Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Cosmetic – antiperspirant – dentifrice
Reexamination Certificate
1999-06-01
2001-04-17
Jones, Dwayne C. (Department: 1614)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Cosmetic, antiperspirant, dentifrice
C514S846000, C514S859000, C514S941000, C514S942000, C514S735000, C514S716000, C510S119000, C510S131000, C510S138000, C510S158000, C510S319000
Reexamination Certificate
active
06217887
ABSTRACT:
TECHNICAL FIELD
The present invention relates to leave-on, topical antimicrobial compositions which provide improved antimicrobial effectiveness when they are applied to the skin. Specifically, the leave-on antimicrobial compositions of the invention provide improved immediate reduction of germs on 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 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, Haemophilus,
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 antibacterial 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 (99%) 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%-1% 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. Finally, these traditional antimicrobial soaps have been developed for use in a washing process with water. This limits their use to locations with available water.
Some of these traditional products, especially the hard surface cleaners, surgical disinfectants, and some alcohol-based leave-on lotions (e.g. Purell®), utilize high levels of alcohol and/or harsh surfactants which have been shown to dry out and irritate skin tissues. 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.
Leave-on, topical lotions, foams and gels have been used, in the past, to moisturize skin, along with a variety of other purposes. However, these leave-on compositions provide minimal antimicrobial effectiveness. Current leave-on products have been found to give about 1.0 log reduction of germs in One-wash tests.
PCT application WO 92/18100, Keegan et al., published Oct. 29, 1992 and PCT application WO 95/32705, Fujiwara et al., published Dec. 7, 1995 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 provide improved immediate germ reduction. Neither Keegan nor Fujiwara teach the use of their compositions in a form which can be used without available water, e.g. a leave-on lotion.
U.S. Pat. No. 3,141,821, issued to Compeau Jul. 21, 1964 and Irgasan DP 300 (Triclosan®) technical literature from Ciba-Giegy, Inc., “Basic Formulation for Hand Disinfection 89/42/01” teach the use of anionic surfactants, antimicrobial actives and acids in antibacterial skin cleansers. However, the selection of highly active surfactants result in personal cleansing compositions which are drying and harsh to the skin. Here, also, neither reference teaches the use of antimicrobial compositions in a form which can be used without available water, e.g. a leave-on lotion.
Given the health impacts of bacteria like
Escherichia coli, Staphylococcus aureus, Streptococcus pyogenes
and
Clostridium botulinum,
it would be highly desirable to formulate leave-on, topical antimicrobial compositions which provide improved immediate germ reduction on the skin, which are also mild to the skin and which can be used without water. Existing products have been unable to deliver all of these benefits.
Applicants have found that leave-on, topical antimicrobial compositions which provide such mildness and a new level of 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 work in combination with 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 leave-on antimicrobial 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 0.05% to about 10% of an anionic surfactant; from about 0.05% to about 10% of a proton donating agent, wherein the proton donating agent is such that the composition is essentially free of C
4
-C
20
alkyl fatty acid; and from about 0% to about 99.85% of water; wherein the composition is adjusted to a pH of from about 3.0 to about 6.0; wherein the leave-on antimicrobial composition has an One-wash Immediate Germ Reduction Index of greater than about 1.0; and wherein the leave-on antimicrobial composition has a Mildness Index of greater than 0.3.
The present invention also relates to methods for reducing the level of germs on the skin, using the leave-on antimicrobial compositions described herein.
DETAILED DESCRIPTION OF THE INVENTION
The leave-on antimicrobial compositions of the present invention are highly efficacious for reducing the number of germs on the skin and are mild to the skin.
The term “leave-on antimicrobial composition” is used herein to mean products suitable for application to the human skin for the purpose controlling the growth and viability of transient bacteria on the skin.
The compositions of the present invention can also be useful for treatment of acne. As used herein “treating acne” means preventing, retarding and/or arresting the process of acne formation in mammalian skin.
The compositions of the invention can also potentially be useful for providing an essentially immediate (i.e., acute) visual improvement in skin appearance following application o
Baier Kathleen Grieshop
Bakken Schuette Theresa Anne
Beerse Peter William
Chen Raymond Wei
Morgan Jeffrey Michael
Jagoe Donna
Jones Dwayne C.
Murphy Stephen T.
The Procter & Gamble & Company
Winter William J.
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