Modified Roller Compaction Model to Account for Roll Speed Effect on Powder Compaction in Dry Granulation Process

被引:3
|
作者
Muthancheri, Indu [1 ]
Rousselin, Mario [2 ]
Espinose, Anna [2 ]
Sanchez, Nicolas [2 ]
Authelin, Jean-Rene [3 ]
机构
[1] Sanofi, Proc Engn & Modeling, 350 Water St, Cambridge, MA 02141 USA
[2] Sanofi, DP Dev & Clin Mfg, 371 Rue Prof Blayac, F-34000 Montpellier, France
[3] Sanofi R&D, 1 Impasse Ateliers, F-94403 Vitry Sur Seine, France
关键词
Roller compaction; Roll speed; Process optimization; SCALE-UP;
D O I
10.1016/j.xphs.2024.05.006
中图分类号
R914 [药物化学];
学科分类号
100701 ;
摘要
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. (c) 2024 American Pharmacists Association. Published by Elsevier Inc. All rights are reserved, including those
引用
收藏
页码:2484 / 2491
页数:8
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