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 Al layer having a perimeter that extends beyond the perimeter of the Al 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 Al 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 Al layer to form a seal that reduces or prevents volatile component loss.

1 - 34 . (canceled) 
     
     
         35 . 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, 
   
       wherein:
 the PSA layer of the overlay is a silicone PSA, a styrene/butadiene/styrene, styrene/isoprene/styrene, a styrene-ethylene/butylenes-styrene, a polyisobutylene (PIB), 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 AI 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 AI layer; 
 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; and 
 the overlay covering is non-tacky, flexible, and moisture permeable. 
 
     
     
         36 . The device of  claim 35  that further comprises: (d) an internal backing layer between the AI layer and the overlay. 
     
     
         37 . The device of  claim 36  in which the at least one volatile component is an organic solvent. 
     
     
         38 . The device of  claim 37  in which the organic solvent is DMSO. 
     
     
         39 . The device of  claim 37  in which the PSA of the AI layer is a polyacrylate PSA. 
     
     
         40 . The device of  claim 39  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. 
     
     
         41 . The device of  claim 39  in which the PSA of the PSA layer of the overlay is a silicone PSA. 
     
     
         42 . The device of  claim 37  in which the release liner comprises a fluorinated or siliconized polymer film, or a foil lined with a siliconized or fluorinated polymer. 
     
     
         43 . The device of  claim 42  in which the overlay consists of the PSA layer and the overlay covering and wherein PSA of the PSA layer of the overlay is a silicone PSA. 
     
     
         44 . 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; 
 (ii) a polymeric intermediate layer; and 
 (ii) an overlay covering, 
   
       wherein:
 the polymeric intermediate layer in the overlay is a PSA which does not permit flow of the PIB PSA but does permit passage of moisture and which is selected from polyacrylates, polyurethanes, plasticized polyvinyl chlorides, copolymers of polyethylene and ethyl vinyl acetate, and rubber-based polymers; 
 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 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 AI layer; 
 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; and 
 the overlay covering is non-tacky, flexible, and moisture permeable. 
 
     
     
         45 . The device of  claim 44  that further comprises: (d) an internal backing layer between the AI layer and the overlay. 
     
     
         46 . The device of  claim 45  in which the at least one volatile component is an organic solvent. 
     
     
         47 . The device of  claim 46  in which the organic solvent is DMSO. 
     
     
         48 . The device of  claim 46  in which the PSA of the AI layer is a polyacrylate PSA. 
     
     
         49 . The device of  claim 48  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. 
     
     
         50 . The device of  claim 48  in which the PSA of the PSA layer of the overlay is a polyisobutylene PSA (PIB PSA). 
     
     
         51 . The device of  claim 50  in which the release liner comprises a fluorinated or siliconized polymer film, or a foil lined with a siliconized or fluorinated polymer. 
     
     
         52 . The device of  claim 50  in which the polymeric intermediate layer is a cross-linkable silicone rubber. 
     
     
         53 . The device of  claim 52  in which the overlay covering comprises a polyurethane film, foam or spun bonded structure, a polyolefin foam, or a woven or non-woven fabric. 
     
     
         54 . The device of  claim 53  in which the release liner comprises a fluorinated or siliconized polymer film, or a foil lined with a siliconized or fluorinated polymer.