safetyriskБезопасность и риск фармакотерапииSafety and Risk of Pharmacotherapy2312-78212619-1164Federal State Budgetary Institution ‘Scientific Centre for Expert Evaluation of Medicinal Products’ of the Ministry of Health of the Russian Federation (FSBI ‘SCEEMP’)10.30895/2312-7821-2025-497safetyrisk-497Research ArticleДОКЛИНИЧЕСКИЕ ИССЛЕДОВАНИЯPRECLINICAL STUDIESКетопрофен: сравнительный анализ фармакокинетики у человека и животных (обзор)Ketoprofen Comparative Pharmacokinetics Analysis in Humans and Animals: A Reviewhttps://orcid.org/0000-0003-1686-7541ПетроваЕ. М.PetrovaE. M.

Петрова Елизавета Михайловна

ул. Заводская, д. 3, к. 245, Всеволожский р-н, г.п. Кузьмоловский, Ленинградская обл., 188663

Elizaveta M. Petrova

3/245 Zavodskaya St., Kuzmolovsky urban-type settlement, Vsevolozhsky district, Leningrad region 188663

petrova.em@doclinika.ruhttps://orcid.org/0000-0001-9690-1935КосманВ. М.KosmanV. M.

Косман Вера Михайловна, канд. фарм. наук

ул. Заводская, д. 3, к. 245, Всеволожский р-н, г.п. Кузьмоловский, Ленинградская обл., 188663

Vera M. Kosman, Cand. Sci. (Pharm.)

3/245 Zavodskaya St., Kuzmolovsky urban-type settlement, Vsevolozhsky district, Leningrad region 188663

kosman.vm@doclinika.ruhttps://orcid.org/0000-0002-6292-8934КарлинаМ. В.KarlinaM. V.

Карлина Марина Валерьевна, канд. биол. наук

ул. Заводская, д. 3, к. 245, Всеволожский р-н, г.п. Кузьмоловский, Ленинградская обл., 188663

Marina V. Karlina, Cand. Sci. (Biol.)

3/245 Zavodskaya St., Kuzmolovsky urban-type settlement, Vsevolozhsky district, Leningrad region 188663

karlina.mv@doclinika.ruhttps://orcid.org/0000-0003-3176-6386МакароваМ. Н.MakarovaM. N.

Макарова Марина Николаевна, д-р мед. наук

ул. Заводская, д. 3, к. 245, Всеволожский р-н, г.п. Кузьмоловский, Ленинградская обл., 188663

Marina N. Makarova, Dr. Sci. (Med.)

3/245 Zavodskaya St., Kuzmolovsky urban-type settlement, Vsevolozhsky district, Leningrad region 188663

makarova.mn@doclinika.ruhttps://orcid.org/0000-0002-2447-7888МакаровВ. Г.MakarovV. G.

Макаров Валерий Геннадьевич, д-р мед. наук, ­профессор

ул. Заводская, д. 3, к. 245, Всеволожский р-н, г.п. Кузьмоловский, Ленинградская обл., 188663

Valery G. Makarov, Dr. Sci. (Med.), Professor

3/245 Zavodskaya St., Kuzmolovsky urban-type settlement, Vsevolozhsky district, Leningrad region 188663

makarov.vg@doclinika.ruАкционерное общество «Научно-производственное объединение «ДОМ ФАРМАЦИИ»РоссияResearch-and-manufacturing company “HOME OF PHARMACY”Russian Federation202518122025134426439Copyright © Петрова Е.М., Косман В.М., Карлина М.В., Макарова М.Н., Макаров В.Г., 20252025Петрова Е.М., Косман В.М., Карлина М.В., Макарова М.Н., Макаров В.Г.Petrova E.M., Kosman V.M., Karlina M.V., Makarova M.N., Makarov V.G.Данная работа распространяется под лицензией Creative Commons Attribution 4.0.This work is licensed under a Creative Commons Attribution 4.0 License.https://www.risksafety.ru/jour/article/view/497ВВЕДЕНИЕ

ВВЕДЕНИЕ. Кетопрофен — представитель группы нестероидных противовоспалительных препаратов, обладающий анальгетической, противовоспалительной и жаропонижающей активностью. Фармакокинетика кетопрофена сравнительно хорошо охарактеризована на различных моделях in vivo. Поскольку потен­циал создания лекарственных форм кетопрофена не исчерпан и изучение фармакокинетики способствует качественной фармацевтической разработке, актуальна сравнительная оценка соответствующих данных у животных и человека.

