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    • 1. 发明申请
    • A PHARMACEUTICAL COMPOSITION CONTAINING BUDESONIDE AND FORMOTEROL
    • 含有BUDESONIDE和FORMOTEROL的药物组合物
    • US20160081925A1
    • 2016-03-24
    • US14783533
    • 2014-04-09
    • ZAMBON S.P.A.
    • Giovanni CaponettiLoretta MaggiMarco SardinaFranco CasteginiGianluigi FaiellaDaniela Rebolini
    • A61K9/00A61K31/167A61K9/16A61K31/58
    • A61K9/0075A61K9/1617A61K9/1623A61K31/167A61K31/58A61K2300/00
    • The present invention relates to drug formulations in dry powder form for administration by inhalation and indicated for the treatment of obstructive airway syndromes such as asthma and chronic obstructive pulmonary disease (COPD). In particular, the invention relates to an inhalable pharmaceutical composition comprising a first powder consisting of budesonide, or one of its pharmaceutically allowable salts, in a quantity greater than 5% w/w of said first powder, leucine in a quantity in the range of 5 to 70% w/w of said first powder, and lactose in a quantity in the range of 20 to 90% w/w of said first powder; a second powder consisting of formoterol, or one of its pharmaceutically allowable salts, in a quantity greater than 1% w/w of said second powder, leucine in a quantity in the range of 5 to 70% w/w of said second powder, and lactose in a quantity in the range of 20 to 90% w/w of said second powder; and a third powder consisting of leucine in a quantity in the range of 5 to 70% w/w of said third powder, and lactose in a quantity in the range of 20 to 90% w/w of said third powder. Said composition has a fine particle fraction (FPF) greater than 60% and a delivered fraction (DF) greater than 90%.
    • 本发明涉及用于通过吸入施用并指示用于治疗阻塞性气道综合征如哮喘和慢性阻塞性肺病(COPD)的干粉形式的药物制剂。 特别地,本发明涉及一种可吸入药物组合物,其包含由布地奈德或其药学上允许的盐之一组成的第一种粉末,其量大于所述第一种粉末的5%w / w,亮氨酸的量范围为 5〜70%w / w的所述第一粉末,所述第一粉末的量为20〜90%w / w的乳糖; 由福莫特罗或其药学上允许的盐之一组成的第二粉末,其量大于所述第二粉末的1%w / w,亮氨酸的量为所述第二种粉末的5-70%w / w, 和所述第二粉末的20至90%w / w范围内的量的乳糖; 和由所述第三粉末的5-70%(w / w)范围内的亮氨酸组成的第三粉末和所述第三粉末的量为20-90%w / w的量的乳糖。 所述组合物具有大于60%的细颗粒级分(FPF)和大于90%的传递级分(DF)。
    • 4. 发明授权
    • Pharmaceutical composition containing budesonide and formoterol
    • US10449147B2
    • 2019-10-22
    • US15517672
    • 2015-10-07
    • Zambon S.P.A.
    • Loretta MaggiGiovanni CaponettiMarco SardinaFranco Castegini
    • A61K9/00A61K9/16A61K31/167A61K31/58
    • 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 35 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%.