Brexanolone is mixture of allopregnanolone and sulfobutylether-beta-cyclodextrin in development for treatment of postpartum depression and refractory status epilepticus. Although exact mechanism leading to post-partum depression is not known, preclinical clinical work suggests a role for GABAA receptors. Allopregnanolone, the active ingredient in brexanolone, is an allosteric modulator of both synaptic and extrasynaptic GABAA receptors. During pregnancy increasing concentrations of allopregnanolone lead to GABA inhibition which must be quickly reversed at parturition when allopregnanolone concentrations rapidly decline. Treatment with brexanolone is intended to make up for the rapid drop in allopregnanolone at parturition.
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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