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J Pharm Sci ; 113(8): 2484-2491, 2024 Aug.
Artículo en Inglés | MEDLINE | ID: mdl-38763415

RESUMEN

This study introduces a modification to the roller compaction model proposed by Sousa et al.1 to account for the effect of roll speed on powder compaction in the dry granulation process. The proposed model enhances the prediction accuracy, particularly at higher roll speeds, which are often overlooked in existing models. The modified model is validated using literature data, demonstrating improved performance compared to the original model. Additionally, the model is applied to a pharmaceutical formulation, showing its applicability in an industrial context. The integration of the model into gPROMS allows for global sensitivity analysis and design space exploration, providing valuable insights for process optimization and scale-up. The study contributes to the understanding of roller compaction dynamics and offers a practical tool for decision-making in pharmaceutical manufacturing.


Asunto(s)
Polvos , Polvos/química , Composición de Medicamentos/métodos , Tamaño de la Partícula , Excipientes/química , Tecnología Farmacéutica/métodos , Química Farmacéutica/métodos , Modelos Teóricos
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