Invention Grant
- Patent Title: Orodispersible dosage unit containing an estetrol component
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Application No.: US17504087Application Date: 2021-10-18
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Publication No.: US11964055B2Publication Date: 2024-04-23
- Inventor: Séverine Francine Isabelle Jaspart , Johannes Jan Platteeuw , Denny Johan Marijn Van Den Heuvel
- Applicant: ESTETRA SRL
- Applicant Address: BE Liège
- Assignee: ESTETRA SRL
- Current Assignee: ESTETRA SRL
- Current Assignee Address: BE Liége
- Agency: Foley & Lardner LLP
- Priority: EP 172767 2015.06.18
- Main IPC: A61K9/20
- IPC: A61K9/20 ; A61K9/00 ; A61K9/16 ; A61K31/565 ; A61P5/00 ; A61P15/18

Abstract:
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.
Public/Granted literature
- US20220096385A1 ORODISPERSIBLE DOSAGE UNIT CONTAINING AN ESTETROL COMPONENT Public/Granted day:2022-03-31
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