Focus on pharmaceutical excipients - How to use physicochemical analysis to ensure drug product quality

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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.


Dr. Rob Taylor- Product Technical Specialist 
Dr. Serena Agostini - Product Technical Specialist - Separations

Más información

- Who should attend?
Scientists working in drug product formulation and process optimization. Process engineers and scientists working in the manufacture of drug products. Scientists de-formulating innovator drug products as part of generic drug development.

- What will you learn?

  • Understand how Malvern Panalytical’s solutions can be used to analyze different types of excipients.
  • Learn the advantages of multi-detector GPC compared to conventional GPC for a more informed selection of supplier and the measurement of critical quality attributes for polymers and polysaccharides.
  • See the importance of characterizing polymer structure and its impact on the excipient’s functionality.
  • Understand how size distribution and particle shape can help verify comparability between two suppliers to minimize supply chain risks or help with cost-down improvements.
  • Learn how chemical identification by Raman spectroscopy coupled with morphologically-directed imaging can measure API size distributions in complex blends of excipients.