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Stabilized formulations containing anti Interleukin 4 receptor (il-4r)
专利权人:
РІДЖЕНЕРОН ФАРМАСЬЮТІКАЛЗ, ІНК.
发明人:
Дікс Деніел Б.,Тан Сяолінь
申请号:
UAA201305598
公开号:
UA111731C2
申请日:
2011.10.05
申请国别(地区):
UA
年份:
2016
代理人:
摘要:
This provides Pharmaceutical formulations comprising a Human Antibody that specifically binds to the Receptor of human interleukin 4 (Group 4). The formulations may also contain a HLL Antibody anti - 4R, at least one amino acid, at least one carbohydrate, or at least a non-ionic surfactant.Pharmaceutical formulations of this exhibit a substantial degree of stability of the Antibody after storage for several months.Claim 1: a Liquid Pharmaceutical formulation comprising: (i) a Human Antibody that specifically binds to the Receptor of human interleukin 4 (HLL - 4ra); (ii) a buffer at a pH of 5.9 + / - 0.5 pH Units; (iii) an organic cosolvent; (iv) a Thermal Stabilizer; and ( (V) a viscosity reducing Agent.Claim 2: The Liquid Pharmaceutical formulation of claim 1, in which the Antibody is a concentration of 150 mg / ml (50 mg / ml.Claim 4: Liquid Pharmaceutical formulation of any of claims 1 - 3, in which the buffer includes a First buffer has an effective pH range of 3.6 to 5.6 and a Second buffer with a pH range of 5.5 - 7.4.Claim 6: Liquid Pharmaceutical formulation of Claim 5, in which the first buffer and the second buffer is acetate is histidine. Claim 8: Liquid Pharmaceutical formulation of any of claims 1 - 7, in which the Organic Co Solvent selected from the group consisting of Polysorbate 20, poloxamer 181 and Pegs 3350.Claim 9: Liquid Pharmaceutical formulation of any of claims 1 to 8, in which the Organic cosolvent is a concentration of around 0.085% to around 1.15% w / V.Claim 10: Liquid Pharmaceutical formulation of any of claims 1 to 9, which is the Organic cosolvent Polysorbate 20, at a concentration of 0.2% (0.03% w / V.Claim 1: The Liquid Pharmaceutical formulation of any of claims 1 - 10, in which the Thermal Stabilizer selected from the group consisting of sucrose, mannitol and Trehalose.Claim 12: Liquid Pharmaceutical formulation of any of claims 1 to 11, in which the Thermal Stabilizer is a concentration of around 3.5% to around 11% w / V.Cl
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