Transdermal systems for the delivery of therapeutic agents including granisetron using iontophoresis

• US 20060253061A1
• Filed: 04/22/2005
• Published: 11/09/2006
• Est. Priority Date: 04/22/2005
• Status: Active Grant

• Current Assignee: Teva Pharmaceuticals International GmbH (Teva Pharmaceutical Industries Limited)
• Original Assignee: Travanti Pharma Inc. (Teikoku Seiyaku)
• Inventors: Anderson, Carter R., Cohen, Robert, Morris, Russell L., Sembrowich, Walter L.
• Granted Patent: US 7,856,263 B2
• Time in Patent Office: Days
• US Class Current: 604/20
• CPC Class Codes: A61M 2037/0007 having means for enhancing the permeation of substances through the epidermis, e.g. using suction or depression, electric or magnetic fields, sound waves or chemical agents
• CPC Class Codes: A61N 1/0428 Specially adapted for iontophoresis, e.g. AC, DC or including drug reservoirs
• CPC Class Codes: A61N 1/044 Shape of the electrode
• 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

A disposable skin-worn device for the transdermal delivery at least one dose of charged therapeutic substances, including granisetron, by iontophoresis, the device comprising a donor reservoir containing an amount of a therapeutic substance to be delivered transdermally by iontophoresis, a counter reservoir, a source of electric power connected in a circuit between the donor reservoir and the counter reservoir and a control system for controlling current flow in the circuit to enable at least one dose of the therapeutic substance to be delivered transdermally by iontophoresis and wherein the control system includes a control element selected from the group consisting of a sensor activated by an external signal and a switch.

Claims

1. A disposable skin-worn device for the transdermal delivery of a plurality of doses of a charged therapeutic substance by iontophoresis comprising:

(a) a donor reservoir containing an amount of a therapeutic substance to be delivered transdermally by iontophoresis, said donor reservoir further including a plurality of donor electrodes providing separate sources of selectively connectable reactive material for providing a plurality of successive doses of a therapeutic substance;

(b) a counter reservoir;

(c) a source of electric power connected in a circuit between said donor reservoir and said counter reservoir; and

(d) a user-operable control system for controlling current flow in said circuit to enable the plurality of successive doses of said therapeutic substance to be administered from said donor reservoir.

2. A device as in claim 1 wherein said control system further comprises switch means for selectively connecting each of said plurality of donor electrodes into said circuit.

3. A device as in claim 1 wherein a circuit is completed and a first dose is provided automatically upon application of said device to a patient'"'"'s skin.

4. A device as in claim 2 wherein a circuit is completed and a first dose is provided automatically upon application of said device to a patient'"'"'s skin.

5. A device as in claim 1 designed to deliver two doses of said therapeutic substance.

6. A device as in claim 4 designed to deliver two doses of said therapeutic substance.

7. A device as in claim 1 wherein said control system further comprises a two-position switch and said donor reservoir contains two donor electrodes selectively connected in said circuit by said switch such that a first reactive donor electrode is connected in said circuit upon application of said skin-worn device to provide a first dose of said therapeutic substance and a second reactive donor electrode may selectively be connected by operation of said switch to provide a second dose of said therapeutic substance.

8. A device as in claim 1 wherein said therapeutic substance is granisetron.

9. A device as in claim 7 wherein said therapeutic substance is granisetron.

10. A device as in claim 8 wherein each said dose is between about 300 μ

g and 1000 μ

g.

11. A device as in claim 10 wherein each said dose is between about 300 μ

g and 1000 μ

g.

12. A device as in claim 10 wherein at least the first dose is delivered in about 1 hour.

13. A device as in claim 11 wherein at least the first dose is delivered in about 1 hour.

14. A device as in claim 8 wherein said granisetron is contained in a hydrogel formulation.

15. A device as in claim 9 wherein said granisetron is contained in a hydrogel formulation.

16. A device as in claim 10 wherein said granisetron is contained in a hydrogel formulation.

17. A device as in claim 11 wherein said granisetron is contained in a hydrogel formulation.

18. A disposable skin-worn device for the transdermal delivery of at least one dose of a charged therapeutic substance by iontophoresis, said device comprising:

(a) a donor reservoir containing an amount of a therapeutic substance to be delivered transdermally by iontophoresis;

(b) a counter reservoir;

(c) a source of electric power connected in a circuit between said donor reservoir and said counter reservoir; and

(d) a control system for controlling current flow in said circuit to enable at least one dose of said therapeutic substance to be delivered transdermally by iontophoresis wherein said control system includes a control element comprising a sensor activated by an externally generated signal to initiate delivery of a dose of said therapeutic substance from a patch device previously applied to the body-of a user.

