Manufacturing pharmaceutical granules: Is the granulation end-point a myth?

摘要: Abstract The moist agglomeration process by high-shear mixing/granulation, i.e. the wet massing, screening and subsequent drying is a wide spread but critical unit operation. Since for decades formulators are looking correct “end-point” of this important process, when do you need to stop massing or with addition granulating liquid? What amount A similar situation exists in case fluidized bed equipment. In latter simultaneous still granules have be taken into account. Recently science-based virtual equipment simulator could developed mimicking granule size evolution granulator during liquid. For Mollier chart used. With it possible simulate “crash situations”, overwetting an incorrect use parameter setting. However determination depends only on operator, who desires certain distribution well-defined final moisture content batch. Thus existence intrinsic has questioned. same can reported mixing/granulation based many years research. fact nobody clearly show “end-point”. continuous low viscous liquid sudden increase power consumption measured, which levels off. Such measurement formulation leads “early signal” not This signal used tight control granulation batch variability distribution. goal PAT (Process Analytical Technology) Initiative emphasizing “Quality Design”.