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Claims for Patent: 5,016,652

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Claims for Patent: 5,016,652

Title: Method and apparatus for aiding in the reduction of incidence of tobacco smoking
Abstract:A dermally applicable patch adapted for application to the skin of the user to enable a transdermal administration to the bloodstream of a user. The patch comprises an outer layer which is impermeable to the passage of nicotine and an inner layer which may operate as a rate controlling membrane to allow the passage of nicotine into the bloodstream of a user. An outer layer and an inner layer form a nicotine receiving area for receiving the nicotine to thereby allow the same to pass through the inner layer. In a preferred embodiment, the patch is highly effective in reducing the incidence of tobacco smoking by allowing transdermal nicotine migration into the bloodstream of a user at a rate sufficient to correspond to the nicotine level in the blood achieved by smoking.
Inventor(s): Rose; Jed E. (Venice, CA), Jarvik; Murray E. (Santa Monica, CA)
Assignee: The Regents of the University of California (Berkely, CA)
Application Number:07/157,627
Patent Claims: 1. A patch adapted for application to the skin of a user for the transdermal administration of nicotine to the user, said patch comprising:

(a) an outer layer which is impermeable to the passage of nicotine,

(b) an inner layer adapted to be placed on the surface of a user's skin, said inner layer being sufficiently porous to enable the passage of nicotine therethrough for transdermal application to the bloodstream of a user,

(c) means associated with said patch to enable said patch to be temporarily and releasably attached to the skin of a user, and

(d) said outer layer and said inner layer forming a nicotine receiving area for receiving nicotine to allow the nicotine to pass through the inner layer.

2. The patch of claim 1 further characterized in that said patch is provided with a membrane in the nicotine receiving area to receive and enable a release of the nicotine.

3. The patch of claim 1 further characterized in that said inner layer is a rate controlling membrane to control the rate of delivery of the nicotine to the user of the patch.

4. A patch for aiding in the reduction of the incidence of tobacco smoking, said patch comprising:

(a) a dermally applicable pad,

(b) nicotine contained by said dermally applicable pad in such manner that it is dispensable therefrom at a controlled rate,

(c) means for applying the patch to the skin of the person to whom smoking reduction is desired, and

(d) a rate controlling membrane on said pad adapted to be placed adjacent a user's skin to allow the nicotine in the patch to transdermally migrate into the person's bloodstream at a rate sufficient to correspond to the nicotine level in the blood achieved by smoking.

5. The patch of claim 4 further characterized in that said patch comprises at least 8 milligrams of nicotine therein.

6. The patch of claim 4 further characterized in that said patch comprises a sufficient amount of nicotine and which is 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.

7. The patch of claim 4 further characterized in that said comprises a sufficient amount of nicotine and is constructed to transdermally administer the nicotine from the pad to maintain about 50 to about 250 micrograms of nicotine in the bloodstream.

8. The patch of claim 4 further characterized in that said patch comprises:

(a) an outer layer which is impermeable to the passage of nicotine, and

(b) an inner rate controlling membrane layer adapted to be placed on the surface of a user's skin and which is sufficiently porous to enable the passage of nicotine therethrough for transdermal application to the bloodstream of a user.

9. The patch of claim 4 further characterized in that said outer layer and said inner layer form a nicotine receiving area for receiving nicotine to release the nicotine to pass through the inner layer.

10. The patch adapted for application to the skin of a user for the transdermal administration of nicotine to the user, said patch comprising:

(a) an outer layer which is impermeable to the passage of nicotine,

(b) an inner layer adapted to be placed on the surface of a user's skin, said inner layer being sufficiently porous to enable the passage of nicotine therethrough for transdermal application to the bloodstream of a user,

(c) means associated with said patch to enable said patch to be temporarily and releasably attached to the skin of a user, and

(d) said outer layer and said inner layer forming a nicotine receiving area for receiving nicotine in admixture with the nicotine carrier to allow the nicotine with the carrier to pass through the inner layer. PG,46

11. A patch adapted for application to the skin of a user for the transdermal administration of nicotine to the user, said patch comprising:

(a) an outer layer which is impermeable to the passage of nicotine,

(b) an inner layer adapted to be placed on the surface of a user's skin, said inner layer being sufficiently porous to enable the passage of nicotine therethrough for transdermal application to the bloodstream of a user,

(c) means associated with said patch to enable said patch to be temporarily and releasably attached to the skin of a user, and

(d) said outer layer and said inner layer forming a nicotine receiving area for receiving nicotine to allow the nicotine to pass through the inner layer, and

(e) an agent in the nicotine receiving area to control penetration of nicotine through a users skin.

