IP Library Granted Patent US 8,246,978
Granted Patent B2
US 8,246,978 · App. 12/668,322 · Granted Aug 21, 2012

Dermal delivery device with reduced loss of its volatile components

Assignee: Agile Therapeutics, Inc.
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Quick Facts
Patent No.
US 8,246,978
App. No.
12/668,322
Granted
Aug 21, 2012
Kind
B2
Abstract

This invention relates to a transdermal drug delivery device that comprises an active ingredient (AI) layer, having a skin contacting surface and a non-skin contacting surface and comprising a volatile component, a release liner impermeable to the volatile component adjacent the skin contacting surface of the AI layer having a perimeter that extends beyond the perimeter of the AI layer in all directions, and an overlay comprising a pressure sensitive adhesive (PSA) that does not absorb the volatile component adjacent the non-skin contacting surface of the AI layer having a perimeter of which extends beyond the perimeter of the AI layer in all directions, wherein the release liner and the PSA of the overlay are in contact with and adhered to each other around the perimeter of the AI layer to form a seal that reduces or prevents volatile component loss.

Claims (20)

1. A transdermal drug delivery device that comprises:

a. an active ingredient (AI) layer, which is a polymer matrix having a skin contacting surface and a non-skin contacting surface and which comprises a volatile component;

b. a release liner adjacent the skin contacting surface of the AI layer, which release liner is impermeable to the volatile component and the perimeter of which extends beyond the perimeter of the AI layer in all directions; and

c. an overlay comprising a first pressure sensitive adhesive (PSA) adjacent the non-skin contacting surface of the AI layer, the perimeter of which extends beyond the perimeter of the AI layer in all directions,

wherein:

the AI layer is a polymer matrix comprising a second PSA, and the volatile component is at least partly solubilized in said second PSA;

the solubility of the volatile component in the first PSA of the overlay is less than the solubility of said component in the second PSA of the AI layer;

the release liner is in direct contact with the AI layer;

the release liner and the first PSA of the overlay are in contact with and adhered to each other around the perimeter of the AI layer to form a PSA seal that reduces or prevents loss of the volatile component from the AI layer;

the release liner is removable by peeling from the AI layer and the overlay PSA prior to applying to the skin; and the AI layer directly adheres to the skin and the first PSA of the overlay supplements the adhesion provided by the second PSA in the AI layer;

the volatile component comprises dimethyl sulfoxide (DMSO);

the first PSA is a polyisobutylene (PIB) PSA;

the second PSA is a polyacrylate PSA;

the overlay further comprises a polyacrylate PSA layer adjacent the non-skin contacting surface of the PIB PSA layer and a non-PSA overlay covering adjacent the non-PIB-PSA-layer-contacting surface of the polyacrylate PSA layer; and

adhesion of the layers is achieved without heat sealing.

2. The device of claim 1 in which

the release liner is a fluorinated or siliconized polyester film, or a foil lined with a siliconized or fluorinated polymer.

3. The device of claim 1 in which the non-PSA overlay covering is a polyurethane film, foam or spun bonded structure, a polyolefin foam, a PVC foam or a woven or non-woven fabric.

4. The device of claim 1 that further comprises an internal backing layer between the AI layer and the overlay.

5. The device of claim 1 in which the active ingredient is levonorgestrel or levonorgestrel in combination with ethinyl estradiol.

Assignments (4)
SECURITY INTEREST Recorded Jun 26, 2024
From: AGILE THERAPEUTICS, INC.
To: EXELTIS USA, INC.
Reel/Frame 067846/0890 →
RELEASE OF SECURITY INTERESTS IN PATENTS AND TRADEMARKS Recorded Apr 24, 2024
From: PERCEPTIVE CREDIT HOLDINGS III, LP, AS ADMINISTRATIVE AGENT
To: AGILE THERAPEUTICS, INC.
Reel/Frame 067204/0103 →
SECURITY INTEREST Recorded Feb 12, 2020
From: AGILE THERAPEUTICS, INC.
To: PERCEPTIVE CREDIT HOLDINGS III, LP
Reel/Frame 051792/0453 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 27, 2010
From: KYDONIEUS, AGIS; CONWAY, ROBERT G.; ROSSI, THOMAS M.
To: AGILE THERAPEUTICS, INC.,
Reel/Frame 024452/0271 →
Continuity (2)
Provisional Application 60948757 · Jul 10, 2007
Related Publication 20100255072A1 · Oct 7, 2010