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Modelling phase separation in amorphous solid dispersions.

Martin Meere1, Giuseppe Pontrelli2, Sean McGinty3

  • 1School of Mathematics, NUI Galway, University Road, Galway, Ireland.

Acta Biomaterialia
|June 26, 2019
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Summary
This summary is machine-generated.

This study introduces a new model to predict phase separation in solid dispersions, crucial for drug stability and bioavailability. The research provides theoretical timescales for amorphous phase separation, enhancing product shelf-life.

Keywords:
Amorphous solid dispersionDrug diffusionMathematical modelPhase separation

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Area of Science:

  • Pharmaceutical Science
  • Materials Science
  • Chemical Engineering

Background:

  • Solid dispersions are vital pharmaceutical formulations, but prone to phase separation, impacting drug bioavailability and shelf-life.
  • Current thermodynamic models lack detailed non-equilibrium approaches to predict the temporal and spatial evolution of solid dispersions.
  • Theoretical predictions for the timescale of phase separation in solid dispersions are unavailable.

Purpose of the Study:

  • To develop a general multicomponent diffusion model for dissolving solid dispersions.
  • To derive an effective drug diffusion coefficient for binary drug/polymer systems to predict phase separation timescales.
  • To investigate the Felodipine/HPMCAS system numerically, including fabrication processes.

Main Methods:

  • Construction of a general multicomponent diffusion model.
  • Specialization to a binary drug/polymer system and derivation of a concentration-dependent diffusion coefficient.
  • Numerical simulations of the Felodipine/HPMCAS system using a Flory-Huggins activity coefficient.
  • Simulation of solid dispersion fabrication in a hot melt extruder.

Main Results:

  • The model provides theoretical predictions for phase separation timescales.
  • Numerical simulations revealed phenomena like polymer droplet formation, Ostwald ripening, phase inversion, and droplet-to-string transitions.
  • A simulation of the hot melt extrusion fabrication process was successfully presented.

Conclusions:

  • The developed model addresses deficiencies in predicting solid dispersion evolution and phase separation.
  • The study provides crucial insights into the behavior of drug/polymer systems, aiding in the design of stable and effective solid dispersions.
  • This work enhances the understanding of solid dispersion stability, impacting drug bioavailability and product shelf-life.