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2.
Angew Chem Int Ed Engl ; 60(5): 2232-2256, 2021 02 01.
Artigo em Inglês | MEDLINE | ID: mdl-32128948

RESUMO

Mitochondria are the powerhouse of cells. They are vital organelles that maintain cellular function and metabolism. Dysfunction of mitochondria results in various diseases with a great diversity of clinical appearances. In the past, strategies have been developed for fabricating subcellular-targeting drug-delivery nanocarriers, enabling cellular internalization and subsequent organelle localization. Of late, innovative strategies have emerged for the smart design of multifunctional nanocarriers. Hierarchical targeting enables nanocarriers to evade and overcome various barriers encountered upon in vivo administration to reach the organelle with good bioavailability. Stimuli-responsive nanocarriers allow controlled release of therapeutics to occur at the desired target site. Synergistic therapy can be achieved using a combination of approaches such as chemotherapy, gene and phototherapy. In this Review, we survey the field for recent developments and strategies used in the smart design of nanocarriers for mitochondria-targeted therapeutics. Existing challenges and unexplored therapeutic opportunities are also highlighted and discussed to inspire the next generation of mitochondrial-targeting nanotherapeutics.


Assuntos
Mitocôndrias/metabolismo , Nanopartículas/normas , Nanoestruturas/normas , Humanos
3.
Small ; 16(36): e2001590, 2020 09.
Artigo em Inglês | MEDLINE | ID: mdl-32656997

RESUMO

Nanotechnology, as a mature enabling technology, has great potential to boost societal welfare. However, nanomaterials' current and foreseen applications raise serious concerns about their impact on human health and the environment. These concerns emerge because a reliable risk assessment in nanotechnology is yet to be achieved. The reasons for such a shortcoming are the inherent difficulties in characterizing nanomaterials properties. The interaction of characterization with modeling is an open issue and, due to overarching concerns about the reliability of research results, usually framed within the context of research integrity. This essay explores the connection between these different, but deeply intertwined concerns and the way they enable the production of responsible nanotechnology, i.e., nanotechnology devoted to societal welfare.


Assuntos
Nanoestruturas , Nanotecnologia , Medição de Risco , Teste de Materiais , Nanoestruturas/normas , Nanoestruturas/toxicidade , Nanotecnologia/métodos , Nanotecnologia/normas , Reprodutibilidade dos Testes , Medição de Risco/métodos , Medição de Risco/normas
4.
Small ; 16(36): e1907667, 2020 09.
Artigo em Inglês | MEDLINE | ID: mdl-32449600

RESUMO

International efforts to promote predictive toxicology incorporate some form of modeling based on the regularities, insights, and hypotheses gained from analyzing laboratory studies compiled in databases. While there has been a broad commentary on definitions, metadata, and test methodologies, all necessary to establishing data repositories, there has been less on translating the resulting insights into computational models. The recent use of a computational model to support a recommended exposure limit for nanoparticulate silver is an opportunity to examine physiologically based toxicokinetics in terms of data availability, model verification and validation, and regulatory acceptance. The resulting suggestions align with findings from the EU-US Roadmap Nanoinformatics 2030 and the 2018 acceptance of a computational model by the European Food Safety Authority.


Assuntos
Simulação por Computador , Nanoestruturas , Prata , União Europeia , Nanoestruturas/química , Nanoestruturas/normas , Nanoestruturas/toxicidade , Prata/química , Prata/toxicidade , Toxicocinética
6.
Small ; 16(21): e1907483, 2020 05.
Artigo em Inglês | MEDLINE | ID: mdl-32239645

RESUMO

The immune system is professional in recognizing and responding to non-self, including nanomaterials. Immune responses by professional and nonprofessional immune cells are thus nearly inevitable upon exposure of cells and organisms to such materials. The state of research into taking the immune system into account in nanosafety studies is reviewed and three aspects in which further improvements are desirable are identified: 1) Due to technical limitations, more stringent testing for endotoxin contamination should be made. 2) Since under overdose conditions immunity shows unphysiological responses, all doses used should be justified by being equivalent to tissue-delivered doses. 3) When markers of acute inflammation or cell stress are observed, functional assays are necessary to distinguish between homeostatic fluctuation and genuine defensive or tolerogenic responses. Since immune activation can also indicate that the immune system considers a stimulus to be harmless and induces tolerance, activation markers by themselves do not necessarily imply a danger to the body. Guidelines such as these are necessary to approach the point where specific nanomaterials are classified as safe based on reliable testing strategies.


