The Granulation Method and Content Uniformity for Standard Formulations―Fluidized Bed Granulation―

Abstract

We investigated the content and blend uniformity of drugs in granules and tablets made by the fluidized bed-granulation method using three active ingredients, ascorbic acid, ethenzamide and acetaminophen, as model drugs. They were used at concentrations of 0.1% and 1%, with lactose/corn starch in a 7/3 mixture and hydroxypropylcellulose as the standard formulation, as recommended by the Standard Formulation Research Association. Consequently, good content uniformity was confirmed for all three model drugs under suitable manufacturing conditions in this study. However, care must be taken when the particles of active ingredients are fine, because the loss of drugs by passing through the bag-filter or adhering to the wall of the granulator during the granulation process is possible.