RT Journal Article
SR Electronic
T1 The Development of an Injection-Molding Process for a Polyanhydride Implant Containing Gentamicin Sulfate
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP 65
OP 77
VO 56
IS 2
A1 Deng, Jone-Shin
A1 Meisters, Marts
A1 Li, Luk
A1 Setesak, Jeff
A1 Claycomb, Lee
A1 Tian, Youqin
A1 Stephens, Dennis
A1 Widman, Matt
YR 2002
UL http://journal.pda.org/content/56/2/65.abstract
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.