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Understanding Dissolution and Crystallization with Imaging: A Surface Point of View.

Dunja Novakovic1, Antti Isomäki2, Bibi Pleunis1

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Surface crystallization in amorphous drugs is a challenge. Nonlinear optical imaging effectively detects subtle changes, revealing how storage impacts drug dissolution and identifying multiple crystalline forms.

Keywords:
amorphousdissolutionindomethacinnonlinear opticspolymorphismsurface crystallization

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Area of Science:

  • Pharmaceutical Sciences
  • Materials Science
  • Analytical Chemistry

Background:

  • Crystallization of amorphous drugs during storage and administration is a major challenge.
  • Detecting subtle surface crystallization and its effect on dissolution is crucial for drug development.
  • Amorphous solid dispersions are vital for poorly water-soluble drugs.

Purpose of the Study:

  • To analyze the interplay between surface crystallization, storage conditions, and dissolution behavior of amorphous drugs.
  • To investigate the influence of storage and dissolution on the formation of crystalline polymorphs.
  • To demonstrate the utility of multimodal nonlinear optical imaging for characterizing amorphous drug formulations.

Main Methods:

  • Amorphous indomethacin tablets were prepared and stored under different humidity and temperature conditions.
  • Multimodal nonlinear optical imaging (coherent anti-Stokes Raman scattering and sum frequency generation) was employed.
  • Complementary analyses included scanning electron microscopy, X-ray diffraction, and vibrational spectroscopies.

Main Results:

  • Trace surface crystallinity after short storage did not significantly impact dissolution; extensive crystallization did.
  • Nonlinear optical imaging revealed complex crystallization behavior during dissolution, influenced by storage.
  • Up to four crystalline polymorphs (α, γ, ε, η) were observed, including less-reported metastable forms.

Conclusions:

  • Nonlinear optical imaging is valuable for understanding complex surface crystallization in amorphous drugs.
  • Storage conditions and time significantly influence crystallization and subsequent dissolution behavior.
  • This approach aids in the development of stable amorphous drug formulations with predictable dissolution profiles.