Formulations of deoxycholic acid and salts thereof

• US 8,367,649 B2
• Filed: 12/12/2011
• Issued: 02/05/2013
• Est. Priority Date: 03/03/2009
• Status: Active Grant

• Current Assignee: Allergan Sales LLC (Abbvie Incorporated)
• Original Assignee: Kythera Biopharmaceuticals, Inc. (Abbvie Incorporated)
• Inventors: Hodge, Robert Emil, Webster, Jeffrey Douglas
• Primary Examiner(s): RICCI, CRAIG D
• Application Number:
  US13/323,605
• Publication Number:
  US 20120083481A1
• Time in Patent Office: 421 Days
• Field of Search: None
• US Class Current: 514/182
• CPC Class Codes: A61K 31/57 substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
• CPC Class Codes: A61K 31/575 substituted in position 17 beta by a chain of three or more carbon atoms, e.g. cholane, cholestane, ergosterol, sitosterol
• CPC Class Codes: 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
• CPC Class Codes: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

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

1. An aqueous pharmaceutical formulation consisting of from about 0.5% w/v to about 1.5% w/v deoxycholate and at least one pharmaceutically acceptable excipient and/or carrier wherein the formulation has a pH of about 8.3.

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

3. The aqueous pharmaceutical formulation of claim 1, wherein said at least one pharmaceutically acceptable excipient and/or carrier is selected from the group consisting of water, a buffer, and a preservative.

4. The aqueous pharmaceutical formulation of claim 2, wherein said at least one pharmaceutically acceptable excipient and/or carrier is selected from the group consisting of water, a buffer, and a preservative.