Current Issue : January - March Volume : 2017 Issue Number : 1 Articles : 5 Articles
An influenza pandemic remains a major public health concern. A key strategy to prevent a\npandemic is to stockpile and pre-position stable influenza vaccine to allow rapid deployment\nin response to an outbreak. However, most influenza vaccines today are formulated\nas liquids that are stable only within a temperature range of 2Ã?Å¡C to 8Ã?Å¡C and require use of a\ncold chain, making vaccine transportation, distribution, and storage complicated and\nexpensive, particularly for developing countries. To support the National Strategy for Pandemic\nInfluenza preparedness in the United States and internationally, we developed two\nlead dry formulations of stable H1N1 influenza subunit vaccines using freeze-drying technology.\nThe stable formulations contain an excipient combination of a disaccharide, such\nas sucrose or trehalose, and glycine, in addition to a surfactant and phosphate buffer. The\nfreeze-dried vaccines were shown to be safe and remained immunogenic in an in vivo\nstudy in mice. Moreover, the lead formulations demonstrated no significant loss of activity\nafter 40 months at storage temperatures of 25Ã?Å¡C and 37Ã?Å¡C. This stability can be particularly\nattractive as it could eliminate the need to use a cold chain for vaccine deployment and\nfacilitate integration of vaccine distribution with general drug distribution where appropriate.\nThese freeze-dried thermostable influenza subunit vaccines could also reduce the frequency\nof vaccine stockpile turnover, offering a cost-effective option for pandemic\npreparedness....
Improving the physicochemical properties and oral bioavailability of quetiapine fumarate (QF) enabling enhanced antipsychotic\nattributes are the main aims of this research. The freeze dried solid dispersion strategy was adopted using nicotinamide (NIC)\nas highly soluble coformer. The prepared dispersions were characterized using scanning electron microscopy (SEM) differential\nscanning calorimetry (DSC), Fourier transform infrared spectroscopy (FTIR), and X-ray diffraction (XRD). Static disc intrinsic\ndissolution rate and ex vivo diffusion through intestinal tissues were conducted and compared to pure quetiapine fumarate. The\nresults demonstrated a highly soluble coamorphous system formed between quetiapine fumarate and nicotinamide at 1 : 3 molar\nratio through H-bonding interactions. The results showed >14-fold increase in solubility of QF from the prepared dispersions.\nIncreased intrinsic dissolution rate (from 0.28 to 0.603mg cmâË?â??2 minâË?â??1) and faster flux rate through duodenum (from 0.027 to\n0.041mg cmâË?â??2 hâË?â??1) and jejunum (0.027 to 0.036mg cmâË?â??2 hâË?â??1) were obtained.The prepared coamorphous dispersion proved to be\neffective in improving the drug solubility and dissolution rate and ex vivo diffusion. Therefore, binary coamorphous dispersions\ncould be a promising solution tomodify the physicochemical properties, raise oral bioavailability, and change the biopharmaceutics\nclassification (BCS) of some active pharmaceutical ingredients....
Osteoarthritis is a disease that attacks human bones especially in older people and usually non-steroidal antiinflammatory\ndrugs are being prescribed for patients with Osteoarthritis. These kinds of drugs usually have low\naqueous solubility, dissolution and bioavailability. In order to maximize their therapeutic effects, these properties\nshould be develped and enhanced. The purpose of this study was to reduce the particle size of ibuprofen by forming\nmicroparticles and thus enhance its dissolution rate. Ibuprofen was encapsulated into a polymer (polyvinylpyrrolidone)\nusing supercritical fluid technology (supercritical CO2\n) to form drug-polymer microparticles. Dissolution rate and\nsurface characteristics of the prepared drug-polymer microparticles were measured using various characterization\ntechniques such as fourier transform infrared spectroscopy (FTIR), ultraviolet spectroscopy (UV), transmission\nelectron microscopy (TEM), scanning electron microscope (SEM), thermogravimetric analysis (TGA) and differential\nscanning calorimetry (DSC). Various drug-polymer formulations were prepared depending on the operating conditions\n(i.e., different temperatures, pressures, flow rates and different drug solution:CO2\n volume ratio). Results from TEM\nimages and FTIR graphs showed that microparticles were successfully prepared. Different conditions gave different\nmorphologies of drug-polymer microparticles as was confirmed using SEM analysis. Finally, dissolution rate of the\ndrug-polymer microparticles in a simulated gastric fluid showed a promising result and better drug release controll\nover extended period of two hours in comparesion with uncapsulated Ibuprofen....
Polysaccharides are a natural and renewable reservoir which can be tailored to obtain a broad spectrum of\nmacromolecular materials. Grafting is the versatile and convenient route to develop polysaccharide based materials. In the\npresent study, an approach was made to prepare and evaluate the fast dissolving tablet of salbutamol sulphate formed by graft\ncassia seed extract polymer by direct compression method. The graft copolymerization of acrylamide on cassia was done by\nmicrowave assisted method using ceric ammonium nitrate as cross linker. The graft copolymerized cassia was characterized by\nFTIR, DSC, SEM studies and confirmed the formation of graft copolymer. Grafting was done by microwave assisted method by\nvarying the concentration of acrylamide. Maximum grafting efficiency (60%) was observed at higher concentration of\nacrylamide. The tablets were evaluated for various pharmacopoeial parameters i.e. weight variation, friability, hardness,\nthickness and diameter, disintegration test and in-vitro release. On comparative evaluation, it was observed that graft\ncopolymerized cassia showed higher disintegration while the dissolution studies revealed that more than 80% of drug was\nreleased in 15 minutes. The release rate data was fitted to various release kinetic models. It was found that formulations F0, F1 F2\nand Fm followed Korsemeyer-Peppas model, while the F3 shows anomalous transport mechanism of drug release. Therefore, it\nmay be concluded that the seed extract of cassia is a candidate as a carrier for drug delivery system. Hence it possesses the scope\nfor exploring it for further pharmaceutical application....
In prospect of developing an oral dosage form of Infliximab, for treatment of Crohnâ��s disease\nand rheumatoid arthritis, freeze-drying (vial vs Lyoguard trays) and spray-drying were\ninvestigated as production method for stable powders. Dextran and inulin were used in\ncombination with sucrose as stabilizing excipients. The drying processes did not affect\nInfliximab in these formulations, i.e. both the physical integrity and biological activity (TNF\nbinding) were retained. Accelerated stability studies (1 month at 60�šC) showed that the\nTNF binding ability of Infliximab was conserved in the freeze-dried formulations, whereas\nthe liquid counterpart lost all TNF binding. After thermal treatment, the dried formulations\nshowed some chemical modification of the IgG in the dextran-sucrose formulation, probably\ndue to Maillard reaction products. This study indicates that, with the appropriate formulation,\nboth spray-drying and freeze-drying may be useful for (bulk) powder production of\nInfliximab....
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