Granted Patent B2

US 9,950,066 · App. 15/095,393 · Granted Apr 24, 2018

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

Assignee: AbbVie Biotechnology Ltd

A61K39/39591A61K9/0019A61K9/19A61K39/3955A61K47/02A61K47/10A61K47/12A61K47/183A61K47/22A61K47/26C07K16/241A61K2039/505C07K2317/21C07K2317/76C07K2317/92C07K2317/94

Abstract

Claims (26)

1. A stable liquid aqueous pharmaceutical formulation comprising

(a) a human IgG1 anti-human Tumor Necrosis Factor alpha (TNFα) antibody at a concentration of 50 mg/ml,

(b) a polyol,

(c) a polysorbate, and

(d) a buffer system comprising citrate and phosphate and having a pH of 4 to 8,

wherein the antibody is D2E7, and

wherein the formulation is suitable for subcutaneous injection.

2. The formulation of claim 1 , wherein the polysorbate is polysorbate 20 or polysorbate 80.

3. The formulation of claim 2 , wherein the polysorbate is polysorbate 80.

4. The formulation of claim 3 , wherein the polysorbate 80 concentration is between 0.1 and 10 mg/ml.

5. The formulation of claim 1 , wherein the pH is from 4.5 to 6.0.

6. The formulation of claim 1 , wherein the pH is from 4.8 to 5.5.

7. The formulation of claim 1 , wherein the polyol is a sugar alcohol.

8. The formulation of claim 7 , wherein the sugar alcohol is mannitol.

9. The formulation of claim 7 , wherein the sugar alcohol is sorbitol.

10. The formulation of claim 7 , wherein the polysorbate is polysorbate 20 or polysorbate 80.

11. The formulation of claim 10 , wherein the polysorbate is polysorbate 80.

12. The formulation of claim 10 , wherein the pH is from 4.5 to 6.0.

13. The formulation of claim 10 , wherein the pH is from 4.8 to 5.5.

14. The formulation of claim 1 , wherein the polyol is a sugar.

15. The formulation of claim 14 , wherein the sugar is a non-reducing sugar.

16. The formulation of claim 14 , wherein the sugar is trehalose or sucrose.

17. The formulation of claim 14 , wherein the polysorbate is polysorbate 20 or polysorbate 80.

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

19. The formulation of claim 17 , wherein the pH is from 4.5 to 6.0.

20. The formulation of claim 17 , wherein the pH is from 4.8 to 5.5.

Continuity (9)