Evaluation and Monitoring of the API Content of a Portable Near Infrared Instrument Combined with Chemometrics Based on Fluidized Bed Mixing Process

Autor: Lanling Liu, Liang Zhong, Hengchang Zang, Hui Zhang, Ruiqi Huang, Lian Li, Haiyan Wang, Dongbo Xu, Kefan Zhang, Wenping Yin
Rok vydání: 2021
Předmět:
Zdroj: Journal of Pharmaceutical Innovation. 17:1136-1147
ISSN: 1939-8042
1872-5120
Popis: With the promulgation of industry guidelines, near infrared spectroscopy (NIRS) monitoring the uniformity of solid oral preparations has become one of the most reported studies. The purpose of the present study is to develop a near infrared (NIR) method for the in-line assessment of the active pharmaceutical ingredient (API) content in the fluidized bed mixing process, as well as to introduce a portable NIR sensor to monitor the fluidized bed production visually. A portable NIR sensor was used to monitor the content of the API in the fluidized bed mixing process. An experimental fluidized bed was performed and the corresponding NIR spectra were collected in-line. The spectrum selection method of cosine distance for in-line spectra was performed, and four wavelength optimization methods were compared to improve the accuracy of the model. Throughout the mixing process, the content uniformity of the API was a critical quality attribute (CQA). The partial least squares regression (PLSR) quantitative model of API content was established. The results showed that the cosine distance combined with the multi-variable selection methods (CC, VIP, RATC, and UVE) could obtain more useful information than the single method. The root mean square error of cross validation (RMSECV) and root mean square error of prediction (RMSEP) values of the optimal PLSR model were 1.8588% and 1.5296%, respectively. Based on the results obtained, this study could be used as a reference for the pilot of in-line monitoring of miniature NIR sensors and the connection of key process parameters to realize intelligent production of solid preparations.
Databáze: OpenAIRE
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