Innovative Approaches to Enhance Dissolution Rate of a Hydrophobic Drug Glimepiride

Abstract

Method: In the proposed study, USP analytical method was validated for the determination of glimepiride in its formulations. The calibration curve was linear over the concentration range of 2.5-12.5 μg/ml with a regression analysis (r2 = 0.9999). For getting an idea about the release of drug from its dosage form, innovator brands were picked and estimated for pharmaceutical parameters. On the basis of this information, 10 experimental batches of tablets were prepared. The optimized batch was prepared by using 2:1 ratios of tween 80 and PVP K30 by slurry technique. Pre-compression and post-compression parameters were evaluated to confirm the validity of the design and development of processes. The optimized batch was subjected to stability studies for 03 months at 40±2 °C & % RH: 75±5%.