Claims for Patent: 9,050,348

Summary for Patent: 9,050,348

Title:	Dermal delivery device
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%.
Inventor(s):	Kydonieus; Agis (Kendall Park, NJ), Conway; Robert G. (Whitehouse Station, NJ), Rossi; Thomas M. (Stockton, NJ)
Assignee:	Agile Therapeutics, Inc. (Princeton, NJ)
Application Number:	13/463,494
Patent Claims:	1. A non-heat sealed transdermal drug delivery device that comprises: (a) a polymer matrix active ingredient (AI) layer having a skin-contacting surface and a non-skin contacting surface; the AI layer comprising an active ingredient, a pressure sensitive adhesive (PSA), and at least one volatile component which is at least partly solubilized in the PSA of the AI layer; (b) a release liner in direct contact with the skin-contacting surface of the AI layer, the perimeter of which extends beyond the perimeter of the AI layer in all directions; (c) an overlay adjacent to the non-skin contacting surface of the AI layer, the perimeter of which extends beyond the perimeter of the AI layer in all directions; the overlay comprising: (i) a PSA layer; and (ii) an overlay covering; and (d) an internal backing layer between the AI layer and the overlay; in which device: the PSA of the Al layer is a polyacrylate PSA; the volatile component comprises DMSO, ethyl lactate, or both; the PSA layer of the overlay is a polyisobutylene (PIB) PSA, a silicone PSA, a styrene/butadiene/styrene PSA, styrene/isoprene/styrene PSA, a styrene-ethylcne /butylene-styrene PSA, a styrene/butadiene PSA, a styrene-ethylene/butylene-styrene PSA, a styrene-ethylene/propylene-styrene PSA or an isoprene rubber PSA; the release liner and the PSA layer of the overlay are in direct contact with and adhered to each other around the perimeter of the Al layer to form a PSA seal between the overlay and the release liner; the solubility of the volatile component in the PSA of the PSA layer of the overlay is less than the solubility of the volatile component in the PSA of the AI layer such that the PSA seal between the overlay and the release liner reduces or prevents loss of the at least one volatile component from the Al layer; and the overlay covering is non-tacky, flexible, and moisture permeable; whereby at the end of an extended wear period, the patch causes cumulative moderate irritation plus significant irritation of less than 5% or exhibits meaningful degree of detachment over a seven day wear period of less than 20%, or both. 2. The device of claim 1, wherein the polyacrylate PSA of the AI layer is a polyacrylate adhesive copolymer having a 2-ethylhexyl acrylate monomer and 50 to 60 wt% vinyl acetate as co-monomer. 3. The device of claim 1, wherein the release liner comprises a fluorinated or siliconized polymer film, or a foil lined with a siliconized or fluorinated polymer. 4. The device of claim 1, wherein the PSA layer of the overlay comprises a silicone PSA. 5. The device of claim 1, wherein the PSA layer of the overlay comprises a PIB PSA and in which the overlay further comprises a polymeric intermediate layer comprising a polyacrylate PSA.