Key result
Custom oral pimobendan solution demonstrates bioequivalence to a reference solution in healthy dogs.
Why the study?
Oral capsule and tablet pimobendan formulations may present dosing difficulties in small patients, prompting evaluation of a custom oral solution formulation.
Does a custom-made oral pimobendan solution formulation demonstrate bioequivalence to a reference solution formulation in healthy dogs?
RCT
crossover
Does a custom-made oral pimobendan solution formulation demonstrate bioequivalence to a reference solution formulation in healthy dogs?
Effect estimate: relative ratios 80-125%
A custom-made oral pimobendan solution is bioequivalent to a reference solution in healthy dogs, providing a potential alternative for accurate dosing in small patients with congestive heart disease.
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.
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Saengklub et al. (2022) conducted an RCT in healthy dogs. custom-made oral pimobendan solution (PS) vs. reference solution (RS) formulation was evaluated on pharmacokinetic (PK) characteristics, bioequivalence, and cardiovascular effects (relative ratios 80-125%). A custom-made oral pimobendan solution demonstrated bioequivalence to a reference solution in healthy dogs, with relative ratios of geometric mean concentrations within 80-125%.
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