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[Application of multivariate models in whole process control of solid preparations]
An-Hui Yang1, Guo-Lin Shi2, Yu-Ling Liu2
1School of Pharmacy, Jiangxi University of Chinese Medicine Nanchang 330004, China Institute of Chinese Materia Medica, China Academy of Chinese Medical Sciences Beijing 100700, China.
Multivariate models are crucial for pharmaceutical monitoring, optimizing solid preparation production, and ensuring drug quality by analyzing complex relationships between materials, processes, and outcomes.
Area of Science:
- Pharmaceutical Sciences
- Chemical Engineering
- Process Analytical Technology
Background:
- Solid preparation production is a complex, multi-step process.
- Product quality is influenced by numerous material properties and process parameters.
- Effective monitoring and control are essential for consistent pharmaceutical manufacturing.
Purpose of the Study:
- To review the application of multivariate models in solid preparation manufacturing.
- To highlight the role of these models in process optimization and quality control.
- To provide a reference for modeling Chinese medicinal preparations.
Main Methods:
- Literature review of multivariate modeling techniques.
- Analysis of model applications in pharmaceutical process monitoring.
- Synthesis of findings related to material properties, process parameters, and quality attributes.
Main Results:
- Multivariate models offer a comprehensive approach to understanding multi-factor relationships.
- These models are vital for optimizing pharmaceutical production processes.
- Applications span various stages of solid preparation manufacturing.
Conclusions:
- Multivariate models are indispensable tools for pharmaceutical quality control and process optimization.
- This review serves as a valuable reference for applying these models to Chinese medicinal preparations.
- Implementing advanced modeling enhances the reliability and efficiency of drug production.
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