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. An aqueous pharmaceutical composition comprising:
(i) adalimumab;
(ii) a stabilizer; and
(iii) a salt; selected from sodium chloride, sodium sulfate and potassium chloride;
wherein the composition is free of buffer and surfactant, has a pH of about 5 to about 6, and is stable for one week at 40° C. or two weeks at 25° C.
2. The composition of claim 1 comprising polyol.
3. The composition of claim 2 , wherein the polyol is selected from mannitol, sorbitol, and trehalose.
4. The composition of claim 1 , wherein the stabilizer comprises an amino acid selected from the group consisting of glycine, alanine, glutamate, arginine, methionine, and combinations thereof.
5. The composition of claim 1 , wherein the amino acid is glycine, arginine or a combination thereof.
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 salt is sodium chloride and the stabilizer is glycine.
8. 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.
9. A buffer-free and surfactant-free aqueous pharmaceutical composition consisting essentially of adalimumab, glycine and sodium chloride, having a pH of about 5 to about 6, and that is stable for one week at 40° C. or two weeks at 25° C.
10. A buffer-free and surfactant-free aqueous pharmaceutical composition consisting essentially of adalimumab, glycine and arginine, having a pH of about 5 to about 6, and that is stable for one week at 40° C. or two weeks at 25° C.