Abstract
The application of process analysis and control is essential to enhance process understanding and ensure output material quality. The present study focuses on the stability of the feedback control system for a fluidized bed granulation process. Two strategies of dynamic moisture control (DMC) and static moisture control (SMC) were established based on the in-line moisture value obtained from the near-infrared sensor and control algorithm. The performance of these strategies on quality consistency control was examined using process moisture similarity analysis and principal component analysis. The stable moisture control performance and low batch-to-batch variability indicated that the DMC method was significantly better than other granulation methods. In addition, the investigation of robustness further showed that the implemented DMC method was able to produce predetermined target moisture values by varying process parameters. This study provides an advanced and simple control method for fluidized bed granulation quality assurance.
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Abbreviations
- API:
-
Active pharmaceutical ingredient
- CQAs:
-
Critical quality attributes
- CWT:
-
Continuous wavelet transform
- DMC:
-
Dynamic moisture control
- HMI:
-
Human machine interface
- MPC:
-
Model predictive control
- NIR:
-
Near-infrared
- OPC:
-
OLE for process control
- PCA:
-
Principal component analysis
- PID:
-
Proportional integral differential
- PLC:
-
Programmable logic controller
- PLS:
-
Partial least squares
- QbD:
-
Quality by design
- RMSEC:
-
Root mean squares error of calibration
- RMSEP:
-
Root mean squares error of prediction
- RMSECV:
-
Root mean squares error of cross-validation
- RPD:
-
Ratio of performance deviation
- RSD:
-
Relative standard deviation
- SFT:
-
Spatial filtering technique
- SMC:
-
Static moisture control
- SNV:
-
Standard normal variate
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Acknowledgements
This work was supported by the National Key Research and Development Program of China (grant numbers 2021YFB3201200, 2021YFB3201202), the Major Science And Technology Innovation Project of Shandong Province (grant number 2019JZZY021020), the Qinghai Special Project of Innovation Platform for Basic Conditions of Scientific Research of China (grant number 2020-ZJ-T05), the Future Scholar Program of Shandong University, and the Major Scientific and Technological Innovation Project of Shandong (grant number 2018CXGC1405).
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Liang Zhong: substantial contributions to the conception or design of the work, acquisition, analysis, drafting the work, final approval of the version to be published; Lele Gao: acquisition, analysis; Lian Li: revising it critically for important intellectual content; Lei Nie: revising it critically for important intellectual content; Hui Zhang: analysis; Zhongyu Sun: analysis; Ruiqi Huang: analysis; Zhaobang Zhou: analysis; Wenping Yin: analysis; Hui Wang: analysis; Hengchang Zang: substantial contributions to the conception or design of the work, resources, supervision, funding acquisition.
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Zhong, L., Gao, L., Li, L. et al. Implementation of Dynamic and Static Moisture Control in Fluidized Bed Granulation. AAPS PharmSciTech 23, 174 (2022). https://doi.org/10.1208/s12249-022-02334-5
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DOI: https://doi.org/10.1208/s12249-022-02334-5