MXPA99010737A - Alkylpolyglucosides containing disinfectant compositions active against pseudomonas microorganism - Google Patents

Abstract

An antiseptic cleansing composition comprising an antimicrobial agent, an effective amount of an alkylpolysaccharide surfactant, at least one alkyl alcohol and at least one aryl alcohol. Suitable surfactant alkylpolysaccharides may contain 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, alloheptulose, sedoheptulose, glucoheptulose, mannoheptulose, guloheptulose, idoheptulose, galactoheptulose, glucoheptulose, mannoheptulose, guloheptulose, idoheptulose, galactoheptulose, taloheptulose and derivatives thereof. Suitable antimicrobial agents include chlorhexidine, chlorhexidine salt, chlorophenol derivative, octenidindihydrochloride (CH3-(CH2)7-NHON-(CH2)10-NO-NH(CH2)7-CH2 or any other salt thereof, and quaternary ammonium compounds.

Description

DISINFECTANT COMPOSITIONS CONTAINING ACTIVE ALKYLPOLIGLUCOSIDES AGAINST PSEUDOMONAS TECHNICAL FIELD This invention relates to a disinfectant cleaning composition.

TECHNICAL BACKGROUND It is known that the infection is spread by the transmission of pathogenic microorganisms by contact with the skin. It is well known, to this day, that in order to adequately reduce the presence of such organisms, the skin is carved with a solution containing a surfactant agent, after which an antiseptic is applied. It has been suggested in recent years that it would be desirable to combine the washing and disinfecting actions in a single operation providing a composition that consists of both an antimicrobial agent and a surfactant. However, it has been found that many antimicrobial agents, such as chlorhexidine digluconate [N, N'-bis (4-chlorophenyl) -3,12-di-amino-2,4,11, 13-tetraazatetradecanediamidamide] and other salts of chlorhexidine are incompatible with the anionic surfactants, and their antimicrobial activity is reduced by the nonionic surfactants, thus requiring the addition of more antimicrobial agent to adequately preserve sufficient biocidal activity in the amount of surfactant required for a satisfactory foam formation. In particular, Patent E.U.A. 3,855,140 assigned to Imperial Chemical Industries discloses a skin cleansing composition comprising a soluble salt of chlorhexidine in combination with a polyoxyethylene-polyoxypropylene block copolymer. In order to obtain sufficient sudsing with the polymer, it is necessary to use high proportions of the surfactant in amounts of the order of 20-25%. Consequently, high amounts of chlorhexidine are required to maintain the desired antimicrobial activity. Such high amounts are undesirable since it is known that surfactants can adversely affect the skin by removing fat, causing, along with biocides such as chlorhexidine, skin irritation. In addition, the ingredients of the composition can be expensive. It would therefore be desirable to provide a composition in which the amounts of the antimicrobial agent and the surfactant are reduced while maintaining sufficient antimicrobial activity and foaming capacity. In this regard, to properly provide a composition as such, WO 95/09605 teaches combining a phenolic disinfectant with an alkylpolyglucoside based surfactant. However, as indicated in that patent, although such compositions show good biocidal activity against most microorganisms, they are unable to disinfect surfaces contaminated with the microorganism Pseudomonas aeruginosa to which said compositions are inactive. It is an object of the invention to substantially improve the disadvantages of the prior art.

DESCRIPTION OF THE INVENTION According to a first aspect of the invention, there is provided an antiseptic cleansing composition comprising an antimicrobial agent, an effective amount of an alkylpolysaccharide based surfactant, at least one alkyl alcohol and at least one aryl alcohol. According to a second aspect of the invention, a method is provided for decontaminating surfaces contaminated with bacteria including Pseudomonas, which method comprises contacting the surface with the disinfecting cleaning composition of the first aspect. Typically the cleaning composition consists of an inert carrier and, optionally, other additives. The alkylpolysaccharide based surfactants are known in the art as alkylpolyglycosides, however, for the purposes of the following discussion, the surfactant will be referred to as alkylpolysaccharide.

