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    • 6. 发明公开
    • PHARMACEUTICAL COMPOSITION CONTAINING BUDESONIDE AND FORMOTEROL.
    • 含有BUDESONIDE和FORMOTEROL的药物组合物。
    • EP3203984A1
    • 2017-08-16
    • EP15784294.9
    • 2015-10-07
    • Zambon S.p.A.
    • MAGGI, LorettaCAPONETTI, GiovanniSARDINA, MarcoCASTEGINI, Franco
    • A61K9/00A61K9/16A61K31/167A61K31/58
    • A61K9/0075A61K9/1617A61K9/1623A61K31/167A61K31/58A61K2300/00
    • The present invention relates to inhalation formulations of drugs in the form of dry powder for inhalation administration, suitable for the treatment of obstructive diseases of the airways, such as asthma and chronic obstructive pulmonary disease (COPD). In particular, the invention relates to a pharmaceutical composition for inhalation comprising a first powder comprising budesonide or a pharmaceutically acceptable salt thereof, in an amount greater than 5% by weight of said first powder, leucine in an amount from 5 to 70% by weight of said first powder, lactose in an amount from 20 to 90% by weight of said first powder; a second powder comprising formoterol or a pharmaceutically acceptable salt thereof, in an amount greater than 1% by weight of said second powder, leucine in an amount from 5 to 70% by weight of said second powder, lactose in an amount from 20 to 90% by weight of said second powder and a third powder comprising a mixture of a first lactose which has an X50 from 3 to 75 µm, with a second lactose which has an X50 from 1.5 to 10 µm, the content of said first and second lactose in said mixture being respectively from 85% to 96% and from 4% to 15%. Said composition has a fine particle fraction (FPF) greater than 60% and a delivered fraction (DF) greater than 80%.
    • 本发明涉及用于吸入给药的干粉形式的药物吸入制剂,其适用于治疗气道阻塞性疾病,如哮喘和慢性阻塞性肺病(COPD)。 特别地,本发明涉及用于吸入的药物组合物,其包含第一粉末和第二粉末,所述第一粉末包含量大于所述第一粉末的5重量%的布地奈德或其药学上可接受的盐,其量为5至70重量%的亮氨酸 所述第一粉末的量为所述第一粉末的20-90重量%的乳糖; 包含福莫特罗或其药学上可接受的盐的第二粉末,其量大于所述第二粉末的1重量%,亮氨酸的量为所述第二粉末的5至70重量%,乳糖的量为20至90 重量%的所述第二粉末和第三粉末,所述第三粉末包含具有3至75μm的X50的第一乳糖与具有1.5至10μm的X50的第二乳糖的混合物,所述第一和第二乳糖 在所述混合物中分别为85%至96%和4%至15%。 所述组合物具有大于60%的细颗粒部分(FPF)和大于80%的递送部分(DF)。