Successful Prediction of Human Pharmacokinetics After Oral Administration by Optimized Physiologically Based Pharmacokinetics Approach and Permeation Assay Using Human Induced Pluripotent Stem Cell-Derived Intestinal Epithelial Cells.

absorption absorption, distribution, metabolism, and excretion (ADME) intestinal absorption pharmacokinetics physiologically based pharmacokinetic (PBPK) modeling

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:
04 2020
Historique:
received: 23 10 2019
revised: 16 12 2019
accepted: 18 12 2019
pubmed: 31 12 2019
medline: 22 6 2021
entrez: 30 12 2019
Statut: ppublish

Résumé

None of the physiologically based pharmacokinetic (PBPK) approaches using preclinical data show high predictability of human pharmacokinetic (PK) profiles for drugs affected by the intestinal first-pass effect. Here we report a novel PBPK approach that incorporated the findings of a permeation study using human induced pluripotent stem cell-derived intestinal epithelial cells (hiPSC-IECs) to predict human PK profiles after oral administration of drugs. In hiPSC-IECs, gene expression levels of cytochrome P450 3A4 (CYP3A4) and P-glycoprotein (P-gp) are enhanced by rifampicin and 1,25-dihydroxyvitamin D

Identifiants

pubmed: 31884012
pii: S0022-3549(19)30865-2
doi: 10.1016/j.xphs.2019.12.019
pii:
doi:

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

1605-1614

Informations de copyright

Copyright © 2020 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.

Auteurs

Kei Mayumi (K)

Research Laboratory for Development, Shionogi & Co., Ltd., 3-1-1, Futaba-cho, Toyonaka, Osaka 561-0825, Japan. Electronic address: kei.mayumi@shionogi.co.jp.

Takanori Akazawa (T)

Research Laboratory for Development, Shionogi & Co., Ltd., 3-1-1, Futaba-cho, Toyonaka, Osaka 561-0825, Japan.

Takushi Kanazu (T)

Research Laboratory for Development, Shionogi & Co., Ltd., 3-1-1, Futaba-cho, Toyonaka, Osaka 561-0825, Japan.

Shuichi Ohnishi (S)

Research Laboratory for Development, Shionogi & Co., Ltd., 3-1-1, Futaba-cho, Toyonaka, Osaka 561-0825, Japan.

Hiroshi Hasegawa (H)

Research Laboratory for Development, Shionogi & Co., Ltd., 3-1-1, Futaba-cho, Toyonaka, Osaka 561-0825, Japan.

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Classifications MeSH