Abstract

BIO-EQUIVALENCE STUDY OF TWO ORAL TYLOSIN PRODUCTS (TYLOSINE 75% KELA® AND VETYLOGUARD 75%®) IN BROILER CHICKENS

Ashraf Elkomy and Mohamed Aboubakr*

ABSTRACT

The comparative bio-equivalence of Tylosine 75% Kela® and Vetyloguard 75%® in broiler chickens was studied after oral administration of both products in a dose of 50 mg tylosin base/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 Tylosine 75% Kela®, while the 2nd group was designed to study the pharmacokinetics of Vetyloguard 75%®. Each broiler chicken in both groups was orally administered with 50 mg tylosin base/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 tylosin in Tylosine 75% Kela® and Vetyloguard 75%® following oral administration of 50 mg tylosin base/kg b.wt, revealed that the maximum blood concentration [Cmax] were 2.84 and 2.72 μg/ml and attained at [tmax.] of 1.02 and 1.04 hours, respectively. Tylosin in Tylosine 75% Kela® and Vetyloguard 75%® was eliminated with half-lives [t1/2el] equal to 8.13 and 6.66 hours, respectively. It was concluded that Vetyloguard 75%® is bioequivalent to Tylosine 75% Kela® since the ratios of Cmax, AUC0-24 and AUC0-∞ (T/R) were 0.95, 0.91 and 0.86 respectively. These are within the bioequivalence acceptance range. Tylosine 75% Kela® and Vetyloguard 75%® are therefore bioequivalent and interchangeable.

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