Claims for Patent: 12,048,709

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Summary for Patent: 12,048,709

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:	US18/150,590
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; 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 wherein 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 150 mM tromethamine or a pharmaceutically acceptable salt thereof, wherein the concentration of furosemide in the unit liquid pharmaceutical formulation is from about 60 mg/mL to about 200 mg/mL and the pH of the liquid pharmaceutical formulation is from about 6.5 to about 8.5. 3. The unit liquid pharmaceutical formulation of claim 2, wherein the pH of the liquid pharmaceutical formulation is from about 7 to about 8. 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. The unit liquid pharmaceutical formulation of claim 1, further comprising one of more of water; a pH adjuster; and an osmolarity adjuster. 6. The unit liquid pharmaceutical formulation of claim 5, wherein the pH adjuster is selected from the group consisting of potassium hydroxide, sodium hydroxide, hydrochloric acid, and combinations thereof; and the osmolarity adjuster is selected from the group consisting of sodium chloride, potassium chloride, and combinations thereof. 7. 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. 8. The method of claim 7, wherein the unit liquid pharmaceutical formulation is administered to the patient by subcutaneous injection. 9. A kit for the treatment of congestion, edema, fluid overload, or hypertension comprising the unit liquid pharmaceutical formulation of claim 1. 10. The kit of claim 9, comprising one, two, three or more units of the unit liquid pharmaceutical formulation. 11. The unit liquid pharmaceutical formulation of claim 1, wherein the liquid pharmaceutical formulation comprises from about 25 mM to about 100 mM of a pharmaceutically acceptable buffer comprising tromethamine or a pharmaceutically acceptable salt thereof. 12. The unit 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 (PEG), propylene glycol, a polysorbate, a polyvinylpyrrolidone (PVP), a cyclodextrin, and any combination thereof. 13. The unit liquid pharmaceutical formulation of claim 1, wherein the one or more pharmaceutically acceptable excipients comprises benzyl alcohol. 14. The unit liquid formulation of claim 13, wherein the one or more pharmaceutically acceptable excipients further comprises a polysorbate. 15. The unit liquid pharmaceutical formulation of claim 12, wherein the one or more pharmaceutically acceptable excipients is benzyl alcohol, a polysorbate, or a combination thereof. 16. The unit liquid pharmaceutical formulation of claim 2, further comprising a polysorbate. 17. The unit liquid pharmaceutical formulation of claim 1, wherein the volume of the unit liquid pharmaceutical formulation is about 2 mL, about 1.5 mL, about 1.0 mL, or about 0.5 mL. 18. The unit liquid pharmaceutical formulation of claim 17, wherein the volume is pre-loaded in a reservoir of a medical device. 19. The unit liquid pharmaceutical formulation of claim 18, 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. 20. The unit liquid pharmaceutical formulation of claim 1, wherein the volume of the unit liquid pharmaceutical formulation is from about 0.5 mL to about 10 mL. 21. The unit liquid pharmaceutical formulation of claim 20, wherein the volume is pre-loaded in a reservoir of a medical device. 22. The unit liquid pharmaceutical formulation of claim 21, 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. 23. The unit liquid pharmaceutical formulation of claim 1, wherein the volume of the unit liquid pharmaceutical formulation is from about 0.5 mL to about 5 mL. 24. The unit liquid pharmaceutical formulation of claim 23, wherein the volume is pre-loaded in a reservoir of a medical device. 25. The unit liquid pharmaceutical formulation of claim 24, 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. 26. The unit liquid pharmaceutical formulation of claim 2, wherein the volume of the unit liquid pharmaceutical formulation is about 2 mL, about 1.5 mL, or about 1.0 mL. 27. The unit liquid pharmaceutical formulation of claim 26, wherein the volume 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. 29. The unit liquid pharmaceutical formulation of claim 2, wherein the volume of the unit liquid pharmaceutical formulation is about 0.5 mL. 30. The unit liquid pharmaceutical formulation of claim 29, wherein the volume is pre-loaded in a reservoir of a medical device. 31. The unit liquid pharmaceutical formulation of claim 30, 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. 32. The unit liquid pharmaceutical formulation of claim 2, wherein the volume of the unit liquid pharmaceutical formulation is from about 0.5 mL to about 5 mL. 33. The unit liquid pharmaceutical formulation of claim 32, wherein the volume is pre-loaded in a reservoir of a medical device. 34. The unit liquid pharmaceutical formulation of claim 33, 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.