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- Title
Long-Term Stability of the Electronic Sensor Component of a Digital Pill System in Real-World Storage Settings.
- Authors
Chai, Peter R.; Goodman, Georgia; Bustamante, Majo J.; Mohamed, Yassir; Castillo-Mancilla, Jose; Boyer, Edward W.; Mayer, Kenneth H.; Rosen, Rochelle K.; Baumgartner, Susan L.; Buffkin, Eric; O'Cleirigh, Conall
- Abstract
Background: Digital pill systems comprise an ingestible sensor integrated into a gelatin capsule that overencapsulates medication allowing real-time measures of medication ingestion. These systems may improve the manner in which medication adherence can be assessed and supported. Objective: In this investigation, we tested the durability of the ingestible sensor as part of a clinical trial to measure the feasibility and acceptability of the system to measure adherence to once daily tenofovir disoproxil fumarate/emtricitabine (NCT03842436). Methods: Digital pills not dispensed during the study were stored in a pharmacy. Seventeen sensors were selected from digital pills stored for at least 12 months and activated in a simulated gastric environment. A radiofrequency spectrum analyzer and the reader device used in the clinical trial to capture ingestion events were used to measure activation of emitters. A passing evaluation was defined as an energized emitter within 30 minutes of immersion, ability to broadcast a signal for 10 minutes, and successful acquisition by the reader. Results: All ingestible sensors passed the stability test. Mean activation time in simulated gastric fluid was 3.33 minutes (SD = 1.47); emitters remained active for a mean of 47.72 minutes (SD = 1.78). These parameters matched guidelines defined in the ID-Cap system requirements for use in patients. Conclusions: Ingestible sensor components of the ID-Cap system were therefore stable after long-term storage.
- Subjects
CLINICAL drug trials; DRUG delivery systems; BIOSENSORS; COMPUTER simulation; CLINICAL trials; AUTOANALYZERS; PHARMACY databases; EMTRICITABINE-tenofovir; DESCRIPTIVE statistics; DRUG storage; PATIENT compliance; SPECTRUM analysis
- Publication
Journal of Pharmacy Technology, 2021, Vol 37, Issue 3, p135
- ISSN
8755-1225
- Publication type
Article
- DOI
10.1177/8755122520985219