Drug Delivery Technology - May 2010

A dminMed is developing an innovative line of novel microneedle-based transdermal drug delivery devices. The current pipeline comprises an advanced microneedle arraybased pen-injector device (the AdminPen) that painlessly and conveniently injects therapeutic levels of standard liquid pharmaceutical drugs or cosmetic actives through the skin. This breakthrough technology revolutionizes the way in which medicines can be administered, increasing efficacy, safety, and compliance. Previous studies have demonstrated that a wide range of pharmaceutical compounds can be delivered using microneedle arrays, including small molecules, peptides, and proteins. Studies with many subjects have shown that the microneedle arrays are essentially painless and have no adverse side effects. Nevertheless, the earlier developed microneedle technologies are not well suited for commercialization because of very high manufacturing costs due to use of exotic fabrication techniques, need for significant changes in drug formulations due to their inability to deliver standard liquid drug formulations, and therefore unclear and lengthy regulatory approval processes. AdminPen is expected to be classified as a Class II medical device with a 510(k) regulatory approval route and can be economically produced to scale using mature high-volume low-cost processes. The injection of vaccines (influenza, HIV, cancer, smallpox, and anthrax), hormones (PTH and hGH), insulin, obesitymanagement drugs (leptin, liraglutide), and cosmetic dermal fillers (hyaluronic acid and PMMA micro-spheres) would be excellent initial indications for this device. The system substantially mimics a conventional liquid-reservoir microneedle transdermal patch that can be attached to a standard syringe. One substantial difference from a standard transdermal patch is that this innovative AdminPen drug delivery device will have the ability to deliver large amounts of a drug in a short period of time similar to a standard injection with a hypodermic needle. By comparison, conventional transdermal patches deliver only a small fraction of the pharmaceutical ingredient incorporated in a transdermal patch. In addition, the technology can deliver therapeutic levels of pharmaceutical drugs in 10 to 60 seconds versus the 1 to 2 hours needed for the currently marketed transdermal patches. Existing transdermal patches are limited to using only a very few (less than 10 compounds are currently being delivered in drug patches), small molecule (< 500 Daltons), lipophilic drug formulations that can cross intact skin at a flux sufficient to be clinically useful. BACKGROUND MICRONEEDLE ARRAYS