On the usefulness of compendial setups and tiny-TIM system in evaluating the in vivo performance of oral drug products with various release profiles in the fasted state: Case example sodium salt of A6197.
Biorelevant dissolution
Dissolution apparatus I
Dissolution apparatus II
Dissolution apparatus IV
Immediate release
Modified release
Pharmaceutical bioaccessibility
Tiny-TIM system
Journal
European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V
ISSN: 1873-3441
Titre abrégé: Eur J Pharm Biopharm
Pays: Netherlands
ID NLM: 9109778
Informations de publication
Date de publication:
Apr 2020
Apr 2020
Historique:
received:
05
09
2019
revised:
13
01
2020
accepted:
05
02
2020
pubmed:
15
2
2020
medline:
1
12
2020
entrez:
15
2
2020
Statut:
ppublish
Résumé
We evaluated the usefulness of quality control dissolution data collected with compendial Apparatus I and II, biorelevant dissolution data collected with compendial apparatus IV, and bioaccessibility data collected with the non-compendial tiny-TIM system in screening modified release formulations during the development of BCS Class I compounds using a Boehringer Ingelheim model experimental compound, A6197. Four products were investigated: an immediate release tablet, an extended release tablet, modified release mini-tablets, and extended release pellets. Data with modified release products collected with the compendial apparatus were evaluated vs. the average intraluminal dissolution estimated after deconvoluting clinical data collected in healthy adults. Data collected with the tiny-TIM system were evaluated vs. the average AUC and C
Identifiants
pubmed: 32057905
pii: S0939-6411(20)30036-9
doi: 10.1016/j.ejpb.2020.02.003
pii:
doi:
Substances chimiques
Delayed-Action Preparations
0
Pharmaceutical Preparations
0
Tablets
0
Sodium
9NEZ333N27
Types de publication
Comparative Study
Journal Article
Randomized Controlled Trial
Langues
eng
Sous-ensembles de citation
IM
Pagination
154-162Informations de copyright
Copyright © 2020 Elsevier B.V. All rights reserved.