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Study of diminutive granules as feed powders for manufacturability of high drug load minitablets

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The maximum drug content in a minitablet is constrained. To reduce the total count of minitablets in a single dose, various pharmaceutical processing techniques can be employed to prepare high drug load minitablets from feed powders with elevated drug content. However, few researchers have explored the impact of these pharmaceutical processing techniques on the properties of high drug load feed powders and, consequently, the manufacturability of high drug load minitablets. In this study, silicification of the high drug load physical mix feed powders alone did not yield satisfactory quality attributes and compaction parameters for producing high-quality minitablets. The abrasive nature of fumed silica increased ejection force and caused damage to the compaction tools. Granulation of fine paracetamol powder proved essential for preparing high-quality high drug load minitablets. The diminutive granules exhibited superior powder packing and flow properties, facilitating homogeneous and consistent filling of the small die cavities during minitablet preparation. Compared to the physical mix feed powders for direct compression, the granules, with higher plasticity, lower rearrangement, and elastic energies, produced superior minitablets with high tensile strength and rapid disintegration time. High shear granulation demonstrated greater process robustness compared to fluid bed granulation, showing less sensitivity to the quality attributes of feed powder. It could proceed without fumed silica, as the high shear forces reduced interparticulate cohesivity. A comprehensive understanding of the properties of high drug load feed powders, characterized by inherently poor compactability and flowability, is crucial for the successful manufacture of high drug load minitablets.
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