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Claims for Patent: 4,983,395

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Claims for Patent: 4,983,395

Title: Device for administering an active agent to the skin or mucosa
Abstract:A transdermal drug delivery device comprising a drug formulation-containing reservoir defined by a backing layer and a drug-permeable membrane layer, a peelable inner liner that underlies the reservoir and a portion of the backing/membrane outwardly of the reservoir periphery, an adhesive layer that underlies the inner liner and outwardly extending portions of the membrane/backing layers, and a peelable release liner layer that underlies the adhesive layer with a first permanent heat seal between the backing and the membrane about the perimeter of the reservoir and another concentric peelable (impermanent) heat seal between the membrane and the inner liner positioned underlying and at a radius not less than the first permanent heat seal, the heat seals and peelable barrier layer providing barriers that isolate the drug formulation from the adhesive.
Inventor(s): Chang; Yunik (Toms River, NJ), Patel; Dinesh C. (Murray, UT), Ebert; Charles D. (Salt Lake City, UT)
Assignee: TheraTech Inc. (Salt Lake City, UT)
Application Number:07/326,536
Patent Claims: 1. A device for administering an active agent to the skin or mucosa of an individual comprising a laminated composite of:

(a) a backing layer;

(b) an active agent-permeable membrane, the backing layer and membrane defining

(c) a reservoir therebetween that contains a formulation of the active agent, said reservoir having a smaller periphery than the backing layer and membrane such that a portion of the backing layer and membrane extends outwardly of the periphery of the reservoir;

(d) a first peelable active agent formulation-impermeable layer that underlies the reservoir and a portion of said outwardly extending portion of the backing layer and membrane;

(e) an adhesive layer that underlies and covers the first peelable active agent formulation-impermeable layer and said outwardly extending portion of the backing layer and membrane;

(f) a second peelable active agent formulation-impermeable layer that underlies and covers the adhesive layer;

(g) a permanent heat seal about the periphery of the reservoir between the backing layer and the membrane; and

(h) a peelable heat seal between the membrane and the first peelable active agent formulation-impermeable layer located underneath and at a radius not less than that of the permanent heat seal, said permanent and peelable heat seals providing barriers to migration of components of the active agent formulation from the reservoir into the adhesive layer and said first and second peelable active agent impermeable layers being bonded together such that when the second peelable layer is removed from the device the peelable heat seal is broken and the first peelable layer and underlying portion of the adhesive layer is removed therewith.

2. The device of claim 1 wherein the adhesive is incompatible with one or more of the components of the formulation that permeate through the membrane to the skin or mucosa.

3. The device of claim 1 wherein the backing layer is a laminated composite of at least one layer that is impermeable to the formulation and an inner heat-sealable layer.

4. The device of claim 1 wherein the adhesive is an acrylic adhesive, the active agent is pindolol hydrochloride, and the formulation includes ethyl alcohol and glycerol monooleate.

5. The device of claim 1 wherein the adhesive is an acrylic adhesive, the active agent is nicardipine hydrochloride, and the formulation includes ethyl alcohol and glycerol monooleate.

6. The device of claim 1 wherein the adhesive is a silicone adhesive, the active agent is calcitriol and the formulation includes ethanol, methyl laurate, and water.
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