MXPA99011300A - Mild, leave-on antimicrobial compositions - Google Patents

Mild, leave-on antimicrobial compositions

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Publication number
MXPA99011300A
MXPA99011300A MXPA/A/1999/011300A MX9911300A MXPA99011300A MX PA99011300 A MXPA99011300 A MX PA99011300A MX 9911300 A MX9911300 A MX 9911300A MX PA99011300 A MXPA99011300 A MX PA99011300A
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Mexico
Prior art keywords
rinsing
acid
antimicrobial
antimicrobial composition
skin
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Application number
MXPA/A/1999/011300A
Other languages
Spanish (es)
Inventor
Grieshop Baier Kathleen
Anne Bakken Theresa
Warren Raphael
William Beerse Peter
Michael Morgan Jeffrey
Cen Wei
Lee Clapp Mannie
Original Assignee
The Procter&Ampgamble Company
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Application filed by The Procter&Ampgamble Company filed Critical The Procter&Ampgamble Company
Publication of MXPA99011300A publication Critical patent/MXPA99011300A/en

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Abstract

The present invention relates to a leave-on antimicrobial composition characterized in that it comprises from 0.001%to 5%of an antimicrobial active;from 0.05%to 10%of an anionic surfactant;from 0.1%to 10%of a proton donating agent;and from 0%to 99.85%of water;wherein the composition is adjusted to a pH of from 3.0 to 6.0;wherein the leave-on antimicrobial composition has a Gram Positive Residual Effectiveness Index of greater than 0.5;and wherein the leave-on antimicrobial composition has a Mildness Index of greater than 0.3. The present invention also relates to a leave-on antimicrobial cleansing composition which has a Gram Positive Residual Effectiveness Index of greater than 0.5. It also relates to a leave-on antimicrobial cleansing composition which has a One-wash Immediate Germ Reduction Index of greater than 1.0. The invention also encompasses methods for cleansing skin and providing residual effectiveness versus Gram positive bacteria using these products.

Description

ANTIMICROB1ANAS COMPOSITIONS NON-RINSING, SOFT TECHNICAL FIELD The present invention relates to non-rinsing topical antimicrobial compositions that provide improved antimicrobial effectiveness when applied to the skin. Specifically, the rinsing antimicrobial compositions of the invention provide residual effectiveness not previously seen against transient Gram-negative bacteria, previously unseen levels of residual effectiveness against Gram-positive bacteria, and provide improved immediate germ reduction on the skin compared to the compositions of the prior art.
BACKGROUND OF THE INVENTION Human health is impacted by many microbial entities. Inoculation by means of viruses and bacteria causes a wide variety of diseases and conditions. Media attention to cases of food poisoning, streptococcal infections and the like is increasing the public's awareness of microbial issues. It is well known that washing hard surfaces, food (for example fruits or vegetables) and skin, especially hands, with antimicrobial or non-medicated soap, can remove many viruses and bacteria from washed surfaces. The removal of viruses and bacteria is due to the surfactant activity of the soap and the mechanical action of the washing process. Therefore, it is known and recommended that people wash frequently to reduce the spread of viruses and bacteria. The bacteria found on the skin can be divided into two groups: resident and transient bacteria. The resident bacteria are Gram-positive bacteria that establish themselves as permanent microcolonies on the surface and outer layers of the skin and play an important and useful role in preventing the colonization of other more harmful bacteria and fungi. Transient bacteria are bacteria that are not part of the normal resident flora of the skin, but can be deposited when material contaminated by air lands on the skin or when contaminated material comes 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 bacteria by an additional protective cell membrane that causes Generally Gram negative bacteria are less susceptible to topical antibacterial active ingredients. The antimicrobial cleansing products have been marketed in a variety of ways for some time. The forms include deodorant soaps, hard surface cleaners and surgical disinfectants. Rinseable antimicrobial soaps have been formulated to provide bacteria removal during washing. Antimicrobial liquid cleaners are described in the U.S.A. Nos. 4,847,072, Bissett et al., Issued July 1, 1989; 4,939,284, Degenhardt, issued July 3, 1990 and 4,820,698, Degenhardt, issued April 1, 1989, all of which are incorporated herein by reference. Finally, these traditional antimicrobial soaps have been developed for use in water washing procedures. This limits its use to places where water is available. Some of these traditional products, especially hard surface cleaners, surgical disinfectants and some non-rinsing alcohol-based lotions (eg PurelIR), use high levels of alcohol and / or strong surfactants which have been found to dry and irritate the tissues of the skin. The ideal personal cleansers should gently clean the skin causing little or no irritation, and not leave the skin too dry after frequent use and preferably should provide a moisturizing benefit to the skin. In the past, lotions, foams and topical gels have been used Non-rinsing to moisturize the skin, along with a variety of other purposes. However, these non-rinsing compositions provide minimal antimicrobial effectiveness. PCT application WO 92/18100 to Keegan et al., Published October 29, 1992 and PCT application WO 95/32705 to Fujiwara et al., Published December 7, 1995, teach liquid skin cleansers comprising mild surfactants, antibacterial agents and acidic compounds to buffer the pH, which provide enhanced germicidal hostility. However, the use of acidic compounds therein only for pH adjustment results in compositions that do not release the undissociated acid required to provide good antimicrobial effectiveness. This situation is arranged by 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 that can be used without available water, for example a non-rinseable lotion. The patent of E.U.A. No. 3,141, 821, issued to Compeau on July 21, 1964 and Irgasan DP 300 (TriclosanR) technical literature from Ciba-Giegy, Inc., "Basic Formulation for Hand Disinfection 89/42/01" teach the use of anionic surfactants , antimicrobial active ingredients and acids in antibacterial skin cleansers. However, the selection of highly active surfactants results in non-rinsing compositions that dry out and are aggressive to the skin. Here too, no reference teaches the use of antimicrobial compositions in a form that can be used without available water, for example a non-rinseable lotion. Given the severe health impacts of Gram-negative bacteria such as Salmonella, Escherichia coli and Shigella, and of Gram-positive bacteria such as Staphylococcus aureus, Streptococcus pyogenes and Clostridium botulinum, it would be highly desirable to formulate non-rinsing topical antimicrobial compositions that provide improved residual effectiveness against these transient Gram negative bacteria, improved residual effectiveness against these Gram positive resident and transient bacteria, or provide immediate improved germ reduction on the skin during its application; They are also gentle on the skin and can be used without water. The existing products have not been able to produce all these benefits. Applicants have discovered that non-rinsing topical antimicrobial compositions can be formulated that provide such antibacterial mildness and effectiveness using known antimicrobial active agents in combination with specific organic and / or inorganic acids as proton donor agents, and specific anionic surfactants, all of which They are deposited on the skin. The deposited proton donor agent and the anionic surfactant function in combination with the selected active agent to provide a new level of hostility against bacteria contacting the skin.
BRIEF DESCRIPTION OF THE INVENTION The present invention relates to a non-rinsing antimicrobial composition characterized in that it comprises from 0.001% to 5% of an antimicrobial active agent; from 0.05% to 10% of an anionic surfactant; from 0.1% to 10% of a proton donor agent; and from 0% to 99.85% water; wherein the composition is adjusted to a pH of 3.0 to 6.0; wherein the non-rinsing antimicrobial composition has a Residual Effectiveness Index of Gram Negatives of more than 0.3; and wherein the non-rinsing antimicrobial composition has a softness index of more than 0.3. The present invention also relates to a non-rinsing antimicrobial cleaning composition having a Gram Positive Residual Effectiveness Index of greater than 0.5. It also refers to a non-rinsing antimicrobial cleaning composition that has an Index of Immediate Reduction of Germs in a wash of more than 1.0. The present invention also relates to methods for reducing the dispersion of transient Gram-positive bacteria using the non-rinsing antimicrobial compositions described herein.
DETAILED DESCRIPTION OF THE INVENTION The non-rinsing antimicrobial compositions of the present invention are very effective in providing a residual antimicrobial effectiveness against Gram-negative bacteria, residual antimicrobial effectiveness against transient Gram-positive bacteria, or to reduce the number of germs on the skin, and are gentle on the skin. The term "non-rinsing antimicrobial composition" is used herein to refer to products suitable for application to human skin for the purpose of controlling the growth and viability of transient bacteria on the skin. By "residual effectiveness" is meant that the bacterial growth on a surface is controlled for some time after the washing / rinsing process. The compositions of the present invention may also be useful for the treatment of acne. As used herein, "acne treatment" refers to the prevention, delay and / or arrest of the acne formation process in the skin of mammals. The compositions of the invention may also be potentially useful in providing essentially immediate (ie, acute) visual improvement in the appearance of the skin after application of the composition thereto. More particularly, the compositions of the present invention are useful for regulating the condition of the skin, including the regulation of visible and / or tactile discontinuities in the skin, including but not limited to visible and / or tactile discontinuities in texture and / or skin color, more specifically discontinuities associated with the aging of the skin Such discontinuities can be induced or caused by internal and / or external factors. Extrinsic factors include ultraviolet radiation (for example, from sun exposure), environmental pollution, wind, heat, low humidity, aggressive surfactants, abrasives and the like. Intrinsic factors include chronological aging and other biochemical changes from within the skin. The regulation of skin conditions includes regular prophylactic and / or therapeutically skin condition. As used herein, prophylactically regulating the condition of the skin includes delaying, minimizing and / or avoiding visible and / or tactile discontinuities in the skin. As used herein, therapeutically regulating the condition of the skin includes improving, for example, decreasing, minimizing and / or eliminating such discontinuities. The regulation of the condition of the skin includes improving the appearance and / or feeling of the skin, for example by giving a smoother and more uniform appearance and / or feeling. As used herein, regulating the condition of the skin includes regular signs of aging. "Regulating signs of skin aging" includes prophylactically and / or therapeutically regulating one or more of such signals (similarly, regulating a given signal of skin aging, eg, lines, wrinkles or pores, includes prophylactically regular and / or therapeutically regulate said signal). The "signs of aging of the skin" include, but are not limited to, all manifestations externally visible and perceptible to touch, as well as any other macro or micro effect. caused by the aging of the skin. These signals can be induced or caused by intrinsic factors or extrinsic factors, for example, chronological aging and / or environmental damage. These signals may originate from processes that include, but are not limited to, the development of texture discontinuities such as wrinkles, including both fine surface wrinkles and deep deep wrinkles, skin lines, folds, rashes, large pores (e.g. , associated with attached structures such as sweat gland ducts, sebaceous glands or hair follicles), scaly and / or other forms of irregularity or roughness of the skin, loss of skin elasticity (loss and / or inactivation of functional elastin in the skin), softening (including swelling in the eye area and dark circles), loss of skin firmness, loss of skin stiffness , loss of skin recovery from deformation, discoloration (including circles under the eye), rashes, pallor, hyperpigmented skin regions such as age spots and freckles, keratosis, abnormal differentiation, hyperkeratinization, elastosis, collagen degradation and other histological changes in the stratum corneum, dermis, epidermis, the vascular system of the skin (eg, telangiectasia or spider vessels), and underlying tissues, especially those close to the skin. All percentages and ratios used herein, unless otherwise indicated, are by weight, and all measurements are made at 25 ° C, unless otherwise designated. The invention present may comprise, consist of or consist essentially of, the essential and optional ingredients and components described herein.
