Pharmaceutical Compositions and Methods for Insulin Treatment

Abstract

Compositions and methods for treating a patient with insulin that combines insulin, a permeation enhancer, and a carrier that maintains an acidic pH, are disclosed.

1 . A pharmaceutical composition comprising: a therapeutically effective amount of insulin, a permeation enhancer, and a liquid carrier; said composition being at an acidic pH, but no greater than a pH of 4.5. 
   
   
       2 . The pharmaceutical composition of  claim 1 , wherein said acidic pH is from about 2 to about 4. 
   
   
       3 . The pharmaceutical composition of  claim 1 , wherein said acidic pH is about 3. 
   
   
       4 . The pharmaceutical composition of  claim 1 , wherein said acidic pH is about 3.5 
   
   
       5 . The pharmaceutical composition of  claim 1 , further comprising a crystallization inhibitor. 
   
   
       6 . The pharmaceutical composition of  claim 1 , wherein said composition is in the form of a solution. 
   
   
       7 . The pharmaceutical composition of  claim 1 , wherein said composition is in the form of a spray solution. 
   
   
       8 . The pharmaceutical composition of  claim 1 , wherein said permeation enhancer is a Hsieh enhancer. 
   
   
       9 . The pharmaceutical composition of  claim 8 , wherein said Hsieh enhancer is cyclopentadecalactone or cylcohexadecanone. 
   
   
       10 . The pharmaceutical composition of  claim 1 , wherein said permeation enhancer is a straight chain or branched compound of the saturated or unsaturated aliphatic type. 
   
   
       11 . The pharmaceutical composition of  claim 10 , wherein said straight chain or branched compound of the saturated or unsaturated aliphatic type is selected from the group consisting of: myristyl myristate, isopropyl myristate, octyl palmitate, and ethyl oleate. 
   
   
       12 . A method for treating a patient with insulin comprising administering to a patient in need of insulin treatment a combination comprising: a therapeutically effective amount of insulin, a permeation enhancer, and a liquid carrier; said combination being at an acidic pH, but no greater than a pH of 4.5. 
   
   
       13 . The method of  claim 12 , wherein said acidic pH is from about 2 to about 4. 
   
   
       14 . The method of  claim 12 , wherein said acidic pH is about 3. 
   
   
       15 . The method of  claim 12 , wherein said acidic pH is about 3.5 
   
   
       16 . The method of  claim 12 , wherein said combination further comprises a crystallization inhibitor. 
   
   
       17 . The method of  claim 12 , wherein said combination is in the form of a solution. 
   
   
       18 . The method of  claim 12 , wherein said combination is in the form of a spray solution. 
   
   
       19 . The method of  claim 12 , wherein said permeation enhancer is a Hsieh enhancer. 
   
   
       20 . The method of  claim 19 , wherein said Hsieh enhancer is cyclopentadecalactone or cylcohexadecanone. 
   
   
       21 . The method of  claim 12 , wherein said permeation enhancer is a straight chain or branched compound of the saturated or unsaturated aliphatic type. 
   
   
       22 . The method of  claim 21 , wherein said straight chain or branched compound of the saturated or unsaturated aliphatic type is selected from the group consisting of: myristyl myristate, isopropyl myristate, octyl palmitate, and ethyl oleate.