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This study screened excellent carriers for co-loading tanshinone Ⅱ_A(TSA) and astragaloside Ⅳ(As) to construct antitumor nano-drug delivery systems for TSA and As. TSA-As microemulsions(TSA-As-MEs) were prepared by water titration. TSA-As metal-organic framework(MOF) nano-delivery system was prepared by loading TSA and As in MOF by the hydrothermal method. Dynamic light scattering(DLS), transmission electron microscopy(TEM), and scanning electron microscopy(SEM) were used to characterize the physicochemical properties of the two preparations. Drug loading was determined by HPLC and the effects of the two preparations on the proliferation of vascular endothelial cells, T lymphocytes, and hepatocellular carcinoma cells were detected by the CCK-8 method. The results showed that the particle size, Zeta potential, and drug loading of TSA-As-MEs were(47.69±0.71) nm,(-14.70±0.49) mV, and(0.22±0.01)%, while those of TSA-As-MOF were(258.3±25.2) nm,(-42.30 ± 1.27) mV, and 15.35%±0.01%. TSA-As-MOF was superior to TSA-As-MEs in drug loading, which could inhibit the proliferation of bEnd.3 cells at a lower concentration and improve the proliferation ability of CTLL-2 cells significantly. Therefore, MOF was preferred as an excellent carrier for TSA and As co-loading.
Subject(s)
Mice , Animals , Endothelial Cells , Abietanes , Cell LineABSTRACT
The α-amino acid ester acyltransferase (SAET) from Sphingobacterium siyangensis is one of the enzymes with the highest catalytic ability for the biosynthesis of l-alanyl-l-glutamine (Ala-Gln) with unprotected l-alanine methylester and l-glutamine. To improve the catalytic performance of SAET, a one-step method was used to rapidly prepare the immobilized cells (SAET@ZIF-8) in the aqueous system. The engineered Escherichia coli (E. coli) expressing SAET was encapsulated into the imidazole framework structure of metal organic zeolite (ZIF-8). Subsequently, the obtained SAET@ZIF-8 was characterized, and the catalytic activity, reusability and storage stability were also investigated. Results showed that the morphology of the prepared SAET@ZIF-8 nanoparticles was basically the same as that of the standard ZIF-8 materials reported in literature, and the introduction of cells did not significantly change the morphology of ZIF-8. After repeated use for 7 times, SAET@ZIF-8 could still retain 67% of the initial catalytic activity. Maintained at room temperature for 4 days, 50% of the original catalytic activity of SAET@ZIF-8 could be retained, indicating that SAET@ZIF-8 has good stability for reuse and storage. When used in the biosynthesis of Ala-Gln, the final concentration of Ala-Gln reached 62.83 mmol/L (13.65 g/L) after 30 min, the yield reached 0.455 g/(L·min), and the conversion rate relative to glutamine was 62.83%. All these results suggested that the preparation of SAET@ZIF-8 is an efficient strategy for the biosynthesis of Ala-Gln.
Subject(s)
Escherichia coli/genetics , Glutamine , Zeolites/chemistry , Amino AcidsABSTRACT
As an excellent hosting matrices for enzyme immobilization, metal-organic framework (MOFs) provides superior physical and chemical protection for biocatalytic reactions. In recent years, the hierarchical porous metal-organic frameworks (HP-MOFs) have shown great potential in enzyme immobilization due to their flexible structural advantages. To date, a variety of HP-MOFs with intrinsic or defective porous have been developed for the immobilization of enzymes. The catalytic activity, stability and reusability of enzyme@HP-MOFs composites are significantly enhanced. This review systematically summarized the strategies for developing enzyme@HP-MOFs composites. In addition, the latest applications of enzyme@HP-MOFs composites in catalytic synthesis, biosensing and biomedicine were described. Moreover, the challenges and opportunities in this field were discussed and envisioned.
