Transdermal delivery device

• US 5,203,768 A
• Filed: 07/24/1991
• Issued: 04/20/1993
• Est. Priority Date: 07/24/1991
• Status: Expired due to Term

• Current Assignee: ALZA Corporation (Johnson & Johnson)
• Original Assignee: ALZA Corporation (Johnson & Johnson)
• Inventors: Gyory, J. Richard, Theeuwes, Felix, Haak, Ronald P.
• Primary Examiner(s): Shay, David M.
• Assistant Examiner(s): Rafa, Michael
• Application Number:
  US07/735,126
• Time in Patent Office: 636 Days
• Field of Search: 604/20, 604/49, 128/798, 128/802, 128/803
• US Class Current: 604/20
• CPC Class Codes: A61K 9/0009 involving or responsive to electricity, magnetism or acoustic waves; Galenical aspects of sonophoresis, iontophoresis, electroporation or electroosmosis microelectromechanical systems A61K9/0097
• CPC Class Codes: A61N 1/0436 Material of the electrode
• CPC Class Codes: A61N 1/044 Shape of the electrode
• CPC Class Codes: A61N 1/0444 Membrane
• CPC Class Codes: A61N 1/0448 Drug reservoir

Abstract

A transdermal drug delivery device (20) is provided having both an active drug reservoir (24) and a passive drug reservoir (26). Drug is actively delivered by iontophoresis from the active drug reservoir (24) by an electric field generated by a power source (21). Simultaneously, drug is delivered from passive reservoir (26) by passive (i.e., non-electrically assisted) diffusion. In one embodiment, the passive drug reservoir (26) is electrically insulated from the active drug reservoir (24). In a second embodiment, both the active and the passive drug are contained in the same reservoir (34). In the second embodiment, the active drug is ionizable while the passive drug is non-ionizable. Most preferably, the active drug is an ionizable form (i.e., a salt form) of the passive drug.

Claims

1. A transdermal agent delivery device, comprising a unitary device having:

an active agent reservoir adapted to be placed in active agent transmitting relation with a body surface and positioned within an electric field generated by electrically connecting the active agent reservoir to a source of electrical power; and

a passive agent reservoir adapted to be placed in passive agent transmitting relation to a body surface, the passive agent being able to passively diffuse through the passive agent reservoir, the passive agent reservoir being electrically insualted from the electrical field generated by the power source.

2. The device of claim 1, wherein the passive agent is present in the passive agent reservoir in excess of saturation.

3. The device of claim 1, wherein the active agent is ionizable.

4. The device of claim 1, wherein the active agent comprises a water soluble salt.

5. The device of claim 1, wherein the active agent comprises an ionizable salt of the passive agent.

6. The device of claim 1, wherein the passive agent is an acid or a base and the active agent is an ionizable salt of the acid or base.

7. The device of claim 1, wherein the active agent and the passive agent ar narcotic analgesics.

8. The device of claim 1, wherein the active agent reservoir is comprised at least in part of a hydrophilic polymer matrix containing the active agent.

9. The device of claim 8, wherein the hydrophilic polymer is selected from the group consisting of polyvinyl pyrrolidones, polyvinyl alcohols, polyethylene oxides, acrylic polymers and cellulosic polymers.

10. The device of claim 1, including means for electrically connecting and electrically disconnecting the power source and the active agent reservoir.

11. The device of claim 10, wherein the means for electrically connecting and electrically disconnecting comprises an on-off switch.

12. The device of claim 1, wherein the passive agent reservoir is ion permeable and the device includes an insulating means which electrically insulates the ion permeable passive agent reservoir from the electric field.

13. The device of claim 12, wherein the insulating means comprises a hydrophobic polymer.

14. The device of claim 1, wherein the passive agent reservoir is substantially ion impermeable.

15. The device of claim 5, including an electrolyte reservoir electrically connected to a counter electrode which is electrically connected to the source of electrical power, wherein the passive agent reservoir is positioned between (i) the active agent reservoir and (ii) the electrolyte reservoir.

16. The device of claim 14, wherein the passive agent reservoir comprises a hydrophobic polymer matrix and the passive agent.

17. The device of claim 13 or 16, wherein the hydrophobic polymer is selected from the group consisting of ethylene vinyl acetate copolymers, polyalkylenes, polyisoprenes, rubbers, polyvinyl acetate, polyamides, polyurethanes, polyvinyl chlorides, and modified cellulosic polymers.

18. The device of claim 16, wherein the passive agent is soluble in the hydrophobic polymer matrix.

22. The method of claim 14, wherein the active agent comprises a water soluble salt.

19. A method of delivering an agent through a body surface from a unitary device having an actively transported agent reservoir and a nonionizable passively transported agent reservoir, comprising:

a) placing the reservoir containing the actively transported agent in agent transmitting relation with a body surface;

b) placing the reservoir containing the nonionizable passively transported agent in agent transmitting relation with a body surface to passively transport said agent through the body surface; and

c) generating an electric field through the reservoir containing the actively transported agent to actively transport said agent through the body surface.

20. The method of claim 19, including periodically deactivating the electric field to stop the active transport of the active agent.

21. The method of claim 19, wherein the active agent is ionizable.

23. The method of claim 19, wherein the active agent comprises an ionizable salt of the passive agent.

24. The method of claim 19, wherein the passive agent is an acid or a base and the active agent is an ionizable salt of the acid or base.

25. A method of treating pain by delivering a narcotic analgesic from a unitary device having an ionizable, actively transported narcotic analgesic reservoir and a nonionizable passively transported narcotic analgesic reservoir, comprising:

a) placing the reservoir containing the ionizable narcotic analgesic in narcotic analgesic transmitting relation with a body surface;

b) placing the reservoir containing the nonionizable narcotic analgesic in narcotic analgesic transmitting relation with a body surface to passively transport said narcotic analgesic through the body surface;

c) dissolving the ionizable narcotic analgesic in a solvent to form narcotic analgesic ions; and

d) generating an electric field through the reservoir containing the narcotic analgesic ions to actively transport said narcotic analgesic ions through the body surface.

26. The method of claim 25, wherein the ionizable narcotic analgesic and the nonionizable narcotic analgesic are contained in separate reservoirs, the reservoir containing the non-ionizable narcotic analgesic being electrically insualted from the electric field.

27. The method of claim 25, wherein the ionizable narcotic analgesic comprises a salt of fentanyl or sufentanil.

28. The method of claim 25, wherein the nonionizable narcotic analgesic comprises fentanyl base or sufentanil base.