公开(公告)号：EP3166595B1

公开(公告)日：2019-05-15

申请号：EP15747618.5

申请日：2015-07-08

申请人： Amphastar Pharmaceuticals, Inc.

发明人： DING, Jeffrey ,  BO, Aili ,  LUO, Mary, Ziping ,  ZHANG, Jack, Yongfeng

IPC分类号： A61K9/14 ,  A61K38/28

公开(公告)号：EP3399961A1

公开(公告)日：2018-11-14

申请号：EP16711707.6

申请日：2016-01-08

申请人： Amphastar Pharmaceuticals, Inc.

发明人： DING, Jeffrey ,  BO, Aili ,  LUO, Mary, Ziping ,  ZHANG, Jack, Yongfeng

IPC分类号： A61K9/00 ,  A61K38/28 ,  C07K14/62 ,  A61K9/14

CPC分类号： A61K38/28 ,  A61K9/0073 ,  A61K9/008 ,  A61K9/143 ,  C07K14/62

摘要： A high-purity inhalable insulin material, used for preparing a pulmonary pharmaceutical product, includes insulin particles having a particle size at the micrometer level and having the following characteristics: (i) the purity of insulin is not less than 96% on the dried basis; (ii) the total amount of insulin-related impurities is not more than 2%; (iii) the total amount of solvent impurities, which is not a co-solvent formulation component for a pulmonary product, is not more than 0.03%; and (iv) the total amount of non-solvent impurities is not more than 0.3%. Up to 99% by volume of the insulin particles in the inhalable insulin have a particle size of less than 5 μm, based on the total volume of the insulin particles. A high-efficiency method prepares high-purity inhalable insulin material. The yield rate for the high-efficiency method is 75 to 85% or more.

公开(公告)号：EP4146246A1

公开(公告)日：2023-03-15

申请号：EP21799494.6

申请日：2021-05-03

申请人： Amphastar Pharmaceuticals, Inc.

发明人： ZHANG, Jack, Yongfeng ,  LUO, Mary, Zi-ping ,  DING, Jie, Fei ,  BO, Aili

IPC分类号： A61K38/18 ,  C07K14/50 ,  G01N33/50

公开(公告)号：EP4146184A1

公开(公告)日：2023-03-15

申请号：EP21800119.6

申请日：2021-05-03

申请人： Amphastar Pharmaceuticals, Inc.

发明人： ZHANG, Jack, Yongfeng ,  LUO, Mary, Zi-ping ,  DING, Jie Fei ,  BO, Aili

IPC分类号： A61K31/137 ,  A61K47/40 ,  A61K9/00

公开(公告)号：EP3856141A1

公开(公告)日：2021-08-04

申请号：EP19794748.4

申请日：2019-09-25

申请人： Amphastar Pharmaceuticals, Inc.

发明人： DING, Jie Fei ,  BO, Aili ,  ZHANG, Jack Yongfeng ,  LUO, Mary Zi-ping ,  BAO, Zhongli

IPC分类号： A61K9/00 ,  A61K9/127 ,  A61K9/51 ,  A61K38/00 ,  A61K9/08 ,  A61K38/28

公开(公告)号：EP3166595A1

公开(公告)日：2017-05-17

申请号：EP15747618.5

申请日：2015-07-08

申请人： Amphastar Pharmaceuticals, Inc.

发明人： DING, Jeffrey ,  BO, Aili ,  LUO, Mary, Ziping ,  ZHANG, Jack, Yongfeng

IPC分类号： A61K9/14 ,  A61K38/28

CPC分类号： A61K9/1688 ,  A61K9/0075 ,  A61K9/008 ,  A61K9/14 ,  A61K9/1617 ,  A61K38/28

摘要： A method of preparing an inhalable insulin suitable for pulmonary delivery includes: dissolving an insulin raw material in an acidic solution to form a dissolved insulin solution; titrating the dissolved insulin solution with a buffer solution to form a suspension comprising micronized insulin particles; and stabilizing the micronized insulin particles.

摘要翻译： 制备适于肺部输送的可吸入胰岛素的方法包括：将胰岛素原料溶解在酸性溶液中以形成溶解的胰岛素溶液; 用缓冲溶液滴定溶解的胰岛素溶液以形成包含微粉化胰岛素颗粒的悬浮液; 并稳定微粉化的胰岛素颗粒。