Risk assessment of phthalates in pharmaceuticals

Bu Young Chung, Seul Min Choi, Tae Hyun Roh, Duck Soo Lim, Mi Young Ahn, Yeon Joo Kim, Hyung Sik Kim, Byung Mu Lee

Research output: Contribution to journalArticlepeer-review

12 Scopus citations

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.

Original languageEnglish (US)
Pages (from-to)351-360
Number of pages10
JournalJournal of Toxicology and Environmental Health - Part A
Volume82
Issue number5
DOIs
StatePublished - Mar 4 2019

Keywords

  • PVC
  • Phthalates
  • endocrine-disrupting chemicals (EDCs)
  • pharmaceuticals
  • risk assessment

ASJC Scopus subject areas

  • Toxicology
  • Health, Toxicology and Mutagenesis

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