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Excipient variability critically impacts crystallization propensity of spray-dried amorphous solid dispersions.

Tanaya Singh Bhadoriya1, Soumalya Chakraborty2, Amit Pariskar2

  • 1Department of Pharmaceutical Technology (Formulations), National Institute of Pharmaceutical Education and Research (NIPER), Sector 67, SAS Nagar, Punjab 160062, India.

European Journal of Pharmaceutical Sciences : Official Journal of the European Federation for Pharmaceutical Sciences
|September 29, 2025
PubMed
Summary

Variability in polymeric stabilizer properties impacts spray-dried amorphous solid dispersion stability. Key properties like solvent evaporation and drug diffusion correlate with stabilizer functionality, ensuring consistent drug product performance.

Keywords:
Amorphous solid dispersionCrystallizationEnthalpy relaxationExcipient variabilityFunctionality-related characteristicsSpray drying

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Area of Science:

  • Pharmaceutics
  • Materials Science
  • Chemical Engineering

Background:

  • Polymeric amorphous solid dispersions (ASDs) enhance oral bioavailability of poorly water-soluble drugs.
  • Stabilizer variability from different sources/batches can affect ASD stability and performance.
  • Understanding these variations is crucial for consistent drug product manufacturing.

Purpose of the Study:

  • To correlate physicochemical property variations of polymeric stabilizers with the stability of spray-dried ASDs.
  • To identify key functionality-related characteristics (FRCs) and tests (FRTs) for stabilizer quality control.
  • To ensure robust performance of spray-dried ASDs across different stabilizer batches and sources.

Main Methods:

  • Spray drying of Polyvinylpyrrolidone-vinyl acetate (PVPVA) and griseofulvin (GSV) to form ASDs.
  • Characterization of ASD amorphous state and homogeneity using pXRD, DSC, and PLM.
  • Quantification of PVPVA functionality (% crystallization) and intermediate functionality (enthalpy relaxation) via pXRD and DSC.
  • Measurement of various PVPVA physicochemical properties (Tg, viscosity, K-value, etc.).
  • Correlation analysis (Pearson's) between PVPVA properties and ASD functionality.

Main Results:

  • Amorphous and phase-homogeneous ASDs were confirmed.
  • Strong correlations (r ≥ 0.6) found between ASD functionality and solvent evaporation kinetics, drug diffusion coefficient, K-value, and water activity increase.
  • These correlations indicate significant drug-polymer and polymer-water interactions influencing ASD stability.

Conclusions:

  • Functionality-related characteristics (FRCs) of polymeric stabilizers significantly impact spray-dried ASD stability.
  • Proposed FRCs and FRTs can guide stabilizer selection and quality control for consistent ASD performance.
  • This study provides a framework for ensuring robust ASD manufacturing for poorly soluble drugs.