PT  - JOURNAL ARTICLE
AU  - Deng, Jone-Shin
AU  - Meisters, Marts
AU  - Li, Luk
AU  - Setesak, Jeff
AU  - Claycomb, Lee
AU  - Tian, Youqin
AU  - Stephens, Dennis
AU  - Widman, Matt
TI  - The Development of an Injection-Molding Process for a Polyanhydride Implant Containing Gentamicin Sulfate
DP  - 2002 Mar 01
TA  - PDA Journal of Pharmaceutical Science and Technology
PG  - 65--77
VI  - 56
IP  - 2
4099  - http://journal.pda.org/content/56/2/65.short
4100  - http://journal.pda.org/content/56/2/65.full
SO  - PDA J Pharm Sci Technol2002 Mar 01; 56
AB  - 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.