Abstract

BIO-EQUIVALENCE STUDY OF TWO SPIRAMYCIN FORMULATIONS (SUANOVIL 20® AND SPIRAVETOX®) IN BROILER CHICKENS

Ashraf Elkomy and Mohamed Aboubakr*

ABSTRACT

The present study was designed to assess the comparative bio-equivalence of Suanovil 20® and Spiravetox® in healthy broiler chickens after intramuscular injection (IM) of both products in a dose of 15 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 Suanovil 20®, while the 2nd group was designed to study the pharmacokinetics of Spiravetox®. Each broiler chicken in both groups was IM injected with 15 mg spiramycin/kg.b.wt in thigh muscles. 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 IM injection. The disposition kinetics of Suanovil 20® and Spiravetox® following IM injection of 15 mg spiramycin/kg.b.wt. revealed that the maximum blood concentration [Cmax] were 2.51 and 2.44 μg/ml and attained at [tmax] of 1.64 and 1.66 hours, respectively. In conclusion: Spiravetox® is bioequivalent to Suanovil 20® since the ratios of Cmax, AUC0-24 and AUC0-∞ (T/R) were 0.97, 0.94 and 0.88 respectively. These are within the Bio-equivalence acceptance range. Suanovil 20® and Spiravetox® are therefore bioequivalent and interchangeable.

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