rapidly growing area in the pharmaceutical industry and gaining popularity due to ease of administration and better patient compliance especially for geriatric and pediatric patients. ODTs are solid unit dosage forms, which disintegrates or dissolves rapidly in the mouth without chewing and water. This type of property in dosage form can be attained by addition of different excipients, from which disintegrant is the key adjuvant. In recent years, several newer agents have been developed known as superdisintegrants. Diverse categories of superdisintegrants such as synthetic, semi-synthetic, natural and co-processed blends etc. have been employed to develop effectual mouth dissolving tablets and to overcome the limitations of conventional tablet dosage forms. The objective of the present article is to highlight the various kinds of superdisintegrants along with their role in tablet disintegration and drug release, which are being used in the formulation to provide the safer, effective drug delivery with patient compliance. This review focuses on various synthetic superdisintegrants, natural superdisintegrants from different plant sources, co-processed excipients blend and their efficiency.

  14. Formulasi Orally Disintegrating Tablet (Odt) Domperidon Menggunakan Superdisintegran Krospovidon Dan Primogel Dengan Metode Sublimasi

    OpenAIRE

    Juliyanti

    2015-01-01

    Background: Sublimation method is one of techniques for preparing Orally Disintegrating Tablet that based on principle can increase porous structure in the tablets and/or adding superdisintegrant and other water soluble ingredients into tablets. Hence, it is necessary to develop a formulation of Orally Disintegrating Tablet that fulfilled the requirement. Purpose: The aim of this study was to evaluate the effect of Camphor to disintegrating time and dissolution of Orally Disintegrating Tab...

  15. Lecithin, gelatin and hydrolyzed collagen orally disintegrating films: functional properties.

    Science.gov (United States)

    Borges, J G; Silva, A G; Cervi-Bitencourt, C M; Vanin, F M; Carvalho, R A

    2016-05-01

    Orally disintegrating films (ODFs) can transport natural active compounds such as ethanol extract of propolis (EEP). This paper aimed to investigate the effect of lecithin on different gelatin and hydrolyzed collagen (HC) polymeric matrices with addition of EEP. ODFs were prepared by casting technique and were characterized (color parameters, water content, mechanical properties, microstructure, disintegration time (DT), infrared spectroscopy (FTIR), contact angle (CA), swelling degree and total phenolic content). The mechanical properties were influenced by HC. The microstructure demonstrated increased porosity and roughness in films with EEP, and the addition of lecithin resulted in an increase in the number of pores. Lecithin-gelatin and lecithin-EEP-gelatin interactions were observed by FTIR. The addition of HC and EEP reduced the DT and CA, and HC and lecithin reduced the swelling capacity. However, the swelling capacity was not affected by presence of EEP. The addition of lecithin to gelatin and HC ODFs may improve the incorporation and the oral transport of active compounds such as EEP. Copyright © 2016 Elsevier B.V. All rights reserved.

  16. Characterization of low cost orally disintegrating film (ODF

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    Riana Jordao Barrozo Heinemann

    Full Text Available Abstract Orally disintegrating films (ODF produced with a hydrophilic polymers are a thin and flexible material, wich disintegrate in contact with saliva and can vehicule bioactive materials. The aim of this study was to develop and characterize ODF formulation with potential to act as a carrier for different bioactives compounds prepared with low cost polymers. Gelatin (G, starch (S, carboxymethyl cellulose (CMC and their blends (G:S, CMC:S, CMC:G, and CMC:S:G were prepared by casting technique with sorbitol as a plasticizer. The formulations were characterized in terms of visual aspects, FTIR, SEM, mechanical characteristics, hygroscopicity, dissolution (in vitro and in vivo and swelling index. FTIR analysis revealed that no interaction between polymers in ODF was observed. By SEM, it was possible to observe differences on surfaces by different polymers. ODF made with CMC and CMC:G presented higher water absorption (P<0.05 and higher swelling index probably due to the higher water affinity by CMC. Formulations with G, CMC:G and CMC:S:G presented the highest values of tensile strength (P<0.05. ODF prepared with S alone presented the highest disintegration time, the others formulations showed in vitro dissolution ranging from 5.22 to 8.50 min, while in vivo dissolution time ranged from 2.15 to 3.38 min. By the formulations made with G and blend of G:S and CMC:S:G it is possible to develop a ODF of low cost with desired characteristics being an alternative vehicle to deliver functional compounds for continuous use.

  17. Stability of benzocaine formulated in commercial oral disintegrating tablet platforms.

    Science.gov (United States)

    Köllmer, Melanie; Popescu, Carmen; Manda, Prashanth; Zhou, Leon; Gemeinhart, Richard A

    2013-12-01

    Pharmaceutical excipients contain reactive groups and impurities due to manufacturing processes that can cause decomposition of active drug compounds. The aim of this investigation was to determine if commercially available oral disintegrating tablet (ODT) platforms induce active pharmaceutical ingredient (API) degradation. Benzocaine was selected as the model API due to known degradation through ester and primary amino groups. Benzocaine was either compressed at a constant pressure, 20 kN, or at pressure necessary to produce a set hardness, i.e., where a series of tablets were produced at different compression forces until an average hardness of approximately 100 N was achieved. Tablets were then stored for 6 months under International Conference on Harmonization recommended conditions, 25°C and 60% relative humidity (RH), or under accelerated conditions, 40°C and 75% RH. Benzocaine degradation was monitored by liquid chromatography-mass spectrometry. Regardless of the ODT platform, no degradation of benzocaine was observed in tablets that were kept for 6 months at 25°C and 60% RH. After storage for 30 days under accelerated conditions, benzocaine degradation was observed in a single platform. Qualitative differences in ODT platform behavior were observed in physical appearance of the tablets after storage under different temperature and humidity conditions.

  18. Ginger Orally Disintegrating Tablets to Improve Swallowing in Older People.

    Science.gov (United States)

    Hirata, Ayumu; Funato, Hiroki; Nakai, Megumi; Iizuka, Michiro; Abe, Noriaki; Yagi, Yusuke; Shiraishi, Hisashi; Jobu, Kohei; Yokota, Junko; Hirose, Kahori; Hyodo, Masamitsu; Miyamura, Mitsuhiko

    2016-01-01

    We previously prepared and pharmaceutically evaluated ginger orally disintegrating (OD) tablets, optimized the base formulation, and carried out a clinical trial in healthy adults in their 20 s and 50s to measure their effect on salivary substance P (SP) level and improved swallowing function. In this study, we conducted clinical trials using the ginger OD tablets in older people to clinically evaluate the improvements in swallowing function resulting from the functional components of the tablet. The ginger OD tablets were prepared by mixing the excipients with the same amount of mannitol and sucrose to a concentration of 1% ginger. Eighteen healthy older adult volunteers aged 63 to 90 were included in the swallowing function test. Saliva was collected before and 15 min after administration of the placebo and ginger OD tablets. Swallowing endoscopy was performed by an otolaryngologist before administration and 15 min after administration of the ginger OD tablets. A scoring method was used to evaluate the endoscopic swallowing. Fifteen minutes after taking the ginger OD tablets, the salivary SP amount was significantly higher than prior to ingestion or after taking the placebo (pginger OD tablets. Our findings showed that the ginger OD tablets increased the salivary SP amount and improved swallowing function in older people with appreciably reduced swallowing function.

  19. Development and evaluation of ofloxacin orally disintegrating tablets

    Directory of Open Access Journals (Sweden)

    Badrinath Pralhadrao Mohite

    2012-06-01

    Full Text Available Bitter taste of ofloxacin, a broad spectrum bactericidal agent, is masked and orally disintegrating tablets were formulated. The bitter taste is masked by forming complex between drug and weak cation exchange resins, Tulsion 335 and Indion 204. Effect of pH and drug:resin ratio on the drug loading was studied. Maximum drug loading was observed at pH 6. Ratio of 1:2 of drug:resin masked almost complete bitterness of ofloxacin. Formation of complexes was confirmed by IR spectroscopy. Physical characterization of taste masked complexes was carried out. Present work envisages the taste masking of ofloxacin and development of orally disintegrating tablets. The effect of pH and resin quantities on drug loading were studied to find the optimum conditions of drug loading for complete taste masking. Effect of superdisintegrants like sodium starch glycolate, croscarmellose sodium and polyplasdone XL at varying level on physical parameters of compressed tablets was also assessed. The formulations containing 5 % w/w polyplasdone XL showed about 90 % of drug release within 5 minutes. No significant differences were observed in the physical parameters of resinates as well as tablets prepared from Tulsion 335 and Indion 204.O gosto amargo de ofloxacina, agente bactericida de largo espectro, é mascarado e formularam-se comprimidos dispersíveis. O sabor amargo é mascarado pela formação de complexo entre o fármaco e resinas de troca catiônica fraca, Tulsion 335 e Indion 204. Efeito do pH e da proporção fármaco: resina sobre a carga de fármaco foi estudada. Carga de fármaco máxima foi observada em pH 6. Proporção 1:2 do fármaco: resina mascarou quase completamente o gosto amargo de ofloxacina. A formação de complexos foi confirmada por espectroscopia no IV. Caracterização física dos complexos de sabor mascarado foi realizada. O presente trabalho preconiza o mascaramento do gosto de ofloxacina e desenvolvimento decomprimidos por via oral, se

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

    Science.gov (United States)

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

    2009-12-01

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

  1. Gelatin/hydroxypropyl methylcellulose matrices - Polymer interactions approach for oral disintegrating films.

    Science.gov (United States)

    Tedesco, Marcela P; Monaco-Lourenço, Carla A; Carvalho, Rosemary A

    2016-12-01

    Oral disintegrating film represents an optimal alternative for delivery system of active compounds. The choice of film-forming polymer is the first step in the development of oral disintegrating films and the knowledge of molecular interactions in this matrix is fundamental to advance in this area. Therefore, this study aimed to characterize gelatin and hydroxypropyl methylcellulose (HPMC) films and their blends as matrices of oral disintegrating films. The films were produced by casting technique and were characterized by scanning electron microscopy, Fourier transform infrared spectroscopy, differential scanning calorimetry, mechanical properties, contact angle, time disintegration and bioadhesive strength. Differential scanning calorimetry showed that enthalpy of fusion and melting temperatures of the blends films were lower than those of the gelatin film, which may be associated with the lack of intra-chain interactions also observed in the Fourier transform infrared spectra. In blends, a less compact cross-section structure was observed in scanning electron microscopy images compared with isolated polymer films. The addition of HPMC increased the elongation, hydrophilicity and in vitro bioadhesive force and decreased in vitro disintegration time, important properties in the development of oral disintegrating films. Although the mixture of the polymers showed no synergistic behavior, this study may contribute to the development of new applications for polymeric matrices in the pharmaceutical industry.

  2. Formulation development and evaluation of orally disintegrating tablets of doxazosin mesylate

    Directory of Open Access Journals (Sweden)

    Shilpa P Chaudhari

    2012-01-01

    Full Text Available Doxazosin mesylate has some of the ideal characteristics required for an orally disintegrating tablet. There were some challenges faced during this formulation development. The aims of the present research were to mask the bitter taste of Doxazosin mesylate and to formulate orally disintegrating tablets of taste masked drug. Taste masking was performed by coating Doxazosin Mesylate with suitable polymer Eudragit powdered E-100 using spray drying technique. The resultant microspheres were then evaluated for thermal analysis, yield, particle size, entrapment efficiency and in vitro taste masking. The tablets were formulated by mixing the taste masked microspheres with different types and concentration of super-disintegrants and granulated Mannitol was selected as diluent and compressed using direct compression method. The tablets prepared were evaluated for weight variation, thickness, hardness, friability, drug content, water content, in vitro disintegration time and in vitro drug release and compared with marketed IR tablet of Doxazosin mesylate.

  3. Development and characterization of orally-disintegrating films for propolis delivery

    OpenAIRE

    2013-01-01

    This study aimed at evaluating the effect of different concentrations of hydrolyzed collagen (HC) on the properties of an orally disintegrating film containing propolis ethanol extract (PEE) as an active component. The films were evaluated in terms of total phenols, mechanical properties, solubility, contact angle, disintegration time, and microstructure. The films were prepared by casting with 2 g of protein mass (gelatin and HC), 30 g of sorbitol/100 g of protein mass, and 100 g of PEE/100 ...

  4. Preparation and characterization of novel fast disintegrating capsules (Fastcaps) for administration in the oral cavity.

    Science.gov (United States)

    Ciper, Mesut; Bodmeier, Roland

    2005-10-13

    The objective of this study was to prepare novel capsule-based fast disintegrating dosage forms for the oral cavity (Fastcaps). First, cast films were prepared from various additive-containing gelatin solutions and evaluated with respect to disintegration time and mechanical properties in order to identify suitable formulations for the capsule preparation. The disintegration time of films decreased with decreasing bloom strength and could be further decreased by the addition of sugars or PEGs. Fast disintegrating capsules were successfully prepared by a dipping process, whereby parameters such as the viscosity and temperature of the dipping solution and the dipping velocity of the steel pins were optimized. The required viscosity range of the dipping solution for Fastcap manufacturing was 500-600 cP. The addition of the hydrophilic additives (xylitol, sorbitol or PEG 1500) did not significantly affect the viscosity and gelation temperature of the dipping solution. The in vitro disintegration of Fastcaps (30-45 s) was twice as rapid as the one of regular hard gelatin capsules. In vivo, Fastcaps disintegrated rapidly (9-13 s) and their content was spread throughout the oral cavity within seconds. Lactose and/or microcrystalline cellulose were suitable fillers for Fastcaps. The mechanical properties of Fastcaps were similar to commercially available gelatin capsules, which assures good processability and handling.

  5. Pengaruh Konsentrasi Polietilen Glikol 400 Terhadap Formulasi Oral Disintegrating Film Antalgin

    OpenAIRE

    2016-01-01

    Background: Oral disintegrating film (ODF) is a new drug dosage form for oral administration. The dosage form ismade from a very thin oral film that can be placed easily on the patient's tongue or the other mucosal tissues. Antalgin is one pirozolone derivate thathas an analgesic andantipyretic effect. Objective: The aim of this study was to determine the effect of addition of polyethylene glycol (PEG) 400 todisintegration and dissolution of ODF Antalgin. Methods: The ODF formulas that ...

  6. Application of freeze-drying technology in manufacturing orally disintegrating films.

    Science.gov (United States)

    Liew, Kai Bin; Odeniyi, Michael Ayodele; Peh, Kok-Khiang

    2016-01-01

    Freeze drying technology has not been maximized and reported in manufacturing orally disintegrating films. The aim of this study was to explore the freeze drying technology in the formulation of sildenafil orally disintegrating films and compare the physical properties with heat-dried orally disintegrating film. Central composite design was used to investigate the effects of three factors, namely concentration of carbopol, wheat starch and polyethylene glycol 400 on the tensile strength and disintegration time of the film. Heat-dried films had higher tensile strength than films prepared using freeze-dried method. For folding endurance, freeze-dried films showed improved endurance than heat-dried films. Moreover, films prepared using freeze-dried methods were thicker and had faster disintegration time. Formulations with higher amount of carbopol and starch showed higher tensile strength and thickness whereas formulations with higher PEG 400 content showed better flexibility. Scanning electron microscopy showed that the freeze-dried films had more porous structure compared to the heat-dried film as a result of the release of water molecule from the frozen structure when it was subjected to freeze drying process. The sildenafil film was palatable. The dissolution profiles of freeze-dried and heat-dried films were similar to Viagra® with f2 of 51.04 and 65.98, respectively.

  7. Formulation and evaluation of orally disintegrating tablet of Rizatriptan using natural superdisintegrant

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    Tabbakhian Majid

    2014-01-01

    Full Text Available Introduction: Rizatriptan benzoate is a potent and selective 5-HT1B/1D receptor agonist and is effective for the treatment of acute migraine. Difficulty in swallowing is common among all age groups, especially elderly and pediatrics. Orally disintegrating tablets may constitute an innovative dosage form that overcome the problem of swallowing and provides a quick onset of action. This study was aimed to formulate and evaluate an Orally Disintegrating Tablet (ODT containing Rizatriptan while using semi-synthetic and natural superdisintegrants. Methods: Orodispersible tablets were prepared by direct compression using natural superdisntegrant (Plantago ovata mucilage and semi-synthetic superdisntegrant (crospovidone. The prepared tablets were evaluated for hardness, friability, thickness, drug content uniformity, water absorption and wetting time. A 32 factorial design was used to investigate the effect of independent variables (amount of crospovidone and Plantago ovata mucilage on dependent variables [disintegration time, wetting time and Q5 (cumulative amount of drug release after 5 minutes]. A counter plot was also presented to graphically represent the effect of independent variable on the disintegration time, wetting time and Q5. The check point batch was also prepared to prove the validity of the evolved mathematical model. The systematic formulation approach helped in understanding the effect of formulation processing variable. Results: According to the results of optimized batches, the best concentration of superdisintegrant were as follows: 9.4 mg Psyllium mucilage and 8.32 mg crospovidone gave rapid disintegration in 35sec and showed 99% drug release within 5 minutes. Conclusion: Plantago ovata mucilage, a natural superdisintegrant, gives a rapid disintegration and high release when used with synthetic superdisntegrant in formulation of orally disintegrating tablet of Rizatriptan.

  8. FORMULATION AND EVALUATION OF TASTE MASKED ORALLY DISINTEGRATING TABLETS OF SITAGLIPTIN PHOSPHATE MONOHYDRATE

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    Abbaraju Prasanna Lakshmi

    2012-09-01

    Full Text Available The purpose of the work is to mask the unpleasant taste of sitagliptin phosphate monohydrate with mannitol by co-grinding method and to formulate it as an oral disintegrating tablet by direct compression method. Drug-mannitol complexes were taken in 1:1, 1:1.5 and 1:2 ratios and tested for in vitro and in vivo bitter masking capacity of mannitol, drug content and molecular property. Different super-disintegrants like croscaramellose, sodium starch glycolate and crospovidone was used as disintegrating agents. The prepared tablets were characterized for tensile strength, wetting time, water absorption ratio, and In vitro and in vivo disintegration time. In addition, aspartame is used as sweetening agent which gives more pleasant taste in the mouth. Among all the formulations F1 to F6, Formulation F6 has good taste masking capacity and fast disintegration within 40sec. Furthermore, 96.7% of the drug has been released in 15min.The results disclosed that the productivity of taste masking of the drug has been done effectively with mannitol and 40mg of crosscarmellose sodium is efficient for rapid disintegrating of tablet.

  9. In vitro and in vivo characteristics of prochlorperazine oral disintegrating film.

    Science.gov (United States)

    Nishimura, Misao; Matsuura, Katsuhiko; Tsukioka, Tadao; Yamashita, Hirotaka; Inagaki, Naoki; Sugiyama, Tadashi; Itoh, Yoshinori

    2009-02-23

    Oral disintegrating film containing prochlorperazine, a dopamine D(2) receptor antagonist with anti-emetic property, was newly developed using microcrystalline cellulose, polyethlene glycol and hydroxypropylmethyl cellulose as the base materials. The uniformity of dosage units of the preparation was acceptable according to the criteria of JP15 or USP27. The film showed an excellent stability at least for 8 weeks when stored at 40 degrees C and 75% in humidity. The dissolution test revealed a rapid disintegration property, in which most of prochlorperazine dissolved within 2 min after insertion into the medium. Subsequently, rats were used to compare pharmacokinetic properties of the film preparation applied topically into the oral cavity with those of oral administration of prochlorperazine solution. None of the parameters, including T(max), C(max), area under curves, clearance and steady-state distribution volume was significantly different between oral disintegrating film and oral solution. These findings suggest that the present prochlorperazine-containing oral film is potentially useful to control emesis induced by anti-cancer agents or opioid analgesics in patients who limit the oral intake.

  10. DESIGN AND DEVELOPMENT OF ONDANSETRON ORALLY DISINTEGRATING TABLETS AND ITS OPTIMIZATION USING DESIGN OF EXPERIMENT

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    Rakesh Kumar Bhasin et al.

    2012-03-01

    Full Text Available Ondansetron is the first of a new class of drugs, selective serotonin receptor antagonist (5 hydroxy tryptamine type 3 used as an anti emetic associated with cancer chemotherapy. Its Orally Disintegrating Tablet has been developed for patients who find swallowing difficult by freeze dried technology by RP Scherer Corporation and Scherer DDS. The aim of this study was to design a new orally disintegrating tablet that has high hardness and a fast disintegration rate using conventional tablet technology. Ondansetron ODT was prepared by using traditional technology like direct compression and wet granulation technique. As blend exhibited poor flow in direct compression process, so wet granulation process was finalized. Bitter taste of Ondansetron has been masked by use of sweetener like aspartame and peppermint flavor. Quick disintegration has been achieved by use of surfactant in the granulating solvent and superdisintegrant like crospovidone in both intra and extragranular part. Design space has been created by use of different concentrations of both binders as well as disintegrant with the help of DOE and a robust formulation has been made. In vitro release profile of both formulations prepared by freeze drying and wet granulation is matching. Formulation prepared by wet granulation process has been found acceptable to volunteers in term of taste, mouth feel and convenience of administration.

  11. PHARMACOKINETICS OF PARACETAMOL ORALLY DISINTEGRATING AND GENERAL TABLETS IN HEALTHY VOLUNTEERS

    Institute of Scientific and Technical Information of China (English)

    ZHU De-qiu; CUI Lan; HUANG Sai-jie; TAO Da-ren; SUN Li; SHEN Jin-fang

    2006-01-01

    Objective To compare the pharmacokinetics and relative biological availability of Paracetamol orally disintegrating tablets and general tablets in healthy volunteers. Methods In a random two periods crossover study, 19 healthy male Chinses volunteers received a single dose of Paracetamol500mg of two formularies respectively. The plasma concentration of paracetamol was determined by HPLC method. The pharmacokinetic parameters of the two preparation and the relative biological availability of Paracetamol orally disintegrating tablets and general tablets were caculated with statistical analysis. Results The main pharmacokinetic parameters of paracetamol orally disintegrating tablets and general tablets were (31436. 70 ± 7062. 80) μg · h-1 · L-1 and (29871.40±7965.04)μg·h-1·L-1 for AUC0~1 (33295.7 ± 7663.10) μg·h -1 ·L-1 and(31845.20±8830.83)μg·h-1·L-1 for A UC0~∞; ( 9.71±2.78 )μg/ml and ( 10.36±3.86 ) μg/ml for Cmax; ( 0.82±0.45 ) h and ( 0.74± 0.67) h for Tmax ; ( 2.90±0.42 ) h and ( 3.13±0.67 ) h for T1/2ke ; ( 0.24±0.04 ) and ( 0.23±0.04 ) for Ke;(4.1481±0.4492 ) and (4.0771±0.8131 ) for mean residence time ( MRT) , respectively. Variance analysis showed that there was significant difference in AUC0~12 and Cmax between the two preparations. Conclusion The paracetamol orally disintegrating tablets and general tablets are bioequivalent and the relative biological availability of Paracetamol orally disintegrating tablets is (108±19)%.

  12. Bioavailability Enhancement of Rizatriptan Benzoate by Oral Disintegrating Strip: In vitro and In vivo Evaluation.

    Science.gov (United States)

    Bhagawati, S T; Chonkar, Ankita D; Dengale, Swapnil J; Reddy, Sreenivasa M; Bhat, Krishnamurthy

    2016-01-01

    Oral disintegrating strips containing rizatriptan benzoate, a selective 5-hydroxy tryptamine receptor agonist with anti migraine property, was developed using polyvinyl alcohol, sodium alginate and hydroxyl propyl methylcellulose as the base materials. The analytical and bioanalytical methods were developed and validated using HPLC (PDA and flouroscence detectors). The dissolution study performed on the strips revealed that all the five formulations, release the drug within eight minutes. Under ICH accelerated stability conditions, strips were stable at 40°C and 75% humidity for eight weeks. Furthermore, pharmacokinetic properties of oral strip were compared with rizatriptan benzoate marketed tablet. Oral disintegrating strip and tablet showed significantly higher bioavailability. Oral strip exhibited better pharmacokinetic parameters than rizatriptan marketed tablet. The Tmax, Cmax, AUC and t1/2 for oral strip were found to be 1.00 h, 64.13±19.46 ng/mL, 352.00±71.57 ng/mL/h and 3.09±1.03 h respectively, whereas, tablet showed 1.5 h, 38.00±13.43 ng/mL, 210.38± 40.37ng/mL/h and 1.66±0.31 h respectively. These findings confirm that the rizatriptan benzoate oral disintegrating strip is potentially a useful tool for an effective treatment of migraine with improved bioavailability, rapid onset of action and with increased patient compliance.

  13. Maltodextrin: a novel excipient used in sugar-based orally disintegrating tablets and phase transition process.

    Science.gov (United States)

    Elnaggar, Yosra Shaaban R; El-Massik, Magda A; Abdallah, Ossama Y; Ebian, Abd Elazim R

    2010-06-01

    The recent challenge in orally disintegrating tablets (ODT) manufacturing encompasses the compromise between instantaneous disintegration, sufficient hardness, and standard processing equipment. The current investigation constitutes one attempt to fulfill this challenge. Maltodextrin, in the present work, was utilized as a novel excipient to prepare ODT of meclizine. Tablets were prepared by both direct compression and wet granulation techniques. The effect of maltodextrin concentrations on ODT characteristics--manifested as hardness and disintegration time--was studied. The effect of conditioning (40 degrees C and 75% relative humidity) as a post-compression treatment on ODT characteristics was also assessed. Furthermore, maltodextrin-pronounced hardening effect was investigated using differential scanning calorimetry (DSC) and X-ray analysis. Results revealed that in both techniques, rapid disintegration (30-40 s) would be achieved on the cost of tablet hardness (about 1 kg). Post-compression conditioning of tablets resulted in an increase in hardness (3 kg), while keeping rapid disintegration (30-40 s) according to guidance of the FDA for ODT. However, direct compression-conditioning technique exhibited drawbacks of long conditioning time and appearance of the so-called patch effect. These problems were, yet, absent in wet granulation-conditioning technique. DSC and X-ray analysis suggested involvement of glass-elastic deformation in maltodextrin hardening effect. High-performance liquid chromatography analysis of meclizine ODT suggested no degradation of the drug by the applied conditions of temperature and humidity. Overall results proposed that maltodextrin is a promising saccharide for production of ODT with accepted hardness-disintegration time compromise, utilizing standard processing equipment and phenomena of phase transition.

  14. Design, development, and optimization of orally disintegrating tablets of etoricoxib using vacuum-drying approach.

    Science.gov (United States)

    Patel, Dharmesh; Shah, Mohit; Shah, Sunny; Shah, Tejal; Amin, Avani

    2008-01-01

    Etoricoxib is a cyclooxygenase 2 (COX-2) inhibitor that selectively inhibits the COX-2 enzyme and decreases the incidences of side effects associated with these agents. It is commonly prescribed for acute pain, gouty arthritis, and rheumatoid arthritis. Conventional tablets of etoricoxib are not capable of rapid action, which is required for faster drug effect onset and immediate relief from pain. Thus, the aim of the present investigation is to formulate orally disintegrating tablets (ODTs) of etoricoxib. A combination of the superdisintegrants with a sublimation technique was used to prepare the tablets. Tablets were prepared using a direct compression method employing superdisintegrants such as low substituted hydroxylpropyl methyl cellulose (L-HPMC), low substituted hydroxyl-propyl cellulose (L-HPC), crospovidone, croscarmellose sodium, and sodium starch glycolate. Tablets of etoricoxib prepared using L-HPC exhibited the least friability and disintegration time (approximately 65 s). To decrease the disintegration time further, a sublimation technique was used along with the superdisintegrants for the preparation of ODTs. The use of sublimating agents including camphor, menthol, and thymol was explored. The addition of camphor lowered the disintegration time (approximately 30 s) further, but the percent friability was increased. A 3(2) full factorial design was employed to study the joint influence of the amount of superdisintegrant (L-HPC) and the amount of sublimating agent (camphor) on the percent of friability and the disintegration time. The results of multiple linear regression analysis revealed that for obtaining an effective ODT of etoricoxib, higher percentages of L-HPC and camphor should be used. Checkpoint batches were prepared to validate the evolved mathematical model. A response surface plot is also presented to graphically represent the effect of the independent variables on the percent of friability and the disintegration time. The approach using

  15. Formulation of cyclodextrin inclusion complex-based orally disintegrating tablet of eslicarbazepine acetate for improved oral bioavailability

    Energy Technology Data Exchange (ETDEWEB)

    Desai, Samixa; Poddar, Aditi; Sawant, Krutika, E-mail: dr_krutikasawant@yahoo.co.in

    2016-01-01

    The present investigation was aimed towards developing a beta-cyclodextrin (β-CD) solid dispersion (SD) based orally disintegrating tablet (ODT) of eslicarbazepine acetate (ESL), for improving the dissolution and providing fast onset of anti-epileptic action. Optimum ratio of ESL and β-CD was determined by Job's plot. Thereafter, solid dispersions were prepared by solvent evaporation method and evaluated for yield, assay, Differential scanning calorimetry (DSC), Fourier transform infra red spectroscopy (FTIR), X-ray diffraction (XRD), and in vitro dissolution. Optimized SD was compressed into ODT by direct compression using super disintegrants and evaluated for wetting time, drug content, in vitro drug release and in vivo studies. The results of DSC, FTIR and XRD analysis supported the formation of inclusion complex. An improved dissolution with 99.95 ± 2.80% drug release in 60 min was observed in comparison to 24.85 ± 2.96% release from a plain drug suspension. Tablets with crosspovidone as a super disintegrant showed the least disintegration time of 24.66 ± 1.52 s and higher in vitro drug release against marketed tablets. In vivo studies indicated that the formulated tablets had 2 times higher bioavailability than marketed tablets. Thus, the developed β-CD–ESL SD-ODT could provide faster onset of action and higher bioavailability, which would be beneficial in case of epileptic seizures. - Highlights: • β-cyclodextrin–eslicarbazepine acetate complex developed with enhanced solubility. • Formulated Orally disintegrating tablets (ODT) disintegrated within 30 s. • Bioavailability from ODT was 2 times higher than marketed tablets. • Onset of action for ODT was also faster than marketed tablets. • Formulated ODT would aid epileptic patients incapable of swallowing tablets.

  16. Risperidone oral disintegrating mini-tablets: A robust-product for pediatrics

    Directory of Open Access Journals (Sweden)

    El-Say Khalid M.

    2015-12-01

    Full Text Available This study was aimed at developing risperidone oral disintegrating mini-tablets (OD-mini-tablets as age-appropriate formulations and to assess their suitability for infants and pediatric use. An experimental Box-Behnken design was applied to assure high quality of the OD-mini-tablets and reduce product variability. The design was employed to understand the influence of the critical excipient combinations on the production of OD-mini-tablets and thus guarantee the feasibility of obtaining products with dosage form uniformity. The variables selected were mannitol percent in Avicel (X1, swelling pressure of the superdisintegrant (X2, and the surface area of Aerosil as a glidant (X3. Risperidone-excipient compatibilities were investigated using FTIR and the spectra did not display any interaction. Fifteen formulations were prepared and evaluated for preand post-compression characteristics. The prepared ODmini- tablet batches were also assessed for disintegration in simulated salivary fluid (SSF, pH 6.2 and in reconstituted skimmed milk. The optimized formula fulfilled the requirements for crushing strength of 5 kN with minimal friability, disintegration times of 8.4 and 53.7 s in SSF and skimmed milk, respectively. This study therefore proposes the risperidone OD-mini-tablet formula having robust mechanical properties, uniform and precise dosing of medication with short disintegration time suitable for pediatric use.

  17. Impact of active ingredients on the swelling properties of orally disintegrating tablets prepared by microwave treatment.

    Science.gov (United States)

    Sano, Syusuke; Iwao, Yasunori; Kimura, Susumu; Noguchi, Shuji; Itai, Shigeru

    2014-07-01

    The impact of different active pharmaceutical ingredients (APIs) loading on the properties of orally disintegrating tablets (ODTs) prepared according to our previously reported microwave (MW) treatment process was evaluated using famotidine (FAM), acetaminophen (AAP), and ibuprofen (IBU). None of the APIs interrupted the tablet swelling during the MW treatment and the tablet hardness were improved by more than 20 N. MW treatment, however, led to a significant increase in the disintegration time of the ODTs containing IBU, but it had no impact on that of the ODTs containing FAM or AAP. This increased disintegration time of the ODTs containing IBU was attributed to the relatively low melting point of IBU (Tm=76 °C), with the IBU particles melting during the MW treatment to form agglomerates, which interrupted the penetration of water into the tablets and delayed their disintegration. The effects of the MW treatment on the chemical stability and dissolution properties of ODTs were also evaluated. The results revealed that MW treatment did not promote the degradations of FAM and AAP or delay their release from the ODTs, while dissolution of the ODTs containing IBU delayed by MW treatment. Based on these results, the MW method would be applicable to the preparation of ODTs containing APIs with melting points higher than 110 °C. Copyright © 2014 Elsevier B.V. All rights reserved.

  18. Part III: the convenience of, and patient preference for, zolmitriptan orally disintegrating tablet.

    Science.gov (United States)

    Dowson, Andrew J; Almqvist, Per

    2005-01-01

    As part of an optimal strategy for the management of migraine, the individual needs and preferences of patients need to be considered when of patients need to be considered when prescribing treatments. Zolmitriptan has been available as a conventional oral tablet for more than seven years, and is established as a highly effective, well-tolerated compound for the acute treatment of migraine. A bioequivalent, orally disintegrating tablet (ODT) of zolmitriptan, which dissolves on the tongue without the need for additional fluid intake, has been developed. In a study designed to compare patient preference for zolmitriptan ODT and conventional oral sumatriptan tablets, > 60% of the 186 patients questioned had an overall preference for zolmitriptan ODT, with > 80% of patients reporting that this was the more convenient and less disruptive therapy to take. Approximately 90% of patients agreed that, unlike a conventional tablet, zolmitriptan ODT can be taken wherever and whenever a migraine occurs. When patient preference for zolmitriptan ODT and the ODT formulation of rizatriptan was compared in 171 migraineurs, 70% had an overall preference for zolmitriptan ODT to be superior to rizatriptan ODT with respect to taste and aftertaste, as well as packaging. In summary, not only is zolmitriptan ODT a convenient tablets, such as the sumatriptan oral tablet, but patients generally consider it to be a more attractive option for the acute treatment of migraine than the orally disintegrating version of rizatriptan.

  19. Development of aprepitant loaded orally disintegrating films for enhanced pharmacokinetic performance.

    Science.gov (United States)

    Sharma, Radhika; Kamboj, Sunil; Singh, Gursharan; Rana, Vikas

    2016-03-10

    The present investigation was aimed to prepare orally disintegrating films (ODFs) containing aprepitant (APT), an antiemetic drug employing pullulan as film forming agent, tamarind pectin as wetting agent and liquid glucose as plasticizer and solubiliser. The ODFs were prepared using solvent casting method. The method was optimized employing 3(2) full factorial design considering proportion of pullulan: tamarind pectin and concentration of liquid glucose as independent variables and disintegration time, wetting time, folding endurance, tensile strength and extensibility as dependent variables. The optimized ODF was evaluated for various physicochemical, mechanical, drug release kinetics and bioavailability studies. The results suggested prepared film has uniform film surface, non-sticky and disintegrated within 18s. The in-vitro release kinetics revealed more than 87% aprepitant was released from optimized ODF as compared to 85%, 49%, and 12% aprepitant release from marketed formulation Aprecap, micronized aprepitant and non micronized aprepitant, respectively. The results of animal preference study indicated that developed aprepitant loaded ODFs are accepted by rabbits as food material. Animal pharmacokinetic (PK) study showed 1.80, 1.56 and 1.36 fold enhancement in relative bioavailability for aprepitant loaded ODF, Aprecap and micronized aprepitant respectively, in comparison with non-micronized aprepitant. Overall, the solubilised aprepitant when incorporated in the form of aprepitant loaded ODF showed enhanced bioavailability as compared to micronized/non-micronized aprepitant based oral formulations. These findings suggested that aprepitant loaded ODF could be effective for antiemesis during cancer chemotherapy.

  20. Development and characterization of orally-disintegrating films for propolis delivery

    Directory of Open Access Journals (Sweden)

    Josiane Gonçalves Borges

    2013-02-01

    Full Text Available This study aimed at evaluating the effect of different concentrations of hydrolyzed collagen (HC on the properties of an orally disintegrating film containing propolis ethanol extract (PEE as an active component. The films were evaluated in terms of total phenols, mechanical properties, solubility, contact angle, disintegration time, and microstructure. The films were prepared by casting with 2 g of protein mass (gelatin and HC, 30 g of sorbitol/100 g of protein mass, and 100 g of PEE/100 g of protein mass. HC was incorporated at concentrations of 0, 10, 20, and 30 g/100 g of protein mass. It was found that increased concentrations of HC reduced tensile strength and increased elongation; however, all films showed plastic behavior. An increase in solubility at 25 ºC, a reduction in the contact angle, and disintegration time were also observed. Thus, higher concentrations of collagen led to more hydrophilic and more soluble polymeric matrices that showed shorter dissolution time, favoring the use of these materials as carriers for active compounds to be delivered in the oral cavity.

  1. [Technical scheme of real-time evaluation of traditional Chinese medicine orally disintegrating tablets].

    Science.gov (United States)

    Qin, Dong; Chen, Xu-dong; Feng, Liang; Gu, Jun-fei; Yuan, Jia-rui; Jia, Xiao-bin

    2014-12-01

    Orally disintegrating tablets (ODT), a kind of new solid tablet that rapidly disintegrates to work in the mouth, has became the hot form of new drug research in recent years with many advantages, such as the convenient taking, a widely applicable people, fast acting, high bioavailability, good compliance, and so on. ODT has been widely used in chemical medicines, while the application of it in traditional Chinese medicines (TCMs) is still in the stage of development The development of TCMs ODT provides a new direction for the research of Chinese medicine new dosage, accelerates the pace of connecting to the world and modernization of Chinese medicine. This dosage has a broad market prospect, and its quality control and assessment standards, taste, the disintegration time in vitro and evaluation method are the key factors that affect the industrialization, standardization of Chinese medicine ODT. Therefore, this paper reviewed the characteristics, preparation, taste masking technology and quality evaluation with new technology of ODT. Meantime, numerous application examples of ODT used in traditional Chinese medicine were described. We expect to provide the reference and utilization for the development of traditional Chinese medicine orally disinteeratine tablets.

  2. New perspective to develop memantine orally disintegrating tablet formulations: SeDeM expert system.

    Science.gov (United States)

    Gülbağ, Sıla; Yılmaz Usta, Duygu; Gültekin, Hazal E; Oktay, Ayşe N; Demirtaş, Özden; Karaküçük, Alptuğ; Çelebi, Nevin

    2017-07-18

    Nowadays pharmaceutical industries and regulatory authorities suggest new approaches such as Quality by Design principles to reduce experiments of formulation studies, improve product quality, save cost and time. SeDeM Expert System is a predictive approach for the preformulation studies and it provides information about suitability of API for direct compression by evaluating 12 parameters. The system also allows selecting appropriate excipients by determining same parameters to improve compressibility of API. The objective of this study was to develop direct compressed memantine orally disintegrating tablets using SeDeM Expert System. Memantine was found to have poor flow and compressibility properties. Three different direct compressibility and super disintegrating agents (Ludiflash(®), Ludipress(®) and Parteck(®)) were used to improve compressibility of memantine and according to SeDeM diagrams, Parteck(®) was selected for final formulation. Memantine direct compressed tablets showed proper friability, hardness and thickness. The disintegration time of the tables were found below 15 s which was suitable for ODTs. It was found that SeDeM Expert System was easy to use and application of this method provided to develop memantine direct compressed ODT formulation was successful.

  3. Lyophilized mucoadhesive-dendrimer enclosed matrix tablet for extended oral delivery of albendazole.

    Science.gov (United States)

    Mansuri, Shakir; Kesharwani, Prashant; Tekade, Rakesh Kumar; Jain, Narendra Kumar

    2016-05-01

    Dendrimers are multifunctional carriers widely employed for delivering drugs in a variety of disease conditions including HIV/AIDS and cancer. Albendazole (ABZ) is a commonly used anthelmintic drug in human as well as veterinary medicine. In this investigation, ABZ was formulated as a "muco-dendrimer" based sustained released tablet. The mucoadhesive complex was synthesized by anchoring chitosan to fifth generation PPI dendrimer (Muco-PPI) and characterized by UV, FTIR, (1)H NMR spectroscopy and electron microscopy. ABZ was entrapped inside Muco-PPI followed by lyophilization and tableting as matrix tablet. A half-life (t1/2) of 8.06±0.15, 8.17±0.47, 11.04±0.73, 11.49±0.92, 12.52±1.04 and 16.9±1.18h was noted for ABZ (free drug), conventional ABZ tablet (F1), conventional ABZ matrix tablet (F2), PPI-ABZ complex, PPI-ABZ matrix tablet (F3) and Muco-PPI-ABZ matrix tablet (F4), respectively. Thus the novel mucoadhesive-PPI based formulation of ABZ (F4) increased the t1/2 of ABZ significantly by almost twofold as compared to the administration of free drug. The in vivo drug release data showed that the Muco-PPI based formulations have a significantly higher Cmax (2.40±0.02μg/mL) compared with orally administered free ABZ (0.19±0.07μg/mL) as well as conventional tablet (0.20±0.05μg/mL). In addition, the Muco-PPI-ABZ matrix tablet displayed increased mean residence time (MRT) and is therefore a potential candidate to appreciably improve the pharmacokinetic profile of ABZ.

  4. Use of Orally Disintegrating Olanzapine During Electroconvulsive Therapy for Prevention of Postictal Agitation.

    Science.gov (United States)

    Hermida, Adriana P; Janjua, A Umair; Tang, Yilang; Syre, Sharyn R; Job, Gregory; McDonald, William M

    2016-11-01

    A major medical problem for patients undergoing electroconvulsive therapy (ECT) is the occurrence of postictal agitation (PIA). This phenomenon is associated with confusion and disorientation that can have severe clinical implications for the safety of the patient and health care professionals. Many different pharmacological strategies have been used to prevent PIA. We present data on 40 patients who suffered from PIA after a course of ECT and evaluate the prophylactic use of orally disintegrating olanzapine in the prevention of PIA in subsequent ECT treatments.

  5. Preparation of puerarin orally disintegrating tablets%葛根素口腔崩解片的研制

    Institute of Scientific and Technical Information of China (English)

    向程

    2015-01-01

    Objective To develop oral disintegrating tablets with puerarin as themodeldrug .Methods The develop-ment selected the disintegration time and sedimentation volume ratio as an indicator .Screened tablet formulation consisting and process of single factor method .Optimized the preparation process .Results Puerarin orally disintegrating tablets were pre-pared by lyopyilization,containing the inactive ingredient:mannitol,gelatin,aspartame and mint flavor.The prepared tablets tas-ted fine and could disintegrate in 4s.The in vitro dissolution test indicated that 96.46%of puerarin dissolved in 4 minutes from the oral disintegrating tablets .Conclusion The prepared of puerarin oral disintegrating tablets disintegrated rapidly in oral cavity,the process of preparation is feasible .%目的:以葛根素为模型药物制备口腔崩解片。方法该研制把崩解时间及沉降容积比为指标,单因素法筛选片剂的处方组成及工艺,并优化制备工艺。结果葛根素口腔崩解片的辅料为甘露醇、明胶、阿司帕坦与薄荷香精,经过冷冻干燥方法制备,口感良好,4s的崩解时间,在4min内体外溶出度达96.46%。结论葛根素口腔崩解片可迅速崩解于口腔内,制备工艺可行。

  6. Preparation and evaluation of swelling induced-orally disintegrating tablets by microwave irradiation.

    Science.gov (United States)

    Sano, Syusuke; Iwao, Yasunori; Kimura, Susumu; Itai, Shigeru

    2011-09-15

    A major challenge in the development of orally disintegrating tablets (ODTs) is to achieve a good balance between tablet hardness and disintegration time. In this study, an advanced method was demonstrated to improve these opposing properties in a molded tablet using a one-step procedure that exploits the swelling induced by microwave treatment. Wet molded tablets consisting of the delta form of mannitol and silicon dioxide were prepared and microwave-heated to generate water vapor inside the tablets. This induced either swelling or shrinking of tablets, in the extent of each being dependent on tablet formulation and manufacturing conditions. A two-level full factorial design method was used to evaluate the effects of several variables in formulation and manufacturing conditions on the tablet properties, hardness, disintegration time and change in shape. The variables investigated in this study were: ratio of silicon dioxide in formulation, water volume added in granulation, ratio of water absorbed by silicon dioxide prior to granulation, and microwave irradiation time. Swelling of tablet by microwave irradiation was observed in the batches with high ratio of silicon dioxide and low levels of water volume. The disintegration time was clearly shortened by induction of the swelling, while tablet hardness increased. We demonstrated that the water vapor generated by microwave irradiation promoted a change in the crystalline form of mannitol from delta to beta, and that this may have contributed to an increase in tablet hardness. Additionally, it was found that new solid bridges were formed between the granules in the tablet via the pathway from dissolution of mannitol in water vapor to congelation, resulting in an increase in tablet hardness. Thus, both tablet hardness and disintegration properties of the molded tablets were improved by the proposed one-step method and the appropriate ranges for variables are indicated. In addition, multiple regression modeling was

  7. Self-Nanoemulsifying Lyophilized Tablets for Flash Oral Transmucosal Delivery of Vitamin K: Development and Clinical Evaluation.

    Science.gov (United States)

    El-Say, Khalid M; Ahmed, Tarek A; Ahmed, Osama A A; Hosny, Khaled M; Abd-Allah, Fathy I

    2017-09-01

    Owing to limited solubility, vitamin K undergoes low bioavailability with large inter-individual variability after oral administration. This article aimed to prepare self-nanoemulsifying lyophilized tablets (SNELTs) for the flash oral transmucosal delivery of vitamin K. Twenty-one formulae of vitamin K self-nanoemulsifying drug delivery systems (SNEDDS) were prepared using different concentrations of vitamin K, Labrasol, and Transcutol according to mixture design. The SNEDDS was loaded on porous carriers and formulated as lyophilized tablets. The release profile and the pharmacokinetic parameters of vitamin K SNELTs were evaluated in comparison with commercial tablets and ampoules on human volunteers. Results revealed that the optimized SNEDDS showed the smallest and most stable nanoemulsion globules. SNELTs were prepared successfully and showed substantial superiority drug release compared with the commercial tablets. Interestingly, SNELTs enhanced both rate and extent of vitamin K absorption as well as relative bioavailability (169.67%) in healthy subjects compared with the commercial tablets. SNELTs revealed promising no significant difference in the area under the curve compared with the commercial intramuscular injection. SNELTs enhanced dissolution and bioavailability that expected to have the strong impact on the efficiency of vitamin K in the prophylaxis and treatment of bleeding disorders in patients with hepatic dysfunction. Copyright © 2017 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.

  8. Formulation,Optimization and Evaluation of Orally Disintegrating Tablet of Non-Steroidal Anti-inflammatory Drug

    Directory of Open Access Journals (Sweden)

    Patel Minal Arvindbhai

    2012-05-01

    Full Text Available Piroxicam is a non steroidal anti-inflammatory drug with analgesic properties. The purpose of this studywas to develop a taste masked orally disintegrating tablet of poorly soluble Piroxicam by directcompression technique with β-cyclodextrin (ß-CD complexes using various superdisintegrants likesodium starch glycolate, crospovidone XL and croscarmellose sodium. Complex was characterizedusing infrared spectroscopy, differential scanning calorimetry, % drug release study, gustatoryevaluation for taste masking. A 32 full factorial design was applied to systematically optimize the drugdisintegration time. The concentration of Crospovidone (X1 and concentration of Croscarmellose (X2were selected as independent variables. The Disintegration time (Y1 and Wetting time (Y2 wereselected as dependent variables. The prepared tablets were evaluated for hardness, friability,disintegration time, wetting time and In-vitro drug release. FT-IR studies and physical compatibilitystudy were conducted for drug, and drug excipient mixture for interactions if any. The differentformulations showed disintegration time between 12 to 58 sec. The results indicated that concentrationof Crospovidone (X1 and concentration of Croscarmellose (X2 significantly affected theDisintegration time (Y1 and Wetting time (Y2. Regression analysis and numerical optimization wereperformed to identify the best formulation. Formulation F10 prepared with croscarmellose (4.23% &crospovidone (6.74% was found to be the best formulation with disintegration time 16 sec, wetting time21 sec and % drug release in 10 min 94.23%.

  9. Taste Masked Orally Disintegrating Pellets of Antihistaminic and Mucolytic Drug: Formulation, Characterization, and In Vivo Studies in Human.

    Science.gov (United States)

    Taj, Yasmeen; Pai, Roopa S; Kusum Devi, V; Singh, Gurinder

    2014-01-01

    The main aim of the present study was to evaluate the potential of orally disintegrating pellets (ODPs) as an approach for taste masking of bitter drugs, namely, Ambroxol hydrochloride (A-HCl) and Cetirizine dihydrochloride (C-DHCl). Pellets were prepared by extrusion/spheronization with Eudragit EPO, kyron T-134, Kyron T-314, mannitol, sorbitol, MCC (Avicel PH-101), sucralose, chocolate flavor, and 5% xanthum gum. The prepared pellets were characterized for percentage yield, drug content, particle size, in vitro drug release, and in vivo evaluation on humans for taste, mouth feel, and in vivo disintegration time. The results revealed that the average size of pellets was influenced greatly by the percentage of binder and extrusion speed. The optimized ODPs disintegrated in less than 20 s and showed more than 98% of drugs in ODPs dissolved within 15 min. Taste perception study was carried out on human volunteers to evaluate the taste masking ability of ODPs for taste, mouth feel, and in vivo disintegration time. Crystalline state evaluation of drugs in the optimized ODPs was conducted for X-ray powder diffraction. In conclusion, the study confirmed that ODPs can be utilized as an alternative approach for effective taste masking and rapid disintegration in the oral cavity.

  10. Taste Masked Orally Disintegrating Pellets of Antihistaminic and Mucolytic Drug: Formulation, Characterization, and In Vivo Studies in Human

    Science.gov (United States)

    Taj, Yasmeen; Pai, Roopa S.; Kusum Devi, V.; Singh, Gurinder

    2014-01-01

    The main aim of the present study was to evaluate the potential of orally disintegrating pellets (ODPs) as an approach for taste masking of bitter drugs, namely, Ambroxol hydrochloride (A-HCl) and Cetirizine dihydrochloride (C-DHCl). Pellets were prepared by extrusion/spheronization with Eudragit EPO, kyron T-134, Kyron T-314, mannitol, sorbitol, MCC (Avicel PH-101), sucralose, chocolate flavor, and 5% xanthum gum. The prepared pellets were characterized for percentage yield, drug content, particle size, in vitro drug release, and in vivo evaluation on humans for taste, mouth feel, and in vivo disintegration time. The results revealed that the average size of pellets was influenced greatly by the percentage of binder and extrusion speed. The optimized ODPs disintegrated in less than 20 s and showed more than 98% of drugs in ODPs dissolved within 15 min. Taste perception study was carried out on human volunteers to evaluate the taste masking ability of ODPs for taste, mouth feel, and in vivo disintegration time. Crystalline state evaluation of drugs in the optimized ODPs was conducted for X-ray powder diffraction. In conclusion, the study confirmed that ODPs can be utilized as an alternative approach for effective taste masking and rapid disintegration in the oral cavity. PMID:27379290

  11. Fast disintegrating tablets: Opportunity in drug delivery system

    Directory of Open Access Journals (Sweden)

    Ved Parkash

    2011-01-01

    Full Text Available Fast disintegrating tablets (FDTs have received ever-increasing demand during the last decade, and the field has become a rapidly growing area in the pharmaceutical industry. Oral drug delivery remains the preferred route for administration of various drugs. Recent developments in the technology have prompted scientists to develop FDTs with improved patient compliance and convenience. Upon introduction into the mouth, these tablets dissolve or disintegrate in the mouth in the absence of additional water for easy administration of active pharmaceutical ingredients. The popularity and usefulness of the formulation resulted in development of several FDT technologies. FDTs are solid unit dosage forms, which disintegrate or dissolve rapidly in the mouth without chewing and water. FDTs or orally disintegrating tablets provide an advantage particularly for pediatric and geriatric populations who have difficulty in swallowing conventional tablets and capsules. This review describes various formulations and technologies developed to achieve fast dissolution/dispersion of tablets in the oral cavity. In particular, this review describes in detail FDT technologies based on lyophilization, molding, sublimation, and compaction, as well as approaches to enhancing the FDT properties, such as spray drying and use of disintegrants. In addition, taste-masking technologies, experimental measurements of disintegration times, and dissolution are also discussed.

  12. Formulation, development and evaluation of patient friendly dosage forms of metformin, Part-I: Orally disintegrating tablets

    OpenAIRE

    Mohapatra Ashutosh; Parikh Rajesh; Gohel Mukesh

    2008-01-01

    Metformin hydrochloride is an orally administered antihyperglycemic agent, used in the management of non-insulin-dependant (type-2) diabetes mellitus. Difficulty in swallowing (dysphagia) is common among all age groups, especially in elderly and pediatrics. Unfortunately, a high percentage of patients suffering from type-2 diabetes are elderly people showing dysphagia. In this study, orally disintegrating tablets were prepared using direct compression and wet granulation method. First, the ta...

  13. Olanzapine orally-disintegrating tablet in severe psychotic agitation: a naturalistic study.

    Science.gov (United States)

    Pascual, J C; Pérez, V; Martín, J L R; Safont, G; Puigdemont, D; Alvarez, E

    2007-01-01

    This study was conducted to determine effectiveness and safety of olanzapine in patients with severe agitation. A naturalistic, open-label study in 80 acutely agitated psychotic patients visited in our psychiatric emergency department. Patients received either a 20-mg olanzapine orally-disintegrating tablet or conventional treatment depending on attending psychiatrist's preference. Efficacy was assessed by the Excitement Component of the Positive and Negative Syndrome Scale (PANSS-EC), the Agitation-Calmness Evaluation Scale (ACES) and pragmatic variables (second pharmacological intervention and need for physical restraints). 60 % patients completed a 6 hour trial. Both groups showed a significant reduction in mean PANSS-EC score. The olanzapine-treated group showed statistically significant improvements: PANSS-EC (F=122.9; df=2.4; p=0.000), ACES (F=68.2; df=2.8; p=0.000). Treatment was well-tolerated and no serious side-effects were observed. In this naturalistic study in patients with severe agitation, 20-mg oral olanzapine was effective, rapid and safe.

  14. Formulation strategy and evaluation of nanocrystal piroxicam orally disintegrating tablets manufacturing by freeze-drying.

    Science.gov (United States)

    Lai, Francesco; Pini, Elena; Corrias, Francesco; Perricci, Jacopo; Manconi, Maria; Fadda, Anna Maria; Sinico, Chiara

    2014-06-05

    Piroxicam (PRX) is a non-steroidal anti-inflammatory drug characterized by a poor water solubility and consequently by a low oral bioavailability. In this work, different nanocrystal orally disintegrating tablets (ODT) were prepared to enhance piroxicam dissolution rate and saturation solubility. PRX nanocrystals were prepared by means of high pressure homogenization technique using poloxamer 188 as stabilizer. Three different ODTs were prepared with the same nanosuspension using different excipients in order to study their effect on the PRX dissolution properties. PRX nanocrystal size and zeta potential were determined by photon correlation spectroscopy. Additional characterization of PRX nanocrystal ODT was carried out by infrared spectroscopy, X-ray powder diffractometry, differential scanning calorimetry. Dissolution study was performed in distilled water (pH 5.5) and compared with PRX coarse suspension ODT, PRX/poloxamer 188 physical mixture, bulk PRX samples and a PRX commercial ODT. All PRX nanocrystal ODT formulations showed a higher drug dissolution rate than coarse PRX ODT. PRX nanocrystal ODT prepared using gelatin or croscarmellose as excipient showed a higher PRX dissolution rate compared with the commercial formulation and ODT prepared using xanthan gum. Overall results confirmed that improved PRX dissolution rate is due to the increased surface-to-volume ratio due to the nanosized drug particle but also revealed the important role of different excipients used.

  15. Optimization of Jiawei Qing'e Oral Fast Disintegrating Tablets Based on Response Surface-Central Composite Design

    Institute of Scientific and Technical Information of China (English)

    ZHANG Wei-ling; WANG Ya-jing; GAO Xiu-mei; GAO Xu; PENG Shu-juan; ZHENG Yin; OKEKE Chukwunweike Ikechukwu

    2013-01-01

    Objective To apply the response surface-central composite design to developing and optimizing the oral fast disintegrating tablets (ODT) formulation for Jiawei Qing'e,a kind of prescription of Chinese herbal medicine.Methods The bitterness of Jiawei Qing'e was masked using Eudragit E-100 by solvent evaporation technique.Response surface approach was applied to investigating the interaction of formulation parameters in optimizing the formulation.The independent variables were Eudragit E-100/drug ratio (X1),amount of disintegrants (X2),and the amount of diluents (X3).The disintegration time (Y1),hardness (Y2),and weight variations of the tablets were characterized.Results The models predicted levels ofX1 =4.63%,X2 =5.25%,and X3 =34.33%,for the optimal formulation having a hardness of 3.0 kg with the disintegration time of 30 s within experimental region.The observed response of Y1 =26.5 s and Y2 =3.14 kg reasonably agreed with the predicted response.Conclusion Response surface methodology shows the good predictability and reliability in optimizing the formulation.The optimized ODT of Jiawei Qing'e has acceptable taste,rapid disintegrating ability,and good mechanical strength.

  16. Development of taste masked fast disintegrating films of levocetirizine dihydrochloride for oral use.

    Science.gov (United States)

    Mahesh, A; Shastri, Nalini; Sadanandam, M

    2010-01-01

    Fast disintegrating films of levocetirizine dihydrochloride useful for the treatment of acute allergic rhinitis and chronic urticaria have been developed by using the taste masking ability of cyclodextrins. The fast disintegrating films were prepared by solvent casting method. The films contained water-soluble polymers such as Kollicoat IR or pullulan, aspartame and sucralose as sweeteners and pre-gelatinized starch as disintegrant. Levocetirizine dihydrochloride was incorporated into these films by in-situ complex formation with hydroxy propyl beta-cyclodextrin. The optimized films were evaluated for weight variation, film thickness, folding endurance, tackiness, tensile strength, assay, content uniformity, in vitro disintegration and dissolution, in vivo disintegration and taste masking ability by human gustatory sensation test. Results revealed that the organoleptic properties of levocetirizine dihydrochloride were improved by complexation with hydroxy propyl beta-cyclodextrin and the complex could be successfully formulated into a fast disintegrating film.

  17. Bioequivalence of ondansetron oral soluble film 8 mg (ZUPLENZ) and ondansetron orally disintegrating tablets 8 mg (ZOFRAN) in healthy adults.

    Science.gov (United States)

    Dadey, Eric

    2015-01-01

    Oral formulations of ondansetron are used to prevent nausea and vomiting associated with chemotherapy, radiotherapy, and surgery. An oral soluble film formulation of ondansetron (OND OSF) was developed using MonoSol Rx's proprietary PharmFilm technology and was formulated to dissolve rapidly on the tongue, without the need for water. This product provides an oral antiemetic treatment option for patients who experience difficulty swallowing. The purpose of this study was to compare the bioequivalence of OND OSF 8 mg (ZUPLENZ, Monosol Rx, Warren, NJ) with ondansetron orally disintegrating tablets (OND ODT) 8 mg (ZOFRAN, GlaxoSmithKline, Research Triangle Park). In 3 individual open-label, randomized studies, healthy adult subjects received a single dose of OND OSF 8 mg and a single dose of OND ODT 8 mg, under fasted conditions (study 1, n = 48), fed conditions (study 2, n = 48), and fasted with and without water (study 3, n = 18). Each dosing period was followed by a 3- or 7-day washout period. Ondansetron pharmacokinetics were assessed predose to 24 hours postdose for the single 8-mg doses of OND OSF and OND ODT. All analyses were conducted on natural log-transformed pharmacokinetic parameters for OND OSF and OND ODT. Under both fasted and fed conditions, the 90% confidence interval for the comparisons of OND OSF and OND ODT plasma ondansetron area under the curve from time 0 to the last measured concentration (AUC0-t), area under the concentration vs. time curve from time 0 to infinity (AUC0-∞), and maximum plasma concentration (Cmax) were within the 80%-125% range, indicating bioequivalence between the formulations. With features designed to make it portable and easy to take, OND OSF 8 mg provides an alternative treatment option, particularly for patients with dysphagia and others who find it difficult to take oral tablets.

  18. Clinical utility of orally disintegrating olanzapine in Chinese patients with schizophrenia: a review of effectiveness, patient preference, adherence, and other properties

    Directory of Open Access Journals (Sweden)

    Zhao J

    2014-02-01

    Full Text Available Jingping Zhao,1 Jianjun Ou,1 Haibo Xue,2 Li Liu,2 William Montgomery,3 Tamas Treuer4 1Mental Health Institute of The Second Xiangya Hospital, Hunan Province Technology Institute of Psychiatry, Key Laboratory of Psychiatry and Mental Health of Hunan Province, Central South University, Changsha, Hunan, 2Lilly Suzhou Pharmaceutical Co, Ltd, Jiangsu, People's Republic of China; 3Global Health Outcomes, Eli Lilly and Company, Sydney, Australia; 4Emerging Markets Business Unit (Neuroscience, Eli Lilly and Company, Budapest, Hungary Abstract: The primary objective of this systematic review was to examine the evidence for the efficacy, effectiveness, and safety of orally disintegrating olanzapine in Chinese populations. A systematic literature search was conducted using databases covering international and Chinese journals, ClinicalTrials.gov, and internal and external trial registries at Eli Lilly and Company using search terms related to target countries (People's Republic of China, Hong Kong, and Taiwan and orally disintegrating olanzapine treatment. A publication and one clinical study report were retrieved. The clinical study showed orally disintegrating olanzapine and the standard oral tablet to have similar efficacy and tolerability profiles. A bioequivalence study has shown that orally disintegrating olanzapine and the standard oral tablet have similar pharmacokinetic profiles. Orally disintegrating olanzapine and the standard oral tablet have similar efficacy and tolerability profiles. Keywords: orally disintegrating, olanzapine, Chinese, schizophrenia, patients

  19. Taste Masked Orally Disintegrating Pellets of Antihistaminic and Mucolytic Drug: Formulation, Characterization, and In Vivo Studies in Human

    OpenAIRE

    Taj, Yasmeen; Pai, Roopa S.; V. Kusum Devi; Singh, Gurinder

    2014-01-01

    The main aim of the present study was to evaluate the potential of orally disintegrating pellets (ODPs) as an approach for taste masking of bitter drugs, namely, Ambroxol hydrochloride (A-HCl) and Cetirizine dihydrochloride (C-DHCl). Pellets were prepared by extrusion/spheronization with Eudragit EPO, kyron T-134, Kyron T-314, mannitol, sorbitol, MCC (Avicel PH-101), sucralose, chocolate flavor, and 5% xanthum gum. The prepared pellets were characterized for percentage yield, drug content, pa...

  20. Taste Masked Orally Disintegrating Pellets of Antihistaminic and Mucolytic Drug: Formulation, Characterization, and In Vivo Studies in Human

    OpenAIRE

    Taj, Yasmeen; Pai,Roopa S.; V Kusum Devi; Singh,Gurinder

    2014-01-01

    The main aim of the present study was to evaluate the potential of orally disintegrating pellets (ODPs) as an approach for taste masking of bitter drugs, namely, Ambroxol hydrochloride (A-HCl) and Cetirizine dihydrochloride (C-DHCl). Pellets were prepared by extrusion/spheronization with Eudragit EPO, kyron T-134, Kyron T-314, mannitol, sorbitol, MCC (Avicel PH-101), sucralose, chocolate flavor, and 5% xanthum gum. The prepared pellets were characterized for percentage yield, drug content, pa...

  1. Enhancement of Solubility of Lamotrigine by Solid Dispersion and Development of Orally Disintegrating Tablets Using 32 Full Factorial Design

    Directory of Open Access Journals (Sweden)

    Jatinderpal Singh

    2015-01-01

    Full Text Available Present investigation deals with the preparation and evaluation of orally disintegrating tablets (ODTs of lamotrigine using β-cyclodextrin and PVP-K30 as polymers for the preparation of solid dispersion which help in enhancement of aqueous solubility of this BCS CLASS-II drug and sodium starch glycolate (SSG and crospovidone as a superdisintegrating agent, to reduce disintegration time. The ODTs were prepared by direct compression method. Nine formulations were developed with different ratios of superdisintegrating agents. All the formulations were evaluated for disintegration time, weight variation, hardness, friability, drug content uniformity, wetting time, and in vitro drug release study. In vitro drug release study was performed using United States Pharmacopoeia (USP type 2 dissolution test apparatus employing paddle stirrer at 50 rpm using 900 mL of 0.1 N HCl maintained at 37°C ± 0.5°C as the dissolution medium. On the basis of evaluation parameters formulations were prepared using β-CD 1 : 1 solid dispersion. Then 32 full factorial design was applied using SSG and crospovidone in different ratios suggested by using design expert 8.0.7.1 and optimized formulation was prepared using amount of SSG and crospovidone as suggested by the software. The optimized formulation prepared had disintegrating time of 15 s, wetting time of 24 s, and % friability of 0.55.

  2. Formulation, development and evaluation of patient friendly dosage forms of metformin, Part-I: Orally disintegrating tablets

    Directory of Open Access Journals (Sweden)

    Mohapatra Ashutosh

    2008-01-01

    Full Text Available Metformin hydrochloride is an orally administered antihyperglycemic agent, used in the management of non-insulin-dependant (type-2 diabetes mellitus. Difficulty in swallowing (dysphagia is common among all age groups, especially in elderly and pediatrics. Unfortunately, a high percentage of patients suffering from type-2 diabetes are elderly people showing dysphagia. In this study, orally disintegrating tablets were prepared using direct compression and wet granulation method. First, the tablets of metformin were prepared using starch RX1500 and microcrystalline cellulose by direct compression. The tablets showed erosion behavior rather than disintegration. Then lactose was incorporated which created pores to cause burst release of drug. But these tablets did not give good mouth feel. Thus, Pearlitol SD 200 (spray dried mannitol was used to prepare tablets by wet granulation (10% polyvinylpyrrolidone in Isopropyl alcohol as binder. The optimized batches of tablets (LMCT3 and MP13 not only exhibited desired mouth feel but also disintegration time, in vitro dispersion time, water absorption ratio, and in vitro drug release. All the batches contained 15% starch 1500 and 4% of croscarmellose sodium. The optimized batches prepared by direct compression and wet granulation showed 85% drug release at 4 min and 8 min, respectively. The strong saline and slight bitter taste of the drug was masked using nonnutritive sweetener and flavor.

  3. A novel spray-dried nanoparticles-in-microparticles system for formulating scopolamine hydrobromide into orally disintegrating tablets

    Directory of Open Access Journals (Sweden)

    Li FQ

    2011-04-01

    Full Text Available Feng-Qian Li1, Cheng Yan2, Juan Bi1, Wei-Lin Lv3, Rui-Rui Ji3, Xu Chen1, Jia-Can Su3, Jin-Hong Hu31Department of Pharmaceutics, Shanghai Eighth People’s Hospital, Shanghai, People’s Republic of China; 2Department of Pharmacy, Bethune International Peace Hospital, Shijiazhuang, People’s Republic of China; 3Changhai Hospital, Second Military Medical University, Shanghai, People’s Republic of ChinaAbstract: Scopolamine hydrobromide (SH-loaded microparticles were prepared from a colloidal fluid containing ionotropic-gelated chitosan nanoparticles using a spray-drying method. The spray-dried microparticles were then formulated into orally disintegrating tablets (ODTs using a wet granulation tablet formation process. A drug entrapment efficiency of about 90% (w/w and loading capacity of 20% (w/w were achieved for the microparticles, which ranged from 2 µm to 8 µm in diameter. Results of disintegration tests showed that the formulated ODTs could be completely dissolved within 45 seconds. Drug dissolution profiles suggested that SH is released more slowly from tablets made using the microencapsulation process compared with tablets containing SH that is free or in the form of nanoparticles. The time it took for 90% of the drug to be released increased significantly from 3 minutes for conventional ODTs to 90 minutes for ODTs with crosslinked microparticles. Compared with ODTs made with noncrosslinked microparticles, it was thus possible to achieve an even lower drug release rate using tablets with appropriate chitosan crosslinking. Results obtained indicate that the development of new ODTs designed with crosslinked microparticles might be a rational way to overcome the unwanted taste of conventional ODTs and the side effects related to SH’s intrinsic characteristics.Keywords: scopolamine hydrobromide, chitosan, nanoparticles-in-microparticles system, spray-drying, orally disintegrating tablets

  4. RP-HPLC analytical method development and optimization for quantification of donepezil hydrochloride in orally disintegrating tablet.

    Science.gov (United States)

    Liew, Kai Bin; Peh, Kok Khiang; Fung Tan, Yvonne Tze

    2013-09-01

    An easy, fast and validated RV-HPLC method was invented to quantify donepezil hydrochloride in drug solution and orally disintegrating tablet. The separation was carried out using reversed phase C-18 column (Agilent Eclipse Plus C-18) with UV detection at 268 nm. Method optimization was tested using various composition of organic solvent. The mobile phase comprised of phosphate buffer (0.01M), methanol and acetonitrile (50:30:20, v/v) adjusted to pH 2.7 with phosphoric acid (80%) was found as the optimum mobile phase. The method showed intraday precision and accuracy in the range of 0.24% to -1.83% and -1.83% to 1.99% respectively, while interday precision and accuracy ranged between 1.41% to 1.81% and 0.11% to 1.90% respectively. The standard calibration curve was linear from 0.125 μg/mL to 16 μg/mL, with correlation coefficient of 0.9997±0.00016. The drug solution was stable under room temperature at least for 6 hours. System suitability studies were done. The average plate count was > 2000, tailing factor method was used to assay donepezil hydrochloride in tablet and dissolution study of in-house manufactured donepezil orally disintegrating tablet and original Aricept.

  5. A novel spray-dried nanoparticles-in-microparticles system for formulating scopolamine hydrobromide into orally disintegrating tablets.

    Science.gov (United States)

    Li, Feng-Qian; Yan, Cheng; Bi, Juan; Lv, Wei-Lin; Ji, Rui-Rui; Chen, Xu; Su, Jia-Can; Hu, Jin-Hong

    2011-01-01

    Scopolamine hydrobromide (SH)-loaded microparticles were prepared from a colloidal fluid containing ionotropic-gelated chitosan nanoparticles using a spray-drying method. The spray-dried microparticles were then formulated into orally disintegrating tablets (ODTs) using a wet granulation tablet formation process. A drug entrapment efficiency of about 90% (w/w) and loading capacity of 20% (w/w) were achieved for the microparticles, which ranged from 2 μm to 8 μm in diameter. Results of disintegration tests showed that the formulated ODTs could be completely dissolved within 45 seconds. Drug dissolution profiles suggested that SH is released more slowly from tablets made using the microencapsulation process compared with tablets containing SH that is free or in the form of nanoparticles. The time it took for 90% of the drug to be released increased significantly from 3 minutes for conventional ODTs to 90 minutes for ODTs with crosslinked microparticles. Compared with ODTs made with noncrosslinked microparticles, it was thus possible to achieve an even lower drug release rate using tablets with appropriate chitosan crosslinking. Results obtained indicate that the development of new ODTs designed with crosslinked microparticles might be a rational way to overcome the unwanted taste of conventional ODTs and the side effects related to SH's intrinsic characteristics.

  6. Application of water-insoluble polymers to orally disintegrating tablets treated by high-pressure carbon dioxide gas.

    Science.gov (United States)

    Ito, Yoshitaka; Maeda, Atsushi; Kondo, Hiromu; Iwao, Yasunori; Noguchi, Shuji; Itai, Shigeru

    2016-09-10

    The phase transition of pharmaceutical excipients that can be induced by humidifying or heating is well-known to increase the hardness of orally disintegrating tablets (ODTs). However, these conditions are not applicable to drug substances that are chemically unstable against such stressors. Here, we describe a system which enhances the hardness of tablets containing water-insoluble polymers by using high-pressure carbon dioxide (CO2). On screening of 26 polymeric excipients, aminoalkyl methacrylate copolymer E (AMCE) markedly increased tablet hardness (+155N) when maintained in a high-pressure CO2 environment. ODTs containing 10% AMCE were prepared and treatment with 4.0MPa CO2 gas at 25°C for 10min increased the hardness to +30N, whose level corresponded to heating at 70°C for 720min. In addition, we confirmed the effects of CO2 pressure, temperature, treatment time, and AMCE content on the physical properties of ODTs. Optimal pressure of CO2 gas was considered to be approximately 3.5MPa for an AMCE formula, as excessive pressure delayed the disintegration of ODTs. Combination of high-pressure CO2 gas and AMCE is a prospective approach for increasing the tablet hardness for ODTs, and can be conducted without additional heat or moisture stress using a simple apparatus. Copyright © 2016 Elsevier B.V. All rights reserved.

  7. Quality by Design approach for studying the impact of formulation and process variables on product quality of oral disintegrating films.

    Science.gov (United States)

    Mazumder, Sonal; Pavurala, Naresh; Manda, Prashanth; Xu, Xiaoming; Cruz, Celia N; Krishnaiah, Yellela S R

    2017-07-15

    The present investigation was carried out to understand the impact of formulation and process variables on the quality of oral disintegrating films (ODF) using Quality by Design (QbD) approach. Lamotrigine (LMT) was used as a model drug. Formulation variable was plasticizer to film former ratio and process variables were drying temperature, air flow rate in the drying chamber, drying time and wet coat thickness of the film. A Definitive Screening Design of Experiments (DoE) was used to identify and classify the critical formulation and process variables impacting critical quality attributes (CQA). A total of 14 laboratory-scale DoE formulations were prepared and evaluated for mechanical properties (%elongation at break, yield stress, Young's modulus, folding endurance) and other CQA (dry thickness, disintegration time, dissolution rate, moisture content, moisture uptake, drug assay and drug content uniformity). The main factors affecting mechanical properties were plasticizer to film former ratio and drying temperature. Dissolution rate was found to be sensitive to air flow rate during drying and plasticizer to film former ratio. Data were analyzed for elucidating interactions between different variables, rank ordering the critical materials attributes (CMA) and critical process parameters (CPP), and for providing a predictive model for the process. Results suggested that plasticizer to film former ratio and process controls on drying are critical to manufacture LMT ODF with the desired CQA. Published by Elsevier B.V.

  8. Using procedure of emulsification-lyophilization to form lipid A-incorporating cochleates as an effective oral mucosal vaccine adjuvant-delivery system (VADS).

    Science.gov (United States)

    Wang, Ning; Wang, Ting; Zhang, Meiling; Chen, Ruonan; Deng, Yihui

    2014-07-01

    Using a procedure of emulsification-lyophilization (PEL), adjuvant lipid A-cochleates (LACs) were prepared as a carrier for model antigen bovine serum albumin (BSA). With phosphatidylserine and lipid A as emulsifiers dissolved in oil phase (O), sucrose and CaCl2 in the inner water phase (W1), and BSA, sucrose and PEG2000 in the outer water phase (W2), the W1/O/W2 emulsions were prepared and subsequently lyophilized to form a dry product which was stable enough to be stored at room temperature. Upon rehydration of the dry products, cochleates formed with a size of 800 nm and antigen association rates of 38%. After vaccination of mice through oral mucosal (o.m.) administration, LACs showed no side effects but induced potent immune responses as evidenced by high levels of IgG in the sera and IgA in the salivary, intestinal and vaginal secretions of mice. In addition, high levels of IgG2a and IFN-γ in the sera or culture supernatants of splenocytes of the immunized mice were also detected. These results revealed that LACs induced a mixed Th1/Th2 response against the loaded antigens. Thus, the LACs prepared by PEL were able to induce both systemic and mucosal immune responses and may act as a potent cold-chain-free oral mucosal vaccine adjuvant delivery system (VADS).

