Comparative pharmacokinetics and absolute bioavailabilities of two enrofloxacin generic preparations after single intracrop bolus administrations to broiler chickens
Abstract
The pharmacokinetics and absolute bioavailabilities of two generics of enrofloxacin (ENRO) 10% oral solution formulation at a dose of 10 mg/Kg body weight were compared after single intracrop (i.c.) bolus administrations in reference to single intravenous (i.v.) standard ENRO administration in broilers using a randomized parallel design. The two tested formulations were Enrol® (Medmac®, Amman, Jordan) as ENRO-A and Syvaquinol® (Syva®, Leon, Spain) as ENRO-B 10% oral solutions. An HPLC assay using pure ENRO base as a standard was used to measure concentrations of ENRO from the selected sources in plasma collected at predetermined time points up to 24 hours. The pharmacokinetic analysis of the C-T data was performed using non-compartmental analysis based on statistical moment theory with the help of computerized WinNonlin program (Version 5.3, Pharsight® Corporation, St. Louis, USA). The maximum plasma concentrations (Cmax) for ENRO-A and ENRO-B were 1.61 ± 0.203 and 1.79 ± 0.283 μg/mL, respectively, attained at time to peak (Tmax) of 2 h. Elimination half-lives (t1/2β) were 8.391 ± 0.312 and 8.458 ± 0.906 h, respectively. While areas under plasma concentration-time curves (AUC0-∞), and systemic bioavailabilities (F) were 12.744 ± 2.951 and 14.354 ± 2.85 mg.h/L; and 78.96 ± 6.728 and 88.94 ± 10.89 % for ENRO-A and ENRO-B, respectively. It could be concluded that despite the superior pharmacokinetic profile of ENRO-B over ENRO-A, however, both generics were within the FDA and EMA bioequivalence acceptance range of 80%–125% and thus can be used as interchangeable therapeutic agents in chickens.
About this article
Keywords
- Bioavailability
- Bioequivalence
- Broiler
- Chicken
- Enrofloxacin
- Intracrop
- Intravenous
- Pharmacokinetics.
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