Compositions for Reducing Nicotine Withdrawal Symptoms and/or Tobacco Usage

• US 20100040679A1
• Filed: 10/08/2007
• Published: 02/18/2010
• Est. Priority Date: 10/09/2006
• Status: Abandoned Application

• Current Assignee: Smithkline Beecham Corporation (Smithkline Beecham PLC)
• Original Assignee: Smithkline Beecham Corporation (Smithkline Beecham PLC)
• Inventors: Lemmonds, Charlotte A., Chang, Shing Yue
• Application Number:
  US12/444,208
• Publication Number:
  US 20100040679A1
• Time in Patent Office: Days
• US Class Current: 424/456
• 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 31/4439 containing a five-membered ring with nitrogen as a ring hetero atom, e.g. omeprazole nicotine A61K31/465
• CPC Class Codes: A61K 31/485 Morphinan derivatives, e.g. morphine, codeine
• CPC Class Codes: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• CPC Class Codes: A61P 25/22 Anxiolytics
• CPC Class Codes: A61P 25/34 Tobacco-abuse
• CPC Class Codes: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

Abstract

Compositions useful for treating an individual with nicotine dependence comprising a combination of an α₃β₄ nicotinic receptor antagonist and a nicotine metabolite are disclosed. More particularly, compositions comprising cotinine or a pharmaceutically acceptable salt thereof are disclosed. Methods of alleviating nicotine withdrawal symptoms and/or tobacco usage by administration of these compositions are also disclosed.

Claims

1. A composition for treating nicotine dependence comprising:

a) at least one α

₃β

₄ nicotinic receptor antagonist; and

b) at least one metabolite of nicotine.

2. The composition of claim 1, wherein the α

₃β

₄ nicotinic receptor antagonist is selected from the group consisting of mecamylamine, 18-methoxycoronardine, burpoprion, dextromethorphan, dextrorphan, and pharmaceutically acceptable salts thereof.

3. The composition of claim 2 wherein the α

₃β

₄ nicotinic receptor antagonist is selected from the group consisting of dextromethorphan, dextrorphan, and pharmaceutically acceptable salts thereof.

4. The composition of claim 3 wherein metabolite of nicotine is selected from the group consisting of cotinine, norcotinine, nornicotine, nicotine N-oxide, cotinine N-oxide, 3-hydroxycotinine and 5-hydroxycotinine and pharmaceutically acceptable salts thereof.

5. The composition of claim 3 wherein the α

₃β

₄ nicotinic receptor antagonist is dextromethorphan.

6. The compositions of claim 5 wherein the at least one metabolite of nicotine is cotinine.

7. The composition of claim 6 wherein the dose range of cotinine is from about 0.01 mg/kg to about 100 mg/kg of an individual'"'"'s body weight per dose.

8. The composition of claim 7 wherein the dose range of cotinine is from about 0.1 mg/kg to about 10 mg/kg of an individual'"'"'s body weight per dose.

9. The composition of claim 8 wherein the dose range of cotinine is from about 0.2 mg/kg to about 3 mg/kg of an individual'"'"'s body weight per dose.

10. The composition of claim 9 wherein the dose range of dextromethorphan is from about 0.01 mg/kg to about 10 mg/kg of an individual'"'"'s body weight per dose.

11. The composition of claim 10 wherein the dose range of dextromethorphan is from about 0.01 mg/kg to about 1.6 mg/kg of an individual'"'"'s body weight per dose.

12. The composition of claim 11 wherein the dose range of dextromethorphan is from about 0.02 mg/kg to about 1 mg/kg of an individual'"'"'s body weight per dose.

13. The composition of claim 1 wherein the composition is adapted for oral administration.

14. The composition of claim 13 wherein the composition is an oral dosage form selected from the group consisting of tablets, caplets, hard gelatin capsules, lozenges, orally dissolving film and chewable gums.

15. A method of reducing nicotine withdrawal symptoms comprising administrating a composition of claim 1 to an individual in need thereof.

16. A method of reducing nicotine withdrawal symptoms comprising administrating a composition of claim 6 to an individual in need thereof.

17. A method of reducing nicotine withdrawal symptoms comprising administrating a composition of claim 12 to an individual in need thereof.

18. A method of reducing tobacco usage comprising administrating a composition of claim 1 to an individual in need thereof.

19. A method of reducing tobacco usage comprising administrating a composition of claim 6 to an individual in need thereof.

20. A method of reducing tobacco usage comprising administrating a composition of claim 12 to an individual in need thereof.