Omarigliptin is a novel dipeptidyl peptidase 4 (DPP4)-inhibitor indicated in the treatment of type 2 diabetes mellitus (T2DM). The incretin hormones, glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP), are released by the gut in response to food intake and an increase in blood glucose. These hormones stimulate insulin secretion in a glucosedependent manner. Additionally, GLP-1 has been shown to inhibit glucagon release and decrease in gastric emptying. In rodent studies, it promotes the regeneration and differentiation of islet β-cells. However, GLP-1 is not a stable peptide and is cleaved rapidly to its inactive form by DPP-4. Inhibition of DPP-4 prolongs the circulating half-life of glucagonlike peptide 1 and glucose-dependent insulinotropic polypeptide. By increasing the circulating concentration of GLP-1 and GIP, DPP-4 inhibitors improve glucose control in patients with type 2 diabetes.
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:
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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.