BIO-EQUIVALENCE STUDY OF TWO ORAL PHENOXYMETHYL PENICILLIN PRODUCTS (PHENOXYPEN® AND VETOXCILLIN®) IN BROILER BREEDERS
Ashraf Elkomy and Mohamed Aboubakr*
ABSTRACT
The comparative bio-equivalence of Phenoxypen® and Vetoxcillin® in broiler breeders was studied after oral administration of both products in a dose of 20 mg phenoxymethyl penicillin base/kg b.wt. Twenty four broiler breeders were divided equally into two groups (12 hen for each group). The first group was designed to study the pharmacokinetics of Phenoxypen®, while the 2nd group was designed to study the pharmacokinetics of Vetoxcillin®. Each hen in both groups was orally administered with 20 mg phenoxymethyl penicillin 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 phenoxymethyl penicillin in Phenoxypen® and Vetoxcillin® following oral administration of 20 mg phenoxymethyl penicillin base/kg b.wt, revealed that the maximum blood concentration [Cmax] were 1.57 and 1.49 μg/ml and attained at [tmax.] of 1.93 and 1.99 hours, respectively. Phenoxymethyl penicillin in Phenoxypen® and Vetoxcillin® was eliminated with half-life [t1/2el] equal to 13.76 and 13.08 hours, respectively. It was concluded that Vetoxcillin® is bioequivalent to Phenoxypen® since the ratios of Cmax, AUC0-24 and AUC0-∞ (T/R) were 0.94, 0.89 and 0.87 respectively. These are within the bioequivalence acceptance range. Phenoxypen® and Vetoxcillin® are therefore bioequivalent and interchangeable.
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