A novel ingestible electronic drug delivery and monitoring device

• Published in: Gastrointestinal endoscopy Vol. 78; no. 3; pp. 520 - 528
• Main Authors: van der Schaar, Peter J., Dijksman, J. Frits, Broekhuizen-de Gast, Henny, Shimizu, Jeff, van Lelyveld, Niels, Zou, Hans, Iordanov, Ventzeslav, Wanke, Christoph, Siersema, Peter D.
• Format: Journal Article
• Language: English
• Published: United States Mosby, Inc 01.09.2013
• Subjects: Adult; Body Temperature; Capsules - adverse effects; Drug Delivery Systems - adverse effects; Drug Delivery Systems - instrumentation; Electrical Equipment and Supplies - adverse effects; Female; Gastroenterology and Hepatology; Gastrointestinal Tract - diagnostic imaging; Gastrointestinal Transit; Humans; Hydrogen-Ion Concentration; Male; Microcomputers; Monitoring, Physiologic - instrumentation; Radionuclide Imaging; Technetium - administration & dosage; Telemetry; Time Factors; Wireless Technology; Young Adult; 99mTc; 99mtechnetium-pertechnetate; (99m)Tc; (99m)technetium-pertechnetate
• ISSN: 0016-5107; 1097-6779; 1097-6779
• DOI: 10.1016/j.gie.2013.03.170

We developed an ingestible electronic drug delivery and monitoring system. This system includes an electronic capsule comprising a drug reservoir, a pH and temperature sensor, a microprocessor and wireless transceiver, a stepper motor, and batteries. The location of the capsule in the gut derived from pH data can be monitored in real time. The stepper motor can be remotely actuated to expel the contents of the drug reservoir. First human study. Two consecutive observational studies. University medical center. Twenty healthy volunteers. Study I: Ingestion and passage of the capsule. Study II: Ingestion and passage of the capsule, loaded with 99mtechnetium-pertechnetate (99mTc); remotely actuated expulsion of 99mTc in the gut. Study I: Safety, tolerability, and functionality (wireless pH and temperature recording). Study II: Tracing of the capsule and expulsion and distribution of 99mTc from the drug reservoir by scintigraphy. Correlating location pH with scintigraphy. Study I: Ingestion and passage of the capsule was safe and well tolerated. Transmitted pH and temperature data were received by the recorder in 96.5% ± 3%. Study II: pH-determined passage of the esophagogastric, gastroduodenal, and ileocolonic junction correlated well with scintigraphy. Expulsion of 99mTc from the capsule was successful in 9 of 10 subjects. Subjects with relatively low body mass index. This electronic drug delivery and monitoring system may be a promising tool for targeted delivery of substances to well-defined areas of the GI tract.