Assuntos
Imunidade , Nanoestruturas , Alergia e Imunologia , Humanos , Imunidade/efeitos dos fármacos , Nanoestruturas/classificação , Nanoestruturas/normas , Nanoestruturas/toxicidade , Segurança
7.
Artigo em Inglês | MEDLINE | ID: mdl-32266791

RESUMO

Various nanomedicinal products (NMPs) have been reported to induce an adverse immune response, which may be related to their tendency to accumulate in or target cells of the immune system. Therefore, before their market authorization, NMPs should be thoroughly evaluated for their immunotoxic potential. Nonclinical regulatory immunotoxicity testing of nonbiological medicinal products, including NMPs, is currently performed by following the guideline S8 "Immunotoxicity Studies for Human Pharmaceuticals" of the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH). However, this guideline does not cover all the immunotoxicity endpoints reported for NMPs in the literature, such as complement activation related pseudo allergy, hypersensitivity and immunosuppression. In addition, ICH-S8 does not provide any nanospecific testing considerations, which is important given their tendency to interfere with many commonly used toxicity assays. We therefore propose a nonclinical regulatory immunotoxicity assessment strategy, which considers the immunotoxicity endpoints currently missing in the ICH-S8. We also list the known pitfalls related to the testing of NMPs and how to tackle them. Next to defining the relevant physicochemical and pharmacokinetic properties of the NMP and its intended use, the proposed strategy includes an in vitro assay battery addressing various relevant immunotoxicity endpoints. A weight of evidence evaluation of this information can be used to shape the type and design of further in vivo investigations. The final outcome of the immunotoxicity assessment can be included in the overall risk assessment of the NMP and provide alerts for relevant endpoints to address during clinical investigation. This article is categorized under: Toxicology and Regulatory Issues in Nanomedicine > Regulatory and Policy Issues in Nanomedicine Toxicology and Regulatory Issues in Nanomedicine > Toxicology of Nanomaterials.


Assuntos
Sistema Imunitário , Nanomedicina , Nanoestruturas , Humanos , Sistema Imunitário/efeitos dos fármacos , Sistema Imunitário/imunologia , Nanomedicina/legislação & jurisprudência , Nanomedicina/normas , Nanoestruturas/efeitos adversos , Nanoestruturas/normas , Nanoestruturas/toxicidade , Medição de Risco , Testes de Toxicidade , Toxicologia
8.
Small ; 16(6): e1904749, 2020 02.
Artigo em Inglês | MEDLINE | ID: mdl-31913582

RESUMO

Advanced material development, including at the nanoscale, comprises costly and complex challenges coupled to ensuring human and environmental safety. Governmental agencies regulating safety have announced interest toward acceptance of safety data generated under the collective term New Approach Methodologies (NAMs), as such technologies/approaches offer marked potential to progress the integration of safety testing measures during innovation from idea to product launch of nanomaterials. Divided in overall eight main categories, searchable databases for grouping and read across purposes, exposure assessment and modeling, in silico modeling of physicochemical structure and hazard data, in vitro high-throughput and high-content screening assays, dose-response assessments and modeling, analyses of biological processes and toxicity pathways, kinetics and dose extrapolation, consideration of relevant exposure levels and biomarker endpoints typify such useful NAMs. Their application generally agrees with articulated stakeholder needs for improvement of safety testing procedures. They further fit for inclusion and add value in nanomaterials risk assessment tools. Overall 37 of 50 evaluated NAMs and tiered workflows applying NAMs are recommended for considering safer-by-design innovation, including guidance to the selection of specific NAMs in the eight categories. An innovation funnel enriched with safety methods is ultimately proposed under the central aim of promoting rigorous nanomaterials innovation.


