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Investigating cascade impactor performance using a modified 3D printed induction port.

Kai Berkenfeld1, Michael Bernauer1, Jason T McConville2

  • 1University of Bonn, Institute of Pharmacy, Laboratory of Pharmaceutical Technology and Biopharmaceutics, Bonn, Germany.

International Journal of Pharmaceutics
|November 9, 2017
PubMed
Summary

A 3D-printed modified induction port (mIP) enhances in vitro/in vivo correlation for salbutamol metered-dose inhalers (pMDIs). This improved device offers better formulation assessment by revealing particle retention not seen with standard induction ports.

Keywords:
3D printingCFDCascade impactorDPIJet nebulizerPMDIRapid prototyping

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Area of Science:

  • Pharmaceutical Technology
  • Inhalation Drug Delivery
  • 3D Printing Applications

Background:

  • The United States Pharmacopoeia Induction Port (USPIP) is standard for in vitro inhalation testing.
  • Accurate prediction of in vivo drug deposition from in vitro data remains a challenge.
  • Novel manufacturing techniques like 3D printing offer opportunities to refine testing apparatus.

Purpose of the Study:

  • To develop and evaluate a 3D-printed modified induction port (mIP) for improved in vitro/in vivo correlation.
  • To assess the impact of induction port geometry and surface properties on particle deposition.
  • To compare the performance of the mIP against standard and 3D-printed USPIP models.

Main Methods:

  • Manufacturing of a modified induction port (mIP) using 3D printing based on human trachea CT scans.
  • Testing of commercial salbutamol formulations using mIP, standard USPIP, and 3D-printed USPIP (USP3DIP).
  • Computational fluid dynamics (CFD) modeling to analyze airflow velocities and geometrical impacts.

Main Results:

  • The mIP demonstrated increased particle retention for a pMDI formulation, reducing fine particle fraction (FPF) and correlating better with literature in vivo data.
  • Geometrical factors, not surface effects, were identified as the cause of increased deposition in the mIP.
  • Standard USPIP, USP3DIP, and a surface-equivalent model (USP3DSEIP) showed equivalent performance.

Conclusions:

  • The 3D-printed mIP provides additional valuable information for formulation assessment of pMDIs.
  • The mIP enhances in vitro/in vivo correlation compared to the standard USPIP.
  • Geometric modifications in induction port design are crucial for accurate in vitro deposition assessments.