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Citation
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HERO ID
5432993
Reference Type
Journal Article
Title
Risk assessment of phthalates in pharmaceuticals
Author(s)
Chung, BY; Choi, SM; Roh, TH; Lim, DS; Ahn, MY; Kim, YJ; Kim, HS; Lee, BM
Year
2019
Is Peer Reviewed?
Yes
Journal
Journal of Toxicology and Environmental Health, Part A: Current Issues
ISSN:
1528-7394
EISSN:
1087-2620
Publisher
Taylor and Francis Inc.
Volume
82
Issue
5
Page Numbers
351-360
Language
English
PMID
30961453
DOI
10.1080/15287394.2019.1598053
Web of Science Id
WOS:000465816600001
URL
https://search.proquest.com/docview/2220279704?accountid=171501
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Abstract
Phthalates are used for industrial plasticizers to impart flexibility and durability to polyvinyl chloride. Despite widespread use of phthalates, reported endocrine-disrupting properties raise safety concerns for consumers. Since phthalates are permitted as excipients in controlled-release capsules and enteric coatings, patients taking drugs containing these chemicals may potentially be at some health risk. In this study, 102 distinct pharmaceutical products were analyzed by gas chromatography/mass spectrometry to determine phthalate content and maximal phthalate exposure rate was calculated. In 102 drug samples, di(2-ethylhexyl) phthalate (DEHP), dibutyl phthalate (DBP), and diethyl phthalate (DEP) were detected in 9.8, 27.45, and 5.88% of cases, respectively. The highest level of DEP was found in extended-release (ER) capsules with concentrations ranging from 935.5 to 1535.37 ppb. The highest levels of DBP (1.32-7.07 ppb) were detected in tablets, whereas highest level (7.07 ppb) of DEHP was found in suspension preparations. The phthalate hazard index (HI) (human exposure tolerable daily intake) was calculated for each sample, but no sample exhibited an HI value exceeding 1; the minimum value taken to indicate a serious health risk. Thus, no apparent serious health risk from phthalate exposure arises from taking these medications. The low HI values suggest that phthalate contamination in pharmaceuticals may not pose an apparent significant risk to humans. However, the sources of phthalate present in pharmaceutical products still needs to be investigated and verified through on-site inspections in manufacturing processes in order to minimize human exposure. It is recommended that measures be taken to prevent phthalate contamination in pharmaceuticals.
Keywords
Phthalates; pharmaceuticals; risk assessment; endocrine-disrupting chemicals (EDCs); PVC
Tags
IRIS
•
Diethyl phthalate (DEP)
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