发明名称 |
DIRECT COMPRESSION FORMULATION AND PROCESS |
摘要 |
Dipeptidylpeptidase IV inhibitor (herein referred to as DPP-IV) that may be 98.5-100% pure is a high-dose drug capable of being directly compressed with specific excipients into sold form dosage forms, such as tablets and capsules having desired, hardness, disintegrating ability and acceptable dissolution characteristics. DPP-IV is not inherently compressible and thus presents formulation problems. Excipients used in the formulation enhance the flow and compaction properties of the drug and tableting mix. Optimal flow contributes to uniform die fill and weight control. The binder used ensures sufficient cohesive properties that allow DPP-IV to be compressed using the direct compression method. The tablets produced provide an acceptable in vitro dissolution profile. |
申请公布号 |
PT1715893(E) |
申请公布日期 |
2009.10.20 |
申请号 |
PT20050700976T |
申请日期 |
2005.01.17 |
申请人 |
NOVARTIS PHARMA AG.;NOVARTIS-PHARMA GMBH |
发明人 |
ARUN P. PATEL,;JAMES KOWALSKI;JAY PARTHIPAN LAKSHMAN |
分类号 |
A61K47/00;A61K9/20 |
主分类号 |
A61K47/00 |
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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