期刊
JOURNAL OF CONTROLLED RELEASE
卷 146, 期 3, 页码 334-340出版社
ELSEVIER SCIENCE BV
DOI: 10.1016/j.jconrel.2010.05.028
关键词
Colon delivery; ColoPulse; Stable isotope; Intestinal metabolism; Bioavailability; Urea
The release profile of a novel oral ileocolonic drug delivery technology (ColoPulse-technology) was assessed by a combination of conventional kinetics of a marker substance in blood and site-specific signaling by stable isotope technology. Since ileocolonic delivery involves the drug release in a region in which bacteria are highly present, a prolonged lag time should coincide with proven bacterial enzyme activity. The latter can be tested using C-13-urea as the marker substance. The study was designed as a two period (uncoated versus coated capsule) crossover single dose bioavailability study in healthy subjects. The C-13-recovery data after oral administration of C-13-urea using the ColoPulse delivery system showed a delayed sigmoid release in all subjects with a lag time of >3 h (median: 330 min.). Release was achieved in a urease-containing intestinal segment in all healthy subjects. Complete release in the ileocolonic region was achieved in 10 of 11 subjects. The ColoPulse-technology therefore enables specific and reliable drug delivery in the ileocolonic region in healthy volunteers. (c) 2010 Elsevier B.V. All rights reserved.
作者
我是这篇论文的作者
点击您的名字以认领此论文并将其添加到您的个人资料中。
推荐
暂无数据