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US 11,992,514 B2Granted
Ready-to-use bivalirudin compositions
AssigneeMaia Pharmaceuticals, Inc.
InventorSrikanth Sundaram
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Abstract
Ready-to-use liquid bivalirudin compositions, methods of using the ready-to-use bivalirudin compositions, and methods of preparing the ready-to-use liquid bivalirudin compositions are provided herein. The liquid ready-to-use bivalirudin compositions comprise a pharmaceutically acceptable amount of bivalirudin.
Claims1
A liquid bivalirudin composition comprising:
- a. bivalirudin (SEQ ID NO:
- 1), or salts thereof, in an amount of about 5 mg/mL,
- b. a pharmaceutically acceptable buffering agent comprising about 6 mM sodium acetate, and
- c. about 10% PEG 400 by weight,
- wherein the composition has a pH of about 5.25,
- wherein the percentage of total impurities increases by no more than about 8% from the time of manufacture up to 12 months of storage at 5° C. or up to 1 month of storage at 25° C. as determined by high performance liquid chromatography at a wavelength of 215 nm,
- wherein the composition is ready-to-use for or ready-to-administer by parenteral injection into a patient in need of an anticoagulant,
- wherein the composition has not been reconstituted from a lyophilized composition and/or diluted from a liquid concentrate, and
- wherein the osmolarity of the composition is 200 to 600 mOsm/kg.
6 more elements
Dependencies are inferred from the claim text.