Patent ID: 8496960

Claim:
A transdermal multi-layered delivery device comprising a single active agent consisting of amorphous terazosin in an amount that is substantially greater than the amount to be delivered to a patient, the amount of amorphous terazosin contained in the device providing a means by which the active agent migrates through the layers of the device to the desired site on the patient's skin, wherein one of the layers is a reservoir layer comprising 20 to 90% of a polymeric matrix, 0.1 to 30% of a softening agent, 0.1 to 20% of the amorphous terazosin, and 0.1 to 30% of a solvent for the amorphous terazosin, the polymeric matrix comprising a polymer selected from the group consisting of polyethylene, polypropylene, ethylene/propylene copolymers, ethylene/ethylacrylate copolymers, ethylenevinyl acetate copolymers, silicones, rubber, polyacrylic esters and the copolymers thereof, polyurethanes, polyisobutylene, chlorinated polyethylene, polyvinylchloride, vinyl chloride-vinyl acetate copolymer, polymethacrylate polymer, polyvinylidene chloride, poly(ethylene terephthalate), ethylene-vinyl alcohol copolymer, ethylene-vinyloxyethanol copolymer, silicones, silicone copolymers, cellulose, polycarbonates, polytetrafluoroethylene and mixtures thereof, the amorphous terazosin is the only active agent in the device, the device is adapted to release a therapeutically effective amount of amorphous terazosin to maintain a terazosin plasma level of from about 1.0 ng/ml to about 60 ng/ml in a human patient over at least 24 hours after application of the transdermal delivery device onto the skin of the patient, and wherein the device is adapted to provide a mean relative release rate of the amorphous terazosin of from about 1 μg/hr/cm 2 to about 30 μg/hr/cm 2 at 24 hours, and an in-vitro cumulative amount of permeation of from about 52.8 μg/cm 2 to about 686.4 μg/cm 2 at 24 hours; from about 105.6 μg/cm 2 to about 1372.8 μg/cm 2 at 48 hours; and from about 158.4 μg/cm 2 to about 2059.2 μg/cm 2 at 72 hours, as determined via an in-vitro permeation test utilizing a Valia-Chien cell where the membrane is a human cadaver skin and the cell has a receptor chamber containing a 30:70 mixture of ethanol:water.