Formulation and evaluation of bisoprolol fumarate extended release tablets

Bisoprolol is a cardio selective -blocker. It is given as the fumarate in the management of hypertension and angina pectoris. On oral administration, the drug undergoes extensive first pass metabolism. The purpose of this study was to develop and evaluate Bisoprolol extended release tablets by the wet granulation method using different proportions of polymers and binder. Pre-formulation studies were done initially and the results were found to be within the limits. All the mentioned batches were prepared and granules were evaluated for pre-compression parameters such as loss on drying, bulk density, tapped density and compressibility index. Tablets were evaluated for weight variation, thickness, hardness, friability; disintegration time and assay were found to be within the limits. In vitro dissolutions were performed with 0.05M 6.8 PH phosphate buffer and effect of various polymers were explored. Final selection of formulation was based on dissolution profile, from dissolution studies, formulation 9 showed 80% drug release within 20 hours, so it will be compared with innovator. Similarity and difference factors which revealed that formulation (F 9) containing HPMC K 200, Eudragit L100 and binder are most successful as it exhibited in vitro drug release that matched with innovative products. In vitro drug release profile reveals that with increased concentration of Eudragit L 100. Accelerated stability studies were performed for the optimized batch, which indicated that there were no changes in drug content and in vitro dissolution.