A subchronic oral toxicity study in rats of ursodeoxycholic acid tablets prepared with micronized drug
Journal Title: Journal of Pharmacy Research - Year 2011, Vol 4, Issue 5
Abstract
Title: A Subchronic Oral Toxicity Study in rats of Ursodeoxycholic Acid Tablets Prepared with Micronized Drug. Aim: The purpose of this study was to find out the potential toxicity of micronized ursodeoxycholic acid in tablet dosage formulation by 28-days repeated oral dose in Wistar albino rats in accordance with the schedule Y of drugs and Cosmetic Act (1940). Experiment: The test articles were administered daily by gavage to male and female rats at dose levels of 0, 15, 30, 60 mg/kg/day. At the end of treatment period, 12 rats/sex/group were sacrificed after 28 days. During the treatment and recovery periods, clinical signs, mortality, body weights, food and water consumption, hematology and serum biochemistry were examined. Observations: The animals of both sexes from control and different dose groups exhibited normal body weight gain throughout the dosing period of 28 days. All the animals survived the duration of the study, with no significant changes in clinical signs, aematological parameters, organ weights, or histopathological findings.Conclusion: The formulation was found to be nontoxic and hence considered to be safe for oral use.
Authors and Affiliations
Tapan K Pal, *Jayanti Mukherjee and Nilendra Chatterjee
Keywords
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