Analytical Sciences

In-line and Real-time Monitoring of Resonant Acoustic Mixing by Near-infrared Spectroscopy Combined with Chemometric Technology for Process Analytical Technology Applications in Pharmaceutical Powder Blending Systems

Ryoma TANAKA,* Naoyuki TAKAHASHI,** Yasuaki NAKAMURA,** Yusuke HATTORI,* Kazuhide ASHIZAWA,*** and Makoto OTSUKA*

*Research Institute of Pharmaceutical Sciences, Faculty of Pharmacy, Musashino University, 1-1-20 Shinmachi, Nishi-Tokyo, Tokyo 202-8585, Japan
**Life Science Division, Daiwa Can Co., Ltd, 2-7-2 Marunouchi, Chiyoda, Tokyo 100-0005, Japan
***SSCI Laboratory, Musashino University, 1-1-20 Shinmachi, Nishi-Tokyo, Tokyo 202-8585, Japan

Resonant acoustic^® mixing (RAM) technology is a system that performs high-speed mixing by vibration through the control of acceleration and frequency. In recent years, real-time process monitoring and prediction has become of increasing interest, and process analytical technology (PAT) systems will be increasingly introduced into actual manufacturing processes. This study examined the application of PAT with the combination of RAM, near-infrared spectroscopy, and chemometric technology as a set of PAT tools for introduction into actual pharmaceutical powder blending processes. Content uniformity was based on a robust partial least squares regression (PLSR) model constructed to manage the RAM configuration parameters and the changing concentration of the components. As a result, real-time monitoring may be possible and could be successfully demonstrated for in-line real-time prediction of active pharmaceutical ingredients and other additives using chemometric technology. This system is expected to be applicable to the RAM method for the risk management of quality.

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