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. A stable 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 at 40° C. for one week or at 25° C. for two weeks.
2. The composition of claim 1 , wherein the composition is:
(1) free of mannitol;
(2) free of surfactant; or
(3) free of both mannitol 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 the group consisting of: glycine, alanine, glutamate, arginine, and methionine, and combinations thereof.
6. The composition of claim 4 , wherein the amino acid is glycine or 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 comprises a chlorine anion.
9. The composition of claim 7 , wherein the salt is sodium chloride or sodium sulfate.
10. The composition of claim 1 , wherein:
the composition has an osmolality of about 180 mOsM to 420 mOsM;
the composition is suitable for administration to a subject as a single dosage;
the composition comprises a concentration of adalimumab in the range of 30 mg/mL to about 50 mg/mL; and
the dosage comprises about 10 mg to 80 mg of adalimumab.
11. The composition of claim 10 , wherein the ionic excipient comprises a salt.
12. The composition of claim 11 , wherein the salt comprises a chlorine anion.
13. The composition of claim 10 , wherein the ionic excipient comprises an amino acid.
14. The composition of claim 10 , wherein the ionic excipient is arginine and sodium chloride.
15. The composition of claim 10 , wherein the ionic excipient is glycine and sodium chloride.
16. The composition of claim 10 , free of both surfactant and mannitol.
17. The composition of claim 10 , wherein the dosage comprises about 40 mg and results in less pain upon administration to a subject in comparison to an adalimumab composition comprising a buffer comprising citrate.