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quinta-feira, 20 de fevereiro de 2014

Nanotechnology and patents in Europe

Here
The number of European applications filed for nanotechnology-related inventions has more than tripled since the mid-1990s.
The interdisciplinary nature of nanotechnology poses a challenge for patent offices, legal representatives, inventors and applicants alike.


A new brochure (Nanotechnology and patents; pdf) from the European Patent Office (EPO) explains how to get started if you want to search for nanotechnology inventions in patent databases, and what to look out for if you are thinking about applying to the EPO for a nanotechnology patent yourself.

In order to monitor the impact of nanotechnology on the development of new products, the European Patent Office uses the following definition to identify patents in this area: The term nanotechnology covers entities with a controlled geometrical size of at least one functional component below 100 nanometres (nm) in one or more dimensions susceptible of making physical, chemical or biological effects available which are intrinsic to that size.

Basic requirements for European patent applications

All European patent applications, including those relating to nanotechnology, have to meet the requirements of the European Patent Convention (EPC).

To get your nanotechnology patent granted:
  • – your invention must be new (the principle of "novelty")
  • – it must involve an inventive step, and
  • – it must be susceptible to industrial application.
  • Furthermore, the invention must be adequately disclosed and the claims of the application must be clear, concise and supported by the description.


    Fonte: Nanowerk

    terça-feira, 11 de fevereiro de 2014

    Picotecnologia ou Nanotecnologia?

    Por: André Luiz Aguiar*

    Que tal um xampu Plancktechnology?




    O que gostaria de refletir aqui é o uso do termo PICOTECNOLOGIA como sendo uma "evolução da NANOTECNOLOGIA". [1]



    Não faz muito tempo, assisti ao comercial de um produto para cabelos  shampoo, condicionador e afins  que afirmava usar a tecnologia do PICÔMETRO (unidade de medida que equivale a 10-12 m, ou seja, 1 trilhão do metro, ou mesmo uma distância aproximadamente 100 vezes menor que o diâmetro de um átomo).


    A propaganda veicula a nova linha Keratinology by Seda, uma das marcas da multinacional Unilever.

    Veja o vídeo em português.
    video
    Veja aqui


    É ressaltado que essa "nova tecnologia" utiliza-se do estado da arte da PICOTECNOLOGIA e reforça que ela é "MIL VEZES MENOR QUE A NANO".

    No site da empresa, encontra-se:
    "Keratinology é a primeira marca a utilizar em 100% de sua linha o poder da Pico Technology™. Pico significa partículas mil vezes menores que as Nano. Por serem tão pequenas, essas partículas penetram fácil e profundamente no córtex dos fios do cabelo, para nutrir e reconstruir intensamente as fibras danificadas. Pode-se dizer que essa nova tecnologia “funciona como uma plástica para os fios” e torna os cabelos saudáveis e bonitos..."


    Para você entender o tamanho, conforme o Sistema Internacional de Unidades (SI):


           NOME                       SÍMBOLO               FATOR DE MULTIPLICAÇÃO DA UNIDADE  
    nano
    n
               10-9 = 0,000 000 001
    pico
    p 
                                                                                         10-12 = 0,000 000 000 001


    É fato que encontramos cada vez mais produtos disponíveis ao consumidor que afirmam utilizar tecnologias emergentes cujas propriedades -- em tese -- reforçam, realçam, melhoram, amplificam, exponenciam, valoram, potencializam, etc  tal produto; seja ele um cosmético ou uma roupa espacial.

    No que diz respeito aos Nanoprodutos, encontramos cada vez mais e mais deles acessíveis aos consumidores. E no campo da higiene, perfumaria e cosméticos, a Nanotecnologia tem sido elevada como 'a tecnologia' promissora para o desenvolvimento da indústria.


    Veja aqui
    Existem grupos no mundo, preocupados com a quantidade desses Nanoprodutos no mercado consumidor, que listam quais já estão à disposição dos usuários. 

    Um desses grupos é o Projeto de Nanotecnologias Emergentes (PEN) que faz um inventário, não exaustivo, sobre os vários nanoprodutos que estão sendo oferecidos aos consumidores. Já listaram quase 1850 produtos. Ressaltando que esse banco de dados apenas lista aqueles que declaram abertamente usar nanotecnologia.


    Também há um banco de dados (Nanodatabasen), alimentado pelo Conselho de Consumidores dinamarquês (Tænk forbrugerrådet - The Danish Consumer Council), que já catalogou, até a presente data, 1236 nanoprodutos disponíveis nas lojas dos dinamarqueses bem como na internet.
    Veja aqui


    Até a presente data, não há -- que eu saiba -- qualquer banco de dados de nanoprodutos oferecidos e disponíveis aos consumidores brasileiros.

    E como a tendência é de 'progressão geométrica' dos nanoprodutos, seria necessário e interessante haver algum banco de dados para o conhecimento e averiguação, respeitando assim o direito garantido na Constituição e no Código de Defesa dos Consumidores de informação adequada e clara!

    Nanoprodutos - cosméticos brasileiros


    Aqui, na terrae brasilis (Brasil), já podemos encontrar muitos produtos que afirmam usar a Nanotecnologia. 

    Mencionar todos os projetos, empresas, indústrias e produtos que empregam Nanotecnologia ocuparia mais espaço que o razoável para este texto. 


