QbD Application in Pharmaceutical Development for Nano Formulation

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“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.

 

1. 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:

 

1. Introduction
   1. Pharmaceutical developments – new prospects
   2. Nanosystems in pharmaceutical technology and nasal delivery
   3. QbD in pharmaceutical nano-development
2. Materials and methods
   1. Definition of the TPP and QTPP
   2. Determination of CQAs
   3. Determination of CPPs
   4. Risk Assessment
   5. Design and preparation of a product for nasal use containing nanosized meloxicam
   6. Testing methods of the developed nanosized product
   7. Particle size and surface morphology
   8. Evaluation of physical state
   9. Solubility testing
   10. Dissolution study
   11. Cell culture model
   12. In vivo tests
3. Results
   1. Risk Assessment and priority sorting
   2. Comparison of the theoretical results and practical measurements
4. Discussion
5. Conclusion

 

Conclusion

 

Read the paper. Also subscribe if you’d like to be notified when Dr. Pallagi’s shares her QbD journey.