Usefulness of the BioGIT system in screening for differences in early exposure in the fasted state on an a priori basis.
BioGIT
Correlation
Early exposure
Enabling formulations
Low solubility
Journal
International journal of pharmaceutics
ISSN: 1873-3476
Titre abrégé: Int J Pharm
Pays: Netherlands
ID NLM: 7804127
Informations de publication
Date de publication:
05 Mar 2023
05 Mar 2023
Historique:
received:
09
11
2022
revised:
20
01
2023
accepted:
28
01
2023
pubmed:
4
2
2023
medline:
25
2
2023
entrez:
3
2
2023
Statut:
ppublish
Résumé
The objective of the present study was to confirm the usefulness of BioGIT data in the evaluation of the impact of dose and/or formulation on early exposure after oral administration of immediate release or enabling products of low solubility active pharmaceutical ingredients (APIs) with a glass of water in the fasted state. BioGIT experiments were performed with four APIs: Compound Α (tablet, three dose levels), Compound E (capsule PiC1, capsule PiC2 and tablet), fenofibrate (Lipidil® capsule and Lipidil 145 ONE® tablet) and Compound F (HP-β-CD aqueous solution and tablet). Based on mean plasma AUC
Identifiants
pubmed: 36736968
pii: S0378-5173(23)00090-X
doi: 10.1016/j.ijpharm.2023.122670
pii:
doi:
Substances chimiques
Fenofibrate
U202363UOS
Diclofenac
144O8QL0L1
Tablets
0
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
122670Informations de copyright
Copyright © 2023 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.