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1.发明授权Composition, vessel, dry powder inhalation system, and related methods for transpulmonary administration 失效成分，血管，干粉吸入系统及相关的肺部给药方法公开(公告)号：US07448379B2
公开(公告)日：2008-11-11
申请号：US10170339
申请日：2002-06-14
CPC分类号： A61K9/0075 , A61K9/0073 , A61K9/19 , A61K47/10 , A61K47/12 , A61K47/183 , A61K47/20 , A61K47/26 , A61K47/40 , A61M11/001 , A61M15/0028 , A61M15/0033 , A61M2202/064 , A61M2205/075
摘要： A non-powder-form freeze-dried composition for transpulmonary administration has a disintegration index greater than or equal to 0.015 and contains at least one active ingredient. The composition becomes fine particles upon receiving air impact at an air speed greater than or equal to 1 meter/second and an air flow rate greater than or equal to 17 milliliters/second. The fine particles have a mean particle diameter less than or equal to 1×10−5 meters and/or a fine particle fraction greater than or equal to 10%. A method of making the composition, a vessel containing the composition, a method of administering the composition, a dry powder inhalation system for transpulmonary administration, and a method of transpulmonary administration are also disclosed.
摘要翻译： 用于经肺给药的非粉末状冻干组合物具有大于或等于0.015的崩解指数，并且含有至少一种活性成分。 以大于或等于1米/秒的空气速度接收空气冲击并且空气流速大于或等于17毫升/秒时，组合物变成细颗粒。 细颗粒具有小于或等于1×10 -5米的平均粒径和/或大于或等于10％的细颗粒分数。 还公开了制备组合物的方法，含有该组合物的容器，施用组合物的方法，用于经肺给药的干粉吸入系统和经肺给药的方法。
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公开(公告)号：US08333193B2
公开(公告)日：2012-12-18
申请号：US12202221
申请日：2008-08-30
CPC分类号： A61K9/0075 , A61K9/0073 , A61K9/19 , A61K47/10 , A61K47/12 , A61K47/183 , A61K47/20 , A61K47/26 , A61K47/40 , A61M11/001 , A61M15/0028 , A61M15/0033 , A61M2202/064 , A61M2205/075
摘要： The present invention provides a novel dry powder inhalation system suitable for transpulmonary administration. The dry powder inhalation system of the invention characterized by using a combination of: (1) a vessel housing a freeze-dried composition that contains a single dose of an active ingredient, and has: (i) a non-powder cake-like form, (ii) a disintegration index of 0.015 or more, and (iii) a property of becoming fine particles having a mean particle diameter of 10 microns or less or a fine particle fraction of 10% or more upon receipt of an air impact having an air speed of at least 1 m/sec and an air flow rate of at least 17 ml/sec; and (2) a device comprising means capable of applying said air impact to the freeze-dried composition in said vessel, and means for discharging the powder-form freeze-dried composition that has been made into fine particles.
摘要翻译： 本发明提供一种适用于经肺给药的新型干粉吸入系统。 本发明的干粉吸入系统的特征在于使用以下组合的组合：（1）容纳含有单剂量活性成分的冷冻干燥组合物的容器，并具有：（i）非粉饼样形式 ，（ii）0.015以上的崩解指数，（iii）在接收到具有空气冲击的空气冲击时，成为平均粒径为10微米以下的细颗粒或微细粒子分数为10％以上的性质 空气速度至少为1米/秒，空气流速为至少17毫升/秒; 和（2）包括能够将所述空气冲击施加到所述容器中的冷冻干燥组合物的装置的装置，以及用于将已制成微粒的粉末状冻干组合物排出的装置。
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公开(公告)号：US20060073105A1
公开(公告)日：2006-04-06
申请号：US10538837
申请日：2003-12-12
CPC分类号： A61K9/0075 , A61K9/0073 , A61K9/19 , A61K47/10 , A61K47/12 , A61K47/183 , A61K47/20 , A61K47/26 , A61K47/40 , A61M11/001 , A61M15/0028 , A61M15/0033 , A61M2202/064 , A61M2205/075
摘要： The present invention provides a novel dry powder inhalation system suitable for transpulmonary administration. The dry powder inhalation system of the present invention characterized by using a combination of: (1) a vessel housing a freeze-dried composition prepared by freeze-drying a composition liquid containing ingredients in a non-dissolved form, and has: (i) a non-powder cake-like form, (ii) a disintegration index of 0.05 or more, and (iii) a property of becoming fine particles having a mean particle diameter (mass median aerodynamic diameter) of 10 microns or less or a fine particle fraction of 10% or more upon receipt of an air impact having an air speed of at least 1 m/sec and an air flow rate of at least 17 ml/sec; and (2) a device comprising a member capable of applying said air impact to the freeze-dried composition in said vessel, and a member for discharging the powder-form freeze-dried composition that has been made into fine particles.
