GMP-compliant automated synthesis of [(18)F]AV-45 (Florbetapir F 18) for imaging beta-amyloid plaques in human brain

Appl Radiat Isot. 2010 Dec;68(12):2293-7. doi: 10.1016/j.apradiso.2010.07.001. Epub 2010 Jul 7.

Abstract

We report herein the Good Manufacturing Practice (GMP)-compliant automated synthesis of (18)F-labeled styrylpyridine, AV-45 (Florbetapir), a novel tracer for positron emission tomography (PET) imaging of beta-amyloid (Abeta) plaques in the brain of Alzheimer's disease patients. [(18)F]AV-45 was prepared in 105 min using a tosylate precursor with Sumitomo modules for radiosynthesis under GMP-compliant conditions. The overall yield was 25.4+/-7.7% with a final radiochemical purity of 95.3+/-2.2% (n=19). The specific activity of [(18)F]AV-45 reached as high as 470+/-135 TBq/mmol (n=19). The present studies show that [(18)F]AV-45 can be manufactured under GMP-compliant conditions and could be widely available for routine clinical use.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Alzheimer Disease / diagnostic imaging
  • Alzheimer Disease / metabolism
  • Amyloid beta-Peptides / metabolism*
  • Aniline Compounds*
  • Automation
  • Chromatography, High Pressure Liquid
  • Ethylene Glycols*
  • Fluorine Radioisotopes*
  • Guideline Adherence*
  • Humans
  • Positron-Emission Tomography

Substances

  • Amyloid beta-Peptides
  • Aniline Compounds
  • Ethylene Glycols
  • Fluorine Radioisotopes
  • florbetapir