  9. Bioavailability of a dexlansoprazole delayed-release orally disintegrating tablet: effects of food and mode of administration

    Directory of Open Access Journals (Sweden)

    Kukulka M

    2017-02-01

    Full Text Available Michael Kukulka, Sai Nudurupati, Maria Claudia Perez Takeda Development Center Americas, Inc., Deerfield, IL, USA Background: Dexlansoprazole is a proton pump inhibitor (PPI approved for use in dual delayed-release capsule and orally disintegrating tablet (ODT formulations.Aim: To assess effects of food, water, and route of administration on the bioavailability of dexlansoprazole 30-mg ODT. Methods: Two separate open-label, phase 1, single-dose crossover studies were conducted in healthy adults. In study 1, pharmacokinetic parameters were analyzed in participants receiving dexlansoprazole ODT in a fed or fasted state with and without water. In study 2, the bioavailability of dexlansoprazole after administration via oral syringe or nasogastric (NG tube, or after swallowing intact with water was compared to ODT administration in the fasted state, swallowed without water. Blood samples for determining dexlansoprazole plasma concentrations and pharmacokinetic parameter estimates were collected before and after dosing. Results: Equivalent values for area under the plasma concentration–time curve (AUC were observed in the fed and fasted states, but the maximum observed plasma concentration (Cmax was 38% lower in the fed state; therefore, bioequivalence was not achieved. A water rinse following standard ODT administration decreased dexlansoprazole bioavailability, with lower Cmax and AUC values than when ODT was administered without a water rinse. Bioequivalence was demonstrated when comparing the alternative routes of administration, including via oral syringe or NG tube with standard ODT administration. Unlike with a water rinse, bioequivalence to standard ODT administration (i.e., without water was demonstrated when swallowing the ODT intact with water. Rates of adverse events were comparable irrespective of administration route in the fasted state (6.7%–9.3% and were 12% higher in the fed state than in the fasted state. Conclusion: The AUC

  10. Bioavailability of a dexlansoprazole delayed-release orally disintegrating tablet: effects of food and mode of administration

    Science.gov (United States)

    Kukulka, Michael; Nudurupati, Sai; Perez, Maria Claudia

    2017-01-01

    Background Dexlansoprazole is a proton pump inhibitor (PPI) approved for use in dual delayed-release capsule and orally disintegrating tablet (ODT) formulations. Aim To assess effects of food, water, and route of administration on the bioavailability of dexlansoprazole 30-mg ODT. Methods Two separate open-label, phase 1, single-dose crossover studies were conducted in healthy adults. In study 1, pharmacokinetic parameters were analyzed in participants receiving dexlansoprazole ODT in a fed or fasted state with and without water. In study 2, the bioavailability of dexlansoprazole after administration via oral syringe or nasogastric (NG) tube, or after swallowing intact with water was compared to ODT administration in the fasted state, swallowed without water. Blood samples for determining dexlansoprazole plasma concentrations and pharmacokinetic parameter estimates were collected before and after dosing. Results Equivalent values for area under the plasma concentration–time curve (AUC) were observed in the fed and fasted states, but the maximum observed plasma concentration (Cmax) was 38% lower in the fed state; therefore, bioequivalence was not achieved. A water rinse following standard ODT administration decreased dexlansoprazole bioavailability, with lower Cmax and AUC values than when ODT was administered without a water rinse. Bioequivalence was demonstrated when comparing the alternative routes of administration, including via oral syringe or NG tube with standard ODT administration. Unlike with a water rinse, bioequivalence to standard ODT administration (i.e., without water) was demonstrated when swallowing the ODT intact with water. Rates of adverse events were comparable irrespective of administration route in the fasted state (6.7%–9.3%) and were 12% higher in the fed state than in the fasted state. Conclusion The AUC from the dexlansoprazole ODT was equivalent when administered in the fed and fasted states. Equivalent systemic exposure to

  11. 吡罗昔康口崩片处方和工艺研究%Formulation and Preparation Technology of Piroxicam Orally Disintegrating Tablets

    Institute of Scientific and Technical Information of China (English)

    徐知; 彭红; 陈文杰

    2011-01-01

    制备了吡罗昔康口腔崩解片,并评价其质量.采用直接粉末压片法制备口腔崩片解,以片剂可压性、崩解时限、口感为指标.在先进行预试验的基础上,进行了最佳处方的筛选,并对其溶出度进行检测.结果采用最佳处方及制备工艺的吡罗昔康口崩片口感良好,与市售普通片比较,口腔崩解片具有明显速释效果.说明吡罗昔康口腔崩处方设计合理、制备工艺可行、产品质量可控.%To make Piroxicam orally disintegrating tablets and investigate its quality, the tablets were pre-pared using the direct compression method. The formulation was optimized with compressibility, disintegration time and taste as reference parameters, earlier on the basis of pre-test, the best prescription was screened and their dis-solutionwere examined. It is resulted the orally disintegrating tablets with the best formulation and preparation taste good, the orally disintegrating tablets had better fast release effect than marketed tablets. It is conclused that formu-lation design is reasonable, the process of preparation is feasible and the quality can be controlled.

  12. Observation of Spleen Aminopeptide Oral Lyophilized Powder Treatment of Immunocompromised%脾氨肽治疗免疫功能低下的疗效观察

    Institute of Scientific and Technical Information of China (English)

    黄琍

    2014-01-01

    Objective:To discuss the clinical effect of using spleen Aminopeptide Oral Lyophilized Powder in treatment of children with bronchial asthma and the effect on children's immune system.Method:86 cases of bronchial asthma were selected from March 2008 to March 2010 in our hospital, they were randomly divided into the test group and the control group,43 cases in each group.The control group was given conventional therapy of bronchial asthma,the test group on the basis of the control group was given Spleen Aminopeptide Oral Lyophilized Powder treatment.Immunoglobulin levels before and after treatment and the clinical curative effect of the two groups were compared.Result:The total efficiency of the test group was 97.67%,it was significantly higher than 58.14%of the control group,the difference was statistically significant(P0.05),but after treatment,IgA and IgG levels were significantly higher than that before treatment and the control group,the differences were statistically significant(P0.05).Conclusion:Spleen Aminopeptide Oral Lyophilized Powder of safe and convenient use,can effectively regulate immune function in children with low,and has a good clinical efficacy in children with asthma.%目的:探讨使用脾氨肽口服冻干粉治疗小儿支气管哮喘的临床疗效以及对患儿免疫系统的影响。方法:选取2008年3月-2010年3月在本院接受治疗的86例支气管哮喘患儿,按照随即数字表法将其分为试验组和对照组各43例,对照组给予支气管哮喘常规基础治疗,试验组在对照组的治疗方案基础上采用脾氨肽口服冻干粉治疗,比较两组患儿的临床疗效及治疗前后的免疫球蛋白水平。结果:试验组患儿总有效率97.67%明显高于对照组的58.14%,比较差异有统计学意义(P0.05),但治疗后的IgA以及IgG水平均明显高于治疗前与对照组,差异均有统计学意义(P0.05)。结论:脾氨肽口服冻干粉使用安全、方便,可有

  13. Preparation and Quality Evaluation of Carbamazepine Orally Disintegrating Tablets%卡马西平口腔速崩片的制备及质量评价

    Institute of Scientific and Technical Information of China (English)

    卫晓晓; 焦海胜

    2011-01-01

    OBJECTIVE: To prepare Carbamazepine (CBZ) orally disintegrating tablets and to evaluate the quality standard of it.METHODS: The tablets were prepared by directly powder compression method using microcrystaline cellulose (MCC) and croscarmellose sodium (CCNa) as disintegrants.The preparation method was optimized by orthogonal test using amount of MCC,CCNa and lactose as factors and with disintegrating time as index.The content of main components was determined by UV spectrophotometry, and the properties of the tablets were evaluated using dissolution rate and stability as index.The dissolution rate of CBZ orally disintegrating tablets was compared with common tablet, and the stability of CBZ orally disintegrating tablets was compared with raw material.RESULTS: The optimal formula was as follows: MCC 75 mg, CCNa 9 mg, lactose 30 mg.The quality of prepared tablets was in line with the standard.The disintegration time was (21 ± 3) s and the accumulative dissolution rate was 81.46% within 2 min.The accumulative dissolution rate was 71.46% within 90 min.Compared with raw material, the absorption peak of prepared tablets changed slightly.CONCLUSION: The preparation technology of orally disintegrating tablets is simple, controllable in quality.It should be kept in drug and cold environment.%目的:制备卡马西平(CBZ)口腔速崩片并评价其质量.方法:选用CBZ为主药,微晶纤维素(MCC)、交联羧甲基纤维素钠(CCNa)为崩解剂,以直接粉末压片法制备片剂;以MCC、CCNa、乳糖用量为考察因素,崩解时间为考察指标设计正交试验筛选处方;采用紫外分光光度法测定制剂中主药的含量,同时以崩解时间、溶出度及稳定性等指标进行质量评价,并与普通片剂比较溶出度,与原料药比较稳定性.结果:优选处方为MCC 75mg、CCNa 9mg、乳糖30mg.所制制剂含量均匀度符合规定,崩解时间为(21±3)s.溶出迅速,2 min内累积溶出率达81.46%;普通片剂90 min

  14. An integrated, quality by design (QbD) approach for design, development and optimization of orally disintegrating tablet formulation of carbamazepine.

    Science.gov (United States)

    Mishra, Saurabh M; Rohera, Bhagwan D

    2016-06-27

    The objective of the present study was to design and develop a formulation for orally disintegrating tablets (ODTs) of carbamazepine using quality by design principles. The target product profile (TPP) and quality target product profile (QTPP) of ODTs were identified. Risk assessment was carried out by leveraging prior knowledge and experience to define the criticality of factors based on their impact by Ishikawa fishbone diagram and preliminary hazard analysis tool. Box-Behnken response surface methodology was used to study the effect of critical factors on various attributes of ODTs. The independent factors selected were compression pressure (X1), concentration of sublimating agent (volatile material) (X2), disintegrant concentration (X3) and the responses were tablet crushing strength, tablet porosity, disintegration time, water absorption time, tablet friability and drug dissolution. ANOVA and lack of fit test illustrated that selected independent variables had significant effect on the response variables, and excellent correlation was observed between actual and predicted values. Optimization by desirability function indicated that compression pressure, X1 (1534 lbs), ammonium bicarbonate concentration, X2 (7.68%) and Kollidon(®) CL-SF concentration, X3 (6%) were optimum to prepare ODT formulation of carbamazepine of desired attributes complying with QTPP. Thus, in the present study, a high level of assurance was established for ODT product quality and performance.

  15. Preparation of Orally Disintegrating Tablets Containing Powdered Tea Leaves with Enriched Levels of Bioactive Compounds by Means of Microwave Irradiation Technique.

    Science.gov (United States)

    Tanaka, Hironori; Iwao, Yasunori; Izumikawa, Masahiro; Sano, Syusuke; Ishida, Hitoshi; Noguchi, Shuji; Itai, Shigeru

    2016-01-01

    In the present study, a microwave treatment process has been applied to prepare orally disintegrating tablets (ODTs) containing powdered tea leaves with enriched levels of the anti-inflammatory compounds such as chafuroside A (CFA) and chafuroside B (CFB). The use of distilled water as the adsorbed and granulation solvents in this preparation process afforded tablets with a long disintegration time (more than 120 s). The CFA and CFB contents of these tablets did not also change after 4 min of microwave irradiation due to the tablet temperature, which only increased to 100°C. In contrast, the tablet temperature increased up to 140°C after 3 min of microwave irradiation when a 1.68 M Na2HPO4 solution instead of distilled water. Notably, the disintegration time of these tablets was considerably improved (less than 20 s) compared with the microwave-untreated tablets, and there were 7- and 11-fold increases in their CFA and CFB contents. In addition, the operational conditions for the preparation of the tablets were optimized by face-centered composite design based on the following criteria: tablet hardness greater than 13 N, disintegration time less than 30 s and friability less than 0.5%. The requirements translated into X1 (the amount of granulation solvent), X2 (tableting pressure) and X3 (content of the powdered tea leaves) values of 45%, 0.43 kN and 32%, respectively, and the ODTs containing powdered tea leaves prepared under these optimized conditions were found to show excellent tablet properties and contain enriched levels of CFA and CFB.

  16. Preparation of orally disintegrating tablets polydatin%正交实验优化虎杖苷口腔崩解片的制备工艺

    Institute of Scientific and Technical Information of China (English)

    王云; 齐红

    2015-01-01

    目的:采用正交试验优选虎杖苷口腔崩解片的最优处方,为虎杖苷口腔崩解片的制备提供最优的方法。方法首先采用乙醇回流提取,过滤,得到虎杖苷,然后使用虎杖苷配合配方制备口腔崩解片,对影响制备工艺的L-HPC,乳糖,淀粉几个因素进行单因素考察,后采用正交试验确定最佳工艺。结果确定虎杖苷口腔崩解片主要成分的配方为L-HPC24.0%,乳糖32.0%,淀粉11.2%。方法学实验表明溶出度曲线回归方程为(以峰面积对浓度进行线性回归) A=3065.7C-0.61,r=0.9999。线性范围为0.076~0.798mg/ml。稳定性RSD在0.729%-2.774%之间,稳定性良好。其精密度RSD在0.634%-2.532%之间,重量差异超过±7.5%的少于2片,无片剂超过±15%。结论本实验制备的虎杖苷口腔崩解片各项指标均符合要求,口感较好。%ğObjective Using Orthogonal Test polydatin orally disintegrating tablet formulation of the optimal preparation of tablets for oral disintegrating polydatin provide the best method method Using ethanol extraction, filtration, get polydatin, with the preparation and use polydatin orally disintegrating tablet formulation, preparation for the impact of L-HPC, lactose, starch, several factors were single factor, after the orthogonal experiment to determine the most good technology.Result polydatin orally disintegrating tablet formulation is the main component of L-HPC24.0%, 32.0% lactose, starch 11.2%.Experiments show that the method of dissolution curve regression equation (peak area concentration linear regression) A = 3065.7C-0.61, r = 0.9999. The linear range of 0.076-0.798mg / ml. RSD stability between 0.729% -2.774%, good stability. Its precision RSD between 0.634% -2.532%, the weight difference of less than± 7.5% 2, no tablets than± 15%.Conclusion Polydatin oral disintegrating tablets prepared in this experiment in the 30s disintegration, taste better.

  17. COMPARATIVE EVALUATION OF ORALLY DISINTEGRATING FILM OF ONDANSETRON VERSUS INTRAVENOUS GRANISETRON IN PREVENTION OF POSTOPERATIVE NAUSEA AND VOMITING FOLLOWING LAPAROSCOPIC CHOLECYSTECTOMY: A PROSPECTIVE, RANDOMIZED DOUBLE - BLIND PLACEBO - CONTROLLED STUDY

    OpenAIRE

    2015-01-01

    BACKGROUND : Ondansetron and granisetron are first generation 5 - hydroxytry - ptamine - 3 (5 - HT3) receptor antagonists widely used in the prophylaxis of postoperative nausea and vomiting (PONV). Orally Disintegrating Film (ODF) formulations are novel and advanced oral drug delivery systems used in management of (PONV). We aimed to study the efficacy of ODF of Ondansetron in the prophylaxis of PONV and to co...

  18. 盐酸氯米帕明口腔崩解片的制备工艺%Preparation Technology of Clomipramine Hydrochloride Orally Disintegrating Tablets

    Institute of Scientific and Technical Information of China (English)

    吴杏梅; 谢燕萍

    2011-01-01

    Objective: To optimize the formulation of clomipramine hydrochloride orally disintegrating tablets by orthogonal experiment and to determine the dissolution. Method: The formulation of the tablets was optimized by orthogonal experiment based on four factors, those were the amount of microcrystalline cellulose, lactose, and sodium carboxymethl starch and the concentration of hydroxypropyl methyl cellulose, and 3 indices, those were disintegrating time (t1,), wetting time (t) and suspending stability (△A). The dissolution of the tablets was determined by HPLC. Result: The optimum preparation technical conditions for the tablets were as follows: the proportions of microcrystalline cellulose,lactose and the sodium carboxymethl starch and the concentration of hydroxypropyl cellulose was 30% ,30% >0. 75% and 1% respectively. The tablets disintegrated completely within 30s with mean td of 13. 2 s,t of 21.6 s,and △A of 0.001 2. Conclusion: The formula of the clomipramine hydrochloride orally disintegrating tablets is reasonable and valuable to be studied further.%目的:采用正交试验筛选盐酸氯米帕明口腔崩解片的处方,并测定其溶出度.方法:以微晶纤维素、乳糖、羧甲基淀粉钠的用量以及羟丙纤维素的浓度为考查因素,以口腔崩解片的崩解时间(td)、润湿时间(t)和混悬稳定性(ΔA)为评价指标进行正交试验,确定最佳处方;对优化处方所制样品测定其溶出度.结果:优选工艺为微晶纤维素30%、乳糖30%、羧甲基淀粉钠0.75%、羟丙纤维素的浓度是1%,所制样品平均td为13.2s,t为21.6s,ΔA为0.001 2;30 min内药物溶出超75%.结论:盐酸氯米帕明口腔崩解片处方设计合理,可进一步开发.

  19. FORMULATION DEVELOPMENT AND IN VITRO – IN VIVO CHARACTERIZATION OF ORAL FAST DISINTEGRATING FILMS OF A DRUG MEANT FOR CHRONIC DISEASE

    Directory of Open Access Journals (Sweden)

    P. Vijayalakshmi*, E. Surender , B. Pragna , Md. Zia Askary , Lohidasu Borubhadra , A.J. Balamurugan and Hemant Joshi

    2013-01-01

    Full Text Available The objective of the work was to design oral FDFs of a drug meant for management of chronic disease like type-2 diabetes mellitus which affects mostly elderly population. Glimepiride was the drug of choice because of its low dose. Since in vitro dissolution rate is the rate limiting step in drug absorption for class II drugs, in the present work, it was also proposed to make a complex of the drug with hydroxypropyl betacyclodextrin (HPBCD to improve the physicochemical-pharmacokinetic characters of the drug. Various batches of FDFs were developed by the solvent casting method using water soluble polymers HPMC-E5 and Maltodextrin as film formers; Glycerol and PEG-600 as plasticizers; Sodium starch glycollate as super disintegrating/channeling agent; Sodium lauryl sulphate, polaxamer 407 and Tween-80 as surfactants; aspartame as a sweetener and brilliant blue as coloring agent. The drug was complexed with HPBCD by kneading method in the ratio of 1:1 and was incorporated in the film in the place of plain drug. Poloxamer containing films gave better physico-chemical characters than the other tested surfactants and addition of HPBCD complexed drug further improved the characters of the films. The formulation containing drug- HPBCD complex and polaxamer 407 as the surfactant gave lowest disintegration time, more uniform and faster dissolution profile, had better taste, highter Cmax and lower tmax values during in vivo studies. It can therefore be concluded that the drug in its most soluble form gives better physicochemical and pharmacokinetic characters which results in better management of the disease as patient compliance improves.

  20. The Effect Observation of Spleen Amino Peptide Oral Lyophilized Powder in the Treatment of Infantile Anorexia%脾胺肽口服冻干粉治疗小儿厌食疗效观察

    Institute of Scientific and Technical Information of China (English)

    叶国静

    2014-01-01

    Objective To investigate the effect of Spleen Aminopeptide Oral Lyophilized Powder in the treatment of infantile ano-rexia. Methods 85 cases with infantile anorexia were randomly selected from June 2011 to June 2013 and were divided into two groups. The observation group (45 cases) was treated with Spleen Aminopeptide Oral Lyophilized Powder, while the control group (40 cases) was given regular treatment. Clinical curative effect and the change of blood trace elements before and after treatment were com-pared between the two groups. Results The total clinical effectiveness was 95.56% in the observation group, significantly higher than that of the control group (72.5%), and there was statistical significance (P0.05). Conclusion Spleen Aminopeptide Oral Lyophilized Powder has good effect in the treatment of infantile anorexia, and the patients' symptoms and trace ele-ments level have improved obviously. It is worthwhile to be widely applied clinically.%目的探讨脾胺肽口服冻干粉治疗小儿厌食症的疗效。方法随机选择我院2011年6月至2013年6月85例非器质性小儿厌食症患儿,随机分两组,观察组45例给予脾胺肽口服冻干粉治疗,对照组40例给予常规治疗,比较两组患儿临床疗效和治疗前、后血微量元素的变化。结果观察组临床治疗总有效率95.56%,显著高于对照组(72.5%),差异有统计学意义(P0.05)。结论脾胺肽口服冻干粉治疗非器质性小儿厌食症的疗效显著,患者症状和微量元素水平明显改善,值得临床推广使用。

  1. An advanced technique using an electronic taste-sensing system to evaluate the bitterness of orally disintegrating films and the evaluation of model films.

    Science.gov (United States)

    Takeuchi, Yoshiko; Usui, Rina; Ikezaki, Hidekazu; Tahara, Kohei; Takeuchi, Hirofumi

    2017-08-05

    Taste detection systems using electronic sensors are needed in the field of pharmaceutical design. The aim of this study was to propose an advanced technique using a taste-sensing system to evaluate the bitterness of an orally disintegrating film (ODF) samples. In this system, a solid film sample is kept in the test medium with stirring, and the sensor output is recorded. Model films were prepared using a solution-casting method with a water-soluble polymer such as pullulan, HPMC, HPC or PVP as film formers, and donepezil hydrochloride and quinine hydrochloride as model bitter-tasting active pharmaceutical ingredients (APIs). The results showed that this advanced techniques could detect the emergence of bitterness along the time course. Increasing the amount of donepezil hydrochloride increased the sensor output. The sensor output was suppressed at the very early stage of the test, and then increased. Both the film thickness and the use of additives markedly affected the delay of the sensor output. The profile of the sensor output was accurately related to the release of APIs. It was concluded that this advanced technique could detect the onset of bitterness during the initial stage of ODF administration. Copyright © 2017 Elsevier B.V. All rights reserved.

  2. Taste-masking effect of physical and organoleptic methods on peppermint-scented orally disintegrating tablet of famotidine based on suspension spray-coating method.

    Science.gov (United States)

    Sugiura, Takeshi; Uchida, Shinya; Namiki, Noriyuki

    2012-01-01

    Orally disintegrating tablets (ODTs) are useful for improving benefits for patients of various ages. Masking the unpleasant taste of a drug is an important factor in the compliance of patients who take ODTs. We evaluated the taste acceptability effects of various taste-masking methods on bitter famotidine ODTs as a clinical pharmacological study. The following methods were tested to compare taste-masking effects: physical masking by spray-coating famotidine with ethyl cellulose versus organoleptic masking with added sweetener and flavor. The ODT samples were prepared as single or combinations of each taste-masking method using a novel suspension spray-coating method including a placebo. A total of 31 healthy volunteers were enrolled in this randomized, double-blind study and asked to score their bitterness, sweetness and total palate impressions by 100 mm visual analogue scale (VAS). VAS scores were significantly improved by the physical and organoleptic methods as compared to without taste-masked ODTs. Furthermore, the combination of both taste-masking methods was most effective for improving palatability and VAS scores were similar to those of placebo ODTs. The results of this study suggest that different taste-masking mechanisms function cooperatively.

  3. Efficacy of orally disintegrating film of ondansetron versus intravenous ondansetron in prophylaxis of postoperative nausea and vomiting in patients undergoing elective gynaecological laparoscopic procedures: A prospective randomised, double-blind placebo-controlled study

    OpenAIRE

    2014-01-01

    Background and Aims: Ondansetron is one of the most widely used drugs for postoperative nausea and vomiting (PONV) prophylaxis. Orally disintegrating film (ODF) formulations are relatively recent innovations. We evaluated the efficacy of ODF of ondansetron for the prophylaxis of PONV. Methods: One hundred and eighty American Society of Anaesthesiologists-I or II women, in the age group 18-65 years, scheduled for elective gynaecological laparoscopic procedures were studied in a prospective ran...

  4. Lyophilization -Solid Waste Treatment

    Science.gov (United States)

    Litwiller, Eric; Flynn, Michael; Fisher, John; Reinhard, Martin

    2004-01-01

    This paper discusses the development of a solid waste treatment system that has been designed for a Mars transit exploration mission. The technology described is an energy-efficient lyophilization technique that is designed to recover water from spacecraft solid wastes. Candidate wastes include feces, concentrated brines from water processors, and other solid wastes that contain free water. The system is designed to operate as a stand-alone process or to be integrated into the International Space Station Waste Collection System. In the lyophilization process, water in an aqueous waste is frozen and then sublimed, separating the waste into a dried solid material and liquid water. The sublimed water is then condensed in a solid ice phase and then melted to generate a liquid product. In the subject system the waste solids are contained within a 0.2 micron bio-guard bag and after drying are removed from the system and stored in a secondary container. This technology is ideally suited to applications such as the Mars Reference Mission, where water recovery rates approaching 100% are desirable but production of CO2 is not. The system is designed to minimize power consumption through the use of thermoelectric heat pumps. The results of preliminary testing of a prototype system and testing of the final configuration are provided. A mathematical model of the system is also described.

  5. Development and characterization of orally-disintegrating films for propolis delivery Desenvolvimento e caracterização de filmes de desintegração para liberação oral de própolis

    Directory of Open Access Journals (Sweden)

    Josiane Gonçalves Borges

    2013-02-01

    Full Text Available This study aimed at evaluating the effect of different concentrations of hydrolyzed collagen (HC on the properties of an orally disintegrating film containing propolis ethanol extract (PEE as an active component. The films were evaluated in terms of total phenols, mechanical properties, solubility, contact angle, disintegration time, and microstructure. The films were prepared by casting with 2 g of protein mass (gelatin and HC, 30 g of sorbitol/100 g of protein mass, and 100 g of PEE/100 g of protein mass. HC was incorporated at concentrations of 0, 10, 20, and 30 g/100 g of protein mass. It was found that increased concentrations of HC reduced tensile strength and increased elongation; however, all films showed plastic behavior. An increase in solubility at 25 ºC, a reduction in the contact angle, and disintegration time were also observed. Thus, higher concentrations of collagen led to more hydrophilic and more soluble polymeric matrices that showed shorter dissolution time, favoring the use of these materials as carriers for active compounds to be delivered in the oral cavity.Este trabalho teve como objetivo avaliar o efeito de diferentes concentrações de colágeno hidrolisado nas propriedades de filmes de desintegração oral contendo extrato etanólico de própolis como componente ativo. Os filmes foram avaliados em relação aos fenóis totais, propriedade mecânica, solubilidade, ângulo de contato, tempo de desintegração e microestrutura. Os filmes foram produzidos por "casting" com concentrações de 2 g de massa proteica (gelatina e colágeno hidrolisado, 30 g de sorbitol/100 g de massa proteica e 100 g de extrato fenólico de própolis/100 g de massa proteica. Colágeno hidrolisado foi incorporado nas concentrações de 0, 10, 20 e 30 g/100 g de massa proteica. Verificou-se que o aumento da concentração de colágeno hidrolisado provocou redução na tensão de ruptura e aumento da elongação, entretanto todos os filmes

  6. 白花蛇舌草口腔崩解片防治青少年青春痘临床试验%Hedyotis Diffusa Orally Disintegrating Tablets Treatment of Adolescent Acne Clinical Trials

    Institute of Scientific and Technical Information of China (English)

    詹晓如; 谭丽荷; 郑小吉

    2015-01-01

    Objective To observe the ef ects of Herba Hedyotis dif usae oral y disintegrating tablet on the clinical ef icacy and safety of adolescent acne. Methods The test group of 76 patients with Oldenlandia oral y disintegrating tablets, 42 cases in the control group with clindamycin hydrochloride capsules, tails capsule, Vitamin B6 Tablets oral, topical clindamycin and 0.1%tretinoin cream gel 1% (before the external) treatment for 1 weeks. Results The experimental group, the total ef iciency was 92.11%, control group, the total ef iciency of 88.10%, compared with two groups of curative ef ect, by the analysis of Ridit, u=1.486 ( >0.O5), no significant treatment group curative ef ect between the control group and the. Conclusion Can ef ectively prevent acne Hedyotis dif usa oral y disintegrating tablets, has the very good development value.%目的:观察白花蛇舌草口腔崩解片防治青少年青春痘临床疗效及安全性。方法试验组76例采用白花蛇舌草口腔崩解片,对照组42例用克林霉素胶囊、泰尔丝胶丸、维生素月远片内服,同时外用员豫克林霉素凝胶及园.员豫迪维霜(睡前外用)疗程均为1 w。结果其中试验组总有效率为92.11%,对照组总有效率为88.10%,两组疗效比较,经Ridit分析,u=1.486(跃0.05),治疗组疗效与对照组无显著性差异。结论白花蛇舌草口腔崩解片能有效地防治青少年青春痘,具有很好开发价值。

  7. Efficacy of orally disintegrating film of ondansetron versus intravenous ondansetron in prophylaxis of postoperative nausea and vomiting in patients undergoing elective gynaecological laparoscopic procedures: A prospective randomised, double-blind placebo-controlled study

    Directory of Open Access Journals (Sweden)

    Harihar V Hegde

    2014-01-01

    Full Text Available Background and Aims: Ondansetron is one of the most widely used drugs for postoperative nausea and vomiting (PONV prophylaxis. Orally disintegrating film (ODF formulations are relatively recent innovations. We evaluated the efficacy of ODF of ondansetron for the prophylaxis of PONV. Methods: One hundred and eighty American Society of Anaesthesiologists-I or II women, in the age group 18-65 years, scheduled for elective gynaecological laparoscopic procedures were studied in a prospective randomised, double-blind, placebo-controlled trial. The patients were randomised into four groups: Placebo, intravenous (IV ondansetron 4 mg, ODF of ondansetron 4 mg (ODF4 and 8 mg (ODF8 groups. PONV was assessed in two epochs of 0-6 and 7-24 h. Primary outcome measure was the incidence of PONV and secondary outcome measures were severity of nausea, need for rescue anti-emetic, analgesic consumption, time to oral intake, overall patient satisfaction and side effects such as headache and dizziness. PONV was compared using analysis of variance or Mann-Whitney U-test as applicable. Results: Data of 173 patients were analysed. The incidence of postoperative nausea was significantly lower (P = 0.04 only during the 0-6 h in the ODF8 group when compared with the placebo group. During the 0-6 h interval postoperatively, the ODF8 group had a significantly lower incidence of vomiting when compared with the placebo (P = 0.002 and the IV group (P = 0.044. During the 0-24 h interval postoperatively, ODF4 (P = 0.01 and ODF8 (P = 0.002 groups had a significantly lower incidence of vomiting compared to the placebo group. Conclusions: Orally disintegrating film of ondansetron is an efficacious, novel, convenient and may be a cost-effective option for the prophylaxis of PONV.

  8. COMPARATIVE EVALUATION OF ORALLY DISINTEGRATING FILM OF ONDANSETRON VERSUS INTRAVENOUS GRANISETRON IN PREVENTION OF POSTOPERATIVE NAUSEA AND VOMITING FOLLOWING LAPAROSCOPIC CHOLECYSTECTOMY: A PROSPECTIVE, RANDOMIZED DOUBLE - BLIND PLACEBO - CONTROLLED STUDY

    Directory of Open Access Journals (Sweden)

    Snehalatha

    2015-05-01

    Full Text Available BACKGROUND : Ondansetron and granisetron are first generation 5 - hydroxytry - ptamine - 3 (5 - HT3 receptor antagonists widely used in the prophylaxis of postoperative nausea and vomiting (PONV. Orally Disintegrating Film (ODF formulations are novel and advanced oral drug delivery systems used in management of (PONV. We aimed to study the efficacy of ODF of Ondansetron in the prophylaxis of PONV and to compare it with intravenous Granisetron and placebo in patients undergoing Laparoscopic cholecystectomy . MATERIALS AND METHODS : In this prospective, randomized double - blind placebo - controlled study, 120 consented adult patients of ASA grade I and grade II, aged between 25 - 55 years of both genders, undergoing elective Laparoscopic cholecystectomy , w ere randomized into 3 groups of 40 patients each as Placebo, intravenous Granisetron 2mg and ODF of Ondansetron 8mg (ODF8 g roups. Study drugs were administered just before induction of Anaesthesia. Standardized anesthetic technique was used, and data was collected. Incidence of PONV was assessed and the number of patients suffering from nausea and vomiting at 0 - 6, 7 - 14, and overall 0 - 24 hours post - operatively was evaluated in all the groups and need for rescue anti - emetic noted. RESULTS : Data was analysed using one - way ANOVA test, Chi ‑ square test and Mann – Whitney test. The incidence and severity of nausea and vomiting at different time intervals in Group G and ODF Group was significantly lower when compared with Placebo Group ( p=0.000 . But there was no significant difference in between the ODF and in travenous groups. There was no significant difference in the incidence of side effects in between the three groups. CONCLUSION : orally disintegrating film of Ondansetron is a safe, simple and cost - effective, novel formulation , equally effective to intraven ous Granisetron in preventing PONV in patients undergoing laparoscopic cholecystectomy.

  9. Childhood disintegrative disorder

    DEFF Research Database (Denmark)

    Mouridsen, Svend Erik

    2003-01-01

    are sometimes associated with this disorder, but contrary to earlier belief this is not typical. Interest in childhood disintegrative disorder has increased markedly in recent years and in this review attention is given to more recently published cases based on ICD-9, ICD-10 and DSM-IV diagnostic systems...

  10. 银杏叶提取物合并利培酮口腔崩解片治疗精神分裂症的临床研究%A clinical study of combined utization of ginkgo biloba extract and risperidone orally disintegrating tablets in the treatment of schlzophrenia

    Institute of Scientific and Technical Information of China (English)

    龚飞中; 曾骥; 余瑞; 龚昌群; 刘均富

    2012-01-01

    Objective To compare clinical efficacy and the side effects between combined utilization of ginkgo biloba extract and risperidone orally disintegrating tablets and only the use of risperidone orally disintegrating tablets in the treatment of schizophrenia. Methods Seventy-five patients with schizophrenia were treated randomly with combined utilization of ginkgo biloba extract and risperidone orally disintegrating tablets or risperidone orally disintegrating tablets only for six weeks,and measured with the brief psychiatric rating scale (BPRS) and treatment emergent symptom scale(TESS) before treatment and 1,2,4,6 weeks after treatment. Results The both programes were different in efficacy, combined utilization of ginkgo biloba extract and risperidone o-rally disintegrating tablets is more effective than risperidone orally disintegrating tablets only in treating schizophrenia, and the side effects combined utilization of ginkgo biloba extract and risperidone orally disintegrating tablets is no more effective than risperidone orally disintegrating tablets only in treating schizophrenia. Conclusion The therapeutic effect of combined utilization of ginkgo biloba extract and risperidone orally disintegrating tablets take a active part earlier than only the use of risperidone orally disintegrating tablets in the treatment of schizophrenia, however, the reduced rate of BPRS was no significant difference after 2 weeks, itcould be necessary to continue the joint use of ginkgo biloba extract.%目的 比较银杏叶提取物合并利培酮口腔崩解片与单用利培酮口腔崩解片治疗精神分裂症的疗效及不良反应.方法 将符合标准的75例精神分裂症患者分为两组,一组给予银杏叶提取物合并利培酮口腔崩解片治疗(治疗组,n=40),另一组给予利培酮口腔崩解片治疗(对照组,n=35),疗程6周.用简明精神量表(BPRS)在治疗前及治疗1、2、4、6周末评定疗效,用副反应量表(TESS)评定不良反应.结果

  11. Preparation of Lamotrigine Orally Disintegrating Tablets based on the co-processed exicipient%基于预混辅料的拉莫三嗪口腔崩解片的制备

    Institute of Scientific and Technical Information of China (English)

    查静; 王铁杰; 王思明; 涂家生

    2015-01-01

    目的:由预混辅料入手,制备拉莫三嗪口腔崩解片。方法以异麦芽酮糖醇、微晶纤维素和交联聚维酮为主要辅料,使用湿法制粒的方法制备预混辅料,并测定了预混辅料产品的粉体学性质。选用拉莫三嗪为主药,与预混辅料及少量崩解剂、润滑剂和矫味剂,通过粉末直压的方法制备拉莫三嗪口腔崩解片,并对拉莫三嗪口腔崩解片进行基本的体外评价。结果通过单因素考察和正交试验,预混辅料的最终处方组成为:异麦芽酮糖醇与微晶纤维素的比例为3:4,加入8%交联聚维酮。拉莫三嗪口腔崩解片的最优处方组成(按1000片计)为:25 g 拉莫三嗪,137 g预混辅料,14.4 g低取代羟丙基纤维素,1.8 g硬脂酸镁,1.8 g矫味剂。拉莫三嗪口腔崩解片的崩解时限为35 s,且在5 min内溶出完全。结论根据试验,制备的预混辅料的性质优良,口腔崩解片的崩解时限、口感和溶出度等均符合规定。%Objective To prepare Lamotrigine Orally Disintegrating Tablets( ODTs)based on the co-processed ex-cipients. Methods Firstly,to prepare the co - processed excipient consisting of isomalt,microcrystalline cellulose and crospovidone by wet granulation method. Afterwards,Lamotrigine ODTs was directly compressed after mixing the co-pro-cessed excipient with a small amount of disintegrant,taste-masked agents and magnesium stearate,and the formula optimi-zation was conducted. Finally,the micromeritic properties of co-processed excipient and the disintegration time of Lam-otrigine ODTs with the optimal formula were investigated. Results The desirable co-processed excipient composed of iso-malt/microcrystalline cellulose at a ratio of 3:4 and 8% crospovidone. And the components of the optimal formula of Lam-otrigine ODTs(in 1 000)included 25 g lamotrigine,137 g co-processed excipient,14. 4 g low-substituted hydroxypropyl cellulose,1. 8 g magnesium stearate,1. 8 g

  12. Study on the Formula and Preparation Technology of Diclofenac Sodium-β-CD Inclusion Complex Orally Disintegrating Tablets%双氯芬酸钠-β-环糊精包合物口腔速崩片的处方及制备工艺研究

    Institute of Scientific and Technical Information of China (English)

    王晓明; 阴元魁

    2011-01-01

    OBJECTIVE: To prepare the orally disintegrating tablets of diclofenac sodium-β-CD inclusion complex and to establish the formula and preparation technology of it. METHODS: With disintegration time as index, 5 kinds of disintegrating agents,2 kinds of lubricants, 3 kinds of hardness scopes and 2 kinds of preparation technologies were screened to obtain and validate optimal formula and prescription technology. RESULTS: Wet granule compression tablet method was used to prepare orally disintegrating tablet with crospovidone as disintegrating agent, aerosil and talc as the lubricant, and the hardness was 20~30 N. The prepared tablets could disintegrate completely within 60 s. CONCLUSION: The orally disintegrating tablets of diclofenac sodium is prepared after being included with β-CD. The method is simple and up to the standard of quality for the industrial production of diclofenac sodium-β-CD inclusion complex orally disintegrating tablets.%目的:制备双氯芬酸钠-β-环糊精包合物的口腔速崩片,确立其处方及制备工艺.方法:以崩解时间为指标,分别对5种崩解剂、2种润滑荆、3种片剂硬度范围和2种压片方法进行筛选得出最佳处方及制备方法,并进行验证.结果:以交联聚维酮为崩解剂,微粉硅胶和滑石粉为润滑剂,硬度为20~30N,采用湿法制粒压片所制得的口腔速崩片,在60 s内可完全崩解.结论:双氯芬酸钠经-β-环糊精包舍后再制成口腔速崩片,制备方法简单,质量合格,且适合工业化生产.

  13. Efficacy, Safety, and Tolerability of an Extended-Release Orally Disintegrating Methylphenidate Tablet in Children 6–12 Years of Age with Attention-Deficit/Hyperactivity Disorder in the Laboratory Classroom Setting

    Science.gov (United States)

    Childress, Ann C.; Kollins, Scott H.; Cutler, Andrew J.; Marraffino, Andrea; Sikes, Carolyn R.

    2017-01-01

    Abstract Objective: Methylphenidate extended-release orally disintegrating tablets (MPH XR-ODTs) represent a new technology for MPH delivery. ODTs disintegrate in the mouth without water and provide a pharmacokinetic profile that is consistent with once-daily dosing. This study sought to determine the efficacy, safety, and tolerability of this novel MPH XR-ODT formulation in school-age children with attention-deficit/hyperactivity disorder (ADHD) in a laboratory classroom setting. Methods: Children aged 6–12 years with ADHD (n = 87) were enrolled in this randomized, multicenter, double-blind, placebo-controlled, parallel, laboratory classroom study. The MPH XR-ODT dose was titrated to an optimized dose during a 4-week open-label period and maintained on that dose for 1 week. Participants (n = 85) were then randomized to receive their optimized dose of MPH XR-ODT or placebo once daily for 1 week (double blind), culminating in a laboratory classroom testing day. Efficacy was evaluated using the Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) Attention, Deportment, and Combined scores along with Permanent Product Measure of Performance (PERMP; Attempted and Correct) assessments. Onset and duration of drug action were also evaluated as key secondary endpoints. Safety assessments included adverse events (AEs), physical examinations, electrocardiograms (ECGs), and the Columbia Suicide Severity Rating Scale (C-SSRS). Results: The average SKAMP-Combined score on the classroom study day was significantly better for the MPH XR-ODT group (n = 43) than for the placebo group (n = 39; p headache, insomnia, upper respiratory tract infection, affect lability, irritability, cough, and vomiting. Conclusions: MPH XR-ODT was effective and well tolerated for the treatment of children with ADHD in a laboratory classroom setting. Clinical Trial Registry: NCT01835548 (ClinicalTrials.gov). PMID:27183299

  14. Efficacy, Safety, and Tolerability of an Extended-Release Orally Disintegrating Methylphenidate Tablet in Children 6-12 Years of Age with Attention-Deficit/Hyperactivity Disorder in the Laboratory Classroom Setting.

    Science.gov (United States)

    Childress, Ann C; Kollins, Scott H; Cutler, Andrew J; Marraffino, Andrea; Sikes, Carolyn R

    2017-02-01

    Methylphenidate extended-release orally disintegrating tablets (MPH XR-ODTs) represent a new technology for MPH delivery. ODTs disintegrate in the mouth without water and provide a pharmacokinetic profile that is consistent with once-daily dosing. This study sought to determine the efficacy, safety, and tolerability of this novel MPH XR-ODT formulation in school-age children with attention-deficit/hyperactivity disorder (ADHD) in a laboratory classroom setting. Children aged 6-12 years with ADHD (n = 87) were enrolled in this randomized, multicenter, double-blind, placebo-controlled, parallel, laboratory classroom study. The MPH XR-ODT dose was titrated to an optimized dose during a 4-week open-label period and maintained on that dose for 1 week. Participants (n = 85) were then randomized to receive their optimized dose of MPH XR-ODT or placebo once daily for 1 week (double blind), culminating in a laboratory classroom testing day. Efficacy was evaluated using the Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) Attention, Deportment, and Combined scores along with Permanent Product Measure of Performance (PERMP; Attempted and Correct) assessments. Onset and duration of drug action were also evaluated as key secondary endpoints. Safety assessments included adverse events (AEs), physical examinations, electrocardiograms (ECGs), and the Columbia Suicide Severity Rating Scale (C-SSRS). The average SKAMP-Combined score on the classroom study day was significantly better for the MPH XR-ODT group (n = 43) than for the placebo group (n = 39; p classroom setting. Clinical Trial Registry: NCT01835548 ( ClinicalTrials.gov ).

  15. Pharmacokinetic and Bioavailability of Donepezil Orally Disintegrating Tablet in Healthy Volunteers%盐酸多奈哌齐口腔崩解片人体药物代谢动力学和生物等效性试验

    Institute of Scientific and Technical Information of China (English)

    余勤; 向瑾; 冯萍; 王颖; 梁茂植; 苗佳; 南峰; 沈奇; 秦永平

    2012-01-01

    目的 采用高效液相色谱-质谱联用法研究盐酸多奈哌齐口腔崩解片的人体药物代谢动力学,并评价其生物等效性.方法 2009年9月-11月对22例健康男性受试志愿者单次交叉口服盐酸多奈哌齐口腔崩解片(试验制剂)和盐酸多奈哌齐普通片(参比制剂),测定给药后不同时间点血浆中多奈哌齐经时血药浓度,采用DAS 2.0软件进行药物代谢动力学参数计算和生物等效性评价.结果 受试者单次口服试验制剂与参比制剂后,达峰时间分别为(2.95±1.16)、(3.19±0.98)h,峰浓度分别为(9.98±2.93)、(9.13±2.05)ng/mL,药时曲线下面积(0-t)分别为(470.76±142.64)、(446.57±137.30) ng/mL·h;药时曲线下面积(0-∞)分别为(517.74±169.79)、(489.47±162.13)ng/mL·h.试验制剂与参比制剂的生物等效性结果为104.7%,其90%置信区间为(98.4%,111.4%).结论 盐酸多奈哌齐口腔崩解片与普通片生物等效.%Objective To study the pharmacokinetic and bioavaiiabiiity of donepezi! orally disintegrating tabiet in healthy volunteers with high performance liquid chromatography-mass spectrometry (HPLC-MS). Methods Twenty-two healthy male volunteers were enrolled in the study between September and November 2009. The subjects orally took a single dose of 5 mg donepezil test or reference preparation. The concentrations of donepezil plasma were assessed and data were analyzed automatically with DAS 2.0 pharmacokinetic program. The relative bioavailability of donepezil test or reference preparation was calculated. Results The parameters of donepezil test and reference preparation were as following: the peak time (Tmax) was (2.95 ±1.16) h and (3.19 ±0.98) h; the peak concentration (Cmax) was (9.98 ±2.93) ng/mL and (9.13 ±2.05) ng/mL; the area under the curve (AUC)(0-t) was (470.76 ±142.64) ng/mL Objective To study the pharmacokinetic and bioavaiiabiiity of donepezi! orally disintegrating tabiet in healthy volunteers with high

  16. Assessment of degree of disorder (amorphicity) of lyophilized formulations of growth hormone using isothermal microcalorimetry.

    Science.gov (United States)

    Mosharraf, Mitra

    2004-05-01

    When determining the degree of disorder of a lyophilized cake of a protein, it is important to use an appropriate analytical technique. Differential scanning calorimetry (DSC) and X-ray powder diffraction (XRPD) are the most commonly used thermoanalytical techniques for characterizing freeze-dried protein formulations. Unfortunately, these methods are unable to detect solid-state disorder at levels IMC) in the assessment of degree of solid-state disorder (amorphicity) of lyophilized formulations of proteins. For this purpose, two formulations of growth hormone were prepared by lyophilization. These formulations consisted of the same amounts of protein, mannitol, glycine, and phosphate buffer, but differed in the freeze-drying procedure. After lyophilization, the recrystallization of the samples was studied using IMC at 25 degrees C under different relative humidities (58-75%). The effect of available surface area was studied by determining the heat of recrystallization (Q) of the samples before and after disintegration of the cakes. The results showed that, in contrast to DSC, IMC allowed detection of the recrystallization event in the formulations. Although both formulations were completely disordered and indistinguishable according to XRPD method, IMC revealed that formulation B had a different solid-sate structure than formulation A. This difference was the result of differences in the freeze-drying parameters, demonstrating the importance of choosing appropriate analytical methodology.

  17. Pharmacokinetic profile of rizatriptan 10-mg tablet and 10-mg orally disintegrating tablet administered with or without water in healthy subjects: an open-label, randomized, single-dose, 3-period crossover study.

    Science.gov (United States)

    Swan, Suzanne K; Alcorn, Harry; Rodgers, Anthony; Hustad, Carolyn M; Ramsey, Karen E; Woll, Susan; Skobieranda, Franck

    2006-02-01

    This open-label, 3-period crossover study compared the plasma concentration profiles of rizatriptan tablet, orally disintegrating tablet with water (ODTc), and ODT without water (ODTs) in 24 healthy volunteers aged 18 to 45 years. At each period, subjects received a single dose of either 10-mg rizatriptan tablet, 10-mg rizatriptan ODTs, or 10-mg rizatriptan ODTc. The authors hypothesized that ODTc has a greater geometric mean AUC(0-2h) than ODTs and that ODTc has a greater geometric mean AUC(0-1h) than tablet. A secondary end point was to compare the time of occurrence of the maximum rizatriptan plasma concentration (t(max)) of each dosing method. ODTc had a statistically significantly greater geometric mean AUC(0-2h) compared with ODTs (33.84 h x ng/mL vs 18.83 h x ng/mL; P rizatriptan tablet (17.07 h x ng/mL vs 13.32 h x ng/mL). The median t(max) was 0.67 hours for ODTc and tablet and 1.33 hours for ODTs. ODTc showed a slightly, but not significantly, faster rate of absorption compared with tablet. ODTs with water had a faster rate of absorption than ODTc. Future studies are needed to determine whether this pharmacokinetic difference produces differential efficacy in a clinical setting.

  18. Storage of ‘umbu-cajá’ pulp powder produced by lyophilization

    Directory of Open Access Journals (Sweden)

    Dyego da C. Santos

    Full Text Available ABSTRACT This work aimed to study the chemical and physical stability of ‘umbu-cajá’ powders produced by lyophilization during storage. ‘Umbu-cajá’ pulps formulated with different concentrations of gum arabic (10, 20 and 30%, previously frozen, were dehydrated in benchtop lyophilizer at -40 °C for 48 h and disintegrated to obtain the powder, which was stored in laminated packages for 180 days at ambient conditions, with physical, chemical and physico-chemical analyzes performed at the beginning and every 30 days of storage. According to the results, all investigated parameters were significantly altered throughout the storage, yet with less intense variations for important variables, such as ascorbic acid, reducing sugars and titratable acidity. At the end of storage, all powders were microbiologically safe.

  19. Bioequivalence of Donepezil Hydrochloride Orally Disintegrating Tablets in Healthy Volunteers%盐酸多奈哌齐口腔崩解片人体生物等效性研究

    Institute of Scientific and Technical Information of China (English)

    宋薇; 杨静; 冯智军; 丁莉坤; 李雪晴; 周伦; 杨林; 文爱东

    2012-01-01

    目的:研究盐酸多奈哌齐口腔崩解片与盐酸多奈哌齐片人体的生物等效性.方法:20名男性健康志愿者随机交叉单剂量口服盐酸多奈哌齐口腔崩解片(受试制剂)与盐酸多奈哌齐片(参比制剂)5 mg,用液质联用法测定人血浆中多奈哌齐的浓度,用DAS 2.1软件计算药动学参数,并评价两制剂的生物等效性.结果:口服受试制剂和参比制剂药动学参数分别为Cmax(8.56±2.10)和(8.08±1.78) ng·ml-1,tmax(2.65±0.74)和(3.05±0.83)h,t1/2 (70.31±19.54)和(71.15±18.47)h,AUC0~216(373.76±94.15)和(353.04±81.42) ng·h·m1-1,AUC0~∞(420.30±110.99)和(399.80±108.56) ng·h·ml-1.受试制剂AUG~216的90%置信区间在参比制剂的等效范围内.结论:两种盐酸多奈哌齐制剂生物等效.%Objective; To study the bioequivalenee of donepezil hydrochloride orally disintegrating tablets and donepezil hydrochlo-ride tablets. Method: 20 healthy male volunteers were enrolled in a randomized crossover study in which the subjects were randomly assigned to receive single dose of 5 mg orally disintegrating tablets (test preparation) or donepezil hydrochloride tablets ( reference preparation). Plasma concentrations of donepezil were determined by liquid chromatography tandem mass spectrometry method. The pharma-cokinetic parameters were calculated by DAS 2. 1 software. Result; The main pharmacokinetic parameters of test and reference preparations after oral administration were as follows;^ of (8.56 ±2. 10) and (8.08 ± 1.78) ng ml"' ,tmax of (2.65 ±0.74) and(3.05 ± 0.83) h,tI/2 of (70.31 ±19.54) and (71.15 ± 18.47) h,AUC0_m of (373.76 ±94.15) and (353.04 ± 81.42) ng -h -ml-', AUC0_, of (420. 30 ±110.99) and (399. 80 ± 108.56) ng -h ml"1. The 90% confidential intervals (CI) of AUC0_2]6 of the test preparation was in the bioequivalent range of the reference preparation. Conclusion; The two kinds of donepezil formulations are bio-equivalent.

  20. Development of lyophilization cycle and effect of excipients on the stability of catalase during lyophilization

    OpenAIRE

    Lale, Shantanu V; Goyal, Monu; Bansal, Arvind K.

    2011-01-01

    Introduction: The purpose of the present study was to screen excipients such as amino acids and non-aqueous solvents for their stabilizing effect on catalase, a model protein, for lyophilization. The present study also includes optimization of lyophilization cycle for catalase formulations, which is essential from the commercial point of view, since lyophilization is an extremely costly process. Materials and Methods: Activity of catalase was determined using catalase activity assay. Differen...

  1. Pharmacokinetics and bioequivalence of terazosin orally disintegrating tablets%盐酸特拉唑嗪口腔崩解片人体生物等效性研究

    Institute of Scientific and Technical Information of China (English)

    张丽; 吴玉柱; 徐海燕; 袁波

    2011-01-01

    Objective To study the pharmacokinetics and bioequivalence between two kinds of terazosin tablets in healthy volunteers. Methods A single oral dose of two kinds of terazosin tablets was given to 18 healthy volunteers in a randomized two-period crossover study. The concentrations of terazosin in plasma were determined by the liquid chromatography tandem mass spectrometry (LC-MS-MS). The plasma concentration-time curves were plotted and the main pharmacokinetic parameters were calculated. Results The main pharmacokinetic parameters of test and reference tablets in plasma were shown as follows: tmax were (1.3 ±0.8) and (1. 2 ±0. 8)h,pmax were (62.9 ±20.4) and (62.0 ± 15.3) μg·Lμ-1 ,t1/2 were (10. 2 ± 1.3) and (10.7 ± 1. 3)h, AUC0-t., were (556.3 ±162.6) and (584.2 ± 124. 2) μg·h·L-1, AUC0-∞, were (576.4 ± 169.9) and (611.7 ± 126.5)μg·H·L-1, respectively. The relative bioavailability of the tested drug was(96. 2 ±22.4) %. Conclusions The two kinds of terazosin formulations are bioequivalent in healthy volunteers.%目的 研究特拉唑嗪口腔崩解片在健康人体内的药动学行为,并以胶囊剂为参比进行生物等效性评价.方法 采用液质联用(LC-MS-MS)法测定服药后受试者血浆中特拉唑嗪的质量浓度并计算主要药动学参数.结果 18名受试者口服含盐酸特拉唑嗪2 mg的受试制剂和参比制剂后,血浆中特拉唑嗪的fmax为(1.3±0.8)、(1.2±0.8)h,ρmax为(62.9±20.4)、(62.0±15.3) μg·L-1,t1/2为(10.2±1.3)、(10.7±1.3)h,AUC0-t为(556.3±162.6)、(584.2±124.2) μg ·h·L-1,AUC0-∞为(576.4±169.9)、(611.7±126.5)μg·h·L-1.以AUC0-t计算,盐酸特拉唑嗪口腔崩解片中特拉唑嗪的相对生物利用度为(96.2±22.4)%.结论 受试制剂和参比制剂具有生物等效性.

  2. Lyophilization for Water Recovery III, System Design

    Science.gov (United States)

    Litwiller, Eric; Reinhard, Martin; Fisher, John; Flynn, Michael

    2005-01-01

    Mixed liquid/solid wastes, including feces, water processor effluents, and food waste, can be lyophilized (freeze-dried) to recover the water they contain and stabilize the solids that remain. Our previous research has demonstrated the potential benefits of using thermoelectric heat pumps to build a lyophilizer for processing waste in microgravity. These results were used to build a working prototype suitable for ground- based human testing. This paper describes the prototype design and presents results of functional and performance tests.

  3. Lyophilization: The process and industrial use

    Directory of Open Access Journals (Sweden)

    Pržić Dejan S.

    2004-01-01

    Full Text Available This article presents a general overview of lyophilization and discusses the underlying principles of the process through the basics of: formulation, freezing, primary drying and secondary drying. In this article lyophilization is defined as a stabilizing process in which the substance is first frozen and then the quantity of the solvent is reduced first by sublimation (primary drying and then by desorption (secondary drying to values that will no longer support biological growth or chemical reactions. Special mention was made of the industrial use of the process and emphasis was placed on the lyophilization of pharmaceutical products and food industry products. Lyophilization equipment, as well as the formulation of materials that can be lyophilized, are described in sufficient detail to give information on the restrictions and advantages of lyophlization. Processing economics and comparison with conventional drying methods are presented. A historical overview of the process and future developments presented from the industrial viewpoint give an insight on the previous application of lyophilization and the prospects of its broad industrial use.

  4. In vitro and in vivo evaluation of lyophilized bovine bone biocompatibility

    Directory of Open Access Journals (Sweden)

    Carlos Roberto Galia

    2008-01-01

    Full Text Available INTRODUCTION: The use of bone grafts in orthopedic, maxillofacial and dental surgery has been growing. Nevertheless, both fresh autografts and frozen allografts have limitations, and therefore, alternative synthetic or natural biomaterials, such as processed and lyophilized bovine bone graft have been developed. OBJECTIVE: To evaluate in vitro and in vivo biocompatibility of lyophilized bovine bone manufactured in a semi-industrial scale, according to a modifical protocol developed by the authors. METHODS: Samples of bovine cancellous bone were processed according to a protocol developed by Kakiuchi et al., and modified to process samples of bovine cancellous bone. The following trials were performed: in vitro cytotoxicity, in vivo acute systemic toxicity, in vivo oral irritation potential, in vitro pyrogenic reaction, and bioburden. RESULTS: The in vitro evaluation of lyophilized bovine cancellous bone revealed an absence of cytotoxicity in 100% of the samples. Regarding in vivo evaluation of acute systemic toxicity, neither macroscopic abnormalities nor deaths were noted in the animals. Pyrogenicity was not greater than 0.125 UE/ml in any of the samples. The bioburden revealed negative results for microbial growth before sterilization. Regarding the oral irritation potential, in vivo evaluation at 24 and 72 hours showed that the animals had no edema or erythema on the oral mucosa. CONCLUSION: The protocol changes established by the authors to prepare lyophilized bovine cancellous bone at a semi-industrial scale is reproducible and yielded a product with excellent biocompatibility.

  5. Trehalose lyophilized platelets for wound healing.

    Science.gov (United States)

    Pietramaggiori, Giorgio; Kaipainen, Arja; Ho, David; Orser, Cindy; Pebley, Walter; Rudolph, Alan; Orgill, Dennis P

    2007-01-01

    Fresh platelet preparations are utilized to treat a wide variety of wounds, although storage limitations and mixed results have hampered their clinical use. We hypothesized that concentrated lyophilized and reconstituted platelet preparations, preserved with trehalose, maintain and possibly enhance fresh platelets' ability to improve wound healing. We studied the ability of a single dose of trehalose lyophilized and reconstituted platelets to enhance wound healing when topically applied on full-thickness wounds in the genetically diabetic mouse. We compared these results with the application of multiple doses of fresh platelet preparations and trehalose lyophilized and reconstituted platelets as well as multiple doses of vascular endothelial growth factor (VEGF) and wounds left untreated. Trehalose lyophilized and reconstituted platelets, in single and multiple applications, multiple applications of fresh platelets and multiple applications of VEGF increased granulation tissue deposition, vascularity, and proliferation when compared with untreated wounds, as assessed by histology and immunohistochemistry. Wounds treated with multiple doses of VEGF and a single dose of freeze-dried platelets reached 90% closure faster than wounds left untreated. A single administration of trehalose lyophilized and reconstituted platelet preparations enhanced diabetic wound healing, therefore representing a promising strategy for the treatment of nonhealing wounds.

  6. 脾氨肽口服冻干粉对小儿肺炎支原体感染的临床疗效及对免疫的影响观察%Influence of Spleen Aminopeptide Oral Lyophilized Powder on the Curative Effect and Immunity of Children with My- coplasma Pneumoniae Infection

    Institute of Scientific and Technical Information of China (English)

    黄丽娜

    2016-01-01

    Objective To explore the clinical effect of spleen aminopeptide oral lyophilized powder for the treatment of children with mycoplasma pneumoniae infection , and analyze the influence to immunity. Methods One hundred cases of children with mycoplasma pneumoniae infection were randomly divided into two groups equally. The control group received routine drug therapy, while the study group received spleen aminopeptide oral lyophilized powder on the basis of routine therapy. The recovery time of clinical symptoms and changes of T-lymphocyte subsets before and after treatment were compared. Results The fever clearance time, disappeared time of cough, and disappeared time of pulmonary rales of study group were significantly shorter than those of control group (P <0.05). After treatment, the levels of CD3+, CD4+and CD4+/CD8+of study group were significantly higher than those of control group, and the level of CD8+was significantly lower than that of control group (P <0.05). Conclusions Spleen aminopeptide oral lyophilized powder has significant effect for the treatment of mycoplasma pneumoniae infection in children, which can effectively improve the immune function, and promote the recovery of disease.%目的:探讨脾氨肽口服冻干粉治疗小儿肺炎支原体感染的疗效及对免疫功能的影响。方法选取2011年4月至2015年4月我院收治的100例肺炎支原体感染患儿作为研究对象,采用随机数字表法将所选患儿分为研究组和对照组,每组各50例,对照组给予常规药物治疗,研究组在对照组的基础上加用脾氨肽口服冻干粉治疗,观察比较两组患儿的临床症状、体征恢复时间及治疗前后T淋巴细胞亚群变化情况。结果研究组患儿热退时间、咳嗽消失时间及肺部啰音消失时间均短于对照组(P<0.05);治疗后研究组患儿CD3+、 CD4+及CD4+/CD8+均高于对照组, CD8+低于对照组(P<0.05)。结论脾氨肽口服冻干粉治疗小儿肺炎

  7. 氯氮平口腔崩解片与氯氮平普通片治疗精神分裂症的对照研究%Comparison study of Clozapine Orally Disintegrating Tablets and Clozapine in the Treatment of Schizophrenia

    Institute of Scientific and Technical Information of China (English)

    蒋丽红

    2013-01-01

    目的比较氯氮平口腔崩解片与氯氮平普通片治疗精神分裂症的疗效及安全性。方法将68例精神分裂症患者随机分为氯氮平口腔崩解片组34例和氯氮平普通片组34例。分别给予氯氮平口腔崩解片和氯氮平普通片治疗8周。分别于治疗前及治疗2、4、6、8周采用阳性与阴性症状量表(PANSS)评定疗效,用不良反应量表(TESS)评定不良反应。结果两组疗效差异无显著性(P>0.05),氯氮平口腔崩解片不良反应显著少于氯氮平普通片。结论氯氮平口腔崩解片和氯氮平普通片对精神分裂症疗效相当,不良反应小,明显改善患者生活质量。%Objective To compare the efficacy and safety of clozapine orally disintegrating tablets and clozapine in the treatment of schizophrenia. Methods There were34 schizophrenia patients in study group treated with clozapine orally disintegrating tablets and34 schizophrenia patients in contyol group with clozapine for the treatment of 8 weeks. The efifcacy was assessed with the positive and negative symptoms scale(PANSS)and TESS was used to evaluate the side effects before and after treatment for. 2.4.6.8 weeks. Restults No signiifcant difference was found in the efifcacy between two groups, but the side effects were signiifcantly less in clozapine orally disintegrating tablets group than in clozapine group. Conclusion Clozapine orally disintegrating tablets and clozapine are similarly effective and safe in the treatment of schizophrenia with improving the patients, quality of life and mild side effects.

  8. Theoretical foundations of ferrosilicium disintegration

    Science.gov (United States)

    Yakushevich, N. F.; Maksimov, A. A.; Pronakin, A. Yu; Polyakh, O. A.

    2016-09-01

    The crystallization processes and solid-phase transformations in alloys FS-75, FS-65, FS-45 and the influence of impurities (aluminum) on the possibility of disintegration of ferroalloys were considered on the basis of state diagrams analysis of Fe - Si and Fe-Si-Al systems. It was shown that the mechanisms of crystallization of melts of different compositions differ quite significantly, both in the chemistry of the process, and in the number and composition of the crystallization products. Process of ferroalloys disintegration depends on many factors: the alloy composition, the degree of superheat, the cooling rate, completeness of solid phase reactions, etc.

  9. Study on Bioequivalence of Ambroxol Hydrochloride Oral Disintegrating Tablets in Healthy Volunteers%盐酸氨溴索口腔崩解片的人体生物等效性研究

    Institute of Scientific and Technical Information of China (English)

    陈白莹; 夏铮铮; 常宏

    2013-01-01

    目的:对生产工艺重大改变前、后盐酸氨溴索口腔崩解片在健康人体的生物等效性进行对比研究.方法:20名健康男性受试者按交叉试验设计方案分别口服受试制剂和参比制剂各30 mg,采集服药后48 h内的动态血标本,以普拉克索为内标,采用液-质联用(LC-MS)法测定血浆中盐酸氨溴索的质量浓度,并用DAS 2.0软件统计分析药动学参数.结果:参比制剂和受试制剂药动学参数分别为:cmax (84.96±32.46)、(90.86±44.81)ng/ml,tmax(1.7±0.7)、(1.4±0.3)h,AUC0-48 h(678.85±235.17)、(663.87±214.37)ng·h/ml,t1/2(9.8±1.9)、(9.7±2.0)h,主要药动学参数无显著性差异.结论:生产工艺重大改变前、后生产的两种制剂生物等效.%OBJECTIVE:To study the bioequivalence of Ambroxol hydrochloride oral disintegrating tablets in healthy volunteers after significant change of manufacturing technology.METHODS:Test preparation and reference preparation each 30 mg were given to 20 male healthy volunteers in randomized two-way crossover design.Blood samples were collected within 48 h after medication using pramipexole as internal standard.Plasma concentrations of ambroxol hydrochloride were determined by LC-MS,and pharmacokinetic parameters were analyzed using DAS 2.0 software.RESULTS:The pharmacokinetics parameters of test preparation and reference preparation were as follows:cmax(84.96 ± 32.46)ng/ml and (90.86 ± 44.81) ng/ml;tmax(1.7 ± 0.7) h and (1.4 ± 0.3) h; AUC0-48 h(678.85 ± 235.17) ng·h/ml and (663.87 ± 214.37)ng·h/ml;t1/2(9.8 ± 1.9) h and (9.7 ± 2.0)h,respectively.There was no significant difference in main pharmacokinetic parameters of them.CONCLUSIONS:Two preparations are bioequivalent after significant change of manufacturing technology.

  10. Study on bioequivalence of ciozapine orally disintegrating tablets in patients with schizophrenia%氯氮平口腔崩解片在精神分裂症患者体内的生物等效性

    Institute of Scientific and Technical Information of China (English)

    刘霞; 黄榕波; 黄锦雄; 邱畅; 张明; 温预关

    2011-01-01

    OBJECTIVE To study the bioequivalence of orally disintegrating tablets and tablets of clozapine in patients with schizophrenia. METHODS The study was a randomized, two-way crossover design in which patients with schizophrenia received test preparation or reference preparation 100 mg twice daily for 10 days. Plasma concentrations of clozapine were determined by HPLC-MS/MS. The pharmacokinetic parameters and relative bioavailability were calculated by DAS. RESULTS The main pharmacokinetic parameters of test preparation or reference preparation were as follows:Cmax were (540. 0 ± 228.3) and (534. 1+205.7) μg·L-1;tmax were(2. 0±0. 9) and (2. 0 + 0. 9)h;t1/2 were(9. 7 ±3. 6)and(11. 4 ±6. 3)h . AUCss were(3 753. 9 ± 1 371. 5)and(3 819. 4± 1 591. 8)μg·h·L-1 , respectively. The mean relative bioavailability of test preparation was(101. 2± 19. 4) %, according to AUCss. CONCLUSION The statistical analysis shows the two preparations are bioequivalent.%目的:研究受试制剂氯氮平口腔崩解片和参比制剂氯氮平片在精神分裂症患者体内的药动学过程并判断两制剂是否具有生物等效性.方法:采用随机双周期,自身交叉设计,20名受试者分别口服受试制剂或参比制剂100 mg,q12 h,连续服用10d后采集血样,HPLC-MS/MS法测定血浆中氯氮平的浓度,DAS软件求算有关药动学参数和相对生物利用度.结果:受试制剂和参比制剂的主要药动学参数Cmax分别为(540.0±228.3) μg·L-1、(534.1±205.7)μg·L-1,tmax分别为(2.0±0.9)h、(2.0±0.9)h,t1/2分别为(9.7±3.6)h、(11.4±6.3)h,AUCss分别为(3753.9±1371.5)μg·h·L-1、(3 819.4±1 591.8)μg·h·L-1;以AUCss计,受试制剂的相对生物利用度为(101.2±19.4)%.20名受试者口服受试制剂口感良好,没有沙砾感,崩解时限为(34.6±10.2)s.结论:两种制剂生物等效.

  11. Lyophilized silica lipid hybrid (SLH) carriers for poorly water-soluble drugs: physicochemical and in vitro pharmaceutical investigations.

    Science.gov (United States)

    Yasmin, Rokhsana; Tan, Angel; Bremmell, Kristen E; Prestidge, Clive A

    2014-09-01

    Lyophilization was investigated to produce a powdery silica-lipid hybrid (SLH) carrier for oral delivery of poorly water-soluble drugs. The silica to lipid ratio, incorporation of cryoprotectant, and lipid loading level were investigated as performance indicators for lyophilized SLH carriers. Celecoxib, a nonsteroidal anti-inflammatory drug, was used as the model poorly soluble moiety to attain desirable physicochemical and in vitro drug solubilization properties. Scanning electron microscopy and confocal fluorescence imaging verified a nanoporous, homogenous internal matrix structures of the lyophilized SLH particles, prepared from submicron triglyceride emulsions and stabilized by porous silica nanoparticles (Aerosil 380), similar to spray-dried SLH. 20-50 wt % of silica in the formulation have shown to produce nonoily SLH agglomerates with complete lipid encapsulation. The incorporation of a cryoprotectant prevented irreversible aggregation of the silica-stabilized droplets during lyophilization, thereby readily redispersing in water to form micrometre-sized particles (drug solubilization than the pure drug under nondigesting and digesting conditions, respectively. The feasibility of lyophilization for producing nanostructured SLH formulations with desirable lipid loading and drug solubilization properties for enhanced oral delivery of poorly water-soluble therapeutics is confirmed. © 2014 Wiley Periodicals, Inc. and the American Pharmacists Association.

  12. Short-term treatment with olanzapine does not modulate gut hormone secretion: olanzapine disintegrating versus standard tablets

    DEFF Research Database (Denmark)

    Vidarsdottir, Solrun; Roelfsema, Ferdinand; Streefland, Trea;

    2009-01-01

    BACKGROUND: Treatment with olanzapine (atypical antipsychotic drug) is frequently associated with various metabolic anomalies, including obesity, dyslipidemia, and diabetes mellitus. Recent data suggest that olanzapine orally disintegrating tablets (ODT), which dissolve instantaneously in the mouth...

  13. Hexaferrite particles by coprecipitation and lyophilization

    Science.gov (United States)

    Calleja, A.; Tijero, E.; Martínez, B.; Piñol, S.; Sandiumenge, F.; Obradors, X.

    1999-05-01

    Fine strontium hexaferrite particles were prepared by lyophilization (known as freeze-drying) and coprecipitation of nitrates and chloride salts, respectively. The resulting powders were calcined at different temperatures between 700°C and 1100°C. As concluded from the measured hysteresis loops at 300 K, the freeze-dried hexaferrite showed good magnetic characteristics, the coercivity being as high as 5690 Oe. However, coprecipitated hexaferrite displayed poor coercivity values, around 1300 Oe at best.

  14. Modeling of Dielectric Heating within Lyophilization Process

    Directory of Open Access Journals (Sweden)

    Jan Kyncl

    2014-01-01

    Full Text Available A process of lyophilization of paper books is modeled. The process of drying is controlled by a dielectric heating system. From the physical viewpoint, the task represents a 2D coupled problem described by two partial differential equations for the electric and temperature fields. The material parameters are supposed to be temperature-dependent functions. The continuous mathematical model is solved numerically. The methodology is illustrated with some examples whose results are discussed.

  15. Lyophilization for Water Recovery From Solid Waste

    Science.gov (United States)

    Flynn, Michael; Litwiller, Eric; Reinhard, Martin

    2003-01-01

    This abstract describes the development of a solid waste treatment system designed for a near term human exploration mission. The technology being developed is an energy- efficient lyophilization technique that recovers water from spacecraft solid waste. In the lyophilization process water in an aqueous waste is frozen and then sublimed, resulting in the separation of the waste into a dried solid material and liquid water. This technology is ideally suited to applications where water recovery rates approaching 100% are desirable but production of CO, is not. Water contained within solid wastes accounts for approximately 3% of the total water balance. If 100% closure of the water loop is desired the water contained within this waste would need to be recovered. To facilitate operation in microgravity thermoelectric heat pumps have be used in place of traditional fluid cycle heat pumps. A mathematical model of a thermoelectric lyophilizer has been developed and used to generate energy use and processing rate parameters. The results of laboratory investigations and discussions with ALS program management have been used to iteratively arrive at a prototype design. This design address operational limitations which were identified in the laboratory studies and handling and health concerns raised by ALS program management. The current prototype design is capable of integration into the ISS Waste Collection System.

  16. Lyophilization for Water Recovery From Solid Waste

    Science.gov (United States)

    Flynn, Michael; Litwiller, Eric; Reinhard, Martin

    2003-01-01

    This abstract describes the development of a solid waste treatment system designed for a near term human exploration mission. The technology being developed is an energy- efficient lyophilization technique that recovers water from spacecraft solid waste. In the lyophilization process water in an aqueous waste is frozen and then sublimed, resulting in the separation of the waste into a dried solid material and liquid water. This technology is ideally suited to applications where water recovery rates approaching 100% are desirable but production of CO, is not. Water contained within solid wastes accounts for approximately 3% of the total water balance. If 100% closure of the water loop is desired the water contained within this waste would need to be recovered. To facilitate operation in microgravity thermoelectric heat pumps have be used in place of traditional fluid cycle heat pumps. A mathematical model of a thermoelectric lyophilizer has been developed and used to generate energy use and processing rate parameters. The results of laboratory investigations and discussions with ALS program management have been used to iteratively arrive at a prototype design. This design address operational limitations which were identified in the laboratory studies and handling and health concerns raised by ALS program management. The current prototype design is capable of integration into the ISS Waste Collection System.

  17. Hygroscopic behavior of lyophilized acerola pulp powder

    Directory of Open Access Journals (Sweden)

    Luciana C. Ribeiro

    2016-03-01

    Full Text Available ABSTRACT Powder products are characterized by their practicality and long life. However, fruit powders have high hygroscopicity and tend to agglomerate due to its hydrophilic nature. The isotherms of equilibrium moisture content apply to the study of dehydrated food preservation potential. Acerola is a nutritionally rich fruit, with great economic and industrial potential. The objective of this study was to analyse acerola powder adsorption isotherms obtained by lyophilization and characterize the powder obtained from lyophilized acerola pulp. Analysis of hygroscopicity, solubility and degree of caking were performed. Isotherms were represented by the mathematical models of GAB, BET, Henderson and Oswin, at temperatures of 25, 35 and 45 °C. According to the results, the obtained powder showed hygroscopicity of 5.96 g of absorbed water 100g-1 of solids, solubility of 95.08% and caking of 14.12%. The BET model showed the best fit to the adsorption isotherms of the acerola pulp powder obtained by lyophilization. The obtained isotherm was of type III, with a "J" shape. There was an inversion of the effect of temperature on the isotherms of acerola powders.

  18. Characterizing Protein Structure, Dynamics and Conformation in Lyophilized Solids

    OpenAIRE

    Moorthy, Balakrishnan S.; Iyer, Lavanya K.; Topp, Elizabeth M.

