Process Development for the Continuous Manufacturing of Carbamazepine-Nicotinamide Co-Crystals Utilizing Hot-Melt Extrusion Technology

Process Development for the Continuous Manufacturing of Carbamazepine-Nicotinamide Co-Crystals Utilizing Hot-Melt Extrusion Technology

<b>Objectives:</b> Hot-melt extrusion (HME) offers a solvent-free, scalable approach for manufacturing pharmaceutical co-crystals (CCs), aligning with the industry’s shift to continuous manufacturing (CM). However, challenges like undefined yield optimization, insufficient risk managemen...

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Bibliographic Details
Main Authors: Lianghao Huang, Wen Ni, Yaru Jia, Minqing Zhu, Tiantian Yang, Mingchao Yu, Jiaxiang Zhang
Format: Article
Language:English
Published: MDPI AG 2025-04-01
Series:Pharmaceutics
Subjects:
hot-melt extrusion
co-crystal
continuous manufacturing
process analytical technology tools
risk assessment
Box–Behnken design
Online Access:https://www.mdpi.com/1999-4923/17/5/568
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