Dermal, transdermal, mucosal or transmucosal ingredient delivery devices
View Patent ↗A dermal, transdermal, mucosal or transmucosal delivery device is provided. The device includes a backing layer, defining an ingredient containing reservoir, a cover for the reservoir having at least one opening therethrough, an adhesive layer and a liner layer. Upon removal of the liner layer, the device may be placed over the desired area of the skin or mucosa and adhesively applied thereto allowing the ingredients to flow from the reservoir through the at least one opening to the dermis or mucosa.
1. An ingredient delivery device, comprising:
a backing member defining an ingredient containing reservoir, said backing member being made of a material which is substantially impermeable to ingredients contained in said reservoir;
an ingredient contained in said reservoir comprising an organic solution, wherein said organic solution comprises:
a topically active drug agent;
an alkylene glycol;
a fatty acid ester;
a dialkylene glycol alkyl ether; and
a polymeric thickening agent;
a cover for said reservoir, said cover being made of a material substantially impermeable to ingredients contained in said reservoir, but having at least one opening therein, such that ingredients to be delivered from said reservoir will flow through said opening, but will not readily flow through said material of which said cover is made;
said cover being sealed to said backing member at the perimeter of said reservoir by a first seal which is not subject to degradation by any ingredient to be contained in said reservoir;
an adhesive layer adhered to said backing member for adhering said device to a patient's skin or mucosa, said adhesive layer not extending to the perimeter of said opening in said cover, such that a portion of said cover surrounding said perimeter of said opening is exposed to thereby define a cover sealing surface; and
a unitary release liner covering said sealing surface of said cover and said opening in said cover, said liner being releasably sealed to said sealing surface of said cover by a second seal which is not subject to degradation by any ingredient contained in said reservoir; whereby ingredients contained in said reservoir are sealed therein during storage and non-use by said first and second seals, said cover and liner, but are free to flow through said opening and onto a subject's skin or mucosa when said liner is removed from said device and said device is applied to such skin or mucosa.
2. The device of claim 1 , wherein said liner is a release liner for said device, said release liner covering said adhesive layer as well as said sealing surface and said opening of said cover.
3. The device of claim 2 , wherein said first and second seals are heat seals between said cover and said backing member and between said liner and said cover respectively.
4. The device of claim 3 in which said liner is a composite member comprising:
an outer protective layer and a barrier layer with an adhesive coating therebetween, and a release coating on the exposed surface of said barrier layer;
said barrier layer, including its adhesive coating and its release coating, having an opening therein which is sufficiently large to expose said opening and said sealing surface of said cover, whereby said outer protective layer is sealed directly to said sealing surface of said cover by said second seal.
5. The device of claim 4 in which said adhesive layer is a composite member comprising:
a first adhesive coating, a second adhesive coating and a barrier layer therebetween;
said barrier layer, including its first adhesive coating and its second adhesive coating, having an opening therein which is sufficiently large to expose said opening and said sealing surface of said cover, whereby said outer protective layer is sealed directly to said sealing surface of said cover by said second seal.
6. The device of claim 5 , wherein said release coating of said liner is releasably adhered to said second adhesive coating of said adhesive layer.
7. The device of claim 6 , wherein said reservoir comprises an absorbable material.
8. The device of claim 7 , wherein said topically active drug agent is salicylic acid.
9. The device of claim 8 , wherein said salicylic acid is present in an amount of from about 5% to about 40% by weight of said organic solution.
10. The device of claim 9 , wherein said alkylene glycol is propylene glycol.
11. The device of claim 10 , wherein said fatty acid ester is glyceryl monoleate.
12. The device of claim 11 , wherein said dialkylene glycol alkyl ether is diethylene glycol monoethyl ether.