A long-term intra-oral drug delivery system capable of releasing over a period of 1-7 days, therapeutically effective quantities of the anti-fungal agent chlorhexidine will be developed. The drug will be incorporated into a patented drug delivery device and part of the research effort will be devoted to developing a controlled release of near zero order of the active ingredient from a monolithic silicone matrix. A drug delivery system of this type and duration never has been developed before. The device itself is tooth anchored and the drug containing cartridge can be removed and replaced periodically while the anchor member remains semi-permanently attached to the tooth. The attachment mechanism of the device to the tooth will be further improved and an in vitro drug release profile will be established to confirm that therapeutically relevant quantities of the active ingredient, chlorhexidine, are being released. At the end of the grant interval, the drug delivery system will be ready for animal safety and toxicology studies in preparation for IND (investigative new drug) application. This system is unique in that it offers superior patient compliance and topical efficacy in the treatment of oro-esophageal candidiasis of immune deficient individuals.
