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Open AccessArticle

Raw Material Variability and Its Impact on the Online Adaptive Control of Cohesive Powder Blend Homogeneity Using NIR Spectroscopy

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Research Center of Traditional Chinese Medicine Information Engineering, School of Chinese Materia Medica, Beijing University of Chinese Medicine, Beijing 10029, China
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Beijing Key Laboratory for Production Process Control and Quality Evaluation of Traditional Chinese Medicine, Beijing 100029, China
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Beijing Tcmages Pharmaceutical Co., Ltd., Beijing 101301, China
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Authors to whom correspondence should be addressed.
Processes 2019, 7(9), 568; https://doi.org/10.3390/pr7090568
Received: 24 July 2019 / Revised: 19 August 2019 / Accepted: 23 August 2019 / Published: 28 August 2019
(This article belongs to the Section Materials Processes)
It is significant to analyze the blend homogeneity of cohesive powders during pharmaceutical manufacturing in order to provide the exact content of the active pharmaceutical ingredient (API) for each individual dose unit. In this paper, an online monitoring platform using an MEMS near infrared (NIR) sensor was designed to control the bin blending process of cohesive powders. The state of blend homogeneity was detected by an adaptive algorithm, which was calibration free. The online control procedures and algorithm’s parameters were fine-tuned through six pilot experiments and were successfully transferred to the industrial production. The reliability of homogeneity detection results was validated by 16 commercial scale experiments using 16 kinds of natural product powders (NPPs), respectively. Furthermore, 19 physical quality attributes of all NPPs and the excipient were fully characterized. The blending end time was used to denote the degree of difficulty of blending. The empirical relationships between variability of NPPs and the blending end time were captured by latent variable modeling. The critical material attributes (CMAs) affecting the blending process were identified as the particle shape and flowability descriptors of cohesive powders. Under the framework of quality by design (QbD) and process analytical technology (PAT), the online NIR spectroscopy together with the powder characterization facilitated a deeper understanding of the mixing process. View Full-Text
Keywords: near-infrared sensor; blend homogeneity; cohesive powder; adaptive modeling algorithm; raw material variability; quality by design near-infrared sensor; blend homogeneity; cohesive powder; adaptive modeling algorithm; raw material variability; quality by design
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MDPI and ACS Style

Shi, G.; Xu, B.; Zhang, Z.; Yang, C.; Dai, S.; Lin, Z.; Shi, X.; Fu, J.; Qiao, Y. Raw Material Variability and Its Impact on the Online Adaptive Control of Cohesive Powder Blend Homogeneity Using NIR Spectroscopy. Processes 2019, 7, 568.

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