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Aerosolized Delivery of Anti-Tubercular Drugs


Background Many currently existing drugs for the treatment of TB, especially MDR TB are moderately potent, show restrictions with absorption or oral bioavailability, and have toxicity profiles that make patient management difficult. Aerosolized delivery offers the potential to bypass these barriers to drug efficacy by achieving high drug concentrations in the infected pulmonary tissue with lower systemic exposure and by bypassing first-pass hepatic metabolism, thus allowing increased immediate potency. Given these potential benefits, an easy to use, aerosolized delivery system would represent a significant advance in the treatment of tuberculosis. Though anti-tubercular drugs have been formulated into aerosolized particles by multiple research groups and numerous papers are available in the literature on formulating inhaled therapies for TB, no formulation has yet to be commercialized. Project Goal The goal of this solicitation is to develop an inexpensive, easy to use, aerosolized delivery system of a combination of anti-tubercular drugs that could be used for the treatment of MDR TB. Phase I activities 1. Development of an aerosolized formulation of a combination of anti-tubercular drugs 2. Development of an inexpensive, easy to use platform for delivery of said formulation 3. Initial testing to quantitatively assess for drug efficacy, toxicity and pharmacokinetics including required in-vitro studies. Phase II activities 1. Preclinical studies including required in-vivo testing in a standardized, reproducible, validated small animal model. 2. Development of a well-defined formulation and delivery platform under good manufacturing practices (GMP); 3. Uniformity from lot to lot and be certified under quality control; 4. Scale-up and production for future Phase I clinical study.
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