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2. 发明申请

US20100239676A1 Stable Aerosolizable Suspensions of Proteins in Ethanol 审中-公开
标题翻译：乙醇中蛋白质的稳定可气溶胶悬浮液
公开(公告)号：US20100239676A1
公开(公告)日：2010-09-23
申请号：US12792328
申请日：2010-06-02
申请人： Siu Man L. Cowan
发明人： Siu Man L. Cowan
IPC分类号： A61K9/14 , A61K9/12
CPC分类号： A61K9/0078 , A61K9/0073 , A61K38/28 , A61K47/10 , A61K47/26
摘要： Stable suspensions of a biologically active protein are disclosed that are suited for aerosol delivery to the lungs of a patient in need of treatment, which comprise particles of biologically active protein suspended in ethanol. In a preferred embodiment, the invention describes a stable suspension of insulin useful for aerosol delivery to the lungs of a patient in need of treatment comprising particles of a pharmaceutically effective amount of insulin suspended in ethanol. A method of delivering a therapeutically effective amount of a protein to the respiratory tract of a patient is described which comprises producing an aerosol of a stable liquid suspension of a protein using an electrohydrodynamic spraying means wherein the liquid suspension comprises particles of the protein suspended in ethanol. The stable ethanol suspensions of the invention may optionally contain up to about 20% (V/V) of a pharmaceutically acceptable formulation additive such as glycerol, propylene glycol and polyethylene glycol as well as minor amounts (from about 0.05% to about 5.0% W/V) of a pharmaceutically acceptable excipient.
摘要翻译：公开了一种生物活性蛋白质的稳定悬浮液，其适用于需要治疗的患者的肺部的气溶胶递送，其包含悬浮在乙醇中的生物活性蛋白质的颗粒。在优选的实施方案中，本发明描述了可用于气雾剂递送至需要治疗的患者的肺的胰岛素的稳定悬浮液，其包括悬浮在乙醇中的药学有效量的胰岛素的颗粒。描述了向患者的呼吸道递送治疗有效量的蛋白质的方法，其包括使用电动液体喷雾装置产生蛋白质的稳定液体悬浮液的气溶胶，其中所述液体悬浮液包含悬浮在乙醇中的蛋白质的颗粒。本发明的稳定的乙醇悬浮液可任选地含有高达约20％（V / V）的药学上可接受的制剂添加剂，例如甘油，丙二醇和聚乙二醇以及少量（约0.05％至约5.0％的W / V）药学上可接受的赋形剂。

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