Abstract

BIOEQUIVALENCE STUDY OF TWO INJECTABLE AMIKACIN FORMULATIONS (AMIKAVET® AND ENTEROPHARMA®) IN CALVES

Ashraf Elkomy* and Mohamed Aboubakr

ABSTRACT

The present study was designed to assess the comparative bio-equivalence of Amikavet® and Enteropharma® in healthy calves after intramuscular injection (IM) of both products in a dose of 10 mg amikacin base/kg b.wt. Ten calves were divided into two groups. The first group was designed to study the pharmacokinetics of Amikavet®, while the 2nd group was designed to study the pharmacokinetics of Enteropharma®. Each calf in both groups was IM injected with 10 mg amikacin base/kg b.wt. Blood samples were obtained from the jugular vein and collected immediately before and at 0.08, 0.16, 0.25, 0.5, 1, 2, 4, 8, 12 and 24 hours after a single IM injection. The disposition kinetics of Amikavet® and Enteropharma® following IM injection of 10 mg amikacin base /kg b.wt, revealed that the maximum blood concentration of amikacin [Cmax] were 13.77 and 13.62 μg/ml and attained at [tmax] of 1.96 and 1.97 hours, respectively. In conclusion: Enteropharma® is bioequivalent to Amikavet® since the ratios of Cmax, AUC0-24 and AUC0-∞ (T/R) was 0.99, 0.97 and 0.97 respectively. These are within the bioequivalence acceptance range. Enteropharma® and Amikavet® are therefore bioequivalent and interchangeable.

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