Наноразмерные лекарственные средства: особенности оценки безопасности

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.

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