Application of FT-NIR Analysis for In-line and Real-Time Monitoring of Pharmaceutical Hot Melt Extrusion: a Technical Note
Category
Published on CMKC
Abstract
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.
Journal
AAPS PharmSciTech. Volume 19, 2018, 3425-3429
DOI
10.1208/s12249-018-1091-3
Type of publication
Peer-reviewed journal
Affiliations
- University of Mississippi
- Thermo Fisher Scientific
Article Classification
Technical note
Classification Areas
- API
- PAT
- Control