Bioequivalence study of veterinary drugs based on oclacitinib «Nicialle» and «Apoquel» in dogs

Abstract

The article presents the results of a study of the comparative pharmacokinetics (bioequivalence) of two drugs for veterinary use-the reproduced drug «Nizialle» and the original drug «Apoquel». The experiments were carried out on 12 dogs divided into two equal groups (six individuals in each). Animals of one group were given a reproduced drug orally, dogs of the other group were given a reference drug. The studied drugs were injected into the body of dogs once (individually) orally. Each animal was given a dose of each drug, corresponding to 0.6 mg oclacitinib per 1 kg of body weight. After a single administration of drugs, blood samples were taken from each dog in the group for subsequent serum collection. In the obtained blood serum samples, the content of oclacitinib was determined by highperformance liquid chromatography. The obtained values of oclacitinib concentrations served as the basis for calculating its pharmacokinetic parameters in dogs. The conducted statistical analysis showed that the two-sided confidence intervals for the Cmax, AUC0-t, AUC0-∞ ratios were in the range of 80–125%, and the Cmax/ AUC0-t ratios were in the range of 75–133%. Thus, the results of the studies demonstrated that the preparations «Apoquel» and «Nizialle» are bioequivalent.