# US 10,946,030 B2 · Formulations of deoxycholic acid and salts thereof

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- Number: US 10,946,030 B2
- Document ID: US10946030B2
- Status: Granted
- Kind: B2
- Application number: 15/663,356
- Filed: 2017-07-28
- Published: 2018-01-18
- Granted: 2021-03-16
- Earliest claimed: 2011-04-05
- Assignees: Allergan Sales, Inc.
- Applicants: Allergan Sales, LLC
- Inventors: Robert Emil Hodge; Jeffrey Douglas Webster; Robert M. Moriarty
- Web page: https://patentgrep.com/patent/US10946030B2

## CPC

- A61K 31/575: substituted in position 17 beta by a chain of three or more carbon atoms, e.g. cholane, cholestane, ergosterol, sitosterol
- 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 47/02: Inorganic compounds
- A61K 47/10: Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
- A61P 3/04: Anorexiants; Antiobesity agents
- 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

## Abstract

The present application is directed to an aqueous pharmaceutical composition comprising from about 0.4% w/v to less than about 2% w/v of a salt of deoxycholic acid, wherein the composition is maintained at a pH from about 8.1 to about 8.5 such that the composition is stabilized against precipitation. Also disclosed herein, are methods for stabilizing an aqueous pharmaceutical composition comprising from about 0.4% w/v to less than about 2% w/v of a salt of deoxycholic acid against precipitation, said method comprising maintaining pH of the solution from about 8.1 to about 8.5.

## Claims

### Claim 1

A composition consisting essentially of about 0.4% w/v to less than 2% w/v of a salt of deoxycholic acid and a pharmaceutically acceptable excipient, wherein said composition, when dissolved in water, is maintained at a pH of about 8.1 to about 8.5 and, when so maintained, said composition does not form a precipitate.

### Claim 2 (depends on 1)

The composition of claim 1, wherein said excipient is a solvent, a buffer, a preservative, a lyophilization aid, or any combination thereof.

### Claim 3 (depends on 2)

The composition of claim 2, wherein said excipient is a solvent.

### Claim 4 (depends on 3)

The composition of claim 3, wherein said solvent is sterile water.

### Claim 5 (depends on 2)

The composition of claim 2, wherein said excipient is a preservative.

### Claim 6 (depends on 5)

The composition of claim 5, wherein said preservative is benzyl alcohol.

### Claim 7 (depends on 6)

The composition of claim 6, wherein said preservative is 0.9% benzyl alcohol.

### Claim 8 (depends on 1)

The composition of claim 1, wherein said composition has a pH of about 8.3.

### Claim 9 (depends on 1)

The composition of claim 1, wherein said salt is an alkali metal salt.

### Claim 10 (depends on 9)

The composition of claim 9, wherein said alkali metal salt is sodium.

### Claim 11 (depends on 2)

The composition of claim 2, wherein said excipient comprises a buffer.

### Claim 12 (depends on 11)

The composition of claim 11, wherein said buffer comprises a phosphate buffer.

### Claim 13 (depends on 11)

The composition of claim 11, wherein said buffer comprises 10 mM phosphate buffer.

### Claim 14 (depends on 11)

The composition of claim 11, wherein said buffer comprises dibasic sodium phosphate buffer.