Study of bioequivalence of veterinary drugs “Pinpramil” and “Milbemax” in dogs

Abstract

The article presents the results of studying the bioequivalence of the reproduced drug “Pinpramil” in comparison with the reference drug “Milbemax”. The experiments were conducted on 12 dogs, which were divided into two equal groups of 6 animals each. Dogs of one of the groups were given a reproduced drug, and animals of the other group were given a reference drug. The studied drugs were injected into the body of dogs once, individually, orally at a dose of the active substance, which corresponded to 0.5 mg of milbemycin oxime and 5 mg of praziquantel per 1 kg of body weight. After administration of the drugs, blood samples were taken from animals 14 times within 96 hours for subsequent production of serum, in which the content of praziquantel (including its active metabolite, trans-4-hydroxypraziquantel) and milbemycin oxime were determined by high-performance liquid chromatography. The obtained concentrations of these substances served as the basis for calculating their pharmacokinetic parameters in the body of dogs. The statistical analysis showed that the two-way confidence intervals for the Cmax, AUC0-t, AUC0-∞ ratios were in the range of 80–125%, and the Cmax/AUC0-t ratios were 75–133%. Thus, the research results have demonstrated that the drugs “Pinpramil” and “Milbemax” are bioequivalent.