Orodispersible dosage unit containing an estetrol component

US10660903B2 · 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: Jul 2, 2018
• Grant date: May 26, 2020
• Expiry date: Jul 2, 2038

Classification

• Technology area (CPC A): Human Necessities
• CPC primary: A61K9/2095
• WIPO field: Pharmaceuticals
• WIPO sector: Chemistry

Abstract

An orodispersible solid pharmaceutical dosage unit having a weight between 30 and 1,000 mg is disclosed. The dosage unit comprises (a) 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 (b) 75-99.9 wt. % of one or more pharmaceutically acceptable excipients. The solid dosage unit comprises at least 100 μg of the estetrol component and 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 suited for sublingual, buccal or sublabial administration.