“This method (in QbD) can improve pharmaceutical nano-developments by achieving shorter development time, lower cost, saving human resource efforts and more effective target-orientation.”
Edina Pallagi, PhD, Rita Ambrus, Piroska Szabó-Révész, and Ildikó Csóka (University of Szeged) recently published, “Adaptation of the quality by design concept in early pharmaceutical development of an intranasal nanosized formulation” (International Journal of Pharmaceutics)
I’m very proud of Dr. Edina Pallagi as I’ve witnessed her commitment to Quality by Design in her field of pharmaceutical sciences.
We will interview Dr. Pallagi in a near future. But first, I wanted to share with you now so that you can benefit first. I recommend you download it and more importantly, read it.
Here’s a summary of the publication:
“This study has confirmed that a QbD-based experimental design and Risk Assessment can help to reduce the practical aspects of the early development research in pharmaceutical technology by predicting the parameters that most strongly influence the final quality.
This QbD-based prediction can result in a shorter development time, lower costs, fewer needs for human resources and more effective target orientation. These can be of considerable importance in developments which are expensive, time-consuming and complex, e.g. nano-technological experiments.
Our model example demonstrates the applicability and relevance of QbD in the early stages of pharmaceutical development.”
Here are a few visuals to get a glimpse of what you will be reading.
Researchers first share their roadmap to QbD Application in Pharmaceutical Development.
2. A snapshot of their QbD Risk Assessment – you can see the full list of QTPP’s, CQA’s and CPP’s in the paper. (They chose Lean QbD as their main QbD software.)
3. The results from their QbD risk assessment shows where the authors should focus on during their design space studies.
4. Authors verify that their QbD risk assessment predictions match the results from design space or process characterization experiments.
For further information, here is the table of contents:
- Pharmaceutical developments – new prospects
- Nanosystems in pharmaceutical technology and nasal delivery
- QbD in pharmaceutical nano-development
- Materials and methods
- Definition of the TPP and QTPP
- Determination of CQAs
- Determination of CPPs
- Risk Assessment
- Design and preparation of a product for nasal use containing nanosized meloxicam
- Testing methods of the developed nanosized product
- Particle size and surface morphology
- Evaluation of physical state
- Solubility testing
- Dissolution study
- Cell culture model
- In vivo tests
- Risk Assessment and priority sorting
- Comparison of the theoretical results and practical measurements
Read the paper. Also subscribe if you’d like to be notified when Dr. Pallagi’s shares her QbD journey.