Faculty of Pharmacy, Lj. (FFALJ)
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Biopharmaceutical classification of desloratadine - not all drugs are classified the easy wayBerginc, Katja, 1980- ...The biopharmaceutical classification of drugs was designed as a basis for bio-waivers % a mechanism with the double ethical benefit of delivering new drug formulations to the market with less human ... testing and lower cost. However, many drugs defy simple classification because in vitro permeability and stability assessment can be challenging as shown in this study for desloratadine. Literature shows that desloratadine is highly soluble, while data on luminal stability and permeability are circumstantial. Combined with borderline bioavailability and not really known fraction of absorbed dose, desloratadine was found to be a good example for showing the innovative in vitro approaches necessary to unambiguously classify desloratadine according to Biopharmaceutical Classification System (BCS) guideline. Presented study undoubtedly confirmed that desloratadine solubility is high and dissolution is very rapid for immediate release reference tablets. We have demonstrated desloratadine stability under legally required conditions and also in more physiologically relevant media. High in vitro desloratadine permeability was confirmed using Caco-2 and Parallel Artificial Membrane Permeability Assay (PAMPA). Well-established in vitro model with rat intestinal tissue could not be used due to reasons elaborated in this paper.Source: Acta pharmaceutica. - ISSN 1330-0075 (Vol. 70, iss. 2, 2020, str. 131-144)Type of material - article, component part ; adult, seriousPublish date - 2020Language - englishCOBISS.SI-ID - 4797553
Author
Berginc, Katja, 1980- |
Sibinovska, Nadica |
Žakelj, Simon, 1976- |
Trontelj, Jurij |
Legen, Igor
Topics
Topnost |
Zdravila |
desloratadine |
BCS-based bio-waiver |
luminal stability |
permeability |
dissolution
Author | Berginc, Katja, 1980- ... |
Title | Biopharmaceutical classification of desloratadine - not all drugs are classified the easy way |
Publication date | 2020-01-16 |
COBISS.SI-ID | 4797553 |
Publication version in repository | Publisher's version |
Publication licence | Creative Commons Attribution 4.0 International |
Embargo | Immediate publication for public |
Project(s) from which the publication was funded
Title | Acronym | Project ID | Funder |
---|---|---|---|
Farmacevtska tehnologija: od dostavnih sistemov učinkovin do terapijskih izidov zdravil pri otrocih in starostnikih | P1-0189-2018 |
Javna agencija za znanstvenoraziskovalno in inovacijsko dejavnost Republike Slovenije |
Files that belong to the publication
Link |
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https://sciendo.com/article/10.2478/acph-2020-0006 |
https://repozitorij.uni-lj.si/IzpisGradiva.php?id=141322 |
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DRS, in which the journal is indexed
Database name | Field | Year |
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Links to authors' personal bibliographies | Links to information on researchers in the SICRIS system |
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Berginc, Katja, 1980- | 25492 |
Sibinovska, Nadica | |
Žakelj, Simon, 1976- | 22659 |
Trontelj, Jurij | 23420 |
Legen, Igor | 20369 |
Source: Personal bibliographies
and: SICRIS
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