Subject(s)
Metal-Organic Frameworks/chemistry , Porosity , Enzymes, Immobilized/chemistry , Biocatalysis , CatalysisABSTRACT
@#In recent years, bio-metal organic frameworks (Bio-MOFs) synthesized with biocompatible ligands have been widely investigated as a potential drug delivery carrier due to their large specific surface area and porosity, rich host-guest intermolecular interactions, and good biocompatibility.In this review, we summarized the design methods of Bio-MOFs including structural and toxic factors, as well as a variety of drug loading methods including click chemistry, with particular focus on recent research advances in Bio-MOFs for pulmonary drug delivery systems, improving pharmaceutical properties of drugs, sustained and controlled drug release, stimulation response and targeted drug delivery systems.Finally, we summarized the bottlenecks that constrain the development of Bio-MOFs in clinical studies of actual pharmaceutical formulations and their future directions for approved formulations, aiming to provide some theoretical reference for promoting the application of Bio-MOFs in drug delivery systems.
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Resumo Nanotecnologia é a utilização de materiais na escala nanométrica, em que estes adquirem características próprias. A área de pesquisa e desenvolvimento de novos nanomedicamentos é uma das mais promissoras atualmente, todavia essas partículas necessitam de avaliação particular e ainda não há consenso referente às testagens específicas a serem seguidas, o que dificulta a formação de uma legislação que garanta a segurança e eficácia destes medicamentos, além de um processo de registro mais eficaz. Assim, é necessária uma abordagem bioética da nanotecnologia e sua utilização em medicamentos, visando garantir que o progresso científico não acarrete impactos irreversíveis. Diante dessa problemática, busca-se promover uma discussão nanoética referente ao processo de pesquisa e desenvolvimento de nanomedicamentos, por meio de estudo qualitativo, exploratório-descritivo e de caráter analítico, utilizando revisão bibliográfica, análise documental e dados quantitativos disponíveis como técnicas de pesquisa.
Abstract Nanotechnology consist of using materials at the nanoscale, in which they acquire specific characteristics. Nanodrug research and development is one of the most promising fields today; however, these particles require particular evaluation. Moreover, studies lack consensus on which specific tests to follow, thus hindering the elaboration of legislation that ensure their safety and efficacy, as well as a more effective registration process. Thus, a bioethical approach to nanotechnology and its use in drug development is necessary to ensure scientific progress without irreversible impacts. Given this scenario, this article proposes a nanoethics discussion regarding nanodrug research and development by means of a qualitative, exploratory and descriptive analysis, based on literature review, documental analysis and quantitative data available.
Resumen La nanotecnología utiliza materiales nanométricos, en que estos adquieren características propias. El área de investigación y desarrollo de nuevas nanomedicinas es una de las más prometedoras en la actualidad, sin embargo, estas partículas requieren de una evaluación particular y aún no existe consenso en cuanto a las pruebas específicas que seguir, lo que dificulta establecer una legislación que garantice la seguridad y eficacia de estos medicamentos, además de un proceso de registro más efectivo. Por lo tanto, se necesita un enfoque bioético de la nanotecnología y su uso en medicamentos para garantizar que el avance científico no tenga impactos irreversibles. Ante esta problemática, se pretende promover el debate sobre la nanoética en el proceso de investigación y desarrollo de nanomedicinas a partir de un estudio cualitativo, exploratorio-descriptivo y analítico, que utiliza como técnicas de investigación la revisión bibliográfica, el análisis de documentos y los datos cuantitativos disponibles.
