# US 11,998,555 B2 · Concentrated liquid pharmaceutical formulations of furosemide and methods of administering the same

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- Number: US 11,998,555 B2
- Document ID: US11998555B2
- Status: Granted
- Kind: B2
- Application number: 17/426,765
- Filed: 2020-01-30
- Published: 2022-03-31
- Granted: 2024-06-04
- Earliest claimed: 2019-01-31
- Assignees: scPharmaceuticals Inc.
- Applicants: scPharmaceuticals Inc.
- Inventors: Alfredo Grossi; Britt Kostraba; Olatokumbo O. Luca Ogunleye; Shannon Terry; Franciscus Koppenhagen
- Web page: https://patentgrep.com/patent/US11998555B2

## CPC

- A61K 31/635: having a heterocyclic ring, e.g. sulfadiazine
- A61P 9/00: Drugs for disorders of the cardiovascular system
- A61K 9/0019: {Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner (non-active ingredients are additionally classified in A61K47/00)}
- A61K 47/10: Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
- A61K 47/18: Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
- A61K 47/22: Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
- A61K 47/32: Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers {, poly(meth)acrylates, or polyvinyl pyrrolidone}
- A61K 47/02: Inorganic compounds
- A61K 47/12: Carboxylic acids; Salts or anhydrides thereof
- A61K 47/183: {Amino acids, e.g. glycine, EDTA or aspartame}
- A61K 47/26: Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
- A61K 47/40: Cyclodextrins; Derivatives thereof
- A61M 5/14248: {of the skin patch type}
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}

## 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.

## Claims

### Claim 1

A liquid pharmaceutical formulation comprising:
(i) furosemide, or a pharmaceutically acceptable salt thereof;
(ii) benzyl alcohol, wherein the amount of benzyl alcohol in the liquid pharmaceutical formulation is from about 0.1% (w/w) to about 10% (w/w); and
(iii) a pharmaceutically acceptable buffer comprising tromethamine or a pharmaceutically acceptable salt thereof, wherein the concentration of tromethamine is from about 25 mM to about 100 mM,
wherein the concentration of furosemide in the liquid pharmaceutical formulation is greater than about 40 mg/mL and the pH of the liquid pharmaceutical formulation is from about 6.5 to about 8.5.

### Claim 2 (depends on 1)

The liquid pharmaceutical formulation of claim 1, wherein the amount of benzyl alcohol in the liquid pharmaceutical formulation is from about 0.5% (w/w) to about 5% (w/w).

### Claim 3

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) 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 liquid pharmaceutical formulation is from about 40 mg/mL to about 250 mg/mL.

### Claim 4 (depends on 3)

The liquid pharmaceutical formulation of claim 3, wherein the amount of benzyl alcohol in the liquid pharmaceutical formulation is from about 0.5% (w/w) to about 5% (w/w).

### Claim 5 (depends on 3)

The liquid pharmaceutical formulation of claim 3, wherein the pH of the liquid pharmaceutical formulation is from about 6.5 to about 8.5.

### Claim 6 (depends on 3)

The liquid pharmaceutical formulation of claim 3, wherein the pH of the liquid pharmaceutical formulation is from about 7.0 to about 8.0.

### Claim 7

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 and the pH of the unit liquid pharmaceutical formulation is from about 6.5 to about 8.5.

### Claim 8 (depends on 7)

The unit liquid pharmaceutical formulation of claim 7, wherein the amount of benzyl alcohol in the unit liquid pharmaceutical formulation is from about 0.5% (w/w) to about 5% (w/w).

### Claim 9 (depends on 1)

The liquid pharmaceutical formulation of claim 1, further comprising one of more of water; a pH adjuster; and an osmolarity adjuster.

### Claim 10 (depends on 9)

The liquid pharmaceutical formulation of claim 9, 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.

### Claim 11 (depends on 1)

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.

### Claim 12 (depends on 11)

The method of claim 11, wherein the liquid pharmaceutical formulation is administered to the patient by subcutaneous injection or subcutaneous infusion.

### Claim 13 (depends on 12)

The method of claim 12, wherein the liquid pharmaceutical formulation is administered to the patient by subcutaneous infusion using an on-body, subcutaneous delivery system.

### Claim 14 (depends on 7)

A kit for the treatment of congestion, edema, fluid overload, or hypertension comprising the unit liquid pharmaceutical formulation of claim 7.

### Claim 15 (depends on 14)

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

### Claim 16 (depends on 3)

The liquid pharmaceutical formulation of claim 3, further comprising one of more of water; a pH adjuster; and an osmolarity adjuster.

### Claim 17 (depends on 16)

The liquid pharmaceutical formulation or the unit liquid pharmaceutical formulation of claim 16, 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.

### Claim 18 (depends on 7)

The unit liquid pharmaceutical formulation of claim 7, further comprising one of more of water; a pH adjuster; and an osmolarity adjuster.

### Claim 19 (depends on 18)

The unit liquid pharmaceutical formulation of claim 18, 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.

### Claim 20 (depends on 7)

The unit liquid pharmaceutical formulation of claim 7, wherein the pH of the unit liquid pharmaceutical formulation is from about 7.0 to about 8.0.