AMOXICILLIN BIOEQUVALANCE STUDIES OF VETERINARY PREPRATIONS IN PAKISTAN

Published: November 18, 2011

By: M. Ashraf*1, M. A. Rasheed *, M.O. Omer*, A. Javeed* and S. Afzal*

Summary

Amoxicillin is a broad spectrum, semi synthetic penicillin used for the treatment of many bacterial diseases of animals. There are more than twenty veterinary preparations of amoxicillin approved, for use in veterinary practice by the ministry of health Pakistan. This project was designed to evaluate the chemical and bioequivalency of local and imported preparations commonly available in the market. For chemical equivalence study, samples of Farmox®, Farmox® L.A. Almox®, Amovet®, Amoxivet® and Clamoxal® L. A. etc were collected from local market and drug concentration was measured by HPLC. For bioequivalence study two long acting preparations (Clamoxal® L. A. and Farmox® L.A.) and two short acting preparations (Farmox® and Amoxi Vet®.) were used in a cross over design using buffalo calves as target animals. Blood samples were collected in heparinised test tubes at 0.166, 0.333, 0.50, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12.0, 24.0, 36.0 and 48.0 hours after drug administration (15 mg/kg body weight I/M) and amoxicillin plasma concentration was measured by HPLC. Based on rate and extent of amoxicillin absorption (AUC, Tmax, Cpmax) there was no significant difference in these preparations. From this study, it was concluded that both imported and local preparations can be used interchangeably with similar results. Based on plasma concentration time profile, observed in this study, it is also recommended that dosage interval for long acting preparations should be 24 hours (as claimed to 48 hours) and 12 hours for short acting preparations (as claimed to 24 hours). Keywords: Amoxicillin, Chemical Equivalence, Bioequivalence, Veterinary Preparations, Buffalo Calves

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