Proof of Principle

The drug delivery principle’s functionality was demonstrated via MRI (magnetic resonance imaging), using the fully developed device loaded with a contrast agent. The trial showed that it is possible to deliver a mucoadhesive film to the esophagus by rolling off from a capsule during swallowing. It was found that the film rolled off in all healthy volunteers participating in the study and was correctly placed and attached to the esophageal mucosa in each single case. MRI images were generated at different time points after application. It was determined that the film is visible on the esophageal mucosa for at least 15 minutes. This is significantly longer than the contact time of less than one minute for oral orodispersible tablets (Burton et al., 1995; Washington et al., 2000). The general swallowability and acceptance were very good and no severe reactions (e.g. vomiting) were observed.