Abstract

Rofecoxib is novel cyclooxygenase-2 inhibitor, which is poorly soluble in aqueous media. The aim of present study was to improve the solubility and dissolution rate of drug by formulating its solid dispersions with various hydrophilic carriers (polyethylene glycol-6000, polyvinyl pyrrolidone K- 30, Eudragit E-100) and inclusion complex with β-cyclodextrin. Drug release profile was studied in 0.1 N HCI as dissolution media. Rofecoxib forms eutectic mixture with polyethylene glycol 6000 and glass solution with polyvinyl pyrrolidone K 30 and Eudragit E 100. Polyvinyl pyrrolidone K 30 was found to be more effective in increasing the drug dissolution, when compared with polyethylene glycol 6000 and Eudragit E 100.The theoretical prediction for the use of β-cyclodextrin as a dissolution enhancing agent was performed. The dissolution was obtained as high as 75% in rofecoxib:β-cyclodextrin molar ratio of 1:5 prepared by kneading method. For further dissolution enhancement the combination of two dissolution enhancing agent i.e. polyvinyl pyrrolidone K-30 and β-cyclodextrin were used. 32 factorial design was conducted to optimize the proportion of both the carriers.