Nano-Syringe Delivers Combination, Targeted Brain Cancer Therapy

Nanomedicine researchers at the Methodist Neurological Institute and Rice University have developed a way to selectively kill brain cancer cells by using a tiny syringe to deliver a combination of chemotherapy drugs directly into the cells. These findings will be published in the April 24 issue of the American Chemical Society journal ACS Nano.

Dr. David Baskin, neurosurgeon, Methodist
Neurological  Institute and Martyn
Sharpe, lead author and researcher,
 Methodist Neurological Institute.
(Credit: Image courtesy of Methodist
Hospital, Houston)

Patients with glioblastoma multiforme (GBM), the most common and aggressive malignant primary brain tumor, typically have a prognosis of 14-month median survival time despite medical interventions, which currently include surgery, chemotherapy and radiation.

The Rice-Methodist group developed the hydrophilic carbon cluster (HCC) antibody drug enhancement system (HADES), named after the Greek god of the underworld. Through a 20-nanometer syringe, which is 2 million times smaller than a coffee mug, this nanovector successfully delivered a combination of three chemotherapy drugs into GBM cells in vivo, resulting in a high kill rate.

"Without our nano-delivery system, we know that current drug delivery would be highly toxic to patients if we tried to deliver all three of these drugs at once," said David Baskin, M.D., neurosurgeon at the Methodist Neurological Institute, who began his nanomedicine research in 2004 with the late Nobel laureate and Rice chemist Richard Smalley. "But delivered in combination using these nano-syringes, our research demonstrated extreme lethality, with at least a three-fold increase in the number of dead cancer cells following treatment. The nano-syringes selectively deliver these drugs only to cancer cells, and appear not to be toxic to normal neurons and other non-cancerous brain cells."

HCCs are nanovectors with protective antioxidant properties, capable of transporting and delivering drugs and bioactive molecules. In order to bring the drug carriers close enough to the cancer cells and successfully deliver the chemotherapy combination, three different antibodies were combined with the HCC to allow the nanoparticle to stick to the cell membrane. The drugs stayed inside the HCC until it attached to the cell membrane. Once binding occurred, the drugs were released into the fatty (lipid) environment in the membrane. The chemical properties of the chemotherapy drugs inside the HCC are such that they prefer to accumulate in areas with high concentrations of lipids and avoid areas with high water content, such as the extracellular space.

"A new and exciting advance is that now we have a carrier with protective properties, unlike previous nanotubes which were shown to be toxic," said Martyn Sharpe, the paper's lead author and a scientist with the Methodist NI's department of neurosurgery. "Some of the chemotherapy agents used in this research traditionally perform poorly with GBMs. Now that we've shown a successful kill rate of these cells in vivo, we're looking at treating human tumors that will be grown in immune-compromised mice models."

As personalized medicine continues to evolve, Baskin says this research could also be significant for other forms of cancer, including breast and head and neck cancers.

The paper represents an important collaboration between the laboratories of Baskin at Methodist, and James Tour, Ph.D. with Rice University's Smalley Institute for Nanoscale Science. Further work developing this system and expanding its utility is under way with continued collaboration between these two research groups.

The research was supported by The Henry J. N. Taub Fund for Neurological Research, The Pauline Sterne Wolff Memorial Foundation, Golfers Against Cancer, The Taub Foundation, The Verdant Foundation Limited and The Methodist Hospital Foundation.

Story Source:

The above story is reprinted from materials provided byMethodist Hospital, Houston, via Newswise.

Note: Materials may be edited for content and length. For further information, please contact the source cited above.

---

Journal Reference:

1. Martyn A. Sharpe, Daniela C. Marcano, Jacob M. Berlin, Marsha A. Widmayer, David S. Baskin, James M. Tour.Antibody-Targeted Nanovectors for the Treatment of Brain Cancers. ACS Nano, 2012; : 120313152927000 DOI:10.1021/nn2048679

Fonte: Science Daily

Nanotechnology and Medicine

Like so much of technology, the hype and fear around nanoparticlessays they will either revolutionize the world we live in or embody the newest high tech scourge. The truth is somewhere in the middle, but both sides have valid points.

