Source: http://www.google.com/patents/US6183763?dq=5,838,906
Timestamp: 2018-01-22 08:28:21
Document Index: 395826790

Matched Legal Cases: ['application No. 08', 'application No. 08', 'application No. 08', 'application No. 08', 'application No. 08', 'application No. 08', 'application No. 08', 'application No. 08', 'application No. 08', 'application No. 08', 'application No. 08', 'application No. 08', 'application No. 08', 'application No. 08', 'application No. 08', 'application No. 08', 'application No. 08', 'application No. 08', 'application No. 08', 'application No. 08', 'application No. 08']

Patent US6183763 - Antimicrobial wipes which provide improved immediate germ reduction - Google Patents
The present invention relates to an antimicrobial wipe effective against Gram positive bacteria, Gram negative bacteria, fungi, yeasts, molds, and viruses comprising a porous or absorbent sheet impregnated with an antimicrobial cleansing composition, wherein the antimicrobial cleansing composition comprises...http://www.google.com/patents/US6183763?utm_source=gb-gplus-sharePatent US6183763 - Antimicrobial wipes which provide improved immediate germ reduction
Publication number US6183763 B1
Application number US 08/868,687
Publication number 08868687, 868687, US 6183763 B1, US 6183763B1, US-B1-6183763, US6183763 B1, US6183763B1
Inventors Peter William Beerse, Jeffrey Michael Morgan, Kathleen Grieshop Baier, Wei Cen, Theresa Anne Bakken
Patent Citations (94), Non-Patent Citations (60), Referenced by (83), Classifications (11), Legal Events (4)
Antimicrobial wipes which provide improved immediate germ reduction
US 6183763 B1
The present invention relates to an antimicrobial wipe effective against Gram positive bacteria, Gram negative bacteria, fungi, yeasts, molds, and viruses comprising a porous or absorbent sheet impregnated with an antimicrobial cleansing composition, wherein the antimicrobial cleansing composition comprises from about 0.001% to about 5.0%, by weight of the antimicrobial cleansing composition, of an antimicrobial active; from about 0.05% to about 10%, by weight of the antimicrobial cleansing composition, of an anionic surfactant; from about 0.1% to about 10%, by weight of the antimicrobial cleansing composition, of a proton donating agent; and from about 3% to about 99.85%, by weight of the antimicrobial cleansing composition, water; wherein the composition is adjusted to a pH of from about 3.0 to about 6.0; wherein the antimicrobial cleansing composition an One-wash Immediate Germ Reduction Index of greater than about 1.3; and wherein the rinse-off antimicrobial cleansing composition has a Mildness Index of greater than 0.3. The present invention also relates to methods for removing germs from the skin using the antimicrobial wipes described herein.
1. An antimicrobial wipe effective against Gram positive bacteria, Gram negative bacteria, fungi, yeasts, molds, and viruses comprising a porous or absorbent sheet impregnated with an antimicrobial cleansing composition, wherein the antimicrobial cleansing composition comprises the following individual components:
a. from about 0.001% to about 5.0%, by weight of the antimicrobial cleansing composition, of an antimicrobial active;
b. from about 0.05% to about 10%, by weight of the antimicrobial cleansing composition, of an anionic surfactant;
c. from about 0.1% to about 10%, by weight of the antimicrobial cleansing composition, of a proton donating agent; and
d. from about 3% to about 99.85%, by weight of the antimicrobial cleansing composition, water;
wherein the antimicrobial cleansing composition exhibits a One-wash Immediate Germ Reduction Index of greater than about 1.3; and wherein the antimicrobial cleansing composition has a Mildness Index of greater than 0.3.
2. An antimicrobial wipe according to claim 1 wherein the antimicrobial active is selected from the group consisting of triclosan, triclocarban, piroctone olamine, PCMX, ZPT, natural essential oils and their key ingredients, and mixtures thereof.
3. An antimicrobial wipe according to claim 2 wherein the antimicrobial active is triclosan.
4. An antimicrobial wipe according to claim 2 wherein the anionic surfactant has a Microtox Response Index of less than about 150.
5. An antimicrobial wipe according to claim 2 wherein the proton donating agent is an organic acid having a Buffering Capacity of greater than about 0.005.
6. An antimicrobial wipe according to claim 2 wherein the proton donating agent is a mineral acid.
7. An antimicrobial wipe according to claim 5 wherein the composition is adjusted to a pH of from about 3.5 to about 5.0.
