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High-Contrast X-Ray Computed Tomography for Quantifying Amorphous Content in Melt-Quenched Acetaminophen.

Tamaki Miyazaki1, Yoshihiro Takeda2, Kazuki Ito2

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Summary
This summary is machine-generated.

X-ray computed tomography (XRCT) reliably monitors pharmaceutical crystallization by quantifying amorphous content. This non-destructive method correlates well with differential scanning calorimetry (DSC), offering a practical tool for early-stage drug development.

Keywords:
acetaminophenamorphouscrystallizationhigh-contrast X-ray computed tomographyvolumetric evaluation

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Area of Science:

  • Materials Science
  • Pharmaceutical Science
  • Analytical Chemistry

Background:

  • X-ray computed tomography (XRCT) is used for non-destructive 3D analysis and monitoring structural changes.
  • Previous XRCT applications in pharmaceuticals lacked systematic quantitative validation against thermal methods.

Purpose of the Study:

  • To evaluate laboratory XRCT for monitoring amorphous pharmaceutical crystallization.
  • To validate XRCT's quantitative accuracy using differential scanning calorimetry (DSC).

Main Methods:

  • Amorphous content in acetaminophen was quantified using XRCT-based voxel segmentation.
  • DSC measured amorphous content via specific heat change at the glass transition temperature.
  • Time-dependent crystallization was monitored at 30°C using both XRCT and DSC.

Main Results:

  • XRCT showed strong correlation (R² = 0.990) with DSC for quantifying amorphous fraction during crystallization.
  • XRCT provided a reliable, voxel-based measure of amorphous content, despite micrometer-scale resolution limits.
  • In situ XRCT visualized crystallization initiation and spatial propagation, offering insights beyond bulk thermal analysis.

Conclusions:

  • XRCT is a practical and efficient tool for rapid screening of physical stability in early-stage pharmaceutical development.
  • The method enables continuous monitoring of a single sample, reducing the number of samples needed.
  • XRCT offers valuable information on crystallization behavior, complementing traditional thermal analysis.