AAPS PharmSciTech

, Volume 19, Issue 8, pp 3425–3429 | Cite as

Application of FT-NIR Analysis for In-line and Real-Time Monitoring of Pharmaceutical Hot Melt Extrusion: a Technical Note

  • Anh Q. Vo
  • Herman He
  • Jiaxiang Zhang
  • Scott Martin
  • Rui Chen
  • Michael A. RepkaEmail author
Technical Note Theme: Advances in PAT, QbD, and Material Characterization
Part of the following topical collections:
  1. Theme: Advances in PAT, QbD, and Material Characterization


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.


process analytical technology (PAT) NIR spectroscopy continuous manufacturing hot melt extrusion (HME) 



The authors would like to thank Thermo Fisher Scientific for generously supporting this project.

Funding Information

This work was also partially supported by Grant Number P20GM104932 from the National Institute of General Medical Sciences (NIGMS), a component of the National Institutes of Health (NIH).


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Copyright information

© American Association of Pharmaceutical Scientists 2018

Authors and Affiliations

  • Anh Q. Vo
    • 1
  • Herman He
    • 2
  • Jiaxiang Zhang
    • 1
  • Scott Martin
    • 2
  • Rui Chen
    • 2
  • Michael A. Repka
    • 1
    • 3
    Email author
  1. 1.Department of Pharmaceutics and Drug DeliveryUniversity of MississippiUniversityUSA
  2. 2.Thermo Fisher ScientificWalthamUSA
  3. 3.Pii Center for Pharmaceutical Technology, School of PharmacyUniversity of MississippiUniversityUSA

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