Authors:

Jayden Pierce

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About Paper:

Dry granulation is a common method used in the pharmaceutical industry to create granules from powders to improve flowability and content uniformity. The powders are first fed into the roller compactor (RC) to produce granules, which are further compressed in the tablet press (TP) to form tablets. The effects of several RC control variables (CV) such as roll pressure on granule properties, tableting critical process parameters (CPPs) and tablet critical quality attributes (CQAs) are well documented. However, the effects of other RC CVs are not well understood. This paper investigates the relationship between a novel CV in the RC, the rotor screen gap (RSG), on granule properties and several tablet CQAs such as tablet density and tensile strength. Two KTron feeders are separately charged with pure acetaminophen (APAP) and microcrystalline cellulose (MCC PH-102) PH-102 with feedrates of 1 kg/hr and 9 kg/hr respectively to create a 10% APAP 90% MCC PH-102 blend. The KTron feeders feed the powders into a continuous blender and then into the RC. The RSG is varied at 6 different gaps, each at 30-bar and 60-bar hydraulic pressure. The granules produced by the RC are fed into the TP to create tablets. Granule properties are characterized using the Canty SolidSizer and tablet CQAs using the Sotax AT4. Preliminary results reveal that the RSG appears to affect bulk density and granule size distribution, but the trend is unclear. Additionally, experiments must be performed to understand the relationship between the RSG and tablet CQAs.

Source:

Purdue University / 2023

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Co-authors:

Jayden Pierce