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Accelerated Physical Stability Testing of Amorphous Dispersions.

Mehak Mehta1, Raj Suryanarayanan1

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PubMed
Summary

Water sorption accelerates drug crystallization in amorphous dispersions by plasticization. This study proposes using water sorption to predict crystallization in poorly crystallizing drug formulations.

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PVPcoupling modelcrystallizationdielectric spectroscopyfelodipinemolecular mobilitypredictionrelative humiditywater

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Area of Science:

  • Pharmaceutical Sciences
  • Materials Science
  • Physical Chemistry

Background:

  • Amorphous dispersions are crucial for drug delivery, but their physical stability is a concern.
  • Water sorption can plasticize amorphous dispersions, increasing molecular mobility and accelerating drug crystallization.
  • Previous work established the plasticization effect of water on amorphous dispersions.

Purpose of the Study:

  • To investigate the influence of water concentration on the relationship between molecular mobility and crystallization in amorphous felodipine dispersions.
  • To develop an accelerated physical stability testing method for amorphous dispersions.
  • To explore the potential of water sorption as a predictive tool for drug crystallization.

Main Methods:

  • Investigated felodipine dispersions with varying water concentrations (up to 1.8% w/w).
  • Measured α-relaxation times and crystallization times.
  • Analyzed the effect of temperature scaling (Tg/T) on relaxation times.
  • Determined the coupling coefficient across different water concentrations.

Main Results:

  • Increased water content decreased both α-relaxation time and the time for 1% felodipine crystallization.
  • Scaled relaxation times overlapped across different water concentrations, indicating temperature independence of water's effect.
  • Temperature dependencies of relaxation and crystallization times were unaffected by water concentration.
  • The coupling coefficient remained constant up to 1.8% w/w water concentration.

Conclusions:

  • Water sorption acts as a plasticizer, accelerating crystallization in amorphous dispersions.
  • "Water sorption" can be utilized to build predictive models for crystallization in slow-crystallizing dispersions.
  • This approach offers a method for accelerated physical stability testing of amorphous drug formulations.