title: PAT tools for the control of co-extrusion implants manufacturing process.
abstract: 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.
authors.affiliation: Laboratory of Pharmaceutical Technology, Department of Pharmacy, C.I.R.M., University of Liège, 4000 Liège, Belgium. Electronic address: Fabrice.krier@ulg.ac.be.
authors.forename: Fabrice
authors.initials: F
authors.lastname: Krier
authors.forename: Jérôme
authors.initials: J
authors.lastname: Mantanus
authors.forename: Pierre-Yves
authors.initials: PY
authors.lastname: Sacré
authors.forename: Pierre-François
authors.initials: PF
authors.lastname: Chavez
authors.forename: Justine
authors.initials: J
authors.lastname: Thiry
authors.forename: Aude
authors.initials: A
authors.lastname: Pestieau
authors.forename: Eric
authors.initials: E
authors.lastname: Rozet
authors.forename: Eric
authors.initials: E
authors.lastname: Ziemons
authors.forename: Philippe
authors.initials: P
authors.lastname: Hubert
authors.forename: Brigitte
authors.initials: B
authors.lastname: Evrard
mesh_terms: D002626:Chemistry, Pharmaceutical / Q000379:methods*; D006358:Hot Temperature; D019265:Spectroscopy, Near-Infrared / Q000379:methods; D013059:Spectrum Analysis, Raman / Q000379:methods; D013678:Technology, Pharmaceutical / Q000379:methods*
keywords: Hot melt extrusion; Implant; NIR spectroscopy; Process Analytical Technology; Raman imaging; Raman spectroscopy