Pre-formulation study of Bisoprolol as fast Dissolve Sublingual Tablet

Abstract

Fast dissolving drug delivery systems offer a solution for patients having difficulty in swallowing tablets.  In this study, an attempt had been made to perform pre-formulation studies of bisoprolol as fast dissolve sublingual tablet, an antihypertensive by direct compression methods using sodium-starch-glycolate, croscarmellose-sodium, & crospovidone as superdisintegrant agent. The basic purpose of the pre-formulation activity is to provide a basis for the formulation approaches, to maximize the chances of success in formulating an acceptable product, optimizing drug product quality and performance. Preformulating activity including drug melting point; analytical wavelength (λ max) detections, drug-excipients physical & chemical compatibility by FT-IR, and Calibration curve of Bisoprolol were studied. It was discovered that the melting point was 100°C, and the UV spectral analysis revealed that the maximum value of λ was between 224 and 273 nm. The physicochemical compatibility studies results indicate that there was no interaction between bisoprolol and the excipients. Strong linear relationship obtained from calibration curve. Based on results, fast dissolving sublingual tablets of Bisoprolol can be prepared successfully by direct compression.