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US 10,093,728 B2Granted
Pharmaceutical formulations of TNF-alpha antibodies
AssigneeCadila Healthcare Limited
InventorsSanjeev Kumar Mendiratta, Sanjay Bandyopadhyay, Chintan G. Patel
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Abstract
The present invention provides certain improved formulations of proteins. Specifically, the present invention provides use of certain excipients that are useful for stabilization of antibody preparations. Additionally, the novel formulations of the present invention prevents the formation of aggregates or fragments or modifications of protein in solution.
Claims11
A liquid pharmaceutical composition comprising:
- (a) an effective amount of adalimumab or an antigen binding portion thereof;
- (b) a stabilizer consisting essentially of:
- (i) from about 0.5% to about 10% arginine, or
- (ii) from about 0.5% to about 10% arginine and from about 1% to about 10% sorbitol;
- (c) 0.01% to 1% of a surfactant selected from polysorbate 80, polysorbate 20 or a combination thereof;
- and
- (d) 5-50 mM succinate buffer, pH 5.0 to 5.5.
4 more elements
Dependencies are inferred from the claim text.