WEBINAR - Nanoparticle Suspensions: History, Applications & CMC Aspects
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).
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