发明名称 |
RAPIDLY DISPERSING GRANULES, ORALLY DISINTEGRATING TABLETS AND METHODS |
摘要 |
This invention relates to rapidly dispersing microgranules comprising at least one sugar alcohol or saccharide, at least one super disintegrant, and a pharmaceutically acceptable additive with multi-functionality (e.g., starch acting as a binder, disintegrant, diluent/filler, glidant, etc) at a low level, which can be formed by not only eliminating a wet milling step but also avoiding an extensive dry milling step. Furthermore, such rapidly dispersing microgranules could also comprise a pharmaceutically active agent thereby providing for a pharmaceutical composition, or the rapidly dispersing microgranules thus produced are suitable for blending with a pharmaceutically active agent that is optionally taste-masked and/or controlled release coated microparticles to also provide for a pharmaceutical composition and the invention is also directed to a method for manufacturing such rapidly dispersing microgranules in a high useable yield, as well as orally disintegrating tablets comprising such rapidly dispersing microgranules. The rapidly dispersing microgranules are also free flowing. |
申请公布号 |
EP2646003(A4) |
申请公布日期 |
2016.08.03 |
申请号 |
EP20110845725 |
申请日期 |
2011.12.02 |
申请人 |
ADARE PHARMACEUTICALS, INC. |
发明人 |
VENKATESH, GOPI M.;SWAMINATHAN, VIJAYA;LAI, JIN-WANG;CLEVENGER, JAMES M. |
分类号 |
A61K9/00;A61K9/16;A61K9/20;A61K31/137;A61K31/167;A61K31/351;A61K31/4453;A61K31/485;A61K31/53;A61K31/5513 |
主分类号 |
A61K9/00 |
代理机构 |
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代理人 |
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主权项 |
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地址 |
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