Biodegradable, Controlled Release of Modern Progestins

In spite of the availability of several newly approved progestins, which could achieve successas modern low-dose oral contraceptives (OC), problems in OC use remain. One consideration inachieving success of these modern progestins is increasing the palatability of the dose form. In orderto address this, our team and others have investigated the long term delivery of the contraceptive froman implantable dose form. We previously found that a single dose of levonorgestrel, given in a smallcylindrical implant of a poly (lactic-co-glycolic) acid polymer was able to release therapeutically activelevels of levonorgestrel for periods of up to two years (as measured in vivo using rats). Two factors nowfavor the continuation of this work: (l) the FDA approval of a new oral contraceptive formulation basedon a modern generation of progestins, derived from levonorgestrel, which allow even lower doses thanprevious OC's, and (2) our development of a proprietary PLGA technology which facilitates FDAapproval, 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 ofdeveloping an acceptable, long-acting fertility regulation dose form.