Claims for Patent: 8,747,888

Summary for Patent: 8,747,888

Title:	Dermal delivery device with in situ seal
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 Al 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.
Inventor(s):	Kydonieus; Agis (Princeton, NJ), Conway; Robert G. (Princeton, NJ), Rossi; Thomas M. (Princeton, NJ)
Assignee:	Agile Therapeutics, Inc. (Princeton, NJ)
Application Number:	13/553,362
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; and (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, (ii) a polymeric intermediate layer, and (iii) an overlay covering; and (d) an internal backing layer between the AI layer and the overlay; in which device: 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 AI layer to form a PSA seal between the overlay and the release liner; the polymeric intermediate layer of the overlay is disposed between the PSA layer of the overlay and the overlay covering, and prevents flow of the PSA of the PSA layer of the overlay into the overlay covering; and 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; the volatile component is selected from ethyl lactate, Dimethyl sulfoxide (DMSO), or a combination thereof; the PSA of the AI layer is a polyacrylate PSA; and the PSA of the PSA layer of the overlay is a polyisobutylene PSA (PIB PSA), wherein adhesion of the AI layer is achieved without heat sealing. 2. The device of claim 1 in which 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 in which 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 3 in which the release liner is a fluorinated or siliconized polyester film. 5. The device of claim 3 in which the overlay covering is non-tacky, flexible, and moisture permeable. 6. The device of claim 5 in which the polymeric intermediate layer comprises a PSA that adheres to both the PSA layer of the overlay and the overlay covering. 7. The device of claim 6 in which the polymeric intermediate layer comprises a polymeric material selected from a polyacrylate PSA, a polyurethane, a copolymer of polyethylene and ethyl vinyl acetate, and a rubber-based polymer. 8. The device of claim 6 in which the polymeric intermediate layer is a cross-linkable silicone rubber. 9. The device of claim 6 in which the polymeric intermediate layer is a polyacrylate PSA. 10. The device of claim 1 in which the overlay covering comprises a polyurethane film, foam or spunbonded structure, a polyolefin foam, or a woven or non-woven fabric. 11. The device of claim 10 in which the overlay covering comprises polyester fabric. 12. The device of claim 1 in which the active ingredient is levonorgestrel or levonorgestrel in combination with ethinyl estradiol. 13. The device of claim 1 in which 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. 14. The device of claim 1 in which the PIB PSA comprises 5 to 45 wt % crospovidone, 10 to 60 wt % low viscosity PIB, 2 to 15 wt % high viscosity PIB, 10 to 60 wt % polybutene, and 0 to 20 wt % mineral oil. 15. The device of claim 1 in which the AI layer further comprises a humectant. 16. The device of claim 15 in which the release liner comprises a fluorinated or siliconized polymer film, or a foil lined with a siliconized or fluorinated polymer. 17. The device of claim 16 in which: the polymeric intermediate layer comprises a PSA that adheres to both the PSA layer of the overlay and the overlay covering. 18. The device of claim 17 in which: the polymeric material of the polymeric intermediate layer is selected from polyacrylates PSA, polyurethanes, copolymers of polyethylene and ethyl vinyl acetate, and rubber-based polymers; and the overlay covering comprises a polyolefin foam, or a woven or non-woven fabric. 19. The device of claim 18 in which the active ingredient is levonorgestrel or levonorgestrel in combination with ethinyl estradiol. 20. The device of claim 19 in which 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. 21. The device of claim 20 in which the PIB PSA comprises 5 to 45 wt % crospovidone, 10 to 60 wt % low viscosity PIB, 2 to 15 wt % high viscosity PIB, 10 to 60 wt % polybutene, and 0 to 20 wt % mineral oil. 22. The device of claim 1 in which: the internal backing layer is a polyester film; the polymeric intermediate layer comprises a polymeric material which is a polyacrylate PSA; the overlay covering is a polyester woven fabric; the release liner is a fluorinated polyester film; the AI layer further comprises a humectant which is PVP or PVP/VA; the volatile component is comprises DMSO; the PIB PSA comprises 5 to 45 wt % crospovidone, 10 to 60 wt % low viscosity PIB, 2 to 15 wt % high viscosity PIB, 10 to 60 wt % polybutene, and 0 to 20 wt % mineral oil; and the polyacrylate PSA of the polymeric intermediate layer is a polyacrylate adhesive copolymer having a 2-ethylhexyl acrylate monomer and 50 to 60 wt % vinyl acetate as co-monomer.