Nanotechnology is sort of a catch all term. Scientists have been able to create precise chemicals on an increasingly small scale, until they reached the nano level.

For reference, microns are used to measure the wavelength of visible light particles, are a thousand times bigger than nanoparticles, which are on the scale of one billionth of a meter. Nanoparticles, molecules with less than a few hundred atoms, are so small that some principles of biology begin to be waived.

The concept behind nanomedicine is fairly simple. Any drug given to a person has to have certain chemical characteristics, otherwise it won't go anywhere.

If a drug is given orally, it has to have suitable properties in order to be taken either with, or without food. It must travel from the stomach to the bloodstream, survive processing by the liver and kidneys, and go to the proper place.

If you want a drug to affect special locations, like the brain, you need even more specific properties.

Benefits

Throughout the history of pharmaceuticals, scientists have consistently run into this problem. Many drugs work great in the laboratory, but don't meet the criteria. Some drugs are processed completely by the liver, or are quickly voided by the kidney. Other drugs never leave the intestine if given orally. Some of these obstacles can be removed by intravenous (IV) delivery, but not always.

Nanoparticles avoid all of these problems. Due to its tiny size, it can travel anywhere in the body without resistance. This allows free access to cellular mechanisms, a previously unknown level of control for medicines. While a great deal of work would have to be done, potential benefits are limitless.

Use

Scientists have struggled with finding medicines to target many kinds of viral infections. From the herpes virus family to HIV, some kinds of viral evolution focus on hiding from the immune system in the nucleus, where medications are unable to reach them. Nanoparticles have no such limitations, and could be used like antibiotics are for bacteria, permanently curing these lifelong viral infections.

With some slight modification, nanoparticles have been used to enhance medical imaging in radiology. Specialized gold nanoparticles have been used in one study to enhance images of brain tumors, showing exactly where the cancer cells were distributed.

Two nanomedicines already developed for use in chemotherapy are Doxil(doxorubicin) and Abraxane (paclitaxel). Doxil is large at 100 nanometers when compared to Abraxane, at 10 nanometers. But the small size ofnanomedicines means they would be found in sweat, blood, tears, and cerebrospinal fluid. The same chemical property that makes it so perfect for treating cancers resistant to chemotherapy also means that you can't avoid it.

Problems

Similar to the issues found in using nanoparticles as chemotherapy, other scientists experimenting with nanoparticles quickly found out, the free ranging nature of these tiny molecules is both a blessing and a curse.

Several studies and papers have found that nanoparticles quickly diffuse throughout the lungs, and enter the bloodstream. Great, perhaps, for ananomedicine that could treat asthma, but not so great for anybody working in a nanomedicine factory.

Unintended Destinations

Experiments on plants found that significant amounts of nanoparticlesend up in the nucleus, where they attach themselves to the DNA. There are several places you don't want strange particles ending up, and DNA is high on that list. Enough mutations from problems with the DNA in a cell can kill the cell, or begin a slow progression into cancer.

Side Effects

Otherwise, when a large enough dose of a caustic chemotherapynanoparticle is given to treat a cancer effectively, you might end up damaging the brain, which is normally very protected from objects in the bloodstream. Cells in high blood volume organs like the kidneys, lungs, and heart might accumulate damage just from accumulation alone.

While some nanoparticles focus on certain types of cells, it's hard to completely avoid these problems. Some of the best research experiments with using an intermediary to guide nanoparticles directly to the targeted cell, a technique that holds a lot of promise but is still quite experimental.

Future

Some studies have found ways to limit the diffusion of nanomedicines by altering the properties of the blood vessels. Further research in this area holds the most promise for specialized areas such as cancers that have become resistant to chemotherapy, and several chemotherapynanoparticles have already been approved by the FDA.

