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The Toxicological Risk Assessment (TRA) of Total Chromium Impurities in Menthae piperitae tinctura (Mentha x piperita L., folium) Available in Polish Pharmacies Including Regulatory Approaches with Special Emphasis of Cr Speciation and Genotoxicity

Chromium is pharmacologically active and is not an essential element but is still very intriguing and demanding from the point of view of toxicological risk assessment. Especially as an elemental impurity in final pharmaceuticals. The aim of this article is toxicological risk assessment (TRA) of tot...

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Autores principales: Jurowski, Kamil, Krośniak, Mirosław
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer US 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10073164/
https://www.ncbi.nlm.nih.gov/pubmed/35902513
http://dx.doi.org/10.1007/s12011-022-03367-4
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author Jurowski, Kamil
Krośniak, Mirosław
author_facet Jurowski, Kamil
Krośniak, Mirosław
author_sort Jurowski, Kamil
collection PubMed
description Chromium is pharmacologically active and is not an essential element but is still very intriguing and demanding from the point of view of toxicological risk assessment. Especially as an elemental impurity in final pharmaceuticals. The aim of this article is toxicological risk assessment (TRA) of total Cr impurities in Menthae piperitae tinctura (Mentha x piperita L., folium) available in Polish pharmacies including triple approach. Obtained raw/basal results shows that impurities of total Cr impurities were present in all investigated pharmaceutical with Mentha x piperita L., folium. but at a relatively low level (in the range: 0.39–2.14 µg/L). The regulatory strategy based on the ICH Q3D (R1) elemental impurities guidelines confirms that all the requirements of the analyzed products meet the European Medicine Agency (EMA) requirements. Obtained results obtained show that the estimated maximum daily exposure to Cr (ng/day) are variable between the samples (0.521–3.792 ng/day), but at a relatively low level (< 4.0 ng/day).The final step confirms the safety of analyzed pharmaceuticals, because the comparison of the estimated results with the oral PDE value for Cr in final drugs suggested by the ICH Q3D guideline (10,700 µg/day) show that all the products are below this value. The approach based on the margin of exposure (MoE) for children and adults also confirms the safety of all the products with Mentha x piperita L., (in all cases MoE >  > 10 000). It can be concluded that all the samples analyzed should not represent any health hazard to patients due to Cr impurities. To our knowledge, this is the first study about application of comprehensive TRA of total Cr impurities in phytopharmaceuticals with Mentha x piperita L., folium available in European pharmacies. Additionally, we confirm the safety of Cr impurities by applying triple regulatory strategy without the application of an expansive and demanding HPLC-ICP-MS technique for Cr speciation. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s12011-022-03367-4.
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spelling pubmed-100731642023-04-06 The Toxicological Risk Assessment (TRA) of Total Chromium Impurities in Menthae piperitae tinctura (Mentha x piperita L., folium) Available in Polish Pharmacies Including Regulatory Approaches with Special Emphasis of Cr Speciation and Genotoxicity Jurowski, Kamil Krośniak, Mirosław Biol Trace Elem Res Article Chromium is pharmacologically active and is not an essential element but is still very intriguing and demanding from the point of view of toxicological risk assessment. Especially as an elemental impurity in final pharmaceuticals. The aim of this article is toxicological risk assessment (TRA) of total Cr impurities in Menthae piperitae tinctura (Mentha x piperita L., folium) available in Polish pharmacies including triple approach. Obtained raw/basal results shows that impurities of total Cr impurities were present in all investigated pharmaceutical with Mentha x piperita L., folium. but at a relatively low level (in the range: 0.39–2.14 µg/L). The regulatory strategy based on the ICH Q3D (R1) elemental impurities guidelines confirms that all the requirements of the analyzed products meet the European Medicine Agency (EMA) requirements. Obtained results obtained show that the estimated maximum daily exposure to Cr (ng/day) are variable between the samples (0.521–3.792 ng/day), but at a relatively low level (< 4.0 ng/day).The final step confirms the safety of analyzed pharmaceuticals, because the comparison of the estimated results with the oral PDE value for Cr in final drugs suggested by the ICH Q3D guideline (10,700 µg/day) show that all the products are below this value. The approach based on the margin of exposure (MoE) for children and adults also confirms the safety of all the products with Mentha x piperita L., (in all cases MoE >  > 10 000). It can be concluded that all the samples analyzed should not represent any health hazard to patients due to Cr impurities. To our knowledge, this is the first study about application of comprehensive TRA of total Cr impurities in phytopharmaceuticals with Mentha x piperita L., folium available in European pharmacies. Additionally, we confirm the safety of Cr impurities by applying triple regulatory strategy without the application of an expansive and demanding HPLC-ICP-MS technique for Cr speciation. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s12011-022-03367-4. Springer US 2022-07-28 2023 /pmc/articles/PMC10073164/ /pubmed/35902513 http://dx.doi.org/10.1007/s12011-022-03367-4 Text en © The Author(s) 2022 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) .
spellingShingle Article
Jurowski, Kamil
Krośniak, Mirosław
The Toxicological Risk Assessment (TRA) of Total Chromium Impurities in Menthae piperitae tinctura (Mentha x piperita L., folium) Available in Polish Pharmacies Including Regulatory Approaches with Special Emphasis of Cr Speciation and Genotoxicity
title The Toxicological Risk Assessment (TRA) of Total Chromium Impurities in Menthae piperitae tinctura (Mentha x piperita L., folium) Available in Polish Pharmacies Including Regulatory Approaches with Special Emphasis of Cr Speciation and Genotoxicity
title_full The Toxicological Risk Assessment (TRA) of Total Chromium Impurities in Menthae piperitae tinctura (Mentha x piperita L., folium) Available in Polish Pharmacies Including Regulatory Approaches with Special Emphasis of Cr Speciation and Genotoxicity
title_fullStr The Toxicological Risk Assessment (TRA) of Total Chromium Impurities in Menthae piperitae tinctura (Mentha x piperita L., folium) Available in Polish Pharmacies Including Regulatory Approaches with Special Emphasis of Cr Speciation and Genotoxicity
title_full_unstemmed The Toxicological Risk Assessment (TRA) of Total Chromium Impurities in Menthae piperitae tinctura (Mentha x piperita L., folium) Available in Polish Pharmacies Including Regulatory Approaches with Special Emphasis of Cr Speciation and Genotoxicity
title_short The Toxicological Risk Assessment (TRA) of Total Chromium Impurities in Menthae piperitae tinctura (Mentha x piperita L., folium) Available in Polish Pharmacies Including Regulatory Approaches with Special Emphasis of Cr Speciation and Genotoxicity
title_sort toxicological risk assessment (tra) of total chromium impurities in menthae piperitae tinctura (mentha x piperita l., folium) available in polish pharmacies including regulatory approaches with special emphasis of cr speciation and genotoxicity
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10073164/
https://www.ncbi.nlm.nih.gov/pubmed/35902513
http://dx.doi.org/10.1007/s12011-022-03367-4
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