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Potential of near-infrared chemical imaging as process analytical technology tool for continuous freeze-drying

(2018) ANALYTICAL CHEMISTRY. 90(7). p.4354-4362
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Abstract
Near-infrared chemical imaging (NIR-CI) is an emerging tool for process monitoring because it combines the chemical selectivity of vibrational spectroscopy with spatial information. 'Whereas traditional near-infrared spectroscopy is an attractive technique for water content determination and solid-state investigation of lyophilized products, chemical imaging opens up possibilities for assessing the homogeneity of these critical quality attributes (CQAs) throughout the entire product. In this contribution, we aim to evaluate NIR-CI as a process analytical technology (PAT) tool for at-line inspection of continuously freeze-dried pharmaceutical unit doses based on spin freezing. The chemical images of freeze-dried mannitol samples were resolved via multivariate curve resolution, allowing us to visualize the distribution of mannitol solid forms throughout the entire cake. Second, a mannitol-sucrose formulation was lyophilized with variable drying times for inducing changes in water content. Analyzing the corresponding chemical images via principal component analysis, vial-to-vial variations as well as within-vial inhomogeneity in water content could be detected. Furthermore, a partial least-squares regression model was constructed for quantifying the water content in each pixel of the chemical images. It was hence concluded that NIR-CI is inherently a most promising PAT tool for continuously monitoring freeze-dried samples. Although some practicalities are still to be solved, this analytical technique could be applied in-line for CQA evaluation and for detecting the drying end point.
Keywords
MULTIVARIATE CURVE RESOLUTION, IN-LINE, NIR SPECTROSCOPY, MOISTURE-CONTENT, LYOPHILIZED MANNITOL, BIOMATH, DRIED PRODUCT, MCR-ALS, QUANTIFICATION, TABLETS, SURFACE

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Chicago
Brouckaert, Davinia, Laurens De Meyer, Brecht Vanbillemont, Pieter-Jan Van Bockstal, Joris Lammens, Séverine Mortier, Jos Corver, Chris Vervaet, Ingmar Nopens, and Thomas De Beer. 2018. “Potential of Near-infrared Chemical Imaging as Process Analytical Technology Tool for Continuous Freeze-drying.” Analytical Chemistry 90 (7): 4354–4362.
APA
Brouckaert, Davinia, De Meyer, L., Vanbillemont, B., Van Bockstal, P.-J., Lammens, J., Mortier, S., Corver, J., et al. (2018). Potential of near-infrared chemical imaging as process analytical technology tool for continuous freeze-drying. ANALYTICAL CHEMISTRY, 90(7), 4354–4362.
Vancouver
1.
Brouckaert D, De Meyer L, Vanbillemont B, Van Bockstal P-J, Lammens J, Mortier S, et al. Potential of near-infrared chemical imaging as process analytical technology tool for continuous freeze-drying. ANALYTICAL CHEMISTRY. 2018;90(7):4354–62.
MLA
Brouckaert, Davinia, Laurens De Meyer, Brecht Vanbillemont, et al. “Potential of Near-infrared Chemical Imaging as Process Analytical Technology Tool for Continuous Freeze-drying.” ANALYTICAL CHEMISTRY 90.7 (2018): 4354–4362. Print.
@article{8581914,
  abstract     = {Near-infrared chemical imaging (NIR-CI) is an emerging tool for process monitoring because it combines the chemical selectivity of vibrational spectroscopy with spatial information. 'Whereas traditional near-infrared spectroscopy is an attractive technique for water content determination and solid-state investigation of lyophilized products, chemical imaging opens up possibilities for assessing the homogeneity of these critical quality attributes (CQAs) throughout the entire product. In this contribution, we aim to evaluate NIR-CI as a process analytical technology (PAT) tool for at-line inspection of continuously freeze-dried pharmaceutical unit doses based on spin freezing. The chemical images of freeze-dried mannitol samples were resolved via multivariate curve resolution, allowing us to visualize the distribution of mannitol solid forms throughout the entire cake. Second, a mannitol-sucrose formulation was lyophilized with variable drying times for inducing changes in water content. Analyzing the corresponding chemical images via principal component analysis, vial-to-vial variations as well as within-vial inhomogeneity in water content could be detected. Furthermore, a partial least-squares regression model was constructed for quantifying the water content in each pixel of the chemical images. It was hence concluded that NIR-CI is inherently a most promising PAT tool for continuously monitoring freeze-dried samples. Although some practicalities are still to be solved, this analytical technique could be applied in-line for CQA evaluation and for detecting the drying end point.},
  author       = {Brouckaert, Davinia and De Meyer, Laurens and Vanbillemont, Brecht and Van Bockstal, Pieter-Jan and Lammens, Joris and Mortier, S{\'e}verine and Corver, Jos and Vervaet, Chris and Nopens, Ingmar and De Beer, Thomas},
  issn         = {0003-2700},
  journal      = {ANALYTICAL CHEMISTRY},
  keyword      = {MULTIVARIATE CURVE RESOLUTION,IN-LINE,NIR SPECTROSCOPY,MOISTURE-CONTENT,LYOPHILIZED MANNITOL,BIOMATH,DRIED PRODUCT,MCR-ALS,QUANTIFICATION,TABLETS,SURFACE},
  language     = {eng},
  number       = {7},
  pages        = {4354--4362},
  title        = {Potential of near-infrared chemical imaging as process analytical technology tool for continuous freeze-drying},
  url          = {http://dx.doi.org/10.1021/acs.analchern.71303647},
  volume       = {90},
  year         = {2018},
}

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