Concentrated liquid pharmaceutical formulations of furosemide
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.
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 150 mg/mL;
benzyl alcohol, wherein the amount of benzyl alcohol 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 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 concentration of furosemide is from about 70 mg/mL to about 90 mg/mL.
4. The liquid pharmaceutical formulation of claim 1 , wherein the amount of benzyl alcohol is from about 0.5% (w/w) to about 5% (w/w).
5. The liquid pharmaceutical formulation of claim 1 , wherein the amount of benzyl alcohol is from about 1% (w/w) to about 3.5% (w/w).
6. The liquid pharmaceutical formulation of claim 1 , wherein the concentration of tromethamine is from about 50 mM to about 125 mM.
7. The liquid pharmaceutical formulation of claim 1 , wherein the liquid pharmaceutical formulation has a pH of between about 7 to about 8.5.
8. The liquid pharmaceutical formulation of claim 1 , wherein the liquid pharmaceutical formulation has a pH of between about 7 to about 8.
9. 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;
benzyl alcohol, wherein the amount of benzyl alcohol is from about 1% (w/w) to about 3.5% (w/w); and
a pharmaceutically acceptable buffer comprising tromethamine or a pharmaceutically acceptable salt thereof, wherein the concentration of tromethamine is from about 50 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 80 mg/mL to 100 mg/mL.
11. The liquid pharmaceutical formulation of claim 9 , wherein the concentration of furosemide is about 80 mg/mL.
12. The liquid pharmaceutical formulation of claim 9 , wherein the liquid pharmaceutical formulation has a pH of between about 7.5 to about 8.5.
13. The liquid pharmaceutical formulation of claim 10 , wherein the liquid pharmaceutical formulation has a pH of between about 7 to about 8.
14. A liquid pharmaceutical formulation comprising:
furosemide, or a pharmaceutically acceptable salt thereof, wherein the concentration of furosemide is from about 80 mg/mL to about 100 mg/mL;
benzyl alcohol, wherein the amount of benzyl alcohol is from about 1% (w/w) to about 3.5% (w/w); and
a pharmaceutically acceptable buffer comprising tromethamine or a pharmaceutically acceptable salt thereof, wherein the concentration of tromethamine is from about 50 mM to about 125 mM;
wherein the liquid pharmaceutical formulation has a pH of between about 7 to about 8.
15. The liquid pharmaceutical formulation of claim 14 , wherein the concentration of furosemide is about 80 mg/mL.
16. The liquid pharmaceutical formulation of claim 14 , wherein the concentration of tromethamine is about 50 mM to 100 mM.
17. The liquid pharmaceutical formulation of claim 15 , wherein the concentration of tromethamine is about 50 mM to 100 mM.
18. The liquid pharmaceutical formulation of claim 14 , wherein the concentration of tromethamine is about 75 mM to 125 mM.
19. The liquid pharmaceutical formulation of claim 14 , further comprising one or more of water, an osmolarity adjuster, and a pH adjuster.
20. The liquid pharmaceutical formulation of claim 15 , further comprising one or more of water, an osmolarity adjuster, and a pH adjuster.