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Predicting process design spaces for spray drying amorphous solid dispersions.

Stefanie Dohrn1, Pranay Rawal1, Christian Luebbert1

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Summary
This summary is machine-generated.

This study presents a predictive method to determine optimal spray-drying conditions for amorphous solid dispersions (ASDs). It identifies a process design space to prevent API crystallization and ensure product homogeneity.

Keywords:
Amorphous solid dispersionCrystallizationGlass transitionPC-SAFTProcess design spaceResidual solventSolvent selectionSpray drying

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Area of Science:

  • Pharmaceutical Sciences
  • Chemical Engineering
  • Materials Science

Background:

  • Amorphous solid dispersions (ASDs) are crucial for enhancing drug solubility and bioavailability.
  • Spray drying is a common manufacturing method for ASDs, but process parameters critically affect product quality.
  • Ensuring ASD homogeneity and preventing API crystallization during drying are key development challenges.

Purpose of the Study:

  • To develop a predictive approach for identifying the spray-drying process design space for ASDs.
  • To avoid API crystallization and amorphous phase separation during the manufacturing of solvent-free, homogeneous ASDs.
  • To establish appropriate spray-drying conditions based on thermodynamic and material-specific interactions.

Main Methods:

  • Utilized the Perturbed-Chain Statistical Associating Theory (PC-SAFT) to calculate ternary API/polymer/solvent phase behavior.
  • Integrated PC-SAFT calculations with mass and energy balances for process condition determination.
  • Applied a quality-by-design approach to define the spray-drying process design space.

Main Results:

  • A predictive method was established to determine spray-drying process conditions.
  • Thermodynamic driving forces for solvent drying and ASD-specific interactions were considered.
  • A process design space was successfully identified for specific ASDs (ritonavir, naproxen) and polymers (PVP, PVPA) using various solvents (acetone, dichloromethane, ethanol).

Conclusions:

  • The developed predictive approach enables the identification of optimal spray-drying conditions for ASD manufacturing.
  • This method facilitates the creation of solvent-free, homogeneous ASDs by preventing undesirable API crystallization and phase separation.
  • The study provides a validated process design space for specific drug-polymer-solvent systems, aiding in robust drug product development.