Compositions and methods for drug delivery

Abstract

A dermal composition for administration of an amphetamine drug comprising a blend of two or more acrylic-based polymers having differing functionalities so as to modulate the drug solubility in the polymer matrix and the delivery rate of the drug, and methods therefor.

What is claimed is:  
     
         1 . A dermal composition comprising a blend of: 
 (a) a polymer composition of two or more polymers which includes: 
 (i) a first acrylic-based polymer having a first functionality and solubility parameter; and  
 (ii) a second acrylic-based polymer having a second functionality and solubility parameter, wherein the first and second functionalities differ in the amount and type of functional groups to provide an acrylic-based polymer combination having a net functionality proportional to the ratio of the first and second acrylic-based polymers used, and are present in proportions to provide a net solubility parameter; and  
   (b) a therapeutically effective amount of one or more drugs incorporated into the polymer composition wherein the one or more drugs are selected from the group consisting of methamphetamine, amphetamine, d-amphetamine, and phentermine.    
     
     
         2 . The dermal composition as claimed in  claim 1 , wherein the first acrylic-based polymer has a functionality which provides a lower drug solubility than the second acrylic-based polymer.  
     
     
         3 . The dermal composition as claimed in  claim 2 , wherein the first acrylic-based polymer is present in an amount to provide a flux of the drug in the dermal drug delivery composition which is greater than a composition based solely on the second acrylic-based polymer.  
     
     
         4 . The dermal composition as claimed in  claim 2 , wherein the amount of the second acrylic-based polymer is in the range of 5-95 weight % and the amount of the first acrylic-based polymer is in the range of 95 to 5% by weight, all based on the total dry weight of the polymer.  
     
     
         5 . The dermal composition as claimed in  claim 2 , wherein the amount of the second acrylic-based polymer is in the range of 20-75 weight % and the amount of the first acrylic-based polymer is in the range of 75 to 20% by weight, all based on the total dry weight of the polymer.  
     
     
         6 . The dermal composition as claimed in  claim 2 , wherein the first acrylic-based polymer has substantially no functional groups and the second acrylic-based polymer has functional groups.  
     
     
         7 . The dermal composition as claimed in  claim 6 , wherein the second acrylic-based polymer has carboxyl and/or hydroxy functional groups.  
     
     
         8 . The dermal composition as claimed in  claim 6 , wherein the second acrylic-based polymer is present in an amount to provide a increased saturation concentration in the dermal drug delivery composition which is greater than a composition based solely on the first acrylic-based polymer.  
     
     
         9 . The dermal composition as claimed in  claim 6 , wherein the functional groups are provided by monomer units containing functional groups which are incorporated into the second acrylic-based polymer in an amount of from 0.1 to 20% by weight, based on the dry weight of the second acrylic-based polymer.  
     
     
         10 . The dermal composition as claimed in  claim 9 , wherein the functional monomers are incorporated into the second acrylic-based polymer in an amount of from 0.1 to 8% by weight, based on the dry weight of the second acrylic-based polymer.  
     
     
         11 . The dermal composition as claimed in  claim 1 , wherein the at least two polymer polymers contain substantially only the first and second acrylic-based polymers.  
     
     
         12 . The dermal composition as claimed in  claim 7 , wherein the second acrylic-based polymer includes carboxyl functional groups.  
     
     
         13 . The dermal composition as claimed in  claim 1 , wherein the one or more drugs are present in base form.  
     
     
         14 . The dermal composition as claimed in  claim 13 , wherein the first acrylic-based polymer has substantially no functional groups and wherein the second acrylic-based polymer includes carboxyl functional groups which are present from about 0.1 to 10% by weight of the polymer.  
     
     
         15 . The dermal composition as claimed in  claim 1 , wherein the drug includes d-amphetamine.  
     
