Topical formulations and uses thereof

Abstract

Provided herein include formulations for topical administration, such as ophthalmic formulations, and methods of using such formulations. In some aspects and embodiments the formulations may include a polyoxyl lipid or fatty acid, and/or a polyalkoxylated alcohol and may include nanomicelles. Also include methods of treating or preventing diseases or conditions, such as ocular diseases or conditions.

What is claimed is: 
     
         1 . A formulation comprising a polyoxyl lipid or fatty acid and a polyalkoxylated alcohol,
 wherein said formulation comprises mixed nanomicelles,   wherein said formulation does not include organic solvents, and   wherein said formulation does not contain any pharmaceutically active agent that has received regulatory approval for the specific treatment of an ocular condition.   
     
     
         2 . The formulation of  claim 1 , wherein said polyoxyl lipid or fatty acid is present in an amount equal to greater than 1% of said formulation. 
     
     
         3 . The formulation of  claim 1 , comprising 0.05-5% of one or more polyoxyl lipid selected from the group consisting of HCO-40, HCO-60, HCO-80, HCO-100, polyoxyl 40 stearate and polyoxyl 35 castor oil; and about 0.01-0.1% octoxynol-40. 
     
     
         4 . The formulation of any of the preceding claims, wherein the formulation does not include any active agent selected from the group consisting of calcineurin inhibitors, mTOR inhibitors, peptides, eicosanoids (e.g. prostacyclins and prostaglandins), anti-inflammatory drugs (such as NSAIDS), autonomic drugs (e.g. beta-blockers, alpha-blockers, beta-agonists, and alpha-agonists), biologics, gene therapy agents (e.g. viral vectors), anti-infectives (e.g. antifungals, antibiotics, and antivirals), retinoids, RNAi, photo sensitizers, steroids (e.g., estrogens and derivatives thereof, and corticosteriods), mixture drugs, immuno-modulators, chemotherapeutic agents, G-coupled protein receptor antagonists, receptor tyrosine kinase (RTK) inhibitors, growth hormone inhibitors, integrin inhibitors, Sdf1/CXCR4 pathway inhibitors, and nACh receptor antagonists, resolvins (or resolvin-like compounds), lipoxins, and oxylipins. 
     
     
         5 . The formulation of any of the preceding claims, wherein the formulation does include a resolvin. 
     
     
         6 . The formulation of any of the preceding claims, wherein formulation does not include compound 1001. 
     
     
         7 . The ophthalmic formulation of any of the preceding claims, wherein the formulation does not include cyclosporine A, voclosporin, ascomycin, tacrolimus, pimecrolimus, an analog thereof, or a pharmaceutically acceptable salt thereof. 
     
     
         8 . The formulation of any of the preceding claims, wherein the formulation does not include cyclosporine A. 
     
     
         9 . A method of treating or preventing an ocular disease or condition, said method comprising topically administering a formulation of any of the preceding claims. 
     
     
         10 . A method of manufacturing an ophthalmic formulation comprising liquefying/melting and mixing (a) a polyoxyl lipid or fatty acid, (b) a polyalkoxylated alcohol and (c) optionally an active agent and subsequently adding a buffer and a saline. 
     
     
         11 . The formulation of  claim 1 , wherein said polyalkoxylated alcohol is Octoxynol-40. 
     
     
         12 . The formulation of  claim 11 , wherein the Octoxynol-40 is present in an amount between 0.002 and 4% of the solution. 
     
     
         13 . The formulation of  claim 1 , wherein said polyoxyl lipid comprises one or more selected from the group consisting of HCO-40, HCO-60, HCO-80, HCO-100, polyoxyl 40 stearate and polyoxyl 35 castor oil; and wherein said polyalkoxylated alcohol is Octoxynol-40. 
     
     
         14 . The formulation of  claim 1 , wherein said polyoxyl lipid comprises one or more selected from the group consisting of HCO-40, HCO-60, HCO-80, HCO-100, polyoxyl 40 stearate and polyoxyl 35 castor oil and is present in an amount between 0.5-2% of the solution; and said polyalkoxylated alcohol is Octoxynol-40 and is present in an amount between 0.002 and 4% of the solution. 
     
     
         15 . The formulation of  claim 1 , wherein said polyoxyl lipid comprises one or more selected from the group consisting of HCO-40, HCO-60, HCO-80, HCO-100, polyoxyl 40 stearate and polyoxyl 35 castor oil and is present in an amount between 0.5-1.5% of the solution; and said polyalkoxylated alcohol is Octoxynol-40 and is present in an amount between 0.02 and 0.1% of the solution. 
     
     
         16 . The formulation of  claim 1 , wherein said polyoxyl lipid comprises one or more selected from the group consisting of HCO-40, HCO-60, HCO-80, HCO-100, polyoxyl 40 stearate and polyoxyl 35 castor oil and is present in an amount between 0.5-5% of the solution; said polyalkoxylated alcohol is Octoxynol-40 and is present in an amount between 0.02 and 4% of the solution. 
     
     
         17 . The formulation of  claim 1 , wherein said polyoxyl lipid comprises one or more selected from the group consisting of HCO-40, HCO-60, HCO-80, HCO-100, polyoxyl 40 stearate and polyoxyl 35 castor oil and is present in an amount between 0.5-1.5% of the solution; and said polyalkoxylated alcohol is Octoxynol-40 and is present in an amount between 0.02 and 0.1% of the solution.