Multi-layer transdermal drug delivery device

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.

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.

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.

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.