Mithra Pharmaceuticals S.A.;Severine Francine Isabelle JASPART;Denny Johan Marijn VAN DEN HEUVEL;JOHANNES JAN PLATTEEUW
发明人:
JOHANNES JAN PLATTEEUW,Severine Francine Isabelle JASPART,Denny Johan Marijn VAN DEN HEUVEL
申请号：
IL25628217
公开号：
IL256282D0
申请日:
2017.12.12
申请国别(地区):
IL
年份:
2018
代理人:
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.
