Highlights: Determination of essential trace elements -copper, manganese and zinc (Cu, Mn and Zn) in prescription food for special medical purposes (FSMPs) and in modified milk products (MMPs) available in Polish pharmacies for babies in the infancy period; Investigation of discrepancies between declared and analysed levels of Cu, Mn and Zn levels in prescription FSMPs and in MMPs available in Polish pharmacies; Safety assessment of the FSMPs and MMPs (one-time administration) in comparison to adequate intake of Cu, Mn and Zn established by the European Food Safety Authority (EFSA); Diet based on prescription FSMPs and MMPs available in Polish pharmacies does not fulfill the infant's dietary need for Cu and Mn; All products investigated in this study do not represent a health hazard to the consumer due to excess of Cu, Mn and Zn.
Graphical abstract
Highlights: Impurity profile of a five teething gels based on herbs available in Polish pharmacies including Cu, Mn and Zn impurities; The level of elemental impurities in a single administration is not a threat to babies in infancy period; The results of the daily intake of EIs through teething gel (ng/day) are satisfactory and confirm the safety of all teething gels; All investigated teething gels meet the standards of directive ICH Q3D; Each of the teething gels do not represent a health hazard to the infants.
Abstract: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.
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Studies related to the toxicological risk assessment (TRA) of heavy metal impurities (HMIs) in pharmaceuticals are an important issue but there is a lack of refereed literature around the safety of Valeriana officinalis L., radix (Valerian root) as herbal medicinal product (HMP) for the relief of mild nervous tension and sleep disorders according to lead and cadmium impurities. The aim of the study was to estimate the TRA of lead and cadmium in Valeriana officinalis L., radix (Valerian root) as HMP (n = 5) available in Polish pharmacies. In the case of herbal pharmaceuticals, it is particularly important to control the level of HMIs accumulated during the plant’s growth. Perhaps, the exposure for a single dose is not relevant; however, justification of our studies is a fact that herbal therapies are usually long term. Therefore, even small HMI doses as present in particular plant may accumulate in patient body over a long period of time. Levels of lead and cadmium were measured by electrothermal atomization atomic absorption spectrometry. The levels of lead and cadmium as HMIs (independently of the producer and declared composition) are quite similar. Our results are satisfactory, confirming the safety of Valeriana officinalis L., radix (Valerian root) as herbal medicinal product for the relief of mild nervous tension and sleep disorders available in Polish pharmacies according to ICH guideline Q3D. To the best of our knowledge, this paper is the first study about lead and cadmium content as HMIs in HMP containing Valeriana officinalis L., radix (Valerian root).
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