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Inhaled Delivery of Clofazimine - A High Efficiency, Flow Independent, Cellular-Targeted System for Mycobacterial Infections

Smyth HD, Koleng J, Brunaugh AD.

Respiratory Drug Delivery 2020. Volume 1, 2020: 35-46.


Drug resistant pulmonary mycobacterial infections are a global healthcare concern, the risk of which is compounded by the poor compliance associated with lengthy drug treatments. Clofazimine (CFZ) is active against mycobacteria, but use is limited by systemic toxicity (hyperpigmentation, GI effects, and QT prolongation). Inhalation of CFZ could overcome these limitations by achieving high local concentrations of drug at the same time as reducing systemic exposure. Our group has developed a low-cost, simple to use, alveolar macrophage targeted, efficient dry powder inhaler (DPI) that provides reproducible delivery regardless of inhalation force. Strong preliminary data demonstrate the scalability of this device–drug combination system and indicates its suitability for future development, human dosing and treatment. The product under development carries the potential to reduce adverse effects and duration of therapy and could be a therapeutic option for both tuberculosis and non-tuberculous lung infections.

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