The use of HEPES-buffer in the production of gallium-68 radiopharmaceuticals – time to reconsider strict pharmacopoeial limits?

The use of HEPES-buffer in the production of gallium-68 radiopharmaceuticals – time to reconsider strict pharmacopoeial limits?

Abstract HEPES (4-(2-hydroxyethyl) piperazine-1-ethanesulfonic acid) is a buffer that is used in the radiolabelling of gallium-68 compounds. The beneficial effects of HEPES on molar activity in bioconjugates have been well described. Current strict regulations on the HEPES content in radiopharmaceut...

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Bibliographic Details
Main Authors: Jannie le Roux, Janke Kleynhans, Sietske Rubow
Format: Article
Language:English
Published: SpringerOpen 2021-04-01
Series:EJNMMI Radiopharmacy and Chemistry
Subjects:
HEPES
Gallium-68
Radiopharmaceuticals
Limits
Toxicity
Human use
Online Access:https://doi.org/10.1186/s41181-021-00129-w
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spelling doaj-6c50b19c745644fc9ddda4ebb09497b42021-04-04T11:03:49ZengSpringerOpenEJNMMI Radiopharmacy and Chemistry2365-421X2021-04-01611410.1186/s41181-021-00129-wThe use of HEPES-buffer in the production of gallium-68 radiopharmaceuticals – time to reconsider strict pharmacopoeial limits?Jannie le Roux0Janke Kleynhans1Sietske Rubow2NuMeRI Node for Infection Imaging, Central Analytical Facilities, Stellenbosch UniversityNuclear Medicine Division, Stellenbosch UniversityNuclear Medicine Division, Stellenbosch UniversityAbstract HEPES (4-(2-hydroxyethyl) piperazine-1-ethanesulfonic acid) is a buffer that is used in the radiolabelling of gallium-68 compounds. The beneficial effects of HEPES on molar activity in bioconjugates have been well described. Current strict regulations on the HEPES content in radiopharmaceuticals limit its use when intended for parenteral administration. This short communication summarizes data from the literature on the toxicity of HEPES in dogs after intravenous infusion and the subsequent use in humans. We also highlight the use of HEPES in an FDA labelled intravenous drug formulation. Regulatory institutions may consider this data to review current strict limits.https://doi.org/10.1186/s41181-021-00129-wHEPESGallium-68RadiopharmaceuticalsLimitsToxicityHuman use
collection DOAJ
language English
format Article
sources DOAJ
author Jannie le Roux
Janke Kleynhans
Sietske Rubow
spellingShingle Jannie le Roux
Janke Kleynhans
Sietske Rubow
The use of HEPES-buffer in the production of gallium-68 radiopharmaceuticals – time to reconsider strict pharmacopoeial limits?
EJNMMI Radiopharmacy and Chemistry
HEPES
Gallium-68
Radiopharmaceuticals
Limits
Toxicity
Human use
author_facet Jannie le Roux
Janke Kleynhans
Sietske Rubow
author_sort Jannie le Roux
title The use of HEPES-buffer in the production of gallium-68 radiopharmaceuticals – time to reconsider strict pharmacopoeial limits?
title_short The use of HEPES-buffer in the production of gallium-68 radiopharmaceuticals – time to reconsider strict pharmacopoeial limits?
title_full The use of HEPES-buffer in the production of gallium-68 radiopharmaceuticals – time to reconsider strict pharmacopoeial limits?
title_fullStr The use of HEPES-buffer in the production of gallium-68 radiopharmaceuticals – time to reconsider strict pharmacopoeial limits?
title_full_unstemmed The use of HEPES-buffer in the production of gallium-68 radiopharmaceuticals – time to reconsider strict pharmacopoeial limits?
title_sort use of hepes-buffer in the production of gallium-68 radiopharmaceuticals – time to reconsider strict pharmacopoeial limits?
publisher SpringerOpen
series EJNMMI Radiopharmacy and Chemistry
issn 2365-421X
publishDate 2021-04-01
description Abstract HEPES (4-(2-hydroxyethyl) piperazine-1-ethanesulfonic acid) is a buffer that is used in the radiolabelling of gallium-68 compounds. The beneficial effects of HEPES on molar activity in bioconjugates have been well described. Current strict regulations on the HEPES content in radiopharmaceuticals limit its use when intended for parenteral administration. This short communication summarizes data from the literature on the toxicity of HEPES in dogs after intravenous infusion and the subsequent use in humans. We also highlight the use of HEPES in an FDA labelled intravenous drug formulation. Regulatory institutions may consider this data to review current strict limits.
topic HEPES
Gallium-68
Radiopharmaceuticals
Limits
Toxicity
Human use
url https://doi.org/10.1186/s41181-021-00129-w
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