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Background: Prescription food for special medical purposes (FSMPs) and modified milk products (MMPs), available in pharmacies, are important for newborns and infants that are not breastfed. In the scientific literature there is a lack of comprehensive studies and corresponding safety assessment of the essential trace elements in these products., Objective: The aim of this article was determination of Cu, Mn and Zn levels in the most frequently available prescription FSMPs (n = 6) and MMPs (n = 6) available in Polish pharmacies., Methods: Flame absorption spectrometry (FAAS) following microwave induced digestion (concentrated nitric acid) was applied to determine the levels of the elements in the products., Results: Our studies are based on a triple approach (1) the "raw results" of Cu, Mn and Zn levels (products in powdered form), (2) single intake - the level of each essential trace element consumed in one portion, (3) the daily intake depending on age and weight including comparison with Adequate Intake established by European Food Safety Authority., Conclusion: The results show the occurrence of differences between the manufacturer's declared composition and the finished product for consumption. The prescription FSMPs in comparison to MMPs available in Polish pharmacies contain similar levels of Cu, Mn and Zn. Our results show additionally that all of the products do not represent a health hazard to the newborns and infants. This is a pioneer study in terms of the safety assessment, and quality of prescription FSMPs and MMPs available in Polish pharmacies from toxicological and nutritional point of view., (Copyright © 2019 Elsevier GmbH. All rights reserved.)

The monitoring of elemental impurities (EIs) in pharmaceutical materials is often not adequately treated, although it is a very important topic because the directive ICH Q3D requires a wide range of elements, often at low concentrations, to be monitored. This article describes the quantitative toxicological analysis of copper, manganese and zinc as EIs in the pharmaceutical gels for teething containing herbs available in Poland. The levels of EIs were measured to evaluate whether the intake of these metals through the gels was within recommended levels. The flame absorption spectrometry (FAAS) following microwave induced digestion (concentrated nitric acid) was applied to determine the levels of Cu, Mn and Zn in the products. This article was motivated especially by the facts that: (i) herbs can be a potential source of EIs; (ii) Cu, Mn and Zn are essential trace elements in the infancy period; (iii) there is a general lack of data around the risk assessment associated with exposure to these EIs in this kind of pharmaceutical. Our safety assessment is based on triple approach including: (1) profile of EIs in gels; (2) the actual amount of EIs in the appropriate amount of gel applied with a single administration (one drop) and (3) the daily exposure of EIs in analysed teething pharmaceuticals due to the maximum daily dose. Our results show that all EI levels meet the standards of directive ICH Q3D. It can be concluded that all of the teething gels investigated, based on herbs, available in Polish pharmacies do not represents a health hazard to babies., (Copyright © 2019 Elsevier GmbH. All rights reserved.)

Studies related to the toxicological analyses of metallic impurities in pharmaceuticals (drugs) is an important issue but there is a lack of refereed literature around the safety of teething remedies from herbal origin related to toxic metals impurities. In this article, the levels of Pb and Cd were measured in samples of local anaesthetics for teething (gels) based on herbs. This article was motivated by the fact that Pb and Cd are relevant toxic metals that may cause an adverse effect in babies even at low levels. Additional justifications were (1) the insufficient control of metal impurities in teething gels, (2) the lack of sufficient validation steps and (3) the inadequate sensitivity of applied analytical techniques. The aim of this article was a qualitative and quantitative analysis of Pb and Cd in the most popular and available local anaesthetic for teething (teething gels) based on herbs (n = 5) available in Poland. Metals were determined by ET AAS (electrothermal atomization atomic absorption spectrometry), after digestion in a microwave unit using concentrated nitric acid. It was observed that all samples contained Pb and Cd. The levels of Pb and Cd as impurities (independently of the producer and declared composition) are similar. The concentrations of Pb and Cd, at ng/day levels, to which the user is exposed at daily doses meet the standards of the directive ICH Q3D., (Copyright © 2018 Elsevier GmbH. All rights reserved.)

There is currently a lack of risk assessments around Pb and Cd in prescription food for special medical purposes (FSMPs) and modified milk products available in from pharmacies in Poland. This article describes and evaluates a toxicological analysis of lead and cadmium in prescription FSMPs (n = 6) and modified milk products (n = 6) available in Polish pharmacies. The metals were determined using electrothermal atomisation atomic absorption spectrometry. To make the appropriate risk assessment, we considered (1) the levels of lead and cadmium in a powdered product, (2) the amount of the metals consumed in one portion (single exposure), (3) the daily dose depending on age (months) and body weight and (4) the weekly intake of Pb and Cd in samples in comparison to provisional tolerable weekly intake (PTWI). The results demonstrated that the samples analysed do not represent a health hazard to newborns and infants. This study is important because of the concerns around the complex risk assessment of prescription FSMP's and modified milk products available in Polish pharmacies related to lead and cadmium., (Copyright © 2018 Elsevier GmbH. All rights reserved.)

Trace elements have an impact on numerous physiological processes. The monitoring of their levels in the organism allows you to detect not only their deficiencies, but also several illnesses. The aim of this study was to compare the levels of essential elements (calcium, magnesium, zinc, copper, iron, manganese) in hair, nails and serum of both patients with laryngeal cancer and healthy people. The determination of six metals was performed by an inductively coupled plasma mass spectrometry (ICP-MS) and an inductively coupled plasma optical emission spectrometry (ICP-OES). The concentration of essential elements in hair and nails of the control group was statistically significantly higher than in the group of patients with laryngeal cancer. In the case of serum, differences were found between the patients and controls in respect of the level of three metals. The results of principal component analysis (PCA) revealed the strong and similar clustering behavior of essential elements in hair and nails. The metals did not correlate between two alternative materials. The present study indicated that, using the level of essential elements in hair and nails as a basis, it is possible to distinguish cancer patients from healthy people. The alternative materials are independent of homeostasis and therefore seem to be more useful in the detection of diseases and mineral deficiencies in human than the classical biological materials, such as blood., (Copyright © 2015 Elsevier GmbH. All rights reserved.)

Chronic exposure even to low doses of manganese may lead to development of neurological syndrome similar to parkinsonism. The aim of this research is to assess the possibility of manganese poisoning based on the level of metal in the urine of long-term methcathinone users from Poland. Graphite furnace atomic absorption spectroscopy (GFAAS) was used to determine manganese in urine, while the detection of the psychoactive drugs was performed by high-performance liquid chromatography (HPLC). Results of survey on longitudinal patterns of drug use showed that users of traditional illicit drugs now turn to cheaper alternatives, such as methcathinone. Parkinsonian features were observed in almost half of methcathinone users. The subjects had a higher mean level of Mn in their urine (8.68±9.27 μg L(-1)) than the controls (4.27±1.91 μg L(-1)). The presence of numerous psychoactive substances (in unchanged forms and their metabolites) was confirmed in all of the samples, with only one exception. The elevated level of manganese in urine (in 29.2% of patients) can be used as a primary marker of recent methcathinone administration, especially in the case of long time intravenous drug users where blood sampling is complicated., (Copyright © 2014 Elsevier GmbH. All rights reserved.)