Functionality and Acceptance of the EsoCap System – A Novel Film-Based Drug Delivery Technology: Results of an In Vivo Study
There are no methods for specific local application of active substances to the mucosa of the esophagus to treat eosinophilic esophagitis or other esophageal diseases. This publication describes the principal in vivo functionality and acceptance of a novel modular drug delivery concept, called EsoCap system, by 12 healthy volunteers. For the first time, the EsoCap system enables targeted placement on the esophageal mucosa of a mucoadhesive polymer film.
Acceptance was determined by means of a standardized questionnaire after administration and functionality of the device by MRI scans. Two different setups of the EsoCap system were tested: one setup with a density of 0.4 g/cm3 and one with a density of 1.0 g/cm3. Acceptability of the dosage form was also confirmed in addition to functionality, by measuring the applied film length.
It was found that acceptance of the variant with the higher density was significantly better. This novel drug delivery technology could enable a targeted, local and long-lasting therapy of the esophagus for the first time, depending on the polymer film used.
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Materials: All materials used were supplied in pharmaceutical or food-grade quality. The hard gelatin capsules (size 00; length 23.3 mm; diameter 8.2 mm) were purchased from Wepa (Hillscheid, Germany). Polyvinyl alcohol (PVA 18-88) was provided by Merck (Darmstadt, Germany). The glycerol needed as a plasticizer for film production was obtained from Caelo (Hilden, Germany). Demineralized water was used as a solvent. Food-grade polylactic acid filament from Formfutura (Nijmegen, the Netherlands) was being used for the production of the drinking cup and applicators. 3D printing of the drinking cup and applicators has been described previously [8]. Hibiscus tea was purchased from Spinnrad (Bad Segeberg, Germany) as a contrasting agent for MRI. A food-grade polyester string used (hereinafter referred to as “retainer”) was purchased from Westmark (Lennestadt-Elspe, Germany). Calcium dihydrogen phosphate and croscarmellose sodium were supplied by JRS Pharma (Rosenberg, Germany), magnesium stearate by Sigma Aldrich Chemie (Taufkirchen, Germany) and iron oxide by Caelo.
Article information: Rosenbaum, C.; Grimm, M.; Krause, J.; Rump, A.; Kessler, R.; Hosten, N.; Weitschies, W. Functionality and Acceptance of the EsoCap System—A Novel Film-Based Drug Delivery Technology: Results of an In Vivo Study. Pharmaceutics 2021, 13, 828. https://doi.org/10.3390/pharmaceutics13060828