Multiparticulates – modern oral drug products for our society; Part 6: DoE case studies in QbD development
In this webinar, Norbert Pöllinger presented a number of case studies showing how the pharmaceutical quality and processing times and cost of multiparticulate manufacturing processes can be optimized. DoE’s are an important tool for product and process development according to the QbD concept.
The Design Space is defined based on the outcome of DoE studies. Moreover, a close look was taken at in vitro dissolution test methods applied – and how individual product quality must be considered when drug release testing method is defined.
At the end, Norbert Pöllinger answered all the questions that arose!
Have a look at the Q&A here:
Question: What kind of software do you use for the DoE statistical processing?
Question: What is the way to optimize the combination between product temperature and other factors in order to obtain the best yield?
Question: Generally, did you try a coating of pellets containing macromolecular drug? If yes, what is the effect of product temperature on the biological activity and release performance?