- 专利标题: CARBETOCIN DRUG PRODUCT AND PROCESS FOR PREPARING THE SAME
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申请号: US16576961申请日: 2019-09-20
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公开(公告)号: US20200093885A1公开(公告)日: 2020-03-26
- 发明人: Christopher BRYANT , Mark C. Manning , Ryan E. Holcomb
- 申请人: Christopher BRYANT , Mark C. Manning , Ryan E. Holcomb
- 主分类号: A61K38/095
- IPC分类号: A61K38/095 ; A61K47/38 ; A61K9/08 ; A61K47/22 ; A61K47/26
摘要:
The present disclosure includes a method of making an improved carbetocin drug product. The disclosed method for making an improved carbetocin drug product comprises agitating a carbetocin preparation containing an aqueous solution of carbetocin and one or more excipients for a period of time to initiate the formation of aggregate-forming solids and filtering off the aggregates that form before further processing the remaining carbetocin into a final drug product. The present disclosure also relates to an improved carbetocin drug product, wherein the drug product is substantially free of aggregate-forming solids. The disclosed carbetocin drug product can be used for the treatment of a neurodevelopmental disorder, such as Präder-Willi syndrome. Additionally, the disclosed carbetocin drug product shows content uniformity of carbetocin over long periods of time before and after one or more freeze/thaw cycles, provides enhanced convenience and patient compliance, and/or are highly concentrated.
公开/授权文献
- US11207373B2 Agitation process for preparing a carbetocin drug product 公开/授权日:2021-12-28
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