小试放大过程中选择将原料药、甘露醇、微晶纤维素和交联聚维酮加入湿法制粒

In the small scale-up process, the raw materials, mannitol, microcrystalline cellulose and cross-linked povidone were added to the wet granulator, premixed for 5 minutes, the stirring parameter was 200 rpm, and the shear parameter was 300 rpm. During the scale-up production process, the pre-mixing method is the same. According to different production equipment, the stirring parameter is selected as 10Hz and the shearing parameter is 15Hz. The prepared product tablet content and content uniformity meet the requirements. Therefore, the tentative pre-mixing process of this product is to add the raw materials, mannitol, microcrystalline cellulose and cross-linked povidone to the wet granulator for direct mixing.

During the pilot scale-up process, the API, mannitol, microcrystalline cellulose and cross-linked povidone were added to the wet granulator, premixed for 5 minutes, stirring parameters of 200 rpm and shear parameters of 300 rpm. In the process of scale-up production, the pre mixing mode is the same. According to different production equipment, the mixing parameter is 10Hz and the shear parameter is 15Hz. The content and content uniformity of the prepared tablets meet the requirements. Therefore, the premixing process of this product is tentatively determined as adding the API, mannitol, microcrystalline cellulose and cross-linked povidone into the wet granulator for direct mixing.<br>

In the process of small scale-up, raw materials, mannitol, microcrystalline cellulose and cross-linked povidone were added into a wet granulator, and premixed for 5 minutes, with stirring parameters of 200rpm and shearing parameters of 300rpm. In the process of scale-up production, the premixing mode is the same. According to different production equipment, the stirring parameter is 10Hz and the shearing parameter is 15Hz. The content and content uniformity of the prepared tablets meet the requirements. Therefore, the pre-mixing process of this product is to add the raw materials, mannitol, microcrystalline cellulose and cross-linked povidone into a wet granulator for direct mixing.