IP Library Granted Patent US 7,182,955
Granted Patent B2
US 7,182,955 · App. 10/744,996 · Granted Feb 27, 2007

Abuse-resistant transdermal dosage form

View Patent ↗
Loading inventors, assignments & file history…
Monitor This Case
Get email alerts when status or documents change.
Order Certified Copies
Most orders are placed with the USPTO same day — all within 24 business hours.
Order via The Patent Place →
Pre-filled with this patent's details
Quick Facts
Patent No.
US 7,182,955
App. No.
10/744,996
Granted
Feb 27, 2007
Kind
B2
Abstract

The invention comprises a transdermal dosage form comprising a active agent component comprising a polymeric matrix and an abusable drug substance, an overlay backing, a porous material, and an antagonist reservoir comprising an antagonist to the abusable drug substance. The porous material adjoins the antagonist reservoir and is in fluid communication with the skin-contacting surface defined by the active agent component. In one embodiment, the device comprises a barrier layer interposed between the active agent component and the antagonist reservoir.

Claims (46)

1. A transdermal dosage form comprising:

an active agent component comprising a polymeric material and an active agent, wherein the active agent component has a proximal, skin-contacting surface and a distal surface opposed to the proximal surface;

an overlay backing;

an adverse agent component comprising an antagonist to the abusable drug substance, wherein the adverse agent component is interposed between the distal surface of the active agent component and the overlay backing; and

a porous material adjacent to and adjoining the adverse agent component;

wherein the porous material is in fluid communication with the proximal surface of the active agent component.

2. A transdermal dosage form according to claim 1 , further comprising a barrier interposed between the active agent component and the adverse agent component.

3. A transdermal dosage form according to claim 2 , further comprising an adhesive material connecting the adverse agent component and the barrier layer.

4. A transdermal dosage form according to claim 2 , further comprising an adhesive material connecting the porous material and the overlay backing.

5. A transdermal dosage form according to claim 2 , wherein the polymeric material of the active agent component comprises an acrylate pressure-sensitive adhesive.

6. A transdermal dosage form according to claim 2 , wherein the adverse agent component comprises a polymeric material.

7. A transdermal dosage form according to claim 6 , wherein the adverse agent component comprises a pressure-sensitive adhesive.

8. A transdermal dosage form according to claim 6 , wherein the adverse agent component comprises a microporous film.

9. A transdermal dosage form according to claim 1 , wherein the adverse agent component is interposed between the distal surface of the active agent component and the porous material.

10. A transdermal dosage form according to claim 1 , wherein the adverse agent component is interposed between the porous material and the overlay backing.

11. A transdermal dosage form according to claim 1 , wherein at least a portion of the overlay backing extending beyond the active agent component is coated with a pressure sensitive adhesive.

12. A transdermal dosage form according to claim 11 , wherein the overlay backing is a continuous, polymeric film.

13. A transdermal dosage form according to claim 12 , wherein the overlay backing comprises a polymer selected from the group consisting of polyethylene, polypropylene, and polyurethane.

14. A transdermal dosage form according to claim 1 , wherein the antagonist comprises a narcotic antagonist.

15. A transdermal dosage form according to claim 14 , wherein the antagonist is selected from the group consisting of naltrexone, naloxone, and nalbuphine.

16. A transdermal dosage form according to claim 1 , wherein the active agent is a narcotic.

17. A transdermal dosage form according to claim 16 , wherein the active agent is fentanyl.

18. A transdermal dosage form comprising:

a release liner;

an overlay backing;

an active agent component interposed between the release liner and the overlay backing, wherein the active agent is in diffusional communication with the release liner;

a barrier interposed between the active agent component and the overlay backing;

an adverse agent component comprising an antagonist to the active agent, wherein the adverse agent component is interposed between the barrier and the overlay backing; and

a porous material adjacent to and adjoining the adverse agent component;

wherein the porous material is in fluid communication with the release liner.

19. A transdermal dosage form according to claim 18 , wherein the active agent component comprises an acrylate copolymer pressure sensitive adhesive.

20. A transdermal dosage form according to claim 18 , further comprising an adhesive layer connecting the porous material and the overlay backing.

21. A transdermal dosage form according to claim 18 , wherein the adverse agent component comprises a polymer.

22. A transdermal dosage form according to claim 21 , wherein the adverse agent component comprises a pressure-sensitive adhesive.

23. A transdermal dosage form according to claim 21 , wherein the adverse agent component comprises a microporous film.

24. A transdermal dosage form according to claim 18 , wherein at least a portion of the overlay backing extending beyond the active agent component is coated with a pressure sensitive adhesive.

25. A transdermal dosage form according to claim 24 , wherein the overlay backing is a continuous, polymeric film.

26. A transdermal dosage form according to claim 25 , wherein the overlay backing comprises a polymer selected from the group consisting of polyethylene, polypropylene, and polyurethane.

27. A transdermal dosage form according to claim 18 , wherein the antagonist comprises a narcotic antagonist.

28. A transdermal dosage form according to claim 27 , wherein the antagonist is selected from the group consisting of naltrexone, naloxone, and nalbuphine.

29. A method of transdermal delivery of an active agent from a tamper-resistant dosage form comprising:

a) providing a transdermal dosage form according to claim 1 ; and

b) applying the dosage form to a portion of the skin or mucosa of a patient for a period sufficient to achieve the desired therapeutic result.

30. A method of transdermal delivery of an active agent from a tamper-resistant dosage form comprising:

a) providing a transdermal dosage form according to claim 18 ; and

b) applying the dosage form to a portion of the skin or mucosa of a patient for a period sufficient to achieve the desired therapeutic result.

Assignments (5)
SECURITY INTEREST Recorded Dec 14, 2022
From: KINDEVA DRUG DELIVERY L.P.
To: JPMORGAN CHASE BANK, N.A., AS COLLATERAL AGENT
Reel/Frame 062122/0618 →
TERMINATION AND RELEASE OF SECURITY INTEREST IN PATENT COLLATERAL RECORDED AT R/F 053586/0715 Recorded Dec 12, 2022
From: MIDCAP FINANCIAL TRUST, AS ADMINISTRATIVE AGENT
To: KINDEVA DRUG DELIVERY L.P.
Reel/Frame 062115/0707 →
SECURITY INTEREST Recorded Aug 24, 2020
From: KINDEVA DRUG DELIVERY L.P.
To: MIDCAP FINANCIAL TRUST, AS ADMINISTRATIVE AGENT
Reel/Frame 053586/0715 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jun 2, 2020
From: 3M COMPANY; 3M INNOVATIVE PROPERTIES COMPANY
To: KINDEVA DRUG DELIVERY L.P.
Reel/Frame 052818/0234 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 23, 2003
From: HART, JOHN R.; STEBBINGS, DEANNA L.
To: 3M INNOVATIVE PROPERTIES COMPANY
Reel/Frame 014903/0043 →