Southern Research Institute proposes to conduct a 10-month research project to develop an improved manufacturing method for the production of the intraoral fluoride-releasing device that is being evaluated by the National Institute of Dental Research as a potential system for providing continual topical fluoride for the prevention of dental caries. The project proposes to adapt techniques used in the pharmaceutical industry for the manufacture of coated tablets to the production of fluoride-releasing devices. Successful completion of this project will change the production of fluoride-releasing device from a slow, laborious, manual process into an efficient, semi-automatic process, while also improving the quality and lowering the cost of the devices. The fluoride-releasing devices will have release rates ranging from 0.3 mg fluoride per day for 30 days to 0.05 mg fluoride per day for 180 days. The device will be designed as a membrane-controlled reservoir-type controlled release delivery system. The inner core or matrix shall consist of an intimate mixture of a random hydroxyethyl methacrylate (HEMA):methyl methacrylate (MMA) copolymer and U.S.P. grade sodium fluoride. The core shall be 80% sodium fluoride by weight. The core copolymer shall comprise 50 mole percent of the HEMA moiety and 50 mole percent of the MMA moiety. The core shall be surrounded by a rate-controlling copolymer membrane. The membrane will be a random copolymer containing 70 mole percent of the MMA moiety and 30 mole percent of the HEMA moiety.
