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

Development of novel zero-order release budesonide tablets for the treatment of ileo-colonic inflammatory bowel disease and comparison with formulations currently used in clinical practice

“…Even though the GISS is a simple in vitro model, we applied it for quality assurance of ColoPulse coating performance in several clinical trials. We have shown that ColoPulse coating performance in vitro correlates with coating performance in vivo, although this does not assure the same in vivo budesonide release profile from the novel formulations (Maurer et al, 2015, 2013, Schellekens et al, 2010. This should be investigated in a clinical trial.…”

“…Previously, we have shown with stable isotope experiments and through comparative profiling with the IntelliCap capsule that ColoPulse-coated tablets and capsules target the ileo-colon in healthy subjects as well as CD patients. Additionally, food and time of food intake did not substantially influence the targeting performance in healthy subjects and CD patients (Maurer et al, 2015, 2013, Schellekens et al, 2010.…”

Applying Structuring Approaches for Satiety

“…A survey of the commercial and patent literature reveals a range of technology routes suggested to have potential application in achieving this (e.g., Mela, 2006;Chu et al, 2009;Knutson et al, 2010;Schellekens et al, 2010;Li et al, 2011;Müller et al, 2012). These can be derived from local hydrolysis of triacylglycerides, as indicated by the infusion studies.…”

Applications of stable isotopes in clinical pharmacology

“…Stable isotope technology has been used to assess oral colon drug delivery systems in a few cases. To this end, 13 C-glucose [50,51] and 13 C-urea [52,53] have so far been used as marker substances. Both marker substances signal their arrival in bacteria-rich intestinal segments.…”