Subject(s)
Toxicology , Regulatory Frameworks for HealthABSTRACT
Resumo Introdução Trazemos à cena a Atenção Básica e o Núcleo Ampliado de Saúde da Família (NASF), equipe multiprofissional que proporciona suporte qualificado para os outros profissionais da Estratégia da Saúde da Família. Objetivo Descrever a trajetória de uma década de NASF (2008-2018) e sua expansão neste período. Método Análise de conteúdo de documentos produzidos pelo Ministério da Saúde (MS), entre janeiro a setembro de 2008. Os achados foram organizados em uma linha cronológica, com análise das ferramentas de trabalho mais frequentes e dados de implantação. Resultados Existem onze Portarias, treze materiais escritos e sete vídeos com conteúdo de suporte técnico-pedagógico para práticas. Ainda que exposto às sucessivas transformações legais, houve uma expansão considerável em 10 anos de existência, com ampliação de equipes e inserção de 19 categorias profissionais, apresentando múltiplas possibilidades de atuação. Os documentos apontam para atuação do NASF através do apoio matricial, embora a atual Política Nacional de Atenção Básica não o reconheça. Conclusão Conhecer a trajetória do NASF é relevante para compreendermos as mudanças que ocorreram e as propostas que surgirão. Uma década é pouco tempo para consolidar uma prática inovadora, em um país cujos direcionamentos por meio das mudanças normativas podem caminhar em uma velocidade bem maior.
Abstract Background We bring to the scene the Primary Health Care and the Support Center for Family Health (NASF) in Brazil, a multi-professional team that provides qualified support to other professionals in the Family Health Strategy. Objective Describe the trajectory of a decade of NASF (2008-2018) and its expansion in this period. Method: Content analysis of documents produced by the Ministry of Health, between January and September 2008. The results were organized in a chronological line, with analysis of the most frequent work tools and implementation data. Results There are 11 ordinances, 13 written materials, and 7 videos as technical and pedagogical support for Core Actions practices. Although exposed to successive legal changes, there has been a considerable expansion in these 10 years of existence, not only in the number of teams, but also in the insertion of 19 professional categories and their multiple possibilities of action. The documents point to NASF's strategy of action through matrix support, although the current National Primary Care Policy does not recognize it. Conclusion Knowing the trajectory of NASF is relevant for understanding the changes that have occurred and the proposals that will arise. A decade is little time to consolidate an innovative practice in a country whose direction through normative changes can move at a much greater speed.
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SUMMARY Introduction: The Transdermal Drug Delivery Systems (TDDS) could circumvent the inconveniences of oral administration, increasing treatment adhesion. Meanwhile, despite being highly widespread systems, there are discrepancies between the performance and quality control methodologies recommended by the leading regulatory agencies, which is an issue for the pharmaceutical industry. Aim: To identify and to compare the requirements for TDDS regulatory approval by important agencies, focusing on the in vitro release and drug permeation studies, which are crucial tests for the evaluation of safety, efficacy, and performance of these systems. Methods: The documents that regulate the scope of TDDS in FDA, EMA and Anvisa were analyze, as well as the contributions of OECD. In addition, an approaching regarding the pharmacopeial requirements was made regarding USA, Europe, and Brazil. Results and conclusion: Concerning the regulatory approval aspects, the FDA is reviewing its documents because the current guidance is not specific to transdermal systems. On the other hand, the EMA presents a unique guideline that includes specific requirements for TDDS. The USA and the European Pharmacopoeias have specific mentions to performance and quality control of TDDS, while the Brazilian Pharmacopoeia does not mention this dosage form. Recently, Anvisa published a guide, which helps Brazilian manufacturers concerning the tests required for the regulatory approval of a new TDDS. The launch of this standardized national statute associated with the use of a validated in vitro release and permeation tests represents a remarkable breakthrough regarding TDDS.
