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An In Vitro Dissolution Method for Inhaled Drugs Depositing in the Tracheobronchial Lung Region.

Alexander Huang1, Scott Tavernini1, Dino J Farina2

  • 1Department of Mechanical Engineering, University of Alberta, Edmonton, Canada.

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|April 28, 2025
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Summary

A new dissolution test method using tracheobronchial (TB) mimic filters accurately assessed inhaled drugs. The method successfully differentiated dissolution profiles between a dry powder inhaler (DPI) and a pressurized metered-dose inhaler (pMDI).

Keywords:
in vitrodissolutionfluticasone propionatepharmaceutical aerosolstracheobronchial

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Area of Science:

  • Pharmaceutical Sciences
  • Drug Delivery Systems
  • Inhalation Technology

Background:

  • Assessing the dissolution behavior of inhaled drugs targeting the tracheobronchial (TB) region is crucial for product development.
  • Existing methods may not adequately mimic the physiological conditions of the TB region for dissolution testing.
  • Fluticasone propionate (FP), a poorly soluble corticosteroid, is commonly delivered via inhalation.

Purpose of the Study:

  • To develop and evaluate a novel dissolution test method utilizing tracheobronchial (TB) mimic filters.
  • To assess the dissolution behavior of inhaled drugs specifically targeting the TB lung region.
  • To compare the dissolution profiles of FP delivered via a dry powder inhaler (DPI) and a pressurized metered-dose inhaler (pMDI).

Main Methods:

  • A filter-based apparatus (FBA) was employed to fractionate inhaled doses into extrathoracic, TB, and alveolar regions.
  • Fluticasone propionate (FP) was administered using a DPI (Flovent Diskus) and a pMDI (Flovent HFA).
  • Dissolution tests were conducted on the captured TB dose using phosphate-buffered saline with 0.5% sodium dodecyl sulfate at 37 °C, followed by analysis of dissolution rate constants and similarity/difference factors. Scanning electron microscopy (SEM) was used to assess filter performance.

Main Results:

  • The TB filter exhibited consistent performance without drug loading effects up to tested limits for both DPI and pMDI.
  • Dissolution profiles showed no significant differences across DPI doses but indicated slower dissolution rates for the pMDI compared to the DPI.
  • SEM analysis confirmed no particle aggregation or filter clogging, with similarity and difference factors supporting the observed dissolution differences.

Conclusions:

  • The novel dissolution test method effectively discriminated between the dissolution profiles of FP delivered by DPI and pMDI.
  • This filter-based dissolution method is a promising new tool for evaluating orally inhaled drug products targeting the tracheobronchial region.
  • The findings support the utility of this method in pharmaceutical quality control and development of inhaled medications.