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低用量薬物を含有する口腔内崩壊錠
专利权人:
MOCHIDA PHARMACEUT CO LTD
发明人:
NISHIMURA MASAHIRO,西村 雅裕,YOSHIOKA NAOYA,吉岡 直哉
申请号:
JP2016172776
公开号:
JP2017075139A
申请日:
2016.09.05
申请国别(地区):
JP
年份:
2017
代理人:
摘要:
PROBLEM TO BE SOLVED: To provide pharmaceutical compositions, particularly orally disintegrating tablets, having inhibited content segregation, an improved feel of ingestion and excellent drug dissolution properties, regarding a physiologically active component (drug) which has a low content (microdose) and has a problem of feel of ingestion.SOLUTION: An orally disintegrating tablet contains a physiologically active component exerting physiological activity in microdose, wherein a) orally disintegrating time is within 30 seconds b) in a dissolution test performed according to the dissolution test method described in the Japanese Pharmacopoeia 16th edition, General Test Method (test solution: water 900 mL, 37°C), the dissolution rate in 15 minutes of the physiologically active component is 80 mass% or more and c) in a dissolution test performed according to the dissolution test method described in the Japanese Pharmacopoeia 16th edition, General Test Method (test solution: water 900 mL, 37°C), the dissolution rate in the time needed for oral disintegration of the physiologically active component of the test liquid is 5 mass% or less.SELECTED DRAWING: NoneCOPYRIGHT: (C)2017,JPO&INPIT【課題】低含量(微量)でかつ服用感が問題となる生理活性成分(薬物)について、含量偏析が抑制され、服用感が改善され、かつ良好な薬物溶出性を有する医薬用組成物、特に、口腔内崩壊錠剤を提供すること。【解決手段】微量で生理活性を示す生理活性成分を含有し、 a)口腔内崩壊時間が30秒以内であり、 b)日局16版、一般試験法に記載の溶出試験法に従い溶出試験を実施したとき(試験液:水900mL、37℃)、15分での生理活性成分の溶出率が80質量%以上であり、かつ c)日局16版、一般試験法に記載の溶出試験法に従い溶出試験を実施したとき(試験液:水900mL、37℃)、口腔内崩壊に要する時間の時点で試験液中の生理活性成分の溶出率が5質量%以下である口腔内崩壊錠剤。【選択図】なし
来源网站:
中国工程科技知识中心
来源网址:
http://www.ckcest.cn/home/

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