Conclusions

Similar to the debates surrounding the early days of nuclear research, it's hard to weigh the potential risks without knowing all of the potential benefits, and we won't know the full story for quite some time. The FDA has released guidelines for additional testing for the use of nanoparticles. While not yet implemented, new requirements testing for toxicity in sensitive areas like the brain, and long term studies for organ damage, should also be strongly considered.

Fonte: DailyRX

Conference report: Nanomedicine. Visions, risks, potential

Nanotechnology is frequently judged to be a key technology of the 21st century. Especially in the field of medicine nanotechnology may help to develop new and effective applications. However, as with many modern technologies, there are considerable moral concerns about the consequences nanotechnology may have for humans and their environment. At this year's Spring Conference of the Europäische Akademie Bad Neuenahr-Ahrweiler, which took place at the Berlin-Brandenburg Academy of Sciences and Humanities from 19 to 20 April with about 50 participants, experts from different involved fields of research presented several aspects of the development in nanomedicine: recent trends in the progress of nanotechnological methods in medical applications, risk and other ethical issues as well as the social impact of nanomedicine in the context of science, industry and the public. Additionally, the conference included a poster session with 14 posters from different research fields such as lab research on nanoparticles, technology assessment and bioethics.

The first session was dedicated to an overview of the current state of art concerning the scientific and technical aspects of nanomedicine, including the attempt to keep the debate on a realistic ground instead of feeding utopian and dystopian views (such as the unlikely nanorobots). First, Professor Hofmann (Ecole Polytechnique Fédérale de Lausanne, Institute of Materials Properties) gave an introduction to nanoparticles, focusing especially on its usage as imaging agents for the diagnosis of rheumatoid arthritis and osteoarthritis. Thereafter, Professor Müller (Freie Universität Berlin, Institute of Pharmacy) presented the possibilities for drug delivery with nanoscaled organic capsules and containers as an example for therapeutic applications. The first two lectures were followed by a lively discussion on the proper definition of "nano-structures" – mere size-related definitions were widely judged as less satisfactorily as those focusing on novel chemical and physical properties due to the small size of the particles. Later on, Dr. Jordan (MagForce AG, a nanomedicine company) reported about cancer therapy by hyperthermia using nanoparticles in brain tumors. From his point of view it was a good example for a method that already underwent the process of scientific development, industrial upscaling and marketing. Dr. Ciofani (Scuola Superiore Sant'Anna, Istituto Italiano di Tecnologia) pointed out the nanomedical application of nanotubes as an alternative material to nanoparticles by exploiting their piezoelectric properties for cell stimulation. In summary, this session did not only outline possible methods of diagnosis and therapy but also the importance of market mechanisms, industry and financing to implement a nanomedical innovation in the market.

The question of risk, one of the most debated issues among the possible adverse consequences of nanomedicine, was discussed during the second session. Researchers often regard toxicological aspects to be the main potential risks. Professor Krug (EMPA, Department "Materials meet Life"), an expert of toxicology, stated that with the currently available methods the reliability of toxicological datasets of nanomaterials was sub-optimal and that it was therefore problematic to come to reliable conclusions about toxicity of nanoscaled substances for medical applications. Thus, these should neither be labeled "risky" nor "safe". Mr. D'Silva (Universiteit Twente, Department of Legal and Economic Governance Studies) then explained the legislation and regulation of nanotechnology from the EU perspective in order to control and govern risk and presented several regulations and policies which had already been made on national and international level.

