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Physical stability of hydroxypropyl methylcellulose-based amorphous solid dispersions: Experimental and computational

Anton Iemtsev1, Fatima Hassouna2, Alex Mathers3

  • 1Department of Chemical Engineering, University of Chemistry and Technology, Prague, Technická 3, 166 28 Prague 6, Czech Republic; Department of Physical Chemistry, University of Chemistry and Technology, Prague, Technická 5, 166 28 Prague 6, Czech Republic.

International Journal of Pharmaceutics
|September 15, 2020
PubMed
Summary

Predicting the long-term physical stability of amorphous solid dispersions (ASDs) is challenging. This study compared models for ibuprofen-polymer systems, finding significant differences in stability predictions, impacting drug formulation development.

Keywords:
Amorphous solid dispersionHot-melt extrusionPC-SAFTPhase diagramPhysical stabilitySolid-liquid equilibrium

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Area of Science:

  • Pharmaceutical Sciences
  • Materials Science
  • Physical Chemistry

Background:

  • Amorphous solid dispersions (ASDs) enhance oral bioavailability of poorly soluble drugs.
  • Predicting the long-term physical stability of ASDs remains a significant challenge in pharmaceutical development.
  • Understanding drug-polymer interactions is crucial for stable ASD formulation.

Purpose of the Study:

  • To evaluate and compare the predictive performance of models for solid-liquid equilibrium (SLE) and glass-transition temperature (Tg) lines.
  • To assess the impact of computational parameters on solubility predictions for ibuprofen (IBU) in cellulosic polymers.
  • To validate model predictions against an 18-month physical stability study of IBU-based ASDs.

Main Methods:

  • Utilized empirical-analytical approach and Perturbed-Chain Statistical Associating Fluid Theory (PC-SAFT) for SLE curve modeling.
  • Employed Gordon-Taylor and Kwei equations for glass-transition temperature (Tg) line determination.
  • Investigated computational setup impacts on IBU solubility prediction and compared with experimental stability data.

Main Results:

  • Ibuprofen formed stable 20 wt% amorphous solid dispersions with HPMC and HPMCAS.
  • Significant discrepancies were observed in thermodynamic stability predictions between the PC-SAFT EOS and the empirical-analytical approach.
  • PC-SAFT EOS predicted higher ibuprofen solubility and lower recrystallization tendency, with predicted liquid-liquid demixing at higher concentrations, contrary to experimental findings.

Conclusions:

  • Model selection significantly influences the prediction of ASD physical stability.
  • PC-SAFT EOS offers a different perspective on ibuprofen solubility and phase behavior compared to empirical models.
  • Further refinement of thermodynamic models is necessary for accurate prediction of ASD long-term stability.