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Biopharmaceutical classification of desloratadine - not all drugs are classified the easy way
ID
Berginc, Katja
(
Avtor
),
ID
Sibinovska, Nadica
(
Avtor
),
ID
Žakelj, Simon
(
Avtor
),
ID
Trontelj, Jurij
(
Avtor
),
ID
Legen, Igor
(
Avtor
)
PDF - Predstavitvena datoteka,
prenos
(433,79 KB)
MD5: 18AE0182CC80D29C61D58358242F21C5
URL - Izvorni URL, za dostop obiščite
https://sciendo.com/article/10.2478/acph-2020-0006
Galerija slik
Izvleček
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.
Jezik:
Angleški jezik
Ključne besede:
desloratadine
,
BCS-based bio-waiver
,
luminal stability
,
permeability
,
dissolution
Vrsta gradiva:
Članek v reviji
Tipologija:
1.01 - Izvirni znanstveni članek
Organizacija:
FFA - Fakulteta za farmacijo
Status publikacije:
Objavljeno
Različica publikacije:
Objavljena publikacija
Leto izida:
2020
Št. strani:
Str. 131-144
Številčenje:
Vol. 70, iss. 2
PID:
20.500.12556/RUL-141322
UDK:
544.351.3:615
ISSN pri članku:
1330-0075
DOI:
10.2478/acph-2020-0006
COBISS.SI-ID:
4797553
Datum objave v RUL:
28.09.2022
Število ogledov:
608
Število prenosov:
90
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Objavi na:
Gradivo je del revije
Naslov:
Acta pharmaceutica
Skrajšan naslov:
Acta pharm.
Založnik:
Hrvatsko farmaceutsko društvo
ISSN:
1330-0075
COBISS.SI-ID:
13497349
Licence
Licenca:
CC BY 4.0, Creative Commons Priznanje avtorstva 4.0 Mednarodna
Povezava:
http://creativecommons.org/licenses/by/4.0/deed.sl
Opis:
To je standardna licenca Creative Commons, ki daje uporabnikom največ možnosti za nadaljnjo uporabo dela, pri čemer morajo navesti avtorja.
Projekti
Financer:
ARRS - Agencija za raziskovalno dejavnost Republike Slovenije
Številka projekta:
P1-0189-2018
Naslov:
Farmacevtska tehnologija: od dostavnih sistemov učinkovin do terapijskih izidov zdravil pri otrocih in starostnikih
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