期刊
INTERNATIONAL JOURNAL OF PHARMACEUTICS
卷 565, 期 -, 页码 419-436出版社
ELSEVIER SCIENCE BV
DOI: 10.1016/j.ijpharm.2019.05.022
关键词
Bilayer tablets; RTRT; NIR; HPLC; PCA; PLS
资金
- Korea Health Technology R&D Project through the Korea Health Industry Development Institute (KHIDI) - Ministry of Health & Welfare, Republic of Korea [HI16C1254]
This study describes how near infrared (NIR) spectroscopy can be used to predict the dissolution of bilayer tablets as a non-destructive approach. Tablets in this study consist of two active pharmaceutical ingredients (APIs) physically separated in layers and manufactured under three levels of hardness. NIR spectra were individually acquired for both layers in diffuse reflectance mode. Reference dissolution profile values were obtained using dissolution apparatus & HPLC. A multivariate partial least squares (PLS) calibration model was developed for each API relating its dissolution profile to spectral data. This calibration model was used to predict dissolution profiles of an independent test set and results of the prediction were compared using model free approaches i.e. dissimilarity (f(1)) & similarity (f(2)) factors to assure similarity in dissolution performance.
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