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/Unit :
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 DGTRE - Région wallonne. Direction générale des Technologies, de la Recherche et de l'Énergie 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.
scite shows how a scientific paper has been cited by providing the context of the citation, a classification describing whether it supports, mentions, or contrasts the cited claim, and a label indicating in which section the citation was made.
Bibliography
United States Food and Drug Administration (FDA), Guidance for industry PAT-A framework for innovative pharmaceutical manufacturing and quality assurance, FDA, 2004.
International Conference on Harmonisation (ICH) of technical requirements for registration of pharmaceuticals for human use, Topic Q9: Quality risk management, Geneva, 2005.
D.A. Burns, and E.W. Ciurczak Handbook of Near-Infrared Analysis 3rd ed. 2008 CRC Press New York
J. Luypaert, D.L. Massart, and Y. Vander Heyden Talanta 72 2007 865 883
C. Bodson, E. Rozet, E. Ziemons, B. Evrard, Ph. Hubert, and L. Delattre J. Pharm. Biomed. Anal. 45 2007 356 361 http://hdl.handle.net/2268/1642
J.J. Moes, M.M. Ruijken, E. Gout, H.W. Frijlink, and M.I. Ugwoke Int. J. Pharm. 357 2008 108 118
E.T.S. Skibsted, J.A. Westerhuis, A.K. Smilde, and D.T. Witte J. Pharm. Biomed. Anal. 43 2007 1297 1305
W. Li, L. Bagnol, M. Berman, R.A. Chiarella, and M. Gerber Int. J. Pharm. 380 2009 49 54
H. Grohganz, M. Fonteyne, E. Skibsted, T. Falck, B. Palmqvist, and J Rantanen Eur. J. Pharm. Biopharm. 74 2010 406 412
J. Mantanus, E. Ziémons, P. Lebrun, E. Rozet, R. Klinkenberg, B. Streel, B. Evrard, and Ph. Hubert Anal. Chim. Acta 642 2009 186 192 http://hdl.handle.net/2268/18780
J. Mantanus, E. Ziémons, P. Lebrun, E. Rozet, R. Klinkenberg, B. Streel, B. Evrard, and Ph. Hubert Talanta 80 2010 1750 1757 http://hdl.handle. net/2268/26616
J. Rantanen, S. Lehtola, P. Rämet, J.P. Mannermaa, and J. Yliruusi Powder Technol. 99 1998 163 170
J. Rantanen, E. Räsänen, O. Antikainen, J.P. Mannermaa, and J. Yliruusi Chemom. Intel. Lab Syst. 56 2001 51 58
N. Sandler, J. Rantanen, J. Heinämäki, M. Römer, M. Marvola, and J. Yliruusi AAPS PharmSciTech 6 2 2005 174 183
S.H. Tabasi, V. Moolchandani, R. Fahmy, and S.W. Hoag Int. J. Pharm. 382 2009 1 6
L. Maurer, and H. Leuenberger Int. J. Pharm. 370 2009 8 16
C. Ravn, E. Skibsted, and R. Bro J. Pharm. Biomed. Anal. 48 2008 554 561
M. Blanco, M. Alcalá, and M. Bautista Eur. J. Pharm. Sci. 33 2008 409 414
International Conference on Harmonization (ICH) of Technical requirements for registration of pharmaceuticals for human use, Topic Q2 (R1): Validation of analytical Procedures: Text and Methodology, Geneva, 2005.
Ph. Hubert, J.J. Nguyen-Huu, B. Boulanger, E. Chapuzet, P. Chiap, N. Cohen, P.A. Compagnon, W. Dewé, M. Feinberg, M. Lallier, M. Laurentie, N. Mercier, G. Muzard, C. Nivet, and L. Valat J. Pharm. Biomed. Anal. 36 2004 579 586 http://hdl.handle.net/2268/6169
Ph. Hubert, J. Nguyen-Huu, B. Boulanger, E. Chapuzet, P. Chiap, N. Cohen, P.A. Compagnon, W. Dewé, M. Feinberg, M. Lallier, M. Laurentie, N. Mercier, G. Muzard, C. Nivet, L. Valat, and E. Rozet J. Pharm. Biomed. Anal. 45 2007 70 81 http://hdl.handle.net/2268/6170
A. Bouabidi, E. Rozet, M. Fillet, E. Ziémons, E. Chapuzet, B. Mertens, R. Klinkenberg, A. Ceccato, M. Talbi, B. Streel, A. Bouklouze, B. Boulanger, and Ph. Hubert J. Chrom. A. 1217 2010 3180 3192 http://hdl.handle. net/2268/29471
This website uses cookies to improve user experience. Read more
Save & Close
Accept all
Decline all
Show detailsHide details
Cookie declaration
About cookies
Strictly necessary
Performance
Strictly necessary cookies allow core website functionality such as user login and account management. The website cannot be used properly without strictly necessary cookies.
This cookie is used by Cookie-Script.com service to remember visitor cookie consent preferences. It is necessary for Cookie-Script.com cookie banner to work properly.
Performance cookies are used to see how visitors use the website, eg. analytics cookies. Those cookies cannot be used to directly identify a certain visitor.
Used to store the attribution information, the referrer initially used to visit the website
Cookies are small text files that are placed on your computer by websites that you visit. Websites use cookies to help users navigate efficiently and perform certain functions. Cookies that are required for the website to operate properly are allowed to be set without your permission. All other cookies need to be approved before they can be set in the browser.
You can change your consent to cookie usage at any time on our Privacy Policy page.