Claims for Patent: 12,318,363

Summary for Patent: 12,318,363

Title:	Pharmaceutical compositions of furosemide and uses thereof
Abstract:	A pharmaceutical composition and a method of administering the pharmaceutical composition to a patient suffering from edema, heart failure, kidney or liver disease or having symptoms thereof are disclosed. The pharmaceutical composition includes furosemide, or a pharmaceutically acceptable salt, hydrate or ester thereof and a cyclodextrin.
Inventor(s):	Pieter Muntendam
Assignee:	SQ Innovation AG
Application Number:	US17/668,519
Patent Claims:	1. A pharmaceutical composition, consisting of: from about 40 mM to about 160 mM of a diuretic selected from the group consisting of 4-chloro-2-((furan-2-ylmethyl)amino)-5-sulfamoylbenzoic acid, a pharmaceutically acceptable salt thereof, and a mixture thereof; from about 45 mM to about 190 mM of a sulfobutyl ether derivative of β-cyclodextrin; about 25 mM of a buffer, wherein the buffer is a tris(hydroxymethyl)aminomethane buffer; optionally a pH adjusting agent; and water; wherein the pharmaceutical composition has a pH value from about 7.0 to about 8.5. 2. The pharmaceutical composition of claim 1, wherein there is from about 135 mM to about 145 mM of the sulfobutyl ether derivative of β-cyclodextrin in the pharmaceutical composition. 3. The pharmaceutical composition of claim 2, wherein the sulfobutyl ether derivative of β-cyclodextrin is sulfobutyl ether beta-cyclodextrin sodium. 4. The pharmaceutical composition of claim 3, wherein there is from about 80 mM to about 100 mM of the diuretic in the pharmaceutical composition. 5. The pharmaceutical composition of claim 3, wherein there is about 91 mM of the diuretic in the pharmaceutical composition. 6. The pharmaceutical composition of claim 5, wherein the pharmaceutical composition has a pH of about 7.4. 7. The pharmaceutical composition of claim 6, wherein less than 1% of the diuretic degrades upon storage of the pharmaceutical composition at 40° C. for 29 days. 8. The pharmaceutical composition of claim 6, wherein less than 1% of the diuretic degrades upon storage of the pharmaceutical composition at 25° C. for 24 months. 9. The pharmaceutical composition of claim 1, wherein there is from 135 mM to 145 mM of the sulfobutyl ether derivative of β-cyclodextrin in the pharmaceutical composition. 10. The pharmaceutical composition of claim 9, wherein there is 91 mM of the diuretic in the pharmaceutical composition. 11. The pharmaceutical composition of claim 10, wherein there is 25 mM of said buffer. 12. The pharmaceutical composition of claim 9, wherein the pharmaceutical composition has a pH of 7.4. 13. The pharmaceutical composition of claim 10, wherein the pharmaceutical composition has a pH of 7.4. 14. The pharmaceutical composition of claim 11, wherein the pharmaceutical composition has a pH of 7.4. 15. A pharmaceutical composition, comprising: about 30 mg/mL furosemide, or a pharmaceutically acceptable salt thereof; about 30% by weight of a sulfobutyl ether derivative of a β-cyclodextrin; about 25 mM of a buffer comprising tris(hydroxymethyl)aminomethane; and water; wherein the pharmaceutical composition has a pH from about 7.0 to about 8.5. 16. The pharmaceutical composition of claim 15, wherein the sulfobutyl ether derivative of β-cyclodextrin is captisol. 17. The pharmaceutical composition of claim 16, wherein the pharmaceutical composition has a pH from about 7.2 to about 7.6. 18. The pharmaceutical composition of claim 15, wherein there is 30 mg/mL furosemide, or a pharmaceutically acceptable salt thereof, in the pharmaceutical composition. 19. The pharmaceutical composition of claim 16, wherein there is 30 mg/mL furosemide, or a pharmaceutically acceptable salt thereof, in the pharmaceutical composition. 20. The pharmaceutical composition of claim 17, wherein there is 30 mg/mL furosemide, or a pharmaceutically acceptable salt thereof, in the pharmaceutical composition. 21. The pharmaceutical composition of claim 15, wherein there is 25 mM of said buffer. 22. The pharmaceutical composition of claim 16, wherein there is 25 mM of said buffer. 23. The pharmaceutical composition of claim 19, wherein there is 25 mM of said buffer. 24. The pharmaceutical composition of claim 20, wherein there is 25 mM of said buffer. 25. A pharmaceutical composition, consisting of: about 30 mg/mL furosemide, or a pharmaceutically acceptable salt thereof; about 30% by weight of a sulfobutyl ether derivative of a β-cyclodextrin; about 25 mM of a tris(hydroxymethyl)aminomethane buffer; optionally a pH adjusting agent; and water; wherein the pharmaceutical composition has a pH from about 7.0 to about 8.5. 26. The pharmaceutical composition of claim 25, wherein the sulfobutyl ether derivative of β-cyclodextrin is captisol.