During the third session social and ethical implications were debated. Professor van Lente (Universiteit Utrecht, Department of Innovation and Environmental Studies) investigated the field of nanotechnology and -medicine from the perspective of political sciences. He argued that the further development of the field should be accompanied by a proper social embedding, i.e., the engagement of the public. Dr. Wullweber (Universität Kassel, Department of Political Science) stated that "nanotechnology" was mainly a politically driven expression which obtained acceptance by political and media campaigns and therefore was more accepted than, for example, genetic engineering, although these two fields of research had many similarities in public perception. Finally, Professor Brownsword (King's College, Research Centre TELOS) provided an overview of his concepts of an ethical analysis of nanotechnological matters, including aspects of "precaution" and "informed consent". He came to the conclusion that the current EU legislation provided sufficient laws in order to regulate a new technological development such as nanotechnology.

Speakers

Professor Dr. Heinrich Hofmann (Ecole Polytechnique Fédérale de Lausanne), Professor Dr. Rainer Müller (Freie Universität Berlin), Dr. Andreas Jordan (MagForce AG), Gianni Ciofani, Ph.D. (Scuola Superiore Sant'Anna), Professor Dr. Harald Krug (EMPA, St. Gallen), Joel D'Silva (Universiteit Twente), Professor Harro van Lente, Ph.D. (Universiteit Utrecht), Dr. Joscha Wullweber (Universität Kassel), Professor Roger Brownsword (King's College)

Scientific Co-ordination

Dr. Jan Mehlich and PD Dr. Felix Thiele (Europäische Akademie Bad Neuenahr-Ahrweiler)

Fonte: Nanowerk

Scientists model nanoparticle risk to aquatic environment

Researchers from the Center for the Environmental Implications of NanoTechnology (CEINT) at Duke University in the US have presented a model to estimate the risk posed by nanomaterials in aquatic environments. 

The scientists demonstrate the model by evaluating the risk posed by nanosilver, concluding that this substance may pose significant risk due to its accumulation in sediments. 

The study is published in Science of the Total Environment.

• Abstract

Fonte: Chemical Watch

Making nanotextured glass that's anti-fogging, self-cleaning and free of glare, Video

One of the most instantly recognizable features of glass is the way it reflects light. But a new way of creating surface textures on glass, developed by researchers at MIT, virtually eliminates reflections, producing glass that is almost unrecognizable because of its absence of glare — and whose surface causes water droplets to bounce right off, like tiny rubber balls.

The new "multifunctional" glass, based on surface nanotextures that produce an array of conical features, is self-cleaning and resists fogging and glare, the researchers say. Ultimately, they hope it can be made using an inexpensive manufacturing process that could be applied to optical devices, the screens of smartphones and televisions, solar panels, car windshields and even windows in buildings.

Through a process involving thin layers of material deposited on a surface and then selectively etched away, the MIT team produced a surface covered with tiny cones, each five times taller than their width. This pattern prevents reflections, while at the same time repelling water from the surface.Hyungryul Choi and Kyoo-Chul Park

The technology is described in a paper published in the journal ACS Nano ("Nanotextured Silica Surfaces with Robust Super-Hydrophobicity and Omnidirectional Broadband Super-Transmissivity"), co-authored by mechanical engineering graduate students Kyoo-Chul Park and Hyungryul Choi, former postdoc Chih-Hao Chang SM '04, PhD '08 (now at North Carolina State University), chemical engineering professor Robert Cohen, and mechanical engineering professors Gareth McKinley and George Barbastathis.

Photovoltaic panels, Park explains, can lose as much as 40 percent of their efficiency within six months as dust and dirt accumulate on their surfaces. But a solar panel protected by the new self-cleaning glass, he says, would have much less of a problem. In addition, the panel would be more efficient because more light would be transmitted through its surface, instead of being reflected away — especially when the sun's rays are inclined at a sharp angle to the panel. At such times, such as early mornings and late afternoons, conventional glass might reflect away more than 50 percent of the light, whereas an anti-reflection surface would reduce the reflection to a negligible level.

While some earlier work has treated solar panels with hydrophobic coatings, the new multifunctional surfaces created by the MIT team are even more effective at repelling water, keeping the panels clean longer, the researchers say. In addition, existing hydrophobic coatings do not prevent reflective losses, giving the new system yet another advantage.