I. INGREDIENTS The non-rinsing antimicrobial compositions of the present invention comprise an antimicrobial active agent, an anionic surfactant and a proton donor agent. These components are selected such that the efficiency and softness requirements defined below for the compositions are met. The selection of each component necessarily depends on the selection of each of the other components. For example, if a weak acid is selected as the proton donor agent, then to be able to obtain an effective composition, a more biologically active (but less mild) surfactant should be employed and / or a high level of acid should be used in The prescribed scale and / or a particularly effective active agent should be employed. Similarly, if a mild but ineffective surfactant is employed, then a stronger acid and / or a high acid level may be necessary to obtain an effective composition. If an aggressive surfactant is used, then a softness agent would have to be used. This document provides guidelines for the selection of individual components.
A. Antimicrobial active agent The non-rinsing antimicrobial composition of the present invention comprises from 0.001% to 5%, preferably from 0.05% to 1%, most preferably from 0.05% to 0.5% and more preferably from 0.1% to 0.25% by weight of the non-rinsable antimicrobial composition, of an antimicrobial active agent. The exact amount of antibacterial active agent that will be used in the compositions will depend on the particular active agent used, since the active agents vary in potency. Non-cationic active agents are required in order to avoid interaction with the anionic surfactants of the invention. Examples of non-cationic antimicrobial agents that are useful in the present invention are given below. Pyrithiones, especially the zinc complex (ZPT) OctopiroxR Dimethyldimethylol Hidantoin (GlydantR) Methylchloroisothiazolinone / methylisothiazolinone (Kathon CG) Sodium sulfite Sodium bisulphite Imidazolidinylurea (Germall 1 15R) Diazolidinylurea (Germall llR) Benzyl alcohol 2-Bromo-2-nitropropane- 1,3-diol (Bronopol®) Formalin (formaldehyde) iodopropenyl Butylcarbamate (Polyphase P100®) Chloroacetamide Methanamine Methyldibromonitrile-Glutaronitrile (1,2-Dibromo-2,4-dicyanobutane or Tektamer®) Glutaraidehyde 5-bromo-5-nitro-1,3-dioxane (Bronidox®) Phenethyl alcohol o-Phenylphenol / o-phenylphenol sodium Sodium hydroxymethylglycinate (Suttocide A) Bicyclic polymethoxyoxazolidine (Nuosept C) 10 Dimetoxan Timerosal Dichlorobenzyl alcohol Captan Chlorphenenesin 15 Dichlorophene Chlorbutanol Glyceryl Laurate Ether Halogenated Diphenylether 2,4,4, -trichloro-2'-hydroxy-diphenyl (Triclosan® or TCS) 2,2'-dihydroxy-5,5'-dibromo-diphenyl ether Phenol 2-methylphenol phenolic compounds 3-Methylphenol 4-Methylphenol 4-Ethylphenol 2,4-Dimethylphenol 2,5-Dimethylphenol 3,4-Dimethylphenol 2,6-Dimethylphenol 4-n-Propylphenol 4-n-Butylphenol 10 4-n-Amylphenol 4-tert-Amylphenol 4-n-Hexylphenol 4-n-Heptyphenol Mono- and poly-alkyl aromatic halophenols P-chlorophenol < • Methyl p-chlorophenol Ethyl p-chlorophenol n-propyl p-chlorophenol n-butyl p-chlorophenol 20 n-amyl p-chlorophenol sec-amyl p-chlorophenol n-hexyl p-chlorophenol Ciciohexyl p-chlorophenol n-heptyl p-chlorophenol n-octyl p-chlorophenol o-chlorophenol Methyl o-chlorophenol Ethyl o-chlorophenol n-propyl o-chlorophenol n-butyl o-chlorophenol n-amyl o-chlorophenol ter-amyl o-ciorophenol n-hexyl o-chlorophenol n-heptyl o-chlorophenol o-benzyl-p-chlorophenol o-benzyl-m-methyl-p-chlorophenol o-benzyl-m, m-dimethyl-p-chlorophenol o-phenylethyl-p-chlorophenol o-phenylethyl-m-methyl-p-chlorophenol 3-methyl-p-chlorophenol 3,5-dimethyl p-chlorophenol 6-ethyl-3-methyl p-chlorophenol 6-n-propyl -3-methyl p-chlorophenol 6-isopropyl-3-methyl p-chlorophenol 2-ethyl-3,5-dimethyl p-chlorophenol 6-sec-butyl-3-methyl p-chlorophenol 2-α-propyl-3,5-d-methyl p-chlorophenol 6-diethylmethyl-3-methyl p-chlorophenol 6-iso-propyl-2-ethyl-3-methyl p-chlorophenol 2-sec-amyl-3 , 5-dimethyl p-chlorophenol 2-diethylmethyl-3,5-dimethyl p-chlorophenol 6-sec-octyl-3-methyl p-chlorophenol p-chloro-m-cresol p-bromophenol Methyl-p-bromophenol 10 Ethyl p- bromophenol n-propyl p-bromophenol n-butyl p-bromophenol n-amyl p-bromophenol sec-amyl-p-bromophenol 15 n-hexyl p-bromophenol Ciciohexyl p-bromophenol o-bromophenol ter-amyl-o-bromophenol n-hexyl o-bromophenol 20 n-propyl-m, m-dimethyl o-bromophenol 2-phenylphenol 4-chloro-2-methylphenol 4-chloro-3-methylphenol 4-chloro-3,5-dimethylphenol 2,4-dichloro-3,5-dimethylphenol 3,4,5,6-terabromo-2-methyl-phenol 5-methyl-2-pentylphenol 4-isopropyl-3-methylphenol For -chloro-meta-xylene (PCMX) Chlorothymol Phenoxyethanol Phenoxyisopropanol 10 5-chloro-2-hydroxydiphenylmethane Resorcinol and its derivatives Resorcinol Methylresorcinol Ethyl resorcinol 15 n-propylresorcinol n-butylresorcinol n-amilresorcinol n-hexylresorcinol n-heptylresorcinol 20 n-octylresorcinol n- nonylresorcinol fenilresorcinol Bencilresorcinol Phenylethyldresorcinol Phenylpropylresorcinol p-chlorobenzylesorcinol 5-chloro 2,4-dihydroxydiphenylmethane 4'-chloro 2,4-dihydroxydiphenylmethane 5-bromo 2,4-dihydroxydiphenylmethane 4'-bromo 2,4-dihydroxydiphenylmethane Bisphenol 2,2'-methylene-bis- (4-chlorophenol) 10 2,2, -methylene-bis- (3,4,6-trichlorophenol) 2,2'-methylene-bis- (4-chloro-6-bromophenol) Bis (2-hydroxy) sulphide 3,5-dichlorophenyl) Bis (2-hydroxy-5-chlorobenzyl) sulphide Benzoic esters (Parabens) 15 Methylparaben Propylparaben Butylparaben Ethylparaben Isopropylparaben 20 Isobutylparaben Benzylparaben Methylparaben sodium Propylparaben sodium Halogenated Carbanilides 3,4,4'-trichlorocarbanilides (Triclocarban® or TCC) 3-trifluoromethyl-4,4'-dichlorocarbanilide 3,3 ', 4-trichlorocarbanilide Another class of antibacterial agents that are useful in the present invention are the so-called "natural" antibacterial agents, referred to as natural essential oils. These active agents derive their names from their natural occurrence in plants. Natural antibacterial active agents of typical essential oils include oils of anise, lemon, orange, rosemary, caulteria, thymus, lavender, clavero, hops, tea tree, citronella, wheat, barley, lemon, cedar leaf, cedar wood, cinnamon, grass pulguera, geranium, sandalwood, violet, blueberry, eucalyptus, verbena, pepper, benzoin gum, basil, fennel, fir, balsam, menthol, Ocmea oríganum, Hydastis carradensis, Berberidaceae daceae, Ratanhiae and Curcuma longa. Also included in this class of natural essential oils are the key chemical components of vegetable oils that have been discovered to provide an antimicrobial benefit. These chemical agents include, but are not limited to, anethole, catechol, camphene, thymol, eugenol, eucalyptol, feriuic acid, famesola, inoquitiol, tropolone, limonene, menthol, methyl salicylate, thymol, terpineoi, verbenone, berberine, extract of ratania, cariophelene oxide, citronellic acid, curcumin, nerolidol and geraniol.
Additional active agents are antibacterial metal salts. This class generally includes salts of metals in groups 3b-7b, 8 and 3a-5a. Specifically, they are aluminum, zirconium, zinc, silver, gold, copper, lanthanum, tin, mercury, bismuth, selenium, strontium, yttrium, cerium, praseodymium, neodymium, prometheus, samarium, europium, gadolinium, terbium, dysprosium salts , holmium, erbium, thulium, ytterbium, lutetium and mixtures thereof. Preferred antimicrobial agents to be used herein are the broad spectrum actives selected from the group consisting of Triclosan®, Triclocarban®, Octopirox PCMX, ZPT, natural essential oils and their key ingredients, and mixtures thereof. The most preferred antimicrobial active agent to be used in the present invention is Triclosan®.
B. Anionic Surfactant The non-rinsing antimicrobial composition of the present invention comprises from 0.05% to 10%, preferably from 0.1% to 2% and more preferably from 0.2% to 1%, based on the weight of the non-rinsing composition, of an anionic surfactant. Without being limited by theory, it is believed that the anionic surfactant breaks down the lipid in the cell membrane of bacteria. The particular acid used herein reduces the negative charges on the cell wall of the bacteria, traverses the cell membrane weakened by the surfactant, and acidifies the cell. cytoplasm of bacteria. The antimicrobial active agent can then pass more easily through the weakened cell wall, and more efficiently poison the bacteria. Non-limiting examples of anionic foam forming surfactants useful in the compositions of the present invention are described in McCutcheon's Deterqents and Emulsifiers, North American edition (1990), published by The Manufacturing Confectioner Publishing Co .; Functional Materials, by McCutcheon, North American edition (1992); and in U.S. Patent No. 3,929,678 to Laughlin et al., issued December 30, 1975, all of which are incorporated by reference. A wide variety of anionic surfactants are potentially useful herein. Non-limiting examples of foaming anionic surfactants include those selected from the group consisting of alkyl sulphates and alkyl ether sulfates, sulphated monoglycerides, sulphonated olefins, alkylarylsulfonates, primary and secondary alkane sulphonates, alkylsulfosuccinates, acyltaurates and acyl isethionates, alkyl glycerylether sulfonates, sulfonated methyl esters, sulfonated fatty acids , alkyl phosphates, acylglutamates, acyl sarcosinates, alkylsulfoacetates, acylated peptides, alkylcarboxylates, acylactylates, fluoroanionic surfactants and mixtures thereof. Mixtures of anionic surfactants can be used effectively in the present invention. Anionic surfactants for use in non-rinsing compositions include alkyl sulfates and alkyl ether sulfates.
