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首页> 外文期刊>The Journal of pharmacy technology: jPT : official publication of the Association of Pharmacy Technicians >Long-Term Stability of the Electronic Sensor Component of a Digital Pill System in Real-World Storage Settings
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Long-Term Stability of the Electronic Sensor Component of a Digital Pill System in Real-World Storage Settings

机译：现实世界存储设置中数字丸系统的电子传感器组件的长期稳定性

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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.
机译：背景：数字药丸系统包括一个集成在明胶胶囊中的可摄取传感器，该胶囊过度包裹药物，允许实时测量药物摄取。这些系统可以改善药物依从性的评估和支持方式。目的：在本研究中，作为临床试验的一部分，我们测试了可摄取传感器的耐用性，以测量系统对每日一次的富马酸替诺福韦二丙酯/恩曲他滨（NCT03842436）依从性的可行性和可接受性。方法：研究期间未配药的数字药丸储存在药房中。从储存至少12个月并在模拟胃环境中激活的数字药丸中选择17个传感器。临床试验中使用了射频频谱分析仪和读取器设备来捕获摄入事件，用于测量发射器的激活情况。合格评估被定义为浸入水中30分钟内的通电发射器、10分钟内广播信号的能力，以及读者的成功捕获。结果：所有可摄取传感器均通过稳定性测试。模拟胃液中的平均激活时间为3.33分钟（SD=1.47）；发射器保持活动状态的平均时间为47.72分钟（SD=1.78）。这些参数符合ID Cap系统要求中定义的用于患者的指南。结论：因此，ID-Cap系统的可摄取传感器组件在长期储存后是稳定的。

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