A novel ingestible electronic drug delivery and monitoring device

BackgroundWe 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.ObjectivesFirst human study.DesignTwo consecutive observational studies.SettingUniversity medical center.SubjectsTwenty healthy volunteers.InterventionsStudy 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.Main Outcome MeasurementsStudy 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.ResultsStudy 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.LimitationsSubjects with relatively low body mass index.ConclusionsThis electronic drug delivery and monitoring system may be a promising tool for targeted delivery of substances to well-defined areas of the GI tract.