scholarly journals The Comprehensive Toxicological Assessment of Total Chromium Impurities in Traditional Herbal Medicinal Product with Thymi herba (Thymus vulgaris L. and Thymus zygis L.) Available in Pharmacies in Poland: Short Communication

2021 ◽  
Author(s):  
Kamil Jurowski ◽  
Maria Fołta ◽  
Barbara Tatar ◽  
Mirosław Krośniak
Keyword(s):  
Single Dose ◽  
Short Communication ◽  
Pharmaceutical Products ◽  
Thymus Vulgaris ◽  
Total Chromium ◽  
Toxicological Assessment ◽  
Daily Exposure ◽  
Elemental Impurities ◽  
Thymus Zygis ◽  
Herbal Medicinal

AbstractScientific reports about elemental impurities in final pharmaceutical products are essential from a regulatory point of view; unfortunately, there is a lack of studies about this important toxicological topic. The aim of our short communication was determination of total Cr impurities in traditional herbal medicinal products (THMP) with Thymi herba (Thymus vulgaris L. and Thymus zygis L.) available in Polish pharmacies (n = 6, because only six manufacturers produce this kind of pharmaceutical products in Poland). The total content of Cr impurities was determined by atomic absorption spectrometry using electrothermal atomization (ETAAS). Applied comprehensive toxicological risk assessment was based on three main tiers: Tier 1, the comparison of raw results as total Cr impurities profile (metal per L of THMP) with ICH Q3D guideline standards; Tier 2, the estimation of total Cr exposure with a single dose; and Tier 3, the estimation of total Cr daily exposure. We confirmed that total Cr impurities were present in all analyzed THMP with thymi herba (the observed level was below 6.0 µg/L). Total Cr concentration in a single dose can be deceptively high in comparison to the raw results but is not a threat to patients (20.15–63.45 ng/single dose). Moreover, the estimation of total Cr daily exposure shows that all analyzed THMP are characterized by daily dose (40.30–181.41 ng/day) below PDE value (10,700 mg/day); hence, all products meet the standards of ICH Q3D elemental impurities guideline.

scholarly journals 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

2021 ◽  
Author(s):  
Kamil Jurowski ◽  
Maria Fołta ◽  
Barbara Tatar ◽  
Mehmet Berkoz ◽  
Mirosław Krośniak
Keyword(s):  
Risk Assessment ◽  
Dermal Exposure ◽  
Pharmaceutical Products ◽  
Dermal Absorption ◽  
Potential Health ◽  
Daily Exposure ◽  
Elemental Impurities ◽  
Toxicological Risk ◽  
Toxicological Risk Assessment ◽  
Herb Extract

AbstractFor 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).

scholarly journals 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

2021 ◽  
Author(s):  
Kamil Jurowski ◽  
Maria Fołta ◽  
Barbara Tatar ◽  
Mirosław Krośniak
Keyword(s):  
Risk Assessment ◽  
Single Dose ◽  
Plantago Lanceolata ◽  
Medicinal Products ◽  
Herbal Medicinal Products ◽  
Elemental Impurities ◽  
Herbal Medicinal ◽  
Toxicological Risk ◽  
Traditional Herbal Medicinal Products ◽  
Toxicological Risk Assessment

AbstractPlantago 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.

Zu den molekularbiologischen Grundlagen der antientzündlichen Wirkungen von Thymiankrautextrakt, Thymus vulgaris L. und Thymus zygis L., herba

2019 ◽  
Vol 40 (04) ◽  
pp. 158-164
Author(s):  
Kurt Appel ◽  
Thorsten Rose ◽  
Juan Antonio Collado Rojas ◽  
Ute Washausen
Keyword(s):  
Thymus Vulgaris ◽  
Thymus Zygis ◽  
Tnf Α

