Stable aqueous formulations of adalimumab

摘要

The invention provides aqueous pharmaceutical adalimumab compositions suitable for long-term storage of adalimumab, methods of manufacture of these compositions, methods of administration, and kits containing same.

主权项

1. A stable aqueous pharmaceutical composition having pH about 5 to about 6 consisting essentially of:
(i) adalimumab; (ii) stabilizer consisting essentially of;
(a) an amino acid selected from glycine, arginine, methionine or combinations thereof; and(b) sodium chloride or sodium sulfate; wherein the composition is free of buffer and polyol; and the composition is stable for one week at 40° C. or two weeks at 25° C.