Biodegradable Antibiotic Beads for Osteomyletis

Deep infection following open fractures or bone surgery are a challenging orthopedic problem. The ugentamicin-impregnated PMMA cement or beads has become a successful part of the management of osteomchronic post-fracture infections, but these materials have disadvantages, such as the need for a secthe PMMA, the existence of many gentamicin-immune organisms, and highly non-uniform delivery. The obprogram is to develop improved anti-osteomyelitic beads based on biodegradable polymers, better anticontrolling coating. The proposed 3 to 6 mm beads will employ two antibiotics in a porous polylactidcore surrounded by a rate-controlling PLG coating. The beads are intended to deliver a minimum inhibantibiotic for 60 days and to disappear within 60-90 days. The proposal describes methods of bead prcharacterization for a six month Phase I program. Phase II will optimize the formulation, conduct instudy stability, and prepare and submit an IND.