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US 12,760,120 B2Granted
Viscosity reducing excipients and combinations thereof for highly concentrated protein formulations
AssigneeMerck Patent GmbH
InventorsTobias Rosenkranz, Stefan Braun
Life of this patent
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Abstract
The present invention relates to liquid compositions and formulations comprising a protein having a reduced viscosity and/or increased stability. Furthermore, the invention relates to methods for reducing the viscosity and/or increasing the stability of a protein solution.
Claims17
A liquid composition, comprising:
- an antibody in a concentration of 90 mg/ml to 300 mg/ml, and
- one of the following viscosity reducing excipient combinations (i), (ii) or (iii):
- (i) 5 mM to 300 mM of pyridoxine and 5 mM to 300 mM of meglumine,
- (ii) 5 mM to 300 mM of pyridoxine and 5 mM to 300 mM of ornithine, or
- (iii) 5 mM to 300 mM of pyridoxine and 5 mM to 300 mM of phenylalanine.
2 more elements
A method for reducing the viscosity of an antibody solution in a concentration of 90 mg/ml to 300 mg/ml, comprising adding to said protein solution one of the following viscosity reducing excipient combinations (i), (ii) or (iii):
- (i) 5 mM to 300 mM of pyridoxine and 5 mM to 300 mM of meglumine,
- (ii) 5 mM to 300 mM of pyridoxine and 5 mM to 300 mM of ornithine, or
- (iii) 5 mM to 300 mM of pyridoxine and 5 mM to 300 mM of phenylalanine.
Dependencies are inferred from the claim text.