A novel multivariate approach using science-based calibration for direct coating thickness determination in real-time NIR process monitoring

• Verfasst von: Möltgen, Carolin-Verena [VerfasserIn]
• Verfasst von: Herdling, Thorsten [VerfasserIn]
• Verfasst von: Reich, Gabriele [VerfasserIn]
• Titel: A novel multivariate approach using science-based calibration for direct coating thickness determination in real-time NIR process monitoring
• Verf.angabe: C.-V. Möltgen, T. Herdling, G. Reich
• E-Jahr: 2013
• Jahr: 19 September 2013
• Umfang: 8 S.
• Teil: volume:85
• Teil: year:2013
• Teil: number:3, Part B
• Teil: pages:1056-1063
• Teil: extent:8
• Fussnoten: Gesehen am 01.06.2021
• Titel Quelle: Enthalten in: European journal of pharmaceutics and biopharmaceutics
• Ort Quelle: New York, NY [u.a.] : Elsevier, 1997
• Jahr Quelle: 2013
• Band/Heft Quelle: 85(2013), 3, Part B, Seite 1056-1063
• ISSN Quelle: 1873-3441
• DOI: doi:10.1016/j.ejpb.2013.09.011
• Datenträger: Online-Ressource
• Sprache: eng
• Sach-SW: Coating process
• Sach-SW: Direct coating thickness
• Sach-SW: Matched filter
• Sach-SW: NIRS
• Sach-SW: PAT
• Sach-SW: Science-based calibration (SBC)
• Sach-SW: Thin film
• Sach-SW: Wiener filter
• K10plus-PPN: 1758930853

Abstract

This study demonstrates an approach, using science-based calibration (SBC), for direct coating thickness determination on heart-shaped tablets in real-time. Near-Infrared (NIR) spectra were collected during four full industrial pan coating operations. The tablets were coated with a thin hydroxypropyl methylcellulose (HPMC) film up to a film thickness of 28μm. The application of SBC permits the calibration of the NIR spectral data without using costly determined reference values. This is due to the fact that SBC combines classical methods to estimate the coating signal and statistical methods for the noise estimation. The approach enabled the use of NIR for the measurement of the film thickness increase from around 8 to 28μm of four independent batches in real-time. The developed model provided a spectroscopic limit of detection for the coating thickness of 0.64±0.03μm root-mean square (RMS). In the commonly used statistical methods for calibration, such as Partial Least Squares (PLS), sufficiently varying reference values are needed for calibration. For thin non-functional coatings this is a challenge because the quality of the model depends on the accuracy of the selected calibration standards. The obvious and simple approach of SBC eliminates many of the problems associated with the conventional statistical methods and offers an alternative for multivariate calibration.