Title of Invention

"AN ANTISEPTIC CLEANSING COMPOSITION"

Abstract

An antiseptic cleaning composition effective against Pseudomonas comprising an antimicrobial agent which is chlorhexidine or triclosan, and characterised in that it further comprises: at least 2% w/v of an alkyl polysaccharide surfactant; at least one alkyl alcohol having less than 6 carbon atoms and; an aryl alcohol selected from the group consisting of benzyl alcohol, phenylethylalcohol, phenoxyethanol, phenoxypropanol, or a chlorinated derivative thereof.

Full Text

This invention relates to a composition for synergistically enhancing the efficacy of an antimicrobial agent. It is known that infection is spread via skin contact through the transmission of pathogenic microorganisms. Hitherto, in order to reduce the presence of such organisms it has been known to scrub the skin with a solution containing a surfactant followed by application of an antiseptic. In recent years it has been suggested that it would be desirable to combine the washing and disinfectant actions in a single operation by providing a composition comprising both an antimicrobial agent and a surfactant. It has been found however that many antimicrobial agents such as chlorhexidine [N,N'-bis(4-chlorphenyl)-3,12-diimino 2,4,11,13-tetraazatetradecanediimidamide] digluconate and other chlorhexidine salts are incompatible with anionic surfactants, and are reduced in their antimicrobial activity by nonionic surfactants, thus requiring addition of more antimicrobial agent in order to retain sufficient biocidal activity at the amount of surfactant required for satisfactory foam formation. In particular, US 3,855,140 assigned to Imperial Chemical Industries describes a skin cleansing composition comprising a soluble salt of chlorhexidine in combination with a polyoxyethylene polyoxypropylene block copolymer. In order to obtain sufficient sudsing of the polymer it is necessary to use high proportions of the surfactant in amounts of order of 20-25%. High amounts of chlorhexidine are consequently required to maintain the desired antimicrobial activity. Such high amounts are undesirable as it is known that surfactants may affect the skin adversely by defatting, and causing in combination with biocides such as chlorhexidine, irritation to the skin. Further the ingredients of the composition can be costly. It would be desirable therefore to provide a composition in which the amount of antimicrobial agent and surfactant is reduced whilst maintaining sufficient antimicrobial activity and sudsing ability. In this regard, in order to provide such a composition, WO 95/09605 teaches one to combine a phenolic disinfectant with an alkyIpolyglucoside surfactant. As indicated in that patent however, such compositions although showing good biocidal activity against most microorganisms, are incapable of disinfecting surfaces contaminated by the microorganism Pseudomonas aeruginosa to which the compositions are inactive. It is an object of the invention to substantially ameliorate the disadvantages of the prior art. According to the present invention, there is provided a composition for synergistically enhancing the efficacy of an antimicrobial agent, said system including, (a) up to 6% alcohol polysaccharide surfactant of the kind as herein described; (b) up to 70% of at least one alkyl alcohol of the kind as herein described; (c) up to 3% of at least one aryl alcohol of the kind as herein described; and (d) wherein the balance to 100% is water. The composition of the present invention is neither a mere admixture nor a product of chemical but a synergistic mixture exhibiting unexpected and surprising properties. According to a second aspect of the invention there is provided a method of decontaminating surfaces contaminated with bacteria including the Pseudomonas