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FORMULATION AND IN-VITRO EVALUATION OF GASTRORETENTIVE DRUG DELIVERY SYSTEM OF ROSIGLITAZONE MALEATE

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  • 2013

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Abstract (2. Language): 
The objective of the present study was to develop floating tablets of Rosiglitazone in order to achieve an extended retention in the upper GIT which may enhance the absorption and improve the bioavailability. The tablets were prepared by gas generation technique using different ratio and concentrations of Methocel K-100, Methocel K-15. The dried floating granules were evaluated for determination of angle of repose, Hausner’s ratio, Carr’s index and porosity. The floating tablets were evaluated for determination of weight variation, hardness, friability, content uniformity, floating lag time, total floating time, in–vitro drug release study, stability studies. The flow properties of prepared floating tablets were found to be excellent. Tablets showed satisfactory characteristics with respect to weight, hardness and friability data. The results of in-vitro release studies showed that optimized formulation (FTR 6) could sustain drug release (97%) for 12h and remain buoyant for 12h because of their low densities. Lessen in the citric acid level increased the floating lag time but tablets floated for longer duration. An amalgamation of sodium bicarbonate (140mg) and citric acid (10mg) was found to achieve optimum in vitro buoyancy. The tablets with methocel K100 were found to float for longer period as compared with formulations containing methocel K15M. The drug liberation from the tablets was adequately sustained and non-fickian transport of the drug from tablets was confirmed.The optimized formulation was subjected to various kinetic release investigations and it was found that the mechanism of drug release was predominantly diffusion with a minor contribution from polymeric relaxation. Optimized formulation (FTR 6) showed no significant change in physical appearance, drug content, buoyancy lag time or in vitro dissolution study after storage at 40°C/75% RH for three months. In vitro drug release studies were performed for all the prepared formulations. All the prepared floating tablets exhibited excellent drug release.
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