Regulating the pH of bicarbonate solutions without purging gases: Application to dissolution testing of enteric coated tablets, pellets and microparticles.
Bicarbonate
Biorelevant
Dissolution
Enteric coating
In vitro testing
Journal
International journal of pharmaceutics
ISSN: 1873-3476
Titre abrégé: Int J Pharm
Pays: Netherlands
ID NLM: 7804127
Informations de publication
Date de publication:
30 Jul 2020
30 Jul 2020
Historique:
received:
06
04
2020
revised:
14
06
2020
accepted:
15
06
2020
pubmed:
23
6
2020
medline:
4
3
2021
entrez:
23
6
2020
Statut:
ppublish
Résumé
Dissolution media based on bicarbonate buffers closely mimic the environment of intestinal fluids and thus improve in vitro in vivo correlation compared to phosphate buffers. Purging gases into the medium is used as a method to stabilise bicarbonate buffers; however, this causes issues due to the disturbance of the hydrodynamics in the dissolution vessel. The aim of this study was to develop a novel system to regulate and stabilise the pH of bicarbonate buffers without purging gases for the application of dissolution testing of enteric coated products. A novel enclosure system was applied to the USP II dissolution vessel to supply N
Identifiants
pubmed: 32565282
pii: S0378-5173(20)30546-9
doi: 10.1016/j.ijpharm.2020.119562
pii:
doi:
Substances chimiques
Bicarbonates
0
Buffers
0
Gases
0
Tablets, Enteric-Coated
0
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
119562Informations de copyright
Copyright © 2020 Elsevier B.V. All rights reserved.
Déclaration de conflit d'intérêts
Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.