The development of an injection-molding process for a polyanhydride implant containing gentamicin sulfate

PDA J Pharm Sci Technol. 2002 Mar-Apr;56(2):65-77.

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.

Publication types

  • Evaluation Study

MeSH terms

  • Anhydrides*
  • Anti-Bacterial Agents / administration & dosage*
  • Anti-Bacterial Agents / therapeutic use
  • Decanoic Acids / chemistry*
  • Drug Implants
  • Fatty Acids / chemistry*
  • Gentamicins / administration & dosage*
  • Gentamicins / therapeutic use
  • In Vitro Techniques
  • Osteomyelitis / drug therapy
  • Polymers / chemistry*
  • Technology, Pharmaceutical / instrumentation
  • Technology, Pharmaceutical / methods*

Substances

  • Anhydrides
  • Anti-Bacterial Agents
  • Decanoic Acids
  • Drug Implants
  • Fatty Acids
  • Gentamicins
  • Polymers
  • poly(fatty acid dimer-sebacic acid)