Claims for Patent: 11,903,993
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Summary for Patent: 11,903,993
| Title: | Ready-to-use bivalirudin compositions |
| 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. |
| Inventor(s): | Srikanth Sundaram |
| Assignee: | Maia Pharmaceuticals Inc |
| Application Number: | US18/060,523 |
| Patent Claims: |
1. A method of administering bivalirudin to a patient in need thereof comprising intravenously administering to the patient a ready-to-use liquid composition consisting of about 5 mg/mL bivalirudin or a salt thereof, about 0.8 mg/mL sodium acetate trihydrate, about 100 mg/mL PEG 400, and water and optionally, glacial acetic acid and/or sodium hydroxide, wherein the ready-to-use liquid composition is prepared by a method that comprises mixing bivalirudin or salt thereof, sodium acetate, PEG 400, and water and optionally glacial acetic acid and/or sodium hydroxide to form the ready-to-use liquid composition, the composition has a pH of about 5.25, and the composition has an osmolality of about 200 to about 600 mOsm/kg. 2. The method of claim 1, wherein the percentage of total impurities increases by no more than about 9% from the time of manufacture of the composition up to 12 months of storage at 5° C. as determined by high performance liquid chromatography at a wavelength of 215 nm. 3. The method of claim 1, wherein the composition is stored at 2-8° C. prior to administration. 4. The method of claim 1, wherein the bivalirudin is in the form of a trifluoroacetate salt. 5. The method of claim 1, wherein the patient has heparin-induced thrombocytopenia (HIT) and/or heparin-induced thrombocytopenia and thrombosis syndrome (HITTS) and is undergoing percutaneous coronary intervention (PCI). 6. The method of claim 1, wherein the composition has not been reconstituted from a lyophilized composition or diluted from a liquid concentrate. |