Assuntos
Ciência dos Materiais , Nanoestruturas , Segurança , Testes de Toxicidade , Simulação por Computador , Humanos , Ciência dos Materiais/métodos , Ciência dos Materiais/tendências , Nanoestruturas/normas , Medição de Risco
9.
Anal Chem ; 91(21): 13847-13854, 2019 11 05.
Artigo em Inglês | MEDLINE | ID: mdl-31575114

RESUMO

Emerging nanomaterials such as nanozymes have recently been applied for the immunoassay-based detection of biomarkers. However, the inferior catalytic activity and low water solubility of nanozymes remain as the major limitations compared to natural enzymes. To overcome these limitations, we successfully synthesized a superior nanozyme with a structure of enriched 2D catalytic interface, namely Nanozyme Nest, which was composed of Fe-based metal-organic frameworks (Fe-MOF) and graphene oxide (GO). Then, we applied it in an ultrasensitive enzyme-linked immunosorbent assay (ELISA) for the detection of benzo[a]pyrene-7,8-diol 9,10-epoxide-DNA adduct (BPDE-DNA), which is a metabolite of benzo[a]pyrene (BP) and used as a typical biomarker of woodsmoke exposure in human blood. The Nanozyme Nest features amplified peroxidase-like catalytic ability from graphene and Fe-MOF due to their large surface area and abundant active sites. By using the proposed Nanozyme Nest-based ultrasensitive ELISA, the BPDE-DNA could be detected at a level as low as 0.268 ng/mL, and the obtained sensitivity was much higher than most of the widely used methods. Our work provides a novel strategy to design ultrasensitive immunosensors with advantages of amplified catalytic activity and improved water solubility compared to classic nanozymes. This illustrates the promising applications of the Nanozyme Nest-based immunosensors in point-of-care settings to conveniently detect exposures and diagnose diseases.


Assuntos
Biomarcadores/sangue , Exposição Ambiental/análise , Ensaio de Imunoadsorção Enzimática/métodos , Nanoestruturas/química , Peroxidase/metabolismo , Fumaça/análise , Benzopirenos/análise , Benzopirenos/química , DNA/análise , DNA/química , Ensaio de Imunoadsorção Enzimática/normas , Grafite , Humanos , Ferro , Estruturas Metalorgânicas , Mimetismo Molecular , Nanoestruturas/normas
10.
AAPS J ; 21(4): 56, 2019 04 17.
Artigo em Inglês | MEDLINE | ID: mdl-30997588

RESUMO

To guide developers of innovative and generic drug products that contain nanomaterials, the U.S. Food and Drug Administration issued the draft guidance for industry titled: "Drug Products, Including Biological Products, that Contain Nanomaterials" in December 2017. During the AAPS Guidance Forum on September 11, 2018, participants from industry, academia, and regulatory bodies discussed this draft guidance in an open setting. Two questions raised by the AAPS membership were discussed in more detail: what is the appropriate regulatory pathway for approval of drug products containing nanomaterials, and how to determine critical quality attributes (CQAs) for nanomaterials? During the meeting, clarification was provided on how the new FDA center-led guidance relates to older, specific nanomaterial class, or specific product-related guidances. The lively discussions concluded with some clear observations and recommendations: (I) Important lessons can be learned from how CQAs were determined for, e.g., biologics. (II) Publication of ongoing scientific discussions on strategies and studies determining CQAs of drug products containing nanomaterials will significantly strengthen the science base on this topic. Furthermore, (III) alignment on a global level on how to address new questions regarding nanomedicine development protocols will add to efficient development and approval of these much needed candidate nanomedicines (innovative and generic). Public meetings such as the AAPS Guidance Forum may serve as the place to have these discussions.


Assuntos
Produtos Biológicos/normas , Indústria Farmacêutica/normas , Medicamentos Genéricos/normas , Guias como Assunto , Nanoestruturas/normas , Aprovação de Drogas/legislação & jurisprudência , Indústria Farmacêutica/legislação & jurisprudência , Regulamentação Governamental , Estados Unidos , United States Food and Drug Administration
11.
J Contemp Dent Pract ; 19(3): 339-344, 2018 Mar 01.
Artigo em Inglês | MEDLINE | ID: mdl-29603709

