Methods and apparatus for transdermal delivery of abusable drugs with a deterrent agent

• US 20040109886A1
• Filed: 08/27/2003
• Published: 06/10/2004
• Est. Priority Date: 08/27/2002
• Status: Abandoned Application

• Current Assignee: Zars, Inc.
• Original Assignee: Zars, Inc.
• Inventors: Rigby, Larry
• Application Number:
  US10/649,322
• Publication Number:
  US 20040109886A1
• Time in Patent Office: Days
• US Class Current: 424/449
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 31/445 Non condensed piperidines, e.g. piperocaine
• CPC Class Codes: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• CPC Class Codes: A61K 9/7069 obtained otherwise than by reactions only involving carbon to carbon unsaturated bonds, e.g. polysiloxane, polyesters, polyurethane, polyethylene oxide
• CPC Class Codes: A61K 9/7092 Transdermal patches having multiple drug layers or reservoirs, e.g. for obtaining a specific release pattern, or for combining different drugs

Abstract

The present invention describes a system and method for reducing the abuse potential of drugs, particularly or especially narcotic agents, in transdermal drug delivery systems. This is achieved by designing the transdermal drug delivery system such that when the active drug is extracted out of the transdermal delivery system, a deterrent agent is also timely co-extracted upon introduction of the system to an extraction solution where abuse may normally be allowed take place. Preferably, the deterrent agent of the present invention is capable of inducing or causing one or more intensely repugnant effects within the abusing person, thus reducing the potential for abuse of the active drug formulation.

Claims

1. A transdermal drug delivery system comprising:

an active drug formulation contained within a transdermal patch, said active drug formulation comprising an abusable drug that is systemically administered to a user;

a deterrent agent also contained within said transdermal patch, said deterrent agent being co-extracted with said active drug formulation upon introduction of said system to an extraction solution; and

means for preventing the delivery of said deterrent agent into human skin when said active drug formulation is applied on skin.

2. The transdermal drug delivery system of claim 1, wherein said abusable drug is a narcotic agent.

3. The transdermal drug delivery system of claim 1, wherein said abusable drug is fentanyl.

4. The transdermal drug delivery system of claim 1, wherein said deterrent agent is selected from the group consisting of irritating agents, central nervous system effecting agents, gastrointestinal system effecting agents, cardiac effecting agents, respiratory system effecting agents, bowel effecting agents, palate effecting agents, sleep inducing agents, and smell effecting agents.

5. The transdermal drug delivery system of claim 1, wherein said abusable drug has the potential to be abused by inhalation.

6. The transdermal drug delivery system of claim 1, wherein said abusable drug has the potential to be abused by injection.e transdermal drug delivery system of claim 1, wherein said abusable drug has the potential to be abused by snortingl drug delivery system of claim 1, wherein said abusable drug has the potential to be abused by ingestion.

7. A transdermal drug delivery system comprising:

an active drug formulation comprising an abusable drug, said active drug formulation being coated on one side of a backing film; and

a deterrent formulation, said deterrent formulation being coated on the other side of said backing film.

9. The transdermal drug delivery system of claim 7, wherein said abusable drug is a narcotic agent.

10. The transdermal drug delivery system of claim 7, wherein said abusable drug is fentanyl.

11. The transdermal drug delivery system of claim 7, wherein said deterrent agent is selected from the group consisting of irritating agents, central nervous system effecting agents, gastrointestinal system effecting agents, cardiac effecting agents, respiratory system effecting agents, bowel effecting agents, palate effecting agents, sleep inducing agents, and smell effecting agents.

12. The transdermal drug delivery system of claim 7, further comprising a separating film separating said active drug formulation from said deterrent agent.

8. A transdermal drug delivery system comprising:

a deterrent formulation coated on one side of a backing film; and

an active drug formulation coated on top of said deterrent formulation, said active drug formulation comprising an abusable drug.

13. A transdermal drug delivery system comprising:

a carrier medium;

a drug formulation contained within said carrier medium and comprising an abusable drug; and

a microencapsulated deterrent agent also contained within said carrier medium;

14. The transdermal drug delivery system of claim 13, wherein said abusable drug is a narcotic agent.

15. The transdermal drug delivery system of claim 13, wherein said abusable drug is fentanyl.

16. The transdermal drug delivery system of claim 15, wherein said deterrent agent is selected from the group consisting of irritating agents, central nervous system effecting agents, gastrointestinal system effecting agents, cardiac effecting agents, respiratory system effecting agents, bowel effecting agents, palate effecting agents, sleep inducing agents, and smell effecting agents

17. The transdermal drug delivery system of claim 13, wherein the deterrent is an emetic.