These materials have the respective formulas RI O-SO3M and RI (CH2H4?) XO-SO3M, where R "f is a saturated or unsaturated, branched or unbranched alkyl group of 8 to 24 carbon atoms, x is 1 to 10, and M is a water-soluble cation such as ammonium, sodium, potassium, magnesium, triethanolamine, diethanolamine and monoethanolamine Alkyl sulfates are preferably made by sulfation of monohydric alcohols (having from 8 to 24 carbon atoms) using trioxide. sulfur or other known sulfation technique The alkyl ether sulphates are typically made as condensation products of ethylene oxide and monohydric alcohols (having 8 to 24 carbon atoms) and then sulfated.These alcohols can be derived from fats, for example, coconut or wood oils, or they can be synthetic Specific examples of alkylsulfates that can be used in cleaning compositions are sodium, ammonium, potassium, magnesium, or TEA salts of lauryl or myristylsulfate. Examples of alkyl ether sulfates that can be used include laureth-3-ammonium sulfate, sodium, magnesium or TEA. Another suitable class of anionic surfactants are the sulphated monoglycerides of the form R 1 CO-0-CH 2 -C (OH) H-CH 2 O-S 3 M, wherein R 4 is a saturated or unsaturated alkyl group, branched or non-branched branched from 8 to 24 carbon atoms, and M is a water-soluble cation such as ammonium, sodium, potassium, magnesium, triethanolamine, diethanolamine and monoethanolamine. These are typically made by reacting glycerin with fatty acids (which have 8 to 24 carbon atoms) to forming a monoglyceride and the subsequent sulfation of this monoglyceride with sulfur trioxide. An example of a sulfated monoglyceride is sodium cocomonoglyceridesulfate. Other suitable anionic surfactants include olefin sulfonates of the form RI SO3M, wherein R ^ is a mono-olefin having from 12 to 24 carbon atoms, and M is a water-soluble cation such as ammonium, sodium, potassium, magnesium, triethanolamine, diethanolamine and monoethanolamine. These compounds can be produced by alpha-olefin sulfonation by means of non-complex sulfur trioxide, followed by neutralization of the acid reaction mixture under conditions such that any sulfone that has been formed in the reaction is hydrolyzed to give the corresponding hydroxyalkanesulfonate. An example of a sulfonated olefin is the sodium alpha-olefin sulphonate of C ^ -Cj g. Other suitable anionic surfactants are the linear alkylbenzene sulphonates of the form RI-C6H4-SO3M, wherein R1 is a saturated or unsaturated, branched or unbranched from 8 to 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 alkylbenzene with sulfur trioxide. An example of this anionic surfactant is sodium dodecylbenzenesulfonate. Still other suitable anionic surfactants for this non-rinsable composition include the primary alkane sulfonates or secondary of the RI SO3M form, wherein R1 is a saturated or unsaturated, branched or unbranched alkyl chain of 8 to 24 carbon atoms, and M is a water soluble cation such as ammonium, sodium, potassium, magnesium, triethanolamine , diethanolamine and monoethanolamine. These are commonly formed by the sulfonation of paraffins using sulfur dioxide in the presence of chlorine and ultraviolet light or another known sulfonating method. Sulfonation can occur in the secondary or primary positions of the alkyl chain. An example of an alkanesulfonate useful herein is alkali metal or ammonium paraffin sulfonate of C-j 3-0-17. Other suitable surfactants are the alkyl sulfosuccinates, which include disodium N-octadecylsulfosuccinamate; diammonium lauryl sulfosuccinate; N- (1,2-dicarboxyethyl) -N-octadecylsulfosuccinate tetrasodium; diamyl ester of sodium sulfosuccinic acid; dihexyl ester of sodium sulfosuccinic acid; and dioctyl esters of sodium sulfosuccinic acid. Taurates that are based on taurine, which is also known as 2-aminoethanosulfonic acid, are also useful. Examples of taurates include N-alkyl taurines such as prepared by reacting dodecylamine with sodium isethionate according to the teachings of U.S. Patent 2,658,072, which is incorporated herein by reference in its entirety. Other examples based on taurine include the acyl taurines formed by the reaction of N-methyltaurine with fatty acids (having from 8 to 24 carbon atoms).
Another class of anionic surfactants suitable for use in the non-rinsing composition are the acyl isethionates. Acyl isethionates typically have the formula RI CO-O-CH2CH2SO3M, wherein R1 is a saturated or unsaturated, branched or unbranched alkyl group having from 10 to 30 carbon atoms, and M is a cation. These are typically formed by the reaction of fatty acids (having from 8 to 30 carbon atoms) with an alkali metal isethionate. Non-limiting examples of these acyl isethionates include ammonium cocoyl isethionate, sodium cocoyl isethionate, sodium lauroyl isethionate, and mixtures thereof. Other suitable anionic surfactants are the alkyl glyceryl ether sulfonates of the form R -OCH2-C (OH) H-CH2-S? 3M, where R "! Is a saturated or unsaturated, branched or unbranched alkyl group of from 8 to 24 carbon atoms, and M is a water-soluble cation such as ammonium, sodium, potassium, magnesium, triethanolamine, diethanolamine and monoethanolamine, which can be formed by the reaction of epichlorohydrin and sodium bisulfite with fatty alcohols (ranging from 8 to 24). carbon atoms) or other known methods An example is sodium co-glyceryl ether sulfonate Other suitable anionic surfactants include the sulfonated fatty acids of the form Rl-CH (S? 4) -COOH and the sulfonated methyl esters of the form R1- CH (S 4) -CO-0-CH 3, wherein R 1 is a saturated or unsaturated, branched or unbranched alkyl group of 8 to 24 carbon atoms, which can be formed by the sulfonation of fatty acids or methylalkyl esters (having from 8 to 24 carbon atoms) with sulfur trioxide or by another known sulfonating technique. Examples include aliphatic acid coconut fatty acid and laurimethyl ester. Other anionic materials include phosphates such as monoalkyl, dialkyl, and trialkyl phosphate salts formed by the reaction of phosphorus pentoxide with branched or unbranched monohydric alcohols having from 8 to 24 carbon atoms. These could also be formed by other known phosphating methods. An example of this class of surfactants is sodium mono or dilauryl phosphate. Other anionic materials include acylglutamates corresponding to the formula R1CO-N (COOH) -CH2CH2-C2M, wherein R1 is a saturated or unsaturated, branched or unbranched alkyl or alkenyl group, from 8 to 24 carbon atoms, and M is a water-soluble cation. Non-limiting examples include sodium lauroylglutamate and sodium cocoylglutamate. Other anionic materials include alkanoylsarcosinates corresponding to the formula R1 CON (CH3) -CH2CH2-C2M, wherein R1 is a saturated or unsaturated, branched or unbranched alkyl or alkenyl group, of 10 to 20 carbon atoms, and M It is a cation soluble in water. Non-limiting examples thereof include sodium lauroyl sarcosinate, sodium cocoyl sarcosinate, and ammonium lauroyl sarcosinate. Other anionic materials include alkyl ether carboxylates that correspond to the formula R ^ - (OCH2CH2)? -OCH2-C? 2M, where R "! is a saturated or unsaturated, branched or unbranched alkyl or alkenylene group of 8 to 24 carbon atoms, x is 1 to 10, and M is a water-soluble cation.Non-limiting examples thereof include sodium laurethcarboxylate.Another anionic materials include acyllactylates corresponding to the formula R1CO- [0-CH (CH3) -CO] xC? 2M, wherein R is a saturated or unsaturated, branched or unbranched alkyl or alkenyl group of 8 to 24 carbon atoms, x is 3, and M is a water-soluble cation, non-limiting examples thereof include sodium lauroylcarboxylate, sodium cocoylcarboxylate, and Ammonium lauroylcarboxylate Fluorinated anionic surfactants can also be used The chain length of the anionic surfactant of the present invention can vary from 8 to 24 carbon atoms, preferably from 10 to 18 carbon atoms, and most preferably from 12 to 16 carbon atoms. Without being limited by theory, it is believed that surfactants with a chain length of 12 to 16 interact optimally with the biology of the cell membrane. Any countercation, M, can be used in the anionic surfactant. Preferably the counter cation is selected from the group consisting of sodium, potassium, ammonium, monoethanolamine, diethanolamine, and triethanolamine. More preferably the countercation is ammonium. Two factors must be taken into account when selecting the surfactant or surfactants employed in the antimicrobial compositions non-rinsable of the present invention: 1) the activity of the surfactant molecule in the cell membrane of the bacteria, and 2) the softness of the surfactant as long as it affects the Softness index (described later) for the antimicrobial composition.
