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Liquid pharmaceutical composition
专利权人:
Fresenius Kabi Deutschland GmbH
发明人:
Rinaldi, Gianluca,Fratarcangeli, Silvia,Del Rio, Alessandra
申请号:
NZ72536015
公开号:
NZ725360A
申请日:
2015.05.15
申请国别(地区):
NZ
年份:
2019
代理人:
摘要:
The present invention relates to an aqueous pharmaceutical composition comprising: (a) adalimumab; (b) an acetate buffering agent or acetate buffer system; (c) a sugar stabiliser, wherein the sugar stabiliser is a non-reducing disaccharide selected from the group including trehalose and sucrose; and (d) polysorbate 80, wherein the composition: • has a pH between 5.0 and 5.5; • is either free of arginine or comprises arginine in a concentration of at most 0.1 mM; • is either free of phosphate buffering agents or comprises a phosphate buffer system in a concentration of at most 0.1 mM; • is either free of amino acids or comprises one or more amino acids in a collective concentration of at most 0.1 mM; and is either free of surfactants, with the exception of polysorbate 80, or comprises one or more of surfactants, excluding polysorbate 80, in a collective concentration of at most 0.001 mM. The invention also relates to a drug delivery device comprising the aqueous pharmaceutical composition, and manufacture of the aqueous pharmaceutical composition for treating rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, moderate to severe chronic psoriasis and/or juvenile idiopathic arthritis.
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