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Exploring the Relationship Between Stability and Dynamics in Polymer-Based Amorphous Solid Dispersions for

Emeline Dudognon1, Jeanne-Annick Bama1, Frédéric Affouard1

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Summary

Amorphous solid dispersions (ASDs) of Terfenadine and Polyvinylpyrrolidone (PVP) show enhanced drug stability. Molecular dynamics reveal structural heterogeneity, suggesting distinct amorphous phases that influence drug recrystallisation.

Keywords:
PolyvinylpyrrolidoneTerfenadineamorphous solid dispersionsglass transitionmolecular dynamicssolubility

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Area of Science:

  • Pharmaceutical Sciences
  • Materials Science
  • Physical Chemistry

Background:

  • Amorphous solid dispersions (ASDs) enhance drug bioavailability by preventing drug recrystallisation.
  • The precise mechanisms of stabilization in ASDs, particularly the role of molecular dynamics, require further elucidation.

Purpose of the Study:

  • To investigate the molecular dynamics governing instability in amorphous solid dispersions (ASDs).
  • To understand the role of Polyvinylpyrrolidone (PVP K12) in stabilizing Terfenadine in ASDs.

Main Methods:

  • Utilized temperature modulated differential scanning calorimetry (MDSC) and dielectric relaxation spectroscopy.
  • Analyzed ASDs composed of Polyvinylpyrrolidone (PVP K12) and Terfenadine across various compositions.

Main Results:

  • ASDs were supersaturated with Terfenadine, with PVP K12 effectively slowing molecular dynamics and inhibiting drug recrystallisation.
  • While MDSC indicated homogeneity (single glass transition), dielectric spectroscopy revealed dynamic heterogeneity below 30 wt.% PVP.
  • This dynamic heterogeneity suggests the presence of two distinct amorphous phases with differing compositions and dynamics.

Conclusions:

  • Dynamic heterogeneity in Terfenadine/PVP ASDs points to structural heterogeneity, with coexisting amorphous phases.
  • The study provides insights into the complex interplay between molecular dynamics, phase behavior, and stabilization mechanisms in ASDs.