Abstract

Valdecoxib is a new non-steroidal antiinflammatory 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 valdecoxib with mannitol, polyethylene glycol 4000, and polyvinyl pyrrolidone K-12, were prepared with a view to increase its water solubility. Valdecoxib solid dispersion with polyvinyl pyrolidone K-12 showed maximum drug release hence, the tablet formulation containing valdecoxib polyvinyl pyrolidone K-12 solid dispersion, was prepared with a view to improve its water solubility. The dissolution profile of best laboratory developed formulation (F1) was compared with marketed tablet products. The drug release profile was studied in 0.1 N HCL. F1 gave far better dissolution than the conventional marketed tablet, which released only 44.3% drug and valdecoxib in b cyclodextrin, which released 53.4% drug in 20 min, while F1 exhibited almost 100% drug release in 20 min. The dissolution efficiency of F1 was compared with pure drug, conventional market tablet, and valdecoxib in b cyclodextrin. F1 showed maximum dissolution efficiency. F1 was considered better than valdecoxib in b cyclodextrin, as far as the cost of raw materials used in the product is concerned. F1 was subjected to stability studies. The formulation was found to be stable for 4 weeks at 45°, with insignificant change in the hardness, disintegration time, and in vitro drug release pattern.