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<p>Pimobendan (PBD) is widely used to manage canine heart failure; however, commercially available formulations present limitations such as restricted dose flexibility and large tablet sizes, which may compromise long-term treatment individualisation. Three-dimensional (3D) printing offers a promising alternative by enabling customisable veterinary formulations. This study presents the first in vivo pharmacokinetic and clinical evaluation of 3D-printed PBD tablets (printlets) specifically designed for and administered to dogs. Printlets containing 2.5&#xa0;mg of PBD were produced by semisolid extrusion 3D printing and compared with the commercial formulation Vetmedin<sup>®</sup>. Both formulations were characterised for weight, dimensions, drug content, and in vitro dissolution. They were orally administered to healthy Beagle dogs at a single dose of 0.2&#xa0;mg/kg. Plasma PBD concentrations were quantified by LC–MS/MS, and pharmacokinetic parameters were determined by non-compartmental analysis. The 3D-printed printlets were safely administered, and no adverse effects were observed during the study. The pharmacokinetic evaluation demonstrated systemic exposure following oral administration of the 3D-printed formulation according to their sustained release profile, showing differences in absorption profiles compared with the commercial formulation. Overall, this study provides in vivo evidence supporting the feasibility of semisolid extrusion 3D printing for the preparation of veterinary PBD dosage forms and highlights the potential of digital manufacturing technologies for individualized veterinary therapy.</p> Graphical Abstract <p></p>

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From prototype to veterinary patient: a pharmacokinetic clinical trial of 3D-printed pimobendan tablets in beagle dogs

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年5月25日

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  • Júlia Leão,
  • Valeria Luiza Winck,
  • Lucas Suchecki Barnet,
  • José Roberto de Lima Junior,
  • Isabelle Vilela Bonfim,
  • Anna Julia Bessa Fernandes,
  • Ingrid Lins Raquel de Jesus,
  • Gabrielle de Lima Monzato,
  • Mathias Pittizer da Silva,
  • Matheus Eduardo Costa da Silva,
  • Fabiano Barreto,
  • Fábio Barbour Scott,
  • Yara Peluso Cid,
  • Diego Fontana de Andrade,
  • Ruy Carlos Ruver Beck

摘要

Pimobendan (PBD) is widely used to manage canine heart failure; however, commercially available formulations present limitations such as restricted dose flexibility and large tablet sizes, which may compromise long-term treatment individualisation. Three-dimensional (3D) printing offers a promising alternative by enabling customisable veterinary formulations. This study presents the first in vivo pharmacokinetic and clinical evaluation of 3D-printed PBD tablets (printlets) specifically designed for and administered to dogs. Printlets containing 2.5 mg of PBD were produced by semisolid extrusion 3D printing and compared with the commercial formulation Vetmedin®. Both formulations were characterised for weight, dimensions, drug content, and in vitro dissolution. They were orally administered to healthy Beagle dogs at a single dose of 0.2 mg/kg. Plasma PBD concentrations were quantified by LC–MS/MS, and pharmacokinetic parameters were determined by non-compartmental analysis. The 3D-printed printlets were safely administered, and no adverse effects were observed during the study. The pharmacokinetic evaluation demonstrated systemic exposure following oral administration of the 3D-printed formulation according to their sustained release profile, showing differences in absorption profiles compared with the commercial formulation. Overall, this study provides in vivo evidence supporting the feasibility of semisolid extrusion 3D printing for the preparation of veterinary PBD dosage forms and highlights the potential of digital manufacturing technologies for individualized veterinary therapy.

Graphical Abstract