Effects of moisture content and compression pressure of various deforming granules on the physical properties of tablets

Abstract

The main purpose of this study was to investigate the effects of moisture content (MC) of different deformation granules (brittle, plastic, and elastic) and compression pressure (CP) on the physical properties of tablets. A general full factorial design was used with three blocks (deformation property of excipient) and two control factors: MC and CP. Lactose monohydrate (LM), microcrystalline cellulose (MCC), and corn starch (CS) were selected as brittle, plastic, and elastic materials, respectively. The granules were prepared with a high-shear granulator having a capacity of 0.9L by adding water using a peristaltic pump. This high-shear granulator allows recording of real-time impeller torque values with 1-s intervals. The torque curves can facilitate determination of the transition between saturation stages of a system. Analysis of variance was performed to determine the significance of each factor and their interactions with response variables. All control factors and deformation properties of excipient showed significant effects on the properties of tablets, including ejection force, tensile strength, and porosity (p<0.05). However, their mutual interaction was not significant on the response variables (p>0.05). Analysis of the relationship between ejection work and peak force (Fmax) demonstrated that the ejection work profiles were associated with the deformation properties of the excipient. Moreover, tablet strength was dependent on the control factors and the deformation nature of excipient. As these factors significantly influenced the physical properties of tablets, achieving high-quality tablets would require comprehensive information on the excipient properties while considering the compression process.