High lathering antibacterial 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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C510S130000, C510S135000, C510S138000, C510S147000, C510S155000, C510S159000, C510S382000, C510S387000, C510S388000, C510S405000, C510S426000, C510S432000, C510S433000

Reexamination Certificate

active

06383997

ABSTRACT:

FIELD OF THE INVENTION
The present invention relates to an alcohol based antibacterial liquid formulation, which exhibits high lathering properties. More specifically, the invention concerns an alcohol based liquid formulation, which can be formulated with a reduced overall surfactant level yet, achieves high lathering properties and exhibits good antibacterial properties. The formulation is suitable for frequent use in disinfecting the hands and body.
DESCRIPTION OF THE RELATED ART
Liquid formulations for disinfecting the hands and body have been in existence in one form or another throughout the history of humankind. The use of alcohol as an anti-microbial dates to biblical times. Studies have shown that use of ethyl or propanol is very effective in reducing acquired microbial flora on the hands. Use of alcohol as a hand dip was in vogue in the United States in the early years of this century. A common complaint after the use of an alcohol dip was drying and chapping of the hands. Alcohol hand dips rapidly declined in popularity when new liquid soaps containing anti-microbials were introduced.
More recently, alcohol and chlorhexidine gluconate compositions have been developed due to their long lasting efficacy and rapid anti-microbial effect. However, the failure of many bacteria to respond to these compositions and the call for the restricted use of antibiotics has resulted in a decline in the use of topical products containing chlorhexidine gluconate.
In the case of disinfecting hands and skin, an antibacterial agent is desired which kills the widest possible range of microorganisms, in the least possible time, without toxicity, irritation, or other hazards.
Hand wash formulations have been developed using triclosan as an antibacterial agent. Triclosan has a broad-spectrum activity against a variety of microorganisms. However, triclosan has very poor solubility in water and generally requires formulation additives to solubilize it. To solubilize triclosan, it is conventional to use a surfactant, usually in an amount of 15-30% of the formulation.
While some surfactants provide good lathering performance and are effective in emulsifying and removing oily dirt from the skin, they also tend to remove lipids and natural oils from the skin and thus dehydrate the skin. Many surfactants also have a hygroscopic effect, removing water from the skin, further drying the skin. As a result, the skin becomes tight, or taut, due to the emulsification and hygroscopic effects of the surfactants.
While it is important that these compositions contain a good cleansing surfactant system (generally containing at least one anionic surfactant and preferably at least an additional amphoteric surfactant), such compositions should ideally also contain a component beneficial to the skin, e.g., component that will counteract the “dry” feeling associated with a good cleansing surfactant.
The addition of skin conditioning components can further improve the skin mildness of these surfactants, but would further degrade lathering and lathering of any alcohol-based formulation, which would already have poor lathering, and lathering properties.
That is, alcohol based formulations are difficult to formulate into lather-producing or foam-producing products because the alcohol has a natural tendency to kill the foam. The addition of alcohol to a surfactant containing formulation will interfere with the lather forming ability of the surfactant. This foam suppression is undesirable because consumers often associate foam and lather with cleansing ability, and tend to prefer foam or lather producing products.
The introduction of an antibacterial into the equation results in additional problems for mildness, lather, and efficacy. Also, certain surfactants have deactivating effects on the degerming properties of the antibacterial agent.
Thus, a need exists for liquid formulations which will produce a rich foam or lather, which are effective antibacterial cleansers, and which are very mild to the skin even when used repeatedly. In particular, it is desirable to provide such a product, which contains both emollients and humectants, which are effective for re-moisturizing and inhibiting dehydration of the skin.
By way of example, the U.S. Pat. No. 5,403,864 to Bruch et al., entitled “Rapidly-Acting Topical Antibacterial Formulation,” teach that ethyl and n-propyl are the most effective alcohols for reducing the bacterial flora on the hands.
The objects of the Bruch et al. invention are to provide an antibacterial formulation that is effective against a broad range of microorganisms, including those pathogenic microorganisms that resist conventional antibacterial formulations; that is easily applied as a topical formulation; and that acts within seconds rather than minutes.
The Bruch et al. formulation comprises triclosan, chloroxylenol, and an alcohol or alcohol mixture. The formulation further contains emollients and humectant ingredients to reduce the normal drying and defatting characteristics of the alcohol. The formulation also contains surfactants as emulsifiers, perfuming agents, and chelating agents.
This reference is limited to teaching liquids of poorly lathering formulations, which do not lather in the manner of a hand soap.
U.S. Pat. No. 5,955,408 to Kaiser et al. entitled “Triclosan Skin Formulation with Enhanced Efficacy” discloses the poor solubility of triclosan in aqueous solvent other than water, and that surfactants which are usually added to solubilize triclosan are skin irritants. Kaiser et al. minimizes this problem (and dissolves triclosan in formulations having about 70% of aqueous solvent other than water) by using aqueous solvents other than water and lower levels of surfactants, preferably less than 10%, to solubilize triclosan. Kaiser et al. use lower than optimal amounts of alcohol, and thus, the disclosed formulations are in need of improvement.
U.S. Pat. No. 5,747,435 to Patel, entitled “Mild Lathering and Conditioning Detergents,” teaches a clear or opacified product, which may contain triclosan as anti-dandruff therapeutic agent. As can be seen from the title, the ability to lather is limited.
U.S. Pat. No. 5,994,286 to Desai et al. entitled, “Antibacterial Formulation containing triclosan and Tocopherol,” teaches an antibacterial cleaning formulation comprising a surfactant, triclosan, and tocopherol and a process for inhibiting the color degradation of triclosan. The Desai et al. formulation does not include alcohol.
Lastly, U.S. Pat. No. 5,968,539 to Beerse et al. entitled, “Mild, Rinse-Off Antibacterial Liquid Cleaning Formulations which provide residual benefit versus gram negative bacteria,” teaches formulations wherein the preferred anti-microbial is triclosan. Beerse et al. fail to produce an antibacterial formulation that is mild to the skin.
While these formulations fulfill their respective, particular objectives and requirements, the aforementioned patents do not describe an alcohol based liquid formulation that exhibits improved mildness to the skin with high lathering properties, and good antibacterial effect.
Therefore, it can be appreciated that there exists a continuing need for a liquid formulation, which exhibits high lathering, good cleaning, and good antibacterial properties, and preferably also good clarity, and which can be used frequently because it exhibits improved mildness.
SUMMARY OF THE INVENTION
In view of the foregoing disadvantages inherent in the known types of liquid formulations in the prior art, the present inventors discovered a unique alcohol-based antibacterial liquid formulation, having improved mildness, with good cleaning, high lathering, and good antibacterial properties. In addition, the present inventors created a method for preparing such a formulation, and a method of cleaning the skin with such formulation.
Unexpectedly, Applicants have found that a combination of a high level of a low carbon alcohol, specified types of surfactants in specified ratios, and a specified antibacterial agent provide a high lathering formulation that is mild to t

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