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Characterization of Spray Dried Particles Through Microstructural Imaging.

Hanmi Xi1, Aiden Zhu2, Gerard R Klinzing1

  • 1Merck & Co., Inc., West Point, PA 19486, USA.

Journal of Pharmaceutical Sciences
|August 8, 2020
PubMed
Summary
This summary is machine-generated.

Spray drying creates amorphous solid dispersions (ASD) for drug delivery. Higher temperatures yield hollower particles, while lower temperatures produce thicker-walled, raisin-like particles, impacting drug performance.

Keywords:
AI-facilitated image analysisAmorphous solid dispersionCompressionFIB-SEMParticle characterizationSpray dryingXRCT

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Area of Science:

  • Pharmaceutical Sciences
  • Materials Science
  • Chemical Engineering

Background:

  • Spray drying is a key technique for producing amorphous solid dispersions (ASD) to enhance the bioavailability of poorly water-soluble drugs.
  • Understanding the microstructure of spray-dried (SD) particles is crucial for optimizing drug product performance.

Purpose of the Study:

  • To investigate the impact of spray drying parameters on the microstructure of amorphous solid dispersions (ASD).
  • To develop and apply an AI-facilitated imaging analysis tool for quantitative characterization of SD particles.
  • To correlate particle microstructure with physical properties and performance.

Main Methods:

  • Utilized focused ion beam-scanning electron microscopy (FIB-SEM) and X-ray microcomputed tomography (XRCT) for microstructure analysis.
  • Developed an artificial intelligence (AI) tool for quantitative XRCT image analysis of thousands of SD particles.
  • Measured particle size distribution, envelope density, and compact tensile strength.

Main Results:

  • Higher spray drying outlet temperatures (Tout) resulted in more spherical, hollow particles with thinner walls.
  • Lower Tout produced raisin-like particles with thicker walls.
  • AI-facilitated XRCT analysis enabled quantitative assessment of particle attributes, with envelope density proving more sensitive to process changes than bulk/tap density.
  • SD particle compact tensile strength correlated with wall thickness, suggesting deformation of thinner-walled particles contributes to interparticle contact.

Conclusions:

  • Spray drying conditions significantly influence SD particle morphology and microstructure.
  • AI-enhanced XRCT analysis provides a powerful tool for detailed particle characterization.
  • Particle microstructure, particularly wall thickness, affects mechanical properties and can inform the design of drug products with improved performance and process robustness.