Pharmaceutical Compositions of Oxazolidinone Antimicrobial Agents
The present invention relates to pharmaceutical compositions useful for administration for treating, preventing, or reducing the risk of microbial infections.
1 . A pharmaceutical composition comprising;
(a) an oxazolidinone antimicrobial agent or a pharmaceutically acceptable salt, ester, or prodrug thereof,
(b) a buffer,
(c) a pH modifier, and
(d) a solvent.
2 . A composition according to claim 1 wherein said oxazolidinone antimicrobial agent comprises a pharmaceutically acceptable amount.
3 . A composition according to claim 1 wherein said oxazolidinone antimicrobial agent comprises a prophylactically acceptable amount.
4 . A composition according to claim 1 wherein said oxazolidinone antimicrobial agent is radezolid, linezolid, torezolid, or a pharmaceutically acceptable salt or prodrug thereof
5 . A composition according to claim 1 wherein said oxazolidinone antimicrobial agent is radezolid or a pharmaceutically acceptable salt thereof
6 . A composition according to claim 5 wherein said pharmaceutically acceptable salt is a hydrochloride salt.
7 . A composition according to claim 1 wherein said oxazolidinone antimicrobial agent is radezolid monohydrochloride.
8 . A pharmaceutical composition according to claim 1 wherein said buffer comprises citric acid and a citric acid salt.
9 . A pharmaceutical composition according to claim 1 wherein said buffer comprises citric acid and sodium citrate tribasic.
10 . A pharmaceutical composition according to claim 1 wherein said pH modifier is selected from sodium hydroxide and phosphoric acid.
11 . A pharmaceutical composition according claim 1 wherein said pH modifier is sodium hydroxide.
12 . A pharmaceutical composition according to claim 1 wherein said pH modifier is phosphoric acid.
13 . A pharmaceutical composition according to claim 1 wherein said sugar is dextrose.
14 . A pharmaceutical composition according to claim 1 wherein said solvent is water.
15 . A pharmaceutical composition comprising 3.009 mg/mL radezolid hydrochloride, 4.00 mg/mL citric acid, 1.22 mg/mL sodium citrate tribasic dihydrate, q.s. 5% dextrose solution, and q.s. 1 normal sodium hydroxide or phosphoric acid, wherein the pH of the composition is 3.5±0.1.
16 . A pharmaceutical composition comprising 0.30 wt. % radezolid hydrochloride, 0.40 wt. % citric acid, 0.12 wt. % sodium citrate tribasic dihydrate, q.s. 5% dextrose solution, and q.s. 1 normal sodium hydroxide or phosphoric acid, wherein the pH of the composition is 3.5±0.1.
17 . A pharmaceutical composition according to claim 1 for intravenous administration.
18 . A pharmaceutical composition according to claim 1 for injectable administration.
19 . A method of treating a microbial infection in a patient comprising administering a pharmaceutically effective amount of a pharmaceutical composition according to claim 1 .
20 . A method of preventing or reducing the risk of a microbial infection in a patient comprising administering a prophylactically effective amount of a pharmaceutical composition according to claim 1 .