Adjustable electrotransport drug delivery using a fixed output controller

• US 6,355,025 B1
• Filed: 06/07/1995
• Issued: 03/12/2002
• Est. Priority Date: 06/07/1995
• Status: Expired due to Term

• Current Assignee: ALZA Corporation (Johnson & Johnson)
• Original Assignee: ALZA Corporation (Johnson & Johnson)
• Inventors: Phipps, J. Bradley, Lattin, Gary A.
• Primary Examiner(s): Bockelman, Mark
• Application Number:
  US08/485,960
• Time in Patent Office: 2,470 Days
• Field of Search: 604/20-21, 604/501, 607/115, 607/149, 607/152-153
• US Class Current: 604/501
• CPC Class Codes: A61N 1/30 Apparatus for iontophoresis, i.e. transfer of media in ionic state by an electromotoric force into the body, or cataphoresis

Abstract

The invention provides a method for adjusting, i.e., varying, the rate of delivery of a therapeutic agent through a body surface from an electrotransport assembly of the type which includes a predetermined, e.g., fixed, output electronic controller and a detachable therapeutic agent source. The method provides a plurality of therapeutic agent sources in which a single parameter or a series of parameters has been varied. The plurality of agent sources are supplied, one at a time, to the controller of the electrotransport assembly, so that together (i.e., source and controller) the agent delivery rate is varied.

Claims

1. A method for delivering a therapeutic agent through a body surface, comprising the steps of:

delivering the therapeutic agent through the body surface from an electrotransport assembly of the type which includes a controller component and a detachable therapeutic agent source coupled to the controller component, the controller component operating at a predetermined, fixed electrical output; and

adjusting the rate of therapeutic agent delivery by uncoupling the therapeutic agent source from the controller component and coupling each of a plurality of therapeutic agent sources in which a single parameter or a series of parameters has been varied so that agent delivery rate is selectively controllable by coupling and uncoupling said plurality of therapeutic agent sources to the controller component one at a time.

2. The method of claim 1, wherein said single parameter or series of parameters are selected from the group consisting of therapeutic agent concentration, competitive co-ion concentration, skin contact area of therapeutic agent source, pH of therapeutic agent source, pH of solvent of therapeutic agent source, ion solvating property of solvent of therapeutic agent source, and enhancer content, and wherein the electrotransport agent delivery rate from the controller with one of the plurality of therapeutic agent sources is substantially different from the controller with another of said sources.

3. The method of claim 2, wherein the pH of the solvent of the therapeutic agent source is varied.

4. The method of claim 1, wherein each said therapeutic source is a drug reservoir which is a hydrogel having a pH.

5. The method of claim 4, wherein, within said plurality, the pH of the hydrogel is varied.

6. A method for varying drug delivery rate of a therapeutic agent through a body surface, comprising the steps of:

delivering the therapeutic agent through the body surface from an electrotransport assembly of the type which includes an electronic controller component and a detachable drug-containing unit coupled to the controller component, the drug-containing unit having an active electrode, the controller component operating at a fixed output; and

uncoupling the drug-containing unit from the controller component and coupling, one at a time, a plurality of drug-containing units to the controller component, each drug-containing unit having a specific dose different from the others of said plurality and coupling and uncoupling said drug-containing unit to the controller component thereby varying drug delivery rate.

7. The method of claim 6, wherein said providing step includes providing drug-containing units comprising multiple reservoirs, each said unit having a first portion of said the reservoirs loaded with drug and a second portion being drug-free, said second portion of reservoirs containing only a biocompatible electrolyte, and wherein the drug delivery rate is varied by varying, within said plurality, the ratio of drug-loaded to drug-free reservoirs in contact with the active electrode.

8. The method of claim 6, wherein said providing step includes providing drug-containing units having a drug and competitive co-ions, and wherein the drug delivery rate is varied by varying, within said plurality, the ratio of drug concentration to co-ion concentration.

9. The method of claim 8, wherein said competitive co-ion concentration is provided by a secondary electrode in the drug-containing unit which generates competitive co-ions.

