The dissolution test in biorelevant media as a prognostic tool for modeling of drug behavior in vivo

   
Ramenskaya G.V.1 , Shohin I.E.1, Savchenko A.Y.2, Volkova E.A.3

1. Sechenov First Moscow State Medical University Scientific Center for Expertise of Medical Products
2. Scientific Center for Expertise of Medical Products
3. Sechenov First Moscow State Medical University
Section: Review
DOI: 10.18097/PBMC20115705482      PubMed Id: 22629598
Year: 2011  Volume: 57  Issue: 5  Pages: 482-489
The review deals with the modern tool for modeling of drug behavior in vivo, - the dissolution test in biorelevant media, imitating gastrointestinal fluids. 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 regulatory practice and science are also shown.
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Keywords: dissolution test, biorelevant media, biopharmaceutical classification system (BCS), FeSSIF, FaSSIF, biowaiver, absorbtion
Citation:

Ramenskaya, G. V., Shohin, I. E., Savchenko, A. Y., Volkova, E. A. (2011). The dissolution test in biorelevant media as a prognostic tool for modeling of drug behavior in vivo. Biomeditsinskaya khimiya, 57(5), 482-489.
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