Staples Mark, Daniel Karen, Cima Michael J, Langer Robert
MicroCHIPS, Inc., 6-B Preston Court, Bedford, Massachusetts 01730, USA.
Pharm Res. 2006 May;23(5):847-63. doi: 10.1007/s11095-006-9906-4. Epub 2006 May 5.
Micro- and nano-electromechanical systems (MEMS and NEMS)-based drug delivery devices have become commercially-feasible due to converging technologies and regulatory accommodation. The FDA Office of Combination Products coordinates review of innovative medical therapies that join elements from multiple established categories: drugs, devices, and biologics. Combination products constructed using MEMS or NEMS technology offer revolutionary opportunities to address unmet medical needs related to dosing. These products have the potential to completely control drug release, meeting requirements for on-demand pulsatile or adjustable continuous administration for extended periods. MEMS or NEMS technologies, materials science, data management, and biological science have all significantly developed in recent years, providing a multidisciplinary foundation for developing integrated therapeutic systems. If small-scale biosensor and drug reservoir units are combined and implanted, a wireless integrated system can regulate drug release, receive sensor feedback, and transmit updates. For example, an "artificial pancreas" implementation of an integrated therapeutic system would improve diabetes management. The tools of microfabrication technology, information science, and systems biology are being combined to design increasingly sophisticated drug delivery systems that promise to significantly improve medical care.
基于微机电系统（MEMS）和纳机电系统（NEMS）的药物递送装置，由于技术融合和监管宽松，已在商业上可行。美国食品药品监督管理局（FDA）组合产品办公室负责协调对融合了多种既定类别（药物、器械和生物制品）元素的创新医疗疗法的审查。使用MEMS或NEMS技术构建的组合产品为解决与给药相关的未满足医疗需求提供了革命性机遇。这些产品有潜力完全控制药物释放，满足按需脉冲式或长期可调持续给药的要求。近年来，MEMS或NEMS技术、材料科学、数据管理和生物科学都有了显著发展，为开发集成治疗系统提供了多学科基础。如果将小型生物传感器和药物储存单元组合并植入，无线集成系统就能调节药物释放、接收传感器反馈并传输更新信息。例如，集成治疗系统的“人工胰腺”应用将改善糖尿病管理。微制造技术、信息科学和系统生物学的工具正在结合起来，以设计出越来越复杂的药物递送系统，有望显著改善医疗护理。
