Transdermal adhesive patch assembly with removable microneedle array and method of using same

• US 9,144,671 B2
• Filed: 12/12/2012
• Issued: 09/29/2015
• Est. Priority Date: 12/21/2011
• Status: Active Grant

• Current Assignee: Kindeva Drug Delivery L.P.
• Original Assignee: 3M Innovative Properties Company (3M Company)
• Inventors: Cantor, Adam S., Stockholm, Andrew J.
• Primary Examiner(s): Berdichevsky, Aarti B
• Assistant Examiner(s): DARB, HAMZA A.
• Application Number:
  US14/352,327
• Publication Number:
  US 20140243788A1
• Time in Patent Office: 1,021 Days
• Field of Search: 604/46, 604/48, 604/49, 604/289, 604/173, 604/501, 604/22, 604/307, 604/304, 604/306, 604/180, 602/48, 602/49, 602/50
• US Class Current: 1/1
• CPC Class Codes: A61K 9/0021 Intradermal administration, e.g. through microneedle arrays, needleless injectors mechanical aspects A61M
• CPC Class Codes: A61K 9/703 characterised by shape or structure; Details concerning release liner or backing; Refillable patches; User-activated patches
• CPC Class Codes: 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
• CPC Class Codes: A61M 2037/0023 Drug applicators using microneedles
• CPC Class Codes: A61M 2037/0061 Methods for using microneedles
• CPC Class Codes: A61M 37/0015 by using microneedles

Abstract

A transdermal adhesive patch assembly and method of using same. The assembly can include a backing, and an adhesive and a matrix coupled to the backing. The matrix can include an active ingredient. The assembly can further include a microneedle array in at least partially overlapping relationship with the matrix; and a carrier that couples the microneedle array to the matrix opposite the backing, wherein the carrier and the microneedle array form a skin treatment assembly that, along with the matrix, can be located on a flap. The method can include adhering at least a portion of the adhesive to skin to form an anchor; applying pressure adjacent the microneedle array to treat an area of the skin; moving the flap away from the skin; removing the skin treatment assembly to expose the matrix; and replacing the flap to position the matrix over the treated area of the skin.

Claims

1. A transdermal adhesive patch assembly, the assembly comprising:

a backing having a first major surface and a second major surface;

a skin-contact adhesive coupled to the second major surface of the backing;

a matrix comprising an active ingredient, the matrix coupled to the second major surface of the backing;

a microneedle array located in at least partially overlapping relationship with the matrix; and

a carrier positioned to couple the microneedle array to the matrix opposite the backing, wherein the carrier and the microneedle array form a skin treatment assembly that is configured to be decoupled from the matrix, when desired, to expose the matrix;

wherein a portion of the backing and at least a portion of the skin-contact adhesive extend beyond the skin treatment assembly in at least one direction to form an anchor, and wherein the matrix and the skin treatment assembly are located on a flap that is movable with respect to the anchor between a first position in which the flap is not folded back relative to the anchor and a second position in which the flap is folded back relative to the anchor.

2. The assembly of claim 1, wherein the flap is movable with respect to the anchor when the anchor is coupled to skin between the first position in which at least one of the matrix and the microneedle array is in contact with skin, and the second position in which neither the matrix nor the microneedle array is in contact with the skin.

3. The assembly of claim 1, wherein the matrix includes a first major surface coupled to the second major surface of the backing and a second major surface, and wherein the carrier is positioned to couple the microneedle array to the second major surface of the matrix.

4. The assembly of claim 1, wherein the carrier includes the microneedle array.

5. The assembly of claim 1, wherein the microneedle array and the carrier are adhesively coupled together, and wherein a coefficient of adhesion between the carrier and the matrix is less than a coefficient of adhesion between the matrix and the backing, and is less than a coefficient of adhesion between the carrier and the microneedle array.

6. The assembly of claim 1, wherein the carrier is further coupled to the skin-contact adhesive.

7. The assembly of claim 6, wherein a coefficient of adhesion between the carrier and the skin-contact adhesive is less than a coefficient of adhesion between the skin-contact adhesive and the backing.

8. The assembly of claim 1, wherein the carrier includes release characteristics for at least one of the skin-contact adhesive and the matrix.

9. The assembly of claim 1, wherein the carrier includes an extension that extends beyond an edge of the backing in a direction generally opposite the anchor.

10. The assembly of claim 9, wherein the extension includes a tab that is folded back toward the backing.

11. The assembly of claim 9, wherein the extension is a first extension and further comprising a second extension located on an opposite end of the carrier from the first extension, the first extension configured to facilitate moving the flap from the first position to the second position, and the second extension configured to facilitate decoupling the skin treatment assembly from the matrix.

12. The assembly of claim 11, wherein the second extension includes a tab that is folded back toward the microneedle array to facilitate grasping.

13. The assembly of claim 12, wherein the tab of the second extension extends at least partially over the microneedle array.

14. The assembly of claim 12, wherein the tab of the second extension extends at least partially over the microneedle array and includes an aperture dimensioned to receive the microneedle array to allow the microneedle array to pass therethrough.

15. The assembly of claim 1, further comprising a release liner coupled to the skin-contact adhesive opposite the backing and including a recess dimensioned to receive the microneedle array.

16. The assembly of claim 1, wherein the assembly includes:

a skin treatment configuration wherein the skin treatment assembly is coupled to the matrix, such that the matrix is at least partially covered by the skin treatment assembly, and

a delivery configuration wherein the skin treatment assembly has been decoupled from the matrix to expose the matrix for delivery of the active ingredient.

17. The assembly of claim 1, wherein the anchor surrounds the flap on all sides.

18. The assembly of claim 1, wherein a portion of the skin-contact adhesive extends alongside the skin treatment assembly in the flap, such that when the microneedle array is positioned in contact with skin, at least a portion of the skin-contact adhesive in the flap is adhered to the skin.

19. The assembly of claim 1, wherein a portion of the skin-contact adhesive extends alongside the matrix and the microneedle array in the flap, and wherein the carrier is positioned to cover the portion of the skin-contact adhesive that is located in the flap, such that when the microneedle array is positioned in contact with the skin, the skin-contact adhesive in the flap is not adhered to the skin.

20. A method of treating skin and applying an active ingredient transdermally, the method comprising:

providing a transdermal adhesive patch assembly, the assembly comprising

a backing having a first major surface and a second major surface,

a skin-contact adhesive coupled to the second major surface of the backing,

a matrix comprising an active ingredient, the matrix coupled to the second major surface of the backing,

a microneedle array located in at least partially overlapping relationship with the matrix, and

a carrier positioned to couple the microneedle array to the matrix opposite the backing, the carrier and the microneedle array forming a skin treatment assembly,

adhering at least a portion of the skin-contact adhesive to the skin to form an anchor, wherein the matrix and the skin treatment assembly are located on a flap that is movable with respect to the anchor;

applying pressure adjacent the microneedle array to treat an area of the skin;

moving the flap away from the skin while the anchor remains adhered to the skin;

removing the skin treatment assembly to expose the matrix; and

replacing the flap to position the matrix in least partially overlapping relationship with the treated area of the skin.