Dissolution Methods for Long-acting Periodontal Drug Products (U01)

There is a lack of compendial or biorelevant in vitro drug release assays for long-acting periodontal dosage forms. These products include biodegradable microspheres, in situ forming implants and matrix tablets. The purpose of this study is to develop a bio-relevant dissolution method for a long-acting periodontal dosage form and to identify the drug product's key physicochemical attributes that affect the drug dissolution behavior and bioavailability. The results from this study will help the FDA in developing recommendations to determine bioequivalence of generic long-acting periodontal drug products.