title: The development of an injection-molding process for a polyanhydride implant containing gentamicin sulfate.
abstract: 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.
authors.affiliation: Hospital Products Division, Abbott Laboratories 97D/AP4, 100 Abbott Park Rd., Abbot Park, IL 60064, USA. DENGJS@HPD.Abbott.com
authors.forename: Jone-Shin
authors.initials: JS
authors.lastname: Deng
authors.forename: Marts
authors.initials: M
authors.lastname: Meisters
authors.forename: Luk
authors.initials: L
authors.lastname: Li
authors.forename: Jeff
authors.initials: J
authors.lastname: Setesak
authors.forename: Lee
authors.initials: L
authors.lastname: Claycomb
authors.forename: Youqin
authors.initials: Y
authors.lastname: Tian
authors.forename: Dennis
authors.initials: D
authors.lastname: Stephens
authors.forename: Matt
authors.initials: M
authors.lastname: Widman
mesh_terms: D000812:Anhydrides; D000900:Anti-Bacterial Agents / Q000008:administration & dosage* / Q000627:therapeutic use; D003652:Decanoic Acids / Q000737:chemistry*; D004343:Drug Implants; D005227:Fatty Acids / Q000737:chemistry*; D005839:Gentamicins / Q000008:administration & dosage* / Q000627:therapeutic use; D066298:In Vitro Techniques; D010019:Osteomyelitis / Q000188:drug therapy; D011108:Polymers / Q000737:chemistry*; D013678:Technology, Pharmaceutical / Q000295:instrumentation / Q000379:methods*
chemical_list: D000812:Anhydrides; D000900:Anti-Bacterial Agents; D003652:Decanoic Acids; D004343:Drug Implants; D005227:Fatty Acids; D005839:Gentamicins; D011108:Polymers; C456619:poly(fatty acid dimer-sebacic acid)