    2015-01-01

    The long-term stability of protein therapeutics in the solid-state depends on the preservation of native structure during lyophilization and in the lyophilized powder. Proteins can reversibly or irreversibly unfold upon lyophilization, acquiring conformations susceptible to degradation during storage. Therefore, characterizing proteins in the dried state is crucial for the design of safe and efficacious formulations. This review summarizes the basic principles and applications of the analytic...

  19. Effect of Spleen Aminopeptide Oral Lyophilized Powder on urinary RBP and CRP in children with mycoplasma pneumoniae infection and asthma%脾氨肽口服冻干粉对小儿支原体感染肺炎伴哮喘患者尿视黄醇结合蛋白与C反应蛋白的影响研究

    Institute of Scientific and Technical Information of China (English)

    陈咏丽; 李俊华

    2015-01-01

    目的:探讨脾氨肽口服冻干粉对小儿支原体感染肺炎伴哮喘患者尿视黄醇结合蛋白(retinol-binding protein,RBP)及C反应蛋白(C reactive protein,CRP)的影响效果。方法选取华中科技大学同济医学院附属普爱医院儿科收治的支原体肺炎伴哮喘患者60例,随机分为2组,其中对照组30例,予常规阿奇霉素抗炎治疗。实验组30例,予脾氨肽口服冻干粉治疗,2组均治疗7 d。正常组30例,选取健康儿童,不予任何治疗。治疗结束后,对比2组患儿尿视黄醇结合蛋白、尿素氮、肌酐、咳喘、哮鸣音症状恢复情况、C反应蛋白、血常规等水平变化情况。结果2组患儿尿视黄醇结合蛋白、尿素氮、肌酐水平不同程度改善,且实验组尿视黄醇结合蛋白、尿素氮、肌酐较对照组明显降低( P<0.05);2组患儿咳喘、哮鸣音均不同程度改善,且实验组咳喘、哮鸣音、咳喘恢复时间、哮鸣音恢复时间较对照组改善明显(P<0.05);2组C反应蛋白及白细胞水平均不同程度改善,且实验组C反应蛋白和白细胞水平较对照组明显降低( P<0.05)。结论脾氨肽口服冻干粉能够明显改善患儿支原体肺炎感染状况,并缓解咳喘及哮鸣音症状,降低尿视黄醇结合蛋白及C反应蛋白等水平,改善因缺氧所致肾脏等功能损害。%Objective To investigate effect of Splenic Aminopeptide Oral Lyophilized Powder on urinary retinol-binding protein and CRP in children of mycoplasma pneumonia infection with asthma .Methods 60 cases were randomly divided into 2 groups, 30 cases of control group were given conventional anti-inflammatory treatment, azithromycin.30 patients of Experimental group were treated with Spleen Aminopeptide Oral Lyophilized Powder treatment, two groups were treated for 7 days.30 cases of healthy children were selected, given no any treatment.After treatment, urinary

  20. Clinical observation of aripiprazole orally disintegrating tablets in the improvement of women's weight,prolactin increase caused by risperidone,sulpiride,olanzapine%阿立哌唑口腔崩解片改善利培酮、舒必利、奥氮平致女性体重、泌乳素增加的临床观察

    Institute of Scientific and Technical Information of China (English)

    卓子禄; 王群英; 熊英; 胡俊英

    2015-01-01

    目的:探讨阿立哌唑口腔崩解片改善利培酮、舒必利、奥氮平等精神类药物所致体重、泌乳素增加的临床效果。方法:收治因服用利培酮、舒必利、奥氮平等精神类药物后引起体重增加及高催乳素血症患者60例,所有患者均维持原抗精神类药物的治疗方案,根据随机数字表将患者分为阿立哌唑口腔崩解片组(观察组)30例和安慰剂组(对照组)30例,两组患者干预12周后测量患者体质指数(BMI)变化及催乳素(PRI)的水平,同时采用不良反应量表(TESS)评定阿立哌唑口腔崩解片治疗的不良反应。结果:与对照组相比,观察组治疗后 BMI 及PRL 显著下降,差异有统计学意义(P<0.01)。观察组总有效率93.33%,对照组总有效率76.67%,两组比较有统计学意义(P<0.05)。TESS 评分观察组(5.12±1.12)分,对照组(4.98±1.08)分,两组比较差异无统计学意义(P>0.05)。结论:阿立哌唑口腔崩解片能有效改善利培酮、舒必利、奥氮平等抗精神病药所致体重、泌乳素增加症状,且安全、可靠,值得临床应用和推广。%Objective:To explore the clinical effect of aripiprazole orally disintegrating tablets in the improvement of women's weight,prolactin increase caused by sulpiride,risperidone,olanzapine.Methods:60 cases of weight gain and hyperprolactinemic patients caused by sulpiride,risperidone,olanzapine were selected.All patients maintained antipsychotic drug treatment scheme of the original.According to the random number table,they were divided into the aripiprazole orally disintegrating tablets group(observation group) with 30 cases and the placebo group(control group) with 30 cases.After 12 weeks of treatment,we measured body mass index patients(BMI) changes and prolactin(PRI) level.At the same time,we evaluated the adverse reactions of aripiprazole orally disintegrating tablets treatment using side effects scale

  1. Brexit and the problem of European disintegration

    DEFF Research Database (Denmark)

    Rosamond, Ben

    2016-01-01

    The Brexit referendum provokes speculation about the likelihood of European disintegration. This article discusses how scholarship might deal with the issue of disintegration and argues that it should be thought of as an indeterminate process rather than an identifiable outcome. Within the EU...... system, Brexit is likely to unleash disintegrative dynamics, which could see the EU stagnate into a suboptimal institutional equilibrium. At the same time, EU studies needs to lift its gaze beyond the internal dynamics of the EU system to consider the disintegration of the democratic capitalist compact...

  2. Brexit and the problem of European disintegration

    DEFF Research Database (Denmark)

    Rosamond, Ben

    2016-01-01

    The Brexit referendum provokes speculation about the likelihood of European disintegration. This article discusses how scholarship might deal with the issue of disintegration and argues that it should be thought of as an indeterminate process rather than an identifiable outcome. Within the EU...

  3. Studies on Lyophilization of Sabin Vaccine 2. Investigation on Long Time Incubation at High and Low Temperatures of Lyophilized Sabin Vaccine

    OpenAIRE

    塩見, 洋; 浦沢, 价子; 浦沢, 正三

    1998-01-01

    Lyophilization of vaccine is one of the possible options for the development of a heat-stable poliovaccine. In our previous study in which conditions affecting the lyophilization of Sabin poliovaccine were investigated, it was found that infectivity titration of lyophilized viruses was under at least three kind of variabilities i. e., i) the variability among different lyophilization experi-ments, ii) the variability within the same lyophilization experiment and iii) the variability inherent ...

  4. Rapid disintegrating tablets of simvastatin dispersions in polyoxyethylene–polypropylene block copolymer for maximized disintegration and dissolution

    Science.gov (United States)

    Balata, Gehan F; Zidan, Ahmad S; Abourehab, Mohamad AS; Essa, Ebtessam A

    2016-01-01

    The objective of this research was to improve the dissolution of simvastatin and to incorporate it in rapid disintegrating tablets (RDTs) with an optimized disintegration and dissolution characteristics. Polyoxyethylene–polypropylene block copolymer (poloxamer 188) was employed as a hydrophilic carrier to prepare simvastatin solid dispersions (SDs). Fourier transform infrared spectroscopy, differential scanning calorimetry (DSC) and X-ray diffractometry were employed to understand the interaction between the drug and the carrier in the solid state. The results obtained from Fourier transform infrared spectroscopy showed absence of any chemical interaction between the drug and poloxamer. The results of differential scanning calorimetry and X-ray diffractometry confirmed the conversion of simvastatin to distorted crystalline state. The SD of 1:2 w/w drug to carrier ratio showed the highest dissolution; hence, it was incorporated in RDT formulations using a 32 full factorial design and response surface methodology. The initial assessments of RDTs demonstrated an acceptable flow, hardness, and friability to indicate good mechanical strength. The interaction and Pareto charts indicated that percentage of croscarmellose sodium incorporated was the most important factor affecting the disintegration time and dissolution parameter followed by the hardness value and their interaction effect. Compression force showed a superior influence to increase RDT’s porosity and to fasten disintegration rather than swelling action by croscarmellose sodium. On the other hand, croscarmellose sodium was most important for the initial simvastatin release. The results suggest the potential use of poloxamer 188-based SD in RDT for the oral delivery of poor water-soluble antihyperlipidemic drug, simvastatin. PMID:27757012

  5. Clinical and immunohistochemical performance of lyophilized platelet-rich fibrin (Ly-PRF) on tissue regeneration.

    Science.gov (United States)

    Zhang, Jianming; Qi, Xingying; Luo, Xiaoding; Li, Dan; Wang, Haorong; Li, Ting

    2017-06-01

    Platelet-rich fibrin (PRF) has been widely used in oral implantology and other fields, but benefits of the fresh PRF (FPRF (fresh platelet-rich fibrin)) were consequently limited because of its short-term application. Thus, a protocol for the combination of PRF and lyophilization comes up in the present study to address the issue of PRF storage and delayed clinical application, which has little been reported in this field at home and abroad by now. The aim of the present study was to evaluate the applicability of lyophilized platelet-rich fibrin (Ly-PRF) used as the scaffold material for craniofacial tissue regeneration and to compare its biochemical properties with commonly used fresh PRF. Two volunteers with both genders were selected as the source of PRF and Ly-PRF samples. Macro- and micro-scopic appearance evaluation as well as immunohistochemical comparison were performed on PRF samples before and after freeze-drying at -196°C. The second experimental phase was to observe clinical performance when fresh and lyophilized PRF were applied in guided bone regeneration (GBR) operations in 39 patients losing teeth in the anterior maxillary region who required an oral implantation followed by labial bone grafting. The conventional histological and transmission electron microscopy images showed the microstructure of Ly-PRF, which resembled a mesh containing apparently irregularly shaped platelets with less alpha-granule than fresh PRF in micro and a translucent membrane with less elasticity than fresh PRF in macro. Simultaneous immunohistological staining results showed positive expression of PDGF-BB, IL-1, IL-4, TNF, TGF-β1 in both fresh and lyophilized PRF, while the expression of PDGF-BB, IL-1, TNF, TGF-β1 has no statistical difference between them (P > .05) but that of IL-4 in Ly-PRF is statistically higher than in fresh PRF (P  .05). This study strongly supports that lyophilization at -196°C does not largely influence the expression of bioactive

  6. 氯氮平联合抗精神病药治疗精神分裂症阴性症状的效果分析%Analysis of efficacy of antipsychotics combined with clozapine orally disintegrating tablets in the treatment of schizophrenia with negative ysmptoms

    Institute of Scientific and Technical Information of China (English)

    蒋丽红; 雷佳峰; 彭灵芝; 许芳; 李玉章; 李亚玲

    2013-01-01

      目的探讨氯氮平口腔崩解片联合抗精神病药治疗精神分裂症阴性症状的效果及安全性。方法以阴性症状为主的精神分裂症患者50例,随机分为观察组(服用抗精神病药物联合氯氮平口腔崩解片)和对照组(单用抗精神病药物),各25例,疗程8周,按阳性与阴性症状量表( PANSS)及有关实验室检查结果评定疗效,分别于治疗前后各评定1次。结果观察组显效17例(68.0%),有效7例,无效1例;对照组显效10例(40.0%),有效12例,无效3例;观察组显效率高于对照组( P <0.05)。治疗8周后,两组各项评分均较治疗前明显下降( P <0.01);治疗后,观察组阴性症状分低于对照组( P <0.05)。结论抗精神病药物联合氯氮平口腔崩解片治疗以阴性症状为主的精神分裂症有较好的疗效,不良反应少。%Objective To explore the efficacy and safety of antipsychotics combined with clozapine orally disintegrating tablets in the treatment of schizophrenia with negative symptoms .Mtehod s Fifty cases of schizophrenia mainly with negative symptoms were randomly divided into obsevation group ( treated with antipsychotics and clozapine orally disintegrating tablets ) and control group ( treated with antipsychotics ) .The course of treatment was eight weeks .Indicators included Positive and Negative Symptoms Scale ( PANSS) and Treatment Emergent Symptom scale ( TESS) before and after treatment .Restults The significant improvement rate was higher in the observation group(68.0%)than that of the control group(40%).Eight weeks after treatment,the total scores and negative symptoms scores of PANSS were significantly lower in both observation groups than these of the patients before treatment ( P <0.01).The nega-tive symptom scores of the observation group was lower than that of the control group after treatment ( P <0.05).Conclusion Antip-sychotics combined

  7. 氨磺必利与阿立哌唑口崩片治疗以阴性症状为主的精神分裂症的临床对照研究%A controlled clinical study of amisulpride and aripiprazole orally disintegrating tablets in treatment of negative schizophrenia

    Institute of Scientific and Technical Information of China (English)

    刘晓

    2014-01-01

    目的:比较氨磺必利和阿立哌唑口崩片治疗以阴性症状为主的精神分裂症的临床疗效和安全性。方法采用随机对照研究,将64例符合《中国精神障碍分类与诊断标准(第3版)》(CCMD-3)诊断标准的以阴性症状为主的精神分裂症患者按照入组先后顺序分为氨磺必利组(研究组)和阿立哌唑口崩片组(对照组)各32例,疗程8周,采用阳性和阴性症状量表( PANSS)评定疗效,采用副反应量表( TESS)评定不良反应。结果治疗8周后,两组PANSS评分均下降(P>0.05),氨磺必利组和阿立哌唑口崩片组有效率分别为90.63%,87.5%,差异无统计学意义(P>0.05)。两组TESS评分分别为(3.98±1.03)分、(4.07±1.89)分,差异无统计学意义(P>0.05)。结论氨磺必利与阿立哌唑口崩片治疗以阴性症状为主的精神分裂症疗效相当,不良反应轻。%Objective To compare the efficacy and safety between amisulpride and aripiprazole in treatment of negative schizo-phrenia. Methods Using randomized controlled trials in this study, 64 patients diagnosed with negative schizophrenia were randomly divided into amisulpride group (study group) and aripiprazole orally disintegrating tablets group (control group). The positive and negative scale ( PANSS) was used to evaluate the efficacy, and treatment emergent side effect scale ( TESS) was used to evaluate the advese reactions. The course of treatment was eight weeks. Results PANSS(P>0. 05) scores of the two groups were both significant-ly decreased after 8 weeks, the efficacy rates of amisulpride group and aripiprazole orally disintegrating tablets group were 90. 63% and 87. 5%, which two groups showed no significant difference fromχ2 test (P>0. 05). The TESS scores of amisulpride group and aripi-prazole group were(3. 98 ± 1. 03)and(4. 07 ± 1. 89), The TESS scores of two groups also showed no significant difference by t-test (P>0. 05). Conclusion Amisulpride are as effective as Aripiprazole orally

  8. Protein aggregation and lyophilization: Protein structural descriptors as predictors of aggregation propensity

    OpenAIRE

    Roughton, Brock C.; Iyer, Lavanya K.; Bertelsen, Esben; Topp, Elizabeth M.; Camarda, Kyle V.

    2013-01-01

    Lyophilization can induce aggregation in therapeutic proteins, but the relative importance of protein structure, formulation and processing conditions are poorly understood. To evaluate the contribution of protein structure to lyophilization-induced aggregation, fifteen proteins were co-lyophilized with each of five excipients. Extent of aggregation following lyophilization, measured using size-exclusion chromatography, was correlated with computational and biophysical protein structural desc...

  9. Evaluation of quick disintegrating calcium carbonate tablets

    OpenAIRE

    Fausett, Hector; Gayser, Charles; Dash, Alekha K.

    2000-01-01

    The purpose of this investigation was to develop a rapidly disintegrating calcium carbonate (CC) tablet by direct compression and compare it with commercially available calcium tablets. CC tablets were formulated on a Carver press using 3 different forms of CC direct compressed granules (Cal-Carb 4450®, Cal-Carb 4457®, and Cal-Carb 4462®). The breaking strength was measured using a Stokes-Monsanto hardness tester. The disintegration and dissolution properties of the tablets were studied using...

  10. Effects of wall materials and lyophilization on the viability of ...

    African Journals Online (AJOL)

    Effects of wall materials and lyophilization on the viability of Weissella confusa. ... AFRICAN JOURNALS ONLINE (AJOL) · Journals · Advanced Search ... (Aloe vera gel, sodium casein, and sodium alginate) as wall materials, were used.

  11. A Comparison of Factors that Influence the Lyophilization Process

    OpenAIRE

    Dumitru Mnerie; Gabriela-victoria Anghel; Alin Vasile Mnerie; Constantin Cheveresan

    2007-01-01

    The lyophilization (or freeze drying) process for agro-foods products depends on a series of technological factors that are in an inter-dependence with the process performance. This paper presents an expert method and its application. This method characterizes the influence factors of the lyophilization process, after the importance level of some factors in correlation with other factors, is defined. Only the most important factors were considered; influence considerations were made in relati...

  12. 速崩钙片剂的研究%The studies on rapidly disintegrating calcium tablets

    Institute of Scientific and Technical Information of China (English)

    林文辉; 崔福德; 雷永; 何继东; 朴洪泽

    2001-01-01

    In order to produce calcium tablets which can rapidly disintegrate in the oral cavity and reduce irritation,the calcium carbonate powders (size between 0.1~20 μm) were prepared by a chemical reaction. Furthermore, the disintegration properties of sodium carboxyl methyl starch (CMS-Na), calcium carboxyl methyl cellulose (ECG-505), pregelatinized starch (PCS), and croscarmellose sodium were investigated under different pressures, and in different ratios. The CMS-Na and croscarmellose sodium were chosen as the disintegrant to make calcium tablets possess excellent disintegration property. The results showed that the disintegration time of the tablets could shorten by 45 seconds.%为了制得崩解迅速,吸收良好的钙制剂,利用化学反应的方法制得粒径为0.1~20 μm的碳酸钙,并对羧甲基淀粉钠、羧甲基纤维素钙、可压性淀粉和交联羧甲基纤维素钠四种崩解剂的性质进行考察,选择了崩解性能良好的羧甲基淀粉钠和交联羧甲基纤维素钠作为崩解剂,将其制成片剂。片剂崩解时间可达45 s。

  13. Formulation and evaluation of nanocrystalline cellulose as a potential disintegrant.

    Science.gov (United States)

    Wang, Chengyu; Huang, Huijin; Jia, Min; Jin, Shanshan; Zhao, Wenjing; Cha, Ruitao

    2015-10-05

    Disintegrant is a typical excipient that improves the solubility, dissolution and bioavailability of drug. In this study, the application of nanocrystalline cellulose (NCC) as a potential disintegrant in the preparation of tablet was investigated. Angle of repose of NCC was 44.26° which was between L-HPC and MCC suggesting a good fluidity of NCC. Swelling property of NCC was between CMS-Na and MCC indicating that NCC was of good absorbent ability. Carbonate calcium tablet of which NCC was used as a disintegrant exhibited fastest disintegration time than known disintegrants. The disintegration and dissolution tests demonstrated that NCC showed effective disintegrant properties, e.g. consistently fast disintegration, rapid dissolution, and effectiveness at low concentrations. Thus, we believe that NCC has a great potential as a disintegrant in tablets.

  14. LYOPHILIZATION EFFECT ON PRODUCTIVITY OF BUTANOL-PRODUCING STRAINS

    Directory of Open Access Journals (Sweden)

    O. O. Tigunova

    2016-10-01

    Full Text Available Investigation of lyophilization effect on the productivity of butanol-producing strains was the aim of our research. For this purpose we used butanol-producing strains; technical glycerol; biomass of switchgrass Panicum virgatum L. Lyophilization was performed using a lyophilization-drying. The effect of the protective medium on residual moisture of freezedrying cultures suspensions depending on the concentration of glucose and sucrose was studed. It was shown that the lowest residual moisture was attained by using glucose and sucrose in amount of 10% and if the samples of freeze-drying bacteria had been saved for one month at 4 οC the productivity did not decrease. As temperature preservation was increased the productivity of the cultures was gradually decreased and it was greatly reduced at 30 οC. So the protective medium composition was optimized for lyophilization of butanol-producing strains as follows: sucrose 10.0%; gelatin 10.0%; agar 0.02%. It was shown that the preservation of samples of freeze-drying bacteria for six months at a temperature of 4 οC did not affect the productivity of strains. It was found that cultures could use glycerol as a carbon source for butanol accumulation before lyophilization.

  15. Lyophilization as a method for pathogens long term preservation

    Directory of Open Access Journals (Sweden)

    Milošević Mirjana B.

    2007-01-01

    Full Text Available Lyophilization (freeze-drying is one of the most suitable methods used for a long term preservation of pathogens. The aim of this paper was the application of lyophilization for storage of three significant plant pathogens: Fusarium graminearum, Helminthosporium gramineum, and Pseudomonas syringae pv. gylicinea, respectively. The plant material was collected continuously (during a four year period 2002-2006, depending on a plant development stage, from different localities in Vojvodina. Pathogens were isolated from diseased parts with characteristic symptoms, and placed on nutritive media specific for a certain pathogen, using standard phytopathological methods. Lyophilization was carried out in marked and coded ampoules by freezing and drying of pathogen suspension and nutritive medium. Revitalization of lyophilized isolates was done after four days. High percentage of revitalization was characteristic for all studied isolates, and it ranged from 85-92%, confirming that lyophilized pathogens would be capable of keeping viability for a long time in the collection. Besides above mentioned pathogens, there were 200 isolates in the collection, originating mostly from field and vegetable crops. Each isolate that was put into the Collection, was followed by all the necessary data such as: name of the pathogen, number of isolates, locality, host plant year of isolation, name of the researcher and other relevant data.

  16. Mild disintegration of green microalgae and macroalgae

    NARCIS (Netherlands)

    Postma, Richard

    2016-01-01

    An increased worldwide protein demand for food and feed and the necessity to release the water soluble proteins in the first stage of the cascade biorefinery require the development of mild protein extraction technologies. Cell disintegration is the first hurdle and is considered as one of the most

  17. Is the second language acquisition discipline disintegrating?

    NARCIS (Netherlands)

    Hulstijn, J.H.

    2013-01-01

    After characterizing the study of second language acquisition (SLA) from three viewpoints, I try to answer the question, raised by DeKeyser (2010), of whether the SLA field is disintegrating. In answering this question, I first propose a distinction between SLA as the relatively fundamental academic

  18. Evaluation of quick disintegrating calcium carbonate tablets.

    Science.gov (United States)

    Fausett, H; Gayser, C; Dash, A K

    2000-07-02

    The purpose of this investigation was to develop a rapidly disintegrating calcium carbonate (CC) tablet by direct compression and compare it with commercially available calcium tablets. CC tablets were formulated on a Carver press using 3 different forms of CC direct compressed granules (Cal-Carb 4450, Cal-Carb 4457, and Cal-Carb 4462). The breaking strength was measured using a Stokes-Monsanto hardness tester. The disintegration and dissolution properties of the tablets were studied using USP methodology. The calcium concentration was determined by an atomic absorption spectrophotometer. Scanning electron microscopy was used to evaluate the surface topography of the granules and tablets. Breaking strength of Cal-Carb 4450, Cal-Carb 4457, and Cal-Carb 4462 tablets was in the range of 7.2 to 7.7 kg, as compared with a hardness of 6.2 kg and 10 kg for the commercially available calcium tablets Citracal and Tums, respectively. The disintegration time for the tablets presented in the order earlier was 4.1, 2.1, 1.9, 2.9, and 9.7 minutes, respectively. The dissolution studies showed that all formulations released 100% of the elemental calcium in simulated gastric fluid in less than 20 minutes. In summary, this study clearly demonstrated that quick disintegrating CC tablets can be formulated without expensive effervescence technology.

  19. Photolytic labeling to probe molecular interactions in lyophilized powders.

    Science.gov (United States)

    Iyer, Lavanya K; Moorthy, Balakrishnan S; Topp, Elizabeth M

    2013-12-02

    Local side-chain interactions in lyophilized protein formulations were mapped using solid-state photolytic labeling-mass spectrometry (ssPL-MS). Photoactive amino acid analogues (PAAs) were used as probes and either added to the lyophilized matrix or incorporated within the amino acid sequence of a peptide. In the first approach, apomyoglobin was lyophilized with sucrose and varying concentrations of photoleucine (L-2-amino-4,4'-azipentanoic acid; pLeu). The lyophilized solid was irradiated at 365 nm to initiate photolabeling. The rate and extent of labeling were measured using electrospray ionization/high-performance liquid chromatography/mass spectrometry (ESI-HPLC-MS), with labeling reaching a plateau at ~30 min, forming up to six labeled populations. Bottom-up MS/MS analysis was able to provide peptide-level resolution of the location of pLeu. ssPL-MS was also able to detect differences in side-chain environment between sucrose and guanidine hydrochloride formulations. In the second approach, peptide GCG (1-8)* containing p-benzoyl-L-phenylalanine (pBpA) in the amino acid sequence was lyophilized with various excipients and irradiated. Peptide-peptide and peptide-excipient adducts were detected using MS. Top-down MS/MS on the peptide dimer provided amino acid-level resolution regarding interactions and the cross-linking partner for pBpA in the solid state. The results show that ssPL-MS can provide high-resolution information about protein interactions in the lyophilized environment.

  20. A comparative study on risperidone orally disintegrating tablets and retard tablets of magnesium valproate treatment in hallucination of schizophrenia%利培酮联合丙戊酸镁治疗伴有幻觉的精神分裂症患者的疗效观察

    Institute of Scientific and Technical Information of China (English)

    王小全; 马素杰; 穆小梅; 周海晓

    2016-01-01

    Objective:Observation of risperidone orally disintegrating tablets combined treatment with retard tablets of magne-sium valproate of the efficacy and safety in hallucination of schizophrenia. Methods:80 schizophrenic patientsmet ICD-10 criteria for schizophrenia and haiiucination with schizophrenia were randomly divided in to groups. With one treated with retard tablets of magnesi-um valproate combined treatment risperidone orally disintegrating tablets and the other with only using risperidone orally disintegrating tablets. Effects and side effects and social function were assessed with Positive And Negative Syndrome Scale ( PANSS) , Treatment E-mergent Symptoms Scale(TESS) and the A Rating Scale for Extrapyramidal Side Effects(RSESE) respectively beforeand after 2,4,6 weeks treatment. Efficacy and safety of the treatment were assessed respectively by Hallucinatory behavior ( p3 ) points reduction in PANSS. Results:The clinical efficiency of experimental and control groups were 90% and 72. 5%, respectively. The difference was significant between the groups(P<0. 05). P3 in PANSS scale points of the clinical efficiency of experimental in the first week has dropped significantly (P<0. 05), While the control group decreased significantly in the second week(P<0. 05). Positive symptoms scale score of the clinical efficiency of experimental in the first week has decreased obviously (P<0. 05) ,While the control group de-creased significantly in the second week(P<0. 05);Team's activation and aggressive factor points of the clinical efficiency of experi-mental in the first weekend have declined significantly (P<0. 05),While the control group decreased significantly in the second week (P<0. 05). Conclusions: Risperidone combined valproic acid magnesium combination than risperidone for schizophrenia hallucina-tions effect more apparent.%目的:观察利培酮联合丙戊酸镁治疗伴有幻觉的精神分裂症患者的疗效及安全性。方法:将80例符合ICD-10

  1. Effects of disintegration-promoting agent, lubricants and moisture treatment on optimized fast disintegrating tablets.

    Science.gov (United States)

    Late, Sameer G; Yu, Yi-Ying; Banga, Ajay K

    2009-01-05

    Effects of calcium silicate (disintegration-promoting agent) and various lubricants on an optimized beta-cyclodextrin-based fast-disintegrating tablet formulation were investigated. Effects of moisture treatment were also evaluated at 75, 85 and 95% relative humidities. A two factor, three levels (3(2)) full factorial design was used to optimize concentrations of calcium silicate and lubricant. Magnesium stearate, being commonly used lubricant, was used to optimize lubricant concentration in optimization study. Other lubricants were evaluated at an obtained optimum concentration. Desiccator with saturated salt solutions was used to analyze effects of moisture treatments. Results of multiple linear regression analysis revealed that concentration of calcium silicate had no effect; however concentration of lubricant was found to be important for tablet disintegration and hardness. An optimized value of 1.5% of magnesium stearate gave disintegration time of 23.4 s and hardness of 1.42 kg. At an optimized concentration, glycerol dibehenate and L-leucine significantly affected disintegration time, while talc and stearic acid had no significant effect. Tablet hardness was significantly affected with L-leucine, while other lubricants had no significant effect. Hardness was not affected at 75% moisture treatment. Moisture treatment at 85 and 95% increased hardness of the tablets; however at the same time it negatively affected the disintegration time.

  2. The influence of excipients on physical and pharmaceutical properties of oral lyophilisates containing a pregabalin-acetaminophen combination.

    Science.gov (United States)

    Chiriac, Aurica P; Diaconu, Alina; Nita, Loredana E; Tudorachi, Nita; Mititelu-Tartau, Liliana; Creteanu, Andreea; Dragostin, Oana; Rusu, Daniela; Popa, Gratiela

    2017-05-01

    The purpose of the study was to investigate and characterize the oral lyophilisates containing the pregabalin-acetaminophen drug combination and as xcipients mannitol with microcrystalline cellulose or hydroxypropyl methylcellulose, in order to conclude upon drug-excipient interactions and their stability implications, impact of excipients on drug release and on the physicochemical and mechanical properties of the pharmaceutical formulations. The oral tablets were made by using a Christ freeze-dryer alpha 2-4-LSC lyophilizer, and evaluated for stability, drug-excipient compatibility and homogeneity of the prepared pharmaceutical formulations. The formulations were evaluated for in vivo absorption in rabbits by histopathological exams. FTIR and thermogravimetric analyses, DLS technique, SEM and NIR-CI studies confirmed the compatibility between compounds. From the determined physical and biochemical parameters of the formulations it was established that they are stable, homogeneous, and meet the conditions for orally disintegrating tablets. In the case of the investigated pharmaceutical formulations the study evidenced the assembling through physical bonds between the excipients and the 'codrug' complex, which do not affect the release of the bioactive compounds.

  3. Improving Activity of Salt-Lyophilized Enzymes in Organic Media

    Science.gov (United States)

    Borole, Abhijeet P.; Davison, Brian H.

    Lyophilization with salts has been identified as an important method of activating enzymes in organic media. Using salt-activated enzymes to transform molecules tethered to solid surfaces in organic phase requires solubilization of enzymes in the solvents. Methods of improving performance of salt-lyophilized enzymes, further, via chemical modification, and use of surfactants and surfactants to create fine emulsions prior to lyophilization are investigated. The reaction system used is transesterification of N-acetyl phenylalanine ethyl ester with methanol or propanol. Initial rate of formation of amino acid esters by subtilisin Carlsberg (SC) was studied and found to increase two to sevenfold by either chemical modification or addition of surfactants in certain solvents, relative to the salt (only)-lyophilized enzyme. The method to prepare highly dispersed enzymes in a salt-surfactant milieu also improved activity by two to threefold. To test the effect of chemical modification on derivatization of drug molecules, acylation of bergenin was investigated using chemically modified SC.

  4. Lyophilization: a useful approach to the automation of analytical processes?

    OpenAIRE

    de Castro, M. D. Luque; Izquierdo, A.

    1990-01-01

    An overview of the state-of-the-art in the use of lyophilization for the pretreatment of samples and standards prior to their storage and/or preconcentration is presented. The different analytical applications of this process are dealt with according to the type of material (reagent, standard, samples) and matrix involved.

  5. Long Shelf Life of a Lyophilized DNA Aptamer Beacon Assay.

    Science.gov (United States)

    Bruno, John G

    2017-03-01

    An aptamer beacon previously developed to detect C-telopeptide (CTx) from human bone collagen breakdown was lyophilized and shown to give a "lights on" concentration-dependent spectral fluorescence response essentially identical to that of the fresh reagent despite storage in a dark dry environment for the past 5.5 years.

  6. Rational estimation of the optimum amount of non-fibrous disintegrant applying percolation theory for binary fast disintegrating formulation.

    Science.gov (United States)

    Krausbauer, Etienne; Puchkov, Maxim; Betz, Gabriele; Leuenberger, Hans

    2008-01-01

    The purpose of this study was to propose a method of determining the exact value of disintegrant ratio in a binary drug-disintegrant compacted mixture for a minimum disintegration time in the case of spherical particles. Disintegration is a limiting factor in dissolution process of compact for low water soluble active ingredients. As disintegration time is shortest at a certain ratio of disintegrant, a calculation of this value is important for solid dosage from design to enhance disintegration and dissolution process. According to percolation theory, a minimum disintegration time corresponds to the formation of a continuous water-conducting cluster through the entire tablet. The critical volumetric ratio at which the cluster is formed is named percolation threshold and has the value of 0.16 for random close packed (RCP) sphere systems. RCP systems where chosen as the best model for compacts consisting of spherical particles. Two cases for water diffusion through the tablet were identified, according to geometrical considerations between disintegrant and drug particles. These cases determine if disintegrant particles can have a contact between each other within the compact and thus if porosity and disintegrant volume are included in the continuous cluster. An equation for both cases is presented in the form of piecewise function to determine the minimal disintegrant volumetric ratio for a binary drug/disintegrant compact in order to achieve a minimum disintegration time. Disintegration tests were performed with tablets at different ratios of modified corn starch mixed with caffeine or paracetamol powders. Estimated and experimental optimal ratio were compared showing coefficient R(2) = 0.96.

  7. Electrostrong Nuclear Disintegration in Condensed Matter

    CERN Document Server

    Swain, J; Widom, A

    2013-01-01

    Photo- and electro-disintegration techniques have been traditionally used for studying giant dipole resonances and through them nuclear structure. Over a long period, detailed theoretical models for the giant dipole resonances were proposed and low energy electron accelerators were constructed to perform experiments to test their veracity. More recently, through laser and "smart" material devices, electrons have been accelerated in condensed matter systems up to several tens of MeV. We discuss here the possibility of inducing electro-disintegration of nuclei through such devices. It involves a synthesis of electromagnetic and strong forces in condensed matter via giant dipole resonances to give an effective "electro-strong interaction" - a large coupling of electromagnetic and strong interactions in the tens of MeV range.

  8. Consumerism vs. integration and disintegration processes

    OpenAIRE

    Sabina Zaremba-Warnke

    2012-01-01

    In the article two kinds of term consumerism are characterized: 1) consumerism as the idea that buying as many goods as possible is desirable for a consumer and/or society, 2) consumerism as a social movement for sustainable consumption. It is shown that consumerism, in its first sense, causes environmental and social problems, which can disintegrate contemporary civilization, and consumerism as a social movement creates and integrates socially responsible consumers, which can lead to the ful...

  9. Fast disintegrating films containing anastrozole as a dosage form for dysphagia patients.

    Science.gov (United States)

    Satyanarayana, Dixit Anil; Keshavarao, Kulkarni Parthasarathi

    2012-12-01

    The objective of the present research was to ensure safety during oral administration of medications to dysphagia patients, by preparing fast disintegrating films (FDF) containing anastrozole (ANS) which disintegrate rapidly when placed on the tongue. Films were prepared by solvent-casting method using various polymers such as hydroxyl propyl methyl cellulose (HPMC E5 LV), hydroxy propyl cellulose (HPC), poly vinyl alcohol (PVA) and sodium alginate (Na Alginate). Among the formulations examined, film prepared using HPMC E5 LV (F1) exhibited shorter disintegration time (15 sec) with satisfactory mechanical properties. Fourier transformer infrared (FTIR) & differential scanning calorimetry (DSC) analysis revealed no chemical incompatibility between drug and excipients used in the formulation. Surface morphology revealed even distribution of ANS in the film. Dissolution of drug from F1 formulation was rapid with more than 90% drug release in 240 sec. Pharmacokinetic parameters showed no statistical difference between F1 (test) and drug solution (control) indicating comparable plasma level-time profiles. The film showed an excellent stability for 24 weeks when stored at refrigerated temperature (2-8°C). These findings suggest that the fast disintegrating film as a promising candidate for delivery of ANS in dysphagic patients.

  10. Confessionality and (disintegration in multiethnic areas

    Directory of Open Access Journals (Sweden)

    Željko Boneta

    2007-12-01

    Full Text Available An attempt is made in the text to sketch out the theoretical framework for empirical research into the influence of confessionality on the processes of integration in the multiethnic areas of Croatian society. The currency of Durkheim's thesis on the integrational role of religion in society is considered in the introductory part of the paper. That is followed by analysis of the four modes of influence wrought by the religious on integration and disintegration in modern societies, drawing on Fox's research. The last part of the text examines the significance of religion and the religious in integrational and disintegrational processes in Croatian society. It is established in that context that confessionality – in those multiethnic milieux in which it coincides with ethnicity – has latent potential that can be instrumentalised in the process of homogenisation and mobilisation of ethnic groups. In such cases, confessionality acts in a twofold manner: integrationally on the ethnic group, as its common denominator that overarches the forces that set it apart, and disintegrationally on society, re-enforcing the ethnic distance. The text concludes with two hypotheses: 1 ethno-confessional instrumentalisation was more successful in regions in which the confessional scene was reduced to only two confessions (the Roman Catholic and Eastern Orthodox; 2 milieux at a higher level of modernisation were more resistant to conflicts.

  11. Sewage sludge disintegration by high-pressure homogenization: A sludge disintegration model

    Institute of Scientific and Technical Information of China (English)

    Yuxuan Zhang; Panyue Zhang; Boqiang Ma; Hao Wu; Sheng Zhang; Xin Xu

    2012-01-01

    High-pressure homogenization (HPH) technology was applied as a pretreatment to disintegrate sewage sludge.The effects of homogenization pressure,homogenization cycle number,and total solid content on sludge disintegration were investigated.The sludge disintegration degree (DDCOD),protein concentration,and polysaccharide concentration increased with the increase of homogenization pressure and homogenization cycle number,and decreased with the increase of sludge total solid (TS) content.The maximum DDCOD of 43.94% was achieved at 80 MPa with four homogenization cycles for a 9.58 g/L TS sludge sample.A HPH sludge disintegration model of DDcoo=kNaPb was established by multivariable linear regression to quantify the effects of homogenization parameters.The homogenization cycle exponent a and homogenization pressure exponent b were 0.4763 and 0.7324 respectively,showing that the effect of homogenization pressure (P) was more significant than that of homogenization cycle number (N).The value of the rate constant k decreased with the increase of sludge total solid content.The specific energy consumption increased with the increment of sludge disintegration efficiency.Lower specific energy consumption was required for higher total solid content sludge.

  12. Ufasomes nano-vesicles-based lyophilized platforms for intranasal delivery of cinnarizine: preparation, optimization, ex-vivo histopathological safety assessment and mucosal confocal imaging.

    Science.gov (United States)

    Salama, Alaa Hamed; Aburahma, Mona Hassan

    2016-09-01

    To circumvent the low and erratic absorption of orally administrated cinnarizine (CN), intranasal lyophilized gels containing unsaturated fatty acid liposomes (ufasomes) and encapsulating CN were prepared from oleic acid using a simple assembling strategy. The effects of varying drug concentration and cholesterol percentage on ufasomes size, polydispersity index and entrapment efficiency were investigated using 3(1)4(1) full factorial design. The optimized ufasomes that contained 14% cholesterol relative to oleic acid displayed spherical morphology with average size of 788 nm and entrapment efficiency of 80.49%. To overcome the colloidal instability of CN-loaded ufasomes dispersions and their short residence time in the nasal cavity, the ufasomes were incorporated into mucoadhesive hydrogels that were lyophilized into unit dosage forms for accurate dosing. Scanning electron micrographs of the lyophilized gel revealed that the included ufasomes were intact, non-aggregating and maintained their spherical morphology. Rheological characterization of reconstituted ufasomal lyophilized gel ensured ease of application. Furthermore, the gel induced minor histopathological alterations in sheeps' nasal mucosa. Ex-vivo confocal laser imaging confirmed the ability of ufasomes to penetrate deep through nasal mucosa layers. The results highlighted in the current work confirm the feasibility of using CN-loaded ufasomal gels for intranasal drug delivery.

  13. A control study of aripiprazole orally disintegrating tablet vs . sulpiride in the treatment of childbearing-age female schizo-phrenia characterized by negative symptoms%阿立哌唑口崩片与舒必利治疗以阴性症状为主的育龄期女性精神分裂症对照研究

    Institute of Scientific and Technical Information of China (English)

    杨银; 杨晶

    2013-01-01

    目的探讨阿立哌唑口崩片与舒必利治疗以阴性症状为主的育龄期女性精神分裂症患者的临床疗效和安全性。方法将120例以阴性症状为主的育龄期女性精神分裂症患者随机分为研究组和对照组,每组60例,分别口服阿立哌唑口崩片、舒必利治疗,观察8周。采用阴性症状量表、临床总体印象量表评定临床疗效,副反应量表评定不良反应。结果研究组显效率为70.7%、总有效率为91.4%,对照组分别为66.7%、89.5%,两组比较差异无显著性(χ2=0.22、0.12,P>0.05)。研究组未出现月经失调、泌乳及体质量增加等不良反应,不良反应发生率显著低于对照组(P<0.01)。结论阿立哌唑口崩片治疗以阴性症状为主的育龄期女性精神分裂症患者疗效显著且与舒必利相当,但阿立哌唑口崩片治疗安全性更高,依从性更好。%Objective To explore the efficacy and safety of aripiprazole orally disintegrating tablet (AODT ) vs .sulpiride in the treatment of childbearing-age female schizophrenia characterized by negative symptoms .Methods A total of 120 childbearing age female schizophrenics characterized by negative symptoms were randomly divided into research and control group of 60 ones each ,they respectively took o-rally AODT and sulpiride for 8 weeks .Efficacies were assessed with the Scale for the Assessment of Nega-tive Symptoms (SANS) and Clinical Global Impression (CGI) and adverse reactions with the Treatment E-mergent Symptom Scale (TESS) .Results The obvious and total effective rate were respectively 70 .7%and 91 .4% in research and 66 .7% and 89 .5% in control group ,which showed no significant group differ-ences (χ2 =0 .22 ,0 .12 ,P>0 .05) .Research group had no such adverse reactions as menstrual disorder , lactation ,weight gain and so on ,incidences of adverse reactions were significantly lower in research than control group (P<0 .01

  14. [Development studies of lyophilized standard diphtheria-tetanus-pertussis vaccines].

    Science.gov (United States)

    Ozcengiz, Erkan; Unver, Derya; Cayan, H Hüseyin; Atakan Ablay, Pinar; Kanik, Esin

    2007-04-01

    In this study, diphtheria, tetanus and pertussis vaccine components were prepared as the formulations of diphtheria-tetanus-pertussis (DTP), diphtheria-tetanus (DT) for children, diphtheria-tetanus (Td) for adults, and tetanus toxoid (TT), respectively. Alhydrogel-adsorbed vaccines prepared to contain the stabilizing substances were lyophilized and the immunogenicity tests were carried out both in vivo and in vitro. The potencies of the tetanus component of the vaccines were obtained by the lethal challenge test in mice. The values were found as 144.86 IU/ml for lyophilized adsorbed (LA)-DTP, 116.5 IU/ml for LA-DT, 98.25 IU/ml for LA-Td and 96.2 IU/ml for LA-TT. Anti-tetanus IgG and anti-diphteria IgG levels determined by ELISA method were found high in the sera taken from the mice immunized with the above-mentioned vaccines. Anti-B.pertussis fimbria IgG antibody levels were also high by both ELISA and microagglutination tests. The test preparations were then compared to adsorbed liquid vaccines and it was shown that the components were quite stable in the lyophilized formulations. It was concluded that the formulations prepared in this study can be used as standard vaccines after being calibrated against World Health Organization standards.

  15. Disintegration of monetary system of medieval Serbia

    Directory of Open Access Journals (Sweden)

    Gnjatović Dragana

    2014-01-01

    Full Text Available The subject matter of this paper is the process of gradual disintegration of monetary system of medieval Serbia during the second half of the 14th and the first half of the 15th century. This period is characterized by an appearance of frequent usurpations of the ruling right to mint coinage by local landlords and the attempts of the rulers from Lazarević and Branković families to restore unified monetary system. Common debasements and restorations of silver coinage provoked economic instability and induced frequent turning backwards to the custom of using weighted silver instead of silver coins as commodity monetary standard. The aim of this paper is to explain the reasons for those phenomena. We apply qualitative, historical, empirical analysis where we consider money minting right holders and their decisions to debase and restore the value of silver dinars. We found that gradual disintegration of monetary system of medieval Serbian State continued until the fall of Serbian Despotate as a consequence of political instability following dissolution of medieval Serbian Empire and economic and financial exhaustion of Serbia by Ottoman suzerains.

  16. An easy-to-use approach for determining the disintegration ability of disintegrants by analysis of available surface area.

    Science.gov (United States)

    Iwao, Yasunori; Tanaka, Shoko; Uchimoto, Takeaki; Noguchi, Shuji; Itai, Shigeru

    2013-05-01

    With the aim of directly predicting the functionality and mechanism of disintegrants during the disintegration and dissolution of tablets, we investigated an analysis method based on available surface area, which is the surface area of a drug in a formulation in direct contact with the external solvent during dissolution. We evaluated the following disintegrants in this study: sodium starch glycolate (Glycolys), crospovidone (Kollidon CL), carboxymethylcellulose calcium (CMC-Ca), low-substituted hydroxypropylcellulose (L-HPC), and croscarmellose sodium (Ac-Di-Sol). When disintegrant was added to a 50% ethenzamide tablet formulation, an increase in the dissolution rate dependent on disintegrant concentration was observed, according to the type of disintegrant. In addition, the available surface area also differed between disintegrants. For Glycolys, CMC-Ca, and Ac-Di-Sol, a rapid increase in available surface area and a large increase in maximum available surface area (Smax) were observed due to high swellability and wicking, even when the disintegrant concentration was only 1.0%. In contrast, for Kollidon CL and LH-21, a gradual increase in available surface area was observed, depending on the disintegrant concentration. To evaluate the disintegrant ability, Δtmax and ΔSmax were calculated by subtracting peak time (tmax) at 5.0% from that at 1.0% and subtracting Smax at 1.0% from that at 5.0%, respectively, and it was found that the water absorption ratio had strong negative correlations with Δtmax and ΔSmax. Therefore, this study demonstrates that analysis of only available surface area and parameters thereby obtained can directly provide useful information, especially about the disintegration ability of disintegrants. Copyright © 2013 Elsevier B.V. All rights reserved.

  17. DISINTEGRANT EFFECT OF FINGER MILLET (ELEUSINE COROCANA STARCH ON DISSOLUTION PROFILE AND DISINTEGRATION TIME IN HIGH DOSE TABLETS

    Directory of Open Access Journals (Sweden)

    S.U. Shiihii et al.

    2012-02-01

    Full Text Available Starch was extracted from the grains of finger millet (Eleusine corocana, by steeping in water for 24 hours. The extracted starch was used as a disintegrant, at the concentrations of 2.5-12.5%w/w to compressed paracetamol tablet in comparism with maize starch BP. Results show that, there is no significant difference in the disintegration time or dissolution rate of tablets containing the two starches. Tablets containing Eleusine corocana met compendia requirements for disintegration time and dissolution rate. The starch is recommended as a disintegrant in tablet formulation.

  18. Acoustics aspects of technological process in the rock disintegration

    Directory of Open Access Journals (Sweden)

    Jozef Futó

    2007-04-01

    Full Text Available The paper describes some results of monitoring and aspects of the acoustic signal in the rock disintegration on the drillig stand of the Institute of Geotechnics, SAS in Košice. The registration and processing of the acoustic signal is solved as a part of the research grant task within the basic research of the rock disintegration by drilling.

  19. Effects of ultrasonic disintegration of excess sewage sludge.

    Science.gov (United States)

    Zielewicz, Ewa

    2016-10-01

    Breaking down sludge floc (sonodyspergation effect) and destruction of the cell membranes of microorganisms forming floc is a direct effect of ultrasonic disintegration of sludge excess. This results in release of organic material by liquid sludge (the sonolysis effect). Desired technological effects of the disintegration are: to shorten the hydrolytic phase of fermentation, to increase the production of biogas (source of renewable energy) and an increased mineralization (stability) of fermented sludge. The presented study demonstrates research covering thickened excess sludge of various physicochemical properties, collected from nine municipal sewage treatment plants. The sludge was subjected to ultrasonic disintegration using three differently constructed disintegrators and different proportions of sonification area. Direct effects of disintegration were monitored and recorded using selected indicators describing changes in the properties of sludge and increase of substance dispersed and dissolved in the supernatant liquid to be filtered. Studies have demonstrated that those (direct) effects of ultrasonic disintegration depend on the physicochemical properties of the sludge (foremost the concentration of dry solids) that determine their variable susceptibility to the disintegration methods. The direct effects also depend on optimal process conditions (which consist of the construction of the ultrasonic disintegrator), the geometric proportions of the sonication area and the operating parameters of disintegration (which could be appropriately matched to the characteristics of sludge). The most preferable results were obtained for ultrasonic disintegration of sludge with a dry matter concentration C 0 dry matter (C 0 = 2.0 %), which was sonicated in a reactor with a short transducer of the largest radiating surface area, as well as the lowest ratio between this area and area of reactor. The best effects of disagglomeration of flocks have corresponded with the

  20. In vitro models for the prediction of in vivo performance of oral dosage forms

    DEFF Research Database (Denmark)

    Kostewicz, Edmund S; Abrahamsson, Bertil; Brewster, Marcus

    2014-01-01

    Accurate prediction of the in vivo biopharmaceutical performance of oral drug formulations is critical to efficient drug development. Traditionally, in vitro evaluation of oral drug formulations has focused on disintegration and dissolution testing for quality control (QC) purposes. The connectio...

  1. Development of polymer-bound fast-dissolving metformin buccal film with disintegrants

    Science.gov (United States)

    Haque, Shaikh Ershadul; Sheela, Angappan

    2015-01-01

    Fast-dissolving drug-delivery systems are considered advantageous over the existing conventional oral dosage forms like tablets, capsules, and syrups for being patient friendly. Buccal films are one such system responsible for systemic drug delivery at the desired site of action by avoiding hepatic first-pass metabolism. Metformin hydrochloride (Met), an antidiabetic drug, has poor bioavailability due to its high solubility and low permeability. The purpose of the study reported here was to develop a polymer-bound fast-dissolving buccal film of metformin to exploit these unique properties. In the study, metformin fast-dissolving films were prepared by the solvent-casting method using chitosan, a bioadhesive polymer. Further, starch, sodium starch glycolate, and microcrystalline cellulose were the disintegrants added to different ratios, forming various formulations (F1 to F7). The buccal films were evaluated for various parameters like weight variation, thickness, folding endurance, surface pH, content uniformity, tensile strength, and percentage of elongation. The films were also subjected to in vitro dissolution study, and the disintegration time was found to be less than 30 minutes for all formulations, which was attributed to the effect of disintegrants. Formulation F6 showed 92.2% drug release within 6 minutes due to the combined effect of sodium starch glycolate and microcrystalline cellulose. PMID:26491321

  2. Energetic approach to the evaluation of rock disintegration process

    Directory of Open Access Journals (Sweden)

    Lucia Ivaničová

    2008-03-01

    Full Text Available Rock disintegration process may be investigated by several methods. Energetic approach represents one of the methods of characterizing the energetic-transformation changes of rock disintegration process, as the rock disintegration occurs after an increase of the inner energy above the binding energy of its components. The paper review theories of disintegration processes with an energetic approach. Methods of investigation are presented in more details, using a rotary disperser with a calorimeter and an experimental drilling stand, the experimental devices designed and constructed at the Institute of Geotechnics, SAS, providing an imitation of the rotary drilling of rocks. The experimental drilling stand enabled to examine the drilling tools used in industry. The monitoring system installed on the stand scans the regime parameters of the disintegration process. Both the specific disintegration energy and the drilling rate, calculated from the monitored input and output parameters of the process, serve as evaluating variables of the rock disintegration process efficiency. The main effort in the evaluation of parameters from the rock drilling monitoring is to derive the relations that would provide data necessary for the control of drilling process in a real time.

  3. Enhancement of ultrasonic disintegration of sewage sludge by aeration.

    Science.gov (United States)

    Zhao, He; Zhang, Panyue; Zhang, Guangming; Cheng, Rong

    2016-04-01

    Sonication is an effective way for sludge disintegration, which can significantly improve the efficiency of anaerobic digestion to reduce and recycle use of sludge. But high energy consumption limits the wide application of sonication. In order to improve ultrasonic sludge disintegration efficiency and reduce energy consumption, aeration was introduced. Results showed that sludge disintegration efficiency was improved significantly by combining aeration with ultrasound. The aeration flow rate, gas bubble size, ultrasonic density and aeration timing had impacts on sludge disintegration efficiency. Aeration that used in later stage of ultrasonic irradiation with low aeration flow rate, small gas bubbles significantly improved ultrasonic disintegration sludge efficiency. At the optimal conditions of 0.4 W/mL ultrasonic irradiation density, 30 mL/min of aeration flow rate, 5 min of aeration in later stage and small gas bubbles, ultrasonic sludge disintegration efficiency was increased by 45% and one third of ultrasonic energy was saved. This approach will greatly benefit the application of ultrasonic sludge disintegration and strongly promote the treatment and recycle of wastewater sludge.

  4. Development of natural gum based fast disintegrating tablets of glipizide

    Directory of Open Access Journals (Sweden)

    Antesh Kumar Jha

    2012-01-01

    Full Text Available Dysphagia and risk of choking are leading causes of patient non-compliance in the self-administration of conventional tablets. To overcome these limitations of conventional tablets fast-disintegrating tablets were developed, using natural gums. Natural gums were evaluated for bulk swelling capacity. Powder mix containing natural gums and glipizide was evaluated for water sorption, swelling index and capillary action. For faster onset and immediate hypoglycemic action, the fast disintegrating tablets were prepared with various types of natural gums using the direct compression technique. Formulations containing guar gum disintegrated within a minute and fulfilled the official requirements for dispersible tablets. As the amount of guar gum increased, the friability increased and hardness decreased, resulting in a shorter wetting and disintegration time. Gum acacia and gum tragacanth did the opposite. The glipizide-loaded fast disintegrating tablet prepared with 18 mg of guar gum gave a friability of 0.46 ± 0.02%, content uniformity of 99.34 ± 0.82%, drug content of 99.15 ± 1.16%, wetting time of 39.0 ± 1.04 sec, hardness of 5.70 ± 1.41 Kg and disintegration time less than 30 sec, suggesting that it was a practical product with a good tablet property. In conclusion, natural gum based patient-friendly fast disintegrating tablets of glipizide can be successfully formulated.

  5. Analysis of electrochemical disintegration process of graphite matrix

    Energy Technology Data Exchange (ETDEWEB)

    Tian Lifang; Wen Mingfen [Institute of Nuclear and New Energy Technology, Tsinghua University, Beijing 100084 (China); Chen Jing, E-mail: jingxia@tsinghua.edu.c [Institute of Nuclear and New Energy Technology, Tsinghua University, Beijing 100084 (China)

    2010-12-30

    The electrochemical method with ammonium nitrate as electrolyte was studied to disintegrate the graphite matrix from the simulative fuel elements for high temperature gas-cooled reactor. The influences of process parameters, including salt concentration, system temperature and current density, on the disintegration rate of graphite fragments were investigated in the present work. The experimental results showed that the disintegration rate depended slightly on the temperature and salt concentration. The current density strongly affected the disintegration rate of graphite fragments. Furthermore, the content of introduced oxygen in final graphite fragments was independent of the current density and the concentration of electrolyte. Moreover, the structural evolution of graphite was analyzed based on the microstructural parameters determined by X-ray diffraction profile fitting analysis using MAUD (material analysis using diffraction) before and after the disintegration process. It may safely be concluded that the graphite disintegration can be ascribed to the influences of the intercalation of foreign molecules in between crystal planes and the partial oxidation involved. The disintegration process was described deeply composed of intercalate part and further oxidation part of carbon which effected together to lead to the collapse of graphite crystals.

  6. Facts and evidences on the lyophilization of polymeric nanoparticles for drug delivery.

    Science.gov (United States)

    Fonte, Pedro; Reis, Salette; Sarmento, Bruno

    2016-03-10

    Lyophilization has been used to improve the long-term stability of polymeric nanoparticles for drug delivery applications, avoiding their instability in suspension. However, this dehydration process may induce stresses to nanoparticles, mitigated by the use of some excipients such as cryo- and lyoprotectants. Still, the lyophilization of polymeric nanoparticles is frequently based in empirical principles, without considering the physical-chemical properties of formulations and the engineering principles of lyophilization. Therefore, the optimization of formulations and the lyophilization cycle is crucial to obtain a good lyophilizate, and guarantee the preservation of nanoparticle stability. The proper characterization of the lyophilizate and nanoparticles has a great importance in achieving these purposes. This review updates the fundaments involved in the optimization procedures for lyophilization of polymeric nanoparticles, with the aim of obtaining the maximum stability of formulations. Different characterization methods to obtain and guarantee a good lyophilized product are also discussed. A special focus is given to encapsulated therapeutic proteins. Overall, this review is a contribution for the understanding of the parameters involved in the lyophilization of polymeric nanoparticles. This may definitely help future works to obtain lyophilized nanoparticles with good quality and with improved therapeutic benefits.

  7. Pig skin apposite dehydrated by lyophilization; Apositos de piel de cerdo deshidratados por liofilizacion

    Energy Technology Data Exchange (ETDEWEB)

    Reyes F, M.L.; Gonzalez V, C.; Flores A, M.; Peralta R, J.; Reboyo B, D.; Rodriguez U, M.D. [ININ, 52750 La Marquesa, Estado de Mexico (Mexico)

    2007-07-01

    Taking like base a work carried out in 2001 in the Radio sterilized Tissue Bank (BTR) in which lyophilized apposite of pig skin were obtained at laboratory scale, this work is presented that had as purpose to process pig skin to produce temporary covers of skin (apposite) dehydrated by lyophilization to commercial scale. (Author)

  8. Sessile Nanodroplets on Elliptical Patches of Enhanced Lyophilicity

    Science.gov (United States)

    2017-01-01

    We theoretically investigate the shape of a nanodroplet on a lyophilic elliptical patch in lyophobic surroundings on a flat substrate. To compute the droplet equilibrium shape, we minimize its interfacial free energy using both Surface Evolver and Monte Carlo calculations, finding good agreement between the two methods. We observe different droplet shapes, which are controlled by the droplet volume and the aspect ratio of the ellipse. In particular, we study the behavior of the nanodroplet contact angle along the three-phase contact line, explaining the different droplet shapes. Although the nanodroplet contact angle is constant and fixed by Young’s law inside and outside the elliptical patch, its value varies along the rim of the elliptical patch. We find that because of the pinning of the nanodroplet contact line at the rim of the elliptical patch, which has a nonconstant curvature, there is a regime of aspect ratios of the elliptical patch in which the nanodroplet starts expanding to the lyophobic part of the substrate, although there is still a finite area of the lyophilic patch free to be wetted. PMID:28248114

  9. The use of hydrodynamic disintegration as a means to improve ...

    African Journals Online (AJOL)

    2008-09-15

    Sep 15, 2008 ... Disintegration by hydrodynamic cavitation has a positive effect on the degree and rate of sludge anaerobic digestion. ... (ball mill, ultrasonic), oxidation (ozone and hydrogen per- .... American Public Health Association, Wash-.

  10. Identifying the ejected population from disintegrating multiple systems

    CERN Document Server

    Yip, A K P; Kurtev, R; Gromadzki, M; Marocco, F

    2016-01-01

    Kinematic studies of the Hipparcos catalogue have revealed associations that are best explained as disintegrating multiple systems, presumably resulting from a dynamical encounter between single/multiple systems in the field (Li et al. 2009). In this work we explore the possibility that known ultra-cool dwarfs may be components of disintegrating multiple systems, and consider the implications for the properties of these objects. We will present here the methods/techniques that can be used to search for and identify disintegrating benchmark systems in three database/catalogues: Dwarf Archive, the Hipparcos Main Catalogue, and the Gliese-Jahrei{\\ss} Catalogue. Placing distance constraints on objects with parallax or colour-magnitude information from spectrophotometry allowed us to identify common distance associations. Proper motion measurements allowed us to separate common proper motion multiples from our sample of disintegrating candidates. Moreover, proper motion and positional information allowed us to sel...

  11. Disintegration of social cognitive processes in schizophrenia

    Directory of Open Access Journals (Sweden)

    Karakuła, Hanna

    2013-12-01

    Full Text Available Despite rapid development of research on social cognition (SC impairments in schizophrenia, efforts are still made to generate new, broader theoretical models which include the neural network approach to those dysfunctions. The aim of this study was the evaluation of the structure of SC in patients with schizophrenia in comparison to healthy subjects. Methods. The studied groups consisted of 55 subjects: 30 patients with paranoid schizophrenia according to DSM-IV criteria, and 25 control healthy subjects matched for age, gender and education to the clinical group. In order to assess processes of SC, a battery of tests was administered: Theory of Mind Picture Stories to assess theory of mind, trials “Faces” (from Ekman and Friesen’s set of emotional expressions and “Figures” (from the publication by Argyle to evaluate recognition of emotions from facial and gesture expression. The methods included also an assessment of self-criticism (insight relating to the subject’s processes of SC. Results. The level of efficacy of SC was lower in the patients compared to the controls. In the clinical group, theory of mind was the most important factor for the overall level of SC and its impairments. There was inadequate, decreased patients’ self-criticism regarding their execution of SC tests. The insight did not correlate with any other SC variables in the clinical group. In general, the group characterized by lower integration of social cognitive processes, also obtained lower scores in individual dimensions of SC. Conclusions. The structure of social cognitive processes in schizophrenic group, unlike in healthy subjects, shows characteristics of generalized disintegration.

  12. Lyophilized Cyclamen europaeum tuber extract in the treatment of rhinosinusitis.

    Science.gov (United States)

    Jurkiewicz, Dariusz; Hassmann-Poznańska, Elżbieta; Kaźmierczak, Henryk; Składzień, Jacek; Pietruszewska, Wioleta; Burduk, Paweł; Rapiejko, Piotr

    2016-02-29

    Nasal and sinus mucositis is a significant health problem associated with significant organizational and financial burden for the health care system. In recent years, several important guidelines and positions of expert groups and scientific associations have been published with regard to the diagnostics and treatment of rhinosinusitis, including European Position Paper on Rhinosinusitis and Nasal Polyps (EPOS 2012) [1] and Polish Standards for the Treatment of Rhinitis (PoSLeNN 2013) [2]. The management of viral and postviral rhinosinusitis involves systemic treatment including administration of plant origin products. The goal of this article is to present the current knowledge on the use of intranasal preparations containing natural saponin fractions from the rhizomes of Alpine cyclamen (Cyclamen europaeum). Saponins contained in the extract of Alpine cyclamen (Cyclamen europaeum) rhizomes are surface-active compounds that reduce the surface tension on the nasal mucosal cells while simultaneously stimulating the trigeminal nerve receptors leading to increased production of seromucous secretion and extensive drainage of the nasal and sinus cavities. The analysis of published studies on the efficacy and safety of intranasal products containing lyophilized extracts from Cyclamen europaeum tuber warrants the conclusion that these products are useful in the management of nasal and sinus mucositis due to their beneficial impact on the course of the treatment of acute rhinosinusitis. When used in patients with acute rhinosinusitis, an intranasal preparation containing lyophilized extracts from Cyclamen europaeum tuber efficiently reduces the symptoms, particularly the feeling of pressure and pain in the face. According to the authors of PROSINUS study, single-agent treatment using Cyclamen europaeum extracts is more efficient (in terms of the percentage of success) than other monotherapy or combination regimens.

  13. Lyophilization monophase solution technique for preparation of amorphous flutamide dispersions.

    Science.gov (United States)

    Elgindy, Nazik; Elkhodairy, Kadria; Molokhia, Abdallah; Elzoghby, Ahmed

    2011-07-01

    Flutamide (FLT) is a poorly soluble anticancer drug. Therefore, lyophilized dispersions (LDs) of FLT with polyvinylpyrrolidone (PVP) K30, polyethylene glycol (PEG) 6000, and pluronic F127 were prepared via lyophilization monophase solution technique with the aim of increasing its dissolution rate. FLT showed an A(L)-type phase solubility diagrams with PVP and PEG, whereas A(N)-type diagram was obtained with pluronic. The amount of residual tertiary butyl alcohol, determined by gas chromatography, was 0.015-0.021% w/w. Differential scanning calorimetry and X-ray diffractometry revealed that FLT-polymer 1:1 LDs were partially amorphous, whereas the 1:3 and 1:5 LDs were completely amorphous. After 6 months storage, polymers under study inhibited FLT recrystallization maintaining its amorphous form. The particle size of FLT-polymer LDs was between 0.81 and 2.13 μm, with a high surface area (268.43-510.82 m²/g) and porosity (354.01-676.23 e⁻³ mL/g). Also, the poor flow properties of FLT could be improved but to a limited extent. FLT dissolution was significantly enhanced with the fastest dissolution that was achieved using pluronic. After 30 min, about 66.52%, 78.23%, and 81.64% of FLT was dissolved from 1:5 FLT-PVP, PEG, and pluronic LDs, respectively, compared with only 13.45% of FLT. These data suggest that these polymers might be useful adjuncts in preparation and stabilization of amorphous immediate-release FLT LDs.

  14. Finite Element Method (FEM) Modeling of Freeze-drying: Monitoring Pharmaceutical Product Robustness During Lyophilization.

    Science.gov (United States)

    Chen, Xiaodong; Sadineni, Vikram; Maity, Mita; Quan, Yong; Enterline, Matthew; Mantri, Rao V

    2015-12-01

    Lyophilization is an approach commonly undertaken to formulate drugs that are unstable to be commercialized as ready to use (RTU) solutions. One of the important aspects of commercializing a lyophilized product is to transfer the process parameters that are developed in lab scale lyophilizer to commercial scale without a loss in product quality. This process is often accomplished by costly engineering runs or through an iterative process at the commercial scale. Here, we are highlighting a combination of computational and experimental approach to predict commercial process parameters for the primary drying phase of lyophilization. Heat and mass transfer coefficients are determined experimentally either by manometric temperature measurement (MTM) or sublimation tests and used as inputs for the finite element model (FEM)-based software called PASSAGE, which computes various primary drying parameters such as primary drying time and product temperature. The heat and mass transfer coefficients will vary at different lyophilization scales; hence, we present an approach to use appropriate factors while scaling-up from lab scale to commercial scale. As a result, one can predict commercial scale primary drying time based on these parameters. Additionally, the model-based approach presented in this study provides a process to monitor pharmaceutical product robustness and accidental process deviations during Lyophilization to support commercial supply chain continuity. The approach presented here provides a robust lyophilization scale-up strategy; and because of the simple and minimalistic approach, it will also be less capital intensive path with minimal use of expensive drug substance/active material.

  15. Stabilization of a recombinant ricin toxin A subunit vaccine through lyophilization.

    Science.gov (United States)

    Hassett, Kimberly J; Cousins, Megan C; Rabia, Lilia A; Chadwick, Chrystal M; O'Hara, Joanne M; Nandi, Pradyot; Brey, Robert N; Mantis, Nicholas J; Carpenter, John F; Randolph, Theodore W

    2013-10-01

    Lyophilization was used to prepare dry, glassy solid vaccine formulations of recombinant ricin toxin A-chain containing suspensions of colloidal aluminum hydroxide adjuvant. Four lyophilized formulations were prepared by using combinations of rapid or slow cooling during lyophilization and one of two buffers, histidine or ammonium acetate. Trehalose was used as the stabilizing excipient. Aggregation of the colloidal aluminum hydroxide suspension was reduced in formulations processed with a rapid cooling rate. Aluminum hydroxide particle size distributions, glass transition temperatures, water contents, and immunogenicities of lyophilized vaccines were independent of incubation time at 40 °C for up to 15 weeks. Mice immunized with reconstituted ricin toxin subunit A (RTA) vaccines produced RTA-specific antibodies and toxin-neutralizing antibodies (TNAs) regardless of the length of high temperature vaccine storage or the degree of aluminum adjuvant aggregation that occurred during lyophilization. In murine studies, lyophilized formulations of vaccines conferred protection against exposure to lethal doses of ricin, even after the lyophilized formulations had been stored at 40 °C for 4 weeks. A corresponding liquid formulation of vaccine stored at 40 °C elicited RTA-specific antibody titers but failed to confer immunity during a ricin challenge.

  16. Stability of Staphylococcus aureus phage ISP after freeze-drying (lyophilization).

    Science.gov (United States)

    Merabishvili, Maia; Vervaet, Chris; Pirnay, Jean-Paul; De Vos, Daniel; Verbeken, Gilbert; Mast, Jan; Chanishvili, Nino; Vaneechoutte, Mario

    2013-01-01

    Staphylococcus aureus phage ISP was lyophilized, using an Amsco-Finn Aqua GT4 freeze dryer, in the presence of six different stabilizers at different concentrations. Stability of the lyophilized phage at 4 °C was monitored up to 37 months and compared to stability in Luria Bertani broth and physiological saline at 4 °C. Sucrose and trehalose were shown to be the best stabilizing additives, causing a decrease of only 1 log immediately after the lyophilization procedure and showing high stability during a 27 month storage period.

  17. Stability of Staphylococcus aureus phage ISP after freeze-drying (lyophilization.

    Directory of Open Access Journals (Sweden)

    Maia Merabishvili

    Full Text Available Staphylococcus aureus phage ISP was lyophilized, using an Amsco-Finn Aqua GT4 freeze dryer, in the presence of six different stabilizers at different concentrations. Stability of the lyophilized phage at 4 °C was monitored up to 37 months and compared to stability in Luria Bertani broth and physiological saline at 4 °C. Sucrose and trehalose were shown to be the best stabilizing additives, causing a decrease of only 1 log immediately after the lyophilization procedure and showing high stability during a 27 month storage period.

  18. Zonal disintegration phenomenon in rock mass surrounding deep tunnels

    Institute of Scientific and Technical Information of China (English)

    WU Hao; FANG Qin; GUO Zhi-kun

    2008-01-01

    Zonal disintegration is a typical static phenomenon of deep rock masses. It has been defined as alternating regions of fractured and relatively intact rock mass that appear around or in front of the working stope during excavation of a deep tunnel. Zonal disintegration phenomenon was successfully demonstrated in the laboratory with 3D tests on analogous gypsum models, two circular cracked zones were observed in the test. The linear Mohr-Coulomb yield criterion was used with a constitutive model that showed linear softening and ideal residual plastic to analyze the elasto-plastic field of the enclosing rock mass around a deep tunnel. The results show that tunneling causes a maximum stress zone to appear between an elastic and plastic zone in the surrounding rock. The zonal disintegration phenomenon is analyzed by considering the stress-strain state of the rock mass in the vicinity of the maximum stress zone. Creep instability failure of the rock due to the development of the plastic zone, and transfer of the maximum stress zone into the rock mass, are the cause of zonal disintegration. An analytical criterion for the critical depth at which zonal disintegration can occur is derived. This depth depends mainly on the character and stress concentration coefficient of the rock mass.

  19. Lyophilization, Reconstitution, and DBP Formation in Reverse-Osmosis Concentrated Natural Organic Matter

    Science.gov (United States)

    Drinking water treatment and disinfection byproduct (DBP) research can be complicated by natural organic matter (NOM) temporal variability. NOM preservation by lyophilization (freeze-drying) has been long practiced to address this issue; however, its applicability for drinking w...

  20. Pulp response of anionic lyophilized collagen matrix with or without hydroxyapatite after pulpotomy in dog's teeth

    Directory of Open Access Journals (Sweden)

    Léa Assed Bezerra da Silva

    2006-06-01

    Full Text Available The aim of the present study was to evaluate histologically the pulp response of anionic lyophilized collagen matrix with or without hydroxyapatite as a biomaterial pulp-capping agent in pulpotomy of dogs' teeth. Sixty pre-molar roots from three dogs were used. After pulpotomy, the remaining pulp tissue was capped with one of the following materials: Group I (20 roots: anionic lyophilized collagen matrix; Group II (20 roots: anionic lyophilized collagen matrix associated with hydroxyapatite; Group III (10 roots: calcium hydroxide (p.a. paste in saline; Group IV (10 roots: zinc oxide eugenol cement. After 90 days the animals were killed by anesthetic overdose and the teeth were removed and submitted to histological processing. According to the histopathological results, we concluded that the zinc oxide eugenol cement and anionic lyophilized collagen matrix with or without hydroxyapatite did not present satisfactory pulp response and that calcium hydroxide is the suitable material for pulpotomy.

  1. Lyophilization, Reconstitution, and DBP Formation in Reverse-Osmosis Concentrated Natural Organic Matter

    Science.gov (United States)

    Drinking water treatment and disinfection byproduct (DBP) research can be complicated by natural organic matter (NOM) temporal variability. NOM preservation by lyophilization (freeze-drying) has been long practiced to address this issue; however, its applicability for drinking w...

  2. Live RB51 vaccine lyophilized hydrogel formulations with increased shelf life for practical ballistic delivery

    Science.gov (United States)

    Ballistic delivery capability is essential to delivering vaccines and other therapeutics effectively to both livestock and wildlife in many global scenarios. Here, lyophilized poly(ethylene glycol) (PEG)-glycolide dimethacrylate crosslinked but degradable hydrogels were assessed as payload vehicles ...

  3. Effects of starches on the mechanical properties of paracetamol tablet formulations. II. Sorghum and plantain starches as disintegrants.

    Science.gov (United States)

    Alebiowu, Gbenga; Itiola, Oludele Adelanwa

    2003-12-01

    This study evaluates the disintegrant properties--tablet disintegration time (DT) and crushing strength--friability/disintegration time (CSFR/DT) ratio of a paracetamol tablet formulation prepared with sorghum and plantain starches in comparison with corn starch BP. The effects of disintegrant concentration, relative density of tablets and the mode of disintegrants addition were studied. The study revealed that the rank order of effectiveness of the starches as disintegrants was corn > plantain > sorghum. The mode of addition of disintegrants, disintegrant concentration and relative density had a significant impact on the disintegrant properties. The tested starches, namely, sorghum and plantain, showed promising results.

  4. Standardization of lyophilization medium for Streptococcus thermophilus subjected to viability escalation on freeze drying

    OpenAIRE

    Rohit Sharma; Bhagwan S. Sanodiya; Gulab S. Thakur; Pallavi Jaiswal; Anjana Sharma; Bisen, Prakash S.

    2014-01-01

    The objective of the present study is to develop a lyophilization medium for Streptococcus thermophilus (NCIM 2904) as the industrial exploitation of this bacterium totally depends upon preservation and lyophilization protocols. Protective effect of 18 compounds were observed individually and in combinations with different sugars, sugar alcohols, polymers, protein concentrates and buffers. Among all the protectants tested, ammonium citrate (1% w/w), K2HPO4 (1% w/w) and KH2PO4 (1% w/w) provide...

  5. Lyophilization-induced reversible changes in the secondary structure of proteins.

    OpenAIRE

    Griebenow, K; Klibanov, A M

    1995-01-01

    Changes in the secondary structure of some dozen different proteins upon lyophilization of their aqueous solutions have been investigated by means of Fourier-transform infrared spectroscopy in the amide III band region. Dehydration markedly (but reversibly) alters the secondary structure of all the proteins studied, as revealed by both the quantitative analysis of the second derivative spectra and the Gaussian curve fitting of the original infrared spectra. Lyophilization substantially increa...

  6. Intranasal inoculation of white-tailed deer (Odocoileus virginianus with lyophilized chronic wasting disease prion particulate complexed to montmorillonite clay.

