Development of sublingual spray formulation containing ondansetron hydrochloride dihydrate

Ondansetron is an antiemetic agent which is used primarily in hospital settings to prevent nausea and vomiting while patient is on chemotherapy or radiotherapy. Oral tablets currently available in the market exhibit a rather slow onset of action due to first pass metabolism. In this study sublingual formulations of ondansetron were developed with the aim of providing an alternative dosage form, potentially with a quicker onset of action. Testing of solubility, stability and spray characteristics were carried out as part of the development process. Solubility was improved by co-solvent system where we studied solubility of ondansetron hydrochloride dihydrate in pure solvents, binary and ternary mixtures. Four ondansetron formulations were subjected on stability to check stability trending. All formulations were identified to produce an expected shelf-life of two years. Pharmacokinetics of sublingual spray formulations with varying solvent compositions was evaluated in New Zealand white rabbits and pharmacokinetic parameters were calculated. Data suggests that by further development of sublingual spray formulation with new permeation enhancers might be an alternative route which can produce fast onset of action.