Volume :

4

Issue :

4

Abstract :

In the present work, an industrially important project entitled “Formulation and In vitro Evaluation of Bosentan Osmotic Controlled Release Tablets” was undertaken. The study was undertaken with an aim to formulate Bosentan as osmotic controlled release tablets. During this phase of investigation various factors that likely to affect the performance of the osmotic controlled release was studied. The release kinetics, dissolution rate, process variables such as hardness, weight variation are some of the factors found critical during the development based on the experimental findings. Preformulation studies were done initially and results directed the further course of formulation. With the literature review data, Preformulation and prototype formulation trails were started. Direct compression method was used for formulation. Granules were evaluated for tests such as bulk density, Tapped density, Compressibility Index and Hausner ratio before being punched as tablets. Tablets were tested for weight variation, thickness and friability, in-vitro dissolution tests were performed and percentage drug release was calculated. Dissolution profile of formulation – F7 was optimized based on evaluation parameters. In the dissolution modeling all the developed formulations followed Korsemeyer-peppas drug release. The optimized formulation F7 followed Korsemeyer-peppas drug release kinetics model i.e super case 2 transports and non-Fickian model. In the present study, polymethacrylates were found to play a great role in controlling release of drug Bosentan from the osmotic system. Accordingly, it can be concluded that the formulation is robust in the performance and it is less likely to be affected by various factors studied.