Abstract

BIOEQUIVALENCE STUDY OF TWO INJECTABLE FLORFENICOL AND FLUNIXIN FORMULATIONS (RESFLOR® AND FINICOMAS®) IN CATTLE

Ashraf Elkomy* and Mohamed Aboubakr

ABSTRACT

The present study was designed to assess the comparative bio-equivalence of Resflor® and Finicomas® in healthy cattle after subcutaneous injection (SC) of both products in a dose of 40 mg florfenicol and 2.2 mg flunixin/kg b.wt. Ten cattle were divided into two groups. The first group was designed to study the pharmacokinetics of Resflor®, while the 2nd group was designed to study the pharmacokinetics of Finicomas®. Each cattle in both groups was SC injected with 40 mg florfenicol and 2.2 mg flunixin/kg b.wt. Blood samples were obtained from the jugular vein and collected immediately before and at 0.16, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 60, 72, 84, 96 and 120 hours after a single SC injection. The disposition kinetics of Resflor® and Finicomas® following SC injection of 40 mg florfenicol and 2.2 mg flunixin /kg b.wt, revealed that the maximum blood concentration of florfenicol [Cmax] were 3.94 and 3.79 μg/ml and attained at [tmax] of 8.76 and 8.81 hours, for Resflor® and Finicomas® respectively. The maximum blood concentration of flunixin [Cmax] were 1.46 and 1.39 μg/ml and attained at [tmax] of 1.14 and 1.21 hours, for Resflor® and Finicomas® respectively. In conclusion: Finicomas® is bioequivalent to Resflor® since the ratios of Cmax, AUC0-120 and AUC0-∞ (T/R) for florfenicol was 0.96, 0.94 and 0.93, respectively. The ratios of Cmax, AUC0-60 and AUC0-∞ (T/R) for flunixin was 0.95, 0.92 and 0.89, respectively. These are within the bioequivalence acceptance range. Finicomas® and Resflor® are therefore bioequivalent and interchangeable in cattle.

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