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Cascade Impactor Performance of Commercial pMDI Formulations Using Modified Induction Ports.

Kai Berkenfeld1, Kathryn Hauschild1, Jason T McConville1,2

  • 1Department of Pharmaceutics, Institute of Pharmacy, University of Bonn, Bonn 53121, Germany.

Molecular Pharmaceutics
|April 17, 2020
PubMed
Summary

Modified induction ports improve in vitro-in vivo correlation for aerosol drug delivery. These new designs enhance the predictability of lung deposition compared to the standard United States and European pharmacopoeia induction port.

Keywords:
3D printingFDMIVIVCNGIpMDI

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Area of Science:

  • Pharmaceutical Sciences
  • Inhalation Technology
  • Aerosol Science

Background:

  • The standard induction port (IP) in the Next Generation Pharmaceutical Impactor (USPIP) lacks physiological relevance, limiting the predictability of in vitro aerosol data for in vivo lung deposition.
  • This limitation is critical for accurate drug delivery assessments.

Purpose of the Study:

  • To evaluate the impact of replacing the USPIP with two modified induction ports (mIP and mIPext) designed using human tracheal geometry.
  • To assess the improved predictability of in vitro aerosol deposition data for in vivo lung deposition.

Main Methods:

  • Developed modified induction ports (mIP, mIPext) based on CT scans of a human trachea.
  • Tested selected formulations with available in vivo lung deposition data.
  • Compared in vitro deposition results with in vivo observations using both modified and standard IPs.

Main Results:

  • All tested formulations showed increased deposition in the modified induction ports.
  • Modified induction ports (mIP, mIPext) demonstrated superior in vitro-in vivo correlation compared to the USPIP.
  • The mIP provided the most accurate correlation, with average deviations of 5 ± 4% (3 μm FPF cutoff).

Conclusions:

  • Modified induction ports significantly enhance the predictability of in vitro aerosol deposition for in vivo lung deposition.
  • The mIP design offers a more physiologically relevant and accurate tool for aerosol analysis in pharmaceutical development.
  • Improved in vitro-in vivo correlation facilitates better drug product design and regulatory assessment.