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 having pH about 5 to about 6 consisting essentially of:
(i) adalimumab;
(ii) salt; selected from sodium chloride, sodium sulfate and potassium chloride; and
(iii) stabilizer consisting essentially of polyol selected from mannitol, sorbitol and trehalose;
wherein the composition is free of buffer and amino acid stabilizers; and the composition is stable for one week at 40° C. or two weeks at 25° C.
2. The composition of claim 1 , wherein the polyol is mannitol.
3. The composition of claim 1 further containing surfactant.
4. The composition of claim 3 , wherein the surfactant is polysorbate 80.
5. The composition of claim 1 , wherein the salt is sodium sulfate.
6. 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 dosage; the composition has a concentration of adalimumab in the range of 30 to about 50 mg/ml; and the dosage contains about 10 to 80 mg of adalimumab.
7. The composition of claim 6 , wherein the dosage is about 40 mg and results in less pain upon administration to a subject in comparison to an adalimumab composition having a buffer comprising citrate.
8. A buffer-free and amino acid-free aqueous pharmaceutical composition consisting essentially of adalimumab, salt and mannitol, having pH about 5 to about 6, and that is stable for one week at 40° C. or two weeks at 25° C.