Iodine-based formulations are used to disinfect epidermal tissue for many clinical applications including pre-surgical, catheterization, burns, needle puncture, wound care or topical infection. The bacteriocidal species, or “bacteria killing” species, in iodine-based disinfectants is molecular iodine (I2). Molecular iodine is the only iodine species that diffuses into the skin. Since molecular iodine is unstable in an aqueous environment, chemists developed iodophors.
Iodophors are highly acidic compositions that provide a small concentration of molecular iodine in equilibrium with a very large concentration of iodide/triiodide and organic molecules that bind molecular iodine to form tri-iodide. This results in a formulation wherein the active agent, molecular iodine, is present at a concentration that is typically less than 0.1% of the total iodine species. Unfortunately, bacteria can survive in iodophors manufactured with concentrations of molecular iodine below 1 ppm. Contaminated 10%-PVP products have caused transmission of infections in the past. In addition, the additional iodine species (iodide, tri-iodide and PVP-I) increase the potential risk of systemic toxicity and contribute to staining but do not contribute antimicrobial activity.
Iogen’s proprietary formulations use preferred emollient organic carriers that (a) solubilize at least two-times as much molecular iodine per unit volume as water and (b) dramatically reduce the loss of molecular iodine to the atmosphere due to evaporation. The vapor pressure of molecular iodine is higher than water at body temperature. Therefore, once applied to an epidermal surface, the molecular iodine will rapidly be lost to the environment. The loss of molecular iodine in Iogen’s formulations has been estimated to be at least 100 times slower than PVP-I. Iogen’s formulations can be combined with water prior to application if it is desirable to increase the rate of molecular iodine release for particular applications.