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Claims for Patent: 5,633,008

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Claims for Patent: 5,633,008

Title: Method of administering nicotine transdermally
Abstract:A method of administering nicotine transdermally in which a nicotine patch, capable of administering nicotine for at least 16 hours at rates that are efficacious in smoking cessation therapy, is applied in the morning upon waking and removed prior to sleep. This method is effective even though nicotine is not essential during sleep and many smokers experience morning craving.
Inventor(s): Osborne; James L. (Mountain View, CA), Nelson; Melinda K. (Sunnyvale, CA), Enscore; David J. (Saratoga, CA), Yum; Su I. (Los Altos, CA), Gale; Robert M. (Los Altos, CA), Causey; Donna D. (Camarillo, CA)
Assignee:
Application Number:08/105,262
Patent Claims: 1. A method for administering nicotine to an individual in need of such administration comprising:

a) applying to the skin of said individual upon waking, a transdermal device comprising a nicotine reservoir containing a sufficient quantity of nicotine to maintain a useful transdermal flux of nicotine from said device for a total time period of at least 16 hours;

b) maintaining said device in nicotine transmitting relationship to the skin during waking hours;

c) removing said device prior to sleep.

2. The method of claim 1, wherein the time elapsed between application and removal and said device is about 16 hours.

3. The method of claim 1, wherein nicotine is administered to said patient at an administration rate of about 250-4,000 .mu.g/h during a substantial portion of the administration period.

4. The method of claim 3 wherein the average flux of nicotine over the administration period does not exceed 200 .mu.g/cm.sup.2 /hr.

5. The method of claim 4 wherein the average flux of nicotine over the administration period does not exceed 120 .mu.g/cm.sup.2 /hr.

6. The method of claim 3 wherein the administration rate is maintained substantially constant over a substantial portion of said administration period.

7. The method of claim 1 wherein the transdermal device comprises a subsaturated nicotine reservoir having a thermodynamic activity of nicotine less than 1.0 and an initial equilibrated loading sufficient to prevent the activity of the nicotine in the reservoir from decreasing by more than 75% over the 16 hour administration period.

8. The method of claim 7 wherein the initial activity is no greater than 0.5.

9. The method of claim 8 wherein the initial nicotine loading is sufficient to prevent the activity from decreasing by more than 25% during the 16 hour administration period.
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