Biological Activity / Smoothness of the Surfactant In general, the higher the biological activity of the surfactant, the greater the residual effectiveness provided by the composition comprising the surfactant. Typically, however, the biological activity of a surfactant and the smoothness thereof are inversely proportional; The higher the biological activity of the surfactant, the more aggressive it will be and the lower the biological activity, the surfactant will be softer. If a biologically active but aggressive surfactant or a mild but biologically inactive surfactant is desired, the selection of the other components will (or will) affect the selection of the other components. The biological activity / smoothness of a pure surfactant can be measured directly by a Microtox Response Test described later in the Analytical Methods section and can be reported as a Microtox Response Index. By "pure surfactant" is meant a chemical composition consisting essentially of a single surfactant entity, wherein the entity has essentially a chain length, head group and salt counter ion. From the point of view of high biological activity, the preferred anionic surfactants of the Non-rinsing antimicrobial compositions of the present invention have a Microtox Response Index of less than 150, preferably less than 100, and preferably less than 50. From the viewpoint of softness, the preferred anionic surfactants of the antimicrobial compositions do not rinsing compositions of the present invention have a Microtox Response Index of greater than 25, preferably more than 50, and preferably more than 100. Typically, surfactants with a Microtox Response Index ranging from 25 to 150 are moderately biologically active and moderately soft For surfactant compositions which are mixtures of surfactants rather than pure surfactants (this includes "commercial grade" surfactants typically comprising mixtures of entities with different chain lengths and potentially having higher levels of impurities), the Microtox Response Index for any Individual surfactant component is not a reliable measure of biological activity or smoothness. In the case of mixtures, the Microtox index of each individual component can be determined and the weighted average can be used as the index for the mixture if all the individual components of the mixture are known. If the individual components of a mixture are not known, then the head head group and the chain lengths of the surfactant mixture are better indicators of biological activity and smoothness. Surfactants or mixtures of anionic surfactants with a chain length mainly in the range of 8 to 24 carbon atoms, preferably, mainly from 10 to 18 carbon atoms, and very preferably from 12 to 16 carbon atoms are preferred from the standpoint of high biological activity. As used herein, "primarily" means at least 50%. From the point of view of softness, it is preferable to reduce to C12. From the point of view of biological activity, it is preferred that the head group of the anionic surfactant be less than 15 Angstroms, preferably less than 10 Angstroms, and most preferably less than 7 Angstroms. The "head group" is defined as the hydrophilic (non-hydrocarbon) portion of the anionic surfactant, measured from the first polar atom to the end of the molecule. The size of the head group is estimated from the Van der Waals radius of the atoms and the configuration of the surfactant molecule. Head groups with sizes of less than 7 Angstroms include sulfates, sulfonates and phosphates. From the point of view of softness, it is preferred that the size of the head group be greater than 7 Angstroms, and preferably greater than 10 Angstroms. Head groups with sizes greater than 10 Angstroms include sulfates, glyceryl ether sulfonates and isethionates. It is considered that as the size of the head group increases, the greater the steric hindrance in the cell wall prevents breakage by the surfactant and thus the biological activity is reduced and the softness is increased. The smoothness of a surfactant or mixture of surfactants can also be determined by means of several other conventional methods known for measuring the smoothness of surfactants. For example, one way to measure the smoothness of surfactants is the Barrier Destruction test described in TJ. Franz, J. Invest. Dermatol., 1975, 64, pages 190-195 and in the patent of E.U.A. No. 4,673,525 for Small and others issued June 16, 1987, both incorporated herein by reference. In general, the milder the surfactant, the lesser the barrier of the destroyed skin in the barrier destruction test. The destruction of the skin barrier is measured by the relative amount of radiolabelled water that passes from the test solution through the epidermis of the skin to the physiological buffer contained in the diffusion chamber. Surfactants having a Relative Penetration Value of the Skin Barrier as close to zero as possible to 75, are considered mild for the purposes of the present invention. Surfactants having a Relative Penetration Value of the Skin Barrier greater than 75 are considered aggressive for the purposes of the present invention. For the antimicrobial compositions of the present invention to be effective, both the biological activity of the surfactant and the smoothness thereof and the acid employed in the composition must be taken into account. For example, ammonium lauryl sulfate, ALS, is biologically very active (Microtox index = 1.0). The compositions comprising ALS can provide very effective residual antibacterial effectiveness due to its activity, even with lower levels of antibacterial active agent and proton donor agent. However, compositions containing ALS may require the addition of associated surfactants or polymers, described herein in the section on optional ingredients, to achieve more preferred levels of softness for the present invention. A selection of laureth-3 ammonium sulfate (Microtox = 120) as a surfactant will result in compositions that are very mild but require higher levels of proton donor agent and antimicrobial active agent to achieve the residual effectiveness of the present invention. Paraffinsulfonate, a commercial grade surfactant sold under the name Hastapur SASR from Hoechst Celanese, is a relatively active surfactant with a small head group and average chain length of 15.5. Compositions comprising lower levels of active agent and acid can be used with higher levels of paraffin sulfonate, in which the surfactant provides a greater component of residual effectiveness. Alternatively, compositions comprising lower levels of paraffin sulphonate with even higher levels of active agent can be combined to achieve a smooth and effective composition. Non-limiting examples of preferred anionic surfactants useful herein include those selected from the group consisting of sodium and ammonium alkyl sulfates and ether sulphates having lengths of chain predominantly of 12 and 14 carbon atoms, olefin sulfonates having chain lengths predominantly of 14 and 16 carbon atoms, and paraffin sulfonates having chain lengths of 13 to 17 carbon atoms, and mixtures thereof. Especially preferred for use herein are ammonium sodium lauryl sulfate, sodium ammonium myristyl sulfate, lauret-1 to sodium-ammonium laureth-4-sulfate, C14-C-Q olefinsulfonates, C-13-C17 paraffin sulfonates, and mixtures thereof. thereof. It has been found that the non-anionic surfactants of the group consisting of nonionic surfactants, cationic surfactants, amphoteric surfactants and mixtures thereof, actually inhibit the benefits of residual effectiveness. It is thought that these surfactants interfere with the breakdown of the lipid in the cell membrane by the anionic surfactant. The proportion of these non-anionic surfactants with respect to the anionic surfactant should be less than 1: 1, preferably less than 1: 2, and preferably less than 1: 4. Preferably, the non-rinsing antimicrobial compositions of the present invention do not comprise hydrotropic sulfonates, particularly terpenoid salts, or mono- or binuclear aromatic compounds such as camphor, toluene, xylene, eumeno and naphthalene sulfonates.
C. Proton donor agent The non-rinsing antimicrobial composition of the present invention comprises from 2% to 10%, preferably from 0.5% to 8%, preferably from 1% to 5%, based on the weight of the non-rinsable composition, of a proton donor agent. By "proton donor agent" is meant any acid compound or mixture thereof, which causes an undissociated acid on the skin after use. The proton donor agents can be organic acids, including polymeric acids, mineral acids or mixtures thereof.
Organic acids The proton donor agents that are organic acids remain at least partially not dissociated in the pure composition. These organic proton donor agents can be added directly to the composition in the acid form or can be formed by adding the conjugate base of the desired acid and separately a sufficient amount of a sufficiently strong acid to form the undissociated acid of the base.
Buffering Capacity Preferred organic proton donor agents are selected and formulated based on their buffering capacity and pKa. The buffer capacity is defined as the amount of protons (% by weight) available in the formulation at the pH of the product for those acid groups with pKa values less than 6.0. The buffer capacity can calculated using the pKa, pH, and conjugate base and acid concentrations, ignoring any pKa greater than 6.0, or can be determined experimentally by a simple acid-base titration using sodium hydroxide or potassium hydroxide using an endpoint of pH equal to 6.0. Preferred organic proton donor agents of the antibacterial compositions of the present invention have a buffer capacity of more than 0.005%, preferably of more than 0.01%, preferably of more than 0.02%, and most preferably of more than 0.04%.
Mineral acids The proton donor agents that are mineral acids will not remain undissociated in the pure composition. Despite this, it has been found that mineral acids can be effective proton donors for use herein. Without being limited by theory, it is believed that the strong mineral acid acidifies the carboxylic and phosphatidyl groups in proteins of the skin cells, thereby providing undissociated acid in situ. These proton donor agents can only be added directly to the composition in the acid form. pH It is critical to achieve the benefits of the invention that the undissociated acid of the proton donor agent (deposited or formed in situ) remain on the skin in the protonated form. Therefore, the pH of the non-rinsing antimicrobial compositions of the present invention should be adjusted to a sufficiently low level in order to form or deposit substantial undissolved acid on the skin. The pH of the compositions should be adjusted and preferably buffered in the range of 3.0 to 6.0, preferably 3.0 to 5.0, and preferably 3.5 to 4.5. A non-exclusive list of examples of organic acids that can be used as the proton donor agent are adipic acid, tartaric acid, citric acid, maleic acid, mellic acid, succinic acid, glycolic acid, glutaric acid, benzoic acid, malonic acid , salicylic acid, gluconic acid, polymeric acids and their salts, and mixtures thereof. A non-exclusive list of examples of mineral acid to be used herein are hydrochloric, phosphoric, sulfuric and mixtures thereof. Polymeric acids are especially preferred acids to be used here from the point of view that they are less spicy to the skin than other acids. As used herein, the term "polymeric acid" refers to an acid with repeating units of carboxylic acid groups linked together in a chain. Suitable polymeric acids may include homopolymers, copolymers and terpolymers, but they must contain at least 30 mol% carboxylic acid groups. Specific examples of suitable polymeric acids useful herein include poly (acrylic) acid and its copolymers, both ionic and non-ionic (e.g., maleic-acrylic, sulfonic-acrylic and styrene-acrylic copolymers), poly (acrylic) acids interlaces having a molecular weight of less than 250,000, preferably less than 100,000, poly (alpha-hydroxylic acids), poly (methacrylic) acid, and natural polymeric acids such as carageenic acid, carboxymethylcellulose, and alginic acid. Straight chain poly (acrylic) acids are especially preferred for use herein.
Water The non-rinsing antimicrobial compositions of the present invention comprise from 0% to 99.85%, preferably from 3% to 98%, more preferably from 5% to about 97.5%, and most preferably from 38% to about 95.99% water. The non-rinsing antimicrobial compositions of the present invention preferably have an apparent viscosity or a pure sample of 500 cps at 60,000 cps at 26.7 ° C, preferably 5,000 to 30,000 cps. The term "viscosity", as used herein, refers to viscosity as measured by means of a Brookfield RVTDCP with a CP-41 spindle at 1 RPM for 3 minutes, unless otherwise indicated. The "pure sample" viscosity is the viscosity of the undiluted liquid cleaner.
