Manidipine hydrochloride is indicated for use in the treatment of hypertension. Manidipine is a calcium channel antagonist (dihydropyridine type) with a high degree of selectivity for vasculature. Because of this selectivity, manidipine induces peripheral vasodilation without producing significant effects on the heart or central nervous system at clinically relevant doses. It binds to and dissociates slowly from L- and T-type voltage dependent calcium channels on smooth muscle cells, blocking the entrance of extracellular calcium into the cell and preventing contraction of vascular smooth muscle. This produces vasodilation, which decreases blood pressure. Manidipine produces renal vasodilation and an increase in natriuresis (sodium excretion in the urine), which likely contributes to the antihypertensive effect by reducing blood volume.
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.