Biowaiver Monograph for Immediate-Release Solid Oral Dosage Forms: Raltegravir Potassium.
Absorption
Bioavailability
Bioequivalence
Biopharmaceutics classification system (BCS)
Biowaiver
Dissolution
Permeability
Raltegravir potassium
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:
16 Aug 2024
16 Aug 2024
Historique:
received:
07
07
2024
revised:
12
08
2024
accepted:
12
08
2024
medline:
19
8
2024
pubmed:
19
8
2024
entrez:
18
8
2024
Statut:
aheadofprint
Résumé
The present monograph discusses the possibility of BCS-based biowaivers for immediate release pharmaceutical products containing raltegravir potassium, which is used to treat human immunodeficiency virus (HIV) infections. Raltegravir potassium can be assigned to BCS class II or IV since this compound has low solubility and uncertain permeability. Therefore, according to the ICH M9 guideline, it is not recommended to apply BCS-based biowaiver to approval of immediate release solid dosage forms of raltegravir potassium, either for new generic versions or when moderate to major changes in composition and/or the manufacturing method of the product are made.
Identifiants
pubmed: 39154736
pii: S0022-3549(24)00309-5
doi: 10.1016/j.xphs.2024.08.006
pii:
doi:
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Informations de copyright
Copyright © 2024. Published by Elsevier Inc.
Déclaration de conflit d'intérêts
Conflict of interest This article is a part of the project of the Focus Group BCS & Biowaiver. The contents of this monograph are based on the data available in the literature and represent the scientific opinion of the authors but not necessarily the policies of regulatory authorities.