Mascarillas en el contexto de la COVID-19: aspectos legales y utilización. Face masks against the background of the COVID 19 pandemic: legal considerations about their use

Objetivo: Revisar los requisitos de calidad y usos recomendados de los diferentes tipos de mascarillas con objeto de optimizar su uso y facilitar la identificación de los productos no conformes. Método: Se hizo una búsqueda bibliográfica en PubMed, en el Boletín Oficial del Estado y Eudralex; se revisaron las páginas web de los Ministerios de Industria, Comercio y Turismo y Sanidad, así como las normas UNE. Resultados: Los diferentes tipos de mascarillas que se pueden encontrar en el mercado se acogen a diferentes exigencias regulatorias. Las mascarillas higiénicas no se consideran productos sanitarios ni equipo de protección individual y no necesitan autorización. No llevan marcado CE y deben cumplir con la normativa general de los productos de consumo. Para las mascarillas quirúrgicas, los criterios de calidad están definidos en la UNE-EN 14683:2019, son productos sanitarios de clase I según el Reglamento (UE) 745/2017, se les requiere declaración UE de conformidad y debe colocar el marcado CE en el producto. Las mascarillas filtrantes son equipos de protección individual de categoría III, están reguladas por el Reglamento (UE) 2016/425 y deben llevar marcado CE conforme al mismo. Por otro lado, los instrumentos de control de mercado han detectado mascarillas fraudulentas, por ello, ante cualquier duda se debe solicitar información adicional al fabricante o proveedor

A New Mathematical Model for the Characterization of Viscosity Variations in the Aqueous Solutions of Monoalcohols and Polyalcohols

This study aims to investigate the viscosity of binary mixtures of water with different monoalcohols and polyalcohols. The viscosity values of the mixtures of methanol, ethanol, 1-propanol, and 2-propanol were taken from a study published by Herraez and Belda (2004). The values for ethylene glycol, glycerin, and sorbitol were measured using a similar protocol. The viscosity of the mixture is expressed as a function of the molar fraction of the alcohols that ranges from 0 (pure solvent, water in this case) to 1 (pure solute). To represent the viscosity of these mixtures, a new variable, Φ, was introduced. This representation provides a function, η = f(Φ), that has an exponential nature, with which excellent correlation coefficients are achieved with only one coefficient for monoalcohols or two coefficients for polyalcohols. Additionally, the variable Φ highlights the possible critical points, where physicochemical interactions occur between the components of the mixture

New scenario in the field of medical devices in the European Union: Switzerland and the United Kingdom become third countries

Objective: To compare the measures taken by the European Union, Switzerland and the United Kingdom to ensure the continuity of the medical devices market, complying with the requirements of Regulation 2017/745. Method: To carry out this work, a review was made of the official websites of the European Commission, the Spanish Agency for Medicines and Health Products, the Swiss Agency for Therapeutic Products and the Medicines and Healthcare Products Regulatory Agency of the United Kingdom. Bibliographic searches were also conducted on Pubmed and the internet (Google), using terms such as 'withdrawal of the Mutual Recognition Agreement of Swiss European Union medical device conformity certificates, new UK medical device regulation', for a period extending from January 2020 to December 2021. Results: As a result of the disappearance of the legal framework that supported free trade between Switzerland, the United Kingdom and the European Union, products that used to be unrestrictedly distributed in Europe have become imports having to comply with the relevant legal requirements. Distributors for their part have become importers, and declarations of conformity and CE certificates have lost their validity. Furthermore, notified bodies from Switzerland and the United Kingdom are no longer recognized by the European Commission. Switzerland, the United reapea. Kingdom and the European Union have had to grant grace periods to allow regulatory agencies and economic operators to adapt to the new situation. Conclusions: The transition period toward the new economic scenario has not yet ended. Both Switzerland and the United Kingdom have had to take stronger measures than the EU to adapt to the changes. Both Switzerland and the United Kingdom are expected to finally incorporate the requirements of the new Regulation in their internal legal systems

Anomalías de los mercados bursátiles de la UEM: análisis del efecto día de la semana

