Date recorded: October 21 2020
Pharmaceutical excipients are a key consideration in the development of oral solid dose drug products. Excipients impact a range of pharmaceutical properties, from drug release profiles and the location and the timing of disintegration, to improving the flow properties of powder blends in tableting. These factors have a bearing on the drug product’s safety and efficacy.
Traditionally used as bulking agents, the functionality of excipients is now more closely linked with the overall behavior and efficacy of the final drug product. The drive to understand excipients and how they can create or maintain desired properties has led to the need for more advanced analytics in excipient characterization.
Analysis requirements for excipients include:
- Selection of excipient suppliers for a new or a generic drug product formulation
- Elucidation of how excipient characteristics inform pharmaceutical Critical Quality Attributes (CQAs)
- Confirmation of batch-to-batch consistency
- Demonstration of supportive in vitro bioequivalence (IVBE) data
Join this webinar to learn how our solutions, including multi-detector GPC/SEC, laser diffraction, automated microscopy and Morphologically-Directed Raman Spectroscopy, support pharmaceutical scientists in understanding the properties of their excipients.