Please note, this OEL/ADE monograph also applies to trimebutine base (CAS RN 39133-31-8). Trimebutine maleate is a noncompetitive, spasmolytic agent indicated for the treatment of irritable bowel syndrome (IBS), lower GI motility disorders, and for postoperative paralytic ileus following abdominal surgery. Trimebutine maleate is the salt form of trimebutine and acts directly on smooth muscle to modulate gastric motility by stimulating or inhibiting spontaneous contractions; thereby, regulating abnormal intestinal activity without altering normal motility. Trimebutine binds with high affinity to inactivated calcium channels, which reduces calcium influx, attenuating membrane depolarization and decreases colon peristalsis.
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.