Implant; NIR Spectroscopy; Raman Spectroscopy; Hot Melt Extrusion; Process Analytical Technology; Raman Imaging
Résumé :
[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.
Centre/Unité de recherche :
Centre Interfacultaire de Recherche du Médicament - CIRM
Disciplines :
Pharmacie, pharmacologie & toxicologie
Auteur, co-auteur :
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
Langue du document :
Anglais
Titre :
PAT tools for the control of co-extrusion implants manufacturing process
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