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Improving the Manufacturability of Cohesive and Poorly Compactable API for Direct Compression of Mini-tablets at High Drug Loading via Particle Engineering

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The aim is to employ a particle engineering approach to enhance the manufacturability of a cohesive and challenging-to-compact active pharmaceutical ingredient (API) with a high drug loading, specifically for the direct compression of mini-tablets. A high-shear mixer was utilized for wet milling in the API manufacturing process to achieve the desired particle size distributions. The resulting particles underwent characterization and were blended with excipients to form formulations. These formulated blends were then directly compressed into mini-tablets using a compaction simulator. The mini-tablets' characteristics, including hardness, weight variation, and friability, were assessed and compared with those of mini-tablets prepared using hammer-milled APIs.
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