Tanaka Ryoma, Takahashi Naoyuki, Nakamura Yasuaki, Hattori Yusuke, Ashizawa Kazuhide, Otsuka Makoto
Research Institute of Pharmaceutical Sciences, Faculty of Pharmacy, Musashino University.
Anal Sci. 2017;33(1):41-46. doi: 10.2116/analsci.33.41.
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.
共振声学混合（RAM）技术是一种通过控制加速度和频率进行振动来实现高速混合的系统。近年来，实时过程监测和预测越来越受到关注，过程分析技术（PAT）系统将越来越多地引入实际制造过程。本研究考察了将PAT与RAM、近红外光谱和化学计量技术相结合的应用，将其作为一套PAT工具引入实际的药物粉末混合过程。含量均匀性基于为管理RAM配置参数和组分浓度变化而构建的稳健偏最小二乘回归（PLSR）模型。结果表明，利用化学计量技术对活性药物成分和其他添加剂进行在线实时预测，实时监测是可行的，并且可以成功实现。该系统有望应用于RAM方法进行质量风险管理。