12. The patch of claim 11 further characterized in that said agent in said patch operates to increase skin permeability of a user to thereby control penetration of nicotine by increasing the rate of nicotine absorption.

13. The patch of claim 11 further characterized in that said agent in the nicotine receiving area adjusts the pH of the nicotine to control delivery rate of nicotine from the patch to a user of same.

14. A patch for application to the skin of a user for the transdermal administration of nicotine to the user, said patch comprising:

(a) an outer layer which is impermeable to the passage of nicotine,

(b) an inner layer adapted to be placed on the surface of a user's skin, said inner layer being sufficiently porous to enable the passage of nicotine therethrough for transdermal application to the bloodstream of a user,

(c) means associated with said patch to enable said patch to be temporarily and releasably attached to the skin of a user,

(d) said outer layer and said inner layer forming a nicotine receiving area for receiving nicotine to allow the nicotine to pass through the inner layer, and

(e) a nicotine antagonist in said nicotine receiving area to reduce peripheral side effects of nicotine.

15. The patch of claim 14 further characterized in that the nicotine antagonist is hexamethonium.

16. The patch of claim 11 further characterized in that said agent in said patch comprises a penetration enhancer.

17. A patch for aiding in the reduction of the incidence of tobacco smoking, said patch comprising:

(a) a dermally applicable pad,

(b) nicotine mixed with a carrier contained by said dermally applicable pad in such manner that it is dispensable therefrom at a controlled rate,

(c) means for applying the patch to the skin of the person to whom smoking reduction is desired, and

(d) a rate controlling membrane on said pad adapted to be placed adjacent a user's skin to allow the nicotine in the patch to transdermally migrate into the person's bloodstream at a rate sufficient to correspond to the nicotine level in the blood achieved by smoking.

18. A patch for aiding in the reduction of the incidence of tobacco smoking, said patch comprising:

(a) a dermally applicable pad,

(b) nicotine contained by said dermally applicable pad in such manner that it is dispensable therefrom at a controlled rate,

(c) means for applying the patch to the skin of the person to whom smoking reduction is desired,

(d) a rate controlling membrane on said pad adapted to be placed adjacent a user's skin to allow the nicotine in the patch to transdermally migrate into the person's bloodstream at a rate sufficient to correspond to the nicotine level in the blood achieved by smoking, and

(e) an agent contained by said dermally applicable pad to control penetration of nicotine through a users skin.

19. The patch of claim 18 further characterized in that said agent contained by said pad comprises an agent to increase skin permeability of a user to thereby increase the rate of nicotine absorption.

20. The patch of claim 18 further characterized in that said agent adjusts the pH of the nicotine to control delivery rate of nicotine from the patch to a user of same.

21. A patch for aiding in the reduction of the incidience of tobacco smoking, said patch comprising:

(a) a dermally applicable pad,

(b) nicotine contained by said dermally applicable pad in such manner that it is dispensable therefrom at a controlled rate,

(c) means for applying the patch to the skin of the person to whom smoking reduction is desired,

(d) a rate controlling membrane on said pad adapted to be placed adjacent a user's skin to allow the nicotine in the patch to transdermally migrate into the person's bloodstream at a rate sufficient to correspond to the nicotine level in the blood achieved by smoking, and

(e) a nicotine antagonist contained by said pad to reduce peripheral side effects.

22. The patch of claim 21 further characterized in that the nicotine antagonist is hexamethonium.

23. The patch of claim 18 further characterized in that said patch comprises about 1 to about 5 milligrams of nicotine and said agent comprises a penetration enhancer.

24. A patch for aiding in the reduction of the incidence of tobacco smoking, said patch comprising:

(a) a dermally applicable pad,

(b) nicotine contained by said dermally applicable pad in such manner that it is dispensable therefrom at a controlled rate,

(c) means for applying the patch to the skin of the person to whom smoking reduction is desired,

(d) a rate controlling membrane on said pad adapted to be placed adjacent a user's skin to allow the nicotine in the patch to transdermally migrate into the person's bloodstream at a rate sufficient to correspond to the nicotine level in the blood achieved by smoking, and

(e) a membrane in the nicotine receiving area to receive and enable a release of nicotine.
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