Development of Discriminative Dissolution Media for Marketed Gliclazide Modified-Release Tablets

Abstract

In vitro release studies were performed for three commercial, modified-release brands of the anti-diabetic drug gliclazide at 30-mg strength. Dissolution media such as 0.1 N HCl (pH 1.2), acetate buffer (pH 4.5), distilled water (pH 7.0), and phosphate buffer (pH 7.4) were evaluated to develop a dissolution method for better evaluation of gliclazide formulations, as there was no official method for gliclazide modified-release tablets. Drug release followed zero-order kinetics in all dissolution media except acetate buffer, where it followed first-order kinetics. The statistically treated data show a significant difference in release rates among the brands. The similarity factor and difference factor values also show the adjustment of differences in release profiles. The drug release studies carried out in 0.1 N HCl show that this medium is the most suitable for providing sink conditions and discriminating conditions.