Mathematical Model Application for In Vitro Release Kinetics of Ranolazine Extended-Release Tablets

Introduction: Mathematical models are vital tools in understanding drug release mechanisms and release kinetics of different dosage forms, which can be achieved by assessing dissolution release profiles. This study aimed to determine and compare the mechanism of drug release using in vitro data for ranolazine extended-release tablets. Methods: Seven formulations of ranolazine extended-release tablets (500 mg) were prepared using a wet granulation technique with matrix-forming polymers. Dissolution tests were conducted in 0.1 N hydrochloric acid using United States Pharmacopeia (USP) apparatus 2 operating at 50 rpm for 24 h. Drug release data were compared using different mathematical models (zero-order, first-order, Higuchi, Korsmeyer--Peppas, and Hixson--Crowell) in DDsolver. Results: Formulation batch F5 and the reference product best fit the Korsmeyer--Peppas model, with a coefficient exponent value of 0.5, indicating Fickian drug release, and Higuchi square root diffusion-controlled mechanisms were noted for both of these formulations, where the fraction of drug released is proportional to the square root of time. Conclusion: Having a similar dissolution profile and diffusion-controlled drug release mechanism, formulation F5 tablets are considered interchangeable with the reference product. KEYWORDS: drug release, mathematical models, dissolution