    Portanto, demonstro alguns, sem o pretexto de exaurir os muitos outros nanocosméticos que já existem no mercado brasileiro, como esmaltes de unhas, maquiagens, tratamento para acnes e espinhas, produtos contra olheiras, contra celulites, etc.

    O Boticário - Linha Active
    É o caso do O Boticário com a sua linha Active (preparação da pele, antissinais e tratamentos específicos) que utiliza a nanotecnologia como mote para desenvolvimento de seus cosméticos.


    Afirmam até que ultrapassaram a simples nanotecnologia ("até as camadas internas da pele") para a tripla nanotecnologia ("ingredientes ativos penetrem nas camadas da pele de forma direcionada"), isto através dos produtos advindos do Active Dermato Nanoserum Elixir
       
    Vejam o vídeo a respeito da tripla nanotecnologia.


    video
    Veja aqui

    Sem falar nos produtos para preparação da pele e os antissinais avançados que também podem fazer uso desse expediente nanotecnológico.



    Outra empresa que lida com Nano é a porto-alegrense Inventiva que dá ênfase à inovação aos nanocosméticos, produzindo insumos para a indústria cosmética e farmácias de manipulação do Brasil e agora para a França e, por conseguinte, toda a Europa.

    Encontramos desde produtos para o corpo, rosto, cabelos e unhas.

    Para o corpo o Nano Hydrate que utiliza óleos vegetais aliados à nanotecnologia. Já para o rosto, existe o NanoAging Reverse que usa uma mistura de nanopartículas (coenzima Q10, vitamina A, vitamina E, semente de uva e linhaça) para combater o envelhecimento cutâneo. E para  os cabelos há o NanoVit Hair que em sua formulação contém nanopartículas de queratina hidrolisada.   

    Veja abaixo o vídeo da empresa sobre Nanotecnologia em Cosméticos.   
    video
    Veja o aqui.


    Como disse, não é minha intenção abordar e falar de todos os Nanocosméticos existentes no mercado brasileiro e feito por empresas nacionais, mas tão só mostrar que já é corriqueiro encontrá-los nas prateleiras-nossas-de-cada-dia.

    E o prognóstico é que cada vez mais encontremos outros tantos nanoprodutos. Muitas vezes sem o saber -- como relatei aqui em "NanoProdutos sempre à mão: só que eu não sabia!"


    E a Picotecnologia com isso?


    Agora, você consumidor deve estar lendo e pensando: e o que eu tenho a ver com isso, ou que benefícios essa tal de Picotenologia pode me trazer?

    Foi nesse ponto que eu quis chegar até então.

    Quando eu vi a propaganda da Picotecnologia referida acima, pensei como possível consumidor: o que isso trará de benefícios para os meus cabelos? 
    Especificadamente os cabelos devido ao objetivo da propaganda. Mas poderia muito bem ser Picotecnologia para cílios, unhas, antissinais, celulites, enfim, os mesmos exemplos ditos sobre a Nanotecnologia.

    Quando você vê uma propaganda como aquela, deveria ser natural parar e pensar: qual o objetivo dessa "nova tecnologia" picotecnológica?

    Como os consumidores não são levados a tal reflexão na hora de adquirir um produto, logo, a veiculação de ser "Picotecnológico mil vezes menor que Nano" é basicamente para atrair a atenção e fazer com que adquiram tal produto pensando estar levando um que dá e garante eficiência mil vezes maior que Nano.

    Se assim fosse, então produtos da Femtotecnologia (10-15), da Attotecnologia (10-18), da Zeptotecnologia (10-21) ou da                    Yoctotecnologia (10-24) cada um teria a sua "potencialidade" penetrante e eficaz cada vez maior? 


    Assim, por uma questão de mercado, ao invés de se veicular que seu produto contém Picotecnologia, por que já não dizer que possui Yoctotecnologia, ou mesmo -- para chutar o pau da barraca de uma vez -- dizer que contém tecnologia do Comprimento de Plank!?

    Já que não precisa provar que efetivamente contém Nano ou contém Pico, logo, vale tudo para dizer que o produto é tão pequeno que vai transformar você num consumidor feliz e saltitante!

    Então, uma dica de marketing para as empresas: 
    "esse produto Contém Plancktechnology"  (nome bonito e em inglês pra ficar chamativo, algo como 16.162 × 10-36 m). 

    Que tal? 

    Ou em bom português: 
    Novo Xampu da Vovó, Contém Plancktecnologia que vai fazer o seu cabelo estar além das Luzes das Estrelas e conquistar qualquer extraterrestre!

    Só não vá se perder no espaço viu! E se por acaso encontrar lá no multiverso um cabelo igual ao teu, aí então teremos que pensar em uma nova linha de produtos para sua cuca! 


    Brincadeiras à parte, é basicamente isso que me propus a levar você a pensar: o fato de ter picotecnologia ou nanotecnologia é realmente um benefício ou apenas é um mecanismo mercadológico para que mais e mais produtos "inovadores" sejam adquiridos?

    Pensemos assim: se um produto é mil vezes, dez mil ou um zirilhão de vezes melhor que o produto "original", logo, matematicamente, você não precisará mais dele, uma vez que ele foi tão "eficaz, penetrante e benfeitor" que a necessidade de usá-lo será eliminada em si mesmo.

