Abstract

DEVELOPMENT OF FORMULATION AND EVALUATION OF METFORMIN HCL SR TABLET

A. V. Moholkar*, M. S. Attar, S. R. Banode, A. R. Jadhav, M. D. Wandhre

ABSTRACT

The present study was designed to formulate Metformin Hydrochloride Sustained release tablets by melt granulation method by using hydrophobic polymer. Seven formulations of Metformin.HCL SR tablets were prepared. Stearic acid in melted form was used for granulation of each batch. HPMC K 100,HPMC K 15,HPMC K 4, polyvinyl pyrrolidone K 90, and hydroxyl propyl cellulose LH-11 in different concentrations were used in different concentrations in those batches. Metformin.HCL SR tablet formulation no. MET 7 containing polymers HPMC K 100, polyvinyl pyrrolidone K 90, and hydroxyl propyl cellulose LH-11 in concentrations as 200,60,50 mg respectively was optimized since it showed friability & percent drug release as 0.56±0.2 & 98.15±0.24 respectively which is required for a better sustained release tablet formulation & passes the assay limit of metformin sustained release tablet as per USP is 90-110%( w/w). The dissolution study for optimized MET 7 batch shows percent drug release of 93.90±29 at 10th hr. which was higher with respect to other formulations at 10th hr. The optimized MET 7 Formulation was subjected to accelerated stability conditions for 3 months did not show any variation in the tested parameters and results were within limit. MET 7 batch revealed first order release kinetics & fickian diffusion, 'n' value 0.492 by Korsmeyer-peppas model.

Keywords: Hydrophobic polymer, HPMC K 100, Polyvinyl pyrrolidone K 90, Hydroxyl propyl cellulose LH – 11, Korsmeyer peppas model).