FORMULATION AND EVALUATION OF GASTRORETENTIVE BILAYERED FLOATING TABLETS OF FAMOTIDINE: EFFECT OF FORMULATION VARIABLES AND IN VITRO IN VIVO EVALUATION
Abstract
The present investigation concerns the development of bilayered floating tablets of famotidine for prolongation of gastric residence time. An attempt was made to prepare bilayered floating tablets of famotidine by direct compression method. Two layered formulations were designed with an immediate release layer (IR) comprising of the drug, the super disintegrant Croscarmellose sodium along with the other diluents like microcrystalline cellulose and dicalcium phosphate. Three batches of immediate release layer were made in order to achieve desired disintegration time and drug release. The third batch (IRL3) with faster disintegration time of nearly 25 S and cumulative drug release of nearly 98% for the first 10 min was selected for the preparation of bilayerd tablets. For the preparation of sustained release layer (SR)15 batches with different polymers like HPMC K100M, HPMC K15M, HPMC K4M, HPMC E50, and Methyl cellulose were tried out along with the drug, Sodium bicarbonate as gas generating agent and other diluents like microcrystalline cellulose and dicalcium phosphate. The concentration of polymers in the sustained release layer was varied in order to study the effect of polymer concentration on drug release and floatation. The powder blends lubricated with magnesium stearate (2%) and talc (1%) were subjected to pre-compression studies like Bulk density, Tapped density, Angle of repose, Carrs index and Hausners ratio. The prepared tablets were also evaluated for Post-compression properties such as in vitro buoyancy studies, Swelling index, Drug content estimation, in vitro dissolution studies, and Compatibility studies by FTIR spectral analysis etc. . Based on the desired properties for bilayered floating tablets as well as in vitro release characteristics best formulations were selected and subjected to in vivo radiographic studies in New Zealand white species rabbits.
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