Study of Drug Release Kinetics of Rosuvastatin Calcium Immediate-Release Tablets Marketed in Saudi Arabia

Abstract

Rosuvastatin (RST), a BCS class II drug, is a poorly water-soluble antihyperlipidemic agent. The aim of the present work was to determine and compare the drug release kinetics from the RST calcium innovator (Crestor) and generic products (Ivarin and Resova) marketed in Saudi Arabia by employing various drug release kinetic mathematical models. A dissolution study was performed on all RST calcium immediate-release tablets. The in vitro drug release profiles were determined in three different dissolution media: 0.1 N HCl (pH 1.2), 0.05 M phosphate buffer (pH 6.8), and 0.05 M citrate buffer (pH 6.6). Drug release data were obtained, correlated quantitatively, and interpreted with the help of mathematical models, then the drug release kinetics were analyzed. The criterion for selecting the most suitable model was based on the highest coefficient of correlation ( R 2 ) with the dissolution profile in each respective media. The innovator product followed the Hixson-Crowell model ( R 2 = 0.955) only in 0.1 N HCl (pH 1.2), whereas in other media all the formulations followed first order release kinetics with non-swellable matrix Fickian diffusion, which is considered ideal for an immediate-release tablet formulation.