Introducción: los sistemas de administración de fármacos transdérmicos (TDDS) podrían sortear los inconvenientes de la administración por vía oral, aumentando la adherencia al tratamiento. Mientras tanto, a pesar de ser sistemas muy extendidos, existen discrepancias entre las metodologías de desempeño y control de calidad recomendadas por las principales agencias reguladoras, lo cual es un problema para la industria farmacéutica. Objetivo: identificar y comparar los requisitos para la aprobación regulatoria de TDDS por parte de las principales agencias reguladoras, enfocándose en los estudios de liberación in vitro y premiación de fármacos. Métodos: se analizaron los documentos que regulan el alcance de la TDDS en la FDA, EMA y Anvisa, así como los aportes de la OCDE. Además, se realizó un planteamiento sobre los requisitos de las farmacopeas de los Estados Unidos, Europa y Brasil. Resultados y conclusión: la FDA está revisando los aspectos de aprobación regulatoria porque la guía actual no es específica para los sistemas transdérmicos. Por otro lado, la EMA presenta una guía única que incluye requisitos específicos para TDDS. Las farmacopeas de los Estados Unidos e Europa tienen menciones específicas al rendimiento y control de calidad de TDDS, mientras que la Farmacopea brasileña no menciona esta forma de dosificación. Recientemente, Anvisa publicó una guía que ayuda a los fabricantes brasileños en cuanto a las pruebas requeridas para la aprobación regulatoria de un nuevo TDDS. El lanzamiento de este estatuto nacional estandarizado asociado con el uso de pruebas validadas de liberación y premiación in vitro representa un avance notable con respecto a TDDS.
Introdução: os sistemas de liberação transdérmica (SLT) são capazes de contornar as desvantagens da administração oral de medicamentos, aumentando a adesão ao tratamento. Entretanto, apesar de serem sistemas difundidos, existem discrepâncias entre as metodologias de desempenho e controle de qualidade recomendadas pelas agências regulatórias, dificultando o desenvolvimento destes pela indústria farmacêutica. Objetivo: identificar e comparar os requisitos para aprovação regulatória de SLT por importantes agências regulatórias, com foco nos estudos de liberação e permeação de fármacos in vitro, testes fundamentais para avaliação da segurança, eficácia e desempenho desses sistemas. Métodos: foram analisados os documentos que regulam o escopo dos SLT publicados pela FDA, EMA e Anvisa e as contribuições da OCDE. Além disso, foi realizada a abordagem sobre os requisitos farmacopeicos nos Estados Unidos, Europa e Brasil. Resultados e conclusão: FDA está revisando os aspectos de aprovação regulatória, pois os documentos atuais não são específicos para os SLT. Em contraponto, a EMA apresenta uma diretriz única que inclui requisitos específicos para estes sistemas. Em relação às farmacopeias, enquanto EUA e Europa apresentam recomendações específicas para desempenho e controle de qualidade dos SLT, a Farmacopeia brasileira não menciona esta forma farmacêutica. Recentemente, a Anvisa publicou um guia com os testes necessários para o registro destes sistemas. O lançamento de tal publicação, associado a ensaios devidamente validados representam um avanço notável no escopo regulatório dos SLT.
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This paper attempts to explore the determination of health and environmental outcomes of smart cities mission (MoHuA, India) and other urban development programs in India. It assesses the programs, evaluates their successes and failures, outlines their complications and gaps in addressing the urban health and environment concerns specific to India and its potential health and environmental impact. The paper further looks at how models adopted by the WHO, World Bank and urban health experts seek to address these gaps, which projects in India could potentially benefit from. The paper concluded by calling for what urban health experts call, 'descriptive urban health frameworks' which addresses some of the challenges posed by India's Smart Cities programs. This paper finally concludes by suggesting that a more qualitative and equity informed urban health framework is necessary to address the gaps that smart cities program in India fail to address. By highlighting issues of sanitation, water, housing, poverty, marginalization and inequalities, the paper calls for a more nuanced approach in addressing the needs of cities, within the context of urban health and environment.
