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Evaluation of a rotary tablet press simulator as a tool for the characterization of compaction properties of pharmaceutical products

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The Stylcam 100R, designed as a rotary press simulator to replicate speed profiles of rotary tablet presses, has undergone qualification by various laboratories. However, its suitability for investigating powder behavior under pressure needs examination. This study aims to assess the Stylcam 100R's performance in characterizing the compaction behavior and tabletting properties of pharmaceutical powders. The compressibility of three pharmaceutical excipients (microcrystalline cellulose, dicalcium phosphate dihydrate, and alpha-lactose monohydrate) was examined at four compression speeds on the compaction simulator. Force-displacement cycles, along with two energy parameters—specific total energy (Es(tot)) and specific expansion energy (Es(exp))—were analyzed. Mean yield pressure, derived from Heckel's plots obtained through the in-die method, and diametral tensile strength of compacts were measured to evaluate mechanical properties. To assess parameter accuracy, a comparative study was conducted on an eccentric instrumented press. Energy parameter values and tablet tensile strengths closely matched between the eccentric press and the compaction simulator, regardless of compression speed on the latter. However, mean yield pressure values differed between the two presses. In conclusion, the Stylcam 100R appears to be a valuable tool for characterizing the tabletting properties of powders, with the exception of the Heckel model, likely due to an inappropriate deformation equation and the displacement transducers' lack of precision. Future enhancements should address these aspects for improved accuracy.
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