Dynamic Calibration for the In-Line NIR Monitoring of Film Thickness of Pharmaceutical Tablets Processed in a Fluid-Bed Coater
- Dynamic Calibration for the In-Line NIR Monitoring of Film Thickness of Pharmaceutical Tablets Processed in a Fluid-Bed Coater
- 이민정; 박초롱; 김아영; 권병수; 방규호; 조영상; 정명영; 최광진
- Fluid-Bed; Near-Infrared Spectroscopy; coating; automation; principal component analysis; processing; tableting
- Issue Date
- Journal of pharmaceutical sciences : a publication of the American Pharmaceutical Association
- VOL 99, NO 1, 325-335
- NIR spectroscopy has been extensively employed for the in-line monitoring
of pharmaceutical processes as one of the key PAT implementation tools. Nevertheless,
pharmaceutical processes such as fluid-bed coating have not fully made the most of the
NIR in-line monitoring primarily due to a difficulty in handling random in-line spectra.
In this study, novel approaches to develop a reasonable dynamic calibration model were
proposed; averaging and clustering. Pharmaceutical test tablets were coated with
HPMC-based materials using a fluid-bed processor. During the 160 min coating process
under tangential spraying mode, 10 tablets were sampled out at every 10 min mark for
actual coating thickness measurements. NIR spectra at and near each 10 min mark
were treated and processed by the averaging and clustering operations. Averaging of
21 spectra resulted in a reasonably good dynamic calibration model whose determination
coefficient was estimated as high as 0.9916. The PCA-based clustering turned out to
be substantially helpful especially when a large number of NIR spectra were averaged. A
prediction experiment verified that our dynamic calibration model can control the
coating thickness in-line as good as 3% deviated from the actual thickness, which
can offer a reasonable end-point for the fluid-bed coating process.
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