Dropropizine is indicated for the symptomatic treatment of non-productive or exaggerated, irritative, spasmodic and dry coughs caused by inflammatory, infectious, irritative and allergic processes of the upper and bronchial airways. The safety profile of this medication makes it effective in the treatment of cough in children, viral infections of the upper respiratory tract and most episodes of acute attacks of cough. Dropropizine, which is a racemic mixture ((+/-)-3-(4-phenyl-1-piperazinyl)-1,2-propanediol), has long been used as a synthetic antitussive drug. In the late 1980s, separation of the two enantiomers, levo (S)(-) and dextro (R)(+), was achieved and their activity investigated compared to the racemate. The (S)(-) enantiomer (hereinafter called levodropropizine) was shown to display the same antitussive activity of the racemate in a panel of different animal models of experimentally-induced cough, while demonstrating a better tolerability profile with less effects on the central nervous system. Levodropropizine and the racemate are orally administered non-opioid agents whose peripheral antitussive action may result from their modulation of sensory neuropeptide level within the respiratory tract. In particular, they exert their antitussive effect through an inhibitory action at the level of the C-fibers and were shown to be able to inhibit, in vitro, the release of sensor neuropeptides from C-fibers. In addition, in anesthetized cats, levodropropizine markedly reduces the activation of Cfibers and abolishes the associated reflexes.
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.