New fabrication results
The paper describes research at the Georgia Institute of Technology on fabricating hollow and solid microneedles in a variety of sizes and shapes from metals, biodegradable polymers, silicon and glass. It also reports on testing with cadaver skin and animals that demonstrates the ability of the micron-scale needles to deliver proteins, nanoparticles, and both small and large molecules through the skin.
"Weve opened up the potential use of microneedles for delivering a broad range of therapeutics," said Mark Prausnitz, a professor in Georgia Techs School of Chemical and Biomolecular Engineering and principal investigator for the project. "Fabricating both hollow and solid microneedles in a variety of shapes, sizes and materials allows us to deliver large molecules with significant therapeutic interest such as insulin, proteins produced by the biotechnology industry, and nanoparticles that could encapsulate a drug or demonstrate the ability to deliver a virus for vaccinations."
Microneedles are expected to be less painful than conventional hypodermic needles because they are too small to significantly stimulate nerve endings, Prausnitz said. Small-scale studies so far have confirmed that expectation, and additional pain studies are planned. The safety and effectiveness of microneedles must still be proven in humans before they can receive Food & Drug Administration approval for clinical use.
Before microneedles find widespread use, the researchers must perfect the techniques for optimally inserting them into the skin, and complete the integration of microneedles into a full drug delivery system. The need to minimize variability in needle insertion is being addressed in part by development of an applicator device that would be part of the delivery system.
Several companies are pursuing development of microneedles, including some that are conducting clinical trials.
"There is an aggressive movement toward bringing microneedles to the market," Prausnitz said. "Weve shown that microneedles can serve as a hybrid drug delivery system, combining the advantages of conventional needles – which deliver drugs easily – with transdermal patches that are more patient-friendly. I expect that within the next five years, a microneedle device will become available for clinical use."
Beyond Prausnitz, the research team includes Devin McAllister, Ping Wang, Shawn Davis, Jung-Hwan Park, Paul Canatella and Mark Allen. The research has been sponsored by the National Institutes of Health (NIH), the National Science Foundation (NSF), the American Diabetes Association and the Defense Advanced Research Projects Agency (DARPA).
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