Подходы к контролю качества носителей лекарственных средств (обзор)

Введение. Развитие нанотехнологий привело к созданию сложных систем доставки лекарственных средств: липосом, дендримеров, неорганических наночастиц, клеточных систем и полимерных наночастиц. Все эти системы требуют комплексного подхода к контролю качества. В данном обзоре рассматриваются ключевые атрибуты контроля качества, среди которых физико-химические и химические методы анализа, а также актуальные регуляторные требования.

Текст. Системы доставки лекарственных средств представляют собой перспективные технологии, направленные на повышение безопасности и эффективности фармакотерапии. Многообразие компонентов и сложность структуры создают ряд трудностей при разработке подходов к контролю качества новых носителей. Существующие физические и физико-химические методы анализа активно используются для определения морфологических характеристик носителей, физических характеристик их мембраны, подтверждения структуры субстратов и конечной частицы. Однако отсутствие ряда стандартизованных подходов, в частности для определения дзета-потенциала мембраны частиц, остается серьезным вызовом для ряда исследователей и регуляторных органов.

Заключение. В данном обзоре представлена системная характеристика подходов к контролю качества систем доставки и их компонентов, которые существуют в настоящее время. Многообразие методов анализа носителей позволяет наиболее полно оценить качество носителей, однако в дальнейшем необходима гармонизация существующих международных норм с российскими стандартами, что минимизирует риски, связанные с использованием носителей в направленной доставке лекарственных средств.

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