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Abstract

BIOEQUIVALENCE STUDY OF TWO ORAL SULFACLOZINE (SULFACLOZINE-NA 60%® AND MASOCLOSAFECT®) IN BROILER CHICKENS

Ashraf Elkomy and Mohamed Aboubakr*

ABSTRACT

The present study was designed to assess the comparative bio-equivalence of Sulfaclozine-Na 60%® and Masoclosafect® 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 Sulfaclozine-Na 60%®, while the 2nd group was designed to study the pharmacokinetics of Masoclosafect®. 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 Sulfaclozine-Na 60%® and Masoclosafect® following oral administration of 30 mg sulfaclozine/Kg b.wt, revealed that the maximum blood concentration of sulfaclozine [Cmax] were 15.61 and 15.34 μg/ml and attained at [tmax] of 4.06 and 4.07 hours, respectively. In conclusion: Masoclosafect® is bioequivalent to Sulfaclozine-Na 60%® since the ratios of Cmax, AUC0-24 and AUC0-∞ (T/R) was 0.98, 0.97 and 0.97 respectively. These are within the bioequivalence acceptance range. Masoclosafect® and Sulfaclozine-Na 60%® are therefore bioequivalent and interchangeable.

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