In-line Fluorescence Spectroscopy for Quantification of Low Amount of Active Pharmaceutical Ingredient
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In-line Fluorescence Spectroscopy for Quantification of Low Amount of Active Pharmaceutical Ingredient. / Sørensen, Dan Henrik; Christensen, Niels Peter Aae; Skibsted, Erik; Rantanen, Jukka; Rinnan, Åsmund.
In: Journal of Pharmaceutical Sciences, Vol. 111, No. 9, 2022, p. 2406-2410.Research output: Contribution to journal › Journal article › Research › peer-review
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TY - JOUR
T1 - In-line Fluorescence Spectroscopy for Quantification of Low Amount of Active Pharmaceutical Ingredient
AU - Sørensen, Dan Henrik
AU - Christensen, Niels Peter Aae
AU - Skibsted, Erik
AU - Rantanen, Jukka
AU - Rinnan, Åsmund
N1 - Funding Information: Dan Henrik Sørensen, Niels Peter Aae Christensen, and Erik Skibsted are employed at Novo Nordisk A/S. Jukka Rantanen and Åsmund Rinnan have not received any consulting fees from Novo Nordisk A/S.
PY - 2022
Y1 - 2022
N2 - The pharmaceutical industry is currently implementing new manufacturing principles and modernizing the related processing solutions. A key element in this development is implementation of process analytical technologies (PAT) for measuring product quality in a real-time mode, ideally for a continuously operating processing line. Near-infrared (NIR) spectroscopy is widely used for this purpose, but has limited use for low concentration formulations, due to its inherent detection limit. Light-induced fluorescence (LIF) spectroscopy is a PAT tool that can be used to quantify low concentrations of active pharmaceutical ingredient, and recent development of instrumentation has made it available for in-line applications. In this study, the content of tryptophan in a dynamic powder flow could be measured as low as 0.10 w/w % with LIF spectroscopy with good accuracy of RMSEP = 0.008 w/w %. Both partial least squares regression and support vector machines (SVM) were investigated, but we found SVM to be the better option due to non-linearities between the calibration test and the in-line measurements. With the use of SVM, LIF spectroscopy is a promising candidate for low concentration applications where NIR is not suitable.
AB - The pharmaceutical industry is currently implementing new manufacturing principles and modernizing the related processing solutions. A key element in this development is implementation of process analytical technologies (PAT) for measuring product quality in a real-time mode, ideally for a continuously operating processing line. Near-infrared (NIR) spectroscopy is widely used for this purpose, but has limited use for low concentration formulations, due to its inherent detection limit. Light-induced fluorescence (LIF) spectroscopy is a PAT tool that can be used to quantify low concentrations of active pharmaceutical ingredient, and recent development of instrumentation has made it available for in-line applications. In this study, the content of tryptophan in a dynamic powder flow could be measured as low as 0.10 w/w % with LIF spectroscopy with good accuracy of RMSEP = 0.008 w/w %. Both partial least squares regression and support vector machines (SVM) were investigated, but we found SVM to be the better option due to non-linearities between the calibration test and the in-line measurements. With the use of SVM, LIF spectroscopy is a promising candidate for low concentration applications where NIR is not suitable.
KW - Fluorescence
KW - Multivariate data analysis
KW - powder mixtures
KW - Process Analytical Technology
U2 - 10.1016/j.xphs.2022.06.008
DO - 10.1016/j.xphs.2022.06.008
M3 - Journal article
C2 - 35724737
AN - SCOPUS:85133316569
VL - 111
SP - 2406
EP - 2410
JO - Journal of Pharmaceutical Sciences
JF - Journal of Pharmaceutical Sciences
SN - 0022-3549
IS - 9
ER -
ID: 314963999