Device for transdermal electrotransport delivery of fentanyl and sufentanil

• US 20060069344A1
• Filed: 10/28/2005
• Published: 03/30/2006
• Est. Priority Date: 06/05/1995
• Status: Active Grant

• Current Assignee: Henk Noorduin, Keith J. Bernstein, Mary Southam
• Original Assignee: Henk Noorduin, Keith J. Bernstein, Mary Southam
• Inventors: Southam, Mary, Bernstein, Keith J., Noorduin, Henk
• Granted Patent: US 7,302,293 B2
• Time in Patent Office: Days
• US Class Current: 604/20
• CPC Class Codes: A61K 31/445 Non condensed piperidines, e.g. piperocaine
• CPC Class Codes: A61K 31/4468 having a nitrogen directly attached in position 4, e.g. clebopride, fentanyl
• CPC Class Codes: A61K 31/4535 containing a heterocyclic ring having sulfur as a ring hetero atom, e.g. pizotifen
• 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 1/0448 Drug reservoir
• 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 associated with major surgical procedures.

Claims

1. A patient-worn device for transdermally delivering fentanyl by electrotransport to a human patient suffering from pain, comprising:

a donor reservoir formulation comprised of a fentanyl salt solution at or above a concentration at which the fentanyl transdermal electrotransport flux is independent of fentanyl salt concentration in said donor reservoir;

a counter reservoir;

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

a control circuit for controlling electrotransport current, said control circuit including a switch which activates said device and wherein said reservoirs, said power source and said 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 said control circuit allows up to about 100 additional of said doses over a period of about 24 hours.

2. The device of claim 1, wherein the fentanyl salt concentration is above about 11 mM.

3. The device of claim 2, wherein the fentanyl salt concentration is above about 16 mM.

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

5. The device of claim 4, wherein the hydrogel matrix comprises polyvinyl alcohol.

6. 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.

7. The device of claim 1, wherein the device delivers about 20 μ

g to about 30 μ

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

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

g of fentanyl over the delivery period.

9. The device of claim 1, wherein the device delivers about 25 μ

g of fentanyl over the delivery period.

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

11. The device of claim 1, wherein the additional doses are 35 μ

g to 45 μ

g doses of fentanyl.

12. The device of claim 1, wherein the additional doses are 20 μ

g to 30 μ

g doses of fentanyl.

13. The method of claim 1, wherein the fentanyl salt solution comprises about 1 to 10 wt % of the donor reservoir formulation.

14. The device of claim 13, wherein the fentanyl salt solution comprises about 1.9 to 2.0 wt % of the donor reservoir formulation.

15. The device of claim 1, wherein the fentanyl salt comprises fentanyl hydrochloride.

16. The device of claim 1, wherein the switch is patient-controlled, thereby allowing the dose or doses to be self-administered by the patient.

17. The device of claim 16, wherein the control circuit allows the patient to self-administer no more than six of said doses per hour.

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

A/cm².

19. The device of claim 15, wherein the donor reservoir formulation further comprises a supplementary source of chloride ions.

20. The device of claim 19, wherein the supplementary source of chloride ions comprises a high molecular weight chloride resin.