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Dermal Delivery Device

a delivery device and skin technology, applied in the direction of bandages, biocide, drug compositions, etc., can solve the problems of inadequate adhesion and/or skin irritation, and the device intended for extended wear, i.e. 3 or more days, is susceptible to inadequate adhesion and/or skin irritation, and the effect of permeation enhancers

Inactive Publication Date: 2010-07-15
AGILE THERAPEUTICS
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0006]This invention relates to extended wear dermal delivery devices, or patches, that cause cumulative moderate irritation plus significant irritation of less than 5%.
[0007]This invention also relates to extended wear dermal delivery devices, or patches, that achieve a meaningful degree of detachment of less than 20%.
[0008]In illustrative embodiments, the device of the invention, over a seven day wear period, causes cumulative moderate irritation plus significant irritation of less than 5% and additionally achieves a meaningful degree of detachment over a seven day period of less than 20%.
[0009]Thus, in general terms, the inventions relates to a transdermal drug delivery patch comprising (A) an active ingredient (AI) layer having a skin contacting surface and a non-skin contacting surface and comprising a pressure sensitive adhesive and the drug and (B) an elastic and porous backing material whereby at the end of an extended wear period, the patch causes cumulative moderate irritation plus significant irritation of less than 5% or causes cumulative moderate irritation plus significant irritation of less than 5% and a meaningful degree of detachment over a seven day period of less than 20%, or both.

Problems solved by technology

Transdermal drug delivery devices intended for extended wear, i.e., 3 or more days, are susceptible to problems of inadequate adhesion and / or skin irritation.
Certain skin permeation enhancers are also known to contribute to irritation.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

example 1

Fabrication of Transdermal Drug Delivery System

[0103]Example 1 is a description of one of the ways to fabricate a dermal delivery system of the invention. It will be appreciated that other ways can also be used. In this example, Part A illustrates preparation of Internal Backing / AI layer / Release Liner Laminate. Part B illustrates fabrication of a foam / acrylic PSA / PIB PSA overlay structure. Part C illustrates fabrication of an integrated device, or system, of the invention utilizing the laminates prepared in Parts A and B.

[0104]Part A. Fabrication of an Internal Backing / AI layer / Release Liner Laminate: After deaeration, an adhesive polymer composition comprising the AI and the volatile component(s) is applied to the backing layer material, and subsequently dried for a set time at a set temperature. In an alternative embodiment, the adhesive polymer matrix may be applied to a release liner instead of to the backing layer. Accordingly, reference herein to application of the adhesive po...

example 2

Control of Loss of Volatile Components

[0112]A transdermal hormone delivery device was prepared comprising an internal backing layer, an AI layer, and a release liner. The AI layer comprised, as a polymer matrix PSA: Duro Tak 87-4098; as a humectant: PVP / VA-5360; as skin permeation enhancers: dimethylsulfoxide (DMSO), lauryl lactate (Ceraphyl® 31), ethyl lactate, and capric acid; as the AI: levonorgestrel and ethinyl estradiol.

[0113]The device also comprised an overlay comprising a polyurethane spun bonded non-woven backing, which is able to absorb large amounts of the volatile excipients, DMSO and ethyl lactate, an acrylic PSA coated onto the polyurethane foam, and a PIB PSA coated on top of the acrylic PSA. The internal backing layer was composed of a Mylar polyester backing film onto which was coated an acrylic PSA containing the AI as well as the volatile excipients, DMSO and ethyl lactate at 8 wt % and 1.7 wt % nominal concentrations, respectively, and a non-volatile excipient, ...

example 3

Clinical Study

[0117]Devices of a type described in Example 2 were analyzed for adhesion and irritation in a clinical study. Placebo patches or patches containing actives were applied to the skin of women for pre-determined time periods, among which were (1) one week, (2) two monthly treatment cycles, and (3) three monthly treatment cycles.

Adhesion Analyses:

[0118]A) Placebo patches applied for one week to 59 women: one out of 59 patches (1.7%) exhibited meaningful degree of detachment;

B) Active patches applied for two treatment cycles to 38 women: 12 out of 149 patches (8.1%) exhibited meaningful degree of detachment;

C) Placebo and active patches applied for three treatment cycles to 59 women: 13 out of 208 patches (6.3%) exhibited meaningful degree of detachment;

[0119]The mean cumulative total adhesion score (calculated per FDA Guidance) was 0.9 with an upper limit of 1.38 (placebo patch, one week, 59 women).

Irritation Analyses:

[0120]A) Placebo patches applied for one week to 54 wom...

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Abstract

A transdermal drug delivery device is disclosed. Over an extended wear period, the device causes cumulative moderate irritation plus significant irritation of less than 5% and / or achieves a meaningful degree of detachment over a seven day period of less than 20%.

Description

CROSS REFERENCE TO RELATED APPLICATION[0001]This is a continuation-in-part of U.S. Application Ser. No. PCT / US2008 / 069618, filed Jul. 10, 2008, which claims benefit of U.S. Provisional Application 60 / 948,757, filed Jul. 10, 2007, and also a continuation-in-part of U.S. Application Ser. No. PCT / US2008 / 069622, filed Jul. 10, 2008, which claims benefit of U.S. Provisional Application 60 / 948,759, filed Jul. 10, 2007, the entire contents of all of the preceding being incorporated by reference herein.FIELD OF THE INVENTION[0002]This invention is in the field of delivery of pharmacologically or cosmetically active agents to the skin for systemic, local, or topical administration.BACKGROUND OF THE INVENTION[0003]A dermal delivery device is an adhesive “patch” for application to the skin that is used to deliver a wide variety of pharmacologically and cosmetically active agents. Such patches can be used to deliver an agent transdermally, i.e., through the skin and into the bloodstream for sys...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61K9/70A61K31/56A61K31/57A61P15/18A61P5/24
CPCA61K9/7061A61K9/7084A61K31/56A61K31/57A61K2300/00A61P5/24A61P15/18
Inventor KYDONIEUS, AGISCONWAY, ROBERT G.ROSSI, THOMAS M.
Owner AGILE THERAPEUTICS
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