发明授权
EP1355631B1 ORAL FAST-MELT FORMULATION OF A CYCLOOXYGENASE-2 INHIBITOR
有权
在口腔中迅速崩解的口服药物制备含有环氧化酶-2抑制剂
- 专利标题: ORAL FAST-MELT FORMULATION OF A CYCLOOXYGENASE-2 INHIBITOR
- 专利标题(中): 在口腔中迅速崩解的口服药物制备含有环氧化酶-2抑制剂
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申请号: EP01965984.6申请日: 2001-08-17
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公开(公告)号: EP1355631B1公开(公告)日: 2007-10-03
- 发明人: LE, Trang, T. , KARARLI, Tugrul, T. , KONTNY, Mark, J. , SASTRY, Srikonda, V. , NYSHADHAM, Janaki, R. , PAGLIERO, Arthur, J., Jr.
- 申请人: Pharmacia Corporation , Yamanouchi Pharma Technologies, Inc.
- 申请人地址: 100 Route 206 North Peapack, NJ 07977 US
- 专利权人: Pharmacia Corporation,Yamanouchi Pharma Technologies, Inc.
- 当前专利权人: Pharmacia Corporation,Yamanouchi Pharma Technologies, Inc.
- 当前专利权人地址: 100 Route 206 North Peapack, NJ 07977 US
- 代理机构: Motion, Keith Robert
- 优先权: US226347P 20000818
- 国际公布: WO2002015885 20020228
- 主分类号: A61K9/20
- IPC分类号: A61K9/20 ; A61K31/635
摘要:
A process is provided for preparing an oral fast-melt composition of a selective cyclooxygenase-2 inhibitory drug, the process comprising (a) a step of wet granulating the drug together with a binding agent comprising a saccharide of high moldability, and (b) a step of blending with the drug a saccharide of low moldability, wherein the above steps (a) and (b) occur in any order or simulatenously to result in formation of granules. The process optionally incorporates means to inhibit agglomeration of the drug, for example addition of a wetting agent. Optionally the process further comprises (c) a step of blending the granules with at least one of a lubricant, a sweetening agent and a flavoring agent to form a tableting blend, and (d) a step of compressing the tableting blend to form oral fast-melt tablets. Also provided is a composition prepared by such a process.
公开/授权文献
- EP1355631A2 ORAL FAST-MELT FORMULATION OF A CYCLOOXYGENASE-2 INHIBITOR 公开/授权日:2003-10-29
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