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1. (WO1991008795) IMPROVED IONTOPHORETIC DELIVERY METHOD
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Cl aims:

1. A method of optimizing the transdermal flux of a beneficial agent from an iontophoretic agent delivery device through intact human skin and decreasing inter-patient skin resistance variability, comprising:

optimizing transdermal flux while decreasing inter-patient skin resistance variability by selecting a skin site on intact back skin of the human;

placing the iontophoretic delivery device in agent
transmitting relation with the intact back skin site; and

iontophoretically delivering the agent through the back skin at a pharmaceutically effective rate.

2. The method of claim 1, wherein the device includes a donor electrode assembly containing the beneficial agent, the donor electrode assembly being placed in agent transmitting relation with the intact back skin site.

3. The method of claim 2, wherein the donor electrode assembly is adhered in agent transmitting relation with the back skin site using an ion-conducting adhesive.

4. The method of claim 1, wherein the device includes a donor electrode assembly containing the beneficial agent, a return electrode assembly and an electrical power source electrically connected to the donor and return electrode assemblies.

5. The method of claim 4, including placing the donor electrode assembly in agent transmitting relation with a first intact back skin site and placing the return electrode assembly in electrolyte transmitting relation with a second intact back skin site, the second back skin site being spaced apart from the first back skin site.

6. The method of claim 4, wherein the power source has a fixed voltage.

7. The method of claim 6, wherein the fixed voltage is in the range of about 1 to 10 volts.

8. The method of claim 1, wherein the beneficial agent is a drug.

9. -The method of claim 1, wherein the beneficial agent is selected from the group consisting of peptides, polypeptides, proteins and macromolecules having a molecular weight of a least about 300 daltons.

10. The method of claim 1, wherein the beneficial agent is selected from the group consisting of insulin, growth hormones, buserelin, leuprolide, LHRH, metoclopramide, fentanyl, lidocaine, ketoprofen, sufentanil, terbutaline, droperidol, heparin, interferon, scopola ine, testosterone, gonadorelin, ciclopirox olamine, buspirone, calcitonin, cromolyn sodium, and midazolam.

11. A method of optimizing transdermal flux of a
beneficial agent from an iontophoretic delivery device to a human patient, the device including a donor electrode assembly
containing the beneficial agent, the donor electrode assembly being adapted to be placed in agent transmitting relation to the skin of the patient, a counter electrode assembly adapted to be placed in electrolyte transmitting relation with the skin at a location spaced apart from the donor electrode assembly and an electric power source, the electrodes and the power source being electrically connected and capable of forming a closed circuit when the electrode assemblies are placed in agent transmitting and electrolyte transmitting relation to the skin of the patient, comprising:

optimizing the transdermal flux from the device while decreasing inter-patient skin resistance variability by (a) selecting a skin site on intact back skin of the human patient, (b) placing the donor electrode in agent transmitting relation with the selected intact back skin site, and (c) iontophoretically delivering the agent through the back skin at a pharmaceutically effective rate.

12. The method of claim 1 or 11, wherein the beneficial agent is co-delivered with a skin permeation enhancer through the intact back skin.

13. The method of claim 11, wherein the power source comprises a battery having a voltage in the range of about 1 to 10 volts.

14. The method of claim 11, wherein the beneficial agent is a drug.

15. The method of claim 11, wherein the beneficial agent is selected from the group consisting of peptides, polypeptides, proteins and macromolecules having a molecular weight of at least about 300 daltons.

16. The method of claim 11, wherein the beneficial agent is selected from the group consisting of insulin, growth hormones, buserelin, leuprolide, LHRH, metoclopramide, fentanyl, lidocaine, ketoprofen, sufentanil, terbutaline, droperidol, heparin, interferon, scopolamine, testosterone, gonadorelin, ciclopirox olamine, buspirone, calcitonin, cromolyn sodium, and midazolam.

17. The method of claim 12, wherein the skin permeation enhancer comprises a surfactant.