    Portanto, se Picotecnologia é mil vezes menor que Nano, logo eu não precisarei desse Picoprotudo tão cedo, já que ele foi mais eficiente que Nano -- ora pois!.[2]     

    Para encerrar, deixo no ar uma pergunta: nessa propaganda não haveria uma quebra dos direitos do consumidor? Veja o que o Código do Consumidor (Lei 8.078 de 1990) diz:

    Art. 6º São direitos básicos do consumidor:
            I - a proteção da vida, saúde e segurança contra os riscos provocados por práticas no fornecimento de produtos e serviços considerados perigosos ou nocivos;
            II - a educação e divulgação sobre o consumo adequado dos produtos e serviços, asseguradas a liberdade de escolha e a igualdade nas contratações;
           III - a informação adequada e clara sobre os diferentes produtos e serviços, com especificação correta de quantidade, características, composição, qualidade, tributos incidentes e preço, bem como sobre os riscos que apresentem
            IV - a proteção contra a publicidade enganosa e abusiva, métodos comerciais coercitivos ou desleais, bem como contra práticas e cláusulas abusivas ou impostas no fornecimento de produtos e serviços; [grifei].


    *André Luiz Aguiar: advogado formado pela 
    Pontifícia Universidade Católica do 
    Paraná (PUC-PR), OAB-PR 60.581,
    pesquisador e consultor 
    em
    Nanotecnologias e regulamentação 


    [1] Um alerta: aqui não pretendo mencionar todos os produtos no mercado consumidor que afirmam usar a picotecnologia, pois não é o meu foco. Mas sim relatar o que assisti em tal comercial e analisar, como consultor e pesquisador em Nanotecnologias, o que tal propaganda quis me passar/oferecer quando da sua veiculação e quais os mecanismos para isso. Nem mesmo é meu intuito, com a transmissão de tais vídeos, fazer propaganda dos produtos. Eles servem apenas para ilustrar e melhor compreender.  

    [2] Nem cogitei falar nos Picoriscos (PicoHazards) ou demais percalços advindos nessa Picotecnologia, já que elas são incipientes e abarcariam os temas já trazidos (com os conhecimentos atuais do estado da arte) pelos Nanoriscos (NanoHazards). Mas fique registrado que, se já há declarações de Nanoriscos, por conseguinte PicoriscosFemtoriscos (FemtoHazards), Attoriscos (AttoHazards),  Zeptoriscos (ZeptoHazards), Yoctoriscos (YoctoHazards), ou Plankriscos (PlankHazards) ocorrerão. 
    __________________________





    terça-feira, 28 de janeiro de 2014

    Lungs may suffer when certain elements go nano

    Nanoparticles are used in all kinds of applications -- electronics, medicine, cosmetics, even environmental clean-ups. More than 2,800 commercially available applications are now based on nanoparticles, and by 2017, the field is expected to bring in nearly $50 billion worldwide.

    But this influx of nanotechnology is not without risks, say researchers at Missouri University of Science and Technology.

    "There is an urgent need to investigate the potential impact of nanoparticles on health and the environment," says Yue-Wern Huang, professor of biological sciences at Missouri S&T.

    Huang and his colleagues have been systematically studying the effects of transition metal oxide nanoparticles on human lung cells. These nanoparticles are used extensively in optical and recording devices, water purification systems, cosmetics and skin care products, and targeted drug delivery, among other applications.

    "In their typical coarse powder form, the toxicity of these substances is not dramatic," says Huang. "But as nanoparticles with diameters of only 16-80 nanometers, the situation changes significantly."


    The researchers exposed both healthy and cancerous human lung cells to nanoparticles composed of titanium, chromium, manganese, iron, nickel, copper and zinc compounds -- transition metal oxides that are on the fourth row of the periodic table. The researchers discovered that the nanoparticles' toxicity to the cells, or cytotoxicity, increased as they moved right on the periodic table.

    "About 80 percent of the cells died in the presence of nanoparticles of copper oxide and zinc oxide," says Huang. "These nanoparticles penetrated the cells and destroyed their membranes. The toxic effects are related to the nanoparticles' surface electrical charge and available docking sites."

    Huang says that certain nanoparticles released metal ions -- called ion dissolution -- which also played a significant role in cell death.

    Huang is now working on new research that may help reduce nanoparticles' toxicity and shed light on how nanoparticles interact with cells.

    "We are coating toxic zinc oxide nanoparticles with non-toxic nanoparticles to see if zinc oxide's toxicity can be reduced," Huang says. "We hope this can mitigate toxicity without compromising zinc oxide's intended applications. We're also investigating whether nanoparticles inhibit cell division and influence cell cycle."

    The researchers' findings, "Cytotoxicity in the age of nano: The role of fourth period transition metal oxide nanoparticle physicochemical properties," were published in the Nov. 25, 2013, issue of the journal Chemico-Biological Interactions.



