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Studies on the influence of high-shear granulation process on the compressibility of microcrystalline cellulose

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Microcrystalline cellulose (MCC) serves as a diluent in the formulation of oral solid dosage forms. In this predictive study, the wet granulation process was chosen to produce tablets containing losartan potassium, with MCC serving as a model excipient. However, it was observed that the hardness of the tablets did not meet quality standards. This investigation focused on characterizing the impact of the high-shear granulation process on the compressibility of MCC. This characterization involved plotting the compression characteristics curve and examining the mechanism of this effect by considering mechanical properties and powder properties. The study also delved into the analysis of solid-state properties. By employing evaluation methods such as the Heckel equation, Ryshkewitch-Duckworth equation, the energy method, and techniques like PXRD and SEM, it was determined that the high-shear granulation process led to a reduction in the compressibility of MCC. This reduction could be attributed to a decrease in the plastic deformation capacity of MCC and alterations in particle morphology structure. The methodology applied in this study can be extrapolated to other excipients, providing a valuable guideline for addressing potential issues and making informed process selections during the preparation stage of solid formulations.
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