Device for transdermal electrotransport delivery of fentanyl and sufentanil

• US 7,018,370 B2
• Filed: 07/02/2002
• Issued: 03/28/2006
• Est. Priority Date: 06/05/1995
• Status: Expired due to Fees

• Current Assignee: ALZA Corporation (Johnson & Johnson)
• Original Assignee: ALZA Corporation (Johnson & Johnson)
• Inventors: Noorduin, Henk, Bernstein, Keith J., Southam, Mary
• Primary Examiner(s): Bockelman, Mark
• Application Number:
  US10/190,022
• Publication Number:
  US 20030083609A1
• Time in Patent Office: 1,365 Days
• Field of Search: 604 20-501, 607/115, 424448-449
• US Class Current: 604/501
• 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 method of obtaining analgesia in a human patient who is suffering from pain, consisting of transdermally delivering 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 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 about 24 hours, wherein the applied electrotransport current density is in the range of about 50 to about 150 microamps per square centimeter.

2. 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.

3. The method of claim 1, wherein about 40 micrograms of fentanyl is delivered over the delivery period.

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

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

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

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

8. The method of claim 1, wherein the doses are self-administered by the patient suffering from pain.

9. The method of claim 8, wherein the patient is allowed to self-administer no more than six of said doses per hour.