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Prescription food for special medical purposes (FSMPs) and modified milk products (MMPs) for babies in the infancy period available in pharmacies are increasingly frequently used for newborns and infants-especially in cases where allergies and food-borne diseases are diagnosed. However, there is a lack of scientific study around the safety assessment of the elemental impurities in these products. Importantly, the allergen Ni and the problematic metal Cr are little considered. Hence, the aim of this article was the toxicological analysis of Ni and Cr impurities in prescription FSMPs (n = 6) and MMPs (n = 6) for newborns and infants available in Polish pharmacies. For the best safety assessment, we include three approaches including (1) the levels of Ni and Cr in powdered products, (2) assessment of the daily dose depending on age and body weight of newborns and infants, and (3) the weekly intake of Ni and Cr in samples in comparison to provisional tolerable weekly intake (PTWI). Our results show that, on the basis of our data, the products from pharmacies in Poland investigated in this study do not represent a real health hazard to newborns and infants, although there may be a requirement for the monitoring of levels of Ni. Our results are pioneer and provide valuable data for other scientists and manufacturers.

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.

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.)