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Improving tablet coating robustness by selecting critical process parameters from retrospective data
A Galí1,2, E García-Montoya2, M Ascaso1
1a Department of Pharmacy and Pharmaceutical Technology , University of Barcelona , Barcelona , Spain and.
Pharmaceutical Development and Technology
|May 29, 2015
Summary
This study optimized pharmaceutical tablet coating by identifying critical process parameters (CPP) using retrospective data. This approach enhances process robustness and quality with minimal experimental investment.
Area of Science:
- Pharmaceutical Manufacturing
- Process Engineering
- Quality by Design
Background:
- Tablet coating processes are vital in pharmaceuticals but often lack robustness, leading to quality variations.
- Up-scaling these processes presents challenges due to parameter sensitivity and inconsistent outcomes.
Purpose of the Study:
- To identify critical process parameters (CPP) for tablet coating using historical commercial batch data.
- To establish a robust design of experiments (DoE) to improve coating process reliability.
Main Methods:
- Retrospective analysis of 36 commercial tablet coating batches with varying quality results.
- Statistical data processing using Statgraphics 5.1 software to determine CPP.
Main Results:
- Identification of critical process parameters (CPP) influencing tablet coating quality.
- Proposal of new, optimized working ranges for improved process control.
Conclusions:
- Retrospective data analysis enables CPP determination and design space creation for existing pharmaceutical processes.
- This statistical approach optimizes process robustness with minimal additional experimental cost.
Keywords:
Coating defectscoating optimizationcritical process parametersdesign of experimentsdesign spaceretrospective dataMore Related Videos
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