Other applications could include optical devices such as microscopes and cameras to be used in humid environments, where both the antireflective and anti-fogging capabilities could be useful. In touch-screen devices, the glass would not only eliminate reflections, but would also resist contamination by sweat.

Ultimately, if the cost of such glass can be lowered sufficiently, even car windows could benefit, Choi says, cleaning themselves of dirt and grit on the exterior surface of the windows, eliminating glare and reflections that can impair visibility, and preventing fogging on the interior surface.

The surface pattern — consisting of an array of nanoscale cones that are five times as tall as their base width of 200 nanometers — is based on a new fabrication approach the MIT team developed using coating and etching techniques adapted from the semiconductor industry. Fabrication begins by coating a glass surface with several thin layers, including a photoresist layer, which is then illuminated with a grid pattern and etched away; successive etchings produce the conical shapes. The team has already applied for a patent on the process.

Since it is the shape of the nanotextured surface — rather than any particular method of achieving that shape — that provides the unique characteristics, Park and Choi say that in the future glass or transparent polymer films might be manufactured with such surface features simply by passing them through a pair of textured rollers while still partially molten; such a process would add minimally to the cost of manufacture.

The researchers say they drew their inspiration from nature, where textured surfaces ranging from lotus leaves to desert-beetle carapaces and moth eyes have developed in ways that often fulfill multiple purposes at once. Although the arrays of pointed nanocones on the surface appear fragile when viewed microscopically, the researchers say their calculations show they should be resistant to a wide range of forces, ranging from impact by raindrops in a strong downpour or wind-driven pollen and grit to direct poking with a finger. Further testing will be needed to demonstrate how well the nanotextured surfaces hold up over time in practical applications.

Andrew Parker, a senior visiting research fellow at Oxford University's Green Templeton College in the U.K. who was not involved in this work, says, "Multifunctional surfaces in animals and plants are common. For the first time, as far as I am aware, this paper learns a lesson in manufacturing efficiency from nature by making an optimized antireflective and anti-fogging device. … This is the way that nature works, and may well be the future of a greener engineering where two structures, and two manufacturing processes, are replaced by one."

The research was funded by the Army Research Office through MIT's Institute for Soldier Nanotechnology; the Air Force Office of Scientific Research; Singapore's National Research Foundation through the Singapore-MIT Alliance for Research and Technology (SMART) Centre, and the Xerox Foundation. Park and Choi are recipients of fellowships from Samsung and the Kwanjeong Educational Foundation/STX Scholarship Foundation, respectively.

Fonte: Nanoacademia

Do Environmental Attitudes and Food Technology Neophobia Affect Perceptions of the Benefits of Nanotechnology?

See here

An international team of researchers investigated Canadian attitudes toward nanotechnology, and its applications in the food industry. A significant amount of research in recent years has focused on consumers’ aversion to new technologies – neophobia - in food production and processing, with other research showing that environmental attitudes may be related to the purchasing behavior of consumers. 

They examined the relationship between the food technology neophobia scale, environmental attitudes, and nanotechnology. 

The results of this study show food technology neophobia is significant in explaining attitudes toward nanotechnology in general, and for food packaging and foods. Environmental attitudes, however, while important in explaining respondents’ attitudes toward nanotechnology in general, do not explain attitudes toward nanotechnology in food packaging or food applications. 

The researchers also found that respondents’ views of whether science and technology make society worse or better off was a more important determinant of attitudes toward nanotechnology than if they had heard of nanotechnology prior to the survey.

Source: International Journal of Consumer Studies

Author(s): Anahita Hosseini Matin, Ellen Goddard, 

Frédéric Vandermoere, Sandrine Blanchemanche, 

Andrea Bieberstein, Stephan Marette, and Jutta Roosen 

The original article may still be available at 

Fonte: Meridian Institute

Artificial nanopore production could lead to early detection of disease

A University of Texas at Arlington multi-disciplinary team has received a $360,000 grant from the National Science Foundation to build artificial nanopores made of silicon that can detect “bad molecules” as a very early indication of cancer and other diseases.

