System and method for biphasic transdermal iontophoretic delivery of therapeutic agents

Patent metadata

Field	Value
Publication number	US-9764131-B2
Application number	US-201514755840-A
Country	US
Kind code	B2
Filing date	Jun 30, 2015
Priority date	Feb 12, 2009
Publication date	Sep 19, 2017
Grant date	Sep 19, 2017

Abstract

Various embodiments provide methods and systems for the biphasic iontophoretic transdermal delivery of therapeutic agents. An embodiment of a method for such delivery comprises positioning at least one electrode assembly in electrical communication with a patient's skin. The assembly includes a solution comprising a therapeutic agent which passively diffuses into the skin. A dose of agent is delivered from the assembly into the skin during a first period using a first current having a characteristic e.g., polarity and magnitude, to repel the agent out of the assembly. During a second period, a second current having a characteristic to attract the agent is used to retain the agent in the assembly such that delivery of agent into skin is minimized. A dose of agent may be delivered on demand by an input from the patient. Embodiments may be used for delivery of agents which cause adverse effects from unwanted passive diffusion.

First claim

What is claimed is:

1. A patch assembly for iontophoretic transdermal delivery of a therapeutic agent to a patient, the assembly comprising:
a patch for iontophoretic transdermal delivery of the therapeutic agent, the patch having a tissue contacting side, a non-tissue contacting side, a therapeutic agent reservoir and a first and second electrode, at least one of the electrodes electrically coupled to the therapeutic agent reservoir;
a current source coupled to the patch and electrically coupled to the first and second electrode; and
a controller coupled to the patch for controlling the iontophoretic transdermal delivery of the therapeutic agent; the controller configured to deliver a dose of therapeutic agent from the patch into the skin during a first period using a first current having a polarity and magnitude to repel the therapeutic agent out of the patch; and retain the therapeutic agent in the patch during a second period using a second current having a polarity and magnitude to retain the therapeutic agent in the patch such that delivery of the therapeutic agent into the skin during the second period is minimized, wherein the first period comprises a delivery period and the second period comprises a non-delivery period which together comprise a delivery cycle.

2. The patch assembly of claim 1 , wherein at least one of the current source or the controller is positioned in a housing coupled to the non-tissue contacting side of the patch, the housing having sufficient flexibility such that when the housing is engaged with the patch to form the patch assembly and the patch is adhered to a target site on a patient's skin, the patch assembly has sufficient flexibility to deform with movement of the patient's skin so as to remain sufficiently adhered to the patient's skin over an extended period of time to transdermally deliver the therapeutic agent.

3. The patch assembly of claim 2 , wherein the extended period of time is up to about seven days.

4. The patch assembly of claim 2 , wherein the housing has a profile shaped and sized to allow the patch assembly to be worn underneath the patient's clothing without substantially detaching from the patient's skin from movement of the patient's clothes or skin.

5. The patch assembly of claim 2 , wherein the housing is conformable to a flexing contour of the patient's skin to allow the patch assembly to remain adhered to the patient's skin over the extended period of time.

6. The patch assembly of claim 1 , wherein the controller comprises a microprocessor.

7. The patch assembly of claim 1 , further comprising an input device for initiating a delivery cycle, the input device operably coupled to the controller.

8. The patch assembly of claim 7 , wherein the input device comprises a patient activated button or switch.

9. The patch assembly of claim 7 , wherein the controller includes logic for control of patient initiation of the delivery cycle.

10. The patch assembly of claim 9 , wherein the controller includes logic for limiting a maximum number of delivered doses of therapeutic agent over a selected period.

11. The patch assembly of claim 9 , wherein the controller includes logic for controlling a start of another delivery period until after a refractory period.

12. The patch assembly of claim 11 , wherein the refractory period is a period of time from an end of the delivery period to an end of the non-delivery period.

13. The patch assembly of claim 1 , wherein at least one of the delivery period and non-delivery period are selected to maintain a plasma concentration of the therapeutic agent within a therapeutic index.

14. The patch assembly of claim 1 , wherein the therapeutic agent reservoir includes at least one of a therapeutic agent or a therapeutic agent solution.

15. The patch assembly of claim 14 , wherein the therapeutic agent comprises an opioid.

16. The patch assembly of claim 15 , wherein the opioid comprises a fentanyl salt or a fentanyl analogue.

17. The patch assembly of claim 16 , wherein the fentanyl salt is selected from the group consisting of fentanyl hydrochloride, fentanyl citrate and fentanyl pamoate.

18. The patch assembly of claim 16 , wherein the fentanyl analogue is selected from the group consisting of alfentanil, sufentanil and remifentanil.

19. The patch assembly of claim 1 , wherein the patch assembly has a substantially oval shape or cassini oval shape.

20. The patch assembly of claim 1 , wherein the current source comprises an electrochemical battery, an alkaline battery, a lithium battery or a lithium-ion battery.

21. The patch assembly of claim 1 , wherein the current source is configured to deliver an alternating current.

Assignees

• Incube Labs Llc

Inventors

• Imran Mir
• Hashim Mir
• Mclaughlin Glen
• Arastu Huma
• Vaidyanathan Rekha
• Harris Joel
• Korupolu Radhika
• Mangogna Andrew
• Ong Chang
• Patel Sanjay
• Wang Lu
• Williams Timothy

Classifications

• A61P25/04

  Centrally acting analgesics, e.g. opioids · CPC title

• A61K31/4178

  not condensed 1,3-diazoles and containing further heterocyclic rings, e.g. pilocarpine, nitrofurantoin · CPC title

• A61K9/0009

  involving or responsive to electricity, magnetism or acoustic waves; Galenical aspects of sonophoresis, iontophoresis, electroporation or electroosmosis · CPC title

• A61K9/0014

  Skin, i.e. galenical aspects of topical compositions (non-active ingredients are additionally classified in A61K47/00; A61K9/0009, A61K9/0021, A61K9/7015, A61K9/7023 take precedence; cosmetic preparations A61K8/00, A61Q; preparations for wound dressings or bandages A61L26/00) · CPC title

• A61N1/044

  Shape of the electrode · CPC title