Leave-on antimicrobial compositions

Details Leave-on antimicrobial compositions Leave-on antimicrobial compositions

1997-06-04

2001-04-03

Henley, III, Raymond (Department: 1614)

Drug, bio-affecting and body treating compositions

Preparations characterized by special physical form

Wearing apparel, fabric, or cloth

C510S130000, C510S131000, C510S138000

Reexamination Certificate

active

06210695

ABSTRACT:

TECHNICAL FIELD
The present invention relates to leave-on antimicrobial compositions which provide enhanced antimicrobial effectiveness compared to prior art compositions. Specifically, the leave-on compositions of the invention provide previously unseen residual effectiveness against transient Gram negative bacteria, improved residual effectiveness against Gram positive bacteria and improved immediate germ removal upon use.
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, 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 deodorant soaps, hard surface cleaners, and surgical disinfectants. These traditional rinse-off antimicrobial products have been formulated to provide bacteria removal during washing. The antimicrobial soaps have also been shown to provide a residual effectiveness against Gram positive bacteria, but limited residual effectiveness versus Gram negative bacteria. By residual effectiveness it is meant that bacteria growth on a surface is controlled for some period of time following the washing/rinsing process. Antimicrobial liquid cleansers are disclosed in U.S. Pat. Nos. 4,847,072, Bissett et al., issued Jul. 11, 1989, 4,939,284, Degenhardt, issued Jul. 3, 1990 and 4,820,698, Degenhardt, issued Apr. 11, 1989, all patents being incorporate herein by reference.
Some of these traditional 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. 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.
Finally, these traditional antimicrobial compositions have been developed for use in a washing process with water. This limits their use to locations with available water.
Leave-on, topical lotions have been used in the past to moisturize skin. However, these leave-on compositions have not provided antimicrobial protection against transient Gram positive or Gram negative organisms.
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 non-wipe 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, results in compositions which do not deliver the undissociated acid required to provide improved antimicrobial benefits. This situation is compounded in Keegan and Fujiwara by the preference of mild surfactants, including nonionic surfactants. 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 composition. 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” set forth antibacterial skin cleanser compositions which could provide improved antibacterial effectiveness using certain anionic surfactants, antimicrobial actives and acids. However, the selection of highly active surfactants results in personal cleansing compositions which are drying and harsh to the skin. Again, neither reference teaches the use of antimicrobial compositions in a form which can be used without available water, e.g. a leave-on.
Given the severe health impacts of bacteria like Salmonella,
Escherichia coli
and Shigella, it would be highly desirable to formulate antimicrobial cleansing products which provides improved reduction of these germs on the skin and improved residual effectiveness versus these transient bacteria, which are 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 antimicrobial compositions which provide such mildness and antimicrobial benefits can be formulated by using known antibacterial 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 leave-on antimicrobial composition comprising from about 0.001% to about 5.0%, by weight of the leave-on antimicrobial composition, of an antimicrobial active; from about 0.05% to about 10%, by weight of the leave-on antimicrobial composition, of an anionic surfactant; from about 0.1% to about 10%, by weight of the leave-on antimicrobial composition, of a proton donating agent; and from about 0% to about 99.85%, by weight of the leave-on antimicrobial composition, water; wherein the composition is adjusted to a pH of from about 3.0 to about 6.0. The invention also encompasses methods for cleansing, reducing the number of germs on the skin and decreasing the spread of transient Gram negative and Gram positive bacteria 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 providing improved germ reduction, and residual antimicrobial effectiveness versus transient bacteria, are mild to the skin and can be used without additional available water. 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 appli

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