Continuous manufacturing, a gaining interest paradigm in the pharmaceutical industry, requires in-process monitoring of critical process parameters to ensure product consistency. This study demonstrated the application of Fourier transform near-infrared (FT-NIR) spectroscopy in conjunction with chemometrics modeling for in-line hot melt extrusion process monitoring. The obtained results suggested that inline FT-NIR analysis, along with a tailored NIR reflector, is a viable process analytical tool to monitor active pharmaceutical ingredient concentration as well as processing parameters.

• University of Mississippi
• Thermo Fisher Scientific

• API
• PAT
• Control

1. API
2. continuous manufacturing
3. Control
4. Hot melt extursion (HME)
5. NIR spectroscopy
6. pat
7. Process analytical technology (PAT)
8. Technical note