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Abstract

BIOEQUIVALENCE STUDY OF TWO ORAL TETRACYCLINE SOLUBLE POWDER (TETRACYCLINE 50 COOPHAVET® AND SPECTROSTER®) IN BROILER CHICKENS

Ashraf Elkomy and Mohamed Aboubakr*

ABSTRACT

The present study was designed to assess the comparative bioequivalence of Tetracycline 50 Coophavet® and Spectroster® in healthy broiler chickens after oral administration of both products in a dose of 20 mg tetracycline/Kg b.wt. Twenty four broiler chickens were divided into two groups. The first group was designed to study the pharmacokinetics of Tetracycline 50 Coophavet®, while the 2nd group was designed to study the pharmacokinetics of Spectroster®. Each broiler chicken in both groups was orally administered with 20 mg tetracycline/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 Tetracycline 50 Coophavet® and Spectroster® following oral administration of 20 mg tetracycline/Kg b.wt, revealed that the maximum blood concentration of tetracycline [Cmax] were 22.02 and 21.51 μg/ml and attained at [tmax] of 2.48 and 2.47 hours, respectively. In conclusion: Spectroster® is bioequivalent to Tetracycline 50 Coophavet® since the ratios of Cmax, AUC0-24 and AUC0-∞ (T/R) was 0.97, 0.96 and 0.96 respectively. These are within the bioequivalence acceptance range. Spectroster® and Tetracycline 50 Coophavet® are therefore bioequivalent and interchangeable.

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