Title:
FORMULATION OF HUMAN ANTIBODIES FOR TREATING TNF-ALPHA ASSOCIATED DISORDERS
Document Type and Number:
Japanese Patent JP2014074034
Kind Code:
A
Abstract:
To provide a stable aqueous pharmaceutical formulation of human antibodies with a long shelf life for treating tumor necrosis factor α (TNF-α) associated disorders.
A liquid aqueous pharmaceutical formulation comprises a therapeutically effective amount of a TNFα-specific antibody in a buffer solution forming a formulation having a pH of about 4 to about 8 and a shelf life of at least 18 months. The buffer solution system contains a polyol, a surfactant, and citric acid and/or phosphoric acid having a pH of about 4 to 8. The polyol is 5-20 mg/ml of mannitol, and the surfactant is 0.1-10 mg/ml of polysorbate 80. The liquid aqueous pharmaceutical formulation of the TNFα-specific antibody is preserved in the buffer solution.
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Inventors:
KRAUSE HANS-JUERGEN
BAUST LISA
DICKES MICHAEL
BAUST LISA
DICKES MICHAEL
Application Number:
JP2013235924A
Publication Date:
April 24, 2014
Filing Date:
November 14, 2013
Export Citation:
Assignee:
ABBVIE BIOTECHNOLOGY LTD
International Classes:
A61K39/395; A61K9/08; A61K9/19; A61K47/02; A61K47/10; A61K47/12; A61K47/34; A61P1/04; A61P9/04; A61P9/10; A61P11/00; A61P31/04; A61P31/12; A61P35/00; A61P37/06; C07K16/24
Domestic Patent References:
| JP2000507810A | 2000-06-27 | |||
| JP2002504907A | 2002-02-12 | |||
| JP2001503781A | 2001-03-21 |
Foreign References:
| WO2000066160A1 | 2000-11-09 | |||
| WO2001047554A1 | 2001-07-05 | |||
| US6024938A | 2000-02-15 | |||
| WO2002013860A1 | 2002-02-21 | |||
| WO2002030463A2 | 2002-04-18 | |||
| WO2002012500A2 | 2002-02-14 | |||
| WO2002012502A2 | 2002-02-14 |
Attorney, Agent or Firm:
Kawaguchi International Patent Office
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