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dc.contributor.authorKelley, Katherine E.
dc.contributor.authorHernández-Díaz, Sonia
dc.contributor.authorChaplin, Erica L.
dc.contributor.authorHauser, Russ B.
dc.contributor.authorMitchell, Allen Avrom
dc.date.accessioned2012-04-25T18:14:36Z
dc.date.issued2011
dc.identifier.citationKelley, Katherine E., Sonia Hernández-Díaz, Erica L. Chaplin, Russ Hauser, and Allen A. Mitchell. 2011. Identification of phthalates in medications and dietary supplement formulations in the United States and Canada. Environmental Health Perspectives 120(3): 379-384.en_US
dc.identifier.issn0091-6765en_US
dc.identifier.urihttp://nrs.harvard.edu/urn-3:HUL.InstRepos:8620716
dc.description.abstractBackground: In animal studies, some :ortho-phthalates, including di(2-ethylhexyl) phthalate (DEHP) and di-n-butyl phthalate (DBP), have been shown to be reproductive and developmental toxicants. Human studies show widespread population exposure to background levels of phthalates. Limited evidence suggests that particularly high exposure levels may result from orally ingested medicinal products containing phthalates as excipients (inactive ingredients). Objective: In this study we aimed to identify and describe the scope of prescription (RX) and nonprescription (over-the-counter; OTC) medicinal products and dietary supplements marketed in the United States and Canada since 1995 that include phthalates as excipients.: Methods: We used lists of modified-release drug products to identify potential drug products. Inclusion of phthalates was verified using available electronic databases, print references, published package inserts, product packages, and direct communication from manufacturers. Additional products were identified using Internet searches utilizing keywords for phthalates. Results: Based on labeling information, 6 RX drug products included DBP as an excipient, and 45 specified the use of diethyl phthalate (DEP). Phthalate polymers with no known toxicity—hypromellose phthalate (HMP), cellulose acetate phthalate (CAP), and polyvinyl acetate phthalate (PVAP)—were included in 75 RX products. Three OTC drug and dietary supplement products listed DBP, 64 listed DEP, and > 90 indicated inclusion of polymers.: Conclusions: Numerous RX and OTC drug products and supplements from a wide range of therapeutic categories may use DBP or DEP as excipients in oral dosage forms. The potential effects of human exposure to these phthalates through medications are unknown and warrant further investigation.en_US
dc.language.isoen_USen_US
dc.publisherNational Institute of Environmental Health Sciencesen_US
dc.relation.isversionofdoi:10.1289/ehp.1103998en_US
dc.relation.hasversionhttp://www.ncbi.nlm.nih.gov/pmc/articles/PMC3295354/pdf/en_US
dash.licenseLAA
dc.subjectcoatingen_US
dc.subjectdietary supplementsen_US
dc.subjectexcipientsen_US
dc.subjectmedicationsen_US
dc.subjectpthalatesen_US
dc.titleIdentification of Phthalates in Medications and Dietary Supplement Formulations in the United States and Canadaen_US
dc.typeJournal Articleen_US
dc.description.versionVersion of Recorden_US
dc.relation.journalEnvironmental Health Perspectivesen_US
dash.depositing.authorMitchell, Allen Avrom
dc.date.available2012-04-25T18:14:36Z
dc.identifier.doi10.1289/ehp.1103998*
dash.contributor.affiliatedMitchell, Allen Avrom
dash.contributor.affiliatedHauser, Russ


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