Mild, rinse-off antimicrobial cleansing compositions which...

Details Mild, rinse-off antimicrobial cleansing compositions which... Mild, rinse-off antimicrobial cleansing compositions which...

1997-06-04

2001-02-06

Krass, Frederick (Department: 1614)

Drug, bio-affecting and body treating compositions

Preparations characterized by special physical form

Cosmetic, antiperspirant, dentifrice

C510S130000, C510S131000, C510S137000, C510S138000, C510S159000

Reexamination Certificate

active

06183757

ABSTRACT:

TECHNICAL FIELD
The present invention relates to mild, rinse-off, personal cleansing compositions which provide enhanced antimicrobial effectiveness. Specifically, the personal cleansing compositions of the invention provide improved immediate germ reduction on the skin compared to prior art compositions. These rinse-off cleansing compositions are also mild to the skin.
BACKGROUND OF THE INVENTION
Human health is impacted by many microbial entities. Inoculation by viruses and bacteria cause a wide variety of sicknesses and ailments. Media attention to cases of food poisoning, strep infections, and the like is increasing public awareness of microbial issues.
It is well known that the washing of hard surfaces, food (e.g. fruit or vegetables) and skin, especially the hands, with antimicrobial or non-medicated soap, can remove many viruses and bacteria from the washed surfaces. Removal of the viruses and bacteria is due to the surfactancy of the soap and the mechanical action of the wash procedure. Therefore, it is known and recommended that the people wash frequently to reduce the spread of viruses and bacteria.
Bacteria found on the skin can be divided into two groups: resident and transient bacteria. Resident bacteria are Gram positive bacteria which are established as permanent microcolonies on the surface and outermost layers of the skin and play an important, helpful role in preventing the colonization of other, more harmful bacteria and fungi.
Transient bacteria are bacteria which are not part of the normal resident flora of the skin, but can be deposited when airborne contaminated material lands on the skin or when contaminated material is brought into physical contact with it. Transient bacteria are typically divided into two subclasses: Gram positive and Gram negative. Gram positive bacteria include pathogens such as
Staphylococcus aureus, Streptococcus pyogenes
and
Clostridium botulinum
. Gram negative bacteria include pathogens such as
Salmonella, Escherichia coli, Klebsiella, Haemophillus, Pseudomonas aeruginosa, Proteus
and
Shigella dysenteriae
. Gram negative bacteria are generally distinguished from Gram positive by an additional protective cell membrane which generally results in the Gram negative bacteria being less susceptible to topical antibacterial actives.
Antimicrobial cleansing products have been marketed in a variety of forms for some time. Forms include deodorant soaps, hard surface cleaners, and surgical disinfectants. These traditional rinse-off antimicrobial products have been formulated to provide bacteria reduction during washing. For example, Dial® liquid soaps, when used in hand washing, have been found to reduce the amount of the bacteria on the skin by from about 2.0 log (97%) to about 2.5 log (99.7%) in one 30 second handwash, as measured by standard Health Care Personal Handwash Tests (HCPHWT). That is skin washed with these soaps were contaminated with only 0.3%-3% of the number of bacteria compared to before washing. Antimicrobial liquid cleansers are disclosed in U.S. Pat. No. 4,847,072, Bissett et al., issued Jul. 11, 1989, U.S. Pat. No. 4,939,284, Degenhardt, issued Jul. 3, 1990 and U.S. Pat. No. 4,820,698, Degenhardt, issued Apr. 11, 1989, all of which are incorporated herein by reference.
Some of these antimicrobial products, especially the hard surface cleaners and surgical disinfectants, utilize high levels of alcohol and/or harsh surfactants which have been shown to dry out and irritate skin tissues. Dial® bar soap has been found to provide from 2.5 to 3.0 log reduction in bacteria in one wash, as measured by the HCPHWT. However, Dial® can be drying to the skin with repeated use. Ideal personal cleansers should gently cleanse the skin, cause little or no irritation, and not leave the skin overly dry after frequent use and preferably should provide a moisturizing benefit to the skin.
