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A linear scale-up approach to fluid bed granulation.
Victor N Emenike1, Ivonne Kulla1, Martin Maus1
1Pharmaceutical Development, Boehringer Ingelheim Pharma, 88397 Biberach an der Riss, Germany.
International Journal of Pharmaceutics
|January 25, 2021
Summary
A new linear scale-up approach (LiSA) simplifies complex pharmaceutical fluid bed granulation (FBG) processes. This method effectively scales up FBG by assuming linearity under specific conditions, improving drug product development.
Area of Science:
- Chemical Engineering
- Pharmaceutical Sciences
- Process Engineering
Background:
- Fluid bed granulation (FBG) is a complex pharmaceutical process.
- Its nonlinear nature and interplay of parameters make scale-up challenging.
- Existing scale-up methods struggle with FBG's inherent complexity.
Purpose of the Study:
- To develop a simplified, linear scale-up approach for fluid bed granulation.
- To address the nonlinearities and scale-up difficulties in FBG processes.
- To validate a novel regression-based linear scale-up approach (LiSA).
Main Methods:
- Derivation of the LiSA equation from first principles.
- Application of the similarity principle for scale-up.
- Development and validation of a regression-based LiSA using moisture content and Maus factor.
Main Results:
- The linear scale-up approach (LiSA) was successfully derived and applied.
- A novel regression-based LiSA demonstrated a plausible linear relationship (R²: 0.86-0.98).
- LiSA proved effective in typical industrial settings for two pharmaceutical formulations.
Conclusions:
- LiSA offers a viable linear scale-up strategy for complex FBG processes.
- The regression-based LiSA provides a practical tool for pharmaceutical development.
- This approach enhances the predictability and efficiency of FBG scale-up.
