safetyriskБезопасность и риск фармакотерапииSafety and Risk of Pharmacotherapy2312-78212619-1164Federal State Budgetary Institution ‘Scientific Centre for Expert Evaluation of Medicinal Products’ of the Ministry of Health of the Russian Federation (FSBI ‘SCEEMP’)10.30895/2312-7821-2019-7-3-127-138safetyrisk-141Research ArticleОБЗОРЫREVIEWSНаноразмерные лекарственные средства: особенности оценки безопасностиNanoscale Therapeutic System: Safety Assessment Featureshttps://orcid.org/0000-0002-1803-7691БовинаЕ. М.BovinaE. M.

Бовина Евгения Михайловна

Петровский бульвар, д. 8, стр. 2, Москва, 127051, Российская Федерация

 

Evgenia M. Bovina

8/2 Petrovsky Blvd, Moscow 127051, Russian Federation

 

bovinaem@expmed.ruhttps://orcid.org/0000-0001-5429-9528РомановБ. К.RomanovB. K.

Романов Борис Константинович, доктор медицинских наук, доцент

Петровский бульвар, д. 8, стр. 2, Москва, 127051, Российская Федерация

Boris K. Romanov, Dr. Sci. (Med.), Associate Professor

8/2 Petrovsky Blvd, Moscow 127051, Russian Federation

romanov@expmed.ruhttps://orcid.org/0000-0003-2665-796XКазаковА. С.KazakovA. S.

Казаков Александр Сергеевич, кандидат медицинских наук

Петровский бульвар, д. 8, стр. 2, Москва, 127051, Российская Федерация

ул. Миклухо-Маклая, д. 6, Москва, 117198, Российская Федерация

Alexander S. Kazakov, Cand. Sci. (Med.)

8/2 Petrovsky Blvd, Moscow 127051, Russian Federation

6 Miklukho-Maklaya St., Moscow 117198, Russian Federation

kazakovas@expmed.ruhttps://orcid.org/0000-0002-9514-6322ВельцН. Ю.VeltsN. Yu.

Вельц Наталья Юрьевна, кандидат биологических наук, доцент

Петровский бульвар, д. 8, стр. 2, Москва, 127051, Российская Федерация

Nataliya Y. Velts, Cand. Sci. (Biol.), Associate Professor

8/2 Petrovsky Blvd, Moscow 127051, Russian Federation

velts@expmed.ruhttps://orcid.org/0000-0002-5165-3808ЖуравлеваЕ. О.ZhuravlevaE. O.

Журавлева Евгения Олеговна

Петровский бульвар, д. 8, стр. 2, Москва, 127051, Российская Федерация

Eugeniya O. Zhuravleva

8/2 Petrovsky Blvd, Moscow 127051, Russian Federation

Gyravleva@expmed.ruhttps://orcid.org/0000-0002-7597-2926БукатинаТ. М.BukatinaT. M.

Букатина Татьяна Михайловна, кандидат медицинских наук

Петровский бульвар, д. 8, стр. 2, Москва, 127051, Российская Федерация

Tatyana M. Bukatina, Cand. Sci. (Med.)

8/2 Petrovsky Blvd, Moscow 127051, Russian Federation

bukatina@expmed.ruhttps://orcid.org/0000-0002-4647-977XАляутдинР. Н.AlyautdinR. N.

Аляутдин Ренад Николаевич, доктор медициских наук, профессор

Петровский бульвар, д. 8, стр. 2, Москва, 127051, Российская Федерация

Renad N. Alyautdin, Dr. Sci. (Med.), Professor

8/2 Petrovsky Blvd, Moscow 127051, Russian Federation

Alyautdin@expmed.ruhttps://orcid.org/0000-0003-4891-973XМеркуловВ. А.MerkulovV. A.

