Granted Patent B2

US 12,491,197 · App. 18/735,889 · Granted Dec 9, 2025

Inventors: Alfredo Grossi (Stoneham, MA); Britt Kostraba (Sandown, NH); Olatokumbo Olajimi Luca Ogunleye (Tewksbury, MA); Shannon Terry (Somerville, MA); Franciscus Koppenhagen (Salem, NH)

Assignee: scPharmaceuticals Inc.

A61K31/635A61K47/10A61K47/18A61K47/32A61M5/14248

Abstract

Claims (36)

1 . A liquid pharmaceutical formulation comprising:

(i) furosemide, or a pharmaceutically acceptable salt thereof;

(ii) from about 0.1% (w/w) to about 10% (w/w) of one or more pharmaceutically acceptable excipients; and

(iii) from about 25 mM to about 150 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 60 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 . 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, N-methyl-pyrrolidone (NMP), sodium chloride, a polyethylene glycol (PEG), propylene glycol, a polysorbate, a polyvinylpyrrolidone (PVP), a cyclodextrin, and any combination thereof.

3 . A liquid pharmaceutical formulation comprising:

(i) furosemide, or a pharmaceutically acceptable salt thereof;

(ii) from about 0.5% (w/w) to about 5% (w/w) of benzyl alcohol; and

(iii) from about 25 mM to about 150 mM of tromethamine or a pharmaceutically acceptable salt thereof,

wherein the concentration of furosemide in the liquid pharmaceutical formulation is from about 60 mg/mL to about 250 mg/mL and the pH of the liquid pharmaceutical formulation is from about 6.5 to about 8.5.

4 . The liquid pharmaceutical formulation of claim 3 , wherein the concentration of tromethamine or a pharmaceutically acceptable salt thereof in the liquid pharmaceutical formulation is from about 25 mM to about 100 mM.

5 . The liquid pharmaceutical formulation of claim 3 , wherein the pH of the liquid pharmaceutical formulation is from about 7 to about 8.

6 . A method of treating congestion, edema, fluid overload, or hypertension in a patient in need thereof, the method comprising administering to the patient the liquid pharmaceutical formulation of claim 1 .

7 . The method of claim 6 , wherein the liquid pharmaceutical formulation is administered to the patient by subcutaneous injection or subcutaneous infusion.

8 . A kit for the treatment of congestion, edema, fluid overload, or hypertension comprising a liquid pharmaceutical formulation of claim 1 ; and instructions for treating the congestion, edema, fluid overload, or hypertension.

9 . The kit of claim 8 , comprising one, two, three or more units of the liquid pharmaceutical formulation.

10 . The kit of claim 8 , further comprising a medical device.

11 . The kit of claim 10 , 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.

12 . A method of treating congestion, edema, fluid overload, or hypertension in a patient in need thereof, the method comprising administering to the patient the liquid pharmaceutical formulation of claim 3 .

13 . The method of claim 12 , wherein the liquid pharmaceutical formulation is administered to the patient by subcutaneous injection or subcutaneous infusion.

14 . A kit for the treatment of congestion, edema, fluid overload, or hypertension comprising the liquid pharmaceutical formulation of claim 3 ; and instructions for treating the congestion, edema, fluid overload, or hypertension.

15 . The kit of claim 14 , comprising one, two, three or more units of the liquid pharmaceutical formulation.

16 . The kit of claim 14 , further comprising a medical device.

17 . The kit of claim 16 , 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.

18 . A liquid pharmaceutical formulation comprising:

(i) furosemide, or a pharmaceutically acceptable salt thereof;

(ii) from about 0.5% (w/w) to about 5% (w/w) of benzyl alcohol; and

(iii) from about 50 mM to about 150 mM of tromethamine or a pharmaceutically acceptable salt thereof,

wherein the concentration of furosemide in the liquid pharmaceutical formulation is about 80 mg/mL and the pH of the liquid pharmaceutical formulation is between about 6.5 to about 8.5.

19 . A method of treating congestion, edema, fluid overload, or hypertension in a patient in need thereof, the method comprising administering to the patient the liquid pharmaceutical formulation of claim 18 .

20 . The method of claim 19 , wherein the liquid pharmaceutical formulation is administered to the patient by subcutaneous injection.

21 . A kit for the treatment of congestion, edema, fluid overload, or hypertension comprising the liquid pharmaceutical formulation of claim 18 ; and instructions for treating the congestion, edema, fluid overload, or hypertension.

22 . The kit of claim 21 , comprising one, two, three or more units of the liquid pharmaceutical formulation.

23 . The kit of claim 21 , further comprising a medical device.

24 . The kit of claim 23 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.

Assignments (4)

Continuity (4)

References Cited (72)