Proof of Principle
EsoCap technology has been validated at the University of Greifswald, Germany, in a functional proof of principle study in man.
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.
This data was presented at the AAPS (American Association of Pharmaceutical Scientists), San Antonio, November 2019 (Grimm et al., 2019) and published in the Journal of Controlled Release in August 2020 (Krause et al., J Control Release 2020; 327:1-7)¹ as well as in Pharmaceutics in May 2021 (Rosenbaum et al., Pharmaceutics 2021, 13, 828)².
¹Krause et al., 2020. The EsoCap-system – An innovative platform to drug targeting in the esophagus. Journal of controlled release, 327, pp.1–7.
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²C Rosenbaum et al, Pharmaceutics 2021; Functionality and Acceptance of the EsoCap System—A Novel Film-Based Drug Delivery Technology: Results of an In Vivo Study, 13, 828
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