10. The method of claim 6, wherein said providing step includes providing a plurality of drug-containing units having differing drug concentrations.

11. An electrotransport device for delivering a therapeutic agent through a body surface, the device including a controller which operates at a predetermined, fixed electrical output, the controller being adapted to be detachably connected, one at a time, to a plurality of therapeutic agent sources, the device having:

a plurality of different classes of therapeutic agent sources in which a parameter in each of said different classes has been varied so that the electrotransport agent delivery rate from the controller with one class of therapeutic agent sources is substantially different from the controller with another of said classes of therapeutic agent sources.

12. The device of claim 11, wherein said parameter is selected from the group consisting of therapeutic agent concentration, competitive co-ion concentration, skin contact area of the therapeutic agent source, pH of the therapeutic agent source, ion solvating property of a liquid solvent in the therapeutic agent source, flux enhancer content, and combinations thereof.

13. The device of claim 11, wherein each said therapeutic source comprises a drug reservoir having a pH.

14. The device of claim 13, wherein, within said plurality of classes of therapeutic agent sources, the pH of the drug reservoir is varied.

15. The device of claim 11, wherein each therapeutic agent source comprises a drug-containing unit having a drug-containing donor reservoir.

16. The device of claim 15, wherein each donor reservoir comprises multiple reservoir segments, each of said unit classes having a first portion of said reservoir segments containing drug and a second portion being substantially drug-free, and wherein the drug delivery rate is varied by varying, within said different classes, the ratio of drug-containing to drug-free reservoir segments.

17. The device of claim 16, wherein said second portion of reservoir segments contain a biocompatible electrolyte.

18. The device of claim 15, wherein said drug-containing units comprise a drug and competitive co-ions.

19. The device of claim 18, wherein said competitive co-ion concentration is provided by a secondary electrode in the drug-containing unit which generates competitive co-ions.

20. The device of claim 15, wherein the plurality of classes of drug-containing units each has different drug concentrations.

21. A method of delivering a therapeutic agent through a body surface from an electrotransport assembly of the type which includes a controller component and a detachable therapeutic agent source, the controller component operating at a predetermined, fixed electrical output, the method comprising the steps of:

providing a plurality of therapeutic agent sources in which a single parameter or a series of parameters has been varied so that, in conjunction with said controller component, agent delivery rate can be selectively controlled by coupling and uncoupling said therapeutic agent sources to the controller component; and

interchanging said agent sources whereby therapeutic agent delivery rate is selectively controlled at fixed controller-component electrical output.

22. An electrotransport delivery system comprising:

an electrotransport device for delivering a therapeutic agent through a body surface, the device including a controller which operates at a predetermined, substantially fixed electrical output, the controller being adapted to be detachably connected to a plurality of therapeutic agent sources; and

a plurality of different therapeutic agent sources in which a parameter in each said different sources has been varied so that electrotransport agent delivery rate from the system with one of said sources is substantially different from the electrotransport agent delivery rate from the system with another of said sources.

23. A system according to claim 22, wherein the parameter of the therapeutic agent source is selected from the group consisting of therapeutic agent concentration, competitive co-ion concentration, skin contact area of therapeutic agent source, pH of the therapeutic agent source, ion solvating property of a liquid solvent in the therapeutic agent source, flux enhancer content, and combinations thereof.

24. A system according to claim 22, wherein each said therapeutic agent source comprises a drug reservoir having a pH.

25. A system according to claim 22, wherein each therapeutic agent source comprises a drug-containing unit having a drug-containing donor reservoir.

26. A system of claim 25, wherein each donor reservoir comprises multiple reservoir segments, a plurality of said reservoir segments containing drug and a plurality of said reservoir segments being substantially drug-free, and wherein the drug delivery rate of the system is varied by varying the ratio of drug-containing to drug-free reservoir segments.

27. The device of claim 26, wherein said drug-free reservoir segments contain a biocompatible electrolyte.

28. A system according to claim 22, wherein the plurality of different therapeutic agent sources each has different agent concentrations.