En los últimos años han aparecido numerosos estudios empíricos referentes a distintas anomalías en los mercados de valores. Dentro de este conjunto de anomalías, destacan las referidas al comportamiento estacional de las rentabilidades de los activos financieros y, en concreto, el efecto día de la semana es uno de los más relevantes. En este sentido, el presente trabajo se centra en la contrastación empírica del efecto día de la semana, mediante la metodología GARCH, en los principales mercados bursátiles de la Unión Económica y Monetaria. Los resultados alcanzados indican la inexistencia de un comportamiento anormal en las rentabilidades de la mayoría de las bolsas analizadas, obteniéndose evidencia de dicho efecto en la volatilidad de estos mercados financieros.For the last years, different empirical studies about stock market anomalies have been published. Among this set of anomalies, the ones related to the seasonal behaviour of the assets have been emphasized, being the day of the week effect one of the most relevant. This work is focussed on the empirical test of the day of the week effect on the main stock markets of the Economical Monetary Union (EMU) by means of the GARCH methodology. The obtained results show the inexistence of an abnormal behaviour in the returns of most of the analysed stock markets, obtaining the evidence of the aforementioned effect on the volatility of these markets

Formulation of liposomes loading lentisk oil to ameliorate topical delivery, attenuate oxidative stress damage and improve cell migration in scratch assay

Pistacia lentiscus L. is a sclerophyllous shrub capable of growing under harsh climatic conditions especially in the Mediterranean Basin. Different products can be obtained from this plant, such as essential oil, mastic gum or even fixed oil. The last is well known for its flavor which is mainly exploited in the food industry. Additionally, it has been traditionally used in the treatment of skin diseases, but, at the moment, any suitable formulation for skin delivery has been formulated and its biological effects was not deeply confirmed. Given that, in the present study, the lentisk oil has been formulated in liposomes at different concentrations (10, 20, 30 mg/ml) and their physicochemical, technological and main biological properties have been evaluated. Vesicles were prepared by using natural soy lecithin and a green and organic solvent free method, thus obtaining spherical, small (~ 118 nm), homogeneously dispersed (0.27) and highly negatively charged (~ -62 mV) vesicles. The used amount of oil loaded in liposomes (10, 20, 30 mg/ml) modulated the penetration ability of vesicles in the skin, favoring the deposition of the payload in the deeper strata. The loading in the vesicles potentiated the ability of oil to counteract the damaging effects caused by hydrogen peroxide in keratinocytes and fibroblasts and facilitate their migration in a cell monolayer lesion. Overall findings suggested that the incorporation of lentisk oil in liposomes made from soy lecithin can be an alternative and natural approach to exploit it in pharmaceutical ad cosmetical applications and manufacturing natural products suitable for the treatment of skin lesions

Innovative strategies to treat skin wounds with mangiferin: fabrication of transferosomes modified with glycols and mucin

im: The moisturizing properties of glycerol, the penetration enhancing capability of propylene glycol and the bioadhesive properties of mucin were combined to improve the carrier capabilities of transfersomes and the efficacy of mangiferin in the treatment of skin lesions. Materials & methods: Mangiferin was incorporated in transfersomes and glycoltransfersomes, which were also modified with mucin. The physico-chemical features were assessed, along with the efficacy against oxidative stress and skin wounds in vitro and in vivo. Results: Glycoltransfersomes promoted the deposition of mangiferin in epidermis and dermis, protected fibroblasts from oxidative stress and stimulated their proliferation. The wound healing and anti-inflammatory efficacy of glycoltransfersomes were confirmed in vivo. Conclusion: Results confirmed the potential of glycoltransfersomes in preventing/treating of skin lesions

Nutriosomes: prebiotic delivery systems combining phospholipid, soluble dextrin and curcumin to counteract intestinal oxidative stress and inflammation

