Terahertz pulsed imaging as an analytical tool for sustained-release tablet film coating.
The ability of terahertz pulsed imaging (TPI) to be employed as an analytical tool for monitoring a film coating unit operation and to assess the success of a subsequent process scale-up was explored in this study. As part of a process scale-up development, a total of 190 sustained-release tablets were sampled at 10% increments of the amount of polymer applied, from a lab-scale and a pilot-scale coating run. These tablets were subjected to TPI analysis, followed by dissolution testing. Information on tablet film coating layer thickness and variations in coating density were extracted using TPI. It was found that both terahertz parameters were more sensitive and informative to product quality when compared with measuring the amount of polymer applied. For monitoring the film coating unit operation, coating layer thickness showed a strong influence on the dissolution behaviour for both the lab-scale and the pilot-scale batches. An R(2) of 0.89, root mean square error (RMSE)=0.22 h (MDT range=3.21-5.48 h) and an R(2) of 0.92, RMSE=0.23 h (MDT range=5.43-8.12 h) were derived from the lab-scale and pilot-scale, respectively. The scale-up process led to significant changes in MDT between the lab-scale and pilot-scale. These changes in MDT could be explained by the differences observed in the film coating density on samples with similar amount of polymer applied between the lab and the pilot-scale. Overall, TPI demonstrated potential to be employed as an analytical tool to help refine the coating unit operation and the scale-up procedure.
Ho
Louise
L
School of Pharmacy, University of Otago, Dunedin, New Zealand. louise.ho@teraview.com
Müller
Ronny
R
Gordon
Keith C
KC
Kleinebudde
Peter
P
Pepper
Michael
M
Rades
Thomas
T
Shen
Yaochun
Y
Taday
Philip F
PF
Zeitler
J Axel
JA
D002626:Chemistry, Pharmaceutical / Q000379:methods; D003692:Delayed-Action Preparations; D005079:Excipients / Q000737:chemistry*; D004364:Pharmaceutical Preparations / Q000737:chemistry*; D010865:Pilot Projects; D011108:Polymers / Q000737:chemistry*; D012995:Solubility; D013607:Tablets; D013678:Technology, Pharmaceutical / Q000379:methods; D055069:Terahertz Imaging / Q000379:methods*
D003692:Delayed-Action Preparations; D005079:Excipients; D004364:Pharmaceutical Preparations; D011108:Polymers; D013607:Tablets