Current nicotine delivery patches rely on the passive diffusion of nicotine through the skin and into the fluid that surrounds the cells beneath the skin (interstitial fluid). From there, the nicotine diffuses into the capillary network, enters the blood stream, and is delivered to the brain. The nicotine is contained in a textile fiber material within the patch and nicotine is delivered continuously, as long as the patch is worn. This method of delivery fails to mimic plasma nicotine levels produced by cigarette smoking since it is not pulsatile and does not deliver the same level of nicotine. The use of passive diffusion nicotine patches as part of a smoking cessation regimen has proven to be ineffective. Since becoming available over the counter, nicotine replacement therapy (NRT) appears no longer effective in increasing long-term successful cessation in smokers. In this project, AST proposes to develop a non-invasive methodology to deliver nicotine, transdermally, in a truly pulsatile manner using iontophoresis. Scientific evidence suggests that following a cessation regimen that replicates the plasma nicotine levels and pattern of delivery obtained while smoking will increase the probability of a successful cessation outcome.
