EMA TIGHTENS RULES ON USING PHTHALATES IN MEDICINE CAPSULES
December 1st, 2014
THE EUROPEAN Medicines Agency (EMA) has released guidance on the maximum amount of three phthalates that should be allowed in pharmaceuticals, because of safety concerns. These plasticisers - diethyl phthalate (DEP), polyvinyl acetate phthalate (PVAP), and dibutyl phthalate (DBP) - can be used to make medicine capsules. An EMA note said that “adverse reproductive and/or developmental effects have been observed in non-clinical studies conducted with DBP, DEP or PVAP.” And because of a dearth of pharmacokinetic exposure data in humans and rats, “it can ...
Full access to this article can be arranged with permission from the client that first ordered it. Please contact us to request access. Entries are uploaded to our archive at least one year after being published by a client – free access is restricted to International News Services journalists for background research only. The article date indicates when copy was filed to a client, not when posted to this archive. Upon client requests, International News Services will remove such articles from the archive or not upload them in the first place. They are included to demonstrate the breadth of topics undertaken by the agency and also to help promote clients’ coverage.