AU2021203265B2 — Orodispersible dosage unit containing an estetrol component

USPTO Abstract

The present invention is directed towards dry estetrol-containing granules comprising: - 70-95 wt.% of one or more granulation excipients, and 5 - 5-30 wt.% of estetrol particles containing at least 90 wt.% of an estetrol component obtainable by a method comprising the steps of: - providing estetrol particles containing at least 90 wt.% of the estetrol component and having a volume median diameter of 2 m to 50 m; - mixing the estetrol particles with one or more granulation excipients to produce a 0 granulation mixture; - mixing the granulation mixture with a granulation liquid to produce estetrol-containing granules, said granulation liquid containing at least 60 wt.% of liquid solvent; and - removing liquid solvent from the estetrol-containing granules to produce said dry estetrol containing granules.