Metadoxine is a pyridoxine mixture with pyrrolidonecarboxylic acid (1 to 1 ratio) and has been used in the treatment of alcoholism, alcohol poisoning, and alcohol withdrawal syndrome. It is also under investigation for use in the treatment of attention deficit/hyperactivity disorder (ADHD) and Fragile X syndrome. Metadoxine is an ion-pair salt of pyridoxine (the 4-methanol or des-phosphate form of vitamin B6) and 2-pyrrolidone-5-carboxylate (PCA). Metadoxine exerts its pharmacological effects through the synergistic activity of PCA and pyridoxine. Pyridoxine is a precursor of coenzymes including pyridoxal phosphate, which are necessary for the biosynthesis of four key neurotransmitters (serotonin, epinephrine, norepinephrine, and γ-aminobutyric acid) and for the acceleration of metabolic ethanol degradation. PCA is present in the diet and is produced endogenously; it is linked to the gamma-glutamyl transferase (GT) activity of the liver and reduced levels of glutathione.
Affygility Solutions has an occupational exposure limit (OEL) and control band assignment for this active pharmaceutical ingredient (API). This monograph also contains the acceptable daily exposure (ADE) value.
OEL Fastrac monographs are a cost-effective and convenient way to meet the requirements for PDEs (ADEs) contained in the EMA Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities (EMA/CHMP/CVMP/SWP/169430/2012), and to obtain the following information:
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Affygility Solutions’s OEL Fastrac service is an user-friendly system that enables us to make confident decisions and focus on moving the compound safely through our facility. We can quickly access the database to determine if a new drug is within the OEL Fastrac library, and if so, immediately download a detailed OEL banding report. The OEL Fastrac system has been a helpful tool in our overall EH&S program.