Abstract

FORMULATION AND EVALUATION OF BILAYER TABLETS OF METFORMIN HCL AND EZETIMIBE

K. Mounika Saranya*, P. Lakshmana Rao, M. Prasada Rao, M. Rama kotaiah

ABSTRACT

The aim of present study was to design the concept of bilayered tablets containing Ezetimibe for immediate release using cross Povidone and sodium starch glycolate as super disintegrant and Metformin hydrochloride for sustained release using ethyl cellulose and hydroxyl propyl cellulose as matrix forming polymer. The tablets were evaluated for physicochemical properties. All the values are found to be satisfactory. In vitro release studies were carried out as per USP in pH 1.2 and phosphate buffer pH 6.8 using the USP apparatus II. The release kinetics of Metformin hydrochloride was evaluated using the regression coefficient analysis. The formulated tablets (M4) shows first order release and diffusion was the dominant mechanism of drug release. The polymers ethyl cellulose and hydroxyl propyl cellulose had significant effect on the release of Metformin HCl matrix tablets (M4).Thus formulated bilayer tablets provided that release of metformin as sustained release over a period of 8 hours. The stability studies and FT-IR studies were also indicating the absence of strong interactions between the components and suggesting drug-excipient compatibility in all the formulations examined.

Keywords: Ethyl cellulose, hydroxyl propyl cellulose, Croscarmalose sodium and sodium starch glycolate.