Preferably, the content of surfactant present in the composition is not greater than 6% w / v. Preferably, the alkyl polysaccharide is an alkyl polysaccharide of the formula: wherein n is an integer between 5 and 19 and m is an integer between 1 and 3. In the above formula the alkyl polysaccharide of the surfactant shown contains glucose units, however the invention is not limited thereto and one or more of the Glucose units can be replaced by other sugar units. Other sugar units that could be included in the alkylpolysaccharide include maltose, arabinose, xylose, mannose, galactose, gulose, idose, talose, allose, algae, sucrose, fructose, sorbose, levulose, lactose, alulose, tagatose, aloheptulose, sedoheptulose, glucoheptulose, mannoheptulose, guloheptose, idoheptulose, galactoheptulose, taloheptulose and derivatives thereof. Suitable antimicrobial agents include chlorhexidine and its salts; dichlorophen, other chlorophenol derivatives such as p-chloro-m-xylenol, chlorophen and o-phenylphenol, 2,4,4-trichloro-2-hydroxy-diphenyl ether (triclosan); octenidino dihydrochloride (CH3- (CH2) 7-NHON- (CH2)? o -NO-NH (CH2) 7-CH2 or any other salt thereof and quaternary ammonium compounds Suitable chlorhexidine salts include gluconate salts, isethioate, formate, acetate, glutamate, succinamate, monodiglycolate, dimethanesulfonate, lactate, diisobutyrate or glucoheptonate Preferably, the antimicrobial agent has a solubility in water of at least 0.001% w / v at room temperature When the antimicrobial agent is digluconate of chlorhexidine, this is used in an amount that preferably does not exceed 4.5% w / v. When the antimicrobial agent is 2,4,4-trichloro-2-hydroxy-diphenyl ether (triclosan), it is used in an amount preferably not exceeding 3% w / v. The alkyl alcohol is preferably a lower alkyl alcohol (defined herein as an alcohol having less than 6 carbon atoms) such as ethanol, iso or n-propanol, 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 vehicle (for example for use in hand washing) it is desired that the alcohol is iso or n-propanol or a combination thereof and that it is preferably present in an amount of 3 to 10% p / v, most preferred from 4 to 8% p / v. When the composition is an alcohol solution (for example for a fast cleaning solution that dries alone), the alkyl alcohol will preferably be between 55-75% w / v. The aryl alcohol is preferably a benzyl alcohol, phenylethyl alcohol, phenoxyethanol, phenoxypropanol or a chlorinated derivative thereof. For application to the skin, phenoxyethanol and phenoxypropanol are preferred.

Preferably, aryl alcohol is present in an amount no greater than 3% p / 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 ingredients: (a) a solubilizing agent for example propylene glycol, a hydrotrope or mixtures thereof. Suitable hydrotropes include urea, cumenesulfonate, toluenesulfonate, xylene sulfonate and the ethanolamine salts of citric acid and other hydroxycarboxylic acids. (b) a foaming agent such as an alkylamine oxide, alkyl mono or diethanolamides. Examples of foaming agents are the condensates of lauryl or cocodiethanolamide or of monoethanolamide or the oxides of lauryl or cetyldimethylamine. (c) viscosity modifiers such as cellulose derivatives, guar resins and carbopol resins. (d) preservatives such as imidazolidinyl derivatives, urea derivatives (Germabenos), methyl- or propylparabens (esters of p-hydroxybenzoic acid). (e) other conventional additives such as coloring agents, fragrances, antioxidants, emollients, humectants, stabilizing 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 laurylethoxysnate, sarcosinates, sodium lauryl ether ste. The additional ingredients are selected to avoid possible incompatibilities with any of the other ingredients of the composition and especially with respect to the antimicrobial agents. The pH of the compositions is typically adjusted to a pH between 5 and 7, preferably 5.5 but 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 chlorhexidine free base. Most organic acids compatible with the composition, such as lactic acid, acetic acid, citric acid and gluconic acid, preferably gluconic acid, can be used to adjust the pH. The term "comprising" as used herein is used in an inclusive sense, ie in the sense of "include" or "contain." The term is not designed in an excluding sense ("consisting of" or "composed of").

BEST MODES FOR CARRYING OUT THE INVENTION The following examples illustrate the preferred embodiments of the present invention. These should not be considered as limiting. Those skilled in the art will also understand that while the present invention is described with reference to a concentrate, such a concentrate may be diluted before being sold (for example up to 55%) or before being used.

EXAMPLES EXAMPLE 1 Comparative composition in accordance with WO 95/09605 Sodium lauryl sulfate (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 Glycerin 0.254 w / v v Sodium chloride 0.49% w / v citric acid up to 10% w / v Water up to 100% by volume EXAMPLE 2 Comparative commercial antibacterial skin cleanser containing 2.0% (triclosan) (complete composition unknown) EXAMPLE 3 Comparative composition for commercial antiseptic surgical brush Chlorhexidine gluconate (CHG) 4.0% w / v Nonionic surfactant * (100%) 25.00% w / v Lauryldimethylamine oxide (100%) 2.60% w / v Water up to 100.0% by volume (Formula in accordance with published data (Manuf.Chemist, October 1973, pp. 25-27 and described in patent E.U.A. 3 855 140) * polyoxyethylene / polyoxypropylene block copolymer PLURONIC F87 (BASF, Germany).

