Transdermal Delivery Device

• US 20100028390A1
• Filed: 10/09/2009
• Published: 02/04/2010
• Est. Priority Date: 03/24/2004
• Status: Active Grant

• Current Assignee: Corium Pharma Solutions, Inc.
• Original Assignee: Corium International, Inc.
• Inventors: Cleary, Gary W., Klemm, Steven R.
• Granted Patent: US 7,914,480 B2
• Time in Patent Office: Days
• US Class Current: 424/400
• CPC Class Codes: A61B 17/205 Vaccinating by means of needles or other puncturing devices
• CPC Class Codes: A61M 2037/0023 Drug applicators using microneedles
• CPC Class Codes: A61M 37/0015 by using microneedles

Abstract

A dermal, transdermal, mucosal or transmucosal delivery device includes a backing layer overlying an ingredient containing reservoir, and having a microprotrusion array attached thereto, 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 skin or mucosa.

Claims

1. A transdermal delivery device, comprising:

a reservoir containing ingredients and defining a perimeter;

a backing member overlying the reservoir, the backing member being made of a material which is substantially impermeable to the ingredients contained in the reservoir;

a cover for the reservoir, the cover being made of a material substantially impermeable to ingredients contained in the reservoir, but having at least one opening therein defining a perimeter, such that ingredients from the reservoir flow through the opening, but will not readily flow through the material of which the cover is made;

a first seal sealing the cover to the backing member at the perimeter of the reservoir, wherein the first seal which is not subject to permeation, disintegration or degradation by any ingredient contained in the reservoir;

an adhesive layer adhered to the backing member for adhering the device to a patient'"'"'s skin or mucosa, the adhesive layer not extending to the perimeter of the opening in the cover, such that a portion of the cover surrounding said perimeter of the opening is exposed to thereby define a cover sealing surface;

an ingredient containing material layer at least partially adhered to the adhesive layer, wherein the ingredient containing material does not extend to the perimeter of the opening;

a liner covering the sealing surface of the cover and the opening in the cover;

a second seal releasably sealing the liner to the sealing surface of the cover, wherein the second seal is not subject to permeation, disintegration or degradation by any ingredient in the reservoir;

whereby ingredients in the reservoir are sealed therein during storage and non-use by the first and second seals, the cover and liner, but are free to flow through the opening and onto a subject'"'"'s skin or mucosa when the liner is removed from the device and the device is applied to such skin or mucosa.

2. The device of claim 1, further including a microprotrusion layer at least partially adhered to the adhesive layer, the microprotrusion layer including at least one opening therethrough substantially aligned with the opening in the cover, such that ingredients from the reservoir may flow through the opening, and wherein the microprotrusion layer pierces at least a portion of the skin or mucosa when the device is applied to a subject'"'"'s skin or mucosa;

the opening in the ingredient containing material layer being sufficiently large that the microprotrusion layer is positioned within the opening in the ingredient containing material layer.

3. The device of claim 2, wherein the liner is a release liner for the device, the release liner covering the microprotrusion layer and the adhesive layer as well as the sealing surface and the opening of the cover.

4. The device of claim 3, wherein the first and second seals comprise heat seals between the cover and the backing member and between the liner and the cover respectively.

5. The device of claim 1, wherein the liner is a composite member comprising:

an outer protective layer and a barrier layer with an adhesive coating therebetween, the barrier layer defining an exposed surface, the outer protective layer further including a release coating on the exposed surface of the barrier layer; and

wherein

the barrier layer, including its adhesive coating and its release coating, has an opening therein which is sufficiently large to expose the opening and the sealing surface of the cover, whereby the outer protective layer is sealed directly to the sealing surface of the cover by the second seal.

6. The device of claim 5, wherein the release coating of the liner is releasably adhered to the second adhesive coating of the adhesive layer.

7. The device of claim 2, wherein a rate-controlling membrane is disposed between the cover and the reservoir.

8. The device of claim 2, wherein a rate controlling membrane is disposed between the cover and the adhesive layer.

16. The device of claim 1, wherein the reservoir includes first and second compartments that are sealed from one another.

17. The device of claim 1, including a pump operably connected to the reservoir for pressurizing the reservoir.

18. The device of claim 17, wherein the pump comprises a syringe.

19. The device of claim 18, wherein the pump is connected to the reservoir by a conduit and a releasable fitting.

20. The device of claim 17, wherein the pump is connected to the reservoir by a needle that extends through a resealing port including a film layer attached to the reservoir.

24. The device of claim 2, wherein the microprotrusion layer includes a plurality of openings therethrough.

33. The transdermal delivery device of claim 2, wherein the microprotrusion layer comprises a biodegradable, biocompatible polymer chosen from the group consisting of poly(lactide)s, poly(glycolide)s, poly(lactide-co-glycolide)s, polyanhydrides, polyorthoesters, polyetheresters, polycaprolactones, polyesteramides, poly(butyric acid), poly(valeric acid), polyurethanes and copolymers and blends thereof.

