Povidone Iodine – The most misunderstood material broadly used inside of the medical community
By Douglas C. Spitz CEO I2Pure Corp, I2Cure Pte Ltd.
I2Cure Pvt Ltd. Povidone Iodine, PVP-I, with 65 years of continuous use and hundreds of studies, is the most misunderstood material broadly used today in medicine. This claim can be easily demonstrated by the label itself, found on every bottle in every hospital and medical practice in the world. The label says “PVP-I 10% (1% titratable iodine)” Why this label doesn’t concern the medical community is a mystery, most likely due to the decades long positive experience the community has witnessed using PVP-I. The label, however, is missing something that every healthcare practitioner and regulatory agency demands before dosing a patient: how much of the active ingredient is present.
The medical community has been using PVP-I for 65 years without knowing much about the quantitative level or the properties of the active ingredient, molecular iodine. One thing is perfectly clear over the 65 years of use: all of the negative characteristics of PVP-I have been blamed on molecular iodine. The negative effects and characterization of PVP-I have been placed arbitrarily without contextualizing the different iodine species or the complexing agents found within.
Not requiring the measurement of the active ingredient prior to product release proved costly in a famously studied event in New York City in 1980. Four hospitals caused 52 patients over 7 months to develop Pseudomonas cepacia infections due to use of PVP-I that had less than 1 ppm of molecular iodine. The analysis of this outbreak can be found in an editorial written by Martin S. Favero, PhD, for Infection Control & Hospital Epidemiology, Volume 3, Issue 1 February 1982, pp 30-32, Iodine – Champagne in a Tin Cup.
Since the early 19th century iodine has been used to disinfect the skin. The preparations for this early use were tinctures of iodine and then later Lugols. In the case of the tinctures, 50% to 60% of the iodine present were iodine species other than molecular iodine, and in the case of Lugols 60% to 70% of present iodine were not molecular. Both of these formulas were irritating, toxic and left dark stains on the patients. These negative effects were immediately attributed to the active ingredient, molecular iodine, without regard to the possibility that these negative characteristics could have come from “benign” species that were present.
In 1955 PVP-I was created. The formulation was and still is 10% povidone and 1% titratable iodine (10,000 ppm total iodine species). Of these 10,000 parts, only about 5 ppm is molecular iodine. The 10,000 ppm of total iodine species acts as a reservoir to produce more molecular iodine as it is consumed, slowly releasing more molecular iodine into solution. Povidone Iodine was shown to be less irritating and toxic than both tinctures and Lugols and the conclusion as to why was: DUE TO THE VERY SMALL BUT CONTINUOUS RELEASE OF MOLECULAR IODINE, THE TOXIC EFFECT OF MOLECULAR IODINE IS LARGELY REDUCED. This turns out to be the best and most misleading marketing campaign that was ever created. We know it’s the best because this messaging is still used after 65 years and has impacted the medical community’s understanding -or rather misunderstanding- of iodine.
In most papers, this is where the author would list the dozens and dozens of examples of misinformation that perpetuates the myth that the active, molecular iodine, is the identified material that causes the negative characteristics of staining, irritation, toxicity and in even some cases, death by acidosis. However, there are no medical organizations untouched by this incorrect information. Any organization that has published research on Povidone Iodine up to this point in time has gotten it wrong. These misconceptions have not only caused an incorrect understanding, but in some cases have drawn dangerous conclusions. My intention in this paper is not to cast blame but to educate the community at large.
The reason I, as the author, am not going to cite examples of this misunderstanding is because I can demonstrate the true characteristics of molecular iodine. My company, I2Cure, is a biotechnology company that will supply therapies to prevent and treat conditions of the skin, and that promote wound healing. The IP of I2Cure’s technology is the stabilization of molecular iodine without the presence of other iodine species or complexing agents. Our first formulation has nearly as much molecular iodine as the tinctures of old, 1500 parts per million. This formulation is: non-staining, non-irritating, and non-toxic. We commissioned InterTek to conduct studies to examine the material’s properties. Our efficacy test ASTM E2315 report showed a 99.999% biocidal effectiveness. In addition, I2Pure aided in demonstrating the true characteristics and understanding of molecular iodine when we proved that a concentration as high as 1500 ppm is not toxic to human cells using the cytotoxicity procedure detailed in ISO 10993-5-2009 (a 24-hour in vitro cytotoxicity study).
If you are a medical professional that has been using Povidone Iodine in research and would like a sample of our material, we would be glad to provide it in order to begin to develop an accurate characterization and understanding of this safe broad-spectrum biocide.