Formulation Development and Evaluation of Fast Dissolving Tablets of Bisoprolol Fumarate using Response Surface Technique

Objectives: The purpose of the current study was to develop and evaluate Fast Dissolving Tablets (FDT) for the successful management of hypertension and heart failure utilizing the response surface technique. Bisoprolol Fumarate is a highly effective cardio selective beta-blocker. Materials and Methods: 12 Fast Dissolving Formulations were developed for Bisoprolol fumarate using various various concentrations of super disintegrants. Among all, The Formulation F6 showed promising results were considered for further optimization studies as per 32 factorial design. The two independent variables under investigation were Lactose (X1) and Magnesium stearate (X2). % Friability (Y1), Wetting time (Y2), Disintegration time (Y3), and % Drug release at the end of 10th min (Y4) were the primary components, or dependent variables. Utilizing the Direct Compression method, FDT formulations of Bisoprolol Fumarate were prepared. Nine trials were created and evaluated as per Pharmaceutical Product Performance. Results: The FDT of Bisoprolol Fumarate with quick disintegration (69 sec) and maximum drug release (45.25 min) was successfully prepared using statistical models. Results show that every formulation satisfies the acceptance standards, and the in vitro dissolution profiles were subjected to kinetic modeling. Conclusion: Based on the desirability, SF5 formulation contained 8 mg of Lactose and 2 mg of Magnesium stearate, was considered as optimsed one. Formulation (SF5) follow zero order kinetics, whereas release mechanism found to be non-fickian diffusion, super case transport (n=1.043) consequently, the present investigation unequivocally shows the possible involvement in terms of quick breakdown and ideal drug release.