Sasakura D, Nakayama K, Chikuma T
Pharmazie. 2015 Oct;70(10):636-9.
Process analytical technology is important for the analysis and control of manufacturing processes. Near-infrared spectroscopy is widely used in various process analytical technologies for the analysis of the chemical componentsof solid dosage forms. Lubrication is an important process carried out before a tablet is produced. In this process, the concentration of lubricant, such as magnesium stearate (StMg), might change for one of many reasons during powder transport, which would be a critical problem such as variation in tablet compressibility and dissolution failure of compressed tablets. Our group investigated the feasibility of the quantitative monitoring of a change in the concentration of StMg in the feeder tube of tableting equipment employing real-time near-infrared spectroscopy.
过程分析技术对于制造过程的分析和控制至关重要。近红外光谱在各种过程分析技术中被广泛用于分析固体剂型的化学成分。润滑是片剂生产前进行的一个重要过程。在此过程中,润滑剂(如硬脂酸镁(StMg))的浓度在粉末输送过程中可能因多种原因之一而发生变化,这将是一个关键问题,例如片剂可压性的变化和压制片剂的溶出失败。我们的团队研究了采用实时近红外光谱对压片设备进料管中StMg浓度变化进行定量监测的可行性。