Reference : Building the quality into pellet manufacturing environment - feasibility study and va...
Scientific journals : Article
Human health sciences : Pharmacy, pharmacology & toxicology
http://hdl.handle.net/2268/69980
Building the quality into pellet manufacturing environment - feasibility study and validation of an in-line quantitative near infrared (NIR) method
English
Mantanus, Jérôme mailto [Université de Liège - ULg > Département de pharmacie > Chimie analytique >]
Ziemons, Eric mailto [Université de Liège - ULg > Département de pharmacie > Chimie analytique >]
Rozet, Eric mailto [Université de Liège - ULg > Département de pharmacie > Chimie analytique >]
Streel, Bruno [Galéphar Research Center M/F > > > >]
Klinkenberg, Régis [Galéphar Research Center M/F > > > >]
Evrard, Brigitte mailto [Université de Liège - ULg > Département de pharmacie > Pharmacie galénique >]
Rantanen, Jukka [University of Copenhagen > Department of Pharmaceutics and Analytical Chemistry > > >]
Hubert, Philippe mailto [Université de Liège - ULg > Département de pharmacie > Chimie analytique >]
2010
Talanta
Elsevier Science
83
305-311
Yes (verified by ORBi)
International
0039-9140
1873-3573
Amsterdam
The Netherlands
[en] Near infrared spectroscopy ; Process Analytical Technology ; Chemometrics ; Validation ; Accuracy profile ; Moving particles
[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.
C.I.R.M.
Fonds Léon Fredericq ; Région wallonne : Direction générale des Technologies, de la Recherche et de l'Energie - DGTRE ; Novo Nordisk A/S
Researchers ; Professionals
http://hdl.handle.net/2268/69980
Jérôme Mantanus and Eric Ziémons contributed equally to this work. Jukka Rantanen and Philippe Hubert contributed equally to this work.

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