Granted Patent B2

US 9,750,808 · App. 15/418,460 · Granted Sep 5, 2017

Inventors: Hans-Juergen Krause (Gruenstadt, DE); Lisa Baust (Ludwigshafen, DE); Michael Dickes (Rodersheim-Gronau, DE)

Assignee: ABBVIE BIOTECHNOLOGY LTD.

A61K39/39591A61K47/26C07K16/241C07K2317/21C07K2317/76C07K2317/92

Abstract

Claims (31)

1. A stable liquid aqueous pharmaceutical formulation comprising: a human anti-human Tumor Necrosis Factor alpha (TNFα) IgG1 antibody at a concentration of 45 to 105 mg/ml, wherein the antibody is D2E7, and a buffer system;

wherein the formulation is isotonic, suitable for single-use subcutaneous injection, and has a pH of 4 to 8.

2. The formulation of claim 1 , wherein the buffer system comprises an organic acid.

3. The formulation of claim 2 , wherein the organic acid is selected from the group consisting of succinate, acetate, and histidine.

4. The formulation of claim 2 , wherein the pH is 4.5 to 6.0.

5. The formulation of claim 2 , wherein the formulation comprises a surfactant.

6. The formulation of claim 5 , wherein the surfactant is a polysorbate.

7. The formulation of claim 6 , wherein the polysorbate is polysorbate-80.

8. The formulation of claim 2 , wherein the formulation comprises a tonicity agent.

9. The formulation of claim 8 , wherein the tonicity agent is a polyol.

10. The formulation of claim 9 , wherein the polyol is a sugar, a sugar alcohol or a sugar acid.

11. The formulation of claim 10 , wherein the sugar is trehalose.

12. The formulation of claim 10 , wherein the sugar is sucrose.

13. The formulation of claim 10 , wherein the sugar alcohol is sorbitol.

14. The formulation of claim 10 , wherein the sugar alcohol is mannitol.

15. The formulation of claim 10 , wherein the formulation comprises a surfactant.

16. The formulation of claim 15 , wherein the surfactant is a polysorbate.

17. The formulation of claim 16 , wherein the polysorbate is polysorbate-80.

18. The formulation of claim 17 , wherein the sugar is trehalose.

19. The formulation of claim 18 , wherein the buffer system comprises succinate, acetate, or histidine.

20. The formulation of claim 17 , wherein the sugar is sucrose.

21. The formulation of claim 20 , wherein the buffer system comprises succinate, acetate, or histidine.

22. The formulation of claim 17 , wherein the sugar alcohol is sorbitol.

23. The formulation of claim 22 , wherein the buffer system comprises succinate, acetate, or histidine.

24. The formulation of claim 17 , wherein the sugar alcohol is mannitol.

25. The formulation of claim 24 , wherein the buffer system comprises succinate, acetate, or histidine.

26. The formulation of claim 17 , wherein the buffer system comprises succinate, acetate, or histidine.

27. The formulation of claim 17 , wherein the polysorbate 80 concentration is between 0.1 and 10 mg/ml.

28. The formulation of claim 1 , wherein the formulation comprises a preservative.

29. The formulation of claim 1 , wherein the formulation comprises a chelating agent.

30. The formulation of claim 1 , wherein the formulation comprises an antioxidant.

Continuity (10)