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In this study,a functionalized covalent-organic framework(COF)was first synthesized using porphyrin as the fabrication unit and showed an edge-curled,petal-like and well-ordered structure.The synthesized COF was then introduced to prepare porous organic polymer monolithic materials(POPMs).Two com-posite POPM/COF monolithic materials with rod shapes,referred to as sorbent A and sorbent B,were prepared in stainless steel tubes using different monomers.Sorbents A and B exhibited relatively uniform porous structures and enhanced specific surface areas of 153.14 m2/g and 80.01 m2/g,respectively.The prepared composite monoliths were used as in-tube solid-phase extraction(SPE)sorbents combined with HPLC for the on-line extraction and quantitative analytical systems.Indole alkaloids(from Catharanthus roseus G.Don and Uncaria rhynchophylla(Miq.)Miq.Ex Havil.)contained in mouse plasma were extracted and quantitatively analyzed using the online system.The two composite multifunctional monoliths showed excellent clean-up ability for complex biological matrices,as well as superior selec-tivity for target indole alkaloids.Method validation showed that the RSD values of the repeatability(n=6)were≤3.46％,and the accuracy expressed by the spiked recoveries was in the ranges of 99.38％-100.91％and 96.39％-103.50％for vinca alkaloids and Uncaria alkaloids,respectively.Furthermore,sorbents A and B exhibited strong reusability,with RSD values≤5.32％,which were based on the peak area of the corresponding alkaloids with more than 100 injections.These results indicate that the composite POPM/COF rod-shaped monoliths are promising media as SPE sorbents for extracting trace compounds in complex biological samples.
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Covalent organic frameworks(COFs)are a novel type of crystalline porous organic polymer materials recently developed.It has several advantages in chromatographic separation field,such as high thermal stability,porosity,structural regularity,and large specific surface area.Here,a novel spherical COF 1,3,5-tris(4-aminophenyl)benzene(TAPB)and 2,5-bis(2-propyn-1-yloxy)-1,4-benzenedicarboxaldehyde(BPTA)was developed as an electrochromatographic stationary phase for capillary electro-chromatography separation.The COFTTAPB-BPTA modified capillary column was fabricated via a facile in situ growth method at room temperature.The characterization results of scanning electron microscopy(SEM),Fourier transform infrared(FT-IR)spectroscopy,and X-ray diffraction(XRD)confirmed that COF TAPB-BPTA were successfully modified onto the capillary inner surface.The electrochromatography separation performance of the COF TAPB-BPTA modified capillary was investigated.The prepared column demonstrated outstanding separation performance toward alkylbenzenes,phenols,and chlorobenzenes compounds.Furthermore,the baseline separations of non-steroidal anti-inflammatory drugs(NSAIDs)and parabens with good efficiency and high resolution were achieved.Also,the prepared column possessed satisfactory precision of the intra-day runs(n=5),inter-day runs(n=3),and parallel columns(n=3),and the relative standard deviations(RSDs)of the retention times of tested alkylbenzenes were all less than 2.58％.Thus,this new COF-based stationary phase shows tremendous application potential in chromatographic separation field.
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Metal-organic frameworks (MOFs) are mixed porous materials which are composed of metal clusters or ions and organic pillars. Given their channel tunability, high porosity, large specific surface area, and good biocompatibility, MOFs can be combined with various biological macromolecules. In recent years, they have been widely studied in the field of biomedicine, especially in the loading of anti-tumor drugs, showing great application prospects. Multifunctional anti-tumor MOF combined with different therapeutic methods provides a new idea and method for tumor treatment. On the basis of the structure of MOF, this paper introduces the advantages of using MOF to load anti-tumor drugs and reviews the application of MOF in tumor therapy.
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Metal-organic frameworks (MOFs) are special materials formed by self-assembly of metal ions and organic ligands, with special physical and chemical properties, such as large specific surface area, excellent biocompatibility and strong pH sensitivity, etc. Through modification, they have synthesized nanomaterials with excellent performance, which have huge application prospects in treating tumors. This paper mainly reviews the properties of MOFs and their derived materials, and the application progress of MOFs in tumor drug-loaded therapy, photodynamic therapy and immunotherapy.
