Formulation and Evaluation of Oral Controlled Release Osmotic Tablets of Glimepiride

Abstract

Glimepiride has a relatively short elimination half-life (5 h), thereby requiring twice or thrice daily dosing in patients, which may lead to non-compliance. Controlled release formulations of Glimepiride were developed based on osmotic technology. Formulation F9 was selected as optimized formulation. The effect of different formulation variable was studied to optimize release profile. The release rate increased significantly as the increase of osmogen ratio from 1:0.5 to 1:1. The release rate increased significantly with the increase of concentration of pore forming agent (PEG-400) as noticed from the dissolution profile of the formulations. Thus drug release was inversely proportional to the concentration of osmogen in the core and the amount of pore forming agents in the coated tablets. The drug release from developed formulations was independent of pH. The manufacturing procedure was standardized and found to be reproducible. Further studies are needed to investigate this formulation for its performance in vivo.