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    PROTEIN FORMULATIONS
    6.
    发明授权
    PROTEIN FORMULATIONS 有权
    蛋白质配方

    公开(公告)号：EP2538974B1

    公开(公告)日：2018-04-18

    申请号：EP11705985.7

    申请日：2011-02-24

    申请人： Arecor Limited

    发明人： JEZEK, Jan ,  DERHAM, Barry Kingston

    IPC分类号： A61K39/395 ,  A61K47/12 ,  A61K9/00

    CPC分类号： A61K47/12 ,  A61K9/0019

    摘要： The invention relates to the discovery that the addition of aromatic carboxylate ions inhibit protein instability caused by aromatic preservatives. Thus, the invention relates to compositions, (preferably aqueous compositions, comprising a protein, an aromatic preservative and aromatic carboxylate ions. The proteins remain stable and suitable for storage at ambient temperatures or lower, even in aqueous form. Preferably, the aqueous composition comprises a protein, a phenolic preservative and benzoate ions, wherein the pH of the composition is at least 1 unit greater than the pKa of benzoic acid. The invention also provides methods of reducing protein degradation by aromatic preservatives in an aqueous formulation of a protein susceptible to such degradation, comprising the step of adding aromatic carboxylate ions to the formulation wherein the formulation is maintained at a pH that is at least 1 unit greater than the pKa of the corresponding aromatic carboxylic acid.

    STABLE AQUEOUS SYSTEMS COMPRISING PROTEINS
    9.
    发明公开
    STABLE AQUEOUS SYSTEMS COMPRISING PROTEINS 无效
    与蛋白质稳定的水系统

    公开(公告)号：EP1899462A1

    公开(公告)日：2008-03-19

    申请号：EP06764894.9

    申请日：2006-07-03

    申请人： Arecor Limited

    发明人： JEZEK, Jan

    IPC分类号： C12N9/96 ,  A61K39/39

    CPC分类号： C12N9/96 ,  A61K47/10 ,  A61K47/183 ,  A61K47/26 ,  Y02A50/412 ,  Y02A50/466

    摘要： An aqueous system comprising a protein and two or more stabilising agents, characterised in that (i) the two or more stabilising agents have ionisable groups capable of exchanging protons with the protein and with the ionised products of water dissociation; (ii) wherein a first stabilising agent has first ionisable groups that are positively charged when protonated and uncharged when deprotonated, and a second stabilising agent has second ionisable groups that are uncharged when protonated and negatively charged when deprotonated, wherein the first and second ionisable groups have pKa values respectively 1 to 5 units higher and 1 to 5 units lower than the pH of the composition, and wherein the first stabilising agent is an amine other than an amino acid; and (iii) the pH of the composition is within a range of protein stability that is at least 50% of the maximum stability of the protein with respect to pH.