Claims for Patent: 11,246,851

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Summary for Patent: 11,246,851

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:	US16/733,359
Patent Claims:	1. A pharmaceutical composition, comprising: from about 15 mg/mL to about 40 mg/mL furosemide, or a pharmaceutically acceptable salt thereof; from about 10% to about 40% by weight of a sulfobutyl ether derivative of a β-cyclodextrin; about 25 mM of a buffer comprising tris(hydroxymethyl)aminomethane; optionally a pH adjusting agent; and water; wherein the pharmaceutical composition has a pH from about 7.0 to about 8.5. 2. A pharmaceutical composition, comprising: about 20 mg/mL to about 40 mg/mL furosemide; from about 10% to about 40% by weight of a sulfobutyl ether derivative of β-cyclodextrin; about 25 mM of a buffer comprising tris(hydroxymethyl)aminomethane; and water; wherein the pharmaceutical composition has a pH of from about 7.0 to about 8.5. 3. The pharmaceutical composition of claim 2, wherein the sulfobutyl ether derivative of β-cyclodextrin is captisol. 4. The pharmaceutical composition of claim 2, wherein the pH value of the pharmaceutical composition is from about 7.2 to about 7.6. 5. The pharmaceutical composition of claim 2, wherein the sulfobutyl ether derivative of β-cyclodextrin is present in an amount of from about 20% to about 30% by weight. 6. The pharmaceutical composition of claim 2, wherein the sulfobutyl ether derivative of β-cyclodextrin is present in an amount of about 30% by weight. 7. A pharmaceutical composition, comprising: 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 comprising tris(hydroxymethyl)aminomethane; and water; wherein the pharmaceutical composition has a pH value from about 7.0 to about 8.5. 8. The pharmaceutical composition of claim 7, wherein the pharmaceutical composition comprises from about 120 mM to about 160 mM of a sulfobutyl ether derivative of β-cyclodextrin. 9. The pharmaceutical composition of claim 7, wherein the pharmaceutical composition comprises from about 135 mM to about 145 mM of a sulfobutyl ether derivative of β-cyclodextrin. 10. The pharmaceutical composition of claim 7, wherein the sulfobutyl ether derivative of β-cyclodextrin is sulfobutyl ether beta-cyclodextrin sodium. 11. The pharmaceutical composition of claim 8, wherein the pharmaceutical composition comprises from about 80 mM to about 100 mM of the diuretic. 12. The pharmaceutical composition of claim 9, wherein the pharmaceutical composition comprises about 91 mM of the diuretic. 13. The pharmaceutical composition of claim 7, wherein the pharmaceutical composition has a pH of from about 7.0 to about 8.0. 14. The pharmaceutical composition of claim 11, wherein the pharmaceutical composition has a pH of about 7.4. 15. The pharmaceutical composition of claim 7, wherein the pharmaceutical composition contains at least 50% (w/w) water. 16. The pharmaceutical composition of claim 7, wherein less than 1% of the diuretic degrades upon storage of the pharmaceutical composition at 40° C. for 29 days. 17. The pharmaceutical composition of claim 7, wherein less than 1% of the diuretic degrades upon storage of the pharmaceutical composition at 25° C. for 24 months. 18. The pharmaceutical composition of claim 7, wherein the pharmaceutical composition comprises: from 40 mM to 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 comprising tris(hydroxymethyl)aminomethane; optionally a pH adjusting agent; and water; wherein the pharmaceutical composition has a pH value from about 7.0 to about 8.5. 19. The pharmaceutical composition of claim 18, wherein the sulfobutyl ether derivative of β-cyclodextrin is present at a concentration of from about 135 mM to about 145 mM in the pharmaceutical composition. 20. The pharmaceutical composition of claim 18, wherein the sulfobutyl ether derivative of β-cyclodextrin is sulfobutyl ether beta-cyclodextrin sodium. 21. The pharmaceutical composition of claim 19, wherein the sulfobutyl ether derivative of β-cyclodextrin is sulfobutyl ether beta-cyclodextrin sodium. 22. The pharmaceutical composition of claim 18, wherein the diuretic is present at a concentration of from about 80 mM to about 100 mM in the pharmaceutical composition. 23. The pharmaceutical composition of claim 21, wherein the diuretic is present at a concentration of from about 80 mM to about 100 mM in the pharmaceutical composition. 24. The pharmaceutical composition of claim 18, wherein the diuretic is present at a concentration of about 91 mM in the pharmaceutical composition. 25. The pharmaceutical composition of claim 21, wherein the diuretic is present at a concentration of about 91 mM in the pharmaceutical composition. 26. The pharmaceutical composition of claim 18, wherein the pharmaceutical composition has a pH of about 7.4. 27. The pharmaceutical composition of claim 25, wherein the pharmaceutical composition has a pH of about 7.4. 28. A method of treating a condition selected from edema, heart failure, kidney disease, or liver disease, or symptoms thereof, comprising administering to a patient in need thereof a therapeutically effective amount of a pharmaceutical composition of claim 2 to treat the condition.