Prednisolone sodium metazoate, also known as prednisolone metasulfobenzoate sodium or PRED-MSB, is indicated for use in the treatment of inflammatory bowel disease, ulcerative colitis, proctitis, and GI disorders. Prednisolone sodium metazoate is a poorly adsorbed analog of prednisolone, a synthetic glucocorticoid with similar properties to prednisolone as an anti-inflammatory agent with immuno-suppressant glucocorticoid properties. After cell surface receptor attachment and cell entry, prednisolone enters the nucleus where it binds to and activates specific nuclear receptors [glucocorticoid response elements (GRE)], resulting in an altered gene expression and inhibition of proinflammatory cytokine production. The anti-inflammatory actions of glucocorticoids are thought to involve phospholipase A2 inhibitory proteins and lipocortins, which control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes.
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.