Methods and Devices for Transdermal Electrotransport Delivery of Lofentanil and Carfentanil

• US 20080009782A1
• Filed: 06/26/2007
• Published: 01/10/2008
• Est. Priority Date: 06/28/2006
• Status: Abandoned Application

• Current Assignee: ALZA Corporation (Johnson & Johnson)
• Original Assignee: ALZA Corporation (Johnson & Johnson)
• Inventors: Gale, Robert, Phipps, Joseph, Padmanabhan, Rama
• Application Number:
  US11/768,569
• Publication Number:
  US 20080009782A1
• Time in Patent Office: Days
• US Class Current: 604/020
• CPC Class Codes: A61N 1/0424 Shape of the electrode
• CPC Class Codes: A61N 1/044 Shape of the electrode
• CPC Class Codes: A61N 1/0444 Membrane
• CPC Class Codes: A61N 1/30 Apparatus for iontophoresis, i.e. transfer of media in ionic state by an electromotoric force into the body, or cataphoresis
• CPC Class Codes: A61N 1/327 for enhancing the absorption properties of tissue, e.g. by electroporation

Abstract

Electrotransport drug delivery devices, systems and methods for delivery of lofentanil or carfentanil are disclosed. The lofentanil or carfentanil may be provided as a water soluble salt (e.g., lofentanil or carfentanil hydrochloride), such as in a hydrogel formulation. A transdermal, electrotransport delivered dose of lofentanil or carfentanil is provided which is sufficient to induce analgesia in (e.g., adult) human patients suffering from chronic, acute and/or breakthrough pain.

Claims

1. A method of obtaining analgesia in a human patient who is suffering from pain consisting of transdermally delivering solely by electrotransport a dose of about 0.5 μ

g to about 5 μ

g of lofentanil or carfentanil from an electrotransport device over a predetermined delivery period of up to about 20 minutes, terminating said delivery at the end of said delivery period and thereafter repeating such transdermal administering up to about 100 additional of said doses over a period of 24 hours.

2. The method of claim 1, wherein the delivery period is about 10 minutes.

3. The method of claim 1, where the lofentanil or carfentanil comprises a lofentanil or carfentanil salt.

4. The method of claim 1, wherein the electrotransport device comprises a donor reservoir hydrogel formulation.

5. The method of claim 4, wherein the donor reservoir hydrogel formulation comprises about 1 to about 2.5 weight % lofentanil or carfentanil salt.

8. The method of claim 1, wherein the electrotransport device comprises a donor reservoir hydrogel formulation.

9. The method of claim 4, wherein the donor reservoir hydrogel formulation comprises about 1 to about 2.5 weight % lofentanil or carfentanil salt.

6. A method of obtaining analgesia in a human patient who is suffering from pain consisting of transdermally delivering solely by electrotransport a dose of about 0.3 μ

g/hr to about 10 μ

g/hr of lofentanil or carfentanil from an electrotransport device over a delivery period of up to about 7 days.

7. The method of claim 6, where the lofentanil or carfentanil comprises a lofentanil or carfentanil salt.

10. A method of obtaining analgesia in a human patient who is suffering from pain consisting of transdermally delivering solely by electrotransport a dose of about 3 μ

g to about 40 μ

g of lofentanil or carfentanil from an electrotransport device over a predetermined delivery period of up to about 20 minutes, terminating said delivery at the end of said delivery period and thereafter repeating such transdermal administering up to about 10 additional of said doses over a period of 24 hours.

11. The method of claim 10, wherein the delivery period is about 10 minutes.

12. The method of claim 10, where the lofentanil or carfentanil comprises a lofentanil or carfentanil salt.

13. The method of claim 10, wherein the electrotransport device comprises a donor reservoir hydrogel formulation.

14. The method of claim 13, wherein the donor reservoir hydrogel formulation comprises about 1 to about 2.5 weight % lofentanil or carfentanil salt.

15. A method of obtaining analgesia in a human patient who is suffering from pain consisting of transdermally delivering solely by electrotransport a dose of lofentanil or carfentanil from an electrotransport device sufficient to alleviate said pain.

16. A device for transdermally delivering lofentanil or carfentanil by electrotransport, comprising a donor reservoir containing lofentanil or carfentanil in a form to be delivered solely by electrotransport, a counter reservoir, a source of electrical power electrically connected to said reservoirs and a control circuit for controlling the magnitude and timing of applied electrotransport current.

17. The device of claim 16, wherein the reservoirs, the power source and the control circuit are configured to deliver by electrotransport about 0.5 μ

g to about 20 μ

g of lofentanil or carfentanil over a delivery period of up to about 20 minutes.

18. The device of claim 16, where the lofentanil or carfentanil comprises a lofentanil or carfentanil salt.

19. The device of claim 16, wherein the donor reservoir comprises a hydrogel formulation.

20. The device of claim 19, further comprising a membrane located on the body surface distal side of the device.