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$On-Chip Crystallization and Large-Scale Serial Diffraction at Room Temperature$

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Amorphous Solid Dispersions Containing Residual Crystallinity: Competition Between Dissolution and Matrix

Dana E Moseson¹, Isaac D Corum¹, Andres Lust¹

¹Department of Industrial and Physical Pharmacy, College of Pharmacy, Purdue University, West Lafayette, Indiana, 47907, USA.

The AAPS Journal

|May 18, 2021

Summary

This summary is machine-generated.

Residual crystallinity in amorphous solid dispersions (ASDs) impairs drug dissolution. This study reveals that matrix crystallization, driven by crystal seeds, and stable polymorph growth in bicalutamide/PVPVA ASDs significantly reduce drug release.

Keywords:

amorphous solid dispersion crystallinity dissolution,hot melt extrusion matrix crystallization

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Area of Science:

Pharmaceutical Sciences
Materials Science

Background:

Amorphous solid dispersions (ASDs) enhance drug solubility but can be destabilized by crystallinity.
Residual crystallinity in ASDs can lead to drug desupersaturation and reduced dissolution.
Bicalutamide (BCL)/polyvinylpyrrolidone vinyl acetate copolymer (PVPVA) ASDs are susceptible to crystallization.

Purpose of the Study:

To investigate the dissolution and crystallization mechanisms of bicalutamide (BCL)/polyvinylpyrrolidone vinyl acetate copolymer (PVPVA) ASDs with varying degrees of residual crystallinity.
To understand the impact of residual crystallinity on drug release and polymorph formation.
To elucidate the role of matrix crystallization versus solution-mediated crystallization.

Main Methods:

Hot melt extrusion (HME) for ASD production.
In-line Raman spectroscopy for real-time crystallization monitoring.
Polarized light microscopy and scanning electron microscopy for solid-state characterization.
Dissolution testing under both sink and non-sink conditions.

Main Results:

Fully amorphous ASDs showed initial supersaturation followed by crystallization to the metastable form.
ASDs with residual crystallinity exhibited reduced supersaturation and faster matrix crystallization to the stable form.
Matrix crystallization in residual crystalline ASDs led to agglomerated crystals with high surface area.
Under sink conditions, fully amorphous ASDs and physical mixtures showed faster drug release than those with residual crystallinity.

Conclusions:

Residual crystallinity in BCL/PVPVA ASDs poses a significant risk to dissolution performance.
Fast matrix crystallization propagating from crystal seeds and stable polymorph growth are key drivers of performance loss.
Understanding these mechanisms is crucial for developing stable and effective amorphous solid dispersions.