BIODEGRADABLE, CONTROLLED RELEASE OF MODERN PROGESTINS

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In spite of the availability of several newly approved progestins, which could achieve success as modern low-dose oral contraceptives (OC), problems in OC use remain. One consideration in achieving success of these modern progestins is increasing the palatability of the dose form. In order to address this, our team and others have investigated the long term delivery of the contraceptive from an implantable dose form. We previously found that a single dose of levonorgestrel, given in a small cylindrical implant of a poly(lactic-co-glycolic) acid polymer was able to release therapeutically active levels of levonorgestrel for periods of up to two years (as measured in vivo using rats). Two factors now favor the continuation of this work: (l) the FDA approval of a new oral contraceptive formulation based on a modern generation of progestins, derived from levonorgestrel, which allow even lower doses than previous OC's, and (2) our development of a proprietary PLGA technology which facilitates FDA approval, formulation manufacture, and sample integrity. Based on the advances in these two areas, i.e., the drug and the formulation technology, this project will couple these interests with the goal of developing an acceptable, long-acting fertility regulation dose form.