# US 10,500,214 B2 · Formulations of deoxycholic acid and salts thereof

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- Number: US 10,500,214 B2
- Document ID: US10500214B2
- Status: Granted
- Kind: B2
- Application number: 16/103,505
- Filed: 2018-08-14
- Published: 2019-02-07
- Granted: 2019-12-10
- Earliest claimed: 2009-03-03
- Assignees: Allergan Sales, Inc.
- Applicants: Allergan Sales, LLC
- Inventors: Robert Emil Hodge; Jeffrey Douglas Webster
- Web page: https://patentgrep.com/patent/US10500214B2

## CPC

- A61K 31/57: substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
- 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 31/575: substituted in position 17 beta by a chain of three or more carbon atoms, e.g. cholane, cholestane, ergosterol, sitosterol
- A61P 43/00: Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
- 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 formulation comprising less than about 5% w/v sodium deoxycholate maintained at a pH sufficient to substantially inhibit precipitation of the sodium deoxycholate. Also disclosed herein, are methods for inhibiting precipitation of sodium deoxycholate in an aqueous solution comprising less than about 5% w/v of sodium deoxycholate, said method comprising maintaining pH of the solution of from at least about 8.0 to about 8.5.

## Claims

### Claim 1

An aqueous pharmaceutical formulation consisting of about 0.05% w/v to about 2% w/v sodium deoxycholate, water, a phosphate buffer, a base, a preservative, and tonicity agent; wherein the formulation has a pH of from about 8.0 to about 8.5.

### Claim 2 (depends on 1)

The aqueous pharmaceutical formulation of claim 1, wherein the aqueous formulation is suitable for subcutaneous injection.

### Claim 3 (depends on 1)

The aqueous pharmaceutical formulation of claim 1, wherein the pH is about 8.3.

### Claim 4 (depends on 1)

The aqueous pharmaceutical formulation of claim 1, wherein said preservative is benzyl alcohol.

### Claim 5 (depends on 1)

The aqueous pharmaceutical formulation of claim 1, wherein said base is sodium hydroxide.

### Claim 6 (depends on 1)

The aqueous pharmaceutical formulation of claim 1, wherein said tonicity agent is sodium chloride.