vedomostiregmedРегуляторные исследования и экспертиза лекарственных средствRegulatory Research and Medicine Evaluation3034-30623034-3453Federal State Budgetary Institution ‘Scientific Centre for Expert Evaluation of Medicinal Products’ of the Ministry of Health of the Russian Federation (FSBI ‘SCEEMP’)10.30895/1991-2919-2023-508vedomostiregmed-508Research ArticleЛИПИДНЫЕ НАНОСТРУКТУРЫNANOSYSTEMS FOR DRUG DELIVERYЛипосомы как носители лекарственных средств: классификация, методы получения и применениеLiposomes as Drug Carriers: Classification, Preparation Methods, and Medicinal Usehttps://orcid.org/0000-0003-0662-495XБурдаевН. И.BurdaevN. I.

Бурдаев Николай Игоревич

Петровский б-р, д. 8, стр. 2, Москва, 127051

Nilolay I. Burdaev

8/2 Petrovsky Blvd, Moscow 127051

burd.mobile@gmail.comhttps://orcid.org/0000-0001-8003-8241НиколаеваЛ. Л.NikolaevaL. L.

Николаева Людмила Леонидовна, канд. фарм. наук

Каширское ш., д. 24, Москва, 115522;Трубецкая ул., д. 8, стр. 2, Москва, 119991

Ludmila L. Nikolaeva, Cand. Sci. (Pharm.)

24 Kashirskoe Hwy, Moscow 115522;8/2 Trubetskaya St., Moscow 119991

alima91@yandex.ruhttps://orcid.org/0000-0001-8353-7863КосенкоВ. В.KosenkoV. V.

Косенко Валентина Владимировна, канд. фарм. наук

Петровский б-р, д. 8, стр. 2, Москва, 127051

Valentina V. Kosenko, Cand. Sci. (Pharm.)

8/2 Petrovsky Blvd, Moscow 127051

General@expmed.ruhttps://orcid.org/0000-0003-3034-750XШпрахЗ. С.ShprakhZ. S.

Шпрах Зоя Сергеевна, д-р фарм. наук

Каширское ш., д. 24, Москва, 115522;Трубецкая ул., д. 8, стр. 2, Москва, 119991

Zoya S. Shprakh, Dr. Sci. (Pharm.)

24 Kashirskoe Hwy, Moscow 115522;8/2 Trubetskaya St., Moscow 119991

z.shprakh@ronc.ruhttps://orcid.org/0000-0003-0936-5551БунятянН. Д.BunyatyanN. D.

Бунятян Наталья Дмитриевна, д-р фарм. наук, профессор

Петровский б-р, д. 8, стр. 2, Москва, 127051;Трубецкая ул., д. 8, стр. 2, Москва, 119991

Natalia D. Bunyatyan, Dr. Sci. (Pharm.), Professor

8/2 Petrovsky Blvd, Moscow 127051;8/2 Trubetskaya St., Moscow 119991

ndbun@mail.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 «Национальный медицинский исследовательский центр онкологии им. Н.Н. Блохина» Министерства здравоохранения Российской Федерации; Федеральное государственное автономное образовательное учреждение высшего образования «Первый Московский государственный медицинский университет им. И.М. Сеченова» Министерства здравоохранения Российской Федерации (Сеченовский Университет)РоссияN.N. Blokhin National Medical Research Centre of Oncology; I.M. Sechenov First Moscow State Medical University (Sechenov University)Russian FederationФедеральное государственное бюджетное учреждение «Научный центр экспертизы средств медицинского применения» Министерства здравоохранения Российской Федерации; Федеральное государственное автономное образовательное учреждение высшего образования «Первый Московский государственный медицинский университет им. И.М. Сеченова» Министерства здравоохранения Российской Федерации (Сеченовский Университет)РоссияScientific Centre for Expert Evaluation of Medicinal Products; I.M. Sechenov First Moscow State Medical University (Sechenov University)Russian Federation202318052023132-1316332Copyright © Бурдаев Н.И., Николаева Л.Л., Косенко В.В., Шпрах З.С., Бунятян Н.Д., 20232023Бурдаев Н.И., Николаева Л.Л., Косенко В.В., Шпрах З.С., Бунятян Н.Д.Burdaev N.I., Nikolaeva L.L., Kosenko V.V., Shprakh Z.S., Bunyatyan N.D.Данная работа распространяется под лицензией Creative Commons Attribution 4.0.This work is licensed under a Creative Commons Attribution 4.0 License.https://www.vedomostincesmp.ru/jour/article/view/508

Липосомы — одна из наиболее известных и перспективных наноразмерных систем доставки лекарственных средств. Липосомальные лекарственные средства успешно применяются в клинической практике для лечения сердечно-сосудистых, онкологических, дерматологических и ряда других заболеваний. Разработка и широкое внедрение липосом в клиническую практику являются актуальными задачами.

Цель работы: обобщение и анализ научных данных о структуре липосом, их составе, классификации, особенностях методов получения.

Приведена актуальная информация о коммерческих липосомальных лекарственных препаратах (ЛЛП). Показана взаимосвязь состава, структуры и способов получения липосом, важными характеристиками которых являются размер и ламеллярность, определяющие эффективность инкапсуляции лекарственного средства и его биораспределение. Выбор вспомогательных веществ проводится в зависимости от области применения липосомального препарата. Обобщены основные методы получения липосом, особенности их использования, преимущества и недостатки. Показано, что традиционные методы получения липосом просты в исполнении и не требуют использования сложного оборудования, основными недостатками традиционных методов являются низкая эффективность инкапсуляции лекарственных средств и сложность масштабирования технологических процессов. Особое внимание уделено микрофлюидным технологиям получения липосом, которые характеризуются высокой степенью контроля технологического процесса (распределения липосом по размерам и ламеллярности), высокой воспроизводимостью, возможностью масштабирования на уровень промышленного производства и могут использоваться для инкапсуляции лекарственных средств различной природы.

Liposomes are one of the most well-known and promising nanoscale drug delivery systems. Liposomal medicinal products are successfully used in clinical practice for cardiovascular, oncological, dermatological, and other indications. The development of liposomes and their widespread implementation in clinical practice are relevant tasks.

The aim of the study was to summarise and analyse scientific data regarding the structure, composition, and classification of liposomes, as well as specific aspects of liposome production methods.

This review covers up-to-date information on marketed liposomal medicinal products. The authors illustrate how production methods affect the composition and structure of liposomes. The size and lamellarity are important characteristics of liposomes that determine the encapsulation efficiency and biodistribution of active pharmaceutical ingredients (APIs). The choice of excipients depends on the intended use of liposomal medicinal products. The article summarises the main liposome production methods, highlighting specific usage aspects, advantages and disadvantages. Conventional liposome production methods are easy to apply and do not require complex equipment, and their principal disadvantages include the low efficiency of API encapsulation within liposomes and the high complexity of scaling up technological processes. The authors pay special attention to microfluidic techniques for liposome preparation, which are characterised by a highly controlled technological process (in terms of size distribution and lamellarity), high reproducibility, and scalability to the level of industrial production and are applicable to encapsulating different APIs.

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