Formulation Development And Evaluation of Immediate Release Indomethacin Tablets Based On The Mixed Solvency Approach

Abstract

The present study focuses on the formulation development and evaluation of immediate-release Indomethacin tablets using the mixed solvency approach to enhance the solubility and dissolution characteristics of the poorly water-soluble drug Indomethacin. As a Biopharmaceutical Classification System (BCS) Class II drug, Indomethacin exhibits limited aqueous solubility, which can adversely affect its oral bioavailability and therapeutic performance. To overcome this limitation, a mixed solvency system comprising hydrotropic agents and co-solvents was employed during formulation. Immediate-release tablets were prepared by the direct compression method using suitable excipients, including superdisintegrants, diluents, binders, and lubricants. The prepared formulations were evaluated for pre-compression parameters such as angle of repose, bulk density, tapped density, Carr’s index, and Hausner ratio, which indicated satisfactory flow properties of the powder blend. Post-compression studies included weight variation, hardness, friability, thickness, drug content uniformity, and dissolution performance. The optimized formulation demonstrated acceptable physicochemical characteristics, uniform drug distribution, adequate mechanical strength, and rapid drug release. Drug content was found to be 99.2% of the labeled claim, while dissolution studies confirmed efficient immediate-release behavior. The findings suggest that the mixed solvency approach is an effective, economical, and promising strategy for improving the performance of immediate-release Indomethacin tablets.