CLOBETAZOLE COMPOSITION IN THE FORM OF OIL-IN-WATER NANO-EMULSION Russian patent published in 2021 - IPC A61K9/107 A61K31/573 A61K47/10 A61K47/14 A61K47/26 A61K47/34 A61K47/44 A61P29/00 

FIELD: chemistry; pharmaceutics.

SUBSTANCE: object 1 is an oil-in-water nano-emulsion composition for use in the prevention and/or treatment of an inflammatory disease or condition selected from an ophthalmic, ear, nasal and oropharyngeal inflammatory disease or condition, having a continuous aqueous phase and dispersed oil droplets and containing clobetazole or its pharmaceutically acceptable salt or complex ester, one or more oil components and one or more surfactants together with pharmaceutically acceptable excipients or carriers, wherein the osmolality of the composition is from 100 to 500 mOsm/kg; the average droplet size is from 1 to 500 nm; the mass ratio between oil components and the sum of oil components and surfactants is from 0.001 to 0.5; the mass ratio between the oil component and clobetazole or its pharmaceutically acceptable salt or complex ester is from 1:1 to 200:1; and the mass ratio between the surfactant and clobetazole or its pharmaceutically acceptable salt or complex ester is from 2:1 to 200:1. The object 2 is a method for producing an oil-in-water nano-emulsion composition.

EFFECT: stability of the active ingredient and the composition containing it, applicable for the prevention and/or treatment of ophthalmic, ear, nasal and oropharyngeal inflammatory diseases or conditions.

15 cl, 1 dwg, 10 tbl, 3 ex