Liquid pharmaceutical composition comprising an anti-IL-6 receptor antibody
The present invention relates to a novel protein formulation. In particular, the invention relates to a liquid pharmaceutical composition of an antibody directed to Interleukin-6 receptor, a method of manufacturing the composition, a kit including the composition, a package including the composition and to methods of treatment using the composition and/or package.
1. A liquid pharmaceutical composition comprising:
(a) an anti-IL-6 receptor (anti-IL-6R) antibody;
(b) an histidine buffer;
(c) a polyol;
(d) 0.4 to 0.6 mM methionine;
(e) a surfactant;
(f) water for injection; and
(g) optionally a salt.
wherein the composition has a pH between 5.5 and 7.5;
wherein the anti-IL6R antibody is selected from the group consisting of tocilizumab, sapelizumab, vobarilizumab or sarilumab.
2. The liquid pharmaceutical according to claim 1 , wherein the composition has a pH between 6.0 and 6.5.
3. The liquid pharmaceutical composition according to claim 1 , wherein the polyol is mannitol.
4. The liquid pharmaceutical composition according to claim 1 , wherein the surfactant is a polysorbate.
5. The liquid pharmaceutical composition as claimed in claim 4 , wherein the polysorbate is polysorbate 80.
6. The liquid pharmaceutical composition according to claim 1 , wherein the optional salt is sodium chloride.
7. The liquid pharmaceutical composition according to claim 1 , wherein the anti-IL6R antibody is tocilizumab.
8. The liquid pharmaceutical composition according to claim 1 , wherein the composition comprises:
15 to 200 mg/ml the anti-IL-6R antibody;
10 to 25 mM histidine (or histidine buffer system);
190 to 210 mM mannitol;
0.4 to 0.6 mM methionine;
0.4 to 0.9 mM polysorbate 80;
water (for injection);
75 to 125 mM sodium chloride.
9. A drug delivery device comprising a liquid pharmaceutical composition as claimed in claim 1 .
10. A kit comprising: (i) the liquid pharmaceutical composition claim 1 and (ii) a drug delivery device; wherein the liquid pharmaceutical composition is optionally contained in a separate package or container from the drug delivery device;
optionally wherein the kit further comprises a set of instructions regarding the administration of the liquid pharmaceutical composition.
11. A method of manufacturing the liquid pharmaceutical composition of claim 1 , comprising mixing together the anti-IL-6R antibody, histidine buffer, polyol, methionine, and surfactant, and optionally the salt.
12. A method of treatment comprising administering a therapeutically effective amount of the liquid pharmaceutical composition of claim 1 to a subject having rheumatoid arthritis, juvenile idiopathic arthritis, Giant cell arteritis or systemic sclerosis.