Abstract

SUB ACUTE TOXICITY STUDY OF ONDANSETRON HYDROCHLORIDE IN WISTAR RATS BY NASAL ROUTE

M.Menaka*, V.P.Pandey, A.Anton Smith

Department of Pharmacy, Annamalai University, Annamalai Nagar-608002. India.

Abstract

The objective of the present study is to evaluate the potential toxicity in wistar rats of the preclinical safety use of Ondansetron hydrochloride nasal spray. The study design involved 4 groups of 6 animals per each (male and female) at different dose levels. Ondansetron hydrochloride nasal spray has been administered in a constant volume of 2 ml/kg nasally for 28 days. No mortality was seen in any of the treatment groups during the course of study. Various physiological, hematological as well as biochemical parameters were studied and found not to be changed significantly, indicating that Ondansetron hydrochloride nasal spray is nontoxic even at higher dose levels in Wistar rats. Overall tolerability and safety profile of Ondansetron hydrochloride nasal spray is proved good and does not appear to carry the risk of serious adverse effects.

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