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Details for Patent: 4,920,989

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Details for Patent: 4,920,989

Title: Method and apparatus for aiding in the reduction of incidence of tobacco smoking
Abstract:A method of aiding in the reduction of incidence of tobacco smoking. The method comprises applying a patch containing nicotine to the skin of a person with whom smoking reduction is desired and allowing the nicotine to transdermally migrate into the person's bloodstream to achieve a desired systemic nicotine level. The method also comprises the simultaneous administration of a nicotine containing aerosol spray to the oral cavity of the user in order to provide the desired sensations in the respiratory tract to which the user is accustomed from normal tobacco smoke. A combination of the spray and transdermal patch is also provided such that an occlusive patch is applied to the skin of the person with whom smoking reduction is desired and the nicotine containing aerosol spray is delivered to the oral cavity simultaneously with the application of the nicotine from the patch.
Inventor(s): Rose; Jed E. (Venice, CA), Jarvik; Murray E. (Santa Monica, CA), Rose; Karce D. (Healdsburg, CA)
Assignee: Regents of the University of California (Alameda, CA)
Filing Date:Feb 19, 1988
Application Number:07/157,536
Claims:1. A method of aiding in the reduction of incidence of tobacco smoking, said method comprising:

(a) applying a patch containing nicotine to the skin of a person with whom smoking reduction is desired,

(b) allowing the nicotine in the patch to transdermally migrate into the person's bloodstream to achieve a desired systemic nicotine level,

(c) administering a nicotine containing aerosol spray to the oral cavity of the user to provide the desired sensation in the respiratory tract to which the user is accustomed from normal tobacco smoking, thereby providing the user with desired systemiic nicotine levels and the sensation of smoking without most of the other harmful effects of smoking.

2. The method of claim 1 further characterized in that said method comprises providing nicotine in the patch so that transdermal migration into the bloodstream is at a rate sufficient to correspond to the nicotine level in the blood achieved by normal smoking patterns of the user.

3. The method of claim 2 further characterized in that the method comprises measuring the nicotine levels in the bloodstream approximating those at the varying spaced apart time measurements.

4. The method of claim 2 further characterized in that said method comprises applying the patch at periodic time intervals to generally correspond with a user's smoking patterns.

5. The method of claim 1 further characterized in that the method comprises measuring the nicotine level in the person's bloodstream and controlling the amount of nicotine applied to the patch to achieve a certain relatively constant nicotine level in the blood over a specified period of time.

6. The method of claim 1 further characterized in that said aerosol spray hs droplets between about 1 micron to about 10 microns in diameter and with size selected to stimulate either the upper respiratory region or the lower respiratory region or both.

7. The method of claim 6 further characterized in that the aerosol spray contains nicotine in an amount to render about 0.005 mg to about 0.03 mg per inhalation.

8. The method of claim 6 further characterized in that said method comprises administering the aerosol spray having droplets within a size range of about 1 micron to about 5 microns for stimulating the lower respiratory regions of a user.

9. The method of claim 6 further characterized in that said method comprises administering the aerosol spray having droplets with a size range of about 5 microns to about 10 microns for stimulating the upper respiratory regions of a user.

10. The method of claim 6 further characterized in that said method comprises administering an aerosol spray having a nicotine content from about 0.008 mg per inhalation to about 0.15 mg per inhalation.

11. A spray and transdermal patch combination for aiding in the reduction of incidence of tobacco smoking by administration of nicotine in a manner which minimizes harmful side effects of nicotine administration, said combination comprising:

(a) an occulsive patch for application to the skin of a person with whom smoking reduction is desired,

(b) a selected amount of nicotine in the patch which is allowed to transdermally migrate from the patch into the person's bloodstream to achieve a desired systemic nicotine level, and

(c) a nicotine containing aerosol spray for delivery of an aerosol to the oral cavity of the user simultaneously with the application of nicotine from the patch, the amount of nicotine contained in the patch and thereby delivered from the patch being generally inversely related to the amount of nicotine normally delivered from the spray but which is still present in an amount to provide the desired sensation in the respiratory tract to which the user is accustomed from normal tobacco smoking and to permit peak levels of nicotine in the bloodstream upon demand by a user, thereby providing the user with desired systemic nicotine levels and the sensation of smoking without most of the other harmful effects of smoking.

12. The combination of claim 11 further characterized in that said combination comprises a selected amount of nicotine in the patch sufficient to maintain transdermal migration into the bloodstream at a rate sufficient to correspond to the nicotine level in the blood achieved by normal smoking patterns of the user.

13. The combination of claim 11 further characterized in that said patch comprises at least 8 milligrams of nicotine therein.

