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Biopharmaceutical classification of desloratadine - not all drugs are classified the easy way
ID Berginc, Katja (Author), ID Sibinovska, Nadica (Author), ID Žakelj, Simon (Author), ID Trontelj, Jurij (Author), ID Legen, Igor (Author)

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Abstract
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.

Language:English
Keywords:desloratadine, BCS-based bio-waiver, luminal stability, permeability, dissolution
Work type:Article
Typology:1.01 - Original Scientific Article
Organization:FFA - Faculty of Pharmacy
Publication status:Published
Publication version:Version of Record
Year:2020
Number of pages:Str. 131-144
Numbering:Vol. 70, iss. 2
PID:20.500.12556/RUL-141322 This link opens in a new window
UDC:544.351.3:615
ISSN on article:1330-0075
DOI:10.2478/acph-2020-0006 This link opens in a new window
COBISS.SI-ID:4797553 This link opens in a new window
Publication date in RUL:28.09.2022
Views:627
Downloads:90
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Record is a part of a journal

Title:Acta pharmaceutica
Shortened title:Acta pharm.
Publisher:Hrvatsko farmaceutsko društvo
ISSN:1330-0075
COBISS.SI-ID:13497349 This link opens in a new window

Licences

License:CC BY 4.0, Creative Commons Attribution 4.0 International
Link:http://creativecommons.org/licenses/by/4.0/
Description:This is the standard Creative Commons license that gives others maximum freedom to do what they want with the work as long as they credit the author.

Projects

Funder:ARRS - Slovenian Research Agency
Project number:P1-0189-2018
Name:Farmacevtska tehnologija: od dostavnih sistemov učinkovin do terapijskih izidov zdravil pri otrocih in starostnikih

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