8. An antimicrobial wipe according to claim 7 wherein the ratio of the amount of non-anionic surfactants to the amount of anionic surfactant in the antimicrobial cleansing composition is less than 1:1.
9. An antimicrobial wipe effective against Gram positive bacteria, Gram negative bacteria, fungi, yeasts, molds, and viruses comprising a porous or absorbent sheet impregnated with an antimicrobial cleansing composition, wherein the antimicrobial cleansing composition comprises the following individual components:
a. from about 0.05% to about 1.0%, by weight of the antimicrobial cleansing composition, of an antimicrobial active;
b. from about 0.1% to about 2%, by weight of the antimicrobial cleansing composition, of an anionic surfactant;
c. from about 0.5% to about 8%, by weight of the antimicrobial cleansing composition, of a proton donating agent; and
wherein the antimicrobial cleansing composition exhibits a One-wash Immediate Germ Reduction Index of greater than about 1.7; and wherein the antimicrobial composition has a Mildness Index of greater than 0.4.
10. An antimicrobial wipe according to claim 9 wherein the antimicrobial active is selected from the group consisting of triclosan, triclocarban, piroctone olamine, PCMX, ZPT, natural essential oils and their key ingredients, and mixtures thereof.
11. An antimicrobial wipe according to claim 10 wherein the antimicrobial active is triclosan.
12. An antimicrobial wipe according to claim 10 wherein the anionic surfactant has a Microtox Response Index of less than about 150.
13. An antimicrobial wipe according to claim 10 wherein the proton donating agent is an organic acid having a Buffering Capacity of greater than about 0.005.
14. An antimicrobial wipe according to claim 10 wherein the proton donating agent is a mineral acid.
15. An antimicrobial wipe according to claim 13 wherein the composition is adjusted to a pH of from about 3.5 to about 5.0.
16. An antimicrobial wipe according to claim 15 wherein the ratio of the amount of non-anionic surfactants to the amount of anionic surfactant in the antimicrobial cleansing composition is less than 1:1.
17. An antimicrobial wipe according to claim 16 which further comprises from about 1% to about 30%, by weight of the antimicrobial cleansing composition, of a lipophilic skin moisturizing agent.
18. A method for providing improved immediate reduction of germs on the skin comprising rubbing the antimicrobial wipe of claim 1 on human skin, wherein the antimicrobial cleansing composition is applied to the skin in a safe and effective amount.
19. A method for providing improved immediate reduction of germs on the skin, comprising rubbing the antimicrobial wipe of claim 9 on human skin, wherein the antimicrobial cleansing composition is applied to the skin in a safe and effective amount.
20. A method for treating acne, comprising rubbing the antimicrobial wipe of claim 1 on human skin, wherein the antimicrobial cleansing composition is applied to the skin in a safe and effective amount.
21. An antimicrobial wipe according to claim 1 wherein the antimicrobial cleansing composition comprises from about 0.05% to about 5%, by weight of the antimicrobial cleansing composition, of the anionic surfactant.
22. An antimicrobial wipe according to claim 1 wherein the antimicrobial cleansing composition comprises from about 0.05% to about 2%, by weight of the antimicrobial cleansing composition, of the anionic surfactant.
23. An antimicrobial wipe according to claim 1 wherein the ratio of the amount of non-anionic surfactants to the amount of anionic surfactant in the antimicrobial cleansing composition is less than 1:2.
24. An antimicrobial wipe according to claim 1 wherein the ratio of the amount of non-anionic surfactants to the amount of anionic surfactant in the antimicrobial cleansing composition is less than 1:4.
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.
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.
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 germ reduction can be formulated by using known porous or absorbent sheets which are impregnated with improved antimicrobial cleansing compositions. These improved antimicrobial cleansing compositions contain 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.
The present invention relates to an antimicrobial wipe effective against Gram positive bacteria, Gram negative bacteria, fungi, yeasts, molds, and viruses comprising a porous or absorbent sheet impregnated with an antimicrobial cleansing composition, wherein the antimicrobial cleansing composition comprises from about 0.001% to about 5.0%, by weight of the antimicrobial cleansing composition, of an antimicrobial active; from about 0.05% to about 10%, by weight of the antimicrobial cleansing composition, of an anionic surfactant; from about 0.1% to about 10%, by weight of the antimicrobial cleansing composition, of a proton donating agent; and from about 3% to about 99.85% , by weight of the antimicrobial cleansing composition, water; wherein the composition is adjusted to a pH of from about 3.0 to about 6.0; wherein the antimicrobial cleansing composition an One-wash Immediate Germ Reduction Index of greater than about 1.3; and wherein the antimicrobial wipe has a Mildness Index of greater than 0.3. The present invention also relates to methods for reducing the number of germs on the skin using the antimicrobial wipes described herein.