Меркулов Вадим Анатольевич, доктор медицинских наук, профессор

Петровский бульвар, д. 8, стр. 2, Москва, 127051, Российская Федерация

Vadim A. Merkulov, Dr. Sci. (Med.), Professor

8/2 Petrovsky Blvd, Moscow 127051, Russian Federation

merkulov@expmed.ruФедеральное государственное бюджетное учреждение «Научный центр экспертизы средств медицинского применения» Министерства здравоохранения Российской ФедерацииРоссияScientific Centre for Expert Evaluation of Medicinal ProductsRussian FederationФедеральное государственное бюджетное учреждение «Научный центр экспертизы средств медицинского применения» Министерства здравоохранения Российской Федерации, Федеральное государственное автономное образовательное учреждение высшего образования «Российский университет дружбы народов»РоссияScientific Centre for Expert Evaluation of Medicinal Products, Peoples' Friendship University of RussiaRussian Federation20190808201973127138Copyright © Бовина Е.М., Романов Б.К., Казаков А.С., Вельц Н.Ю., Журавлева Е.О., Букатина Т.М., Аляутдин Р.Н., Меркулов В.А., 20192019Бовина Е.М., Романов Б.К., Казаков А.С., Вельц Н.Ю., Журавлева Е.О., Букатина Т.М., Аляутдин Р.Н., Меркулов В.А.Bovina E.M., Romanov B.K., Kazakov A.S., Velts N.Y., Zhuravleva E.O., Bukatina T.M., Alyautdin R.N., Merkulov V.A.Данная работа распространяется под лицензией Creative Commons Attribution 4.0.This work is licensed under a Creative Commons Attribution 4.0 License.https://www.risksafety.ru/jour/article/view/141

Наноразмерные лекарственные средства отличаются особыми физико-химическими, биологическими, фармакокинетическими параметрами. Эти свойства могут использоваться для обеспечения адресной доставки препаратов, пролонгирования их эффекта и уменьшения побочного действия. Важной задачей, требующей внимания, остается изучение потенциальных рисков, возникающих при терапии такими препаратами. Цель работы: анализ требований отечественных и зарубежных регуляторных органов, предъявляемых к безопасности наноразмерных лекарственных средств. В работе представлена классификация наиболее перспективных наносистем, содержащих лекарственные средства, и проведен анализ существующих подходов к оценке безопасности наноразмерных лекарственных средств в России и за рубежом. Показано, что при оценке безопасности наряду со свойствами активной субстанции необходимо учитывать особенности наносистемы (полимерного покрытия, носителя и т.д.), связанные с ее размерами, характером распределения в организме, зарядом наночастиц, способностью к индукции окислительного стресса. Проанализированы отечественные и зарубежные нормативные документы, регламентирующие процедуру оценки безопасности наноразмерных лекарственных средств. Выводы: несмотря на наличие рекомендаций регуляторных органов, необходимо дальнейшее совершенствование требований к регистрации и оценке безопасности наноразмерных лекарственных средств. Необходимо расширение нормативной базы, регламентирующей разработку, контроль качества, эффективности и безопасности применения в медицине наноматериалов с учетом структурных особенностей активной субстанции и наноносителей.

Nanoscale drugs differ in special physicochemical, biological, pharmacokinetic parameters. These properties can be used to provide targeted delivery, prolong the action of drugs, as well as reduce their side effects. An important problem that needs attention is the study of the potential risks arising from the treatment of such drugs. The aim of the study: analysis of the requirements of domestic and foreign regulators for the safety of nanoscale drugs. The paper presents the classification of the most promising nanosystems containing drugs, and an analysis of the existing principles for assessing their safety in Russia and abroad has been carried out. It was shown that when assessing the safety of nano-sized drugs, along with the properties of the active substance, it is necessary to take into account the properties of the nanosystem (polymer coating, carrier, etc.), related to its size, distribution pattern, charge of nanoparticles, and ability to induce oxidative stress. Domestic and foreign regulatory documents governing the procedure for assessing the safety of pharmacological substances derived from nanotechnology was analyzed. Conclusions: Despite the availability of recommendations from regulatory authorities, further improvement of the requirements for registration and safety assessment of nanoscale drugs is necessary. Further development of the regulatory framework governing the development, quality, efficiency and safety of nanomaterials in medicine is necessary, taking into account the structural issues of the active substance and nano-carriers.

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The authors declare that there are no conflicts of interest present.