摘要翻译： 本发明提供一种适用于经肺给药的新型干粉吸入系统。 本发明的干粉吸入系统的特征在于使用以下组合的组合：（1）容纳通过冷冻干燥含有未溶解形式的成分的组合物液体而制备的冷冻干燥组合物的容器，并具有：（i） 非粉饼形状，（ii）崩解指数为0.05以上，（iii）成为平均粒径（质量中值空气动力学直径）为10微米以下的细颗粒或微粒子的性质 在接收到空气速度至少为1m /秒和空气流速为至少17ml / sec的空气冲击时，分数为10％或更多; 和（2）一种装置，其特征在于，包括能够将所述空气冲击施加到所述容器中的所述冷冻干燥组合物的构件，以及用于将已形成微粒的粉末状冻干组合物排出的构件。
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4.发明授权公开(公告)号：US08216588B2
公开(公告)日：2012-07-10
申请号：US12529893
申请日：2008-03-07
申请人： Chikamasa Yamashita
发明人： Chikamasa Yamashita
IPC分类号： A61K39/145 , A01N25/02
CPC分类号： A61K39/145 , A61K9/0019 , A61K9/19 , A61K39/12 , A61K47/183 , C12N7/00 , C12N2760/16034 , C12N2760/16051
摘要： The present invention aims to provide a freeze-dried preparation in which the influenza vaccine exhibits improved stability.A freeze-dried preparation in which the influenza vaccine exhibits significantly improved stability can be obtained by freeze-drying an aqueous solution that meets the following conditions (A) to (C): (A) (i) an influenza vaccine, (ii) a hydrophobic amino acid, and (iii) arginine and an acid addition salt thereof are incorporated; (B) the proportion of the component (iii) is from 20 to 85% by weight relative to the total amount of the resulting freeze-dried preparation; and (c) the pH is adjusted to be from 8 to 10 by controlling the proportion of arginine and an acid addition salt thereof that form the component (iii).
摘要翻译： 本发明的目的在于提供一种冻干制剂，其中流感疫苗表现出改进的稳定性。 通过冷冻干燥满足以下条件（A）至（C）的水溶液可以获得流感疫苗显示出显着改善的稳定性的冷冻干燥制剂：（A）（i）流感疫苗，（ii） 疏水性氨基酸，（iii）精氨酸及其酸加成盐; （B）成分（iii）的比例相对于所得冷冻干燥制剂的总量为20〜85重量％ 和（c）通过控制形成组分（iii）的精氨酸及其酸加成盐的比例将pH调节至8至10。
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公开(公告)号：US07735485B2
公开(公告)日：2010-06-15
申请号：US10538837
申请日：2003-12-12
CPC分类号： A61K9/0075 , A61K9/0073 , A61K9/19 , A61K47/10 , A61K47/12 , A61K47/183 , A61K47/20 , A61K47/26 , A61K47/40 , A61M11/001 , A61M15/0028 , A61M15/0033 , A61M2202/064 , A61M2205/075
摘要： A dry powder inhalation system suitable for transpulmonary administration. The dry powder inhalation system is characterized by using a combination of: (1) a vessel housing a freeze-dried composition prepared by freeze-drying a composition liquid containing ingredients in a non-dissolved form, and has: (i) a non-powder cake-like form, (ii) a disintegration index of 0.05 or more, and (iii) a property of becoming fine particles having a mean particle diameter (mass median aerodynamic diameter) of 10 microns or less or a fine particle fraction of 10% or more upon receipt of an air impact having an air speed of at least 1 m/sec and an air flow rate of at least 17 ml/sec; and (2) a device comprising a member capable of applying the air impact to the freeze-dried composition in said vessel, and a member for discharging the powder-form freeze-dried composition that has been made into fine particles.
