Drug – bio-affecting and body treating compositions – Live hair or scalp treating compositions – Cationic surfactant containing
Reexamination Certificate
2001-03-27
2003-09-09
Page, Thurman K. (Department: 1615)
Drug, bio-affecting and body treating compositions
Live hair or scalp treating compositions
Cationic surfactant containing
C424S070100, C424S070270, C424S400000, C424S404000
Reexamination Certificate
active
06616922
ABSTRACT:
FIELD OF THE INVENTION
The present invention is directed to antibacterial compositions, like personal care compositions, having improved antibacterial effectiveness and excellent esthetic properties. More particularly, the present invention is directed to antibacterial compositions comprising an antibacterial agent, an alkamine oxide, a cosurfactant, and an optional polymeric thickener. Preferred compositions have a pH of about 5.5 to about 7.5. A present composition provides a substantial reduction, e.g., greater than 99%, in Gram positive and Gram negative bacterial populations within one minute.
BACKGROUND OF THE INVENTION
Antibacterial personal care compositions are known in the art. Especially useful are antibacterial cleansing compositions, which typically are used to cleanse the skin and to destroy bacteria and other microorganisms present on the skin, especially the hands, arms, and face of the user.
Antibacterial compositions are used, for example, in the health care industry, food service industry, meat processing industry, and in the private sector by individual consumers. The widespread use of antibacterial compositions indicates the importance consumers place on controlling bacteria and other microorganism populations on skin. It is important, however, that antibacterial compositions provide a substantial and broad spectrum reduction in microorganism populations quickly and without problems associated with toxicity and skin irritation.
In particular, antibacterial cleansing compositions typically contain an active antibacterial agent, a surfactant, and various other ingredients, for example, dyes, fragrances, pH adjusters, thickeners, skin conditioners, and the like, in an aqueous carrier. Several different classes of antibacterial agents have been used in antibacterial cleansing compositions. Examples of antibacterial agents include bisguanidines (e.g., chlorhexidine digluconate), diphenyl compounds, benzyl alcohols, trihalocarbanilides, quaternary ammonium compounds, ethoxylated phenols, and phenolic compounds, such as halo-substituted phenolic compounds, like PCMX (i.e., p-chloro-m-xylenol) and triclosan (i.e., 2,4,4′-trichloro-2′hydroxy-diphenylether). Present-day antimicrobial compositions based on such antibacterial agents exhibit a wide range of antibacterial activity, ranging from low to high, depending on the microorganism to be controlled and the particular antibacterial composition.
Most commercial antibacterial compositions, however, generally offer a low to moderate antibacterial activity. Antibacterial activity is assessed against a broad spectrum of microorganisms, including both Gram positive and Gram negative microorganisms. The log reduction, or alternatively the percent reduction, in bacterial populations provided by the antibacterial composition correlates to antibacterial activity. A log reduction of 3-5 is most preferred, a 1-3 reduction is preferred, whereas a log reduction of less than 1 is least preferred, for a particular contact time, generally ranging from 15 seconds to 5 minutes. Thus, a highly preferred antibacterial composition exhibits a 3-5 log reduction against a broad spectrum of microorganisms in a short contact time. Prior disclosures illustrate attempts to provide such antibacterial compositions, which, to date, do not provide the rapid, broad range control of microorganisms desired by consumers.
It should be noted that high log reductions have been achieved at pH values of 4 and 9, but such log reductions are attributed at least in part to these relatively extreme pH values. Compositions having such pH values can irritate the skin or damage other surfaces, and, therefore, typically are avoided. It has been difficult to achieve a high log reduction using an antibacterial composition having a neutral pH of about 5.5 to about 7.5, and especially about 6 to about 7.3. Antibacterial compositions having a near neutral pH are disclosed in U.S. Pat. Nos. 6,107,261 and 6,136,771.
In addition to an antibacterial agent, antibacterial personal care compositions typically contain an anionic surfactant for cleansing and foam generation, skin conditioning agents for cosmetic effects, and dyes, perfumes, and optional thickening agents, such as clays, polymers, or colloids, for esthetic effects. The most common antibacterial agents are selected from the classes of phenolic compounds, carbanalide compounds, lower alcohols, and quaternary ammonium compounds. Quaternary ammonium germicides are not widely used in antibacterial personal care compositions, predominantly because of an inherent chemical incompatibility with the commonly used, and preferred, anionic surfactants, such as soaps, alcohol sulfates, alcohol ether sulfates, and the like.
Although a composition containing a quaternary ammonium compound and a selected anionic surfactant has been disclosed as being effective in some applications (e.g., U.S. Pat. No. 5,798,329), no reference disclosing such a combination for use in personal care compositions has been found. Accordingly, antibacterial personal care compositions based on quaternary ammonium germicides generally incorporate nonionic or amphoteric surfactants, and avoid anionic surfactants because of chemical incompatibility problems.
However, personal care compositions based on nonionic and/or amphoteric surfactants suffer in comparison to anionic surfactant-based compositions with respect to acceptable consumer properties, especially foam generation. It also is difficult to provide phase stable compositions having a consumer acceptable viscosity using a low to moderate level of nonionic and amphoteric surfactants.
In particular, when the nonionic/amphoteric surfactant level is low to moderate, the compositions initially are viscous, or thick, when first prepared, but often undergo phase separation under ambient, and especially under stressed (i.e., high temperature) storage conditions. Further, present-day antibacterial personal care compositions do not provide an effective antibacterial activity, especially against pathogenic Gram negative bacteria. Thus, a need exists for phase stable, efficacious antibacterial personal care compositions containing a quaternary ammonium germicide and a low or moderate level of nonionic or amphoteric surfactant, and that further are consumer acceptable and mild to the skin. A need also exists for phase stable compositions having a high viscosity and containing a phenolic antibacterial agent and an alkamine oxide surfactant.
An example of patents and published applications disclosing compositions comprising triclosan, surfactants, solvents, chelating agents, thickeners, buffering agents, and water is WO 98/01110. WO 98/01110 is directed to reducing skin irritation by employing a reduced amount of surfactant.
Fendler et al. U.S. Pat. No. 5,635,462 discloses compositions comprising PCMX and selected surfactants. The compositions disclosed therein are devoid of anionic surfactants and nonionic surfactants.
WO 97/46218 and WO 96/06152 disclose compositions based on triclosan, organic acids or salts, hydrotropes, and hydric solvents.
EP 0 505 935 discloses compositions containing PCMX in combination with nonionic and anionic surfactants, particularly nonionic block copolymer surfactants.
WO 95/32705 discloses a mild surfactant combination that can be combined with antibacterial compounds, like triclosan.
WO 95/09605 discloses antibacterial compositions containing anionic surfactants and alkylpolyglycoside surfactants.
WO 98/55096 discloses antimicrobial wipes having a porous sheet impregnated with an antibacterial composition containing an active antimicrobial agent, an anionic surfactant, an acid, and water, wherein the composition has a pH of about 3.0 to about 6.0.
Beerse et al. U.S. Pat. Nos. 5,968,539; 6,106,851; and 6,113,933 disclose antibacterial compositions having a pH of about 3 to about 6. The compositions contain an antibacterial agent, an anionic surfactant, and a proton donor.
N. A. Allawala et al.,
J. Amer. Pharm. Assoc.—Sci. Ed.,
Vol. XLII, no. 5, pp. 267-275, (1953) di
Fox Priscilla S.
Seitz E. Phil
Slayton Michael D.
Taylor Timothy J.
Bennett Rachel M.
Marshall Gerstein & Borun
Page Thurman K.
The Dial Corporation
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