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Non-pulsatile prolonged-release betahistine oral solid compositions
专利权人:
Intas Pharmaceuticals Ltd.
发明人:
Patel, Himanshukumar Dasharathlal,Dube, Vinod Purushottam,Naidu, Venkataramana,Borude, Sunil Shantwan
申请号:
AU2018302771
公开号:
AU2018302771A1
申请日:
2018.07.16
申请国别(地区):
AU
年份:
2020
代理人:
摘要:
The present invention relates to an oral solid non-pulsatile 24 hours prolonged-release composition comprising an amount of betahistine, or of a pharmaceutically acceptable salt thereof, equivalent to 48 mg of betahistine dihydrochloride, together with one or more pharmaceutically acceptable excipients or carriers, wherein the composition exhibits a dissolution profile according to which: up to 30% by weight of betahistine is dissolved in 1 hour; from 35% to 45% by weight of betahistine is dissolved in 2 hours; from 46% to 60% by weight of betahistine is dissolved in 4 hours; from 61% to 80% by weight of betahistine is dissolved in 8 hours; from 81% to 97% by weight of betahistine is dissolved in 16 hours; and from 98% to 100% by weight of betahistine is dissolved in 24 hours. It also relates to its use in therapy, particularly in the treatment of a vestibular disease or condition, more particularly in the treatment of Ménière's disease.
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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