scbmtБИОМЕДИЦИНАJournal Biomed2074-59822713-0428Scientific center of biomedical technologies of Federal Medical and Biological Agencyscbmt-677Research ArticleСтатьиБиорелевантные среды растворения - современный инструмент для моделирования процессов растворения и всасывания ЛСВолковаЕ. А.noemail@neicon.ruШохинИ. Е.noemail@neicon.ruРаменскаяГ. В.noemail@neicon.ruСавченкоА. Ю.alursav@mail.ruГОУ ВПО Первый Московский Государственный Медицинский Университет имени И.М.Сеченова Минздравсоцразвития РоссииRussian FederationГОУ ВПО Первый Московский Государственный Медицинский Университет имени И.М.Сеченова Минздравсоцразвития России ФГБУ «НЦ ЭСМП» Минздравсоцразвития РоссииRussian FederationФГБУ «НЦ ЭСМП» Минздравсоцразвития РоссииRussian Federation20111302202013133140Copyright © Волкова Е.А., Шохин И.Е., Раменская Г.В., Савченко А.Ю., 20202020Волкова Е.А., Шохин И.Е., Раменская Г.В., Савченко А.Ю.Волкова Е.А., Шохин И.Е., Раменская Г.В., Савченко А.Ю.Данная работа распространяется под лицензией Creative Commons Attribution 4.0.This work is licensed under a Creative Commons Attribution 4.0 License.https://journal.scbmt.ru/jour/article/view/677

Статья посвящена биорелевантным средам, применяемым при проведении испытания «Растворе- ние». Приведены состав и методики приготовления современных биорелевантных сред, моделирую- щих кишечный сок натощак и после еды - FeSSIF, FaSSIF. Описаны особенности растворения ЛС раз- личных классов биофармацевтической классификационной системы (БКС) в данных средах. Показаны возможные области применения биорелевантных сред. This work is devoted to biorelevant media used for dissolution test. The formulations and preparation methods of fasted state simulation intestinal fluid, FaSSIF and fed state simulation intestinal fluid, FeSSIF, are defined. In addition, the dissolution characteristics of APIs from different BCS classes in biorelevant media are described. Possible applications of biorelevant media in science are also shown.

