Influencing Factors in Fluidized Bed Granulation Process of Metformin Hydrochloride / 中国药师

ABSTRACT

Objective:To study the effects of process parameters of fluidized bed granulation on the physical properties of metform-in hydrochloride granule. Methods:The physical properties of metformin hydrochloride were used as the evaluation indices. Single fac-tor experiment was conducted to investigate the influences of equipment factors ( including the nozzle height and the nozzle orifice) and the process parameters ( including binder dosage, inlet air temperature, inlet air flow rate, spray rate and atomization pressure) on the physical prperties. Results: The influences of equipment factors on the physical properties of the granule were not significant. The binder dosage, inlet air temperature, inlet air flow rate, spray rate and atomization pressure showed significant influences on the physi-cal properties of metformin hydrochloride granule. Conclusion:The parameters of fluidized bed granulation process ( binder dosage, in-let air temperature, inlet air flow rate, spray rate and atomization pressure) have significant effects on the physical properties of met-formin hydrochloride granule, which should be controlled according to the requirements of granule properties.