ORO-DISPERGERBAR DOSERINGSENHED INDEHOLDENDE EN ESTETROLKOMPONENT

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;...

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Hauptverfasser: JASPART, Séverine Francine Isabelle, van den Heuvel, Denny Johan Marijn, Platteeuw, Johannes Jan
Format: Patent
Sprache:dan
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Zusammenfassung: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.