pulmoПульмонологияPULMONOLOGIYA0869-01892541-9617Scientific and Practical Journal “PULMONOLOGIYA” LLC10.18093/0869-0189-2017-27-4-529-536pulmo-902Research ArticleОБЗОРЫREVIEWВозможна ли взаимозаменяемость лекарственных препаратов для ингаляционного применения?Could inhalational drugs be interchangeable?ЗыряновС. К.ZyryanovS. K.

д. м. н., профессор, заведующий кафедрой общей и клинической фармакологии, 117198, Москва, ул. Миклухо-Маклая, 6;

заместитель главного врача по терапии, 127015, Москва, Писцовая, 10

Doctor of Medicine, Professor, Head of Department of General and Clinical Pharmacology, ul. Miklukho-Maklaya 6, Moscow, 117198;

Deputy Director for Therapy, ul. Pistsovaya 10, Moscow, 127015

sergey.k.zyryanov@gmail.comЗатолочинаК. Э.ZatolochinaK. E.

к. м. н., ассистент кафедры общей и клинической фармакологии, 117198, Москва, ул. Миклухо-Маклая, 6;

начальник научно-аналитического отдела Центра экспертизы безопасности лекарственных средств, 127051, Москва, Петровский б-р, 8 / 2

Candidate of Medicine, Assistant Lecturer, Department of General and Clinical Pharmacology, ul. Miklukho-Maklaya 6, Moscow, 117198;

Head of Scientific and Analytical Division, Center of Expertise and Safety of Drugs, Petrovskiy bul'var 8/2, Moscow, 127051

w00100@yandex.ruЧельцовВ. В.CheltsovV. V.

д. м. н., профессор кафедры общей и клинической фармакологии,

117198, Москва, ул. Миклухо-Маклая, 6

Doctor of Medicine, Professor, Department of General and Clinical Pharmacology,

ul.Miklukho-Maklaya 6, Moscow, 117198

vcheltsov@mail.ruФедеральное государственное автономное образовательное учреждение высшего образования «Российский университет дружбы народов»; Государственное бюджетное учреждение здравоохранения «Городская клиническая больница № 24 Департамента здравоохранения города Москвы»РоссияThe Peoples' Friendship University of Russia; City Clinical Hospital No.24, Moscow Healthcare DepartmentRussian FederationФедеральное государственное автономное образовательное учреждение высшего образования «Российский университет дружбы народов»: Федеральное государственное бюджетное учреждение «Научный центр экспертизы средств медицинского применения» Министерства здравоохранения Российской ФедерацииРоссияThe Peoples' Friendship University of Russia; Federal Scientific Center of Expertise of Medical Agents, Healthcare Ministry of RussiaRussian FederationФедеральное государственное автономное образовательное учреждение высшего образования «Российский университет дружбы народов»РоссияThe Peoples' Friendship University of RussiaRussian Federation201716102017274529536Copyright © Зырянов С.К., Затолочина К.Э., Чельцов В.В., 20172017Зырянов С.К., Затолочина К.Э., Чельцов В.В.Zyryanov S.K., Zatolochina K.E., Cheltsov V.V.Данная работа распространяется под лицензией Creative Commons Attribution 4.0.This work is licensed under a Creative Commons Attribution 4.0 License.https://journal.pulmonology.ru/pulm/article/view/902

В статье рассматривается актуальная проблема взаимозаменяемости лекарственных препаратов (ЛП) для ингаляционного применения, которая затрагивает как экономическую сферу их обращения, так и практическое применение в клинической практике. Подчеркивается значение ингаляционного устройства в обеспечении клинического эффекта препарата. Обсуждаются подходы к установлению эквивалентности препаратов в ингаляционных лекарственных формах, на основании которых могут быть сделаны выводы об эффективности и безопасности замены ингаляционных препаратов в рамках одной активной субстанции в условиях реальной клинической практики. Продемонстрировано, что такой подход на всех этапах обращения ЛП позволит повысить эффективность и безопасность лечения пациентов с бронхиальной астмой и хронической обструктивной болезнью легких.

Clinical efficacy of an inhalational drugs depends on proper inhalation technique and aerodynamic properties of aerosol including the respirable fraction. Investigations of systemic pharmacokinetics of inhalational drugs could not always estimate their pharmacological equivalence so as relationships between the inhaled dose, the systemic concentration and the topic activity of an inhalational drug are not fully investigated. Therefore, identical formulation and similar route of administration are not sufficient to estimate pharmacological interchangeability. Possibility to interchange inhalational agents has still been controversial. As such, equal efficacy and safety of inhalational drugs with the same active substance could be estimated in real clinical practice according to results of postmarketing trials and pharmacological surveillance. Spontaneous messages are a tool for gathering information about unwanted reactions or drug inefficacy and possible risks of substitution of drugs within the same international nonproprietary name.

In summary, it is necessary to estimate pharmacological equivalence and interchangeability of inhalational drugs carefully. This approach could improve efficacy and safety of treatment of patients with asthma and COPD.

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