FORMULATION AND EVALUATION OF IMMEDIATE RELEASE TABLETS OF MACITENTAN

The present study aimed to formulate and evaluate immediate-release tablets of Macitentan using super disintegrants to enhance rapid drug release. Tablets were prepared by incorporating cross povidone, croscarmellose sodium, and sodium starch glycolate in a 1:1 ratio using a suitable manufacturing method. The powder blends were evaluated for pre-compression parameters such as bulk density, tapped density, angle of repose, Carr’s index, and Hausner’s ratio, which indicated good flow properties. The compressed tablets were assessed for post-compression parameters including weight variation, hardness, thickness, friability, disintegration time, drug content, and in-vitro dissolution. All evaluated parameters were found to be within Indian Pharmacopoeia (IP) limits, confirming acceptable tablet quality. Among the developed formulations, F2 was identified as the optimized formulation, exhibiting rapid disintegration and a maximum drug release of 99.76%, which was superior compared to other formulations. The results suggest that the combination of cross povidone, croscarmellose sodium, and sodium starch glycolate in equal proportion is effective in developing immediate-release tablets of Macitentan with enhanced dissolution and potential for improved therapeutic performance. Keywords: Macitentan, cross povidone, croscarmellose sodium, and sodium starch glycolate