DPI Aerosol Robustness – Managing Impact of Environmental Relative Humidity

ABSTRACT

It is common that binary dry powder inhalation (DPI) formulations result in variable dose quality when exposed to differences in the surrounding relative humidity (RH) during storage and/or during dose firing. The present work presents two different and complementary approaches to mitigate such general inherent features and produce formulations with robust and predictable aerosolization properties, for instance the fine particle fraction (FPF). The obtained results clearly show that it is possible to produce DPI formulations with virtually no humidity dependence by applying any of the two suggested approaches; active conditioning of API and lactose fines or adding small amount of a force control agent.

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