Meeting Formulation Challenges for Reproducible Delivery using eFlow® Technology
Denk O, Egle R, Gruber F, Knoch M.
RDD Europe 2013. Volume 1, 2013: 163-174.
Abstract:
Regulatory demands for developing new nebulized drug products for vibrating membrane nebulizers as drug-device combinations have imposed new challenges on formulation as well as device design aspects. This article compares the regulatory requirements of pharmaceutical development in the US and Europe. Traditional and novel formulation approaches are described, including solutions, suspensions, nanosuspensions and colloidal formulation techniques, as well as liposomal or micellar formulations. Formulations for vibrating membrane nebulizers demand additional considerations (e.g., nebulizer residual volume, viscosity, surface tension) and it is important to consider the interactions of the nebulizer configuration and the formulation during development to optimize the drug-device combination to achieve efficient and reproducible delivery.
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