发明名称 |
Method for producing granules |
摘要 |
In a production process of granules containing a biologically active substance, variation in the elution profile of the biologically active substance is reduced by heating the temperature of granules to about 50° C. or higher and maintaining the temperature for about 1 minute or longer. By setting the spray speed to about 90 mg/min or more per 1 g of cores when a spray agent for a primary agent containing the biologically active substance is sprayed while spraying a binding liquid to the cores and setting the total feeding weight per unit area for a centrifugal fluidized bed coating granulation machine to about 1.5 g/cm2 or more, the variation in the elution profile of the biologically active substance from the granules is reduced. |
申请公布号 |
US9011926(B2) |
申请公布日期 |
2015.04.21 |
申请号 |
US201414488823 |
申请日期 |
2014.09.17 |
申请人 |
Takeda Pharmaceutical Company Limited |
发明人 |
Nagahara Naoki;Asakawa Naoki;Nonomura Muneo |
分类号 |
A61K9/16;B05D7/00;A61K31/4439 |
主分类号 |
A61K9/16 |
代理机构 |
Hamre, Schumann, Mueller & Larson, P.C. |
代理人 |
Hamre, Schumann, Mueller & Larson, P.C. |
主权项 |
1. A centrifugal fluidized bed granulation method for granules of an active pharmaceutical ingredient, which comprises spraying or dusting a spraying or dusting material containing an active pharmaceutical ingredient containing a biologically active substance at a spraying or dusting speed of about 90 mg/min or more per 1 g of cores while spraying a binder liquid to cores, wherein a total feeding weight per unit area for a centrifugal fluidized bed coating granulation machine is about 1.5 g/cm2 or more. |
地址 |
Osaka JP |