RESUMO

AIM: The purpose of the study was to evaluate and compare the flexural strength of nano-reinforced zirconia feldspathic porcelain, lithium disilicate ceramics, and zirconia. MATERIALS AND METHODS: Ten bar-shaped specimens of computer-aided design (CAD)/computer-aided manufacturing (CAM) zirconia, reinforced feldspathic porcelain, and reinforced lithium disilicate were fabricated in accordance to International Organization for Standardization (ISO 6872; n = 10). Feldspathic porcelain and lithium disilicate ceramic specimens were reinforced with 5, 10, 15, and 20% of zirconia nanoparticles through a customized technique. The specimens were subjected to three-point flexural strength test using universal testing machine (UTM) and examined for crack propagation using a scanning electron microscope (SEM). Oneway analysis of variance (ANOVA) and Tukey test were used to analyze the data (p < 0.05). RESULTS: The flexural strength of feldsphatic porcelain increased with the increase in the concentration of zirconia particles. The mean flexural strength of 5, 10, 15, and 20% nano-zirconia-incorporated lithium disilicate was 93.8, 97.1, 100.6, and 100.8 MPa respectively, and was lower than the control group (221.7 MPa). A significant difference in the flexural strength was found with the incorporation of nano-zirconia particles. CONCLUSION: The flexural strength of zirconia-integrated feld-spathic porcelain increased and lithium disilicate ceramics decreased with the nano-zirconia reinforcement. CLINICAL SIGNIFICANCE: The simplified approach of reinforcing feldspathic porcelain with zirconia nanoparticles can be adapted in clinical situations of higher masticatory forces.


Assuntos
Porcelana Dentária/química , Nanoestruturas/química , Zircônio/química , Desenho Assistido por Computador , Porcelana Dentária/normas , Planejamento de Prótese Dentária , Análise do Estresse Dentário , Microscopia Eletrônica de Varredura , Nanoestruturas/normas , Resistência à Tração , Zircônio/normas
12.
Regul Toxicol Pharmacol ; 95: 207-219, 2018 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-29574195

RESUMO

The commercialization of engineered nanomaterials (ENMs) began in the early 2000's. Since then the number of commercial products and the number of workers potentially exposed to ENMs is growing, as is the need to evaluate and manage the potential health risks. Occupational exposure limits (OELs) have been developed for some of the first generation of ENMs. These OELs have been based on risk assessments that progressed from qualitative to quantitative as nanotoxicology data became available. In this paper, that progression is characterized. It traces OEL development through the qualitative approach of general groups of ENMs based primarily on read-across with other materials to quantitative risk assessments for nanoscale particles including titanium dioxide, carbon nanotubes and nanofibers, silver nanoparticles, and cellulose nanocrystals. These represent prototypic approaches to risk assessment and OEL development for ENMs. Such substance-by-substance efforts are not practical given the insufficient data for many ENMs that are currently being used or potentially entering commerce. Consequently, categorical approaches are emerging to group and rank ENMs by hazard and potential health risk. The strengths and limitations of these approaches are described, and future derivations and research needs are discussed. Critical needs in moving forward with understanding the health effects of the numerous EMNs include more standardized and accessible quantitative data on the toxicity and physicochemical properties of ENMs.


Assuntos
Nanoestruturas/normas , Exposição Ocupacional/normas , Animais , Humanos , Concentração Máxima Permitida , Medição de Risco
13.
Arch Toxicol ; 92(1): 121-141, 2018 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-29273819

RESUMO

Development and market introduction of new nanomaterials trigger the need for an adequate risk assessment of such products alongside suitable risk communication measures. Current application of classical and new nanomaterials is analyzed in context of regulatory requirements and standardization for chemicals, food and consumer products. The challenges of nanomaterial characterization as the main bottleneck of risk assessment and regulation are presented. In some areas, e.g., quantification of nanomaterials within complex matrices, the establishment and adaptation of analytical techniques such as laser ablation inductively coupled plasma mass spectrometry and others are potentially suited to meet the requirements. As an example, we here provide an approach for the reliable characterization of human exposure to nanomaterials resulting from food packaging. Furthermore, results of nanomaterial toxicity and ecotoxicity testing are discussed, with concluding key criteria such as solubility and fiber rigidity as important parameters to be considered in material development and regulation. Although an analysis of the public opinion has revealed a distinguished rating depending on the particular field of application, a rather positive perception of nanotechnology could be ascertained for the German public in general. An improvement of material characterization in both toxicological testing as well as end-product control was concluded as being the main obstacle to ensure not only safe use of materials, but also wide acceptance of this and any novel technology in the general public.