    Directory of Open Access Journals (Sweden)

    Tracy A Nichols

    Full Text Available Chronic wasting disease (CWD, the only known prion disease endemic in wildlife, is a persistent problem in both wild and captive North American cervid populations. This disease continues to spread and cases are found in new areas each year. Indirect transmission can occur via the environment and is thought to occur by the oral and/or intranasal route. Oral transmission has been experimentally demonstrated and although intranasal transmission has been postulated, it has not been tested in a natural host until recently. Prions have been shown to adsorb strongly to clay particles and upon oral inoculation the prion/clay combination exhibits increased infectivity in rodent models. Deer and elk undoubtedly and chronically inhale dust particles routinely while living in the landscape while foraging and rutting. We therefore hypothesized that dust represents a viable vehicle for intranasal CWD prion exposure. To test this hypothesis, CWD-positive brain homogenate was mixed with montmorillonite clay (Mte, lyophilized, pulverized and inoculated intranasally into white-tailed deer once a week for 6 weeks. Deer were euthanized at 95, 105, 120 and 175 days post final inoculation and tissues examined for CWD-associated prion proteins by immunohistochemistry. Our results demonstrate that CWD can be efficiently transmitted utilizing Mte particles as a prion carrier and intranasal exposure.

  7. Effects of lyophilization on the infectivity of enveloped and non-enveloped viruses in bone tissue.

    Science.gov (United States)

    Uhlenhaut, Christine; Dörner, Thomas; Pauli, Georg; Pruss, Axel

    2005-11-01

    Recently reported qualitative experiments proved that retroviral infectivity is not destroyed by lyophilization performed on systemically infected bone and tendon. The now accomplished quantitative determination of residual infectivity for enveloped and non-enveloped viruses allows a validation of the production process regarding viral safety in freeze-dried bone transplants. The lyophilization effect on the infectivity of two non-enveloped viruses (Maus Elberfeld virus, MEV; Porcine parvovirus, PPV) and one enveloped virus (Vesicular Stomatitis virus, VSV) was examined for virus-spiked bone material in comparison to lyophilized viruses, original virus stock, and air-dried viruses. All experiments were carried out with both cell-free and cell-associated virus. Significant differences were observed regarding the reduction of virus titers (TCID50). Infectivity of VSV was reduced by about 3-4 log10 using lyophilization in presence of bone matrix and of MEV by 6-7 log10, while no substantial reduction in virus titers was observed for PPV. Lyophilization of cell-free or cell-associated virus is not sufficient to inactivate viruses completely. However, lyophilization could have an additive effect in line with other production steps used in the manufacturing process.

  8. EVIDENCE FOR GAS FROM A DISINTEGRATING EXTRASOLAR ASTEROID

    Energy Technology Data Exchange (ETDEWEB)

    Xu, S. [European Southern Observatory, Karl-Schwarzschild-Straße 2, D-85748 Garching (Germany); Jura, M.; Zuckerman, B. [Department of Physics and Astronomy, University of California, Los Angeles CA 90095-1562 (United States); Dufour, P., E-mail: sxu@eso.org, E-mail: jura@astro.ucla.edu, E-mail: ben@astro.ucla.edu, E-mail: dufourpa@astro.umontreal.ca [Institut de Recherche sur les Exoplanètes (iREx), Université de Montréal, Montréal, QC H3C 3J7 (Canada)

    2016-01-10

    We report high-resolution spectroscopic observations of WD 1145+017—a white dwarf that was recently found to be transitted by multiple asteroid-sized objects within its tidal radius. We discovered numerous circumstellar absorption lines with linewidths of ∼300 km s{sup −1} from Mg, Ca, Ti, Cr, Mn, Fe, and Ni, possibly from several gas streams produced by collisions among the actively disintegrating objects. The atmosphere of WD 1145+017 is polluted with 11 heavy elements, including O, Mg, Al, Si, Ca, Ti, V:, Cr, Mn, Fe, and Ni. Evidently, we are witnessing the active disintegration and subsequent accretion of an extrasolar asteroid.

  9. Ceramic/metal nanocomposites by lyophilization: Processing and HRTEM study

    Energy Technology Data Exchange (ETDEWEB)

    Gutierrez-Gonzalez, C.F. [Centro de Investigacion en Nanomateriales y Nanotecnologia (CINN), Consejo Superior de Investigaciones Cientificas - CSIC - Universidad de Oviedo - UO - Principado de Asturias - PA, Parque Tecnologico de Asturias, 33428 Llanera (Spain); Agouram, S. [Department of Applied Physics and Electromagnetism, Universitat de Valencia, 46100 Burjassot (Spain); Torrecillas, R. [Centro de Investigacion en Nanomateriales y Nanotecnologia (CINN), Consejo Superior de Investigaciones Cientificas - CSIC - Universidad de Oviedo -UO - Principado de Asturias- PA, Parque Tecnologico de Asturias, 33428 Llanera (Spain); Moya, J.S. [Instituto de Ciencia de Materiales de Madrid, Consejo Superior de Investigaciones Cientificas (ICMM-CSIC), Cantoblanco, 28049 Madrid (Spain); Lopez-Esteban, S., E-mail: s.lopez@cinn.es [Centro de Investigacion en Nanomateriales y Nanotecnologia (CINN), Consejo Superior de Investigaciones Cientificas - CSIC - Universidad de Oviedo - UO - Principado de Asturias - PA, Parque Tecnologico de Asturias, 33428 Llanera (Spain)

    2012-02-15

    Highlights: Black-Right-Pointing-Pointer A cryogenic route has been used to obtain ceramic/metal nanostructured powders. Black-Right-Pointing-Pointer The powders present good homogeneity and dispersion of metal. Black-Right-Pointing-Pointer The metal nanoparticle size distributions are centred in 17-35 nm. Black-Right-Pointing-Pointer Both phases, ceramic and metal, present a high degree of crystallinity. Black-Right-Pointing-Pointer Good metal/ceramic interfaces due to epitaxial growth, studied by HRTEM. -- Abstract: This work describes a wet-processing route based on spray-freezing and subsequent lyophilization designed to obtain nanostructured ceramic/metal powders. Starting from the ceramic powder and the corresponding metal salt, a water-based suspension is sprayed on liquid nitrogen. The frozen powders are subsequently freeze-dried, calcined and reduced. The material was analyzed using X-ray diffraction analysis at all stages. High resolution transmission electron microscopy studies showed a uniform distribution of metal nanoparticles on the ceramic grain surfaces, good interfaces and high crystallinity, with an average metal particle size in the nanometric range.

  10. Stability of lyophilized human platelets loaded with small molecule carbohydrates.

    Science.gov (United States)

    Wang, J X; Yang, C; Wan, W; Liu, M X; Ren, S P; Quan, G B; Han, Y

    2011-01-01

    Long-term preservation of platelets is a great challenge for blood transfusion centers, due to the required narrow storage temperature arange (22 ± 2 degree C). Short shelf life and potential bacterial growth often lead to the shortage of high-quality platelets. Freeze-dried preservation is thus believed to be a potential solution for long-term platelet storage without losing the hemostasis function. Here we report a new platelet preservation method, which uses small molecule carbohydrates to extend storage time and to maintain platelet function. The activities of lyophilized platelets that were stabilized with small molecule carbohydrate (e.g., cell viability, mean platelet volume, activation characteristics, and aggregation kinetics) were maintained after storage of 30, 60, and 90 days at room temperature, 4 degree C, and -20 degree C. The recovery of freeze-dried platelets was 87 percent in comparison to fresh platelets. The mean platelet volume of rehydrated platelets increased (from 6.8 fl to 8.0 fl). About 40 percent of rehydrated platelets was in the early-activated stage (PCA-1 positive) and 30 percent was in the terminal-activated stage (CD62P positive). The cell viability was about 60 percent as measured with CMFDA vital probes. The aggregation rate of rehydrated platelets after 90-day storage was similar to fresh platelets stored at 22 degree C ± 2 degree C.

  11. Hypoglycemic activities of lyophilized powder of Gynura divaricata by improving antioxidant potential and insulin signaling in type 2 diabetic mice

    Directory of Open Access Journals (Sweden)

    Bing-Qing Xu

    2015-12-01

    Full Text Available Background: Diabetes mellitus is a serious disease affecting about 5% of people worldwide. Although several studies have indicated hypoglycemic activities of Gynura divaricata (GD, the mechanisms by which GD improves the symptoms of diabetes remain unclear. Objective: The aim of this study was to investigate the potential hypoglycemic effects of GD. Design: The leaves and stems of GD were prepared and lyophilized into a powder, which was added to the diet of mice with type 2 diabetes induced by a high-fat diet in combination with streptozotocin for 4 weeks. During this period, fasting blood glucose (FBG levels and body weight of mice were measured. In addition, at the end of the experiment, a series of assays was performed. Results: GD administration effectively alleviates insulin resistance and induces a decrease in FBG by 59.54% in 1.2% (L GD-treated diabetic group and 56.13% in 4.8% (H GD-treated diabetic group after 4 weeks, respectively, relative to diabetic model mice. The antioxidant capacity was improved by increasing the activities of glutathione peroxidase (GSH-Px and total superoxide dismutase (T-SOD by 64.87% and 53.42% in treatment group H, compared to diabetic model mice, while GD treatment induced a significant decrease in malondialdehyde (MDA level by 50% in treatment group L, compared to the level in diabetic model mice. Furthermore, glucose metabolism was ameliorated by the increased glycogen synthesis in the livers of diabetic mice. In addition, we also demonstrated that the messenger RNA (mRNA and protein expression levels of AKT, PI3K and PDK-1, which are involved in insulin signaling, were significantly increased. Conclusions: Oral administration of the GD-lyophilized powder has been effectively hypoglycemic, which is done by activating insulin signaling and improving antioxidant capacity in mice with type 2 diabetes.

  12. Microbial profile of a kefir sample preparations: grains in natura and lyophilized and fermented suspension

    Directory of Open Access Journals (Sweden)

    Rafaela Strada de Oliveira Bergmann

    2010-12-01

    Full Text Available Probiotics are supplementary foods developed by microbial strains that improve animal health beyond basic nutrition. Probiotics are consumed orally, regardless of being considered as normal inhabitants of the intestines, able to survive in enzimatic and biliary secretions. Kefir is a probiotic originated from the old continent, fermented by several bacteria and yeasts, encapsulated in a polyssacharide matrix, and resembles jelly grains. Kefir is also presented as its sourish product both in sugary or milky suspensions containing vitamins, aminoacids, peptides, carbohydrates, ethanol, and volatile compounds. Kefir is known to have a diverse microbial content depending on the country and fermentative substrates, which cause distinct probiotic effects. In this sense, the purpose of this work was to isolate, identify, and quantify the microbial content of a native sugary kefir sample (fermented suspension and lyophilized natural grains. Serial dilutions were plated on Rogosa agar (AR and De Man, Rogosa and Sharpe (MRS, for Lactobacillus; Brain Heart Infusion (BHI, for total bacteria; Sabouraud-Dextrose-Agar (SDA, for yeasts and filamentous fungi; Thioglycolate Agar (TA, for Streptococcus, Acetobacteria and Leuconostoc; and Coconut Water Agar (CWA, and CWA supplemented with yeast extract (CWAY, for various genera. Genera and species for all strains were identified through biochemical reactions and specific API systems. The microbial profile of kefir was different from other sources of grains despite the presence of similar microorganisms and others which have not been reported yet. The data obtained with the CWA and CWAE media suggest that both substrates are alternative and salutary media for culture of kefir strains.

  13. Nucleation, aggregation, annealing, and disintegration of granular clusters

    Science.gov (United States)

    González-Gutiérrez, Jorge; Carrillo-Estrada, J. L.; Ruiz-Suárez, J. C.

    2014-05-01

    The processes of nucleation, aggregation, annealing, and disintegration of clusters of non-Brownian paramagnetic beads in a vibrofluidized system are experimentally investigated. The interaction among the beads is induced by a magnetic seed composed of two dipoles allocated outside the container cell. We observe a clearly differentiated nucleation stage, whose evolution (nucleation time versus acceleration strength) follows a power law. Thereafter, the beads aggregate forming 2D disordered clusters around the nucleus. Both processes (nucleation and aggregation) are determined by the competition between magnetic forces and the drag produced by a thermal bath created by glass particles. Once the agglomerates reach a final state (shape and length), they are annealed by increasing and decreasing the granular temperature. We found that the fractal dimension and the lacunarity index clearly describe the structural variations of the clusters. Our discussion on this phenomenon is addressed, making a rough analogy with the glass transition in a super-cooled liquid. Finally, we study the disintegration of the clusters as a function of time and the density of the surrounding gas. The question is not if, but how they disintegrate upon removing the external field; we find that the disintegration follows an exponential decay.

  14. Formulation and evaluation of rizatriptan benzoate mouth disintegrating tablets.

    Science.gov (United States)

    Keny, R V; Desouza, Chrisma; Lourenco, C F

    2010-01-01

    The present investigation deals with development of mouth disintegrating tablets of rizatriptan benzoate to produce the intended benefits. Mouth disintegrating tablets of rizatriptan benzoate were prepared using superdisintegrants crospovidone, carboxymethylcellulose calcium, Indion 414 and Indion 234 using the direct compression method. The tablets prepared were evaluated for thickness, uniformity of weight, content uniformity, hardness, friability, wetting time, in vitro and in vivo disintegration time, mouth feel, in vitro drug release and assay by high performance liquid chromatography. The tablets disintegrated in vitro and in vivo within 4 to 7 s and 6 to 19 s, respectively. Almost 90% of drug was released from all formulations within 20 min. The drug release from the formulations followed first order kinetics. Stability studies of the tablets at 40+/-2 degrees /75%+/-5% RH for 1 mo showed non significant drug loss. The formulation containing combination of crospovidone and Indion 234 was found to give the best results. Apart from fulfilling all official and other specifications, the tablets exhibited higher rate of release.

  15. Formulation and evaluation of rizatriptan Benzoate mouth disintegrating tablets

    Directory of Open Access Journals (Sweden)

    Keny R

    2010-01-01

    Full Text Available The present investigation deals with development of mouth disintegrating tablets of rizatriptan benzoate to produce the intended benefits. Mouth disintegrating tablets of rizatriptan benzoate were prepared using superdisintegrants crospovidone, carboxymethylcellulose calcium, Indion 414 and Indion 234 using the direct compression method. The tablets prepared were evaluated for thickness, uniformity of weight, content uniformity, hardness, friability, wetting time, in vitro and in vivo disintegration time, mouth feel, in vitro drug release and assay by high performance liquid chromatography. The tablets disintegrated in vitro and in vivo within 4 to 7 s and 6 to 19 s, respectively. Almost 90% of drug was released from all formulations within 20 min. The drug release from the formulations followed first order kinetics. Stability studies of the tablets at 40±2 o /75%±5% RH for 1 mo showed non significant drug loss. The formulation containing combination of crospovidone and Indion 234 was found to give the best results. Apart from fulfilling all official and other specifications, the tablets exhibited higher rate of release.

  16. Evidence for the disintegration of KIC 12557548 b

    NARCIS (Netherlands)

    M. Brogi; C.U. Keller; M. de Juan Ovelar; M.A. Kenworthy; R.J. de Kok; M. Min; I.A.G. Snellen

    2012-01-01

    Context. The Kepler object KIC 12557548 b is peculiar. It exhibits transit-like features every 15.7 h that vary in depth between 0.2% and 1.2%. Rappaport et al. (2012, ApJ, 752, 1) explain the observations in terms of a disintegrating, rocky planet that has a trailing cloud of dust created and const

  17. Plenary Speeches: Is the Second Language Acquisition Discipline Disintegrating?

    Science.gov (United States)

    Hulstijn, Jan H.

    2013-01-01

    After characterizing the study of second language acquisition (SLA) from three viewpoints, I try to answer the question, raised by DeKeyser (2010), of whether the SLA field is disintegrating. In answering this question, I first propose a distinction between SLA as the relatively fundamental academic discipline and SLA as the relatively applied…

  18. Probabilistic Analysis of the Hard Rock Disintegration Process

    Directory of Open Access Journals (Sweden)

    K. Frydrýšek

    2008-01-01

    Full Text Available This paper focuses on a numerical analysis of the hard rock (ore disintegration process. The bit moves and sinks into the hard rock (mechanical contact with friction between the ore and the cutting bit and subsequently disintegrates it. The disintegration (i.e. the stress-strain relationship, contact forces, reaction forces and fracture of the ore is solved via the FEM (MSC.Marc/Mentat software and SBRA (Simulation-Based Reliability Assessment method (Monte Carlo simulations, Anthill and Mathcad software. The ore is disintegrated by deactivating the finite elements which satisfy the fracture condition. The material of the ore (i.e. yield stress, fracture limit, Young’s modulus and Poisson’s ratio, is given by bounded histograms (i.e. stochastic inputs which better describe reality. The results (reaction forces in the cutting bit are also of stochastic quantity and they are compared with experimental measurements. Application of the SBRA method in this area is a modern and innovative trend in mechanics. However, it takes a long time to solve this problem (due to material and structural nonlinearities, the large number of elements, many iteration steps and many Monte Carlo simulations. Parallel computers were therefore used to handle the large computational needs of this problem. 

  19. Plenary Speeches: Is the Second Language Acquisition Discipline Disintegrating?

    Science.gov (United States)

    Hulstijn, Jan H.

    2013-01-01

    After characterizing the study of second language acquisition (SLA) from three viewpoints, I try to answer the question, raised by DeKeyser (2010), of whether the SLA field is disintegrating. In answering this question, I first propose a distinction between SLA as the relatively fundamental academic discipline and SLA as the relatively applied…

  20. The Effects of Lyophilization on the Physico-Chemical Stability of Sirolimus Liposomes

    Directory of Open Access Journals (Sweden)

    Parvin Zakeri-Milani

    2013-02-01

    Full Text Available Purpose: The major limitation in the widespread use of liposome drug delivery system is its instability. Lyophilization is a promising approach to ensure the long-term stability of liposomes. The aim of this study was to prepare sirolimus-loaded liposomes, study their stability and investigate the effect of lyophilization either in the presence or in the absence of lyoprotectant on liposome properties. Methods: Two types of multi-lamellar liposomes, conventional and fusogenic, containing sirolimus were prepared by modified thin film hydration method with different ratio of dipalmitoylphosphatidylcholine (DPPC, cholesterol and dioleoylphosphoethanolamine (DOPE, and were lyophilized with or without dextrose as lyoprotectant. Chemical stability investigation was performed at 4°C and 25°C until 6 months using a validated HPLC method. Physical stability was studied with determination of particle size (PS and encapsulation efficiency (EE % of formulations through 6 months. Results: Chemical stability test at 4°C and 25°C until 6 months showed that drug content of liposomes decreased 8.4% and 20.2% respectively. Initial mean EE % and PS were 72.8 % and 582 nm respectively. After 6 months mean EE % for suspended form, lyophilized without lyoprotectant and lyophilized with lyoprotectant were 54.8 %, 62.3% and 67.1 % at 4°C and 48.2%, 60.4 % and 66.8 % at 25°C respectively. Corresponding data for mean PS were 8229 nm, 2397 nm and 688nm at 4°C and 9362 nm, 1944 nm and 737 nm at 25°C respectively. Conclusion: It is concluded that lyophilization with and without dextrose could increase shelf life of liposome and dextrose has lyoprotectant effect that stabilized liposomes in the lyophilization process.

  1. EFFECT OF VARIOUS STABILIZERS ON TITRE OF LYOPHILIZED LIVE-ATTENUATED PESTE DES PETITS RUMINANTS (PPR VACCINE

    Directory of Open Access Journals (Sweden)

    M. ASIM, A. RASHID AND A. H. CHAUDHARY

    2008-12-01

    Full Text Available Lyophilization stabilizes the biological materials by using two overlapping drying procedure i.e. primary drying by sublimation of the ice crystal from frozen material and secondary drying or desorption by evaporation of the free water adsorbed into the dried product. Three different stabilizers i.e. lactalbumin hydrolysate-sucrose, Weybridge medium and lactalbumin hydrolysate-manitol were used to lyophilize the Peste des petits ruminants (PPR vaccine. Titre of live-attenuated PPR cell culture experimental vaccine was studied after lyophilization which revealed that PPR vaccine lyophilized with Weybridge medium was more stable and maintained the virus titre longer than rest of stabilizers used in the study.

  2. Influence of Magnetic Field Amplitude on Quantity and Sizes of Disintegration Fragments of Magnetic Particles Cluster

    Institute of Scientific and Technical Information of China (English)

    2000-01-01

    The disintegration of a mass of magnetic particles is investigated at pulsing switching on a magnetic field. The influence of field value on quantity, sizes and allocation of fragments of disintegration is explored. The presence of two critical fields, defining the process of disintegration, is revealed. The results can be used at manufacture of packings to magnetic filters.

  3. Lyophilized standards for the calibration of real time PCR assay for hepatitis C virus RNA

    Institute of Scientific and Technical Information of China (English)

    WANG Lu-nan; WU Jian-min; DENG Wei; SHEN Zi-yu; CHEN Wen-xiang; LI Jin-ming

    2006-01-01

    Background Since October 1997, an international standard for hepatitis C virus (HCV) nucleic acid amplification technology assay, 96/790, has been available. We compared a series of lyophilized standards with known HCV RNA concentrations against the international standard in fluorescence quantitative PCR detection.Methods A series of lyophilized sera were calibrated by ROCHE COBAS AMPLICOR HCV Monitor test against the international standard and sent to various manufacturers to analyse the samples using their own kits.Then calibration curves from the series were compared with that obtained from the external standard calibration curve with the manufacture's series.Results The standard calibration curve with the series of lyophilized serum showed an excellent correlation(R2>0.98), slope and intercept that were similar to those from the manufacture's series. When the standard calibration curve from the series of lyophilized standards were used to define the values of the given sample,lower coefficients of variation between kits from different manufactures were obtained.Conclusion The results showed that the lyophilized standards could be used to setup the standard calibration curve for clinical HCV RNA quantitative PCR detection.

  4. The Pyrolytic Profile of Lyophilized and Deep-Frozen Compact Part of the Human Bone

    Directory of Open Access Journals (Sweden)

    Jolanta Lodowska

    2012-01-01

    Full Text Available Background. Bone grafts are used in the treatment of nonunion of fractures, bone tumors and in arthroplasty. Tissues preserved by lyophilization or deep freezing are used as implants nowadays. Lyophilized grafts are utilized in the therapy of birth defects and bone benign tumors, while deep-frozen ones are applied in orthopedics. The aim of the study was to compare the pyrolytic pattern, as an indirect means of the analysis of organic composition of deep-frozen and lyophilized compact part of the human bone. Methods. Samples of preserved bone tissue were subjected to thermolysis and tetrahydroammonium-hydroxide- (TMAH- associated thermochemolysis coupled with gas chromatography and mass spectrometry (Py-GC/MS. Results. Derivatives of benzene, pyridine, pyrrole, phenol, sulfur compounds, nitriles, saturated and unsaturated aliphatic hydrocarbons, and fatty acids (C12–C20 were identified in the pyrolytic pattern. The pyrolyzates were the most abundant in derivatives of pyrrole and nitriles originated from proteins. The predominant product in pyrolytic pattern of the investigated bone was pyrrolo[1,2-α]piperazine-3,6-dione derived from collagen. The content of this compound significantly differentiated the lyophilized graft from the deep-frozen one. Oleic and palmitic acid were predominant among fatty acids of the investigated samples. The deep-frozen implants were characterized by higher percentage of long-chain fatty acids than lyophilized grafts.

  5. Preservation of aerial conidia and biomasses from entomopathogenic fungi Beauveria brongniartii and Metarhizium anisopliae during lyophilization.

    Science.gov (United States)

    Toegel, Stefan; Salar-Behzadi, Sharareh; Horaczek-Clausen, Andrea; Viernstein, Helmut

    2010-09-01

    In this study, we assessed the stability provided by different formulations to aerial conidia or biomasses (conidia, blastospores, and mycelia) of Beauveria brongniartii and Metarhizium anisopliae subjected to lyophilization. First, the impact of the freezing and drying processes on spore survival was evaluated. Whereas unprotected B. brongniartii spores showed high cryosensitivity, those of M. anisopliae were markedly harmed by the drying process. Then, the protective efficiency of 14 excipients was systematically evaluated and optimized regarding required concentrations. Fructose, glucose, and saccharose significantly enhanced viabilities for B. brongniartii and M. anisopliae spores following lyophilization, especially as a result of their cryoprotective effects. In addition, the effect of various bulking agents on spore survival was studied and dextran 4 was selected to enhance the physical properties of the lyophilized products. The combination of fructose and dextran 4 was further applied to prepare lyophilized biomasses of both fungi. In comparison to freshly harvested biomasses, the lyophilized products showed similar growth rates and a comparable production of virulent secondary metabolites such as destruxin A, destruxin B, or oosporein, suggesting their applicability as biological control agents.

  6. Formulation, lyophilization and solid-state properties of a pegylated protein.

    Science.gov (United States)

    Mosharraf, Mitra; Malmberg, Michael; Fransson, Jonas

    2007-05-24

    In this paper the importance of formulation and process parameters on the solid-state properties of a lyophilized, pegylated growth hormone antagonist (pegvisomant) was studied. The degree of solid-state disorder (amorphicity), protein/polyethylene glycol (PEG)/sucrose interactions, and dissolution characteristics of the resultant cakes were examined. Using isothermal microcalorimetry (IMC) and differential scanning calorimetry (DSC), it was shown that in co-lyophilized pegylated protein/sucrose systems there was an interaction between sucrose and pegylated protein molecules. This interaction was evidenced by a decrease in the melting temperature (Tm) and melting enthalpy of PEG as a function of sucrose concentration. It was also shown that the sum of the heat of interaction with water for the individual constituents, lyophilized pegylated protein and lyophilized sucrose, was higher than the heat of interaction for the co-lyophilized system. As the concentration of sucrose was increased, the degree of solid-state disorder increased and the solid dissolved faster. A correlation was found among heat of interaction with water, degree of solid-state disorder, and dissolution time. Pegylation caused a shorter dissolution time, lower moisture content, increased amorphicity, and a more rapid moisture-induced crystallization of sucrose.

  7. Enhanced osteogenic activity and anti-inflammatory properties of Lenti-BMP-2-loaded TiO2 nanotube layers fabricated by lyophilization following trehalose addition

    Directory of Open Access Journals (Sweden)

    Zhang X

    2016-01-01

    Full Text Available Xiaochen Zhang,1 Zhiyuan Zhang,1 Gang Shen,2 Jun Zhao2 1Department of Oral and Maxillofacial Surgery, 2Department of Orthodontics, College of Stomatology, Ninth People’s Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, People’s Republic of China Abstract: To enhance biocompatibility and osseointegration between titanium implants and surrounding bone tissue, numerous efforts have been made to modify the surface topography and composition of Ti implants. In this paper, Lenti-BMP-2-loaded TiO2 nanotube coatings were fabricated by lyophilization in the presence of trehalose to functionalize the surface. We characterized TiO2 nanotube layers in terms of the following: surface morphology; Lenti-BMP-2 and trehalose release; their ability to induce osteogenesis, proliferation, and anti-inflammation in vitro; and osseointegration in vivo. The anodized TiO2 nanotube surfaces exhibited an amorphous glassy matrix perpendicular to the Ti surface. Both Lenti-BMP-2 and trehalose showed sustained release over the course of 8 days. Results from real-time quantitative polymerase chain reaction studies demonstrated that lyophilized Lenti-BMP-2/TiO2 nanotubes constructed with trehalose (Lyo-Tre-Lenti-BMP-2 significantly promoted osteogenic differentiation of bone marrow stromal cells but not their proliferation. In addition, Lyo-Tre-Lenti-BMP-2 nanotubes effectively inhibited lipopolysaccharide-induced interleukin-1β and tumor necrosis factor-α production. In vivo, the formulation also promoted osseointegration. This study presents a promising new method for surface-modifying biomedical Ti-based implants to simultaneously enhance their osteogenic potential and anti-inflammatory properties, which can better satisfy clinical needs. Keywords: osteogenesis, anti-inflammation, TiO2 nanotube layers, Lenti-BMP-2, lyophilization, trehalose 

  8. The effect of glicerol and sorbitol plasticizers toward disintegration time of phyto-capsules

    Science.gov (United States)

    Pudjiastuti, Pratiwi; Hendradi, Esti; Wafiroh, Siti; Harsini, Muji; Darmokoesoemo, Handoko

    2016-03-01

    The aim of research is determining the effect of glycerol and sorbitol toward the disintegration time of phyto-capsules, originated capsules from plant polysaccharides. Phyto-capsules were made from polysaccharides and 0.5% (v/v) of glycerol and sorbitol of each. The seven capsules of each were determined the disintegration time using Erweka disintegrator. The mean of disintegration time of phyto-capsules without plasticizers, with glycerol and sorbitol were 25'30"; 45'15" and 35'30" respectively. The color and colorless gelatin capsules showed the mean of disintegration time 7'30" and 2'35" respectively.

  9. Transparent Yttrium Aluminium Garnet Obtained by Spark Plasma Sintering of Lyophilized Gels

    Directory of Open Access Journals (Sweden)

    M. Suárez

    2009-01-01

    Full Text Available Lyophilized YAG gel, synthesized by the coprecipitation technique, has been sintered to transparency by spark plasma sintering method at 1500∘C. Whereas conventionally dried gels show large agglomerates, over 1 μm, powders from lyophilized gels show no agglomeration with an average particle size below 100 nm. The absence of agglomerates affects on the optical properties of the sintered materials: conventionally dried powders are opaque after sintering, whereas 0.8 mm thick transparent YAG materials with in-line transmittances close to 60% at 680 nm and over 80% in the infrared range have been obtained for the lyophilized gels.

  10. Carbon-deuterium rotational-echo double-resonance NMR spectroscopy of lyophilized aspartame formulations.

    Science.gov (United States)

    Luthra, Suman A; Utz, Marcel; Gorman, Eric M; Pikal, Michael J; Munson, Eric J; Lubach, Joseph W

    2012-01-01

    In this study, changes in the local conformation of aspartame were observed in annealed lyophilized glasses by monitoring changes in the distance between two labeled sites using C-(2)H rotational-echo double-resonance (REDOR) nuclear magnetic resonance (NMR) spectroscopy. Confirmation that the REDOR experiments were producing accurate distance measurement was ensured by measuring the (13)C-(15)N distance in glycine. The experiment was further verified by measuring the REDOR dephasing curve on (13)C-(2)H methionine. (13)C-(2)H REDOR dephasing curves were then measured on lyophilized aspartame-disaccharide formulations. In aspartame-sucrose formulation, the internuclear distances increased upon annealing, which correlated with decreased chemical reactivity. By contrast, annealing had only a minimal effect on the dephasing curve in aspartame-trehalose formulation. The results show that stability is a function of both mobility and local structure (conformation), even in a small molecule system such as lyophilized aspartame-sucrose.

  11. Whey protein nanofibrils: the environment-morphology-functionality relationship in lyophilization, rehydration, and seeding.

    Science.gov (United States)

    Loveday, Simon M; Su, Jiahong; Rao, M Anandha; Anema, Skelte G; Singh, Harjinder

    2012-05-23

    Amyloid-like fibrils from β-lactoglobulin have potential as efficient thickening and gelling agents for food and biomedical applications, but the link between fibril morphology and bulk viscosity is poorly understood. We examined how lyophilization and rehydration affects the morphology and rheological properties of semiflexible (i.e., straight) and highly flexible (i.e., curly) fibrils, the latter made with 80 mM CaCl(2). Straight fibrils were fractured into short rods by lyophilization and rehydration, whereas curly fibrils sustained little damage. This was reflected in the viscosities of rehydrated fibril dispersions, which were much lower for straight fibrils than for curly fibrils. Lyophilized straight or curly fibrils seeded new fibril growth, but viscosity enhancement due to seeding was negligible. We believe that the increase in fibril concentration caused by seeding was counterbalanced by a decrease in fibril length, reducing the ability of fibrils to form physical entanglement networks.

  12. X-ray scattering for the characterization of lyophilized breast tissue samples

    Science.gov (United States)

    Elshemey, Wael M.; Mohamed, Fayrouz S.; Khater, Ibrahim M.

    2013-09-01

    This work investigates the possibility of characterizing breast cancer by measuring the X-ray scattering profiles of lyophilized excised breast tissue samples. Since X-ray scattering from water-rich tissue is dominated by scattering from water, the removal of water by lyophilization would enhance the characterization process. In the present study, X-ray scattering profiles of 22 normal, 22 malignant and 10 benign breast tissue samples are measured. The cut-offs of scatter diagrams, sensitivity, specificity and diagnostic accuracy of three characterization parameters (full width at half maximum (FWHM) for the peak at 1.1 nm-1, area under curve (AUC), and ratio of 1st to 2nd scattering peak intensities (I1/I2%)) are calculated and compared to the data from non-lyophilized samples. Results show increased sensitivity (up to 100%) of the present data on lyophilized breast tissue samples compared to previously reported data for non-lyophilized samples while the specificity (up to 95.4%), diagnostic accuracy (up to 95.4%) and receiver operating characteristic (ROC) curve values (up to 0.9979) for both sets of data are comparable. The present study shows significant differences between normal samples and each of malignant and benign samples. Only subtle differences exist between malignant and benign lyophilized breast tissue samples where FWHM=0.7±0.1 and 0.8±0.3, AUC=1.3±0.2 and 1.4±0.2 and I1/I2%=44.9±11.0 and 52.4±7.6 for malignant and benign samples respectively.

  13. Assessment of disintegrant efficacy with fractal dimensions from real-time MRI.

    Science.gov (United States)

    Quodbach, Julian; Moussavi, Amir; Tammer, Roland; Frahm, Jens; Kleinebudde, Peter

    2014-11-20

    An efficient disintegrant is capable of breaking up a tablet in the smallest possible particles in the shortest time. Until now, comparative data on the efficacy of different disintegrants is based on dissolution studies or the disintegration time. Extending these approaches, this study introduces a method, which defines the evolution of fractal dimensions of tablets as surrogate parameter for the available surface area. Fractal dimensions are a measure for the tortuosity of a line, in this case the upper surface of a disintegrating tablet. High-resolution real-time MRI was used to record videos of disintegrating tablets. The acquired video images were processed to depict the upper surface of the tablets and a box-counting algorithm was used to estimate the fractal dimensions. The influence of six different disintegrants, of different relative tablet density, and increasing disintegrant concentration was investigated to evaluate the performance of the novel method. Changing relative densities hardly affect the progression of fractal dimensions, whereas an increase in disintegrant concentration causes increasing fractal dimensions during disintegration, which are also reached quicker. Different disintegrants display only minor differences in the maximal fractal dimension, yet the kinetic in which the maximum is reached allows a differentiation and classification of disintegrants.

  14. Neuronal network disintegration: common pathways linking neurodegenerative diseases

    Science.gov (United States)

    Ahmed, Rebekah M; Devenney, Emma M; Irish, Muireann; Ittner, Arne; Naismith, Sharon; Ittner, Lars M; Rohrer, Jonathan D; Halliday, Glenda M; Eisen, Andrew; Hodges, John R; Kiernan, Matthew C

    2016-01-01

    Neurodegeneration refers to a heterogeneous group of brain disorders that progressively evolve. It has been increasingly appreciated that many neurodegenerative conditions overlap at multiple levels and therefore traditional clinicopathological correlation approaches to better classify a disease have met with limited success. Neuronal network disintegration is fundamental to neurodegeneration, and concepts based around such a concept may better explain the overlap between their clinical and pathological phenotypes. In this Review, promoters of overlap in neurodegeneration incorporating behavioural, cognitive, metabolic, motor, and extrapyramidal presentations will be critically appraised. In addition, evidence that may support the existence of large-scale networks that might be contributing to phenotypic differentiation will be considered across a neurodegenerative spectrum. Disintegration of neuronal networks through different pathological processes, such as prion-like spread, may provide a better paradigm of disease and thereby facilitate the identification of novel therapies for neurodegeneration. PMID:27172939

  15. Determination of moisture content of lyophilized allergen vaccines by NIR spectroscopy

    DEFF Research Database (Denmark)

    Zheng, Yiwu; Lai, Xuxin; Bruun, Susanne Wrang

    2008-01-01

    Moisture content is an important parameter for lyophilized vaccines. Currently, Karl Fischer titration is widely used for moisture determination in routine analysis. However, this method is time-consuming, sample destructive and requires environment polluting reagents, as well as the results rely...... on the random samplings. In this study, near infrared spectroscopy was used as a fast, non-invasive and non-destructive method to determine the moisture content in lyophilized allergy vaccines. Five different vaccine products were investigated, which contained water in the range of 0.17-1.51% (w/w, KF...

  16. Design and Testing of a Lyophilizer for Water Recovery from Solid Waste

    Science.gov (United States)

    Litwiller, Eric; Fisher, John; Flynn, Michael

    2005-01-01

    Mixed liquid/solid wastes, including feces, water processor effluents, and food waste, can be lyophilized (freeze-dried) to recover the water they contain and stabilize the solids remain. Previous research has demonstrated the potential benefits of using thermoelectric heat pumps to build a lyophilizer for processing waste in microgravity. These results were used to build a working prototype suitable for ground-based human testing. This paper describes the prototype design and presents the results of functional and performance tests. Equivalent system mass parameters are calculated, and practical issues such as sanitary waste handling in microgravity are addressed.

  17. Design and Testing of a Lyophilizer for Water Recovery from Solid Waste

    Science.gov (United States)

    Litwiller, Eric; Fisher, John; Flynn, Michael

    2005-01-01

    Mixed liquid/solid wastes, including feces, water processor effluents, and food waste, can be lyophilized (freeze-dried) to recover the water they contain and stabilize the solids remain. Previous research has demonstrated the potential benefits of using thermoelectric heat pumps to build a lyophilizer for processing waste in microgravity. These results were used to build a working prototype suitable for ground-based human testing. This paper describes the prototype design and presents the results of functional and performance tests. Equivalent system mass parameters are calculated, and practical issues such as sanitary waste handling in microgravity are addressed.

  18. Biochemicals characteristics and pre-clinical testing of lyophilized bothropic antivenom against bothrops atrox snake venom

    OpenAIRE

    García, Patricia J.; Centro Nacional de Productos Biológicos, Instituto Nacional de Salud. Lima, Perú. Médico.; Yarlequé, Armando; Laboratorio de Biología Molecular. Facultad de Ciencias Biológicas, Universidad Nacional Mayor de San Marcos, Lima.; Bonilla-Ferreyra, Cesar; Centro Nacional de Productos Biológicos, Instituto Nacional de Salud. Lima, Perú. Biólogo.; Pessah, Silvia; Centro Nacional de Productos Biológicos, Instituto Nacional de Salud. Lima, Perú. Médico.; Vivas, Dan; Laboratorio de Biología Molecular. Facultad de Ciencias Biológicas, Universidad Nacional Mayor de San Marcos. Lima, Perú. Biólogo.; Sandoval, Gustavo Adolfo; Laboratorio de Biología Molecular. Facultad de Ciencias Biológicas, Universidad Nacional Mayor de San Marcos. Lima, Perú. Biólogo; Lazo, Fanny; Laboratorio de Biología Molecular. Facultad de Ciencias Biológicas, Universidad Nacional Mayor de San Marcos. Lima, Perú. Biólogo

    2008-01-01

    Biochemical features and neutralizing capacity of lyophilized bothropic antivenom elaborated by the Peruvian National Health Institute (Lima, Peru). It was found that the antivenom protein contents is 51.4 mg/mL. Lyophilized preparations can be reconstituted in 10 minutes, reaching Abs600nm and pH values reported as 0.091 and 7.0, respectively. Regarding toxicity of the venom for mice, LD50 was 3.33 µg, minimal hemorrhagic dose was 4.10 ± 0.64 µg, minimal myotoxic dose was 30.2 ± 2.5 µg, m...

  19. Computational Fluid Dynamics Simulation of Hydrodynamics and Stresses in the PhEur/USP Disintegration Tester Under Fed and Fasted Fluid Characteristics.

    Science.gov (United States)

    Kindgen, Sarah; Wachtel, Herbert; Abrahamsson, Bertil; Langguth, Peter

    2015-09-01

    Disintegration of oral solid dosage forms is a prerequisite for drug dissolution and absorption and is to a large extent dependent on the pressures and hydrodynamic conditions in the solution that the dosage form is exposed to. In this work, the hydrodynamics in the PhEur/USP disintegration tester were investigated using computational fluid dynamics (CFD). Particle image velocimetry was used to validate the CFD predictions. The CFD simulations were performed with different Newtonian and non-Newtonian fluids, representing fasted and fed states. The results indicate that the current design and operating conditions of the disintegration test device, given by the pharmacopoeias, are not reproducing the in vivo situation. This holds true for the hydrodynamics in the disintegration tester that generates Reynolds numbers dissimilar to the reported in vivo situation. Also, when using homogenized US FDA meal, representing the fed state, too high viscosities and relative pressures are generated. The forces acting on the dosage form are too small for all fluids compared to the in vivo situation. The lack of peristaltic contractions, which generate hydrodynamics and shear stress in vivo, might be the major drawback of the compendial device resulting in the observed differences between predicted and in vivo measured hydrodynamics.

  20. The Lyophilization Process Maintains the Chemical and Biological Characteristics of Royal Jelly

    Directory of Open Access Journals (Sweden)

    Andresa Piacezzi Nascimento

    2015-01-01

    Full Text Available The alternative use of natural products, like royal jelly (RJ, may be an important tool for the treatment of infections caused by antibiotic-resistant bacteria. RJ presents a large number of bioactive substances, including antimicrobial compounds. In this study, we carried out the chemical characterization of fresh and lyophilized RJ and investigated their antibacterial effects with the purpose of evaluating if the lyophilization process maintains the chemical and antibacterial properties of RJ. Furthermore, we evaluated the antibacterial efficacy of the main fatty acid found in RJ, the 10-hydroxy-2-decenoic acid (10H2DA. Chromatographic profile of the RJ samples showed similar fingerprints and the presence of 10H2DA in both samples. Furthermore, fresh and lyophilized RJ were effective against all bacteria evaluated; that is, the lyophilization process maintains the antibacterial activity of RJ and the chemical field of 10H2DA. The fatty acid 10H2DA exhibited a good antibacterial activity against Streptococcus pneumoniae. Therefore, it may be used as an alternative and complementary treatment for infections caused by antibiotic-resistant S. pneumoniae.

  1. Mass spectrometric approaches to study protein structure and interactions in lyophilized powders.

    Science.gov (United States)

    Moorthy, Balakrishnan S; Iyer, Lavanya K; Topp, Elizabeth M

    2015-04-14

    Amide hydrogen/deuterium exchange (ssHDX-MS) and side-chain photolytic labeling (ssPL-MS) followed by mass spectrometric analysis can be valuable for characterizing lyophilized formulations of protein therapeutics. Labeling followed by suitable proteolytic digestion allows the protein structure and interactions to be mapped with peptide-level resolution. Since the protein structural elements are stabilized by a network of chemical bonds from the main-chains and side-chains of amino acids, specific labeling of atoms in the amino acid residues provides insight into the structure and conformation of the protein. In contrast to routine methods used to study proteins in lyophilized solids (e.g., FTIR), ssHDX-MS and ssPL-MS provide quantitative and site-specific information. The extent of deuterium incorporation and kinetic parameters can be related to rapidly and slowly exchanging amide pools (N fast, N slow) and directly reflects the degree of protein folding and structure in lyophilized formulations. Stable photolytic labeling does not undergo back-exchange, an advantage over ssHDX-MS. Here, we provide detailed protocols for both ssHDX-MS and ssPL-MS, using myoglobin (Mb) as a model protein in lyophilized formulations containing either trehalose or sorbitol.

  2. Human milk bactericidal properties: effect of lyophilization and relation to maternal factors and milk components.

    Science.gov (United States)

    Salcedo, Jaime; Gormaz, Maria; López-Mendoza, Maria C; Nogarotto, Elisabetta; Silvestre, Dolores

    2015-04-01

    Lyophilization appears to be a viable method for storing human milk, assuring no microbiological contamination and preserving its health benefits and antibacterial properties. The aim of the study is to evaluate and compare the effects of different storage methods (lyophilization and freezing at -20°C and -80°C) and maternal factors (gestational length or time postpartum) upon the microbiological contents and bactericidal activity of human milk. The possible relation between bactericidal activity and the content of certain nutrients and functional components is also investigated. Microbiological content, bactericidal activity, sialic acid, and ganglioside contents, as well as protein, fat, and lactose concentrations were assessed in 125 human milk samples from 65 healthy donors in the Human Milk Bank of La Fe (Valencia, Spain). Lyophilization and storage at -80°C significantly reduced the content of mesophilic aerobic microorganisms and Staphylococcus epidermidis when compared with storage at -20°C. Bactericidal activity was not significantly modified by lyophilization when compared with freezing at either -20°C or -80°C. Bactericidal activity was not correlated with fat, protein, or lactose content, but was significantly correlated to ganglioside content. The bactericidal activity was significantly greater (P milk and in milk from women with term delivery than in milk from early lactation (days 1-7 postpartum) and milk from women with preterm delivery, respectively. Lyophilization and storage at -80°C of human milk yields similar results and are superior to storage at -20C with regard to microbial and bactericidal capacities, being a feasible alternative for human milk banks.

  3. Ultrasonically enhanced disintegration. Polymers, sludge, and contaminated soil

    Energy Technology Data Exchange (ETDEWEB)

    Groenroos, A.

    2010-05-15

    There are a great variety of potential applications of high-intensity ultrasonic energy. Of these, cleaning, plastic pounding, and at present also sludge disintegration and the remediation of contaminated soil are probably the best known and offer the most general market for high-intensity ultrasonics. All developments within the area of ultrasound applications lead to the creation of environmentally friendly processes and compounds, emphasizing the role of ultrasound in 'green chemistry'. Ultrasound technology is considered not easy to use in industrial processes, since devices providing high sonic energy are not easy to construct. This thesis investigates on a semi-pilot scale if it is possible to enhance the disintegration of three quite different samples: polymers, sludge, and contaminated soil by using ultrasound. The results indicate that it is possible to enhance the disintegration of polymers by means of ultrasonic power only when the cavitation threshold is exceeded. Above the cavitation threshold, the most extensive degradation took place at the lowest ultrasonic frequency used. The biggest decrease (from 115,000 g/mol to 30,000 g/mol) in relative molecular mass (RMM) was observed when the concentration of polyvinyl alcohol (PVA) was the lowest (1.0%). However, in the case of carboxymethylcellulose (CMC) it was observed that when viscosity was not adjusted there is an optimum polymer concentration (1.5-2.0%) where degradation is most efficient. The thesis shows that the extent of ultrasonic depolymerization decreases with decreasing molecular mass of the CMC polymer. The study also reveals that ultrasonic irradiation causes narrowing of the molecular mass distribution. The degradation of CMC polymer proceeded linearly and the rate of ultrasonic depolymerization decreased with decreasing molecular mass. In cases where the initial dynamic viscosities of polymer solutions were not the same, the sonolytic degradation of CMC polymer mainly depended

  4. Protein Quantity on the Air-Solid Interface Determines Degradation Rates of Human Growth Hormone in Lyophilized Samples

    Science.gov (United States)

    Xu, Yemin; Grobelny, Pawel; von Allmen, Alexander; Knudson, Korben; Pikal, Michael; Carpenter, John F.; Randolph, Theodore W.

    2014-01-01

    rhGH was lyophilized with various glass-forming stabilizers, employing cycles that incorporated various freezing and annealing procedures to manipulate glass formation kinetics, associated relaxation processes and glass specific surface areas (SSA’s). The secondary structure in the cake was monitored by IR and in reconstituted samples by CD. The rhGH concentrations on the surface of lyophilized powders were determined from ESCA. Tg, SSA’s and water contents were determined immediately after lyophilization. Lyophilized samples were incubated at 323 K for 16 weeks, and the resulting extents of rhGH aggregation, oxidation and deamidation were determined after rehydration. Water contents and Tg were independent of lyophilization process parameters. Compared to samples lyophilized after rapid freezing, rhGH in samples that had been annealed in frozen solids prior to drying, or annealed in glassy solids after secondary drying retained more native-like protein secondary structure, had a smaller fraction of the protein on the surface of the cake and exhibited lower levels of degradation during incubation. A simple kinetic model suggested that the differences in the extent of rhGH degradation during storage in the dried state between different formulations and processing methods could largely be ascribed to the associated levels of rhGH at the solid-air interface after lyophilization. PMID:24623139

  5. Thiol-Disulfide Exchange in Peptides Derived from Human Growth Hormone during Lyophilization and Storage in the Solid State

    Science.gov (United States)

    Chandrasekhar, Saradha; Topp, Elizabeth M.

    2015-01-01

    Lyophilization (freeze-drying) is frequently used to stabilize protein therapeutics. However, covalent modifications such as thiol-disulfide exchange and disulfide scrambling can occur even in the solid state. The effects of lyophilization and storage of lyophilized powders on the mechanism and kinetics of thioldisulfide exchange have not been elucidated and are explored here. Reaction kinetics were monitored in peptides corresponding to tryptic fragments of human growth hormone (T20 + T20-T21 or T20 + cT20-T21) during different stages of lyophilization and during storage of the lyophilized powders at 22 °C and ambient RH. The concentrations of reactants and products were determined using RP-HPLC and product identity confirmed using LC-MS. Loss of native disulfide was observed for the reaction of T20 with both linear (T20-T21) and cyclic (cT20-T21) peptides during the primary drying step, however, the native disulfides were regenerated during secondary drying with no further change till the end of lyophilization. Deviations from Arrhenius parameters predicted from solution studies and the absence of buffer effects during lyophilization suggest that factors such as temperature, initial peptide concentration, buffer type and concentration do not influence thiol-disulfide exchange during lyophilization. Results from a ‘cold finger’ method used to study peptide adsorption to ice indicate that there is no preferential adsorption to the ice surface and that its presence may not influence disulfide reactivity during primary drying. Overall, reaction rates and product distribution differ for the reaction of T20 with T20-T21 or cT20-T21 in the solid state and aqueous solution, while the mechanism of thiol-disulfide remains unchanged. Increased reactivity of the cyclic peptide in the solid state suggests that peptide cyclization does not offer protection against lyophilization and that damage induced by a process stress further affects storage stability at 22 °C and

  6. Disintegration rate measurement of a 192Ir solution.

    Science.gov (United States)

    Fonseca, K A; Koskinas, M F; Dias, M S

    2001-01-01

    The disintegration rate of 192Ir has been measured using the 4pibeta-gamma coincidence technique. This radionuclide decays by electron capture (EC) and beta-emission. Since the EC contribution is low (4.5%), it has been corrected using decay scheme data taken from the literature. This measurement has been performed in collaboration with the Laboratório Nacional de Metrologia das Radiações Ionizantes (IRDDM), in Rio de Janeiro. The results, which were obtained independently and employed different techniques, are compared with the Systéme International Reference (SIR) maintained at the Bureau International des Poids et Mesures.

  7. Microwave-Assisted Resolution of α-Lipoic Acid Catalyzed by an Ionic Liquid Co-Lyophilized Lipase

    Directory of Open Access Journals (Sweden)

    Ning Liu

    2015-05-01

    Full Text Available The combination of the ionic liquid co-lyophilized lipase and microwave irradiation was used to improve enzyme performance in enantioselective esterification of α-lipoic acid. Effects of various reaction conditions on enzyme activity and enantioselectivity were investigated. Under optimal condition, the highest enantioselectivity (E = 41.2 was observed with a high enzyme activity (178.1 μmol/h/mg when using the ionic liquid co-lyophilized lipase with microwave assistance. Furthermore, the ionic liquid co-lyophilized lipase exhibited excellent reusability under low power microwave.

  8. Enzyme disintegration with spatial resolution reveals different distributions of sludge extracellular polymer substances

    National Research Council Canada - National Science Library

    Lü, Fan; Wang, Jingwen; Shao, Liming; He, Pinjing

    2016-01-01

    To understand the intrinsic role of hydrolytic enzymes in sludge treatment, particularly their effect on the digestibility and dewaterability of sludge, activated sludge flocs were disintegrated using...

  9. Mimosa pudica seed mucilage: isolation; characterization and evaluation as tablet disintegrant and binder.

    Science.gov (United States)

    Ahuja, Munish; Kumar, Ashok; Yadav, Parvinder; Singh, Kuldeep

    2013-06-01

    In the present study Mimosa pudica seed mucilage was isolated, characterized and evaluated as tablet binder and disintegrant. Several properties of mucilage like high swelling index and gelling nature prompted us to explore its applications as disintegrating and binding agent. Disintegrant properties were evaluated by formulating directly compressed hydrochlorothiazide tablets containing 1%-10% (w/w) of seed mucilage as disintegrant and compared with the standard disintegrants. The disintegration time of mucilage containing tablets was found to be in the order of 3%>1%>5%>7.5%>10%. On comparative evaluation with standard disintegrants, it was observed that the order of disintegration of tablets was Ac-Di-SolMimosa mucilage at 6%, 8%, and 10% (w/w) concentration as the binder and compared with tablets prepared using PVP-K25 (1.7%, w/w) and acacia (6.8%, w/w) as the binder. Mimosa mucilage at 10% (w/w) concentration provided tablets with adequate hardness and friability. In conclusion, M. pudica seed mucilage is a potential tablet disintegrant and binder. Copyright © 2013 Elsevier B.V. All rights reserved.

  10. Electron scattering disintegration processes on light nuclei in covariant approach

    Science.gov (United States)

    Kuznietsov, P. E.; Kasatkin, Yu. A.; Klepikov, V. F.

    2016-07-01

    We provide general analysis of electro-break up process of compound scalar system. We use covariant approach with conserved EM current, which gives the ability to include strong interaction into QED. Therefore, we receive the ability to describe disintegration processes on nonlocal matter fields applying standard Feynman rules of QED. Inclusion of phase exponent into wave function receives a physical sense while we deal with the dominance of strong interaction in the process. We apply Green's function (GF) formalism to describe disintegration processes. Generalized gauge invariant electro-break up process amplitude is considered. One is a sum of traditional pole series and the regular part. We explore the deposits of regular part of amplitude, and its physical sense. A transition from virtual to real photon considered in photon point limit. The general analysis for electro-break up process of component scalar system is given. Precisely conserved nuclear electromagnetic currents at arbitrary square of transited momentum are received. The only undefined quantity in theory is vertex function. Therefore, we have the opportunity to describe electron scattering processes taking into account minimal necessary set of parameters.

  11. Electron scattering disintegration processes on light nuclei in covariant approach

    Directory of Open Access Journals (Sweden)

    Kuznietsov P.E.

    2016-01-01

    Full Text Available We provide general analysis of electro-break up process of compound scalar system. We use covariant approach with conserved EM current, which gives the ability to include strong interaction into QED. Therefore, we receive the ability to describe disintegration processes on nonlocal matter fields applying standard Feynman rules of QED. Inclusion of phase exponent into wave function receives a physical sense while we deal with the dominance of strong interaction in the process. We apply Green’s function (GF formalism to describe disintegration processes. Generalized gauge invariant electro-break up process amplitude is considered. One is a sum of traditional pole series and the regular part. We explore the deposits of regular part of amplitude, and its physical sense. A transition from virtual to real photon considered in photon point limit. The general analysis for electro-break up process of component scalar system is given. Precisely conserved nuclear electromagnetic currents at arbitrary square of transited momentum are received. The only undefined quantity in theory is vertex function. Therefore, we have the opportunity to describe electron scattering processes taking into account minimal necessary set of parameters.

  12. In Vivo Disintegration of Four Different Luting Agents

    Directory of Open Access Journals (Sweden)

    Deniz Gemalmaz

    2012-01-01

    Full Text Available The purpose of this study was to evaluate the disintegration of luting agents. An intraoral sample holder was made having four holes of 1.4 mm diameter and 2 mm depth. The holder was soldered onto the buccal surface of an orthodontic band, which was cemented to the first upper molar in 12 patients, average age 26 years. The holes were filled with a zinc phosphate (Phosphate Kulzer, a glass ionomer (Ketac Cem, a resin-modified-glass ionomer (Fuji Plus, and a resin cement (Calibra. Impressions were made at baseline, and 6, 12, and 18 months from which epoxy replicas were made, which were scanned with an optical scanner. Total volume loss was calculated. The rank order of mean volume loss was as follows: Phosphate cement > Ketac Cem = Fuji Plus = Calibra. Cement type and time had statistically significant effects on volume loss of cements (P<0.001. Under in vivo conditions, zinc phosphate cement disintegrated the most, whereas no significant difference was observed for glass ionomer and resin-based cements. As intraoral conditions are considerably less aggressive than experimental laboratory conditions, the erosion behavior of glass ionomer cement was found to be similar to the resin-based cements in contradiction to previous laboratory results.

  13. Soot particle disintegration and detection using two laserELFFS

    Energy Technology Data Exchange (ETDEWEB)

    Stipe, Christopher B.; Lucas, Donald; Koshland, Catherine P.; Sawyer, Robert F.

    2004-11-17

    A two laser technique is used to study laser-particle interactions and the disintegration of soot by high power UV light. Two separate 20 ns laser pulses irradiate combustion generated soot nanoparticles with 193 nm photons. The first laser pulse, from 0 to 14.7 J/cm{sup 2}, photofragments the soot particles and electronically excites the liberated carbon atoms. The second laser pulse, held constant at 13 J/cm{sup 2}, irradiates the remaining particle fragments and other products of the first laser pulse. The atomic carbon fluorescence at 248 nm produced by the first laser pulse increases linearly with laser fluence from 1 to 6 J/cm{sup 2}. At higher fluences, the signal from atomic carbon signal saturates. The carbon fluorescence from the second laser pulse decreases as the fluence from the first laser increases, ultimately approaching zero as first laser fluence approaches 10 J/cm{sup 2}, suggesting that the particles fully disintegrate at high laser fluences. We use an energy balance parameter, called the photon-atom ratio (PAR), to aid in understanding laser-particle interactions. These results help define the regimes where photofragmentation fluorescence methods quantitatively measure total soot concentrations.

  14. The forensic aspects of contemporary disintegrating rifle bullets.

    Science.gov (United States)

    Haag, Lucien C

    2013-03-01

    A relatively new type of rifle bullet has appeared in the last few years that contains no lead and rapidly disintegrates into very small particles and jacket fragments immediately upon entry into soft tissue. These bullets are intended for use by 'varmint' hunters in high-velocity centerfire rifles where the effect on such animals as prairie dogs, gophers, ground hogs, and other similarly sized animals is nothing short of explosive. The shooting of much larger animals to include human beings will typically result in nonperforating wounds with short wound paths. X-ray views of a decedent or gunshot victim will lack any recognizable bullet or projectile. Only 1 jacket fragment among the many present in the wound tract is suitable for subsequent firearms identification purposes, namely, the small copper disc that represents the base or heel of the bullet jacket. This small circular fragment bears vestiges of the rifling marks of the responsible firearm.This article will aid the forensic pathologist in recognizing gunshot wounds produced by these atypical bullets and the importance of recovering the base portion of the disintegrated bullet jacket.

  15. Disinfection Byproduct Formation in Reverse-Osmosis Concentrated and Lyophilized Natural Organic Matter from a Drinking Water Source

    Science.gov (United States)

    Drinking water treatment and disinfection byproduct (DBP) research can be complicated by natural organic matter (NOM) temporal variability. NOM preservation by lyophilization (freeze-drying) has been long practiced to address this issue; however, its applicability for drinking wa...

  16. Lyophilized bovine hemoglobin as a possible reference material for the determination of hemoglobin derivatives in human blood

    NARCIS (Netherlands)

    Maas, BHA; Buursma, A; Ernst, RAJ; Maas, AHJ; Zijlstra, WG

    1998-01-01

    We investigated the suitability of a lyophilized bovine hemoglobin (LBH) preparation containing various fractions of oxyhemoglobin (O(2)Hb), carboxyhemoglobin (COHb), and methemoglobin (MetHb) for quality assessment in multicomponent analysis (MCA) of hemoglobin derivatives. It was demonstrated that

  17. Disinfection Byproduct Formation in Reverse-Osmosis Concentrated and Lyophilized Natural Organic Matter from a Drinking Water Source

    Science.gov (United States)

    Drinking water treatment and disinfection byproduct (DBP) research can be complicated by natural organic matter (NOM) temporal variability. NOM preservation by lyophilization (freeze-drying) has been long practiced to address this issue; however, its applicability for drinking wa...

  18. Biokinetics and dosimetry in patients of {sup 99m}Tc-EDDA/HYNIC-Tyr{sup 3}-octreotide prepared from lyophilized kits

    Energy Technology Data Exchange (ETDEWEB)

    Gonzalez-Vazquez, Armando [Departamento de Medicina Nuclear, Hospital Militar (Mexico); Facultad de Medicina, Universidad Autonoma del Estado de Mexico (Mexico); Ferro-Flores, Guillermina [Departamento de Materiales Radiactivos, Gerencia de Aplicaciones Nucleares en la Salud, Instituto Nacional de Investigaciones Nucleares, Km. 36.5 Carretera Mexico-Toluca, Ocoyoacac, Estado de Mexico, C.P. 52045 (Mexico)]. E-mail: gff@nuclear.inin.mx; Arteaga de Murphy, Consuelo [Departamento de Medicina Nuclear, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran (Mexico); Gutierrez-Garcia, Zohar [Departamento de Medicina Nuclear, Hospital Militar (Mexico)

    2006-07-15

    {sup 99m}Tc-EDDA/HYNIC-Tyr{sup 3}-octreotide ({sup 99m}Tc-HYNIC-TOC) has shown high in vitro and in vivo stability, rapid background clearance and rapid detection of somatostatin receptor-positive tumors. The aim of this study was to establish a biokinetic model for {sup 99m}Tc-HYNIC-TOC prepared from lyophilized kits, and to evaluate its dosimetry as a tumor imaging agent in patients with histologically confirmed neuroendocrine tumors. Whole-body images from eight patients were acquired at 5, 60, 90, 180 min and 24 h after {sup 99m}Tc-HYNIC-TOC administration obtained from instant freeze-dried kit formulations with radiochemical purities >95%. Regions of interest (ROIs) were drawn around source organs on each time frame. The same set of ROIs was used for all eight scans and the count per minute (cpm) of each ROI was converted to activity using the conjugate view counting method. The image sequence was used to extrapolate {sup 99m}Tc-HYNIC-TOC time-activity curves in each organ, to adjust a biokinetic model using the SAAM software, and to calculate the total number of disintegrations (N) that occurred in the source regions. N data were the input for the OLINDA/EXM code to calculate internal radiation dose estimates. Images showed an average tumor/blood (heart) ratio of 4.3{+-}0.7 in receptor-positive tumors at 1 h. The mean radiation absorbed dose calculated for a study using 740 MBq was 24, 21.5, 5.5 and 1.0 mSv for spleen, kidneys, liver and bone marrow respectively and the effective dose was 4.4 mSv.

  19. A Study on in vitro antiviral activities of lyophilized extracts of Glycyrrhiza glabra on Hepatitis B Virus

    Directory of Open Access Journals (Sweden)

    Sangeetha Vani

    2016-06-01

    Full Text Available The present study is to determine the effect of lyophilized extracts of different solvents of Glycyrrhiza glabra on Hepatitis B. The lyophilized plant extracts were collected and studied for its cytotoxicity in HepG2 cell line and in vitro antiviral activity of these extracts was investigated by HBs Ag binding Inhibition Assay, Hepatitis B Virus DNA Polymerase Inhibition Assay using fluorescent probes. The results from Glycyrrhiza glabra were promising in acting as a potent antiviral agent.

  20. Characterization and optimization of lyophilization and storage conditions of Leech saliva extract from the tropical leech Hirudinaria manillensis.

    Science.gov (United States)

    Abdualkader, Abdualrahman Mohammed; Ghawi, Abbas Mohammad; Alaama, Mohamed; Awang, Mohamed; Merzouk, Ahmed

    2013-05-01

    The medicinal Malaysian leeches have been used in traditional medicine to treat many different ailments. In this study, leech saliva extract (LSE) was collected from the medicinal Malaysian leech Hirudinaria manillensis. Gel electrophoresis of LSE was carried out to estimate the peptide and protein molecular weights of its content. Results showed that LSE contains more than 60 peptides and proteins with molecular masses ranging from 1.9-250kDa. Thrombin time assay in vitro was employed to assess the collected LSE antithrombin activity. First, to study its stability, LSE was lyophilized under the following different conditions: pre-freezing temperature, type of container and lyophilization cycle. Pre-freezed LSE sample at -20°C and lyophilized for 24 hours retained about 100-95% of its original biological activities. Second, the LSE antithrombin activity was monitored for a period of six months. Storage temperature, type of the container and photosensitivity effects on antithrombin activity of the lyophilized (solid state) and non-lyophilized (liquid state) were investigated. Results showed that storage temperature drastically affected the biological activity of LSE with -20 °C as the optimum temperature. Samples stored at ambient temperature and +4 °C were light photosensitive and adversely affected when stored in polypropylene tubes. Lyophilized samples were more stable than non-lyophilized ones over the period of study. To sum up, in order to have a biologically active stock of LSE, it has to be lyophilized for no more than 24 hours following freezing at -20°C and has to be stored at -20°C in glass tubes protected from light.

  1. Disinfection byproduct formation in reverse-osmosis concentrated and lyophilized natural organic matter from a drinking water source.

    Science.gov (United States)

    Pressman, Jonathan G; McCurry, Daniel L; Parvez, Shahid; Rice, Glenn E; Teuschler, Linda K; Miltner, Richard J; Speth, Thomas F

    2012-10-15

    Drinking water treatment and disinfection byproduct (DBP) research can be complicated by natural organic matter (NOM) temporal variability. NOM preservation by lyophilization (freeze-drying) has been long practiced to address this issue; however, its applicability for drinking water research has been limited because the selected NOM sources are atypical of most drinking water sources. The purpose of this research was to demonstrate that reconstituted NOM from a lyophilized reverse-osmosis (RO) concentrate of a typical drinking water source closely represents DBP formation in the original NOM. A preliminary experiment assessed DBP formation kinetics and yields in concentrated NOM, which demonstrated that chlorine decays faster in concentrate, in some cases leading to altered DBP speciation. Potential changes in NOM reactivity caused by lyophilization were evaluated by chlorination of lyophilized and reconstituted NOM, its parent RO concentrate, and the source water. Bromide lost during RO concentration was replaced by adding potassium bromide prior to chlorination. Although total measured DBP formation tended to decrease slightly and unidentified halogenated organic formation tended to increase slightly as a result of RO concentration, the changes associated with lyophilization were minor. In lyophilized NOM reconstituted back to source water TOC levels and then chlorinated, the concentrations of 19 of 21 measured DBPs, constituting 96% of the total identified DBP mass, were statistically indistinguishable from those in the chlorinated source water. Furthermore, the concentrations of 16 of 21 DBPs in lyophilized NOM reconstituted back to the RO concentrate TOC levels, constituting 86% DBP mass, were statistically indistinguishable from those in the RO concentrate. This study suggests that lyophilization can be used to preserve concentrated NOM without substantially altering the precursors to DBP formation.

  2. Validation and substantiation of 25 kGy as sterilization dose for lyophilized human amnion membrane.

    Science.gov (United States)

    Djefal, A; Tahtat, D; Khodja, A Nacer; Bouzid, S Saad; Remane, N

    2007-01-01

    The validation and substantiation of sterilization dose for lyophilized human amnion membrane by gamma irradiation delivered by Co60 source were investigated. The validation experiments were conducted according to ISO 13409 method B. A total of 120 human amnion membranes were collected. Of these, 10 membranes were used for estimation of bioburden and 20 membranes were used for the individual sterility test at verification dose. The average bioburden per product unit with sample item portion (SIP = 1) for lyophilized human amnion membrane was 572 cfu. The verification dose experiments were done at dose of 8.1 kGy and the results of sterility tests showed that human amnion membrane got one positive. Consequently, the sterilization dose of 25 kGy was confirmed and substantiated.

  3. Successful ram semen cryopreservation with lyophilized egg yolk-based extender.

    Science.gov (United States)

    Alcay, Selim; Berk Toker, M; Gokce, Elif; Ustuner, Burcu; Tekin Onder, N; Sagirkaya, Hakan; Nur, Zekariya; Kemal Soylu, M

    2015-10-01

    The aim of this study was to evaluate the effects of lyophilized egg yolk extender on ram semen cryopreservation. Ejaculates with a thick consistency, rapid wave motion (3-5 on a 0-5 scale) and >75% initial motility were pooled. Sperm were diluted to final concentration of 1/5 (semen/extender) in lyophilized egg yolk or fresh egg yolk extenders using two-step dilution method. The equilibrated semen was frozen in 0.25 mL straws. Semen samples were assessed for sperm motility, plasma membrane functional integrity using hypoosmotic swelling test (HOST), damaged acrosome using FITC-Pisum sativum agglutinin (PSA-FITC) and DNA integrity using terminal deoxynucleotidyl transferase-mediated dUTP nick-end labeling (TUNEL) at three time points: after dilution with extender A, equilibration and post-thaw. The results showed that freezing and thawing procedures (dilution, equilibration and thawing) had negative effects on motility (Pram semen.

  4. Modeling of Heat and Mass Transfer in a TEC-Driven Lyophilizer

    Science.gov (United States)

    Yuan, Zeng-Guang; Hegde, Uday; Litwiller, Eric; Flynn, Michael; Fisher, John

    2006-01-01

    Dewatering of wet waste during space exploration missions is important for crew safety as it stabilizes the waste. It may also be used to recover water and serve as a preconditioning step for waste compaction. A thermoelectric cooler (TEC)-driven lyophilizer is under development at NASA Ames Research Center for this purpose. It has three major components: (i) an evaporator section where water vapor sublimes from the frozen waste, (ii) a condenser section where this water vapor deposits as ice, and (iii) a TEC section which serves as a heat pump to transfer heat from the condenser to the evaporator. This paper analyses the heat and mass transfer processes in the lyophilizer in an effort to understand the ice formation behavior in the condenser. The analysis is supported by experimental observations of ice formation patterns in two different condenser units.

  5. Genomic stability of lyophilized sheep somatic cells before and after nuclear transfer.

    Directory of Open Access Journals (Sweden)

    Domenico Iuso

    Full Text Available The unprecedented decline of biodiversity worldwide is urging scientists to collect and store biological material from seriously threatened animals, including large mammals. Lyophilization is being explored as a low-cost system for storage in bio-banks of cells that might be used to expand or restore endangered or extinct species through the procedure of Somatic Cell Nuclear Transfer (SCNT. Here we report that the genome is intact in about 60% of lyophylized sheep lymphocytes, whereas DNA damage occurs randomly in the remaining 40%. Remarkably, lyophilized nuclei injected into enucleated oocytes are repaired by a robust DNA repairing activity of the oocytes, and show normal developmental competence. Cloned embryos derived from lyophylized cells exhibited chromosome and cellular composition comparable to those of embryos derived from fresh donor cells. These findings support the feasibility of lyophylization as a storage procedure of mammalian cells to be used for SCNT.

  6. Determination of moisture content of lyophilized allergen vaccines by NIR spectroscopy.

    Science.gov (United States)

    Zheng, Yiwu; Lai, Xuxin; Bruun, Susanne Wrang; Ipsen, Henrik; Larsen, Jørgen Nedergaard; Løwenstein, Henning; Søndergaard, Ib; Jacobsen, Susanne

    2008-02-13

    Moisture content is an important parameter for lyophilized vaccines. Currently, Karl Fischer titration is widely used for moisture determination in routine analysis. However, this method is time-consuming, sample destructive and requires environment polluting reagents, as well as the results rely on the random samplings. In this study, near infrared spectroscopy was used as a fast, non-invasive and non-destructive method to determine the moisture content in lyophilized allergy vaccines. Five different vaccine products were investigated, which contained water in the range of 0.17-1.51% (w/w, KF). Different data pre-treatments, wavelength selection and partial least squares regression were applied to construct calibration models. Multi-products model and product-specific models were obtained, which show the possibility of NIR as a rapid method to discriminate whether moisture content fit into the specifications of a pharmaceutical company.

  7. Standardization of lyophilization medium for Streptococcus thermophilus subjected to viability escalation on freeze drying

    Directory of Open Access Journals (Sweden)

    Rohit Sharma

    2014-09-01

    Full Text Available The objective of the present study is to develop a lyophilization medium for Streptococcus thermophilus (NCIM 2904 as the industrial exploitation of this bacterium totally depends upon preservation and lyophilization protocols. Protective effect of 18 compounds were observed individually and in combinations with different sugars, sugar alcohols, polymers, protein concentrates and buffers. Among all the protectants tested, ammonium citrate (1% w/w, K2HPO4 (1% w/w and KH2PO4 (1% w/w provided lowest protection to these bacterial cells while 10% (w/w sodium caseinate, whey protein concentrate, sweet whey powder, and skim milk showed significant results in viability escalation. Survival in carbon sources like lactose, sucrose and maltodextrine was also favored maximally. Combination of sodium caseinate 10%, skim milk 5%, sucrose 5%, lactose 5% and mono sodium glutamate 1% in distilled water in ratio of 1:5 with S. thermophilus showed survival percentage of 96%.

  8. Lyophilization protects [FeFe]-hydrogenases against O2-induced H-cluster degradation

    OpenAIRE

    Jens Noth; Ramona Kositzki; Kathrin Klein; Martin Winkler; Michael Haumann; Thomas Happe

    2015-01-01

    Nature has developed an impressive repertoire of metal-based enzymes that perform complex chemical reactions under moderate conditions. Catalysts that produce molecular hydrogen (H2) are particularly promising for renewable energy applications. Unfortunately, natural and chemical H2-catalysts are often irreversibly degraded by molecular oxygen (O2). Here we present a straightforward procedure based on freeze-drying (lyophilization), that turns [FeFe]-hydrogenases, which are excellent H2-produ...

  9. Impact of controlled ice nucleation on process performance and quality attributes of a lyophilized monoclonal antibody.

    Science.gov (United States)

    Awotwe-Otoo, David; Agarabi, Cyrus; Read, Erik K; Lute, Scott; Brorson, Kurt A; Khan, Mansoor A; Shah, Rakhi B

    2013-06-25

    An efficient and potentially scalable technology was evaluated to control the ice nucleation step of the freezing process for a model monoclonal antibody formulation and the effect on process performance and quality attributes of the final lyophilized product was compared with the conventional shelf ramping method of freezing. Controlled ice nucleation resulted in uniform nucleation at temperatures between -2.3 and -3.2 °C while uncontrolled nucleation resulted in random nucleation at temperatures between -10 and -16.4 °C. The sublimation rate (dm/dt) during primary drying was higher in the controlled nucleation cycle (0.13 g/h/vial) than in the uncontrolled nucleation cycle (0.11 g/h/vial). This was due to the formation of larger ice crystals, leading to lower product resistance (Rp) and 19% reduction in the primary drying for the controlled nucleation cycle. Controlled ice nucleation resulted in lyophilized cakes with more acceptable appearance, no visible collapse or shrinkage and decreased reconstitution times compared with uncontrolled nucleation. There were no observed differences in the particle size, concentration (A280 nm) and presence of aggregates (A410 nm) between the two nucleation cycles when the lyophilized cakes were reconstituted. These were confirmed by SEC and protein A-HPLC analyses which showed similar peak shapes and retention times between the two cycles. However, uncontrolled nucleation resulted in cakes with larger specific surface area (0.90 m(2)/g) than controlled nucleation (0.46 m(2)/g). SEM images of the lyophilized cakes from uncontrolled nucleation revealed a sponge-like morphology with smaller pores while cakes from controlled nucleation cycle revealed plate-like structures with more open and larger pores. While controlled nucleation resulted in a final product with a higher residual moisture content (2.1±0.08%) than uncontrolled nucleation (1.62±0.11%), this was resolved by increasing the secondary drying temperature.