Samir Iqbal, an assistant professor of Electrical Engineering who focuses on nanotechnology, is leading the project. He is working with Purnendu “Sandy” Dasgupta, the Jenkins Garrett Professor of Chemistry and Biochemistry, and Richard Timmons, a Distinguished Professor of Chemistry.

Nanopores are tiny openings about 1,000 times smaller than a human pore on the skin or a human hair, made in very thin silicon chips. The silicon chips are the same material in computer processors and memories.

Iqbal’s team will run human blood-derived samples through these artificially created nanopores in a silicon chip and record how the composition may change as a function of disease.

Researchers will measure the reaction between ions of blood and nanopores and compare the data with other non-reactive nanopores, which will determine abnormal levels of particular chemicals that indicate whether a disease is present at the molecular level.

“We know many variants of certain chemicals like enantiomers, or the abnormal amounts of certain chemicals like cholesterol. These chemicals tell us if someone is subject to certain diseases,” Iqbal said. “Now we will be able to detect these variants at extremely small amounts and in a portable system format. We’ll be able to detect even a few hundred copies of bad molecules to identify risks of diseases like cancer. That is very, very early detection.”

An Atomic Force Microscope image of a 100 nm nanopore on right. The sketch shows molecules in a sample passing through an engineered nanopore.

Enantiomers are mirror-imaged optical isomers or compounds with the same molecular formula but different structural shapes such as a pair of human hands. They are mirror images of each other but not superimposable.

Another example is thalidomide, a drug introduced in the late 1950s to treat morning sickness in pregnant women. One enantiomer of the drug was found to be a good sedative for morning sickness. The mirror image of that enantiomer, present in the drug formulation, however, caused birth defects, leading to the drug being pulled from the market.

Through the new research, Iqbal and his colleagues would be able to determine similar differences at the molecular level, before the bad variants of new molecules cause devastating effects.
With the assistance from the nanopores, researchers will be able to identify what cancer looks like at the molecular level. That’s where the expertise of the two UT Arlington chemists lie, Iqbal said.

Timmons has expertise in inserting chemicals in the nanopores. Dasgupta’s expertise is in detecting chemicals in trace amounts.

“It’s thrilling that we can have a small broadly applicable platform that will be usable in a variety of areas,” Dasgupta said.

Team members said crossover applications for the technology also exist. For instance, the nanopore technology detection could be applied to gauge air or water quality.

“Again, the earlier we know whether a water or air source is polluted, the better off the people who live there will be,” Iqbal said.

Carolyn Cason, UT Arlington’s interim vice president for research, said such collaborative research advances the University’s mission.

“It tells everyone here that we can use resources available to us to solve real-world health problems,” Cason said. “This research has health-related consequences that can be felt across the industry.”

Fonte: Phys.org

Do the US FDA guidance documents for nanotechnology in food and in cosmetics matter?

The US Food and Drug Administration (FDA) has issued two documents that provide guidance to manufactures of food products and cosmetics according to the April 20, 2012 news item on Nanowerk,

Two draft guidance documents that address the use of nanotechnology by the food and cosmetics industries were issued today by the U.S. Food and Drug Administration.
Nanotechnology is an evolving technology that allows scientists to create, explore, and manipulate materials on a scale measured in nanometers – particles so small that they can not be seen with a regular microscope. The technology has a broad range of potential applications, such as the packaging of food or altering the look and feel of cosmetics. [emphasis mine]

They might also have indicated food additives and other ingredients are covered in the guidance. I mention this because I noticed that some of the news coverage does not make that point and people are likely to believe that it covers only food packaging and not ingredients.

