Abstract

BIO-EQUIVALENCE STUDY OF TWO ORAL TIAMULIN SOLUTIONS (TRIAMULOX® AND OROTAM ORAL SOLUTION®) IN CHICKENS

Ashraf Elkomy and Mohamed Aboubakr*

ABSTRACT

The comparative bio-equivalence of Triamulox® and Orotam oral solution® in broiler chickens was studied after oral administration of both products in a dose of 25 mg tiamulin hydrogen fumarate/kg b.wt. Twenty four broiler chickens were divided equally into two groups (12 chickens for each group). The first group was designed to study the pharmacokinetics of Triamulox®, while the 2nd group was designed to study the pharmacokinetics of Orotam oral solution®. Each broiler chicken in both groups was orally administered with 25 mg tiamulin hydrogen fumarate/kg b.wt. Blood samples were obtained from the wing vein and collected immediately before and at 0.08, 0.16, 0.25, 0.5, 1, 2, 4, 6, 8, 12 and 24 hours after a single oral administration. The disposition kinetics of tiamulin in Triamulox® and Orotam oral solution® following oral administration of 25 mg tiamulin hydrogen fumarate/kg b.wt, revealed that the maximum blood concentration [Cmax] were 0.85 and 0.79 μg/ml and attained at [tmax.] of 1.23 and 1.24 hours, respectively. Tiamulin in Triamulox® and Orotam oral solution® was eliminated with half-lives [t1/2el] equal to 6.37 and 5.47 hours, respectively. It was concluded that Orotam oral solution® is bioequivalent to Triamulox® since the ratios of Cmax, AUC0-24 and AUC0-∞ (T/R) were 0.93, 0.82 and 0.83 respectively. These are within the bioequivalence acceptance range. Triamulox® and Orotam oral solution® are therefore bioequivalent and interchangeable.

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