Jornal de Bioequivalência e Biodisponibilidade

Abstrato

Pharmacokinetics and Bioequivalence of Florfenicol Oral Solution Formulations (Flonicol® and Veterin®10%) in Broiler Chickens

Ehab A H Abu-Basha,Ronette Gehring,Ahmad F Al-Shunnaq and Saad M Gharaibeh

A pharmacokinetic and bioequivalence evaluation of two florfenicol oral solutions was carried out in 28 healthy broiler chickens after oral administration of a single dose of 20 mg/kg bw, according to a randomized, parallel experimental design. The two formulations were: Flonicol® (Mobedco, Jordan) as a test product and Veterin®10% (Centrovet, Chile) as a reference product. The pharmacokinetic analysis was performed using non-compartmental analysis based on statistical moment theory with the help of a commercially available software program (WinNonlin®, Pharsight Corp., Cary, NC, USA). There were no significant differences in the Cmax (9.02 ± 0.68, 9.20 ± 0.77 μg/ ml), tmax (1.02 ± 0.13, 1.05 ± 0.30 h), t1/2β (1.41 ± 0.06, 1.35 ± 0.05 h), AUC0-12h (26.45 ± 1.33, 26.06 ± 1.20 μg.h/ml), AUC0-∞ (26.61 ± 1.33, 26.26 ± 1.21μg.h/ml), AUMC (71.78 ± 4.65, 69.98 ± 8.80μg.h2/ml), MRT (2.72 ± 0.18, 2.62 ± 0.27 h), ClB/F (12.82 ± 0.63, 12.96 ± 0.60 ml/min/kg) and Vdz/F (1.55 ± 0.08, 1.51 ± 0.08 l/kg) between Flonicol® and Veterin®10%, respectively. The 90% confidence interval for test: reference ratio of the AUC0-12h (91.86-111. 67 μg.h/ml), AUC0-∞ (91.77-111.57 μg.h/ml) and Cmax (82.36-118.54 μg/ml) were within the European Agency for Evaluation of Medicinal Product (EMEA) and the US Food and Drug Administration (FDA) bioequivalence acceptable range (80%–125%). In conclusion, Flonicol® was found to be bioequivalent to Veterin®10% and can be used as interchangeable therapeutic agents in veterinary practice.