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ORODISPERSIBLE DOSAGE UNIT CONTAINING AN ESTETROL COMPONENT
专利权人:
Mithra Pharmaceuticals S.A.
发明人:
Séverine Francine Isabelle JASPART,Johannes Jan PLATTEUW,Denny Johan Marijn VAN DEN HEUVEL
申请号:
US15185337
公开号:
US20160367567A1
申请日:
2016.06.17
申请国别(地区):
US
年份:
2016
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 comprising:0.1-25 wt. % of estetrol particles containing at least 80 wt. % of an estetrol component selected from estetrol, estetrol esters and combinations thereof; and75-99.9 wt. % of one or more pharmaceutically acceptable excipients;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 that comprises compressing a dry blend of estetrol particles and one or more pharmaceutically acceptable excipients into a solid dosage unit.The solid dosage unit is easy to manufacture and perfectly suited for sublingual, buccal or sublabial administration.
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