OEL Fastrac Catalog

Fluocinonide is a topical glucocorticoid indicated for the for the treatment of eczema and plaque-type psoriasis. Fluocinonide, 0.1% cream (Class I - super-high potency) or 0.05% cream (Class II - high potency), is a glucocorticoid steroid that binds to the cytosolic glucocorticoid receptor. The mechanism of the anti-inflammatory activity of topical corticosteroids, in general, is unclear. However, corticosteroids are thought to act by induction of phospholipase A2 inhibitory proteins, collectively called lipocortins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation (prostaglandins and leukotrienes) by inhibiting the release of their common precursor, arachadonic acid. Arachadonic acid is released from membrane phospholipids by phospholipase A2. Glucocorticoids also facilitate the lipocortin-1 escaping to the extracellular space, where it binds to the leukocyte membrane receptors and inhibits various inflammatory events, respiratory burst and the release of various inflammatory mediators from neutrophils, macrophages and mastocytes. Furthermore, the immune system is suppressed by corticosteroids due to a decrease in the function of the lymphatic system, a reduction in immunoglobulin and complement concentrations, the precipitation of low lymphocyte levels in the blood (lymphocytopenia), and interference with antigen-antibody binding. Like other glucocorticoid agents, fluocinolone acetonide acts as a physiological antagonist to insulin by decreasing the formation of glycogen. It also promotes the breakdown of lipids (lipolysis), and proteins, leading to the mobilization of extrahepatic amino acids and ketone bodies. This leads to increased circulating glucose concentrations in the blood. There is also decreased glycogen formation in the liver.

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.

Why do you need this OEL Fastrac monograph?

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:

• The numerical OEL and control band assignment needed to determine the level of required engineering controls and personal protective equipment
• A listing of all cited references utilized in the derivation of the OEL and ADE
• An expert review and discussion with respect to the critical endpoints of concern, the rationale for the choice of endpoints, and dose that is to be used in the derivation of the ADE (PDE), as required by the EMA's Guideline on setting health-based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities

Benefits of OEL Fastrac monographs

• Fully documented. Over 20 pages in length, with calculations and cited references.
• Save time! Unsurpassed delivery with instant download.
• Save money. Similar documents cost 5-12 times as much.
• Stay current. Automatic notification of revisions.

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HBEL

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