Abstract

BIOEQUIVALENCE STUDY OF TWO ORAL DIFLOXACIN FORMULATIONS (DICURAL® AND WIDIFLOX®) IN BROILER CHICKENS

Ashraf El-komy* and Mohamed Aboubakr

ABSTRACT

A bioequivalence of two oral formulation of difloxacin (Dicural® and Widiflox®) was tested in broiler chickens using a parallel design at 10 mg/kg bodyweight orally. Twenty four healthy broiler chickens were divided into two groups. The first group was designed to study the pharmacokinetics of Dicural®, while the 2nd group was designed to study the pharmacokinetics of Widiflox®. Each broiler chickens in both groups were orally administered with 10 mg difloxacin/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. Plasma difloxacin concentrations were analyzed using microbiological assay. Following a single oral administration, peak plasma concentrations (Cmax) was 2.39 and 2.24 μg/ml were obtained in chickens given Dicural® and Widiflox® products, respectively which attained at tmax at 1.01 and 1.03 h for Dicural® and Widiflox®, respectively. Ratios of Cmax, AUC0-24 and AUC0-∞ (T/R) were 1.07, 1.09 and 1.10 respectively. These are within the bioequivalence acceptance range. Dicural® and Widiflox® are therefore bioequivalent and interchangeable.

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