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US 11,951,207 B2Granted
Stable liquid pharmaceutical preparation
AssigneeCelltrion Inc.
InventorsJoon Won Lee, Won Yong Han, Su Jung Kim, Jun Seok Oh, So Young Kim, Su Hyeon Hong, Yeon Kyeong Shin
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Abstract
The present invention provides a stable liquid pharmaceutical formulation containing: an antibody or its antigen-binding fragment; a surfactant; a sugar or its derivative; and a buffer. The stable liquid pharmaceutical formulation according to the present invention has low viscosity while containing a high content of the antibody, has excellent long-term storage stability based on excellent stability under accelerated conditions and severe conditions, and may be administered subcutaneously.
Claims14
A stable liquid pharmaceutical formulation, comprising:
- (A) 90 to 145 mg/ml of infliximab;
- (B) 0.02 to 0.1% (w/v) of a surfactant comprising polysorbate 80;
- (C) 1 to 10% (w/v) of a sugar comprising sorbitol;
- and
- (D) 1 to 50 mM of a buffer comprising sodium acetate.
2 more elements
Dependencies are inferred from the claim text.