Monitoring the film coating unit operation and predicting drug dissolution using terahertz pulsed imaging
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Monitoring the film coating unit operation and predicting drug dissolution using terahertz pulsed imaging. / Ho, Louise; Müller, Ronny; Gordon, Keith C; Kleinebudde, Peter; Pepper, Michael; Rades, Thomas; Shen, Yaochun; Taday, Philip F; Zeitler, J Axel.
I: Al Azhar Journal of Pharmaceutical Sciences, Bind 98, Nr. 12, 2009, s. 4866-76.Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › fagfællebedømt
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TY - JOUR
T1 - Monitoring the film coating unit operation and predicting drug dissolution using terahertz pulsed imaging
AU - Ho, Louise
AU - Müller, Ronny
AU - Gordon, Keith C
AU - Kleinebudde, Peter
AU - Pepper, Michael
AU - Rades, Thomas
AU - Shen, Yaochun
AU - Taday, Philip F
AU - Zeitler, J Axel
N1 - 2009 Wiley-Liss, Inc. and the American Pharmacists Association
PY - 2009
Y1 - 2009
N2 - Understanding the coating unit operation is imperative to improve product quality and reduce output risks for coated solid dosage forms. Three batches of sustained-release tablets coated with the same process parameters (pan speed, spray rate, etc.) were subjected to terahertz pulsed imaging (TPI) analysis followed by dissolution testing. Mean dissolution times (MDT) from conventional dissolution testing were correlated with terahertz waveforms, which yielded a multivariate, partial least squares regression (PLS) model with an R(2) of 0.92 for the calibration set and 0.91 for the validation set. This two-component, PLS model was built from batch I that was coated in the same environmental conditions (air temperature, humidity, etc.) to that of batch II but at different environmental conditions from batch III. The MDTs of batch II was predicted in a nondestructive manner with the developed PLS model and the accuracy of the predicted values were subsequently validated with conventional dissolution testing and found to be in good agreement. The terahertz PLS model was also shown to be sensitive to changes in the coating conditions, successfully identifying the larger coating variability in batch III. In this study, we demonstrated that TPI in conjunction with PLS analysis could be employed to assist with film coating process understanding and provide predictions on drug dissolution.
AB - Understanding the coating unit operation is imperative to improve product quality and reduce output risks for coated solid dosage forms. Three batches of sustained-release tablets coated with the same process parameters (pan speed, spray rate, etc.) were subjected to terahertz pulsed imaging (TPI) analysis followed by dissolution testing. Mean dissolution times (MDT) from conventional dissolution testing were correlated with terahertz waveforms, which yielded a multivariate, partial least squares regression (PLS) model with an R(2) of 0.92 for the calibration set and 0.91 for the validation set. This two-component, PLS model was built from batch I that was coated in the same environmental conditions (air temperature, humidity, etc.) to that of batch II but at different environmental conditions from batch III. The MDTs of batch II was predicted in a nondestructive manner with the developed PLS model and the accuracy of the predicted values were subsequently validated with conventional dissolution testing and found to be in good agreement. The terahertz PLS model was also shown to be sensitive to changes in the coating conditions, successfully identifying the larger coating variability in batch III. In this study, we demonstrated that TPI in conjunction with PLS analysis could be employed to assist with film coating process understanding and provide predictions on drug dissolution.
U2 - 10.1002/jps.21766
DO - 10.1002/jps.21766
M3 - Journal article
C2 - 19367620
VL - 98
SP - 4866
EP - 4876
JO - Al Azhar Journal of Pharmaceutical Sciences
JF - Al Azhar Journal of Pharmaceutical Sciences
SN - 1110-1644
IS - 12
ER -
ID: 40353178