Topical formulation

Abstract

Provided herein are topical formulations. The topical formulation may comprise: (i) pregabalin, (ii) water, (iii) DMSO, (iv) a keto acid, and (v) and/or a fatty alcohol. The topical formulation may also comprise (i) pregabalin, (ii) DMSO, (iii) a keto acid and (iv) a fatty acid ester. It has been discovered that the combinations of DMSO with a keto acid such as levulinic acid and/or and a fatty acid ester such as lauryl lactate, or combinations of DMSO with a keto acid such as levulinic acid and/or with a fatty alcohol such as oleyl alcohol are excellent penetration enhancers and, as such, can be incorporated in a skin-applied formulation to facilitate administration of pregabalin.

1 .- 24 . (canceled) 
     
     
         25 . A topical formulation comprising: (i) at least one active agent, (ii) water, (iii) dimethyl sulfoxide (“DMSO”), (iv) a keto acid and (v) an ester of a fatty alcohol and an α-hydroxy acid and/or of a fatty acid and an alcohol. 
     
     
         26 . The topical formulation of  claim 25 , wherein said keto acid is levulinic acid. 
     
     
         27 . The topical formulation of  claim 25 , wherein said ester of a fatty alcohol and an α-hydroxy acid is lauryl lactate. 
     
     
         28 . The topical formulation of  claim 25 , wherein said ester of a fatty acid and an alcohol is isopropyl myristate. 
     
     
         29 . The topical formulation of  claim 25 , further comprising a polyalkylene glycol alkyl ether. 
     
     
         30 . The topical formulation of  claim 25 , further comprising cetylpyridinium chloride. 
     
     
         31 . The topical formulation of  claim 29 , wherein said polyalkylene glycol alkyl ether is a polyethylene glycol alkyl ether. 
     
     
         32 . The topical formulation of  claim 25 , further comprising a monohydric alcohol. 
     
     
         33 .- 43 . (canceled) 
     
     
         44 . A topical formulation comprising: (i) at least one active agent, (ii) water, (iii) about 10% to about 20% w/w dimethyl sulfoxide (“DMSO”), (iv) about 0.5% to about 5% w/w of a keto acid, and (v) about 0.5% to about 5% of an ester of a fatty alcohol and an α-hydroxy acid and/or of a fatty acid and an alcohol, (vi) about 5% to about 15% propylene glycol, and (vii) about 1% to about 4% polyalkylene glycol alkyl ether. 
     
     
         45 . The topical formulation of  claim 44 , wherein the keto acid is levulinic acid. 
     
     
         46 . The topical formulation of  claim 44 , wherein the ester of a fatty alcohol and an α-hydroxy acid is lauryl lactate. 
     
     
         47 . The topical formulation of  claim 44 , wherein the polyalkylene glycol alkyl ether is polyethylene glycol dodecyl ether. 
     
     
         48 . The topical formulation of  claim 44 , further comprising cetylpyridinium chloride. 
     
     
         49 . The topical formulation of  claim 44 , further comprising dimethyl isosorbide. 
     
     
         50 . The topical formulation of  claim 44 , further comprising a monohydric alcohol. 
     
     
         51 . The topical formulation of  claim 44 , comprising about 50% to about 70% water. 
     
     
         52 . The topical formulation of  claim 45 , comprising about 1% to about 3% w/w levulinic acid. 
     
     
         53 . The topical formulation of  claim 46 , comprising about 1% to about 3% lauryl lactate. 
     
     
         54 . The topical formulation of  claim 44 , comprising about 12% to about 20% w/w DMSO. 
     
     
         55 . The topical formulation of  claim 48 , comprising about 1% to about 2% cetylpyridinium chloride.