  10. Co-encapsulation of lyoprotectants improves the stability of protein-loaded PLGA nanoparticles upon lyophilization

    DEFF Research Database (Denmark)

    Fonte, Pedro; Araújo, Francisca; Seabra, Vítor;

    2015-01-01

    The purpose of this work was to evaluate the influence of the co-encapsulation of lyoprotectants with insulin into PLGA nanoparticles, on the stability of the protein and nanoparticles upon lyophilization. Different lyoprotectants were used, namely trehalose, glucose, sucrose, fructose and sorbitol...... confirmed by circular dichroism spectroscopy. Surprisingly, the simultaneous co-encapsulation and addition of lyoprotectants was detrimental to protein stabilization. The insulin in vitro release studies demonstrated that formulations with co-encapsulated trehalose, glucose, sucrose, fructose and sorbitol...

  11. Toward low-cost affinity reagents: lyophilized yeast-scFv probes specific for pathogen antigens.

    Directory of Open Access Journals (Sweden)

    Sean A Gray

    Full Text Available The generation of affinity reagents, usually monoclonal antibodies, remains a critical bottleneck in biomedical research and diagnostic test development. Recombinant antibody-like proteins such as scFv have yet to replace traditional monoclonal antibodies in antigen detection applications, in large part because of poor performance of scFv in solution. To address this limitation, we have developed assays that use whole yeast cells expressing scFv on their surfaces (yeast-scFv in place of soluble purified scFv or traditional monoclonal antibodies. In this study, a nonimmune library of human scFv displayed on the surfaces of yeast cells was screened for clones that bind to recombinant cyst proteins of Entamoeba histolytica, an enteric pathogen of humans. Selected yeast-scFv clones were stabilized by lyophilization and used in detection assay formats in which the yeast-scFv served as solid support-bound monoclonal antibodies. Specific binding of antigen to the yeast-scFv was detected by staining with rabbit polyclonal antibodies. In flow cytometry-based assays, lyophilized yeast-scFv reagents retained full binding activity and specificity for their cognate antigens after 4 weeks of storage at room temperature in the absence of desiccants or stabilizers. Because flow cytometry is not available to all potential assay users, an immunofluorescence assay was also developed that detects antigen with similar sensitivity and specificity. Antigen-specific whole-cell yeast-scFv reagents can be selected from nonimmune libraries in 2-3 weeks, produced in vast quantities, and packaged in lyophilized form for extended shelf life. Lyophilized yeast-scFv show promise as low cost, renewable alternatives to monoclonal antibodies for diagnosis and research.

  12. Genomic Stability of Lyophilized Sheep Somatic Cells before and after Nuclear Transfer

    OpenAIRE

    Domenico Iuso; Marta Czernik; Fiorella Di Egidio; Silvestre Sampino; Federica Zacchini; Michal Bochenek; Zdzislaw Smorag; Modlinski, Jacek A.; Grazyna Ptak; Pasqualino Loi

    2013-01-01

    The unprecedented decline of biodiversity worldwide is urging scientists to collect and store biological material from seriously threatened animals, including large mammals. Lyophilization is being explored as a low-cost system for storage in bio-banks of cells that might be used to expand or restore endangered or extinct species through the procedure of Somatic Cell Nuclear Transfer (SCNT). Here we report that the genome is intact in about 60% of lyophylized sheep lymphocytes, whereas DNA da...

  13. A Novel Mechanism for $J/\\psi$ Disintegration in Relativistic Heavy Ion Collisions

    CERN Document Server

    Atreya, Abhishek; Srivastava, Ajit M

    2014-01-01

    In this paper we discuss the possibility of $J/\\psi$ disintegration due the $Z(3)$ domain walls that are expected to form in QGP medium. These domain walls give rise to localised color electric field which disintegrates $J/\\psi$, on interaction, by changing the color composition and simultaneously exciting it to higher states of $c\\bar{c}$ system.

  14. Mild disintegration of the green microalgae Chlorella vulgaris using bead milling

    NARCIS (Netherlands)

    Postma, P.R.; Miron, T.L.; Olivieri, G.; Barbosa, M.J.; Wijffels, R.H.; Eppink, M.H.M.

    2015-01-01

    In this work, the mild disintegration of the microalgae Chlorella vulgaris for the release of intracellular products has been studied. By means of bead milling the microalgae suspensions were successfully disintegrated at different biomass concentrations (25–145 gDW kg-1) over a range of agitator sp

  15. Studies of disintegrant properties of seed mucilage of Ocimum gratissimum

    OpenAIRE

    Ravikumar; Shirwaikar A; Shirwaikar Annie; Prabu S; Mahalaxmi R; Rajendran K; Kumar C

    2007-01-01

    Dispersible tablets of Metformin Hydrochloride were prepared using Ocimum gratissimum mucilage powder and Ocimum gratissimum seed powder as disintegrants. Specifications for herbal raw materials and finished products were set according to the Committee for Proprietary Medicinal Products. Several formulations were prepared and evaluated for physical parameters such as thickness, hardness, friability, weight variation, drug content, and disintegration time and drug dissolution. The formulat...

  16. Brief Report: Childhood Disintegrative Disorder as a Likely Manifestation of Vitamin B12 Deficiency

    Science.gov (United States)

    Malhotra, Savita; Subodh, B. N.; Parakh, Preeti; Lahariya, Sanjay

    2013-01-01

    Childhood disintegrative disorder is a rare disorder, characterized by regression of acquired skills after a period of normal development. The case of childhood disintegrative disorder presented here was found to have vitamin B12 deficiency and hyperhomocysteinemia on extensive evaluation to find a probable cause for regression. This case…

  17. Brief Report: Childhood Disintegrative Disorder as a Likely Manifestation of Vitamin B12 Deficiency

    Science.gov (United States)

    Malhotra, Savita; Subodh, B. N.; Parakh, Preeti; Lahariya, Sanjay

    2013-01-01

    Childhood disintegrative disorder is a rare disorder, characterized by regression of acquired skills after a period of normal development. The case of childhood disintegrative disorder presented here was found to have vitamin B12 deficiency and hyperhomocysteinemia on extensive evaluation to find a probable cause for regression. This case…

  18. Mild disintegration of the green microalgae Chlorella vulgaris using bead milling

    NARCIS (Netherlands)

    Postma, P.R.; Miron, T.L.; Olivieri, G.; Barbosa, M.J.; Wijffels, R.H.; Eppink, M.H.M.

    2015-01-01

    In this work, the mild disintegration of the microalgae Chlorella vulgaris for the release of intracellular products has been studied. By means of bead milling the microalgae suspensions were successfully disintegrated at different biomass concentrations (25–145 gDW kg-1) over a range of agitator

  19. Formulation, optimization and evaluation of levocetirizine dihyrochloride oral thin strip

    Directory of Open Access Journals (Sweden)

    J Gunjan Patel

    2012-01-01

    Full Text Available The aim of present research was to develop a fast releasing oral polymeric film, with good mechanical properties, instant disintegration and dissolution, producing an acceptable taste when placed on tongue. Solvent casting method was used to prepare oral films. Levocetirizine dihydrochloride, an antihistaminic was incorporated to relieve the symptoms of allergic rhinitis. The polymers selected were HPMC E 15 and PVA. Propylene glycol was the plasticizers used. Nine batches of films with drug were prepared using different combinations of polymers and plasticizer concentration. The resultant films were evaluated for weight variation, content uniformity, folding endurance, thickness, surface pH, in vitro disintegration and in vitro dissolution. The optimized films which disintegrated in less than 30 sec, releasing 85-98% of drug within 2 minutes. The percentage release was varying with concentration of plasticizer and polymer. The films made with HPMC: PVA (1:2 released 96% of drug in 1 min, which was the best release amongst all.

  20. Immunogenicity of Lyophilized MVA Vaccine for HIV-1 in Mice Model

    Institute of Scientific and Technical Information of China (English)

    ZHANG Yi-zhe; JIANG Chun-lai; YU Xiang-hui; LOU Chao-ping; ZHAO Dong-hai; WU Yong-ge; JIN Ying-hua; LIU Cheng-shan; KONG Wei

    2007-01-01

    Highly attenuated modified vaccinia Ankara(MVA) is sensitive to repeat freeze-thaw cycle and easy to lose activity. In order to make the activity of MVA vaccine remain stable during its manufacturing, storage, and administration, the lyophilization as a good option could be resorted to; through screening, the right stabilizer composition and its production procedure were obtained. The final moisture content of freezing-dried recombinant MVA-HIV vaccine was lower than 3%. It can be reconstituted quickly and shows regular physical appearance and stable potency. In vivo functional experiment, mice were divided randomly into the liquid vaccination group, the lyophilized vaccination group, and the control group. Having been DNA vaccine priming, the mice were boosted with a dose of 107 pfu MVA-HIV vaccine, which produced indistinguishable antibody titer and cytotoxic T-lymphocyte(CTL) level compared with those of liquid vaccination group(P>0.05). These results demonstrate that lyophilized MVA vaccine can induce high immunogenicity in mice.

  1. Cryoprotection effectiveness of low concentrations of natural and lyophilized LDL (low density lipoproteins on canine spermatozoa

    Directory of Open Access Journals (Sweden)

    M.M. Neves

    2014-06-01

    Full Text Available The aim of this study was to evaluate the use of low concentrations of natural and lyophilized low density lipoprotein (LDL from hen's egg yolk for cryopreservation of canine semen. Different ammonium sulphate concentrations were tested to extract LDL from egg yolk. The yolk was centrifuged, and LDL was isolated using 10, 20, 40, 45, or 50% ammonium sulphate solution (ASS. The LDL-rich floating fraction was collected for chemical characterization. Dry matter content was lowest (P<0.05 in the LDL extracted with the 50% ASS. The purification of LDL increased in association with increasing ammonium sulphate concentrations. SDS-PAGE showed that the 50% ASS solution yielded a purer fraction of LDL from egg yolk. For semen cryopreservation, TRIS extender was used replacing 20% egg yolk (control by natural or lyophilized LDL using 1, 2, and 3% (w/v. Semen was centrifuged (755Xg for 7 min, diluted with one of the extenders, packed into 0.5mL straws (100x106 sperm/mL, and placed in a programmable cryopreservation machine. Thawed semen (37°C/ 30s was analyzed for sperm motility, morphology, and by the hypoosmotic and epifluorescence tests (CFDA/ PI. Natural LDL extracted with 50% ASS was as effective as whole egg yolk to preserve canine frozen sperm when using low concentrations. The lyophilized LDL, mainly in the two higher concentrations tested (2 and 3%, was unsuitable to maintain the effectiveness of the LDL cryoprotective effect on dog sperm.

  2. VIABILITY AND ANTIMICROBIAL ACTIVITY OF STREPTOMYCES STRAINS FROM NCNM AFTER LYOPHILIZATION

    Directory of Open Access Journals (Sweden)

    Oleg CHISELIŢA

    2016-05-01

    Full Text Available The article deals with the aspects related to lyophilization of streptomycetes strains, preserved in the National Collection of Nonpathogenic Microorganisms (NCNM. Was determined that lyophilization do not significantly modify the antimicrobial activity of streptomycetes. Maximum viability of strains of genus Streptomyces (83,2-90,2% is ensured after lyophilization at initial titer by 9-11 log10UFC ml-1 in protective medium (gelatin 2,5% + glucose 7,5% by rehydra­tion with distillate water.VIABILITATEA ŞI ACTIVITATEA ANTIMICROBIANĂ A TULPINELOR DE STREPTOMYCES DIN CNMN DUPĂ LIOFILIZAREAcest articol prezintă aspecte legate de liofilizarea tulpinilor de streptomicete, depozitate în Colecţia Naţională de Microorganisme Nepatogene (CNMN. A fost stabilit că liofilizarea nu modifică esenţial activitatea antimicrobiană a streptomicetelor. Viabilitatea maximă a tulpinilor genului Streptomyces (83,2-90,2% este asigurată după liofilizarea la titrul iniţial 9-11 log10UFC ml-1 în mediu protectiv (gelatină 2,5% + glucosă 7,5% şi la rehidratarea cu apă distilată. 

  3. Multiresidue determination of veterinary medicines in lyophilized egg albumen with subsequent consumer exposure evaluation.

    Science.gov (United States)

    Piątkowska, Marta; Gbylik-Sikorska, Małgorzata; Gajda, Anna; Jedziniak, Piotr; Błądek, Tomasz; Żmudzki, Jan; Posyniak, Andrzej

    2017-08-15

    The process of lyophilization causes that the veterinary drugs residues present in egg albumen do not decompose, as it takes place during the process of high-temperature drying. Thus, lyophilized albumen may be a potential source of their residues for consumers. As a consequence, reliable methods for the determination of veterinary medicinal products from egg albumen are needed. The method for the determination of 85 analytes in lyophilized egg albumen was developed and successfully validated. The recoveries were between 84 and 110%, within laboratory repeatability and reproducibility - in the range of 3.29-16.8% and -5.93 to 19.3%. The presence of enrofloxacin and doxycycline was confirmed in real egg albumen samples. The concentrations ranged from 5.65-596µg/kg for doxycycline to 0.89-134µg/kg for enrofloxacin. Nevertheless, the evaluated daily intake and % of the ADI (Acceptable Daily Intake) received by the consumers' were at a toxicologically accepted level. Copyright © 2017 Elsevier Ltd. All rights reserved.

  4. Utility of lyophilized PMA and ionomycin to stimulate lymphocytes in whole blood for immunological assays.

    Science.gov (United States)

    Belouski, Shelley Sims; Wilkinson, Julie; Thomas, John; Kelley, Keith; Wang, Shen-Wu; Suggs, Sid; Ferbas, John

    2010-01-01

    The need to implement robust biomarkers in clinical trials has never been greater, and such efforts can be easily compromised by reagent instability or simple human error during assay set-up. Many biotechnology and pharmaceutical companies are introducing efforts to conduct biomarker studies under more rigorous settings, and the use of plates or tubes pre-loaded with stimulation or staining reagents could be of value for studies that involve flow cytometry. Five reagents lyophilized from ethanol or CHAPS buffer stock solution of phorbol 12-myristate 13-acetate (PMA) and ionomycin were benchmarked against standard DMSO liquid formulation for their stimulation equivalency. The median fluorescence intensity of phosphorylated ribosomal protein S6 in lymphocytes was assessed on a BD FACSCalibur. We demonstrate here that tubes pre-loaded with lyophilized versions of the liquid reagents can provide equivalent stimulation in healthy volunteer specimens. The value of this approach is that it safeguards against omission or erroneous addition of bulk liquid formulations of PMA and ionomycin to the reaction vessel (i.e., plate or tube) and also lends itself to extended stability/shelf-life of these reagents. On the basis of this initial success, we plan to expand our evaluation of lyophilized reagents so that they can be incorporated into our clinical biomarker campaigns as appropriate.

  5. Physical characterization of pentamidine isethionate during freeze-drying-relevance to development of stable lyophilized product.

    Science.gov (United States)

    Sundaramurthi, Prakash; Burcusa, Michael R; Suryanarayanan, Raj

    2012-05-01

    The purpose of this study was to perform physical characterization of pentamidine isethionate (PI) in frozen and freeze-dried systems and to monitor the phase behavior during all the stages of freeze-drying. Frozen aqueous PI solutions as well as the final lyophiles were characterized by differential scanning calorimetry and X-ray diffractometry. The effect of cosolutes, cosolvents, and processing conditions on the PI crystallization behavior during freeze-drying was evaluated. In frozen aqueous solutions, irrespective of the cooling rate and the initial solute concentration, PI readily crystallized as a trihydrate (C(19) H(24) N(4) O(2) ·3H(2) O). It dehydrated to a poorly crystalline anhydrate upon drying at 100 mTorr. The presence of a readily crystallizing cosolute or an organic cosolvent did not influence the physical form of PI in the final lyophile. On the contrary, even in the absence of cosolutes and cosolvents, the crystalline trihydrate was retained when the chamber pressure was increased to 500 mTorr. By altering the drying conditions, it was possible to obtain either a crystalline trihydrate or a poorly crystalline anhydrate. The stability of PI is dependent on its physical form and only the amorphous PI undergoes discoloration. The PI stability can be enhanced by retaining it in a crystalline state in the lyophile.

  6. Investigating factors leading to fogging of glass vials in lyophilized drug products.

    Science.gov (United States)

    Abdul-Fattah, Ahmad M; Oeschger, Richard; Roehl, Holger; Bauer Dauphin, Isabelle; Worgull, Martin; Kallmeyer, Georg; Mahler, Hanns-Christian

    2013-10-01

    Vial "Fogging" is a phenomenon observed after lyophilization due to drug product creeping upwards along the inner vial surface. After the freeze-drying process, a haze of dried powder is visible inside the drug product vial, making it barely acceptable for commercial distribution from a cosmetic point of view. Development studies were performed to identify the root cause for fogging during manufacturing of a lyophilized monoclonal antibody drug product. The results of the studies indicate that drug product creeping occurs during the filling process, leading to vial fogging after lyophilization. Glass quality/inner surface, glass conversion/vial processing (vial "history") and formulation excipients, e.g., surfactants (three different surfactants were tested), all affect glass fogging to a certain degree. Results showed that the main factor to control fogging is primarily the inner vial surface hydrophilicity/hydrophobicity. While Duran vials were not capable of reliably improving the level of fogging, hydrophobic containers provided reliable means to improve the cosmetic appearance due to reduction in fogging. Varying vial depyrogenation treatment conditions did not lead to satisfying results in removal of the fogging effect. Processing conditions of the vial after filling with drug product had a strong impact on reducing but not eliminating fogging.

  7. In vivo disintegration of four different luting agents.

    Science.gov (United States)

    Gemalmaz, Deniz; Pameijer, Cornelis H; Latta, Mark; Kuybulu, Ferah; Alcan, Toros

    2012-01-01

    The purpose of this study was to evaluate the disintegration of luting agents. An intraoral sample holder was made having four holes of 1.4 mm diameter and 2 mm depth. The holder was soldered onto the buccal surface of an orthodontic band, which was cemented to the first upper molar in 12 patients, average age 26 years. The holes were filled with a zinc phosphate (Phosphate Kulzer), a glass ionomer (Ketac Cem), a resin-modified-glass ionomer (Fuji Plus), and a resin cement (Calibra). Impressions were made at baseline, and 6, 12, and 18 months from which epoxy replicas were made, which were scanned with an optical scanner. Total volume loss was calculated. The rank order of mean volume loss was as follows: Phosphate cement > Ketac Cem = Fuji Plus = Calibra. Cement type and time had statistically significant effects on volume loss of cements (P contradiction to previous laboratory results.

  8. The social psychology of disintegrative shaming in education.

    Science.gov (United States)

    Brown, Joel H; Clarey, Amy M

    2012-01-01

    Despite considerable research concerning drug education and zero tolerance policies, few have examined their combined youth impact. Comprehensive and nationally recognized mixed method evidence is drawn from 77 school districts and 118 schools in the Drug, Alcohol and Tobacco Education (DATE) evaluation. For the first time it is found that the combined negative impact of traditional prevention and intervention efforts--e.g., Life Skills Training (LST) and zero tolerance policies-are so serious that they extend into the wider conditions of educational achievement. Findings are explained by the social psychological processes of "disintegrative shaming," where young people are to be shamed into abstinence and experiencing or witnessing school removal rather than help when needed. With more research needed the negative effects of traditional prevention and intervention-particularly salient among disproportionately affected urban/minority youth-suggest that related efforts be reconsidered together as well as part of mainstream education.

  9. Enhancement of activated sludge disintegration and dewaterability by Fenton process

    Science.gov (United States)

    Heng, G. C.; Isa, M. H.

    2016-06-01

    Municipal and industrial wastewater treatment plants produce large amounts of sludge. This excess sludge is an inevitable drawback inherent to the activated sludge process. In this study, the waste activated sludge was obtained from the campus wastewater treatment plant at Universiti Teknologi PETRONAS (UTP), Malaysia. Fenton pretreatment was optimized by using the response surface methodology (RSM) to study the effects of three operating conditions including the dosage of H2O2 (g H2O2/kg TS), the molar ratio of H2O2/Fe2+ and reaction time. The optimum operating variables to achieve MLVSS removal 65%, CST reduction 28%, sCOD 11000 mg/L and EPS 500 mg/L were: 1000 g H2O2/kg TS, H2O2/Fe2+ molar ratio 70 and reaction time 45 min. Fenton process was proved to be able to enhance the sludge disintegration and dewaterability.

  10. Disintegration rate measurement of a 152Eu solution.

    Science.gov (United States)

    Koskinas, Marina F; Fonseca, Kátia A; Dias, Mauro S

    2002-01-01

    The procedure followed by the Laboratório de Metrologia Nuclear at the IPEN-CNEN/SP, in São Paulo, for the standardization of 152Eu is described. The disintegration rate of 152Eu has been measured using the 4pi beta-gamma coincidence technique, using a 4pi proportional counter, filled with P-10 gas and operated at 0.1 MPa, coupled to one HPGe detector for the gamma-ray emission. Two discrimination windows were set in the gamma-channel, one related to the beta branch (344 keV) and the other related to the electron capture events (1408.03 keV), in order to determine the counting efficiencies for beta, X-ray and Auger electron events in the proportional counter. The activity of solution was determined by a biparametric extrapolation curve obtained for the two selected gamma-windows.

  11. Induction of osteogenic differentiation of stem cells via a lyophilized microRNA reverse transfection formulation on a tissue culture plate

    Directory of Open Access Journals (Sweden)

    Wu K

    2013-05-01

    Full Text Available Kaimin Wu,1,* Jie Xu,2,* Mengyuan Liu,1 Wen Song,1 Jun Yan,1 Shan Gao,3 Lingzhou Zhao,2 Yumei Zhang1 1Department of Prosthetic Dentistry, 2Department of Periodontology and Oral Medicine, School of Stomatology, The Fourth Military Medical University, Xi’an, People’s Republic of China; 3The Interdisciplinary Nanoscience Center and Department of Molecular Biology and Genetics, Aarhus University, Aarhus C, Denmark; School of Stomatology, Tianjin Medical University, Tianjin, People’s Republic of China*Both authors contributed equally to this workAbstract: MicroRNA (miRNA regulation is a novel approach to manipulating the fate of mesenchymal stem cells, but an easy, safe, and highly efficient method of transfection is required. In this study, we developed an miRNA reverse transfection formulation by lyophilizing Lipofectamine 2000-miRNA lipoplexes on a tissue culture plate. The lipoplexes can be immobilized on a tissue culture plate with an intact pseudospherical structure and lyophilization without any lyoprotectant. In this study, reverse transfection resulted in highly efficient cellular uptake of miRNA and enabled significant manipulation of the intracellular target miRNA level. Reverse transfection formulations containing Lipofectamine 2000 1 µL per well generated much higher transfection efficiency without obvious cytotoxicity compared with conventional and other transfection methods. Further, the transfection efficiency of the reverse transfection formulations did not deteriorate during 90 days of storage at 4°C and -20°C. We then assessed the efficiency of the miRNA reverse transfection formulation in promoting osteogenic differentiation of mesenchymal stem cells. We found that transfection with anti-miR-138 and miR-148b was efficient for enhancing osteogenic differentiation, as indicated by enhanced osteogenesis-related gene expression, amount of alkaline phosphatase present, production of collagen, and matrix mineralization. Overall

  12. [Non-autistic pervasive developmental disorders: Rett syndrome, disintegrative disorder and pervasive developmental disorder not otherwise specified

    NARCIS (Netherlands)

    Mercadante, M.T.; Gaag, R.J. van der; Schwartzman, J.S.

    2006-01-01

    The category "Pervasive Developmental Disorders" includes autistic disorder, Asperger's syndrome, Rett's syndrome, childhood disintegrative disorder, and a residual category, named pervasive developmental disorder not otherwise specified. In this review, Rett's syndrome and childhood disintegrative

  13. Investigation of the in vitro performance difference of drug-Soluplus® and drug-PEG 6000 dispersions when prepared using spray drying or lyophilization

    Directory of Open Access Journals (Sweden)

    Mohammad A. Altamimi

    2017-03-01

    Full Text Available Purpose: To evaluate the physicochemical and in vitro characteristics of solid dispersions using BCS II model drugs with Soluplus® and one of its component homopolymers, PEG 6000. Methods: Nifedipine (NIF and sulfamethoxazole (SMX of 99.3% and 99.5% purity, respectively, were selected as BCS II model drugs, such that an improved dissolution rate and concentration in the gastrointestinal tract should increase oral bioavailability. Soluplus® is an amorphous, tri-block, graft co-polymer with polyvinyl caprolactam, polyvinyl acetate, and polyethylene glycol (PCL:PVAc:PEG6000 in the ratio 57:30:13. PEG 6000 (BASF is a waxy material with melting point of about 60 °C. Solid dispersions were prepared using lyophilization or spray drying techniques. Dissolution study, crystallinity content, and analysis for new chemical bond formation have been used to evaluate the dispersed materials. Results: Although each polymer improved the drug dissolution rate, dissolution from Soluplus® was slower. Enhanced dissolution rates were observed with NIF solid dispersions, but the dissolution profiles were quite different due to the selected technique, polymer, and dissolution medium. For SMX, there was similarity across the dissolution profiles despite the medium, polymer, or applied technique. Each polymer was able to maintain an elevated drug concentration over the three hour duration of the dissolution profile, i.e., supersaturation was supported by the polymer. DSC thermograms revealed no melting endotherm, suggesting that the drug is amorphous or molecularly dispersed. Conclusion: NIF and SMX solid dispersions were successfully prepared by spray drying and lyophilization using Soluplus® or PEG 6000. Each polymer enhanced the drug dissolution rate; NIF dissolution rate was improved to a greater extent. Dispersions with PEG 6000 had a faster dissolution rate due to its hydrophilic nature. DSC analysis showed that no crystalline material exists in the

  14. Investigation of the in vitro performance difference of drug-Soluplus® and drug-PEG 6000 dispersions when prepared using spray drying or lyophilization.

    Science.gov (United States)

    Altamimi, Mohammad A; Neau, Steven H

    2017-03-01

    To evaluate the physicochemical and in vitro characteristics of solid dispersions using BCS II model drugs with Soluplus® and one of its component homopolymers, PEG 6000. Nifedipine (NIF) and sulfamethoxazole (SMX) of 99.3% and 99.5% purity, respectively, were selected as BCS II model drugs, such that an improved dissolution rate and concentration in the gastrointestinal tract should increase oral bioavailability. Soluplus® is an amorphous, tri-block, graft co-polymer with polyvinyl caprolactam, polyvinyl acetate, and polyethylene glycol (PCL:PVAc:PEG6000) in the ratio 57:30:13. PEG 6000 (BASF) is a waxy material with melting point of about 60 °C. Solid dispersions were prepared using lyophilization or spray drying techniques. Dissolution study, crystallinity content, and analysis for new chemical bond formation have been used to evaluate the dispersed materials. Although each polymer improved the drug dissolution rate, dissolution from Soluplus® was slower. Enhanced dissolution rates were observed with NIF solid dispersions, but the dissolution profiles were quite different due to the selected technique, polymer, and dissolution medium. For SMX, there was similarity across the dissolution profiles despite the medium, polymer, or applied technique. Each polymer was able to maintain an elevated drug concentration over the three hour duration of the dissolution profile, i.e., supersaturation was supported by the polymer. DSC thermograms revealed no melting endotherm, suggesting that the drug is amorphous or molecularly dispersed. NIF and SMX solid dispersions were successfully prepared by spray drying and lyophilization using Soluplus® or PEG 6000. Each polymer enhanced the drug dissolution rate; NIF dissolution rate was improved to a greater extent. Dispersions with PEG 6000 had a faster dissolution rate due to its hydrophilic nature. DSC analysis showed that no crystalline material exists in the dispersions.

  15. The effect of ultrasonic disintegration process conditions on the physicochemical characteristics of excess sludge

    Directory of Open Access Journals (Sweden)

    Tytła Malwina

    2016-03-01

    Full Text Available Ultrasonic disintegration, as a method of sludge pre-treatment (before the stabilization process, causes changes in their physicochemical characteristics. The aim of this study was to determine the influence of ultrasonic disintegration conditions (sonication on the changes in the physicochemical characteristics of sonicated sludge, i.e. an increase in the content of organic substances in the supernatant, sludge dewaterability and flocs structure. Thickened and non-thickened excess sludge from the municipal wastewater treatment plant in Gliwice was disintegrated. The process was conducted, using a high-power disintegrator equipped with a lenticular horn. In order to determine the most favorable conditions, the sewage sludge was sonicated at a wave frequency of f=25 kHz (as a function of time, with a different samples volume (V1=0.5 and V2=1 L and emitter position of 1 and the 2.5 cm from the bottom of the chamber in which the process was conducted. The disintegration of sewage sludge was carried out with a specific energy density (EV in the range from 10 to 30 kWh/m3. The evaluation of the disintegration effects was based on changes in the physicochemical characteristics of the sludge and/or supernatant at the end of the process, expressed by commonly used and author’s disintegration indicators. The best results were obtained for the sludge disintegrated with a volume of V2=1 L and the emitter position of 2.5 cm from the bottom of the chamber. The study confirms that in various operating conditions of ultrasonic disintegration, there is a possibility for obtaining different effects which may influence the course of anaerobic stabilization and quality of the final products of the process.

  16. A laboratory scale model of abrupt ice-shelf disintegration

    Science.gov (United States)

    Macayeal, D. R.; Boghosian, A.; Styron, D. D.; Burton, J. C.; Amundson, J. M.; Cathles, L. M.; Abbot, D. S.

    2010-12-01

    An important mode of Earth’s disappearing cryosphere is the abrupt disintegration of ice shelves along the Peninsula of Antarctica. This disintegration process may be triggered by climate change, however the work needed to produce the spectacular, explosive results witnessed with the Larsen B and Wilkins ice-shelf events of the last decade comes from the large potential energy release associated with iceberg capsize and fragmentation. To gain further insight into the underlying exchanges of energy involved in massed iceberg movements, we have constructed a laboratory-scale model designed to explore the physical and hydrodynamic interactions between icebergs in a confined channel of water. The experimental apparatus consists of a 2-meter water tank that is 30 cm wide. Within the tank, we introduce fresh water and approximately 20-100 rectangular plastic ‘icebergs’ having the appropriate density contrast with water to mimic ice. The blocks are initially deployed in a tight pack, with all blocks arranged in a manner to represent the initial state of an integrated ice shelf or ice tongue. The system is allowed to evolve through time under the driving forces associated with iceberg hydrodynamics. Digitized videography is used to quantify how the system of plastic icebergs evolves between states of quiescence to states of mobilization. Initial experiments show that, after a single ‘agitator’ iceberg begins to capsize, an ‘avalanche’ of capsizing icebergs ensues which drives horizontal expansion of the massed icebergs across the water surface, and which stimulates other icebergs to capsize. A surprise initially evident in the experiments is the fact that the kinetic energy of the expanding mass of icebergs is only a small fraction of the net potential energy released by the rearrangement of mass via capsize. Approximately 85 - 90 % of the energy released by the system goes into water motion modes, including a pervasive, easily observed seich mode of the tank

  17. Disintegration of nano-embedded microparticles after deposition on mucus: A mechanistic study

    DEFF Research Database (Denmark)

    Ruge, Christian A; Bohr, Adam; Beck-Broichsitter, Moritz

    2016-01-01

    and then evaluated for their disintegration behavior after aerosolization onto model mucus. Although a rapid and complete aqueous redispersion was observed for specific excipient/nanoparticle weight ratios (i.e., greater than 1/1), the same formulations revealed no disintegration after deposition onto a static mucus...... layer. Double-labeled NEMs powders (i.e., dual color staining of polymeric nanoparticles and trehalose) demonstrated rapid matrix dissolution, while the nanoparticle aggregates persisted. When deposited onto agitated mucus, however, sufficient disintegration of NEMs into individual polymeric...

  18. Comparative Plasma Exposure of Albendazole after Administration of Rapidly Disintegrating Tablets in Dogs

    Directory of Open Access Journals (Sweden)

    Silvina G. Castro

    2013-01-01

    Full Text Available The main objectives of this study were (a to evaluate the in vitro performance of the rapid disintegration tablets as a way to improve the solid dispersions and (b to study the in vivo pharmacokinetics of the albendazole modified formulation in dogs. Rapid disintegration of tablets seems to be a key factor for efficiency of solid dispersions with regard to improvement of the albendazole bioavailability. The in vivo assays performed on dogs showed a marked increase in drug plasma exposure when albendazole was given in solid dispersions incorporated into rapid disintegration tablets compared with conventional solid dosage form.

  19. Comparative plasma exposure of albendazole after administration of rapidly disintegrating tablets in dogs.

    Science.gov (United States)

    Castro, Silvina G; Dib, Alicia; Suarez, Gonzalo; Allemandi, Daniel; Lanusse, Carlos; Sanchez Bruni, Sergio; Palma, Santiago D

    2013-01-01

    The main objectives of this study were (a) to evaluate the in vitro performance of the rapid disintegration tablets as a way to improve the solid dispersions and (b) to study the in vivo pharmacokinetics of the albendazole modified formulation in dogs. Rapid disintegration of tablets seems to be a key factor for efficiency of solid dispersions with regard to improvement of the albendazole bioavailability. The in vivo assays performed on dogs showed a marked increase in drug plasma exposure when albendazole was given in solid dispersions incorporated into rapid disintegration tablets compared with conventional solid dosage form.

  20. Effects of Processing and Storage on Pediococcus pentosaceus SB83 in Vaginal Formulations: Lyophilized Powder and Tablets

    Directory of Open Access Journals (Sweden)

    Sandra Borges

    2013-01-01

    Full Text Available Vaginal probiotics have an important role in preventing the colonization of the vagina by pathogens. This study aimed to investigate different formulations with Pediococcus pentosaceus SB83 (lyophilized powder and tablets with and without retarding polymer in order to verify its stability and antilisterial activity after manufacture and during storage. The bacteriocinogenic activity of P. pentosaceus SB83 against Listeria monocytogenes was evaluated in simulated vaginal fluid. Suspension of Pediococcus pentosaceus SB83 reduced the pathogen only after 2 h and the lyophilized bacteria after 24 h of contact, and, in the tablets, P. pentosaceus SB83 lost the antimicrobial activity. The pH of simulated vaginal fluid decreased for all the tested conditions. As lyophilized powder demonstrated better results concerning antimicrobial activity, this formulation was selected to evaluate the antilisterial activity during the 12 months of storage. During storage at room temperature, lyophilized bacteria totally inhibited the pathogen only until one month of storage. At 4°C, P. pentosaceus SB83 showed antimicrobial activity during all the time of storage investigated. Therefore, the better formulation of P. pentosaceus SB83 is the lyophilized powder stored at 4°C, which may be administered intravaginally as a washing solution.

  1. Research progress of orally disintegrating films%口腔崩解膜研究进展

    Institute of Scientific and Technical Information of China (English)

    章斌; 姚永秀

    2015-01-01

    口腔崩解膜具有优于常规快速崩片的许多优点,例如给药方便、机械强度高、快速崩解、低窒息风险等,因此比口腔崩解片具有更广的市场开发和应用的潜力.本文对口腔崩解膜的处方组成、制备方法、评价指标等方面的研究进行简要综述.

  2. Severe arrhythmia induced by orally disintegrating aripiprazole tablets (Bosiqing®: a case report

    Directory of Open Access Journals (Sweden)

    Shao Q

    2015-12-01

    Full Text Available Qing Shao,1,2,* Wei Quan,1,2,* Xiaoni Jia,1 Jianbo Chen,1 Shanbo Ma,3 Xiaohong Zhang11Xi’an Mental Health Center, Institute of Mental Health, Xi’an Medical University, Xi’an, Shaanxi, People’s Republic of China; 2Institute of Materia Medica, School of Pharmacy, Fourth Military Medical University, Xi’an, Shaanxi, People’s Republic of China; 3Department of Pharmacy, Xijing Hospital, Fourth Military Medical University, Xi’an, Shaanxi, People’s Republic of China*These authors contributed equally to this workAbstract: Psychotropic medications have been known to cause cardiac conduction disturbances. Not much is known about the cardiovascular side effects of newer atypical antipsychotics such as aripiprazole. A case of a 13-year-old girl with schizophrenia is presented. An analysis of the presented patient’s clinical history indicates the need for a detailed analysis of the severe arrhythmia induced by aripiprazole. This presented case report contains valuable guidelines that can be of assistance in the treatment of patients with aripiprazole.Keywords: schizophrenia, aripiprazole, arrhythmia, antipsychotics

  3. Preparation, in vitro release, and pharmacokinetics in rabbits of lyophilized injection of sorafenib solid lipid nanoparticles

    Directory of Open Access Journals (Sweden)

    Zhang H

    2012-06-01

    Full Text Available Hong Zhang, Fu-Ming Zhang, Shi-Jun YanDepartment of Pharmacy, Renmin Hospital of Wuhan University, Wuhan, People’s Republic of ChinaAbstract: Sorafenib solid lipid nanoparticles (S-SLN were prepared by emulsion evaporation–solidification at low temperature. Morphology was examined by transmission electron microscope. Particle size and zeta potential were determined by laser granularity equipment. Encapsulation efficiency (EE was detected by Sephadex gel chromatography and high-performance liquid chromatography (HPLC. The in vitro release profile of S-SLN was studied with dialysis technology. The lyophilized injection of S-SLN was prepared by freeze drying and analyzed by differential scanning calorimetry. The plasma concentration of sorafenib in blood was determined by HPLC. The solid lipid nanoparticles assumed a spherical shape with an even distribution of diameter and particle size 108.23 ± 7.01 nm (n = 3. The polydispersity index, zeta potential, and EE were determined to be 0.25 ± 0.02, -16.37 ± 0.65 mV, and 93.49% ± 1.87%, respectively (n = 3. The in vitro release accorded with the Weibull distribution model. An equal volume of 15% (w/v mannitol performed better as the protective agent for a lyophilized injection of S-SLN with a new material phase formation. The pharmacokinetic processes of sorafenib solution and lyophilized injection of S-SLN in vivo were in accordance with the two-compartment and one-compartment models, respectively. S-SLN nanoparticles are thus considered a promising drug-delivery system.Keywords: sorafenib, solid lipid nanoparticles, material phase analysis, HPLC, release profile, pharmacokinetics

  4. Effects of ionizing radiation on proteins in lyophilized or frozen demineralized human bone

    Science.gov (United States)

    Antebi, Uri; Mathor, Monica Beatriz; da Silva, André Ferreira; Guimarães, Rodrigo Pereira; Honda, Emerson Kiyoshi

    2016-01-01

    Objective The aim was to study the effects of application of ionizing radiation (gamma and electrons) as sterilizing agents at doses of 15 kGy, 25 kGy and 50 kGy, on lyophilized or frozen demineralized bone tissue for use in transplants. Methods Five human femoral diaphyses from different donors of musculoskeletal tissue were demineralized and preserved as lyophilized or frozen at −80 °C. The samples were divided into two groups: non-irradiated (control) and irradiated by means of gamma rays or an electron beam. The bone proteins were extracted and used to determine the concentrations of total protein and BMP 2 and 7. Results Decreases in total protein and BMP 2 and 7 concentrations were observed. The decreases in total protein concentrations, in comparison with the respective control groups, were significant in the lyophilized and frozen samples that were irradiated at a dose of 50 kGy of gamma radiation and electron beam, with reductions of more than 30%. Significant decreases in the levels of BMP 2 and 7 were also observed at higher doses and especially through use of the electron beam. Conclusion The reductions in the concentrations of total proteins and osteoinductive proteins (BMP 2 and 7) were related to the radiation dose, i.e. they increased with higher doses of ionizing radiation type and the type of bone preservation. The largest reductions in concentrations were observed in the bones irradiated by means of an electron beam and at a dose of 50 kGy. However, this type of radiation and this high dose are not usual practices for sterilization of bone tissue. PMID:27069893

  5. Quality of freeze-dried (lyophilized) quarantined single-donor plasma.

    Science.gov (United States)

    Bux, Jürgen; Dickhörner, Dieter; Scheel, Edgar

    2013-12-01

    Transfusion of plasma is a basic treatment for complex coagulopathies as well as in major blood loss. Early transfusion of plasma after trauma with major hemorrhage has been recommended by retrospective studies. However, the use of plasma is often hampered by the need to maintain a cold chain and the time needed for thawing fresh-frozen plasma (FFP). With freeze-dried (lyophilized) plasma (FDP) both difficulties can be avoided. Here, we describe the production, quality characteristics, and our experiences with FDP. Quarantine plasma samples were freeze-dried. The clotting factors fibrinogen, Factor (F)V, FVIII, FXI, von Willebrand factor (vWF), protein S, antithrombin, plasminogen, and plasmin inhibitor were determined after manufacturing and after storage at room temperature and refrigeration. Reported adverse transfusion events were evaluated and compared to that of FFP. Clinical effectiveness was estimated by inquiry among experienced users. Lyophilization resulted in a loss of coagulation factor activity between 0% and up to 20% to 25% (FVIII, vWF). When stored refrigerated, coagulation factors did not lose more than 10% of their activities. Storage at room temperature for 24 months mainly affected vWF/ristocetin cofactor activity and fibrinogen activity. From 2007 to 2011 more than 230,000 units of FDP were delivered. There were no reports about clinical ineffectiveness. The frequency of transfusion reactions was not different from that of FFP. Lyophilized plasma showed characteristics similar to FFP. Since FDP requires neither complex logistics nor time-consuming thawing, it allows rapid treatment of coagulopathies. © 2013 American Association of Blood Banks.

  6. Disintegration process and performance of a coaxial porous injector

    Science.gov (United States)

    Lee, Keonwoong; Kim, Dohun; Koo, Jaye

    2016-10-01

    In order to understand the breakup performance of coaxial porous injectors, the sprays of coaxial porous injectors with two different porous material cylinder lengths were compared with those of conventional shear coaxial injectors. To allow comparison, the wall injection lengths were designed to be equivalent to the value of the recess depth. Cold flow sprays were visualized using back-lit photography methods and analyzed quantitatively with a laser diffraction apparatus, in order to study the effects of the momentum flux ratio and Weber number on the breakup for each type of injector. In case of the shear coaxial injector, the large liquid core was observed in low air mass flow rate condition. However, the destabilization of the liquid jet from the coaxial porous injector is almost complete within the inner region, near the injector face plate. Additionally, better breakup performance in low gas flow rate condition was obtained when the porous cylinder length decreased, while the shear coaxial injectors showed better breakup efficiency when the recess length increased. In conclusion, the different breakup process caused by the radial momentum in the inner region of the porous injector disintegrated the liquid core.

  7. Meteotsunami disintegration and soliton forerunners on Atchafalaya shelf, Lousiana

    Science.gov (United States)

    Sheremet, Alex; Gravois, Uriah; Shrira, Victor

    2016-04-01

    Field observations collected on the Atcahfalaya shelf in 2008 captured in high detail the shoaling evolution of a meteotsunami, including its disintegration into a undular bore. One of the intriguing elements of this process is a spectacular 1.5-m solitary-wave (soliton) forerunner, that precedes the arrival of the meteotsunami by approximately 5 min, reaching the observation site propagating through relatively calm waters (a wave field of approximately 20-cm height). The source of the meteotsunami is identified as a squall line associated with a strong atmospheric perturbation. An inverse ray method used to estimate the meteotsunami path suggests that the meteotsunami propagated as a trapped wave, originating in shallow water and ending in shallow water. The process of the generation of the soliton forerunner is investigated using the variable-coefficient KdV equation first proposed by Ostrovsky and Pelinovsky (1975). Numerical scenarios indicate that the soliton is the product of the collision of a shoaling "multiple-bump" tsunami structure. Given the natural irregularities of the generation mechanism of the meteotsunami, this suggests that such solitary-wave foreunners might be more common than expected. Ostrovsky L.A., and E.N. Pelinovsky (1975). Refraction of nonlinear ocean waves in a beach zone. Izv Atmos Ocean Phys 11, 37-41.

  8. A disintegrating minor planet transiting a white dwarf

    CERN Document Server

    Vanderburg, Andrew; Rappaport, Saul; Bieryla, Allyson; Irwin, Jonathan; Lewis, John Arban; Kipping, David; Brown, Warren R; Dufour, Patrick; Ciardi, David R; Angus, Ruth; Schaefer, Laura; Latham, David W; Charbonneau, David; Beichman, Charles; Eastman, Jason; McCrady, Nate; Wittenmyer, Robert A; Wright, Jason T

    2015-01-01

    White dwarfs are the end state of most stars, including the Sun, after they exhaust their nuclear fuel. Between 1/4 and 1/2 of white dwarfs have elements heavier than helium in their atmospheres, even though these elements should rapidly settle into the stellar interiors unless they are occasionally replenished. The abundance ratios of heavy elements in white dwarf atmospheres are similar to rocky bodies in the Solar system. This and the existence of warm dusty debris disks around about 4% of white dwarfs suggest that rocky debris from white dwarf progenitors' planetary systems occasionally pollute the stars' atmospheres. The total accreted mass can be comparable to that of large asteroids in the solar system. However, the process of disrupting planetary material has not yet been observed. Here, we report observations of a white dwarf being transited by at least one and likely multiple disintegrating planetesimals with periods ranging from 4.5 hours to 4.9 hours. The strongest transit signals occur every 4.5 ...

  9. Producing Magnesium Metallic Glass By Disintegrated Melt Deposition

    Science.gov (United States)

    Shanthi, M.; Gupta, M.; Jarfors, A. E. W.; Tan, M. J.

    2011-01-01

    Bulk metallic glasses are new class of engineering materials that exhibit high resistance to crystallization in the under cooled liquid state. The development of bulk metallic glasses of thickness 1cm or less has opened new doors for fundamental studies of both liquid state and glass transition previously not feasible in metallic materials. Moreover, bulk metallic glasses exhibit superior hardness, strength, specific strength, and elastic strain limit, along with good corrosion and wear resistance. Thus they are potential candidates in various sports, structural, engineering and medical applications. Among several BMGs investigated, magnesium-based BMGs have attracted considerable attention because of their low density and superior mechanical properties. The major drawback of this magnesium based BMGs is poor ductility. This can be overcome by the addition of ductile particles/reinforcement to the matrix. In this study, a new technique named disintegrated melt deposition technique was used to synthesize magnesium based BMGs. Rods of different sizes are cast using the current method. Mechanical characterization studies revealed that the amorphous rods produced by the current technique showed superior mechanical properties.

  10. Calpains mediate axonal cytoskeleton disintegration during Wallerian degeneration.

    Science.gov (United States)

    Ma, Marek; Ferguson, Toby A; Schoch, Kathleen M; Li, Jian; Qian, Yaping; Shofer, Frances S; Saatman, Kathryn E; Neumar, Robert W

    2013-08-01

    In both the central nervous system (CNS) and peripheral nervous system (PNS), transected axons undergo Wallerian degeneration. Even though Augustus Waller first described this process after transection of axons in 1850, the molecular mechanisms may be shared, at least in part, by many human diseases. Early pathology includes failure of synaptic transmission, target denervation, and granular disintegration of the axonal cytoskeleton (GDC). The Ca(2+)-dependent protease calpains have been implicated in GDC but causality has not been established. To test the hypothesis that calpains play a causal role in axonal and synaptic degeneration in vivo, we studied transgenic mice that express human calpastatin (hCAST), the endogenous calpain inhibitor, in optic and sciatic nerve axons. Five days after optic nerve transection and 48 h after sciatic nerve transection, robust neurofilament proteolysis observed in wild-type controls was reduced in hCAST transgenic mice. Protection of the axonal cytoskeleton in sciatic nerves of hCAST mice was nearly complete 48 h post-transection. In addition, hCAST expression preserved the morphological integrity of neuromuscular junctions. However, compound muscle action potential amplitudes after nerve transection were similar in wild-type and hCAST mice. These results, in total, provide direct evidence that calpains are responsible for the morphological degeneration of the axon and synapse during Wallerian degeneration.

  11. Size and shape controllable preparation of graphene sponge by freezing, lyophilizing and reducing in container

    Institute of Scientific and Technical Information of China (English)

    ZHAO LianQin; YU BaoWei; ZHANG XiaoLiang; WU RuiHan; LIU XiaoYang; LIAO Rong; YANG ShengTao

    2016-01-01

    Graphene sponge (GS) is a porous 3D structure of graphene.Although hydrothermal reduction,chemical vapor deposition,solution reduction and high temperature annealing could be used for the preparation of GS,the size and shape cannot be well controlled.Herein,we reported a facile method to prepare GS under mild condition in a size and shape controllable way.Graphene oxide was lyophilized to form the spongy structure and reduced by steamy hydrazine hydrate to produce GS.The size and shape of GS prepared were nearly identical to that of the container.The reduction degree of GS could be regulated by the reduction temperature and time.

  12. Effect of disintegration wave grinding on fractional protein and amino acid composition of chickpea

    Directory of Open Access Journals (Sweden)

    G. O. Magomedov

    2013-01-01

    Full Text Available The study of fractional changes and amino acid composition of proteins in the application of chickpea disintegration wave grinding. Comparative analysis of six varieties of chickpea before and after grinding.

  13. How Integrated are Students with and without Graduation? Social Disintegration and its Possible Outcomes

    Directory of Open Access Journals (Sweden)

    Kirsten Endrikat

    2011-09-01

    Full Text Available This article takes a closer look at the so-called „losers“ of the educational system in Germany. For this purpose different groups of young people with and without higher graduation are examined. The dependent variables are social disintegration and prejudices towards different target groups. A sample of 1230 youths at the age of 16 – 21 has been drawn from different surveys of the Bielefeld Group-Focused Emnity study. According to the hypotheses the quantitative results show that those adolescents who are less qualified suffer from fear of disintegration. Surprisingly the group without any academic graduation suffers significantly less from strain of social disintegration. Furthermore fear of disintegration can be linked to problematic attitudes and problematic behaviour towards different target groups. Results of this work show as well gender specific effects in prejudices towards target groups.

  14. Atrazine in sub-acute exposure results in sperm DNA disintegrity and nuclear immaturity in rats

    Directory of Open Access Journals (Sweden)

    Rajab-Ali Sadrkhanloo

    2012-03-01

    Full Text Available This study was designed to evaluate the detrimental effect of atrazine (ATR on germinal epitheliums (GE cytoplasmic carbohydrate (CH and unsaturated fatty acids (UFA ratio and to clarify the effect of ATR on serum levels of FSH, LH, testosterone and inhibin-B (INH-B. The impact of ATR exposure on total antioxidant capacity (TAC, sperm DNA packing and integrity were also investigated. Seventy two Wistar rats were used. The rats in control group received vehicle and the animals in test groups received 100, 200 and 300 mg kg-1 BW of ATR orally on daily bases for 12, 24 and 48 days. In ATR-received groups the spermatogenesis cell were presented with dense reactive sites for lipidophilic staining associated with faint cytoplasmic CH accumulation. Dissociated germinal epithelium, negative tubular and repopulation indexes were manifested. The serum levels of testosterone, FSH, LH and INH-B decreased by 85% after 48 days exposure to high dose of ATR. TAC was reduced in a time- and dose-dependent manner. The sperm DNA damage was marked in animals which exposed to high dose of ATR (72.50 ± 2.25% and the percentage of nuclear immature sperm increased up to 83.40 ± 0.89%. In conclusion, ATR not only induced its detrimental effect on the endocrine function of the testes and pituitary gland but also affected the cytoplasmic CH ratio and consequently leads to inadequate energy supplement in spermatogenesis cells. Therefore the imbalanced oxidative stress occurs in testicular tissue, which in turn enhances the sperm DNA disintegrity and nuclear immaturity.

  15. Model test of anchoring effect on zonal disintegration in deep surrounding rock masses.

    Science.gov (United States)

    Chen, Xu-Guang; Zhang, Qiang-Yong; Wang, Yuan; Liu, De-Jun; Zhang, Ning

    2013-01-01

    The deep rock masses show a different mechanical behavior compared with the shallow rock masses. They are classified into alternating fractured and intact zones during the excavation, which is known as zonal disintegration. Such phenomenon is a great disaster and will induce the different excavation and anchoring methodology. In this study, a 3D geomechanics model test was conducted to research the anchoring effect of zonal disintegration. The model was constructed with anchoring in a half and nonanchoring in the other half, to compare with each other. The optical extensometer and optical sensor were adopted to measure the displacement and strain changing law in the model test. The displacement laws of the deep surrounding rocks were obtained and found to be nonmonotonic versus the distance to the periphery. Zonal disintegration occurs in the area without anchoring and did not occur in the model under anchoring condition. By contrasting the phenomenon, the anchor effect of restraining zonal disintegration was revealed. And the formation condition of zonal disintegration was decided. In the procedure of tunnel excavation, the anchor strain was found to be alternation in tension and compression. It indicates that anchor will show the nonmonotonic law during suppressing the zonal disintegration.

  16. Model Test of Anchoring Effect on Zonal Disintegration in Deep Surrounding Rock Masses

    Directory of Open Access Journals (Sweden)

    Xu-Guang Chen

    2013-01-01

    Full Text Available The deep rock masses show a different mechanical behavior compared with the shallow rock masses. They are classified into alternating fractured and intact zones during the excavation, which is known as zonal disintegration. Such phenomenon is a great disaster and will induce the different excavation and anchoring methodology. In this study, a 3D geomechanics model test was conducted to research the anchoring effect of zonal disintegration. The model was constructed with anchoring in a half and nonanchoring in the other half, to compare with each other. The optical extensometer and optical sensor were adopted to measure the displacement and strain changing law in the model test. The displacement laws of the deep surrounding rocks were obtained and found to be nonmonotonic versus the distance to the periphery. Zonal disintegration occurs in the area without anchoring and did not occur in the model under anchoring condition. By contrasting the phenomenon, the anchor effect of restraining zonal disintegration was revealed. And the formation condition of zonal disintegration was decided. In the procedure of tunnel excavation, the anchor strain was found to be alternation in tension and compression. It indicates that anchor will show the nonmonotonic law during suppressing the zonal disintegration.

  17. Assessing the impact of lyophilization process in production of implants based on the bacterial cellulose using Raman spectroscopy method

    Science.gov (United States)

    Timchenko, E. V.; Timchenko, P. E.; Pisareva, E. V.; Vlasov, M. Yu; Revin, V. V.; Klenova, N. A.; Asadova, A. A.

    2017-01-01

    In this article we present the research results of lyophilization process influence on the composition of hybrid materials based on the bacterial cellulose (BC) using Raman spectroscopy method. As an object of research was used BC, as well as hybrids based on it, comprising the various combinations of hydroxyapatite (HAP) and collagen. Our studies showed that during the lyophilization process changes the ratio of the individual components. It was found that for samples hybrid based on BC with addition of HAP occurs increase of PO4 3- peak intensity in the region 956 cm-1 with decreasing width, which indicates a change in the degree of HAP crystallinity.

  18. PCR amplification of 16S rDNA from lyophilized cell cultures facilitates studies in molecular systematics

    Science.gov (United States)

    Wisotzkey, J. D.; Jurtshuk, P. Jr; Fox, G. E.

    1990-01-01

    The sequence of the major portion of a Bacillus cycloheptanicus strain SCH(T) 16S rRNA gene is reported. This sequence suggests that B. cycloheptanicus is genetically quite distinct from traditional Bacillus strains (e.g., B. subtilis) and may be properly regarded as belonging to a different genus. The sequence was determined from DNA that was produced by direct amplification of ribosomal DNA from a lyophilized cell pellet with straightforward polymerase chain reaction (PCR) procedures. By obviating the need to revive cell cultures from the lyophile pellet, this approach facilitates rapid 16S rDNA sequencing and thereby advances studies in molecular systematics.

  19. Lyophilized platelet-rich fibrin (PRF) promotes craniofacial bone regeneration through Runx2.

    Science.gov (United States)

    Li, Qi; Reed, David A; Min, Liu; Gopinathan, Gokul; Li, Steve; Dangaria, Smit J; Li, Leo; Geng, Yajun; Galang, Maria-Therese; Gajendrareddy, Praveen; Zhou, Yanmin; Luan, Xianghong; Diekwisch, Thomas G H

    2014-05-14

    Freeze-drying is an effective means to control scaffold pore size and preserve its composition. The purpose of the present study was to determine the applicability of lyophilized Platelet-rich fibrin (LPRF) as a scaffold for craniofacial tissue regeneration and to compare its biological effects with commonly used fresh Platelet-rich fibrin (PRF). LPRF caused a 4.8-fold±0.4-fold elevation in Runt-related transcription factor 2 (Runx2) expression in alveolar bone cells, compared to a 3.6-fold±0.2-fold increase when using fresh PRF, and a more than 10-fold rise of alkaline phosphatase levels and mineralization markers. LPRF-induced Runx2 expression only occurred in alveolar bone and not in periodontal or dental follicle cells. LPRF also caused a 1.6-fold increase in osteoblast proliferation (pPRF. When applied in a rat craniofacial defect model for six weeks, LPRF resulted in 97% bony coverage of the defect, compared to 84% for fresh PRF, 64% for fibrin, and 16% without scaffold. Moreover, LPRF thickened the trabecular diameter by 25% when compared to fresh PRF and fibrin, and only LPRF and fresh PRF resulted in the formation of interconnected trabeculae across the defect. Together, these studies support the application of lyophilized PRF as a biomimetic scaffold for craniofacial bone regeneration and mineralized tissue engineering.

  20. The evidence for clinically significant bias in plasma glucose between liquid and lyophilized citrate buffer additive.

    Science.gov (United States)

    Juricic, Gordana; Saracevic, Andrea; Kopcinovic, Lara Milevoj; Bakliza, Ana; Simundic, Ana-Maria

    2016-12-01

    Citrate buffer additive has been suggested to be of supreme performance in inhibiting glycolysis. However, there is little evidence in the literature regarding the comparability of glucose concentrations in liquid and lyophilized citrate buffer containing tubes. The aim of this study was to compare glucose concentrations in tubes containing liquid (Glucomedics) and lyophilized citrate buffer (Terumo VENOSAFE™ Glycemia) additive, measured immediately after centrifugation. Blood was collected from forty volunteers into both Glucomedics and Venosafe Glycemia tubes. Blood was centrifuged within 15min from venipuncture and glucose concentration was measured immediately after centrifugation, on the Abbott Architect analyzer. Differences between glucose concentrations in Glucomedics and Terumo tubes were tested using the paired t-test. Mean bias was calculated and compared to recommended quality specification for glucose (i.e. 2.2%). Glucose concentration in Terumo tubes was 3.4% lower than in Glucomedics tubes (Pbuffer additive tubes (Glucomedics vs. Terumo tubes) measured immediately after centrifugation. This difference may affect the patient outcome due to the misclassification of diabetes. Copyright © 2016 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved.

  1. Lyophilized Platelet-Rich Fibrin (PRF Promotes Craniofacial Bone Regeneration through Runx2

    Directory of Open Access Journals (Sweden)

    Qi Li

    2014-05-01

    Full Text Available Freeze-drying is an effective means to control scaffold pore size and preserve its composition. The purpose of the present study was to determine the applicability of lyophilized Platelet-rich fibrin (LPRF as a scaffold for craniofacial tissue regeneration and to compare its biological effects with commonly used fresh Platelet-rich fibrin (PRF. LPRF caused a 4.8-fold ± 0.4-fold elevation in Runt-related transcription factor 2 (Runx2 expression in alveolar bone cells, compared to a 3.6-fold ± 0.2-fold increase when using fresh PRF, and a more than 10-fold rise of alkaline phosphatase levels and mineralization markers. LPRF-induced Runx2 expression only occurred in alveolar bone and not in periodontal or dental follicle cells. LPRF also caused a 1.6-fold increase in osteoblast proliferation (p < 0.001 when compared to fresh PRF. When applied in a rat craniofacial defect model for six weeks, LPRF resulted in 97% bony coverage of the defect, compared to 84% for fresh PRF, 64% for fibrin, and 16% without scaffold. Moreover, LPRF thickened the trabecular diameter by 25% when compared to fresh PRF and fibrin, and only LPRF and fresh PRF resulted in the formation of interconnected trabeculae across the defect. Together, these studies support the application of lyophilized PRF as a biomimetic scaffold for craniofacial bone regeneration and mineralized tissue engineering.

  2. A STUDY ABOUT PHYSICOCHEMICAL COMPOSITION OF FRESH AND LYOPHILIZED ROYAL JELLY

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    OLIMPIA POPESCU

    2013-12-01

    Full Text Available This paper contents a summery about physicochemical composition of frash and lyophilized royal jelly. Royal jelly (RJ is a yellowish and creamy secretion from hypo pharyngeal and mandibular glands of young worker bees (Apis mellifera L. to feed all larvae for the first three days of their life and the queen bee for both her larval life and adulthood.. Royal jelly is a honey bee secretion that is used in the nutrition of the larvae. Queen bees are made, not born, and their feeding with royal jelly is the key to that process. The geographical authenticity of royal jelly can be determined also by pollen analysis (Ricciardelli d'Albore et al., 1978; Ricciardelli d'Albore, 1986. The physicochemical composition of pure royal jelly are analyzed by determining moisture, ash, lipids, proteins, carbohydrates, 10-HDA; and for lyophilized royal jelly are analyzed by determining ash, lipids, protein, carbohydrates, 10-HDA, sugars. 10-HDA content is the criteria of royal jelly quality analysis and it is a freshness parameter(Antinelli J.F., Sarah Zeggane, Renee Davico, Catherine Rognone, Jean Paul Faucon, Louisette Lizzani.

  3. Effect of the mode of incorporation on the disintegrant properties of acid modified water and white yam starches.

    Science.gov (United States)

    Odeku, Oluwatoyin A; Akinwande, Babatunde L

    2012-04-01

    Acid modified starches obtained from two species of yam tubers namely white yam - Dioscorea rotundata L. and water yam - D. alata L. DIAL2 have been investigated as intra- and extra-granular disintegrants in paracetamol tablet formulations. The native starches were modified by acid hydrolysis and employed as disintegrant at concentrations of 5 and 10% w/w and their disintegrant properties compared with those of corn starch BP. The tensile strength and drug release properties of the tablets, assessed using the disintegration and dissolution (t 50 and t 80 - time required for 50% and 80% of paracetamol to be released) times, were evaluated. The results showed that the tensile strength and the disintegration and dissolution times of the tablets decreased with increase in the concentration of the starch disintegrants. The acid modified yam starches showed better disintegrant efficiency than corn starch in the tablet formulations. Acid modification appeared to improve the disintegrant efficiency of the yam starches. Furthermore, tablets containing starches incorporated extragranularly showed faster disintegration but lower tensile strength than those containing starches incorporated intragranularly. This emphasizes the importance of the mode of incorporation of starch disintegrant.

  4. Development and characterization of seed gums from Tamarindus indica and Cassia fistula as disintegrating agent for fast disintegrating Thai cordial tablet

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    Kampanart Huanbutta

    2017-07-01

    Full Text Available Crude seed gum and their carboxymethyl derivatives from Tamarindus indica and Cassia fistula seeds were developed and characterized to apply as the pharmaceutical disintegrant in fast disintegrating Thai cordial tablet. The chemical structure of crude gum was chemically modified via carboxymethylation. Degree of substitution (DS of carboxymethylated gums was determined. Carboxymethylated gums with minimum and maximum DS values were chosen for further application. IR absorption spectra of gum samples were observed to verify their chemical structure changes. In physical properties, the intrinsic viscosity and swelling property of all gum samples were evaluated. The results showed that carboxymethylated gums had higher intrinsic viscosity than those of crude gum. Moreover, they could swell and be soluble in cold water better than those of crude gums. In conclusion, the modified gums from both plants could provide higher hardness and be better used than that crude gums for fast disintegrating Thai cordial tablet. However, this is a preliminary assessment to expressing pharmaceutical application possibility of these gums as disintegrants, diluents and drug release controlling agents.

  5. Integration and disintegration processes of ethnic communities in a globalized world: challenges and trends

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    A. A. Paronikian

    2016-06-01

    Full Text Available The article examines the challenges and trends in integration and disintegration processes of ethnic communities in the world of globalization. Established that ethnic disintegration is inevitable consequence of ethnic integration, and its intensity depends on what method is carried Integration: voluntary or forced. What is important is the fact that in the era of globalization integration and disintegration processes of ethnic communities that are inherent in the very essence of ethnicity, greatly amplified. It was found that entering to the cultural field of ethnic communities of other ethnic entities, penalized sustainable ethnic balance, contributes to the phenomenon of «rejection of other» causes of ethnic conflict and the consequent threat of disintegration of ethnic communities. Disintegration often leads to weakening of the linkages and interactions between components of the integrated system in a multi-ethnic society. However, the author concludes that the process of disintegration cannot be regarded as unambiguously negative because, on the one hand, it contributes to the weakening and decline; and sometimes division of multi-ethnic countries, but on the other hand - it contributes to the birth of the new and revival of the old nation-states, which is particularly important in conditions of transformation of the global community towards the post-industrial and information epoch in the future. In general, the integration and disintegration change each other depending on global processes and their transformations. Therefore, in the era of globalization’s challenges it is important is the effective management of these processes to prevent adverse effects.

  6. Combination of alkaline and microwave pretreatment for disintegration of meat processing wastewater sludge.

    Science.gov (United States)

    Erden, G

    2013-01-01

    Meat processing wastewater sludge has high organic content but it is very slow to degrade in biological processes. Anaerobic digestion may be a good alternative for this type of sludge when the hydrolysis, known to be the rate-limiting step of biological sludge anaerobic degradation, could be eliminated by disintegration. This investigation deals with disintegration of meat processing wastewater sludge. Microwave (MW) irradiation and combined alkaline pretreatment and MW irradiation were applied to sludge for disintegration purposes. Disintegration performance of the methods was evaluated with disintegration degree based on total and dissolved organic carbon calculations (DD(TOC)), and the solubilization of volatile solids (S(VS)) in the pretreated sludge. Optimum conditions were found to be 140 degrees C and 30 min for MW irradiation using response surface methodology (RSM) and pH = 13 for combined pretreatment. While DD(TOC) was observed as 24.6% and 54.9, S(VS) was determined as 8.54% and 42.5% for MW pretreated and combined pretreated sludge, respectively. The results clearly show that pre-conditioning of sludge with alkaline pretreatment played an important role in enhancing the disintegration efficiency of subsequent MW irradiation. Disintegration methods also affected the anaerobic biodegradability and dewaterability of sludge. An increase of 23.6% in biogas production in MW irradiated sludge was obtained, comparing to the raw sludge at the end of the 35 days of incubation. This increase was observed as 44.5% combined pretreatment application. While MW pretreatment led to a little improvement of the dewatering performance of sludge, in combined pretreatment NaOH deteriorates the sludge dewaterability.

  7. Family disintegration in Latin America: the consequences for children.

    Science.gov (United States)

    Siqueira, L

    1982-12-01

    A federal study on children conducted by Brazil's Chamber of Deputies in 1975 concluded that some 25 million children, 40% of the total population below the age of 18 years, could be classified as disadvantaged. By 1980 this figure was estimated to have grown by an additional 3 million. An estimated 11 million of the disadvantaged children were literally destitute and homeless. They have been abandoned by their impoverished parents to a precarious life on the streets of the major cities of Brazil. The parents of many such abandoned children are recent migrants from rural areas. Unable to find adequate work and too poor to partake of health and other services, such families slip slowly into a state of destitution and disarray. The children end up on the streets where they are abused, exploited, and drawn into lives of crime and violence. Abandoned children are not the only young victims of the imbalances in Brazilian society. As many as 80% of Brazil's children suffer from some degree of malnutrition. Infant mortality is 84 deaths/1000 compared to an average of 12/1000 for Western Europe. In the Western hemisphere, several nations with lower per capita incomes have made greater progress in reducing infant and child mortality. These facts point up the fallacy of confusing economic growth with development. Economic growth is quantitative, mechanical, and materialistic. Development is organic and includes social dimensions, such as the educational, nutritional, and health status of the population. The problem of the disadvantaged children in Brazil is a problem of families and of the stresses placed on them by rapid, disorienting changes in social, economic, political, and cultural systems. The loss of the traditional functions of the family in the process of technological evolution has throughout modern history placed great strains on the family. This historical tendency toward family disintegration is greatly aggravated throughout the countries of the 3rd and 4th

  8. Determination of moisture content in lyophilized mannitol through intact glass vials using NIR micro-spectrometers

    Directory of Open Access Journals (Sweden)

    Cristian Rodrigo Muzzio

    2011-06-01

    Full Text Available Determination of moisture content in lyophilized solids is fundamental to predict quality and stability of freeze-dried products, but conventional methods are time-consuming, invasive and destructive. The aim of this study was to develop and optimize a fast, inexpensive, noninvasive and nondestructive method for determination of moisture content in lyophilized mannitol, based on an NIR micro-spectrometer instead of a conventional NIR spectrometer. Measurements of lyophilized mannitol were performed through the bottom of rotating glass vials by means of a reflectance probe. The root mean standard error of prediction (RMSEP and the correlation coefficient (R²pred, yielded by the pre-treatments and calibration method proposed, was 0.233% (w/w and 0.994, respectively.A determinação do conteúdo de umidade em sólidos liofilizados é fundamental para se prever a qualidade e a estabilidade de produtos liofilizados, mas os métodos convencionais consomem muito tempo, são invasivos e destrutivos. O objetivo desse estudo foi desenvolver e otimizar um método rápido, econômico, não invasivo e não destrutivo para a determinação do conteúdo de umidade em manitol liofilizado, com base em microespectrômetro de infravermelho próximo ao invés de um espectrômetro de infravermelho próximo convencional. As medidas de manitol liofilizado foram realizadas através do fundo de recipiente de vidro em rotação por meio de sonda de reflectância. A raíz do erro médio padrão de predição (RMSEP e o coeficiente de correlação (R²pred obtidos pelo prétratamento e pelo método de calibração proposto foram, respectivamente, 0,233% (p/p e 0,994.

  9. Lyophilized phytosomal nanocarriers as platforms for enhanced diosmin delivery: optimization and ex vivo permeation

    Directory of Open Access Journals (Sweden)

    Freag MS

    2013-07-01

    Full Text Available May S Freag, Yosra SR Elnaggar, Ossama Y AbdallahDepartment of Pharmaceutics, Faculty of Pharmacy, Alexandria University, Alexandria, EgyptAbstract: Diosmin (DSN is an outstanding phlebotonic flavonoid with a tolerable potential for the treatment of colon and hepatocellular carcinoma. Being highly insoluble, DSN bioavailability suffers from high inter-subject variation due to variable degrees of permeation. This work endeavored to develop novel DSN loaded phytosomes in order to improve drug dissolution and intestinal permeability. Three preparation methods (solvent evaporation, salting out, and lyophilization were compared. Nanocarrier optimization encompassed different soybean phospholipid (SPC types, different solvents, and different DSN:SPC molar ratios (1:1, 1:2, and 1:4. In vitro appraisal encompassed differential scanning calorimetry, infrared spectroscopy, particle size, zeta potential, polydispersity index, transmission electron microscopy, drug content, and in vitro stability. Comparative dissolution studies were performed under sink versus non-sink conditions. Ex vivo intestinal permeation studies were performed on rats utilizing noneverted sac technique and high-performance liquid chromatography analysis. The results revealed lyophilization as the optimum preparation technique using SPC and solvent mixture (Dimethyl sulphoxide:t-butylalchol in a 1:2 ratio. Complex formation was contended by differential scanning calorimetry and infrared data. Optimal lyophilized phytosomal nanocarriers (LPNs exhibited the lowest particle size (316 nm, adequate zeta-potential (−27 mV, and good in vitro stability. Well formed, discrete vesicles were revealed by transmission electron microscopy, drug content, and in vitro stability. Comparative dissolution studies were performed. LPNs demonstrated significant enhancement in DSN dissolution compared to crude drug, physical mixture, and generic and brand DSN products. Permeation studies revealed 80% DSN

  10. Use of natural antioxidants from lyophilized water extracts of Borago officinalis in dry fermented sausages enriched in ω-3 PUFA.

    Science.gov (United States)

    Ciriano, Mikel García-Iñiguez de; García-Herreros, Cecilia; Larequi, Eduardo; Valencia, Idoia; Ansorena, Diana; Astiasarán, Iciar

    2009-10-01

    An evaluation of the capacity of a lyophilized water extract of borage leaves to delay the lipid oxidation process in dry fermented sausages enriched with ω-3 PUFAs has been performed. Lyophilized extract (340ppm) showed an antioxidant capacity equivalent to 200ppm of a butylhydroxyanisol (BHA) and butylhydroxytoluene (BHT) mixture. Two batches of dry fermented sausages enriched in ω-3 PUFA were developed. One of them was supplemented with a synthetic antioxidants mixture (200ppm of BHA+BHT) and the other one with natural antioxidants (340ppm of lyophilized water extract of borage leaves). Furthermore, a traditional formulation of this type of dry fermented sausage (Control), was also manufactured. The natural extract gave rise to lower amount of volatile compounds (including hexanal), than the mixture of synthetic antioxidants (2202 and 2713ng dodecane/g dry matter, respectively). TBARS and Cholesterol Oxidation Products (COPs) did not show significant differences between products with different antioxidants. The sensorial analysis showed that lyophilized water extracts of borage leaves did not affect the sensorial properties of the products. From the economical and safety standpoints, the use of a by-product (borage leaves) and water as extracting solvent are valuable alternatives for obtaining natural antioxidants to be added to dry fermented sausages enriched in ω-3 PUFA.

  11. GLYCOHEMOGLOBIN - COMPARISON OF 12 ANALYTICAL METHODS, APPLIED TO LYOPHILIZED HEMOLYSATES BY 101 LABORATORIES IN AN EXTERNAL QUALITY ASSURANCE PROGRAM

    NARCIS (Netherlands)

    WEYKAMP, CW; PENDERS, TJ; MUSKIET, FAJ; VANDERSLIK, W

    1993-01-01

    Stable lyophilized ethylenediaminetetra-acetic acid (EDTA)-blood haemolysates were applied in an external quality assurance programme (SKZL, The Netherlands) for glycohaemoglobin assays in 101 laboratories using 12 methods. The mean intralaboratory day-to-day coefficient of variation (CV), calculate

  12. Using the fluorescence red edge effect to assess the long-term stability of lyophilized protein formulations.

    Science.gov (United States)

    Qian, Ken K; Grobelny, Pawel J; Tyagi, Madhusudan; Cicerone, Marcus T

    2015-04-06

    Nanosecond relaxation processes in sugar matrices are causally linked through diffusional processes to protein stability in lyophilized formulations. Long-term protein degradation rates track mean-squared displacement (⟨u(2)⟩) of hydrogen atoms in sugar glasses, a parameter describing dynamics on a time scale of picoseconds to nanoseconds. However, measurements of ⟨u(2)⟩ are usually performed by neutron scattering, which is not conducive to rapid formulation screening in early development. Here, we present a benchtop technique to derive a ⟨u(2)⟩ surrogate based on the fluorescence red edge effect. Glycerol, lyophilized trehalose, and lyophilized sucrose were used as model systems. Samples containing 10(-6) mole fraction of rhodamine 6G, a fluorophore, were excited at either 532 nm (main peak) or 566 nm (red edge), and the ⟨u(2)⟩ surrogate was determined based the corresponding Stokes shifts. Results showed reasonable agreement between ⟨u(2)⟩ from neutron scattering and the surrogate from fluorescence, although deviations were observed at very low temperatures. We discuss the sources of the deviations and suggest technique improvements to ameliorate these. We expect that this method will be a valuable tool to evaluate lyophilized sugar matrices with respect to their ability to protect proteins from diffusion-limited degradation processes during long-term storage. Additionally, the method may have broader applications in amorphous pharmaceutical solids.

  13. Pluronic F68 enhanced the conformational stability of salmon calcitonin in both aqueous solution and lyophilized solid form.

