Stabilized Formulations Containing Anti-Interleukin-6 (IL-6) Antibodies
First Claim
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1. A pharmaceutical formulation comprising:
- (i) a human antibody that specifically binds to human interleukin-6 receptor (hIL-6R);
(ii) histidine; and
(iii) a carbohydrate.
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Abstract
The present invention provides pharmaceutical formulations comprising a human antibody that specifically binds to human interleukin-6 receptor (hIL-6R). The formulations may contain, in addition to an anti-hIL-6R antibody, at least one amino acid, at least one sugar, and/or at least one non-ionic surfactant. The pharmaceutical formulations of the present invention exhibit a substantial degree of antibody stability after storage for several months.
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31 Claims
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1. A pharmaceutical formulation comprising:
- (i) a human antibody that specifically binds to human interleukin-6 receptor (hIL-6R);
(ii) histidine; and
(iii) a carbohydrate. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 29, 30)
- (i) a human antibody that specifically binds to human interleukin-6 receptor (hIL-6R);
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9. A pharmaceutical formulation comprising:
- (i) about 5 to 200 mg/mL of a human antibody that specifically binds to human interleukin-6 receptor (hIL-6R);
(ii) about 5 to 50 mM histidine; and(iii) about 1 to 20% sucrose. - View Dependent Claims (10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28)
- (i) about 5 to 200 mg/mL of a human antibody that specifically binds to human interleukin-6 receptor (hIL-6R);
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31. A pharmaceutical formulation comprising:
- (i) about 175 mg/mL of a human antibody that specifically binds to human interleukin-6 receptor (hIL-6R), wherein said antibody comprises a heavy chain and light chain variable region (HCVR/LCVR) amino acid sequence pair of SEQ ID NOs;
18/26;
(ii) about 25 mM histidine;
(iii) about 5% sucrose;
(iv) about 0.2% polysorbate 20; and
(v) about 50 mM arginine.
- (i) about 175 mg/mL of a human antibody that specifically binds to human interleukin-6 receptor (hIL-6R), wherein said antibody comprises a heavy chain and light chain variable region (HCVR/LCVR) amino acid sequence pair of SEQ ID NOs;
Specification