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. An aqueous pharmaceutical composition comprising:
(i) adalimumab; and
(ii) an ionic excipient;
wherein the composition is free of buffer, 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 which is (1) free of polyol; or (2) free of surfactant; or (3) free of both polyol and surfactant.
3. The composition of claim 1 , wherein the ionic excipient comprises a stabilizer.
4. The composition of claim 1 , wherein the ionic excipient comprises an amino acid.
5. The composition of claim 4 , wherein the amino acid is selected from glycine, alanine, glutamate, arginine, methionine, serine, lysine, proline, and combinations thereof.
6. The composition of claim 4 , wherein the amino acid is glycine, arginine or a combination thereof.
7. The composition of claim 1 , wherein the ionic excipient comprises a salt.
8. The composition of claim 7 , wherein the salt is selected from sodium chloride and sodium sulfate.
9. 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.
10. The composition of claim 9 , wherein the ionic excipient comprises a salt.
11. The composition of claim 9 , wherein the ionic excipient comprises an amino acid.
12. The composition of claim 9 , wherein the ionic excipient is arginine and sodium chloride.
13. The composition of claim 9 , wherein the ionic excipient is glycine and sodium chloride.
14. The composition of claim 9 , free of both surfactant and polyol.
15. The composition of claim 9 , 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.
16. The composition of claim 9 , wherein the concentration of adalimumab is about 50 mg/ml and the dosage is about 40 mg of adalimumab.
17. The composition of claim 7 , wherein the composition comprises an amino acid.
18. The composition of claim 17 , wherein the composition is (1) free of polyol; or (2) free of surfactant; or (3) free of both polyol and surfactant.
19. The composition of claim 17 , 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.
20. The composition of claim 19 , wherein the concentration of adalimumab is about 50 mg/ml and the dosage is about 40 mg of adalimumab.