The Bioequivalence Determination of Two Different Formulations of Enrofloxacin in Heifers Following Intramuscular Administration
Küçük Resim Yok
Tarih
2010
Yazarlar
Dergi Başlığı
Dergi ISSN
Cilt Başlığı
Yayıncı
Kafkas Univ, Veteriner Fakultesi Dergisi
Erişim Hakkı
info:eu-repo/semantics/closedAccess
Özet
The aim of this study was to evaluate the bioequivalence (BE) of two medicinal products of enrofloxacin, which have been also marketed as 10% injectable solution in Turkey, after the intramuscular injection (IM) at a single dose of 2.5 mg/kg of BW in the heifers. The present study was performed on healthy 6 Swiss-Brown (12-18 months and 340-400 kg BW) heifers. This study was carried out on the based a single dose cross-over design. Blood samples were taken into sterilized tubes just before, and 10(th), 20(th), 30(th), 45(th), 60(th) and 90(th) min. and 2(th), 3(th), 4(th), 6(th), 8(th), 12(th) and 24(th) h following injections. The plasma concentrations of enrofloxacin (ENR) were measured by high performance liquid chromatography (HPLC) following the extraction process. The plasma concentration-time curves for each animals showed that both products distributed according two-compartment open model. The basic pharmacokinetic parameters at this study were only the AUC(0-24) and AUC(total) were statistically significant (P<0.05) before logarithmic (log) transformation. Log transformed the AUC(0-24), AUC(total) and C(max) parameters and observed t(max) were used in BE evaluation. Minimum, maximum and mean AUC(0-24) AUC(total) and C(max) for A and B products were found in the acceptable ranges (70-143%). For the t(max) value log transformation has not been done and that were determined within the limits 80-125%. As a result; it is concluded that both products could be used instead of each other as an inter-changeable drugs.
Açıklama
Anahtar Kelimeler
Bioequivalence, Enrofloxacin, Heifer
Kaynak
Kafkas Universitesi Veteriner Fakultesi Dergisi
WoS Q Değeri
Q4
Scopus Q Değeri
Cilt
16
Sayı
3
