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%.

1 . 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 overlay adjacent the non-skin contacting surface of the AI layer, said overlay comprising: (i) a pressure sensitive adhesive (PSA) layer that is applied directly or indirectly to the AI layer and (ii) an elastomeric and permeable overlay covering,   whereby at the end of an extended wear period, the patch causes cumulative moderate irritation plus significant irritation of less than 5%.   
     
     
         2 . The patch of  claim 1  in which the AI layer is a polymeric matrix that comprises a humectant. 
     
     
         3 . The patch of  claim 2  in which the humectant is polyvinyl pyrrolidone (PVP). 
     
     
         4 . The patch of  claim 2  which further comprises an internal backing layer between the AI layer and the overlay, said internal backing layer being impermeable to moisture and to the components of the polymeric matrix. 
     
     
         5 . The patch of  claim 4  in which the overlay additionally comprises an intermediate layer between the PSA layer and the overlay covering, said intermediate layer being permeable to moisture but impermeable to the PSA in the PSA layer. 
     
     
         6 . The patch of  claim 5  in which the PSA layer comprises a hydrophobic PSA and a humectant. 
     
     
         7 . The patch of  claim 6  in which the PSA layer in the overlay comprises a polyisobutylene (PIB) PSA and a humectant, the intermediate layer in the overlay is a polyacrylate PSA, and the overlay covering is non-tacky, flexible and permeable. 
     
     
         8 . The patch of  claim 1  in which the AI layer comprises a skin permeation enhancer that is dimethyl sulfoxide (DMSO) or a C 8 -C 20  saturated or unsaturated fatty acid or an ester or alcohol thereof. 
     
     
         9 . The patch of  claim 5  in which the AI layer comprises a skin permeation enhancer that is DMSO or a C 8 -C 20  saturated or unsaturated fatty acid or an ester or alcohol thereof. 
     
     
         10 . The patch of  claim 7  in which the AI layer comprises a skin permeation enhancer that is DMSO or a C 8 -C 20  saturated or unsaturated fatty acid or an ester or alcohol thereof. 
     
     
         11 . The patch of  claim 1  in which the overlay covering is a foam or a woven or nonwoven fabric that allows water vapor permeation through it at a rate that is greater than the transepidermal water loss. 
     
     
         12 . The patch of  claim 1  in which the AI layer comprises a progestin, an estrogen, or both a progestin and an estrogen. 
     
     
         13 . 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 overlay adjacent the non-skin contacting surface of the AI layer, said overlay comprising: (i) a pressure sensitive adhesive (PSA) layer that is applied directly or indirectly to the AI layer and (ii) an elastomeric and permeable overlay covering,   whereby, at the end of a seven day wear period, the patch exhibits meaningful degree of detachment over a seven day period of less than 20%.   
     
     
         14 . The patch of  claim 13  in which the AI layer is a polymeric matrix that comprises a humectant. 
     
     
         15 . The patch of  claim 14  in which the humectant is PVP. 
     
     
         16 . The patch of  claim 14  which further comprises an internal backing layer between the AI layer and the overlay, said internal backing layer being impermeable to moisture and to the components of the polymeric matrix. 
     
     
         17 . The patch of  claim 16  in which the overlay additionally comprises an intermediate layer between the PSA layer and the overlay covering, said intermediate layer being permeable to moisture but impermeable to the PSA in the PSA layer. 
     
     
         18 . The patch of  claim 17  in which the PSA layer comprises a hydrophobic PSA and a humectant. 
     
     
         19 . The patch of  claim 18  in which the PSA layer in the overlay comprises a PIB PSA and a humectant, the intermediate layer in the overlay is a polyacrylate PSA, and the overlay covering is non-tacky, flexible and permeable. 
     
     
         20 . The patch of  claim 13  in which the AI layer comprises a skin permeation enhancer that is DMSO or a C 8 -C 20  saturated or unsaturated fatty acid or an ester or alcohol thereof. 
     
     
         21 . The patch of  claim 17  in which the AI layer comprises a skin permeation enhancer that is DMSO or a C 8 -C 20  saturated or unsaturated fatty acid or an ester or alcohol thereof. 
     
     
         22 . The patch of  claim 19  in which the AI layer comprises a skin permeation enhancer that is DMSO or a C 8 -C 20  saturated or unsaturated fatty acid or an ester or alcohol thereof. 
     
     
         23 . The patch of  claim 13  in which the overlay covering is a foam or a woven or nonwoven fabric that allows water vapor permeation through it at a rate that is greater than the transepidermal water loss. 
     
     
         24 . The patch of  claim 13  in which the AI layer comprises a progestin, an estrogen, or both a progestin and an estrogen. 
     
     
         25 . 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 overlay adjacent the non-skin contacting surface of the AI layer, said overlay comprising: (i) a pressure sensitive adhesive (PSA) layer that is applied directly or indirectly to the AI layer and (ii) an elastomeric and permeable overlay covering,   whereby at the end of an extended wear period, the patch 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%.   
     
     
         26 . A method of delivering a drug to a patient in need thereof that comprises applying to the skin of the patient a transdermal drug delivery patch of  claim 1 , wherein the AI layer comprises an effective amount of the drug.