IP Library › Patent Application 17126500
Patent Application
App. No. 17/126,500

FORMULATION OF HUMAN ANTIBODIES FOR TREATING TNF-ALPHA ASSOCIATED DISORDERS

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Patent No.
US None
App. No.
17/126,500
Abstract

A liquid aqueous pharmaceutical formulation is described which has a high protein concentration, a pH of between about 4 and about 8, and enhanced stability.

Claims (42)

1 . A stable liquid aqueous pharmaceutical formulation comprising

(a) a human IgG1 anti-human Tumor Necrosis Factor alpha (TNFα) antibody, at a concentration of 45 to 105 mg/ml,

(b) a polyol that is a sugar or sugar alcohol,

(c) a polysorbate, which is polysorbate 20 or polysorbate 80, at a concentration of 0.1 to 10 mg/ml, and

(d) a buffer system comprising acetate and having a pH of 4.5 to 7.0,

wherein the antibody is D2E7.

2 . The formulation of claim 1 , wherein the concentration of the antibody is 50 to 100 mg/ml.

3 . The formulation of claim 1 , wherein the formulation has a shelf life of at least 18 months.

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

5 . The formulation of claim 4 , wherein the sugar alcohol is mannitol, xylitol, erythritol, threitol, sorbitol, or glycerol.

6 . The formulation of claim 5 , wherein the sugar alcohol is mannitol.

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

8 . The formulation of claim 7 , wherein the sugar is a nonreducing sugar.

9 . The formulation of claim 8 , wherein the nonreducing sugar is sucrose.

10 . The formulation of claim 8 , wherein the nonreducing sugar is trehalose.

11 . The formulation of claim 1 , wherein the polysorbate is polysorbate 20.

12 . The formulation of claim 11 , wherein the polysorbate 20 concentration is from 0.5 to 5 mg/ml.

13 . The formulation of claim 12 , wherein the polysorbate 20 concentration is 1 mg/ml.

14 . The formulation of claim 1 , wherein the polysorbate is polysorbate 80.

15 . The formulation of claim 14 , wherein the polysorbate 80 concentration is from 0.5 to 5 mg/ml.

16 . The formulation of claim 15 , wherein the polysorbate 80 concentration is 1 mg/ml.

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

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

19 . The formulation of claim 1 , which is suitable for single use subcutaneous injection.

20 . The formulation of claim 6 , wherein the polysorbate is polysorbate 20.

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

22 . The formulation of claim 9 , wherein the polysorbate is polysorbate 20.

23 . The formulation of claim 9 , wherein the polysorbate is polysorbate 80.

24 . The formulation of claim 10 , wherein the polysorbate is polysorbate 20.

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

26 . The formulation of claim 1 , comprising:

(a) 50 to 100 mg/ml of the antibody,

(b) trehalose, and

(c) a polysorbate, which is polysorbate 20 or polysorbate 80,

wherein said buffer system has a pH of 5.0 to 6.5.

27 . The formulation of claim 26 , wherein the polysorbate is polysorbate 20.

28 . The formulation of claim 1 , comprising

(a) 50 to 100 mg/ml of the antibody,

(b) sucrose, and

(c) a polysorbate, which is polysorbate 20 or polysorbate 80,

wherein said buffer system has a pH of 5.0 to 6.5.

29 . The formulation of claim 28 , wherein the polysorbate is polysorbate 20.