Please note, this OEL/ADE monograph also applies to tianeptine sodium salt (CAS RN 30123-17-2). Tianeptine is a drug used primarily in the treatment of major depressive disorder (MDD). It has been studied in the treatment of irritable bowel syndrome (IBS). Structurally, it is classified as a tricyclic antidepressant (TCA), however, it possesses different pharmacological properties than typical tricyclic antidepressants. Recent studies suggest that tianeptine acts as a full agonist at the mu-type opioid receptor (MOR). The mu opioid receptors are currently being studied as effective targets for antidepressant therapies. It is believed that the clinical effects of tianeptine are owed to its modulation of these receptors. In addition to its actions on the opioid receptor, previous studies have owed its action to its effect on the serotonin receptor, dopamine (D2/3) receptors and glutamate receptors.
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), as well as PIC/S and ANVISA requirements, and to obtain the following information:
To order an OEL/ADE monograph for Tianeptine, just click the ADD TO CART button.
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Affygility Solutions’ 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.