SBIR/STTR Phase I: Formulation of Non-Phospholipid Nanoparticles for Delivery of Drugs with Poor Aqueous Solubility

This Small Business Innovation Research Phase I project proposes to improve delivery of clinically used drugs through formulation of a non-toxic, tissue-specific drug delivery vehicle. A number of drugs and drug delivery vehicles cause toxic side effects,thereby limiting the drug dose that can be administered. This Phase I Project proposes to solve these problems by using a proprietary mixture of non-phospholipid lipids for drug delivery. Suspensions of lipid-coated microbubbles (LCM), made with this lipid mixture, have been found to be highly tumor selective. Paclitaxel, delivered in LCM, has been shown to reduce tumors in rats more effectively when compared to paclitaxel delivered in the traditional vehicle, and produced less systemic toxicity. However, there are no methods currently available to generate LCM on a commercial scale. In the course of this Phase I Project, lipid nanoparticles from the proprietary lipid mixture will be developed using a high pressure homogenizer. This will be followed by the formulation of a number of clinically used drugs in lipid and trsting of these formulations in cultured tumor cells. The commercial application of this project will be in the area of pharmaceutical drug delivery.