19. A device as in claim 18 wherein said therapeutic substance is granisetron.

20. A device as in claim 19 wherein said granisetron is contained in a hydrogel formulation.

21. A device as in claim 19 wherein each said dose is between about 300 μ

g and 1000 μ

g per hour.

40. A device as in claim 18 including a user-activated switch element to enable said control system to activate said device.

41. A device as in claim 19 including a user-activated switch element to enable said control system to activate said device.

22. A disposable skin-worn patch device for the delivery of granisetron by iontophoresis, capable of providing a plurality of doses of granisetron to the body, comprising:

(a) a donor reservoir containing granisetron, said donor reservoir further including a source of reactive material for providing a plurality of successive doses of a granisetron;

(b) a counter reservoir;

(c) A source of electrical power; and

(d) a control system for controlling administration using a first completed circuit for supplying a primary dose of between about 300 μ

g and about 1000 μ

g of granisetron in a less than 2-hour time period upon application of the patch to the body surface, and user-operable device to allow user to self-administer sequentially an additional dose of between about 300 μ

g and about 1000 μ

g of granisetron.

25. A device as in claim 22 wherein said granisetron is contained in a hydrogel formulation.

28. A device as in claim 22 wherein said granisetron is in a form that can only be delivered by iontophoresis.

31. A device as in claim 22 wherein said control system provides steady low level delivery of about 40 μ

g/hr of granisetron after said first primary dose.

32. A device as in claim 22 wherein said donor reservoir contains a single source of reactive material.

33. A device as in claim 32 wherein said control circuit electronically controls dosage administration.

34. A device as in claim 22 wherein the amount of granisetron supplied in the donor reservoir exceeds a desired total quantity to be delivered by the devices to a user.

37. A device as in claim 22 wherein the amount of granisetron supplied in the donor reservoir is at least twice a desired total quantity to be delivered by the devices to a user.

23. A disposable skin-worn patch device for the delivery of granisetron by iontophoresis, which optionally provides a plurality of doses to the body, comprising:

(a) a donor reservoir containing granisetron, said donor reservoir further including a plurality of donor electrodes providing separate sources of reactive material for providing a plurality of successive doses of granisetron;

(b) a counter reservoir;

(c) A source of electrical power; and

(d) a control circuit for controlling current, providing a first completed circuit including a first donor electrode for supplying a primary dose of between about 300 μ

g and about 1000 μ

g of granisetron in a less than 2-hour hour time period upon application of the patch to the body surface, and user-operable device to connect a second donor electrode in a completed circuit to administer an additional dose of between about 300 μ

g and about 1000 μ

g of granisetron.

26. A device as in claim 23 wherein said granisetron is contained in a hydrogel formulation.

29. A device as in claim 23 wherein said granisetron is in a form that can only be delivered by iontophoresis.

35. A device as in claim 23 wherein the amount of granisetron supplied in the donor reservoir exceeds a desired total quantity to be delivered by the devices to a user.

38. A device as in claim 23 wherein the amount of granisetron supplied in the donor reservoir is at least twice a desired total quantity to be delivered by the devices to a user.

24. A disposable skin-worn patch device for the delivery of granisetron by iontophoresis, comprising:

(a) a donor reservoir containing granisetron;

(b) a counter reservoir;

(c) a source of electrical power; and

(d) a control circuit for controlling current in response to an externally generated alarm signal, providing an automated current dose supplying between about 300 μ

g and about 1000 μ

g of granisetron in a period of approximately one hour.

27. A device as in claim 24 wherein said granisetron is contained in a hydrogel formulation.

30. A device as in claim 24 wherein said granisetron is in a form that can only be delivered by iontophoresis.

36. A device as in claim 24 wherein the amount of granisetron supplied in the donor reservoir exceeds a desired total quantity to be delivered by the devices to a user.

39. A device as in claim 24 wherein the amount of granisetron supplied in the donor reservoir is at least twice a desired total quantity to be delivered by the devices to a user.

42. A device as in claim 24 wherein said control system provides steady low level delivery of about 40 μ

g/hr of granisetron after said first primary dose.