Emollient alcohol skin disinfecting formulation

Cleaning compositions for solid surfaces – auxiliary compositions – Cleaning compositions or processes of preparing – For cleaning a specific substrate or removing a specific...

Reexamination Certificate

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C510S101000, C510S131000, C510S138000, C510S159000, C510S383000, C510S384000, C510S386000, C510S391000, C510S419000, C424S404000, C424S070280, C424S078070

Reexamination Certificate

active

06723689

ABSTRACT:

BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates to an antimicrobial composition for use as an emollient alcohol based skin disinfectant that will not irritate or dry the skin. The skin disinfecting formulations of the present invention arc particularly useful in the healthcare profession as a hand healthcare preparation or as a pre-surgical scrub without requiring a secondary emollient application.
2. Description of Relevant Art
Hand washing by healthcare professionals is an essential component of infection control activities. Healthcare professionals attending to patient care wash their hands to control the spread of infection from patient to patient and surgical procedures are routinely proceeded by surgical hand scrubbing and patient pre-operative skin preparation.
Hand washing procedures are performed in several ways. Several procedures include an ordinary antimicrobial bar soap, a skin disinfecting alcohol based preoperative preparation agent, or rubbing alcohol. The repeated use of these procedures causes the hands to become rough, dry and cracked.
The majority of the commercially available scrubs include detergents and an antimicrobial agent or a preservative. Examples of the antimicrobial or preservative agents include iodine formulations, iodophors, phenolic compounds such as parachlorometaxylenol and hexachlorophene and bis-biguanides such as chlorhexidine gluconate (CHG).
Although alcohol in general is recognized for its very effective disinfecting properties, it is not used directly with skin or in scrub formulations because it is a defatting agent. When alcohol is applied to the human skin, it makes it very dry, often developing chapped and cracked skin. Furthermore, it is difficult to formulate a detergent solution with alcohol that will lather like ordinary soaps and detergents when used with water. However, due to the disinfecting properties of alcohol, it is desirable to produce a skin disinfecting formulation with alcohol which is mild and gentle to the skin, and is effective at controlling microorganism populations on the skin.
SUMMARY OF THE INVENTION
The present invention is a skin disinfecting formulation that provides antimicrobial effectiveness and is mild and gentle to human skin. The skin disinfecting formulation desirably comprises an alcohol, a thickening agent, a preservative, an emulsifier, a moisturizer and/or emollient and water. The disinfecting formulation is used in a method of disinfecting a substrate comprising the step of applying an effective amount of the disinfecting formulation to the substrate, such as a hand. Additionally, an antimicrobial formulation of alcohol or a solution of chlorhexidine gluconate may be applied to the substrate.
Preferably, the skin disinfecting formulation may further comprise a colorant or a fragrance. Most preferably, the skin disinfecting formulations comprise by weight:
(a) from about 60% to about 95% of an alcohol;
(b) from about 0% to about 3%, preferably from about 0.01 to about 3.0%, of a thickening agent;
(c) from about 1% to about 5%, preferably from about 0.01 to about 3.0%, of a cationic emulsifier;
(c) from about 0% to about 5%, preferably from about 0.001 to about 5.0%, of a preservative/antimicrobial agent;
(d) from about 0.05% to about 5% of a fragrance;
(e) from about 0.05% to about 1% of a colorant; and
(j) from about 6% to about 30% of water.
The skin disinfecting formulations of the present invention are useful in providing substantial antimicrobial effectiveness and surprisingly, provide substantial non-irritancy to the skin view of the alcohol component of the formulations.
Another attribute of the skin disinfecting formulation is its ability to not dry the skin.
Another advantage of the skin disinfecting formulation is the compatibility with other Chlorohexidine Gluconate products, which enhances the antimicrobial activity of both formulations by further reducing the microbial flora on the substrate.
A further advantage of the skin disinfecting formulations of the present invention is the potential to provide long-term residual activity on the applicant's skin to prevent bacteria growth back to the base line of normal skin flora population.
The skin disinfecting formulations of the present invention will disinfect the skin while also providing emolliency to the skin. Further, the skin disinfecting formulations of the present invention can also be used as a general purpose hand wash to decontaminate the hands of healthcare professionals before examining any patient.
Healthcare professionals perform a routine hand scrubbing procedure many times a day. The typical and/or commonly used scrub solutions contain chemical compounds such as iodine, chlorhexidine gluconate (CHG), PCMX and hexachlorophenc. All of these chemical compounds disinfect the skin as well as bind to the skin, thus providing persistent activity. Healthcare professionals may also use the skin disinfecting formulation of the present invention throughout the day. Since health care professionals scrub and wash their hands many times a day, the chemical compounds may buildup on their skin and accumulate through out the day. The intended use of the present invention includes rinsing off the hands and forearms with water to remove any residual chemical build up. Therefore the skin disinfecting formulation of the present invention would be ideal for both routine use throughout the day and as a final wash before leaving the work place.
Surprisingly, the formulations of the present invention provide substantially effective skin disinfecting properties with the use of alcohol in the formulations as well as being mild and gentle to the skin, and substantially effective against microorganisms. Antimicrobial formulations of the present invention are typically packaged in a container. Typically, a foot pump is used to create an increased pressure inside the closed container. The positive pressure difference across the container wall results in the solution being forced up a solution delivery straw. Such a formula must therefore satisfy certain physical requirements, which include: viscosity in the range of 100-2500 cps; alcohol as an active ingredient in the range of 60-95% w/w; and antimicrobial agents in a preservative range of 0.001-5.0% w/w. In addition, the formulation must be efficacious and non-irritating when used. With these parameters in mind the present invention provides an alcohol scrub with greater than 60% alcohol that is effective against microorganisms and causes rapid bacterial reduction.


REFERENCES:
patent: 6136771 (2000-10-01), Taylor et al.

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