Formulations were established to evaluate the dispensing characteristics of fine granules.
The formulations were prepared mainly according to “the Standard Formula for Fine Granules” established by the Particulate Preparation and Designing Group of the Society of Powder Technology of Japan. Granulation was performed either by agitating granulation, fluidized-bed granulation or extrusion granulation. The dispensing characteristics were comprehensively assessed on the basis of “average weight”, “coefficient of variation”, “weight loss”, and “time for dividing”, as well as “operativeness” based on a sensory test by pharmacists.
As the results, it was observed that the dispensing characteristics of fine granules might greatly depend on the granulation method, the amount of binders, the size of bulk materials and the shape of the fine granules. In was also observed that content uniformity of a fine granule, i. e., relationship between its particle size and content, was closely related to the granulation procedure employed.
