DEVICE FOR TRANSDERMAL ELECTROTRANSPORT DELIVERY OF FENTANYL AND SUFENTANIL

• US 20060275352A1
• Filed: 07/12/2006
• Published: 12/07/2006
• 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, Noorduin, Henk, Bernstein, Keith J.
• Granted Patent: US 8,200,327 B2
• Time in Patent Office: Days
• US Class Current: 424/448
• 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. 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 method of using fentanyl to produce analgesia in a human patient who is suffering from pain, comprising transdermally delivering fentanyl using a transdermal system that delivers fentanyl solely by electrotransport, wherein a dose of about 20 micrograms to about 60 micrograms of fentanyl is delivered over a predetermined delivery period of up to about 20 minutes;

terminating the delivery of the dose at the end of the delivery period; and

thereafter repeating delivery of the dose by the system such that transdermal delivery of up to about 100 additional of the doses is delivered over a period of about 24 hours.

2. The method of claim 1, wherein the fentanyl comprises a fentanyl salt.

3. The method of claim 2, wherein the fentanyl salt comprises fentanyl hydrochloride.

4. The method of claim 1, wherein about 35 micrograms to about 45 micrograms of fentanyl is delivered over a delivery period of about 5 to 15 minutes.

5. The method of claim 1, wherein the additional doses are about 35 micrograms to about 45 micrograms doses of fentanyl.

6. A method of using fentanyl to produce analgesia in a human patient who is suffering from pain, comprising transdermally delivering fentanyl from a transdermal system solely by electrotransport a dose of about 20 micrograms to about 60 micrograms of fentanyl over a predetermined delivery period of up to about 20 minutes;

terminating the delivery of the dose at the end of the delivery period; and

thereafter repeating the step of transdermally delivering of up to about 100 additional times to deliver the doses over a period of about 24 hours.

7. The method of claim 6, wherein the fentanyl comprises a fentanyl salt.

8. The method of claim 7, wherein the fentanyl salt comprises fentanyl hydrochloride.

9. The method of claim 6, wherein about 35 micrograms to about 45 micrograms of fentanyl is delivered over a delivery period of about 5 to 15 minutes.

10. The method of claim 6, wherein the additional doses are about 35 micrograms to about 45 micrograms doses of fentanyl.

11. A method of using sufentanil to produce analgesia in a human patient who is suffering from pain, comprising transdermally delivering sufentanil using a transdermal system that delivers the sufentanil solely by electrotransport, wherein a dose of about 2.3 to about 7.0 micrograms of sufentanil is delivered over a predetermined delivery period of up to about 20 minutes;

terminating the delivery of the dose at the end of the delivery period; and

thereafter repeating delivery of the dose by the system such that transdermal delivery of up to about 100 additional of the doses is delivered over a period of about 24 hours.

12. The method of claim 11, wherein the sufentanil comprises a sufentanil salt.

13. The method of claim 12, wherein the sufentanil salt comprises sufentanil hydrochloride.

14. The method of claim 11, wherein about 4 micrograms to about 5.5 micrograms of sufentanil is delivered over a delivery period of about 5 to 15 minutes.

15. The method of claim 11, wherein the additional doses are about 4 micrograms to about 5.5 micrograms doses of sufentanil.

16. A method of using sufentanil to produce analgesia in a human patient who is suffering from pain, comprising transdermally delivering sufentanil from a transdermal system solely by electrotransport a dose of about 2.3 micrograms to about 7.0 micrograms of sufentanil over a predetermined delivery period of up to about 20 minutes;

terminating the delivery of the dose at the end of the delivery period; and

thereafter repeating the step of transdermally delivering of up to about 100 additional times to deliver the doses over a period of about 24 hours.

17. The method of claim 16, wherein the sufentanil comprises a sufentanil salt.

18. The method of claim 17, wherein the sufentanil salt comprises sufentanil hydrochloride.

19. The method of claim 16, wherein about 4 micrograms to about 5.5 micrograms of sufentanil is delivered over a delivery period of about 5 to 15 minutes.

20. The method of claim 16, wherein the additional doses are about 4 micrograms to about 5.5 micrograms doses of sufentanil.