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In vivo pharmacokinetic study and PBPK modeling: Comparison between 3D-printed nanocrystals and solid dispersions.

Lucia Lopez-Vidal1, Mariano Tinti2, Maria Elisa Melian3

  • 1Facultad de Ciencias Químicas, Universidad Nacional de Córdoba (FCQ-UNC), Haya de la Torre y Medina Allende, X5000XHUA Córdoba, Argentina; Unidad de Investigación y Desarrollo en Tecnología Farmacéutica (UNITEFA) - CONICET, Argentina.

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|December 19, 2024
PubMed
Summary

Nanocrystal (NC) technology showed superior in vivo performance for poorly soluble albendazole compared to solid dispersion (SD) technology when formulated using 3D printing. This highlights NCs as a more effective strategy for enhancing drug delivery of Class II drugs.

Keywords:
3D-printing technologyAlbendazoleBioequivalence analysisDogsMESO-PPPBPK modelParameter Sensitivity AnalysisPharmacokinetic study

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Area of Science:

  • Pharmaceutical Sciences
  • Drug Delivery Systems
  • Materials Science

Background:

  • Drug solubility is a major challenge in formulation development.
  • Nanocrystal (NC) and solid dispersion (SD) technologies are key strategies for enhancing solubility.
  • 3D printing offers a novel approach for drug delivery system fabrication.

Purpose of the Study:

  • To compare the efficacy of nanocrystal (NC) and solid dispersion (SD) technologies for enhancing the solubility and bioavailability of albendazole, a Class II drug.
  • To evaluate the performance of 3D-printed NC and SD formulations.
  • To investigate the in vivo pharmacokinetic behavior and utilize a PBPK model for analysis.

Main Methods:

  • Preparation and characterization of albendazole nanocrystals (NCs) and solid dispersions (SDs).
  • Assessment of solid-state properties (TGA, DSC, XRD, FTIR, SEM) and formulation homogeneity (confocal Raman microscopy).
  • In vitro solubility and dissolution testing under simulated gastric and intestinal conditions, followed by in vivo pharmacokinetic studies in dogs and PBPK modeling.

Main Results:

  • While in vitro dissolution in acid was similar, NCs showed reduced precipitation and higher solubility at intestinal pH (6.8) compared to SDs.
  • Both 3D-printed NC and SD formulations improved pharmacokinetic profiles over the pure drug.
  • The nanocrystal system exhibited significantly superior pharmacokinetic parameters in vivo.

Conclusions:

  • Nanocrystal technology is more effective than solid dispersion technology for enhancing the in vivo performance of Class II drugs, using albendazole as a model.
  • 3D printing is a viable technology for fabricating advanced drug delivery systems like NCs and SDs.
  • PBPK modeling successfully elucidated the observed in vivo differences between the formulation strategies.