Abstract

BIO-EQUIVALENCE STUDY OF TWO ORAL SPIRAMYCINTRIMETHOPRIM FORMULATIONS (CRD 92® AND TRIMOSPIRIX®) IN BROILER CHICKENS

Ashraf Elkomy and Mohamed Aboubakr*

ABSTRACT

The present study was designed to assess the comparative bioequivalence of CRD 92® and Trimospirix® in healthy broiler chickens after oral administration of both products in a dose of 100.000 IU spiramycin and 10 mg trimethoprim/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 CRD 92®, while the 2nd group was designed to study the pharmacokinetics of Trimospirix®. Each broiler chicken in both groups was orally administered with 100.000 IU spiramycin and 10 mg trimethoprim/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 spiramycin in CRD 92® and Trimospirix® following oral administration of 100.000 IU spiramycin and 10 mg trimethoprim/kg b.wt., revealed that the maximum blood concentration [Cmax] were 2.17 and 2.07 μg/ml and attained at [tmax] of 1.83 and 1.84 hours, respectively. The disposition kinetics of trimethoprim in CRD 92® and Trimospirix® following oral administration of 100.000 IU spiramycin and 10 mg trimethoprim/kg b.wt., revealed that the maximum blood concentration [Cmax] were 1.16 and 1.12 μg/ml and attained at [tmax] of 1.92 and 1.99 hours, respectively. In conclusion: Trimospirix® is bioequivalent to CRD 92® since the ratios of Cmax, AUC0-24 and AUC0-∞ (T/R) for spiramycin were 0.95, 0.92 and 0.93 respectively, and the ratios of Cmax, AUC0-24 and AUC0-∞ (T/R) for trimethoprim were 0.96, 0.90 and 0.88 respectively. These are within the Bio-equivalence acceptance range. CRD 92® and Trimospirix® are therefore bioequivalent and interchangeable.

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