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Evaluating Scale-Up Rules of a High-Shear Wet Granulation Process

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This study aimed to assess the applicability of commonly employed scale-up rules for the high-shear wet granulation process, utilizing a formulation with low drug loading based on microcrystalline cellulose-lactose. Various granule properties, including particle size, porosity, flow, tabletability, and tablet dissolution, were compared across different scales, employing scale-up rules based on distinct impeller speed calculations or extended wet massing time. The application of the constant tip speed rule resulted in a slightly lower production of granulated material at larger scales. To offset the reduced shear experienced by the granules in larger scales, a prolonged wet massing time proved effective. Rules based on constant Froude number and constant empirical stress generated granules that exhibited greater comparability in terms of compaction performance and tablet dissolution across different scales. The study highlighted the correlation between granule porosity and blend tabletability, as well as tablet dissolution, underscoring the significance of monitoring granule densification (porosity) during scale-up. Ultimately, the research demonstrated the flexibility of choosing different routes during scale-up to achieve comparable granule growth and densification by adjusting water amount, impeller speed, or wet massing time.
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