Prediction of dissolution time and coating thickness of sustained release formulations using Raman spectroscopy and terahertz pulsed imaging

Mean dissolution time (MDT) over coating time predicted by Raman spectroscopy (top left) and in correlation to coating thickness measured by terahertz spectroscopy (top right). Layer thickness maps and histograms from TPI measurements after a short (left) and a longer (right) coating time. Raman spe...

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Bibliographic Details
Published in:European journal of pharmaceutics and biopharmaceutics 2012-04, Vol.80 (3), p.690-697
Main Authors: Müller, Joshua, Brock, Daniela, Knop, Klaus, Axel Zeitler, J., Kleinebudde, Peter
Format: Article
Language:English
Subjects:
Biological and medical sciences
Chemistry, Pharmaceutical - methods
Delayed-Action Preparations - chemistry
Dyphylline - chemistry
Excipients - chemistry
Functional coating
General pharmacology
Mean dissolution time
Medical sciences
Multivariate data analysis
Pharmaceutical technology. Pharmaceutical industry
Pharmacology. Drug treatments
Polyvinyls - chemistry
Process analytical technology
Raman spectroscopy
Solubility
Spectrum Analysis, Raman - methods
Tablets - chemistry
Technology, Pharmaceutical - methods
Terahertz Imaging - methods
Terahertz pulsed imaging
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Summary:Mean dissolution time (MDT) over coating time predicted by Raman spectroscopy (top left) and in correlation to coating thickness measured by terahertz spectroscopy (top right). Layer thickness maps and histograms from TPI measurements after a short (left) and a longer (right) coating time. Raman spectroscopy was implemented successfully as a non-invasive and rapid process analytical technology (PAT) tool for in-line quantitative monitoring of functional coating. Coating experiments were performed at which diprophylline tablets were coated with a sustained release formulation based on Kollicoat® SR 30 D. Using PLS a multivariate model was constructed by correlating Raman spectral data with the mean dissolution time as determined by dissolution testing and the coating thickness as measured by terahertz pulsed imaging. By performing in-line measurements it was possible to monitor the progress of the coating process and to detect the end point of the process, where the acquired coating amount was achieved for the desired MDT or coating thickness.
ISSN:0939-6411
1873-3441
DOI:10.1016/j.ejpb.2011.12.003