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Genetic modification of living organisms has been a prosperous activity for research and development of agricultural, industrial and biomedical applications. Three decades have passed since the first genetically modified products, obtained by transgenesis, become available to the market. The regulatory frameworks across the world have not been able to keep up to date with new technologies, monitoring and safety concerns. New genome editing techniques are opening new avenues to genetic modification development and uses, putting pressure on these frameworks. Here we discuss the implications of definitions of living/genetically modified organisms, the evolving genome editing tools to obtain them and how the regulatory frameworks around the world have taken these technologies into account, with a focus on agricultural crops. Finally, we expand this review beyond commercial crops to address living modified organism uses in food industry, biomedical applications and climate change-oriented solutions.
Subject(s)
Crops, Agricultural/genetics , Gene Editing/methods , Biotechnology , Plants, Genetically Modified/genetics , Genome, Plant , AgricultureABSTRACT
RESUMO A toxicologia é aplicada aos processos regulatórios tendo como base central a linearidade das relações entre a dose e o efeito e a possibilidade de estabelecer condições de exposição seguras. Isso ocorre apesar das limitações apontadas pela literatura cientifica. A concepção, a definição das metodologias e a condução da avaliação de risco dos agrotóxicos acabam por atender aos interesses econômicos e à definição de cenários de segurança distantes da realidade. As limitações metodológicas dos estudos exigidos para fins de registro de um agrotóxico envolvem: a desconsideração das interações entre as misturas utilizadas; a não previsão de curvas dose-resposta não lineares (horméticas); a compartimentalização dos desfechos analisados; a exposição nos períodos críticos do desenvolvimento; e a desconsideração do contexto, das diversidades individuais, coletivas e dos territórios expostos aos agrotóxicos, entre outros aspectos discutido nesse ensaio. A toxicologia crítica propõe que a avaliação toxicológica parta da integralidade do problema no contexto apresentando propostas que podem ser adotadas nos processos de regulação de agrotóxicos e outras substâncias potencialmente perigosas.
ABSTRACT Toxicology is applied to regulatory processes based on the linear basis of the relationship between dose and effect and the possibility of establishing safe exposure conditions. This occurs despite the limitations pointed out by the scientific literature. The conception, definition of methodologies, and the conduct of risk assessment of pesticides ends up meeting economic interests and the definition of security scenarios that are far from reality. The methodological limitations of the studies required for the purpose of registering a pesticide involve: disregarding the interactions between the mixtures used; the failure to predict non-linear dose-response curves (hormetical); compartmentalization of the analyzed outcomes; exposure in critical periods of development; and disregarding of the context, individual and collective diversity and the territories exposed to pesticides, among other aspects discussed in this essay. Critical toxicology proposes that the toxicological assessment should start from the integrality of the problem in the context, presenting proposals that can be adopted in the regulation processes of pesticides and other potentially dangerous substances.
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ABSTRACT Objectives. To map the timing and nature of regulatory reliance pathways used to authorize COVID-19 vaccines in Latin America. Methods. An observational study was conducted assessing the characteristics of all COVID-19 vaccine authorizations in Latin America. For every authorization it was determined whether reliance was used in the authorization process. Subgroups of reference national regulatory authorities (NRAs) and non-reference NRAs were compared. Results. 56 authorizations of 10 different COVID-19 vaccines were identified in 18 countries, of which 25 (44.6%) used reliance and 12 (21.4%) did not. For the remaining 19 (33.0%) it was not possible to determine whether reliance was used. Reference agencies used reliance less often (40% of authorizations with a known pathway) compared to non-reference agencies (100%). The median review time was just 15 days and does not meaningfully differ between reliance and non-reliance authorizations. Conclusions. This study demonstrated that for these vaccines, despite reliance pathways being associated with numerous rapid authorizations, independent authorization review times were not considerably longer than reliance reviews; reliance pathways were not a prerequisite for rapid authorization. Nevertheless, reliance pathways provided rapid authorizations in response to the COVID-19 emergency.
