Abstract

BIO-EQUIVALENCE STUDY OF TWO ORAL TIAMULIN PRODUCTS (VETMULIN® AND OROTAM®) IN CHICKENS

Ashraf Elkomy and Mohamed Aboubakr*

ABSTRACT

The comparative bio-equivalence of Vetmulin® and Orotam® 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 Vetmulin®, while the 2nd group was designed to study the pharmacokinetics of Orotam®. 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 Vetmulin® and Orotam® following oral administration of 25 mg tiamulin hydrogen fumarate/kg b.wt, revealed that the maximum blood concentration [Cmax] were 0.82 and 0.74 μg/ml and attained at [tmax.] of 1.27 and 1.35 hours, respectively. Tiamulin in Vetmulin® and Orotam® was eliminated with half-lives [t1/2el] equal to 8.83 and 8.03 hours, respectively. It was concluded that Orotam® is bioequivalent to Vetmulin® since the ratios of Cmax, AUC0-24 and AUC0-∞ (T/R) were 0.90, 0.85 and 0.85 respectively. These are within the bioequivalence acceptance range. Vetmulin® and Orotam® are therefore bioequivalent and interchangeable.

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