Preliminary Bioequivalence of an Oral Pimobendan Solution Formulation with Reference Solution Formulation in Beagle Dogs
4
Issued Date
2022-03-01
Resource Type
eISSN
23067381
Scopus ID
2-s2.0-85127651643
Journal Title
Veterinary Sciences
Volume
9
Issue
3
Rights Holder(s)
SCOPUS
Bibliographic Citation
Veterinary Sciences Vol.9 No.3 (2022)
Suggested Citation
Saengklub N., Boonyarattanasoonthorn T., Kijtawornrat A., Chantasart D. Preliminary Bioequivalence of an Oral Pimobendan Solution Formulation with Reference Solution Formulation in Beagle Dogs. Veterinary Sciences Vol.9 No.3 (2022). doi:10.3390/vetsci9030141 Retrieved from: https://repository.li.mahidol.ac.th/handle/123456789/87086
Title
Preliminary Bioequivalence of an Oral Pimobendan Solution Formulation with Reference Solution Formulation in Beagle Dogs
Author's Affiliation
Other Contributor(s)
Abstract
Oral capsule and tablet formulations of pimobendan are widely used but may present difficulties for accurately dosing small patients. This study aimed to compare the pharmacokinetic (PK) characteristics, bioequivalence, and cardiovascular effects of a custom-made oral pimobendan solution (PS) formulation compared to a reference solution (RS) formulation in conscious, healthy dogs. A randomized crossover design was performed on dogs that received RS and PS formulations at a dose of 0.3 mg/kg. Blood samples were collected at 0, 0.083, 0.167, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, and 24 h after oral administration for PK analysis; bioequivalence was also calculated. Echocardiography was also performed to assess the cardiovascular effects. The results revealed that the plasma concentrations of pimobendan and o-desmethyl-pimobendan (active metabolite) in the case of both formulations were comparable. The relative ratios of geometric mean concentrations for all significant parameters of PK were within a range of 80–125%, indicating bioequivalence. In addition, both formulations increased cardiac contraction significantly when compared with the baseline, and no differences in cardiac contractility were detected between the formulations. The PS formulation can be used as alternative to the RS formulation for the management of congestive heart disease because of the bioequivalence between the two formulations.