%0 Journal Article %A Jone-Shin Deng %A Marts Meisters %A Luk Li %A Jeff Setesak %A Lee Claycomb %A Youqin Tian %A Dennis Stephens %A Matt Widman %T The Development of an Injection-Molding Process for a Polyanhydride Implant Containing Gentamicin Sulfate %D 2002 %J PDA Journal of Pharmaceutical Science and Technology %P 65-77 %V 56 %N 2 %X A production-scale manufacturing process has been developed for polyanhydride/gentamicin sulfate implants for the treatment of osteomyelitis. Gentamicin sulfate was first dried to an acceptable moisture level by using a tumble vacuum dryer. Dried gentamicin sulfate powder and polyanhydride granules were separately fed into the twin-screw extruder at a pre-determined metering rate using a gravimetric feeding device. The extruded molten mixture was solidified to form strands which were subsequently cut into pellets by using a pelletizer. The pellets were characterized with respect to copolymer molecular weight and drug content uniformity. The pellets were later fed into production-scale injection-molding equipment for implant fabrication. The injection-molding cycle was developed and evaluated in terms of cycle reproducibility. Implants were tested and shown to yield an oriented skin-core structure exhibiting a desirable in-vitro drug release profile. %U https://journal.pda.org/content/pdajpst/56/2/65.full.pdf