E. Preferred Optional Ingredients Smoothness improving additives In order to achieve the required softness of the present invention, optional ingredients may be added to improve softness to the skin. These ingredients include cationic and nonionic polymers, associated surfactants, humectants 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 softness improving polymers comprise from 0.1% to 1%, preferably from 0.2% to 1% and most preferably from 0.2% to 0.6% by weight of the non-rinsing antimicrobial composition. Associated 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 polypropylene oxide / ethylene oxide block polymers Pluronic® , and amphoteric surfactants such as alkyl betaines, alkylsultaines, alkylamphoacetates, alkylalaphodiacetates, alkylamphopropionates and alkylalaniphodipionates. When used, the mild surfactant-associated surfactants comprise from about 20% to 70%, preferably from 20% to 50% by weight of anionic surfactant, of the non-rinsing composition. Another group of softness improvers are skin wetting lipid agents that provide a moisturizing benefit to the user of the non-rinsing composition when the lipophilic skin moistening agent is deposited on the wearer's skin. When they are used in the compositions present non-rinsing antimicrobial agents, the lipophilic skin moisturizing agents are used at a level of 0.1% to 30%, preferably 0.2% to 10%, more preferably 0.5% to 5% by weight of the composition. In some cases, the lipophilic skin moisturizing agent can be conveniently defined in terms of its solubility parameter, as defined by Vaughan in Cosmetics and Toiletries, Vol. 103, p. 47-69, October 1988. A lipophilic skin moisturizing agent having a Vaughan solubility parameter (VSP) of from 5 to 10, preferably from 5.5. to 9, is suitable for use in the present non-rinsing antimicrobial compositions. A wide variety of materials and mixtures of lipid-type materials are suitable for use in the non-rinsing antimicrobial compositions of the present invention. Preferably, the lipophilic skin conditioning agent is selected from the group consisting of hydrocarbon oils and waxes, silicones, fatty acid derivatives, cholesterol, cholesterol derivatives, di- and tri-glycerides, vegetable oils, vegetable oil derivatives, oils not digestible liquids, such as those described in U.S. Patents 3,600,186 to Mattson; of August 17, 1971 and 4,005,195 and 4,005,196 to Jandacek and others; both of January 25, 1977, all of which are incorporated herein by reference, or mixtures of digestible or non-digestible liquid oils with solid polyol polyesters such as those described in U.S. Patent 4,797,300 to Jandacek, issued on Jan. 10, January 1989; United States Patents ,306,514 and 5,306,516 and 5,306,515 to Letton, all issued on April 26, 1994, all of which are incorporated herein by reference, and acetoglyceride esters, alkyl esters, alkenyl esters, lanolin and its derivatives, milk triglycerides, wax esters, beeswax derivatives, sterals, phospholipids and mixtures thereof. Fatty acids, fatty acid soaps and water soluble polyols are specifically excluded from the definition herein mentioned of a lipophilic skin moisturizing agent.
Oils and hydrocarbon waxes: Some examples are petrolatum, microcrystalline waxes of mineral oil, polyalkenes, (for example, polybutene and hydrogenated and non-hydrogenated polydekene), paraffins, cerasin, ozokerite, polyethylene and perhydrosqualene. Hydrogenated and non-hydrogenated high molecular weight petrolatum and polybutene mixtures in which the ratio of petrolatum to polybutene is in the range of 90:10 to 40:60 are also suitable for use as the lipid skin-moisturizing agent in the present compositions . Silicone Oils: Some examples are dimethicone copolyol, dimethyl polysiloxane, diethyl polysiloxane, high molecular weight dimethicone, mixed C1-C30 alkylpolysiloxane, phenyldimethicone, dimethiconoi and mixtures thereof. More preferred are the non-volatile silicones selected from dimethicone, dimethiconoi, mixed C1-C30 alkyl polysiloxane, and mixtures thereof. Non-limiting examples of silicones useful herein are described in U.S. Patent No. 5,01,1681 to Ciotti et al., April 30, 1991, which is incorporated by reference.
Di- and Tri-glycerides: Some examples are castor oil, soybean oil, derived soybean oils such as maleated soybean oil, sunflower oil, cottonseed oil, corn oil, hazelnut oil, peanut oil, olive oil, cod liver oil, almond oil, avocado oil, palm oil and sesame oil, vegetable oils and vegetable oil derivatives; coconut oil and derived coconut oil, cottonseed oil and derived cottonseed oil, jojoba oil, cocoa butter, and the like. Acetochlorotrite esters are used and one example is the acetylated monoglycerides. Lanolin and its derivatives are preferred and some examples are lanolin, lanolin oil, lanolin wax, lanolin alcohols, lanolin fatty acids, isopropyl lanolate, acetylated lanolin, acetylated lanolin alcohols, lanolin alcohol linoleate, lanolin alcohol ricinoleate. It is most preferred when at least 75% of the lipophilic skin conditioning agent consists of lipids selected from the group consisting of: petrolatum, mixtures of petrolatum and high molecular weight polybutene, mineral oil, liquid non-digestible oils (octaesters of cottonseed sucrose) liquid) or mixtures of liquid digestible or non-digestible oils with solid polyol polyesters (for example sucrose octaesters prepared from C22 fatty acids) in which the ratio of digestible or non-digestible liquid oil to solid polyol polyester is in the range of 96: 4 to 80:20, hydrogenated polybutene or non-hydrogenated, microcrystalline wax, polylakene, paraffin, waxen, ozokerite, polyethylene, perhydrosqualene; dimethicones, alkylsiloxane, polymethylsiloxane, methylphenylpolysiloxane and mixtures thereof. When used as a mixture of petrolatum and other lipids, the ratio of petrolatum to the other selected lipids (hydrogenated or non-hydrogenated polybutene or polydequene or mineral oil) is preferably from 10: 1 to 1: 2, more preferably from 5: 1 to eleven.
Stabilizers When a lipophilic skin moisturizing agent is used as the softness improver in the antimicrobial compositions present, a stabilizer can also be included at a level on the scale of 0.1% a %, preferably from 0.1% to 8%, more preferably from 0.1% to 5% by weight of the non-rinsing antimicrobial composition. The stabilizer is used to form a crystalline stabilizing network in the non-rinsing composition which prevents the coalescence of drops of the lipophilic skin moisturizing agent and its phase separation in the product. The network exhibits time dependent viscosity recovery after shear (for example, thixotropy). The stabilizers used in the present are not agents surfactants. The stabilizers provide improved stability in storage and effort. Some preferred hydroxyl-containing stabilizers include 12-hydroxystearic acid, 9,10-dihydroxystearic acid, tri-9,10-dihydroxystearin and tri-12-hydroxytetearin (hydrogenated castor oil is primarily tri-12-hydroxystearin). Tri-12-hydroxystearin is most preferred for use in the present compositions. When these crystalline hydroxyl-containing stabilizers are used in the non-rinsing compositions present, they are typically present at 0.1% to 10%, preferably 0.1% to 8%, more preferably 0.1% to 5% of the non-rinsing antimicrobial compositions. . The stabilizer is insoluble in water under ambient to near ambient conditions. Alternatively, the stabilizer used in the non-rinsable compositions herein may consist of a polymeric thickener. When polymeric thickeners are present as a stabilizer in the present non-rinsing compositions, they are typically included in an amount in the range of 0.01% to 5%, preferably 0.3% to 3% by weight of the composition. The polymeric thickener is preferably an anionic, nonionic, cationic or hydrophobically modifying polymer selected from the group consisting of cationic polysaccharides of the cationic guar gum class with molecular weights of 1,000 to 3,000,000, anionic, cationic, and nonionic homopolymers. Acrylic and / or methacrylic acid derivatives, anionic cellulose resins, cationic resins, and ionic, cationic copolymers of dimethyldialkylammonium chloride, and acrylic acid, cationic homopolymers of dimethylacylammonium chloride, cationic polyalkylene, and ethoxypolyalkyleneimines, polyethylene glycol of molecular weight 100,000 to 4,000.00, and mixtures thereof. Preferably, the polymer is selected from the group consisting of sodium polyacrylate, hydroxyethylcellulose, hydroxyethylcellulose, cetylhydroxyethylcellulose and Polyquatemium 10. Alternatively, the stabilizer used in the non-rinsing compositions herein may consist of fatty acid esters of C 10 -C 22 ethylene glycol. C10-C22 ethylene glycol fatty acid esters can also be desirably used in combination with the polymeric thickeners described hereinbefore. The ester is preferably a diester, more preferably a C14-C18 diester, more preferably ethylene glycol distearate. When fatty acid esters of C10-C22 ethylene glycol are used as the stabilizer in the non-rinsing antimicrobial compositions herein, typically from 3% to 10%, preferably from 5% to 8%, more preferably from 6% to 8% of the non-rinsable compositions. Another class of stabilizer that can be used in the non-rinsing antimicrobial compositions of the present invention consists of dispersed amorphous silica selected from the group consisting of fuming silica and precipitated silica and mixtures thereof. As used herein, the term "dispersed amorphous silica" refers to non-crystalline silica finely divided, small, having an average agglomerated particle size of less than 100 microns. Fuming silica, which is also known as arc silica, is produced by the vapor phase hydrolysis of silicon tetrachloride in a flame of oxygen and hydrogen. It is believed that the combustion process creates silicon dioxide molecules that condense to form particles. The particles collide, adhere and concretize each other. The result of this process is a three-dimensional branched chain aggregate. Once the aggregate cools below the melting point of the silica, which is 1710 ° C, further collisions cause mechanical entanglement of the chains to form agglomerates. The precipitated silicas and the silica gels are generally made in aqueous solution. See, Cabot Tehcnical Data Pamphlet TD-100 titled "CAB-0-SILR Untreated Fumed Silica Properties and Functions", October 1993, and Cabot Technical Data Pamphlet TD-104 titled "CAB-0-SILR Fumed Silica in Cosmetic and Personal Care Products ", March 1992, both of which are incorporated herein by reference. The fumed silica preferably has an average particle size of agglomerate which varies from 0.1 microns to 100 microns, preferably from 1 micron to 50 microns, and more preferably from 10 microns to 30 microns. The agglomerates are composed of aggregates having an average particle size ranging from 0.01 microns to 15 microns, preferably from 0.05 microns to 10 microns, more preferably 0.1 Myrrhs at 5 microns and more preferably from 0.2 microns at 0.3 microns. The silica preferably has a surface area of greater than 50 m2 / gram, more preferably greater than 130 m2 / gram, more preferably greater than 180 m / gram. When amorphous silicas are used as the stabilizer herein, they are typically included in the non-rinsing compositions at levels ranging from 0.1% to 10%, preferably from 0.25% to 8%, more preferably from 0.5% to 5%. A fourth class of stabilizer that can be used in the non-rinsing antimicrobial compositions of the present invention consists of dispersed smectite clay selected from the group consisting of bentonite and hectorite and mixtures thereof. Bentonite is a colloidal aluminum clay sulfate. See Merck Index, 1st edition, 1989, entry 1062, p. 164, which is incorporated by reference. Hectorite is a clay that contains sodium, magnesium, lithium, silica, oxygen, hydrogen and fluorine. See Merck Index, 11th edition, 1989, entry 4538, p. 729, which is incorporated herein by reference. When smectite clay is used as a stabilizer in the non-rinsing compositions of the present invention, it is typically included in amounts ranging from 0.1% to 10%, preferably from 0.25% to 8%, and more preferably from 0.5% to 5%. Other known stabilizers, such as fatty acids and fatty alcohols, can also be used in the present compositions. He Palmitic acid and lauric acid are especially preferred for use herein.
