Advertisement

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. Repka
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

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.

KEY WORDS

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

Notes

Acknowledgements

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).

References

  1. 1.
    Repka MA, Bandari S, Kallakunta VR, Vo, McFall H, Pimparade MB, et al. Melt extrusion with poorly soluble drugs—an integrated review. Int J Pharm. 2018;535(1–2):68–85.CrossRefPubMedGoogle Scholar
  2. 2.
    Schaber SD, Gerogiorgis DI, Ramachandran R, Evans JMB, Barton PI, Trout BL. Economic analysis of integrated continuous and batch pharmaceutical manufacturing: a case study. Ind Eng Chem Res. 2011;50(17):10083–92.CrossRefGoogle Scholar
  3. 3.
    Food, Administration D. Guidance for industry, PAT-A Framework for Innovative Pharmaceutical Development, Manufacturing and Quality Assurance. 2004. http://www.fda.gov/cder/guidance/published html.
  4. 4.
    Guideline IHT. Pharmaceutical development. Q8 (2R) as revised in August. 2009.Google Scholar
  5. 5.
    Markl D, Wahl PR, Menezes JC, Koller DM, Kavsek B, Francois K, et al. Supervisory control system for monitoring a pharmaceutical hot melt extrusion process. AAPS PharmSciTech. 2013;14(3):1034–44.CrossRefPubMedPubMedCentralGoogle Scholar
  6. 6.
    Chablani L, Taylor MK, Mehrotra A, Rameas P, Stagner WC. Inline real-time near-infrared granule moisture measurements of a continuous granulation-drying-milling process. AAPS PharmSciTech. 2011;12(4):1050–5.CrossRefPubMedPubMedCentralGoogle Scholar
  7. 7.
    Smith-Goettler B, Gendron C, MacPhail N, Meyer R, Phillips J. NIR monitoring of a hot-melt extrusion process. Spectroscopy. 2011;26(8).Google Scholar
  8. 8.
    Rinnan Å, Berg FV, Engelsen SB. Review of the most common pre-processing techniques for near-infrared spectra. TrAC Trends Anal Chem. 2009;28(10):1201–22.CrossRefGoogle Scholar
  9. 9.
    Geladi P, Kowalski BR. Partial least-squares regression: a tutorial. Anal Chim Acta. 1986;185(Supplement C):1–17.CrossRefGoogle Scholar
  10. 10.
    Abdi H, Williams LJ. Principal component analysis. Wiley Interdisciplinary Reviews: Computational Statistics. 2010;2(4):433–59.CrossRefGoogle Scholar
  11. 11.
    Workman J Jr, Weyer L. Practical guide to interpretive near-infrared spectroscopy. Boca Raton: CRC press; 2007.Google Scholar

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
  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

Personalised recommendations