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Optimization of Critical Quality Attributes in Tablet Film Coating and Design Space Determination Using Pilot-Scale
Huolong Liu1, Robert Meyer2, Matthew Flamm3
1Department of Chemical Engineering, University of Massachusetts Lowell, 1 University Avenue, Lowell, Massachusetts, 01854, USA.
This study optimized high-speed tablet film coating in continuous manufacturing. Key variables were identified to ensure consistent tablet moisture and coating uniformity, facilitating quality by design.
Area of Science:
- Pharmaceutical Manufacturing
- Chemical Engineering
Background:
- Continuous manufacturing offers advantages over traditional batch processing.
- Tablet film coating is a critical step in pharmaceutical production.
- Optimizing coating processes ensures drug efficacy and stability.
Purpose of the Study:
- To investigate a novel high-speed tablet film coating process for continuous manufacturing.
- To determine the influence of key process variables on coating outcomes.
- To establish a design space for robust and efficient tablet coating.
Main Methods:
- Box-Behnken experimental design to study process variables.
- Development of statistical regression models for predicting process responses.
- Monte Carlo simulations to define the design space based on critical quality attributes.
- Validation of the design space through independent experimental runs.
Main Results:
- Inlet air flow rate, temperature, and suspension spray rate significantly impact coating efficiency, tablet moisture, and uniformity.
- Mathematical models and plots provided comprehensive insights into variable effects.
- A validated design space was established, ensuring tablet moisture below 3.5% and coating uniformity.
Conclusions:
- The study successfully optimized a high-speed tablet film coating process for continuous manufacturing.
- The established design space ensures consistent product quality and facilitates Quality by Design (QbD) implementation.
- This research supports the advancement of efficient and reliable pharmaceutical production lines.
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