Liquid preparation containing anti-IL-17 antibody
Provided is a liquid preparation containing an anti-IL-17 antibody at a concentration of 20 mg/mL to 200 mg/mL, a citrate buffer at a concentration of 10 mM to 50 mM, a sucrose at a concentration of 20 mg/mL to 120 mg/mL or arginine at a concentration of 50 mM to 250 mM, and polysorbate 80 at a concentration of 0.1 mg/mL to 5 mg/mL. In addition, the liquid preparation has a pH of 6.0±0.5, wherein the anti-IL-17 antibody is an anti-IL-17A/F monoclonal antibody. The liquid preparation can be a stable subcutaneous injection preparation, and can be used to treat IL-17A and/or IL-17F related diseases, such as psoriasis, psoriatic arthritis, ankylosing spondylitis, rheumatoid arthritis, multiple sclerosis, systemic lupus erythematosus, osteoarthritis or inflammatory bowel disease.
1 . A liquid formulation comprising:
an anti-IL-17 antibody at a concentration ranging from 90 mg/ml to 110 mg/mL, wherein the anti-IL-17 antibody is an anti-IL-17A/F monoclonal antibody comprising two heavy chains (HCs) each comprising an amino acid sequence as shown in SEQ ID NO: 9 and two light chains (LCs) each comprising an amino acid sequence as shown in SEQ ID NO: 10;
citrate buffer at a concentration ranging from 15 mM to 25 mM;
sucrose at a concentration ranging from 70 mg/mL to 90 mg/ml or arginine at a concentration ranging from 100 mM to 150 mM; and
polysorbate 80 at a concentration ranging from 0.1 mg/ml to 0.5 mg/mL,
wherein the liquid formulation has a pH value of 6.0±0.3, and
wherein the liquid formulation does not comprise sodium chloride.
2 . The liquid formulation according to claim 1 , wherein the concentration of the anti-IL-17 antibody is 100 mg/mL.
3 . The liquid formulation according to claim 1 , wherein the concentration of the citrate buffer is 20 mM.
4 . The liquid formulation of claim 3 , wherein the concentration of sucrose is 80 mg/ml;
alternatively, the concentration of arginine is 150 mM.
5 . The liquid formulation according to claim 3 , wherein the citrate buffer is a citric acid-sodium citrate buffer.
6 . The liquid formulation according to claim 3 , wherein the citrate buffer consists of 0.66 mg/mL citric acid and 4.95 mg/mL sodium citrate dihydrate.
7 . The liquid formulation according to claim 1 , wherein the concentration of polysorbate 80 is 0.5 mg/mL.
8 . The liquid formulation according to claim 1 , wherein the liquid formulation has a pH value of 6.0.
9 . The liquid formulation according to claim 1 , wherein the liquid formulation comprises no antioxidant; and/or, the liquid formulation comprises no viscosity reducer.
10 . The liquid formulation according to claim 1 , wherein the liquid formulation comprises:
the anti-IL-17 antibody at a concentration of 100 mg/mL;
the citrate buffer at a concentration of 20 mM;
sucrose at a concentration of 80 mg/ml or arginine at a concentration of 150 mM; and
polysorbate 80 at a concentration of 0.5 mg/mL, and
wherein the liquid formulation has a pH value of 6.0.
11 . The liquid formulation according to claim 10 , wherein the citrate buffer is citric acid-sodium citrate buffer.
12 . The liquid formulation according to claim 10 , wherein the citrate buffer consists of 0.66 mg/mL citric acid and 4.95 mg/mL sodium citrate dihydrate.
13 . The liquid formulation according to claim 10 , wherein the liquid formulation is in the form of a solution, an emulsion, or a suspension.
14 . The liquid formulation according to claim 1 , wherein the liquid formulation is a pharmaceutical formulation of the anti-IL-17 antibody.
15 . The liquid formulation according to claim 14 , wherein the liquid formulation is in the form of a solution, an emulsion, or a suspension.
16 . A kit comprising the liquid formulation according to claim 1 in a container.