Tech Forum: Excipients and Processes: Ensuring Successful Development and Scale-Up of Solid Particles for Extended Release

When designing and developing any new controlled release product, it is essential to take a deep look at requirements and investigate how best to fill gaps for every component and process in order to ensure success. Understandably, pharmaceutical companies primarily focus on the drug products and APIs. However, finding the right partners with the extensive excipients and process expertise you need is vital. Quite commonly, extended release particle technology shows great promise in the lab, but encounters difficulties during scale-up with batch-to-batch variability in particle size, drug encapsulation or other factors, and adjustments to the extraction process are often required.

This session will help you understand how excipient composition and properties play a critical role in controlling the release of specific APIs. Looking closely at critical material attributes and critical process parameters not only influences product design, but also helps determine how safe excipients may be manufactured and scaled up to GMP production. We will discuss critical aspects to be considered and controlled when looking at excipient alternatives. Other topics will include particle processing and what should be gathered during scale-up prior to clinical stages. In this forum, we will explore the importance of knowing and controlling aspects of particle manufacturing through scale-up to ensure the successful clinical testing and commercialization of innovative new products.

The aim of this session will be to close any gaps in your understanding of key steps and requirements between research and commercialization, particularly those impacted by your choice of excipients and particle manufacturing process. With access to relevant expertise, you can achieve the control necessary to ensure the successful scale-up of your new drug product.