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The biorelevant simulation of gastric emptying and its impact on model drug dissolution and absorption kineticsVrbanac, Helena ...The highly variable physiological conditions within the gastrointestinal tract can cause variable drug release and absorption from the orally administrated dosage forms. The emptying of the gastric ... content is one of the most critical physiological processes, dictating the amount of the active ingredient available for absorption into the systemic circulation. In this study, we prepared two water gastric emptying regimes on advanced gastric simulator (AGS) with programmable %pyloric% valve. Gastric emptying regimes were designed in such a way to capture the main findings of the MRI (magnetic resonance imaging) in vivo studies, conducted under fasted conditions according to the EMA and FDA guidelines for bioavailability and bioequivalence studies. Four immediate release formulations containing a model drug of BCS class III were tested. Comparative dissolution tests were also performed with the USP2 apparatus. In vitro release profiles were compared to the in vivo data in order to evaluate the importance of gastric emptying for subsequent absorption of the active substance from the tested formulations. Our bio-relevant in vitro dissolution model showed good discriminatory power for all of the tested formulations. Moreover, a better relation to in vivo data was achieved with AGS with respect to the tested conventional dissolution method.Source: European journal of pharmaceutics and biopharmaceutics. - ISSN 0939-6411 (Vol. 149, 2020, str. 113-120)Type of material - article, component part ; adult, seriousPublish date - 2020Language - englishCOBISS.SI-ID - 4884849
Author
Vrbanac, Helena |
Trontelj, Jurij |
Berglez, Sandra |
Petek, Boštjan |
Opara, Jerneja |
Jereb, Rebeka |
Krajcar, Dejan |
Legen, Igor
Topics
Zdravila |
Želodec |
stomach |
gastric emptying |
biorelevant dissolution testing |
immediate release |
magenstrasse |
topnost zdravil |
sproščanje zdravilnih učinkovin |
praznenje želodca
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Author | Vrbanac, Helena ... |
Title | The biorelevant simulation of gastric emptying and its impact on model drug dissolution and absorption kinetics |
Publication date | 2020-04-28 |
COBISS.SI-ID | 4884849 |
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 |
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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 |
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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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Vrbanac, Helena | 50717 |
Trontelj, Jurij | 23420 |
Berglez, Sandra | 33369 |
Petek, Boštjan | ![]() |
Opara, Jerneja | 14105 |
Jereb, Rebeka | 50714 |
Krajcar, Dejan | ![]() |
Legen, Igor | 20369 |
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