Orally disintegrating solid dosage unit containing an estetrol component
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.
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