US2016058747A1PendingUtilityA1

Transparent transdermal nicotine delivery devices

Assignee: ALZA CORPPriority: Dec 18, 1998Filed: Nov 6, 2015Published: Mar 3, 2016
Est. expiryDec 18, 2018(expired)· nominal 20-yr term from priority
Inventors:Robert M. Gale
A61P 25/34A61K 47/34A61K 31/4465A61K 2800/262A61K 9/7023A61K 31/465A61K 9/7084A61K 47/32A61K 9/703A61K 9/0014A61K 9/70
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Claims

Abstract

A transparent transdermal delivery device for delivering nicotine which has an Opacity Index of less than 48.6%.

Claims

exact text as granted — not AI-modified
1 - 9 . (canceled) 
     
     
         10 . A method for transdermal administration of nicotine, the method comprising:
 applying a transdermal nicotine delivery device to a skin surface, the device comprising:
 a backing layer comprising a material selected from the group consisting of PET/EVA laminates, HDPE/EAA/nylon/EAA multilaminate, and a film comprising a graft copolymer formed from about 73-77% acrylonitrile and from about 23-27% methyl acrylate copolymerized in the presence of about 8-10 parts by weight of butadiene/acrylonitrile copolymers; and 
 a drug reservoir layer comprising nicotine, 
 wherein the device is sufficiently transparent to permit the skin surface to be visible through the device. 
   
     
     
         11 . The method of  claim 10 , wherein the drug reservoir layer further comprises a self-adhesive drug reservoir. 
     
     
         12 . The method of  claim 10 , wherein the drug reservoir layer further comprises one or more adhesives. 
     
     
         13 . The method of  claim 12 , wherein the one or more adhesives comprises one or more pressure sensitive adhesives selected from the group consisting of polysiloxanes, polyacrylates, polyurethanes, acrylic adhesives, vinyl acetate adhesives, ethylene vinyl acetate copolymers, natural or synthetic rubbers, and mixtures and graft copolymers thereof. 
     
     
         14 . The method of  claim 10 , wherein the device is provided with one or more hydrophilic water absorbing polymers. 
     
     
         15 . The method of  claim 10 , wherein the backing layer has a nicotine permeability of less than 1.0 μg/cm 2 /hr. 
     
     
         16 . The method of  claim 10 , wherein the backing layer has a nicotine permeability of less than 0.5 μg/cm 2 /hr. 
     
     
         17 . The method of  claim 10 , wherein the backing layer has a solubility for nicotine of less than 1 wt %. 
     
     
         18 . The method of  claim 10 , wherein the backing layer has a solubility for nicotine of less than 0.1 wt %. 
     
     
         19 . The method of  claim 10 , wherein the device has an Opacity Index of less than 48.6%. 
     
     
         20 . The method of  claim 10 , wherein the device has an Opacity Index of less than 35.11%. 
     
     
         21 . The method of  claim 10 , wherein the device has an Opacity Index of less than 20%. 
     
     
         22 . The method of  claim 10 , wherein the backing layer comprises a PET/EVA laminate. 
     
     
         23 . The method of  claim 10 , wherein the backing layer comprises a HDPE/EAA/nylon/EAA multilaminate. 
     
     
         24 . The method of  claim 10 , wherein the backing layer comprises a film comprising a graft copolymer formed from about 73-77% acrylonitrile and from about 23-27% methyl acrylate copolymerized in the presence of about 8-10 parts by weight of butadiene/acrylonitrile copolymers containing approximately 70% by weight of polymer units derived from butadiene. 
     
     
         25 . The method of  claim 10 , wherein the device provides delivery of nicotine for a period of 18-24 hours. 
     
     
         26 . The method of  claim 10 , wherein the device further comprises an adhesive for maintaining the device on the skin surface. 
     
     
         27 . A method for transdermal administration of nicotine, the method comprising:
 administering a transdermal nicotine delivery device to a skin surface, the device comprising:
 a backing layer comprising a material selected from the group consisting of PET/EVA laminates, HDPE/EAA/nylon/EAA multilaminate, and a film comprising a graft copolymer formed from about 73-77% acrylonitrile and from about 23-27% methyl acrylate copolymerized in the presence of about 8-10 parts by weight of butadiene/acrylonitrile copolymers; and 
 a drug reservoir layer comprising nicotine, 
 wherein the device has an Opacity Index of less than 48.6%. 
   
     
     
         28 . A method for transdermal administration of nicotine, the method comprising:
 obtaining a transdermal nicotine delivery device, the device comprising:
 a backing layer comprising a material selected from the group consisting of PET/EVA laminates, HDPE/EAA/nylon/EAA multilaminate, and a film comprising a graft copolymer formed from about 73-77% acrylonitrile and from about 23-27% methyl acrylate copolymerized in the presence of about 8-10 parts by weight of butadiene/acrylonitrile copolymers; and 
 a drug reservoir layer comprising nicotine, 
 wherein the device is sufficiently transparent to permit the skin of a subject to which it is applied to be visible through the device, and applying the device to the skin of a subject. 
   
     
     
         29 . The method of  claim 28 , wherein the device has an Opacity Index of less than 48.6%.

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