GMP-compliant automated synthesis of [18F]AV-45 (Florbetapir F 18) for imaging Β-amyloid plaques in human brain
Journal
Applied Radiation and Isotopes
Journal Volume
68
Journal Issue
12
Pages
2293-2297
Date Issued
2010
Author(s)
Yao, C.-H.
Lin, K.-J.
Weng, C.-C.
Hsiao, I.-T.
Ting, Y.-S.
Yen, T.-C.
Skovronsky, D.
Kung, M.-P.
Wey, S.-P.
Abstract
We report herein the Good Manufacturing Practice (GMP)-compliant automated synthesis of 18F-labeled styrylpyridine, AV-45 (Florbetapir), a novel tracer for positron emission tomography (PET) imaging of Β-amyloid (AΒ) plaques in the brain of Alzheimer's disease patients. [18F]AV-45 was prepared in 105min 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 [18F]AV-45 reached as high as 470±135TBq/mmol (n=19). The present studies show that [18F]AV-45 can be manufactured under GMP-compliant conditions and could be widely available for routine clinical use. ? 2010 Elsevier Ltd.
Subjects
Β-amyloid plaque imaging; Alzheimer's disease; PET tracer synthesis
SDGs
Other Subjects
Alzheimer's disease; Amyloid plaques; Automated synthesis; Clinical use; Good Manufacturing Practices; Human brain; PET tracer; Radiochemical purity; Radiosynthesis; Specific activity; Sumitomo; Diseases; Glycoproteins; Proteins; Positron emission tomography; 2 [2 [2 [5 [4 [tert butoxycarbonyl(methyl)amino]styryl]pyridin 2 yloxy]ethoxy]ethoxy]ethyl 4 methylbenzenesulfonate f 18; amyloid beta protein; radiopharmaceutical agent; unclassified drug; Alzheimer disease; article; automation; drug purification; drug specificity; drug synthesis; good manufacturing practice; isotope analysis; molecular imaging; neuroimaging; positron emission tomography; priority journal; radioactivity; radiochemistry; Alzheimer Disease; Amyloid beta-Peptides; Aniline Compounds; Automation; Chromatography, High Pressure Liquid; Ethylene Glycols; Fluorine Radioisotopes; Guideline Adherence; Humans; Positron-Emission Tomography
Type
journal article