Research progress of on-line monitoring technology for drug powder blending process / 中国药学杂志

ABSTRACT

Blending process is one of the key links of the pharmaceutical process, since the uniformity of drug products not only affects the appearance but also influences homogeneity and stability of the intrinsic quality, and then affects the efficacy of the products. Therefore, to ensure the safety and effectiveness of drugs, it is necessary to analyze and control the uniformity of the drug powder in the process of blending. Compared with the traditional method for the end point determination of the blending process, online monitoring technology has obvious advantages and broad application prospects. This paper summarized the research progress of online monitoring technologies for blending process in the pharmaceutical industry. Firstly, four kinds of online monitoring technologies were introduced and compared, which were the near infrared spectroscopy, thermal sensing technology, Raman spectroscopy and chemical imaging technology. Then the methods and principles of on-line monitoring algorithms were summarized and expounded. After that, a brief introduction of the application of near infrared monitoring equipment for pharmaceutical blending process was given. And then the research progress of the online monitoring of the blending process in the domestic pharmaceutical industry was summarized. Finally, the development trend of online monitoring technology of blending process was looked into the future.