Transdermal Delivery Using a Novel Electrochemical Device, Part 2: In Vivo Study in Humans

A single-center, open-label, and dose-escalation clinical trial has been performed using a novel electrochemical transdermal patch comprising a drug-loaded hydrogel sandwiched between two silver electrodes. The lower electrode is attached flatly to skin via an adhesive layer. This noniontophoretic device produces flux enhancement via voltage-induced electrolysis of the water in the hydrogel. A voltage application of 2 V over 60 s produced release of approximately 315 to 340 μg of fentanyl from a patch. A single-voltage application at t = 16 h produced a maximum plasma level of approximately 200 pg/mL before patch removal at t = 41 h. Consecutive voltage applications at t = 16 h and t = 40 h produced a maximum plasma level of approximately 730 pg/mL. The lag time between voltage application and achievement of a plasma profile plateau is longer than that reported for an iontophoretic patch. The patch's advantage is production of an on-demand plasma profile without the use of potentially irritating iontophoresis. In contrast to a passive transdermal system, it is possible to adjust the plasma profile by using voltage application. It is not necessary to apply a continual current, in contrast to iontophoretic systems. © 2012 Wiley Periodicals, Inc. and the American Pharmacists Association J Pharm Sci 101:2262-2268, 2012