ZUsammenfassungBereits früher publizierte Daten zeigten günstige Effekte von Thymian bei entzündlichen Prozessen. Um diese Erkenntnisse zu vertiefen, wurde in verschiedenen experimentellen Modellen ein Thymianextrakt auf die hier zugrundeliegenden molekularbiologischen Mechanismen in vitro untersucht. Nachgewiesen wurde eine Hemmung der LPS-induzierten Zytokin-Freisetzung von IL-1β, PGE2 sowie TNF-α in humanen Monozyten, eine Hemmung der LPS-induzierten Phosphorylierung und eine Aktivierung von IκBα sowie eine Inhibition der Transkriptionsaktivität von NF-κB und AP-1 in der Bronchialepithel-Zelllinie A549. Ein weiterer interessanter Befund war eine antagonistische Aktivität des untersuchten Thymianextraktes am TRPA1-Rezeptor, ein Rezeptor, der Hustenreize vermitteln kann. Die Anwendung des Thymianextraktes bei Erkältungs- bzw. Bronchitis-bedingtem Husten, bei dem entzündliche Prozesse auf bzw. in der Schleimhaut involviert sind, darf daher als plausibel gelten.

Elemental impurities in pharmaceutical products adding fuel to the fire

2019 ◽  
Vol 108 ◽  
pp. 104435 ◽  
Author(s):  
M. Maithani ◽  
R. Raturi ◽  
P. Sharma ◽  
V. Gupta ◽  
P. Bansal
Keyword(s):  
Pharmaceutical Products ◽  
Elemental Impurities

scholarly journals Impact of Herbicide Treatments on the Construction Materials in the Roman Wall of Lugo, Spain (UNESCO World Heritage Site)

2021 ◽  
Vol 11 (11) ◽  
pp. 5276
Author(s):  
Beatriz Prieto ◽  
Patricia Sanmartín ◽  
Javier Cancelo-González ◽  
Lucía Torres ◽  
Benita Silva
Keyword(s):  
Construction Materials ◽  
Field Research ◽  
World Heritage ◽  
World Heritage Site ◽  
Thymus Vulgaris ◽  
Thymus Zygis ◽  
Heritage Site ◽  
Herbicide Treatments ◽  
Colour Changes ◽  
Physical Treatments

Combined laboratory and field research examining the possible alterations caused by herbicide treatments applied to the construction materials (schist and some granite, bound with mortar) in the Roman wall of Lugo (NW Spain), declared a World Heritage site by UNESCO in 2000, was performed in three separate studies in the past 20 years. In the summers of 1998 and 1999, the herbicides glyphosate, sulphosate and glufosinate–ammonium, as well as physical treatments (infrared and burning) were separately applied to different areas of the wall. In the spring of 2016, the oxyfluorfen herbicide Goal Supreme® was applied to test areas. In the winter of 2018, three essential oils, Origanum vulgare L., Thymus zygis Loefl. ex L., and Thymus vulgaris L., were each applied to test areas. Mineralogical modifications in the materials (determined by X-ray diffraction analysis), as well as visible physical changes, such as colour changes, and the appearance of saline residues were evaluated after the treatments. In the 1998/9 trial, glyphosate and both physical treatments triggered changes in the vermiculite clay minerals in the schists, and the physical treatments also caused changes in the kaolinite. None of the treatments caused highly perceptible colour changes. The oxyfluorfen herbicide did not cause any mineralogical alterations in the construction materials, but it did generate an increase in chloride, nitrate and sulphate contents of the granite and a slight darkening of this material. In the most recent study, the only deleterious effect observed was a perceptible increase in lightness and reduction in the yellow component after the application of Thymus zygis Loefl. ex L. essential oil to granite.

Antimicrobial activity and chemical composition of Thymus vulgaris, Thymus zygis and Thymus hyemalis essential oils

Food Control ◽  
2008 ◽  
Vol 19 (7) ◽  
pp. 681-687 ◽  
Author(s):  
María C. Rota ◽  
Antonio Herrera ◽  
Rosa M. Martínez ◽  
Jose A. Sotomayor ◽  
María J. Jordán
Keyword(s):  
Antimicrobial Activity ◽  
Chemical Composition ◽  
Essential Oils ◽  
Thymus Vulgaris ◽  
Thymus Zygis
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