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Claims for Patent: 5,364,630

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Claims for Patent: 5,364,630

Title: Subsaturated nicotine transdermal therapeutic system
Abstract:Rate controlled transdermal nicotine delivery systems are disclosed which utilize an in-line adhesive to maintain the systems on the skin. The initial equilibrated concentration of nicotine in the nicotine reservoir and the adhesive is below saturation, preferably at a thermodynamic activity no greater than 0.50, and the reservoir comprises the nicotine dissolved in a material with respect to which the rate controlling element of the device is substantially impermeable. In preferred embodiments the initial loading of nicotine in the reservoir is sufficient to prevent the activity of the nicotine in the reservoir from decreasing by more than about 75% and preferably no more than about 25% during the predetermined period of administration; and the thickness of the adhesive, rate controlling membrane and reservoir layers are selected so that at least 50% and, preferably at least 75% of the initial equilibrated nicotine loading is in the reservoir layer.
Inventor(s): Osborne; James L. (Mountain View, CA), Nelson; Melinda (Sunnyvale, CA), Enscore; David J. (Saratoga, CA), Yum; Su I. (Los Altos, CA), Gale; Robert M. (Los Altos, CA)
Assignee: Alza Corporation (Palo Alto, CA)
Application Number:08/080,280
Patent Claims: 1. A transdermal nicotine delivery device for delivering nicotine over a predetermined administration period and utilizing an in-line adhesive whose adhesive properties are degraded by nicotine comprising, in combination:

a) a nicotine reservoir containing nicotine dissolved therein at an initial equilibrated thermodynamic activity less than 1.0 and at which said adhesive retains adhesive properties and at an initial equilibrated loading sufficient to prevent the thermodynamic activity of nicotine in said reservoir from decreasing by more than 75% during said administration period; and

b) in-line adhesive means for maintaining said nicotine reservoir in nicotine transmitting relationship to the skin.

2. The device of claim 1 wherein said initial equilibrated activity is in the range of 0.05-0.50.

3. The device of claim 1 wherein said initial equilibrated activity is in the range of 0.20-0.40.

4. A method for transdermally administering nicotine from a nicotine delivery device utilizing an in-line adhesive, said device comprising nicotine dissolved in a reservoir at a concentration less than saturation and in-line adhesive means for maintaining said reservoir in nicotine transmitting relationship to the skin, the adhesive properties of said adhesive being degraded by nicotine, which method comprises:

a) applying said device to the skin of a subject when the thermodynamic activity of said nicotine in said reservoir is less than 1.0 and at which said adhesive retains adhesive properties; and

b) removing said device from the skin before the activity of the nicotine in the reservoir has decreased by more than 75%.

5. The method of claim 4 wherein the activity when applied is in the range of 0.05-0.50.

6. The method of claim 4 wherein the activity when applied is in the range of 0.20-0.40.

7. In a transdermal nicotine delivery device for delivering nicotine during a predetermined administration period comprising an agent reservoir containing nicotine dissolved therein at a concentration less than saturation with an in-line adhesive disposed in the path of nicotine migration to the skin, the adhesive properties of said adhesive being degraded by nicotine, the improvement comprising:

a) the initial equilibrated activity of nicotine in said reservoir is less than 1.0 and at which said adhesive retains adhesive properties; and

b) the initial equilibrated loading of nicotine in said reservoir is sufficient to prevent the activity of nicotine from decreasing by more than 75% during said administration period.

8. The device of claim 7 wherein said initial equilibrated activity is in the range of 0.05-0.50.

9. The device of claim 7 wherein said initial equilibrated activity is in the range of 0.20-0.40.

10. The device of claim 1 wherein the initial equilibrated activity of nicotine is no greater than 0.50.

11. The method of claim 4 wherein the activity of the nicotine in the reservoir at the time the device is applied is no greater than 0.50.

12. The improved device of claim 7 wherein the initial equilibrated activity of nicotine is no greater than 0.50.

13. The device of claim 1 wherein said administration period is 24 hours.

14. The device of claim 1 wherein the administration period is 16 hours.

15. The method of claim 4 wherein said administration period is 24 hours.

16. The method of claim 4 wherein the administration period is 16 hours.

17. The improved device of claim 7 wherein said administration period is 24 hours.

18. The improved device of claim 7 wherein said administration period is 16 hours.
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