The toxicological analysis of lead and cadmium in prescription food for special medical purposes and modified milk products for newborns and infants available in Polish pharmacies

Jurowski, Kamil; Krośniak, Mirosław; Fołta, Maria; Cole, Michael; Piekoszewski, Wojciech

doi:10.1016/j.jtemb.2018.10.007

Cited by 25 publications

(15 citation statements)

References 17 publications

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“…The target value of Cd was 0.560 ± 0.020 mg/kg and the obtained value was 0.528 ± 0.011 mg/kg. Additionally, the quality control and validation of applied methodology were confirmed by our previously described studies using the similar methodology and apparatus [17][18][19].…”

Section: Analytical Calibration and Analytical Quality Control Strategiesmentioning

confidence: 65%

The Level of Cadmium Impurities in Traditional Herbal Medicinal Products with Plantago lanceolata L., folium (Ribwort Plantain Leaves) Available in Polish Pharmacies — Comprehensive Toxicological Risk Assessment Including Regulatory Point of View and ICH Q3D Elemental Impurities Guideline

Jurowski

Fołta

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et al. 2021

Biol Trace Elem Res

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Plantago lanceolata L., folium (ribwort plantain) is an active pharmaceutical ingredient in traditional herbal medicinal products (THMP) available in pharmacies as a demulcent for the symptomatic treatment of oral or pharyngeal irritations and associated dry cough. This kind of THMP is widely applied among the European population; however, recently, voices have been heard in the public about alleged cadmium impurities. The idea of our study was a comprehensive risk assessment of the Cd impurity exposure and its effect on human health. Our assessment strategy was based on regulatory aspects (raw results versus limits set by FAO/WHO for herbal medicines) and toxicological risk assessment approach based on ICH Q3D guideline for elemental impurities in final pharmaceutical products. The cadmium was determined by electrothermal atomization atomic absorption spectrometry based on our previously described methodology. Obtained results show that all analysed THMP with P. lanceolata L., folium available in the Polish pharmacies contain cadmium impurities, but at a very low level (ranged 0.73 – 20.6 μg/L). The content of Cd in a single dose (ng/single dose) is also very low and is not a threat to patients. The estimated maximum daily exposure (ng/day) of Cd based on the ‘worst-case scenario’ (maximum concentrations by oral administration) meets the standards of ICH Q3D guideline (all results were below oral permitted daily exposure; PDE for Cd, i.e. < 5.0 µg/day). It can be concluded that all analysed samples of THMP with P. lanceolata L., folium should not represent any health hazard to the patients due to cadmium levels. To the best of our knowledge, this is the first study about Cd impurity level in THMP with P. lanceolata L., folium (ribwort plantain leaves) available in European pharmacies.

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Section: Analytical Calibration and Analytical Quality Control Strategiesmentioning

confidence: 65%

The Level of Cadmium Impurities in Traditional Herbal Medicinal Products with Plantago lanceolata L., folium (Ribwort Plantain Leaves) Available in Polish Pharmacies — Comprehensive Toxicological Risk Assessment Including Regulatory Point of View and ICH Q3D Elemental Impurities Guideline

Jurowski

Fołta

Tatar

et al. 2021

Biol Trace Elem Res

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“…In scientific literature, there is a lot of articles focused on the determination of essential trace elements and toxic elements in many commercially available products [9][10][11][12][13]; however, there is a lack of studies about sensitizing metals (nickel) and problematic metals (chromium) in pharmaceutical herbal products, like ointment with Marjoram herb extract (Majoranae herbae extractum) used adjunctively in rhinitis (runny nose). To increase the knowledge around the exposure of the assessment of dermal exposure of patients exposed to nickel and chromium due to application of ointments with Marjoram herb extract, we have assessed the levels of these elements in ointments available in Polish pharmacies.…”

Section: Introductionmentioning

confidence: 99%

The Toxicological Risk Assessment of Dermal Exposure of Patients Exposed to Nickel and Chromium due to Application of Ointments with Marjoram Herb Extract (Majoranae Herbae Extractum) Available in Polish Pharmacies

