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Application of Micro- and Nano-Electromechanical Devices to Drug Delivery

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Abstract

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.

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Abbreviations

ANN:

artificial neural network

AUC:

area under the plasma drug concentration vs. time curve; a measure of drug exposure

BCNU:

carmustine, an antineoplastic agent

Bio-IT:

convergence of bioscience with information technology

BLA:

biologics license application

DNA:

deoxyribonucleic acid

DRIE:

deep-reactive ion etching

FDA:

Food and Drug Administration of the United States Dept. of Health and Human Services

HGH:

humangrowth hormone

NDA:

New Drug Application

MEMS:

micro‐electromechanical systems

NEMS:

nano‐electromechanical systems

OCP:

Office of Combination Products

PDMS:

polydimethylsiloxane

PLA:

poly(L-lactic acid)

PLGA:

poly(lactide-co-glycolide)

PMA:

Premarket Approval (Device Application)

PMMA:

polymethylmethacrylate

PZT:

piezoelectric transducer

SD:

standard deviation

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Acknowledgments

The authors thank Norman Sheppard, Jim Prescott and John Santini for their helpful comments during preparation of this review.

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Staples, M., Daniel, K., Cima, M.J. et al. Application of Micro- and Nano-Electromechanical Devices to Drug Delivery. Pharm Res 23, 847–863 (2006). https://doi.org/10.1007/s11095-006-9906-4

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