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Simultaneous Water Sorption and Crystallization in ASDs 2: Modeling Long-Term Stabilities.

Birte Grönniger1, Espen Fritschka1, Kristof Kimpe2

  • 1Department of Biochemical and Chemical Engineering, Laboratory of Thermodynamics, TU Dortmund University, Emil-Figge-Str. 70, Dortmund D-44227, Germany.

Molecular Pharmaceutics
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PubMed
Summary
This summary is machine-generated.

A new modeling framework predicts amorphous solid dispersion (ASD) physical stability, reducing costly experiments. This approach accurately forecasts crystallization kinetics and long-term stability using short-term measurements.

Keywords:
amorphous solid dispersionclassical nucleation theorycrystallization kineticsmolecular mobilitythermodynamic driving forcewater-sorption kinetics

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Area of Science:

  • Pharmaceutical Sciences
  • Materials Science
  • Physical Chemistry

Background:

  • Physical stability of amorphous solid dispersions (ASDs) is critical for oral dosage forms.
  • Investigating long-term ASD stability requires extensive, time-consuming experiments.

Purpose of the Study:

  • To develop a thermodynamic and kinetic modeling framework to predict ASD crystallization kinetics.
  • To understand the factors influencing ASD physical stability during storage below the glass transition temperature.

Main Methods:

  • Simultaneous consideration of water-sorption and active pharmaceutical ingredient (API) crystallization kinetics.
  • Development of a model predicting viscosity, supersaturation, and crystallinity over time.
  • Validation against two-year crystallization experiments of ASDs containing nifedipine.

Main Results:

  • The model accurately describes the interplay between water sorption and API crystallization.
  • The framework successfully predicts long-term ASD stability based on short-term measurements.
  • The approach explains diverse and unexpected crystallization behaviors observed in ASDs.

Conclusions:

  • The developed modeling framework offers a powerful tool for predicting and understanding ASD physical stability.
  • This approach minimizes the need for lengthy experimental investigations.
  • It provides insights into the underlying mechanisms governing ASD crystallization.