Article (Scientific journals)
PAT tools for the control of co-extrusion implants manufacturing process
Krier, Fabrice; Mantanus, Jérome; Sacre, Pierre-Yves et al.
2013In International Journal of Pharmaceutics, 458, p. 15-24
Peer Reviewed verified by ORBi
 

Files


Full Text
1-s2.0-S0378517313009034-main.pdf
Publisher postprint (2.59 MB)
Request a copy

All documents in ORBi are protected by a user license.

Send to



Details



Keywords :
Implant; NIR Spectroscopy; Raman Spectroscopy; Hot Melt Extrusion; Process Analytical Technology; Raman Imaging
Abstract :
[en] Hot melt extrusion is a novel pharmaceutical manufacturing process technique. In this study, we identified four Critical Quality Attributes (CQAs) of the implant manufacturing process by hot melt extrusion: the implant diameter, the quantity of the Active Pharmaceutical Ingredient (API), the homogeneity distribution of API and the thickness of the membrane. We controlled the implant diameter and the quantity of API in-line with a laser measurement, NIR and Raman spectroscopy, respectively. These two different spectroscopic techniques provided comparable results. In fact, the RMSEC and RMSECV were very close in each PAT technique but NIR spectroscopy was easier to use and less sensitive to external changes. For the control of the homogeneity of API distribution and the thickness of the membrane, we used successfully Raman spectroscopy imaging. These PAT tools help reducing analysis time.
Research center :
Centre Interfacultaire de Recherche du Médicament - CIRM
Disciplines :
Pharmacy, pharmacology & toxicology
Author, co-author :
Krier, Fabrice ;  Université de Liège - ULiège > Département de pharmacie > Pharmacie galénique
Mantanus, Jérome
Sacre, Pierre-Yves  ;  Université de Liège - ULiège > Département de pharmacie > Chimie analytique
Chavez, Pierre-François ;  Université de Liège - ULiège > Département de pharmacie > Chimie analytique
Thiry, Justine ;  Université de Liège - ULiège > Département de pharmacie > Pharmacie galénique
Pestieau, Aude ;  Université de Liège - ULiège > Département de pharmacie > Pharmacie galénique
Rozet, Eric ;  Université de Liège - ULiège > Département de pharmacie > Chimie analytique
Ziemons, Eric  ;  Université de Liège - ULiège > Département de pharmacie > Département de pharmacie
Hubert, Philippe  ;  Université de Liège - ULiège > Département de pharmacie > Chimie analytique
Evrard, Brigitte  ;  Université de Liège - ULiège > Département de pharmacie > Pharmacie galénique
Language :
English
Title :
PAT tools for the control of co-extrusion implants manufacturing process
Publication date :
2013
Journal title :
International Journal of Pharmaceutics
ISSN :
0378-5173
eISSN :
1873-3476
Publisher :
Elsevier Science, Amsterdam, Netherlands
Volume :
458
Pages :
15-24
Peer reviewed :
Peer Reviewed verified by ORBi
Available on ORBi :
since 06 November 2013

Statistics


Number of views
153 (42 by ULiège)
Number of downloads
7 (5 by ULiège)

Scopus citations®
 
32
Scopus citations®
without self-citations
26
OpenCitations
 
30

Bibliography


Similar publications



Contact ORBi