Previously marketed formulations of Head & Shoulders® Dandruff Shampoo, marketed until 1994, comprised anionic surfactants, an antibacterial active and citric acid as a pH adjuster. Head & Shoulders® controlled
Pityrosorum ovale
fungus, which causes dandruff. PCT application WO 92/18100, Keegan et al., published Oct. 29, 1992 (“Kegean”) and PCT application WO 95/32705, Fujiwara et al., published Dec. 7, 1995 (“Fujiwara”) teach liquid skin cleansers comprising mild surfactants, antibacterial agents and acidic compounds to buffer the pH, which provide improved germ hostility. However, the use of the acid compounds for only pH adjustment therein, result in compositions which do not deliver the undissociated acid required to enhance the antimicrobial actives in order to provide improved levels of immediate germ removal upon use. This situation is compounded in Keegan and Fujiwara by the preference of mild surfactants, including nonionic surfactants.
Hibiclens® Surgical Scrub provides 2.5 to 3.0 log reduction in germs in one wash and U.S. Pat. No. 3,141,821, issued to Compeau Jul. 21, 1964; Irgasan DP 300 (Triclosan®) technical literature from Ciba-Giegy, Inc., “Basic Formulation for Hand Disinfection 89/42/01”; Bartzokas, C. A., et al, “Evaluation of the Skin Disinfecting Activity and Cumulative Effect of Chlorhexidine and Triclosan Handwash Preparations on Hands Artificially Contaminated with
Serratia marcescens
”, Infection Control, 1987/Vol. 8, No. 4; all set forth antibacterial skin cleansers compositions which could provide improved immediate germ reduction using certain anionic surfactants, antimicrobial actives and acids. However, the selection, therein, of highly active surfactants or cationic actives with safety issues (i.e. chlorohexidine gluconate) results in personal cleansing compositions which are potentially drying and harsh to the skin, or potentially unsafe.
Germ Reduction
Germ reduction
after 1 wash
after 10 washes
on HCPHWT
on HCPHWT
Low active levels
1.7-2.5 log
2.0-2.8 log
Mild composition
reduction
reduction
(Softsoap)
Low active levels
2.0-3.0 log
2.7-3.2 log
Harsh composition
reduction
reduction
(Dial ®, fatty acid bars)
High Active levels
2.5-3.0 log
3.7-4.2 log
Harsh composition
reduction
reduction
(Hibiclens)
Even with the reduction in bacteria seen with the referenced products, hundreds to thousands of bacteria can be left behind at a wash site. Given the health impacts of bacteria like
Staphylococcus aureus, Streptococcus pyogenes, Salmonella
and
Escherichia coli
, it would be highly desirable to formulate antimicrobial cleansing compositions which provide improved immediate germ reduction and which are mild to the skin. Existing consumer products have been unable to achieve both of these benefits.
Applicants have found that rinse-off antimicrobial cleansing compositions which provide such mildness and such improved immediate germ reduction can be formulated by using known antimicrobial actives in combination with specific organic and/or inorganic acids as proton donating agents, and specific anionic surfactants, all of which are deposited on the skin. The deposited proton donating agent and anionic surfactant enhance the selected active, to provide a new level of hostility to bacteria contacting the skin.
SUMMARY OF THE INVENTION
The present invention relates to a rinse-off antimicrobial cleansing composition effective against Gram positive bacteria, Gram negative bacteria, fungi, yeasts, molds and viruses comprising from about 0.001% to about 5% of an antimicrobial active; from about 1% to about 80% of an anionic surfactant; from about 0.1% to about 12% of a proton donating agent; and from about 3% to about 98.899% of water; wherein the composition is adjusted to a pH of from about 3.0 to about 6.0; wherein the rinse-off antimicrobial cleansing composition has a One-wash Immediate Germ Reduction Index of greater than about 2.5 and a Mildness Index of greater than 0.3. The invention also relates to rinse-off antimicrobial cleansing compositions which have a Ten-wash Immediate Germ Reduction Index of greater than about 2.8 and a Mildness Index of greater than 0.3.
The present invention also relates to methods f

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