Ibuprofen for Topical Administration

Abstract

Set forth herein is a preparation of ibuprofen (2-(4-isobutylphenyl) propionic acid) in the free acid form that is suitable for topical administration. The topical ibuprofen formulation is prepared by dissolving the free acid form of ibuprofen, or preparing a homogeneous suspension of the free acid form of ibuprofen, in the presence of a pharmaceutically acceptable solvent so as to produce a topical drug formulation compatible with the penetration of 2-(4-isobutylphenyl) propionic acid through the skin tissue. Topical formulations of ibuprofen can be based on a pharmaceutically acceptable solvent such as, e.g., a pyrrolidone solvent or dimethylacetamide.

What is claimed is: 
     
         1 . A physically and chemically stable topical pharmacological composition prepared by a process comprising the steps of:
 (a) creating a first mixture by dissolving ibuprofen in a solvent;   (b) creating second mixture comprising at least one water soluble ingredient;   (c) creating a third mixture comprising at least one hydrophobic ingredient;   (d) creating a fourth mixture by combining the second mixture and the third mixture; and   (e) combining the first mixture and the fourth mixture to create the physically and chemically stable topical pharmacological composition.   
     
     
         2 . The composition of  claim 1 , wherein step (b) further comprises heating the at least one water soluble ingredient. 
     
     
         3 . The composition of  claim 2 , wherein the at least one water soluble ingredient is heated to about 70° C. 
     
     
         4 . The composition of  claim 1 , wherein step (c) further comprises heating the at least one hydrophobic ingredient. 
     
     
         5 . The composition of  claim 4 , wherein the at least one hydrophobic ingredient is heated to about 70° C. 
     
     
         6 . The composition of  claim 1 , wherein step (d) further comprises cooling the fourth mixture. 
     
     
         7 . The composition of  claim 6 , wherein the fourth mixture is cooled to about 40° C. 
     
     
         8 . The composition of  claim 1 , wherein the solvent is a pyrrolidone solvent. 
     
     
         9 . The composition of  claim 8 , wherein the solvent is selected from the group consisting of N-methyl-2-pyrrolidone and 2-pyrrolidone. 
     
     
         10 . The composition of  claim 1 , wherein the solvent is water. 
     
     
         11 . The composition of  claim 1 , wherein the solvent is dimethylacetamide. 
     
     
         12 . The composition of  claim 1 , wherein the solvent is selected from the group consisting of dimethylsulfoxide, dimethylformamide, and dimethylisosorbide. 
     
     
         13 . A method for treating inflammation in a patient in need of therapy, comprising applying to the skin of the patient the stable topical pharmacological composition of  claim 1 .