Inhalation: Connecting Formula to Filling
Justin Lacombe, PhD, Vice President, Operations, Experic
Dry powder inhalation (DPI) drug products are rightfully developed for patients with efficacy and safety in mind. However, as products move forward in the drug development process to clinical development, the ability to efficiently manufacture these products becomes critical in order to determine if a process is commercially feasible.
Whether a DPI product can be manufactured at scale is dependent upon chemical and physical properties of the powder. However, if the filling process is evaluated after the formula has been established, filling process risk can be introduced, and in some cases a robust process may not be able to be achieved.
In this webinar, DPI product formulation characteristics, including rheology, density and cohesiveness, will be examined as sources of potential process risk and a case study will demonstrate the impact drug product characteristics can have on processing.
Strategies for mitigating process risk will be presented to avoid revisiting formulation development and the resulting delays in getting DPI products to market.
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