You can check out the guidance documents (both the one for foods and the one for cosmetics) for yourself,

Draft Guidance for Industry: Assessing the Effects of Significant Manufacturing Process Changes, Including Emerging Technologies, on the Safety and Regulatory Status of Food Ingredients and Food Contact Substances, Including Food Ingredients that are Color Additives
Draft Guidance for Industry: Safety of Nanomaterials in Cosmetic Products

This US FDA April 20, 2012 press announcement offers some details,

The food draft guidance describes the factors manufacturers should consider when determining whether changes in manufacturing processes, including those involving nanotechnology, create a significant change that may:

• affect the identity of the food substance;
• affect the safety of the use of the food substance;
• affect the regulatory status of the use of the food substance; or
• warrant a regulatory submission to FDA.

The cosmetic product draft guidance discusses the FDA’s current thinking on the safety assessment of nanomaterials when used in cosmetic products. Key points include:

• The legal requirements for cosmetics manufactured using nanomaterials are the same as those for any other cosmetics. While cosmetics are not subject to premarket approval, companies and individuals who market cosmetics are legally responsible for the safety of their products and they must be properly labeled.
• To conduct safety assessments for cosmetic products containing nanomaterials, standard safety tests may need to be modified or new methods developed.

Both guidances encourage manufacturers to consult with the agency before taking their products to market. Such consultation can help FDA experts address questions related to the safety or other attributes of nanotechnology products, or answer questions about their regulatory status.
Strong science is critical to FDA’s ongoing review of the products it regulates.  FDA is investing in an FDA-wide nanotechnology regulatory science program to further enhance FDA’s scientific capabilities, including developing necessary data and tools to identify properties of nanomaterials and assess the impact they may have on products.
“Understanding nanotechnology remains a top FDA priority. FDA is strengthening the scientific tools and methods for evaluating food products, cosmetics, drugs and medical devices,” said FDA Commissioner Margaret A. Hamburg, M.D. “We are taking a prudent scientific approach to assess each product on its own merits and to not make broad, general assumptions about the safety of nanotechnology products.”
The FDA’s current thinking concerning nanomaterials for food and cosmetics uses, explained in the two guidance documents, is not intended to provide guidance to manufacturers about the use of nanomaterials in other products, such as drugs or medical devices, regulated by the FDA.

It’s still possible to comment on the guidelines as they are at a ‘draft’ stage, from the FDA’s April 20, 2012 press announcement,

In order to ensure that FDA considers comments on these draft guidances in developing the final guidances, electronic or written comments should be submitted within 90 days of the publication of the notices of availability in the Federal Register. The FDA will carefully consider all relevant, substantive comments during the development of the final guidance documents.
Electronic comments should be submitted to http//www.regulations.gov. Written comments should be submitted to the Division of Dockets Management, (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852.

It looks to me like this is an attempt to develop a relationship where the industry players in the food industry to police their nanotechnology initiatives with the onus being on industry to communicate with the regulators in a continuous process, if not at the research stage certainly at the production stage. That same request is being made to the cosmetics industry, from the draft guidance document for cosmetic products,

If you wish to use a nanomaterial in a cosmetic product, either a new material or an altered version of an already marketed ingredient, FDA encourages you to meet with us to discuss the test methods and data needed to substantiate the product’s safety, including chronic toxicity and other long-term toxicity data as appropriate.  Individuals outside the Federal Government may request a private meeting with a representative of FDA to discuss a matter, and FDA will make reasonable efforts to accommodate such requests (21 CFR 10.65(c)).  We encourage you to take advantage of this provision and contact us to discuss any aspect of the safety assessment of cosmetic ingredients or finished products.

You can read some additional commentary about both draft guidelines in the April 22, 2012 posting on redOrbit, the April 20, 2012 news item by Torie Bosch for Slate magazine, and  the April 20, 2012 Reuters article by Anna Yukhananov in the Chicago Tribune.

