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    • 5. 发明授权
    • Stabilized interferon liquid formulations
    • 稳定的干扰素液体制剂
    • US07846427B2
    • 2010-12-07
    • US10582027
    • 2004-12-10
    • Maria Dorly Del Curto
    • Maria Dorly Del Curto
    • A61K38/21A61K38/00C07K14/565
    • A61K38/215A61K47/183A61K47/26A61K47/40
    • Stabilized liquid pharmaceutical composition comprising an interferon (IFN) or an isoform, mutein, fused protein, functional derivative, active fraction or salt thereof, wherein said formulation is a solution that comprises a buffer, a cyclodextrin, an isotonicity agent and an anti-oxidant are described here. Preferably the interferon is interferon beta-1a and the cyclodextrin is HPBCD. These formulations are stable at room temperature, thus bringing the advantage of lower costs for formulation storage and increased safety for the patient with respect to possible “errors” during handling. As a matter of fact, having such formulations stable at room temperature reduces the risk of formation of degradation products potentially responsible for adverse events (e.g. immunogenicity).
    • 包含干扰素(IFN)或同工型,突变蛋白,融合蛋白,功能衍生物,活性成分或其盐的稳定液体药物组合物,其中所述制剂是包含缓冲液,环糊精,等渗剂和抗氧化剂 在这里描述。 干扰素优选为干扰素β-1a,环糊精为HPBCD。 这些制剂在室温下是稳定的,因此带来了降低制剂储存成本和增加患者对于处理过程中可能“错误”的安全性的优点。 事实上,使这种制剂在室温下稳定降低了潜在地对不利事件(例如免疫原性)负责的降解产物的形成风险。