Abstract High shear wet granulation (HSWG) is considered a complicated and multivariate pharmaceutical process that is influenced by a large number of variables derived from equipment, formulations, and processes. A better understanding and effective control of the granulation process are required to achieve the desired attributes of the final target products and to improve the efficiency of product development. This review provides a comprehensive introduction to the improvement of HSWG-based product development, including the granulation mechanism, factors affecting the granulation process, in-line monitoring technologies, and modeling methods for HSWG process. We also discuss the application of quality by design in process control, especially its two important tools, risk management and design of experience. Additionally, some potential problems and challenges in current research are analyzed and highlighted. The main purpose is to provide comprehensive guidance for formulation scientists to better understand and control the HSWG process and then improve the product development.

中文翻译：

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回顾高剪切湿法制粒以更好地理解、控制和产品开发

摘要 高剪切湿法制粒 (HSWG) 被认为是一种复杂且多变量的制药过程，受到来自设备、配方和工艺的大量变量的影响。需要更好地理解和有效控制造粒过程，以实现最终目标产品的所需属性并提高产品开发效率。本综述全面介绍了基于 HSWG 的产品开发的改进，包括造粒机制、影响造粒过程的因素、在线监测技术和 HSWG 过程的建模方法。我们还讨论了质量源于设计在过程控制中的应用，特别是它的两个重要工具，风险管理和经验设计。此外，分析和强调了当前研究中的一些潜在问题和挑战。主要目的是为配方科学家提供全面的指导，以更好地理解和控制 HSWG 过程，进而改进产品开发。