Abstract

BIO-EQUIVALENCE STUDY OF TWO ORAL ERYTHROMYCIN PRODUCTS (ERYTHROSOL® AND ERYTHROMOND®) IN CHICKENS

Ashraf Elkomy and Mohamed Aboubakr*

ABSTRACT

The comparative bio-equivalence of Erythrosol® and Erythromond® in chickens was studied after oral administration of both products in a dose of 20 mg erythromycin base/kg b.wt. Twenty four chickens were divided equally into two groups (12 chickens for each group). The first group was designed to study the pharmacokinetics of Erythrosol®, while the 2nd group was designed to study the pharmacokinetics of Erythromond®. Each chicken in both groups was orally administered with 20 mg erythromycin 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 erythromycin in Erythrosol® and Erythromond® following oral administration of 20 mg erythromycin base/kg b.wt, revealed that the maximum blood concentration [Cmax] were 5.17 and 5.05 μg/ml and attained at [tmax.] of 2.50 and 2.52 hours, respectively. Erythromycin in Erythrosol® and Erythromond® was eliminated with half-life [t1/2el] equal to 4.04 and 3.81 hours, respectively. It was concluded that Erythromond® is bioequivalent to Erythrosol® since the ratios of Cmax, AUC0-24 and AUC0-∞ (T/R) were 0.97, 0.95 and 0.95 respectively. These are within the bioequivalence acceptance range. Erythrosol® and Erythromond® are therefore bioequivalent and interchangeable.

Keywords: .