Integration and innovation of wet granulation and continuous manufacturing technology: a review of on-line detection, modeling, and process scale-up.
10.19540/j.cnki.cjcmm.20241216.303
- Author:
Guang-di YANG
1
;
Ge AO
2
;
Yang CHEN
3
;
Yu-Fang HUANG
3
;
Shu CHEN
3
;
Dong-Xun LI
3
;
Wen-Liu ZHANG
3
;
Tian-Tian WANG
3
;
Guo-Song ZHANG
4
Author Information
1. Guangxi University of Chinese Medicine Nanning 530200, China National Engineering Research Center of Chinese Medicine Solid Preparation Manufacturing Technology Nanchang 330006, China.
2. National Engineering Research Center of Chinese Medicine Solid Preparation Manufacturing Technology Nanchang 330006, China Jiamusi University Jiamusi 154007, China.
3. Jiangxi University of Chinese Medicine Nanchang 330006, China National Engineering Research Center of Chinese Medicine Solid Preparation Manufacturing Technology Nanchang 330006, China.
4. Guangxi University of Chinese Medicine Nanning 530200, China Jiangxi University of Chinese Medicine Nanchang 330006, China National Engineering Research Center of Chinese Medicine Solid Preparation Manufacturing Technology Nanchang 330006, China.
- Publication Type:English Abstract
- Keywords:
continuous manufacturing;
on-line detection;
process modeling;
process scale-up;
wet granulation
- MeSH:
Drug Compounding/instrumentation*;
Technology, Pharmaceutical/methods*;
Drugs, Chinese Herbal/chemistry*;
Models, Theoretical
- From:
China Journal of Chinese Materia Medica
2025;50(6):1484-1495
- CountryChina
- Language:Chinese
-
Abstract:
Continuous manufacturing, as an innovative pharmaceutical production model, offers advantages such as high production efficiency and ease of control compared to traditional batch production, aligning with the future trend of drug production moving toward greater efficiency and intelligence. However, the development of continuous manufacturing technology in wet granulation has been slow. On one hand, this is closely related to its high technical complexity, substantial equipment investment costs, and stringent process control requirements. On the other hand, the long-term use of the traditional batch production model has created strong path dependence, and the lack of mature standardized processes further increases the difficulty of technological transformation. To promote the deep integration of wet granulation technology with continuous manufacturing, this review systematically outlines the current application of wet granulation in continuous manufacturing. It focuses on the development of key technologies such as online detection, process modeling, and process scale-up, with the aim of providing a reference for process innovation and application in wet granulation.
