Abstract

Rofecoxib is a non-steroidal anti-inflammatory drug, mainly used for osteoarthritis, rheumatoid arthritis, and dysmenorrhea. The major problem with this drug is its very low solubility in biological fluids, which results in poor bioavailability after oral administration. Therefore, solid dispersions of Rofecoxib with urea, polyethylene glycol (PEG) 6000 and polyvinyl pyrrolidone (PVP) K30 were prepared by different methods and evaluated with a view to increase its water solubility and hence to improve the dissolution profile. Solid dispersions were prepared and evaluated for solubility, melting point and % practical yield. Two solid dispersions showing maximum solubility were selected and formulated into tablet. The tablets were exposed to routine quality control tests like hardness, friability, weight variation and disintegration. The dissolution profiles of these formulations were studied in 0.1 N HCl and compared with marketed tablet as well as pure drug. At the end of 30 min, formulation TFG3 gave the highest drug release that is 99.10%, followed by TSG3 (90.32%) whereas marketed tablet and plain drug gave 71.22 and 24.14% respectively. The present study conclusively demonstrated that, solubility and dissolution profile of Rofecoxib was significantly improved by preparing solid dispersion with water soluble carriers.

Key words: Rofecoxib, solubility, solid dispersion, hydrophilic carriers, dissolution.