Generic tobramycin elutes from bone cement faster than proprietary tobramycin.

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.

Particle size of fillers affects permeability of polymethylmethacrylate.

Particulate soluble filler added to polymethylmethacrylate increases its permeability, leading to increased elution. We asked whether particle size affects permeability and elution rate associated with a given volume fraction of filler. Permeability of filler-loaded PMMA was measured in 9 mm rods with a 32% volume fraction of four particle sizes (106 microm, 212 microm, 425 microm, 850 microm) and two filler materials (sucrose and xylitol) using a modified phenolphthalein-sodium hydroxide technique, which allowed quantitative serial observation on the same specimens. Fluid penetration was faster for larger particle sizes. The elution rate was greater for smaller particle sizes on qualitative visual assessment. Sucrose fillers were not different from xylitol fillers independent of particle size. For the volume fraction of 32%, larger particles lead to larger caliber porosity, less pore interconnectivity, and faster fluid penetration. Smaller size particles lead to smaller caliber porosity, greater pore interconnectivity, smaller areas between the pores with no fluid penetration and greater increase in the effective surface area causing a greater elution rate.