Fast-acting antimicrobial lotion with enhanced efficacy

Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Biocides; animal or insect repellents or attractants

Reexamination Certificate

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C514S643000, C424S405000

Reexamination Certificate

active

06383505

ABSTRACT:

BACKGROUND OF THE INVENTION
The present invention relates to the antimicrobial arts. It finds particular application in conjunction with the reduction of microorganisms on and moisturization of the skin of health care personnel and will be described with particular reference thereto. It should be appreciated, however, that the invention is also applicable outside the medical area, such as a skin conditioning lotion for workers in the food preparation industry, in home health care, or in other areas where skin disinfection and moisturization is desired.
The chemical control of bacteria and viruses is assuming increasing importance in the hospital and medical fields. A wide variety of topical compositions for treatment of the skin are available, including moisturizers, anti-acne compositions, sunscreens, topical anesthetics, artificial tanning compositions, skin lightening compositions, anti-wrinkle compositions, and the like, often in the form of lotions. The most common lotions use anionic, or negatively charged, emulsifiers to stabilize the composition. These lotions have no antimicrobial activity and are used for moisturization only. Nonionic emulsifier-based lotions can also be made, however these tend to be low viscosity fluids.
Lotions are also available which are compatible with an antimicrobial residue left behind on the skin after washing or rinsing with an antimicrobial-containing product. However, these antimicrobial wash products are not themselves moisturizing and are therefore used prior to separate moisturizing product. The antimicrobial wash product is not left on the skin but is washed off prior to the application of the moisturizers. Such antimicrobial wash products would be harsh to the skin if utilized repeatedly in leave-on applications.
Lotions have been developed which provide antimicrobial activity to destroy microorganisms, such as bacteria, on the surface of the skin, while also providing a moisturizing function. Several leave-on products have been developed including those which contain triclosan as the active ingredient. These tend to be relatively ineffective at reducing the antimicrobial population on the skin.
Alcohol-containing products, which include chlorhexidine, are also known. Such compositions use both alcohol and chlorhexidine for quick and persistent activity. However, the alcohol tends to be drying to the skin. Those formulas which also contain emollients to counteract this drying effect tend have a reduced moisturizing effect on the dry skin. Additionally, these products are not actually lotions (stable oil-in-water emulsions) but function as a gel in which the antimicrobial agent is dispersed throughout the composition.
The present invention provides a new and improved skin care composition and method of use which overcomes the above-referenced problems and others.
SUMMARY OF THE INVENTION
In accordance with one aspect of the present invention, an oil-in-water emulsion for antimicrobial skin treatment is provided. The composition includes a nonionic emulsifier, an anionic emulsifier, a cationic antimicrobial agent, a carrier oil, and water.
In accordance with another aspect of the present invention, a fast acting antimicrobial lotion is provided. The lotion includes, as a percent by weight, 0.25-8.0% of a nonionic emulsifier, 0.1-2.0% of an anionic emulsifier, 0.5-10.0% of a thickener, 0-15.0 % of a humectant, 0.02-5.0% of a skin conditioner, 2.0-20.0% of an oil, 0.25-5% of a cationic antimicrobial agent, and water.
One advantage of the present invention is that the skin is microbially decontaminated and moisturized in a single application.
Another advantage of the present invention is that the composition is fast-acting.
Yet another advantage of the present invention is that it avoids the use of substantial quantities of alcohol in the composition, which tends to be drying to the skin.
Yet another advantage of the present invention is that it provides equivalent antimicrobial activity to conventional cationic antimicrobial containing wash products at substantially lower concentrations of the active ingredient.
Another advantage of the present invention is that it enables the viscosity of the composition to be increased to a level which retains the antimicrobial on the skin for an extended period of time.
Yet another advantage of the present invention is that the composition need not be removed from the skin as it is moisturizing and nondrying.
Still further advantages of the present invention will become apparent to those of ordinary skill in the art upon reading and understanding the following detailed description of the preferred embodiments.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
A skin care composition which provides antimicrobial activity while moisturizing the skin is provided. The composition may be used in place of hand washing, as an adjunct to hand washing, as a surgical scrub, or as a surgical preoperative skin preparation. The composition is preferably used as a leave-on composition, which is applied to the skin and left in place to provide both immediate and long term antimicrobial activity and moisturizing functions. While use of the composition is described with reference to application to skin, particularly human skin, the composition may also be used for treatment of hair, scalp, and on animals.
By antimicrobial activity, it is meant that the composition reduces the number of viable microorganisms on the skin, primarily by inactivating or killing the microorganisms, rather than by physically removing them.
The skin care composition comprises an oil-in-water emulsion which includes an antimicrobial agent, preferably a cationic antimicrobial agent. By oil-in-water emulsion, it is meant that the composition is formulated to have a discontinuous oil phase that is dispersed in a water, i.e., the aqueous phase. Specifically, a fine dispersion of oil phase droplets is held in the surrounding water phase by suitable emulsifiers. In the present case, the formulation maintains the antimicrobial agent primarily in the external phase (water) rather than in the internal phase (oil). This allows the antimicrobial to be more readily available and increases the rate of kill of microorganisms. This is in contrast to prior compositions, in which a large portion of the active is found in the internal phase, where it is unavailable for immediate activity on the skin.
The oil in water emulsion comprises an aqueous phase at from about 40% to about 95% by weight of the total composition. Preferably, the compositions includes from about 60 to about 80% by weight of an aqueous phase, in which the oil phase is dispersed.
Emulsifier System
The composition includes a combination of at least one anionic emulsifier and at least one nonionic emulsifier, the nonionic emulsifier(s) preferably being at a higher concentration than the anionic emulsifier(s). It has been found that a combination of anionic and nonionic emulsifiers provides better stability to the emulsion, while simultaneously providing unexpectedly better antimicrobial activity. While a single emulsifier may be used, the microbial activity and physical stability are generally significantly reduced.
The preferred emulsifiers are surfactants which are non-foaming, and thus differ from the conventional high-foaming surfactants used in wash-off compositions. Additionally the concentration of the emulsifiers is less than that used in wash-off compositions, which typically use significantly greater than 5% total surfactants. Specifically, the emulsifiers of the present composition are preferably used in a sufficient amount to just coat the surface area of all of the oil droplets. However, if too much emulsifier is used, it tends to move into the water phase, where it binds and micellizes the chlorhexidine gluconate or other antimicrobial agent, reducing its antimicrobial activity. If too little emulsifier is used, the oil droplets are not fully coated and the chlorhexidine gluconate tends to attach to the surfaces of the oil droplets, also leading to reduced antimicrobial activity

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