Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Cosmetic – antiperspirant – dentifrice
Reexamination Certificate
2000-03-27
2002-12-03
Dees, Jose′ G. (Department: 1616)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Cosmetic, antiperspirant, dentifrice
C424S404000, C424S405000
Reexamination Certificate
active
06488943
ABSTRACT:
TECHNICAL FIELD
The present invention relates to cleansing wipes comprising absorbent sheets impregnated with antimicrobial cleansing compositions. These cleansing wipes provide enhanced antimicrobial effectiveness compared to prior art compositions. Specifically, the cleansing wipe personal cleansing compositions of the invention provide previously unseen immediate germ reduction.
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 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. Hibiclens® Surgical Scrub provides 2.5 to 3.0 log reduction in germs in one wash, however it utilizes a potent cationic antibacterial agent, chlorohexidine, which has product safety concerns. 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.
Cleansing wipes have been used, in the past, to wash hands and face while traveling or in public or anytime water is not available. In fact, consumers have used absorbent sheets impregnated with topical compositions for a variety of purposes. U.S. Pat. No. 4,045,364, Richter, et al., issued Aug. 30, 1977 teaches a dry disposable paper impregnated with a germicidal composition comprising an anionic surfactant, an elemental iodine or iodophor active ingredient and a weak acid for pH adjustment. The compositions utilize iodine actives which are not stable in the presence of substantial amounts of water and insufficient acid levels to provide the improved immediate germ reduction of the present invention. European Patent Application, EP 0 619 074, Touchet et al., published Oct. 12, 1994, teaches the use of sorbic or benzoic acids as antimicrobial agents in a wipe, however does not teach the anionic surfactant and separate antimicrobial active necessary to achieve the residual effectiveness of the present invention. U.S. Pat. No. 4,975,217, Brown-Skrobot et al., issued Dec. 4, 1990 teaches the use of anionic surfactants and organic acids on a wipe, however does not teach the use of the active required to provide the improved residual effectiveness benefits.
Currently marketed Nice'n Clean®, Wash'n Dry® and No More Germies® are all antibacterial wipes which utilize harsh cationic surfactants with no additional antibacterial active. These products do not provide the improved immediate germ reduction and are harsh to the skin. Current wipes 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 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 the improved immediate germ reduction of the present invention. 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 wipe.
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 drying and harsh, or potentially unsafe to use.
Given the health impacts of bacteria like
Staphylococcus aureus, Streptococcus pyogenes
and
Clostridium botulinum,
it would be highly desirable to formulate antimicrobial cleansing products which provides improved immediate germ reduction on the skin, 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 antimicrobial wipes which provide such mildness and a new level of immediate g
Baier Kathleen Grieshop
Bakken Schuette Theresa Anne
Beerse Peter William
Cen Raymond Wei
Morgan Jeffrey Michael
Dees Jose′ G.
DeWitty Robert M
Dressman Marianne
The Procter & Gamble & Company
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