    Science.gov (United States)

    Lee, Ting-Huei; Lin, Shan-Yang

    2011-11-01

    The effects of different surfactants on the conformational stability and structural similarity of salmon calcitonin (sCT) in aqueous solution and lyophilized forms were investigated by using microscopic Fourier transform infrared (FTIR) spectroscopy with second-derivative spectral analysis. Six surfactants, HCO-60, sodium dodecyl sulfate (SDS), Tween 80, PEG 400, Pluronic 68, and F127 were selected. The sCT aqueous solution with or without different surfactants was, respectively, incubated at 40°C for up to 35 h. sCT films were casted on the CaF(2) plates and IR spectra were collected as a function of incubation time. Second derivative analysis showed that the native sCT having a major α-helical structure was gradually changed to the combination of α-helix, random coil, and β-sheet conformations in aqueous solution at 40°C. Similar conformational changes with delayed β-sheet formation were obtained for sCT after co-incubation with all the surfactants except Pluronic F68. When the native sCT was freeze-dried alone, a marked conformational alteration was found as illustrated by a poor spectral correlation coefficient (r) value of 0.823 as compared to that of the unlyophilized native sCT. This r value was significantly deviated from 1, strongly indicating the influence of lyophilization stress on the surfactant-free sCT. The r value for sCT after lyophilizing with HCO-60, Pluronic F127, PEG 400, or Pluronic F68 was >0.9, suggesting the possible stabilization of these surfactants in the lyophilization process. The sCT sample after lyophilizing with Pluronic F68 showed a highest r value (>0.968), indicating the most optimal stabilization effect of Pluronic F68 for sCT sample via lyophilization. Pluronic F68 was found to be the preferential surfactant for preventing the secondary structure changes in aqueous solution at 40°C as well as in lyophilized powder.

  14. Transitioning from preclinical to clinical chemopreventive assessments of lyophilized black raspberries: interim results show berries modulate markers of oxidative stress in Barrett's esophagus patients.

    Science.gov (United States)

    Kresty, Laura A; Frankel, Wendy L; Hammond, Cynthia D; Baird, Maureen E; Mele, Jennifer M; Stoner, Gary D; Fromkes, John J

    2006-01-01

    Increased fruit and vegetable consumption is associated with decreased risk of a number of cancers of epithelial origin, including esophageal cancer. Dietary administration of lyophilized black raspberries (LBRs) has significantly inhibited chemically induced oral, esophageal, and colon carcinogenesis in animal models. Likewise, berry extracts added to cell cultures significantly inhibited cancer-associated processes. Positive results in preclinical studies have supported further investigation of berries and berry extracts in high-risk human cohorts, including patients with existing premalignancy or patients at risk for cancer recurrence. We are currently conducting a 6-mo chemopreventive pilot study administering 32 or 45 g (female and male, respectively) of LBRs to patients with Barrett's esophagus (BE), a premalignant esophageal condition in which the normal stratified squamous epithelium changes to a metaplastic columnar-lined epithelium. BE's importance lies in the fact that it confers a 30- to 40-fold increased risk for the development of esophageal adenocarcinoma, a rapidly increasing and extremely deadly malignancy. This is a report on interim findings from 10 patients. To date, the results support that daily consumption of LBRs promotes reductions in the urinary excretion of two markers of oxidative stress, 8-epi-prostaglandin F2alpha (8-Iso-PGF2) and, to a lesser more-variable extent, 8-hydroxy-2'-deoxyguanosine (8-OHdG), among patients with BE.

  15. Cadmium-induced colony disintegration of duckweed (Lemna paucicostata Hegelm.) and as biomarker of phytotoxicity.

    Science.gov (United States)

    Li, T Y; Xiong, Z T

    2004-10-01

    The toxic effect of cadmium on Lemna paucicostata was investigated with hydroponic culture in a culture facility. Cadmium treatment (0.4-6.4 micromol L(-1) Cd) induced L. paucicostata to release daughter fronds from the mother frond before maturity, resulting in colony disintegration. The 8-h and 24-h EC(50) values for colony disintegration in L. paucicostata plants were 0.12 and 0.11 mg L(-1), respectively. The maximum permissible concentrations (MPCs) were 0.012 and 0.011 mg L(-1) accordingly (MPC = 10% x EC(50)). These values were lower than the values of most of these biomarkers in duckweed reported in the literature, suggesting that colony disintegration in L. paucicostata may serve as a sensitive biomarker for the phytotoxicity test. Nutrient concentrations (1/2, 1/10, 1/20, 1/40, and 0-fold concentrations of Hoagland's solution) and Cd salt form (CdCl(2) or CdSO(4)) did not have a significant effect on colony disintegration. In addition, resistance to Cd stress differed significantly among clones of the plants. Approximately 2% of colonies in the wild population of L. paucicostata were tolerant of cadmium. These results indicate that colony disintegration of L. paucicostata could be used as a sensitive, cost-effective, and valuable biomarker to assess the acute phytotoxicity of cadmium and other heavy metals.

  16. Mechanism of zonal disintegration in surrounding rock mass around deep rock engineering and its application

    Institute of Scientific and Technical Information of China (English)

    2011-01-01

    The mechanical behaviors of deep rock mass are different from those of shallow rock mass.Through cases of Jinping II Hydropower Station,the special phenomenon of zonal disintegration in the surrounding rock mass around the diversion tunnels,is analyzed.On the basis of fracture mechanics,a new strength criterion for deep rock mass is derived.The new nonlinear strength criterion that is relative to the rock mass rating classification can be applied to the study of the tensile failure of deep rock mass.Subsequently,zonal disintegration model is established,and the radius of fractured zone and none-fractured zone of deep surrounding rock mass around cylindrical tunnel are obtained,their exact positions and the evolution law of zonal disintegration of surrounding rock mass is determined.To validate the present model,comparison between calculation results and the experiment observation on facture and failure around underground openings is carried out.It is found that the numerical simulation result is in good agreement with the experimental one on failure modes around the hole.Through sensitivity analysis,the effects of stress condition,cohesion and the angle of internal friction on the phenomenon of zonal disintegration are determined.Finally,the present model is adopted in the analysis of the zonal disintegration in the surrounding rock mass around the diversion tunnels in Jinping II Hydropower Station.Meanwhile,the magnitude and distributions of fractured zones are determined by numerical simulation.

  17. Brand to brand variation in the disintegrant functionality of Polacrilin Potassium, NF

    Directory of Open Access Journals (Sweden)

    Mrudula H. Bele

    2011-09-01

    Full Text Available The current monograph for Polacrilin Potassium, NF does not specify tests that could assist in distinguishing between different brands of this disintegrant. The objective of this work was to examine the physical characteristics of four brands of Polacrilin Potassium, NF and relate the observed differences to differences in their functionality. Significant differences were observed in the particle size, true density, porosity, surface area and morphology of the samples. Functionality tests, such as settling volume, intrinsic swelling, rate and extent of water uptake were carried out. Significant differences were observed in intrinsic swelling and the initial rate of water uptake. The disintegration times of the tablets were found to be a function of the initial rate of water uptake. Since the disintegration times were shown to be significantly different despite negligible differences in settling volumes, wicking and water uptake, as opposed to the magnitude of swelling, appear to be the major mechanisms that distinguish disintegration performance between different brands of Polacrilin Potassium, NF when incorporated into insoluble tablet matrices. Thus, the measurement of the rate of water uptake may be a useful functionality test for Polacrilin Potassium in particular, and for ion exchange resin type disintegrants in general.

  18. Photolytic Cross-Linking to Probe Protein-Protein and Protein-Matrix Interactions in Lyophilized Powders.

    Science.gov (United States)

    Iyer, Lavanya K; Moorthy, Balakrishnan S; Topp, Elizabeth M

    2015-09-08

    Protein structure and local environment in lyophilized formulations were probed using high-resolution solid-state photolytic cross-linking with mass spectrometric analysis (ssPC-MS). In order to characterize structure and microenvironment, protein-protein, protein-excipient, and protein-water interactions in lyophilized powders were identified. Myoglobin (Mb) was derivatized in solution with the heterobifunctional probe succinimidyl 4,4'-azipentanoate (SDA) and the structural integrity of the labeled protein (Mb-SDA) confirmed using CD spectroscopy and liquid chromatography/mass spectrometry (LC-MS). Mb-SDA was then formulated with and without excipients (raffinose, guanidine hydrochloride (Gdn HCl)) and lyophilized. The freeze-dried powder was irradiated with ultraviolet light at 365 nm for 30 min to produce cross-linked adducts that were analyzed at the intact protein level and after trypsin digestion. SDA-labeling produced Mb carrying up to five labels, as detected by LC-MS. Following lyophilization and irradiation, cross-linked peptide-peptide, peptide-water, and peptide-raffinose adducts were detected. The exposure of Mb side chains to the matrix was quantified based on the number of different peptide-peptide, peptide-water, and peptide-excipient adducts detected. In the absence of excipients, peptide-peptide adducts involving the CD, DE, and EF loops and helix H were common. In the raffinose formulation, peptide-peptide adducts were more distributed throughout the molecule. The Gdn HCl formulation showed more protein-protein and protein-water adducts than the other formulations, consistent with protein unfolding and increased matrix interactions. The results demonstrate that ssPC-MS can be used to distinguish excipient effects and characterize the local protein environment in lyophilized formulations with high resolution.

  19. Dielectric properties of residual water in amorphous lyophilized mixtures of sugar and drug

    Energy Technology Data Exchange (ETDEWEB)

    Moznine, R El [School of Pharmacy, De Montfort University, Leiceste (United Kingdom); Smith, G [School of Pharmacy, De Montfort University, Leicester (United Kingdom); Polygalov, E [School of Pharmacy, De Montfort University, Leicester (United Kingdom); Suherman, P M [School of Pharmacy, De Montfort University, Leicester (United Kingdom); Broadhead, J [AstraZeneca Charnwood R and D, Bakewell Rd, Loughborough (United Kingdom)

    2003-02-21

    Dielectric relaxation spectroscopy was used to investigate the properties of residual water in lyophilized formulations of a proprietary tri-phosphate drug containing a sugar (trehalose, lactose or sucrose) or dextran. The dielectric properties of each formulation were determined in the frequency range (0.1 Hz-0.1 MHz) and temperature range (30 deg. C-T{sub g}). The temperature dependence of the relaxation times for all samples showed Arrhenuis behaviour, from which the activation energy was derived. Proton hopping through the hydrogen-bonded network (clusters) of water molecules was suggested as the principle mode of charge transport. Significant differences in dielectric relaxation kinetics and activation energy were observed for the different formulations, which were found to correlate with the amount of monophosphate degradation product.

  20. Preparation and evaluation of (99m)Tc-DMSA lyophilized kit for renal imaging.

    Science.gov (United States)

    Jan, Syed Umer; Abbass, Hafiz Ghulam

    2013-05-01

    Dimercaptosuccinic acid (DMSA) has been evaluated and used with technetium 99m ((99m)Tc) in imaging of kidneys. DMSA lyophilized kits were prepared and radiolabelled with (99m)Tc. Paper and thin-layer chromatography have been employed using various eluent systems for the radiochemical analysis, percentage labeling and binding capacity of (99m)Tc-DMSA. Female albino rabbits were used for this study. Biological data obtained after intravenous injection of radiolabelled DMSA to female albino rabbits revealed 32.42% uptake and long retention time in the kidneys. On the basis of animal biodistribution data, it is suggested that DMSA when labeled with (99m)Tc is useful complex for renal imaging and can be successfully applied as a diagnostic tool in nuclear medicine. Clinical biodistribution and radiation dosimetry studies are planned in future.

  1. Pharmaceutics, Drug Delivery and Pharmaceutical Technology: A New Test Unit for Disintegration End-Point Determination of Orodispersible Films.

    Science.gov (United States)

    Low, Ariana; Kok, Si Ling; Khong, Yuetmei; Chan, Sui Yung; Gokhale, Rajeev

    2015-11-01

    No standard time or pharmacopoeia disintegration test method for orodispersible films (ODFs) exists. The USP disintegration test for tablets and capsules poses significant challenges for end-point determination when used for ODFs. We tested a newly developed disintegration test unit (DTU) against the USP disintegration test. The DTU is an accessory to the USP disintegration apparatus. It holds the ODF in a horizontal position, allowing top-view of the ODF during testing. A Gauge R&R study was conducted to assign relative contributions of the total variability from the operator, sample or the experimental set-up. Precision was compared using commercial ODF products in different media. Agreement between the two measurement methods was analysed. The DTU showed improved repeatability and reproducibility compared to the USP disintegration system with tighter standard deviations regardless of operator or medium. There is good agreement between the two methods, with the USP disintegration test giving generally longer disintegration times possibly due to difficulty in end-point determination. The DTU provided clear end-point determination and is suitable for quality control of ODFs during product developmental stage or manufacturing. This may facilitate the development of a standardized methodology for disintegration time determination of ODFs. © 2015 Wiley Periodicals, Inc. and the American Pharmacists Association J Pharm Sci 104:3893-3903, 2015.

  2. Kozeny-Carman permeability relationship with disintegration process predicted from early dissolution profiles of immediate release tablets.

    Science.gov (United States)

    Kumari, Parveen; Rathi, Pooja; Kumar, Virender; Lal, Jatin; Kaur, Harmeet; Singh, Jasbir

    2017-07-01

    This study was oriented toward the disintegration profiling of the diclofenac sodium (DS) immediate-release (IR) tablets and development of its relationship with medium permeability kperm based on Kozeny-Carman equation. Batches (L1-L9) of DS IR tablets with different porosities and specific surface area were prepared at different compression forces and evaluated for porosity, in vitro dissolution and particle-size analysis of the disintegrated mass. The kperm was calculated from porosities and specific surface area, and disintegration profiles were predicted from the dissolution profiles of IR tablets by stripping/residual method. The disintegration profiles were subjected to exponential regression to find out the respective disintegration equations and rate constants kd. Batches L1 and L2 showed the fastest disintegration rates as evident from their bi-exponential equations while the rest of the batches L3-L9 exhibited the first order or mono-exponential disintegration kinetics. The 95% confidence interval (CI95%) revealed significant differences between kd values of different batches except L4 and L6. Similar results were also spotted for dissolution profiles of IR tablets by similarity (f2) test. The final relationship between kd and kperm was found to be hyperbolic, signifying the initial effect of kperm on the disintegration rate. The results showed that disintegration profiling is possible because a relationship exists between kd and kperm. The later being relatable with porosity and specific surface area can be determined by nondestructive tests.

  3. Alpha-2-Macroglobulin Is Acutely Sensitive to Freezing and Lyophilization: Implications for Structural and Functional Studies.

    Directory of Open Access Journals (Sweden)

    Amy R Wyatt

    Full Text Available Alpha-2-macroglobulin is an abundant secreted protein that is of particular interest because of its diverse ligand binding profile and multifunctional nature, which includes roles as a protease inhibitor and as a molecular chaperone. The activities of alpha-2-macroglobulin are typically dependent on whether its conformation is native or transformed (i.e. adopts a more compact conformation after interactions with proteases or small nucleophiles, and are also influenced by dissociation of the native alpha-2-macroglobulin tetramer into stable dimers. Alpha-2-macroglobulin is predominately present as the native tetramer in vivo; once purified from human blood plasma, however, alpha-2-macroglobulin can undergo a number of conformational changes during storage, including transformation, aggregation or dissociation. We demonstrate that, particularly in the presence of sodium chloride or amine containing compounds, freezing and/or lyophilization of alpha-2-macroglobulin induces conformational changes with functional consequences. These conformational changes in alpha-2-macroglobulin are not always detected by standard native polyacrylamide gel electrophoresis, but can be measured using bisANS fluorescence assays. Increased surface hydrophobicity of alpha-2-macroglobulin, as assessed by bisANS fluorescence measurements, is accompanied by (i reduced trypsin binding activity, (ii increased chaperone activity, and (iii increased binding to the surfaces of SH-SY5Y neurons, in part, via lipoprotein receptors. We show that sucrose (but not glycine effectively protects native alpha-2-macroglobulin from denaturation during freezing and/or lyophilization, thereby providing a reproducible method for the handling and long-term storage of this protein.

  4. Stability study and lyophilization of vitamin E-loaded nanocapsules prepared by membrane contactor.

    Science.gov (United States)

    Khayata, N; Abdelwahed, W; Chehna, M F; Charcosset, C; Fessi, H

    2012-12-15

    In this research, we studied the accelerated stability of vitamin E-loaded nanocapsules (NCs) prepared by the nanoprecipitation method. Vitamin E-loaded NCs were optimized firstly at the laboratory scale and then scaled up using the membrane contactor technique. The optimum conditions of the membrane contactor preparation (pilot scale) produced vitamin E-loaded NCs with an average size of 253 nm, polydispersity index 0.19 and a zeta potential -16 mV. The average size, polydispersity index and zeta potential values were 185 nm, 0.12 and -15 mV, respectively for the NCs prepared at laboratory scale. No significant changes were noticed in these values after 3 and 6 months of storage at high temperature (40±2 °C) and relative humidity (75±5%) in spite of vitamin E sensitivity to light, heat and oxygen. The entrapment efficiency of NCs prepared at pilot scale was 97% at the beginning of the stability study, and became (95%, 59%) after 3 and 6 months of storage, respectively. These values at lab-scale were (98%, 96%, and 89%) at time zero and after 3 and 6 months of storage, respectively. This confirms the ability of vitamin E encapsulation to preserve its stability, which is one major goal of our work. Lyophilization of the optimized formula at lab-scale was also performed. Four types of cryoprotectants were tested (poly(vinyl pyrrolidone), sucrose, mannitol, and glucose). Freeze-dried NCs prepared with sucrose were found acceptable. The other lyophilized NCs obtained at different conditions presented large aggregates.

  5. Impurities in a lyophilized formulation of BMS-204352: identification and role of sanitizing agents.

    Science.gov (United States)

    Nassar, Munir N; Nesarikar, Vishwas V; Khaselev, Nona; Lozano, Ruben

    2006-01-01

    The purpose of this study was to identify two impurities in the parenteral lyophilized formulation of BMS-204352, investigate the role of sanitizing agents as their potential source, evaluate their effect on drug product stability, and develop a strategy to prevent their contamination of the drug product. The two impurities were identified as o-phenylphenol and 4-t-amylphenol based on liquid chromatography/mass spectroscopy (LC/MS) and chromatographic comparison to authentic samples. The LC/MS spectra of commercially available o-phenylphenol and 4-t-amylphenol showed identical patterns of fragmentation and the same retention times as the impurities identified in the BMS-204352 lyophilized product. Levels of these impurities were low and ranged between 0.2-0.3 microg/vial as determined by HPLC and using an authentic external reference standard. To confirm the hypothesis that the commercial sanitizing agents used in the sterile area were the source of these phenolic impurities, several product samples were spiked with the sanitizing agents. Both o-phenylphenol and 4-t-amylphenol were detected in the spiked samples. Further investigation revealed that o-phenylphenol and 4-t-amylphenol are active ingredients of these commercial sanitizing agents. Drug product samples containing the phenolic impurities showed no potency loss following storage at 30, 50, and 70 degrees C indicating these impurities had no adverse effect on product stability. These studies suggest that sanitizing agents used in the sterile area, although may be present at trace levels below typical cleaning procedure detection methods, need to be properly controlled and closely monitored during the manufacturing of injectable products, particularly highly potent drugs. Sanitizing agents, even though not used on product contact surfaces, may potentially contaminate a product through vapor transfer in an open environment.

  6. Development of highly stabilized curcumin nanoparticles by flash nanoprecipitation and lyophilization.

    Science.gov (United States)

    Chow, Shing Fung; Wan, Ka Yee; Cheng, Kwok Kin; Wong, Ka Wai; Sun, Changquan Calvin; Baum, Larry; Chow, Albert Hee Lum

    2015-08-01

    The influence of critical operating parameters on the Flash Nanoprecipitation (FNP) and resulting material properties of curcumin (CUR) nanoparticles has been evaluated using a confined impinging jets-with-dilution mixer (CIJ-D-M). It has been shown that the mixing rate, molecular weight of polymeric stabilizer (i.e., polyethylene glycol-b-poly(dl-lactide) di-block copolymer; PEG-PLA) and drug-to-copolymer mass ratio all exert a significant impact on the particle size and stability of the generated nanosuspensions. The attainable mean particle size and span of the nanoparticles through optimization of these process parameters were approximately 70nm and 0.85 respectively. However, the optimized nanosuspension was only stable for about two hours after preparation. Co-formulation with polyvinylpyrrolidone (PVP) substantially extended the product lifespan to 5days at ambient conditions and two weeks at 4°C. Results from zeta potential measurement and X-ray photoelectron spectroscopy (XPS) suggested that the enhanced stability is probably due to the formation of an additional protective barrier by PVP around the particle surface, thereby suppressing the dissociation of PEG-PLA from the particles and preventing CUR leakage from inside. Long-term storage stability (>1year) could be achieved by lyophilization of the optimized nanosuspension with Kleptose (hydroxypropyl-β-cyclodextrin), which was shown to be the only effective lyoprotectant among all the ones tested for the CUR nanoparticles. At an optimal concentration of Kleptose (1.25% w/v), the redispersibility (Sf/Si; ratio of the final and initial particle sizes) and encapsulation efficiency of lyophilized CUR nanoparticles were about 1.22% and 94%, respectively.

  7. Effects of ionizing radiation on proteins in demineralized, lyophilized or frozen human bone

    Energy Technology Data Exchange (ETDEWEB)

    Antebi, Uri; Mathor, Monica B., E-mail: uri@usp.br, E-mail: mathor@ipen.br [Instituto de Pesquisas Energeticas e Nucleares (IPEN/CNEN-SP), Sao Paulo, SP (Brazil); Guimaraes, Rodrigo P., E-mail: clinicaguimaraes@gmail.com [Santa Casa de Sao Paulo (FCM/SCSP), Sao Paulo, SP (Brazil). Faculdade de Ciencias Medicas

    2015-07-01

    The aim is the study of the application of ionizing radiation (gamma and electron) as sterilizing agents at doses of 15 kGy, 25 kGy and 50 kGy, the demineralized bone tissue frozen and freeze-dried for use in transplants. Five human femoral diaphysis of different donors demineralized bone tissues were preserved as lyophilized or frozen at - 80 deg C. The samples were divided into non-irradiated groups (control) and irradiated by gamma rays or electron beam. The bone proteins were extracted and used to determine the concentrations of total protein, BMP 2 and 7. It was observed a decrease in total protein concentrations, and BMP 2 and 7. The decrease in total protein concentrations, as compared to respective control groups was significant in the lyophilized and frozen samples irradiated at a dose of 50 kGy gamma radiation and beam electrons with greater than 30% reduction. The significant decrease in the levels of BMP 2 and 7 were also observed in higher doses and especially by electron beam. The reductions in the concentrations of total protein and osteoinductive proteins (BMP 2 and 7), were related to the radiation dose, i.e., increase with higher doses of ionizing radiation type and the type of preservation of the bones. The largest reductions in concentrations were observed in bone irradiated by electron beam and at a dose of 50 kGy. But this type of radiation and this high dose are not usual practice for the sterilization of bone tissue. Keywords: demineralized bone tissue, ionizing radiation, Tissue Bank, BMP 2, BMP 7, bone proteins. (author)

  8. The freezing step in lyophilization: physico-chemical fundamentals, freezing methods and consequences on process performance and quality attributes of biopharmaceuticals.

    Science.gov (United States)

    Kasper, Julia Christina; Friess, Wolfgang

    2011-06-01

    Lyophilization is a common, but cost-intensive, drying process to achieve protein formulations with long-term stability. In the past, typical process optimization has focused on the drying steps and the freezing step was rather ignored. However, the freezing step is an equally important step in lyophilization, as it impacts both process performance and product quality. While simple in concept, the freezing step is presumably the most complex step in lyophilization. Therefore, in order to get a more comprehensive understanding of the processes that occur during freezing, the physico-chemical fundamentals of freezing are first summarized. The available techniques that can be used to manipulate or directly control the freezing process in lyophilization are also reviewed. In addition, the consequences of the freezing step on quality attributes, such as sample morphology, physical state of the product, residual moisture content, reconstitution time, and performance of the primary and secondary drying phase, are discussed. A special focus is given to the impact of the freezing process on protein stability. This review aims to provide the reader with an awareness of not only the importance but also the complexity of the freezing step in lyophilization and its impact on quality attributes of biopharmaceuticals and process performance. With a deeper understanding of freezing and the possibility to directly control or at least manipulate the freezing behavior, more efficient lyophilization cycles can be developed, and the quality and stability of lyophilized biopharmaceuticals can be improved. Copyright © 2011 Elsevier B.V. All rights reserved.

  9. Photo-dynamics of the lyophilized photo-activated adenylate cyclase NgPAC2 from the amoeboflagellate Naegleria gruberi NEG-M strain

    Energy Technology Data Exchange (ETDEWEB)

    Penzkofer, A., E-mail: alfons.penzkofer@physik.uni-regensburg.de [Fakultät für Physik, Universität Regensburg, Universitätsstrasse 31, D-93053 Regensburg (Germany); Tanwar, M.; Veetil, S.K.; Kateriya, S. [Department of Biochemistry, University of Delhi South Campus, Benito Juarez Road, New Delhi 110021 (India); Stierl, M.; Hegemann, P. [Institut für Biologie/Experimentelle Biophysik, Humboldt Universität zu Berlin, Invalidenstrasse 42, D-10115 Berlin (Germany)

    2013-09-23

    Highlights: • Lyophilizing of NgPAC2 from Naegleria gruberi caused loss of BLUF domain activity. • Photo-induced tyrosine to flavin electron transfer in lyophilized NgPAC2. • Photo-induced Tyr–Tyr cross-linking to o,o′-dityrosine in lyophilized NgPAC2. • Photo-induced partial flavin cofactor reduction in lyophilized NgPAC2. • Two NgPAC2 conformations with fast and slow photo-induced electron transfer. - Abstract: The absorption and emission spectroscopic behavior of lyophilized photo-activated adenylate cyclase NgPAC2 from the amoeboflagellate Naegleria gruberi NEG-M strain consisting of a BLUF domain (BLUF = Blue Light sensor Using Flavin) and a cyclase homology domain was studied in the dark, during blue-light exposure and after blue-light exposure at a temperature of 4 °C. The BLUF domain photo-cycle dynamics observed for snap-frozen NgPAC2 was lost by lyophilization (no signaling state formation with flavin absorption red-shift). Instead, blue-light photo-excitation of lyophilized NgPAC2 caused sterically restricted Tyr–Tyr cross-linking (o,o′-ditysosine formation) and partial flavin cofactor reduction.

  10. Large Eddy Simulation Study for Fluid Disintegration and Mixing

    Science.gov (United States)

    Bellan, Josette; Taskinoglu, Ezgi

    2011-01-01

    A new modeling approach is based on the concept of large eddy simulation (LES) within which the large scales are computed and the small scales are modeled. The new approach is expected to retain the fidelity of the physics while also being computationally efficient. Typically, only models for the small-scale fluxes of momentum, species, and enthalpy are used to reintroduce in the simulation the physics lost because the computation only resolves the large scales. These models are called subgrid (SGS) models because they operate at a scale smaller than the LES grid. In a previous study of thermodynamically supercritical fluid disintegration and mixing, additional small-scale terms, one in the momentum and one in the energy conservation equations, were identified as requiring modeling. These additional terms were due to the tight coupling between dynamics and real-gas thermodynamics. It was inferred that if these terms would not be modeled, the high density-gradient magnitude regions, experimentally identified as a characteristic feature of these flows, would not be accurately predicted without the additional term in the momentum equation; these high density-gradient magnitude regions were experimentally shown to redistribute turbulence in the flow. And it was also inferred that without the additional term in the energy equation, the heat flux magnitude could not be accurately predicted; the heat flux to the wall of combustion devices is a crucial quantity that determined necessary wall material properties. The present work involves situations where only the term in the momentum equation is important. Without this additional term in the momentum equation, neither the SGS-flux constant-coefficient Smagorinsky model nor the SGS-flux constant-coefficient Gradient model could reproduce in LES the pressure field or the high density-gradient magnitude regions; the SGS-flux constant- coefficient Scale-Similarity model was the most successful in this endeavor although not

  11. Photo-Disintegration of the Iron Nucleus in Fractured Magnetite Rocks with Magnetostriction

    CERN Document Server

    Widom, A; Srivastava, Y N

    2013-01-01

    There has been considerable interest in recent experiments on iron nuclear disintegrations observed when rocks containing such nuclei are crushed and fractured. The resulting nuclear transmutations are particularly strong for the case of magnetite rocks, i.e. loadstones. We argue that the fission of the iron nucleus is a consequence of photo-disintegration. The electro-strong coupling between electromagnetic fields and nuclear giant dipole resonances are central for producing observed nuclear reactions. The large electron energies produced during the fracture of piezomagnetic rocks are closely analogous to the previously discussed case of the fracture of piezoelectric rocks. In both cases electro-weak interactions can produce neutrons and neutrinos from energetic protons and electrons thus inducing nuclear transmutations. The electro-strong condensed matter coupling discussed herein represents new many body collective nuclear photo-disintegration effects.

  12. COMPARATIVE EVALUATION OF TAPIOCA SAGO AND POTATO STARCHES AS DISINTEGRATING AGENTS IN TABLET FORMULATION

    Directory of Open Access Journals (Sweden)

    Gulam Rabbani

    2011-02-01

    Full Text Available In the present study Tapioca sago starch was employed as a disintegrating agent in Chloroquine based tablets at concentration of 5–15% w/w. Properties of the starch were evaluated for angle of repose, bulk density, tapped density, carr’s compressibility index, hausner’s ratio, hydration capacity and swelling capacity. The granules were evaluated for moisture content, angle of repose, bulk density and tapped density, carr’s compressibility index and hausner’s ratio. The tablets were evaluated for thickness, weight variation, crushing strength, friability, disintegration time and dissolution profiles. Batches of tablets containing equivalent concentration of potato starch were employed as standard. Results obtained indicate that as a disintegrant Tapioca sago starch showed comparable results in Chloroquine phosphate tablets with the standard.

  13. MECHANICAL DISINTEGRATION OF WHEAT STRAW BY ROLLER-PLATE GRIND SYSTEM WITH SHARP-EDGED SEGMENTS

    Directory of Open Access Journals (Sweden)

    Lukas Kratky

    2015-04-01

    Full Text Available Colloid mills and extruders are widely used for disintegrating wet fibrous biomass. However, their main disadvantages are a high energy requirement in the range of hundreds or thousands of kWh per ton of material, and the fact that they grind in process cycles. Efforts have therefore been made to design a new type of continuously operated grinder. Its disintegration principle uses a roller-plate grinding system with sharp-edged segments, where the compressive and shear forces combine to comminute the particles. Test experiments verified that the grinder disintegrates wet untreated straw to particles below 10mm in an effective manner in a single pass, with an energy requirement of 50 kWht−1 TS. A 23% increase in biogas yield was achieved, leading to a net gain in electric energy of310 kWht−1 TS.

  14. Influence of the temperature on the cement disintegration in cement-retained implant restorations.

    Science.gov (United States)

    Linkevicius, Tomas; Vindasiute, Egle; Puisys, Algirdas; Linkeviciene, Laura; Svediene, Olga

    2012-01-01

    The aim of this study was to estimate the average disintegration temperature of three dental cements used for the cementation of the implant-supported prostheses. One hundred and twenty metal frameworks were fabricated and cemented on the prosthetic abutments with different dental cements. After heat treatment in the dental furnace, the samples were set for the separation to test the integration of the cement. Results have shown that resin-modified glass-ionomer cement (RGIC) exhibited the lowest disintegration temperature (pcement (ZPC) and dual cure resin cement (RC) (p>0.05). Average separation temperatures: RGIC - 306 ± 23 °C, RC - 363 ± 71 °C, it could not be calculated for the ZPC due to the eight unseparated specimens. Within the limitations of the study, it could be concluded that RGIC cement disintegrates at the lowest temperature and ZPC is not prone to break down after exposure to temperature.

  15. Preparation and quality evaluation of Sodium fusidate lyophilized powder%夫西地酸钠冻干粉的制备及质量评价

    Institute of Scientific and Technical Information of China (English)

    马苗锐; 周立明; 张丽霞

    2015-01-01

    Sodium fusidate lyophilized powder was prepared by lyophilization,the stability was investigated. The Results showed that Sodium fusidate lyophilized powder had been stable at room temperater for 1 years. It was feasible for the clinical application.%采用冷冻干燥技术制备了较稳定的注射用夫西地酸钠冻干粉,并对其进行质量评价.结果表明:该制剂常温储存1年稳定性良好,工艺可行,是理想的临床用药.

  16. 水蛭素冻干粉对大鼠的致畸性研究%Teratogenicity of lyophilized hirudin powder in rats 

    Institute of Scientific and Technical Information of China (English)

    黄超培; 何为涛; 赵鹏; 李彬; 王彦武; 傅伟忠; 何励; 苏爱荣

    2011-01-01

    OBJECTIVE: To determine the potentially teratogenic effects of lyophilized hirudin powder in rats. METHODS: Sixty pregnant rats were divided randomly into 5 groups, 3 groups treated with lyophilized hirudin powder (contain 3 mg which was equivalent to 50 AT-U natural hirudin per gram) with doses of 312.5,1 250,5 000 mg/kg, one negative control(distilled water) and a positive control(300 mg/kg aspirin), 12 pregnant rats in each group. The drugs were given orally for 10 days from 6th to 15tb day after gestation. At 20th day the rats were sacrificed to examine the appearance,viscera, bones and physical growth of the fetuses. RESULTS: The body weight of pregnant rats, litter weight, live birth rate, fetal body weight and length in all treated groups were not significantly different from negative control group (P>0. 05),and no abnormality of organ or appearance was observed in the fetuses of treated groups. CONCLUSION: Lyophilized hirudin powder had no maternal toxicity, embryo toxicity and teratogenicity in rats at doses tested.%目的:检测水蛭素冻干粉的致畸性.方法:将60只妊娠大鼠随机分为水蛭素冻干粉(每克含3mg、相当于50抗凝血酶单位的天然水蛭素)312.5、1 250、5 000 mg/kg 3个剂量组,同时设蒸馏水阴性对照和阿司匹林(300 mg/kg)阳性对照组,共5组,每组12只.各组孕鼠于妊娠第6~15天灌胃给予受试物,每天1次,连续灌胃10d,于妊娠第20天解剖孕鼠,检查胎鼠外观、内脏和骨骼及生长发育等指标.结果:水蛭素冻干粉各剂量组的孕鼠体质量、窝质量、胎鼠体质量、身长、尾长、活胎率、吸收胎率及死胎率与阴性对照组比较,差异均无统计学意义(P>0.05),未见胎鼠外观、内脏和骨骼发育异常及畸形.结论:水蛭素冻干粉在本实验条件下,对大鼠无母体毒性、胚胎毒性和致畸性.

  17. Reduction disintegration mechanism of cold briquettes from blast furnace dust and sludge

    Directory of Open Access Journals (Sweden)

    Leandro Rocha Lemos

    2015-07-01

    Full Text Available It is important to understand the reduction disintegration mechanism in ferriferous burden that is used in blast furnaces. The behavior of this burden in the granular zone of this metallurgical reactor is important for smooth operation. The objective of this work was to prepare cold self-reducing briquettes using blast furnace dust and sludge and binders and compare the reduction disintegration index (RDI of these agglomerates with conventional ferriferous burdens such as pellets, sinter and iron ore. In the present work, 25 different mixtures were prepared to produce briquettes in two geometries: pillow and cylindrical. The RDI value was determined for the briquettes that passed the tumbling test.

  18. Bore formation, evolution and disintegration into solitons in shallow inhomogeneous channels

    Directory of Open Access Journals (Sweden)

    J.-G. Caputo

    2003-01-01

    Full Text Available The propagation of nonlinear surface waves in channels of smoothly variable in space cross section is studied theoretically and by means of numerical computations. The mathematical model describing wave evolution is based on the generalized Korteweg-de Vries equation with additional terms due to spatial inhomogeneity and energy dissipation. Specifically we consider channels of variable depth and width. The breaking of Riemann waves and the disintegration of hydraulic jumps into trains of solitons have been examined. The results obtained can be useful in particular for the understanding some peculiarities of bore (mascaret formation, viscous evolution and disintegration into solitons in inhomogeneous channels or rivers.

  19. High-Throughput Synthetic Chemistry Enabled by Organic Solvent Disintegrating Tablet.

    Science.gov (United States)

    Li, Tingting; Xu, Lei; Xing, Yanjun; Xu, Bo

    2017-01-17

    Synthetic chemistry remains a time- and labor-intensive process of inherent hazardous nature. Our organic solvent disintegrating tablet (O-Tab) technology has shown potential to make industrial/synthetic chemistry more efficient. As is the case with pharmaceutical tablets, our reagent-containing O-Tabs are mechanically strong, but disintegrate rapidly when in contact with reaction media (organic solvents). For O-Tabs containing sensitive chemicals, they can be further coated to insulate them from air and moisture. © 2017 Wiley-VCH Verlag GmbH & Co. KGaA, Weinheim.

  20. Results of ultrasonic disintegration of sewage sludge in practice; Ergebnisse des Praxiseinsatzes der Schlammdesintegration mittels Ultraschall

    Energy Technology Data Exchange (ETDEWEB)

    Friedrich, E. [IWE-Ingenieurgesellschaft fuer Wasser und Entsorgung mbH, Radebeul (Germany); Friedrich, H. [Fraunhofer-Institut fuer Keramische Technologien und Sinterwerkstoffe (IKTS), Dresden (Germany); Hielscher, H. [Hielscher GmbH, Teltow (Germany)

    1999-07-01

    Using high-performance ultrasonic sludge disintegration in different stages of sewage and sludge treatment is found to be an innovative approach for reducing the accruing amounts of sewage sludge in terms of both mass and volume. By means of practical tests with sludge disintegration at sewage treatment plants, its effects are demonstrated. (orig.) [German] Der Einsatz einer Hochleistungs-Ultraschalltechnik zur Schlammdesintegration in verschiedenen Stufen der Abwasser- und Schlammbehandlung zeigt sich als innovativer Loesungsweg zur weitestgehenden massenmaessigen sowie volumenmaessigen Minimierung des Klaerschlammanfalles. An Hand von Einsatzerprobungen der Desintegration in der Klaeranlagenpraxis werden die Effekte der Desintegration vorgestellt. (orig.)

  1. Influence of culture conditions and preconditioning on survival of Lactobacillus delbrueckii subspecies bulgaricus ND02 during lyophilization.

    Science.gov (United States)

    Shao, Yuyu; Gao, Shuran; Guo, Huiling; Zhang, Heping

    2014-03-01

    The cryotolerance of Lactobacillus delbrueckii ssp. bulgaricus is weak during vacuum freeze-drying. Many factors affect cryoresistance of these bacteria, such as cryoprotectant composition, the lyophilization technology used, and the intrinsic characteristics of the bacteria. In this research, we explored the fermentation technology and other preconditioning treatments of cells in improving the cryoresistance of Lactobacillus delbrueckii ssp. bulgaricus strains during lyophilization. The addition of yeast extract in the propagation medium exerted a negative effect on the cryotolerance of these bacteria and decreased survival during lyophilization. The count of the freeze-dried cells from medium containing a high level (4%) of yeast extract was only 4.1 × 10(9) cfu/g, indicating a death rate as high as 88%, compared with the culture medium without yeast extract, with a lower death rate of 44.7%. When Lactobacillus delbrueckii ssp. bulgaricus ND02 was propagated in yeast extract-free de Man, Rogosa, and Sharpe broth at a set pH value of 5.1, the cells showed unexpectedly higher survival after freeze-drying. Viable counts of the lyophilized cell of strain ND02 cultivated at pH 5.1 could reach 1.05 × 10(11)cfu/g and survival of the freeze-drying process was 68.3%, whereas at pH 5.7, survival was only 51.2%. We also examined the effects of pretreatment of cells on survival of the bacteria after vacuum freeze-drying. By analyzing the effect of pretreatment conditions on the expression of cold- and heat-shock genes, we established 2 pretreatments that improved survival of cells after lyophilization. Optimal fermentation conditions and pretreatment of the cell-cryoprotectant mixture at 10°C for 2h or 37°C for 30 min improved the cryoresistance of 4 strains of Lactobacillus delbrueckii ssp. bulgaricus to varying degrees. Cells of IMAU20269 and IMAU20291 that were pretreated showed enhanced survival of 16.06 and 16.82%, respectively, after lyophilization. Expression of

  2. Energy efficient bead milling of microalgae: Effect of bead size on disintegration and release of proteins and carbohydrates

    NARCIS (Netherlands)

    Postma, P.R.; Suarez Garcia, E.; Safi, Carl; Yonathan, K.; Olivieri, G.; Barbosa, M.J.; Wijffels, R.H.; Eppink, M.H.M.

    2017-01-01

    The disintegration of three industry relevant algae (Chlorella vulgaris, Neochloris oleoabundans and Tetraselmis suecica) was studied in a lab scale bead mill at different bead sizes (0.3–1 mm). Cell disintegration, proteins and carbohydrates released into the water phase followed a first order

  3. Osteointegração de enxertos liofilizados impactados Osteointegration of impacted lyophilized grafts

    Directory of Open Access Journals (Sweden)

    Carlos Roberto Galia

    2009-01-01

    Full Text Available OBJETIVO: Avaliar clínica e radiograficamente os resultados e a capacidade de osteointegração dos enxertos ósseos liofilizados humano e bovino impactados em revisões de artroplastia total de quadril (RATQ cimentadas e não-cimentadas. MÉTODOS: Coorte não concorrente de 63 pacientes (66 quadris submetidos à RATQ com enxerto ósseo liofilizado moído e impactado. O estudo foi realizado no Serviço de Ortopedia e Traumatologia do Hospital de Clínicas de Porto Alegre, entre maio/1997 e setembro/2004. Os pacientes foram divididos em dois grupos: Grupo 1 (n=35, enxerto de origem humana; Grupo 2 (n=31, enxerto de origem bovina. O tempo médio de seguimento foi de 59 meses. Os enxertos ósseos liofilizados foram produzidos segundo protocolo desenvolvido pelos autores. A análise clínica baseou-se no escore de Merle, d'Aubigné e Postel; a radiográfica, nos critérios de radioluscência, densidade, formação de trabeculado ósseo, migração dos componentes e floculação, formulando-se um escore radiográfico de osteointegração. RESULTADOS: Não foram encontradas diferenças clínicas ou radiográficas relevantes entre os grupos, obtendo-se em torno de 85% de integração do enxerto, tanto no componente acetabular quanto femoral. CONCLUSÕES: Os enxertos ósseos liofilizados de origem bovina ou humana, produzidos segundo este protocolo, não acarretaram nenhum prejuízo aos pacientes, tendo o enxerto bovino apresentado resultados similares ao humano.OBJECTIVE: The purpose of the study was to provide a clinical and X-ray based evaluation of the results and osteointegration ability of lyophilized human and bovine bone grafts. METHODS: This is a non-concurrent cohort trial of 63 patients (66 hips submitted to revision total hip arthroplasty (RTHA using impacted freeze-dried human and bovine cancellous bone grafts. The study was carried out in the Hospital de Clinicas de Porto Alegre from May 1997 to September 2002. The patients were divided

  4. Oral Medication

    Science.gov (United States)

    ... Size: A A A Listen En Español Oral Medication The first treatment for type 2 diabetes blood ... new — even over-the-counter items. Explore: Oral Medication How Much Do Oral Medications Cost? Save money ...

  5. Oral myiasis

    OpenAIRE

    Thalaimalai Saravanan; Mathan A Mohan; Meera Thinakaran; Saneem Ahammed

    2015-01-01

    Myiasis is a pathologic condition in humans occurring because of parasitic infestation. Parasites causing myiasis belong to the order Diptera. Oral myiasis is seen secondary to oral wounds, suppurative lesions, and extraction wounds, especially in individuals with neurological deficit. In such cases, neglected oral hygiene and halitosis attracts the flies to lay eggs in oral wounds resulting in oral myiasis. We present a case of oral myiasis in 40-year-old male patient with mental disability ...

  6. Application of Optical Coherence Tomography Freeze-Drying Microscopy for Designing Lyophilization Process and Its Impact on Process Efficiency and Product Quality.

    Science.gov (United States)

    Korang-Yeboah, Maxwell; Srinivasan, Charudharshini; Siddiqui, Akhtar; Awotwe-Otoo, David; Cruz, Celia N; Muhammad, Ashraf

    2017-08-07

    Optical coherence tomography freeze-drying microscopy (OCT-FDM) is a novel technique that allows the three-dimensional imaging of a drug product during the entire lyophilization process. OCT-FDM consists of a single-vial freeze dryer (SVFD) affixed with an optical coherence tomography (OCT) imaging system. Unlike the conventional techniques, such as modulated differential scanning calorimetry (mDSC) and light transmission freeze-drying microscopy, used for predicting the product collapse temperature (Tc), the OCT-FDM approach seeks to mimic the actual product and process conditions during the lyophilization process. However, there is limited understanding on the application of this emerging technique to the design of the lyophilization process. In this study, we investigated the suitability of OCT-FDM technique in designing a lyophilization process. Moreover, we compared the product quality attributes of the resulting lyophilized product manufactured using Tc, a critical process control parameter, as determined by OCT-FDM versus as estimated by mDSC. OCT-FDM analysis revealed the absence of collapse even for the low protein concentration (5 mg/ml) and low solid content formulation (1%w/v) studied. This was confirmed by lab scale lyophilization. In addition, lyophilization cycles designed using Tc values obtained from OCT-FDM were more efficient with higher sublimation rate and mass flux than the conventional cycles, since drying was conducted at higher shelf temperature. Finally, the quality attributes of the products lyophilized using Tc determined by OCT-FDM and mDSC were similar, and product shrinkage and cracks were observed in all the batches of freeze-dried products irrespective of the technique employed in predicting Tc.

  7. Effect of the hydration state of supports before lyophilization on subtilisin-A activity in organic media.

    Science.gov (United States)

    Kim, J; Kim, B G

    1996-06-20

    Subtilisin-A was colyophilized with various types of support materials, such as Amberlite IRC-50, Celite545, chitosan, DEAE-cellulose, DOWEX-1, zeolite, glass bead, and polystyrene. The colyophilized enzyme was used for the optical resolution of racemic 1-phenylethylamine with 2,2,2-trifluoroethylbutyrate in 3-methyl-3-pentanol. The enzyme activity in organic media changed dramatically according to the hydration state of the support materials before lyophilization. This effect was especially marked with supports of high water capacity (aquaphilicity), such as chitosan and DEAE-cellulose. By hydrating these supports of high aquaphilicity prior to lyophilization, subtilisin-A activity in organic media increased ca. 4-8 times, depending upon the supports used. This result suggests that the hydration state of aquaphilic support materials for colyophilization is critical to determining enzyme activity in organic solvents.

  8. Polyols as filler-binders for disintegrating tablets prepared by direct compaction

    NARCIS (Netherlands)

    Bolhuis, Gerad K.; Rexwinkel, Erik G.; Zuurman, Klaas

    2009-01-01

    Background: Although polyols are frequently used as tablet excipients in lozenges, chewing tablets, and orodisperse tablets, special directly compressible (DC) forms are recommended as filler-binder in common disintegrating tablets. Aim: In this article, DC types of isomalt, lactitol, mannitol, sorb

  9. [Effect of food thickener on disintegration and dissolution of magnesium oxide tablets].

    Science.gov (United States)

    Tomita, Takashi; Goto, Hidekazu; Yoshimura, Yuya; Tsubouchi, Yoshiko; Nakanishi, Rie; Kojima, Chikako; Yoneshima, Mihoko; Yoshida, Tadashi; Tanaka, Katsuya; Sumiya, Kenji; Kohda, Yukinao

    2015-01-01

    It has been reported that magnesium oxide tablets are excreted in a non-disintegrated state in the stool of patients when the tablets are administered after being immersed in a food thickener. Therefore we examined whether immersion in a food thickener affects the pharmacological effect in patients taking magnesium oxide tablets, and whether immersion affects its disintegration and solubility. The mean dosage (1705 mg/d) was higher for patients who took tablets after immersion in a food thickener than for those who took non-immersed tablets (1380 mg/d). The disintegration time and dissolution rate of the immersed tablets were lower than those of non-immersed tablets in vitro. Furthermore, components that constitute the food thickener and differences in composition concentrations differentially affect the disintegration and solubility of magnesium oxide tablets. This suggests that commercially available food thickeners are likely to be associated with changes in the degradation of magnesium oxide tablets, and they therefore should be carefully used in certain clinical situations.

  10. Equivalence and Disintegration Theorems for Fell Bundles and their C*-algebras

    CERN Document Server

    Muhly, Paul S

    2008-01-01

    We study the C*-algebras of Fell bundles. In particular, we prove the analogue of Renault's disintegration theorem for groupoids. As in the groupoid case, this result is the key step in proving a deep equivalence theorem for the C*-algebras of Fell bundles.

  11. Preparation of cross-linked carboxymethyl jackfruit starch and evaluation as a tablet disintegrant.

    Science.gov (United States)

    Kittipongpatana, Nisit; Suwakon, Janta; Kittipongpatana, Ornanong

    2011-10-01

    The main purposes of this study are to prepare cross-linked carboxymethyl jackfruit starch (CL-CMJF) and to evaluate its pharmaceutical property as a tablet disintegrant. CL-CMJF was prepared by a dual carboxymethyl-crosslinking reaction in a flask containing jackfruit seed starch (JFS), chloroacetic acid (CAA), sodium hydroxide (NaOH) and sodium trimetaphosphate (STMP). The reaction was carried out using methanol as a solvent for 60 min at 70°C and at JFS:CAA:NaOH:STMP ratio of 1.0:0.29:0.28:0.07. The obtained CL-CMJF, with degree of substitution and degree of crosslinking calculated to be 0.34 and 0.06, respectively, was insoluble but swellable in water. Rheological study revealed a decreased in solution viscosity compared to the non-crosslinked CMJF. The water uptake of CL-CMJF was 23 times higher than that of native starch and was comparable to that of a commercial superdisintegrant, sodium starch glycolate (SSG). The swelling ability of CL-CMRS was similar to that of crosscarmellose sodium (CCS), another commercial superdisintegrant. Disintegration test of aspirin tablets containing 2%w/w of JFS, CL-CMJF, SSG and CCS showed disintegration times in the order of SSG < CCS ~ CL-CMJF < JFS. The results suggested that CL-CMJF could be developed as a tablet disintegrant.

  12. Adult Education and (Dis)integration Processes in Yugoslavia. Uppsala Reports on Education 22.

    Science.gov (United States)

    Bron, Michal, Jr.

    This report is a synopsis of a study that dealt with the dominant problem in Yugoslavian society, namely the phenomenon of social and economic crisis, and with the role of adult education within the disintegration processes. In addition to an introduction, the report consists of five sections concerning the following issues: (1) the country in a…

  13. Kazimierz Dabrowski's Theory of Positive Disintegration and the American Humanistic Psychology.

    Science.gov (United States)

    Weckowicz, T. E.

    1988-01-01

    Discusses the differences and similarities between Dabrowski's theory of positive disintegration and the theories of the American humanistic psychologists. Stresses the suffering associated with attaining higher levels of spiritual development. Suggests that Dabrowski and humanists followed different theodicies. (Author/ABL)

  14. Through the Dabrowski Lens: A Fresh Examination of the Theory of Positive Disintegration

    Science.gov (United States)

    Harper, Amanda; Cornish, Linley; Smith, Susen; Merrotsy, Peter

    2017-01-01

    Dabrowski's theory of positive disintegration is an emotion-centered, nonontogenetic, five-level theory of personality development where the experience of all emotions is essential for the process of growth. In this article, we examine the complexities of the three factors of development, which are essential to the notion of development within the…

  15. The Effect of Human Serum Albumin and Hematocrit on the Cake Collapse Temperature of Lyophilized Red Blood Cells.

    Science.gov (United States)

    Runyon, Daniel E; Higgins, Adam Z

    2015-10-01

    Freeze-drying, or lyophilization, has shown great promise in addressing many of the logistical challenges of storing and preserving red blood cells (RBCs). A crucial part of any RBC lyophilization protocol is the primary drying temperature, which affects the sample drying rate and the dried cake's ability to form a stable glassy solid. Primary drying is most efficient just below the temperature at which the porous structure of the cake begins to collapse, known as the cake collapse temperature. In this short report, we utilize freeze-drying microscopy to examine the effects of human serum albumin (HSA) and hematocrit on the cake collapse temperature. Increasing the hematocrit from 0% to 20% significantly raised the cake collapse temperature from - 37.8°C to -34.8°C. Addition of 5% HSA to a 20% hematocrit RBC suspension further increased the cake collapse temperature to -20.4°C. These data provide a basis for future study of the relationship between cake collapse and overall cell survival, with the object of building a clinically-viable RBC lyophilization protocol.

  16. Evaluation of protein stability and in vitro permeation of lyophilized polysaccharides-based microparticles for intranasal protein delivery.

    Science.gov (United States)

    Cho, Hyun-Jong; Balakrishnan, Prabagar; Chung, Suk-Jae; Shim, Chang-Koo; Kim, Dae-Duk

    2011-09-15

    Biocompatible microparticles prepared by lyophilization were developed for intranasal protein delivery. To test for the feasibility of this formulation, stability of the incorporated protein and enhancement of in vitro permeation across the nasal epithelium were evaluated. Lyophilization was processed with hydroxypropylmethylcellulose (HPMC) or water soluble chitosan (WCS) as biocompatible polymers, hydroxypropyl-β-cyclodextrin (HP-β-CD) and d-alpha-tocopheryl poly(ethylene glycol 1000) succinate (TPGS 1000) as permeation enhancers, sugars as cryoprotectants and lysozyme as the model protein. As a result, microparticles ranging from 6 to 12μm were developed where the maintenance of the protein conformation was verified by sodium dodecyl sulfate-polyacrylamide gel electrophoresis (SDS-PAGE), circular dichroism and fluorescence intensity detection. Moreover, in vitro bioassay showed that the lysozyme activity was preserved during the preparation process while exhibiting less cytotoxicity in primary human nasal epithelial (HNE) cells. Results of the in vitro release study revealed slower release rate in these microparticles compared to that of the lysozyme itself. On the other hand, the in vitro permeation study exhibited a 9-fold increase in absorption of lysozyme when prepared in lyophilized microparticles with HPMC, HP-β-CD and TPGS 1000 (F4-2). These microparticles could serve as efficient intranasal delivery systems for therapeutic proteins. Copyright © 2011 Elsevier B.V. All rights reserved.

  17. Hydrophobic ion pairing as a method for enhancing structure and activity of lyophilized subtilisin BPN' suspended in isooctane.

    Science.gov (United States)

    Kendrick, B S; Meyer, J D; Matsuura, J E; Carpenter, J F; Manning, M C

    1997-11-01

    The use of enzymes in low water environments permits reactions to occur that are difficult or impossible in aqueous solution. In this manner, proteases can be used to form, rather than hydrolyze, ester and amide linkages. Presumably, the native-like structure of the enzyme must remain intact for catalysis to transpire. However, little is known regarding the integrity of the overall structure of lyophilized proteins suspended in organic media. In this study, the structural changes that occur during the freeze-drying process and those effected by suspension in the organic solvent were examined. Using Fourier-transform infrared spectroscopy, the secondary structure of lyophilized subtilisin BPN' was monitored and correlated to the level of enzymatic activity when suspended in isooctane. In addition, the ability of ionic detergents to stabilize subtilisin BPN' via ion pairing was evaluated. It was found that subtilisin unfolds to some degree during lyophilization, whether it is ion paired or not. Furthermore, there are structural changes observed when the enzyme is placed in isooctane, although the effects are less with ion-paired subtilisin. This higher level of retention of secondary structure results in increased enzymatic activity.

  18. Effects of plantain and corn starches on the mechanical and disintegration properties of paracetamol tablets.

    Science.gov (United States)

    Akin-Ajani, Olufunke D; Itiola, Oludele A; Odeku, Oluwatoyin A

    2005-10-22

    The effects of plantain starch obtained from the unripe fruit of the plant Musa paradisiaca L. (Musaceae) on the mechanical and disintegration properties of paracetamol tablets have been investigated in comparison with the effects of corn starch BP using a 2(3) factorial experimental design. The individual and combined effects of nature of starch binder (N), concentration of starch binder (C), and the relative density of tablet (RD) on the tensile strength (TS), brittle fracture index (BFI), and disintegration time (DT) of the tablets were investigated. The ranking of the individual effects on TS was RD > C > N, on BFI was C > RD > N and on DT was N > C > RD. The ranking for the interaction effects on TS and DT was N-C > N-RD > C-RD, while that on BFI was N-C > C-RD > N-RD. Changing nature of starch from a "low" (plantain starch) to a "high" (corn starch) level, increasing the concentration of starch binding agent from 2.5% to 10.0% wt/wt, and increasing relative density of the tablet from 0.80 to 0.90, led to increase in the values of TS and DT, but a decrease in BFI. Thus, tablets containing plantain starch had lower tensile strength and disintegration time values than those containing corn starch, but showed better ability to reduce the lamination and capping tendency in paracetamol tablet formulation. The interaction between N and C was significantly (P starch used as binding agent in tablet formulations to obtain tablets of desired bond strength and disintegration properties. Furthermore, plantain starch could be useful as an alternative binding agent to cornstarch, especially where faster disintegration is required and the problems of lamination and capping are of particular concern.

  19. Stability and biocompatibility of photothermal gold nanorods after lyophilization and sterilization

    Energy Technology Data Exchange (ETDEWEB)

    Gomez, Leyre [Department of Chemical Engineering, Nanoscience Institute of Aragon (INA), C/ Mariano Esquillor, R and D Building, University of Zaragoza, 50018 Zaragoza (Spain); Cebrian, Virginia [CIBER de Bioingeniería, Biomateriales y Nanomedicina, CIBER-BBN, Zaragoza (Spain); Hospital Universitario La Paz-IdiPAZ, Paseo de la Castellana 261, 28046 Madrid (Spain); Martin-Saavedra, Francisco [Hospital Universitario La Paz-IdiPAZ, Paseo de la Castellana 261, 28046 Madrid (Spain); CIBER de Bioingeniería, Biomateriales y Nanomedicina, CIBER-BBN, Zaragoza (Spain); Arruebo, Manuel, E-mail: arruebom@unizar.es [Department of Chemical Engineering, Nanoscience Institute of Aragon (INA), C/ Mariano Esquillor, R and D Building, University of Zaragoza, 50018 Zaragoza (Spain); CIBER de Bioingeniería, Biomateriales y Nanomedicina, CIBER-BBN, Zaragoza (Spain); Vilaboa, Nuria [Hospital Universitario La Paz-IdiPAZ, Paseo de la Castellana 261, 28046 Madrid (Spain); CIBER de Bioingeniería, Biomateriales y Nanomedicina, CIBER-BBN, Zaragoza (Spain); Santamaria, Jesus, E-mail: Jesus.Santamaria@unizar.es [Department of Chemical Engineering, Nanoscience Institute of Aragon (INA), C/ Mariano Esquillor, R and D Building, University of Zaragoza, 50018 Zaragoza (Spain); CIBER de Bioingeniería, Biomateriales y Nanomedicina, CIBER-BBN, Zaragoza (Spain)

    2013-10-15

    Graphical abstract: - Highlights: • Morphological changes are observed for CTABr capped gold nanorods over time. • Polystyrenesulfonate (PSS) and polyethyleneglycol (PEG) coated nanorods are stable. • Re-suspendible and sterilizable colloids are prepared using those capping agents. • Those materials are efficient heat sinks potentially used in photothermal therapy. - Abstract: Suspensions in phosphate buffered saline (PBS) of gold nanorods stabilized with cetyltrimethyl ammonium chloride (CTABr), polystyrenesulfonate (PSS) and methyl-polyethyleneglycol-thiol (m-PEG-SH) have been prepared and the evolution of their colloidal stability and plasmonic response over time has been evaluated. Their performance after lyophilization, alcoholic sterilization and resuspension has also been characterized. Sub-cytotoxic doses on HeLa cells were calculated for the three surface functionalizations used. Their heating efficiency at different exposure times was also evaluated after being irradiated with near infrared light. The best results were obtained for m-PEG-SH stabilized rods, which were not only stable, sterilizable and lyophilizable, but also biocompatible at all doses tested, showing potential as a stable, re-suspendible and biocompatible hyperthermic agent.

  20. Effect of Freezing on Lyophilization Process Performance and Drug Product Cake Appearance.

    Science.gov (United States)

    Esfandiary, Reza; Gattu, Shravan K; Stewart, John M; Patel, Sajal M

    2016-04-01

    This study highlights the significance of the freezing step and the critical role it can play in modulating process performance and product quality during freeze-drying. For the model protein formulation evaluated, the mechanism of freezing had a significant impact on cake appearance, a potential critical product quality attribute for a lyophilized drug product. Contrary to common knowledge, a freezing step with annealing resulted in 20% increase in primary drying time compared to without annealing. In addition, annealing resulted in poor cake appearance with shrinkage, cracks, and formation of a distinct skin at the top surface of the cake. Finally, higher product resistance (7.5 cm(2).Torr.hr/g) was observed in the case of annealing compared to when annealing was not included (5 cm(2).Torr.hr/g), which explains the longer primary drying time due to reduced sublimation rates. An alternative freezing option using controlled ice nucleation resulted in reduced primary drying time (i.e., 30% reduction compared to annealing) and a more homogenous batch with elegant uniform (i.e., significantly improved) cake appearance. Here, a mechanistic understanding of the distinct differences in cake appearance as a function of freezing mechanism is proposed within the context of ice nucleation temperature, ice crystal growth, and presumed solute distribution within the frozen matrix.

  1. Spray freeze drying as an alternative technique for lyophilization of polymeric and lipid-based nanoparticles.

    Science.gov (United States)

    Ali, Mohamed Ehab; Lamprecht, Alf

    2017-01-10

    The use of nanoparticles for drug delivery is still restricted by their limited stability when stored in an aqueous medium. Freeze drying is the standard method for long-term storage of colloidal nanoparticles; however the method needs to be elaborated for each formulation. Spray freeze drying (SFD) is proposed here as a promising alternative for lyophilizing colloidal nanoparticles. Different types of polymeric and lipid nanoparticles were prepared and characterized. Afterwards, samples were spray freeze dried by spraying into a column of cold air with a constant concentration of different cryoprotectants, and the frozen spherules were collected for further freeze drying. Similar samples were prepared using the commonly used technique, freeze drying, as controls. Using SFD, fast-dissolving, spherical and porous nanocomposite microparticles with remarkably high flowability (CI≤10) were produced. On the contrary to similar samples prepared using the freeze drying technique, the investigated polymeric and lipid nanoparticles were completely reconstituted (Sf/Si ratio nanoparticles. Copyright © 2016 Elsevier B.V. All rights reserved.

  2. Neuroprotective Effect of Xueshuantong for Injection (Lyophilized in Transient and Permanent Rat Cerebral Ischemia Model

    Directory of Open Access Journals (Sweden)

    Xumei Wang

    2015-01-01

    Full Text Available Xueshuantong for Injection (Lyophilized (XST, a Chinese Materia Medica standardized product extracted from Panax notoginseng (Burk., is used extensively for the treatment of cerebrovascular diseases such as acutely cerebral infarction clinically in China. In the present study, we evaluated the acute and extended protective effects of XST in different rat cerebral ischemic model and explored its effect on peroxiredoxin (Prx 6-toll-like receptor (TLR 4 signaling pathway. We found that XST treatment for 3 days could significantly inhibit transient middle cerebral artery occlusion (MCAO induced infarct volume and swelling percent and regulate the mRNA expression of interleukin-1β (IL-1β, IL-17, IL-23p19, tumor necrosis factor-α (TNFα, and inducible nitric oxide synthase (iNOS in brain. Further study demonstrated that treatment with XST suppressed the protein expression of peroxiredoxin (Prx 6-toll-like receptor (TLR 4 and phosphorylation level of p38 and upregulated the phosphorylation level of STAT3. In permanent MCAO rats, XST could reduce the infarct volume and swelling percent. Moreover, our results revealed that XST treatment could increase the rats’ weight and improve a batch of functional outcomes. In conclusion, the present data suggested that XST could protect against ischemia injury in transient and permanent MCAO rats, which might be related to Prx6-TLR4 pathway.

  3. Product and process understanding to relate the effect of freezing method on glycation and aggregation of lyophilized monoclonal antibody formulations.

    Science.gov (United States)

    Awotwe-Otoo, David; Agarabi, Cyrus; Read, Erik K; Lute, Scott; Brorson, Kurt A; Khan, Mansoor A

    2015-07-25

    The objective of the study was to analyze the effect of controlled and uncontrolled freezing step of a lyophilization process on the extent of non-enzymatic glycation and aggregation of an IgG1 formulation at two concentrations (1mg/ml and 20mg/ml). The degree of glycation (%) was determined through boronate affinity chromatography and its effect on the formation of soluble aggregates and higher molecular weight species was studied using dynamic light scattering (DLS) and size exclusion chromatography with multi-angle light scattering (SEC-MALS). The effect of non-enzymatic glycation on the secondary structure of the formulations was also studied using circular dichroism (CD) spectroscopy and Fourier transform infrared (FT-IR) spectroscopy. Results indicated that controlled nucleation yielded higher residual moisture contents and significantly lower specific surface areas for the two monoclonal antibody concentrations compared with uncontrolled nucleation cycle (p<0.05). For the two concentrations, uncontrolled nucleation resulted in significantly higher levels of glycation compared with controlled nucleation samples (p<0.05). Further, it was observed that higher storage temperatures (25°C/60% RH) versus 5°C resulted in higher glycation. Even though SEC-MALS analyses of the low concentrated formulations did not reveal the formation of higher molecular weight species, DLS analyses at two storage conditions revealed increases in the hydrodynamic radii and polydispersity index of the reconstituted formulations, suggesting the onset of formation of smaller species in the formulations. CD spectroscopy did not reveal any differences in the secondary structure of the mAb for the two concentrations after lyophilization. In conclusion, the freezing step method impacted the extent of glycation in lyophilized samples and the hydrolyzed component of sucrose was critical for increasing glycation. Even though some level of glycation was observed in lyophilized samples, the

  4. Adaptogenic Activity of Lyophilized Hydroethanol Extract of Pandanus odoratissimus in Swiss Albino Mice

    Science.gov (United States)

    Jadhav, Pranita P.; Ambavade, Shirishkumar D.; Shelke, Tushar

    2014-01-01

    Background. The leaves of Pandanus odoratissimus Linn have been widely used in Ayurveda to treat a variety of common and stress related disorders. In the present investigation, hydroethanol extract of leaves of Pandanus odoratissimus Linn (LEPO) were evaluated for antistress activity in normal and stress induced mice. Furthermore, the extract was studied for nootropic (adaptogenic) activity in mice and in vitro antioxidant potential to correlate with its adaptogenic and antistress activity. LEPO (100 and 200 mg/kg p.o) was evaluated against forced swimming endurance stress test, anoxia stress tolerance and immobilization stress and chronic cold resistant stress tests, and biomarkers (serum glucose, Corticosterone, WBC, RBC, and DLC count) to assess the antistress activity in mice. Withania somnifera (WS) (100 mg/kg p.o) was selected as reference standard. The parameters like anoxia stress tolerance time were recorded in anoxia stress and estimation of biochemical marker levels and determination of organs weight were carried out in immobilization stress models. Results. Concomitant treatment with LEPO 200 mg/kg significantly increased in anoxia stress tolerance time. Dose dependent significant reduction in serum glucose, corticosterone, and WBC, RBC, and DLC was observed in immobilisation stress model as compared to stressed group. LEOP 200 mg/kg and WS 100 mg/kg significantly reversed/inhibited the stress induced changes in these parameters. The results from the present study indicate that these values also express that dose dependent significant adaptogenic activity in stressed animals. Conclusion. The present study provides scientific support for the antistress (adaptogenic) and nootropic activities of lyophilized hydroethanol extract of Pandanus odoratissimus Linn and substantiate the traditional claims for the usage of Pandanus in stress induced disorders. PMID:27379263

  5. Improving the biogas production performance of municipal waste activated sludge via disperser induced microwave disintegration.

    Science.gov (United States)

    Kavitha, S; Rajesh Banu, J; Vinoth Kumar, J; Rajkumar, M

    2016-10-01

    In this study, the influence of disperser induced microwave pretreatment was investigated to analyze the proficiency of floc disruption on subsequent disintegration and biodegradability process. Initially, the flocs in the sludge was disrupted through disperser at a specific energy input of 25.3kJ/kgTS. The upshot of the microwave disintegration presents that the solids reduction and solubilization of floc disrupted (disperser induced microwave pretreated) sludge was found to be 17.33% and 22% relatively greater than that achieved in microwave pretreated (9.3% and 16%) sludge alone. The biodegradability analysis, affords an evaluation of parameter confidence and correlation determination. The eventual biodegradability of microwave pretreated, and floc disrupted sludges were computed to be 0.15(gCOD/gCOD) and 0.28(gCOD/gCOD), respectively. An economic assessment of this study offers a positive net profit of about 104.8USD/ton of sludge in floc disrupted sample.

  6. Distress from Motivational Dis-integration: When Fundamental Motives Are Too Weak or Too Strong.

    Science.gov (United States)

    Cornwell, James F M; Franks, Becca; Higgins, E Tory

    2016-01-01

    Past research has shown that satisfying different kinds of fundamental motives contributes to well-being. More recently, advances in motivational theory have shown that z is also tied to the integration of different motives. In other words, well-being depends not only on maximizing effectiveness in satisfying specific motives, but also on ensuring that motives work together such that no individual motive is too weak or too strong. In this chapter, we review existing research to show that specific forms of psychological distress can be linked to specific types of motivational imbalance or dis-integration. Such disintegration can arise from either excessive weakness of a specific motive or the excessive strength and/or dominance of a specific motive, thereby inhibiting other motives. Possible neural correlates and avenues of intervention are discussed.

  7. Novel coherent receivers for AF distributed STBC using disintegrated channel estimation

    KAUST Repository

    Khan, Fahd Ahmed

    2011-05-01

    For a single relay network, disintegrated channel estimation (DCE), where the source-relay channel is estimated at the relay and the relay-destination channel is estimated at the destination, gives better performance than the cascaded channel estimation. We derive novel receivers for the relay network with disintegrated channel estimation. The derived receivers do not require channel estimation at the destination, as they use the received pilot signals and the source-relay channel estimate for decoding directly. We also consider the effect of quantized source-relay channel estimate on the performance of the designed receivers. Simulation results show that a performance gain of up to 2.2 dB can be achieved by the new receivers, compared with the conventional mismatched coherent receiver with DCE. © 2011 IEEE.

  8. Zonal disintegration mechanism of isotropic rock masses around a deep spherical tunnel

    Institute of Scientific and Technical Information of China (English)

    谷新保; 毕靖; 许明

    2015-01-01

    In order to investigate zonal disintegration mechanism of isotropic rock masses around a deep spherical tunnel, a new mechanical model subjected to dynamic unloading under hydrostatic pressure condition is proposed. The total elastic stress-field distributions is determined using the elastodynamic equation. The effects of unloading rate and dynamic mechanical parameters of isotropic deep rock masses on the zonal disintegration phenomenon of the surrounding rock masses around a deep spherical tunnel as well as the total elastic stress field distributions are considered. The number and size of fractured and non-fractured zones are determined by using the Hoek-Brown criterion. Numerical computation is carried out. It is found from numerical results that the number of fractured zones increases with increasing the disturbance coefficient, in-situ stress, unloading time and unloading rate, and it decreases with increasing parameter geological strength index, the strength parameter and the uniaxial compressive strength of intact rock.

  9. Structures, nanomechanics, and disintegration of single-walled GaN nanotubes: atomistic simulations

    Energy Technology Data Exchange (ETDEWEB)

    Kang, Jeong Won; Hwang, Ho Jung; Song, Ki Oh; Choi, Won Young; Byun, Ki Ryang [Chung-Ang University, Seoul (Korea, Republic of); Kwon, Oh Keun [Semyung University, Jecheon (Korea, Republic of); Lee, Jun Ha [Sangmyung University, Chonan (Korea, Republic of); Kim, Won Woo [Juseong College, Cheongwon (Korea, Republic of)

    2003-09-15

    We have investigated the structural, mechanical, and thermal properties of single-walled GaN nanotubes by using atomistic simulations and a Tersoff-type potential. The Tersoff potential for GaN effectively describes the properties of GaN nanotubes. The nanomechanics of GaN nanotubes under tensile and compressive loadings have also been investigated, and Young's modulus has been calculated. The caloric curves of single-walled GaN nanotubes can be divided into three regions corresponding to nanotubes, the disintegrating range, and vapor. Since the stability or the stiffness of a tube decreases with increasing curving sheet-to-tube strain energy, the disintegration temperatures of GaN nanotubes are closely related to the curving sheet-to-tube strain energy.

  10. Disintegration of {sup 12}C nuclei by 700–1500 MeV photons

    Energy Technology Data Exchange (ETDEWEB)

    Nedorezov, V. [Institute for Nuclear Research, Russian Academy of Sciences, Prospekt 60-letiya Oktyabrya 7a, 117312 Moscow (Russian Federation); D' Angelo, A.; Bartalini, O. [Dipartimento di Fisica – Università degli Studi di Roma “Tor Vergata”, via della Ricerca Scientifica 1, I-00133 Roma (Italy); INFN – Sezione di Roma “Tor Vergata”, via della Ricerca Scientifica 1, I-00133 Roma (Italy); Bellini, V. [Dipartimento di Fisica – Università degli Studi di Catania, via Santa Sofia 64, I-95123 Catania (Italy); INFN – Sezione di Catania, via Santa Sofia 64, I-95123 Catania (Italy); Capogni, M. [Dipartimento di Fisica – Università degli Studi di Roma “Tor Vergata”, via della Ricerca Scientifica 1, I-00133 Roma (Italy); INFN – Sezione di Roma “Tor Vergata”, via della Ricerca Scientifica 1, I-00133 Roma (Italy); Casano, L.E. [INFN – Sezione di Roma “Tor Vergata”, via della Ricerca Scientifica 1, I-00133 Roma (Italy); Castoldi, M. [Dipartimento di Fisica – Università degli Studi di Genova, via Dodecaneso 33, I-16146 Genova (Italy); Curciarello, F.; De Leo, V. [Dipartimento di Fisica e di Scienze della Terra, Università di Messina, salita Sperone 31, I-98166 Messina (Italy); INFN – Sezione di Catania, via Santa Sofia 64, I-95123 Catania (Italy); Didelez, J.-P. [IN2P3, Institut de Physique Nucléaire, Rue Georges Clemenceau, F-91406 Orsay (France); and others

    2015-08-15

    Disintegration of {sup 12}C nuclei by tagged photons of 700–1500 MeV energy at the GRAAL facility has been studied by means of the LAGRANγE detector with a wide angular acceptance. The energy and momentum distributions of produced neutrons and protons as well as their multiplicity distributions were measured and compared with corresponding distributions calculated with the RELDIS model based on the intranuclear cascade and Fermi break-up models. It was found that eight fragments are created on average once per about 100 disintegration events, while a complete fragmentation of {sup 12}C into 12 nucleons is observed typically only once per 2000 events. Measured multiplicity distributions of produced fragments are well described by the model. The measured total photoabsorption cross section on {sup 12}C in the same energy range is also reported.

  11. Production of Indigenous and Enriched Khyber Pakhtunkhwa Coal Briquettes: Combustion and Disintegration Strength Analysis

    Directory of Open Access Journals (Sweden)

    Unsia Habib

    2013-06-01

    Full Text Available Khyber Pakhtun Khwa province of Pakistan has considerable amounts of low ranked coal. However, due to the absence of any centrally administered power generation system there is a need to explore indigenous methods for effectively using this valuable energy resource. In the present study an indigenous coal briquetting technology has been developed and evaluated in terms of combustion characteristics such as moisture content, volatile matter, ash, fixed carbon and calorific value of the resulting coal briquette and disintegration strength using polyvinyl acetate (PVA in combination with calcium carbonate (sample no 3 with highest disintegration strength value of 2059N. Comparison of test samples with the commercially available coal briquettes revealed improved combustion characteristics for the PVA bonded (sample no 1 and 5 coal briquettes having higher fixed carbon content and calorific value, lower ash contents as well as lower initial ignition time.