тест «Растворение»биорелевантные средыбиофармацевтическая классифика- ционная система (БКС)FeSSIFFaSSIFбиовейверабсорбцияReferencesAaltonen J., Rades T. Commentary: Towards Physico-Relevant Dissolution Testing: The Importance of Solid-State Analysis in Dissolution, Dissolution Technologies. 2009. 16(2). Р. 47-54.Aaltonen J., Rades T. Commentary: Towards Physico-Relevant Dissolution Testing: The Importance of Solid-State Analysis in Dissolution, Dissolution Technologies. 2009. 16(2). Р. 47-54.Boni J. E., Brickl R. S., Dressman J. B., Pfefferle M. L. Instant FaSSIF and FeSSIF-Biorelevance Meets Practicality. Dissolution Technologies. 2009. 16(3). Р. 41-46.Boni J. E., Brickl R. S., Dressman J. B., Pfefferle M. L. Instant FaSSIF and FeSSIF-Biorelevance Meets Practicality. Dissolution Technologies. 2009. 16(3). Р. 41-46.Dressman, J. B., Amidon G. L.;, Reppas C., Shah V. P. Dissolution testing as a prognostic tool for oral drug absorption: immediate release dosage forms. Pharm. Res. 1998. 15 (1). Р. 11-22.Dressman, J. B., Amidon G. L.;, Reppas C., Shah V. P. Dissolution testing as a prognostic tool for oral drug absorption: immediate release dosage forms. Pharm. Res. 1998. 15 (1). Р. 11-22.Dressman J. B., Reppas C. In vitro- in vivo correlations for lipophilic, poorly water-soluble drugs. Eur. J. Pharm. Sci. 2000. 11 (Suppl 2). Р. 73-80.Dressman J. B., Reppas C. In vitro- in vivo correlations for lipophilic, poorly water-soluble drugs. Eur. J. Pharm. Sci. 2000. 11 (Suppl 2). Р. 73-80.Galia, E.; Nicolaides, E.; Hörter, D.; Löbenberg, R.; Reppas, C.; Dressman, J. B. Evaluation of various dissolution media for predicting in vivo performance of class I and II drugs. Pharm. Res. 1998. 15 (5). Р. 698-705.Galia, E.; Nicolaides, E.; Hörter, D.; Löbenberg, R.; Reppas, C.; Dressman, J. B. Evaluation of various dissolution media for predicting in vivo performance of class I and II drugs. Pharm. Res. 1998. 15 (5). Р. 698-705.Jogia H.; Mehta T.; and Patel M. Evaluation of Dissolution Media Containing a Novel Synthetic Sur-factant by In Vitro Testing of BCS Class II Drugs, Dissolution Technologies. 2009. 16(3). Р. 14-19.Jogia H.; Mehta T.; and Patel M. Evaluation of Dissolution Media Containing a Novel Synthetic Sur-factant by In Vitro Testing of BCS Class II Drugs, Dissolution Technologies. 2009. 16(3). Р. 14-19.Jantratid Е; Dressman J. B. Biorelevant Dissolution Media Simulating the Proximal Human Gas-trointestinal Tract: An Update. Dissolution Technologies. 2009. 16(3). Р. 21-25.Jantratid Е; Dressman J. B. Biorelevant Dissolution Media Simulating the Proximal Human Gas-trointestinal Tract: An Update. Dissolution Technologies. 2009. 16(3). Р. 21-25.Jantratid, E.; Janssen, N.; Reppas, C.; Dressman, J. B. Dissolution media simulating conditions in the proximal human gastrointestinal tract: an update. Pharm. Res. 2008. 25 (7). Р. 1663-1676.Jantratid, E.; Janssen, N.; Reppas, C.; Dressman, J. B. Dissolution media simulating conditions in the proximal human gastrointestinal tract: an update. Pharm. Res. 2008. 25 (7). Р. 1663-1676.Klein S. Predicting Food Effects on Drug Release from Extended-Release Oral Dosage. Forms Containing a Narrow Therapeutic Dissolution Technologies. 2009. 16(3). Р. 28-40.Klein S. Predicting Food Effects on Drug Release from Extended-Release Oral Dosage. Forms Containing a Narrow Therapeutic Dissolution Technologies. 2009. 16(3). Р. 28-40.Kostewicz, E. S.; Brauns, U.; Becker, R.; Dressman, J. B. Forecasting the oral absorption behavior of poorly soluble weak bases using solubility and dissolution studies in biorelevant media. Pharm. Res. 2002. 19 (3). Р. 345-349.Kostewicz, E. S.; Brauns, U.; Becker, R.; Dressman, J. B. Forecasting the oral absorption behavior of poorly soluble weak bases using solubility and dissolution studies in biorelevant media. Pharm. Res. 2002. 19 (3). Р. 345-349.Lehto P., Aaltonen J., Tenho M., Rantanen J., Hirvonen J., Tanninen V.P.,Peltonen L. Solvent-mediated solid phase transformations of carbamazepine: Effects of simulated intestinal fluid and fasted state simulated intestinal fluid. J Pharm Sci. 2009. Mar; 98(3). Р. 985-96.Lehto P., Aaltonen J., Tenho M., Rantanen J., Hirvonen J., Tanninen V.P.,Peltonen L. Solvent-mediated solid phase transformations of carbamazepine: Effects of simulated intestinal fluid and fasted state simulated intestinal fluid. J Pharm Sci. 2009. Mar; 98(3). Р. 985-96.Löbenberg R., Shah V., Krämer J., Amidon G. L., Dressman J. B. Dissolution testing as a prognos-tic tool for oral drug absorption: dissolution behavior of glibenclamide. Pharm. Res. 2000. 17 (4). Р. 439-444.Löbenberg R., Shah V., Krämer J., Amidon G. L., Dressman J. B. Dissolution testing as a prognos-tic tool for oral drug absorption: dissolution behavior of glibenclamide. Pharm. Res. 2000. 17 (4). Р. 439-444.Marques M. Dissolution Media Simulating Fasted and Fed States. Dissolution Technol. 2004. 11(2). 16 р.Marques M. Dissolution Media Simulating Fasted and Fed States. Dissolution Technol. 2004. 11(2). 16 р.Nicolaides E., HempenstallJ.M., Reppas C. Biorelevant Dissolution Tests with the Flow-Through Apparatus. Dissolution Technologies. 2000. 7(1). Р. 8-11.Nicolaides E., HempenstallJ.M., Reppas C. Biorelevant Dissolution Tests with the Flow-Through Apparatus. Dissolution Technologies. 2000. 7(1). Р. 8-11.Nicolaides E., SymillidesM., Dressman J. B., Reppas C. Biorelevant dissolution testing to pre-dict the plasma standardized instantly dissolving powder. AAPS. 2009.Nicolaides E., SymillidesM., Dressman J. B., Reppas C. Biorelevant dissolution testing to pre-dict the plasma standardized instantly dissolving powder. AAPS. 2009.Wang Q.:, Fotaki N.; Yun Mao. Biorelevant Dissolution: Methodology and Application in Drug Development. Dissolution Technologies. 2009. 16 (3). Р. 6-12.Wang Q.:, Fotaki N.; Yun Mao. Biorelevant Dissolution: Methodology and Application in Drug Development. Dissolution Technologies. 2009. 16 (3). Р. 6-12.Wei H., Lobenberg R. Biorelevant dissolution media as a predictive tool for glyburide a class II drug. Eur. J. Pharm. Sci. 2006. 29 (1). Р. 45-52.Wei H., Lobenberg R. Biorelevant dissolution media as a predictive tool for glyburide a class II drug. Eur. J. Pharm. Sci. 2006. 29 (1). Р. 45-52.WHO Technical Report Series 937, annex 8 «Proposal to waive in vivo bioequivalence requirements for WHO Model List of Essential Medicines immediate-release, solid oral dosage forms». WHO Expert Committee on Specifications for Pharmaceutical Prepa-rations (2006).WHO Technical Report Series 937, annex 8 «Proposal to waive in vivo bioequivalence requirements for WHO Model List of Essential Medicines immediate-release, solid oral dosage forms». WHO Expert Committee on Specifications for Pharmaceutical Prepa-rations (2006).Zoeller T., Klein S. Simplified BiorelevantMediaforScreening Dissolution Performance of Poorly Soluble Drugs. Dissolution Technologies. 2007. 14 (4). Р. 8-14.Zoeller T., Klein S. Simplified BiorelevantMediaforScreening Dissolution Performance of Poorly Soluble Drugs. Dissolution Technologies. 2007. 14 (4). Р. 8-14.Раменская Г.В., Шохин И.Е. Современные подходы к оценке гене- рических лекарственных средств при их регистрации (обзор). // Химико-фар- мацевтический журнал, 2009. том 43. № 9. С. 30-34.Раменская Г.В., Шохин И.Е. Современные подходы к оценке гене- рических лекарственных средств при их регистрации (обзор). // Химико-фар- мацевтический журнал, 2009. том 43. № 9. С. 30-34.

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