microorganism, which method comprises contacting the surface with the disinfectant cleansing composition of the first aspect. Typically the cleansing composition comprises an inert carrier, and optionally other additives. The alkylpolysaccharide surfactants are also known in the art as alkylpolyglucosides, however, for the purposes of the following discussion, the surfactant will be termed an alkylpolysaccharide. Preferably, the content of the surfactant present in the composition does not exceed 6% w/v. Preferably the alkylpolysaccharide is an alkylpolysaccharide of the formula: (Figure Remove) wherein n is an integer between 5 and 19, and m is an integer between 1 and 3. In the above formula the surfactant alkyl polysaccharide shown contains glucose units, however the invention is not limited thereto and other sugar units can be substituted for one or more of the glucose units. Other sugar units which might be / included in the alkylpolysaccharide include maltose, arabinose, xylose, mannose, galactose, gulose, idose, talose, allose, altrose, sucrose, fructose, sorbose, levulose, lactose, allulose, tagatose, alloheprulose, sedoheptulose, glucoheptulose, mannoheptulose, guloheptulose, idoheptulose, galactoheptulose, taloheptulose and derivatives thereof. Suitable antimicrobial agents include chlorhexidine and its salts; dichlorophene, other chlorophenol derivatives such as p-chloro-m-xylenol, chlorophene and o-phenylphenol, 2,4,4-trichloro-2-hydroxy-diphenylether (triclosan); octenidindihydrochloride (CH3 -(CH2)7-NHON-(CH2),0-NO-NH(CH2)7-CH2 or any other salt thereof and quaternary ammonium compounds. Suitable salts of chlorhexidine include the gluconate, isethionate, formate, acetate, glutamate, succinamate, monodiglycolate, dimethanesulfonate, lactate, diisobutyrate or the glucoheptonate salts. Preferably the antimicrobial agent has a water solubility of at least 0.001% w/v at ambient temperature. When the antimicrobial agent is chlorhexidine digluconate it is used in an amount preferably not exceeding 4.5% w/v. When the antimicrobial agent is 2,4,4-trichloro-2-hydroxydiphenylether (triclosan) it is used in an amount preferably not exceeding 3% w/v. The alkyl alcohol is preferably a lower alkyl alcohol (herein defined as an alcohol having less than 6 carbon atoms) such as ethanol, iso or n-propanol, most preferably the alkyl alcohol is isopropanol or n-propanol. The alcohol content preferably does not exceed 70% w/v. When the composition is in an aqueous carrier (for example for use in hand washing) the alcohol is desirably iso or n-propanol or a combination thereof and is preferably present in an amount of from 3 to 10% w/v, most preferably 4 to 8% w/v. When the composition is an alcoholic solution (for example for a rapid cleaning self-drying solution) the alkyl alcohol will be preferably be 55-75% w/v. The aryl alcohol is preferably a benzylalcohol, phenylethylalcohol, / phenoxyethanol, phenoxypropanol or a chlorinated derivative thereof. For application to skin, phenoxyethanol and phenoxypropanol are preferred. Preferably the aryl alcohol is present in an amount not exceeding 3% w/v. An inert carrier can be used - for example water or a lower alcohol such as ethanol. The composition may further comprise one or more of the following integers: (a) a solubilising agent for example propylene glycol, a hydrotrope or mixtures thereof. Suitable hydrotropes include urea, cumene sulphonate, toluene sulfonate, xylenesulphonate and the ethanolamine salts of citric and other hydroxycarboxylic acids. (b) a foaming agent such as an alkylaminooxide, alkylmono or diethanolamides. Examples of foaming agents are lauryl or cocodiethanolamide or monoethanolamide condensates or the lauryl or cetyl dimethylamineoxides. (c) viscosity modifiers such as cellulose derivatives, guar resins and