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Polymorphism refers to the existence of a drug substance in multiple crystalline forms, known as polymorphs. Recently, this term has been expanded to include solvates (forms containing a solvent), amorphous forms (non-crystalline forms), and desolvated solvates (forms from which the solvent has been removed).
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Phase behavior of pharmaceutically relevant polymer/solvent mixtures.

Stefanie Dohrn1, Christian Luebbert1, Kristin Lehmkemper2

  • 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 study predicts polymer-solvent miscibility for amorphous solid dispersions (ASDs) using PC-SAFT, identifying ideal solvents for pharmaceutical formulations and avoiding phase separation during manufacturing.

Keywords:
Amorphous solid dispersionHPMCASLiquid-liquid phase separationMiscibility gapPC-SAFTPVPPVPVA64Solvent selection

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Area of Science:

  • Pharmaceutical Science
  • Materials Science
  • Computational Chemistry

Background:

  • Polymers are crucial excipients in pharmaceutical formulations, particularly for amorphous solid dispersions (ASDs) of poorly water-soluble active pharmaceutical ingredients (APIs).
  • Solvent-based processes like spray drying are common for ASD production, requiring homogeneous API/polymer solutions to prevent phase separation during solvent evaporation.
  • Understanding polymer-solvent interactions is critical for successful ASD formulation and manufacturing.

Purpose of the Study:

  • To investigate polymer-solvent interactions in mixtures relevant to pharmaceutical amorphous solid dispersions (ASDs).
  • To predict miscibility and phase behavior of polymer/solvent systems using computational methods.
  • To identify suitable solvents and solvent mixtures for the efficient production of pharmaceutical ASDs.

Main Methods:

  • Utilized vapor-sorption experiments to gather data on polymer-solvent mixtures.
  • Applied the Perturbed-Chain Statistical Associating Fluid Theory (PC-SAFT) to predict demixing and miscibility.
  • Investigated pharmaceutically relevant polymers: poly(vinylpyrrolidone) (PVP), poly(vinylpyrrolidone-co-vinyl acetate) (PVPVA64), and hydroxypropyl methylcellulose acetate succinate (HPMCAS).
  • Examined solvents including acetone, dichloromethane (DCM), ethanol, ethyl acetate, methanol, and water.

Main Results:

  • PC-SAFT predictions accurately reflected experimental observations for all investigated solvent/polymer mixtures.
  • Identified specific solvents completely miscible with PVPVA64 (acetone, DCM, ethanol, methanol, water) and PVP K90 (DCM, ethanol, methanol, water).
  • Determined that none of the tested solvents were suitable for avoiding immiscibility with HPMCAS.
  • Successfully predicted the influence of temperature, polymer molecular weight, and solvent-mixture composition on miscibility.

Conclusions:

  • The PC-SAFT methodology provides a reliable and low-effort approach for predicting polymer-solvent miscibility in ASD formulations.
  • This predictive capability is essential for selecting optimal solvents or solvent mixtures in pharmaceutical manufacturing processes.
  • The findings facilitate the development of homogeneous and stable amorphous solid dispersions, improving drug delivery.