Abstract

BIO-EQUIVALENCE STUDY OF TWO ORAL TYLOSIN SOLUBLE POWDER (TYLOPHOS® AND BACTISEAS®) IN BROILER CHICKENS

Ashraf Elkomy and Mohamed Aboubakr*

ABSTRACT

The comparative bio-equivalence of Tylophos® and Bactiseas® in broiler chickens was studied after oral administration of both products in drinking water at a dose of 50 mg tylosin/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 Tylophos®, while the 2nd group was designed to study the pharmacokinetics of Bactiseas®. Each broiler chicken in both groups was orally administered in drinking water with 50 mg tylosin/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 in drinking water. The disposition kinetics of tylosin in Tylophos® and Bactiseas® following oral administration in drinking water with 50 mg tylosin base/kg.b.wt. revealed that the maximum blood concentration [Cmax.] were 3.03 and 2.87 μg/ml and attained at [tmax.] of 1.01 and 1.02 hours, respectively. Tylosin in Tylophos® and Bactiseas® was eliminated with half-lives [t1/2el] equal to 8.43 and 8.45 hours, respectively. It was concluded that Bactiseas® is bioequivalent to Tylophos® since the ratios of Cmax, AUC0-24 and AUC0-∞ (T/R) were 0.94, 0.91 and 0.91 respectively. These are within the bioequivalence acceptance range. Tylophos® and Bactiseas® are therefore bioequivalent and interchangeable.

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