Ophthalmic microemulsion, procedure for obtaining it and its use. The present invention relates to ophthalmic microemulsions compatible with the precorneal film that can be used as artificial tears and as a drug vehicle for topical ocular administration. In the same way it refers to the procedure for obtaining the microemulsion. (Machine-translation by Google Translate, not legally binding)
1. An ophthalmic microemulsion with a droplet size between 10 nm to 100 nm comprising: an aqueous phase and an oil phase comprising: a vegetable oil, a pharmaceutically acceptable fatty acid ester, a glycol compound, squalene, surfactants and cosurfactants. 2. The microemulsion of claim 1 characterized in that the vegetable oil is soybean oil, the pharmaceutically acceptable fatty acid ester is ethyl oleate and the glycol compound is propylene glycol, the surfactant is soybean phosphatidylcholine and the co-surfactant is polyoxyl castor oil 35. 3. The microemulsion according to any one of claims 1 to 2 characterized in that the aqueous phase comprises mucoadhesive and/or mucomimetic compounds are selected from: hyaluronic acid and its salts, dextran, cellulose derivatives, chondroitin sulfate, chitosan, dextran, alginates and gelane gum. 4. The microemulsion according to any one of claims 1 to 3 characterized in that the oil phase comprises lipid-soluble actives selected from oleanolic acid, ubiquinol, and/or lipid-soluble vitamins. 5. The microemulsion according to any one of claims 1 to 4 characterized in that the oily phase comprises latanoprost. 6. The microemulsion according to any one of claims 1 to 5 characterized in that the aqueous phase comprises an isotonic agent is selected from trehalose, sodium chloride, glucose, fructose, mannitol, sorbitol, ribitol, erythritol, and dextrose. 7. The microemulsion according to any one of claims 1 to 6 characterized in that the aqueous phase comprises water-soluble actives selected from: water-soluble vitamins, betaine, clusterin, leucine, L-carnitine, taurine, glycine, ribitol, ectoine and amino acids. 8. The microemulsion according to any one of claims 1 to 7, characterized in that the aqueous phase has an osmolarity between 150 mOsm/kg and 330 mOsm/kg. 9. A process for obtaining the microemulsion according to claims 1 to 8 comprising the steps of: (a) mixing the compounds comprising the oily phase. (b) adding the aqueous phase. (c) filtering. (d) stabilizing. 10. The process according to claim 9 characterized in that: step a) is carried out at a temperature between 20°C and 30°C and with protection from light, in step b) the aqueous phase is added in one step to the oily phase under agitation, in step c) the filtering is carried out with a filter having a pore size between 0.20 µm and 0.25 µm and wherein step d) of stabilization is carried out at a temperature between 2°C and 25°C. 11. The microemulsion according to claims 3 to 4 and 6 to 8 for use as artificial tears. 12. The microemulsion according to claims 1 to 4 and 6 to 8 for use as a drug vehicle for topical ocular administration. 13. The microemulsion according to any one of claims 5 to 8 for use in the treatment of ocular hypertension. 14. The microemulsion according to claim 5 to 8 for use in the treatment of glaucoma.