Article (Scientific journals)
Building the quality into pellet manufacturing environment - feasibility study and validation of an in-line quantitative near infrared (NIR) method
Mantanus, Jérôme; Ziemons, Eric; Rozet, Eric et al.
2010In Talanta, 83, p. 305-311
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Keywords :
Near infrared spectroscopy; Process Analytical Technology; Chemometrics; Validation; Accuracy profile; Moving particles
Abstract :
[en] The present study focuses on the implementation of an in-line quantitative near infrared (NIR) spectroscopic method for determining the active content of pharmaceutical pellets. The first aim was to non-invasively interface a dispersive NIR spectrometer with four realistic particle streams existing in the pellets manufacturing environment. Regardless of the particle stream characteristics investigated, NIR together with principal component analysis (PCA) was able to classify the samples according to their active content. Further, one of these particle stream interfaces was non-invasively investigated with a FT-NIR spectrometer. A predictive model based on Partial Least Squares (PLS) regression was able to determine the active content of pharmaceutical pellets. The NIR method was finally validated with an external validation set for an API concentration range from 80 to 120 % of the targeted active content. The prediction error of 0.9 % (root mean standard error of prediction, RMSEP) was low, indicating the accuracy of the NIR method. The accuracy profile on the validation results, an innovative approach based on tolerance intervals, demonstrated the actual and future performance of the in-line NIR method. Accordingly, the present approach paves the way for real-time release-based quality system.
Research center :
C.I.R.M.
Disciplines :
Pharmacy, pharmacology & toxicology
Author, co-author :
Mantanus, Jérôme ;  Université de Liège - ULiège > Département de pharmacie > Chimie analytique
Ziemons, Eric  ;  Université de Liège - ULiège > Département de pharmacie > Chimie analytique
Rozet, Eric ;  Université de Liège - ULiège > Département de pharmacie > Chimie analytique
Streel, Bruno;  Galéphar Research Center M/F
Klinkenberg, Régis;  Galéphar Research Center M/F
Evrard, Brigitte  ;  Université de Liège - ULiège > Département de pharmacie > Pharmacie galénique
Rantanen, Jukka;  University of Copenhagen > Department of Pharmaceutics and Analytical Chemistry
Hubert, Philippe  ;  Université de Liège - ULiège > Département de pharmacie > Chimie analytique
Language :
English
Title :
Building the quality into pellet manufacturing environment - feasibility study and validation of an in-line quantitative near infrared (NIR) method
Publication date :
2010
Journal title :
Talanta
ISSN :
0039-9140
eISSN :
1873-3573
Publisher :
Elsevier Science, Amsterdam, Netherlands
Volume :
83
Pages :
305-311
Peer reviewed :
Peer Reviewed verified by ORBi
Funders :
Fonds Léon Fredericq [BE]
DGTRE - Région wallonne. Direction générale des Technologies, de la Recherche et de l'Énergie [BE]
Novo Nordisk A/S
Commentary :
Jérôme Mantanus and Eric Ziémons contributed equally to this work. Jukka Rantanen and Philippe Hubert contributed equally to this work.
Available on ORBi :
since 23 August 2010

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