Assessment of chemometric methods for the non-invasive monitoring of solid blending processes using wireless near infrared spectroscopy

Juan G. Rosas, Marcel Blanco, Fernando Santamaría, Manel Alcalà

Research output: Contribution to journalArticleResearchpeer-review

6 Citations (Scopus)

Abstract

The US Food and Drug Administration's process analytical technology (PAT) initiative has encouraged the pharmaceutical industry to strengthen research with a view to developing new analytical technologies for improving blending processes. Near infrared (NIR) spectroscopy, which is sensitive to both physical and chemical attributes of substances, has proved a powerful non-invasive analytical technique for this purpose. In this paper, we propose a criterion to assess blending uniformity and accurately detect the end-point of a blending process. The criterion was established by using partial least squares (PLS) regression and calibration-free methods including moving block standard deviation of spectra, principal component scores distance analysis and the mixing index (M). The mixing index was found to provide accurate, robust results with a view to assessing blending uniformity, as was PLS for detecting blending endpoints. This novel criterion allowed us to assess the homogeneity of a mixture, without the need of a reference method, a golden batch or a calibration set. In fact, the M index was found to be an easy method and it is a highly suitable tool for PAT as it allows the accurate, precise real-time monitoring of blending processes with minimal intervention of the analyst. © IM Publications LLP 2013. All rights reserved.
Original languageEnglish
Pages (from-to)97-106
JournalJournal of Near Infrared Spectroscopy
Volume21
Issue number2
DOIs
Publication statusPublished - 29 Apr 2013

Keywords

  • Blending
  • Blending end-point
  • MBSD
  • Mixing index
  • NIR spectroscopy
  • PAT
  • PC-SDA
  • PLS
  • Uniformity

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