An increasing pressure to resist the hospital-acquired infection rates by insurance providers is expected to play a crucial role in the growth of the infection resistant treatments and materials according to Frost &Sullivan research. Muti-drug resistant bacterial biofilms pose a constant threat to medical devices and recently the health insurance companies are showing a strong trend of non-coverage of hospital related infection episodes. Technologies such as coating of the catheters or devices with antibiotics or antiseptics like as nano silver, silver sulfadiazine and/or chlorhexidine, antibiotics have been commercialized with limited success due to rapid release rates resulting in depletion of the eluting antimicrobials. Most medical devices such as vascular and other catheters and non-vascular stents are made of thermoplastic medical grade polymers such as polyurethanes. Additives such as colors, inert fillers etc are compounded with a resin under melt conditions, pelletized and then used for extrusion. We propose the idea of incorporating on lab scale, a thermally stable, antimicrobial, biofilm inhibiting formula by compounding it into a medical grade polyurethane followed by extrusion. We will develop compositions with an ability to release active material for up to 30days in sustained manner at effective levels. Such materials could be further optimized to show ultra slow release over several months. (6months is the ultimate target) During the Phase I, for the proof of our concept, we will synthesize and develop formulations that function as antimicrobial inhibitors and form unique silver species that are more soluble and stable in biological media. These will be used as additives at various defined levels into to a medical grade polyurethane matrix using a water insoluble nanosize natural carrier, compounded and processed as flat plastic samples for the Phase I study. We hope to demonstrate a highly controlled long term release from such matrices that provide the surface with biofilm resistance against clinical pathogens in a biological medium with sera. We will create materials with precise concentrations of the active materials and screen them for elution profile, bacterial attachment kinetics and biofilm abrogation.
Recent analysis from Frost &Sullivan found that the U.S. antimicrobial treatment markets earned revenues of $175.4M in 2005 with estimates to reach $558.7M by 2012. The market expects to grow with the increasing need to address microbial growth in end-application markets like health care facilities.
