Ibuprofen for topical administration
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.
1. A method of preparing a topical pharmacological composition that is physically and chemically stable, comprising the steps of:
(a) creating a first mixture by dissolving ibuprofen and potassium hydroxide in a solvent;
(b) creating second mixture comprising at least one water soluble ingredient, wherein the at least one water soluble ingredient is L-arginine;
(c) creating a third mixture comprising at least two hydrophobic ingredients, wherein one of the at least two hydrophobic ingredients is stearyl alcohol;
(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 topical pharmacological composition that is physically and chemically stable.
2. The method of claim 1 , wherein step (b) further comprises heating the at least one water soluble ingredient.
3. The method of claim 2 , wherein the at least one water soluble ingredient is heated to about 70° C.
4. The method of claim 1 , wherein step (c) further comprises heating the at least two hydrophobic ingredients.
5. The method of claim 4 , wherein the at least two hydrophobic ingredients are heated to about 70° C.
6. The method of claim 1 , wherein step (d) further comprises cooling the fourth mixture.
7. The method of claim 5 , 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 1 , 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 method of claim 1 , wherein the solvent is dimethylacetamide.
12. A topical pharmacological composition that is physically and chemically stable, prepared by the method of claim 1 .