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Formulations of etanercept Stabilized with Sodium chloride
专利权人:
COHERUS BIOSCIENCES; INC.
发明人:
申请号:
ARP120103886
公开号:
AR088380A1
申请日:
2012.10.18
申请国别(地区):
AR
年份:
2014
代理人:
摘要:
Requirement 1: a stable ethane hydrate formulation to reduce instability, polymerization, misfolding, and / or ethane fragmentation, comprising about 25-75 mg / m of ethane and one or more stabilizers selected from the mixture. A group consisting of (I) sodium chloride and (II) sodium chloride combined with sucrose or trihalogens; and (III) a mixture of sodium chloride, sucrose and trihalogens. Requirement 2: composition according to requirement 1,It also includes one or more additional ingredients selected from the closed solution, a pigment modifier and a prosthetic. 3. Claim 3: the component in line with claim 2, the stabilizer basically includes: (a) sodium chloride; or (b) sodium chloride combined with sucrose; or (c) sodium chloride combined with trichloroethane; in this claim, the stabilizer is prepared optionally, It's free or basically not aginina,e. The long-term storage stability of the preparation is at least one: SEC analysis a m83232o t832222 or t8324de: monomer content is more than about 90%;a. Components with total content less than 3% (wt%) and fragment content less than 5% (wt%): analysis with hic-m8323 or t832222 or t8324, wherein the components represented by peak value of hic-chromatography-1 are less than about 3% (wt%); Peak 2 of HIC chromatography is more than 80% by weight; peak 3 of HIC chromatography represents less than 20% by weight. 11. Claim 11: the composition in accordance with claim 2, including: about 50 mg / M ethane;approximately 120 mM sodium chloride; approximately 10 to 30 mM sodium phosphate; about 1% by weight sucrose; about 5 mM arginine, and it has a pH of about 6.3 to 6.5. Claim 16: The composition according to claim 1, which does not contain arginine, or is basically free of arginine, wherein the composition, at M₃ or T₂ or T₄, obtains long-term storage stability that meets one or both of the following criteria: (A) stability comparable to, or better than, etanercept commercially available and marketed under the Enbrel®
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