FORMULATIONS OF DEOXYCHOLIC ACID AND SALTS THEREOF

• US 20120083481A1
• Filed: 12/12/2011
• Published: 04/05/2012
• 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
• Granted Patent: US 8,367,649 B2
• Time in patent office: Days
• 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 comprising less than about 5% w/v sodium deoxycholate wherein the formulation is maintained at a pH sufficient to substantially inhibit precipitation of the sodium deoxycholate.

2-37. -37. (canceled)