公开(公告)号：US20240238209A1

公开(公告)日：2024-07-18

申请号：US18621501

申请日：2024-03-29

申请人： ESTETRA SRL

发明人： Séverine Francine Isabelle JASPART ,  Johannes Jan PLATTEEUW ,  Denny Johan Marijn VAN DEN HEUVEL

IPC分类号： A61K9/20 ,  A61K9/00 ,  A61K31/565 ,  A61P5/00 ,  A61P15/18 ,  A61K9/16

CPC分类号： A61K9/2095 ,  A61K9/0056 ,  A61K9/2027 ,  A61K9/2054 ,  A61K9/2059 ,  A61K9/2077 ,  A61K31/565 ,  A61P5/00 ,  A61P15/18 ,  A61K9/1623

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.

公开(公告)号：US20230293442A1

公开(公告)日：2023-09-21

申请号：US18196617

申请日：2023-05-12

申请人： ESTETRA SRL

发明人： Séverine Francine Isabelle JASPART ,  Johannes Jan PLATTEEUW ,  Denny Johan Marijn VAN DEN HEUVEL

IPC分类号： A61K9/20 ,  A61K9/00 ,  A61K31/565 ,  A61P5/00 ,  A61P15/18

CPC分类号： A61K9/2095 ,  A61K9/0056 ,  A61K9/2027 ,  A61K9/2054 ,  A61K9/2059 ,  A61K9/2077 ,  A61K31/565 ,  A61P5/00 ,  A61P15/18 ,  A61K9/1623

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.