Invention Grant
- Patent Title: Orally disintegrating solid dosage unit containing an estetrol component
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Application No.: US15103180Application Date: 2014-12-10
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Publication No.: US09884064B2Publication Date: 2018-02-06
- Inventor: Johannes Jan Platteeuw , Herman Jan Tijmen Coelingh Bennink
- Applicant: Donesta Bioscience B.V.
- Applicant Address: NL Zeist
- Assignee: Donesta Bioscience B.V.
- Current Assignee: Donesta Bioscience B.V.
- Current Assignee Address: NL Zeist
- Agency: Foley & Larder LLP
- Agent Gilberto M. Villacorta; Sunit Talapatra
- Priority: EP13196904 20131212
- International Application: PCT/EP2014/077127 WO 20141210
- International Announcement: WO2015/086643 WO 20150618
- Main IPC: A61K31/565
- IPC: A61K31/565 ; A61K9/00 ; A61K9/16 ; A61K31/573

Abstract:
The present invention provides an orally disintegrating solid pharmaceutical dosage unit having a weight of 50-1,000 mg and containing at least 0.1 mg of an estetrol component selected from estetrol, estetrol esters and combinations thereof. This solid dosage unit consists of: 4-95 wt. % of granules consisting of: 3-80 wt. % of an estetrol component selected from estetrol, estetrol esters and combinations thereof; 20-97 wt. % C4-C12 sugar alcohol; 0-45 wt. % of one or more other pharmaceutically acceptable ingredients; and 5-96 wt. % of one or more pharmaceutically acceptable excipients. The solid dosage units of the present invention are particularly suited for sublingual, buccal or sublabial administration of the estetrol component.
Public/Granted literature
- US20160310506A1 ORALLY DISINTEGRATING SOLID DOSAGE UNIT CONTAINING AN ESTETROL COMPONENT Public/Granted day:2016-10-27
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