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Claims for Patent: 5,656,255

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Claims for Patent: 5,656,255

Title: Composition to help stop smoking
Abstract:A composition for administration to the nasal mucosa of a subject comprises a solution of nicotine or a pharmaceutically acceptable salt thereof in a pharmaceutically acceptable solvent. The composition has a nicotine concentration in the range of about 10 to about 40 mg/ml and contains a suitable agent to produce a viscosity in the range of about 1 to about 30 centipoise. The composition assists in reduction of the desire of the subject to smoke tobacco or provides a substitute for tobacco smoking.
Inventor(s): Jones; Richard L. (Edmonton, CA)
Assignee: Pharmacia & Upjohn AB (SE)
Application Number:08/256,312
Patent Claims: 1. A nicotine-containing spray for administration to the nasal mucosa of a subject to assist in reduction of the desire of the subject to smoke tobacco or to provide a substitute for tobacco smoking, the spray being in the form of droplets of a size in the range of from about 10 to about 200 microns and comprising a solution of nicotine or a pharmaceutically acceptable salt thereof in a pharmaceutically acceptable solvent, the spray having a nicotine concentration in the range of about 10 to about 40 mg/ml and further comprising a viscosity agent providing the spray with a viscosity in the range of about 1 to about 30 centipoise.

2. A spray in accordance with claim 1 wherein the pharmaceutically acceptable solvent is phosphate buffered saline.

3. A spray in accordance with claim 1 wherein the viscosity agent is cellulose or a substituted cellulose.

4. A spray in accordance with claim 1 wherein the viscosity agent is carboxymethyl cellulose.

5. A spray in accordance with claim 1 wherein the viscosity agent is a pharmaceutically acceptable oil emulsion.

6. A spray in accordance with claim 1 wherein the pH is in the range of about 5 to about 6.5

7. A spray in accordance with claim 1 wherein the pH is about 5.8 and the nicotine concentration is about 20 mg/ml, and wherein the spray contains carboxymethyl cellulose to provide the spray with a viscosity of about 5 to about 20 centipoise.

8. A nicotine containing spray in accordance with claim 1, wherein the droplets are about 100 to about 200 microns in diameter.

9. A spray in accordance with claim 1, wherein the spray is delivered from a spray device for delivering an effective dose of the spray to the nose.

10. A spray in accordance with claim 1, further comprising one or more agents selected from the group consisting of a flavouring agent, a preserving agent and an antioxidant.

11. A method of assisting in the reduction of the desire of a subject to smoke tobacco, comprising administering an effective dose of a nicotine-containing spray in accordance with any one of claims 2 to 5, 6 or 8 to the nasal mucosa of the subject.

12. A method of assisting in the reduction of the desire of a subject to smoke tobacco, comprising administering an effective dose of a nicotine-containing spray in accordance with claim 8 to the nasal mucosa of the subject.

13. A method of assisting in the reduction of the desire of a subject to smoke tobacco, comprising administering a nicotine-containing spray in accordance with claim 7 to the nasal mucosa of the subject.

14. A method of providing to a smoker a substitute for tobacco smoking, comprising administering an effective dose of a nicotine-containing spray in accordance with any one of claims 2 to 5, 6 or 7 to the nasal mucosa of the subject.

15. A method of providing to a smoker a substitute for tobacco smoking, comprising administering an effective dose of a nicotine-containing spray in accordance with claim 8 to the nasal mucosa of the subject.

16. A method of providing to a smoker a substitute for tobacco smoking, comprising administering a nicotine-containing spray in accordance with claim 7 to the nasal mucosa of the subject.

17. A method of assisting in the reduction of the desire of a subject to smoke tobacco, comprising administering an effective dose of a nicotine-containing spray in accordance with claim 1.

18. A method of assisting in the reduction of the desire of a subject to smoke tobacco, comprising administering a nicotine-containing spray in accordance with claim 1 to the nasal mucosa of the subject in an amount which delivers a nicotine dose in the range of about 1 to about 3 mg.

19. A method of providing to a smoker a substitute for tobacco smoking, comprising administering an effective dose of a nicotine-containing spray according to claim 1 to the nasal mucosa of the subject.

20. A method of providing to a smoker a substitute for tobacco smoking, comprising administering a nicotine-containing spray in accordance with claim 1 to the nasal mucosa of the subject in an amount which delivers a nicotine dose in the range of about 1 to about 3 mg.

21. A method according to claim 17, wherein the nicotine-containing spray is administered in a volume of about 0.03 to about 0.08 ml.

22. A method according to claim 19, wherein the nicotine-containing spray is administered in a volume of about 0.03 to about 0.08 ml.
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