    Fonte: ScienceDaily

    Nanoparticules synthétiques: Une nouvelle liste des risques pour la santé et la sécurité

    Les nanotechnologies se développent rapidement, mais les impacts au regard de la santé et de la sécurité des travailleurs ne sont pas toujours tous évalués. Pour pallier cette situation, des chercheurs ont dressé une liste détaillée des risques que représentent les nanoparticules synthétiques pour les travailleurs. Pour ce faire, ils ont d’abord réalisé une revue exhaustive des articles scientifiques publiés à ce sujet entre 2001 et 2011. Ensuite, ils ont recensé, catégorisé et hiérarchisé les facteurs de risques. Trente-quatre facteurs de risques ont été identifiés en lien avec la santé et la sécurité au travail et classifiés selon qu’ils faisaient partie d’un facteur de danger, d’un paramètre lié à l’exposition ou d’un effet sur la santé ou la sécurité.

    Adicionar legenda

    Des incertitudes
    « En recourant uniquement à une revue de la littérature, il demeure encore trop d’incertitudes et celles-ci limitent les comparaisons et les liens existant entre certaines catégories de risques. Huit grands groupes de risques ont tout de même pu être identifiés dans la littérature et représentés sous la forme d’un réseau hiérarchisé des risques. Il apparaît que de nouvelles méthodes d’évaluation et de gestion des risques sont requises, mais entre-temps cette première hiérarchisation permettra, par son approfondissement, de mieux prioriser les risques associés aux nanoparticules synthétiques. Ce travail pourrait servir de base au développement d’un outil d’aide à la décision », explique l’associé de recherche, Julien Fatisson de l’École de technologie supérieure (ÉTS), auteur principal de cette étude originale financée par l’Institut de recherche Robert-Sauvé en santé et en sécurité du travail (IRSST) par le biais du Réseau  Ne3LS.
    Cette liste détaillée des risques pour la santé et la sécurité est destinée aux producteurs de nanoparticules synthétiques et aux intervenants en prévention au travail. Elle peut être consultée gratuitement au http://www.irsst.qc.ca/-publication-irsst-nanoparticules-synthetiques-r-798.html

    Résumé

    De plus en plus les nanotechnologies suscitent un grand intérêt autant sur le plan industriel que médical. Cependant, la production de nanoparticules synthétiques (NPS) continue de croître alors que les impacts sanitaires et environnementaux n’ont pas tous été évalués, amenant ainsi de nouveaux problèmes. Consécutivement à l’expansion du marché des nanotechnologies, le nombre de travailleurs exposés continue d’augmenter. Bien qu’aucun consensus mondial ne se dégage en ce qui a trait à une définition et une règlementation clairement adaptées aux NPS, le besoin de protéger les travailleurs reste capital et passe par une gestion des risques adaptée.

    Depuis 10 ans, la science explore les nombreuses propriétés des NPS, mais de multiples incertitudes persistent. Elles portent sur les facteurs de risque les plus susceptibles de causer un effet néfaste sur la santé humaine, ainsi que sur les mécanismes menant à une détérioration de la santé et de la sécurité humaine à la suite d’une exposition à ces NPS. Les connaissances sur les risques (exposition, toxicité, incendie, explosion, etc.) évoluent à un rythme effréné. 

    Elles découlent d’approches méthodologiques et s’appliquent à des nanoparticules provenant de différentes sources (celluloses, fullerènes, métaux et oxydes de métaux, etc.). De ce fait, la comparaison des résultats et des études devient ardue. 
    De plus, il n’existe actuellement aucune procédure de mesure standardisée pour la caractérisation des nanoparticules même si certaines équipes de recherche travaillent pour atteindre cet objectif.

    Par ailleurs, la mise en marché des NPS précède souvent les études toxicologiques appropriées, ce qui en inquiète plus d’un. Cette situation donne plus de poids aux recommandations relatives au développement de stratégies de gestion des risques en parallèle de la recherche et du développement desdites particules. Plusieurs souhaitent une stratégie de gestion des risques adaptative qui évolue avec l’avancement des connaissances et qui inclut une communication transparente au regard des incertitudes qui demeurent. 

    Dans ce contexte, l’objectif ultime de ce projet était de construire le prototype d’un outil d’aide à la décision en matière de gestion des risques pour la santé et la sécurité des travailleurs posés par les NPS. Mais avant de pouvoir développer un outil de gestion des risques adapté aux NPS, il était nécessaire de réaliser une revue exhaustive des articles scientifiques publiés entre 2001 et 2011. Ce rapport a donc été construit de façon à dresser une liste détaillée des risques associés aux NPS dans un cadre de santé et de sécurité du travail (SST). Ces risques ont par la suite  été catégorisés et hiérarchisés pour illustrer la complexité d’un tel système à travers l’interdépendance de chaque élément du risque.

    Des étapes ultérieures à la catégorisation des risques présentée dans ce rapport seraient donc nécessaires afin de peaufiner un prototype d’outil d’aide à la décision. Cet outil serait destiné aux producteurs de NPS et aux intervenants en prévention au travail pour les aider à mettre en place des mesures de contrôle pour assurer la santé et la sécurité des travailleurs exposés aux NPS.


