PHASE SOLUBILITY STUDIES OF ONDANSETRON -2- HYDROXYPROPYL BETACYCLODEXTRIN FOR DEVELOPMENT OF ONDANSETRON ORODISPERSIBLE FILMS

The present research work was aimed to formulate transparent mouth dissolving films of ondansetron. Ondansetron is poorly soluble in aqueous solvents (less than 5 mg/mL) and thus improvisation in solubility was crucial. The phase solubility studies were carried in order to study the formation of inclusion complex with Hydroxy Propyl Beta cyclodextrin. The phase solubility diagrams revealed the formation of stable inclusion complex and apparent stability constants were evaluated. The calculated apparent stability constant, Kc was found to be 288.5 mol-1. The shape of solubility graph indicated that there is probability of the formation of 1:1complex with respect to HP-b-CD concentration (Slope of less than 1). The Scanning Electron Microscopy study of plain ondansetron and ondansetron orodispersible film revealed the formation of stable inclusion complex, which renders the complete solubilisation of ondansetron, yielding the formation of transparent mouth dissolving films.