Method for transdermal delivery of permeant substances

• US 9,033,950 B2
• Filed: 07/29/2011
• Issued: 05/19/2015
• Est. Priority Date: 10/24/2003
• Status: Active Grant

• Current Assignee: ​Passport Technologies, Inc.
• Original Assignee: Nitto Denko Corporation
• Inventors: Smith, Alan, Eppstein, Jonathan A., Messier, Bernadette, Novakovic, Zoran, McRae, Stuart
• Primary Examiner(s): STIGELL, THEODORE J
• Application Number:
  US13/194,328
• Publication Number:
  US 20120101426A1
• Time in Patent Office: 1,390 Days
• Field of Search: 604/20, 604/500, 604/501, 606/27, 600/309
• US Class Current: 604/500
• CPC Class Codes: A61K 9/0009 involving or responsive to electricity, magnetism or acoustic waves; Galenical aspects of sonophoresis, iontophoresis, electroporation or electroosmosis microelectromechanical systems A61K9/0097
• CPC Class Codes: A61K 9/0046 Ear
• 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: A61M 2037/0023 Drug applicators using microneedles
• CPC Class Codes: A61M 2037/0061 Methods for using microneedles
• CPC Class Codes: A61M 37/00 Other apparatus for introducing media into the body for reproduction or fertilisation A61B17/425; apparatus for iontophoresis or cataphoresis A61N1/30; Percutany, i.e. introducing medicines into the body by diffusion through the skin salt baths A61H33/04
• CPC Class Codes: A61M 37/0015 by using microneedles
• CPC Class Codes: A61M 37/0092 using ultrasonic, sonic or infrasonic vibrations, e.g. phonophoresis
• CPC Class Codes: A61N 1/0412 Specially adapted for transcutaneous electroporation, e.g. including drug reservoirs
• 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
• CPC Class Codes: A61N 1/327 for enhancing the absorption properties of tissue, e.g. by electroporation

Abstract

A method for delivering permeant substances transdermally into a membrane of an animal includes forming at least one delivery opening in the skin tissue, with the at least one delivery opening having a mean opening depth of between about 40 and about 90 microns.

Claims

1. A method for delivering permeant substances through a biological membrane of an animal comprising forming a plurality of delivery openings in the membrane, wherein an opening depth of the majority of said delivery openings falls within the range between 40 and 90 microns, and delivering a permeant through the plurality of delivery openings by placing a patch comprising the permeant over the plurality of delivery openings,

wherein the plurality of delivery openings are formed by microporation conducted with positive pressure being present between a microporator and said membrane, wherein said positive pressure results from a vacuum of about 0.25 to about 0.80 bar being applied between said microporator and said membrane.

2. The method of claim 1 wherein the opening depth of a majority of said delivery openings falls within the range of 50 to 70 microns.

3. The method of claim 2 wherein 75% of said delivery openings have an opening depth falling within the range of 50 to 70 microns.

4. The method of claim 3 wherein 75% of said delivery openings have an opening depth falling within the range of 55 microns to 65 microns.

5. The method of claim 1 wherein said delivery openings have a range of opening depths falling within one standard deviation of 50 microns to 70 microns.

6. The method of claim 5 wherein said delivery openings have a range of opening depths falling within one standard deviation of 60 microns.

7. The method of claim 1 wherein said delivery openings have a range of opening depths falling within one standard deviation of 90 microns.

8. The method of claim 1 wherein the plurality of delivery openings are formed by a planar array microporation device.

9. The method of claim 1 wherein the plurality of delivery openings are formed by a microporator selected from the group consisting of a heated probe element capable of conductively delivering thermal energy via direct contact to a biological membrane to cause the ablation of some portion of the membrane deep enough to form a micropore, the heated probe comprising an electrically heated resistive element capable of ablating a biological membrane or an optically heated topical dye/absorber layer, electro-mechanical actuator, a microlancet, an array of microneedles (solid or hollow), microprojections, microcstructures or lancets, a sonic energy ablator, a laser ablation system, and a high pressure fluid jet puncturer.

11. The method of claim 1 wherein said positive pressure results from a vacuum of about 0.50 bar being applied between said device and said membrane.

10. A method for delivering drugs transdermally into a biological membrane of an animal comprising forming a plurality of delivery openings through a membrane, wherein said delivery openings have a distribution resulting in a bell-shaped curve with said delivery openings having a mean opening depth of between 40 and 90 microns, and delivering a drug through the plurality of delivery openings by placing a patch comprising the drug over the plurality of delivery openings,

wherein the plurality of delivery openings are formed by microporation conducted with positive pressure being present between a microporator and said membrane, wherein said positive pressure results from a vacuum of about 0.25 to about 0.80 bar being applied between said microporator and said membrane.

12. The method of claim 10 wherein said positive pressure results from a vacuum of about 0.50 bar being applied between said device and said membrane.