Stabilized interferon liquid formulations

• US 7,731,948 B2
• Filed: 05/27/2005
• Issued: 06/08/2010
• Est. Priority Date: 06/01/2004
• Status: Active Grant

• Current Assignee: Ares Trading SA (Merck & Co., Inc.)
• Original Assignee: Ares Trading SA (Merck & Co., Inc.)
• Inventors: Del Rio, Alessandra, Samaritani, Fabrizio
• Primary Examiner(s): LANDSMAN, ROBERT S
• Application Number:
  US11/597,987
• Publication Number:
  US 20070292391A1
• Time in Patent Office: 1,838 Days
• Field of Search: None
• US Class Current: 424/85.6
• CPC Class Codes: A61K 38/21 Interferons [IFN]
• 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 25/00 Drugs for disorders of the nervous system
• CPC Class Codes: A61P 25/28 for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
• CPC Class Codes: A61P 31/12 Antivirals
• CPC Class Codes: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

Abstract

A stabilized HSA-free liquid pharmaceutical composition is described, which comprises an interferon (IFN), wherein said formulation is a solution that comprises a buffer, an amino acid and an antioxidant. Preferably, the interferon is human recombinant IFN-beta.

Claims

1. A composition comprising:

a) about 88 μ

g/ml interferon-beta 1a

b) about 27.3 mg/ml lysine;

c) about 0.12 mg/ml methionine;

d) about 0.5 mg/ml poloxomer 188; and

c) an aqueous acetate buffer at a pH of 3.5 to 5.5.

2. A composition comprising interferon-beta 1a, lysine, methionine and poloxomer 188 in an aqueous acetate buffer having a pH of about 3.4 to 5.5, said composition containing interferon-beta 1a, lysine, methionine and poloxomer 188 at a ratio of interferon-beta 1a:

lysine;

methionine;

poloxomer 188 of about;

1;

310;

1.4;

5.7.