OTAMIXABAN FORMULATIONS WITH IMPROVED STABILITY

摘要

The invention relates to an aqueous pharmaceutical composition for injection, comprising from 0.1 to 60 mg/mL methyl (2R3R)-2-{3-[amino(imino)methyl]benzyl}-3-{[4-(1-oxidopyridin-4-yl)benzoyl]amino}butanoate and from 1 to 1000 mMol/L acidic reacting compound, wherein the acidic reacting compound is selected from the group consisting of citric acid, tartaric acid, succinic acid, maleic acid or phosphoric acid, or salts of said acids, or a mixture of one or more of said acidic reacting compounds, wherein said composition is adjusted to a pH from about pH 3 to about pH 5.0 by adding said acidic reacting compound. Said composition is used in the treatment of acute myocardial infarction, non-ST elevation myocardial infarction, unstable angina, thromboembolism, acute vessel closure associated with thrombolytic therapy, percutaneous transluminal coronary angioplasty, transient ischemic attacks, stroke, intermittent claudication and restenosis.