    ,
    Fonte: IRSST

    UE: FutureNanoNeeds: "Framework to respond to regulatory needs of future nanomaterials and markets"

    FutureNanoNeeds, "Framework to respond to regulatory needs of future nanomaterials and markets", FP7 project started on January 1st . The KICK-off meeting was celebrated in Dublin on February 9th and 10th hosted by the coordinator the University College Dublin (UCD).
    This project will develop, during the next 4 years, a novel framework to enable naming, classification, hazard and environmental impact assessment of the next generation nanomaterials prior to their widespread industrial use. 
    It will uniquely achieve this by integrating concepts and approaches from several well established contiguous domains, such as phylontology and crystallography to develop a robust, versatile and adaptable naming approach, coupled with a full assessment of all known biological protective responses as the basis for a decision tree for screening potential impacts of nanomaterials at all stages of their lifecycle. 
    Together, these tools will form the basis of a "value chain" regulatory process which allows a each nanomaterial to be assessed for different applications on the basis of available data and the specific exposure and life cycle concerns for that application.
    The FutureNanoNeeds consortium is uniquely placed to achieve this, on the basis of expertise, positioning, open mindedness and a belief that new approaches are required.
    More info can be found at: www.futurenanoneeds.eu

    Project Summary

    Project Full Title: Framework to respond to regulatory needs of future nanomaterials and markets.
    Project Acronym: FutureNanoNeeds.
    Project Keywords: nano-objects, regulation, industry sectors, roadmap of future nanomaterials,
    value chain, hazard, exposure, risk, communication.
    Duration: from 1st January 2014 to 31st December 2017 (4 years).
    Program: FP7-NMP-2013-LARGE-7.
    Acitivity Code: NMP.2013.1.3-3: Development of a systematic framework for naming and assessing safety of
    the next generations of nanomaterials being developed for industrial applications.
    Project Abstract:
    Rapidly developing markets such as green construction, energy harvesting and storage, advanced materials for aerospace, electronics, medical implants and environmental remediation are potential key application targets for nanomaterials. There, nanotechnology has the potential to make qualitative improvements or indeed even to enable the technology. Impacts range from increased efficiency of energy harvesting or storage batteries, to radical improvements in mechanical properties for construction materials. In addition, concerns of these markets such as scarcity of materials, cost, security of supply, and negative environmental impact of older products could also be addressed by new nano-enabled materials (e.g. lighter aircraft use less fuel). 
    FutureNanoNeeds will develop a novel framework to enable naming, classification, hazard and environmental impact assessment of the next generation nanomaterials prior to their widespread industrial use. It will uniquely achieve this by integrating concepts and approaches from several well established contiguous domains, such as phylontology and crystallography to develop a robust, versatile and adaptable naming approach, coupled with a full assessment of all known biological protective responses as the basis for a decision tree for screening potential impacts of nanomaterials at all stages of their lifecycle. Together, these tools will form the basis of a “value chain” regulatory process which allows a each nanomaterial to be assessed for different applications on the basis of available data and the specific exposure and life cycle concerns for that application. Exemplar materials from emerging nano-industry sectors, such as energy, construction and agriculture will be evaluated via this process as demonstrators. The FutureNanoNeeds consortium is uniquely placed to achieve this, on the basis of expertise, positioning, open mindedness and a belief that new approaches are required.
    Fonte: NANOfutures

    Conclusions that nano-ingredients in sunscreen are safe are premature


    Recent media reports that “nanoparticles in sunscreen are harmless” on the basis of a recently published study don’t reflect the paper’s own conclusions nor the current state of the science.

    Whilst the results of this lab study study are interesting, more studies are needed reflecting real life conditions before any conclusions about the safety of nano zinc oxide in sunscreen can be drawn. Importantly, the paper draws no conclusions about the safety of nano-ingredients in sunscreen and also doesn’t look at other nano sunscreen ingredients such as titanium dioxide and cerium oxide.

    What the study does acknowledge is that nano-ingredients can penetrate the skin and get into the bloodstream. This is something our sunscreen regulator the Therapeutic Goods Administration has so far denied.

    The view that nano-ingredients in sunscreen are safe is not shared by the European Commission's Scientific Committee on Consumer Safety. This body recently recommended that certain nano titanium dioxide (TiO2) ingredients not be used in sunscreen because they strongly react with sunlight to produce free radicals and that nano TiO2 and nano zinc oxide (ZnO) not be used in powder or sprayable products because of the toxicity risk associated with inhalation.

    A recent Italian study using pig ear skin found that nano titanium dioxide damaged the outer layer of skin. The researchers warned that this could allow nanoparticles and other unwanted chemicals to penetrate the skin - posing a potential human health risk.

    The European Chemical Agency (ECHA) is currently reviewing the safety of titanium dioxide (including the nano form) because of concerns in may be harmful to the environment and human health. Meanwhile our regulators here have taken no action to remove these ingredients from sunscreen.

    Fonte: FoE- Friends of the Earth Australia - Nanotechnology Projectd - 

    Scientists discover nanoparticles in sunscreen are harmless


    Fears about dangers of nanoparticles in sunscreen may be unfounded, with research finding they are unlikely to harm beachgoers
    .

    Scientists have for the first time been able to see how the body's immune system deals with zinc oxide nanoparticles - an ingredient found in many popular sunscreens.

    Researchers from the Australian Synchrotron, the Melbourne Centre for Nanofabrication, CSIRO, RMIT and Monash University found while the body absorbed the nanoparticles, it was able to identify and remove the particles before they reached the bloodstream.

