Dissolution Methods for Long-acting Levonorgestrel Intrauterine System (U01)

There is a lack of compendial or biorelevant in vitro drug release assays for long-acting contraceptive intrauterine systems. The objective of this study is to investigate dissolution methods, both real time and accelerated conditions, for levonorgestrel intrauterine system (5-year application) and to analyze their capability of detecting manufacturing differences, predicting in vivo performance, and to evaluate method robustness. The results from this study will help the FDA in developing recommendations to determine bioequivalence of generic intrauterine systems.