Jurowski

Fołta

Tatar

et al. 2021

Biol Trace Elem Res

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For elemental impurities that have been studied for transcutaneous absorption, the available data are rarely suitable for proper toxicological risk assessment — there are multiple factors that can influence this dermal absorption. Hence, in our studies, we applied generic and conservative approach — cutaneous permitted daily exposure (CPDE) described in International Conference on Harmonisation’s Q3D Guideline on Elemental Impurities (ICH Q3D). The aim of this article is toxicological risk assessment (TRA) of dermal exposure of patients exposed to nickel and chromium due to application of ointments with Marjoram herb extract (Majoranae herbae extractum) available in Polish pharmacies (n = 5, because only five manufacturers produce this kind of pharmaceutical products in Poland). To make the appropriate TRA approach, we considered (1) raw results (metal per kg of ointment), (2) one-time administration of applied ointments, and (3) daily exposure versus CPDE. Due to the fact the concentrations of Ni generally present in cutaneous products as impurities are not considered sufficient to induce sensitization, the cutaneous and transcutaneous concentration limits (CTCLs) approach was applied for this element assessment. The toxicological analysis was carried out using microwave-assisted wet digestion with concentrated nitric acid and electrothermal atomization atomic absorption spectrometry. Our results show that the ointments with Marjoram herb extract from pharmacies in Poland represent a potential health hazard to patients; however, there may be a requirement for the monitoring of impurities of nickel in future. To the best of our knowledge, this paper is the first study about nickel and chromium content in ointments with Marjoram herb extract (Majoranae herbae extractum).

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“…To the best of our knowledge, there are only few reports on determination of elements in foods for medical purposes in Poland [3][4][5]. These articles report the content of selected metals in prescription food products for special medical purposes and modified milk products for newborns and infants.…”

Section: Introductionmentioning

confidence: 99%

“…There are also single publications on determination of certain minerals in enteral nutrition formulas from Brazil [6] and Spain [7]. In published works, the content of such main elements as Ca, Mg, P, Na, K [6,7], or essential trace elements, i.e., Cu, Mn, Fe and Zn [5][6][7], and potentially toxic metals, i.e., Cd, Cr, Ni and Pb [3,4,7], were quantified. Most often, total concentrations of elements were assessed [3][4][5][6][7], but the dialyzable fraction of Ca, Mg, Fe, Cu and Mn was additionally apportioned [7].…”

Section: Introductionmentioning

confidence: 99%

“…In published works, the content of such main elements as Ca, Mg, P, Na, K [6,7], or essential trace elements, i.e., Cu, Mn, Fe and Zn [5][6][7], and potentially toxic metals, i.e., Cd, Cr, Ni and Pb [3,4,7], were quantified. Most often, total concentrations of elements were assessed [3][4][5][6][7], but the dialyzable fraction of Ca, Mg, Fe, Cu and Mn was additionally apportioned [7]. Prior to element analysis, medicinal food samples were mineralized in concentrated nitric acid [3][4][5][6] in addition to hydrogen peroxide [6].…”

Section: Introductionmentioning

confidence: 99%

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Mineral Constituents Profiling of Ready-To-Drink Nutritional Supplements by Inductively Coupled Plasma Optical Emission Spectrometry

2020

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Nutritional drinks (NDs) are medicinal food products intended for people with different health issues constricting nutrients provision. Eight varieties of milkshake style NDs were analyzed in this work. Prior to element analysis, they were freeze-dried, and concentrations of twenty macro- and microelements in analyzed samples were simultaneously measured by ICP-OES after their mineralization in a closed-vessel microwave-assisted digestion system. Results of this analysis indicated that these NDs must be considered as nutrient-dense foods, taking into account mineral constituents. Consumption of two bottles of such NDs per day provides very a high amount or even an excess of human daily requirements set as Recommended Dietary Allowances (RDAs). Generally, concentrations of determined elements in examined NDs were consistent with data given on the labels—most of differences did not exceed 30% (median: −5.91%, standard deviation: 14%). Discovered very strong and moderate positive correlations between concentrations of major and essential elements (Ca, Mg, P, Cu, Fe, Mn, Zn) were likely due to their incorporation into formulations of analyzed NDs. However, relationships between contents of trace elements were the result of concomitance of these elements in substrates used for examined products production or contamination of substrates.

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The toxicological analysis of lead and cadmium in prescription food for special medical purposes and modified milk products for newborns and infants available in Polish pharmacies

Cited by 25 publications

References 17 publications

The Level of Cadmium Impurities in Traditional Herbal Medicinal Products with Plantago lanceolata L., folium (Ribwort Plantain Leaves) Available in Polish Pharmacies — Comprehensive Toxicological Risk Assessment Including Regulatory Point of View and ICH Q3D Elemental Impurities Guideline

The Level of Cadmium Impurities in Traditional Herbal Medicinal Products with Plantago lanceolata L., folium (Ribwort Plantain Leaves) Available in Polish Pharmacies — Comprehensive Toxicological Risk Assessment Including Regulatory Point of View and ICH Q3D Elemental Impurities Guideline

The Toxicological Risk Assessment of Dermal Exposure of Patients Exposed to Nickel and Chromium due to Application of Ointments with Marjoram Herb Extract (Majoranae Herbae Extractum) Available in Polish Pharmacies

Mineral Constituents Profiling of Ready-To-Drink Nutritional Supplements by Inductively Coupled Plasma Optical Emission Spectrometry

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