RESUMEN Objetivos. Determinar dónde y cuándo se usaron las decisiones de autoridades regulatorias de otras jurisdicciones y la naturaleza de estos mecanismos para autorizar vacunas contra la COVID-19 en América Latina. Métodos. Se realizó un estudio observacional para evaluar las características de todas las autorizaciones de vacunas contra la COVID-19 en América Latina. Para cada autorización se determinó si se emplearon las decisiones de autoridades regulatorias de otras jurisdicciones en el proceso de autorización. Se compararon subgrupos de autoridades regulatorias nacionales (ARN) consideradas de referencia con otras ARN no usadas como referencia. Resultados. Se determinó dónde se otorgaron 56 autorizaciones de 10 vacunas diferentes contra la COVID-19 en 18 países; de estas 56 autorizaciones, 25 (44,6%) hicieron uso de las decisiones de autoridades regulatorias de otras jurisdicciones y 12 (21,4%), no. Para las 19 restantes (33,0%) no fue posible determinar si se hizo uso de las decisiones de autoridades regulatorias de otras jurisdicciones. Los organismos de referencia utilizaron las decisiones de autoridades regulatorias de otras jurisdicciones con menos frecuencia (40% de las autorizaciones con un mecanismo conocido) en comparación con los organismos no usados como referencia (100%). El plazo medio de revisión fue de tan solo 15 días y no difiere significativamente entre las autorizaciones que emplearon decisiones de autoridades regulatorias de otras jurisdicciones y las que no las emplearon. Conclusiones. En este estudio se demostró que, a pesar de que los mecanismos de utilización de las decisiones de autoridades regulatorias de otras jurisdicciones se asocian en muchos casos con autorizaciones rápidas, para estas vacunas los plazos de revisión independiente para la autorización no fueron considerablemente mayores que los de las revisiones que emplearon decisiones de autoridades regulatorias de otras jurisdicciones. También se demostró que para obtener una autorización rápida no se requería la utilización de las decisiones de autoridades regulatorias de otras jurisdicciones. Sin embargo, estos mecanismos proporcionaron autorizaciones rápidas en respuesta a la emergencia por la COVID-19.
RESUMO Objetivos. Mapear a tempestividade e a natureza do uso de decisões regulatórias de outras autoridades (reliance regulatório) para autorização de vacinas contra a COVID-19 na América Latina. Métodos. Em um estudo observacional, foram avaliadas as características de todas as autorizações de vacinas contra COVID-19 na América Latina. Para cada autorização, foi determinado se foram utilizadas decisões de outras autoridades regulatórias para embasar o processo de autorização. Foram comparados subgrupos de autoridades reguladoras nacionais (ARN) de referência (ARNr) e ARN não consideradas de referência. Resultados. Foram identificadas 56 autorizações de 10 vacinas diferentes contra a COVID-19 em 18 países, das quais 25 (44,6%) utilizaram decisões de outras ARN como base para o registro e 12 (21,4%) não. Para as 19 (33,0%) autorizações restantes, não foi possível determinar se decisões de outras ARN foram utilizadas. As ARNr utilizaram decisões de outras autoridades com menos frequência (40% das autorizações com via regulatória conhecida) em comparação com as ARN não consideradas de referência (100%). A mediana do tempo de tramitação foi de apenas 15 dias, sem diferença significativa entre processos nos quais foram utilizadas decisões de outras agências e processos que não as utilizaram. Conclusões. Este estudo demonstrou que, para estas vacinas, apesar de o uso do reliance regulatório estar associado a várias autorizações rápidas, os tempos de tramitação não foram consideravelmente maiores em autorizações independentes do que quando foram utilizadas decisões de outras ARN; o reliance regulatório não foi um pré-requisito para autorização rápida. No entanto, o uso de tais processos viabilizou autorizações rápidas em resposta à emergência de COVID-19.
