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’)10.30895/1991-2919-2023-530vedomostiregmed-530Research ArticleВСПОМОГАТЕЛЬНЫЕ ВЕЩЕСТВАEXCIPIENTSБлок-сополимеры этиленоксида и пропиленоксида: перспективы применения в отечественной медицине и фармацииBlock Copolymers of Ethylene Oxide and Propylene Oxide: Prospects for Medical and Pharmaceutical Application in Russiahttps://orcid.org/0000-0001-8695-0346БахрушинаЕ. О.BakhrushinaE. O.

Бахрушина Елена Олеговна, канд. фарм. наук, доцент

Трубецкая ул., д. 8, стр. 2, Москва, 119991

Elena O. Bakhrushina, Cand. Sci. (Pharm.), Associate Professor

8/2 Trubetskaya St., Moscow 119991

bakhrushina_e_o@staff.sechenov.ruhttps://orcid.org/0000-0003-2174-7157ПыжовВ. С.PyzhovV. S.

Пыжов Виктор Сергеевич

Трубецкая ул., д. 8, стр. 2, Москва, 119991

Victor S. Pyzhov

8/2 Trubetskaya St., Moscow 119991

vitya.pyzhov@gmail.comhttps://orcid.org/0000-0003-4870-6232СахароваП. С.SakharovaP. S.

Сахарова Полина Сергеевна

Трубецкая ул., д. 8, стр. 2, Москва, 119991

Polina S. Sakharova

8/2 Trubetskaya St., Moscow 119991

sakharova_p_s@student.sechenov.ruhttps://orcid.org/0000-0003-4307-8791ДеминаН. Б.DeminaN. B.

Демина Наталья Борисовна, д-р фарм. наук, профессор

Трубецкая ул., д. 8, стр. 2, Москва, 119991

Natalia B. Demina, Dr. Sci. (Pharm.), Professor

8/2 Trubetskaya St., Moscow 119991

demina_n_b@staff.sechenov.ruhttps://orcid.org/0000-0002-6082-4461ЧижоваД. А.ChizhovaD. A.

Чижова Диана Александровна, канд. биол. наук

Рахмановский пер., д. 3, ГСП-4, Москва, 127994

Diana A. Chizhova, Cand. Sci. (Biol.)

3 Rakhmanovsky Ln., GSP-4, Moscow 127994

ChijovaDA@minzdrav.gov.ruhttps://orcid.org/0000-0001-7965-6050ТабанскаяТ. В.TabanskayaT. V.

Табанская Татьяна Валерьевна

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

Tatiana V. Tabanskaya

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

TabanskayaTV@minzdrav.gov.ruhttps://orcid.org/0000-0003-1484-6587ЛутфуллинМ. Ф.LutfullinM. F.

Лутфуллин Марсель Фанисович

Рахмановский пер., д. 3, ГСП-4, Москва, 127994

Marsel F. Lutfullin

3 Rakhmanovsky Ln., GSP-4, Moscow 127994

LutfullinMF@minzdrav.gov.ruФедеральное государственное автономное образовательное учреждение высшего образования «Первый Московский государственный медицинский университет им. И.М. Сеченова» (Сеченовский Университет) Министерства здравоохранения Российской Федерации, Институт фармации имени А.П. НелюбинаРоссияI.M. Sechenov First Moscow State Medical University (Sechenov University), A.P. Nelyubin Institute of PharmacyRussian FederationМинистерство здравоохранения Российской ФедерацииРоссияMinistry of Health of the Russian FederationRussian FederationФедеральное государственное автономное образовательное учреждение высшего образования «Первый Московский государственный медицинский университет им. И.М. Сеченова» (Сеченовский Университет) Министерства здравоохранения Российской Федерации, Институт фармации имени А.П. Нелюбина; Федеральное государственное бюджетное учреждение «Научный центр экспертизы средств медицинского применения» Министерства здравоохранения Российской ФедерацииРоссияI.M. Sechenov First Moscow State Medical University (Sechenov University), A.P. Nelyubin Institute of Pharmacy; Scientific Centre for Expert Evaluation of Medicinal ProductsRussian Federation202329062023132-1333344Copyright © Бахрушина Е.О., Пыжов В.С., Сахарова П.С., Демина Н.Б., Чижова Д.А., Табанская Т.В., Лутфуллин М.Ф., 20232023Бахрушина Е.О., Пыжов В.С., Сахарова П.С., Демина Н.Б., Чижова Д.А., Табанская Т.В., Лутфуллин М.Ф.Bakhrushina E.O., Pyzhov V.S., Sakharova P.S., Demina N.B., Chizhova D.A., Tabanskaya T.V., Lutfullin M.F.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/530

Блок-сополимеры этиленоксида и пропиленоксида (блок-сополимеры ЭО и ПО), также называемые плюрониками, полоксамерами или проксанолами — это полимерные неионогенные поверхностно-активные вещества с высоким гидрофильно-липофильным балансом, являющиеся одними из самых востребованных современных вспомогательных веществ в производстве лекарственных средств. Они используются как при производстве традиционных лекарственных форм (жидких, мягких, твердых), так и в составе систем направленной доставки. Это связано с наличием у таких блок-сополимеров, помимо солюбилизирующей, эмульгирующей, гелеобразующей и других способностей, термореверсивных свойств, которые необходимы при создании in situ систем и технологий 3D-печати.

Цель работы — оценка перспектив применения блок-сополимеров ЭО и ПО в медицинских целях, а также анализ номенклатуры лекарственных препаратов, содержащих блок-сополимеры ЭО и ПО, зарегистрированных в Российской Федерации.

В настоящем обзоре проанализирован реестр зарегистрированных в Российской Федерации лекарственных средств, содержащих полоксамеры, приведен перечень крупнейших мировых производителей блок-сополимеров ЭО и ПО и изучена возможность применения полоксамеров в медицинских целях. На сегодня в мире насчитывается более десяти химических концернов и компаний, производящих блок-сополимеры ЭО и ПО для фармацевтических, биотехнологических и других отраслей. Отмечено, что полоксамеры входят в состав более шестидесяти препаратов на российском фармацевтическом рынке, что свидетельствует о необходимости импортозамещения данных компонентов.

Block copolymers of ethylene oxide and propylene oxide (EO/PO block copolymers) are polymeric non-ionic surfactants with a high hydrophilic–lipophilic balance also referred to as pluronics, poloxamers, or proxanols. These compounds are among the most demanded modern excipients for the production of medicines. EO/PO block copolymers are used both in the production of traditional (liquid, semi-solid, and solid) dosage forms and as part of targeted delivery systems. The extensive application of EO/PO block copolymers is due to the diverse array of their properties, including not only solubilising, emulsifying, gelling, and other effects but also thermoreversibility, which is essential for developing in situ delivery systems and 3D printing technologies.

The aim of the study was to evaluate the potential of EO/PO block copolymers for medicinal use and to assess the range of medicinal products approved in the Russian Federation that contain EO/PO block copolymers.

This review presents an analysis of the register of poloxamer-containing medicines approved in the Russian Federation, a list of the largest manufacturers of EO/PO block copolymers in the world, and a study of the possibility to use copolymers for medical purposes. Currently, there are more than 10 chemical manufacturers producing EO/PO block copolymers for the pharmaceutical, biotechnology, and other industries around the world. EO/PO block copolymers are included in more than 60 medicinal products present in the Russian pharmaceutical market; this observation indicates the need to phase out the import of poloxamers.  

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