EXAMPLE IV Composition of the invention containing triclosan The same composition as Example 1 to which 5.0% w / v of n-propanol and 1% w / v of phenoxyethanol was added. EXAMPLE V Composition of the invention containing triclosan Same composition as Example 1 to which was added 5% w / v of n-propanol and 1% w / v of phenoxyethanol and triclosan was increased to 1% w / v.

EXAMPLE VI Composition of the invention 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 Up to 100% by volume Oramix ™ NS10 55% p / v (Sepic SA, France) EXAMPLE VII Compositions of the invention which contain 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% p / v Water Up to 100% by volume * Any commercial alkylpolysaccharide such as Plantaren ™ can be used 2000 (Henkel) or Atlas ™ G73500 (ICI).

EXAMPLE Vlll Composition of the invention containing triclosan Triclosan 1.0% p / v Alkylporisaccharide * (100%) 4.00% p / v 2-sodium lauryl ether sulphate (100%) 0.20% w / v Cocodiethanolamide (100%) 2.00% p / v Isopropanol 8.0% p / v Propylene glycol 10.0% p / v Conservative ** 1.0% p / v Phenoxyethanol 2.0% w / v Water Up to 100% by volume * Oramix ™ NS12 (Sepic SA, France) ** Germabene ™ II 0.2% p / v EXAMPLE IX Composition of the invention containing Triclosan Triclosan 1.0% w / v Alkylpolysaccharide * (100%) 4.00% w / v 2-lauryl ether sulphate (100%) 0.25% w / v Sodium Cumensulfate 4.00% w / v Ethanol 4.0% w / v n-propanol 4.0% p / v Phenoxyethanol 1.5% w / v Water Up to 100% by volume * Any commercial alkyl polysaccharide such as Plantaren ™ 2000 (Henkel) or Atlas ™ G73500 (ICI) can be used.

EXAMPLE X Composition of the invention containing Triclosan Triclosan 1.00% w / v Alkylpolysaccharide (100%) 2.75% w / v Cocodiethanolamide (100) 0.80% w / v Sodium xylenesulphate (100%) 4.0% w / v Isopropanol 8.0% w / v Propylene glycol 2.0% w / v Phenoxyethanol 1.0 % p / v Carboxymethylcellulose 0.6% w / v Fenoxipropanol 1.0% w / v Water Up to 100.0% by volume EXAMPLE XI Composition of the invention containing Dichlorophene Dichlorophen 1.5% w / v Alkylpolysaccharide (100%) 4.00% w / v 2-lauryl ether sodium sulfate (100%) 0.20% w / v Cocodiethanolamide (100%) 2.00% p / v Isopropanol 5.00% p / v Phenoxyethanol 1.0% w / v Water Up to 100.0 in volume EXAMPLE Xll Composition of the invention containing Dichlorophene Dichlorophen 1.5% w / v Alkylpolysaccharide (100%) 4.00% w / v 2 sodium lauryl ether sulphate (100%) 0.50% w / v Cocodiethanolamide (100%) 1.00% w / v Ethanol 5.0% w / v Phenoxyethanol 1.0% w / o v Water Up to 100% by volume Adjust pH to 7.0-7.2 with triethanolamine The suspension tests were performed (in accordance with the European standard CEN / TC216 / WG IN) in the presence of a number of organisms. The results are shown in the following table: TABLE 1 Suspension tests Results expressed as: logarithmic reduction Test temperature: 23 ° C; Contact time: 60 seconds Neutralizing medium: TweendO 100 g / L, Lecithin 50 g / L, Histidine 1 g / L Test organism E. Coli S. aureus P. aeruginosa S. faecalis NCTC 8196 NCTC 4163 NCTC 6749 NCTC 775 Pure pure pure concentration contact T. (sec) 60 60 60 60 Formulations Ex. I comparative 0.49% w / v triclosan NC NC > 2 > 2 Ex IV of the invention NC NC NC CN 0.49% w / v triclosan Ex. I i comparative 2% w / v > 2 > 2 > 2 > 2 of triclosan Ex. V of the invention 1.0% w / v of triclosan NC NC NC NC Ex. Lll comparative 2% w / v of CHG NC 3.8 NC 3.9 Ex VI of the invention 2.0% NC NC NC NC p / v of CHG Injection level 2.5x108 2.8x108 1.3x108 1.8x108 N.C. means NOT GROW Suspension tests were also carried out for the composition of Example X (1% w / v triclosan). The results were as follows: Microbicidal results Suspension-contact test 30 sec / concentration 75% Expressed as a logarithmic reduction of microorganisms Microorganisms Inoculation level Reduction S. aureus ATTC 6538 Log 6.8 > 5.8 E. coli ATTC 11229 Log 6.9 > 5.9 PS aeruginosa ATTC 15442 Log 7.0 > 6.0 P. mirabilia ATTC 14153 Log 6.8 > 6.0 The compositions according to the invention have an equal or greater effectiveness with respect to the biocidal activity and are less toxic, at much lower concentrations of the antimicrobial agent compared to the conventional compositions in the prior art. In the preferred embodiments, the use of an alkylpolysaccharide based surfactant in amounts below 6% (w / v), allows the amount of triclosan to be successfully reduced from 1.0% to 0.5% (w / v) without substantial loss in the biocidal activity. Unexpectedly, the amount of chlorhexidine can be reduced from 4% to 2% (w / v) while maintaining good biocide activity and foaming properties. Furthermore, by using the alkylpolysaccharide in amounts as low as 2% it is possible to achieve sufficient foaming properties for skin cleansing, which can not be obtained with other conventional surfactants. The known interference of the surfactants with the antimicrobial properties of the biocides is also considerably reduced.

