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Water-Assisted Drying of PVPVA-Based Amorphous Solid Dispersions.

Jana Kerkhoff^1,2, Niklas Opitz¹, Luca Peters¹

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

Molecular Pharmaceutics

|April 16, 2025

Summary

Water-assisted drying significantly enhances the removal of residual solvents from amorphous solid dispersions (ASDs). This method, using controlled humidity, effectively eliminates ethanol from ASDs, meeting strict regulatory limits.

Keywords:

ICH-limit PC-SAFT PVPVA amorphous solid dispersions dynamic vapor sorption phase separation secondary drying

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Area of Science:

Pharmaceutical Technology
Materials Science
Chemical Engineering

Background:

Amorphous solid dispersions (ASDs) require secondary drying to remove residual solvents to meet regulatory standards.
Drying glassy ASDs at low solvent content is challenging due to slow kinetics.
Efficient residual solvent removal is critical for ASD stability and efficacy.

Purpose of the Study:

To develop and evaluate a water-assisted drying approach for enhancing secondary drying of ASDs.
To accelerate residual solvent removal and reduce final solvent content in ASDs.
To investigate the kinetics of water-assisted secondary drying at low residual solvent levels.

Main Methods:

Utilized dynamic vapor sorption with integrated Raman spectroscopy to monitor drying kinetics.
Employed a water-assisted drying approach with constant relative humidity (RH).
Modeled ASD solutions using perturbed-chain statistical associating fluid theory (PC-SAFT) and its nonequilibrium (NE) version.

Main Results:

Water-assisted drying at RH = 0.8 completely removed ethanol from an indomethacin/PVPVA ASD in 1500 min.
Conventional drying left 3.5 wt % residual ethanol in the ASD under the same conditions.
PC-SAFT modeling successfully predicted ASD solution behavior and prevented phase separation.
NE-PC-SAFT accurately predicted ASD composition during drying.

Conclusions:

Water-assisted drying is a highly effective method for accelerating residual solvent removal from ASDs.
This approach ensures residual solvent content meets stringent regulatory requirements.
Predictive modeling (PC-SAFT) is crucial for optimizing ASD drying processes and preventing water-induced issues.