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) 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.
2. The composition of claim 1 wherein the amino acid is glycine.
3. The composition of claim 1 wherein the amino acid is arginine.
4. The composition of claim 1 wherein the amino acid is a combination of arginine and glycine.
5. The composition of claim 1 wherein (c) 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 stable aqueous pharmaceutical composition having pH about 5 to about 6 consisting essentially of:
(i) adalimumab;
(ii) stabilizer consisting essentially of
glycine, arginine, or both
wherein the composition does not contain any of the following: buffer, surfactant, sodium chloride, and sodium sulfate; and the composition is stable for one week at 40° C. or two weeks at 25° C.
9. The composition of claim 8 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.
10. The composition of claim 9 wherein the dosage contains about 40 mg and results in less pain upon administration to a subject in comparison to an adalimumab composition having a buffer comprising citrate.