The project focuses on development of a nanoparticulate delivery system for therapeutic agents which are difficult to solubilize in aqueous media. The formulations are particularly aimed at establishing sustained release of anti-cancer agents such as paclitaxel. Significantly improved bioavailability of the agents and reduced toxicity are afforded through the use of non-covalently associated polymeric carriers. The composition of the formulation is optimized for criteria including size, stability and drug loading. This optimization process is performed in connection with animal studies to establish toxicity and efficacy of the newly formulated drug in rodents. The pharmacokinetics of distribution of the therapeutic agent and its carriers is also investigated with the aim of optimizing the circulatory lifetime of the active agents. PROPOSED COMMERCIAL APPLICATIONS: Current estimates put the total US oncology drug market alone at $12 billion, and projected estimates of up to $25 billion in five years appear justified given the nation's aging demographics. Bristol-Myers Squibb's Taxol is a potent anti-cancer drug which posted worldwide sales of over $650 Million in the first half of 1999. Despite its potential to treat a variety of solid tumors, Taxol's use is limited due to toxic side effects. A product with the proven characteristics of paclitaxel combined with reduced toxicity and improved efficacy would be welcomed by the oncology community and gain a significant market share.