公开(公告)号：EP2780327A1

公开(公告)日：2014-09-24

申请号：EP12839184.4

申请日：2012-11-12

申请人： Cadila Healthcare Limited

发明人： DWIVEDI, Shriprakash Dhar ,  PRASAD, Ashok ,  SHARMA, Mukul Hariprasad ,  SHARMA, Piyush Rajendra ,  PARIHAR, Jaiprakash Ajitsingh

IPC分类号： C07D223/16 ,  A61K31/55 ,  A61P9/06

CPC分类号： C07D223/16 ,  B65B7/02 ,  B65B31/00 ,  B65B61/20 ,  B65D31/02 ,  B65D31/04 ,  B65D81/266 ,  C07B2200/13 ,  C30B7/02 ,  C30B29/54 ,  Y10T428/2982

摘要： A storage stable crystalline Form II of ivabradine hydrochloride having characteristic X-ray powder diffraction peaks at about 15.50°, 18.02°, 19.00°, 19.80°, 22.42°, 24.16°, and 25.46°±0.2° (2¸); comprising a packaging which includes placing crystalline ivabradine hydrochloride in a non-permeable bag; placing the non-permeable bag in polyethylene bag, optionally containing oxygen busters and sealing it; placing the polyethylene bag in a triple laminated bag, optionally containing oxygen busters and sealing it; placing the triple laminated bag inside a high density polyethylene (HDPE) container and sealing it.

摘要翻译： 公开了伊伐布雷定盐酸盐的稳定结晶形式II和稳定结晶形式III及其制备方法。

公开(公告)号：EP3156399A1

公开(公告)日：2017-04-19

申请号：EP16184235.6

申请日：2012-11-12

申请人： Cadila Healthcare Limited

发明人： DWIVEDI, Shriprakash Dhar ,  PRASAD, Ashok ,  SHARMA, Mukul Hariprasad ,  SHARMA, Piyush Rajendra ,  PARIHAR, Jaiprakash Ajitsingh

IPC分类号： C07D223/16 ,  A61K31/55 ,  A61P9/06 ,  B65B31/00

CPC分类号： C07D223/16 ,  B65B7/02 ,  B65B31/00 ,  B65B61/20 ,  B65D31/02 ,  B65D31/04 ,  B65D81/266 ,  C07B2200/13 ,  C30B7/02 ,  C30B29/54 ,  Y10T428/2982

摘要： A storage stable crystalline Form II of ivabradine hydrochloride having characteristic X-ray powder diffraction peaks at about 15.50°, 18.02°, 19.00°, 19.80°, 22.42°, 24.16°, and 25.46°±0.2° (2θ); comprising a packaging which includes placing crystalline ivabradine hydrochloride in a non-permeable bag; placing the non-permeable bag in polyethylene bag, optionally containing oxygen busters and sealing it; placing the polyethylene bag in a triple laminated bag, optionally containing oxygen busters and sealing it; placing the triple laminated bag inside a high density polyethylene (HDPE) container and sealing it.

摘要翻译： 在约15.50°，18.02°，19.00°，19.80°，22.42°，24.16°和25.46°±0.2°（2θ）处具有特征X射线粉末衍射峰的储存稳定的伊伐布雷定盐酸盐的晶型II; 包括一种包装，该包装包括将结晶伊伐布雷定盐酸盐放入不可渗透袋中; 将不可渗透的袋放入聚乙烯袋中，可选地包含氧气栓并将其密封; 将聚乙烯袋放入三层层压袋中，任选地包含氧气阻隔器并将其密封; 将三层层压袋放入高密度聚乙烯（HDPE）容器内并密封。