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Investigating phase separation in amorphous solid dispersions via Raman mapping.

Christian Luebbert1, Christian Klanke1, Gabriele Sadowski1

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

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Summary
This summary is machine-generated.

Amorphous solid dispersions (ASDs) enhance drug bioavailability but can destabilize. This study introduces a novel method to quantify amorphous phase separation (APS) in ASDs, a crucial step for ensuring drug product stability.

Keywords:
Amorphous solid dispersionAmorphous-amorphous phase separationConfocal Raman spectroscopyIndirect Hard ModelingLong-term stabilityPoorly-soluble drugWater sorption

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Area of Science:

  • Pharmaceutical Sciences
  • Materials Science
  • Analytical Chemistry

Background:

  • Amorphous solid dispersions (ASDs) improve the bioavailability of poorly water-soluble active pharmaceutical ingredients (APIs).
  • Long-term stability of ASDs can be compromised by API recrystallization and amorphous phase separation (APS).
  • Quantifying APS in ASDs has been a significant challenge in pharmaceutical development.

Purpose of the Study:

  • To develop and apply a novel method for the quantitative determination of APS in ASDs.
  • To investigate the kinetics and compositions of amorphous phases formed during APS.
  • To explore the influence of temperature, humidity, and polymer architecture on APS.

Main Methods:

  • Confocal Raman spectroscopy was employed for quantitative analysis of APS.
  • Non-linear multivariate Indirect Hard Modeling was used to evaluate Raman spectra.
  • Differential scanning calorimetry and hot-stage microscopy were utilized for verification.

Main Results:

  • The study successfully quantified APS in ASDs for the first time.
  • Phase-separation kinetics and compositions of amorphous phases were determined.
  • Water absorption at elevated temperature and humidity was shown to promote APS in specific ASD formulations.

Conclusions:

  • Confocal Raman spectroscopy combined with Indirect Hard Modeling provides a robust method for quantifying APS in ASDs.
  • Understanding APS is critical for predicting and ensuring the long-term stability of amorphous drug formulations.
  • Environmental factors like water significantly impact ASD stability, necessitating careful formulation design.