The antimicrobial wipes of the present invention are highly efficacious for providing a improved immediate germ reduction on the skin, are mild to the skin and can be used without additional available water.
“Signs of skin aging” include, but are not limited to, all outward visibly and tactilely perceptible manifestations as well as any other macro or micro effects due to skin aging. Such signs may be induced or caused by intrinsic factors or extrinsic factors, e.g., chronological aging and/or environmental damage. These signs may result from processes which include, but are not limited to, the development of textural discontinuities such as wrinkles, including both fine superficial wrinkles and coarse deep wrinkles, skin lines, crevices, bumps, large pores (e.g., associated with adnexal structures such as sweat gland ducts, sebaceous glands, or hair follicles), scaliness, flakiness and/or other forms of skin unevenness or roughness, loss of skin elasticity (loss and/or inactivation of functional skin elastin), sagging (including puffiness in the eve area and jowls), loss of skin firmness, loss of skin tightness, loss of skin recoil from deformation, discoloration (including undereye circles), blotching, sallowness, hyperpigmented skin regions such as age spots and freckles, keratoses, abnormal differentiation, hyperkeratinization, elastosis, collagen breakdown, and other histological changes in the stratum corneum, dermis, epidermis, the skin vascular system (e.g., telangiectasia or spider vessels), and underlying tissues, especially those proximate to the skin.
The absorbent sheets used in the present invention are impregnated with an antimicrobial cleansing composition. The term “antimicrobial cleansing composition” as used herein means a composition suitable for application to a surface for the purpose of removing dirt, oil and the like which additionally reduces the number of germs on the surface. The compositions, herein, are effective against Gram positive bacteria, Gram negative bacteria, fungi, yeasts, molds, and viruses. Preferred embodiments of the present invention are cleansing compositions suitable for use on the human skin.
Methylchloroisothiazol inone/methyl isothiazolinone (Kathon CG®)
lodopropenyl Butylcarbamate (Polyphase P100®)
5-Chloro-2-hydroxydiphenylinethane
3,4,4′-Trichlorocarbanilides (Triclocarban® TCC)
Another class of antibacterial agents, which are useful in the present invention, are the so-called “natural” antibacterial actives, referred to as natural essential oils. These actives derive their names from their natural occurrence in plants. Typical natural essential oil antibacterial actives include oils of anise, lemon, orange, rosemary, wintergreen, thyme, lavender, cloves, hops, tea tree, citronella, wheat, barley, lemongrass, cedar leaf, cedarwood, cinnamon, fleagrass, geranium, sandalwood, violet, cranberry, eucalyptus, vervain, peppermint, gum benzoin, basil, fennel, fir, balsam, menthol, ocmea origanum, Hydastis carradensis, Berberidaceae daceae, Ratanhiae and Curcunia longa. Also included in this class of natural essential oils are the key chemical components of the plant oils which have been found to provide the antimicrobial benefit. These chemicals include, but are not limited to anethol, catechole, camphene, carvacol, eugenol, eucalyptol, ferulic acid, farnesol, hinokitiol, tropolone, limonene, menthol, methyl salicylate, thymol, terpineol, verbenone, berberine, ratanhiae extract, caryophellene oxide, citronellic acid, curcumin, nerolidol and geraniol.
The antimicrobial cleansing compositions of the present invention comprise from about 0.05% to about 10%, preferably from about 0.1% to about 2%, and more preferably from about 0.2% to about 1%, by weight of the cleansing composition, of an anionic surfactant. Without being limited by theory, it is believed that the anionic surfactant disrupts the lipid in the cell membrane of the bacteria. The particular acid used herein reduces the negative charges on the cell wall of the bacteria, crosses through the cell membrane, weakened by the surfactant, and acidifies the cytoplasm of the bacteria. The antimicrobial active can then pass more easily through the weakened cell wall, and more efficiently poison the bacteria.
