US2018339046A1PendingUtilityA1
Formulation of human antibodies for treating tnf-alpha associated disorders
Est. expiryAug 16, 2022(expired)· nominal 20-yr term from priority
A61P 37/02A61P 9/10A61P 43/00A61P 9/04A61P 37/00A61P 37/08A61P 3/10A61P 7/00A61P 9/00A61P 37/06A61P 25/04A61P 31/00A61P 33/06A61P 31/18A61P 35/00A61P 3/04A61P 31/12A61P 27/02A61P 31/04A61P 29/00A61P 25/02A61P 1/02A61P 17/06A61P 19/04A61P 11/00A61P 11/06A61P 19/08A61P 19/02A61P 1/18A61P 1/16A61P 15/00A61P 1/04A61P 1/00A61P 19/06A61P 17/00A61P 13/12A61K 47/12A61K 9/19A61K 9/0019C07K 2317/21C07K 2317/94A61K 47/26A61K 39/3955C07K 2317/76A61K 39/39591C07K 16/241A61K 47/10A61K 47/02A61K 2039/505A61K 47/22C07K 2317/92A61K 47/183Y02A50/388Y02A50/412A61K 39/395Y02A50/30
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Claims
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
exact text as granted — not AI-modifiedWhat is claimed is:
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) 12 mg/ml mannitol, (c) 1 mg/ml polysorbate 80, and (d) a buffer system comprising citrate and having a pH of 5.0 to 5.2,
wherein the antibody is D2E7, and wherein the formulation is suitable for subcutaneous injection.
2 . The formulation of claim 1 , wherein the formulation further comprises sodium chloride.
3 . The formulation of claim 1 , wherein the formulation further comprises 6.2 mg/ml sodium chloride.Join the waitlist — get patent alerts
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