Scintigraphic evaluation of a new capsule-type colon specific drug delivery system in healthy volunteers.

Abstract:

:Colonic drug delivery is intended for local or systemic therapies. The lack of predictive in vitro or animal model leads to considerable time delays in colonic product development. The objective of this scintigraphic study was to provide "proof of concept" for a novel capsule-type colonic delivery system (Colon-Targeted Delivery Capsule) in healthy volunteers. The human data validates the design concept behind the release mechanism, in that capsule disintegration, and hence drug release, did not start until 5 h after gastric emptying, irrespective of whether the product was administered to fasted or fed subjects. However, the potential for prolonged gastric residence for large enteric coated products intended for intestinal targeting was also observed; overall, the study provides a focus for subsequent product development and highlights the role of scintigraphy in dynamically visualizing the drug delivery process.

journal_name

J Pharm Sci

authors

Ishibashi T,Pitcairn GR,Yoshino H,Mizobe M,Wilding IR

doi

10.1021/js9704588

subject

Has Abstract

pub_date

1998-05-01 00:00:00

pages

531-5

issue

5

eissn

0022-3549

issn

1520-6017

pii

S0022-3549(15)50571-6

journal_volume

87

pub_type

临床试验,杂志文章,随机对照试验
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