Generic Tobramycin Elutes From Bone Cement Faster Than Proprietary Tobramycin

Abstract

Elution of antibiotics from antibiotic-loaded polymethylmethacrylate (AL-PMMA) increases when soluble particulate filler is added to increase the permeability of the PMMA. Antibiotic powder is in itself soluble particulate filler. For greater volume fractions of filler, greater elution occurs. The volume of generic tobramycin powder is more than 3.5 times the volume of proprietary tobramycin powder for a 1.2 g dose leading to the question: Does generic tobramycin elute from AL-PMMA faster than proprietary tobramycin? We performed elution studies on AL-PMMA beads made with 1.2 g of either generic tobramycin or proprietary tobramycin per batch of PMMA. Generic tobramycin eluted more than two times faster than proprietary tobramycin. The release mechanism started as dissolution-driven zero-order release for the generic bead set but for the proprietary bead set the released mechanism started as anomalous diffusion. The release mechanism progressed to diffusion-driven first-order release in both. The increased volume of the generic tobramycin caused more tobramycin to be available for release. The increased elution of tobramycin associated with the greater volume of generic tobramycin powder could lead to clinically higher levels of tobramycin in wound fluid and local tissues; however, the higher volume of powder could potentially cause greater mechanical compromise of the PMMA.