Other optional ingredients The compositions of the present invention may comprise a wide range of optional ingredients. The CTFA International Cosmetic Inqredient Dictionary, 6th edition, 1995, which is incorporated by reference herein in its entirety, discloses a wide variety of non-limiting cosmetic and pharmaceutical ingredients commonly used in the skin care industry, which are suitable for use in the compositions of the present invention. Non-limiting examples of functional classes of ingredients are described on page 537 of this reference. Examples of these functional classes include: abrasives, anti-acne agents, cake antiforming agents, antioxidants, mixers, biological additives, volumetric agents, chelating agents, chemical additives, colorants, cosmetic astringents, cosmetic biocides, denaturants, astringents drugs, emulsifiers, external analgesics, film formers, fragrance components, humectants, opacifiers, plasticizers, preservatives, propellants, reducing agents, skin whitening agents, hair conditioning agents skin, (emollients, humectants, various, and occlusives), skin protectants, solvents, foam boosters, hydrotropes, solubilizing agents, suspending agents (non-surfactants), sunscreen agents, ultraviolet light absorbers, and agents to increase viscosity (aqueous and non-aqueous). Examples of other functional classes of materials useful herein that are well known to those skilled in the art include solubilizing, sequestering, and keratolytic agents, and the like.
II. CHARACTERISTICS The non-rinsing antimicrobial compositions of the present invention have the following characteristics.
A. Bacterial Effectiveness The rinsing of the antimicrobial cleansing compositions of the present invention has one of three characteristics of bacterial effectiveness.
Residual Effectiveness Index of Gram Negatives The non-rinsing antimicrobial compositions of the present invention have a Gram negative Residual Effectiveness Index of greater than about 0.3 (50% reduction), preferably greater than about 1.0 (90% reduction), and very preferably greater than about 2.0 (99% reduction). The Residual Effectiveness Index of Gram Negatives is measured by means of the test of residual effectiveness in vivo on Escherichia coli that is described later in the section of Analytical Methods. The index represents a difference in values of ten-base logarithms of bacterial concentrations between a test sample and a control. For example, an index of 0.3 represents a reduction in logarithmic values of 0.3 (delta log = 0.3) which in turn represents a 50% reduction of the bacterial count.
Residual Effectiveness Index of Gram positives The non-rinsing antimicrobial compositions of the present invention comprise a Residual Effectiveness Index of Gram positives of greater than 0.5 (68% reduction), preferably greater than 1.0 (90.0% reduction), preferably greater 2.0 (99% reduction), and most preferably greater than 2.3 (99.5% reduction). The Residual Effectiveness Index of Gram positive is measured by means of the in vivo residual effectiveness test on Staphylococcus aureus described herein. The index represents a difference in base-ten logarithm values of bacterial concentrations between a sample test and a placebo control. For example, an index of 1.0 represents a reduction of logarithm values of 1.0 (delta log = 1.0) which in turn represents a reduction of 90.0% of the bacterial count. rates of immediate reduction of germs The non-rinsing antimicrobial compositions provide immediate reduction of germs improved. The degree of reduction can be measured after a wash (application) of the In vivo washing test. hands for personal health care described here. When measured after a wash, the non-rinsing antimicrobial composition has an Index of Immediate Reduction of Germs in a wash of more than 1.0% (90% reduction), preferably greater than about 1.5% (96.8% reduction) , preferably greater than about 2.3 (99.5% reduction). The index represents a difference in base ten logarithm values of bacterial concentrations before and after washing. For example, an index of 1.0 represents a reduction in logarithm values of 1.0 (delta log = 1.0) which in turn represents a 90% reduction of the bacterial count.
B. Softness - Softness Index The non-rinsing antimicrobial compositions of the present invention comprise a Smoothness Index greater than 0.3, preferably greater than 0.4, and preferably greater than 0.6. The Softness index is measured by means of the Controlled Forearm Application Test (FCAT) that is described herein.
III MANUFACTURING METHODS OF NON-RINSEABLE ANTIMICROBIAL COMPOSITIONS The non-rinsing antimicrobial compositions of the present invention are prepared by techniques known in the art for the different forms of non-rinsing products.
IV METHODS OF USE OF THE NON-RINSING ANTIMICROBIAL COMPOSITION The non-rinsing antimicrobial compositions of the present invention are useful for controlling the dispersion of Gram-positive bacteria with the passage of time. Typically, an adequate or effective amount of the composition is applied in the area to be treated. Alternatively, an appropriate amount of the cleaning composition can be applied by the intermediate application to a wash cloth, sponge, pad, cotton ball, or other application device. In general, the effective amount of product to be used will depend on the needs and habits of use of the individual. Typical amounts of the present compositions that are useful for cleaning range from 0.1 mg / cm2 to 10 mg / cm2, preferably from 0.6 mg / cm2 to 5 mg / cm2 of area of the skin to be cleaned.
V. ANALYTICAL TEST METHODS Microtox Response Test • Reference: Microtox Manual: A Toxicity Testing Handbook, 1992, Volume I-IV; Microbics Corporation. • Equipment: Microtox M500 toxicity test unit; Microbics Corporation. Connected to a computer for data acquisition and analysis according to the previous reference. • Process: Preparation of sample supply solution (Standard concentration: 1000 ppm) The sample solution of sample anionic surfactant is prepared and used as a supply solution from which all other dilutions can be made. The "standard starting concentration", which is the highest concentration tested, is 500 ppm. (If a starting concentration of 500 ppm does not produce a calculable result, for example a surfactant actively kills all dilutions, the starting concentration can be adjusted based on a known scale of EC50 values of previously tested surfactants). The supply solution is prepared at twice the starting concentration. a) Add 0.1 g (or adjust the amount if necessary) of anionic surfactant, considering the activity of the raw material, to a flask. b) Microtox Thinner (2% NaCl, Microbics Corp.) is added up to a total of 100g. c) Shake the solution to ensure adequate mixing. Reconstitution of the Microtox reagent and preparation of the test a) Turn on the test unit and let equilibrate the temperature of the cavity at 5.5 ° C and the temperature of the incubator block and the reading cavity at 15 ° C. b) Place a clean bucket (Microbics Corp.) in the cavity of the Reagent and fill with 1.0 ml of Microtox reconstitution solution (distilled water, Microbics Corp.). Allow to cool for 15 minutes. c) Reconstitute the standard bottle of Microtox acute toxicity reagent. { Vibrio fischerio, Microbics Corp.) by rapidly adding 1.0 ml of the cooled reconstitution solution to the reagent bottle. d) Swirl the solution in the reagent bottle for 2 to 3 seconds and then pour the reconstituted reagent back into the cooled cuvette and return the bottle to the reagent well.
Let stabilize for 15 minutes. e) Place 8 cuvettes containing 500 μl of Microtox Diluent, as a test, in the incubator cavities of the test unit. Allow to cool for 15 minutes.
Illution of the test substance Prepare 7 serial dilutions of the test substance starting from the test supply solution. The final volume of all cuvettes should be 1.0 ml. a) Place 8 empty buckets in a rack of test tubes. b) Add 1.0 ml of Microtox Diluent solution to tubes 1-7. c) Add 2.0 ml of the sample supply solution (1000 ppm) in cuvette 8. d) Transfer 1.0 ml of solution from cuvette 8 to cuvette 7 and mix cuvette 7. e) Transfer in series 1 .0 ml of the newly formed solution to the subsequent cuvette (7 to 6, 6 to 5, etc.). ). Remove 1.0 ml of solution from cell 2 and discard. Bucket 1 is the blank containing only Microtox Diluent. Place the cuvettes in the incubation cavities of the test unit keeping them in order from the lowest concentration to the highest concentration. These buckets should correspond to the 8 buckets prepared in step 2 above. Allow to cool for 15 minutes.
Test bioluminescence slide and sample a) Add 10 μl of reconstituted reagent to the 8 pre-cooled cuvettes of the assay prepared in step 2 above (containing 500 μl of diluent). Allow the reagent to stabilize for 15 minutes. b) Start the Microtox Data Capture and Reporting Software (Microbics Corp.), select START TESTING, enter file name and description, correct the starting concentration in ppm (500 if standard concentration is used) and the numbers of the controls (1 ) and dilutions (7). Time 1 must be selected 5 minutes, time 2 is NONE. Press the space bar then to start the test. c) Place the test cuvette containing the reagent that corresponds to the blank of the test in the reading cavity and press SET. After the cuvette has appeared again, press READ and the value will be captured by the computer. d) Read similarly the remaining 7 cuvettes containing the reagent when indicated by the computer and press the READ button with the correct cuvette in the READ cavity. e) After taking the initial 8 readings, transfer 500 μl of the diluted test substance into the corresponding cuvette containing the reagent. Mix by vortex or vortex and return to the incubation cavities. The computer will count five minutes and indicate that it starts with the final readings. f) Take the final readings by placing the correct cuvette containing the reagent and the diluted test surfactant in the reading cavity and pressing READ when indicated by the computer.
Data analysis The concentration of the test substance in ppm can be calculated which reduces the bioluminescence of the acute toxicity reagent of Microtox by 50% of the initial value (EC50 value) using the Run option Statistics on Data File of the Microtox software (recommended) or performing a linear regression of the data (% reduction versus logarithm of the concentration). The% reduction is calculated using the following formulas: Final reading of the white reagent = Correction factor Initial reading of the white reagent Final reagent reading with diluted test substance = Correction factorx Initial reading of the reagent with diluted test substance Where x means a corresponding concentration.
Correction factor ,, - Reduction factor Reduction% = Correction factor The Microtox index is the EC50 value in ppm.
Residual effectiveness in vivo on E. coli References: Aly R .; Maibach H.I .; Aust L.B .; Corbin N.C .; Finkey M.B., 1994 1. In vivo effect of antimicrobial soap bars containing 1.5% and 0.8% trichlorocarbanilide against two strains of pathogenic bacteria. J. Soc. Cosmet. Chem., 35, 351-355, 1981. 2. In vivo methods for testing topical antimicrobial agents. J. Soc. Cosmet. Chem., 32, 317-323. 1 . Test design The residual antibacterial efficacy of antimicrobial products from liquid and bar soaps can be quantified in the following method. Reductions of a non-antibacterial control placebo soap, without additional treatment, used on one of the subjects' forearms are reported. By definition, the antibacterial placebo will not show residual effectiveness in the test.
. Pre-test The subjects were instructed not to use antibacterial products for 7 days before the test. Immediately before the test, the subjects' hands were examined to determine cuts or skin lesions that could impede their participation. . Procedure for application of the non-rinsing test product a) Wash both forearms once with placebo soap to Remove any contaminants or transient bacteria. Rinse and dry the forearms, b) The monitor of the test marks a treatment area of 10 cm x 5 cm on the forearm. c) The test tester applies 0.5 ml of the test product to the treatment site by rubbing for 10 seconds, d) It is allowed to air dry and the test sites are marked (a circle of approximately 8.6 cm2 with rubber stamp) ), e) Mark the site with a stamp on the other forearm of the subject for evaluation of the placebo product. Inoculation procedure a) Inoculate E. coli (ATCC 10536 developed from a lyophilized supply suspension in casein broth at 37 ° C for 18-24 hours) to approximately 108 organisms / ml (0.45 transmittance against TSB target in spectrophotometer). b) Each test site is inoculated with 10 μl of E. coli. The inoculum is extended with an inoculation loop in a circle of approximately 3 cm2 and covered with a Hilltop Chamber (Hilltop Research Inc.). c) This procedure is repeated for each test site on each forearm.
