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Formation of Dispersible Taohong Siwu Tablets
Published on: February 3, 2023
Quality by design approach for formulation development: a case study of dispersible tablets
Naseem A Charoo1, Areeg A A Shamsher, Ahmed S Zidan
1Blue Nile Pharmaceutical Company, Khartoum, Sudan.
International Journal of Pharmaceutics
|January 3, 2012
Summary
The quality by design (QbD) approach enhances dispersible tablet development by linking critical parameters to quality attributes. This systematic method improves product quality, reduces risks, and boosts productivity for better patient compliance.
Area of Science:
- Pharmaceutical Sciences
- Drug Delivery Systems
Background:
- The development of orally disintegrating tablets (ODTs) requires robust manufacturing processes to ensure consistent quality and patient compliance.
- Traditional methods often lack the systematic approach needed to proactively identify and mitigate risks.
- Quality by Design (QbD) offers a framework for enhanced product development and understanding.
Purpose of the Study:
- To apply the Quality by Design (QbD) paradigm to the development of dispersible tablets.
- To identify critical quality attributes (CQAs) and critical material/process attributes (CMAs/CPAs) for dispersible tablets.
- To establish a design space and control strategy for robust dispersible tablet manufacturing.
Main Methods:
- Utilized a QbD approach, including risk assessment and Quality Target Product Profiling (QTPP).
- Performed physicochemical characterization and excipient compatibility studies for a model biopharmaceutical Class II drug.
- Employed Design of Experiments (DoE) to investigate the impact of CMAs/CPAs on CQAs.
- Defined a design space and implemented a control strategy to manage risks.
Main Results:
- Critical quality attributes (CQAs) were identified through initial risk analysis.
- Physicochemical properties and excipient compatibility were thoroughly evaluated.
- A design space was successfully established, demonstrating that risk factors for potential failure modes were maintained below critical levels after control strategy implementation.
- Compliance with the design space allows for real-time batch release.
Conclusions:
- The QbD approach, integrated with risk and quality management tools, provides an effective and efficient framework for building quality into dispersible tablets.
- This methodology leads to improved product quality, reduced variability, and enhanced patient compliance.
- The QbD paradigm facilitates flexible regulatory approaches and continuous improvement opportunities.
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