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Phase behavior of ASDs based on hydroxypropyl cellulose.

Christian Luebbert1, Edmont Stoyanov2, Gabriele Sadowski1,3

  • 1amofor GmbH, Otto-Hahn-Str. 15, D-44227 Dortmund, Germany.

International Journal of Pharmaceutics: X
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Summary

Hydroxypropyl celluloses (HPC) stabilize amorphous solid dispersions (ASDs) for poorly soluble drugs. Lower molecular weight HPC grades better prevent drug crystallization, enabling prediction of phase separation and crystallization in ASDs.

Keywords:
Amorphous solid dispersionHydroxypropyl celluloseLong-term stabilityMiscibilityPC-SAFTSolubility

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Area of Science:

  • Pharmaceutical Science
  • Materials Science
  • Polymer Chemistry

Background:

  • Amorphous solid dispersions (ASDs) are crucial for enhancing the bioavailability of poorly soluble drugs.
  • Hydroxypropyl celluloses (HPC) are increasingly recognized as effective polymeric carriers for ASD production due to their ability to stabilize drug molecules.
  • Predicting the long-term stability of ASDs is essential for pharmaceutical development.

Purpose of the Study:

  • To predict the thermodynamic long-term stability of HPC-based ASDs containing itraconazole and fenofibrate using PC-SAFT.
  • To investigate the influence of HPC molecular weight on drug crystallization and phase separation.
  • To estimate the glass transition temperature of HPC, which is challenging to detect directly.

Main Methods:

  • Utilized predictive PC-SAFT modeling to forecast ASD stability.
  • Conducted three-month experimental stability studies for comparison.
  • Employed differential scanning calorimetry (DSC) to analyze amorphous phase separation and drug crystallization.
  • Investigated HPC blends with miscible polymers to determine HPC's glass transition temperature.

Main Results:

  • PC-SAFT predictions correlated well with experimental stability data.
  • Low-molecular weight HPC grades (e.g., HPC-UL) demonstrated superior inhibition of fenofibrate crystallization compared to higher molecular weight grades.
  • Amorphous phase separation was observed in higher drug load ASDs, as indicated by DSC thermograms.
  • Critical drug loads predicting phase separation or crystallization were successfully identified.

Conclusions:

  • HPC is a viable polymer for creating stable amorphous solid dispersions.
  • HPC molecular weight significantly impacts the crystallization kinetics of incorporated drugs.
  • Predictive modeling and experimental studies can effectively determine critical parameters for ASD formulation design.