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Area of Science:

  • Pharmaceutical Sciences
  • Physical Chemistry
  • Materials Science

Background:

  • Amorphous solid dispersions (ASDs) enhance solubility and bioavailability of poorly water-soluble drugs.
  • Kinetically stabilized ASDs face challenges with drug crystallization during shelf life, potentially impacting efficacy.
  • Predicting and mitigating crystallization is crucial for reliable ASD drug product performance.

Purpose of the Study:

  • To outline a risk assessment and mitigation strategy for active pharmaceutical ingredient (API) crystallization in packaged ASD drug products.
  • To model the physical stability of ASD drug products during storage, considering crystallization kinetics.
  • To provide a framework for ensuring the long-term stability and bioavailability of ASD formulations.

Main Methods:

  • Quantification of crystal growth kinetics using transmission Raman spectroscopy (TRS).
  • Modeling the effect of water sorption on the glass-transition temperature (Tg) of the ASD.
  • Prediction of moisture uptake in packaged ASD drug products during storage.

Main Results:

  • A risk assessment methodology for shelf-life crystallization was developed and applied.
  • The study successfully modeled the physical stability of an ASD of fenofibrate.
  • Fenofibrate ASD showed rapid crystallization under accelerated conditions but stability in protective packaging.

Conclusions:

  • The developed methodology enables prediction and mitigation of API crystallization in ASDs.
  • Protective packaging is key to ensuring the long-term physical stability of susceptible ASDs.
  • This approach supports the development of stable and effective ASD drug products.