HOCl and its composition of matter chemistry is not well understood and researched. In 1834, Antoine Jérôme Balard made the first discovery that HOCl is a potent infection-fighting compound that are naturally found within the white blood cells. Balard’s novel invention was used by militaries around the world in World War I and World War II to clean and manage battle wounds.  

The research on HOCl was then further funded by Soviet Union government prior to the collapse of communism as well as in other Asian countries including Japan, China, etc.  Therefore various crude methods of manufacturing for production of HOCl was developed, improved and later commercialized. In late 1990’s, these HOCl related discoveries were brought in the U.S. where they were approved as both wound care solutions by the FDA as well as others approved as disinfectants by EPA.  Today, HOCl is produced with various impurities, pH differences, various concentrations, shelf life and stability claims and, packaging. 

The various challenges associated with manufacturing, storage, distribution of HOCl are as follows;

 -       Shelf life and stability defined as follows;

o   Presence of HOCl in solution – most manufacturers of HOCl relay on the presence of any amounts of HOCl in their solution for claiming stability.  The challenge remains that any end user will notice a significant benefit with fresh product as compared to those nearing their expiration dates.

o   Dose variances and stability – similar to other drug dosages, the stability of a drug cannot exceed more than 10% of its manufactured dosage claim. Until today, with the exception of Spectrum Antimicrobials drug dosages, no other HOCl manufacturer has been able to achieve such drug status stability.

-       Distribution – nearly all HOCl manufacturers cannot safely ship product during freezing temperatures without the use of a temperature controlled vehicles. Spectricept is the only freeze-resistant HOCl in the market.

-       Serum – All HOCl product become instantly neutralized with the addition of 5% serum (regulatory requirement for testing of antimicrobials).  Spectricept remains highly effective in presence of 5% serum. Thus, Spectricept can deliver one-million fold more power of any other HOCl product in the market.

 Are all HOCl product the same;

 All HOCl products are equivalent for use in cleaning and debriefing wounds to qualify under 510K regulations. However, HOCl based solutions are manufactured with various osmolality, impurities, pH, concentration, packaging sizes, stability and in vitro antimicrobial effectiveness in presence of serum. Therefore, it is only natural that HOCl products manufactured with such diverse chemistries behave differently under different set of testing conditions, storage and use.

 Is HOCl diluted bleach?

 Dilute bleach or otherwise known as Dakin’s solution which has been cleared by FDA for use in safe debridement and cleaning of chronic and acute wounds. (Link to https://www.accessdata.fda.gov/cdrh_docs/pdf15/K150208.pdf).  Dakin's solution is a dilute solution of sodium hypochlorite and other stabilizing ingredients and the impregnated chlorine species are formed in a basic pH solution (>8). Clinical research to date has shown the use of Dakin solution on chronic wounds may hinder or damage wound healing. (Hyperlink https://pubmed.ncbi.nlm.nih.gov/3348732/).

In contrast, the use of HOCl in wound care has been studied and published. The research suggests that the use of HOCl in wound bed encourages normal wound healing process. (Hyper link to the clinical use paper by chris sanders).

How does Spectricept perform against other stable forms of HOCl based product;