Sampling of bacteria (Extraction procedure) a) Prepare the sampling solution of KH2P04 0.04%, Na2HP04 1 .01%, Triton X-100 0.1%, polysorbate 80 1.5%, lecithin in water 0.3%, adjusted to pH 7.8 with 1N HCl. B) Exactly 60 minutes after inoculation, remove the Hilltop Chamber of the site from which a sample is taken. A sample cup of 8.6 cm2 is placed on the site. c) 5 ml of sampling solution is added to the cup. d) Extract the bacteria by gently rubbing the site with glass gendarme for 30 seconds. e) Remove the sampling solution with pipette and place in a sterile labeled test tube. f) Repeat the extraction with 5 ml of sampling fluid. This complete extraction procedure is repeated for each site 60 minutes after inoculation. Bacteria a) Prepare Na2HP04 phosphate buffer 0. 1 17%, 0.022% NaH2P04 and 0.85% NaCl adjusted to pH 7.2-7.4 with 1 N HCl. B) 1.1 ml of the sampling solution is removed aseptically from the tube; 0.1 ml of the solution is spread on trypticase soy agar containing Polysorbate 80 1.5%. 1 ml remaining is placed in 9 ml of sterile phosphate buffer reaching a 1: 10 dilution of the sampling solution. This procedure is repeated 3 times more (each dilution in series). c) The plates are inverted and incubated at 35 ° C for 24 hours. d) The colonies formed on the plates are then enumerated and the results are calculated by multiplying the counts by the dilution factor (original sample = 10, first dilution = 100, second dilution = 1000, etc.) and the final results are reported as the number of colony forming units per ml (CFU's / ml). 7. Calculation of the index of residual efficacy index of Gram negative = log-io (CFU's / ml of placebo site) - log-io (CFU's / ml of test product site) Residual effectiveness in vivo on Staphylococcus aureus • References: Aly R .; Maibach H.I .; Aust L.B .; Corbin N.C .; Finkey M.B., 1994 1. In vivo effect of antimicrobial soap bars containing 1.5% and 0.8% trichlorocarbanilide against two strains of pathogenic bacteria. J. Soc. Cosmet. Chem., 35, 351-355, 1981. 2. in vivo methods for testing topical antimicrobial agents. J. Soc. Cosmet. Chem., 32, 317-323.
Test Case The residual antibacterial efficacy of liquid and bar soap antimicrobial products can be quantified in the following method. Reductions of a non-antibacterial control placebo soap, without additional treatment, used on one of the subjects' forearms are reported. By definition, the antibacterial placebo will not show residual effectiveness in the test. Test refraction Subjects are instructed not to use antibacterial products for 7 days before the test. Immediately before the test, the subjects' hands are examined to determine cuts or skin lesions that could impede their participation. application procedure of the non-rinsing test product a) Wash both forearms once with placebo soap to remove any contaminants or transient bacteria. Rinse and dry the forearms. b) The monitor of the test marks a treatment area of 10 cm x 5 cm on the forearm. c) The tester of the test applies 0.5 ml of the test product to the treatment site by rubbing for 10 seconds. d) Allow to air dry and mark the test sites (a circle of approximately 8.6 cm2 with rubber seal). e) Mark the site with a stamp on the other forearm of the subject for evaluation of the placebo product. Inoculation procedure a) S. aureus inoculum is adjusted (ATCC 27217 developed from a freeze-dried supply suspension in casein broth a 37 ° C for 18-24 hours) at approximately 108 organisms / ml (0.45 transmittance against TSB target in spectrophotometer). b) Each test site is inoculated with 10 μl of S. aureus. The inoculum is spread with an inoculation loop in a circle of approximately 3 cm2 and covered with a Hilltop Chamber (Hilltop Research Inc.). c) This procedure is repeated for each test site on each forearm. Sampling of bacteria (Extraction procedure) a) Prepare the sampling solution of KH2PO4 0.04%, Na2HP? 4 1.01%, Triton X-100 0.1%, polysorbate 80 1.5%, lecithin in water 0.3%, adjusted to pH 7.8 with 1N HCl. B) Exactly 60 minutes after inoculation, the Hílltop Chamber is removed from the site from which a sample is taken. A sample cup of 8.6 cm2 is placed on the site. c) 5 ml of sampling solution is added to the cup. d) Extract the bacteria by gently rubbing the site with gendarme of glass for 30 seconds. e) Remove the sampling solution with pipette and place in a sterile labeled test tube. f) Repeat the extraction with 5 ml of sampling fluid. This complete extraction procedure is repeated for each site 60 minutes after inoculation. Bacteria a) Prepare Na2HP04 0.1% phosphate buffer, 0.022% NaH2P04 and 0.85% NaCl adjusted to pH 7.2-7.4 with 1N HCl. b) 1.1 ml of the sampling solution is removed aseptically from the tube; 0.1 ml of the solution is spread on trypticase soy agar containing Polysorbate 80 1.5%. 1 ml remaining is placed in 9 ml of sterile phosphate buffer reaching a 1: 10 dilution of the sampling solution. This procedure is repeated 3 times more (each dilution in series). c) The plates are inverted and incubated at 35 ° C for 24 hours. d) The colonies formed on the plates are then enumerated and the results are calculated by multiplying the counts by the dilution factor (original sample = 10, first dilution = 100, second dilution = 1000, etc.) and the final results are reported as the number of colony forming units per ml (CFU's / ml). 7. Calculation of the index of residual efficacy index of Gram positive = log-io (CFU's / ml of placebo site) - log-io (CFU's / ml of test product site) Hand washing test for personal health care in vivo (HCPHWT) • Reference: Annual Book of ASTM Standards, Vol. 1 1.05; ASTM designation: E 1 174-94; "Standard Test Method for Evaluation of Health Care Personnel Handwash Formulation" 1. The test method used is identical to the method explained in this reference with the following changes / clarifications. a) The test on a subject ended after the extraction of a wash, when the data of only one wash were searched. The test requires at least four subjects. b) Historical data were used as a control in this protocol (that is, no control soap was operated on each test). c) Test materials: Organism: Serratia marcescens ATCC 14756 (incubated 18-24 hours at 25 ° C in soy casein broth, adjusted to approximately 108 organisms / ml diluted to 0.45 transmittance with a spectrophotometer).
Dilution fluid: Phosphate buffer (Triton X-100 0.1%, lecithin 0.3%, Tween 80 1.5%) adjusted to pH 7.2 with 1 N HCl. Agar: Soybean casein agar with Polysorbate 80 1.5%. d) Application procedure: Laboratory technicians place 2.0 ml of the non-rinsing test composition in the subjects' hands. Then the subject extends the composition in the hands, rubbing for thirty (30) seconds, covering the palm, the back of the hand, the fingers and areas between the fingers, cuticles and nail beds. It does not dry on hands. e) Bacteria were enumerated by serial dilutions (1: 10) of inoculum or extracted samples and spreading 0.1 ml of dilution on plates. The results are reported as the logarithmic reduction of bacteria from the baseline.
Index of Immediate Reduction of Germs in a wash = Log (CFU's) in extraction of baseline - Log (CFU's) in the extraction after a wash.
Index of Immediate Reduction of Germs in ten washes = Log (CFU's) in extraction of baseline - Log (CFU's) in extraction after ten washes. e) Hands were decontaminated by immersion in 70% ethanol for 15 seconds and then a five minute wash with control soap and water.
Controlled forearm application test (FCAT) • Reference: Ertel K.D. and others, "A Forearm Controlled Application Technique for Estimating the Relative Mildness of Personal Cleansing Products," J. Soc. Chem. 46 (1995) 67-76.
The Controlled Forearm Application Test, or FCAT, is a comparative test that discriminates differences in product softness for the skin. A test product is compared to a standard soap control control bar.
Restrictions of the test group. Test groups of 20 to 30 subjects 18 to 55 years of age were used, who washed regularly with soap. We excluded potential subjects who (1) had an initial dryness of 3.0 or greater on the forearm, determined during the initial examination; (2) had skin cancer, eczema or psoriasis on the forearms, (3) received injectable insulin, (4) were pregnant or breast-feeding, or (5) were receiving treatment for skin problems or contact allergy. The subjects have to avoid hot tubes, swimming and sunlamps, and refrain from applying any soap, cleansing product, cream or gel on your forearms during the study. Subjects should keep their forearms away from the water for at least two hours before the qualification procedure. The studies are executed using a blind random product order format. The clinical assistant should verify the correct sequence of treatment and document it before washing each subject. The products are applied to the forearms a total of nine (9) times: two (2) times each day in the first four (4) days of the study and one (1) on the last day. The visits to the test facilities for washing must be separated a minimum of three (3) hours. All clinical assistants should wear disposable gloves during the wash procedure, rinse them between treatments and change them with each subject.
Control product The control product is a cylindrical bar soap containing: Seboato sodium 56.1% Sodium cocoate 18.7% Sodium chloride 0.7% Water 24% Other (perfume, impurities) 0.5% Product application procedure The test and control products were tested in the same arm. The following test procedure was used. 1. The subject moistens the entire surface of his inner forearm with tap water at 35-38 ° C by briefly holding the arm under the water jet of the tap. 2. A clinical assistant moistens a quarter sheet (approximately 20 x 15 cm) of Massiinn® towel with tap water; then squeeze the towel gently to remove excess water. 3. A clinical assistant applies the products to the arm, starting with the product designated for the site closest to the elbow using the appropriate procedure as follows: Liguid product: a ^ Dispense 0.10 cc of test product with a syringe in the center of the appropriate marked area, tx Moisten two fingers of the gloved hand (latex) under the running water of the wrench (index and middle fingers), Move the wet fingers in a circular motion over the application site for 10 seconds to lather the product. cL The suds remains on the application site for 90 seconds, then it is rinsed in the water jet of the tap for 15 seconds, taking care not to wash the suds of the adjacent sites. After 10 seconds of finishing the rinse, the clinical assistant gently rubs the rinse site with both gloved fingers for the remaining 5 seconds of rinsing. Bar product é Moisten two fingers of the gloved hand (latex) under the water jet of the wrench (middle and index fingers). t Dampen the bar holding the bar briefly under the water jet of the tap. The test bars should be moistened under the water jet of the tap at the start of each day. to. Rub wet fingers in a circular motion on the surface of the bar for 15 seconds to form suds on the bar and fingers. g \ Rub the soaped fingers over the application site in a circular motion for 10 seconds to lather the product on the skin. e ^ The suds remains in the application site for 90 seconds, then it is rinsed under the water jet of the tap for 15 seconds, taking care not to wash the suds from the adjacent sites. After 10 seconds of finishing the rinse, the clinical assistant will gently rub the rinse site with your two gloved fingers for the remaining 5 seconds of the rinse.
