The aim of the present study was to develop a gastroretentive drug delivery system of lamivudine, an antiretroviral drug. The tablets of the active pharmaceuticals agent lamivudine were prepared by direct compression technique using HPMC K15M as a polymer with additional standard excipients. The assortment of sodium bicarbonate and citric acid was used as gas generating agent. Prelude studies established that the, tablets remained buoyant for over 15 hr in the dissolution medium. 32 factorial designs were used to thoroughly optimize the drug release profile. The amount of retardant material HPMC K15M (X1) and gas generating agent (X2) were chosen as independent variables. The time requisite for drug release t50% (Y1) was selected as dependent variable. The statistical analysis of the drug release data was done by multiple regression analysis using software microsoft excel and statplus 2008. Analysis of variance was performed using biostatplus to evaluate contribution of factors. The response surface plots were generated using table curve 3D V4. The resultant polynomial equations for t50% were demonstrated by two check point formulations, which expressed that factor X1 and X2 appreciably affects the studied dependent variable. The non fickian diffusion release transport was inveterate as the release mechanism for the optimized formulation. The predicated values approved well with the experimental values and the consequences demonstrated practicability of the model in the development of gastroretentive drug delivery system.
Loading....