| publication name | Evaluation of bioequivalence of two enrofloxacin formulations after intramuscular administration in goats. |
|---|---|
| Authors | Aboubakr M |
| year | 2013 |
| keywords | enrofloxacin, goats, bioequivalence |
| journal | Korean Journal of Veterinary Research, 2013, 53(2): 77-82. |
| volume | 53 |
| issue | 2 |
| pages | 77-82 |
| publisher | Not Available |
| Local/International | International |
| Paper Link | https://astp.jst.go.jp/modules/search/DocumentDetail/1225-0198%2B%2540%2B2234-134x%2B%2540%2B_53_2_Evaluation%2Bof%2Bbioequivalence%2Bof%2Btwo%2Benrofloxacin%2Bformulations%2Bafter%2Bintramuscular%2Badministration%2Bin%2Bgoats_N%252FA |
| Full paper | download |
| Supplementary materials | Not Available |
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 ($C_{max}$), time to reach peak concentration ($T_{max}$), area under concentration-time curve (AUC), elimination half-life ($t_{0.5el}$) were 1.14 and $1.05{mu}g/mL$, 0.79 and 0.83 h, 5.70 and $5.79{mu}g.h/mL$, 5.19 and 5.39 h for Baytril and Spectrama Vet, respectively. The 90% confidence interval for the mean ratio of $T_{max}$, $C_{max}$ 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 $T_{max}$ and AUC and between 75-133% for $C_{max}$. In conclusion, Spectrama-Vet is bioequivalent to Baytril and both products can be used as interchangeable drug in veterinary medicine practice.