Electrotransport Agent Delivery Method and Apparatus

• US 20090036822A1
• Filed: 10/07/2008
• Published: 02/05/2009
• Est. Priority Date: 09/11/2000
• Status: Abandoned Application

• Current Assignee: ALZA Corporation (Johnson & Johnson)
• Original Assignee: ALZA Corporation (Johnson & Johnson)
• Inventors: Kleiner, Lothar W., Young, Wendy A.
• Application Number:
  US12/246,579
• Publication Number:
  US 20090036822A1
• Time in Patent Office: Days
• US Class Current: 604/20
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61N 1/0448 Drug reservoir
• CPC Class Codes: A61P 25/04 Centrally acting analgesics, e.g. opioids

Abstract

An electrotransport device for delivering or sampling an agent through a body surface by electrotransport, the device having a housing including an upper, exterior housing portion and a lower housing portion, the housing enclosing electronic components, and at least one hydratable or hydrated reservoir containing water or an at least partially aqueous solution of the agent. At least a portion of the housing is composed of an ethylene-octene copolymer.

Claims

1. An electrotransport device for transporting a drug through a body surface by electrotransport, the device having a housing, said housing having at least one molded portion with a depression and enclosing electronic components, at least one electrode, and at least one hydrated reservoir comprising fentanyl or sufentanil or a pharmaceutically acceptable salt thereof, wherein at least a portion of the molded portion comprises an ethylene-octene copolymer.

2. The electrotransport device of claim 1, wherein the ethylene-octene copolymer has a Shore A hardness value between approximately 66 and 96.

3. The electrotransport device of claim 1, wherein the ethylene-octene copolymer has an octene content between approximately 5.0 percent and approximately 30.0 percent.

4. The electrotransport device of claim 3, wherein the ethylene-octene copolymer has an octane content between approximately 9.5 percent and approximately 24 percent.

5. The electrotransport device of claim 1, adapted to be applied to human skin.

6. The electrotransport device of claim 1, wherein the hydrated reservoir further comprises a polymeric hydrogel.

7. The electrotransport device of claim 1, wherein the electrode comprises silver or silver chloride.

8. The electrotransport device of claim 1, wherein the molded portion of the device exhibits less than 1.25% shrinkage at temperatures between 40°

and 55°

C.

9. The electrotransport device of claim 1, wherein the moisture vapor transmission rate of the device is less than about 40 gm/m²/day.

10. The electrotransport device of claim 1, wherein the device exhibits substantially no gassing-off of acetic acid.

11. The electrotransport device of claim 1, wherein the fentanyl or sufentanil or a pharmaceutically acceptable salt thereof comprises about 1 to 10 wt % of the reservoir formulation on a fully hydrated basis.

12. The electrotransport device of claim 11, wherein the fentanyl or sufentanil or a pharmaceutically acceptable salt thereof comprises about 1 to 5 wt % of the reservoir formulation on a fully hydrated basis.

13. The electrotransport device of claim 1, adapted to transdermally deliver the drug over a delivery period of up to about 20 minutes.

14. The electrotransport device of claim 1, wherein the applied electrotransport current density is about 50 to 150 μ

A/cm² and the applied electrotransport current is about 150 to 240 μ

A.

15. The electrotransport device of claim 6, wherein the polymeric hydrogel is PVOH.

16. The electrotransport device of claim 1, wherein the device comprises an upper housing portion and a lower housing portion, and the electronic components are enclosed between the upper and lower housing portions.

17. The electrotransport device of claim 16, wherein the device comprises two hydrated reservoirs and two electrodes, and wherein the hydrated reservoir comprising fentanyl or sufentanil or a pharmaceutically acceptable salt thereof is in electrical contact with the anodic electrode, and the drug-free hydrated reservoir is in electrical contact with the cathodic electrode.

18. The electrotransport device of claim 17, wherein the upper housing portion and lower housing portion comprises an ethylene-octene copolymer.

19. The electrotransport device of claim 18, wherein the ethylene-octene copolymer has a Shore A hardness value between approximately 66 and 96.

20. The electrotransport device of claim 18, wherein the ethylene-octene copolymer has an octene content between approximately 5.0 percent and approximately 30.0 percent.

21. The electrotransport device of claim 18, wherein the device exhibits less than 1.25% shrinkage at temperatures between 40°

and 55°

C.

22. The electrotransport device of claim 18, wherein the moisture vapor transmission rate of the device is less than about 40 gm/m²/day.

23. The electrotransport device of claim 1, wherein the device exhibits substantially no gassing-off of acetic acid.