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- W1996714246 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." @default.
- W1996714246 created "2016-06-24" @default.
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- W1996714246 date "2013-12-01" @default.
- W1996714246 modified "2023-09-25" @default.
- W1996714246 title "PAT tools for the control of co-extrusion implants manufacturing process" @default.
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- W1996714246 doi "https://doi.org/10.1016/j.ijpharm.2013.09.040" @default.
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