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High-throughput eutectic screening and hot-melt extrusion enable rapid development of nifedipine amorphous solid dispersions

AI Summary
  • Picolitre 2D inkjet microarray screening enables rapid, material-efficient identification of promising eutectic drug-coformer pairs for nifedipine.
  • Schroeder-Van Laar thermodynamic modelling predicted eutectic compositions and onset temperatures, then validated by scale-up and full phase-diagram construction.
  • End-to-end workflow couples microarray screening with hot-melt extrusion to produce nifedipine ASDs rapidly via continuous manufacturing.
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Int J Pharm. 2026 Aug 4:127282. doi: 10.1016/j.ijpharm.2026.127282. Online ahead of print.

ABSTRACT

The development of eutectic-based amorphous solid dispersions (ASDs) is often constrained by the time and material required to identify suitable drug-coformer combinations. Here, we present a miniaturised high-throughput workflow that integrates picolitre-volume 2D inkjet printing, predictive thermodynamic modelling, and scalable processing to accelerate eutectic formulation design for the model API nifedipine. Binary systems were printed as microarrays and screened microscopically, enabling rapid identification of promising eutectic pairs using minimal material. The Schroeder-Van Laar equation was applied to predict eutectic compositions and onset temperatures, which were subsequently validated through scale-up and full phase-diagram construction. Selected formulations were then processed by hot-melt extrusion to generate amorphous solid dispersions. This end-to-end strategy, spanning ultrafast microarray screening to continuous manufacturing, provides a robust and material-efficient platform for eutectic-based ASD development and substantially shortens formulation timelines for poorly soluble APIs such as nifedipine.

PMID:42551721 | DOI:10.1016/j.ijpharm.2026.127282

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