Assuntos
Exposição Ambiental/análise , Nanoestruturas/análise , Nanoestruturas/toxicidade , Medição de Risco/métodos , Administração Oral , Animais , Desinfetantes , Ecotoxicologia/métodos , Exposição Ambiental/efeitos adversos , Embalagem de Alimentos , Alemanha , Humanos , Indústrias/métodos , Exposição por Inalação/efeitos adversos , Exposição por Inalação/análise , Legislação sobre Alimentos , Nanoestruturas/administração & dosagem , Nanoestruturas/normas , Opinião Pública
14.
Crit Rev Food Sci Nutr ; 58(2): 297-317, 2018 Jan 22.
Artigo em Inglês | MEDLINE | ID: mdl-27052385

RESUMO

Nanotechnology has seen exponential growth in last decade due to its unique physicochemical properties; however, the risk associated with this emerging technology has withdrawn ample attention in the past decade. Nanotoxicity is majorly contributed to the small size and large surface area of nanomaterials, which allow easy dispersion and invasion of anatomical barriers in human body. Unique physio-chemical properties of nanoparticles make the investigation of their toxic consequences intricate and challenging. This makes it important to have an in-depth knowledge of different mechanisms involved in nanomaterials's action and toxicity. Nano-toxicity has various effects on human health and diseases as they can easily enter into the humans via different routes, mainly respiratory, dermal, and gastrointestinal routes. This also limits the use of nanomaterials as therapeutic and diagnostic tools. This review focuses on the nanomaterial-cell interactions leading to toxicological responses. Different mechanisms involved in nanoparticle-mediated toxicity with the main focus on oxidative stress, genotoxic, and carcinogenic potential has also been discussed. Different methods and techniques used for the characterization of nanomaterials in food and other biological matrices have also been discussed in detail. Nano-toxicity on different organs-with the major focus on the cardiac and respiratory system-have been discussed. Conclusively, the risk management of nanotoxicity is also summarized. This review provides a better understanding of the current scenario of the nanotoxicology, disease progression due to nanomaterials, and their use in the food industry and medical therapeutics. Briefly, the required rules, regulations, and the need of policy makers has been discussed critically.


Assuntos
Agroquímicos/toxicidade , Poluentes Ambientais/toxicidade , Aditivos Alimentares/efeitos adversos , Contaminação de Alimentos , Nanoestruturas/toxicidade , Gestão de Riscos , Agroquímicos/normas , Animais , Carcinógenos Ambientais/toxicidade , Aditivos Alimentares/normas , Contaminação de Alimentos/legislação & jurisprudência , Contaminação de Alimentos/prevenção & controle , Humanos , Legislação de Medicamentos , Legislação sobre Alimentos , Mutagênicos/toxicidade , Nanoestruturas/efeitos adversos , Nanoestruturas/normas , Oxidantes/efeitos adversos , Oxidantes/normas , Oxidantes/toxicidade , Gestão de Riscos/legislação & jurisprudência , Gestão de Riscos/normas , Gestão de Riscos/tendências , Testes de Toxicidade/normas
15.
Rocz Panstw Zakl Hig ; 68(4): 321-329, 2017.
Artigo em Inglês | MEDLINE | ID: mdl-29264907

RESUMO

Nanotechnology applications in the food industry, including food contact materials, offer many potential benefits for consumers and manufacturers alike. The article discusses the migration of nanoparticles from food contact materials and the possible health risks associated with in the context of insufficient knowledge of the potential exposure to nanomaterial. The importance of gaps in the general knowledge on the behaviour and biological interactions of nanomaterials in biological systems becomes crucial for risk assessment. The article also discussed numerous doubts concerning the measurements of biological reactions in animal tests and the need for new approaches in the interpretation of data from nanoparticles studies in vivo. The article underlines the need to develop predictive and validated toxicological tests that can be used to screen for potential hazards, and also to develop new methodology for measuring nanoparticles in biological matrices to assess human exposure. Further studies should focus on understanding the mechanisms of action. Nanoparticles exhibit chemical and physical properties that significantly differ from those substances at a large size. Different properties of nanoparticles may lead to different toxicological properties. From that reason nanoparticles, in each case, are individually assessed by the European Food Standard Agency (EFSA) in terms of health risk before the European Commission authorizes them to be used in food contact materials.


