Effect of API Particle Size Applied to Continuous Granulator against Characteristics of Prepared Granules

Abstract

Particle size of raw materials is one of the most important factors in granulation, a general particle processing method. Especially in the case of granulation of multiple materials, component uniformity depends on the particle size. Therefore, pulverizing raw materials to a smaller particle size before granulation is often selected as a preprocessing method. Currently, there is a direct granule producing apparatus, which produces granules direct from a suspension of raw materials. The granules produced from this apparatus have unique features such as content uniformity, spherical shape, and high content yield due to less addition of excipients. From these features, the granules have advantages-such as ease to swallow and downsizing of final dosage form if they used for drugs. Here, we describe the necessity of raw material pulverization by confirming the correlation between particle size of the pulverized raw material and component uniformity of the granules produced by direct granule producing apparatus.