title: Transdermal delivery using a novel electrochemical device, part 2: in vivo study in humans.
abstract: 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.
authors.affiliation: Acino AG, Miesbach 83714, Germany.
authors.forename: Britta
authors.initials: B
authors.lastname: Schröder
authors.forename: Ulrich
authors.initials: U
authors.lastname: Nickel
authors.forename: Elisabeth
authors.initials: E
authors.lastname: Meyer
authors.forename: Geoffrey
authors.initials: G
authors.lastname: Lee
mesh_terms: D000279:Administration, Cutaneous; D000293:Adolescent; D000328:Adult; D000701:Analgesics, Opioid / Q000008:administration & dosage; D055664:Electrochemical Techniques / Q000295:instrumentation*; D005283:Fentanyl / Q000008:administration & dosage; D006801:Humans; D007478:Iontophoresis; D008297:Male; D008875:Middle Aged
chemical_list: D000701:Analgesics, Opioid; D005283:Fentanyl