OEL Fastrac Catalog

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.

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.

How to order

To order an OEL/ADE monograph for Dropropizine, just click the ADD TO CART button.

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