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Claims for Patent: 5,342,623

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Claims for Patent: 5,342,623

Title: Subsaturated transdermal therapeutic system having improved release characteristics
Abstract:Rate controlled transdermal delivery devices are disclosed which utilize an in-line adhesive to maintain the device on the skin and deliver an agent which is a solvent or a plasticizer for the in-line adhesive. The initial equilibrated concentration of the agent in the agent reservoir and the adhesive is below saturation, and the reservoir comprises the agent dissolved in a solvent with respect to which the rate controlling element of the device is substantially impermeable. In preferred embodiments the initial loading of the agent in reservoir is sufficient to prevent the activity of the agent in the reservoir from decreasing by more than about 50% and preferably no more than about 25% during the predetermined period of administration; and the thicknesses of the adhesive, rate controlling membrane and reservoir layers are selected so that at least 50% and preferably at least 75% initial equilibrated agent loading is in the reservoir layer. The devices are usable to deliver agents which are liquid at body temperatures such as benztropine, secoverine, nicotine, arecoline, polyethylene glycol monolaurate, glycerol monolaurate, glycerol monooleate and ethanol, for example.
Inventor(s): Enscore; David J. (Sunnyvale, CA), Campbell; Patricia S. (Palo Alto, CA), Osborne; James L. (Mountain View, CA), Smart; Melinda K. (Sunnyvale, CA), Yum; Su I. (Los Altos, CA)
Assignee: Alza Corporation (Palo Alto, CA)
Application Number:08/080,645
Patent Claims: 1. A medical device utilizing an in-line adhesive for the transdermal administration of an agent that is a solvent for said adhesive, said device being adapted to deliver said agent throughout a predetermined administration period said device comprising, in combination:

a) an agent reservoir comprising said agent dissolved in a solvent at a concentration less than saturation and at an initial equilibrated agent loading sufficient to prevent the activity of said agent in said solvent from decreasing by more than 75% during said administration period;

b) agent release rate controlling means disposed in the path of agent migration from said reservoir to the skin, said rate controlling means being permeable to said agent and substantially impermeable to said solvent; and

c) adhesive means disposed in the path of agent migration from said release rate controlling means to the skin, said adhesive being soluble in said agent the initial equilibrated concentration of said agent in said reservoir being at a level at which the adhesive maintains adhesive properties.

2. The device of claim 1 wherein at least 50% of the initial loading of the agent in the device is in the agent reservoir.

3. The device of claim 1 wherein said decrease in activity is no greater than 25%.

4. The device of claim 1 wherein at least 75% of the initial agent loading is in the reservoir.

5. The device of claim 1 wherein said agent is an oily, non-polar material, liquid at body temperature.

6. The device of claim 1 wherein said reservoir contains more than one agent at least one of which is an oily, nonpolar material, liquid at body temperature.

7. The device of claim 1 wherein said agent solubilizes said adhesive.

8. The device of claim 1 wherein said agent plasticizes said adhesive.

9. The device of claim 1 wherein the activity of the agent in the reservoir is no greater than 0.50.

10. The device of claim 2 wherein the activity of the agent in the reservoir is no greater than 0.50.

11. The device of claim 3 wherein the activity of the agent in the reservoir is no greater than 0.50.

12. The device of claim 4 wherein the activity of the agent in the reservoir is no greater than 0.50.

13. The device of claim 1 wherein the activity of the agent in the reservoir is no greater than 0.25.

14. The device of claim 2 wherein the activity of the agent in the reservoir is no greater than 0.25.

15. The device of claim 3 wherein the activity of the agent in the reservoir is no greater than 0.25.
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