Electrotransport delivery of leuprolide

• US 20030088205A1
• Filed: 08/06/2002
• Published: 05/08/2003
• Est. Priority Date: 09/07/1994
• Status: Abandoned Application

• Current Assignee: Felix Theeuwes, Gyory J. Richard, Richard D. Prather, Ronald P. Haak, Santosh Kumar Chandrasekaran, Tyler Watanable
• Original Assignee: Felix Theeuwes, Gyory J. Richard, Richard D. Prather, Ronald P. Haak, Santosh Kumar Chandrasekaran, Tyler Watanable
• Inventors: Gyory, J. Richard, Prather, Richard D., Watanable, Tyler, Theeuwes, Felix, Haak, Ronald P., Chandrasekaran, Santosh Kumar
• Application Number:
  US10/213,511
• Publication Number:
  US 20030088205A1
• Time in Patent Office: Days
• 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

A membrane capable of inhibiting agent release from a delivery system when no electrical current is flowing and yet provide minimal impedance to electrically-assisted agent delivery, useful both for incorporating into electrotransport agent delivery systems and for use in measuring agent release rates in in vitro testing.

Claims

1. An electromigration agent delivery electrode assembly adapted for placement on skin for delivery of a polypeptide drug therethrough by electromigration, the electrode assembly including an electrode, a means for connecting said electrode to a source of electrical power, and a drug reservoir electrically connected to the electrode, the drug reservoir containing a polypeptide drug in a form susceptible to delivery by electromigration through the skin the drug being selected from the group consisting of ionizable salts of leuprolide, and ionizable salts of analogues of leuprolide.

2. The electrode assembly of claim 1, wherein the drug comprises a water soluble leuprolide salt.

3. The electrode assembly of claim 1, wherein the source of electrical power provides a current density of about 50 to 625 μ

A/cm².

4. The electrode assembly of claim 1, wherein the source of electrical power provides a current density of about 100 μ

A/cm².

5. An electrically powered delivery device for delivering an ionized polypeptide drug by electromigration, the device including a donor electrode assembly adapted to be placed in polypeptide drug ion transmitting relation with skin, a counter electrode assembly adapted to be placed in ion transmitting relation with skin and a source of electrical power adapted to be electrically connected to the donor electrode assembly and the counter electrode assembly, wherein the donor electrode assembly contains a drug selected from the group consisting of an ionized or ionizable salt of leuprolide, and an ionized or ionizable salt of analogues of leuprolide.

6. The device of claim 5, wherein the source of electrical power provides a current density of about 50 to 625 μ

A/cm².

7. The device of claim 5, wherein the source of electrical power provides a current density of about 100 μ

A/cm².

8. The device of claim 5, wherein at least one of the donor and counter electrode assemblies contains an electrode comprising metal powder in a polymeric matrix;

and including a control membrane positioned between a donor reservoir and the body surface, the membrane exhibiting an electrically-assisted flux (J_EK) of the drug therethrough and impeding passive flux (J_P) of the drug therethrough, the membrane exhibiting a ratio of J_EK;

J_P of at least about 2.5.

9. A method of delivering a drug through skin, comprising:

placing a drug reservoir in drug-transmitting relation with the skin, the drug reservoir containing a drug in a form susceptible to electrotransport delivery through the skin, the drug being selected from the group consisting of leuprolide, analogues of leuprolide and pharmaceutically acceptable salts thereof; and

electrically connecting the drug reservoir to a source of electrical power;

delivering the drug through the skin by means of electrotransport, the drug being delivered at a rate sufficient to induce a therapeutic effect.

10. The method of claim 9, wherein the drug comprises a water soluble leuprolide salt.

11. The method of claim 9, wherein the source of electrical power provides a current density of about 50 to 625 μ

A/cm².

12. The method of claim 9, wherein the source of electrical power provides a current density of about 100 μ

A/cm².

13. A method of inducing an antineoplastic effect in a human patient, comprising:

placing in drug transmitting relation with a body surface of the patient an electrically powered iontophoretic delivery device, the delivery device including a donor electrode assembly and a counter electrode assembly, the donor electrode assembly containing an ionized or ionizable source of a drug selected from the group consisting of leuprolide, analogues of leuprolide and pharmaceutically acceptable salts thereof;

placing the counter electrode assembly in ion transmitting relation with the body surface at a location spaced apart from the donor electrode assembly;

electrically connecting a source of electrical power to the donor electrode assembly and the-counter electrode assembly; and

iontophoretically delivering the drug through the body surface at a rate sufficient to induce an antineoplastic effect in the patient.

14. The method of claim 13, wherein the drug comprises a water soluble leuprolide salt.

15. The method of claim 13, wherein the source of electrical power provides a current density of about 50 to 625 μ

A/cm².

16. The method of claim 13, wherein the source of electrical power provides a current density of about 100 μ

A/cm².