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High Dose Powders: A Critical Assessment of Needs, Formulation and Delivery Technologies

Young PM.

Respiratory Drug Delivery 2018. Volume 1, 2018: 201-210.

Abstract:

Historically, target drug doses for dry powder inhalers (DPIs) are in the microgram range. However, recently there has been a shift to higher dose therapies that require doses in the milligram range. In order to deliver higher doses, existing powder inhalers have been adapted or new devices have been developed from the ground up.

In general, the use of existing low dose devices results in the requirement for the patient to inhale multiple capsules of a given medicament to reach the target dose (ca. multiple 10-40 mg capsules). Furthermore, the repeated inhalation of multiple doses often results in a cough response. To overcome these issues, high dose devices have been developed (such as TwinCaps®) that utilize two discrete powder compartments or cyclonic-based blister systems such as Cyclops. Again, these are limited in terms of maximum dose and for ultra-high dose powders (> 100 mg) we have seen the development of multi-breath devices such as the Orbital® (Pharmaxis, Australia) and fluidized bed DPI (FB-DPI). Because Orbital and the FB-DPI are multi-breath devices, and require several smaller dose inhalation maneuvers, this could have the potential to reduce tolerability issues.

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