JASPART Severine Francine Isabelle,PLATTEEUW Johannes Jan,VAN DEN HEUVEL Denny Johan Marijn
申请号:
SI201630752
公开号:
SI3310333T1
申请日:
2016.06.17
申请国别(地区):
SI
年份:
2020
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.