Other suitable anionic surfactants are the linear alkylbenzene sulfonates of the form R1−—C6H4—SO3M, wherein R1 is a saturated or unsaturated, branched or unbranched alkyl group from about 8 to about 24 carbon atoms, and M is a water-soluble cation such as ammonium, sodium, potassium, magnesium, triethanolamine, diethanolamine and monoethanolamine. These are formed by the sulfonation of linear alkyl benzene with sulfur trioxide. An example of this anionic surfactant is sodium dodecylbenzene sulfonate.
Other anionic materials include alkyl ether carboxylates corresponding to the formula R1−—(OCH12CH2)x—OCH2—CO2M wherein R1 is a saturated or unsaturated, branched or unbranched alkyl or alkenyl group of about 8 to about 24 carbon atoms, x is 1 to 10, and M is a water-soluble cation. Nonlimiting examples of which include sodium laureth carboxylate.
Other anionic materials include acyl lactylates corresponding to the formula R1CO—[O—CH(CH3)—CO]x—CO2M wherein R1 is a saturated or unsaturated, branched or unbranched alkyl or alkenyl group of about 8 to about 24 carbon atoms, x is 3, and M is a water-soluble cation. Nonlimiting, examples of which include sodium cocoyl lactylate.
Any counter cation, M, can be used on the anionic surfactant. Preferably the counter cation is selected from the group consisting of sodium, potassium, ammonium, monoethanolamine, diethanolamine, and triethanolamilne. More preferably the counter cation is ammonium.
The biological activity/mildness of a pure surfactant can measured directly via a Microtox Response Test hereinafter described in the Analytical Methods section and can be reported as a Microtox Response Index. By “pure surfactant” it is meant a chemical composition consisting essentially of a singale surfactant entity, wherein the entity has essentially one chain length, head group and salt counter ion. From a standpoint of high biological activity, preferred anionic surfactants of the antimicrobial cleansing compositions of the present invention have a Microtox Response Index of less that about 150, more preferably less than about 100 and most preferably less than about 50. From a standpoint of mildness, preferred anionic surfactants of the antimicrobial cleansing compositions of the present invention have a Microtox Response Index of greater than about 25, more preferably greater than about 50 and most preferably greater than about 100. Surfactants with a Microtox Response Index ranging from about 25 to about 150 are typically moderately biologically active and moderately mild.
From the standpoint of biological activity, it is preferred that the head group of the anionic surfactant be less than about 15 Angstroms, preferably less than about 10 Angstroms, and more preferably less than about 7 Angstroms. The “head group” is defined as the hydrophilic portion (non-hydrocarbon) of the anionic surfactant, measured from the first polar atom to the end of the molecule. The head group size is estimated from the Van der Waals radius of the atoms and the configuration of the surfactant molecule. Head groups with sizes less than about 7 Angstroms include sulfates, sulfonates, and phosphates. From the standpoint of mildness, it is preferred that the head group size is greater than about 7 Angstroms, and preferably greater than about 10 Angstroms. Head groups with sizes greater than about 10 Angstroms include ethoxylated sulfates, glyceryl ether sulfonates, and isethionates. It is believed that as the head group size increases, more stearic hindrance at the cell wall prevents disruption by the surfactant and, thus, biological activity is decreased and mildness is increased.
In order to achieve the mildness required of the present invention, optional ingredients to enhance the mildness to the skin can be added. These ingredients include cationic and nonionic polymers, co-surfactants, moisturizers and mixtures thereof. Polymers useful herein include polyethylene glycols, polypropylene glycols, hydrolyzed silk proteins, hydrolyzed milk proteins, hydrolyzed keratin proteins, guar hydroxypropyltrimonium chloride, polyquats, silicone polymers and mixtures thereof. When used, the mildness enhancing polymers comprise from about 0.1% to about 1%, preferably from about 0.2% to about 1.0%, and more preferably from about 0.2% to about 0.6%, by weight of the antimicrobial cleansing composition, of the composition. Co-surfactants useful herein include nonionic surfactants such as the Genapol® 24 series of ethoxylated alcohols, POE(20) sorbitan monooleate (Tween® 80), polyethylene glycol cocoate and Pluronic® propylene oxide/ethylene oxide block polymers, and amphoteric surfactants such as alkyl betaines, alkyl sultaines, alkyl amphoacetates, alkyl amphodiacetates, alkyl amphopropionates, and alkyl amphodipropionates. When used, the mildness enhancing co-surfactants comprise from about 20% to about 70%, preferably from about 20% to about 50%, by weight of the anionic surfactant, of the cleansing composition.
