Bioequivalence of Milpravet® and Milbemax® administered orally to dogs

The purpose of the study. To investigate the bioequivalence of drugs «Milpravet® for dogs» (test drug, developer AVZ Ltd, Russia) and «Milbemax® for dogs» (reference drug, developer Elanco Europe Ltd, Great Britain) for oral administration. Materials and methods. The studies were performed on clinically healthy mongrel dogs (n=12) in a crossover two-period design. The products were administered once orally at the minimum therapeutic dose of 0.5 mg milbemycin oxime and 5 mg praziquantel per 1 kg of body weight. Blood samples were collected before administration and at 15; 30; 45 min; 1; 1.5; 2; 3; 4; 6; 10; 24; 30; 48; 56; 72 and 96 h after administration. The concentration of active substances in blood plasma was determined by HPLC-MS/MS. Pharmacokinetic parameters were calculated using a non-compartmental method, statistical analysis was performed using ANOVA. Results and conclusions. It was established that the 95% confidence intervals for the and ratios for milbemycin oxime A3 and A4, praziquantel and hydroxy-praziquantel are within the range of 80–125%, falls within the 75–133% range; therefore, the products «Milpravet® for dogs» and «Milbemax® for dogs» are pharmacokinetically equivalent (bioequivalent) in terms of bioavailability and pharmacokinetic characteristics. The drug Milpravet® for dogs is well tolerated by animals and does not cause adverse events or side effects.