PLATTEEUW, Johannes Jan,COELINGH BENNINK, Herman Jan Tijmen
申请号：
EP15813589
公开号：
EP3200773B1
申请日:
2015.09.29
申请国别(地区):
EP
年份:
2018
代理人:
摘要：
The present invention provides an orally disintegrating solid pharmaceutical dosage unit having a weight between 50 and 1,000 mg, said dosage unit consisting of: 1-100 wt. % of particles consisting of: 0.01-10 wt. % of a partus control substance selected from oxytocin, carbetocin, atosiban and combinations thereof 5-70 wt. % of buffering agent 20-94 wt. % of branched glucan 0-70 wt. % of other pharmaceutically acceptable ingredients 0-95 wt. % of one or more pharmaceutically acceptable excipients the solid dosage unit comprising at least 5 μg of the partus control substance and having a pH buffer range of 3.5-5.7. The solid dosage unit of the present invention is easy to manufacture and perfectly suited for sublingual, buccal or sublabial administration. Furthermore, the dosage unit does not need to be stored and distributed under temperature controlled conditions.
