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DOI: https://doi.org/10.29296/25877313-2022-06-05
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G.E. Brkich
Ph.D. (Pharm.), Head of the Center for Pharmaceutical Technologies, Institute of Translational Medicine and Biotechnology,
Federal State Autonomous Educational Institution of Higher Education I.M. Sechenov (Sechenov University)
of the Ministry of Health of the Russian Federation (Moscow, Russia)
E-mail: brkich@yandex.ru
N.V. Pyatigorskaya
Dr.Sc. (Pharm.), Professor, Deputy Director of the Institute of Translational Medicine and Biotechnology,
Head of the Department of Industrial Pharmacy,Institute of Professional Education
of the Federal State Autonomous Educational Institution of Higher Education I.M. Sechenov (Sechenov University)
of the Ministry of Health of the Russian Federation (Moscow, Russia)

The required quality of the medicinal product is ensured by a strategy for controlling the critical characteristics of starting materials and critical process parameters. In industrial pharmacy, the decisive factor for the choice of the composition and technology for the preparation of the drug under development is the determination of the particle size of the components, in order to develop the grinding process and determine the control strategy associated with the starting materials, the pharmaceutical substance and the drug, the process conditions and the equipment used. Despite the development of new technologies, as well as significant improvements in existing methods, particle size reduction by grinding remains essentially an empirical science requiring knowledge management to better understand it in order to meet new regulatory requirements. Aim. To analyze modern publications and information and analytical materials on the technological process of grinding in industrial pharmacy in order to use them in the work of the Center for Pharmaceutical Technologies to develop the composition and technology for the production of drugs and biologically active additives. The object of research is the technology of grinding. For the preparation of materials, information resources (publications, scientific publications, information and reference materials) were used. From the point of view of process control, modeling of solid particle grinding processes is applied, based on known physical laws. Grinding is necessary not only to achieve a greater therapeutic effect, but also for more accurate dosing: when grinding, the particle size of medicinal substances is leveled, after which they mix well and do not delaminate during dosing. Despite its widespread use, grinding is one of the least understood processes due to the complexity of the materials used and the technological pa-rameters associated with grinding. Prior knowledge of the process is required to develop valid models that take into account the properties of the material and the grinding method. However, the applicability of known models is limited due to the inherent complexity of the grinding process. Traditional experimental methods are limited in providing a mechanistic model of the influence of particle properties and operating parameters on the grinding process. Therefore, there is a need to develop consistent methods or models to quantify and predict this process, which will facilitate the development of predictive tools and knowledge transfer.

quality control strategy
industrial pharmacy.

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