Optimization and evaluation of different fast acting tablet formulations containing bisoprolol fumarate.

Abstract

This study aimed to develop and evaluate orally disintegrating tablets (ODTs) and sublingual tablets (SLTs) containing Bisoprolol fumarate (BF) to enhance the onset of action and provided rapid relief of these cardiovascular diseases. For ODTs, experimental design was used to evaluate the effect of different independent factors on dissolution efficiency (DE%), disintegration time (DT), and hardness. Two independent variables, namely superdisintegrant concentration (crospovidone; CPV; X1) and taste masking agent concentration (Eudragit E100; X2) were selected to study their impact on the attributes of the BF ODTs. For SLTs, super disintegrant concentration (X1) and mixing time (X2) were selected to study their impact on SLTs attributes, as in the case of ODTs. The optimized ODTs formula (based on 8.3% CPV and 3.7% Eudragit) showed DE% of 85%, disintegration time (DT) of 39.3 s, and hardness of 2.55 Kp. Moreover, the optimized SLTs formula (based on 9.26% CPV and 16.2 min mixing time) showed DE% of 92%, DT was 35 s and hardness was 3.6 Kp. The optimized formula was compressed into an ODT and SLTs and studied according to USP criteria. All tablet examinations (Friability, Hardness, Disintegration Time, Drug Content, and Weight Variation) were within the accepted values and showed a high stability after six months of storage under accelerated conditions. The obtained results of the current study verified the efficacious formulation of BF as ODTs and SLTs to improve the onset of action and convalesce patient compliance in managing hypertension and arrhythmia.