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Process optimization in pharmaceutical hot-melt extrusion: real-time volatile detection via SIFT-MS combined with
Aaron D Smith1, Ecaterina Bordos1, Michael Devlin1
1CMAC, University of Strathclyde, Technology and Innovation Centre, Glasgow, United Kingdom; Strathclyde Institute for Pharmacy and Biomedical Sciences, University of Strathclyde, Glasgow, United Kingdom.
International Journal of Pharmaceutics
|January 27, 2026
Summary
Selected-ion-flow-tube-mass-spectrometry (SIFT-MS) precisely defines pharmaceutical polymer processing windows for hot-melt extrusion (HME). This method detects early chemical changes, enabling optimized amorphous solid dispersion manufacture.
Area of Science:
- Pharmaceutical Science
- Polymer Chemistry
- Process Engineering
Background:
- Hot-melt extrusion (HME) is crucial for amorphous solid dispersion (ASD) manufacture.
- Establishing robust processing windows for pharmaceutical polymers during HME is challenging due to limitations in conventional thermal analysis.
- Early chemical changes in polymers during HME are often undetected by standard methods.
Purpose of the Study:
- To utilize selected-ion-flow-tube-mass-spectrometry (SIFT-MS) for real-time characterization of volatile evolution during polymer processing.
- To establish data-driven methods for defining the onset of significant chemical change in pharmaceutical polymers.
- To determine precise, polymer-specific processing windows for HME to enhance ASD manufacture.
Main Methods:
- Selected-ion-flow-tube-mass-spectrometry (SIFT-MS) coupled with principal component analysis (PCA) was employed.
- Real-time volatile evolution was monitored under thermogravimetric analysis (TGA) and HME conditions.
- Centroid-distance mapping and PCA loadings were used to identify distinct thermal transitions and chemical changes.
Main Results:
- SIFT-MS and PCA successfully identified distinct transitions indicating the onset of temperature-driven chemical evolution in four polymers: Soluplus®, Affinisol™15LV, Kollidon® VA64, and Plasdone™ S630 Ultra.
- Specific processing windows were defined: Soluplus® and Plasdone™ S630 Ultra (150-170°C), Kollidon® VA64 (160-180°C), and Affinisol™15LV (170-185°C).
- These chemically defined limits, supported by rheological data, were narrower and more precise than manufacturer-provided ranges.
Conclusions:
- SIFT-MS offers a rapid, non-destructive method to detect subtle, early chemical changes in polymers during HME, well before conventional thermal analysis.
- This technique enables the precise definition of polymer-specific extrusion windows, improving process understanding and optimization for ASD.
- The findings facilitate more robust and efficient manufacturing of amorphous solid dispersions.
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