Orodispersible dosage unit containing an estetrol component

US11147771B2 · kind B2 · utility

Assignee

• Estetra SPRL · BE

Inventors

• Séverine Francine Isabelle Jaspart · Bois-et-Borsu, BE
• Johannes Jan Platteeuw · Boxtel, NL
• Denny Johan Marijn Van Den Heuvel · Beuningen, NL

Key dates

• Filing date: Jun 17, 2016
• Grant date: Oct 19, 2021
• Expiry date: Jun 17, 2036

Classification

• Technology area (CPC A): Human Necessities
• CPC primary: A61K9/1623
• WIPO field: Pharmaceuticals
• WIPO sector: Chemistry

Abstract

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.