With excipients being crucial for the formulation and performance of a medicine, it is vital that they are carefully selected. Adopting a systematic, QbD approach for excipient selection ultimately leads to better products. It also helps enable more efficient and effective formulation and development processes.
In this Pharmaceutical Technology podcast, HERMES PHARMA experts, Dr Verena Garsuch and Dr Martin Koeberle, discuss:
- How adopting a QbD approach allows you to carefully control and adjust critical quality attributes, such as stability and dissolution rate
- The benefits of using DoE as part of your QbD process
- Recent technological and methodological advances that have significantly improved pharmaceutical formulation and manufacture, including multivariate data analysis, spectroscopy/imaging techniques, and other new process analytical technologies
- The need for QbD when developing innovative dosage forms using novel excipients, such as when using hot melt coating to create orally disintegrating granules (ODGs)