carbopol resins. (d) preservatives such as imidazolidinyl, urea derivatives (Germabenes), methyl or propyl parabens (p-hydroxy benzoic esters). (e) other conventional additives such as colouring agents, fragrances, antioxidants, emolients, moisturisers, stabilising agents and thickeners such as carboxymethylcellulose. (f) optionally, additional surfactants including amphoteric surfactants, anionic surfactants and nonionic surfactants. Suitable additional surfactants include quaternary ammonium compounds or a small amount of a high foaming anionic surfactant such as laurylethoxysulfonate, sarcosinates, sodium laurylethersulphate. The additional ingredients are selected to avoid possible incompatibility with any of the other ingredients of the composition and especially with regard to the antimicrobial agents. The pH of the composition is typically adjusted to pH 5 to 7, most preferably 5.5 but is not limited to this pH. When chlorhexidine is used as the antimicrobial agent, a pH greater than 8 should be avoided to prevent precipitation of the t chlorhexidine free base. Most organic acids compatible with the composition, such as lactic, acetic, citric and gluconic acids, preferably gluconic acid, can be used to adjust the pH. The term "comprising" as herein used is used in an inclusive sense, that is to say in the sense of "including" or "containing". The term is not intended in an exclusive sense ("consisting of or "composed of). BEST MODES FOR CARRYING OUT THE INVENTION The following examples illustrate preferred embodiments of the present invention. They should not be construed as limiting. It will also be understood by those skilled in the art that while the present invention is described herein with reference to a concentrate, such a concentrate could be diluted prior to sale (for example to 55%) or use. EXAMPLES Example I - Comparative composition in accordance with WO 95/09605 Sodium laurylsulfate (100%) 4.67% w/v Alkylpolysaccharide (100%) 3.92% w/v Coconut Betaine (100%) 0.90% w/v Triclosan 0.49% w/v Propylene glycol 0.254% w/v Glycerine 0.254% w/v Sodium chloride 0.49% w/v Citric acid up to 10% w/v Water to 100% by volume Example II - Comparative Commercial Antibacterial Skin Cleanser Containing 2.0% (Triclosan) Full Comosition Unknown) ITT -Comparative Composition of Commercial Antiseptic Surgical Scrub Chlorhexidine Gluconate (CHG) 4.0% w/v Nonionic Surfactant* (1 00%) 25.00% w/v Lauryl Dimethylamineoxide ( 1 00%) 2.60% w/v Water to 100.0% by volume (formula as per published data (Manuf. Chemist, October 1973, p. 25-27 and disclosed in US Patent 3 855 140) *polyoxyethylene/polyoxypropylene block copolymer PLURONIC F87 (BASF, Germany). IV - Inventive Comosition containin Triclosan Same composition as Example 1 to which n-propanol 5.0% w/v and phenoxyethanol 1% w/v have been added. Example V - Inventive Composition containing Triclosan Same composition as Example 1 to which 5.0% w/v n-propanol and 1% w/v phenoxyethanol have been added and the triclosan increased to 1% w/v. Example VI - Inventive Composition Containing Chlorhexidine Gluconate Chlorhexidine Gluconate (CHG) 2.0% w/v Alkylpolysaccharide* (100%) 4.00% w/v Cocodiethanolamide (100%) 2.00% w/v Propylene Glycol 2.0% w/v Isopropanol 8.0% w/v Phenoxyethanol 2.0% w/v / Water to 100% by volume *Oramix™ NS10 55% w/v (Sepic SA, France). Example VII - Inventive Compositions Containing Chlorhexidine Gluconate Chlorhexidine gluconate (CHG) 1.0% w/v Alkylpolysaccharide* (100%) 4.00% w/v Cocodiethanolamide (100%) 0.80% w/v Propylene glycol 2.0% w/v n-propanol 6.0% w/v Phenoxypropanol 1.0% w/v Water to 100.0% by volume * Any commercial alkylpolysaccharide can be used such as Plantaren™ 2000 (Henkel) or Atlas™ G73500 (ICI). Example Vlll - Inventive Composition Containing Triclosan Triclosan 1.0% w/v Alkylpolysaccharide* (100%) 