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Orally disintegrating solid pharmaceutical dosage unit containing parturition control substances
专利权人:
オキシトーン;バイオサイエンス;ビー.ブイ.
发明人:
プラテュウ, ヨハネス ヤン,コーリン ベンニンク, ハーマン, ヤン, ティジュメン
申请号:
JP2017518256
公开号:
JP6607508B2
申请日:
2015.09.29
申请国别(地区):
JP
年份:
2019
代理人:
摘要:
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.
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