  12. Oral myiasis

    Directory of Open Access Journals (Sweden)

    Thalaimalai Saravanan

    2015-01-01

    Full Text Available Myiasis is a pathologic condition in humans occurring because of parasitic infestation. Parasites causing myiasis belong to the order Diptera. Oral myiasis is seen secondary to oral wounds, suppurative lesions, and extraction wounds, especially in individuals with neurological deficit. In such cases, neglected oral hygiene and halitosis attracts the flies to lay eggs in oral wounds resulting in oral myiasis. We present a case of oral myiasis in 40-year-old male patient with mental disability and history of epilepsy.

  13. Disintegration-wave method of recovery of industrial waste iron and steel industry enterprises

    Directory of Open Access Journals (Sweden)

    M. A. Vasechkin

    2016-01-01

    Full Text Available Rational use of raw materials and waste is one of the most important factors determining the effectiveness of any processing enterprise. Industrial wastes of mining and metallurgical industries are a valuable source of many elements. However, little activity of the mineral and inconsistent chemical and phase composition of the waste reduce their attractiveness for use as a secondary raw material, and the presence of heavy metals and water-soluble compounds is a serious environmental threat. Fractional excretion of elements that make up the slag can be carried out with the help of their recovery by disintegration-wave method. The paper presents a machine-hardware circuits for the implementation of recovery process of slag and disintegrator design. In conducting research on the example of slag samples of the enterprises in Stavropol and Krasnoyarsk territories, it was found out that the observed enrichment of slags on the composition of iron takes place, its physical and chemical activity increases and persists for a long period of time. These facts were noted in the study of the microstructure and the results of spectral analysis of the initial slags and subjected to recovery by disintegration-wave method. The results analysis led to the conclusion about the possibility of waste recovery of mining and metallurgical industries with by disintegration-wave method. Resulting in the processing materials with enhanced activity of the mineral part and certain chemical and phase composition, can be used as raw material for the production of metallurgical, cement and other industries.

  14. Effects of plantain and corn starches on the mechanical and disintegration properties of paracetamol tablets

    OpenAIRE

    Akin-Ajani, Olufunke D.; Itiola, Oludele A.; ODEKU, OLUWATOYIN A.

    2005-01-01

    The effects of plantain starch obtained from the unripe fruit of the plantMusa paradisiaca L. (Musaceae) on the mechanical and disintegration properties of paracetamol tablets have been investigated in comparison with the effects of corn starch BP using a 23 factorial experimental design. The individual and combined effects of nature of starch binder (N), concentration of starch binder (C), and the relative density of tablet (RD) on the tensile strength (TS), brittle fracture index (BFI), and...

  15. Development of oral dispersible tablets containing prednisolone nanoparticles for the management of pediatric asthma

    Directory of Open Access Journals (Sweden)

    Chen YD

    2015-11-01

    Full Text Available Yi-Dan Chen,1 Zhong-Yuan Liang,1 Yan-Yan Cen,1 He Zhang,2 Mei-Gui Han,2 Yun-Qiao Tian,2 Jie Zhang,2 Shu-Jun Li,2 Da-Sheng Yang2 1College of Pharmacy, The Third Military Medical University, Chongqing, 2Department of Pediatrics, The First Affiliated Hospital of Xinxiang Medical University, Xinxiang, People’s Republic of ChinaAbstract: The purpose of the present study was to develop oral dispersible tablets containing prednisolone (PDS-loaded chitosan nanoparticles using microcrystalline cellulose (MCC 101, lactose, and croscarmellose sodium (CCS. The PDS-loaded chitosan nanoparticles were formulated by ionotropic external gelation technique in order to enhance the solubility of PDS in salivary pH. Prepared nanoparticles were used for the development of oral fast disintegrating tablets by direct compression method. The prepared tablets were evaluated for disintegration time (DT, in vitro drug release (DR, thickness, weight variation, drug content uniformity, friability, and hardness. The effect of concentrations of the dependent variables (MCC, lactose, CCS on DT and in vitro DR was studied. Fast disintegrating tablets of PDS can be prepared by using MCC, CCS, and lactose with enhanced solubility of PDS. The minimum DT was found to be 15 seconds, and the maximum DR within 30 minutes was 98.50%. All independent variables selected for the study were statistically significant. Oral fast disintegrating tablets containing PDS nanoparticles could be the better choice for the pediatric patients that would result in better patient compliance. From this study, it can be concluded that fast disintegrating tablets could be a potential drug delivery technology for the management of asthma in pediatrics. Keywords: asthma, superdisintegrant, prednisolone, oral tablets, MCC, CCS, factorial design, ANOVA

  16. Efficient network disintegration under incomplete information: the comic effect of link prediction

    Science.gov (United States)

    Tan, Suo-Yi; Wu, Jun; Lü, Linyuan; Li, Meng-Jun; Lu, Xin

    2016-03-01

    The study of network disintegration has attracted much attention due to its wide applications, including suppressing the epidemic spreading, destabilizing terrorist network, preventing financial contagion, controlling the rumor diffusion and perturbing cancer networks. The crux of this matter is to find the critical nodes whose removal will lead to network collapse. This paper studies the disintegration of networks with incomplete link information. An effective method is proposed to find the critical nodes by the assistance of link prediction techniques. Extensive experiments in both synthetic and real networks suggest that, by using link prediction method to recover partial missing links in advance, the method can largely improve the network disintegration performance. Besides, to our surprise, we find that when the size of missing information is relatively small, our method even outperforms than the results based on complete information. We refer to this phenomenon as the “comic effect” of link prediction, which means that the network is reshaped through the addition of some links that identified by link prediction algorithms, and the reshaped network is like an exaggerated but characteristic comic of the original one, where the important parts are emphasized.

  17. Role of superporous hydrogel particles as a superdisintegrant in fast disintegrating tablet of Glipizide

    Directory of Open Access Journals (Sweden)

    Hitesh V Chavda

    2014-01-01

    Full Text Available Background: Superporous hydrogel (SPH swells very rapidly in a shorter period of time to an equilibrium size and contains highly porous structure. The literature survey reflects the preparation of SPHs and its composite, but its application as an excipient in a drug delivery system is not well focused. Aim: Efforts were made to develop fast disintegrating tablets of Glipizide using superporous hydrogel particles (SPHPs as a wicking agent, which act as a superdisintegrant to decrease disintegration time. Materials and Methods: The SPH of poly (acrylamide-co-acrylic acid was prepared by solution polymerization and characterized. Prepared tablets were evaluated for concerned parameters. Formulation optimization was carried out using 3 2 full factorial design and analysis of variance. Results: Scanning electron microscopy pictures clearly confirmed the superporous structure of hydrogel. Batch F 4 containing 4% w/w of SPH of poly (acrylamide-co-acrylic acid as a superdisintegrant showed extremely fast wicking effect and lesser disintegration time compared with other potential superdisintegrants. Drug release was good compared with conventional immediate release marketed product. Conclusion: It can be concluded that SPHPs can be used as a potential superdisintegrant in tablet formulation.

  18. The use of beta-cyclodextrin in the manufacturing of disintegrating pellets with improved dissolution performances.

    Science.gov (United States)

    Zema, Lucia; Palugan, Luca; Maroni, Alessandra; Foppoli, Anastasia; Sangalli, Maria Edvige; Gazzaniga, Andrea

    2008-01-01

    It has recently been highlighted that the release behavior of pellets containing microcystalline cellulose (MCC) as the spheronizing agent may be impaired by the lack of disintegration. Although alternative spheronizing excipients have been proposed, their overall advantages have not thoroughly been assessed. In the present work, the possible use of beta-cyclodextrin (betaCD) was therefore explored for the manufacturing of pellets with a potential for effective disintegration and immediate release of poorly soluble active ingredients. MCC/betaCD powder formulations containing no drug or model drugs with different water solubility, able to form inclusion compounds with the employed cyclodextrin, were pelletized by agglomeration in rotary fluid bed equipment. By applying successive statistical experimental designs, the most critical formulation and operating parameters were identified and optimal manufacturing processes were ultimately set up. High yields of pellets provided with satisfactory physical-technological characteristics were obtained using powder formulations with up to 80% betaCD. Based on dissolution testing results, the suitability of betaCD for the preparation of disintegrating MCC-containing pellets with improved dissolution performance was finally demonstrated.

  19. Effects of Ultrasonic and Acid Pretreatment on Food Waste Disintegration and Volatile Fatty Acid Production

    Institute of Scientific and Technical Information of China (English)

    Qinglian Wu; Wanqian Guo∗; Shanshan Yang; Haichao Luo; Simai Peng; Nanqi Ren

    2015-01-01

    This study aims at investigating the effects of ultrasonic and acid pretreatment on food waste ( FW) disintegration and volatile fatty acid ( VFA ) production. Single⁃factor experiments are carried out to obtain optimal conditions of individual ultrasonic and acid pretreatment, and response surface method ( RSM ) is applied to optimize the conditions of the combination of ultrasonic and acid ( UA) pretreatment. Results show that the optimal acid, ultrasonic and UA pretreatments conditions are individual pH 2, individual ultrasonic energy density of 1�0 W/mL and the combination of ultrasonic energy density1�11 W/mL and pH 1�43, respectively. Correspondingly, the maximum disintegration degrees ( DD) of 46�90%, 57�38% and68�83%are obtained by acid, ultrasonic and UA pretreatments, respectively. After optimizing pretreatment conditions, batch experiments are operated to produce VFA from raw and pretreated FW under anaerobic fermentation process. Both the maximum VFA production ( 976�17 mg COD/gVS) and VFA/SCOD ( 72�89%) are obtained with ultrasonic pretreatment, followed by UA pretreatment, non⁃pretreatment and acid pretreatment, respectively. This observation demonstrates that a higher acidity on acid and UA pretreatments inhibits the generation of VFA. Results suggest that ultrasonic pretreatment is preferable to promote the disintegration degree of FW and VFA production.

  20. Investigating the effect of processing parameters on pharmaceutical tablet disintegration using a real-time particle imaging approach.

    Science.gov (United States)

    Rajkumar, Arthi D; Reynolds, Gavin K; Wilson, David; Wren, Stephen; Hounslow, Michael J; Salman, Agba D

    2016-09-01

    Tablet disintegration is a fundamental parameter that is tested in vitro before a product is released to the market, to give confidence that the tablet will break up in vivo and that active drug will be available for absorption. Variations in tablet properties cause variation in disintegration behaviour. While the standardised pharmacopeial disintegration test can show differences in the speed of disintegration of different tablets, it does not give any mechanistic information about the underlying cause of the difference. With quantifiable disintegration data, and consequently an improved understanding into tablet disintegration, a more knowledge-based approach could be applied to the research and development of future tablet formulations. The aim of the present research was to introduce an alternative method which will enable a better understanding of tablet disintegration using a particle imaging approach. A purpose-built flow cell was employed capable of online observation of tablet disintegration, which can provide information about the changing tablet dimensions and the particles released with time. This additional information can improve the understanding of how different materials and process parameters affect tablet disintegration. Standard USP analysis was also carried out to evaluate and determine whether the flow cell method can suitably differentiate the disintegration behaviour of tablets produced using different processing parameters. Placebo tablets were produced with varying ratios of insoluble and soluble filler (mannitol and MCC, respectively) so that the effect of variation in the formulation can be investigated. To determine the effect of the stress applied during granulation and tableting on tablet disintegration behaviour, analysis was carried out on tablets produced using granular material compressed at 20 or 50bar, where a tableting load of either 15 or 25kN was used. By doing this the tablet disintegration was examined in terms of the

  1. Studies of ultrasound disintegration of residual sludge and its energy consumption in water treatment of petrochemical plant

    Institute of Scientific and Technical Information of China (English)

    SHEN Jinfeng; YIN Xuan; GU Heping; L(U) Xiaoping

    2007-01-01

    To investigate the influence of ultrasound pretreatment on sludge anaerobic digestion,the ultrasound disintegration of residual sludge in water treatment of petrochemical plant was studied,and the mechanisms of ultrasound and medium were introduced.Experimental results indicate that ultrasound cavitation induces the rise of sludge temperature,which improves ultrasound disintegration on sludge.Ultrasound pretreatment can advance observably the quantity of chemical oxygen demand in sludge supernatant fluid (SCOD),which increases with ultrasound intensity and sonication time.The degree of ultrasound disintegration increases with the specific energy input.When the specific energy input is 10 000 kJ/kg of total dry solids,the degree of ultrasonic sludge disintegration reaches 40%.

  2. Oral Thrush

    Science.gov (United States)

    ... feeding mothers In addition to the distinctive white mouth lesions, infants may have trouble feeding or be fussy ... candidiasis (yeast infection) patient information. American Academy of Oral & Maxillofacial Pathology. http://www.aaomp.org/public/oral-candidiasis.php. ...

  3. Achieving long-term stability of lipid nanoparticles: examining the effect of pH, temperature, and lyophilization

    Science.gov (United States)

    Ball, Rebecca L; Bajaj, Palak; Whitehead, Kathryn A

    2017-01-01

    The broadest clinical application of siRNA therapeutics will be facilitated by drug-loaded delivery systems that maintain stability and potency for long times under ambient conditions. In the present study, we seek to better understand the stability and effect of storage conditions on lipidoid nanoparticles (LNPs), which have been previously shown by our group and others to potently deliver RNA to various cell and organ targets both in vitro and in vivo. Specifically, this study evaluates the influence of pH, temperature, and lyophilization on LNP efficacy in HeLa cells. When stored under aqueous conditions, we found that refrigeration (2°C) kept LNPs the most stable over 150 days compared to storage in the −20°C freezer or at room temperature. Because the pH of the storage buffer was not found to influence stability, it is suggested that the LNPs be stored under physiologically appropriate conditions (pH 7) for ease of use. Although aggregation and loss of efficacy were observed when LNPs were subjected to freeze–thaw cycles, their stability was retained with the use of the cryoprotectants, trehalose, and sucrose. Initially, lyophilization of the LNPs followed by reconstitution in aqueous buffer also led to reductions in efficacy, most likely due to aggregation upon reconstitution. Although the addition of ethanol to the reconstitution buffer restored efficacy, this approach is not ideal, as LNP solutions would require dialysis prior to use. Fortunately, we found that the addition of trehalose or sucrose to LNP solutions prior to lyophilization facilitated room temperature storage and reconstitution in aqueous buffer without diminishing delivery potency. PMID:28115848

  4. Oral Dysfunction

    OpenAIRE

    鈴木, 規子; スズキ, ノリコ; Noriko, SUZUKI

    2004-01-01

    The major oral functions can be categorized as mastication, swallowing, speech and respiratory functions. Dysfunction of these results in dysphagia, speech disorders and abnormal respiration (such as Sleep Apnea). These functions relate to dentistry in the occurrence of : (1) oral preparatory and oral phases, (2) articulation disorders and velopharyngeal incompetence (VPI), and (3) mouth breathing, respiratory and blowing disorders. These disorders are related to oral and maxillofacial diseas...

  5. Influence of ginger and banana starches on the mechanical and disintegration properties of chloroquine phosphate tab-lets

    Institute of Scientific and Technical Information of China (English)

    O.A.Odeku; M.A.Odeniyi; G.O.Ogunlowo

    2009-01-01

    Objective:The influence of two experimental starches -ginger starch obtained from Zingiber officinale and ba-nana starch from Musa sapientum -on the mechanical and disintegration properties of chloroquine tablets have been studied in comparison with the influence of official corn starch.Methods:Chloroquine tablets were for-mulated using various concentarions of the starches as binding agent.The mechanical properties of the tablets were assessed in terms of crushing strength and friability and the crushing strength-friability ratio (CSFR) while drug release properties were evaluated based on disintegration and the time of tablets.Results:The ranking for crushing strength and CSFR was corn >banana >ginger starch while the ranking was reverse for friability.The disintegration time increased with packing fraction and starch concentration in the rank order of formulations containing corn >banana >ginger starch.The CSFR/DT values increased with concentration of starch binder indicating an improved balance between binding and disintegrant properties of the starches.Sta-tistical analysis showed that there were significant (P <0.001)difference in the CSFR/DT for tablets contai-ning the various starch binders.Conclusion:The mechanical and disintegration properties of the experimental starches compared favorably with those of corn starch and ginger starch could be more useful when faster tablet disintegration is desired.

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

    Science.gov (United States)

    Sharma, Deepak; Singh, Mankaran; Kumar, Dinesh; Singh, Gurmeet

    2014-01-01

    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. PMID:26556203

  7. 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.

  8. Effects of Different Lyophilizing Protectants on Lyophilized Trehalose-loading Red Blood Cells%不同冻干保护体系对海藻糖负载红细胞冻干保存影响的研究

    Institute of Scientific and Technical Information of China (English)

    陈燕; 陆志刚; 白海

    2013-01-01

    This study was purposed to evaluate the effect of different lyophilizing protectants including human albumin,glucan,polyvinyl pyrrolidone and glycerine on lyophilized trehalose-loading red blood cells (RBC),then to screen the optimal lyophilizing protectant.The RBC were incubated in 800 mmol/L concentration of trehalose solution at 37℃ for 7 hours,and washed 3 times with PBS solution to obtain the trehalose-loading RBC.The trehalose-loading RBC in control group were directly lyophilized without lyophilizing protectants,the trehalose-loading RBC in the experimental group were mixed with Lyophilizing protectants.The samples of 2 groups were kept at room temperature for 30 minutes,pre-frozen at-80℃ for 24 hours,then lyophilized in freeze-dryer for 24 hours.Finally the samples were quickly rehydrated by 6% HES at 37℃.The recovery rate and hemolysis rate of hemoglobin were detected by using cyanohemeglobin detection kit.The water content of unhydrated samples were detected at the same time.The results showed that when the moisture content of sample was 3%-5%,the recovery rate of hemoglobin in control group was 33.57 ± 2.89%,and that in experimental group was 51.15 ± 1.98%,there was statistically significant difference between the control and experimental group (P <0.05).When the different concentration of dextran solution was chosen as protectants,the recovery rate of hemoglobin of lyophilized RBC was obviously lower.The higher concentration of dextran,the better the recovery rate.The recovery rate of hemoglobin was 22.15 ±4.12% when the concentration of dextran was 36%,there were statistically significant difference between the two groups(P <0.05).When the different concentration of polyvinyl pyrrolidone (PVP) solutions was chosen as protectants,especially the concentration below 40%,the recovery rate of hemoglobin of lyophilized RBC was significantly belower than the control group,there was statistically significant difference between the

  9. Quality by design: impact of formulation variables and their interactions on quality attributes of a lyophilized monoclonal antibody.

    Science.gov (United States)

    Awotwe-Otoo, David; Agarabi, Cyrus; Wu, Geoffrey K; Casey, Elizabeth; Read, Erik; Lute, Scott; Brorson, Kurt A; Khan, Mansoor A; Shah, Rakhi B

    2012-11-15

    The purpose of this study was to use QbD approaches to evaluate the effect of several variables and their interactions on quality of a challenging model murine IgG3κ monoclonal antibody (mAb), and then to obtain an optimized formulation with predefined quality target product profile. This antibody was chosen because it has a propensity to precipitate and thus represents a challenge condition for formulation development. Preliminary experiments were conducted to rule out incompatible buffer systems for the mAb product quality. A fractional factorial experimental design was then applied to screen the effects of buffer type, pH and excipients such as sucrose, sodium chloride (NaCl), lactic acid and Polysorbate 20 on glass transition temperature ( [Formula: see text] ), monoclonal antibody concentration (A(280)), presence of aggregation, unfolding transition temperature (T(m)) of the lyophilized product, and particle size of the reconstituted product. A Box-Behnken experimental design was subsequently applied to study the main, interaction, and quadratic effects of these variables on the responses. Pareto ranking analyses showed that the three most important factors affecting the selected responses for this particular antibody were pH, NaCl, and Polysorbate 20. The presence of curvature in the variables' effects on responses indicated interactions. Based on the constraints set on the responses, a design space was identified for this mAb and confirmed with experiments at three different levels of the variables within the design space. The model indicated a combination of high pH (8) and NaCl (50mM) levels, and a low Polysorbate 20 (0.008 mM) level at which an optimal formulation of the mAb could be achieved. Moisture contents and other analytical procedures such as size exclusion chromatography, protein A analysis and SDS-PAGE of the pre-lyophilized and final reconstituted lyophilized products indicated an intact protein structure with minimal aggregation after

  10. Photo-dynamics of the lyophilized photo-activated adenylate cyclase NgPAC2 from the amoeboflagellate Naegleria gruberi NEG-M strain

    Science.gov (United States)

    Penzkofer, A.; Tanwar, M.; Veetil, S. K.; Kateriya, S.; Stierl, M.; Hegemann, P.

    2013-09-01

    The absorption and emission spectroscopic behavior of lyophilized photo-activated adenylate cyclase NgPAC2 from the amoeboflagellate Naegleria gruberi NEG-M strain consisting of a BLUF domain (BLUF = Blue Light sensor Using Flavin) and a cyclase homology domain was studied in the dark, during blue-light exposure and after blue-light exposure at a temperature of 4 °C. The BLUF domain photo-cycle dynamics observed for snap-frozen NgPAC2 was lost by lyophilization (no signaling state formation with flavin absorption red-shift). Instead, blue-light photo-excitation of lyophilized NgPAC2 caused sterically restricted Tyr-Tyr cross-linking (o,o‧-ditysosine formation) and partial flavin cofactor reduction.

  11. Randomized Phase II Trial of Lyophilized Strawberries in Patients with Dysplastic Precancerous Lesions of the Esophagus

    Science.gov (United States)

    Chen, Tong; Yan, Fei; Qian, Jiaming; Guo, Mingzhou; Zhang, Hongbing; Tang, Xiaofei; Chen, Fang; Stoner, Gary D.; Wang, Xiaomin

    2016-01-01

    Dysplasia is a histologic precursor of esophageal squamous cell carcinoma (SCC). We previously showed that dietary freeze-dried, or lyophilized, strawberry powder inhibits N-nitrosomethylbenzylamine-induced SCC in the rat esophagus. On the basis of this observation, we conducted a randomized (noncomparative) phase II trial in China to investigate the effects of two doses of freeze-dried strawberries in patients with esophageal dysplastic lesions in a high-risk area for esophageal cancer. We randomly assigned 75 patients identified by endoscopy to have dysplastic esophageal premalignant lesions to receive freeze-dried strawberry powder at either 30 g/d (37 patients) or 60 g/d (38 patients) for six months; the powder was mixed with water and drunk. After six months, we assessed the changes in histologic grade of these lesions (primary endpoint) in a blinded fashion. The dose of 30 g/d, did not significantly affect histology or any other measured parameter. The dose of 60 g/d, however, reduced the histologic grade of dysplastic premalignant lesions in 29 (80.6%) of the 36 patients at this dose who were evaluated for histology (P < 0.0001). The strawberry powder was well tolerated, with no toxic effects or serious adverse events. Strawberries (60 g/d) also reduced protein expression levels of inducible nitric oxide synthase (iNOS) by 79.5% (P < 0.001), cyclooxygenase-2 (COX-2) by 62.9% (P < 0.001), phospho-nuclear factor kappa B (NFκB)-p65 (pNFκB-p65) by 62.6% (P < 0.001), and phospho-S6 (pS6) by 73.2% (P < 0.001). Freeze-dried strawberries (60 g/d) also significantly inhibited the Ki-67 labeling index by 37.9% (P = 0.023). Our present results indicate the potential of freeze-dried strawberry powder for preventing human esophageal cancer, supporting further clinical testing of this natural agent in this setting. PMID:22135048

  12. Lyophilization-induced protein denaturation in phosphate buffer systems: monomeric and tetrameric beta-galactosidase.

    Science.gov (United States)

    Pikal-Cleland, K A; Carpenter, J F

    2001-09-01

    During freezing in phosphate buffers, selective precipitation of a less soluble buffer component and subsequent pH shifts may induce protein denaturation. Previous reports indicate significantly more inactivation and secondary structural perturbation of monomeric and tetrameric beta-galactosidase (beta-gal) during freeze-thawing in sodium phosphate (NaP) buffer as compared with potassium phosphate (KP) buffer. This observation was attributed to the significant pH shifts (from 7.0 to as low as 3.8) observed during freezing in the NaP buffer (1). In the current study, we investigated the impact of the additional stress of dehydration after freezing on the recovery of active protein on reconstitution and the retention of the native structure in the dried state. Freeze-drying monomeric and tetrameric beta-gal in either NaP or KP buffer resulted in significant secondary structural perturbations, which were greatest for the NaP samples. However, similar recoveries of active monomeric protein were observed after freeze-thawing and freeze-drying, indicating that most dehydration-induced unfolding was reversible on reconstitution of the freeze-dried protein. In contrast, the tetrameric protein was more susceptible to dehydration-induced denaturation as seen by the greater loss in activity after reconstitution of the freeze-dried samples relative to that measured after freeze-thawing. To ensure optimal protein stability during freeze-drying, the protein must be protected from both freezing and dehydration stresses. Although poly(ethylene glycol) and dextran are preferentially excluded solutes and should confer protection during freezing, they were unable to prevent lyophilization-induced denaturation. In addition, Tween did not foster maintenance of native protein during freeze-drying. However, sucrose, which hydrogen bonds to dried protein in the place of lost water, greatly reduced freezing- and drying-induced denaturation, as observed by the high retention of native

  13. Validation of a stability-indicating RP-LC method for the determination of tigecycline in lyophilized powder.

    Science.gov (United States)

    da Silva, Lucélia Magalhães; Salgado, Hérida Regina Nunes

    2013-02-01

    A reversed-phase liquid chromatography (RP-LC) method was validated for the determination of tigecycline in lyophilized powder. The LC method was conducted on a Luna C18 column (250 × 4.6 mm i.d.), maintained at room temperature. The mobile phase consisted of buffer containing sodium phosphate monobasic (0.015M) and oxalic acid (0.015M) (pH 7.0)-acetonitrile (75:25, v/v), run at a flow rate of 1.0 mL/min and using ultraviolet detection at 280 nm. The chromatographic separation was obtained with a retention time of 8.6 min, and was linear in the range of 40-100 µg/mL (r(2) = 0.9997). The specificity and stability-indicating capability of the method was proven through forced degradation studies, which also showed no interference of the excipients. The accuracy was 99.01% with a bias lower than 1.81%. The limits of detection and quantitation were 1.67 and 5.05 µg/mL, respectively. Moreover, method validation demonstrated satisfactory results for precision and robustness. The proposed method was applied for the analysis of the lyophilized powder formulation, contributing to improve the quality control and to assure the therapeutic efficacy.

  14. Extraction efficiency of hydrophilic and lipophilic antioxidants from lyophilized foods using pressurized liquid extraction and manual extraction.

    Science.gov (United States)

    Watanabe, Jun; Oki, Tomoyuki; Takebayashi, Jun; Takano-Ishikawa, Yuko

    2014-09-01

    The efficient extraction of antioxidants from food samples is necessary in order to accurately measure their antioxidant capacities. α-Tocopherol and gallic acid were spiked into samples of 5 lyophilized and pulverized vegetables and fruits (onion, cabbage, Satsuma mandarin orange, pumpkin, and spinach). The lipophilic and hydrophilic antioxidants in the samples were sequentially extracted with a mixed solvent of n-hexane and dichloromethane, and then with acetic acid-acidified aqueous methanol. Duplicate samples were extracted: one set was extracted using an automated pressurized liquid extraction apparatus, and the other set was extracted manually. Spiked α-tocopherol and gallic acid were recovered almost quantitatively in the extracted lipophilic and hydrophilic fractions, respectively, especially when pressurized liquid extraction was used. The expected increase in lipophilic oxygen radical absorbance capacity (L-ORAC) due to spiking with α-tocopherol, and the expected increase in 2,2-diphenyl-1-picrylhydrazyl radical scavenging activities and total polyphenol content due to spiking with gallic acid, were all recovered in high yield. Relatively low recoveries, as reflected in the hydrophilic ORAC (H-ORAC) value, were obtained following spiking with gallic acid, suggesting an interaction between gallic acid and endogenous antioxidants. The H-ORAC values of gallic acid-spiked samples were almost the same as those of postadded (spiked) samples. These results clearly indicate that lipophilic and hydrophilic antioxidants are effectively extracted from lyophilized food, especially when pressurized liquid extraction is used.

  15. Assessment of immune response to a lyophilized peste-des-petitsruminants virus vaccine in three different breeds of goats

    Directory of Open Access Journals (Sweden)

    S. S. Begum

    2016-06-01

    Full Text Available Aim: Immune response to a lyophilized peste-des-petits-ruminants virus (PPRV vaccine was evaluated in three different breeds of goats. Materials and Methods: Three breeds of goats consisting six number of animals in three groups, i.e., Group A (local Assam hill goat, Group B (cross-bred, and Group C (Beetal goats were randomly selected for evaluating the immune response to a lyophilized PPRV vaccine. Results: A higher rise in the overall mean serum antibody titer was observed in Group A (40.50±3.74 than in Group B (37.58±37.58 and Group C (35.90±3.29 during the study period. Conclusion: Initially, a negative PPRV specific serum antibody titer was recorded in all the groups at 0th day of vaccination. Serum antibody titer in the vaccinated goats started rising gradually from the 14th day post vaccination. Later higher rise in the overall mean serum antibody titer in Group A (local Assam hill goat lead to the conclusion that higher serum antibody titer in local non-descript breed might be due to their better adaptation to the environmental condition.

  16. Assessment of immune response to a lyophilized peste-des-petits-ruminants virus vaccine in three different breeds of goats

    Science.gov (United States)

    Begum, S. S.; Mahato, G.; Sharma, P.; Hussain, M.; Saleque, A.

    2016-01-01

    Aim: Immune response to a lyophilized peste-des-petits-ruminants virus (PPRV) vaccine was evaluated in three different breeds of goats. Materials and Methods: Three breeds of goats consisting six number of animals in three groups, i.e., Group A (local Assam hill goat), Group B (cross-bred), and Group C (Beetal goats) were randomly selected for evaluating the immune response to a lyophilized PPRV vaccine. Results: A higher rise in the overall mean serum antibody titer was observed in Group A (40.50±3.74) than in Group B (37.58±37.58) and Group C (35.90±3.29) during the study period. Conclusion: Initially, a negative PPRV specific serum antibody titer was recorded in all the groups at 0th day of vaccination. Serum antibody titer in the vaccinated goats started rising gradually from the 14th day post vaccination. Later higher rise in the overall mean serum antibody titer in Group A (local Assam hill goat) lead to the conclusion that higher serum antibody titer in local non-descript breed might be due to their better adaptation to the environmental condition. PMID:27397978

  17. Design and optimization of disintegrating pellets of MCC by non-aqueous extrusion process using statistical tools.

    Science.gov (United States)

    Gurram, Rajesh Kumar; Gandra, Suchithra; Shastri, Nalini R

    2016-03-10

    The objective of the study was to design and optimize a disintegrating pellet formulation of microcrystalline cellulose by non-aqueous extrusion process for a water sensitive drug using various statistical tools. Aspirin was used as a model drug. Disintegrating matrix pellets of aspirin using propylene glycol as a non-aqueous granulation liquid and croscarmellose as a disintegrant was developed. Plackett-Burman design was initially conducted to screen and identify the significant factors. Final optimization of formula was performed by response surface methodology using a central composite design. The critical attributes of the pellet dosage forms (dependent variables); disintegration time, sphericity and yield were predicted with adequate accuracy based on the regression model. Pareto charts and contour charts were studied to understand the influence of factors and predict the responses. A design space was constructed to meet the desirable targets of the responses in terms of disintegration time 0.95 and friability <1.7%. The optimized matrix pellets were enteric coated using Eudragit L 100. The drug release from the enteric coated pellets after 30min in the basic media was ~93% when compared to ~77% from the marketed pellets. The delayed release pellets stored at 25°C/60% RH were stable for a period of 10mo. In conclusion, it can be stated that the developed process for disintegrating pellets using non-aqueous granulating agents can be used as an alternative technique for various water sensitive drugs, circumventing the application of volatile organic solvents in conventional drug layering on inert cores. The scope of this study can be further extended to hydrophobic drugs, which may benefit from the rapid disintegration property and the use of various hydrophilic excipients used in the optimized pellet formulation to enhance dissolution and in turn improve bioavailability. Copyright © 2016 Elsevier B.V. All rights reserved.

  18. Monitoring aggregate disintegration with laser diffraction: A tool for studying soils as sediments

    Science.gov (United States)

    Mason, Joseph; Kasmerchak, Chase; Liang, Mengyu

    2016-04-01

    One of the more important characteristics of soil that becomes hillslope, fluvial, or aeolian sediment is the presences of aggregates, which disintegrate at varying rates and to varying degrees during transport. Laser diffraction particle size analyzers allow monitoring of aggregate disintegration as a sample of soil or sediment suspended in water is circulated continuously through the measurement cell (Bieganowski et al., 2010, Clay Minerals 45-23-34; Mason et al., Catena 87:107-118). Mason et al. (2011) applied this approach to aeolian sedimentary aggregates (e.g. clay pellets eroded from dry lakebeds), immersing dry samples in DI water and circulating them through a Malvern Mastersizer 2000 particle size analyzer for three hours while repeated size distribution (SD) measurements were made. A final measurement was made after sonication and treatment with Na-metaphosphate. In that study, most samples approached a steady SD within three hours, which included both primary mineral grains and persistent aggregates. The disintegration process could be modeled with a first-order rate law representing the disintegration of a single population of aggregates. A wide range of model parameters were observed among the samples studied, and it was suggested that they could be useful in predicting the behavior of these aggregates, under rainfall impact and during slopewash or fluvial transport. Addition of Ca++ to the suspension altered aggregate behavior in some but not all cases. We applied the same method to dry, unground material from upper horizons of soils sampled along a bioclimatic gradient in northern Minnesota, USA, all formed in lithologically similar glacigenic sediment. These ranged from Alfisols (Luvisols) formed under forest since the last deglaciation, to Alfisols under forest that more recently replaced grassland, and Mollisols (Chernozems) that formed entirely under grassland vegetation. Few of these soil samples approached a steady SD within three hours, and

  19. Modeling the Disintegration Process in Anaerobic Digestion of Tannery Sludge and Fleshing

    Directory of Open Access Journals (Sweden)

    Cecilia Polizzi

    2017-06-01

    Full Text Available Mathematical modeling of anaerobic digestion (AD is widely acknowledged as a powerful tool to v of the process and to support full-scale plant design, operation and optimization. In this work, a modified version of the IWA-ADM1 model is proposed to simulate the AD of tannery primary sludge (TPS and fleshing, with special emphasis on the disintegration formulation. Multiple batch tests were performed at different inoculum/substrate VS-mass ratio, in order to evaluate the biodegradability of the two substrates and to provide experimental data for modeling purposes. Beside the necessary adjustments of substrates' COD fractionation, the structure modifications of the model focused on the disintegration and hydrolysis. The Contois Monod-based model was adopted to describe disintegration kinetics and the results were compared to the traditionally adopted first-order kinetic. The fate of particulate matter generated from biomass lysis was also questioned and a new model variable was introduced to account for cellular lysis products. Finally, a further modification differentiated substrate particulate matter into a readily and a slowly hydrolysable fraction. Batch tests confirmed that TPS and fleshing are suitable substrates for AD, exhibiting specific methane productions of: 0.26 ± 0.06 and 0.47 ± 0.05 Nm3 Kg−1 VS, respectively. Modeling results showed that the proposed modifications were crucial for successful simulation of experimental data referring to fleshing, whereas did not have a significant effect on the results related to primary sludge degradation. This work is the first application of an IWA-ADM1-based model to AD of tannery waste.

  20. Resistive method for measuring the disintegration speed of Prince Rupert's drops

    CERN Document Server

    Gusenkova, Daria; Glushkov, Evgenii; Zotova, Julia; Zhabin, S N

    2016-01-01

    We have successfully applied the resistance grid technique to measure the disintegration speed in special type of glass objects, widely known as Prince Rupert's drops. We use a digital oscilloscope and a simple electrical circuit, glued to the surface of the drops, to detect the voltage changes, corresponding to the breaks in the specific parts of the drops. The results obtained using this method are in good qualitative and quantitative agreement with theoretical predictions and previously published data. Moreover, the proposed experimental setup doesn't include any expensive equipment (such as a high-speed camera) and can therefore be widely used in high schools and universities.

  1. One-nucleon channels of the /sup 16/O disintegration in a coincidence experiment

    Energy Technology Data Exchange (ETDEWEB)

    Kirpichnikov, I.V.; Kuznetsov, V.A.; Starostin, A.S. (Institut Teoreticheskoj i Ehksperimental' noj Fiziki, Moscow (USSR)); Kislyakov, E.F.; Korotkikh, V.L.; Lanskoy, D.E. (Moskovskij Gosudarstvennyj Univ. (USSR). Nauchno-Issledovatel' skij Inst. Yadernoj Fiziki)

    1983-01-17

    The differential cross sections for the reactions /sup 16/O(..pi../sup +/, ..pi../sup +/p)/sup 15/Nsup(*)(6.32 MeV) and /sup 16/O(..pi../sup +/, ..pi../sup +/n)/sup 15/Osup(*)(6.18 MeV) are measured with a 2.0 GeV/c pion beam in a ..pi../sup +/..gamma.. coincidence experiment. Calculations in the framework of the unified theory of nuclear disintegration are in qualitative agreement with the experimental data.

  2. Resistive method for measuring the disintegration speed of Prince Rupert's drops

    Science.gov (United States)

    Bochkov, Mark; Gusenkova, Daria; Glushkov, Evgenii; Zotova, Julia; Zhabin, S. N.

    2016-09-01

    We have successfully applied the resistance grid technique to measure the disintegration speed in a special type of glass objects, widely known as Prince Rupert's drops. We use a fast digital oscilloscope and a simple electrical circuit, glued to the surface of the drops, to detect the voltage changes, corresponding to the breaks in the specific parts of the drops. The results obtained using this method are in good qualitative and quantitative agreement with theoretical predictions and previously published data. Moreover, the proposed experimental setup does not include any expensive equipment (such as a high-speed camera) and can therefore be widely used in high schools and universities.

  3. Theoretic analysis of liquid film movement and its disintegration near the orifice of atomizer

    Science.gov (United States)

    Zhou, Meng; Zhuang, Fengchen

    1993-04-01

    The movement of a conic liquid film in a restricted space is studied in this paper. The film is produced by a centrifugal nozzle and impinged on by a high-speed gas stream. Based on the theory of aerodynamics, some theoretical formulas for liquid film movement are established, a criterion of breaking up the moving liquid film is proposed and a formula for calculating the size of droplet formed by disintegration of the liquid film is presented. The calculation results can be used as a reference for atomizer design.

  4. Detailed calculation of K- and L-Auger electron emission intensities following radioactive disintegration

    Energy Technology Data Exchange (ETDEWEB)

    Be, Marie-Martine [LNE-LNHB, Laboratoire National Henri Becquerel CEA Saclay, 91191 Gif-sur-Yvette cedex (France)]. E-mail: mmbe@cea.fr; Chiste, Vanessa [LNE-LNHB, Laboratoire National Henri Becquerel CEA Saclay, 91191 Gif-sur-Yvette cedex (France); Dulieu, Christophe [LNE-LNHB, Laboratoire National Henri Becquerel CEA Saclay, 91191 Gif-sur-Yvette cedex (France)

    2006-10-15

    A program has been set up to calculate the K- and L-Auger electron emissions resulting from the radioactive disintegration process, and to study all the possible emissions in detail. Due to the fact that only a small number of experimental results are available in the measurements of K- and L-Auger electrons, the calculated values obtained in this work were compared with the other calculated values available. Good agreement was found between the values. Some of the results are given as examples.

  5. The disintegration of GaSb/GaAs nanostructures upon capping

    Energy Technology Data Exchange (ETDEWEB)

    Martin, Andrew J; Jinyoung, Hwang; Marquis, Emmanuelle A; Smakman, Erwin; Saucer, Timothy W; Rodriguez, Garrett; Hunter, Allen H; Sih, Vanessa; Koenraad, Paul M; Phillips, Jamie D.; Millunchick, Joanna M

    2013-01-01

    Atom probe tomography and cross-sectional scanning tunneling microscopy show that GaSb/GaAs quantum dots disintegrate into ring-like clusters of islands upon capping. Band transition energies calculated using an 8-band k.p model of the capped dots with the observed dimensions are consistent with emission energies observed in photoluminescence data. These results emphasize the need for full three-dimensional characterization to develop an accurate understanding of the structure, and thus the optical properties, of buried quantum dots.

  6. Influence of slow disintegrating fertilizer rates on quality of gazania (Gazania rigens L. seedlings

    Directory of Open Access Journals (Sweden)

    Vujošević Ana

    2007-01-01

    Full Text Available The work has examined the influence of slow disintegrating fertilizer rates of Scotts (Osmocote Exact formulation 15:9:9:MgO + Me on quality of Gazania rigens L. seedlings. The seedlings of Gazania rigens L. was produced in polystyrene containers (speedling system and polypropylene pots (pot system. During the production of seedlings the fertilizer has been applied in rates (0, 1, 2, 3, and 4g/l. The results show that the fertilizer rate of substrata 4g/l influences the qualitative properties of Gazania rigens L. seedlings.

  7. Oral histoplasmosis

    Directory of Open Access Journals (Sweden)

    Patil Karthikeya

    2009-01-01

    Full Text Available Histoplasmosis is a systemic fungal disease that takes various clinical forms, among which oral lesions are rare. The disseminated form of the disease that usually occurs in association with Human Immunodeficiency Virus (HIV is one of the AIDS-defining diseases. Isolated oral histoplasmosis, without systemic involvement, with underlying immunosuppression due to AIDS is very rare. We report one such case of isolated oral histoplasmosis in a HIV-infected patient.

  8. A novel spray-dried nanoparticles-in-microparticles system for formulating scopolamine hydrobromide into orally disintegrating tablets

    OpenAIRE

    Li FQ; Yan C; Bi J; Lv WL; Ji RR; Chen X; Su JC; Hu JH

    2011-01-01

    Feng-Qian Li1, Cheng Yan2, Juan Bi1, Wei-Lin Lv3, Rui-Rui Ji3, Xu Chen1, Jia-Can Su3, Jin-Hong Hu31Department of Pharmaceutics, Shanghai Eighth People’s Hospital, Shanghai, People’s Republic of China; 2Department of Pharmacy, Bethune International Peace Hospital, Shijiazhuang, People’s Republic of China; 3Changhai Hospital, Second Military Medical University, Shanghai, People’s Republic of ChinaAbstract: Scopolamine hydrobromide (SH)-loaded microparticl...

  9. Disintegration of excess sludge enhanced by a combined treatment of gamma irradiation and modified coal fly ash

    Science.gov (United States)

    Xiang, Yulin; Wang, Lipeng; Jiao, Yurong

    2016-03-01

    In order to improve the disintegration performance and accelerate the disintegration rate of excess sludge, the individual and combined influences of γ-ray irradiation and modified coal fly ash treatment on the disintegration of excess sludge were investigated based on physicochemical properties of excess sludge. The changes in constituents of excess sludge were examined by means of UV/vis spectra and SEM images. The results showed that the disintegration performance of excess sludge was effectively improved by gamma ray irradiation in the presence of modified coal fly ash. A new band from 250 nm to 290 nm appeared on all irradiated sludge samples. The SEM images illustrated the cells surfaces of the sludge by the combined treatment were disfigured. The SCOD, soluble carbohydrate and protein from sludge supernatant increased obviously with increasing modified CFA dosage from 0 to 0.2 g ml-1 and dose from 0 to 10 kGy. The sludge SRF and filter cake moisture declined significantly, and the filtration speed was faster. In conclusion, γ-ray irradiation-modified coal fly ash pretreatment is an effective method to disintegrate excess sludge.

  10. Freeze drying of red blood cells: the use of directional freezing and a new radio frequency lyophilization device.

    Science.gov (United States)

    Arav, Amir; Natan, Dity

    2012-08-01

    Red blood cell (RBC) units are administered routinely into patients expressing a wide range of acute and chronic conditions (e.g., anemia, traumatic bleeding, chronic diseases, and surgery). The modern blood banking system has been designed to answer this need and assure a continuous, high quality blood supply to patients. However, RBCs units can be stored under hypothermic conditions for only up to 42 days, which leads to periodic shortages. Cryopreservation can solve these shortages, but current freezing methods employ high glycerol concentrations, which need to be removed and the cells washed prior to transfusion, resulting in a long (more than 1 hour) and cumbersome washing step. Thus, frozen RBCs have limited use in acute and trauma situations. In addition, transportation of frozen samples is complicated and costly. Freeze drying (lyophilization) of RBCs has been suggested as a solution for these problems, since it will allow for a low weight sample to be stored at room temperature, but reaching this goal is not a simple task. We studied the effect of different solutions (IMT2 and IMT3) containing trehalose and antioxidants or trehalose and human serum albumin, respectively, on freezing/thawing and freeze drying of RBCs. In addition, we evaluated the effect of cells concentrations and cooling rates on the post thaw and post rehydration recoveries of the RBCs. Finally, we developed a new radio frequency (RF) lyophilization device for a more rapid and homogeneous sublimation process of the frozen RBCs samples. Recovery and free Hb were measured as well as oxygen association/dissociation and cell's deformability. We found that IMT3 (0.3 M trehalose and 10% HSA) solution that was directionally frozen at a rapid interface velocity of 1 mm/sec (resulting in a cooling rate of 150°C/min) yielded the best results (better than IMT2 solution and slow interface velocity). Freeze thawing gave 100% survival, while freeze drying followed by rehydration with 20% dextran-40k

  11. Preservation of differentiation and clonogenic potential of human hematopoietic stem and progenitor cells during lyophilization and ambient storage.

    Directory of Open Access Journals (Sweden)

    Sandhya S Buchanan

    Full Text Available Progenitor cell therapies show great promise, but their potential for clinical applications requires improved storage and transportation. Desiccated cells stored at ambient temperature would provide economic and practical advantages over approaches employing cell freezing and subzero temperature storage. The objectives of this study were to assess a method for loading the stabilizing sugar, trehalose, into hematopoietic stem and progenitor cells (HPC and to evaluate the effects of subsequent freeze-drying and storage at ambient temperature on differentiation and clonogenic potential. HPC were isolated from human umbilical cord blood and loaded with trehalose using an endogenous cell surface receptor, termed P2Z. Solution containing trehalose-loaded HPC was placed into vials, which were transferred to a tray freeze-dryer and removed during each step of the freeze-drying process to assess differentiation and clonogenic potential. Control groups for these experiments were freshly isolated HPC. Control cells formed 1450+/-230 CFU-GM, 430+/-140 BFU-E, and 50+/-40 CFU-GEMM per 50 microL. Compared to the values for the control cells, there was no statistical difference observed for cells removed at the end of the freezing step or at the end of primary drying. There was a gradual decrease in the number of CFU-GM and BFU-E for cells removed at different temperatures during secondary drying; however, there were no significant differences in the number of CFU-GEMM. To determine storage stability of lyophilized HPC, cells were stored for 4 weeks at 25 degrees C in the dark. Cells reconstituted immediately after lyophilization produced 580+/-90 CFU-GM ( approximately 40%, relative to unprocessed controls p<0.0001, 170+/-70 BFU-E (approximately 40%, p<0.0001, and 41+/-22 CFU-GEMM (approximately 82%, p = 0.4171, and cells reconstituted after 28 days at room temperature produced 513+/-170 CFU-GM (approximately 35%, relative to unprocessed controls, p<0

  12. X-ray absorption spectroscopy of soybean lipoxygenase-1 : Influence of lipid hydroperoxide activation and lyophilization on the structure of the non-heme iron active site

    NARCIS (Netherlands)

    Vliegenthart, J.F.G.; Heijdt, L.M. van der; Feiters, M.C.; Navaratnam, S.; Nolting, H.-F.; Hermes, C.; Veldink, G.A.

    1992-01-01

    X-ray absorption spectra at the Fe K-edge of the non-heme iron site in Fe(II) as well as Fe(III) soybean lipoxygenase-1, in frozen solution or lyophilized, are presented; the latter spectra were obtained by incubation of the Fe(II) enzyme with its product hydroperoxide. An edge shift of about 23 eV

  13. A 10% ready-to-use intravenous human immunoglobulin offers potential economic advantages over a lyophilized product in the treatment of primary immunodeficiency

    NARCIS (Netherlands)

    Kallenberg, C. G. M.

    2007-01-01

    Intravenous immunoglobulin (IVIg) replacement therapy is the standard of care for patients with primary humoral immunodeficiencies. This study evaluated differences in infusion time between a 10% IVIg ready-to-use solution and a 6% IVIg lyophilized product and addressed potential cost implications.

  14. Simple and rapid quantification of total carotenoids in lyophilized apricots (prunus armeniaca L.) by means of reflectance colorimetry and photoacoustic spectrometry spectroscopy

    NARCIS (Netherlands)

    Doka, O.; Ficzek, G.; Luterotti, S.; Bicanic, D.D.; Spruijt, R.B.; Buijnsters, J.; Vegvari, G.

    2013-01-01

    Photoacoustic spectroscopy (PAS) and reflectance colorimetry are suggested as new tools for the analysis of total carotenoids in lyophilized apricot powders. The data obtained by these two techniques from seven apricot cultivars were compared to those acquired by spectrophotometry and high-performan

  15. Fast Disintegrating Quercetin-Loaded Drug Delivery Systems Fabricated Using Coaxial Electrospinning

    Directory of Open Access Journals (Sweden)

    Xiao-Yan Li

    2013-10-01

    Full Text Available The objective of this study is to develop a structural nanocomposite of multiple components in the form of core-sheath nanofibres using coaxial electrospinning for the fast dissolving of a poorly water-soluble drug quercetin. Under the selected conditions, core-sheath nanofibres with quercetin and sodium dodecyl sulphate (SDS distributed in the core and sheath part of nanofibres, respectively, were successfully generated, and the drug content in the nanofibres was able to be controlled simply through manipulating the core fluid flow rates. Field emission scanning electron microscope (FESEM images demonstrated that the nanofibres prepared from the single sheath fluid and double core/sheath fluids (with core-to-sheath flow rate ratios of 0.4 and 0.7 have linear morphology with a uniform structure and smooth surface. The TEM images clearly demonstrated the core-sheath structures of the produced nanocomposites. Differential scanning calorimetry (DSC and X-ray diffraction (XRD results verified that quercetin and SDS were well distributed in the polyvinylpyrrolidone (PVP matrix in an amorphous state, due to the favourite second-order interactions. In vitro dissolution studies showed that the core-sheath composite nanofibre mats could disintegrate rapidly to release quercetin within 1 min. The study reported here provides an example of the systematic design, preparation, characterization and application of a new type of structural nanocomposite as a fast-disintegrating drug delivery system.

  16. Disintegration of the self and the regeneration of 'psychic skin' in the treatment of traumatized refugees.

    Science.gov (United States)

    Luci, Monica

    2017-04-01

    This paper presents a tentative understanding of the characteristics of the extreme traumas, elsewhere called 'complex PTSD', that some refugees and asylum-seekers bring into therapy. It suggests that these kinds of traumas suffered during adulthood may involve a disintegration of the self and a loss of 'psychic skin'. This conceptualization is derived from the treatment of a refugee who survived multiple extreme traumas and with whom efforts were made in therapy to identify a complex methodology making use of supplementary therapeutic tools in addition to individual psychotherapy. The case demonstrates how the disintegration of self implies not only a deep somato-psychic dissociation, but also a loss of intrapsychic and interpersonal space. In the treatment this was worked through via repetition of the victim-aggressor dynamics at multiple levels. In the end, the therapeutic context was structured like a set of concentric layers, creating a 'bandage' over the patient's wounds whilst his 'psychic skin' was able to regenerate. The conditions triggered by extreme traumas in refugees challenge some of the cornerstones of individual psychoanalytic technique, as well as the idea that individual therapy may be thought of as existing in an environmental vacuum. © 2017, The Society of Analytical Psychology.

  17. Kinetic modelling of anaerobic hydrolysis of solid wastes, including disintegration processes.

    Science.gov (United States)

    García-Gen, Santiago; Sousbie, Philippe; Rangaraj, Ganesh; Lema, Juan M; Rodríguez, Jorge; Steyer, Jean-Philippe; Torrijos, Michel

    2015-01-01

    A methodology to estimate disintegration and hydrolysis kinetic parameters of solid wastes and validate an ADM1-based anaerobic co-digestion model is presented. Kinetic parameters of the model were calibrated from batch reactor experiments treating individually fruit and vegetable wastes (among other residues) following a new protocol for batch tests. In addition, decoupled disintegration kinetics for readily and slowly biodegradable fractions of solid wastes was considered. Calibrated parameters from batch assays of individual substrates were used to validate the model for a semi-continuous co-digestion operation treating simultaneously 5 fruit and vegetable wastes. The semi-continuous experiment was carried out in a lab-scale CSTR reactor for 15 weeks at organic loading rate ranging between 2.0 and 4.7 gVS/Ld. The model (built in Matlab/Simulink) fit to a large extent the experimental results in both batch and semi-continuous mode and served as a powerful tool to simulate the digestion or co-digestion of solid wastes.

  18. Kinetic modelling of anaerobic hydrolysis of solid wastes, including disintegration processes

    Energy Technology Data Exchange (ETDEWEB)

    García-Gen, Santiago [Department of Chemical Engineering, Institute of Technology, University of Santiago de Compostela, 15782 Santiago de Compostela (Spain); Sousbie, Philippe; Rangaraj, Ganesh [INRA, UR50, Laboratoire de Biotechnologie de l’Environnement, Avenue des Etangs, Narbonne F-11100 (France); Lema, Juan M. [Department of Chemical Engineering, Institute of Technology, University of Santiago de Compostela, 15782 Santiago de Compostela (Spain); Rodríguez, Jorge, E-mail: jrodriguez@masdar.ac.ae [Department of Chemical Engineering, Institute of Technology, University of Santiago de Compostela, 15782 Santiago de Compostela (Spain); Institute Centre for Water and Environment (iWater), Masdar Institute of Science and Technology, PO Box 54224 Abu Dhabi (United Arab Emirates); Steyer, Jean-Philippe; Torrijos, Michel [INRA, UR50, Laboratoire de Biotechnologie de l’Environnement, Avenue des Etangs, Narbonne F-11100 (France)

    2015-01-15

    Highlights: • Fractionation of solid wastes into readily and slowly biodegradable fractions. • Kinetic coefficients estimation from mono-digestion batch assays. • Validation of kinetic coefficients with a co-digestion continuous experiment. • Simulation of batch and continuous experiments with an ADM1-based model. - Abstract: A methodology to estimate disintegration and hydrolysis kinetic parameters of solid wastes and validate an ADM1-based anaerobic co-digestion model is presented. Kinetic parameters of the model were calibrated from batch reactor experiments treating individually fruit and vegetable wastes (among other residues) following a new protocol for batch tests. In addition, decoupled disintegration kinetics for readily and slowly biodegradable fractions of solid wastes was considered. Calibrated parameters from batch assays of individual substrates were used to validate the model for a semi-continuous co-digestion operation treating simultaneously 5 fruit and vegetable wastes. The semi-continuous experiment was carried out in a lab-scale CSTR reactor for 15 weeks at organic loading rate ranging between 2.0 and 4.7 g VS/L d. The model (built in Matlab/Simulink) fit to a large extent the experimental results in both batch and semi-continuous mode and served as a powerful tool to simulate the digestion or co-digestion of solid wastes.

  19. Dis-integration of communication in healthcare education: Workplace learning challenges and opportunities.

    Science.gov (United States)

    Rosenbaum, Marcy E

    2017-11-01

    The purpose of this paper, based on a 2016 Heidelberg International Conference on Communication in Healthcare (ICCH) plenary presentation, is to examine a key problem in communication skills training for health professional learners. Studies have pointed to a decline in medical students' communication skills and attitudes as they proceed through their education, particularly during their clinical workplace training experiences. This paper explores some of the key factors in this disintegration, drawing on selected literature and highlighting some curriculum efforts and research conducted at the University of Iowa Carver College of Medicine as a case study of these issues. Five key factors contributing to the disintegration of communication skills and attitudes are presented including: 1) lack of formal communication skills training during clinical clerkships; 2) informal workplace teaching failing to explicitly address learner clinical communication skills; 3) emphasizing content over process in relation to clinician-patient interactions; 4) the relationship between ideal communication models and the realities of clinical practice; and 5) clinical teachers' lack of knowledge and skills to effectively teach about communication in the clinical workplace. Within this discussion, potential practical responses by individual clinical teachers and broader curricular and faculty development efforts to address each of these factors are presented. Copyright © 2017 Elsevier B.V. All rights reserved.

  20. Comparative Study the Physical Properties of Flow, Solubility and Disintegration of Some Root Canal Sealers

    Directory of Open Access Journals (Sweden)

    Mirian Fátima Zacarro SCELZA

    2006-09-01

    Full Text Available Objective: The aim of this study was to evaluate comparatively the physical properties of solubility, disintegration and flow of some root canal sealers: SEALAPEX™, PULP CANAL SEALER™, TUBLISEAL™, AH PLUS™, AH 26™, TOP SEAL™, SEALER PLUS™, SEALER 26™ and ENDOFILL™. Method: Methodology used was according ISO 6786 which test the physicochemical properties using five proof specimens for each test. Results: In terms of solubility, the root canal sealers analyzed have been classified in the following decreasing order: ENDOFILL™, SEALAPEX™, PULP CANAL SEALER™, AH 26™, TUBLISEAL™, SEALER PLUS™, AH PLUS™, TOP SEAL™ and SEALER 26™, where a statistically significant difference was found at a 1% level. Between TOP SEAL™ and SEALER™ 26 root canal sealers there was no statistically significant difference. None of the sealers above have shown disintegration. Regarding flow, the root canal sealers in the study have been classified in the following decreasing order: TUBLISEAL™ root canal sealer, followed by ENDOFILL™, SEALAPEX™, PULP CANAL SEALER™, AH PLUS™, TOP SEAL™, AH 26™, SEALER 26™ and SEALER PLUS™, where a statistically significant difference was found at a 1% level. Conclusion: The solubility, only the SEALAPEX™ and ENDOFILL™ have shown a limit above determined by ISO 6786.

  1. 葫芦素毫微粒冻干针剂的研究%A Study on Lyophilization Injection of Cucurbitacin Polylactic Acid Nanoparticles

    Institute of Scientific and Technical Information of China (English)

    李超英; 侯世祥; 阳长明; 孙毅毅; 张继芬

    2001-01-01

    目的:制备稳定的、易再分散的葫芦素聚乳酸毫微粒(Cu-PLA-NP)冻干针剂。方法:选用适宜填充剂制备Cu-PLA-NP冻干针剂,并评价其相关理化性质。结果:冻干前后毫微粒形态、粒径、pH、包封率及载药量无明显变化,再分散性良好,制剂稳定,含水量合格。其临界相对湿度为69.52%。结论:在适宜的处方及工艺条件下制备的Cu-PLA-NP冻干针剂是可行的。%Objective:To prepare stable and redispersable Lyophilization injection of cucurbitacin polylactic acid nanoparticles(Cu-PLA-NP).Method:An optimal supporting agent was chosen to prepare the Cu-PLA-NP lyophilization injection.The physical and chemical properties of the injection were evaluated.Result:The shape,diameters,association ratio,drug loading and pH of Cu-PLA-NP colloidal solution and lyophilization injection were not changed.The content of water consisted with the requirement of lyophilization injection.The critical relative humidity was 69.52%.The stability was good.Conclusion:It is practicable to prepare Cu-PLA-NP lyophilization injection with proper formulas and preparation processes.

  2. An integrated process analytical technology (PAT) approach to monitoring the effect of supercooling on lyophilization product and process parameters of model monoclonal antibody formulations.

    Science.gov (United States)

    Awotwe Otoo, David; Agarabi, Cyrus; Khan, Mansoor A

    2014-07-01

    The aim of the present study was to apply an integrated process analytical technology (PAT) approach to control and monitor the effect of the degree of supercooling on critical process and product parameters of a lyophilization cycle. Two concentrations of a mAb formulation were used as models for lyophilization. ControLyo™ technology was applied to control the onset of ice nucleation, whereas tunable diode laser absorption spectroscopy (TDLAS) was utilized as a noninvasive tool for the inline monitoring of the water vapor concentration and vapor flow velocity in the spool during primary drying. The instantaneous measurements were then used to determine the effect of the degree of supercooling on critical process and product parameters. Controlled nucleation resulted in uniform nucleation at lower degrees of supercooling for both formulations, higher sublimation rates, lower mass transfer resistance, lower product temperatures at the sublimation interface, and shorter primary drying times compared with the conventional shelf-ramped freezing. Controlled nucleation also resulted in lyophilized cakes with more elegant and porous structure with no visible collapse or shrinkage, lower specific surface area, and shorter reconstitution times compared with the uncontrolled nucleation. Uncontrolled nucleation however resulted in lyophilized cakes with relatively lower residual moisture contents compared with controlled nucleation. TDLAS proved to be an efficient tool to determine the endpoint of primary drying. There was good agreement between data obtained from TDLAS-based measurements and SMART™ technology. ControLyo™ technology and TDLAS showed great potential as PAT tools to achieve enhanced process monitoring and control during lyophilization cycles. © 2014 Wiley Periodicals, Inc. and the American Pharmacists Association.

  3. Synthesis and characterization of Gd 2O 3:Eu 3+ phosphor nanoparticles by a sol-lyophilization technique

    Science.gov (United States)

    Louis, C.; Bazzi, R.; Flores, Marco A.; Zheng, W.; Lebbou, K.; Tillement, O.; Mercier, B.; Dujardin, C.; Perriat, P.

    2003-07-01

    The characterization and luminescence properties of nanostructured Gd 2O 3:Eu 3+ phosphors synthesized by a sol-lyophilization process are presented. After preparation of gadolinium-based sols from gadolinium nitrate and ammonium hydroxide, the so-prepared sols were freeze dried at -10°C and calcinated at different temperatures. For temperatures lower than 1300 K, highly crystalline samples with the cubic structure can be obtained without concomitant grain growth of the particles (<50 nm). The luminescence spectra contain all possible transitions of Eu 3+ with C2 symmetry and present two major features: an increase of the luminescence efficiencies of the phosphors in comparison with that obtained by solid-state reaction and the presence of an additional peak at about 609 nm at the vicinity of the 5D0→ 7F0…4 transition.

  4. Comparative study and histomorphometric analysis of bone allografts lyophilized and sterilized by autoclaving, gamma irradiation and ethylene oxide in rats

    Directory of Open Access Journals (Sweden)

    Otavio Machado de Almeida

    2013-01-01

    Full Text Available PURPOSE: To compare three sterilization methods (autoclave, gamma irradiation and ethylene oxide over non demineralized lyophilized bone allografts. METHODS: Bone allografts were implanted on paravertebral muscles of 21 rats. After 30 days animals were sacrificed and grafts underwent comparative analysis regarding histomorphometric and macroscopic parameters. RESULTS: Allografts that underwent the three sterilization methods presents similar weight gain, cortical thickness similar to control group, and less fibrosis than the control group. Grafts that underwent sterilization in autoclave presented less presence of multinucleated giant cells, although not statistically significant. There was also no statistically significant difference regarding mineralization on the three groups. CONCLUSION: The three sterilization methods cause similar effects on bone allografts regarding macroscopic and histomorphometric parameters.

  5. Interactions among lactose, β-lactoglobulin and starch in co-lyophilized mixtures as determined by Fourier Transform Infrared Spectroscopy.

    Science.gov (United States)

    Hajihashemi, Zohreh; Nasirpour, Ali; Scher, Joël; Desobry, Stéphane

    2014-11-01

    Processing and storage change food powders containing a large quantity of lactose due to lactose crystallization and interactions among components. Model food systems were prepared by co-lyophilization of lactose, β-lactoglobulin (BLG), and gelatinized starch. A mixture design was used to define the percentage of each mixture component to simulate a wide range of food powders. Interactions among lactose, BLG and starch were studied using Fourier Transform Infrared (FT-IR) at different relative humidities (RH), before and after 3 months storage. Results showed the presence of hydrogen bonds among these components. Moreover, interactions or formation of hydrogen bonds among lactose, starch and BLG preserved BLG against freezing and freeze-drying shocks. Lactose crystallization could be identified by comparing infrared spectra of amorphous and crystallized lactose at O - H and C - H stretching vibration bands.

  6. Wound-Healing Potential of Cultured Epidermal Sheets Is Unaltered after Lyophilization: A Preclinical Study in Comparison to Cryopreserved CES

    Directory of Open Access Journals (Sweden)

    H. Jang

    2013-01-01

    Full Text Available Lyophilized Cultured Epidermal Sheets (L-CES have been reported to be as effective as the cryopreserved CES (F-CES in treating skin ulcers. However, unlike F-CES, no preclinical study assessing wound-healing effects has been conducted for L-CES. The present study was set out to investigate the microstructure, cytokine profile, and wound-healing effects of L-CES in comparison to those of F-CES. Keratinocytes were cultured to prepare CES, followed by cryopreservation at −70°C and lyophilization. Under microscopic observation, intact cells with apparent intracellular junctions were observed in L-CES. The L-CES, like fresh CES, consisted of three to four well-maintained epidermal layers, as shown by the expression of keratins, involucrin, and p63. There were no differences in the epidermal layer or protein expression between L-CES and F-CES, and both CES were comparable to fresh CES. TGF-α, EGF, VEGF, IL-1α, and MMPs were detected in L-CES at levels similar to those in F-CES. In a mouse study, wounds treated with L-CES or F-CES completely healed at least 4 days faster than untreated wounds. CES-treated wounds completely healed by day 10, while the untreated wounds did not heal by day 14. Masson’s trichrome staining showed that collagen deposition in the CES-treated wounds was highly increased in the dermis of the wound center compared to that in the control wounds. Thus, this study demonstrates that L-CES is as clinically effective as F-CES for wound treatment.

  7. Lyophilized allografts without pre-treatment with glutaraldehyde are more suitable than cryopreserved allografts for pulmonary artery reconstruction

    Directory of Open Access Journals (Sweden)

    J.R. Olmos-Zúãiga

    2016-01-01

    Full Text Available Various methods are available for preservation of vascular grafts for pulmonary artery (PA replacement. Lyophilization and cryopreservation reduce antigenicity and prevent thrombosis and calcification in vascular grafts, so both methods can be used to obtain vascular bioprostheses. We evaluated the hemodynamic, gasometric, imaging, and macroscopic and microscopic findings produced by PA reconstruction with lyophilized (LyoPA grafts and cryopreserved (CryoPA grafts in dogs. Eighteen healthy crossbred adult dogs of both sexes weighing between 18 and 20 kg were used and divided into three groups of six: group I, PA section and reanastomosis; group II, PA resection and reconstruction with LyoPA allograft; group III, PA resection and reconstruction with CryoPA allograft. Dogs were evaluated 4 weeks after surgery, and the status of the graft and vascular anastomosis were examined macroscopically and microscopically. No clinical, radiologic, or blood-gas abnormalities were observed during the study. The mean pulmonary artery pressure (MPAP in group III increased significantly at the end of the study compared with baseline (P=0.02 and final [P=0.007, two-way repeat-measures analysis of variance (RM ANOVA] values. Pulmonary vascular resistance of groups II and III increased immediately after reperfusion and also at the end of the study compared to baseline. The increase shown by group III vs group I was significant only if compared with after surgery and study end (P=0.016 and P=0.005, respectively, two-way RM ANOVA. Microscopically, permeability was reduced by ≤75% in group III. In conclusion, substitution of PAs with LyoPA grafts is technically feasible and clinically promising.

  8. Acceptability and safety of novel infant porridges containing lyophilized meat powder and iron-fortified wheat flour.

    Science.gov (United States)

    Pachón, Helena; Domínguez, María Reyna Liria; Creed-Kanashiro, Hilary; Stoltzfus, Rebecca J

    2007-03-01

    Lyophilized meat powder with iron-fortified wheat flour can be used to produce an infant porridge with bioavailable iron, but its acceptability and safety are unknown. To evaluate the acceptability and safety of porridges containing lyophilized meat powder and iron-fortified wheat flour. Peruvian mothers' input was used to develop porridges without (no meat) and with meat powder (low or high chicken liver, low or high chicken thigh). Acceptability was determined by maternal hedonic scoring, 9-day infant intake, and videotape analysis of how well infants liked each porridge. Dry and cooked porridges and meat ingredients were tested for microorganisms; meats were tested for pesticides. Mothers gave higher acceptability scores to the no-meat porridge, followed in order by low and high quantities of meat powder (e.g., mean +/- SD "taste"scores were 4.5 +/- 0.9 for the no-meat, 3.7 +/- 1.1 for the low-liver, and 3.3 +/- 1.1 for the high-liver porridges, p = .0001). Infants' porridge intake did not differ: 61.4 +/- 47.1 g of no-meat, 62.1 +/- 44.9 g of low-thigh, and 67.5 +/- 42.0 g of low-liver (p = .7), as supported by the video analysis. Microbiologic safety was acceptable except for marginally acceptable molds and yeasts in dry ingredients. No pesticide residues were detected. Despite mothers' clear preference for no-meat porridges, infants consumed equal amounts of porridges with and without meat. Thus, if mothers can be convinced to feed the meat-containing porridges to the infants despite their own preferences, the infants will consume these porridges. The mold and yeast content of the porridge ingredients must be reduced.

  9. Lyophilized allografts without pre-treatment with glutaraldehyde are more suitable than cryopreserved allografts for pulmonary artery reconstruction

    Energy Technology Data Exchange (ETDEWEB)

    Olmos-Zúãiga, J.R.; Jasso-Victoria, R. [Department of Experimental Surgery, National Institute of Respiratory Diseases ' Ismael Cosío Villegas' , Mexico City (Mexico); Díaz-Martínez, N.E. [Medical and Pharmaceutical Biotechnology, Center for Research and Assistance in Technology and Design of the State of Jalisco, Guadalajara, Jalisco (Mexico); Gaxiola-Gaxiola, M.O. [Laboratory of Morphology, National Institute of Respiratory Diseases ' Ismael Cosío Villegas' , Mexico City (Mexico); Sotres-Vega, A.; Heras-Romero, Y.; Baltazares-Lipp, M. [Department of Experimental Surgery, National Institute of Respiratory Diseases ' Ismael Cosío Villegas' , Mexico City (Mexico); Baltazares-Lipp, M.E. [Hemodynamics and Echocardiography Service, National Institute of Respiratory Diseases ' Ismael Cosío Villegas' , Mexico City (Mexico); Santillán-Doherty, P. [Medical Administration, National Institute of Respiratory Diseases ' Ismael Cosío Villegas' , Mexico City (Mexico); Hernández-Jiménez, C. [Department of Experimental Surgery, National Institute of Respiratory Diseases ' Ismael Cosío Villegas' , Mexico City (Mexico)

    2015-12-04

    Various methods are available for preservation of vascular grafts for pulmonary artery (PA) replacement. Lyophilization and cryopreservation reduce antigenicity and prevent thrombosis and calcification in vascular grafts, so both methods can be used to obtain vascular bioprostheses. We evaluated the hemodynamic, gasometric, imaging, and macroscopic and microscopic findings produced by PA reconstruction with lyophilized (LyoPA) grafts and cryopreserved (CryoPA) grafts in dogs. Eighteen healthy crossbred adult dogs of both sexes weighing between 18 and 20 kg were used and divided into three groups of six: group I, PA section and reanastomosis; group II, PA resection and reconstruction with LyoPA allograft; group III, PA resection and reconstruction with CryoPA allograft. Dogs were evaluated 4 weeks after surgery, and the status of the graft and vascular anastomosis were examined macroscopically and microscopically. No clinical, radiologic, or blood-gas abnormalities were observed during the study. The mean pulmonary artery pressure (MPAP) in group III increased significantly at the end of the study compared with baseline (P=0.02) and final [P=0.007, two-way repeat-measures analysis of variance (RM ANOVA)] values. Pulmonary vascular resistance of groups II and III increased immediately after reperfusion and also at the end of the study compared to baseline. The increase shown by group III vs group I was significant only if compared with after surgery and study end (P=0.016 and P=0.005, respectively, two-way RM ANOVA). Microscopically, permeability was reduced by ≤75% in group III. In conclusion, substitution of PAs with LyoPA grafts is technically feasible and clinically promising.

  10. The effect of natural biostimulators and slow-disintegrating fertilizers on the quality of rosemary seedlings (Rosmarinus officinalis L.

    Directory of Open Access Journals (Sweden)

    Jelačić Slavica

    2007-01-01

    Full Text Available In the present work the effect of natural biostimulators and different doses of slow disintegrating fertilizer on the quality of rosemary seedlings was studied. Rosemary seedlings were produced in containers, according to the 'speedling system'. During the production of seedlings natural biostimulators Megafol and Viva and microbiological fertilizer Slavol were added. The applied biostimulators made a significant effect on the quality of rosemary seedlings. Different doses of the slow disintegrating fertilizer Scotts (Osmocote Extact were applied (0, 1, 2, 3 and 4 g/l, which also produced a significant influence.

  11. Advance in investigation of zonal disintegration phenomenon%分区破裂化现象的研究进展

    Institute of Scientific and Technical Information of China (English)

    戚承志; 钱七虎; 王明洋; 罗健

    2011-01-01

    通过对分区破裂化现象的发现过程进行回顾、对分区破裂化现象的研究现状进行综述,对深部巷道围岩的受力变形的特点有了更好的认识,并利用弹塑性理论、断裂力学理论、非线性科学理论等对分区破裂化现象形成的机理进行了探索,得到了一些有益的结论.在现场观测到了分区破裂化现象,从试验上再现了分区破裂化现象的一些主要特点,在数值模拟方面能够定性地模拟这一现象.但还有很多问题没有解决,包括岩体的力学性质及结构特性对于分区破裂化现象时间演化过程的影响、分区破裂化现象与受损岩石变形增量变符号现象之间的关系、岩爆与分区破裂化现象之间的关系问题等.%The finding process of the zonal disintegration phenomenon was reviewed, and the state-of-the-art of investigations of zonal disintegration phenomenon overviewed. The review shows that our understanding on the stressing and the deformation of the rock mass near the deep level openings has been greatly improved. This phenomenon was investigated with the help of the elasticity and plasticity theories, fracture mechanics and nonlinear science etc. , and many helpful conclusions reached. In situ observations the existence of zonal disintegration phenomenon was observed, laboratory model experiments reproduced the main features of zonal disintegration phenomenon,and numerical modeling qualitatively reproduced zonal disintegration phenomenon. But many problems still exist, including the influence of the mechanical and the structural properties of the rock mass on the temporal evolution process of the zonal disintegration, the relationship between the zonal disintegration and the phenomenon of the sign change of deformation increment after the beginning of the damaging process in rock, the relationship between the zonal disintegration and the rock bursts etc.

  12. ANOMALIES ON EEG IN PATIENTS WITH COGNITIVE EPILEPTIFORM DISINTEGRATION AND EPILEPTIC ENCEPHALOPATHIES, ASSOCIATED WITH С BENIGN EPILEPTIFORM PATTERNS OF CHILDHOOD

    Directory of Open Access Journals (Sweden)

    M. B. Mironov

    2012-01-01

    Full Text Available On background of review and discussion of current scientific literature è own data the article presents the main clinical characteristics and anomalies on EEG in patients with cognitive epileptiform disintegration and epileptic encephalopathies, associated with ñ benign epileptiform patterns of childhood. The author describes in detail EEGpatterns — continuous spike and wave activity during sleep and benign epileptiform patterns of childhood, the role of these patterns and their special features in different syndromes of cognitive epileptiform disintegration. The article illustrated own data of the author.

