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Abstract

BIO-EQUIVALENCE STUDY OF TWO ORAL ERYTHROMYCIN PRODUCTS (ERYTHROCIN 16.5%® AND ERYTHROBION®) IN CHICKENS

Ashraf Elkomy and Mohamed Aboubakr

ABSTRACT

The comparative bio-equivalence of Erythrocin 16.5%® and Erythrobion® 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 Erythrocin 16.5%®, while the 2nd group was designed to study the pharmacokinetics of Erythrobion®. 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 Erythrocin 16.5%® and Erythrobion® following oral administration of 20 mg erythromycin base/kg b.wt, revealed that the maximum blood concentration [Cmax] were 4.80 and 4.66 μg/ml and attained at [tmax.] of 2.58 and 2.59 hours, respectively. Erythromycin in Erythrocin 16.5%® and Erythrobion® was eliminated with half-life [t1/2el] equal to 4.04 and 3.79 hours, respectively. It was concluded that Erythrobion® is bioequivalent to Erythrocin 16.5%® since the ratios of Cmax, AUC0-24 and AUC0-∞ (T/R) were 0.97, 0.95 and 0.94 respectively. These are within the bioequivalence acceptance range. Erythrocin 16.5%® and Erythrobion® are therefore bioequivalent and interchangeable.

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