Robustness Optimization of an Existing Tablet Coating Process Applying Retrospective Knowledge (rQbD) and Validation

Area of Science:

• Pharmaceutical Technology
• Process Engineering
• Quality by Design (QbD)

Background:

• Ensuring consistent inter-tablet coating uniformity is crucial for commercialized coated tablets.
• Optimizing manufacturing processes without dossier variation presents a significant challenge.

Purpose of the Study:

• To verify and validate improvements in inter-tablet coating uniformity for an existing commercial product.
• To demonstrate the effectiveness of a Quality by Design (QbD) approach using design of experiments (DoE).

Main Methods:

• Utilized retrospective statistical analysis to identify critical process parameters (CPP).
• Employed a 2^2 experimental design focusing on product temperature and drum speed.
• Validated optimized parameters through the manufacturing of 42 industrial batches.

Main Results:

• Reduced aesthetic defects in tablet batches manufactured with new working ranges.
• Demonstrated the reliability and effectiveness of the QbD approach for process optimization.
• Confirmed the suitability of the developed model for industrial coating processes.

Conclusions:

• Optimized tablet coating uniformity is achievable for existing commercial products using DoE and retrospective data.
• The validated QbD approach enhances process efficiency without requiring dossier variations.
• This methodology provides a valuable tool for industrial pharmaceutical process optimization.