FORMULATION AND EVALUATION OF SUSTAINED RELEASE BILAYER TABLETS OF PROPRANOLOL HYDROCHLORIDE

Abstract

Objective: The present study was to formulate and evaluate of sustained release bilayer tablets of anti-hypertensive drugs propranolol hydrochloride. Methods: The tablets were prepared by direct compression method by using superdisintegrants Sodium Starch Glycolate (SSG) for immediate release layer and mucoadhesive materials such as Hydroxy Propyl Methyl Cellulose (HPMC-K4M) and Carbopol 934 P for sustained release layer which could release the drug up to 12 hours in predetermined rate. Poly vinyl Pyrrolidone (PVP) K-30 was used as binder. The blends were evaluated for physicochemical parameter such as bulk density, tap density, compressibility index and angle of repose. The tablets were evaluated for post compression parameter such as hardness, thickness, diameter, weight variation, drug content uniformity and friability. In vitro drug release studies were performed by using USP type II apparatus (paddle method). The FTIR study revealed that there was no chemical interaction between drug and excipients. Results: The formulation ME5 containing HPMC-K4M and Carbopol 934 P in the ratio of 3:1 gave an initial burst effect and followed by sustained release of drug without disintegration up to 12 hours. Conclusion: The optimized formulation ME5 showed the best drug release profile up to 12 hours and fulfilled the many requirements reduced dosing frequency, increase the bioavailability and provide better patient compliance.