ЦЕЛЬ

ЦЕЛЬ. Выявление релевантных видов животных для доклинических исследований различных лекарственных форм кетопрофена путем обобщения данных о биоаналитических методиках для оценки фармакокинетики препарата и сравнения фармакокинетических параметров на разных тест-системах.

ОБСУЖДЕНИЕ

ОБСУЖДЕНИЕ. Для анализа кетопрофена в биоматериале наиболее часто используют метод обращенно-фазовой высокоэффективной жидкостной хроматографии с ультрафиолетовым или масс-спектрометрическим детектированием и элюенты на основе ацетонитрила или метанола и различных буферных растворов. Фармакокинетика кетопрофена изучена на животных разного филогенетического типа и на людях с использованием различных лекарственных форм (растворы для инъекций, таблетки, пастообразные формы и др.) и соответствующих им путей введения (внутривенное, внутримышечное, пероральное, трансдермальное). Отмечена высокая биодоступность препарата при разных путях введения. Сопоставимый диапазон максимальных концентраций (Cmax) при близких дозах и схожие значения временны́х фармакокинетических параметров (времени достижения максимальной концентрации, Tmax, периода полувыведения, T1/2, и среднего времени удержания препарата в организме, MRT) при трех основных путях введения (пероральном, внутривенном и внутримышечном) у человека с соответствующими параметрами у крыс, кошек и собак позволили предположить релевантность этих тест-систем при изучении фармакокинетики препаратов кетопрофена.

ВЫВОДЫ

ВЫВОДЫ. Результаты проведенного анализа позволили предположить, что релевантными тест-системами при изучении фармакокинетики кетопрофена, по крайней мере при пероральном, внутривенном и внутримышечном путях введения, могут быть грызуны и крупные животные (кошки, собаки). На примере кетопрофена показана целесообразность сбора и обобщения разнородных фармакокинетических данных, а также сложность их сопоставления в связи с вариабельностью тест-систем, объектов исследования, дозировок и путей введения.

INTRODUCTION

INTRODUCTION. Ketoprofen is a non-steroidal anti-inflammatory drug (NSAID) with pronounced analgesic, anti-inflammatory and antipyretic effect. Ketoprofen pharmacokinetics is comparatively well described in various in vivo models. Since it is potentially possible to create new dosage forms of ketoprofen, with pharmacokinetics studies contributing to high-quality pharmaceutical development, a comparative assessment is relevant for the data on animals and humans.

AIM

AIM. This study aimed to identify animal species relevant for preclinical studies of different ketoprofen dosage forms by summarising bioanalytical methods used to assess pharmacokinetics and by comparing various test systems.

DISCUSSION

DISCUSSION. Reversed-phase high-performance liquid chromatography with ultraviolet/mass spectrometric detection and acetonitrile or methanol-based eluents in various buffer solutions is the most ubiquitous method for ketoprofen analysis in biomaterials. Ketoprofen pharmacokinetics was studied in humans and animals of several phylogenetic species using various dosage forms (injectable solutions, tablets, paste forms, etc.) and the relevant administration (intravenous, intramuscular, oral, transdermal). High drug bioavailability was noted for different routes. Maximum concentration (Cmax) range at similar doses and similar time parameters (time to maximum concentration, Tmax, half-life, T1/2 and mean residence time, MRT) for the three main administration routes (oral, intravenous and intramuscular) was comparable in humans and rats, cats, and dogs; thus these test systems were suggested for pharmacokinetics studies of ketoprofen preparations.

CONCLUSIONS

CONCLUSIONS. The analysis suggested that rats and larger animals (cats, dogs) can serve as test systems in ketoprofen pharmacokinetics studies, at least for oral, intravenous, and intramuscular administration. Using ketoprofen as an example, the study showed feasibility of integrating heterogeneous pharmacokinetic data, as well as comparison challenges due to variable test systems, study objects, dosages, and administration routes.

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