Development of Sustained-Release Aceclofenac Tablets: Optimization of Polymer Matrices for Controlled Drug Delivery

Abstract

Background: Aceclofenac is a widely used non-steroidal anti-inflammatory drug requiring frequent administration, making it a suitable candidate for a sustained-release formulation to improve patient compliance. Objective: This study aimed to formulate and evaluate sustained-release tablets of Aceclofenac using different polymer matrices to achieve a prolonged drug release profile. Methods: Tablets were formulated with varying concentrations of Carbopol, Kollidon SR, Eudragit L100, and their combinations using the wet granulation technique. The prepared granules were evaluated for flow properties (bulk density, tapped density, Hausner ratio, Carr's index, angle of repose). The resulting tablets were assessed for thickness, hardness, friability, weight variation, and content uniformity. In vitro drug release studies were conducted for 12 hours in 0.1 N KOH and phosphate buffer (pH 6.8) using USP apparatus II, and the drug release data were fitted to various kinetic models. Main Outcome: The primary outcomes were the physicochemical properties of the granules and tablets, and the drug release kinetics from the formulated matrix systems. Results: All formulated granules demonstrated acceptable flow properties, and the tablets complied with official limits for evaluated physicochemical parameters. The drug release from the optimized formulation U18 (Kollidon SR with Eudragit L100) best fitted the Higuchi model, while formulation U20 (Kollidon SR with Carbopol) followed zero-order release kinetics. Conclusion: The study successfully developed sustained-release Aceclofenac tablets. The optimized formulations U18 and U20, based on their distinct release kinetics, were identified as suitable matrix systems for providing sustained drug release