# US 8,784,874 B2 · Multi-layer transdermal drug delivery device > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 8,784,874 B2 - Document ID: US8784874B2 - Status: Granted - Kind: B2 - Application number: 10/939,163 - Filed: 2004-09-10 - Published: 2005-06-16 - Granted: 2014-07-22 - Earliest claimed: 2003-09-10 - Assignees: Noven Pharmaceuticals, Inc. - Applicants: Robert C. Strauss - Inventors: Robert C. Strauss - Web page: https://patentgrep.com/patent/US8784874B2 ## CPC - A61K 9/703: {characterised by shape or structure; Details concerning release liner or backing; Refillable patches; User-activated patches} - A61K 9/7084: {Transdermal patches having a drug layer or reservoir, and one or more separate drug-free skin-adhesive layers, e.g. between drug reservoir and skin, or surrounding the drug reservoir; Liquid-filled reservoir patches} - A61K 9/7092: {Transdermal patches having multiple drug layers or reservoirs, e.g. for obtaining a specific release pattern, or for combining different drugs} - A61K 31/00: Medicinal preparations containing organic active ingredients - A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D) ## Abstract A drug delivery device initially having two adhesive layers containing at least one active agent in each layer are kept separate from each other prior to administration of the active agent. At the time of administration, the separated layers are combined to form a dual layer adhesive transdermal drug delivery device which results in the administration of the at least one active compound after topical application of the device. ## Claims ### Claim 1 A multi-layer transdermal delivery system comprising: a first layer assembly and a second layer assembly, each having a first face and a second face and each containing a therapeutically effective amount of at least one systemically pharmaceutically active agent; wherein: said first layer assembly is capable of being selectively adhesively adhered to said second layer assembly, which is capable of being selectively adhesively adhered to a user's epidermis; said first layer assembly and said second layer assembly are separate from each other to maintain characteristics of the assemblies until use; said first layer assembly comprises (i) a first face release liner adhered to said first face, (ii) a backing layer adhered to said second face; and (iii) a second face release liner adhered to said backing layer; said second layer assembly comprises (i) a first face release liner adhered to said first face and a (ii) a second face release liner adhered to said second face, and does not include a backing layer; and said first face of said first layer assembly and said first face of said second layer assembly are adapted to be applied to each other, upon removal of said first face release liner(s), and prior to use, to form a single multi-layer system wherein said first and second layer assemblies are arranged vertically with respect to one another. ### Claim 2 (depends on 1) The transdermal delivery system of claim 1, wherein the at least one systemically pharmaceutically active agent in each of the first and second assemblies is the same agent. ### Claim 3 (depends on 2) The transdermal delivery system of claim 2, wherein the at least one systemically pharmaceutically active agent in each of the first and second assemblies is present in different concentrations. ### Claim 4 (depends on 1) The transdermal delivery system of claim 1, wherein the at least one systemically pharmaceutically active agent in each of the first and second assemblies is a different pharmaceutically active agent. ### Claim 5 (depends on 1) The transdermal delivery system of claim 1, wherein the at least one systemically pharmaceutically active agent in each of the first and second assemblies is delivered at a selected delivery rate from each of the assemblies. ### Claim 6 (depends on 5) The transdermal delivery system of claim 5, wherein the delivery rate of the at least one systemically pharmaceutically active agent from each of the assemblies is different. ### Claim 7 (depends on 5) The transdermal delivery system of claim 5, wherein the delivery rate of the at least one systemically pharmaceutically active agent from each of the assemblies is selected such that during use of the single multilayer system, the at least one systemically pharmaceutically active agent is provided at a selected delivery rate from said single multilayer system. ### Claim 8 (depends on 5) The transdermal delivery system of claim 5, wherein each of the first and second assemblies comprises at least two systemically pharmaceutically active agents, and the delivery rate from each of the assemblies is selected such that during use of the single multilayer system, the systemically pharmaceutically active agents are provided at a selected delivery rate from said single multilayer system. ### Claim 9 (depends on 1) The transdermal delivery system of claim 1, wherein the first and second layer assemblies are formed as matrix or reservoir devices. ### Claim 10 (depends on 1) The transdermal delivery system of claim 1, comprising: a plurality of first layer assemblies capable of being selectively adhered to at least one second layer assembly, and at least one second layer assembly, wherein said first face of each of said first layer assemblies is adapted to be applied to a first face of at least one of said at least one second layer assembly to form said single multi-layer system. ### Claim 11 (depends on 1) The transdermal delivery system of claim 1, comprising a single second face release liner adhered to both said backing layer of said first layer assembly and said second face of said second layer assembly. ### Claim 12 (depends on 11) The transdermal delivery system of claim 11, wherein said second face release liner further comprises a fold line facilitating the folding of the liner to facilitate the application of said first face of said first layer assembly to said first face of said second layer assembly to form said single multi-layer system. ### Claim 13 (depends on 1) The transdermal delivery system of claim 1, comprising a single first face release liner adhered to both said first face of said first layer assembly and said first face of said second layer assembly. ### Claim 14 (depends on 10) The transdermal delivery system of claim 10, comprising a plurality of first layer assemblies and one second layer assembly. ### Claim 15 (depends on 10) The transdermal delivery system of claim 10, comprising a plurality of first layer assemblies and a plurality of second layer assemblies. ### Claim 16 A transdermal delivery system for delivering at least one systemically pharmaceutically active agent transdermally comprising: a first layer assembly having a first face and a second face and containing a therapeutically effective