4.00% w/v Sodium 2 laurylethersulfate (100%) 0.20% w/v Cocodiethanolamide (100%) 2.00% w/v Isopropanol 8.0% w/v Propylene Glycol 10.0% w/v Preservative* * 1.0% w/v / Phenoxyethanol 2.0% w/v Water to 100.0% by volume *Oramix™ NS12 (Sepic SA, France) **Germabene™ II 0.2% w/v Example IX - Inventive Composition Containing Triclosan Triclosan 1.0% w/v Alkylpolysaccharide* (100%) 4.00% w/v Sodium 2 laurylethersulphate (100%) 0.25% w/v Sodium cumene sulfete (100%) 4.00% w/v Ethyl alcohol 4.0% w/v n-propanol 4.0% w/v Phenoxyethanol 1.5% w/v Water to 100% by volume *Any commercial alkylpolysaccharide can be used such as Plantaren™ 2000 (Henkel) or Atlas™ G73500 (ICI). Example X - Inventive Composition Containing Triclosan Triclosan 1.00% w/v Alkylpolysaccharide (100%) 2.75% w/v Cocodiethanolamide (100%) 0.80% w/v Sodium xylene sulphonate (100%) 4.00% w/v Isopropanol 8.0% w/v Propylene glycol 2.0% w/v Phenoxyethanol 1.0% w/v Carboxymethyl cellulose 0.6% w/v Phenoxypropanol 1.0% w/v Water to 100.0 by volume % Example XI - Inventive Composition Containing Dichlorophene Dichlorophene 1.5% w/v Alkylpolysaccharide (100%) 4.00% w/v Sodium 2 laurylethersulfate (100%) 0.20% w/v Cocodiethanolamide (100%) 2.00% w/v Isopropanol 5.0% w/v Phenoxyethanol 1.0% w/v Water to make 100.0% by volume Example XII - Inventive Comoosition Containing Dichloronhene 1.5%w/v 4.00% w/v 0.50% w/v 1.00% w/v 5.0% w/v 1.0% w/v to make 100.0% by volume Dichlorophene Alkylpolysaccharide (100%) Sodium 2 laurylethersulphate (100%) Cocodiethanolamide (100%) Ethanol Phenoxyethanol Water adjust pH to 7.0 - 7.2 with triethanolamine. Suspension tests were performed (in accordance with European Standard CEN/TC216/WG IN) in the presence of a number of organisms. The results are shown in the following table: TABLE I - SUSPENSION TESTS RESULTS EXPRESSED AS: log reduction Test temperature: 23°C; Contact time: 60 seconds Neutralising Medium: TweenSO 100 g/L, Lecithin 50 g/L, Histidine 1 g/L (Table Remove) NG: Means NO GROWTH Suspension tests were also conducted for the composition of Example X (1.0% w/v Triclosan). The results were as follows: Microbicidal Results Suspension test - 30 sec contact/con. 75% Expressed as a Log reduction of microorganisms. Microorganism Inoculum level Reduction S. aureus ATTC 6538 Log 6.8 > 5.8 E.coliATTC 11229 Log 6.9 >5.9 PS aeruginosa ATTC 15442 Log 7.0 > 6.0 P. mirabilia ATTC 14153 Log 6.8 > 6.0 Compositions according to the invention have the same or greater effectiveness with respect to biocidal activity and are less toxic, at much lower concentrations of the antimicrobial agent in comparison with conventional prior art compositions. In preferred embodiments, the use of an alkylpolysaccharide surfactant in amounts below 6% (w/v), the amount of triclosan can be successfully reduced from 1.0% to 0.5% (w/v) with substantially no loss in biocidal activity. Surprisingly the amount of chlorhexidine can be reduced 4% to 2% (w/v) whilst maintaining good biocidal activity and foaming properties. Further, by use of alkylpolysaccharides in amounts as low as 2% it is possible to obtain sufficient foaming skin cleansing properties not obtainable with other conventional surfactants. Further, the known interference with the antimicrobial properties of biocides with surfactants is considerably reduced. Further, by the inclusion of an alkyl and aryl alcohol combination, the compositions of the invention are effective against the pseudomonas microorganism. The invention is a significant and important improvement on the art as taught in US 3,855,140 as illustrated by the fact that, while the composition of US Patent 3,855,140 showed no activity against Pseudomonas, the compositions of the present invention are effective against Pseudomonas at concentrations containing as low as 0.49% triclosan. Compositions according