发明名称 |
MOISTURE-ACTIVATED GRANULATION PROCESS |
摘要 |
The present invention relates to a moisture-activated granulation process for the manufacture of a pharmaceutical dosage form containing at least one moisture- sensitive active substance selected from the group consisting of aliskiren and its pharmaceutically acceptable salts, esters and cocrystals, said process comprising: a) mixing the active substance (s) with one or more dry excipients in solid form, said excipient being selected in particular from the group consisting of diluents, surfactants, binders, lubricants, disintegrators, granulation aids, buffering/alkalizing agents, fillers and antioxidants; b) contacting the mixture with a granulation liquid containing water and optionally one or more excipients to form a granulate, said excipient being selected in particular from the group consisting of binders, buffering/ alkalizing agents, surfactants and antioxidants, to form a granulate wherein the ratio of the total amount of water to the total amount of all the solid ingredients including the active substance (s) and all intragranular excipients is less than 30:100, based on weight; c) further processing the mixture including the addition of further dry excipients to obtain the pharmaceutical dosage form, said excipients being in particular selected from the group consisting of diluents, disintegrants, glidants and lubricants. |
申请公布号 |
WO2010089105(A3) |
申请公布日期 |
2011.01.13 |
申请号 |
WO2010EP00667 |
申请日期 |
2010.02.03 |
申请人 |
KRKA, TOVARNA ZDRAVIL, D.D., NOVO MESTO;STUKELJ, MITJA;SKRABANJA, VIDA;FERLAN, ANDREJ;VRECER, FRANC;KUKEC, SIMON |
发明人 |
STUKELJ, MITJA;SKRABANJA, VIDA;FERLAN, ANDREJ;VRECER, FRANC;KUKEC, SIMON |
分类号 |
A61K31/165;A61K9/20;A61K9/26;A61K31/4985 |
主分类号 |
A61K31/165 |
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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