Claims for Patent: 11,571,434
Summary for Patent: 11,571,434
| Title: | Concentrated liquid pharmaceutical formulations of furosemide |
| Abstract: | Disclosed herein, in part, are liquid pharmaceutical formulations comprising furosemide or a pharmaceutically acceptable salt thereof, one or more pharmaceutically acceptable excipients, and a pharmaceutically acceptable buffer. Methods of treating congestion, edema, fluid overload, or hypertension in a patient in need thereof are also provided. |
| Inventor(s): | Alfredo Grossi, Britt Kostraba, Olatokumbo O. Luca Ogunleye, Shannon Terry, Franciscus KOPPENHAGEN |
| Assignee: | ScPharmaceuticals Inc |
| Application Number: | US17/879,041 |
| Patent Claims: |
1. A liquid pharmaceutical formulation comprising: furosemide, or a pharmaceutically acceptable salt thereof, wherein the concentration of furosemide is from about 60 mg/mL to about 200 mg/mL; one or more pharmaceutically acceptable excipients, wherein the amount of the one or more pharmaceutically acceptable excipients is from about 0.1% (w/w) to about 30% (w/w); and a pharmaceutically acceptable buffer comprising tromethamine or a pharmaceutically acceptable salt thereof, wherein the concentration of tromethamine is from about 25 mM to about 150 mM; wherein the liquid pharmaceutical formulation has a pH of between about 6.5 to about 8.5. 2. The liquid pharmaceutical formulation of claim 1, wherein the concentration of furosemide is from about 60 mg/mL to about 120 mg/mL. 3. The liquid pharmaceutical formulation of claim 1, wherein the amount of the one or more pharmaceutically acceptable excipients is from about 0.1% (w/w) to about 10% (w/w). 4. The liquid pharmaceutical formulation of claim 1, wherein the concentration of tromethamine is from about 50 mM to about 125 mM. 5. The liquid pharmaceutical formulation of claim 1, wherein the liquid pharmaceutical formulation has a pH of between about 7 to about 8.5. 6. The liquid pharmaceutical formulation of claim 1, wherein the liquid pharmaceutical formulation has a pH of between about 7 to about 8. 7. The liquid pharmaceutical formulation of claim 1, wherein the one or more pharmaceutically acceptable excipients is selected from the group consisting of ethanol, benzyl alcohol, glycerin, sodium chloride, a polyethylene glycol, propylene glycol, a polysorbate, a polyvinylpyrrolidone, a cyclodextrin, and a combination thereof. 8. The liquid pharmaceutical formulation of claim 1, further comprising one or more of water, an osmolarity adjuster, and a pH adjuster. 9. A liquid pharmaceutical formulation comprising: furosemide, or a pharmaceutically acceptable salt thereof, wherein the concentration of furosemide is from about 60 mg/mL to about 120 mg/mL; one or more pharmaceutically acceptable excipients, wherein the amount of the one or more pharmaceutically acceptable excipients is from about 0.1% (w/w) to about 10% (w/w); and a pharmaceutically acceptable buffer comprising tromethamine or a pharmaceutically acceptable salt thereof, wherein the concentration of tromethamine is from about 25 mM to about 125 mM; wherein the liquid pharmaceutical formulation has a pH of between about 7 to about 8.5. 10. The liquid pharmaceutical formulation of claim 9, wherein the concentration of furosemide is about 60 mg/mL to 100 mg/mL. 11. The liquid pharmaceutical formulation of claim 9, wherein the concentration of furosemide is about 70 mg/mL to about 90 mg/mL. 12. The liquid pharmaceutical formulation of claim 9, wherein the liquid pharmaceutical formulation has a pH of between about 7 to about 8.5. 13. The liquid pharmaceutical formulation of claim 9, wherein the one or more pharmaceutically acceptable excipients is selected from the group consisting of ethanol, benzyl alcohol, glycerin, sodium chloride, a polyethylene glycol, propylene glycol, a polysorbate, a polyvinylpyrrolidone, a cyclodextrin, and a combination thereof. 14. The liquid pharmaceutical formulation of claim 9, further comprising one or more of water, an osmolarity adjuster, and a pH adjuster. 15. A liquid pharmaceutical formulation comprising: furosemide, or a pharmaceutically acceptable salt thereof, wherein the concentration of furosemide is from about 70 mg/mL to about 100 mg/mL; one or more pharmaceutically acceptable excipients, wherein the amount of the one or more pharmaceutically acceptable excipients is from about 0.5% (w/w) to about 5% (w/w); and a pharmaceutically acceptable buffer comprising tromethamine or a pharmaceutically acceptable salt thereof, wherein the concentration of tromethamine is from about 25 mM to about 125 mM; wherein the liquid pharmaceutical formulation has a pH of between about 7 to about 8.5. 16. The liquid pharmaceutical formulation of claim 15, wherein the concentration of furosemide is about 80 mg/mL. 17. The liquid pharmaceutical formulation of claim 15, wherein the concentration of tromethamine is about 25 mM to 100 mM. 18. The liquid pharmaceutical formulation of claim 17, wherein the liquid pharmaceutical formulation has a pH of between about 7 to about 8. 19. The liquid pharmaceutical formulation of claim 17, wherein the one or more pharmaceutically acceptable excipients is selected from the group consisting of ethanol, benzyl alcohol, glycerin, sodium chloride, a polyethylene glycol, propylene glycol, a polysorbate, a polyvinylpyrrolidone, a cyclodextrin, and a combination thereof. 20. The liquid pharmaceutical formulation of claim 19, further comprising one or more of water, an osmolarity adjuster, and a pH adjuster. |
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