    ''This is the first time that we have shown that the cells of the immune system can break down the nanoparticles directly,'' said Australian Synchrotron and CSIRO bio-inorganic chemist Simon James. ''Previous work was only able to infer that.''


    Zinc oxide is added to sunscreen because of its ability to absorb or scatter the sun's ultraviolet radiation and prevent sunburn, but it had not been clear how the body dealt with the nanoparticles that penetrate the skin.

    The researchers used a type of white blood cell called a macrophage which was exposed to zinc oxide nanoparticles. They then counted how many of the tiny cube-shaped particles were absorbed.

    Dr James said on average 60,000 tiny nanoparticles made it into a single white blood cell.
    ''It's a tiny, tiny number, especially seeing as the cells are able to break them down,'' Dr James said.

    Within 24-hours, the cells were able to break down 50 per cent to 60 per cent of the nanoparticles, with the majority of the remaining particles in the process of decomposition.
    The results published in the journal ACS Nano found the body's immune system did what it should: it broke down nanoparticles before they could enter the bloodstream.

    Cancer Council Australia chief executive Ian Olver said the results should reassure those concerned about nanoparticles in sunscreen.

    ''The nanoparticles in sunscreen are unlikely to cause harm to beachgoers,'' he said.



    Fonte: The Age

    Nanotechnology: Is the Magic Bullet Becoming Reality?

    Researchers at a recent New York conference discuss what the future of nanomedicine may hold.

    Richard A. Stein, M.D., Ph.D.

    Nanotechnology: Is the Magic Bullet Becoming Reality?
    Nanotech seems promising, but regulatory
    and patent issues remain. [© Anterovium - Fotolia.com]
    Slightly over a century ago, Paul Ehrlich coined the term “magic bullet” to refer to therapeutic compounds designed to selectively target a pathogen without affecting the host. Subsequently, this idea flourished not only for infectious diseases but also for other fields, such as cancer therapy. At the recent Nanomedicines: Addressing the Scientific and Regulatory Gap” conference held at the New York Academy of Sciences in late November, investigators discussed key concepts shaping a vibrant field that promises to bring this concept closer to the clinic.

    Liposomes


    “When we entered this field, from the few systems that existed, we chose to work on liposomes,” said Yechezkel Barenholz, Ph.D., professor of biochemistry at the Hebrew University – Hadassah Medical School in Jerusalem. Liposomes presented the advantage that relatively more knowledge existed about their pharmacokinetic properties. The compound that Dr. Barenholz and colleagues started to work on, doxorubicin, is one of the most effective first-line anticancer therapeutics ever developed, but one of its disadvantages is that adverse effects occur in many organs upon systemic administration. Work by Dr. Barenholz and colleagues on a liposome-based doxorubicin formulation culminated with the development of Doxil (doxorubicin), the first nanodrug approved by the FDA in 1995.

    “In a way, the success of this project started from a failure,” Dr. Barenholz said. Investigators in his lab initially developed a liposome-based doxorubicin formulation to reach the liver and treat hepatocellular carcinoma, and even though this worked well in an animal model, the pharmacokinetics was not favorable in humans. “As a result we became more determined, and in a new approach, we decided to first determine what kind of performance we need from liposomes, and then we used a materials science approach,” he added.

    A key concept in developing the doxorubicin-loaded liposomes was the enhanced permeability and retention effect. This phenomenon, which results from differences in vasculature between normal and inflamed tissue, refers to the ability of the poorly aligned, fenestrated endothelial cells from the malignant tumor neovasculature to allow 10–300 nm diameter nanoparticles to cross and become selectively enriched in the tumor.

    “This is not the case in normal tissues, and it represents the Achilles’ heel of the tumor,” said Dr. Barenholz. The defective lymphatic drainage of malignant tissues further facilitates the accumulation of nanoparticles.

    To load the liposomes with doxorubicin, Dr. Barenholz and colleagues relied on a transmembrane ammonium sulfate gradient that acted as the driving force for the loading process. As a result, doxorubicin reached 100-fold higher concentrations in the intraliposomal aqueous phase as compared to the loading medium. The circulation time of liposomes was extended by stabilizing them with a formulation composed of phospholipids with high melting temperature, cholesterol, and a pegylated lipopolymer. Clinical studies in humans revealed that the nanoparticles accumulated in tumors, and doxorubicin reached higher concentrations in the tumor than what could what could be achieved with systemic administration.

    “This formulation improves patient compliance and the quality of life,” Dr. Barenholz said.

    TNF


    “We wanted to use nanotechnology in cancer therapy and change the way we treat this disease,” said Lawrence Tamarkin, Ph.D., president and CEO of CytImmune. The approach that Dr. Tamarkin and colleagues developed relies on 27 nm gold nanoparticles that have been used since the 1930s to treat psoriatic arthritis and present an established history of safety.

    The surface of the colloidal gold nanoparticles was simultaneously bound to covalently linked thiolyated PEG, to avoid immune detection, and recombinant human tumor necrosis factor (TNF). Clinically, TNF has been successfully used in Europe to treat tumors of the extremities, in a procedure known as isolated limb perfusion. Infusing high-dose TNF prior to chemotherapy can achieve 15–25-fold higher concentrations as compared to systemic administration, without the same risks of adverse effects. With this strategy, several studies found up to 95% response rates after one treatment in patients with melanoma and sarcoma. “We wanted to mimic this clinical experience systemically,” said Dr. Tamarkin.

