Применение биологической модели для оценки кишечной проницаемости in vitro – монослоя эпителиальных клеток Сасо-2
Аннотация
Об авторах
И. Е. ШохинРоссия
Ю. И. Кулинич
Россия
Г. В. Раменская
Россия
В. Г. Кукес
Россия
Список литературы
1. Amidon G.L., Lennerlas H., Shah V.P., Crison J.R. A theoretical basis for a biopharmaceutic drug classification: The correlation of in vitro drug product dissolution and in vivo bioavailability // Pharmaceutical Recearch. 1995. № 12. P. 413-420.
2. Proposal to waive in vivo bioequivalence requirements for WHO Model List of Essential Medicines immediate-release, solid oral dosage forms. Technical Report Series, No 937, 40th Report, Annex 8 of WHO Expert Committee on Specifications for Pharmaceutical Preparations. World Health Organization (WHO). 2006.
3. Kasim N.A., Whitehouse M., RamachandranC.,BermejoM., Lennernäs H., Hussain A.S., Junginger H.E., Stavchansky S.A., Midha K.K., Shah V.P., Amidon G.L. Molecular properties of WHO essential drugs and provisional biopharmaceutical classification // Molecular Pharmaceutics. 2004. Vol. 1. № 1. Р. 85-96.
4. Kim J.-S., Mitchell S., Kijek P., Tsume Y., Hilfinger J., Amidon G.L. The suitability of an in situ perfusion model for permeability determinations: utility for BCS Class I biowaiver requests // Molecular Pharmaceutics. 2004. Vol. 1. № 1. Р. 85-96.
5. Yee S. In vitro permeability across Caco-2 cells (colonic) can predict in vivo (small intestinal) absorption in man – Fact or myth // Pharmaceutical Research. 1997. Vol. 14. № 6. P. 763-766.
6. Wu C.-Y., Benet L. Predicting DrugDispositionviaApplication of BCS: Transport / Absorption / Elimination Interplay and Development of a Biopharmaceutics Drug Disposition Classification System // Pharmaceutical Research. 2005. Vol. 22. № 1. Р. 11-23.
7. Artursson P., Palm K., Luthman K. Caco-2 monolayers in experimental and theoretical predictions of drug transport // Advanced Drug Delivery Reviews. 2001. Vol. 46. P. 27-43.
8. Le Ferrec E., Chesne C., Artursson P. et al. In Vitro Models of the Intestinal Barrier. The Report and Recommendations of ECVAM Workshop 46 // ATLA. 2001. Vol. 29. P. 649-668.
9. Shah P., Jogani V., Bagchi T., Misra A. Role of Caco-2 Cell Monolayers in Prediction of Intestinal Drug Absorption // Biotechnology Progress. 2006. Vol. 22. № 1. P. 186-198.
10. Lennernas H., Palm K., Fagerholm U., Artursson P. Comparison between active and passive drug transport in human intestinal epithelial (Caco-2) cells: In vitro and human jejunum in vivo // International Journal of Pharmaceutics. 1996. Vol. 127. № 1. P. 103-107.
11. Artursson P., Karlsson J. Correlation between oral drug absorption in humans and apparent drug permeability coefficients in human intestinal epithelial (Caco-2) cells. Biochemical and Biophysical Research Communications. 1991. Vol. 175. №3. P. 880-885.
12. Dahan A., Miller J.M., Amidon G.L. Prediction of Solubility and Permeability Class Membership: Provisional BCS Classification of the World’s Top Oral Drugs // AAPS J. 2009. Vol. 11. № 6. P. 740-746.
13. Guidance for industry: Waiver of in vivo bioavailability and bioequivalence studies for immediate-release solid oral dosage forms based on a Biopharmaceutics Classification System. U.S., Department of Health and Human Services, Food and Drug Administration (HHS-FDA), Center for Drug Evaluation and Research (CDER), 2000.
14. Соловьев А.И., Резников А.Г., Тарасенко Л.В., Маргитич В.М. Первый в Украине успешный опыт применения биовейвера для экспертной оценки лекарственного средства (Летромара) // Журнал АМН Украины. 2006. т. 12. № 4. С. 781-794.
Рецензия
Для цитирования:
Шохин И.Е., Кулинич Ю.И., Раменская Г.В., Кукес В.Г. Применение биологической модели для оценки кишечной проницаемости in vitro – монослоя эпителиальных клеток Сасо-2. БИОМЕДИЦИНА. 2012;1(3):91-97.
For citation:
Shohin I.E., Kulinich J.I., Ramenskaya G.V., Kukes V.G. Application of biological model for assessment of intestinal permeability of in vitro – a monolayer of epitelialny Caco-2 cells. Journal Biomed. 2012;1(3):91-97. (In Russ.)