SBIR Phase II: Electronic Pills for Medication Compliance

本小企业创新研究（SBIR）第二阶段研究项目将评估电子药丸用于药物依从性监测的使用。药物依从性监测在药物临床试验、老年医学和精神健康/成瘾医学中至关重要。准确确定药物依从性的唯一经过验证的方法是直接观察治疗，其中人员在患者摄入期间在场。这项技术是劳动密集型的，但有效。体内生物遥测和监测是一个快速发展的领域，可能会提供医疗监测的下一个关键突破。这项研究将集中在这两种解决方案的开发上，即在现有胶囊或药丸的外部印刷UHF可吸收天线，有或没有旨在提高信噪比和提供ID能力的芯片。天线将采用标准喷墨技术打印。手持射频通信设备将感应到胃肠道中药丸的存在，并积极确认药物治疗方案得到了适当的遵循。电子药丸技术和研发将有助于扩大快速发展的体内遥测领域。可生物降解的低功耗微型电路的发展将是未来生物植入芯片和传感器的重要一步。此外，药物依从性在许多医学领域都非常重要。特别是，更好的合规性监测可以大大降低与FDA批准药物相关的成本，并为准确确定低概率副作用提供显着改进的数据。

This Small Business Innovation Research (SBIR) Phase II research project shall evaluate the use of electronic pills for medication compliance monitoring. Medication compliance monitoring is critical in pharmaceutical clinical trials, geriatrics, and mental health /addiction medicine. The only proven method for accurately determining medication compliance is directly observed therapy where personnel are present duringingestion by the patient. This technique is labor intensive, but effective. In vivo biotelemetry and monitoring is a rapidly growing field that may provide the next critical breakthrough in medical monitoring. This research will focus on the development of these two solutions, namely a UHF resorbable antenna printed on the outside of an existing capsule or pill with or without a chip designed to improve signal to noise ratio and provide ID capability. The antennas will be printed with standard ink-jet technology. A handheld RF communication device will sense the presence of the pill in the GI tract and positively confirm that the medication regimen was followed appropriately.Electronic pill technology and R&D will help expand the rapidly growing field of in vivo telemetry. The development of biodegradable low power miniature circuits will be an important step to future bio-implantable chips and sensors. Additionally, the field of medication compliance is tremendously important in many areas of medicine. In particular, better compliance monitoring can greatly reduce the costs associated with FDA approval of pharmaceuticals as well as provide dramatically improved data for accurate determination of low probability side effects.