9. A microprotrusion transdermal delivery device comprising:

an ingredient containing reservoir defining a perimeter;

a backing member overlying the reservoir, the backing member being made of a material which is substantially impermeable to ingredients contained in the reservoir;

a membrane covering the reservoir, the membrane being permeable by ingredients to be dispensed by the device;

a first seal sealing the membrane to the backing member at the perimeter of the reservoir by a first seal which is not subject to permeation, disintegration or degradation by any ingredient to be contained in the reservoir;

an adhesive layer adhered to the backing member for adhering the device to a patient'"'"'s skin or mucosa, the adhesive layer including an opening therein which is aligned with at least a portion of the membrane, such that a portion of the membrane is exposed to define a membrane sealing surface;

a microprotrusion layer at least partially adhered to the adhesive layer, the microprotrusion layer including at least one opening therethrough substantially aligned with the opening in said adhesive layer such that ingredients to be delivered from the reservoir through the membrane may flow through the opening in the adhesive layer and the opening in the microprotrusion layer, and wherein the microprotrusion layer pierces at least a portion of the skin or mucosa when the device is applied to a subject'"'"'s skin or mucosa;

a second seal which is not subject to permeation, disintegration or degradation by any ingredient contained in the reservoir;

a liner covering the sealing surface of the membrane, the liner being releasably sealed to the sealing surface of the membrane by the second seal;

ingredients contained in the reservoir are sealed therein during storage and nonuse by the first and second seals, and the liner, but are free to flow through the membrane and the opening and onto a subject'"'"'s skin or mucosa when the liner is removed from the device and the device is applied to such skin or mucosa.

10. The device of claim 9 wherein the adhesive layer extends at least partially over the membrane.

11. The device of claim 9 wherein the backing member includes a force gauge, the force gauge including an indicator which indicates when the microprotrusion layer has penetrated to a desired depth in a patient'"'"'s skin.

12. The device of claim 11, wherein the force gauge comprises a raised area of the backing member.

13. A transdermal delivery device comprising:

an ingredient containing reservoir;

a backing member overlying the reservoir, the backing member being made of a material which is substantially impermeable to ingredients contained in the reservoir;

a first seal which is not subject to permeation, disintegration or degradation by any ingredient to be contained in the reservoir;

a membrane made of a microporous material covering the reservoir, the membrane being sealed to the backing member at the perimeter of the reservoir by the first seal;

an adhesive layer adhered to the backing member for adhering the device to a patient'"'"'s skin or mucosa, the adhesive layer including an opening therein which is aligned with at least a portion of the membrane such that a portion of the membrane is exposed to define a membrane sealing surface;

an ingredient containing material layer at least partially adhered to the adhesive layer, the ingredient containing material layer including an opening aligned with the opening in the adhesive layer;

a second seal which is not subject to permeation, disintegration or degradation by any ingredient contained in the reservoir;

a liner covering said sealing surface of said membrane, the liner being releasably sealed to the sealing surface of the membrane by the second seal;

whereby ingredients contained in the reservoir are sealed therein during storage and nonuse by the first and second seals, and the liner, but are free to flow through the opening and onto a subject'"'"'s skin or mucosa when the liner is removed from the device and the device is applied to such skin or mucosa.

14. The device of claim 13, wherein the liner is a composite member comprising:

an outer protective layer and a barrier layer with an adhesive coating therebetween, and a release coating on an exposed surface of the barrier layer;

the barrier layer, including its adhesive coating and its release coating, having an opening therein which is sufficiently large to expose the opening and the sealing surface of the cover, whereby the outer protective layer is sealed directly to the sealing surface of the cover by the second seal.

15. The device of claim 14, wherein the microprotrusion layer comprises at least one microprotrusion, and wherein the microprotrusion layer is comprised of a synthetic material.

21. The device of claim 15, including a resilient member that tends to cause a recoil force pulling the at least one microprotrusion away from and out of a patient'"'"'s skin.

22. The device of claim 21, wherein the resilient member comprises a layer of foam extending across at least a portion of the microprotrusion layer.

23. The device of claim 21, wherein the resilient member has a ring-like shape and extends around a perimeter surrounding the at least one microprotrusion.

25. The device of claim 15, including a bumper member adjacent the microprotrusion layer, the bumper member having sufficient thickness to protect the at least one microprotrusion from damage prior to use.

26. The device of claim 25, wherein the bumper member extends around at least a portion of the at least one microprotrusion.

27. The device of claim 26, wherein the bumper member has a ring-like shape and is made of a substantially incompressible material.

28. A method of making a transdermal delivery device, comprising:

providing a polymer film backing layer;

permanently deforming the polymer film to form a depression defining a perimeter;

providing a cover layer;

sealing the cover layer to the backing layer around the perimeter of the depression so that the depression forms a reservoir cavity;

at least partially filling the cavity with an active ingredient;

providing at least one opening through the cover layer to the reservoir cavity;

adhering a liner to at least a selected one of the backing layer and the cover with the liner covering the opening through the cover layer.

29. The method of claim 28, wherein:

the depression in the polymer film backing layer is made by thermoforming.

30. The method of claim 28, including providing a device for forming at least one opening in a layer of skin.

31. The method of claim 30, including securing the device to the transdermal delivery device proximate the cavity.

32. The method of claim 31, wherein the device comprises an array of microneedles that is adhered to the cover layer.