发明授权
- 专利标题: DILTIAZEM CONTROLLED RELEASE FORMULATION
- 专利标题(中): 地尔硫制剂具有控释
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申请号: EP96910439.7申请日: 1996-03-13
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公开(公告)号: EP0814780B1公开(公告)日: 2003-10-01
- 发明人: CHEN, Chih-Ming
- 申请人: ANDRX PHARMACEUTICALS, INC.
- 申请人地址: Suite 201, 4001 S.W. 47th Avenue Fort Lauderdale, FL 33314 US
- 专利权人: ANDRX PHARMACEUTICALS, INC.
- 当前专利权人: ANDRX PHARMACEUTICALS, INC.
- 当前专利权人地址: Suite 201, 4001 S.W. 47th Avenue Fort Lauderdale, FL 33314 US
- 代理机构: Gervasi, Gemma, Dr.
- 优先权: US409449 19950324
- 国际公布: WO96029992 19961003
- 主分类号: A61K9/16
- IPC分类号: A61K9/16 ; A61K9/58 ; A61K9/62 ; A61K31/55 ; A61K9/50
摘要:
A once-a-day controlled release diltiazem formulation is described which includes: (a) from 20 to 50 % by weight of enteric polymeric membrane coated pellets comprising a polymer membrane coated core which comprises a biologically inert core which is coated with a first layer which consists essentially of diltiazem and a polymeric binder; and a second layer which comprises a membrane comprising a pH dependent polymeric material; and (b) from 50 % to 80 % by weight of delayed pulse polymeric membrane coated pellets comprising a polymeric membrane coated core which comprises a biologically inert core which is coated with a first layer which consists essentially of diltiazem and a polymeric binder and a second layer which comprises a polymeric membrane which will substantially maintain its integrity in the varying pH conditions of the gastrointestinal tract but is permeable to diltiazem; and (c) a unit dose containment system.
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