Comparative pharmacokinetic and bioequivalence of nine oral ivermectin formulations in dogs
- Author:
Suyoung KIM
1
;
Syed Al Jawad SAYEM
;
HyunYoung CHAE
;
Sung-Won PARK
;
Ling GUI
;
Seung-Chun PARK
;
JeongWoo KANG
Author Information
- Publication Type:Research Report
- From:Journal of Veterinary Science 2025;26(6):e88-
- CountryRepublic of Korea
- Language:English
-
Abstract:
Objective:This study evaluated the pharmacokinetics and bioequivalence of eight oral IVM formulations (B–I) compared with the innovator product (A) in dogs.
Methods:Forty-five healthy dogs (mean body weight: 14.3 kg) were divided into nine groups (n = 5). Each received 6.2 µg/kg of IVM orally. Blood samples were collected up to 72 h post-dosing, and plasma IVM concentrations were quantified by liquid chromatography– mass spectrometry. Pharmacokinetic parameters were analyzed using a one-compartment model. Bioequivalence was assessed non-compartmentally using 90% confidence intervals for maximum concentration (Cmax ) and area under the plasma concentration–time curve (AUC72h ), with acceptance limits of 80–125%.
Results:Absorption (Ka = 0.09–0.16 h −1 ), elimination half-life (T1/2 = 4.89–14.97 h), and systemic exposure (Cmax = 6.07–7.59 ng/mL) varied among formulations. Formulation C showed prolonged elimination (14.97 h) and higher exposure (AUC72h = 214.16 ng·h/ mL), whereas formulation H exhibited faster absorption but lower exposure (AUC72h = 114.36 ng·h/mL). Simulated dosing indicated that most formulations maintained plasma levels above the minimum effective concentration (0.2 ng/mL), except formulation E. Only formulation G met full bioequivalence with the reference product.
Conclusions:and Relevance: All formulations achieved plasma concentrations sufficient for prophylaxis, but only B, C, and G satisfied bioequivalence criteria. Larger sample sizes and standardized evaluation guidelines are recommended for multi-formulation bioequivalence studies.