    The 27 nm-diameter gold nanoparticles are small enough to travel through the blood vessels, and the 2–4 nm gaps between endothelial cells in healthy blood vessels are too small to allow them to cross into tissues, due to the presence of the tight junctions. “But at the site of the tumor, where the neovasculature fenestrations are 200–400 nm, the blood pressure forces them into the tumor bed, where TNF molecules bind to TNF receptors on the endothelial cells and start causing vascular disruption,” he added.

    In a Phase I clinical trial, CYT-6091, the nanotherapeutic that Dr. Tamarkin and colleagues developed, delivered up to 1.2 mg TNF, as compared to 0.4 mg, which is the maximum tolerated human dose, without any signs of dose-limiting toxicity. “The promise of nanotechnology is that we can reduce or eliminate toxicity and improve the therapeutic index,” he said. Moreover, the drug accumulated at tumor sites, and very few gold nanoparticles were seen in healthy tissues.

    We intended not simply to reformulate an already approved drug, but to create a safe and effective therapeutic by using nanotechnology,” he said. Two patients, one with inoperable breast cancer and another one with pancreatic cancer, neither of them having previously undergone surgical treatment, showed the most nanoparticles accumulating in the tumor, as compared to the adjacent healthy tissue. “This indicated that perhaps treating patients surgically so quickly might not be a good idea, because it tears up the roadway that nanoparticles use to reach their targets,” he commented.

    Gold nanoparticles accumulated in malignant tissues even at the lowest doses, but accumulation was not increasing in a dose-dependent manner. Reducing the tumor burden in situ offers the possibility to reduce the need for sophisticated surgery and the hospitalization time.

    “We have the promise to dramatically improve healthcare because of decreased treatment costs,” he concluded.

    Generic Nanotech


    The concept of generic substitution, which guides the replacement of a prescribed brand of a drug with an identical formulation of the same active compound made by a different manufacturer, appears to open uncharted territory when applied to nanomedicine. Generic medicinal products are normally therapeutically equivalent and therefore interchangeable and substitutable to the reference (innovator) product because they are pharmaceutically comparable and bioequivalent, and they do not require additional clinical efficacy or safety studies.

    “But it has to be ensured that the drug can be fully characterized,” said Stefan Mühlebach, Ph.D., professor of pharmacology at the University of Basel and scientific director at Vifor Pharma. The generic paradigm was successful in the past for small molecules such as aspirin, but it is more problematic for the more complex biological drugs, which are much larger and more difficult to characterize. A third category of medicinal products, the nonbiological complex drugs, is distinct from both the small molecules and the biological therapeutics by the presence of multiple different large molecular structures, some of which may be nanoparticulate, and by not being a biological.
    In nonbiological complex drugs, the entire product represents the active pharmaceutical ingredient, all the components contribute to the characteristics of the final product, and the properties cannot be fully characterized by physicochemical means, which is a prerequisite to show pharmaceutical comparability to a reference listed drug (RLD) and requested for generics.

    “The characterization of nonbiological complex drugs is seriously limited by the fact that we do not always know what to look for when characterizing clinical meaningful differences,” said Dr. Mühlebach. Additionally, the characteristics of nonbiological complex drugs are highly dependent on the elaborate, multistep synthetic manufacturing process.

    Examples of nonbiological complex drugs are the iron carbohydrates, such as iron sucrose used for intravenous iron treatment, liposomal drugs, and some polymeric polypeptides like the glatiramoids. Iron sucrose, a colloidal solution, was introduced into therapy almost 50 years ago and used safely without knowing its nanomedicine character. “A challenge for some of these products is that the first generation of compounds started to be even replaced by competitors (similars) in the absence of the awareness on their nano properties and a lack of established or appropriate regulatory evaluation tools,” he added.

    The example of an iron sucrose similar that was used to substitute for the original compound is revealing. A retrospective analysis that investigated adverse effects in 600–700 postpartum gynecology patients from South Korea showed that the original product always caused fewer adverse effects compared to the new formulation. When diluted and administered over a longer time, classically used to improve the tolerance for a parenteral drug, even more adverse effects were reported with the new formulation, contrary to the predictions, but understandable from the complexity and the fragile stability of the products. As these results indicate, the conventional generic paradigm is not reliable any longer in the case of nanosimilars, and concluding that two products could be interchangeable, substitutable, or therapeutically equivalent may be wrong.

    “What we know about nanosimilars is that we need to go into the details of understanding the complexity of the manufacturing process, not only starting with the materials, but also regarding the final product, because these aspects are of highest importance for pharmaceutical equivalence, bioequivalence or the fate of the product in the body and finally efficacy and safety of the therapeutic product for the patient,” Dr. Mühlebach said.

    Regulatory Issues


    “Nanotechnology, along with the promise and benefits that it brings, may also raise some questions and concerns over safety and effectiveness,” says Ritu Nalubola, Ph.D, senior policy advisor at the Food and Drug Administration. 
    Some of the most significant regulatory considerations revolve around unveiling the properties of nanomaterials and understanding the relevance of those properties to the regulatory status of the specific products.

