Latex In, Allergens Out

Shown is a catheter with a bag, as an example of a product that can be made with Vytex NRL. The product shown has not been approved for use with Vytex NRL yet, but manufacturers are currently working with it.
More than 40,000 types of commercial products are made from natural rubber latex (NRL), an extract of the Pará rubber tree (Hevea brasiliensis). NRL is used in numerous products in the medical industry, from gloves to condoms, catheters, and rubber tubing. However, out of more than 200 proteins contained within NRL, 13 are known to be allergens, according to the I.U.I.S. Allergen Nomenclature of the International Union of Immunological Societies and the World Health Organization. The American Latex Allergy Association estimates that 3% of the general population and 17% of healthcare workers exhibit some form of latex allergy, hindering the use of such products.

Fortunately, an alternative to the traditional NRL with all of its 200 proteins exists. It involves the patented process of adding aluminum hydroxide, Al(OH)3, a well-known protein binding chemical, to latex while it is still in liquid form. This compound acts as a binding agent to the latex and produces protein complexes that can be removed using existing industry practices. The result is an ultra low-protein variant of NRL that retains all of the advantages of the material while reducing allergenic proteins to individuals.

Improved Latex
The list of latex medical products is long, and it can include elastic bandages, adhesive tape, urinary catheters, electrode pads, wound drains, stomach and intestinal tubes, and much more.

All such products that routinely directly or indirectly come into contact with mucosa, non-intact skin, and internal body spaces may trigger complications. Therefore the medical market represents a potential target for modified NRL manufacturers.

Natural rubber latex products are generally less expensive than many synthetic alternatives, such as polyisoprene, polychloroprene, polyurethane, co-polymer, and often nitrile so there is an obvious market for modified NRL for use in medical devices. Additionally, manufacturers using the modified NRL as their raw feedstock can adhere to ASTM protein compliance levels with only pre-leaching since the starting protein levels of Vytex NRL are significantly lower than standard NRL.

One promising medical application for Vytex NRL is bandages. Many cohesive medical bandages use NRL as the bonding agent; posing a potential risk of alergic reactions. Bandages produced with Vytex NRL-formulated adhesive have a 20-fold lower protein content than bandages made with standard NRL. A combination of greatly reduced protein, improved processing, and effective adhesion.

Certain catheters, including urinary catheters, have NRL tips. All such products that routinely directly or indirectly come into contact with mucosa, non-intact skin, and internal body spaces may trigger complications. Therefore they represent another potential target for modified NRL manufacturers.

One major healthcare company has recently introduced a new condom made with Vytex NRL that retains all the positive qualities of the standard variety, including barrier protection, tensile strength, tactile sensitivity, elasticity, comfort, and fit. This in fact is the first product made with Vytex NRL available to consumers and with a labeling claim of less than 2µg/dm2 of antigenic protein.

Ultra Low-Protein Latex
The availability, ease of production, and performance of natural rubber latex products make it a raw material preferred by product manufacturers and users around the globe.

The patented treatment process discussed here for Vytex Natural Rubber Latex removes specific non-rubber impurities from NRL through the directed application of aluminum hydroxide. A commonly used absorbent, emulsifier, ion-exchanger, and antacid, aluminum hydroxide is commonly used in water purification. It forms a jelly-like structure suspending any unwanted materials in water, including bacteria. Using traditional latex processing methods, a slurry of aluminum hydroxide is strategically added to the pure latex. The effective binding of protein and other non-rubber impurities from the pure latex emulsion to insoluble Al(OH)3 occurs, with some of the non-rubber impurities adsorbed to the reactive surface of the aluminum hydroxide crystals.

With this patented process integrated into the latex processing stage, there is no added expense of capital equipment. Reacted Al(OH)3 complexes are removed by a combination of filtration and centrifugation. The remaining rubber particles retain the surrounding lipid layer, which, during subsequent maturation, improves the mechanical stability of the latex as higher fatty acids are formed. Notably, scientists at commercial partners have observed that this process yields products that exhibit greater clarity and significantly reduced odor, in addition to fewer antigenic proteins, without sacrificing the properties that give NRL its advantages over synthetic alternatives. Prior industry efforts have produced low protein source latex through the treatment of raw latex with enzymes but have not achieved widespread commercial success.

Advantages
One advantage to the use of the patented Vytex NRL discussed here is the decreased amount of water required for its manufacture. Within the latex dipped goods industry, manufacturers have demonstrated increased efficiency by reducing processes such as excessive washing and leaching. This reduction can significantly lower water and energy consumption, and simultaneously reduce the presence of harmful leachates such as zinc. The overall environmental impact is minimized, resulting in an increased production cost savings. Vytex NRL is slightly more expensive than traditional NRL, but is priced comparably to, and in many cases less expensively than alternative materials, and provides significant cost value when compared to other synthetic substitutes.

Raw, natural latex is a liquid. When dried and cured, the film dries semi-transparent yellow. Manufacturers can add whitening agents, such as titanium dioxide or calcium carbonate, to the latex to express whiteness in the finished product or to provide a white background for which color pigments can be used. A common alternative, the use of titanium dioxide can be more expensive. Because Vytex NRL is dramatically more translucent and whiter in appearance, its use reduces the amount and cost of the whitening agents.

Manufacturers continue to see the value in Vytex NRL, allowing them to increase production efficiency. Recognizing the need and importance of natural products that minimize the environmental impact while maximizing economic, health, and safety benefits is critical. This need is addressed by commercializing the process of modifying NRL while enhancing its attributes and performance. The patented process of using aluminum hydroxide eliminates a significant portion of proteins and other non-rubber composition in latex. This allows manufacturers to offer notably enhanced pigmented products.

The use of Vytex Natural Rubber Latex is a logical move for manufacturers that use standard latex across a broad scope of industries, including medical manufacturing. The overall performance benefits and attributes of this aluminum hydroxide modified latex offer a unique value proposition to manufacturers, allowing them to capitalize on its green advantages while addressing health and safety concerns. Production cost saving opportunities using Vytex NRL makes this a sensible material for future generations.

It is clear that the development of this modified NRL has the potential to pave the way for a new era in the use of latex products in the healthcare arena. As production of this material is ramped up in coming years, it is reasonable to expect that hospitals and other facilities will find it a welcome alternative to standard NRL. Both patients and their caregivers who are prone to latex allergies may find a new class of products at their disposal.

Vystar Corp. Duluth, GA 770.965.0383