Acetoelyceride esters are used and an example is acetylated monoglycerides.
It is most preferred when at least 75% of the lipophilic skin conditioning agent is comprised of lipids selected from the group consisting: petrolatum, blends of petrolatum and high molecular weight polybutene, mineral oil, liquid nondigestible oils (e.g. liquid cottonseed sucrose octaesters) or blends of liquid digestible or nondigestible oils with solid polyol polyesters (e.g. sucrose octaesters prepared from C22 fatty acids) wherein the ratio of liquid digestible or nondigestible oil to solid polyol polyester ranges from about 96:4 to about 80:20, hydrogenated or nonhydrogenated polybutene, microcrystalline wax, polyalkene, paraffin, cerasin, ozokerite, polyethylene, perhydrosqualene; dimetlicones, alkyl siloxane, polymethylsiloxane, methylphenylpolysiloxane and mixtures thereof. When as blend of petrolatum and other lipids is used, the ratio of petrolatum to the other selected lipids (hydrogenated or unhydrogenated polybutene or polydecene or mineral oil) is preferably from about 10:1 to about 1:2, more preferably from about 5:1 to about 1:1.
Fumed silica, which is also known as arced silica, is produced by the vapor phase hydrolysis of silicon tetrachloride in a hydrogen oxygen flame. It is believed that the combustion process creates silicone dioxide molecules which condense to form particles. The particles collide, attach and sinter together. The result of this process is a three dimensional branched chain aggregate. Once the aggregate cools below the fusion point of silica, which is about 1710° C., further collisions result in mechanical entanglement of the chains to form agglomerates. Precipitated silicas and silica gels are generally made in aqueous solution. See, Cabot Technical Data Pamphlet TD-100 entitled “CAB-O-SIL® Untreated Fumed Silica Properties and Functions”, October 1993, and Cabot Technical Data Pamphlet TD-104 entitled “CAB-O-SIL® Fumed Silica in Cosmetic and Personal Care Products”, March 1992, both of which are herein incorporated by reference.
Immediate Germ Reduction Indexes
The antimicrobial wipes provide improved immediate reduction of germs on the skin. The degree of reduction can be measured after one-wash of the In-Vivo Health Care Personal Handwash Test described herein. When measured after one wash (application) the antimicrobial wipe has One-wash Immediate Germ Reduction Index of greater than about 1.3 (95% reduction), preferably greater than about 1.7 (98% reduction), more preferably greater than about 2.0 (99% reduction), and most preferably greater than about 2.3 (99.5% reduction). The index represents a difference in base ten logarithm values of bacterial concentrations between before and after washing. For example, an index of 1.3 represents a reduction in log values of 1.3 (Δlog=1.3) which in turn represents a 95% reduction of bacteria counts.
The antimicrobial wipes of the present invention comprise a Mildness Index of greater than about 0.3, preferably greater than about 0.4, and more preferably greater than about 0.6. The Mildness Index is measured by the Forearm Controlled Application Test (FCAT) described herein.
The antimicrobial wipe of the present invention are useful for personal cleansing, reducing germs on skin, and providing residual effectiveness Gram negative and Gram positive bacteria, especially on the hands and face. Typically the wipe is used to apply cleansing compositions to the area to be cleansed. The wipes herein can be used for personal cleansing when the use of cleansing products requiring water cannot be, or are inconvenient. Typical quantities of the present wipes useful for cleansing, range from about 1 to about 4 wipes per use, preferably from about 1 to about 2 wipes per use. Typical amounts of antimicrobial cleansing composition used range from about 4 mg/cm2 to about 6 mg/cm2, preferably about 5 mg/cm2 of skin area to be cleansed.
