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Disparities of Single-Particle Growth Rates in Buried Versus Exposed Ritonavir Crystals within Amorphous Solid

Scott R Griffin1, Nita Takanti1, Sreya Sarkar1

  • 1Department of Chemistry, Purdue University, 560 Oval Drive, West Lafayette, Indiana 47907, United States.

Molecular Pharmaceutics
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Summary

Ritonavir crystallization is ~3-fold slower at the surface of amorphous solid dispersions (ASDs) compared to the bulk. This difference impacts drug product shelf life and stability under varying humidity conditions.

Keywords:
active pharmaceutical ingredientsamorphous solid dispersionscrystallization kineticsnonlinear opticssecond harmonic generation

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Area of Science:

  • Pharmaceutical Sciences
  • Materials Science
  • Physical Chemistry

Background:

  • Amorphous solid dispersions (ASDs) are crucial for enhancing drug solubility and bioavailability.
  • Crystallization of the active pharmaceutical ingredient (API) in ASDs can compromise drug product shelf life and efficacy.
  • Understanding crystallization kinetics at different locations within ASDs (surface vs. bulk) is vital for formulation development.

Purpose of the Study:

  • To quantitatively assess and compare ritonavir crystal growth rates at the surface versus the bulk of copovidone-based amorphous solid dispersions.
  • To investigate the impact of relative humidity (RH) on crystallization kinetics in different regions of ASDs.
  • To elucidate the factors influencing crystal habit and growth rates in surface-exposed versus bulk environments.

Main Methods:

  • Preparation of 'sandwich' (bulk) and 'open-faced' (surface) ASD samples containing ritonavir seeds.
  • Utilized single-particle tracking second harmonic generation (SHG) microscopy for time-series analysis of *in situ* crystallization.
  • Measured crystal growth rates and analyzed crystal habit differences between surface and bulk locations.

Main Results:

  • Ritonavir crystal growth rates were approximately 3-fold slower at the ASD surface (1.0–1.3 μm/h) compared to the bulk (3.8 μm/h).
  • Surface seeding resulted in radiating crystal habits, attributed to reduced solubility and higher defect densities upon water adsorption.
  • Geometric effects accounted for a factor of 4 difference, leading to minor but significant kinetic variations between surface and bulk environments.

Conclusions:

  • Water adsorption at the ASD surface influences ritonavir solubility and crystal growth kinetics, leading to slower growth and altered crystal habits.
  • Viscosity shows a weak dependence on water absorption, suggesting diffusion-limited growth kinetics are dominant.
  • These findings highlight the importance of considering spatial variations in crystallization behavior for predicting and extending the shelf life of ASD drug products.