Abstract

BIOEQUIVALENCE STUDY OF TWO ORAL SULFACLOZINE (ESB3® AND ORACLOZIN®) IN BROILER CHICKENS

Ashraf Elkomy and Mohamed Aboubakr*

ABSTRACT

The present study was designed to assess the comparative bio-equivalence of ESB3® and Oraclozin® in healthy broiler chickens after oral administration of both products in a dose of 30 mg sulfaclozine/Kg b. wt. Twenty four broiler chickens were divided into two groups. The first group was designed to study the pharmacokinetics of ESB3®, while the 2nd group was designed to study the pharmacokinetics of Oraclozin®. Each broiler chicken in both groups was orally administered with 30 mg sulfaclozine/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, 8, 12 and 24 hours after a single oral administration. The disposition kinetics of ESB3® and Oraclozin® following oral administration of 30 mg sulfaclozine/Kg b. wt, revealed that the maximum blood concentration of sulfaclozine [Cmax] were 16.21 and 15.24 μg/ml and attained at [tmax] of 4.06 and 4.01 hours, respectively. In conclusion: Oraclozin® is bioequivalent to ESB3® since the ratios of Cmax, AUC0-24 and AUC0-∞ (T/R) was 0.94, 0.92 and 0.92 respectively. These are within the bioequivalence acceptance range. Oraclozin® and ESB3® are therefore bioequivalent and interchangeable.

Keywords: These are within the bioequivalence acceptance range.