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Microstructural insight into inhalation powder blends through correlative multi-scale X-ray computed tomography.

Parmesh Gajjar1, Ioanna Danai Styliari2, Victoria Legh-Land2

  • 1Henry Moseley X-ray Imaging Facility, Department of Materials, The University of Manchester, Manchester M13 9PL, UK; National Facility for Laboratory X-ray Computed Tomography, The University of Manchester, Manchester M13 9PL, UK; Henry Royce Institute for Advanced Materials, Oxford Road, Manchester M13 9PL, UK; Seda Pharmaceutical Development Services, Unit D, Oakfield Road, Cheadle Royal Business Park, Stockport SK8 3GX, UK.

European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Fur Pharmazeutische Verfahrenstechnik E.V
|September 1, 2023
PubMed
Summary

Characterizing dry powder inhaler (DPI) microstructures is crucial for lung drug delivery. This study used X-ray Computed Tomography (XCT) to reveal drug distribution heterogeneity within DPI powders, aiding performance prediction.

Keywords:
Correlative tomographyInhalationMicrostructural equivalenceMicrostructurePowder characterisationX-ray computed tomography

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Area of Science:

  • Pharmaceutical Sciences
  • Materials Science
  • Medical Imaging

Background:

  • Dry powder inhalers (DPIs) are vital for targeted lung drug delivery.
  • Understanding the pre-aerosolized powder microstructure is essential for predicting post-aerosolized blend performance.
  • Current methods often lack the resolution to fully characterize complex powder microstructures.

Purpose of the Study:

  • To characterize the 3D microstructure of a pre-aerosolized inhalation blend.
  • To identify and map lactose and drug-rich phases at multiple length scales within the same sample.
  • To establish a relationship between drug proportion and carrier particle size based on microstructural analysis.

Main Methods:

  • Correlative multi-scale X-ray Computed Tomography (XCT) was employed.
  • The 3D microstructure of the inhalation blend was analyzed.
  • Drug-rich phase distribution and thickness relative to carrier particle size were quantified.

Main Results:

  • The drug-rich phase distribution was found to be homogeneous at a bulk scale but heterogeneous at a particulate scale.
  • Individual clusters exhibited varying amounts of the drug-rich phase.
  • Different regions of carrier particles showed differential coating with the drug-rich phase.

Conclusions:

  • The study successfully characterized the 3D microstructure of DPI powders using multi-scale XCT.
  • The findings reveal complex drug distribution patterns at the particulate level.
  • This microstructural assessment method offers potential for bioequivalence studies of DPIs.