- 专利标题: Orodispersible dosage unit containing an estetrol component
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申请号: US18196617申请日: 2023-05-12
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公开(公告)号: US11793760B2公开(公告)日: 2023-10-24
- 发明人: Séverine Francine Isabelle Jaspart , Johannes Jan Platteeuw , Denny Johan Marijn Van Den Heuvel
- 申请人: ESTETRA SRL
- 申请人地址: BE Liège
- 专利权人: ESTETRA SRL
- 当前专利权人: ESTETRA SRL
- 当前专利权人地址: BE Liège
- 代理机构: Foley & Lardner LLP
- 优先权: EP 172767 2015.06.18
- 主分类号: A61K9/20
- IPC分类号: A61K9/20 ; A61K9/00 ; A61K31/565 ; A61P5/00 ; A61P15/18 ; A61K9/16
摘要:
The invention provides an orodispersible solid pharmaceutical dosage unit having a weight between 30 and 1,000 mg, said dosage unit consisting of: 0.1-25 wt. % of estetrol particles containing at least 80 wt. % of an estetrol component selected from estetrol, estetrol esters and combinations thereof; and 75-99.9 wt. % of one or more pharmaceutically acceptable ingredients; the solid dosage unit comprising at least 100 μg of the estetrol component; and wherein the solid dosage unit can be obtained by a process comprising wet granulation of estetrol particles having a volume weighted average particle size of 2 μm to 50 μm. The solid dosage unit is easy to manufacture and perfectly suited for sublingual, buccal or sublabial administration.
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