Robert Lee, President of CDMO Division at Lubrizol Life Science – Health
Laurie Goldman, Senior Director of Analytical Services at Lubrizol Life Science – Health
This webinar describes the history, CMC aspects and potential applications of nanoparticle suspensions (NSs). This drug delivery technology should be considered for crystalline, sparingly water-soluble APIs. The presentation highlights applications for sterile products. It may be a viable option to enable IV administration of insoluble APIs and may also be used for long-acting injectables when the nanoparticle suspensions are dosed via IM or SC injection.
Key Takeaways:
- CMC aspects:
- Be able to describe analytical characterization of nanoparticle suspension formulations that include both general properties and those that are specific to the nanoparticle suspensions.
- Have an understanding of the manufacturing process and scalability of nanoparticle suspensions.
- Hear about the importance of excipients along with their function in formulation development of nanoparticle suspensions.
- Have a good idea of the value proposition for using this technology for water-insoluble APIs (i.e., improved bioavailability and/or decreased food variability for oral administration and the potential of pharmaceutically elegant formulations for parenteral delivery along with enabling IV administration and the development of long-acting injectables for IM/SC administration).
