Abstract
Control of elemental impurities (EIs) in pharmaceutical herbal products is currently important but not a very popular topic in modern toxicological analysis. The occurrence and concentration of EIs in the pharmaceutical herbal products should be controlled and meet the standards of directive International Conference on Harmonisation’s Q3D Guideline on Elemental Impurities. An interesting area of interest is measuring EIs including toxic and allergic metals in pharmaceutical herbal products for teething. The aim of this article was determination of Ni and Cr impurities in pharmaceutical herbal products for teething available in Polish pharmacies. Justifications were (1) herbs as an important source of EIs and (2) infants may be particularly sensitive to the toxic effects of metals because they tend to absorb a higher fraction of an oral dose. The analysis was carried out using microwave-assisted wet digestion with concentrated nitric acid and electrothermal atomisation atomic absorption spectrometry. The safety assessment involved a triple approach: (1) level of Ni and Cr impurities in pharmaceutical samples; (2) level of Ni and Cr impurities including one-time administration of teething gels and (3) daily intake of metals. In all three cases, the results indicate that the standards of directive ICH Q3D are met for Ni and Cr. Overall, it can be concluded that none of the teething gels represents a health hazard to infants.
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Abbreviations
- AAS:
-
Atomic absorption spectrometry technique
- CRM:
-
Certified reference material
- ET AAS:
-
Electrothermal atomisation atomic absorption spectrometry
- EIs:
-
Elemental impurities
- IARC:
-
International Agency for Research on Cancer;
- ICH Q3D:
-
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
- PDE:
-
Permitted daily exposure
- SD:
-
Standard deviation
- US EPA:
-
The United States Environmental Protection Agency
- WHO:
-
World Health Organisation
References
US Food and Drug Administration (2015) Q3D Elemental impurities - guidance for industry, U. S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER). https://www.fda.gov/downloads/drugs/guidances/ucm371025.pdf. Accessed 16 January 2019.
Tsang KA (2010) Teething, teething pain and teething remedies. Int Dent SA 12(5):48–61. http://www.moderndentistrymedia.com/sept_oct2010/tsang.pdf. Accessed 16 January 2019
Cranswick N, McGillivray G (2001) Over-the-counter medication in children: friend or foe? Aust. Prescr 24(6):149–151. https://doi.org/10.1006/taap.1998.8577
Nielsen GD, Soderberg U, Jorgensen PJ, Templeton DM, Rasmussen SN, Andersen KE, Grandjean P (1999) Absorption and retention of nickel from drinking water in relation to food intake and nickel sensitivity. Toxicol Appl Pharmacol 154:67–75. https://doi.org/10.1006/taap.1998.8577
Vincent JB (2017) New evidence against chromium as an essential trace element. J Nutr 147(12):2212–2219. https://doi.org/10.3945/jn.117.255901
Anderson RA (1993) Recent advances in the clinical and biochemical effects of chromium deficiency. Prog Clin Biol Res 380:221–234 8456128
Anderson RA (1995) Chromium and parenteral nutrition. Nutrition 11(1 suppl):83–86
Sun H, Brocato J, Costa M (2015) Oral chromium exposure and toxicity. Curr Environ Health Rep 2(3):295–303. https://doi.org/10.1007/s40572-015-0054-z
EFSA Panel on Dietetic Products, Nutrition and Allergies (2014) Scientific opinion on dietary reference values for chromium. EFSA J 12(10) https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2014.3845. Accessed 16 January 2019
Jurowski K, Krośniak M, Fołta M, Cole M, Piekoszewski W (2019) The toxicological analysis of Pb and Cd by ET AAS in local anaesthetics for teething (teething gels) based on herbs available in Polish pharmacies. Trace Elem Biol Med 52:18–21. https://doi.org/10.1016/j.jtemb.2018.11.005
Kasznia-Kocot J, Zachwieja Z, Chłopicka J, Krośniak M (1996) The content of certain trace elements and heavy metals in the hair of children from Chorzów. Pediatr Pol 71(2):31–36
IARC (2012) Arsenic, metals, fibres, and dusts: a review of human carcinogens. Monographs on the evaluation of carcinogenic risks to humans. International Agency for Research on Cancer, World Health Organization, Lyon, 100C. https://monographs.iarc.fr/wp-content/uploads/2018/06/mono100C.pdf. Accessed 16 January 2019
US EPA (1996) Nickel, soluble salts (CASRN various). Integrated Risk Information System (IRIS). https://cfpub.epa.gov/ncea/iris/iris_documents/documents/subst/0271_summary.pdf. Accessed 16 January 2019
Alhusban A, Ata S, Shraim S (2018) The safety assessment of toxic metals in commonly used pharmaceutical herbal products and traditional herbs for infants in Jordanian Market. Biol Trace Elem Res 187:307–315. https://doi.org/10.1007/s12011-018-1367-1
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Jurowski, K., Krośniak, M., Fołta, M. et al. Safety Assessment of the Trace Element Impurities Ni and Cr in Pharmaceutical Herbal Products for Teething from Polish Pharmacies. Biol Trace Elem Res 191, 517–521 (2019). https://doi.org/10.1007/s12011-019-1643-8
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DOI: https://doi.org/10.1007/s12011-019-1643-8