The effect of binder particle size on granule and tablet properties in high shear and extrusion granulation

We investigated the effects of binder particle size on high shear and extrusion granulation using the wet granulation method by evaluating the properties of granules and tablets. Ethenzamide was used as a model drug at a concentration of 1% with lactose/corn starch in a 7/3 mixture, with 3.5% hydroxypropylcellulose and 0.5% magnesiuu stearate as the standard formulation, as recommended by the Standard Formulation Research Association. Hydroxypropylcellulose, as the binder, was classified into three particle size grades with the sieving method and used by the powder and solution addition method. In conclusion, although an effect of differences in the binder particle size on the particle size and its distribution in high shear granulation granules was observed, it was not an important parameter in the product properties. Accordingly, it was thought that standardization of the binder particle size was useful to control the granule particle size.