pharmjournalРазработка и регистрация лекарственных средствDrug development & registration2305-20662658-5049LLC «CPHA»pharmjournal-332Research ArticleЭФФЕКТИВНОСТЬ И БЕЗОПАСНОСТЬ ЛЕКАРСТВЕННЫХ СРЕДСТВDRUG PRODUCTS EFFICACY AND SAFETYОСОБЕННОСТИ ПРОВЕДЕНИЯ ПРЕДИКТИВНОГО ТЕСТА РАСТВОРЕНИЯ (ОБЗОР)THE FEATURES OF THE PREDICTIVE DISSOLUTION TESTING (REVIEW)МустафинР. И.MoustafineR. I.noemail@neicon.ruСитенкова (Буховец)А. В.Sitenkova (Bukhovets)A. V.noemail@neicon.ruФотакиН.FotakiN.noemail@neicon.ruФГБОУ ВО «Казанский государственный медицинский университет» Министерства здравоохранения Российской ФедерацииKazan State Medical UniversityУниверситет Бата, ВеликобританияUniversity of Bath20170901201901156162Copyright © Мустафин Р.И., Ситенкова (Буховец) А.В., Фотаки Н., 20192019Мустафин Р.И., Ситенкова (Буховец) А.В., Фотаки Н.Moustafine R.I., Sitenkova (Bukhovets) A.V., Fotaki N.Данная работа распространяется под лицензией Creative Commons Attribution 4.0.This work is licensed under a Creative Commons Attribution 4.0 License.https://www.pharmjournal.ru/jour/article/view/332

Тест «Растворение» играет важную роль на различных уровнях разработки и производства лекарственных препаратов, как один из основных инструментов контроля качества серий выпускаемой фармацевтическими предприятиями продукции и как неотъемлемая часть испытаний in vitro при изучении механизма высвобождения активного фармацевтического ингредиента из разрабатываемых лекарственных форм. В статье описаны основные параметры, которые необходимо учитывать при проведении предиктивного теста «Растворение», а именно: критерии выбора и состав биорелевантных сред растворения, моделирующих как «голодное», так и «сытое» состояние различных отделов желудочно-кишечного тракта, гидродинамика, объем и трансфер сред растворения.

Dissolution test plays an important role at different levels of the development and manufacturing drugs as one of the major quality control tools and an integral part of In vitro tests in the study of drug release from the developed dosage forms. Article describes the basic parameters that should be considered in predictive dissolution tests, such as the selection criteria and the composition of biorelevant dissolution media, fluid dynamics, volume and transfer of the dissolution media.

тест «Растворение»биорелевантные средыпроточная ячейкапоршневой цилиндрвращающаяся корзинкавращающаяся лопастьdissolution testbiorelevant mediaflow-through cellreciprocating cylinderrotating basketrotating paddleReferencesТест «Растворение» в разработке и регистрации лекарственных средств. Научно-практическое руководство для фармацевтической отрасли / Под ред. И.Е. Шохина - М.: Перо, 2015. 320 с.Тест «Растворение» в разработке и регистрации лекарственных средств. Научно-практическое руководство для фармацевтической отрасли / Под ред. И.Е. Шохина - М.: Перо, 2015. 320 с.Q. Wang, N. Fotaki, Y. Mao. Biorelevant Dissolution: Methodology and Application in Drug Development // Dissolution Technologyes. 2009. V. 16(3). P. 6-12.Q. Wang, N. Fotaki, Y. Mao. Biorelevant Dissolution: Methodology and Application in Drug Development // Dissolution Technologyes. 2009. V. 16(3). P. 6-12.D.S. Evans, G. Pye, R. Bramley, A.G. Clark, T.J. Dyson, J.D. Hardcastle. 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The authors declare that there are no conflicts of interest present.