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GRANULATED MATERIAL CONTAINING IMIDAFENACIN HAVING LESS PRODUCTION PROCESS DECOMPOSED PRODUCT

机译:含有米达非星的粒状材料生产量少分解产物

摘要

To provide a preparation containing imidafenacin having less novel process decomposed product.SOLUTION: There is provided a method for producing a granulated material containing imidafenacin in which a granulated material obtained via the following process a) and process b) is produced via a drying process of either process c)-1 or c)-2; a) a process of dissolving or suspending imidafenacin into pharmaceutically acceptable solvent to produce solution or suspension; b) a process of spraying the solution or suspension obtained in the process a) onto 1 or 2 kinds or more of fluidized pharmaceutically acceptable excipient to produce a granulated material in a fluidized bed granulator ; c)-1 a process of drying granulated material obtained in the process b) under reduced pressure; c)-2 a process of drying granulated material obtained in the process b) within 100 minutes in the fluidized bed granulator.SELECTED DRAWING: None
机译:为了提供一种包含具有新的过程分解产物的咪达非那定的制剂。解决方案:提供了一种制备含有咪达非那定的颗粒状材料的方法,其中通过以下步骤a)和步骤b)获得的颗粒状材料是通过干燥步骤制备的。过程c)-1或c)-2; a)将伊达非那星溶解或悬浮在药学上可接受的溶剂中以产生溶液或悬浮液的方法; b)将在步骤a)中获得的溶液或悬浮液喷洒到一种或两种或更多种流化的药学上可接受的赋形剂上的方法,以在流化床制粒机中产生颗粒状材料; c)-1是在减压下干燥步骤b)中获得的粒状材料的过程; c)-2是在流化床制粒机中在100分钟内干燥步骤b)中获得的粒状物料的过程。

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