Crystalline form of r)-3-(4-(2-(2-methyltetrazol-5-yl)pyridin-5-yl)-3-fluorophenyl)-5-hydroxymethyl oxazolidin-2-one dihydrogen phosphate

摘要

Disclosed is a pharmaceutical composition that is a lyophilisate of a sodium salt formed in situ from a reaction mixture including (i) sodium hydroxide and (ii) crystalline particles including 96% or more by weight of (R)-3-(4-(2-(2-methyltetrazol-5-yl)pyridin-5-yl)-3-fluorophenyl)-5-hydroxymethyl oxazolidin-2-one (tedizolid) dihydrogen phosphate; and at least one pharmaceutically acceptable carrier, excipient or diluent. Also disclosed is a lyophilised powder for injection made by a process comprising mixing tedizolid dihydrogen phosphate with a sodium hydroxide solution to form a disodium salt of said compound and then lyophilizing the resulting solution.