摘要翻译： 适用于经肺给药的干粉吸入系统。 干粉吸入系统的特征在于使用以下组合：（1）容纳通过冷冻干燥含有非溶解形式的成分的组合物液体而制备的冷冻干燥组合物的容器，并具有：（i） 粉饼样形式，（ii）0.05以上的崩解指数，（iii）成为平均粒径（质量中值空气动力学直径）为10微米以下或微细粒子分数为10的微粒的性质 接收空气速度至少为1m / sec，空气流速为至少17ml / sec的空气冲击时的％或更多; 和（2）一种装置，其特征在于，包括能够对所述容器内的冷冻干燥组合物施加空气冲击的部件，以及将已形成微粒的粉末状冻干组合物排出的部件。
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公开(公告)号：US20090095293A1
公开(公告)日：2009-04-16
申请号：US12202221
申请日：2008-10-10
CPC分类号： A61K9/0075 , A61K9/0073 , A61K9/19 , A61K47/10 , A61K47/12 , A61K47/183 , A61K47/20 , A61K47/26 , A61K47/40 , A61M11/001 , A61M11/02 , A61M15/0028 , A61M15/0036 , A61M15/004 , A61M2202/064 , A61M2205/071 , A61M2205/075
摘要： The present invention provides a novel dry powder inhalation system suitable for transpulmonary administration. The dry powder inhalation system of the invention characterized by using a combination of: (1) a vessel housing a freeze-dried composition that contains a single dose of an active ingredient, and has: (i) a non-powder cake-like form, (ii) a disintegration index of 0.015 or more, and (iii) a property of becoming fine particles having a mean particle diameter of 10 microns or less or a fine particle fraction of 10% or more upon receipt of an air impact having an air speed of at least 1 m/sec and an air flow rate of at least 17 ml/sec; and (2) a device comprising means capable of applying said air impact to the freeze-dried composition in said vessel, and means for discharging the powder-form freeze-dried composition that has been made into fine particles.
摘要翻译： 本发明提供一种适用于经肺给药的新型干粉吸入系统。 本发明的干粉吸入系统的特征在于使用以下组合的组合：（1）容纳含有单剂量活性成分的冷冻干燥组合物的容器，并具有：（i）非粉饼样形式 ，（ii）0.015以上的崩解指数，（iii）在接收到具有空气冲击的空气冲击时，成为平均粒径为10微米以下的细颗粒或微细粒子分数为10％以上的性质 空气速度至少为1米/秒，空气流速为至少17毫升/秒; 和（2）包括能够将所述空气冲击施加到所述容器中的冷冻干燥组合物的装置的装置，以及用于将已制成微粒的粉末状冻干组合物排出的装置。
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公开(公告)号：US20070065371A2
公开(公告)日：2007-03-22
申请号：US10538837
申请日：2005-06-13
CPC分类号： A61K9/0075 , A61K9/0073 , A61K9/19 , A61K47/10 , A61K47/12 , A61K47/183 , A61K47/20 , A61K47/26 , A61K47/40 , A61M11/001 , A61M11/02 , A61M15/0028 , A61M15/0036 , A61M15/004 , A61M2202/064 , A61M2205/071 , A61M2205/075
摘要： The present invention provides a novel dry powder inhalation system suitable for transpulmonary administration. The dry powder inhalation system of the present invention characterized by using a combination of: (1) a vessel housing a freeze-dried composition prepared by freeze-drying a composition liquid containing ingredients in a non-dissolved form, and has: (i) a non-powder cake-like form, (ii) a disintegration index of 0.05 or more, and (iii) a property of becoming fine particles having a mean particle diameter (mass median aerodynamic diameter) of 10 microns or less or a fine particle fraction of 10% or more upon receipt of an air impact having an air speed of at least 1 m/sec and an air flow rate of at least 17 ml/sec; and (2) a device comprising a member capable of applying said air impact to the freeze-dried composition in said vessel, and a member for discharging the powder-form freeze-dried composition that has been made into fine particles.
