# US 2014/0155364 A1 · Formulations of deoxycholic acid and salts thereof

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- Number: US 2014/0155364 A1
- Document ID: US20140155364A1
- Status: Published application
- Kind: A1
- Application number: 14/175,086
- Filed: 2014-02-07
- Published: 2014-06-05
- Earliest claimed: 2009-03-03
- Assignees: Kythera Biopharmaceuticals, Inc.
- Applicants: Kythera Biopharmaceuticals, Inc.
- Inventors: Robert Emil Hodge; Jeffrey Douglas Webster
- Web page: https://patentgrep.com/patent/US20140155364A1

## 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 at position 1

1-37. (canceled)

### Claim 38

A method for inhibiting precipitation of sodium deoxycholate in an aqueous solution to increase the shelf life of the solution, comprising preparing an aqueous solution of sodium deoxycholate and adjusting the alkalinity of the solution to be sufficient to substantially inhibit precipitation of the sodium deoxycholate, wherein the solution comprising from about 0.05% w/v to about 2% w/v sodium deoxycholate and at least one pharmaceutically acceptable excipient and/or carrier.

### Claim 39 (depends on 38)

The method of claim 38, wherein precipitation of the sodium deoxycholate is substantially inhibited for a period of at least about six months.

### Claim 40 (depends on 39)

The method of claim 39, wherein precipitation of the sodium deoxycholate is substantially inhibited for a period of at least about six months at a temperature of from about 17° C. to about 27° C., from about 25° C. to about 37° C., or from about 2° C. to about 8° C.

### Claim 41 (depends on 40)

The method of claim 40, wherein the solution is suitable for subcutaneous injection after the period.

### Claim 42 (depends on 38)

The method of claim 38, wherein the pH of the solution is adjusted to be between about 8.0 and about 8.5.

### Claim 43 (depends on 38)

The method of claim 38, wherein the pH is adjusted to about 8.3.

### Claim 44 (depends on 38)

The method of claim 38, wherein the sodium deoxycholate is present in an amount from about 0.5% w/v to about 1.5% w/v.

### Claim 45 (depends on 38)

The method of claim 38, wherein the sodium deoxycholate is present in an amount of about 1% w/v.

### Claim 46 (depends on 38)

The method of claim 38, wherein the at least one pharmaceutically acceptable excipient and/or carrier is selected from the group consisting of water, a buffer and a preservative.