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Title: In-line NIR spectroscopy for the understanding of polymer-drug interaction during pharmaceutical hot-melt extrusion
Authors: Saerens, Lien
Dierickx, Lien
Quinten, Thomas
CARLEER, Robert 
Vervaet, Chris
Remon, Jean Paul
De Beer, Thomas
Issue Date: 2012
Abstract: The aim was to evaluate near-infrared spectroscopy for the in-line determination of the drug concentration, the polymer-drug solid-state behaviour and molecular interactions during hot-melt extrusion. Kollidon (R) SR was extruded with varying metoprolol tartrate (MPT) concentrations (20%, 30% and 40%) and monitored using NIR spectroscopy. A PLS model allowed drug concentration determination. The correlation between predicted and real MPT concentrations was good (R-2 = 0.97). The predictive performance of the model was evaluated by the root mean square error of prediction, which was 1.54%. Kollidon (R) SR with 40% MPT was extruded at 105 degrees C and 135 degrees C to evaluate NIR spectroscopy for in-line polymer-drug solid-state characterisation. NIR spectra indicated the presence of amorphous MPT and hydrogen bonds between drug and polymer in the extrudates. More amorphous MPT and interactions could be found in the extrudates produced at 135 degrees C than at 105 degrees C. Raman spectroscopy, DSC and ATR FT-IR were used to confirm the NIR observations. Due to the instability of the formulation, only in-line Raman spectroscopy was an adequate confirmation tool. NIR spectroscopy is a potential PAT-tool for the in-line determination of API concentration and for the polymer-drug solid-state behaviour monitoring during pharmaceutical hot-melt extrusion. (C) 2012 Elsevier B.V. All rights reserved.
Notes: [Saerens, Lien; De Beer, Thomas] Univ Ghent, Lab Pharmaceut Proc Analyt Technol, B-9000 Ghent, Belgium. [Dierickx, Lien; Quinten, Thomas; Vervaet, Chris; Remon, Jean Paul] Univ Ghent, Lab Pharmaceut Technol, B-9000 Ghent, Belgium. [Adriaensens, Peter; Carleer, Robert] Hasselt Univ, Diepenbeek, Belgium.
Keywords: NIR spectroscopy; Hot-melt extrusion (HME); Process Analytical Technology (PAT); In-line monitoring; Continuous production;Pharmacology & Pharmacy; NIR spectroscopy; Hot-melt extrusion(HME); Process Analytical Technology(PAT); In-line monitoring; Continuous production
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ISSN: 0939-6411
e-ISSN: 1873-3441
DOI: 10.1016/j.ejpb.2012.01.001
ISI #: 000304730700027
Category: A1
Type: Journal Contribution
Validations: ecoom 2013
Appears in Collections:Research publications

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