Assuntos
Exposição Dietética/normas , Contaminação de Alimentos/prevenção & controle , Embalagem de Alimentos/normas , Nanoestruturas/normas , Qualidade de Produtos para o Consumidor , Exposição Dietética/análise , Contaminação de Alimentos/análise , Humanos , Nanoestruturas/efeitos adversos , Nanoestruturas/análise , Tamanho da Partícula , Polônia , Medição de Risco
16.
Carbohydr Polym ; 170: 271-280, 2017 Aug 15.
Artigo em Inglês | MEDLINE | ID: mdl-28521997

RESUMO

Efficient and biodegradable hemostatic materials become increasingly important in civilian and military clinical. However, traditional hemostatic materials are difficult to achieve expected effects especially in parenchymal organs with rich vascularity. In facing these challenges, we designed a biodegradable collagen sponge reinforced with chitosan/calcium pyrophosphate nanoflowers (CPNFs-Col sponge) for rapid hemostasis. With specific performances, such as rapid water absorption ability, the positive surface rich in amino groups and high specific surface area (952.5m2g-1), the obtained CNPFs-Col sponge with optimized composition could activate the intrinsic pathway of coagulation cascade, induce haemocytes and platelets adherence, promote the blood clotting and achieve hemorrhage control in vitro and in vivo. In addition, the CNPFs-Col sponge can be completely biodegraded in 3 weeks, which is suitable for post-operative treatment and peritoneal adhesion prevention. It can be concluded that the CPNFs-Col sponge would become a promising candidate for clinical hemostatic applications.


Assuntos
Pirofosfato de Cálcio/química , Quitosana/química , Colágeno/química , Hemorragia/terapia , Hemostasia , Nanoestruturas/química , Hemostáticos/química , Nanoestruturas/normas
17.
AAPS J ; 19(1): 92-102, 2017 01.
Artigo em Inglês | MEDLINE | ID: mdl-27612680

RESUMO

The vast majority of drug product candidates in early development fail to progress to clinics. This is true for products containing nanomaterials just as for other types of pharmaceuticals. Early development pathways should therefore place high priority on experiments that help candidates fail faster and less expensively. Nanomedicines fail for many reasons, but some are more avoidable than others. Some of the points of failure are not considerations in the development of small molecules or biopharmaceuticals, and so may be unexpected, even to those with previous experience bringing drug products to the clinic. This article reviews experiments that have proven useful in providing "go/no-go" decision-making data for nanomedicines in early preclinical development. Of course, the specifics depend on the particulars of the drug product and the nanomaterial type, and not every product shares the same development pathway or the same potential points of failure. Here, we focus on challenges that differ from those in the development of traditional small molecule therapeutics, and on experiments that reveal deficiencies that can only be corrected by essentially starting over-altering the nanomedicine to an extent that all previous characterization and proof-of-concept testing must be repeated. Conducting these experiments early in the development process can save significant resources and time and allow developers to focus on derisked candidates with a greater likelihood of ultimate success.


Assuntos
Descoberta de Drogas/métodos , Nanoestruturas/química , Nanotecnologia/métodos , Preparações Farmacêuticas/química , Bibliotecas de Moléculas Pequenas/química , Avaliação de Medicamentos , Liberação Controlada de Fármacos , Estabilidade de Medicamentos , Nanoestruturas/normas , Preparações Farmacêuticas/sangue , Preparações Farmacêuticas/normas , Bibliotecas de Moléculas Pequenas/normas
18.
Eur J Pharm Sci ; 98: 4-16, 2017 Feb 15.
Artigo em Inglês | MEDLINE | ID: mdl-27622921

RESUMO

Extracellular vesicles (EVs) mediate normal physiological homeostasis and pathological processes by facilitating intercellular communication. Research of EVs in basic science and clinical settings requires both methodological standardization and development of reference materials (RM). Here, we show insights and results of biological RM development for EV studies. We used a three-step approach to find and develop a biological RM. First, a literature search was done to find candidates for biological RMs. Second, a questionnaire was sent to EV researchers querying the preferences for RM and their use. Third, a biological RM was selected, developed, characterized, and evaluated. The responses to the survey demonstrated a clear and recognized need for RM optimized for the calibration of EV measurements. Based on the literature, naturally occurring and produced biological RM, such as virus particles and liposomes, were proposed as RM. However, none of these candidate RMs have properties completely matching those of EVs, such as size and refractive index distribution. Therefore, we evaluated the use of nanoerythrosomes (NanoE), vesicles produced from erythrocytes, as a potential biological RM. The strength of NanoE is their resemblance to EVs. Compared to the erythrocyte-derived EVs (eryEVs), NanoE have similar morphology, a similar refractive index (1.37), larger diameter (70% of the NanoE are over 200nm), and increased positive staining for CD235a and lipids (Di-8-ANEPPS) (58% and 67% in NanoE vs. 21% and 45% in eryEVs, respectively). Altogether, our results highlight the general need to develop and validate new RM with similar physical and biochemical properties as EVs to standardize EV measurements between instruments and laboratories.