to the invention are especially suitable for skin and hand disinfection, surface disinfection, impregnation of sponges, woven and non-woven textiles and the like. The composition of the invention is suitable for cleansing any object. The composition of the invention is particularly suitable for cleansing hands in clinical situations and before surgery but can also be used for cleansing inanimate objects such as surgical instruments. WE CLAIM: 1. An antiseptic cleaning composition effective against Pseudomonas comprising an antimicrobial agent which is chlorhexidine or triclosan, and characterised in that it further comprises: at least 2% w/v of an alkyl polysaccharide surfactant; at least one alkyl alcohol having less than 6 carbon atoms and; an aryl alcohol selected from the group consisting of benzyl alcohol, phenylethylalcohol, phenoxyethanol, phenoxypropanol, or a chlorinated derivative thereof. 2. A composition as claimed in claim 1, wherein the selected aryl alcohol is phenoxyethanol. 3. A composition as claimed in claim 1 or 2, wherein the content of the surfactant present in the composition does not exceed 6% w/v. 4. A composition as claimed in any one preceding claim wherein the alkylpolysaccharide is an alkylpolysaccharide of the formula (Formula Removed) wherein n is an integer between 5 and 19, and m is an integer between 1 and 3. A composition as claimed in any one of claims 1 to 3, wherein surfactant alkyl polysaccharide surfactant contains one or more sugar units selected from the group consisting of maltose, arabinose, xylose, mannose, galactose, gulose, idose, talose, allose, altrose, sucrose, fructose, sorbose, levulose, lactose, allulose, tagatose, allohetulose, sedoheptulose, glucoheptulose, mannoheptuloae, galoheptulose, idoheptulose, golactoheptulose, taloheptulose and derivatives thereof. 6. A composition as claimed in any one preceding claim wherein the antimicrobial agent is chlorhexidine or a chlorhexidine salt. 7. A composition as claimed in claim 6 wherein the chlorhexidine salt is chlorhexidine gluconate. 8. A composition as claimed in any one of claims 1 to 5, wherein the antimicrobial agent is chlorhexidine digluconate. 9. A composition as claimed in claim 6 wherein the chlorhexidine does not exceed 4.5% w/v. 10. A composition as claimed in any one of claims 1 to 5 wherein the antimicrobial agent is 2,4,4-trichloro-2-hydroxy-diphenylether (triclosan). 11. A composition as claimed in claim 10 wherein the 2,4,4-trichloro-2-hydroxydiphenylether does not exceed 3% w/v. 12. A composition as claimed in any one preceding claim, wherein the antimicrobial agent has a water solubility of at least 0.001% w/v at ambient temerpature. 13. A composition as claimed in any one preceding claim, wherein the alkyl alcohol is ethanol, isopropanol or n-propanol. 14. A composition as claimed in claim 13, wherein the alkyl alcohol is isopropanol or n-propanol or a combination thereof. 15. A composition as claimed in any one preceding claim, wherein the alcohol content does not exceed 70% w/v. 16. A composition as claimed in any one preceding claim, wherein the alcohol content is between 55 to 70% w/v. 17. A composition as claimed in claim 13 wherein the alcohol is present in an amount from 3 to 10% w/v. 18. A composition as claimed in claim 17 wherein the alcohol is present in an amount of from 4 to 8% w/v. 19. A composition as claimed in any one preceding claim wherein the aryl alcohol is selected from the group consisting of phenoxyethanol and phenoxypropanol. 20. A composition as claimed in anyone of the preceding claims wherein the aryl alcohol does not exceed 3% w/v. 21. A composition as claimed in any one of the preceding claims further including an inert carrier. 22. A composition as claimed in claim 21 wherein the inert carrier is water. 