发明申请
US20050053660A1 Multi-particulate form of medicament, comprising at least two differently coated forms of pellet
有权
多颗粒形式的药物,包含至少两种不同的包衣形式的丸剂
- 专利标题: Multi-particulate form of medicament, comprising at least two differently coated forms of pellet
- 专利标题(中): 多颗粒形式的药物,包含至少两种不同的包衣形式的丸剂
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申请号: US10949323申请日: 2004-09-27
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公开(公告)号: US20050053660A1公开(公告)日: 2005-03-10
- 发明人: Thomas Beckert , Hans-Ulrich Petereit , Jennifer Dressman , Markus Rudolph
- 申请人: Thomas Beckert , Hans-Ulrich Petereit , Jennifer Dressman , Markus Rudolph
- 申请人地址: DE Darmstadt
- 专利权人: ROEHM GMBH & CO. KG
- 当前专利权人: ROEHM GMBH & CO. KG
- 当前专利权人地址: DE Darmstadt
- 优先权: DE10104504.2 20010131; DE10104880.7 20010201
- 主分类号: A61K9/16
- IPC分类号: A61K9/16 ; A61K9/20 ; A61K9/26 ; A61K9/50 ; A61K9/54 ; A61K9/58 ; A61K9/62 ; A61K31/573 ; A61K31/58 ; A61K31/606 ; A61K31/635 ; A61K47/32 ; A61K47/36 ; A61K47/38 ; A61P1/00
摘要:
The invention relates to a multiparticulate drug form suitable for uniform release of an active pharmaceutical ingredient in the small intestine and in the large intestine, comprising at least two forms of pellets A and B which comprise an active pharmaceutical ingredient in the core and have different polymer coatings which determine the release of the active ingredient at different pH values, characterized in that pellet form A is provided with an inner polymer coating which enables continuous release of active ingredient, and has an outer enteric coating which rapidly dissolves above about pH 5.5, and pellet form B is provided with a polymer coating which, in the USP release test, releases less than 20% of the active ingredient at pH 6.8 in 6 hours and releases more than 50% of the active ingredient at pH 7.2 in 6 hours. The invention additionally relates to a process for producing the multiparticulate drug form and to the use of pellet forms A and B for producing the drug form.
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