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Resumen: Objetivo: Documentar la evolución de los marcos reguladores de la publicidad de alimentos y bebidas no alcohólicas (PABNA) dirigida a la población infantil (PI) en México. Material y métodos: Revisión documental de las leyes, reglamentos y lineamientos encargados de regular la PABNA publicados en el Diario Oficial de la Federación (DOF) desde 1926 hasta 2016. Resultados: Se revisaron 18 documentos del DOF, se identificaron ventajas y limitaciones que tienen los marcos reguladores respecto a la PABNA dirigida a la PI y cómo se ha adecuado la regulación a los cambios en los medios de comunicación. Conclusiones: Es necesario implementar una regulación estricta sobre la PABNA dirigida a la PI, la cual evite mensajes que promuevan el consumo de productos de baja calidad nutrimental, relacionados con el incremento de prevalencias de sobrepeso, obesidad y enfermedades crónicas.
Abstract: Objective: To document how regulatory frameworks of food and non-alcoholic beverage advertising (FABA) that are directed towards children in Mexico have evolved since 1926. Materials and methods: Document analysis of laws, regulations and guidelines regarding FABA regulations that were published in the Official Gazette (OG) from 1926 - 2016. Results: 18 documents from the OG were reviewed. Advantages and limitations of the regulatory frameworks were identified. This analysis provided an understanding of how FABA directed to children has been regulated and how it has adapted to changes in the media. Conclusions: A strict regulation of FABA directed to children is needed, specifically to control messages that promote the consumption of products with low nutritional quality as this is related to increasing prevalence of overweight, obesity and chronic diseases.
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Ferroptosis, as a newly discovered cell death form, has become an attractive target for precision cancer therapy. Several ferroptosis therapy strategies based on nanotechnology have been reported by either increasing intracellular iron levels or by inhibition of glutathione (GSH)-dependent lipid hydroperoxidase glutathione peroxidase 4 (GPX4). However, the strategy by simultaneous iron delivery and GPX4 inhibition has rarely been reported. Herein, novel tumor microenvironments (TME)-activated metal-organic frameworks involving Fe & Cu ions bridged by disulfide bonds with PEGylation (FCSP MOFs) were developed, which would be degraded specifically under the redox TME, simultaneously achieving GSH-depletion induced GPX4 inactivation and releasing Fe ions to produce ROS
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Metal-organic frameworks (MOFs) are formed by self-assembly of metal ions or clusters with organic ligands, and are widely used in the fields of catalysis, sensing, energy and biomedicine. Recently, biological composites based on MOFs have attracted increasing attention. MOFs can be used as a platform for encapsulating bioactive substances due to the advantages such as large pore capacity, large specific surface area and diverse structure composition. These features can protect bioactive substances from adverse conditions, e.g. high temperature, high pressure, and organic solvents, thus improving the anti-adversity of bioactive substances. This review summarizes the advances of using MOFs as protective coatings to improve the anti-adversity of different bioactive substances, and introduces the synthesis strategy of MOFs-based biological composites, with the aim to promote the practical application of MOFs-based biological composites.
Subject(s)
Catalysis , Ions , Metal-Organic Frameworks , MetalsABSTRACT
Metal-organic frameworks (MOFs), comprised of organic ligands and metal ions/metal clusters
ABSTRACT
Malignant tumor has become an urgent threat to global public healthcare. Because of the heterogeneity of tumor, single therapy presents great limitations while synergistic therapy is arousing much attention, which shows desperate need of intelligent carrier for co-delivery. A core‒shell dual metal-organic frameworks (MOFs) system was delicately designed in this study, which not only possessed the unique properties of both materials, but also provided two individual specific functional zones for co-drug delivery. Photosensitizer indocyanine green (ICG) and chemotherapeutic agent doxorubicin (DOX) were stepwisely encapsulated into the nanopores of MIL-88 core and ZIF-8 shell to construct a synergistic photothermal/photodynamic/chemotherapy nanoplatform. Except for efficient drug delivery, the MIL-88 could be functioned as a nanomotor to convert the excessive hydrogen peroxide at tumor microenvironment into adequate oxygen for photodynamic therapy. The DOX release from MIL-88-ICG@ZIF-8-DOX nanoparticles was triggered at tumor acidic microenvironment and further accelerated by near-infrared (NIR) light irradiation. The