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PROCESS OF MAKING DOSAGE UNIT BY NOVEL HIGH SHEAR WET GRANULATION

机译:新型高剪切湿法制粒制备配料装置的过程

摘要

A novel high-shear wet granulation process was invented for modified release formulation of active ingredients, which involves addition of a granulating fluid into the powder dry mixture of API with or without additives other than release retarding polymer to prepare a semisolid mass. Addition of release retarding polymer to the semisolid mass obtained above and further kneading to yield uniform granules. These granules which upon compression into tablets gives desired dissolution profile with significantly less quantity of release retarding polymer than that of tablets containing same release retarding polymer, prepared by conventional high shear wet granulation process.
机译:发明了用于活性成分的调释制剂的新颖的高剪切湿法制粒方法,该方法包括将制粒液添加到具有或不具有除缓释聚合物以外的添加剂的API的粉末干燥混合物中以制备半固体物质。向上述获得的半固体物质中加入阻滞聚合物,然后进一步捏合,得到均匀的颗粒。与通过常规高剪切湿法制粒法制备的含有相同的阻滞聚合物的片剂相比,这些颗粒在压制成片剂后可提供所需的溶出曲线,且阻滞聚合物的量明显更少。

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