An Assessment of Occasional Bio-Inequivalence for BCS1 and BCS3 Drugs: What are the Underlying Reasons?
Bioequivalence
Biopharmaceutics classification system (BCS)
Biowaiver
Dissolution
Motility
Pharmacokinetics
Solubility
Journal
Journal of pharmaceutical sciences
ISSN: 1520-6017
Titre abrégé: J Pharm Sci
Pays: United States
ID NLM: 2985195R
Informations de publication
Date de publication:
01 2022
01 2022
Historique:
received:
04
06
2021
revised:
02
08
2021
accepted:
02
08
2021
pubmed:
8
8
2021
medline:
17
3
2022
entrez:
7
8
2021
Statut:
ppublish
Résumé
Despite having adequate solubility properties, bioequivalence (BE) studies performed on immediate release formulations containing BCS1/3 drugs occasionally fail. By systematically evaluating a set of 17 soluble drugs where unexpected BE failures have been reported and comparing to a set of 29 drugs where no such reports have been documented, a broad assessment of the risk factors leading to BE failure was performed. BE failures for BCS1/3 drugs were predominantly related to changes in C
Identifiants
pubmed: 34363838
pii: S0022-3549(21)00399-3
doi: 10.1016/j.xphs.2021.08.001
pii:
doi:
Substances chimiques
Excipients
0
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
124-134Informations de copyright
Copyright © 2021 American Pharmacists Association. Published by Elsevier Inc. All rights reserved.
Déclaration de conflit d'intérêts
Declaration of interests 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.