Formulation Development and In Vitro Evaluation of Immediate-Release Olmesartan Medoxomil Tablets Using Superdisintegrants for Enhanced Dissolution

Abstract

Background: Olmesartan medoxomil is a selective angiotensin II receptor blocker extensively prescribed for the management of hypertension. Despite its therapeutic efficacy, the drug exhibits poor aqueous solubility, resulting in slow dissolution and variable oral bioavailability. The incorporation of suitable superdisintegrants into immediate-release tablet formulations represents a promising strategy to enhance drug dissolution and therapeutic performance. Objective: The present study aimed to formulate and evaluate immediate-release tablets of olmesartan medoxomil using different concentrations of superdisintegrants and to identify an optimized formulation capable of providing rapid disintegration and enhanced in vitro drug release. Materials and Methods: Immediate-release tablets containing olmesartan medoxomil were prepared by the direct compression technique using sodium starch glycolate (SSG), croscarmellose sodium (CCS), and crospovidone (CP) at varying concentrations. The prepared formulations were evaluated for pre-compression parameters, including angle of repose, bulk density, tapped density, Carr's index, and Hausner's ratio. Post-compression evaluations included tablet hardness, friability, weight variation, thickness, drug content, wetting time, disintegration time, and in vitro dissolution studies using USP dissolution apparatus II. Results: All formulations exhibited satisfactory flow characteristics and complied with pharmacopeial specifications for physical quality attributes. Tablets formulated with crospovidone demonstrated the shortest disintegration time and the highest percentage drug release. The optimized formulation released more than 95% of olmesartan medoxomil within 30 minutes, exhibiting superior dissolution performance compared with the marketed reference product. Conclusion: The study demonstrated that the type and concentration of superdisintegrants significantly influence the disintegration behavior and dissolution profile of olmesartan medoxomil immediate-release tablets. Crospovidone was identified as the most effective superdisintegrant, producing rapid tablet disintegration and improved drug release. The optimized formulation may enhance oral bioavailability and improve therapeutic efficacy in the treatment of hypertension.