摘要翻译： 本发明提供一种适用于经肺给药的新型干粉吸入系统。 本发明的干粉吸入系统的特征在于使用以下组合的组合：（1）容纳通过冷冻干燥含有未溶解形式的成分的组合物液体而制备的冷冻干燥组合物的容器，并具有：（i） 非粉饼形状，（ii）崩解指数为0.05以上，（iii）成为平均粒径（质量中值空气动力学直径）为10微米以下的细颗粒或微粒子的性质 在接收到空气速度至少为1m /秒和空气流速为至少17ml / sec的空气冲击时，分数为10％或更多; 和（2）一种装置，其特征在于，包括能够将所述空气冲击施加到所述容器中的所述冷冻干燥组合物的构件，以及用于将已形成微粒的粉末状冻干组合物排出的构件。
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公开(公告)号：US06479048B2
公开(公告)日：2002-11-12
申请号：US09902573
申请日：2001-07-12
申请人： Chikamasa Yamashita , Masaaki Odomi
发明人： Chikamasa Yamashita , Masaaki Odomi
IPC分类号： A61K4500
CPC分类号： A61K9/19 , A61K9/0019 , A61K47/183
摘要： Provisions of a foam inhibitor which effectively inhibits foaming (bubbling) caused at the time of dissolving dry compositions and of a water-soluble dry composition which comprises the foam inhibitor. The form inhibitor is suitable for inhibiting foaming caused at the time of dissolving dry compositions comprising saccharide which contain a hydrophobic amino acid as essential ingredient; and the water-soluble dry composition contains pharmacologically active proteinaceous substance, saccharide and hydrophobic amino acid having the hydropathy index of about not less than 2, wherein the concentration of the hydrophobic amino acid is in the range of 0.05 wt. % to less than 40 wt. % based on the total amount of the dry composition.
摘要翻译： 泡沫抑制剂的设计，其有效地抑制了干燥组合物溶解时引起的起泡（起泡）和包含泡沫抑制剂的水溶性干组合物。 形式抑制剂适用于在含有疏水性氨基酸作为必需成分的含有糖类的干燥组合物溶解时引起的发泡抑制; 所述水溶性干燥组合物含有药理活性蛋白质物质，亲水性指数为2以上的糖类和疏水性氨基酸，其中所述疏水性氨基酸的浓度为0.05重量％。 ％至小于40wt。 基于干组合物的总量的％。
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公开(公告)号：US4784855A
公开(公告)日：1988-11-15
申请号：US61973
申请日：1987-06-15
IPC分类号： A61K9/02 , A61K31/485 , A61K47/34 , A61F9/02
CPC分类号： A61K9/02 , A61K31/485 , Y10S424/15
摘要： A pharmaceutical composition for suppository which comprises buprenorphine or its pharmaceutically acceptable acid addition salt as the active ingredient and a mixed base composed of 70 to 95 wt. % of polyethylene glycol with average molecular weight of 200 to 20,000 and 30 to 5 wt. % of propylene glycol.
摘要翻译： 一种用于栓剂的药物组合物，其包含丁丙诺啡或其药学上可接受的酸加成盐作为活性成分，和由70〜95重量％ ％的平均分子量为200〜20,000的聚乙二醇和30〜5重量％ ％的丙二醇。
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公开(公告)号：US08443799B2
公开(公告)日：2013-05-21
申请号：US12202220
申请日：2008-08-30
IPC分类号： A61M15/00
CPC分类号： A61K9/0075 , A61K9/0073 , A61K9/19 , A61K47/10 , A61K47/12 , A61K47/183 , A61K47/20 , A61K47/26 , A61K47/40 , A61M11/001 , A61M15/0028 , A61M15/0033 , A61M2202/064 , A61M2205/075
摘要： A dry powder inhalation system suitable for transpulmonary administration characterized by using a combination of: (1) A vessel housing a freeze-dried composition that contains a single dose of an active ingredient, and has: (i) a non-powder cake-like form, (ii) a disintegration index of 0.015 or more, and (iii) a property of becoming fine particles having a mean particle diameter of 10 microns or less or a fine particle fraction of 10% or more upon receipt of an air impact having an air speed of at least 1 m/sec and an air flow rate of at least 17 ml/sec; and (2) A device capable of applying said air impact to the freeze-dried composition in said vessel and for discharging the powder-form freeze-dried composition that has been made into fine particles.
摘要翻译： 适用于经肺给药的干粉吸入系统，其特征在于使用以下组合的组合：（1）容纳含有单剂量活性成分的冷冻干燥组合物的容器，并具有：（i）非粉饼状 形式，（ii）0.015以上的崩解指数，以及（iii）当接收到具有空气冲击的平均粒径为10微米或更小的细颗粒或10％或更多的细颗粒分数时， 至少1m / sec的空气速度和至少17ml / sec的空气流速; 和（2）一种能够将所述空气冲击施加到所述容器中的冷冻干燥组合物并将已经制成细颗粒的粉末状冻干组合物排出的装置。
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