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Polymorphism refers to the existence of a drug substance in multiple crystalline forms, known as polymorphs. Recently, this term has been expanded to include solvates (forms containing a solvent), amorphous forms (non-crystalline forms), and desolvated solvates (forms from which the solvent has been removed).
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Predicting the Water Sorption in ASDs.

Dominik Borrmann1, Andreas Danzer1, Gabriele Sadowski1

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

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Summary

This study presents a new method to predict water sorption in amorphous solid dispersions (ASDs), crucial for pharmaceutical stability. The approach accurately forecasts water absorption extent and rate using polymer and drug properties alone.

Keywords:
ASDsNET-GPPC-SAFTwater-sorption isothermswater-sorption kinetics

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Area of Science:

  • Pharmaceutical Science
  • Materials Science
  • Physical Chemistry

Background:

  • Water sorption compromises the stability of amorphous solid dispersions (ASDs).
  • Preventing water uptake during storage is critical for maintaining ASD integrity.
  • Predictive models for water sorption in ASDs are needed to guide formulation and storage.

Purpose of the Study:

  • To develop and validate a methodology for predicting water sorption isotherms and kinetics in ASDs.
  • To assess the accuracy of predictions based solely on neat polymer and active pharmaceutical ingredient (API) properties.
  • To provide insights into water-sorption behavior relevant to pharmaceutical formulation.

Main Methods:

  • Combining the Perturbed-Chain Statistical Association Theory (PC-SAFT) with the Non-Equilibrium Thermodynamics of Glassy Polymers (NET-GP) approach for isotherm prediction.
  • Utilizing Maxwell-Stefan diffusion coefficients for predicting water sorption kinetics.
  • Experimental validation using ASD films of polyvinylpyrrolidone-based polymers and indomethacin at various drug loads and relative humidity (RH) levels.

Main Results:

  • Accurate prediction of water sorption isotherms and kinetics in ASDs was achieved.
  • The model successfully predicted water sorption for drug loads of 0.2 and 0.5 across a humidity range of 0 to 0.9 RH at 25 °C.
  • Predictions relied exclusively on the sorption properties of the neat polymer and API.

Conclusions:

  • The proposed methodology offers a reliable way to predict water sorption in ASDs.
  • This predictive capability is valuable for optimizing ASD formulation and storage conditions.
  • Understanding and controlling water sorption is key to enhancing the long-term stability of amorphous pharmaceutical systems.