Claims for Patent: 12,472,224

Summary for Patent: 12,472,224

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:	US18/426,692
Patent Claims:	1. A ready-to-use liquid composition comprising about 5 mg/mL bivalirudin or a salt thereof, about 0.8 mg/mL sodium acetate, about 100 mg/mL PEG 400, and water and optionally, glacial acetic acid and/or sodium hydroxide, wherein the composition has a pH of from greater than 5.0 to 5.7. 2. The composition of claim 1, wherein the composition has a pH of 5.1 to 5.4. 3. The composition of claim 1, wherein the pH of the composition is about 5.25. 4. The composition of claim 1, wherein the sodium acetate is sodium acetate trihydrate. 5. The composition 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. 6. The composition of claim 1, wherein the bivalirudin is in the form of a trifluoroacetate salt. 7. The composition of claim 1, wherein the composition has an osmolality of about 200 to about 600 mOsm/kg. 8. A ready-to-use liquid composition comprising about 2.5 to about 7.5 mg/mL bivalirudin or a salt thereof, polyethylene glycol, and water, wherein the composition has a pH of from greater than 5.0 to 5.7, and the composition has an osmolality of about 200 to about 600 mOsm/kg. 9. The composition of claim 8, wherein the polyethylene glycol is PEG 400. 10. The composition of claim 8, wherein the composition further comprises glacial acetic acid and/or sodium hydroxide. 11. The composition of claim 8, wherein the composition has a pH of 5.1 to 5.4. 12. The composition of claim 8, wherein the pH of the composition is about 5.25. 13. The composition of claim 8, wherein the composition further comprises sodium acetate. 14. The composition of claim 8, 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. 15. The composition of claim 8, wherein the bivalirudin is in the form of a trifluoroacetate salt. 16. The composition of claim 13, wherein the sodium acetate is sodium acetate trihydrate. 17. A method of administering bivalirudin to a patient in need thereof comprising intravenously administering to the patient the ready-to-use liquid composition of claim 1. 18. The method of claim 17, wherein the composition is stored at 2-8° C. prior to administration. 19. A method of inhibiting blood clots in a patient in need thereof comprising intravenously administering to the patient a therapeutically effective amount of the ready-to-use liquid composition of claim 1. 20. The method of claim 19, wherein the patient has heparin-induced thrombocytopenia (HIT) and/or heparin-induced thrombocytopenia and thrombosis syndrome (HITTS) and is undergoing percutaneous coronary intervention (PCI).