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Commentary on AAPS Workshop: dissolution testing for the twenty-first century: linking critical quality attributes
Cheng Tong1, Susan S D'Souza, Jan E Parker
1Pfizer Global Research and Development, Pfizer, Inc., Eastern Point Road, Groton, CT 06340, USA. Cheng.C.Tong@pfizer.com
Pharmaceutical Research
|March 27, 2007
Summary
This workshop explored how traditional dissolution testing aligns with Quality by Design (QbD) and Process Analytical Technology (PAT). Further research is needed to advance dissolution science for better drug development.
Area of Science:
- Pharmaceutical Sciences
- Drug Delivery
- Analytical Chemistry
Background:
- Traditional dissolution testing is a cornerstone of pharmaceutical quality assessment.
- Emerging paradigms like Quality by Design (QbD) and Process Analytical Technology (PAT) necessitate a re-evaluation of existing methods.
- International collaboration is crucial for harmonizing dissolution testing practices.
Purpose of the Study:
- To review and discuss the evolving role of dissolution testing in the context of QbD and PAT.
- To explore challenges and advancements in dissolution testing for novel dosage forms and specification setting.
- To examine methods for dissolution apparatus calibration, including performance verification tablets.
Main Methods:
- Summary report of a workshop attended by pharmaceutical industry, regulatory, and academic experts.
- Discussions focused on integrating dissolution testing with QbD and PAT principles.
- Comparative analysis of calibration methods for dissolution apparatus.
Main Results:
- Identified the need to link critical quality attributes and critical process parameters to clinically relevant dissolution profiles.
- Highlighted challenges in dissolution testing for new drug delivery systems.
- Emphasized the importance of performance verification tablets for apparatus calibration.
Conclusions:
- Advancements in dissolution testing are essential for modern drug development under QbD.
- Further research and collaboration are required to enhance the scientific understanding and application of dissolution testing.
- Harmonization of dissolution testing methodologies globally is a key objective.
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