Cloth cleaning products a. Fold the cloth in half, crosswise, and gently rub the cloth in a circular motion within the appropriate area. b_i Let the room dry with air for 90 seconds. Do not rinse the site. Non-rinsable product a. Dispense 0.10 cc of the test product with a syringe in the center of the appropriate marked area. b_i Move gloved fingers in a circular motion over the application site for 10 seconds, a. Let the room dry for 90 seconds. Do not rinse the site. While the completion of the 90 seconds of residence time is expected, it will be repeated at the remaining application site on the arm working on it down towards the wrist. Steps 1-4 are repeated in the appropriate test areas in order to perform two applications of the product to the test areas. After all application areas have two product applications, the clinical assistant dries gently touching the subject's arm with a disposable paper towel.
Evaluation The skin is evaluated on each treatment area by an expert qualifier in the baseline and three hours after the final study wash. Treatment areas are evaluated under 2.75x magnification (Luxo Illuminated Amplifier Lamp model KFM-1A, Marshall Industries, Dayton, OH) with controlled illumination (Circuline 8"22 watt Cool White General Electric Fluorescent Focus.) An expert assessor assesses dryness of the skin and a score is assigned based on the following definitions.
TABLE 1 Rating scale of the forearm Score Dryness of skin 0 No dryness 1.0 Lightly dusty-looking plates and occasional flake plates can be observed. 2.0 Lightweight generalized dusty appearance. Premature cracking or occasional small raised flakes may be present. 3.0 Moderate generalized dusty appearance and / or dense cracking and raised scales. 4.0 Dense generalized dusty appearance and / or dense cracking and raised scales. 5.0 Strong generalized cracking and raised scales. An eczematous change may be present. The dusty appearance may be present but it is not prominent. Bleeding cracking may be observed. 6.0 Severe generalized cracking. An eczematous change may be present. Bleeding cracking may be present. Large scales may be starting to disappear.
Generally, FCAT only causes mild to moderate skin irritation; however, if a treated site reaches a rating of 5.0 or higher at any time during the study, treatment of all sites in that subject should be discontinued.
Data The following values were determined after evaluating all subjects at the end of the test: Rc0 = The average score of the control product area in the baseline. Rcf = The average score of the control product area at the end of the test. Rt0 = The average score of the test product area in the baseline. Rtf = The average score of the test product area at the end of the test.
There are many external conditions that can affect the FCAT such as relative humidity and water softness. The test is valid only if sufficient response is observed on the skin for the control product. The control response must be greater than 1.0 (ie, Rcf - Rc0 > 1.0) for the test to be valid.
Given a valid test, the Softness index of the test product is the difference in skin responses to two products.
Softness index = (Rcf - Rc0) - (Rtf - Rt0) Consistency (k) and shear rate (n) of the lipophilic skin moisturizing agent The Carrimed CSL 100 Controlled Shear Stress Rheometer is used to determine the shear rate, n, and the Consistency k of the lipophilic wetting agent of the skin used in this invention. The determination is made at 35 ° C with the cone measurement system of 4 cm of 2 ° typically with a space of 51 microns, and is performed by the programmed application of a shear stress (typically from 0.06 dynes / cm2 to 5,000 dynes / cm2) for a time. If this effort causes a deformation of the sample, that is, it deforms the measurable geometry of at least 10"4 rad / sec, then this degree of stress is reported as a degree of shear stress.This data is used to create a curve of flow viscosity μ against shear rate? ' For this material, this flow curve can then be modeled to provide a mathematical expression that describes the behavior of the material within specific limits of shear stress and cutting degree.These results were adjusted with the following well-accepted model of power law (see for example Chemical Engineering, by Coulson and Richardson, Pergamon, 1982, or Transport Phenomena by Bird, Stewart and Lightfoot, Wiley, 1960): Viscosity, μ = k (? ')' N-1 Viscosity of the non-rinsing antimicrobial composition The Wells-Brookfield Cone / Plate viscometer Model DV-II + is used to determine the viscosity of the non-rinsing antimicrobial compositions of this invention. The determination is made at 25 ° C with the cone measuring system of 2.4 cm (Spindle CP-41) with a gap of 0.013 mm between the two small bolts on the respective cone and plate. The measurement is made by injecting 0.5 ml of the sample to be analyzed between the cone and the plate and rotating the cone at an established speed of 1 rpm. The resistance to 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 in absolute units of centipoise (mPa's) based on the geometric constants of the cone, the speed of rotation and the torsion related to the effort.
EXAMPLES The following examples further describe and demonstrate embodiments within the scope of the present invention. In the following examples, all the ingredients are listed at an active level. The examples are given solely for the purpose of illustration and should not be considered as limitations of the present invention, since many variations thereof are possible without departing from the spirit and scope of the invention. The ingredients are identified by the chemical or CTFA name. Fifteen non-rinsing antimicrobial compositions are prepared according to the following tables.
Non-rinsing antimicrobial compositions Acumer 1020 sold by Rohm & Haas.
All the non-rinsing antimicrobial compositions showed a Residual Effectiveness Index of Gram Negatives greater than about 0.3, a Residual Effectiveness Index of Gram positive greater than 0.5, and have an Index of Immediate Reduction of Germs in a wash greater than about 1 .0 and a Softness index greater than 0.3.
PROCEDURE FOR MANUFACTURING EXAMPLES OF NON-RINSEABLE ANTIMICROBIAL COMPOSITION When mineral oil is used, the mineral oil, propylene glycol, active agent, Steareth 2 and 20, Oleth 2 and 20, and 50% by weight of the oil, glycol, active agent, are premixed. steareth and oleth materials, water in a premix container. It is heated to 74 ° C ± 12 ° C. Additional 50% by weight of the oil, glycol, active agent, steareth and oleth materials, of water is added to the premix tank. All except 5% by weight of the remaining water is added to the second mixing tank. If required, add the premix to the mixing tank. The surfactants are added to the mixing tank. The materials are heated to 68 ° C ± 12 ° C and mixed until they dissolve. It is cooled to less than 38 ° C, acid and antibacterial active agent are added, if they are not in the premix, and perfumes. Mix until the materials dissolve. The pH is adjusted to the target pH with the necessary buffer (NaOH or buffer salt). Add the remaining water to complete the product.

Claims (10)

NOVELTY OF THE INVENTION CLAIMS
1. - A non-rinsing antimicrobial composition characterized in that it comprises: (a) from 0.001% to 5% of an antimicrobial active agent; (b) from 0.05% to 10% of an anionic surfactant; (c) from 0.1% to 10% of a proton donor agent; and (d) from 0% to 99.85% water; wherein the composition is adjusted to a pH of 3.0 to 6.0; wherein the non-rinsing antimicrobial composition has a Negative Gram Residual Effectiveness Index greater than 0.5; and wherein the non-rinsing antimicrobial composition has a softness index greater than 0.3.
2. A non-rinsing antimicrobial composition characterized in that it comprises: (a) from 0.001% to 5% of an antimicrobial active agent; (b) from 0.05% to 10% of an anionic surfactant; (c) from 0.1% to 10% of a proton donor agent; and (d) from 0% to 99.85% water; wherein the composition is adjusted to a pH of 3.0 to 6.0; wherein the non-rinsing antimicrobial composition has a Gram-Positive Residual Effectiveness Index greater than 0.5; and wherein the non-rinsing antimicrobial composition has a softness index greater than 0.
3. 3. A non-rinsing antimicrobial composition characterized by being effective against Gram-positive bacteria, Gram-negative bacteria, fungi, yeasts, molds and viruses, comprising: (a) from 0.001% to 5% of a antimicrobial active agent; (b) from 0.05% to 10% of an anionic surfactant; (c) from 0.1% to 10% of a proton donor agent; and (d) from 0% to 99.85% water; wherein the composition is adjusted to a pH of 3.0 to 6.0; wherein the non-rinsing antimicrobial composition has an Index of Immediate Reduction of Germs in a wash greater than 1.0; and wherein the non-rinsing antimicrobial composition has a softness index greater than 0.3.
4. The non-rinsing antimicrobial composition according to any of the preceding claims, further characterized in that the antimicrobial active agent is selected from the group consisting of Triclosan®, Triclocarban®, Octopirox®, PCMX, ZPT, natural essential oils and their key ingredients, and mixtures thereof.
5. The non-rinsing antimicrobial composition according to any of the preceding claims, further characterized in that the anionic surfactant has a Microtox index of less than 150.
6. The non-rinsing antimicrobial composition according to any of the preceding claims, further characterized in that the anionic surfactant is selected from the group consisting of sodium and ammonium alkyl sulfates and ether sulfates having chain lengths of predominantly 12 and 14 carbon atoms, olefin sulfonates having chain lengths predominantly of 14 and 16 carbon atoms. carbon, and paraffinsulfonates having average chain length of 13 to 17 carbon atoms, and mixtures thereof.
7. The non-rinsing antimicrobial composition according to any of the preceding claims, further characterized in that the proton donating agent is an organic acid having a Shock Capacity greater than 0.005.
8. The non-rinsing antimicrobial composition according to any of the preceding claims, further characterized in that the proton donor agent is selected from the group consisting of adipic acid, tartaric acid, citric acid, maleic acid, melic acid, succinic acid, glycolic acid, glutaric acid, benzoic acid, malonic acid, salicylic acid, gluconic acid, polyacrylic acid, their salts and mixtures thereof.
9. The non-rinsing antimicrobial composition according to any of claims 1 to 5, further characterized in that the proton donor is a mineral acid.
10. Anti-rust-proof antimicrobial composition according to any of the preceding claims, further characterized in that the ratio between the amount of non-anionic surfactants and the amount of anionic surfactant is less than 1: 1. 1 .- The non-rinsing antimicrobial composition according to any of the preceding claims, characterized also because it comprises from 0.2% to 10% of a lipophilic skin moisturizing agent. 12. The use of a safe and effective amount of the composition of any of the preceding claims, for preparing a medicament for providing residual effectiveness against Gram-negative bacteria on human skin. 13. The use of a safe and effective amount of the composition of any of the preceding claims for preparing a medicament for treating acne on human skin.
MXPA/A/1999/011300A 1997-06-04 1999-12-06 Mild, leave-on antimicrobial compositions MXPA99011300A (en)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US869303 1997-06-04
US868718 1997-06-04
US869301 1997-06-04
US08967972 1997-11-12

Publications (1)

Publication Number Publication Date
MXPA99011300A true MXPA99011300A (en) 2000-12-06

Family

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