Assuntos
Eritrócitos/citologia , Vesículas Extracelulares , Nanoestruturas/normas , Proteolipídeos/normas , Vesículas Extracelulares/ultraestrutura , Citometria de Fluxo , Humanos , Microscopia Eletrônica de Transmissão , Nanoestruturas/química , Nanoestruturas/ultraestrutura , Proteolipídeos/química , Padrões de Referência
19.
Plant Physiol Biochem ; 110: 236-264, 2017 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-27289187

RESUMO

Recent investigations show that carbon-based and metal-based engineered nanomaterials (ENMs), components of consumer goods and agricultural products, have the potential to build up in sediments and biosolid-amended agricultural soils. In addition, reports indicate that both carbon-based and metal-based ENMs affect plants differently at the physiological, biochemical, nutritional, and genetic levels. The toxicity threshold is species-dependent and responses to ENMs are driven by a series of factors including the nanomaterial characteristics and environmental conditions. Effects on the growth, physiological and biochemical traits, production and food quality, among others, have been reported. However, a complete understanding of the dynamics of interactions between plants and ENMs is not clear enough yet. This review presents recent publications on the physiological and biochemical effects that commercial carbon-based and metal-based ENMs have in terrestrial plants. This document focuses on crop plants because of their relevance in human nutrition and health. We have summarized the mechanisms of interaction between plants and ENMs as well as identified gaps in knowledge for future investigations.


Assuntos
Produtos Agrícolas/química , Nanoestruturas/química , Plantas Comestíveis/química , Poluentes do Solo/química , Produtos Agrícolas/efeitos dos fármacos , Produtos Agrícolas/fisiologia , Dieta , Monitoramento Ambiental/métodos , Monitoramento Ambiental/normas , Análise de Alimentos/métodos , Análise de Alimentos/normas , Humanos , Nanopartículas Metálicas/química , Nanopartículas Metálicas/normas , Nanopartículas Metálicas/toxicidade , Nanoestruturas/normas , Nanoestruturas/toxicidade , Valor Nutritivo , Plantas Comestíveis/efeitos dos fármacos , Plantas Comestíveis/fisiologia , Poluentes do Solo/normas , Poluentes do Solo/toxicidade
20.
AAPS J ; 19(1): 18-25, 2017 01.
Artigo em Inglês | MEDLINE | ID: mdl-27822601

RESUMO

The increasing use of nanotechnology, including nanoparticles, in the preparation of drug products requires both manufacturing and analytical considerations in order to establish the quality metrics suitable for performance and risk assessment. A range of different nanoparticle systems exists including (but not limited to) nano-drugs, nano-additives, and nano-carriers. These systems generally require more complex production and characterization strategies than conventional pharmaceutical dosage forms. The advantage of using nanoparticle systems in pharmaceutical science is that the effective and desired function of the material can be designed through modern manufacturing processes. This paper offers a systematic nomenclature which allows for greater understanding of the drug product under evaluation based on available data from other nanoparticle reports. Analytical considerations of nano-drugs, nano-additives, and nano-carriers and the way in which they are measured are directly connected to quality control. Ultimately, the objective is to consider the entire nano-drug, nano-additive, and nano-carrier product life cycle with respect to its manufacture, use, and eventual fate. The tools and approaches to address the needs of these products exist; it should be the task of the pharmaceutical scientists and those in related disciplines to increase their understanding of nanomedicine and its novel products.


Assuntos
Avaliação de Medicamentos/tendências , Indústria Farmacêutica/normas , Nanoestruturas/química , Nanoestruturas/normas , Preparações Farmacêuticas/química , Preparações Farmacêuticas/normas , Indústria Farmacêutica/tendências , Tamanho da Partícula , Propriedades de Superfície
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