Optimized Dry Powder Formulation and Delivery for Inhaled Clofazimine

Treatment regimens for multi drug resistant tuberculosisMDR TBinvolve a spectrum of second tier drugs delivered over a long periodoften over a yearA drug that has shown promise in short regimenssuch as the Bangladesh regimenis oral ClofazimineCFZbut tolerance to oral CFZ is limitedInhaled delivery could potentially limit adverse effects and maximize delivery to the infected pulmonary tissueFormulating CFZ for inhaled delivery is difficult because CFZ has remarkably low solubility in waterCreare and our partners at Creighton University propose to develop an optimizeddry powder formulation and delivery device for inhaled CFZCreighton University has previously developed a process for generating lipid stabilized CFZ powders in a size range suitable for inhaled deliveryCreare will develop a low costdisposable delivery system for inhaled CFZin effecta single use disposable dry powder inhalerDPIWe will develop the CFZ formulation and delivery device in parallelwith the goal of producing a combination drug product that could be used in short MDR TB regimens worldwideA viablelow cost inhaled CFZ product could significantly impact global MDR TB treatment