  13. Toxicological evaluation of the lyophilized fruit juice extract of Annona muricata Linn. (Annonaceae) in rodents.

    Science.gov (United States)

    Awodele, Olufunsho; Ishola, Ismail O; Ikumawoyi, Victor O; Akindele, Abidemi J; Akintonwa, Alade

    2013-12-18

    Abstract Background: Annona muricata Linn. (Annonaceae) (AM) fruit juice is widely consumed either raw or after processing in tropical countries because of its very juicy, creamy and sweet character including its medicinal importance. The safety of AM fruit was investigated in Sprague-Dawley rats for acute and 60-day subchronic toxicity effects. Methods: Rats were administered distilled water (DW) and AM daily at doses of 80, 400 and 2000 mg/kg orally for 60 days. At the end of the study, blood samples were assayed for biochemical and hematological parameters. Vital organs were harvested and assessed for antioxidants and histopathology. Results: There was no mortality recorded up to 2000 mg/kg following acute administration. There were no significant changes in vital organ weights and hematological and biochemical parameters. However, significant (p<0.05) reduction in platelet count and packed cell volume was observed at 2000 and 400 mg/kg, respectively, which was reversed after cessation of treatment. Interestingly, subchronic oral administration of AM (80, 400 or 2000 mg/kg) significantly (p<0.001) increased sperm count and motility in comparison to vehicle-treated control. AM long-term treatment induced significant (p<0.05, <0.01 and <0.001) increases in the levels of glutathione, superoxide dismutase (SOD) and catalase, respectively, in the liver and kidney. Conversely, AM (2000 mg/kg) produced significant (p<0.001) increase in malondialdehyde level with decreased (p<0.05) SOD activity in the brain. Conclusions: The study established that AM did not induce any significant toxic effect, indicating that it is safe in rats following oral administration for 60 consecutive days.

  14. Oral Histoplasmosis.

    Science.gov (United States)

    Folk, Gillian A; Nelson, Brenda L

    2017-02-20

    A 44-year-old female presented to her general dentist with the chief complaint of a painful mouth sore of 2 weeks duration. Clinical examination revealed an irregularly shaped ulcer of the buccal and lingual attached gingiva of the anterior mandible. A biopsy was performed and microscopic evaluation revealed histoplasmosis. Histoplasmosis, caused by Histoplasma capsulate, is the most common fungal infection in the United States. Oral lesions of histoplasmosis are generally associated with the disseminated form of histoplasmosis and may present as a fungating or ulcerative lesion of the oral mucosa. The histologic findings and differential diagnosis for oral histoplasmosis are discussed.

  15. Oral leukoplakia

    DEFF Research Database (Denmark)

    Holmstrup, Palle; Dabelsteen, Erik

    2016-01-01

    The idea of identifying oral lesions with a precancerous nature, i.e. in the sense of pertaining to a pathologic process with an increased risk for future malignant development, of course is to prevent frank malignancy to occur in the affected area. The most common oral lesion with a precancerous...... nature is oral leukoplakia, and for decades it has been discussed how to treat these lesions. Various treatment modalities, such as systemic therapies and surgical removal, have been suggested. The systemic therapies tested so far include retinoids, extracts of green tea, inhibitors of cyclooxygenase-2...

  16. Oral pathology.

    Science.gov (United States)

    Niemiec, Brook A

    2008-05-01

    Oral disease is exceedingly common in small animal patients. In addition, there is a very wide variety of pathologies that are encountered within the oral cavity. These conditions often cause significant pain and/or localized and systemic infection; however, the majority of these conditions have little to no obvious clinical signs. Therefore, diagnosis is not typically made until late in the disease course. Knowledge of these diseases will better equip the practitioner to effectively treat them. This article covers the more common forms of oral pathology in the dog and cat, excluding periodontal disease, which is covered in its own chapter. The various pathologies are presented in graphic form, and the etiology, clinical signs, recommended diagnostic tests, and treatment options are discussed. Pathologies that are covered include: persistent deciduous teeth, fractured teeth, intrinsically stained teeth, feline tooth resorption, caries, oral neoplasia, eosinophilic granuloma complex, lymphoplasmacytic gingivostomatitis, enamel hypoplasia, and "missing" teeth.

  17. Herpes - oral

    Science.gov (United States)

    ... this page: //medlineplus.gov/ency/article/000606.htm Herpes - oral To use the sharing features on this page, ... 374. Read More Atopic dermatitis Cancer Fever Genital herpes Mouth ulcers Vesicles Review Date 8/14/2015 Updated ...

  18. Disparities in Oral Health

    Science.gov (United States)

    ... 2020: Oral Health Objectives Site Map Disparities in Oral Health Recommend on Facebook Tweet Share Compartir Oral health ... to get and keep dental insurance. Disparities in Oral Health Some of the oral health disparities that exist ...

  19. Is the corporate elite disintegrating? Interlock boards and the Mizruchi hypothesis

    CERN Document Server

    Mentzer, Kevin; Haughton, Dominique; Latouche, Pierre; Rossi, Fabrice

    2016-01-01

    This paper proposes an approach for comparing interlocked board networks over time to test for statistically significant change. In addition to contributing to the conversation about whether the Mizruchi hypothesis (that a disintegration of power is occurring within the corporate elite) holds or not, we propose novel methods to handle a longitudinal investigation of a series of social networks where the nodes undergo a few modifications at each time point. Methodologically, our contribution is twofold: we extend a Bayesian model hereto applied to compare two time periods to a longer time period, and we define and employ the concept of a hull of a sequence of social networks, which makes it possible to circumvent the problem of changing nodes over time.

  20. Disintegration of Magnetic Flux in Decaying Sunspots as Observed with the Hinode SOT

    CERN Document Server

    Kubo, M; Ichimoto, K; Shimizu, T; Suematsu, Y; Katsukawa, Y; Tarbell, T D; Shine, R A; Title, A M; Nagata, S; Tsuneta, S

    2008-01-01

    Continuous observations of sunspot penumbrae with the Solar Optical Telescope aboard \\textit{Hinode} clearly show that the outer boundary of the penumbra fluctuates around its averaged position. The penumbral outer boundary moves inward when granules appear in the outer penumbra. We discover that such granules appear one after another while moving magnetic features (MMFs) are separating from the penumbral ``spines'' (penumbral features that have stronger and more vertical fields than those of their surroundings). These granules that appear in the outer penumbra often merge with bright features inside the penumbra that move with the spines as they elongate toward the moat region. This suggests that convective motions around the penumbral outer boundary are related to the disintegration of magnetic flux in the sunspot. We also find that dark penumbral filaments frequently elongate into the moat region in the vicinity of MMFs that detach from penumbral spines. Such elongating dark penumbral filaments correspond ...

  1. Development and disintegration of Maya political systems in response to climate change.

    Science.gov (United States)

    Kennett, Douglas J; Breitenbach, Sebastian F M; Aquino, Valorie V; Asmerom, Yemane; Awe, Jaime; Baldini, James U L; Bartlein, Patrick; Culleton, Brendan J; Ebert, Claire; Jazwa, Christopher; Macri, Martha J; Marwan, Norbert; Polyak, Victor; Prufer, Keith M; Ridley, Harriet E; Sodemann, Harald; Winterhalder, Bruce; Haug, Gerald H

    2012-11-09

    The role of climate change in the development and demise of Classic Maya civilization (300 to 1000 C.E.) remains controversial because of the absence of well-dated climate and archaeological sequences. We present a precisely dated subannual climate record for the past 2000 years from Yok Balum Cave, Belize. From comparison of this record with historical events compiled from well-dated stone monuments, we propose that anomalously high rainfall favored unprecedented population expansion and the proliferation of political centers between 440 and 660 C.E. This was followed by a drying trend between 660 and 1000 C.E. that triggered the balkanization of polities, increased warfare, and the asynchronous disintegration of polities, followed by population collapse in the context of an extended drought between 1020 and 1100 C.E.

  2. Disintegration of sewage sludge - an economically efficient alternative?; Desintegration von Klaerschlamm - eine wirtschaftliche Alternative?

    Energy Technology Data Exchange (ETDEWEB)

    Nickel, K. [ULTRAWAVES Wasser- und Umwelttechnologien GmbH, Hamburg (Germany); Neis, U. [Technische Univ. Hamburg-Harburg, Hamburg (Germany). Arbeitsbereich Abwasserwirtschaft

    2003-07-01

    The solid fraction of biological sewage sludge is mostly comprised of organic cell substance. Thermal, chemical or mechanical treatment will release organic compounds from the cells for better biodegradation. This contribution discusses the applicability of ultrasonic treatment for disintegration of sludge cells. For this, extensive research was carried out at the Technical University of Hamburg-Harburg. (orig.) [German] Die Feststoffe biologischer Klaerschlaemme bestehen zu grossem Teil aus organischer Zellsubstanz. Durch einen thermischen, chemischen oder mechanischen Aufschluss des Zellmaterials koennen organische Verbindungen aus dem Zellinneren freigesetzt werden und sind damit dem nachfolgenden biologischen Abbau besser zugaenglich. Den Ueberblick ueber die verschiedenen Desintegrationsverfahren gibt ein separater Beitrag dieser Veranstaltung. Dieses Paper beschaeftigt sich mit dem Einsatz der Ultraschallbehandlung zur Desintegration von Schlammzellen. Zu diesem Verfahren wurden umfangreiche Erkenntnisse in langjaehrigen Forschungsarbeiten an der Technischen Universitaet Hamburg-Harburg gesammelt. (orig.)

  3. Scintigraphic study of gastrointestinal transit and disintegration sites of mesalazine tablets labelled with technetium 99m

    Energy Technology Data Exchange (ETDEWEB)

    Sciarretta, G.; Furno, A.; Mazzoni, M.; Ferrieri, A.; Malaguti, P. (Ospedale Maggiore, Bologna (Italy))

    1993-09-01

    Tablets of mesalazine covered with a pH-dependent coating, labelled by an original technique with technetium-99m, were administered to 12 patients, 9 with Crohn's disease, 3 of which recurrent, 1 with ulcerative colitis, and 2 with irritable bowel syndrome, with the aim of verifying in vivo the intestinal site of disintegration and how the contents spread throughout the intestine. In all cases the tablet was broken down in the distal ileum at extremely variable intervals, from 5 to 27 h, and the contents spread into the nearby loops and into the colon. The notable differences in the residence time of the whole tablet in the ileum can be explained by differences in adhesion the inflamed mucosa and by a lower pH in the part of the ileum affected by the disease. 7 refs., 2 figs., 1 tab.

  4. Extruded, partially disintegrated, poly-HEMA orbital implant (AlphaSphere).

    Science.gov (United States)

    Yadav, Prashant; Jakobiec, Frederick A; De Castro, Dawn K; Mendoza, Pia R; Fay, Aaron

    2014-01-01

    A 54-year-old diabetic man underwent enucleation for endophthalmitis. Secondary implantation of a 2-hydroxyethyl methacrylate (HEMA) sphere (AlphaSphere, Addition Technology) was performed 2 weeks later. Six weeks after insertion, noninfectious disintegration of sutured tissue planes represented by Tenon's capsule, rectus muscle, and conjunctiva occurred, requiring removal of the fragmenting implant before uncontrolled extrusion occurred. Histopathologic analysis revealed an absence of infectious pathogens and no tissue necrosis, but rather breakup of the implant material that elicited a granulomatous response with sparse T-lymphocytes and almost no polymorphonuclear leukocytes. This distinctively designed poly-HEMA orbital implant incited a dramatic and irreversible host tissue response. Investigation of other cases will be necessary to determine the frequency of such a complication and should include rigorous histopathologic techniques.

  5. Evaluation of Rapidly Disintegrating Vaginal Tablets of Tenofovir, Emtricitabine and Their Combination for HIV-1 Prevention

    Directory of Open Access Journals (Sweden)

    Meredith R. Clark

    2014-12-01

    Full Text Available Vaginal tablets are being developed as an alternative to gels as an inexpensive, discreet dosage form for the administration of microbicides. This work describes the pharmacokinetic (PK evaluation of rapidly disintegrating vaginal tablets containing tenofovir (TFV, 10 mg, emtricitabine (FTC, 10 mg, and the combination of TFV and FTC (10 mg each under in vitro and in vivo conditions, and in direct comparison to the clinical TFV 1% gel, a microbicide product in Phase III clinical testing. The PK of TFV and FTC from tablets were also evaluated in female rabbits following intravaginal administration. Direct comparison of a single dose of TFV tablets (intact or predissolved at 10 mg/mL and TFV 1% gel showed no differences in the vaginal PK of TFV between groups; however systemic bioavailability of TFV was significantly higher from the gel. When rabbits were dosed either once or daily for seven days with intact tablets of TFV, FTC, or the combination of TFV/FTC, vaginal and systemic concentrations of TFV and FTC were unaffected by co-formulation. Moreover, plasma PK parameters were similar following a single dose or seven once-daily doses. Tissue concentrations of TFV and FTC in the cranial vagina 4 h after administration ranged between 104 and 105 ng/g. Concentrations of TFV-diphospate (TFV-DP, the active metabolite were also high (over 103 ng/g or about 3000 to 6000 fmol/mg in the cranial vagina 4 h after administration and similar to those measured following administration of TFV 1% gel. These data demonstrate that rapidly disintegrating vaginal tablets may be a suitable topical microbicide dosage form providing similar vaginal TFV PK to that of TFV 1% gel. The data also support co-administration of FTC with TFV in a single vaginal tablet to create a combination microbicide in a simple and inexpensive dosage form.

  6. STUDY ON THE EFFECTS OF VARIOUS DISINTEGRANTS ON AMOXICILLIN TRIHYDRATE DISPERSIBLE TABLETS

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    Jayaprakash S

    2012-05-01

    Full Text Available The objective of this work was to develop a formulation of amoxicillin trihydrate dispersible tablets of 320mg in a low production value, using cheap amoxicillin trihydrate raw materials available in the market, with direct compression or wet granulation method. Amoxicillin trihydrate is a semisynthetic antibiotic, an analogue of ampicillin with a broad spectrum of bactericidal activity against gram +ve and gram –ve organism. Dispersible tablets are uncoated or film coated tablets intended to be dispersed in water before administration giving a homogeneous dispersion. The WHO prefers dispersible dosage form for the elderly and paediatric patients due to its ease in the administration. Amoxicillin trihydrate dispersible tablet was manufactured with the different disintegrants such as maize starch, crospovidone, croscarmellose, sodium starch glycolate, croscarmellose. The powder blend was evaluated for angle of repose, bulk density, tapped density, compressibility index and hausner’s ratio. After compression the tablets were subjected to weight variation, %drug content, buoyancy studies and in-vitro release studies. The wet granulation was excluded from the formulation due to its high cost if production, direct compression was selected due to its low cost and ease of production. The optimized formulation F10 had showed 99.11% of drug release in 40 min and disintegration of tablet was 25 seconds. The result of FTIR analysis of pure drug alone and drug with excipients there was not showed any physical and chemical interaction. F10 had undergone DTA, which shows the thermal stability of the formulation. The stability studies of optimized formulation F10 at 30◦C / 65%RH, 40◦C / 75%RH did not show any change in tested parameters and release.

  7. Characterization of procoagulant extracellular vesicles and platelet membrane disintegration in DMSO-cryopreserved platelets

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    Tseday Z. Tegegn

    2016-05-01

    Full Text Available Background: Freezing is promising for extended platelet (PLT storage for transfusion. 6% DMSO cryopreserved PLTs (CPPs are currently in clinical development. CPPs contain significant amount of platelet membrane vesicles (PMVs. PLT-membrane changes and PMV release in CPP are poorly understood, and haemostatic effects of CPP PMVs are not fully elucidated. This study aims to investigate PLT-membrane alterations in CPPs and provide comprehensive characterization of CPP PMVs, and their contribution to procoagulant activity (PCA of CPPs. Methods: CPPs and corresponding liquid-stored PLTs (LSPs were characterized by flow cytometry (FC, fluorescence polarization (FP, nanoparticle tracking analysis (NTA, electron microscopy (SEM, TEM, atomic force microscopy (AFM and thrombin-generation (TG test. Results: SEM and TEM revealed disintegration and vesiculation of the PLT-plasma membrane and loss of intracellular organization in 60% PLTs in CPPs. FP demonstrated that 6% DMSO alone and with freezing–thawing caused marked increase in PLT-membrane fluidity. The FC counts of annexin V-binding PMVs and CD41a+ PMVs were 68- and 56-folds higher, respectively, in CPPs than in LSPs. The AFM and NTA size distribution of PMVs in CPPs indicated a peak diameter of 100 nm, corresponding to exosome-size vesicles. TG-based PCA of CPPs was 2- and 9-folds higher per PLT and per volume, respectively, compared to LSPs. Differential centrifugation showed that CPP supernatant contributed 26% to CPP TG-PCA, mostly by the exosome-size PMVs and their TG-PCA was phosphatidylserine dependent. Conclusions: Major portion of CPPs does not show activation phenotype but exhibits grape-like membrane disintegration with significant increase of membrane fluidity induced by 6% DMSO alone and further aggravated by freezing–thawing process. DMSO cryopreservation of PLTs is associated with the release of PMVs and marked increase of TG-PCA, as compared to LSPs. Exosome-size PMVs have

  8. The disintegration of populations of underwater plants in soft water lakes enriched with acidic organic matter

    Directory of Open Access Journals (Sweden)

    Józef Szmeja

    2011-01-01

    Full Text Available The characteristics of habitats, individuals and populations of four submerged macrophytes, Lobelia dortmanna L., Isoetes lacustris L., Sphagnum denticulatum Brid. and Fontinalis antipyretica Hedw., were studied in 12 soft water oligohumic lakes which had no inflow of allochtonic DOM and the DOC concentration in the water was <4.0 mg C dm-3 and 13 humic lakes enriched with allochthonous dissolved organic matter (DOM from drained peat bogs and ranging in DOC water concentration from 4.1 to 44.0 mg C dm-3. The analyses of population disintegration were conducted basing on characteristics of individuals (size, habitat, fertility and populations (aggregation density index, settlement index of the population area. The settlement index of the population area for Lobelia, Fontinalis, Isoetes, Sphagnum decreased from 8.4 to 6.2 g d.w. m-2, 4.6 to 0.01 g d.w. m-2, 85.4 to <0.001 g d.w. m-2 and 39.3 to 7.2 g d.w. m-2, respectively. Similar trends were observed in aggregation density. The general pattern of the disintegration of populations of these species was always similar. It was independent of the source macrophytes drew resources from or their susceptibility to environmental changes. Individuals began to be eliminated from the deep and central parts of the population area. The remainder of the populations, which persist in the shallowest, best-illuminated part of the area, are themselves endangered by disturbances caused by wavy motion. The only populations of submerged macrophytes which can survive in polyhumic lakes under such conditions are those which are resistant to disturbances common in the shallow littoral (Lobelia dortmanna, Fontinalis antipyretica.

  9. Solid-assisted melt disintegration (SAMD), a novel technique for metal powder production

    Energy Technology Data Exchange (ETDEWEB)

    Akhlaghi, F. [School of Metallurgy and Materials Engineering, Faculty of Engineering, University of Tehran, P.O. Box 11365-4563, Tehran (Iran, Islamic Republic of) ], E-Mail: fakhlagh@ut.ac.ir; Esfandiari, H. [School of Metallurgy and Materials Engineering, Faculty of Engineering, University of Tehran, P.O. Box 11365-4563, Tehran (Iran, Islamic Republic of)

    2007-04-15

    A new process termed 'solid-assisted melt disintegration (SAMD)' has been developed for the preparation of aluminum alloy powder particles. The method consists of introducing and mixing a specified amount of as-received alumina particles (in the range of +700 to 500 {mu}m) in A356 aluminum melt at the temperature of 715 deg. C. Melt disintegration occurs in 10 min by kinetic energy transfer from a rotating impeller (450 rpm) to the metal via the solid atomizing medium (alumina particles). The resulting mixture of aluminum droplets and alumina particles was cooled in air and screened through 300 {mu}m sieve to separate alumina from solidified aluminum powder particles. A356 aluminum alloy was also gas atomized by using a free-fall atomizer operating by nitrogen gas at the pressure of 1.1 MPa and the sub-300 {mu}m of the produced powder was used as a base of comparison. The SAMD produced powders of diameter above 53 {mu}m were mostly spherical while powders less than 53 {mu}m showed various elongated shapes. No evidence was found for satelliting of small particles on to large ones or agglomerated particles. While gas atomized particles in the +53 {mu}m sieve size range showed some signs of porosity, the SAMD particles were dense and did not show any signs of internal porosity in any of the sieve fractions investigated. Comparison of the microstructure of the SAMD and gas-atomized powders revealed that for the same size powder of A356 alloy, the former exhibited a coarser microstructure as a result of a slower cooling rate.

  10. Comparison of reduction disintegration characteristics of TiO2-rich burdens prepared with sintering process and composite agglomeration process

    Science.gov (United States)

    Yu, Zheng-wei; Li, Guang-hui; Liu, Chen; Zhou, Feng; Peng, Zhi-wei; Jiang, Tao

    2016-04-01

    To reveal the impact of the composite agglomeration process (CAP) on the reduction disintegration properties of TiO2-rich ironmaking burden for a blast furnace, the reduction disintegration indices (RDIs), mineral constituents, and microstructure of the products prepared by the CAP and the traditional sintering process (TSP) were investigated. The results showed that, compared to the sinter with a basicity of 2.0 prepared by the TSP, the RDI+6.3 and the RDI+3.15 of the CAP product with the same basicity increased by 28.2wt% and 13.7wt%, respectively, whereas the RDI-0.5 decreased by 2.7wt%. The analysis of the mineral constituents and microstructure of the products indicated that the decreasing titanohematite content decreased the volume expansion during reduction. Meanwhile, the decreasing perovskite content decreased its detrimental effect on the reduction disintegration properties. In addition, the higher silicoferrite of calcium and aluminum (SFCA) content improved the strength of the CAP product. Together, these factors result in an improvement of the RDI of the CAP products. In addition, compared to the sinter, the reduced CAP products clearly contained fewer cracks, which also led to mitigation of reduction disintegration.

  11. Percolation theory and the role of maize starch as a disintegrant for a low water-soluble drug.

    Science.gov (United States)

    Kimura, Go; Puchkov, Maxim; Betz, Gabriele; Leuenberger, Hans

    2007-01-01

    The objective of the present work is to investigate the presence or absence of a critical concentration of maize starch according to the percolation theory for a truly ternary system with respect to a minimum disintegration time. The results of this study show that the application of percolation theory is not limited to the study of binary systems. In this work it is shown how it can be used to analyze the behavior of binary and ternary systems for caffeine and mefenamic acid formulations containing a starch-based disintegrant. The percolation threshold p(c) can be described by the volumetric ratio of the disintegrant to the drug substance being equal to p(c) = 0.2 (v/v) in in which both components have similar average particle sizes. In addition, the behavior of the disintegration time in the neighborhood of the percolation threshold can be mathematically modeled with the basic equation of the percolation theory yielding a critical exponent q = 0.28 +/- 0.06.

  12. How Deformation Behavior Controls Product Performance After Twin Screw Granulation With High Drug Loads and Crospovidone as Disintegrant.

    Science.gov (United States)

    Meier, Robin; Moll, Klaus-Peter; Krumme, Markus; Kleinebudde, Peter

    2017-01-01

    This study addresses the quantitative influence of 12 different materials (active pharmaceutical ingredients and excipients as surrogate active pharmaceutical ingredients) on the critical quality attributes of twin screw granulated products and subsequently produced tablets. Prestudies demonstrated the significant influence of the chosen model materials (in combination with crospovidone) on the disintegration behavior of the resulting tablets, despite comparable tablet porosities. This study elucidates possible reasons for the varying disintegration behavior by investigating raw material, granule, and tablet properties. An answer could be found in the mechanical properties of the raw materials and the produced granules. Through compressibility studies, the materials could be classified into materials with high compressibility, which deform rather plastically under compression stress, and low compressibility, which display breakages under compression stress. In general, and apart from (pseudo)-polymorphic transformations, brittle materials featured excellent disintegration performance, even at low resulting tablet porosities <8%, whereas plastically deformable materials mostly did not reveal any disintegration. These findings must be considered in the development of simplified formulations with high drug loads, in which the active pharmaceutical ingredient predominantly defines the deformation behavior of the granule.

  13. Comparison of reduction disintegration characteristics of TiO2-rich burdens prepared with sintering process and composite agglomeration process

    Institute of Scientific and Technical Information of China (English)

    Zheng-wei Yu; Guang-hui Li; Chen Liu; Feng Zhou; Zhi-wei Peng; Tao Jiang

    2016-01-01

    To reveal the impact of the composite agglomeration process (CAP) on the reduction disintegration properties of TiO2-rich iron-making burden for a blast furnace, the reduction disintegration indices (RDIs), mineral constituents, and microstructure of the products pre-pared by the CAP and the traditional sintering process (TSP) were investigated. The results showed that, compared to the sinter with a ba-sicity of 2.0 prepared by the TSP, the RDI+6.3 and the RDI+3.15 of the CAP product with the same basicity increased by 28.2wt%and 13.7wt%, respectively, whereas the RDI−0.5 decreased by 2.7wt%. The analysis of the mineral constituents and microstructure of the products indicated that the decreasing titanohematite content decreased the volume expansion during reduction. Meanwhile, the decreasing perovskite content decreased its detrimental effect on the reduction disintegration properties. In addition, the higher silicoferrite of calcium and aluminum (SFCA) content improved the strength of the CAP product. Together, these factors result in an improvement of the RDI of the CAP products. In addition, compared to the sinter, the reduced CAP products clearly contained fewer cracks, which also led to mitigation of reduction disintegration.

  14. Effects of the KIF2C neck peptide on microtubules: lateral disintegration of microtubules and β-structure formation.

    Science.gov (United States)

    Shimizu, Youské; Shimizu, Takashi; Nara, Masayuki; Kikumoto, Mahito; Kojima, Hiroaki; Morii, Hisayuki

    2013-04-01

    Members of the kinesin-13 sub-family, including KIF2C, depolymerize microtubules. The positive charge-rich 'neck' region extending from the N-terminus of the catalytic head is considered to be important in the depolymerization activity. Chemically synthesized peptides, covering the basic region (A182-E200), induced a sigmoidal increase in the turbidity of a microtubule suspension. The increase was suppressed by salt addition or by reduction of basicity by amino acid substitutions. Electron microscopic observations revealed ring structures surrounding the microtubules at high peptide concentrations. Using the peptide A182-D218, we also detected free thin straight filaments, probably protofilaments disintegrated from microtubules. Therefore, the neck region, even without the catalytic head domain, may induce lateral disintegration of microtubules. With microtubules lacking anion-rich C-termini as a result of subtilisin treatment, addition of the peptide induced only a moderate increase in turbidity, and rings and protofilaments were rarely detected, while aggregations, also thought to be caused by lateral disintegration, were often observed in electron micrographs. Thus, the C-termini are not crucial for the action of the peptides in lateral disintegration but contribute to structural stabilization of the protofilaments. Previous structural studies indicated that the neck region of KIF2C is flexible, but our IR analysis suggests that the cation-rich region (K190-A204) forms β-structure in the presence of microtubules, which may be of significance with regard to the action of the neck region. Therefore, the neck region of KIF2C is sufficient to cause disintegration of microtubules into protofilaments, and this may contribute to the ability of KIF2C to cause depolymerization of microtubules.

  15. Predicting protein aggregation during storage in lyophilized solids using solid state amide hydrogen/deuterium exchange with mass spectrometric analysis (ssHDX-MS).

    Science.gov (United States)

    Moorthy, Balakrishnan S; Schultz, Steven G; Kim, Sherry G; Topp, Elizabeth M

    2014-06-02

    Solid state amide hydrogen/deuterium exchange with mass spectrometric analysis (ssHDX-MS) was used to assess the conformation of myoglobin (Mb) in lyophilized formulations, and the results correlated with the extent of aggregation during storage. Mb was colyophilized with sucrose (1:1 or 1:8 w/w), mannitol (1:1 w/w), or NaCl (1:1 w/w) or in the absence of excipients. Immediately after lyophilization, samples of each formulation were analyzed by ssHDX-MS and Fourier transform infrared spectroscopy (FTIR) to assess Mb conformation, and by dynamic light scattering (DLS) and size exclusion chromatography (SEC) to determine the extent of aggregation. The remaining samples were then placed on stability at 25 °C and 60% RH or 40 °C and 75% RH for up to 1 year, withdrawn at intervals, and analyzed for aggregate content by SEC and DLS. In ssHDX-MS of samples immediately after lyophilization (t = 0), Mb was less deuterated in solids containing sucrose (1:1 and 1:8 w/w) than in those containing mannitol (1:1 w/w), NaCl (1:1 w/w), or Mb alone. Deuterium uptake kinetics and peptide mass envelopes also indicated greater Mb structural perturbation in mannitol, NaCl, or Mb-alone samples at t = 0. The extent of deuterium incorporation and kinetic parameters related to rapidly and slowly exchanging amide pools (Nfast, Nslow), measured at t = 0, were highly correlated with the extent of aggregation on storage as measured by SEC. In contrast, the extent of aggregation was weakly correlated with FTIR band intensity and peak position measured at t = 0. The results support the use of ssHDX-MS as a formulation screening tool in developing lyophilized protein drug products.

  16. A Comparative Study to Evaluate the Effect of Different Carbohydrates on the Stability of Immunoglobulin G during Lyophilization and Following Storage

    Directory of Open Access Journals (Sweden)

    Homa Faghihi 1, Sara Merrikhihaghi 1, Abdolhosein Ruholamini Najafabadi 1, Vahid Ramezani 2, Soroush Sardari 3, Alireza Vatanara 1 *

    2016-12-01

    Full Text Available Background: Although the stabilizing effects of cyclodextrins (CDs on the liquid protein formulations have been proven, there is no comprehensive data on evaluation of their effects on the lyophilized antibody powders. In this study, the influence of two CD derivatives namely beta-cyclodextrin (βCD and hydroxypropyl beta-cyclodextrin (HPβCD was compared with trehalose and mannitol regarding the molecular and thermodynamic stability of lyophilized IgG formulations as well as its biological activity. Methods: Sugars were separately added to IgG solutions and lyophilization process was conducted. In each group of carbohydrates, the formulations with lowest amounts of aggregates were examined regarding the biological activity. The storage stability of selected formulations was subsequently determined following 1 and 3 month of storage at 45 °C. Results: Trehalose and HPβCD in the ratios of 80% showed the most stabilizing effects by control of aggregated forms in the orders of 1.02% and 0.83%, respectively. Also, it was shown that trehalose and HPβCD could incomparably preserve IgG activity in values of 100% and 96.5%. The results of DSC and SEM analysis confirmed the existence of crystalline parts in mannitol and βCD formulations of antibody. During the storage time, the lowest rate constant of aggregation was observed in formulations containing trehalose 80% (0.16/month. All prepared formulations were beta-dominant and no fragmentation was detected. Conclusion: Molecular, thermodynamic and biological stability of lyophilized IgG was more desirable in the presence of trehalose and HPβCD in comparison to mannitol and βCD.

  17. Oral candidiasis.

    Science.gov (United States)

    Millsop, Jillian W; Fazel, Nasim

    2016-01-01

    Oral candidiasis (OC) is a common fungal disease encountered in dermatology, most commonly caused by an overgrowth of Candida albicans in the mouth. Although thrush is a well-recognized presentation of OC, it behooves clinicians to be aware of the many other presentations of this disease and how to accurately diagnose and manage these cases. The clinical presentations of OC can be broadly classified as white or erythematous candidiasis, with various subtypes in each category. The treatments include appropriate oral hygiene, topical agents, and systemic medications. This review focuses on the various clinical presentations of OC and treatment options.

  18. Oral myiasis

    Directory of Open Access Journals (Sweden)

    Treville Pereira

    2010-01-01

    Full Text Available Myiasis is a relatively rare condition arising from the invasion of body tissues or cavities of living animals or humans by maggots or larvae of certain species of flies. It is an uncommon clinical condition, being more frequent in underdeveloped countries and hot climate regions, and is associated with poor hygiene, suppurative oral lesions; alcoholism and senility. Its diagnosis is made basically by the presence of larvae. The present article reports a case of oral myiasis involving 20 larvae in a patient with neurological deficiency.

  19. Comparison of lyophilization, and freezing in honey as techniques to preserve cortical bone allografts used to repair experimental femoral defects in domestic adult cats

    Directory of Open Access Journals (Sweden)

    M.P. Ferreira

    2012-04-01

    Full Text Available Cats with orthopedic conditions are a prominent part of the clinical work of veterinary. Conditions such as comminuted fractures, bone tumors and non-unions are often difficult to repair and may require the use of bone grafts for treatment. This study evaluated cortical bone allografts preserved in honey, frozen or lyophilized for correcting long bone defects created in the diaphysis of the right femur of domestic cats (n=24. In the control group (n=6, the defect was repaired using autogenous cortical bone graft. In the remaining animals (n=6/group, the defect was repaired with cortical bone allografts preserved in honey, frozen or lyophilized. Success of graft incorporation and length of time for consolidation were assessed through clinical, radiographic and histological evaluations performed up to 180 days. In the control, frozen, honey and lyophylized groups, respectively, success of graft incorporation was 91.6%, 83.3%, 75%, and 25%, with corresponding mean length of time for consolidation of 83.1, 78, 105 and 120 days. Incorporation percentage in the lyophilized group was significantly lower than in the frozen and control groups. In conclusion, bone grafts preserved in honey or frozen were effective for repairing cortical defects in the femurs of cats as compared to autogenous cortical bone grafts.

  20. Homogenization, lyophilization or acid-extraction of meat products improves iron uptake from cereal-meat product combinations in an in vitro digestion/Caco-2 cell model.

    Science.gov (United States)

    Pachón, Helena; Stoltzfus, Rebecca J; Glahn, Raymond P

    2009-03-01

    The effect of processing (homogenization, lyophilization, acid-extraction) meat products on iron uptake from meat combined with uncooked iron-fortified cereal was evaluated using an in vitro digestion/Caco-2 cell model. Beef was cooked, blended to create smaller meat particles, and combined with electrolytic iron-fortified infant rice cereal. Chicken liver was cooked and blended, lyophilized, or acid-extracted, and combined with FeSO4-fortified wheat flour. In the beef-cereal combination, Caco-2 cell iron uptake, assessed by measuring the ferritin formed by cells, was greater when the beef was blended for the greatest amount of time (360 s) compared with 30 s (P flour combination. Compared to liver blended for 60 s, acid-extraction of liver significantly enhanced iron uptake (P = 0.03) in the liver-flour combination. Homogenization of beef and homogenization, lyophilization, or acid-extraction of chicken liver increases the enhancing effect of meat products on iron absorption in iron-fortified cereals.

  1. Modeling of heat and mass transfer processes for the gap-lyophilization system using the mannitol-trehalose-NaCl formulation.

    Science.gov (United States)

    Kuu, Wei Y; Doty, Mark J; Nisipeanu, Eugen; Rebbeck, Christine L; Cho, Yong K; Smit, Mark H

    2014-09-01

    Gap freezing (GF) is a new concept that was developed to reduce the primary drying time using an alternative freezing process. The purpose of this investigation was to determine the gap-tray heat transfer coefficient, Kgtr , and to investigate the effect of gap lyophilization on cycle reduction of a mannitol-trehalose-NaCl (MTN) formulation. The values of Kgtr were measured using the product temperature profiles in three different configurations: (1) shelf freezing followed by shelf drying (denoted as SF-SD), (2) GF followed by SD (denoted as GF-SD), and (3) GF followed by gap drying (denoted as GF-GD). For the lyophilization cycle using shelf drying (SF-SD), 80% of the heat transferred during primary drying was from the bottom shelf to the vial, versus 20% via radiation from the top shelf. For the lyophilization cycle using gap drying (GF-GD), only 37% of the heat transferred during primary drying was from the bottom shelf to the vial versus 63% via radiation from the top shelf. Furthermore, GF in conjunction with annealing significantly reduces the dry layer resistance of the MTN formulation, which is the opposite of what was observed with a conventional freezing cycle.

  2. Degradation of lycopene and beta-carotene in model systems and in lyophilized guava during ambient storage: kinetics, structure, and matrix effects.

    Science.gov (United States)

    Ferreira, J E M; Rodriguez-Amaya, D B

    2008-10-01

    Being highly unsaturated, carotenoids are susceptible to isomerization and oxidation during the processing and storage of food. In the present study, the degradation of acyclic lycopene and dicyclic beta-carotene in low-moisture and aqueous model systems, as well as in lyophilized guava, during storage at ambient temperature, in the absence or presence of light, was investigated. Both carotenoids followed first order kinetics under the various conditions investigated. Lycopene degraded much faster than beta-carotene in all the model systems. In a comparison of lycopene isolated from guava, tomato, and watermelon, greater losses were observed with lycopene from tomato. Since the model system was identical in the 3 cases, these results indicated that other compounds from the food sources, co-extracted with lycopene, might have influenced the oxidation. Light consistently and strongly promoted degradation under all conditions studied. The susceptibility of lycopene to degradation was much less in lyophilized guava than in the model systems, showing the marked protective influence of the food matrix. Loss of beta-carotene, found at a concentration of about 18 times lower than lycopene, was only slightly lower than that of lycopene in lyophilized guava, indicating that the effect of matrix and/or the initial concentration overshadowed the structural influence.

  3. Softening temperature of lyophilized bovine serum albumin and gamma-globulin as measured by spin-spin relaxation time of protein protons.

    Science.gov (United States)

    Yoshioka, S; Aso, Y; Kojima, S

    1997-04-01

    We investigated the usefulness of the spin-spin relaxation time (T2) of protein protons as a probe for evaluating the molecular flexibility of freeze-dried protein formulations. It is proposed that the microscopic softening temperature determined from changes in the T2 of protein protons (Ts(T2)) is an important characteristic of freeze-dried protein formulations, the glass transition temperature (Tg) of which is generally difficult to determine by differential scanning calorimetry. We determined the molecular flexibility of lyophilized bovine serum albumin (BSA) and bovine gamma-globulin (BGG) by measuring the T2 of protein and water protons as well as the spin-lattice relaxation time (T1) of the latter as a function of temperature. The flexibility of freeze-dried BSA and BGG cakes markedly varied at temperatures above and below the Ts(T2), affecting the stability of the proteins. The denaturation and subsequent aggregation of lyophilized BSA and BGG cakes with a relatively high water content was enhanced in the softened state at temperatures above the Ts(T2). Lyophilized cakes with an extremely low water content were significantly denatured, even in the unsoftened state at temperatures below the Ts(T2), probably due to the thermodynamically unstable structures of protein molecules generated by a loss of structural water.

  4. Reconstruction of Rabbit Corneal Layer Composed of Corneal Fibroblasts and Corneal Epithelium on the Lyophilized Amniotic Membrane

    Institute of Scientific and Technical Information of China (English)

    2006-01-01

    Many researchers have employed the cryopreserved amniotic membrane(CAM) and corneal epithelial cells in the treatment of a severely damaged burned cornea, with corneal epithelial cells cultured on an amniotic membrane (AM). The lyophilized amniotic membrane (LAM) has a higher graft take and a longer shelf life; it is easier to store and safer because of gamma irradiation. Two Teflon rings(Ahn's supporter) were made for culturing the cells on the LAM, and were then used to support the LAM. To reconstruct a corneal layer composed of corneal fibroblasts and epithelium, the corneal fibroblasts were first cultivated on the stromal side of LAM for five days, followed by epithelial cells culture on the epithelial side, by using the air-liquid interface culture. The reconstructed corneal layer composed of corneal fibroblasts and corneal epithelial cells has a much healthier basal layer of corneal epithelium than the reconstructed corneal epithelium, which was got by using only corneal epithelial cells, and resembles the epithelium of normal corneas, without the horny layer. Thus, the reconstruction of the corneal layer by using a LAM is considered to be a good in vitro model, not only for its application in toxicological test kits, but also for transplantation in patients with a severely damaged cornea.

  5. Precipitation-lyophilization-homogenization (PLH) for preparation of clarithromycin nanocrystals: influencing factors on physicochemical properties and stability.

    Science.gov (United States)

    Morakul, Boontida; Suksiriworapong, Jiraphong; Leanpolchareanchai, Jiraporn; Junyaprasert, Varaporn Buraphacheep

    2013-11-30

    Nanocrystals is one of effective technologies used to improve solubility and dissolution behavior of poorly soluble drugs. Clarithromycin is classified in BCS class II having low bioavailability due to very low dissolution behavior. The main purpose of this study was to investigate an efficiency of clarithromycin nanocrystals preparation by precipitation-lyophilization-homogenization (PLH) combination method in comparison with high pressure homogenization (HPH) method. The factors influencing particle size reduction and physical stability were assessed. The results showed that the PLH technique provided an effective and rapid reduction of particle size of nanocrystals to 460 ± 10 nm with homogeneity size distribution after only the fifth cycle of homogenization, whereas the same size was attained after 30 cycles by the HPH method. The smallest nanocrystals were achieved by using the combination of poloxamer 407 (2%, w/v) and SLS (0.1%, w/v) as stabilizers. This combination could prevent the particle aggregation over 3-month storage at 4 °C. The results from SEM showed that the clarithromycin nanocrystals were in cubic-shaped similar to its initial particle morphology. The DSC thermogram and X-ray diffraction pattern of nanocrystals were not different from the original drug except for intensity of peaks which indicated the presenting of nanocrystals in the crystalline state and/or partial amorphous form. In addition, the dissolution of the clarithromycin nanocrystals was dramatically increased as compared to the coarse clarithromycin.

  6. Comparison of Lyophilized Glutaraldehyde-Preserved Bovine Pericardium with Different Vascular Prostheses for Use as Vocal Cords Implants: Experimental Study

    Science.gov (United States)

    Olmos-Zuñiga, J. Raúl; Jasso-Victoria, Rogelio; Gaxiola-Gaxiola, Miguel; Sotres-Vega, Avelina; Hernández-Jiménez, Claudia; Baltazares-Lipp, Matilde; Arredondo del Bosque, Fernando; Santillan-Doherty, Patricio

    2015-01-01

    This study compared the use of lyophilized glutaraldehyde-preserved bovine pericardium (LGPBP), polytetrafluoroethylene (PTFE), polyethylene terephthalate (PET), and Teflon felt (TF) as implants for vocal cords (VC) medialization and aimed to assess the endoscopic, macroscopic, and microscopic VC changes after medialization in a canine model. In 18 mongrel dogs, the right VC were medialized with LGPBP and the left were implanted as follows: Group I (n = 6): LGPBP and PTFE; Group II (n = 6): LGPBP and PET; Group III (n = 6): LGPBP and TF. Surgical handling of the implants was compared. Three months after surgery, macroscopic and microscopic changes of VC and implants were evaluated. LGPBP offered the best surgical handling (p = 0.005, Kruskal-Wallis). TF implants showed extrusion (p = 0.005, Kruskal-Wallis) and severe inflammation. All VC formed fibrous capsules around the implants; the ones developed by LGPBP implants were thinner (p = 0.001, ANOVA, Tukey). VC implanted with synthetic materials showed eosinophilic infiltration (p = 0.01, Kruskal-Wallis). We concluded that the LGPBP could be used as an implant for VC medialization because it is biocompatible, easy to handle and remove during surgical procedures, and nonabsorbable or extrudable and produces an inflammatory reaction similar to PTFE and PET. PMID:26075232

  7. The evolving role of lyophilized plasma in remote damage control resuscitation in the French Armed Forces Health Service.

    Science.gov (United States)

    Sailliol, Anne; Martinaud, Christophe; Cap, Andrew P; Civadier, Corinne; Clavier, Benoit; Deshayes, Anne-Virginie; Mendes, Anne-Christine; Pouget, Thomas; Demazeau, Nicolas; Chueca, Marine; Martelet, François-Régis; Ausset, Sylvain

    2013-01-01

    Freeze-dried plasma was developed by the US Army for the resuscitation of combat casualties during World War II. The French Military Blood Institute began producing French lyophilized plasma (FLYP) in 1949, in accordance with French blood product guidelines. Since 2010, a photochemical pathogen inactivation process has been implemented to reduce the remaining transfusion-related infectious risk. All quality controls for this procedure verify that the hemostatic properties of FLYP are conserved. FLYP is compatible with all blood types, can be stored at room temperature for 2 years, and its reconstitution requires less than 6 minutes. As a result, FLYP allows quick delivery of all the coagulation proteins and the application of a 1:1 ratio of FLYP and red blood cells in the context of a massive transfusion. Hemovigilance data collected in France since 1994 have included FLYP. Results indicate no reporting of infection related to the use of FLYP. Clinical monitoring with a focus on hemostasis was implemented in 2002 and expanded in 2010. The data, obtained from overseas operations, confirmed the indications, the safety and the clinical efficacy of FLYP. Further research is needed to determine specific indications for FLYP in the therapeutic management of civilian patients with severe hemorrhage.

  8. Development, Optimization, and Validation of a Green and Stability-Indicating HPLC Method for Determination of Daptomycin in Lyophilized Powder.

    Science.gov (United States)

    Tótoli, Eliane Gandolpho; Salgado, Hérida Regina Nunes

    2015-01-01

    Daptomycin is an antimicrobial that plays an important role in clinical practice today because it is considered a promising drug to combat resistant strains, such as methicilin and vancomycin-resistant Gram-positive bacteria. Considering the analysis of daptomycin in a pharmaceutical dosage form, the only method found in literature uses potentially toxic organic solvents. Therefore, the objective of this work was to develop a green and stability-indicating HPLC method for determination of daptomycin in lyophilized powder. The mobile phase was ethanol-water (55+45, v/v) at pH 4.5 pumped at a flow rate of 0.6 mL/min. A C18 column was used, and UV detection was performed at 221 nm. Stress degradation studies were conducted in order to demonstrate the specificity and stability-indicating capability of the method. The method was validated according to International Conference on Harmonization guidelines, proving to be linear (r=0.9996), precise, accurate, robust (demonstrated by the Plackett-Burman model), and specific within the range 20-70 μg/mL. The retention time of daptomycin was 5.8 min. It can be concluded that the validated method can be a fast, safe, and environmentally friendly alternative for the analysis of daptomycin.

  9. A Preliminary Evaluation of Lyophilized Gelatin Sponges, Enhanced with Platelet-Rich Plasma, Hydroxyapatite and Chitin Whiskers for Bone Regeneration

    Directory of Open Access Journals (Sweden)

    Andrew J. Spence

    2013-04-01

    Full Text Available The purpose of this study was to perform a number of preliminary in vitro evaluations on an array of modified gelatin gel sponge scaffolds for use in a bone graft application. The gelatin gels were modified through the addition of a number of components which each possess unique properties conducive to the creation and regeneration of bone: a preparation rich in growth factors (PRGF, a bioactive, lyophilized form of platelet-rich plasma, hydroxyapatite, and chitin whiskers. Platelet-rich plasma therapy is an emerging practice that has proven effective in a number of clinical applications, including enhancing bone repair through improved deposition of new bony matrix and angiogenesis. As such, the inclusion of PRGF in our gelatin scaffolds was intended to significantly enhance scaffold bioactivity, while the addition of hydroxyapatite and chitin whiskers were anticipated to increase scaffold strength. Additionally, the gelatin sponges, which readily dissolve in aqueous solutions, were subjected to 1-Ethyl-3-[3-dimethylaminopropyl]carbodiimide hydrochloride (EDC cross-linking, either during or post-gelation, to control their rate of degradation. Scaffolds were evaluated in vitro with respect to compressive strength, mass loss/degradation, protein release, and cellular interaction, with results demonstrating the potential of the gelatin gel sponge scaffold for use in the regeneration of bone.

  10. Oral calcitonin

    Directory of Open Access Journals (Sweden)

    Hamdy RC

    2012-09-01

    Full Text Available Ronald C Hamdy,1,2 Dane N Daley11Osteoporosis Center, College of Medicine, East Tennessee State University, 2Veterans Affairs Medical Center, Johnson City, TN, USAAbstract: Calcitonin is a hormone secreted by the C-cells of the thyroid gland in response to elevations of the plasma calcium level. It reduces bone resorption by inhibiting mature active osteoclasts and increases renal calcium excretion. It is used in the management of postmenopausal osteoporosis, Paget's disease of bone, and malignancy-associated hypercalcemia. Synthetic and recombinant calcitonin preparations are available; both have similar pharmacokinetic and pharmacodynamic profiles. As calcitonin is a peptide, the traditional method of administration has been parenteral or intranasal. This hinders its clinical use: adherence with therapy is notoriously low, and withdrawal from clinical trials has been problematic. An oral formulation would be more attractive, practical, and convenient to patients. In addition to its effect on active osteoclasts and renal tubules, calcitonin has an analgesic action, possibly mediated through β-endorphins and the central modulation of pain perception. It also exerts a protective action on cartilage and may be useful in the management of osteoarthritis and possibly rheumatoid arthritis. Oral formulations of calcitonin have been developed using different techniques. The most studied involves drug-delivery carriers such as Eligen® 8-(N-2hydroxy-5-chloro-benzoyl-amino-caprylic acid (5-CNAC (Emisphere Technologies, Cedar Knolls, NJ. Several factors affect the bioavailability and efficacy of orally administered calcitonin, including amount of water used to take the tablet, time of day the tablet is taken, and proximity to intake of a meal. Preliminary results looked promising. Unfortunately, in two Phase III studies, oral calcitonin (0.8 mg with 200 mg 5-CNAC, once a day for postmenopausal osteoporosis and twice a day for osteoarthritis failed to

  11. Development of a Certified Reference Material for Lyophilized Vitamin K 1%维生素 K1冻干标准物质的研制

    Institute of Scientific and Technical Information of China (English)

    张晓光; 黄挺; 张伟; 黄亮; 全灿; 李红梅; 杨屹

    2015-01-01

    采用二甲基亚砜(DMSO)作为冻干标准物质的溶剂,以重量法准确配制维生素 K1/ DMSO 溶液,再进行分装、冷冻干燥,经定性分析、定值分析、均匀性检验、稳定性考察和不确定度评定,研制了维生素 K1冻干标准物质。以维生素 K1纯度标准物质溶液为校准品,对得到的冻干物质进行了高效液相色谱法定值分析,冻干标准物质的准确定值结果为0.96 mg/ mL,相对扩展不确定度为7%。建立的维生素 K1冻干标准物质研制方法,对于临床检验中维生素 K1的准确测定和相关疾病的正确诊断治疗以及维生素 K1长期保存具有重要意义。%Dimethyl sulfone( DMSO)is firstly applied as the solvent for a lyophilized certified reference material (CRM). Vitamin K1 / DMSO solution is prepared by gravimetry,and is sub-divided and lyophilized,the lyophilized vitamin K1 CRM is developed through qualitative analysis,quantitative analysis,homogeneity study,stability study and uncertainty evaluation. Certified value of lyophilization vitamin K1 is analyzed by high performance liquid chromatography method, using the vitamin K1 purity CRM as a calibrant. The certified value is 0. 96 mg/ mL,with the relative expanded uncertainty of 7% . The method of CRM lyophilized vitamin K1 makes great significance for the accurate determination the disease in clinical examination and the long-term preservation of vitamin K1 .

  12. Preparation and Analysis of Lyophilization Characterization of Human D-dimer%人D-二聚体的制备及其冻干性质的分析

    Institute of Scientific and Technical Information of China (English)

    武建伟; 才蕾; 王继华; 唐时幸

    2014-01-01

    以人源纤维蛋白原为原材料制备D-二聚体,将其制成冻干品并分析其冻干性质。使用凝血酶、Factor XIIIa酶解纤维蛋白原,获得交联纤维蛋白。经纤溶酶降解交联纤维蛋白,生成纤维蛋白降解产物。超滤除去纤维蛋白降解产物中的小分子物质,可获得较高纯度的D-二聚体。通过筛选和优化冻干方案,将D-二聚体制备成冻干品。经检测可知,D-二聚体冻干品可在37℃稳定保存12 d;复溶后在25℃稳定保存8 d;复溶后在4℃稳定保存30 d;复溶时,常用复溶溶剂对其复溶后的活性检测无明显影响。%D-dimer is formed by sequential action of 3 enzymes from fibrinogen. After producing D-dimer, we did the research on its lyophilization process. To produce cross-linked fibrin, fibrinogen was digested by thrombin and Factor XIIa. Then, fibrin degradation products (FDP)was prepared from cross-linked fibrin being degraded by plasmin. D-dimer was purified from FDP through ultrafiltration and prepared into lyophilized powder. By optimizing the lyophilization program, lyophilized D-dimer was stable for at least 12 days at 37℃, stable for at least 8 days at 25℃ and 30 days at 4℃ after reconstitution, and not different when being dissolved by different solvent.The preparation system established in this research is feasible and efficient. Depend on its stability, lyophilized D-dimer could be provided as biological raw materials for further research.

  13. Trehalose maintains bioactivity and promotes sustained release of BMP-2 from lyophilized CDHA scaffolds for enhanced osteogenesis in vitro and in vivo.

    Directory of Open Access Journals (Sweden)

    Jun Zhao

    Full Text Available Calcium phosphate (Ca-P scaffolds have been widely employed as a supportive matrix and delivery system for bone tissue engineering. Previous studies using osteoinductive growth factors loaded Ca-P scaffolds via passive adsorption often experience issues associated with easy inactivation and uncontrolled release. In present study, a new delivery system was fabricated using bone morphogenetic protein-2 (BMP-2 loaded calcium-deficient hydroxyapatite (CDHA scaffold by lyophilization with addition of trehalose. The in vitro osteogenesis effects of this formulation were compared with lyophilized BMP-2/CDHA construct without trehalose and absorbed BMP-2/CDHA constructs with or without trehalose. The release characteristics and alkaline phosphatase (ALP activity analyses showed that addition of trehalose could sufficiently protect BMP-2 bioactivity during lyophilization and achieve sustained BMP-2 release from lyophilized CDHA construct in vitro and in vivo. However, absorbed BMP-2/CDHA constructs with or without trehalose showed similar BMP-2 bioactivity and presented a burst release. Quantitative real-time PCR (RT-qPCR and enzyme-linked immunosorbent assay (ELISA demonstrated that lyophilized BMP-2/CDHA construct with trehalose (lyo-tre-BMP-2 promoted osteogenic differentiation of bone marrow stromal cells (bMSCs significantly and this formulation could preserve over 70% protein bioactivity after 5 weeks storage at 25°C. Micro-computed tomography, histological and fluorescent labeling analyses further demonstrated that lyo-tre-BMP-2 formulation combined with bMSCs led to the most percentage of new bone volume (38.79% ± 5.32% and area (40.71% ± 7.14% as well as the most percentage of fluorochrome stained bone area (alizarin red S: 2.64% ± 0.44%, calcein: 6.08% ± 1.37% and mineral apposition rate (4.13 ± 0.62 µm/day in critical-sized rat cranial defects healing. Biomechanical tests also indicated the maximum stiffness (118.17 ± 15.02 Mpa and

  14. Preparation of Lyophilized Epirubicin Long Circulation Liposome Powder%表柔比星长循环脂质体冻干粉的制备

    Institute of Scientific and Technical Information of China (English)

    周晖; 贺霞; 杨文涛; 姜伟化; 杨磊; 王东凯

    2014-01-01

    目的:对表柔比星长循环脂质体进行冷冻干燥以提高制剂稳定性,并对所得的冻干制剂进行初步质量评价。方法考察冻干保护剂种类、预冻时间及总干燥时间对制剂的影响;并考察表柔比星长循环脂质体冻干粉在温度为(25±2)℃、相对湿度(60±10)%条件下放置3个月的稳定性。结果以海藻糖为保护剂,保护剂与脂质体的比例为31。预冻温度-70℃,预冻时间8 h,冷冻干燥时间24 h。表柔比星长循环脂质体冻干后粒径、包封率、含量基本不变;加速条件下放置3个月,冻干制剂的再分散性好,包封率>94%,含量>99%。结论将表柔比星长循环脂质体进行冷冻干燥,可以有效提高制剂的稳定性。%Objective To improve the stability of epirubicin long circulation liposomes via lyophilizing technology and preliminarily evaluate their quality. Methods The effect of the various cryoprotectant,different pre-freezing and total drying time on the preparation was analyzed. The stability of the lyophilized powder was tested at (25±2) ℃ and (60±10)% relative humidity for 3 months. Results The protective agent trehalose to liposomes was 31. The freeze-drying was conducted with pre-freezing temperature at -70 ℃,precooling for 8 h and total drying for 24 h. There were no significant differences in particle size,encapsulation efficiency and drug content of lyophilized long-circulating liposomes compared with those un-lyophilized. After 3 months under the accelerated condition,it had good redispersibility, entrapment rate (>94%) and drug content (>99%) . Conclusion Lyophilizing the long-circulation epirubicin liposomes can effectively improve the stability of the preparation.

  15. Oral Cancer Exam

    Medline Plus

    Full Text Available ... Topics > Oral Cancer > Oral Cancer Exam Video Oral Cancer Exam Video This video shows what happens during an oral cancer examination. Quick and painless, the exam can detect ...

  16. Oral Cancer Exam

    Medline Plus

    Full Text Available ... Topics > Oral Cancer > Oral Cancer Exam Video Oral Cancer Exam Video This video shows what happens during an oral cancer examination. Quick and painless, the exam can detect ...

  17. Formulation and evaluation of acyclovir nanosuspension for enhancement of oral bioavailability

    Directory of Open Access Journals (Sweden)

    Mangesh Ramesh Bhalekar

    2014-01-01

    Full Text Available Acyclovir, an antiviral drug used against herpes simplex virus and varicella zoster virus. The dose ranges between 200 and 800 mg and the oral bioavailability is 10-20%, which decreases as the dose is increased. The aim of this research work was to formulate and characterize nanosuspensions of acyclovir with an intention to increase the oral bioavailability. Nanosuspensions were prepared by the precipitation-ultra sonication method and the effects of important process parameters i.e., precipitation temperature, stirring speed, end point temperature of probe sonicator, energy input and sonication time were investigated systematically, the optimal nanosuspension (particle size 274 nm was obtained at values of 4°C, 10,000 rpm, 30°C, 600 Watt and 20 min, respectively. The nanosuspension was lyophilized using different matrix formers and sucrose (100% w/w to drug was found to prevent agglomeration and particle size upon reconstitution was found to be 353 nm. The lyophilized nanocrystals appeared flaky in scanning electron microscopy images, the X-ray powder diffraction and differential scanning calorimetry analysis showed the nanoparticles to be in the crystalline state. Ex vivo permeation study for calculating absorption rate and in vivo bioavailability area under the curve both showed three-fold increase over marketed suspension.

  18. Cellular immunity of monovalent influenza vaccine lyophilized liposome%单价流感疫苗脂质体干粉细胞免疫研究

    Institute of Scientific and Technical Information of China (English)

    刘洁; 马波; 鲁卫东; 徐勇军; 林华; 代云波

    2011-01-01

    从细胞免疫水平考察流感疫苗脂质体干粉肺部免疫的免疫原性,以验证在稳定性提高的同时,流感疫苗脂质体干粉肺部免疫原性不低于现行应用的流感疫苗原液腹腔注射免疫.将实验小鼠分为2个大组,每组分为阴性对照组、疫苗脂质体冻干粉组、非脂质体流感疫苗原液组和阳性对照组(n=5).非脂质体流感疫苗原液组和疫苗脂质体冻干粉组分别以每只6μg血凝素(以H1N1计)肺部灌注免疫,同时以每只6μg非脂质体流感疫苗原液组腹腔免疫作为阳性对照.分别免疫14d和28 d后,用四甲基偶氮唑盐微量酶反应比色法(MTT法)检测脾淋巴细胞增殖情况,以考察其细胞免疫原性.脂质体肺部免疫可以诱导细胞免疫,且其免疫原性明显高于流感疫苗原液传统腹腔注射免疫组.与流感疫苗原液腹腔注射免疫相比,流感疫苗脂质体干粉通过肺部免疫,细胞免疫效果明显提高.%To evaluate the immunogenicity of the influenza vaccine lyophilized liposomes through cellular immunity, it could be confirm that, with the increasing of the stability, the immunogenicity of the influenza vaccine lyophilized liposomes by pulmonary delivery was better than that of the influenza vaccine non-liposome immunized by intraperitoneal injection. Experimental mice were divided into two groups, and each group was divided into the negative control group, the influenza vaccine lyophilized liposome group, the influenza vaccine non-liposome group, and the positive control group (n = 5). The influenza vaccine lyophilized liposome group and the influenza vaccine non-liposome group were immunized with 6 |xg hemagglutinin of H1N1 per mouse through pulmonary deli very, and the positive control group was immunized with 6 u,g hemagglutinin of H1N1 per mouse through intraperitoneal injection. MTT method was used to measure the spleen cell proliferation after immunization to mice 14 days and 28 days in order to study

  19. Correlations between the disintegration of melt and the measured impulses in steam explosions

    Energy Technology Data Exchange (ETDEWEB)

    Froehlich, G.; Linca, A.; Schindler, M. [Univ. of Stuttgart (Germany)

    1995-09-01

    To find our correlations in steam explosions (melt water interactions) between the measured impulses and the disintegration of the melt, experiments were performed in three configurations i.e. stratified, entrapment and jet experiments. Linear correlations were detected between the impulse and the total surface of the fragments. Theoretical considerations point out that a linear correlation assumes superheating of a water layer around the fragments of a constant thickness during the fragmentation process to a constant temperature (here the homogeneous nucleation temperature of water was assumed) and a constant expansion velocity of the steam in the main expansion time. The correlation constant does not depend on melt temperature and trigger pressure, but it depends on the configuration of the experiment or of a scenario of an accident. Further research is required concerning the correlation constant. For analysing steam explosion accidents the explosivity is introduced. The explosivity is a mass specific impulse. The explosivity is linear correlated with the degree of fragmentation. Knowing the degree of fragmentation with proper correlation constant the explosivity can be calculated and from the explosivity combined with the total mass of fragments the impulse is obtained which can be used to an estimation of the maximum force.

  20. The imbalance of glaciers after disintegration of Larsen-B ice shelf, Antarctic Peninsula

    Directory of Open Access Journals (Sweden)

    H. Rott

    2011-03-01

    Full Text Available The outlet glaciers to the embayment of the Larsen-B Ice Shelf started to accelerate soon after the ice shelf disintegrated in March 2002. We analyse high resolution radar images of the TerraSAR-X satellite, launched in June 2007, to map the motion of outlet glaciers in detail. The frontal velocities are used to estimate the calving fluxes for 2008/2009. As reference for pre-collapse conditions, when the glaciers were in balanced state, the ice fluxes through the same gates are computed using ice motion maps derived from interferometric data of the ERS-1/ERS-2 satellites in 1995 and 1999. Profiles of satellite laser altimetry from ICESat, crossing the terminus of several glaciers, indicate considerable glacier thinning between 2003 and 2007/2008. This is taken into account for defining the calving cross sections. The difference between the pre- and post-collapse fluxes provides an estimate on the mass imbalance. For the Larsen-B embayment the 2008 mass deficit is estimated at 4.34 ± 1.64 Gt a−1, significantly lower than previously published values. The ice flow acceleration follows a similar pattern on the various glaciers, gradually decreasing in magnitude with distance upstream from the calving front. This suggests stress perturbation at the glacier front being the main factor for acceleration. So far there are no signs of slow-down indicating that dynamic thinning and frontal retreat will go on.

  1. Childhood disintegrative disorder with seasonal total mutism: A rare clinical presentation

    Directory of Open Access Journals (Sweden)

    Elham Shirazi

    2016-01-01

    Full Text Available Childhood disintegrative disorder (CDD is a rare autistic-like clinical condition with unknown etiology, in that previously acquired age-appropriate language, social and adaptive abilities deteriorate significantly in 2-10-year-old healthy children, although physical and neurological evaluations display no observable abnormality. Our case is a 22-year-old female born of a consanguineous marriage, with the appearance of CDD symptoms in her fifth year of age following normal mental and physical development during her initial four years of life. Without any precipitating factor, she gradually lost her language abilities, social relational skills, affectionate behavior, adaptive capacities, peer play and meaningful interest in her surrounding, friends and family members over a period of 4 years, reaching a plateau in her ninth year of age. The unique special clinical symptom in this case is a seasonal total mutism, which after the beginning of her CDD symptoms is revealing every year covering the spring. As no additional physical or psychological change accompanies her total seasonal speech loss, it cannot be attributed to any mental condition known as having a seasonal pattern. Because in the literature CDD is presented mostly as case reports with lacking of advanced research data, describing any new case is recommended to improve the knowledge about this rare condition, especially if it displays some new unusual signs, not reported till now.

  2. Disintegration and dissolution of spent radioactive cationic exchange resins using Fenton-like oxidation process

    Energy Technology Data Exchange (ETDEWEB)

    Wan, Zhong; Xu, Lejin [Collaborative Innovation Center for Advanced Nuclear Energy Technology, INET, Tsinghua University, Beijing 100084 (China); Wang, Jianlong, E-mail: wangjl@tsinghua.edu.cn [Collaborative Innovation Center for Advanced Nuclear Energy Technology, INET, Tsinghua University, Beijing 100084 (China); Beijing Key Laboratory of Radioactive Wastes Treatment, Tsinghua University, Beijing 100084 (China)

    2015-09-15

    Highlights: • The spent radioactive resins could be oxidized by Fenton-like process. • The influencing factors on resin oxidation were evaluated. • Chemical oxygen demand (COD) reduction rate was more than 99%. • SEM and Raman spectrum were used to analyze the resins morphological change. - Abstract: The treatment and disposal of the spent radioactive resins is essential for the sustainable development of the nuclear industry. In this paper, the disintegration and dissolution of spent cationic resins were studied by Fenton-like process. The influencing factors on resin dissolution, such as pH, temperature, type and concentration of catalysts were evaluated. The results showed that the spent resins could be effectively dissolved at pH < 1, [Fe{sup 2+}] = 0.2 M and T = 97 ± 2 °C. Chemical oxygen demand (COD) reduction rate was more than 99%. The scanning electron microscopy and the Raman spectrum were used to observe the morphological changes of the spent resins during the dissolution process. Fenton-like oxidation is an efficient method for the volume reduction and stabilization of the spent resins before further immobilization.

  3. THE PROJECT “SKOPJE 2014”: BETWEEN SOCIAL COHESION AND SOCIAL DISINTEGRATION

    Directory of Open Access Journals (Sweden)

    Loreta Georgievska-Jakovleva

    2015-03-01

    Full Text Available In this paper we shall posit that the "Skopje 2014" Project, proposed and realized by the Government of the Republic of Macedonia, is one form of reaction to the efforts made to dispute the Macedonian identity and as such has direct effect on Macedonia's strategic goal to join EU and NATO as an equal member. In a situation of “threatened identity”, the Project aims, through “collecti-on of memory” and its spatial integration, to recreate Macedonian identity through the construction of a nar-rative about its continuity from antiquity to the present day. The strategies for “a top down”implementation of the“politics of memory” is to promote the idea of the “glorious and heroic past” of the Macedonian nation. Ha-ving in mind that the Project is being implemented in the very centre of Skopje, the capital of the Republic of Ma-cedonia, its realisation concerns not only the local popu-lation but the citizens of the Republic of Macedonia in general. Havin in mind that the Project very controver-sial reception goal of research is to define the issues that make this so provocative and, by that, atttempt to answer the question if the “Skopje 2014” Project contributes to social cohesion or social disintegration.

  4. Design of a double diaphragm shock tube for fluid disintegration studies.

    Science.gov (United States)

    Stotz, Ingo; Lamanna, Grazia; Hettrich, Harald; Weigand, Bernhard; Steelant, Johan

    2008-12-01

    A double diaphragm shock tube facility for studying liquid-spray atomization and combustion-related phenomena at elevated pressures and temperatures is described. The present shock tube is specifically intended for the investigation of fundamental processes related to fluid disintegration and mixing under realistic engine conditions. Special features of the facility include a variable-area driver section to compensate for shock attenuation, a square test section to allow flow visualization in the postshock region, a skimmer to dispose part of the boundary layer, a heated, fast-response injector, a fully automated gas-filling system, and a new control system and electronics. Test times of the order of 2-5 ms are possible with reflected shock pressures up to 50 bar and temperatures of 2000 K. Details on the setup design, construction and operation are given. Particular emphasis is placed on the accuracy and reproducibility of the test conditions. To that aim, qualification tests have been performed to assess the shock tube performance in terms of effectiveness of the skimmer concept, the capability to compensate for boundary layer effects and the generation of uniform and reproducible test and injection conditions.

  5. Multiwavelength Transit Observations of the Candidate Disintegrating Planetesimals Orbiting WD 1145+017

    CERN Document Server

    Croll, Bryce; Vanderburg, Andrew; Eastman, Jason; Rappaport, Saul; DeVore, John; Bieryla, Allyson; Muirhead, Philip S; Han, Eunkyu; Latham, David W; Beatty, Thomas G; Wittenmyer, Robert A; Wright, Jason T; Johnson, John Asher; McCrady, Nate

    2015-01-01

    We present multiwavelength, multi-telescope, ground-based follow-up photometry of the white dwarf WD 1145+017, that has recently been suggested to be orbited by up to six or more, short-period, low-mass, disintegrating planetesimals. We detect 9 significant dips in flux of between 10% and 30% of the stellar flux from our ground-based photometry. We observe transits deeper than 10% on average every ~3.6 hr in our photometry. This suggests that WD 1145+017 is indeed being orbited by multiple, short-period objects. Through fits to the multiple asymmetric transits that we observe, we confirm that the transit egress timescale is usually longer than the ingress timescale, and that the transit duration is longer than expected for a solid body at these short periods, all suggesting that these objects have cometary tails streaming behind them. The precise orbital periods of the planetesimals in this system are unclear from the transit-times, but at least one object, and likely more, have orbital periods of ~4.5 hours....

  6. Effects of alga polysaccharide capsule shells on in-vivo bioavailability and disintegration

    Institute of Scientific and Technical Information of China (English)

    LI Ting; GUO Shuju; MA Lin; YUAN Yi; HAN Lijun

    2012-01-01

    Gelatin has been used in hard capsule shells for more than a century,and some shortcomings have appeared,such as high moisture content and risk of transmitting diseases of animal origin to people.Based on available studies regarding gelatin and vegetable shells,we developed a new type of algal polysaccharide capsule (APPC) shells.To test whether our products can replace commercial gelatin shells,we measured in-vivo plasma concentration of 12 selected volunteers with a model drug,ibuprofen,using high performance liquid chromatography (HPLC),by calculating the relative bioavailability of APPC and Qualicaps(R) referenced to gelatin capsules and assessing bioequivalence of the three types of shells,and calculated pharmacokinetic parameters with the software DAS 2.0 (China).The results show that APPC shells possess bioequivalence with Qualicaps(R) and gelatin shells.Moreover,the disintegration behavior of four types of shells (APPC,Vegcaps(R),Qualicaps(R) and gelatin shells) with the content of lactose and radioactive element (99mTc) was observed via gamma-scintigraphic images.The bioavailability and gamma-scintigraphic studies showed that APPC was not statistically different from other vegetable and gelatin capsule shells with respect to in-vivo behavior.Hence,it can be concluded that APPCs are exchangeable with other vegetable and gelatin shells.

  7. Multiwavelength Observations of the Candidate Disintegrating sub-Mercury KIC 12557548b

    CERN Document Server

    Croll, Bryce; DeVore, John; Gilliland, Ronald L; Crepp, Justin R; Howard, Andrew W; Star, Kimberly M; Chiang, Eugene; Levine, Alan M; Jenkins, Jon M; Albert, Loic; Bonomo, Aldo S; Fortney, Jonathan J; Isaacson, Howard

    2014-01-01

    We present multiwavelength photometry, high angular resolution imaging, and radial velocities, of the unique and confounding disintegrating low-mass planet candidate KIC 12557548b. Our high angular resolution imaging, which includes spacebased HST/WFC3 observations in the optical, and groundbased Keck/NIRC2 observations in K'-band, allow us to rule-out background and foreground candidates at angular separations greater than 0.2 arcsec that are bright enough to be responsible for the transits we associate with KIC 12557548. Our radial velocity limit from Keck/HIRES allows us to rule-out bound, low-mass stellar companions to KIC 12557548 on orbits less than 10 years, as well as placing an upper-limit on the mass of the candidate planet of 1.2 Jupiter masses; therefore, the combination of our radial velocities, high angular-resolution imaging, and photometry are able to rule-out most false positive interpretations of the transits. Our precise multiwavelength photometry includes two simultaneous detections of the...

  8. Effects of alga polysaccharide capsule shells on in-vivo bioavailability and disintegration

    Science.gov (United States)

    Li, Ting; Guo, Shuju; Ma, Lin; Yuan, Yi; Han, Lijun

    2012-01-01

    Gelatin has been used in hard capsule shells for more than a century, and some shortcomings have appeared, such as high moisture content and risk of transmitting diseases of animal origin to people. Based on available studies regarding gelatin and vegetable shells, we developed a new type of algal polysaccharide capsule (APPC) shells. To test whether our products can replace commercial gelatin shells, we measured in-vivo plasma concentration of 12 selected volunteers with a model drug, ibuprofen, using high performance liquid chromatography (HPLC), by calculating the relative bioavailability of APPC and Qualicaps® referenced to gelatin capsules and assessing bioequivalence of the three types of shells, and calculated pharmacokinetic parameters with the software DAS 2.0 (China). The results show that APPC shells possess bioequivalence with Qualicaps® and gelatin shells. Moreover, the disintegration behavior of four types of shells (APPC, Vegcaps®, Qualicaps® and gelatin shells) with the content of lactose and radioactive element (99mTc) was observed via gamma-scintigraphic images. The bioavailability and gamma-scintigraphic studies showed that APPC was not statistically different from other vegetable and gelatin capsule shells with respect to in-vivo behavior. Hence, it can be concluded that APPCs are exchangeable with other vegetable and gelatin shells.

  9. Disintegration of lysosomes mediated by GTPgammaS-treated cytosol: possible involvement of phospholipases.

    Science.gov (United States)

    Sai, Y; Matsuda, T; Arai, K; Ohkuma, S

    1998-04-01

    We showed previously that cytosol treated with guanosine 5'-O-(3-thiotriphosphate) (GTP-gammaS) disintegrated lysosomes in vitro [Sai, Y. et al. (1994) Biochem. Biophys. Res. Commun. 198, 869-877] in time-, temperature-, and dose-dependent manners. This also requires ATP, however, the latter can be substituted with deoxy-ATP, ADP, or ATPgammaS, suggesting no requirement of ATP hydrolysis. The lysis was inhibited by several chemical modifiers, including N-ethylmaleimide, 7-chloro-4-nitrobenzo-2-oxa-1,3-diazole, and 4,4'-diisothiocyanatostilbene-2,2'-disulfonic acid, and by various phospholipase inhibitors (trifluoperazine, p-bromophenacyl bromide, nordihydroguaiaretic acid, W-7, primaquine, compound 48/80, neomycin, and gentamicin), but not by ONO-RS-082, an inhibitor of phospholipase A2. The reaction was also inhibited by phospholipids (phosphatidylinositol, phosphatidylserine, phosphatidic acid, and phosphatidylcholine) and diacylglycerol. Among the phospholipase A2 hydrolysis products of phospholipids, unsaturated fatty acids (oleate, linoleate, and arachidonate) and lysophospholipid (lysophosphatidylcholine) by themselves broke lysosomes down directly, whereas saturated fatty acids (palmitate and stearate) had little effect. We found that GTPgammaS-stimulated cytosolic phospholipase A2 activity was highly sensitive to ONO-RS-082. These results suggest the participation of phospholipase(s), though not cytosolic phospholipase A2, in the GTPgammaS-dependent lysis of lysosomes.

  10. Characteristics of disintegration of different emulsion nuclei by relativistic 28Si nuclei at 3.7 A GeV

    Indian Academy of Sciences (India)

    Ashwini Kumar; A Prakash; Ashok Kumar; R K Jain; B K Singh

    2015-04-01

    An analysis of the data based on 924 inelastic interaction events induced by 28 Si nuclei in a nuclear emulsion is presented. The nuclear fragmentation process is studied by analysing the total charge () distribution of the projectile spectators for different emulsion target groups along with the comparison of Monte Carlo Glauber model results. Probability distributions for total disintegrated events as a function of different projectile masses are shown and compared with cascade evaporation model results at same ener