Oral ileocolonic drug delivery by the colopulse-system: a bioavailability study in healthy volunteers

Journal of Controlled Release : Official Journal of the Controlled Release Society
R C A SchellekensJ G W Kosterink

Abstract

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 13C-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 13C-recovery data after oral administration of 13C-urea using the ColoPulse delivery system showed a delayed sigmoid release in all subjects with a lag time of > 3h (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.

Citations

Jun 4, 2013·International Journal of Pharmaceutics·Alessandra MaroniAndrea Gazzaniga
Dec 10, 2013·Isotopes in Environmental and Health Studies·Marina J M MaurerFrans Stellaard
Mar 22, 2016·International Journal of Pharmaceutics·Jacoba M MaurerHenderik W Frijlink
Aug 2, 2011·British Journal of Clinical Pharmacology·Reinout C A SchellekensJos G W Kosterink
Mar 24, 2016·European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Für Pharmazeutische Verfahrenstechnik E.V·Bahez GarebHendrik W Frijlink
Oct 8, 2013·Journal of Controlled Release : Official Journal of the Controlled Release Society·J M MaurerJ G W Kosterink
Aug 18, 2017·Angewandte Chemie·Jens AtzrodtMarc Reid
Jul 28, 2017·Expert Opinion on Drug Delivery·Alessandra MaroniAndrea Gazzaniga
Nov 6, 2020·Drug Design, Development and Therapy·Abdel Naser Zaid

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