Compositions and medical device for transdermal delivery of a drug and methods of making and using same

A medical device for transdermal administration of a drug through an area of human skin during an administration period, the medical device comprising:

• a) a solid drug reservoir layer having a top side and a bottom side and an external edge, wherein the solid drag reservoir layer is a composition consisting essentially of:
• i) an amine-resistant polydimethylsiloxane adhesive matrix having a molecular weight of between 100,000 and 5,000,000;
• ii) a drug selected from the group consisting of fentanyl and sufentanyl;
• and
• iii) a drug flux rate-lowering amount of between 4 and 7% w/w of dimethicone having a viscosity of 20 to 12,500 centistoke mixed with the adhesive matrix;
• b) a rate controlling membrane having a top and a bottom side, wherein the top side of the rate controlling membrane is contiguously disposed with respect to the bottom side of the drug reservoir layer;
• c) an adhesive layer having a top and a bottom side, wherein
• i) the top side of the adhesive layer is contiguously disposed with respect to the bottom side of the rate controlling membrane;
• ii) the adhesive layer is adapted to be maintained in drug-transferring relationship to the human skin;
• iii) the adhesive layer comprises an amine-resistant polydimethylsiloxane adhesive matrix having a molecular weight of between 100,000 and 5,000,000;
• and
• iv) a drug flux rate-lowering amount of between 4 and 7% w/w of the adhesive composition of dimethicone having a viscosity of 20 to 12,500 centistoke mixed with the adhesive matrix, and
• wherein the drug reservoir layer comprises at least about 1% w/w drug.