发明公开
- 专利标题: STABLE INFUSION DOSAGE FORM OF MORPHINE
- 专利标题(中): 吗啡的稳定输注剂量形式
-
申请号: EP17189128.6申请日: 2017-09-01
-
公开(公告)号: EP3290025A1公开(公告)日: 2018-03-07
- 发明人: KUMAR, Samarth , KANE, Prashant , BHOWMICK, Subhas Balaram , THAKKAR, Milan Natvarbhai , DAVE, Kandarp Maheshkumar
- 申请人: Sun Pharmaceutical Industries Ltd
- 申请人地址: Sun House, Plot N°. 201 B/1 Western Express Highway Goregoan (E) 400063 Mumbai, Maharashtra IN
- 专利权人: Sun Pharmaceutical Industries Ltd
- 当前专利权人: Sun Pharmaceutical Industries Ltd
- 当前专利权人地址: Sun House, Plot N°. 201 B/1 Western Express Highway Goregoan (E) 400063 Mumbai, Maharashtra IN
- 代理机构: Harrison IP Limited
- 优先权: IN201621030175 20160902
- 主分类号: A61K9/00
- IPC分类号: A61K9/00 ; A61K31/485
摘要:
The present invention relates to an infusion dosage form comprising (i) an aqueous solution of morphine or its pharmaceutically acceptable salt as a sole active ingredient in a concentration ranging from about 0.1 mg/ml to about 10.0 mg/ml, filled in containers in volumes ranging from about 50 ml to about 250 ml, and having dissolved oxygen content of less than 2 ppm, (ii) the container being surrounded by an outer covering, and (iii) an inert gas or vacuum is present in the space between the container and outer covering, wherein the infusion dosage form is sterilized by autoclaving and is stable upon autoclaving, and further wherein the space between the container and outer covering does not have an oxygen scavenger pouch before or during autoclaving.
公开/授权文献
- EP3290025B1 STABLE INFUSION DOSAGE FORM OF MORPHINE 公开/授权日:2020-02-12
信息查询