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Stable aqueous formulations of adalimumab
专利权人:
INC.;COHERUS BIOSCIENCES
发明人:
MARK MANNING,ROBERT W. PAYNE
申请号:
ARP130103178
公开号:
AR092470A1
申请日:
2013.09.06
申请国别(地区):
AR
年份:
2015
代理人:
摘要:
Aqueous Pharmaceutical compositions of adalimumab suitable for long-term storage of adalimumab, Methods of making these compositions, and Methods of Administration sets of elements that contain them.Claim 2: the composition of claim 1, comprising at least one selected from the group consisting of buffer solution in buffer Solutions of histidine succinate, phosphate, Citrate, acetate, maleate and tartrate, including combinations of L Themselves,Provided that no such combinations include a combination of a buffer solution of citrate and phosphate buffer.Claim 8: the composition of claim 1, further comprises a Stabilizer selected from the group consisting of Glycine, alanine, glutamate, arginine, methionine, EDTA, Sodium Chloride, SODIUM SULFATE, metal ions and combinations thereof.Claim 12: the composition of claim 1, further comprises a polyol selected from the group consisting of mannitol, sorbitol and Trehalose. Claim 13: the composition of claim 1, further comprises a Surfactant Polysorbate and Poloxamer.Claim 90: a method to improve the long-term stability in a pH buffered aqueous formulation, adalimumab, comprising one or more of the steps of: (a) to incorporate a histidine Buffer Solution, buffer solution, or a combination of the succinate Same,In the formulation based on Empirical Data that indicate that these buffer Solutions contribute to the stability of the formulation to a greater degree than other buffer solutions or combinations of buffer Solutions; or (b) incorporate Glycine, arginine, or a combination The same as stabilizers in the formulation,Based on Empirical Data that indicate that the Stabilizer helps to the stability of the formulation in a higher degree than other stabilizers; or (c) exclude the presence of a buffer solution or combinations of buffer Solutions comprising a so Citrate Buffer Solution.Based on Empirical Data that indicate that these combinations of buffer or buffer Solutions Exhibit poor performance in terms of Stabilization of t
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