Stable aqueous formulations of adalimumab
View Patent ↗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 single buffer;
iii) a surfactant; and
iv) a sugar,
wherein the composition is free of mannitol and has a pH of about 5 to about 6.
2. The composition of claim 1 , wherein the composition is free of citrate buffer.
3. The composition of claim 2 , wherein the single buffer is acetate.
4. The composition of claim 1 , wherein the surfactant is polysorbate 80.
5. The composition of claim 1 , wherein the sugar is sucrose.
6. The composition of claim 5 , wherein the single buffer is acetate and the surfactant is polysorbate 80.
7. The composition of claim 6 , wherein the composition is free of sodium chloride.
8. 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.
9. The composition of claim 8 , wherein the single buffer is acetate, the surfactant is polysorbate 80, and the sugar is sucrose.