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TFF Tac-Lac is an investigational inhaled thin-film freeze-dried formulation of the calcineurin inhibitor tacrolimus combined 1:1 w/w with lactose as a brittle matrix powder designed for pulmonary delivery via nebulizer or dry powder inhaler. Developed using TFF Pharmaceuticals’ thin-film freezing technology, the formulation enables high-aerosol-performance tacrolimus particles that deposit in the transplanted lung to provide local immunosuppression while minimizing systemic exposure, with the goal of preventing or treating lung transplant rejection and potentially other lung diseases requiring immunosuppression. Nonclinical and early clinical studies have shown that inhaled TFF Tac-Lac achieves high lung tacrolimus concentrations with low systemic levels, is generally well tolerated in rodents and healthy volunteers, and may offer similar anti-rejection efficacy to systemic tacrolimus with reduced renal and systemic toxicity.
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