BIOEQUIVALENCE STUDY OF TWO ENROFLOXACIN PREPARATIONS IN BROILERS
Abstract
The pharmacokinetics and absolute bioavailabilities of two generic formulations of enrofloxacin (ENRO- A; Enrol®: Medmac®, Amman, Jordan and ENRO- B; Syvaquinol® Syva®, Leon, Spain) 10% oral solutions were compared after single intracrop (i.c.) bolus administrations in reference to single intravenous bolus (i.v.) administration of standard ENRO at a dose of 10 mg/Kg body weight in broilers using a randomized parallel design. Plasma collected at predetermined time points up to 24 hours. Clinicochemical, hematological and histopathological alterations were also, demonstrated after repeated intracrop (i.c.) bolus administrations of the two different enrofloxacin generic preparations given at a dose regimen of 10 mg/Kg body weight for 5 consecutive days in ENRO-A and ENRO-B treated groups whereas control group was kept untreated and given water instead. Blood samples were collected from all birds on the 5th day for clinicochemical and hematological examinations. Birds were then humanely sacrificed liver, kidneys and heart were dissected out for histopathological examination. HPLC assay was used to measure concentrations of ENRO in plasma. The pharmacokinetic analysis of the C-T data was performed using non-compartmental analysis based on statistical moment theory. 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. Results of safety study revealed that ENRO-A induced a significant (p
ناصــر الطـاهـــر احويـسج(1-2016)
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