February 10, 2015

This discussion centers on the US FDA recommendation that all biological products, drugs and devices should be endotoxin or pyrogen free  It is a known fact that endotoxins are one of the most dangerous contaminants for any commercial product that makes contact with the human body. Its effects can be fatal to life, and catastrophic to business.

Nanotechnology has been defined by physicist Richard Freyman as the science, engineering and technology which is conducted at the nanoscale. It is the manipulation of matter at the size of 1 to several hundred nanometers. A nanometer is measured to be one billionth of a meter (1 nm = 10−9 m). To be able to grasp this size more, the smallest bacteria measures to about 200 nm long. A virus may range from 30 to 50 nm and our DNA strands have diameters of about 2 nm. Working in the sizes of 100 nm and less has been known as the quantum realm. It has been found out that materials may behave differently or have different properties at the quantum realm scale as compared to the macroscale. These discoveries have had several useful applications in different industries. At the nanometer scale, gold appears red to purple and can become chemically reactive when it is normally an inert metal. Nanoscale zinc oxide is clear and does not scatter light, making it a useful material for sun blocks. Nano sized copper becomes transparent. Other physical properties of matter are also altered at the quantum realm.

These properties include magnetism, boiling points, conductivity and chemical reactions. The applications of nanotechnology have led to research and development  in diverse fields of science and industry. There is nanotechnology for medicine, molecular biology, engineering, military and many other fields. The Project on Emerging Nanotechnologies provides an updated 2015 inventory of 1,600 plus merchandise which are considered nanotechnology containing products. As if that isn’t a great number of products by itself, there are even more nano products reaching the market on a weekly basis. The great majority of these nano products are related to the food, medicine and consumer product sectors. These applications of nanotechnology involve entry or contact with the human body. Following the US FDA recommendations, these products should also be pyrogen free.

Nanotechnology is well integrated into the food industry. It is used in almost all stages of food preparation. There are nanotech applications used from food cultivation to production to processing and even packaging. Scientists are constantly working on biological molecules which control pests, hasten growth, improve food taste, bind vitamins and minerals and more. Nanoparticles are purposely utilized to make food taste better. It is used to improve food texture, enhance nutrient absorption and prevent bacterial infection. The nanoparticles are also used to improve the physical characteristics of the packaging materials. These properties include the strength, lightness and heat resistance of the packaging material. These technologies all find their way into the food market ready for consumption.

In medicine, nanobots performing therapeutic interventions might remain to be too far-fetched for now. It might not stay still in theory, however. As of present, we do have functional nanomedicine. It is defined as the application of nanotechnology in medical diagnosis and management. Nanomedicine has existent applications in drug development, diagnostic and imaging procedures and biologic and non-biologic devices. Nanotechnology has greatly improved drug delivery systems. Several chemotherapeutic agents are bound to nanoparticles to improve their absorption, delivery, specificity and adverse effect profile. Nanoparticles are used in drugs and supplements. These nanoparticles serve functions like increasing nutrient absorption, carriers of active components and improving drug delivery.  More clinical trials are progressing to test the benefits of nanoparticles in medicine. These include diagnostic imaging which utilizes the unique characteristics of fluorescence and reactivity of materials like gold. In this case, gold may serve to become a contrast agent. These trials may greatly impact the diagnosis of different types of cancers and other diseases.

Tissue engineering is a very popular area of study. Human tissue has been grown using scaffoldings made up from nanoparticles and other biologic materials. The scaffolds simulate normal growth conditions for human cells.  They are used to grow new bone, muscle and other tissues. These tissues grown through nanotechnology can replace damaged or missing organs. There is extensive literature on this.  Using nanobiology, there are existing accounts of cultured urinary bladders, uterus, bone and heart valves which have been transplanted into recipient patients.

Nanotechnology is actually quite abundant in consumer products. These products that contain nanoparticles mostly include sunscreen, cosmetics and personal care items. Most sunscreens contain titanium dioxide and zinc oxide. They are nanopigments, inert and naturally occurring. These nanopigments provide excellent filtration of ultra violet rays and pose very little toxicity. They are also transparent, less greasy and more fragrant. Titanium dioxide is even used in food and in oral hygiene products. The cosmetics and personal care industries use nanoparticles as delivery vehicles for certain active components in their products. Liposomes and niosomes are lipids arranged at the nano level. Newer lines of nanoparticles such as solid lipid nanoparticles have been recently introduced in the market. They all function as delivery agents for cosmetic and personal care products. They improve product properties like better skin penetration and distribution, prolonged hydration, stability and bioavailabity. Nanospheres or nanoemulsions enclose or suspend active ingredients in nanoparticles. These are nanometric scale mixtures of oil and water that protect the encapsulated ingredient. They improve the penetrance and product delivery to the skin. The emulsion allows the agents to reach the target site faster. Vitamin A and other vitamins and minerals are examples of what the nanospheres encapsulate. To name a few personal care companies that utilize such nanotechnology, there is Johnson and Johnson, Avon and Proctor and Gamble. Such companies have been researching and incorporating nanoparticles in their products for more than a decade.

It is a fact that the market is flourishing with products that utilize nanotechnology. The correlation between nanotechnology, consumer welfare and thus, endotoxin and pyrogen testing has been established from the start. This relationship between quality product delivery and consumer welfare should even be reinforced. This is in view of the fact that the possibilities are endless and that the utilization of nanotechnology in many products and industries only ever grows stronger.





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