4.4 Article

A rapid method for creating drug implants: Translating laboratory-based methods into a scalable manufacturing process

Publisher

WILEY
DOI: 10.1002/jbm.b.31617

Keywords

controlled drug release; extrusion; implant; poly-lactic-co-glycolic acid (PLGA); scanning electron microscopy (SEM); formulation

Funding

  1. Stanley Medical Research Institute [RCG 01-314]
  2. National Institute of Mental Health [R01MH074672-01]

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Low compliance with medication is the major cause of poor outcome in schizophrenia treatment While surgically implantable solvent-cast pellets were produced to improve outcome by increased compliance with medication, this process is laborious and time-consuming, inhibiting its broader application (Siegel et al, Eur J Pharm Biopharm 2006,64 287-293) In this study, the previous fabrication process was translated to a continuous and scalable extrusion method Extrusion processes were modified based on in vitro release studies, drug load consistency examination, and surface morphology analysis using scanning electron microscopy Afterward, optimized haloperidol implants were implanted into rats for preliminary analysis of biocompatibility Barrel temperature, screw speed and resulting processing pressure influenced surface morphology and drug release Data suggest that fewer surface pores shift the mechanism from bulk to surface PLGA degradation and longer lag period Results demonstrate that extrusion is a viable process for manufacturing antipsychotic implants (C) 2010 Wiley Periodicals, Inc J Biomed Mater Res Part B Appl Biomater 93B 562-572, 2010

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