23. A composition as claimed in claim 21 wherein the inert carrier is a lower alcohol. 24. A composition as claimed in claim 23 wherein the inert carrier is ethanol. 25. A composition as claimed in any one preceding claim, further including one or more of the integers selected from the group consisting of: (a) a solubilising agent; (b) a foaming agent; (c) one or more viscosity modifiers; (d) preservatives; (e) conventional additives selected from the group consisting of colouring agents, fragrances, antioxidants, emollients, moisturisers, stabilising agents, and thickeners; and (f) additional surfactants. 26. A composition as claimed in claim 25 wherein the solubilising agent is propylene glycol, a hydrotrope or mixture thereof. 27. A composition as claimed in claim 26 wherein the hydrotrope is selected from the group consisting of urea, cumenesulfonate, toluensulfonale, xylenesulphonate and the ethanolamine salts of citric and other hydroxycarboxylic acids. 28. A composition as claimed in any one of claims 25 to 27 wherein the foaming agent is an alkylaminooxide, alkylmono or diethanolamide. 29. A composition as claimed in claim 28 wherein the foraming agent is selected from the group consisting of lauryl condensates, coco diethanolamide condensates, monoethanolamide condensates, lauryl dimethylamine oxides and cetyl dimethylamine oxides. 30. A composition as claimed in any one of claims 25 to 29, wherein the viscosity modifier is selected from the group consisting of cellulose derivatives, guar ersins and carbopol resins. 31. A composition as claimed in any one of claims 25 to 30, wherein the preservative is selected from the group consisting of imidazolidinyl derivatives, urea derivatives (Germabenes), methyl parabens (p-hydroxy benzoic esters) or propyl parabens (p-hydroxy benzoic esters). 32. A composition as claimed in claim 25 wherein the thickener is carboxymethylcellulose. 33. A composition as claimed in any one of claims 25 to 32, wherein the additional surfactant is selected from the group consisting of amphoteric surfactants, anionic surfactants and non-ionic surfactants. 34. A composition as claimed in any one of claims 25 to 32, wherein the additional surfactants include a quaternary ammonium compound or a high anionic surfactant. 35. A composition as claimed in claim 34, wherein the high foaming anionic surfactant is selected from the group consisting of laurylethoxysulfonste, a sarcosinate and sodium 2 laurylethersulphate. 36. A composition as claimed in any one preceding claim, wherein the pH is 8 or less. 37. A composition as claimed in any one preceding claim, wherein the pH is in the range of 5 to 7. 38. A composition as claimed in claim 37 wherein the pH is 5.5. 39. A composition as claimed in any one preceding claim, wherein the pH is adjusted by an organic acid. 40. A composition as claimed in claim 39 wherein the organic acid is selected from the group consisting of lactic acid, acetic acid, citric acid and gluconic acid. 41. A composition as claimed in claim 40 wherein the organic acid is gluconic acid. 42. A method of decontaminating surfaces with bacteria, comprising contacting the surface with a disinfectant cleansing composition as claimed in any one of the preceding claims.

Documents:

1195-DEL-2002-Abstract-(17-10-2008).pdf

1195-del-2002-abstract.pdf

1195-DEL-2002-Claims-(17-10-2008).pdf

1195-del-2002-claims.pdf

1195-DEL-2002-Correspondence-Others-(17-10-2008).pdf

1195-del-2002-correspondence-others.pdf

1195-del-2002-description (complete).pdf

1195-del-2002-form-1.pdf

1195-del-2002-form-18.pdf

1195-del-2002-form-2.pdf

1195-DEL-2002-Form-3-(17-10-2008).pdf

1195-del-2002-form-3.pdf

1195-del-2002-form-5.pdf

1195-DEL-2002-GPA-(17-10-2008).pdf

1195-del-2002-gpa.pdf

1195-DEL-2002-Petition-137-(17-10-2008).pdf

1195-DEL-2002-Petition-138-(17-10-2008).pdf