Reference : Development of an analytical method for crystalline content determination in amorphou...
Scientific journals : Article
Human health sciences : Pharmacy, pharmacology & toxicology
http://hdl.handle.net/2268/213212
Development of an analytical method for crystalline content determination in amorphous solid dispersions produced by Hot-Melt Extrusion using transmission Raman spectroscopy: A feasibility study.
English
Netchacovitch, Lauranne mailto [Université de Liège > Département de pharmacie > Chimie analytique >]
Dumont, Elodie mailto [Université de Liège > Département de pharmacie > Chimie analytique >]
Cailletaud, Johan mailto [Université de Liège > Département de pharmacie > Chimie analytique >]
Thiry, Justine mailto [Université de Liège > Département de pharmacie > Pharmacie galénique >]
De Bleye, Charlotte mailto [Université de Liège > Département de pharmacie > Département de pharmacie >]
Sacre, Pierre-Yves mailto [Université de Liège > Département de pharmacie > Chimie analytique >]
Boiret, Mathieu []
Evrard, Brigitte mailto [Université de Liège > Département de pharmacie > Pharmacie galénique >]
Hubert, Philippe mailto [Université de Liège > Département de pharmacie > Chimie analytique >]
Ziemons, Eric mailto [Université de Liège > Département de pharmacie > Département de pharmacie >]
2017
International Journal of Pharmaceutics
Elsevier Science
530
1-2
249-255
Yes (verified by ORBi)
International
0378-5173
1873-3476
Amsterdam
The Netherlands
[en] Amorphous solid dispersions ; Crystalline content ; Analyzed sampling volume ; confocal Raman microspectroscopy ; transmission Raman spectroscopy ; Hot-Melt-Extrusion
[en] The development of a quantitative method determining the crystalline percentage in an amorphous solid dispersion is of great interest in the pharmaceutical field. Indeed, the crystalline Active Pharmaceutical Ingredient transformation into its amorphous state is increasingly used as it enhances the solubility and bioavailability of Biopharmaceutical Classification System class II drugs. One way to produce amorphous solid dispersions is the Hot-Melt Extrusion (HME) process. This study reported the development and the comparison of the analytical performances of two techniques, based on backscattering and transmission Raman spectroscopy, determining the crystalline remaining content in amorphous solid dispersions produced by HME.

Principal Component Analysis (PCA) and Partial Least Squares (PLS) regression were performed on preprocessed data and tended towards the same conclusions: for the backscattering Raman results, the use of the DuoScan™ mode improved the PCA and PLS results, due to a larger analyzed sampling volume. For the transmission Raman results, the determination of low crystalline percentages was possible and the best regression model was obtained using this technique. Indeed, the latter acquired spectra through the whole sample volume, in contrast with the previous surface analyses performed using the backscattering mode. This study consequently highlighted the importance of the analyzed sampling volume.
Centre Interdisciplinaire de Recherche sur le Médicament - CIRM
Région wallonne : Direction générale des Technologies, de la Recherche et de l'Energie - DGTRE
Mycomelt
Researchers ; Professionals
http://hdl.handle.net/2268/213212
10.1016/j.ijpharm.2017.07.052
http://www.sciencedirect.com/science/article/pii/S0378517317306609

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