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Probing Miscibility of Spray-Dried and Melt-Quenched Amorphous Dispersions Using Rheology and Solid-State NMR

Sichen Song1,2, Tianyun Zhang3, Jianchao Xu3

  • 1Department of Pharmaceutics, University of Minnesota, Minneapolis, Minnesota 55455, United States.

Molecular Pharmaceutics
|January 24, 2026
PubMed
Summary

A new rheological approach effectively estimates miscibility and predicts crystallization in amorphous solid dispersions (ASDs) of celecoxib (CEL) and polyvinylpyrrolidone (PVP). This method aids in designing stable ASD formulations for improved drug storage.

Keywords:
amorphous solid dispersioncrystallizationmelt quenchmiscibilityoverlap concentrationphysical stabilityrheologysolid-state NMRspray drying

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Area of Science:

  • Pharmaceutical Sciences
  • Materials Science
  • Solid-State Chemistry

Background:

  • Amorphous solid dispersions (ASDs) enhance drug solubility and bioavailability.
  • Controlling drug crystallization in ASDs is crucial for long-term stability.
  • Assessing miscibility and crystallization propensity of ASDs is essential for formulation development.

Purpose of the Study:

  • To evaluate a c*-guided high-temperature rheological approach for estimating miscibility in celecoxib (CEL)/polyvinylpyrrolidone (PVP) ASDs.
  • To compare the miscibility and crystallization behavior of ASDs prepared by melt quench and spray drying.
  • To validate the rheological approach against solid-state Nuclear Magnetic Resonance (ssNMR) measurements.

Main Methods:

  • Preparation of CEL/PVP ASDs using melt quench and spray drying techniques.
  • High-temperature rheological measurements guided by the critical polymer concentration (c*).
  • Solid-state Nuclear Magnetic Resonance (ssNMR) 1H T1ρ and 1H T1 relaxation time measurements and spin diffusion studies.

Main Results:

  • General agreement was found between the rheological approach and ssNMR for estimating ASD miscibility.
  • The rheological method is suitable for as-is ASD powders, unlike ssNMR which can erase processing history.
  • Crystallization tendency was significantly reduced when polymer concentration exceeded c* (c > c*), delaying drug crystallization.
  • When c < c*, the onset of crystallization was similar to neat amorphous CEL.

Conclusions:

  • The c*-guided rheological approach is an efficient, material-sparing method for assessing ASD miscibility and predicting crystallization stability.
  • This approach is applicable to both melt-extruded and spray-dried ASDs.
  • Findings support the rational design of robust ASDs with enhanced long-term storage stability.