Approaches to quality control of drug carriers (review)
https://doi.org/10.33380/2305-2066-2025-14-3-2075
Abstract
Introduction. The development of nanotechnology has led to the creation of complex drug delivery systems: liposomes, dendrimers, inorganic nanoparticles, cellular systems, and polymer nanoparticles. All these systems require an integrated approach to quality control. This review examines the key attributes of quality control, including physico-chemical and chemical analysis methods, as well as current regulatory requirements.
Text. Drug delivery systems represent promising technologies aimed at improving the safety and effectiveness of pharmacotherapy. The variety of components and complexity of the structure create a number of difficulties in developing approaches to quality control of new media. Existing physical and physico-chemical analysis methods are actively used to determine the morphological characteristics of carriers, the physical characteristics of their membrane, and to confirm the structure of substrates and the final particle. However, the lack of a number of standardized approaches, in particular, for determining the zeta potential of a particle membrane, remains a serious challenge for a number of researchers and regulatory authorities.
Conclusion. This review provides a systematic description of the approaches to quality control of delivery systems and their components that currently exist. The variety of media analysis methods makes it possible to fully assess the quality of media, but in the future it is necessary to harmonize existing international standards with Russian standards, which minimizes the risks associated with the use of media in the targeted delivery of medicines.
About the Authors
U. A. Efremova
Saint-Petersburg State Chemical and Pharmaceutical University
Russian Federation
Russian Federation
14A, Prof. Popova str., Saint-Petersburg, 197022
P. A. Chugunova
Saint-Petersburg State Chemical and Pharmaceutical University
Russian Federation
Russian Federation
14A, Prof. Popova str., Saint-Petersburg, 197022
E. S. Ponikarovskaya
Saint-Petersburg State Chemical and Pharmaceutical University
Russian Federation
Russian Federation
14A, Prof. Popova str., Saint-Petersburg, 197022
I. I. Terninko
Saint-Petersburg State Chemical and Pharmaceutical University
Russian Federation
Russian Federation
14A, Prof. Popova str., Saint-Petersburg, 197022
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Efremova U.A., Chugunova P.A., Ponikarovskaya E.S., Terninko I.I. Approaches to quality control of drug carriers (review). Drug development & registration. (In Russ.) https://doi.org/10.33380/2305-2066-2025-14-3-2075
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