Formulation Development and Evaluation of Mouth Spray of Ondansetron Hydrochloride

Author(s)

Patel, R. V., Patel, K. N., Patel, P. A., Nayak, B. S., Shah, V.

Author's Affiliation

Abstract

The main objective of this study to formulate mouth spray of Ondansetron hydrochloride and to achieve immediate release of drug and increased bioavailability. Ondansetron hydrochloride is a highly specific and selective serotonin 5-HT₃ receptor antagonist, not shown to have activity at other known serotonin receptors and with low affinity for dopamine receptors. Ondansetron is a potent antiemetic drug, which is used in control of nausea, vomiting associated with cancer chemotherapy. It exhibits only 60–70% of oral bioavailability because of first pass metabolism and has a relative short half-life of 3–5 hours. It is BCS class-III drug. A Box-behnken design was applied to systematically optimize the taste masking of drug. The concentration of Sucralose (X₁), concentration of Neotame (X₂) and concentration of Sorbitol (X₃₎ were selected as independent variables. The sweetness (Y) was selected as dependent variables. The prepared mouth spray was evaluated for pH, Spray volume, microbial testing, true density, taste by panel and %drug content. The results indicated that concentration of sucralose (X₁), concentration of Neotame (X₂) and concentration of sorbitol (X₃) significantly affected the sweetness (Y). Experimental design was used to identify the best formulation. Formulation O15 prepared with Sucralose (100 mg), Neotame (6 mg) & Sorbitol (5 ml) was found to be the best formulation with taste masking of drug, no microbial growth and 99.11% drug content.

Keywords

Ondansetron Hydrochloride, Mouth Spray, Sucralose, Neotame, Sorbitol, Sweetness, Box-Behnken Design

Cite This Article

Patel, R. V., Patel, K. N., Patel, P. A., Nayak, B. S., & Shah, V. (2014). Formulation Development and Evaluation of Mouth Spray of Ondansetron Hydrochloride. International Journal for Pharmaceutical Research Scholars (IJPRS), 3(2), 175-187.