Reference : Near infrared and Raman spectroscopy as Process Analytical Technology tools for the manu...
Scientific journals : Article
Human health sciences : Pharmacy, pharmacology & toxicology
http://hdl.handle.net/2268/90203
Near infrared and Raman spectroscopy as Process Analytical Technology tools for the manufacturing of silicone-based drug reservoirs
English
Mantanus, Jérôme mailto [Université de Liège - ULg > Département de pharmacie > Chimie analytique >]
Rozet, Eric mailto [Université de Liège - ULg > Département de pharmacie > Chimie analytique >]
Van Butsele, K. [Odyssea pharma > > > >]
De Bleye, Charlotte mailto [Université de Liège - ULg > > > 2e an. master sc. pharm., fin. approf.]
Ceccato, Attilio [Université de Liège - ULg > Département de pharmacie > Analyse des médicaments >]
Evrard, Brigitte mailto [Université de Liège - ULg > Département de pharmacie > Pharmacie galénique >]
Hubert, Philippe mailto [Université de Liège - ULg > Département de pharmacie > Chimie analytique >]
Ziemons, Eric mailto [Université de Liège - ULg > Département de pharmacie > Département de pharmacie >]
2011
Analytica Chimica Acta
Elsevier
699
96-106
Yes (verified by ORBi)
International
0003-2670
1873-4324
Amsterdam
The Netherlands
[en] Vibrational spectroscopy ; silicone-based drug reservoirs ; Quality by Design ; Process Analytical Technology ; Chemometrics ; Validation
[en] Using Near Infrared (NIR) and Raman spectroscopy as PAT tools, 3 critical quality attributes of a silicone-based drug reservoir were studied. First, the Active Pharmaceutical Ingredient (API) homogeneity in the reservoir was evaluated using Raman spectroscopy (mapping): the API distribution within the industrial drug reservoirs was found to be homogeneous while API aggregates were detected in laboratory scale samples manufactured with a non optimal mixing process. Second, the crosslinking process of the reservoirs was monitored at different temperatures with NIR spectroscopy. Conformity tests and Principal Component Analysis (PCA) were performed on the collected data to find out the relation between the temperature and the time necessary to reach the crosslinking endpoints. An agreement was found between the conformity test results and the PCA results. Compared to the conformity test method, PCA had the advantage to discriminate the heating effect from the crosslinking effect occurring together during the monitored process. Therefore the 2 approaches were found to be complementary. Third, based on the HPLC reference method, a NIR model able to quantify the API in the drug reservoir was developed and thoroughly validated. Partial Least Squares (PLS) regression on the calibration set was performed to build prediction models of which the ability to quantify accurately was tested with the external validation set. The 1.2 % RMSEP of the NIR model indicated the global accuracy of the model. The accuracy profile based on tolerance intervals was used to generate a complete validation report. The 95 % tolerance interval calculated on the validation results indicated that each future result will have a relative error below ±5 % with a probability of at least 95 %. In conclusion, 3 critical quality attributes of silicone-based drug reservoirs were quickly and efficiently evaluated by NIR and Raman spectroscopy.
C.I.R.M.
Région wallonne : Direction générale des Technologies, de la Recherche et de l'Energie - DGTRE ; Fonds de la Recherche Scientifique (Communauté française de Belgique) - F.R.S.-FNRS
Researchers ; Professionals
http://hdl.handle.net/2268/90203

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