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This Small Business Innovation Research Phase I (SBIR) project will use ink-jet printing technology to fabricate precision biodegradable microspheres, 20-200m in diameter, for sustained-release of bioactive substances. The microspheres will be fabricated at specific diameters, as determined by the application, thereby producing an excellent platform for delivery of drugs, hormones, growth factor, DNA vectors / plasmids, cytokines, and enzymes. For the initial application, the microspheres will incorporate antineoplastic agents, such as taxol, for the treatment of head and neck cancer. The physical parameters of the microspheres will be verified with a scanning electron microscope. Release kinetics profiles of the taxol loaded microspheres will be determined by in vitro pharmacokinetic modeling. Quantification of antineoplastic agent release will be performed by High Performance Liquid Chromatography. Retention of efficacy will be tested by first fabricating the taxol microspheres and then extracting and testing the antineoplastic agent in a cell culture model of squamous cell carcinoma. The intact microspheres will also be tested in a nude mouse model of human squamous cell carcinoma.
The commercial applications of this project will be in human therapeutics as an alternative to conventional administration of those drugs that have a short half-life or that cause considerable systemic effects.