     
         16 . The dermal composition as claimed in  claim 15 , wherein the first acrylic-based polymer has substantially no functional groups and wherein the second acrylic-based polymer includes carboxyl functional groups present from about 0.1 to 12% by weight of the polymer.  
     
     
         17 . The dermal composition as claimed in  claim 16 , wherein the carboxyl functional monomer units are acrylic acid.  
     
     
         18 . The dermal composition as claimed in  claim 1 , wherein the drug includes methamphetamine.  
     
     
         19 . The dermal composition as claimed in  claim 18 , wherein the first acrylic-based polymer has substantially no functional groups and wherein the second acrylic-based polymer includes carboxyl functional groups present from about 0.1 to 12% by weight of the polymer.  
     
     
         20 . The dermal composition as claimed in  claim 19 , wherein the carboxyl containing functional monomer units are acrylic acid.  
     
     
         21 . The dermal composition as claimed in  claim 1 , wherein the drug includes phentermine.  
     
     
         22 . The dermal composition as claimed in  claim 21 , wherein the first acrylic-based polymer has substantially no functional groups and wherein the second acrylic-based polymer includes carboxyl functional groups present from about 0.1 to 12% by weight of the polymer.  
     
     
         23 . The dermal composition as claimed in  claim 22 , wherein the carboxyl containing functional monomer units are acrylic acid.  
     
     
         24 . The dermal composition as claimed in  claim 1 , wherein the drug includes amphetamine.  
     
     
         25 . The dermal composition as claimed in  claim 24 , wherein the first acrylic-based polymer has substantially no functional groups and wherein the second acrylic-based polymer includes carboxyl functional groups present from about 0.1 to 12% by weight of the polymer.  
     
     
         26 . The dermal composition as claimed in  claim 25 , wherein the carboxyl containing functional monomer units are acrylic acid.  
     
     
         27 . A method of producing a dermal composition, comprising the steps of: 
 (1) producing a blend of: 
 (a) a polymer composition of two or more polymers which includes: 
 (i) a first acrylic-based polymer having a first functionality and solubility parameter; and  
 (ii) a second acrylic-based polymer having a second functionality and solubility parameter, wherein the first and second functionalities differ in the amount and type of functional groups to provide an acrylic-based polymer combination having a net functionality proportional to the ratio of the first and second acrylic-based polymers used, and are blended in proportions to provide a net solubility parameter; and  
 
 (b) a therapeutically effective amount of one or more drugs selected from the group consisting of amphetamine, methamphetamine, d-amphetamine, and phentermine;  
   (2) forming the blend into a polymer matrix; and    (3) drying the polymer matrix to remove the solvent system to form the dermal composition.    
     
     
         28 . The method as claimed in  claim 27 , wherein the first acrylic-based polymer has a functionality which provides a lower solubility parameter than the second acrylic-based polymer.  
     
     
         29 . The method as claimed in  claim 27 , further comprising the step of applying a backing material to one side of the composition, the backing material being substantially impermeable to the drug contained therein.  
     
     
         30 . The method as claimed in  claim 29 , further comprising the step of applying a release liner to a surface of the composition opposite said backing material.  
     
     
         31 . A method of controlling the flux of a drug from a dermal drug delivery composition, comprising the steps of: 
 (a) selecting at least two polymer polymers which includes: 
 (i) a first acrylic-based polymer having a first functionality and solubility parameter; and  
 (ii) a second acrylic-based polymer having a second functionality and solubility parameter, wherein said first and second functionalities differ in the amount and type of functional groups to provide a polymer combination having a net solubility of one or more drugs within the composition proportional to the ratio of the first and second acrylic-based polymers used;  
   (b) combining the at least two acrylic-based polymers with a therapeutically effective amount of one or more drugs selected from the group consisting of amphetamine, methamphetamine, d-amphetamine, and phentermine to form the dermal drug delivery composition, wherein the net solubility is different than the flux of a composition produced solely from said first or second acrylic-based polymers alone.