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Stabilized formulations of etanercept with amino acids
专利权人:
COHERUS BIOSCIENCES; INC.
发明人:
申请号:
ARP120103884
公开号:
AR088460A1
申请日:
2012.10.18
申请国别(地区):
AR
年份:
2014
代理人:
摘要:
The hydrate of amphetamine type stimulants, which is stable with amino acids and suitable for long-term storage, the method of manufacturing these components, the method of management and the kit containing these components. Claim 1: an aqueous pharmaceutical component consisting of ethane and a stabilizer to inhibit the instability, polymerization, misfolding and / or cleavage of ethane. The stabilizer is composed of one or more amino acids selected from the SERINA group,Prolina and glutamate. 13. Claim 3: the component of acetylpropane which has been stabilized according to claim 2, wherein the stabilizer is glutamic acid, a. The formulation is free or basically free to use alcinia, with at least one long-term storage characteristic: sec-m8323 or t832222 or t8324de analysis with monomer content more than 90%;p. The total content is less than 3%;e. The content of P. Y fragment 3 is less than 5%, and hic-m83232o t832222 or t83244a is analyzed. The composition represented by peak 1 of HIC chromatography is less than 3% in P;a. The peak 2 of HIC chromatography represented more than 80% of the components in P;However, the number of components represented by the third peak of HIC is less than 20% in P Claim 12: the component of ethane stabilized according to the second requirement, in which the stabilizer is SERINA, the formula can be free or basically free of argon, and the formula can generate long-term storage stability according to at least one of the following characteristics: sec-m8323 or t832222; O t8324de: monomer content over 90%;p. The total content is less than 3%;And the content of fragment 3 in P. is less than 5%;e. In the analysis from HIC to m83223 or t832222 or t83244, the peak value 1 of HIC represents less than 3% of the components in P;a. The peak 2 of HIC chromatography represented more than 80% of the components in P;However, the number of components represented by the third peak of HIC is less than 20% in PComposiciones farmacéuticas acuosas de e
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