1 Preparation of Sample Stock Solution (Standard Concentration: 1000 ppm)
4. Assay and Sample Bioluminescence Testino
The concentration of test substance, in ppm, that decreases the bioluminescence of the Microtox Acute Toxicity Reagent by 50% from the starting value (EC50 Value) can be calculated using the Run Statistics on Data File option of the Microtox Software (recommended) or by conducting a linear regression of the data (% reduction vs. log of concentration). % Reductions are calculated using the following formulas: Final   Reading   of   Reagent   Blank Initial   Reading   of   Reagent   Blank = Correction Factor Final   Reading   of   Reagent   with   Diluted   Test   Substance Initial   Reading   of   Reagent   with   Diluted   Test   Substance = Reduction   Factor x where   x   means   at    a   corresponding   concentration %   Reduction = Correction   Factor x - Reduction   Factor Correction   Factor
Reference: Annual Book of ASTM Standards Vol. 11.05; ASTM Designation: E 1174-94; “Standard Test Method for Evaluation of Health Care Personnel Handwash Formulation”
a. Testing on a subject was finished after the one wash extraction, when only one-wash data was desired. The test requires at least four subjects to be valid.
Laboratory technical places wipe in subject's hand. Subject then wipes his/her entire hand with wipe for fifteen (15) seconds, wiping palm, back of hand, fingers and web areas between fingers, cuticles, and nail beds. Repeat the process for wiping of other hand. Discard wipe. Hands are not dried.
One-wash Immediate Germ Reduction Index=Log (CFU's) in Baseline Extraction−Log (CFU's) in Post−One Wash Extraction
Ten-wash Immediate Germ Reduction Index=Log (CFU's) in Baseline Extraction−Log (CFU's) in Post−Ten Wash Extraction
f. Hands were decontaminated by submersion in 70% ethanol for 15 sec. and then a five minute wash with control soap and water.
d. Rub the lathered fingers on the application site in a circular motion for 10seconds to lather product on the skin.
The skin on each treatment area is evaluated by an expert grader at baseline and three hours after the final study wash. The treatment areas are evaluated under 2.75×magnification (model KFM-1A Luxo Illuminated Magnifying Lamp, Marshall Industries, Dayton, Ohio) with controlled lighting (General Electric Cool White, 22-watt, 8″ Circuline fluorescent bulb).
0  No dryness
1.0 Patches of slight powderiness and occasional patches of small
scales may be seen.
3.0 Generalized moderate powderiness and/or heavy cracking and
change may be present.
Powderiness may be present but not prominent. May see
bleeding crack.
Rto=The average ratting of test product area at baseline
VISCOSITY OF THE ANTIMICROBIAL CLEANSING COMPOSITION
The Wells-Brookfield Cone/Plate Model DV-II+Viscometer is used to determine the viscosity of the antimicrobial cleansing compositions herein. The determination is performed at 25° C. with the 2.4 cm° cone (Spindle CP-41) measuring system with a gap of 0.013 mm between the two small pins on the respective cone and plate. The measurement is performed by injecting 0.5 ml of the sample to be analyzed between the cone and plate and rotating the cone at a set speed of 1 rpm. The resistance to the rotation of the cone produces a torque that is proportional to the shear stress of the liquid sample. The amount of torque is read and computed by the viscometer into absolute centipoise units (mPa's) based on geometric constants of the cone, the rate of rotation, and the stress related torque.
Substrate samples are placed in a temperature and relative humidity-controlled location for at least 2 hours prior to testing (temperature=73° F.±2° F., relative humidity 50%±2%).
The substrate sheet, still supported in the basket, is lowered into a distilled water bath having a temperature of 73° F.±2° F. for one minute. The basket is then raised from the bath and the substrate sheet is allowed to drain for 1 minute. The basket and sheet are then re-weighed to obtain the weight of the water absorbed by the substrate sheet.
Primary Chain Length 12 12 12 12 12
of Anionic Surfactant
Microtox of Anionic 1 1 1 1
Microtox of Anionic n/a 150 26 <15 1
Head Group Size Small Large Small Large Small
Primary Chain Length 15.5 12 14-16 12 12
The antimicrobial cleansing compositions shown all have a One-wash Immediate Germ Reduction Index of greater than about 1.3 and a Mildness Index of greater than 0.3.
Procedure for Making Antimicrobial Wipe Examples Compositions 1-15 are impregnated onto absorbent sheets as follows:
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U.S. Classification 424/404, 510/138, 510/131, 510/130, 510/157
International Classification A61K8/02, A61Q17/00
Cooperative Classification A61Q17/005, A61K8/0208
European Classification A61K8/02C, A61Q17/00F
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:BEERSE, PETER WILLIAM;MORGAN, JEFFREY MICHAEL;BAIER, KATHLEEN GRIESHOP;AND OTHERS;REEL/FRAME:009319/0130;SIGNING DATES FROM 19970604 TO 19970904