ORALLY DISINTEGRATING SOLID PHARMACEUTICAL DOSAGE UNIT CONTAINING A PARTUS CONTROL SUBSTANCE

The present invention provides an orally disintegrating solid pharmaceutical dosage unit having a weight between 50 and 1,000 mg, said dosage unit consisting of: * 5-100 wt.% of coated particles comprising 50-99 wt.% of a core particle and 1-50 wt.% of a coating that envelops the core particle, said...

Ausführliche Beschreibung

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Bibliographische Detailangaben
Hauptverfasser: COELINGH BENNINK, Herman Jan Tijmen, PLATTEEUW, Johannes Jan
Format: Patent
Sprache:eng ; hun
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Zusammenfassung:The present invention provides an orally disintegrating solid pharmaceutical dosage unit having a weight between 50 and 1,000 mg, said dosage unit consisting of: * 5-100 wt.% of coated particles comprising 50-99 wt.% of a core particle and 1-50 wt.% of a coating that envelops the core particle, said coating consisting of: - 0.01-10 wt.%) of a partus control substance selected from oxytocin, carbetocin, atosiban and combinations thereof; - 5-50 wt.%) of buffering agent; - 15-80 wt.%) of branched glucan; - 0-78 wt.%) of other pharmaceutically acceptable ingredients; * 0-95 wt.%) of one or more pharmaceutically acceptable excipients; the solid dosage unit comprising at least 20 μg of the partus control substance and having a pH buffer range of 3.5-5.7. The solid dosage unit of the present invention is easy to manufacture and perfectly suited for sublingual, buccal or sublabial administration. Furthermore, the dosage unit does not need to be stored and distributed under temperature controlled conditions.