One odd thing I noticed in some articles and commentaries (e.g. Reuters article by Anna Yukhananov) is a reference to the European Union rules with regard to cosmetics products. The observers seemed to be under the impression that cosmetics companies with European production facilities and/or headquarters would operate under the same rules in North America. From the Yukhananov article,

The FDA does not require cosmetic companies to submit safety data before selling their products, and the guidance is unlikely to have a big impact on large cosmetic firms like Avon Products Inc, which already comply with European rules.

Why would Avon extend its compliance with European Union (EU) rules to its US operations? Companies routinely operate under different rules in different countries and regions.

Getting back to the question I asked in the headline, do these guidance documents matter? Yes, as stated earlier, I think this is an attempt to develop a relationship with open communication and where industry is being respected enough to manage/police itself. One hopes that this is not misplaced trust.

Fonte: FrogHeart

Nanotechnology in Cosmetic and Personal Care Industry

 

Nanotechnology has been dominating the news lately, but what exactly is it and how can it benefit us humans. Well, nanotechnology (nanotech for short) refers to the exploitation of microscopic materials for various uses such as dental bonding agents, in toothpaste and for cosmetic and medical uses as well as in manufacturing; it is the joining of different fields of science, biology, physics, chemistry and engineering. A nanometer-sized particle is approximately one billionth of a meter and can only be seen by a very powerful microscope.

History of Nanotechnology

Although referred to as the next big thing in manufacturing and medicine, and the ‘hottest thing in cosmetics”, the concept of nanotechnology is not that new. As a matter of fact, the concept has been around since 1959, and Professor Richard P. Feynman is credited with describing nanotechnology in a speech, `There`s Plenty of Room at the Bottom`.   At the time Feynman’s idea was seen as purely theoretical. The term ‘nanotechnology’ was first used in a 1986 book, “Engines of Creation” by K. Eric Drexler

French researchers have found that ancient Egyptians, Greeks and Romans were using nanotechnology in hair dye over 4000 years ago.  

Nanotechnology and Cosmetics

Today nanotechnology is being used in computer science, medicine and cosmetic manufacturing. Research in the medical field has shown where nanotechnology can help with the healing and repair of skin tissue. In the cosmetic arena it is believed that the smaller particles are more readily absorbed into the skin and as such repair damage easier and more efficiently. It is believed that as new products are developed nanotechnology may be used to prevent graying hair and combat hair loss in some cases.

Nanotechnology is elevating the development of skin care products and cosmetics to another level, making them high-tech so as to deliver increased benefits to users. In addition to improving the efficacy of cosmetics and skin care products, nanotechnology is making it possible for other ingredients to be used in the manufacturing of beauty products.

Nanotechnology in the beauty industry involves making products with nanoparticles that can go deeper below the skin’s surface to give better results. Sunscreens and some anti-aging products are the main cosmetic products on the market currently being made using nanotechnology.

See here 

Some large cosmetic players are leading the charge in the field of nanotechnology in the beauty industry. Chief among these companies are L’Oreal who has employed the technology in products such as Revitalift anti-wrinkle cream. According to L’Oreal Revitalift’s results are immediate because the product contains “nanosiomes of Pro-Retinol A”. 

Estee Lauder also has a number of nanocosmetics on the market, as does Proctor & Gamble, Shiseido and Duprey Cosmetics. 

However, because of the relative newness of the technology in terms of cosmetics manufacturing there is still concern as to how safe nanotech cosmetics are and their long-term effect. 

Agencies such as the Federal Drug Administration (US) and The Royal Society (UK) have issued statements calling for continued testing and transparency governing research on the use of nanotechnology in cosmetics. 

Some nanoparticles have received FDA approval, such as zinc oxide and titanium dioxide which have been included in sunscreen; in 1996 the FDA is reported to have concluded that “… smaller, micronized particles of titanium dioxide are not new substances and that there is no evidence demonstrating that these micronized particles are unsafe.”

Nanotechnology is not going away, it will become a part of life and is expected to result in significant improvement in the quality of life as we know it.

Fonte: Carefair