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首页> 外文期刊>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
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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

机译：通过近红外光谱结合化学计量技术在线实时监测共振声混合，在制药粉末共混系统中进行过程分析技术应用

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摘要

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.
机译：共振声？混合（RAM）技术是一种通过控制加速度和频率通过振动进行高速混合的系统。近年来，实时过程监视和预测已引起越来越多的关注，并且过程分析技术（PAT）系统将越来越多地引入到实际制造过程中。这项研究检查了结合RAM，近红外光谱和化学计量技术作为一组PAT工具引入实际药物粉末混合工艺中的PAT的应用。内容均一性基于健壮的偏最小二乘回归（PLSR）模型，该模型构建用于管理RAM配置参数和不断变化的成分浓度。结果，实时监测是可能的，并且可以成功地证明使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。该系统有望适用于RAM方法进行质量风险管理。

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