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Stabilized formulations containing anti interleukin-6 receptor (il-6r)
专利权人:
发明人:
申请号:
UAA201209619
公开号:
UA107211C2
申请日:
2011.01.07
申请国别(地区):
UA
年份:
2014
代理人:
摘要:
This provides Pharmaceutical formulations comprising a Human Antibody that binds specifically to Human interleukin-6 receptor (HIL 6R). The formulations may also contain an Antibody anti Hil 6R, at least one amino acid, at least one sugar and / or at least a nonionic surfactant.Pharmaceutical formulations of this application show a substantial degree of stability of the Antibody after storage for several months. Claim 2: the pharmaceutical formulation of claim 1, in which the Sugar is a carbohydrate selected from the group consisting of sucrose, glucose, mannitol, Lactose and Trehalose.Claim 7: a Pharmaceutical formulation of any of claims 1 - 6, in which histidine is a concentration of approximately 5 to 50 mm. Claim 1: the pharmaceutical formulation of any of claims 1 - 7, in which the carbohydrate is a concentration of approximately 1% to 20%.Claim 1: the pharmaceutical formulation of claim 1, in which said non-ionic Surfactant selected from the group consisting of Polysorbate 20, Polysorbate 80 and sorbitan polioxietilensorbit u00e1n.Claim 1: the pharmaceutical formulation of any of claims 1 to 11, in which the nonionic Surfactant is at a concentration of approximately 0.01% to 1%.Claim 1: the pharmaceutical formulation of any of claims 1 - 12, which includes: (i) of approximately 25 to 200 mg / ml of Human Antibody that binds specifically to Hil 6R; (ii) histidine approximately 10 to 25 mm; (iii) of approximately 5% sucrose The 10%; and (iv) polysorbate 20 approximately 0.1% to 0.2%.Claim 1: the pharmaceutical formulation of any of claims 1 to 14, which also includes arginine. Claim 1: the pharmaceutical formulation of claim 15, in which arginine is a concentration of approximately 5 to 100 mm.Claim 1: the pharmaceutical formulation of claim 15, includes: (i) approximately 175 mg / ml of Human Antibody that binds specifically to Hil 6R; (ii) histidine approximately 25 mm; (iii) approximately 5% sucrose Polysorbate 20; (iv) approximately L 0.2%; and (V) argin
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