Fentanyl suspension-based silicone adhesive formulations and devices for transdermal delivery of fentanyl

Abstract

Silicone adhesive formulations are provided, in which fentanyl particles are suspended one or more a solvated silicone adhesives. The formulations can be used for manufacturing improved, matrix-type transdermal devices for administering fentanyl.

1 . A transdermal or transmucosal dosage form comprising: 
 a matrix; and    a drug; wherein the total amount of said drug present in said dosage form exceeds the solubility limit of said drug in said matrix.    
     
     
         2 . A dosage form according to aspect  1 , wherein said drug is dispersed in said matrix at a concentration greater than the solubility limit of the drug in the matrix.  
     
     
         3 . A dosage form according to aspect  2 , wherein said drug is substantially uniformly dispersed in said matrix.  
     
     
         4 . A dosage form according to aspect  1 , wherein said drug and said matrix are present as substantially discrete layers.  
     
     
         5 . A dosage form according to aspect  1 , wherein said dosage form further comprises a pressure sensitive adhesive layer on one surface of said dosage form.  
     
     
         6 . A dosage form according to aspect  1 , wherein said dosage form further comprises a backing layer on one surface of said dosage form.  
     
     
         7 . A dosage form according to aspect  1 , wherein said dosage form further comprises a pressure sensitive adhesive layer on one surface of said dosage form and a backing layer on an opposing surface of said dosage form.  
     
     
         8 . A dosage form according to aspect  7 , wherein said pressure sensitive adhesive layer comprises a mucoadhesive.  
     
     
         9 . A dosage form according to aspect  1 , wherein said dosage form further comprises a pressure sensitive adhesive layer on one surface of said dosage form and a release liner in contact with said pressure sensitive adhesive layer.  
     
     
         10 . A method for preparing a transdermal or transmucosal dosage form comprising a matrix and a drug dispersed in the matrix, wherein the total amount of the drug present in the dosage form exceeds the solubility limit of the drug in the matrix, said method comprising: 
 sequentially forming two or more layers of drug and two or more layers of matrix such that the amount of drug contained in the two or more layers of drug exceeds the solubility limit of the drug in the matrix.    
     
     
         11 . A method according to aspect  10 , wherein, subsequent to said forming, the drug becomes dispersed in the matrix.  
     
     
         12 . A method according to aspect  10 , wherein, subsequent to said forming, the drug becomes substantially uniformly dispersed in the matrix.  
     
     
         13 . A method according to aspect  10 , wherein, subsequent to said forming, said drug and said matrix remain as substantially discrete layers.  
     
     
         14 . A method according to aspect  10 , wherein the drug layers and the matrix layers are sequentially formed over a substrate.  
     
     
         15 . A method according to aspect  14 , wherein the substrate is a backing layer.  
     
     
         16 . A method according to aspect  15 , wherein said method further comprises: 
 forming a pressure sensitive adhesive layer over the drug layers and the matrix layers.    
     
     
         17 . A method according to aspect  14 , wherein the substrate is a pressure sensitive adhesive layer.  
     
     
         18 . A method according to aspect  17 , wherein said method further comprises: forming a backing layer over the drug layers and the matrix layers.