14. The combination of claim 11 further characterized in that said patch comprises about 1 to about 5 milligrams of nicotine and said patch also comprises a penetration enhancer.

15. The combination of claim 11 further characterized in that said patch comprises a sufficient amount of nicotine to be delivered at a rate to produce a level of about 10 nanograms of nicotine per milliliter of blood at the start of a smoking reduction program.

16. The combination of claim 11 further characterized in that said patch comprises a sufficient amount of nicotine in the patch and is constructed to transdermally administer the nicotine from the patch to maintain about 50 to about 250 micrograms of nicotine in the user's bloodstream.

17. The combination of claim 11 further characterized in that the pH of the nicotine and any carrier therefore in the patch is maintained between 7 and 9.

18. The combination of claim 11 further characterized in that said aerosol spray has droplets between about 1 micron to about 10 microns in diameter and with size selected to stimulate either the upper respiratory region or the lower respiratory region or both.

19. The combination of claim 11 further characterized in that the aerosol spray contains nicotine in an amount to render about 0.005 mg to about 0.03 mg per inhalation.

20. The combination of claim 11 further characterized in that said aerosol spray has droplets within a size range of about 1 micron to about 5 microns for stimulating the lower respiratory regions of a user.

21. The combination of claim 11 further characterized in that said aerosol spray has droplets within a size range of about 5 microns to about 10 microns for stimulating the upper respiratory regions of a user.

22. The combination of claim 11 further characterized in that said aerosol spray has a nicotine content sufficient to provide from about 0.008 mg per inhalation to about 0.015 mg per inhalation.

23. A spray and transdermal patch combination for aiding in the reduction of incidence of tobacco smoking by administration of nicotine in a manner which minimizes harmful side effects of nicotine administration, said combination comprising:

(a) an occulsive patch for application to the skin of a person with whom smoking reduction is desired,

(b) a selected amount of nicotine in the patch which is allowed to transdermally migrate from the patch into the person's bloodstream to achieve a desired systemic nicotine level, and

(c) a nicotine containing aerosol spray for delivery of an aerosol to the oral cavity of the user, the amount of nicotine being deliverable with each spray being substantially less than the amount of nicotine deliverable from a puff of tobacco smoke and generally in an amount insufficient to provide any substantial level of nicotine but nevertheless present in an amount to provide the desired sensation in the respiratory tract to which the user is accustomed from normal tobacco smoking and to permit peak levels of nicotine in the bloodstream upon demand by a user, the combination of the patch and spray thereby providing the user with desired systemic nicotine levels and the sensation of smoking without most of the other harmful effects of smoking.

24. The combination of claim 23 further characterized in that said aerosol spray has droplets between about 1 micron to about 10 microns in diameter and with size selected to stimulate either the upper respiratory region or the lower respiratory region or both.

25. The combination of claim 23 further characterized in that the aerosol spray contains nicotine in an amount to render about 0.005 mg to about 0.03 mg per inhalation.

26. The combination of claim 23 further characterized in that said aerosol spray has a nicotine content sufficient to provide from about 0.008 mg per inhalation to about 0.015 mg per inhalation.

27. The combination of claim 23 further characterized in that the amount of nicotine in the nicotine containing aerosol spray for delivery to the oral cavity being delivered simultaneously with the application of nicotine from the patch, the amount of nicotine delivered from the patch being generally inversely related to the amount of nicotine normally delivered from the spray but which is still present in an amount to provide the desired sensation in the respiratory tract to which the user is accustomed from normal tobacco smoking and to permit peak levels of nicotine in the bloodstream upon demand by a user.

28. A spray and transdermal patch combination for aiding in the reduction of incidence of tobacco smoking by administration of nicotine in a manner which minimizes harmful side effects of nicotine administration, said combination comprising:

(a) an occlusive patch for application to the skin of a person with whom smoking reduction is desired,

(b) a selected amount of nicotine in the patch which is allowed to transdermally migrate from the patch into the person's bloodstream to achieve a desired systemic nicotine level,

(c) a nicotine antagonist in said patch which is allowed to migrate from the patch into a users skin to reduce peripheral side effects of the nicotine, and

(d) a nicotine containing aerosol spray for delivery of an aerosol to the oral cavity of the user to provide the desired sensation in the respiratory tract to which the user is accustomed from normal tobacco smoking and to permit peak levels of nicotine in the bloodstream upon demand by a user, thereby providing the user with desired systemic nicotine levels and the sensation of smoking without most of the other harmful effects of smoking.

29. The combination of claim 28 characterized in that the nicotine antagonist is hexamethonium.
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