Abstract

FORMULATION AND EVALUATION OF MULTIPARTICULATE DRUG DELIVERY SYSTEM OF METFORMIN HYDROCHLORIDE AND PIOGLITAZONE HYDROCHLORIDE

Grace Rathnam* and Santhosh D.

ABSTRACT

The objective of present study was to prepare and characterize pellets of metformin hydrochloride and pioglitazone hydrochloride by extrusion-spheronization technique to avoid repetitive dosage form administration in diabetic patients. Materials & Methods: Pioglitazone hydrochloride was formulated as immediate release pellets, and metformin hydrochloride as sustained release pellets. These characterized pellets with good density and flow property were filled in size 0 hard gelatin capsules with accurate quantity of 500 mg of metformin hydrochloride and 7.5 mg of pioglitazone hydrochloride. The capsules were evaluated for its weight variation, disintegration, dissolution profile and stability. The release of drug from F4 where Metformin pellets are coated with 10% ethyl cellulose and 4% HPMC K100 was found to be 99.8 % w/w at 12 h. The drug release kinetic shows that it follows Fickian diffusion. The stability study of F4 at 40°C±2°C/75%±5% RH for 3 months also revealed that there was no significant difference in both the appearance and drug content. Hence the formulation was found to be stable. Studies demonstrated that use of hydrophobic and hydrophilic polymers lead to formation of stable formulation of multi-unit immediate and sustained release pellets.

Keywords: Extrusion-spheronization, Metformin, Pellets, Pioglitazone.