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Evaluation of lactose based direct tableting agents compressibility behaviour using compaction simulator

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INTRODUCTION: The Compaction Simulator (CS) is a single-punch apparatus designed to record data during the powder compaction process. This study aims to assess the behavior of lactose-based direct tableting agents (DTAs) using the CS, with recorded data utilized for evaluating powder flowability and compressibility. Specifically, the focus is on comparing the compressibility of StarLac® [alpha lactose monohydrate (85%) and white maize starch (15%)] and FlowLac®100 (spray-dried alpha lactose monohydrate) to formulate tablets containing poorly flowable Paracetamol. METHODS: Two lactose-based DTAs were utilized, and their physical characteristics were assessed through measurements of bulk, tapped, and true densities, alongside SEM analysis. Flow properties were calculated using Angle of Repose, Hausner Ratio, and Carr’s Compressibility Index. During in-die compression, compaction simulator data, including force, in-die thickness, and punch displacement, were recorded. Compressibility was determined using the Heckel equation. RESULTS: Results from physical characterization tests revealed no significant differences between the two DTAs. Hardness results indicated that tablet formulations with FlowLac® exhibited greater sensitivity to increases in compression force compared to StarLac®. Heckel plots generated by the compaction simulator during the compression cycle allowed the calculation of yield pressure (Py) values for FlowLac®100 and StarLac®. The Heckel parameter (Py) for FlowLac®100 and StarLac® was determined as 87.5MPa and 85.2MPa, respectively, during the compaction cycle at 5kN. These data suggested that both powders are compressible and exhibit brittle behavior. DISCUSSION AND CONCLUSION: StarLac® displayed less brittle properties, as evidenced by lower sensitivity to compression force. The Py values obtained from the Heckel equation provided insights into the real-time compressibility and plasticity of particles for both DTAs during the compaction cycle.
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