Synthesize three kilograms of poly-L-(-)lactide RSV + 1.0 (+,-)0.2 dl/g for the encapsulation of levonorgestrel. Prepare sufficient quantity of microcapsules, using Good Manufacturing Practice as specified by the FDA, for use in physical-chemical characterization, preclinical evaluation in animals, and future clinical studies. Determine the in vitro hormone release properties and the physical-chemical properties of the microcapsules. Provide microcapsules to NICHD for in vivo studies to determine hormone blood levels, duration of release, dose response, and reproducibility. Provide microcapsules to NICHD to evaluate the safety of the microcapsules in animals. Submit application for IND to the FDA for clinical studies.