    To provide a framework for the regulatory oversight of emerging technologies in general and ofnanotechnology products in particular, in 2011 the Emerging Technologies Policy Coordination Committee prepared two strategic documents. “Building on these U.S. government policy principles, the FDA developed its own agency-specific regulatory approach, and these emphasize our mission to protect and promote public health, adopt risk-based regulatory approaches based on sound science, and develop transparent and predictable regulatory pathways that are grounded in the best available science,” says Dr. Nalubola.

    The definition of nanoparticles—including their size, which has commonly been placed in the 1-100 nm range—continues to present ample interest for regulatory purposes. “There are challenges in deciding how to address aggregates, agglomerates, and some other complex structures, and whether, in addition, we should also take into account novel engineering properties for regulatory purposes”, Dr. Nalubola commented.

    In 2011, the FDA issued a draft guidance that provides a broad screening tool for regulatory processes. “The FDA draft guidance recognizes our interests in size, but also that our interest extends beyond size, and that other properties are also relevant for safety and efficacy reviews,” she said. The guidance document encourages industry to seek FDA consultation early during product development, to ensure that any questions related to safety, effectiveness, and regulatory status can be adequately and timely identified and addressed.

    We also articulated our general position, which is that we do not categorically judge all nanotechnology products as being inherently benign or harmful but, rather, that we are looking at products and their characteristics on a case-by-case basis,” she added. This ensures that the current regulatory framework is sufficiently robust and flexible enough to consider a variety of nanomaterials, and to concomitantly identify existing regulatory gaps.

    The FDA is actively engaged in the national nanotechnology initiative and participates in some of its research activities. “On the policy side, and in context of the Emerging Technologies Interagency Policy Coordination Committee, we have ongoing dialogues on developing policy approaches and policy-related coordination, and we also participate in the international arena with our regulatory counterparts,” Dr. Nalubola said.

    From more than 80,000 articles on nanoparticles that were available on PubMed in January 2014, over half were published after 2010, revealing the interest and progress that are marking this area. As a multidisciplinary field, nanotechnology impacted diverse disciplines including agriculture, engineering, energy production, communications, information technology, cosmetics, and biomedicine. Among these, the diverse biomedical applications provide a clear indication that Ehrlich’s era of the “magic bullet” is becoming reality.

    Fool’s Gold in the Nanotech Patent Rush


    The past few years, especially the past decade, have witnessed a nanotechnology patent boom, a sort of patent ‘land grab’ by ‘patent prospectors’ who have captured upstream, foundational nanotechnology-related technologies,” says Raj Bawa, Ph.D., patent agent at Bawa Biotech LLC in Ashburn, VA, and adjunct professor at Rensselaer Polytechnic Institute, Troy, NY.

    A lack of a universal nanonomenclature
    is one factor complicating the
    patenting of nanotechnologies. [© Raj Bawa]

    At the recently concluded New York Academy of Sciences meeting, Dr. Bawa discussed some of the main considerations with respect to nanotechnology and nanopharma patents. According to information obtained from the U.S. Patent and Trademark Office (PTO), as of December 2012 over 8,000 U.S. nanopatents have been issued by various PTO technology centers and classified under Class 977. However, Dr. Bawa does not put too much stake into these numbers and even considers the classification strategy inadequate.

    These data simply reflects an upward trend, a sort of ‘nano-explosion’ and nothing more,” he commented. “It is based on the ill-conceived National Nanotechnology Initiative (NNI) definition of nanotechnology that limits all nanostructures and nanoproducts to a subnanometer range. Obviously, such a narrow (1-100 nm) and arbitrary classification scheme by the PTO misses many, if not most U.S. nanopatents and the actual numbers are meaningless to a researcher, policy-maker, or patent practitioner.”

    Another significant conundrum pertaining to nanotechnology patenting is the lack of a universal nanonomenclature whereby researchers and policy-makers often use distinct terms to refer to the same or similar nanostructure. Furthermore, the late 1980s and early 1990s have witnessed issuance of more than one U.S. nanopatent for the same invention.

    “This is contrary to the foundation of U.S. patent law where only one U.S. patent may be issued per invention,” Dr. Bawa added. “Partly, this situation developed because the search tools and commercial databases that were being used by patent examiners at the PTO, while well-suited to search patents on established technologies, were not well scaled to search most of the early scientific literature residing in scientific publications, as opposed to U.S. patents. Also, the U.S. patent examiners generally lacked expertise and training with respect to the emerging field of nanotechnology.”

    The classic example of these limitations is the issuance of multiple U.S. patents on carbon nanotubes. In a study on carbon nanotubes, Dr. Bawa and colleagues analyzed the claims from approximately 200 existing patents. “We discovered many foundational patents on carbon nanotubes recited overlapping or ‘legally identical’ patent claims,” he said. “A classical patent thicket exists today with respect to carbon nanotube patents.”


    One of the reasons that major conflicts have not emerged in this area is that not too many products have been commercialized yet. “The hope is that such U.S. patents will expire prior to widespread commercialization so that there is little or no need for litigation. However, some have proposed that the government employ provisions under the Bayh-Dole Act of 1980 by imposing compulsory licensing while others have even urged creation of an open-source type process to rectify the erroneous issuance of some of these basic, foundational U.S. nanopatents so that downstream development of nanotechnologies are not stifled,” Dr. Bawa said.



    Fonte: GEN