Stable Aqueous Formulations of Adalimumab
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.
1 . A stable aqueous pharmaceutical composition comprising:
i) adalimumab;
ii) a buffer; and
iii) a tonicity modifier; and
iv) a surfactant,
wherein the formulation has a pH of about 5 to about 6 and is free of citrate buffer and phosphate buffer.
2 . The composition of claim 1 , wherein the composition has osmolality of about 180 to 420 mOsM; the composition is suitable for administration to a subject as a single dose; and the dose contains about 40 mg of adalimumab.
3 . The composition of claim 1 , wherein the buffer comprises acetate.
4 . The composition of claim 1 , wherein the tonicity modifier comprises trehalose.
5 . The composition of claim 4 , wherein the buffer comprises acetate.
6 . The composition of claim 5 , wherein the composition has osmolality of about 180 to 420 mOsM; the composition is suitable for administration to a subject as a single dose; and the dose contains about 40 mg of adalimumab.
7 . The composition of claim 1 , wherein the composition is free of sodium chloride.
8 . The composition of claim 7 , wherein the composition has osmolality of about 180 to 420 mOsM; the composition is suitable for administration to a subject as a single dose; and the dose contains about 40 mg of adalimumab.
9 . The composition of claim 7 , wherein the buffer comprises acetate.
10 . The composition of claim 7 , wherein the tonicity modifier comprises trehalose.
11 . The composition of claim 10 , wherein the buffer comprises acetate.
12 . The composition of claim 11 , wherein the composition has osmolality of about 180 to 420 mOsM; the composition is suitable for administration to a subject as a single dose; and the dose contains about 40 mg of adalimumab.