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Implementation of Quality by Design (QbD) for development of bilayer tablets
J Simão1, S A Chaudhary2, A J Ribeiro3
1Faculdade de Farmácia, Universidade de Coimbra, Coimbra, Portugal.
Summary
Implementing Quality by Design (QbD) principles is crucial for developing bilayer tablets. This approach ensures drug product quality and performance by assessing critical material attributes and process parameters.
Area of Science:
- Pharmaceutical Technology
- Drug Delivery Systems
- Quality Management
Background:
- Bilayer tablets enable unique drug release profiles and prevent drug-excipient incompatibilities, unlike conventional tablets.
- Manufacturing complex bilayer tablets requires careful screening of material attributes and optimization of processing parameters for safety and efficacy.
- Common production challenges include weight variation, segregation, and delamination, necessitating strict control over manufacturing stages.
Purpose of the Study:
- To provide a foundation for applying Quality by Design (QbD) principles in bilayer tablet development.
- To systematically assess critical material attributes (CMAs) and critical process parameters (CPPs) against critical quality attributes (CQAs).
- To discuss the application of QbD methodology with practical examples in bilayer tablet technology.
Main Methods:
- Reviewing the principles of Quality by Design (QbD) for pharmaceutical product development.
- Conducting preliminary and systematic risk assessments of CMAs and CPPs.
- Analyzing the relationship between CMAs, CPPs, and in-process/finished product CQAs.
- Examining manufacturing processes like blending, granulation, and compression for bilayer tablets.
Main Results:
- QbD implementation provides a structured approach to identify and control factors affecting bilayer tablet quality.
- Risk assessment identifies critical parameters influencing tablet attributes such as weight, segregation, and layer adhesion.
- Optimized formulation and processing, guided by QbD, can mitigate common bilayer tablet manufacturing issues.
Conclusions:
- QbD is essential for the successful design and development of bilayer tablets, ensuring consistent quality and performance.
- Systematic risk assessment and control of CMAs and CPPs are key to achieving desired CQAs.
- The QbD framework supports regulatory compliance and the development of safe and effective bilayer drug products.
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