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KMID : 0359320130530020077
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Korean Journal of Veterinary Research
2013 Volume.53 No. 2 p.77 ~ p.82
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Evaluation of bioequivalence of two enrofloxacin formulations after intramuscular administration in goats
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Aboubakr Mohamed Hafez
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Abstract
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The present study was planned to evaluate the bioequivalence of two commercial formulations of enrofloxacin, which have been marketed as 10% injectable solution after intramuscular administration at a single dose of 2.5 mg/kg body weight to 12 clinically healthy goats The study was carried out on the basis of crossover design. The two formulations were: Baytril as a reference product and Spectrama Vet as a test product. The plasma concentrations of enrofloxacin were measured by high performance liquid chromatography (HPLC) with UV detector. The pharmacokinetics of that data was performed using non-compartmental analysis. The maximum plasma concentration (Cmax), time to reach peak concentration (Tmax), area under concentration-time curve (AUC), elimination half-life (t0.5el) were 1.14 and 1.05 μg/mL, 0.79 and 0.83 h, 5.70 and 5.79 μg.h/mL, 5.19 and 5.39 h for Baytril and Spectrama Vet, respectively. The 90% confidence interval for the mean ratio of Tmax, Cmax and AUC were 94.72~116.2, 87.88~97.16 and 86.44~118.72%, respectively. These values falls within the European Medicines Agency bioequivalence acceptance range of 80~125% for both Tmax and AUC and between 75~133% for Cmax. In conclusion, Spectrama-Vet is bioequivalent to Baytril and both products can be used as interchangeable drug in veterinary medicine practice.
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KEYWORD
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bioequivalence, fluoroquinolones, HPLC, pharmacokinetics
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