Evaluation of bioequivalence of two enrofloxacin formulations after intramuscular administration in goats.
- Author:
Mohamed Hafez ABOUBAKR
1
Author Information
1. Department of Pharmacology, Faculty of Veterinary Medicine, Benha University, 13736 Moshtohor, Egypt. mohamedhafez19@yahoo.com
- Publication Type:Original Article
- Keywords:
bioequivalence;
fluoroquinolones;
HPLC;
pharmacokinetics
- MeSH:
Area Under Curve;
Body Weight;
Chromatography, High Pressure Liquid;
Chromatography, Liquid;
Confidence Intervals;
Cross-Over Studies;
Fluoroquinolones;
Goats;
Half-Life;
Plasma;
Therapeutic Equivalency;
Veterinary Medicine
- From:Korean Journal of Veterinary Research
2013;53(2):77-82
- CountryRepublic of Korea
- Language:English
-
Abstract:
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 microg/mL, 0.79 and 0.83 h, 5.70 and 5.79 microg.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.