Nutriosomes, new phospholipid nanovesicles specifically designed for intestinal protection were developed by simultaneously loading a water-soluble dextrine (Nutriose® FM06) and a natural antioxidant (curcumin). Nutriosomes were easily fabricated in a one-step, organic solvent-free procedure. The stability and the delivery performances of the vesicles were improved by adding hydroxypropylmetylcellulose. All the vesicles were small in size (mean diameter ~168 nm), negatively charged (zeta potential ~-38 mV, irrespective of their composition), self-assembled predominantly in unilamellar vesicles stabilized by the presence of Nutriose® , which was located in both the inter-lamellar and inter-vesicle medium, as confirmed by cryo-TEM and SAXS investigation. The dextrin acted also as a cryo-protector, avoiding vesicle collapse during the lyophilization process, and as a protector against high ionic strength and pH changes encountered in the gastrointestinal environment. Thanks to the antioxidant properties of curcumin, nutriosomes provided an optimal protective effect against hydrogen peroxide-induced oxidative stress in Caco-2 cells. Moreover, these innovative vesicles showed promising efficacy in vivo, as they improved the bioavailability and the biodistribution of both curcumin and dextrin upon oral administration, which acted synergically in reducing colonic damage chemically-induced in rats

Entrapment of Citrus limon var. pompia Essential Oil or Pure Citral in Liposomes Tailored as Mouthwash for the Treatment of Oral Cavity Diseases

This work aimed at developing a mouthwash based on liposomes loading Citrus limon var. pompia essential oil or citral to treat oropharyngeal diseases. Vesicles were prepared by dispersing phosphatidylcholine and pompia essential oil or citral at increasing amounts (12, 25 and 50 mg/mL) in water. Transparent vesicle dispersions were obtained by direct sonication avoiding the use of organic solvents. Cryogenic transmission electron microscopy (cryo-TEM) confirmed the formation of unilamellar, spherical and regularly shaped vesicles. Essential oil and citral loaded liposomes were small in size (~110 and ~100 nm, respectively) and negatively charged. Liposomes, especially those loading citral, were highly stable as their physico-chemical properties did not change during storage. The formulations were highly biocompatible against keratinocytes, were able to counteract the damages induced in cells by using hydrogen peroxide, and able to increase the rate of skin repair. In addition, liposomes loading citral at higher concentrations inhibited the proliferation of cariogenic bacteriu

A novel ultradeformable liposomes of Naringin for anti-inflammatory therapy

Ultradeformable liposomes were formulated using naringin (NA), a flavanone glycoside, at different concentrations (3,6 and 9 mg/mL). Nanovesicles were small size (∼100 nm), regardless of the NA concentration used, and monodisperse (PI < 0.30). All formulations showed a high entrapment efficiency (∼88%) and a highly negative zeta potential (around −30 mV). The selected formulations were highly biocompatible as confirmed by in vitro studies using 3T3 fibroblasts. In vitro assay showed that the amounts (%) of NA accumulated in the epidermis (∼10%) could explain the anti-inflammatory properties of ultradeformable liposomes. In vivo studies confirmed the higher effectiveness of ultradeformable liposomes respect to betamethasone cream and NA dispersion in reducing skin inflammation in mice. Overall, it can conclude that NA ultradeformable liposomes can be considered as a promising formulation for the treatment of skin inflammatory diseases

Quantification of nortriptyline in plasma by HPLC and fluorescence detection

[EN] A simple, sensitive and specific high-performance liquid chromatography method has been developed for the determination of nortriptyline (NT) in plasma samples. The assay involved derivatization with 9H-fluoren-9-ylmethyl chloroformate (Fmoc-Cl) and isocratic reversed-phase (C-18) chromatography with fluorescence detection. The developed method required only 100 mu l of plasma sample, deproteinized and derivatized in one step. Calibration curves were lineal over the concentration range of 5-5000 ng/ml. The derivatization reaction was performed at room temperature in 20 min and the obtained NT derivative was stable for at least 48 h at room temperature. The within-day and between-day relative standard deviation was below 8%. The limit of detection (LOD) was 2 ng/ml, and the lower limit of quantification (LLOQ) was established at 10 ng/ml. The method was applied on plasma collected from rats, at different time intervals, after intravenous administration of 0.5 mg of NT.This research was supported by Institut de Salud Carlos III grant FIS (FI 060944 953/2006).Almudéver-Folch, P.; Peris, J.; Garrigues, T.; Díez-Sales, O.; Melero, A.; Alós, M. (2010). Quantification of nortriptyline in plasma by HPLC and fluorescence detection. Journal of Chromatography B. 879(9-10):841-844. https://doi.org/10.1016/j.jchromb.2010.01.0338418448799-1