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

  • Technical Note
  • Theme: Advances in PAT, QbD, and Material Characterization
  • Published:
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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.

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References

  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.

    Article  CAS  Google Scholar 

  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.

    Article  CAS  Google Scholar 

  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. Guideline IHT. Pharmaceutical development. Q8 (2R) as revised in August. 2009.

  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.

    Article  CAS  Google Scholar 

  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.

    Article  CAS  Google Scholar 

  7. Smith-Goettler B, Gendron C, MacPhail N, Meyer R, Phillips J. NIR monitoring of a hot-melt extrusion process. Spectroscopy. 2011;26(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.

    Article  CAS  Google Scholar 

  9. Geladi P, Kowalski BR. Partial least-squares regression: a tutorial. Anal Chim Acta. 1986;185(Supplement C):1–17.

    Article  CAS  Google Scholar 

  10. Abdi H, Williams LJ. Principal component analysis. Wiley Interdisciplinary Reviews: Computational Statistics. 2010;2(4):433–59.

    Article  Google Scholar 

  11. Workman J Jr, Weyer L. Practical guide to interpretive near-infrared spectroscopy. Boca Raton: CRC press; 2007.

    Book  Google Scholar 

Download references

Acknowledgements

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

Funding

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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Authors and Affiliations

  1. Department of Pharmaceutics and Drug Delivery, University of Mississippi, University, Mississippi, 38677, USA

    Anh Q. Vo, Jiaxiang Zhang & Michael A. Repka

  2. Thermo Fisher Scientific, Waltham, Massachusetts, USA

    Herman He, Scott Martin & Rui Chen

  3. Pii Center for Pharmaceutical Technology, School of Pharmacy, University of Mississippi, University, Mississippi, 38677, USA

    Michael A. Repka

Authors
  1. Anh Q. Vo
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  2. Herman He
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  3. Jiaxiang Zhang
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  4. Scott Martin
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  5. Rui Chen
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  6. Michael A. Repka
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Corresponding author

Correspondence to Michael A. Repka.

Additional information

Guest Editors: William C. Stagner and Rahul V. Haware

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Vo, A.Q., He, H., Zhang, J. et al. Application of FT-NIR Analysis for In-line and Real-Time Monitoring of Pharmaceutical Hot Melt Extrusion: a Technical Note. AAPS PharmSciTech 19, 3425–3429 (2018). https://doi.org/10.1208/s12249-018-1091-3

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  • DOI: https://doi.org/10.1208/s12249-018-1091-3

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