Device for transdermal electrotransport delivery of fentanyl and sufentanil

• US 6,216,033 B1
• Filed: 03/17/1998
• Issued: 04/10/2001
• Est. Priority Date: 05/22/1996
• Status: Expired due to Term

• Current Assignee: ALZA Corporation (Johnson & Johnson)
• Original Assignee: ALZA Corporation (Johnson & Johnson)
• Inventors: Southam, Mary, Noorduin, Henk, Bernstein, Keith J.
• Primary Examiner(s): Bockelman, Mark
• Application Number:
  US08/952,657
• Time in Patent Office: 1,120 Days
• Field of Search: 604/20, 604/501, 424/449
• US Class Current: 604/20
• 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 an improved electrotransport drug delivery system for analgesic drugs, namely fentanyl and sufentanil. The fentanyl/sufentanil is provided as a water soluble salt (e.g., fentanyl hydrochloride), preferably in a hydrogel formulation, for use in an electrotransport device (10). In accordance with the present invention, a transdermal electrotransport delivered dose of fentanyl/sufentanil is provided which is sufficient to induce analgesia in (e.g., adult) human patients suffering from moderate-to-severe pain as associated with major surgical procedures.

Claims

1. A patient-worn device for transdermally delivering fentanyl by electrotransport and which allows a patient who is suffering from pain and who is wearing the device to obtain self-administered analgesia, the device comprising:

a donor reservoir hydrogel formulation comprised of fentanyl in a form to be delivered solely by electrotransport;

a counter reservoir;

a source of electrical power electrically connected to the reservoirs; and

a control circuit for controlling electrotransport current, the control circuit including a patient-controlled switch which activates the device and wherein the reservoir, the power source and the control circuit deliver solely by electrotransport a dose of about 20 μ

g to about 60 μ

g of fentanyl over a predetermined delivery period of up to about 20 minutes and terminate said delivery at the end of said delivery period, and wherein the control circuit allows the patient to self-administer from about 10 to about 100 additional of said doses over a period of 24 hours.

2. The device of claim 1, wherein the device delivers about 35 μ

g to about 45 μ

g of fentanyl over a delivery period of about 5 to 15 minutes.

3. The device of claim 1, wherein the device delivers about 40 μ

g of fentanyl over the delivery period.

4. The device of claim 1, wherein the device is used to treat less severe pain and the device delivers about 20 μ

g to about 30 μ

g of fentanyl over the delivery period.

5. The device of claim 1, wherein the delivery period is about 10 minutes.

6. The device of claim 1, wherein the hydrogel formulation comprises a fentanyl salt.

7. The device of claim 6, wherein the fentanyl salt comprises about 1.9 to 2.0 wt % of the formulation.

8. The device of claim 7, wherein the fentanyl salt is fentanyl hydrochloride.

9. The device of claim 1, wherein the hydrogel formulation comprises polyvinyl alcohol.

10. A patient-worn device for transdermally delivering sufentanil by electrotransport and which allows a patient who is suffering from pain and who is wearing the device to obtain self-administered analgesia, the device comprising:

a donor reservoir hydrogel formulation comprised of sufentanil in a form to be delivered solely by electrotransport;

a counter reservoir;

a source of electrical power electrically connected to the reservoirs; and

a control circuit for controlling electrotransport current, the control circuit including a patient-controlled switch which activates the device and wherein the reservoirs, the power source and the control circuit deliver solely by electrotransport a dose of about 2.3 μ

g to about 7.0 μ

g of sufentanil over a predetermined delivery period of up to about 20 minutes and terminate said delivery at the end of said delivery period, and wherein the control circuit allows the patient to self-administer from about 10 to about 100 additional of said doses over a period of 24 hours.

11. The device of claim 10, wherein the device delivers about 4 μ

g to about 5.5 μ

g of sufentanil over a delivery period of about 5 to 15 minutes.

12. The device of claim 10, wherein the device delivers about 4.7 μ

g of sufentanil over the delivery period.

13. The device of claim 10, wherein the device is used to treat less severe pain and the device delivers about 2.3 μ

g to about 3.5 μ

g of sufentanil over the delivery period.

14. The device of claim 10, wherein the delivery period is about 10 minutes.

15. The device of claim 10, wherein the hydrogel formulation comprises a sufentanil salt.

16. The device of claim 10, wherein the sufentanil salt comprises about 1.9 to 2.0 wt % of the formulation.

17. The device of claim 16, wherein the sufentanil salt is sufentanil hydrochloride.

18. The device of claim 10, wherein the hydrogel formulation comprises polyvinyl alcohol.