Sodium hypochlorite gel composition

Abstract

A gel composition including a sodium hypochlorite solution; at least one viscosity-enhancing agent; and at least one electrolyte is disclosed. Methods of making the composition, methods of disinfecting, and methods of treating are also disclosed.

Description

FIELD [0001] The present invention relates to compositions for disinfecting substrates, including tissue, and methods of disinfection. The inventive gel composition can comprise a sodium hypochlorite solution, at least one viscosity-enhancing agent, and at least one electrolyte. INTRODUCTION [0002] Sodium hypochlorite has a long and well developed history of use as an antiseptic and disinfecting agent. In 1915, Henry Dakin published his classic investigations of antiseptics in the treatment of battlefield wounds encountered in World War I. He evaluated the antiseptic qualities of chemical agents including: phenol, salicylic acid, hydrogen peroxide, iodine, mercuric chloride, silver nitrate and sodium hypochlorite. However, Dakin preferred sodium hypochlorite and recognized not only “its exceptional antiseptic qualities but also the ability of hypochlorite to debride wounds.” See McDonnell, K. J., et al., “Dakin's Solution Revisited,”The American Journal of Orthopedics, July, 1997, p...

AI Technical Summary

Benefits of technology

[0009] According to various aspects of the disclosure, there is provided a gel composition comprising a sodium hypochlorite solution; at least one viscosity-enhancing agent; and at least one electrolyte.

[0010] According to various aspects of the disclosure, there is provided a method of topically disinfecting a substrate comprising applying to the substrate an effective amount of a composition comprising a sodium hypochlorite solution; at least one viscosity-enhancing agent; and at least one electrolyte.

[0011] According to various aspects of the disclosure, there is provided a method of treating a topical infection comprising applying to a patient in need thereof an effective amount of a disinfectant composition comprising a sodium hypochlorite solution; at least one viscosity-enhancing agent; and at least one electrolyte to the infected area and / or the surrounding infected area.

[0012] According to various aspects of the disclosure, there is provided a method of treating a heavily contaminated or infected wound comprising applying to a patient in need thereof an effective amount of a composition comprising a sodium hypochlorite solution; at least one viscosity-enhancing agent; and at least one electrolyte to the contaminated or infected wound and / or the surrounding contaminated or infected area.

[0013] According to various aspects of the disclosure, there is provided a method of disinfecting an intact skin site prior to a surgical or invasive procedure comprising applying to a patient in need thereof an effective amount of a composition comprising a sodium hypochlorite solution; at least one viscosity-enhancing agent; and at least one electrolyte.

Problems solved by technology

While Dakin's solution has been a mainstay in topical antisepsis for almost 90 years, it has fallen into disuse in recent years because of reports of chemical trauma and cytotoxicity as ascertained by in-vitro laboratory tissue culture investigations.

In particular, several studies have shown that the commonly used concentrations of sodium hypochlorite can inhibit host defense cells, such as macrophages, leucocytes and fibroblasts and thereby negatively interfere with the healing process.

Moreover, laboratory studies have determined that dilute concentrations of Dakin's solution, such as 0.5%, 0.25% and 0.125% w / w, exhibit cytotoxic properties and can cause tissue damage.

It is known that Dakin's solution exhibited cytotoxic properties that inhibited the wound healing process and impaired the host defense mechanism.

Moreover, Dakin's solution diminishes rapidly in antimicrobial effectiveness and chemical activity over the course of its 30 day shelf life limiting its commercial availability to local or hospital pharmacies where it is made fresh to ensure potency.

However, it was noted in the years following this protocol recommendation that isotonic or normal saline was ineffective in reducing wound bioburden (concentration of microorganisms per gram of tissue), a pre-infection state, or treating actual wound infection.

Bioburden of greater than 105 represent a significant challenge for local tissue defenses in the wound environment.

The emergence of bacterial resistance to a battery of previously effective antibiotic agents, coupled with an inadequate spectrum of action, and ineffective treatment outcomes, exposed the Achilles heel of antibiotics.

Prior art antiseptics or disinfectants containing chlorine are typically unsatisfactory for topical applications.