Claims for Patent: 12,491,194

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Summary for Patent: 12,491,194

Title:	Concentrated liquid pharmaceutical formulations of furosemide and methods of administering the same
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 Olajimi Luca Ogunleye, Shannon Terry, Franciscus KOPPENHAGEN
Assignee:	ScPharmaceuticals Inc
Application Number:	US18/667,326
Patent Claims:	1. A unit liquid pharmaceutical formulation comprising: (i) from about 10 mg to about 200 mg furosemide, or a pharmaceutically acceptable salt thereof; (ii) from about 0.1% (w/w) to about 30% (w/w) of one or more pharmaceutically acceptable excipients comprising benzyl alcohol; and (iii) from about 25 mM to about 100 mM of a pharmaceutically acceptable buffer comprising tromethamine or a pharmaceutically acceptable salt thereof, wherein the concentration of furosemide in the liquid pharmaceutical formulation is from about 40 mg/mL to about 250 mg/mL and the pH of the liquid pharmaceutical formulation is from about 6.5 to about 8.5. 2. A unit liquid pharmaceutical formulation comprising: (i) from about 10 mg to about 200 mg furosemide, or a pharmaceutically acceptable salt thereof; (ii) from about 0.1% (w/w) to about 10% (w/w) benzyl alcohol; and (iii) from about 25 mM to about 100 mM tromethamine or a pharmaceutically acceptable salt thereof, wherein the concentration of furosemide in the unit liquid pharmaceutical formulation is from about 40 mg/mL to about 200 mg/mL. 3. The unit liquid pharmaceutical formulation of claim 2, wherein the pH of the liquid pharmaceutical formulation is from about 6.5 to about 8.5. 4. The unit liquid pharmaceutical formulation of claim 2, wherein the amount of benzyl alcohol in the unit liquid pharmaceutical formulation is from about 0.5% (w/w) to about 5% (w/w). 5. A method of treating congestion, edema, fluid overload, or hypertension in a patient in need thereof, the method comprising administering to the patient the unit liquid pharmaceutical formulation of claim 1. 6. The method of claim 5, wherein the unit liquid pharmaceutical formulation is administered to the patient by subcutaneous injection or subcutaneous infusion. 7. A kit for the treatment of congestion, edema, fluid overload, or hypertension comprising the unit liquid pharmaceutical formulation of claim 1; and instructions for treating the congestion, edema, fluid overload, or hypertension. 8. The kit of claim 7, comprising one, two, three or more units of the unit liquid pharmaceutical formulation. 9. The kit of claim 7, further comprising a medical device. 10. The kit of claim 9, wherein the medical device is selected from the group consisting of a needle and syringe set, an autoinjector, a single use fixed dose injection pen, a multiuse fixed dose injection pen, a single use variable dose injection pen, and a multiuse variable dose injection pen. 11. The unit liquid pharmaceutical formulation of claim 1, wherein the unit liquid pharmaceutical formulation has a volume of about 0.5 mL, about 1 mL, about 1.5 mL, about 2 mL, about 2.5 mL, about 3 mL, or about 3.5 mL. 12. The unit liquid pharmaceutical formulation of claim 1, wherein the unit liquid pharmaceutical formulation has a volume of about 1 mL. 13. The unit liquid pharmaceutical formulation of claim 1, wherein the unit liquid pharmaceutical formulation has a volume of about 0.5 mL. 14. The unit liquid pharmaceutical formulation of claim 1, wherein the unit liquid pharmaceutical formulation or the volume of the unit liquid pharmaceutical formulation is pre-loaded in a reservoir of a medical device. 15. The unit liquid pharmaceutical formulation of claim 14, wherein the medical device is selected from the group consisting of a needle and syringe set, an autoinjector, a single use fixed dose injection pen, a multiuse fixed dose injection pen, a single use variable dose injection pen, and a multiuse variable dose injection pen. 16. The unit liquid pharmaceutical formulation of claim 4, wherein the unit liquid pharmaceutical formulation has a volume of about 0.5 mL, about 1 mL, about 1.5 mL, about 2 mL, about 2.5 mL, about 3 mL, or about 3.5 mL. 17. The unit liquid pharmaceutical formulation of claim 4, wherein the unit liquid pharmaceutical formulation has a volume of about 1 mL. 18. The unit liquid pharmaceutical formulation of claim 4, wherein the unit liquid pharmaceutical formulation has a volume of about 0.5 mL. 19. The unit liquid pharmaceutical formulation of claim 4, wherein the unit liquid pharmaceutical formulation or the volume of the unit liquid pharmaceutical formulation is pre-loaded in a reservoir of a medical device. 20. The unit liquid pharmaceutical formulation of claim 19, wherein the medical device is selected from the group consisting of a needle and syringe set, an autoinjector, a single use fixed dose injection pen, a multiuse fixed dose injection pen, a single use variable dose injection pen, and a multiuse variable dose injection pen. 21. A unit liquid pharmaceutical formulation comprising: (iv) from about 40 mg to about 120 mg furosemide, or a pharmaceutically acceptable salt thereof; (v) from about 0.5% (w/w) to about 5% (w/w) benzyl alcohol; and (vi) from about 50 mM to about 100 mM tromethamine or a pharmaceutically acceptable salt thereof, wherein the concentration of furosemide in the unit liquid pharmaceutical formulation is about 80 mg/mL and the pH of the liquid pharmaceutical formulation is from about 7 to about 8. 22. The unit liquid pharmaceutical formulation of claim 21, comprising about 40 mg furosemide, or a pharmaceutically acceptable salt thereof. 23. The unit liquid pharmaceutical formulation of claim 21, comprising about 80 mg furosemide, or a pharmaceutically acceptable salt thereof. 24. The unit liquid pharmaceutical formulation of claim 21, wherein the unit liquid pharmaceutical formulation has a volume of about 0.5 mL, about 1 mL, about 1.5 mL, about 2 mL, about 2.5 mL, about 3 mL, or about 3.5 mL. 25. The unit liquid pharmaceutical formulation of claim 21, wherein the unit liquid pharmaceutical formulation has a volume of about 1 mL. 26. The unit liquid pharmaceutical formulation of claim 21, wherein the unit liquid pharmaceutical formulation has a volume of about 0.5 mL. 27. The unit liquid pharmaceutical formulation of claim 21, wherein the unit liquid pharmaceutical formulation is pre-loaded in a reservoir of a medical device. 28. The unit liquid pharmaceutical formulation of claim 27, wherein the medical device is selected from the group consisting of a needle and syringe set, an autoinjector, a single use fixed dose injection pen, a multiuse fixed dose injection pen, a single use variable dose injection pen, and a multiuse variable dose injection pen.