Abstract

FORMULATION DEVELOPMENT AND EVALUATION OF METFORMIN HYDROCHLORIDESUSTAINED RELEASE MATRIX TABLETBY USING DIRECTLY COMPRESSIBLE CO-PROCESSED EXCIPIENT

Avinash Bhaskar Gangurde*, Purnima Dhanraj Amin

ABSTRACT

The aim of the present study was to formulate and evaluate an oral sustained release matrix tablet of Metformin hydrochloride to increase therapeutic effect, reduced frequency of administration and improved patient compliance. Metformin HCl tablet was formulated by using directly compressible (DC) co-processed excipient of Polyethylene oxide (PEO) and Hydroxyl propyl methyl cellulose (HPMC). The coprocessed excipient was prepared by roller compaction method. The influence of individual polymers, their physical mixture and coprocessed excipient on the release of Metformin HCl was studied. Formulations were prepared by varying the polymer concentration between 10-30%. Both the granules and tablets were tested for their physical, morphological and analytical parameters. In vitro release study proved that30 % concentration of co-processed excipient showed the release profile according to USP specification.It was also observed that polyethylene oxide controls the initial burst releasewhereas HPMCextendthedrug release for longer period.In vitro release data was best fitted in Higuchi equation followed by first order kineticswhich indicatedthat drug releases mainly by diffusion mechanism from matrix tablet. FTIR and DSC studies confirmed that there was no significant interaction between drug and polymer. The optimized formulations were found to be stable for three month as per ICH guidelines.

Keywords: Metformin HCl, Direct compression,Sustained release, In-vitro dissolution study, Release kinetics.