Abstract

BIO-EQUIVALENCE STUDY OF TWO ORAL SPIRAMYCIN FORMULATIONS (GANAPORK F® AND NILESPIRASOL®) IN BROILER CHICKENS

Ashraf Elkomy and Mohamed Aboubakr*

ABSTRACT

The present study was designed to assess the comparative bio-equivalence of Ganapork F® and Nilespirasol® in healthy broiler chickens after oral administration of both products in a dose of 38 mg spiramycin/kg.b.wt. Twenty four broiler chickens were divided equally into two groups (12 chickens for each group). The first group was designed to study the pharmacokinetics of Ganapork F®, while the 2nd group was designed to study the pharmacokinetics of Nilespirasol®. Each broiler chicken in both groups was orally administered of 38 mg spiramycin/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 Ganapork F® and Nilespirasol® following oral administration of 38 mg spiramycin/kg.b.wt. revealed that the maximum blood concentration [Cmax] were 2.28 and 2.02 μg/ml and attained at [tmax] of 1.75 and 1.84 hours, respectively. In conclusion: Nilespirasol® is bioequivalent to Ganapork F® since the ratios of Cmax, AUC0-24 and AUC0-∞ (T/R) were 0.88, 0.87 and 0.86 respectively. These are within the Bio-equivalence acceptance range. Ganapork F® and Nilespirasol® are therefore bioequivalent and interchangeable.

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