Abstract

BIO-EQUIVALENCE STUDY OF TWO TILMICOSIN PHOSPHATE FORMULATIONS (ORAL MIKORARU® AND TILMITREAT®) IN BROILER CHICKENS AND TURKEYS

Ashraf Elkomy* and Mohamed Aboubakr

ABSTRACT

The present study was designed to assess the comparative bio-equivalence of Oral Mikoraru® and Tilmitreat® in healthy broiler chickens and turkeys after oral administration of both products in a dose of 15 mg tilmicosin base/kg.b.wt in chickens and 25 mg tilmicosin base/kg.b.wt in turkeys. Twenty four broiler chickens and twenty four turkeys were divided equally into Four groups (First and second groups contains 12 chickens for each group), while (third and fourth groups contains 12 tyrkeys for each group). The first and third groups were designed to study the pharmacokinetics of Oral Mikoraru®, while the second and fourth groups were designed to study the pharmacokinetics of Tilmitreat®. Each broiler chicken in the 1st and 2nd groups was orally administered with 15 mg tilmicosin base/kg.b.wt. Each turkey in the 3rd and 4th groups was orally administered with 25 mg tilmicosin base/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 Oral Mikoraru® and Tilmitreat® following oral administration of 15 mg tilmicosin base/kg.b.wt. in broiler chickens revealed that the maximum blood concentration [Cmax] were 1.80 and 1.71 μg/ml and attained at [tmax] of 1.96 and 1.99 hours, respectively. The disposition kinetics of Oral Mikoraru® and Tilmitreat® following oral administration of 25 mg tilmicosin base/kg.b.wt. in turkeys chickens revealed that the maximum blood concentration [Cmax] were 1.75 and 1.67 μg/ml and attained at [tmax] of 1.98 and 1.99 hours, respectively. In conclusion: Tilmitreat® is bioequivalent to Oral Mikoraru® since the ratios of Cmax, AUC0-24 and AUC0-∞ (T/R) in broiler chickens were 0.95, 0.92 and 0.90 respectively. The ratios of Cmax, AUC0-24 and AUC0-∞ (T/R) in turkeys were 0.96, 0.93 and 0.89 respectively. These are within the Bio-equivalence acceptance range. Oral Mikoraru® and Tilmitreat® are therefore bioequivalent and interchangeable in chickens and turkeys.

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