amount of at least one systemically pharmaceutically active agent, wherein said first layer assembly has a first release rate for said at least one systemically pharmaceutically active agent; and a second layer assembly having a first face and a second face and containing a therapeutically effective amount of at at least one systemically pharmaceutically active agent, wherein said second layer assembly has a second release rate for said at least one systemically pharmaceutically active agent; wherein said first and second release rates are different; wherein said first layer assembly is capable of being selectively adhesively adhered to said second layer assembly, which is capable of being selectively adhesively adhered to a user's epidermis; wherein said first layer assembly and said second layer assembly are separate from each other to maintain characteristics of the assemblies until use; wherein said first layer assembly comprises (i) a first face release liner adhered to said first face, (ii) a backing layer adhered to said second face; and (iii) a second face release liner adhered to said backing layer; wherein said second layer assembly comprises (i) a first face release liner adhered to said first face and a (ii) a second face release liner adhered to said second face, and does not include a backing layer; and wherein said first face of said first and second layer assemblies are adapted to be applied to each other, upon removal of said first face release liner(s) and prior to use, to form a single multi-layer system wherein said first and second layer assemblies are arranged vertically with respect to one another. ### Claim 17 A transdermal delivery system for delivering systemically pharmaceutically active agents transdermally comprising: at least one first layer assembly having a first face and a second face and containing a therapeutically effective amount of at least one first systemically pharmaceutically active agent, wherein said first layer assembly has a first release rate for said at least one systemically pharmaceutically active agent; and a second layer assembly having a first face and a second face and containing a therapeutically effective amount of at least one second systemically pharmaceutically active agent, wherein said second layer assembly has a second release rate for said at least one systemically pharmaceutically active agent; wherein said first and second systemically pharmaceutically active agents are different; wherein said first layer assembly is capable of being selectively adhesively adhered to said second layer assembly, which is capable of being selectively adhesively adhered to a user's epidermis; wherein said first layer assembly and said second layer assembly are separate from each other to maintain characteristics of the assemblies until use; wherein said first layer assembly comprises (i) a first face release liner adhered to said first face, (ii) a backing layer adhered to said second face; and (iii) a second face release liner adhered to said backing layer; wherein said second layer assembly comprises (i) a first face release liner adhered to said first face and a (ii) a second face release liner adhered to said second face, and does not include a backing layer; and wherein said first face of said first and second layer assemblies are adapted to be applied to each other, upon removal of said first face release liner(s) and prior to use, to form a single multi-layer system wherein said first and second layer assemblies are arranged vertically with respect to one another. ### Claim 18 A method for delivering at least one systemically active compound transdermally to a subject comprising the steps of: providing a first layer assembly having a first face and a second face and containing a therapeutically effective amount of at least one systemically pharmaceutically active agent and a second layer assembly having a first face and a second face and containing a therapeutically effective amount of at least one systemically pharmaceutically active agent, wherein said first layer assembly is capable of being selectively adhesively adhered to said second layer assembly, which is capable of being selectively adhesively adhered to a user's epidermis, wherein said first layer assembly comprises (i) a first face release liner adhered to said first face, (ii) a backing layer adhered to said second face; and (iii) a second face release liner adhered to said backing layer and said second layer assembly comprises (i) a first face release liner adhered to said first face and a (ii) a second face release liner adhered to said second face, and does not include a backing layer; and maintaining said first layer assembly and said second layer assembly separate from each other prior to use; removing said first face release liner(s) and applying said first face of said first layer assembly and said first face of said second layer assembly to one another to form a single multi-layer system wherein said first and second layer assemblies are arranged vertically with respect to one another; removing said second face release liner(s), and applying the single multilayer system to a subject's epidermis. ### Claim 19 A multi-layer transdermal delivery system comprising: a first layer assembly having a first face and a second face and containing a therapeutically effective amount of at least one systemically pharmaceutically active agent; a second layer assembly having a first face and a second face and containing a therapeutically effective amount of at least one systemically pharmaceutically active agent; a third layer assembly having a first face and a second face and, optionally, containing at least one systemically pharmaceutically active agent; wherein said first layer assembly is capable of being selectively adhesively adhered to said second layer assembly, which is capable of being selectively adhesively adhered to said third layer assembly, which is capable of being selectively adhesively adhered to a user's epidermis; wherein said layer assemblies are separate from each other to maintain characteristics of the assemblies until use; wherein said first layer assembly comprises (i) a first face release liner adhered to said first face, (ii) a backing layer adhered to said second face; and (iii) a second face release liner adhered to said backing layer; wherein said second and third layer assemblies comprise (i) a first face release liner adhered to said first face and a (ii) a second face release liner adhered to second face, and do not include a backing layer; and wherein said assemblies are adapted to be applied to each other, upon removal of said first face release liner(s) and prior to use to form a single multi-layer system wherein said first, second and third layer assemblies are arranged vertically with respect to one another.