Mining Label Data: Assessing the Presence of Ortho-Phthalates in Pharmaceuticals and Dietary Supplements

By Tillett, Tanya | Environmental Health Perspectives, March 2012 | Go to article overview

Mining Label Data: Assessing the Presence of Ortho-Phthalates in Pharmaceuticals and Dietary Supplements


Tillett, Tanya, Environmental Health Perspectives


Plasticizers known as phthalates are used in many medical and household products. They also are used in the coatings on timed-release pharmaceuticals and dietary supplements, and high levels of phthalate metabolites have been found in subjects who take such produces regularly. In a new study, investigators examined available data to determine the extent and scope of ortbo-phrhalate use in pharmaceutical and dietary supplement products marketed in the United Scares and Canada since 1995 [EHP 120(3):379-384; Kelley et al.]

Past studies in animals have shown that some 0/t/w-phthalates such as di(2-cthylhexyi) phthalate (DEHP) and dwz-butyl phrhalate (DBP) exhibit reproductive and developmental toxicity, although no such effects were seen for diethyl phthalate (DEP). Limited data suggest that all 3 compounds may adversely affect male reproductive health in humans.

ortbo-Phthalates are used extensively as excipients (inactive ingre-dienrs) in modified-release medications taken by mouth. These include drugs delivered through controlled release, delayed release, or targeted release systems. Depending on the product, the phthalate coating may protect ingredients from being degraded prematurely by stomach acid, reduce stomach irritation, minimize aftertaste, or make the product easier to swallow.

In the current study, investigators searched a variety of print and electronic information sources to identify brand-name and generic medications and dietary supplements sold in the United States and Canada that contained phthalates as excipients. …

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Mining Label Data: Assessing the Presence of Ortho-Phthalates in Pharmaceuticals and Dietary Supplements
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