Prediction of tablet film-coating thickness using a rotating plate coating system and NIR spectroscopy.
The purpose of this research was to create a calibration model based on near-infrared (NIR) spectroscopy data obtained during a small-scale coating process to predict in-line the coating layer thickness of tablets coated in a side-vented drum coater. The developed setup for the small-scale coating process consisted of a rotating plate with 20 tablets molds that pass a spraying unit, a heating unit, and an in-line NIR spectroscopy probe during one rotation. High-density polyethylene (HDPE) was compressed to flat-faced tablets, and these were coated with a sustained release coating suspension containing Kollicoat IR and Kollicoat SR 30D. The film thickness of these tablets was determined for each tablet individually with a digital micrometer. A calibration model of predicted film thickness versus real-film thickness using PLS regression was developed. This model was tested against in-line NIR data obtained from a coating drum process, in which biconvex HDPE tablets were film-coated with the same film-coating suspension. The model predicted a final coating thickness of 240 mum, while the measured average thickness (n = 100 tablets) was 210 mum. Taking into account the use of a different setup and differently shaped tablets, it was possible to predict the coating thickness with accuracy comparable to the one of the digital micrometer. Thus, the small-scale rotating plate system was found to be an efficient means of preparing calibration model for a tablet-coating drum process.
Division of Pharmaceutical Technology, Faculty of Pharmacy, University of Helsinki, P.O. Box 56, Helsinki 00014, Finland. meike.romer@helsinki.fi
Meike
M
Römer
Jyrki
J
Heinämäki
Clare
C
Strachan
Niklas
N
Sandler
Jouko
J
Yliruusi
D002626:Chemistry, Pharmaceutical; D015999:Multivariate Analysis; D019265:Spectroscopy, Near-Infrared / Q000379:methods*; D013607:Tablets
D013607:Tablets