In addition, by including a combination of alkyl and aryl alcohol, the compositions of the invention are effective against Pseudomonas. The invention is a significant and important improvement in the art as taught in US Pat. No. 3,855,140 which is illustrated by the fact that, while the composition of the patent E.U.A. No. 3,855,140 showed no activity against Pseudomonas, the compositions of the present invention are effective against Pseudomonas in concentrations containing as low as 0.49% triclosan. The compositions according to the invention are especially suitable for disinfecting skin and hands, disinfecting surfaces, impregnating sponges, woven and non-woven fabrics and the like. The composition of the invention is suitable for cleaning any object. The composition of the invention is particularly suitable for cleaning hands in clinical situations and before surgical intervention but it can also be used to clean inanimate objects such as surgical instruments.

Claims (50)

NOVELTY OF THE INVENTION CLAIMS

1. - An effective antiseptic cleansing composition against Pseudomonas comprising an antimicrobial agent, an effective amount of an alkylpolysaccharide based surfactant, at least one alkyl alcohol and at least one aryl alcohol.

2. A cleaning composition according to claim 1, further characterized in that it comprises an inert vehicle.

3. A composition according to claim 1 or claim 2, further characterized in that the content of the surfactant present in the composition is not greater than 6%.

4. A composition according to any of the preceding claims, further characterized in that the alkylpolysaccharide is an alkylpolysaccharide of the formula: where n is an integer between 5 and 19 and m is an integer between 1 and 3.

5. - A composition according to any of claims 1 to 3, further characterized in that the alkylpolysaccharide of the surfactant contains one or more sugar units that are selected from the group consisting of maltose, arabinose, xylose, mannose, galactose, gulose, idosa, talose, allose, altrose, sucrose, fructose, sorbose, levulose, lactose, alulose, tagatose, aloheptulose, sedoheptulose, glucoheptulose, mannoheptulose, guloheptulose, idoheptulose, galactoheptulose, taloheptulose and derivatives thereof.

6. A composition according to any of the preceding claims, further characterized in that the antimicrobial agent is selected from the group consisting of chlorhexidine, chlorhexidine salt, chlorophenol derivatives, octenidino dihydrochloride (CH3- (CH2) 7-NHON- (CH2)? O-NO-NH (CH2) 7-CH2 or any other salt thereof, and quaternary ammonium compounds

7. A composition according to claim 6, further characterized in that the chlorhexidine salt is selected from the group consisting of the salts gluconate, setionate, formate, acetate, glutamate, succinamate, monodiglycolate, dimethanesulfonate, lactate, diisobutyrate or glucoheptonate

8. A composition according to any of claims 1 to 7, further characterized in that the agent antimicrobial is chlorhexidine digluconate.

9. - A composition according to claim 8, further characterized in that the chlorhexidine does not exceed 4.5% w / v.

10. A composition according to claim 6, further characterized in that the chlorophenol derivative is selected from the group consisting of dichlorophen, p-chloro-m-xylenol, chlorophene, o-phenylphenol and 2,4,4-trichloro ether -2-hydroxy-diphenyl.

11. A composition according to claim 10, further characterized in that the antimicrobial agent is 2,4,4-trichloro-2-hydroxy-diphenyl ether.

12. A composition according to claim 11, further characterized in that the 2,4,4-trichloro-2-hydroxy-diphenyl ether does not exceed 3% w / v.

13. A composition according to any of the preceding claims, further characterized in that the antimicrobial agent has a solubility in water of at least 0.001 w / v at room temperature.

14. A composition according to any of the preceding claims, further characterized in that the alkyl alcohol is a lower alkyl alcohol.

15. A composition according to claim 14, further characterized in that the lower alkyl alcohol is ethanol, isopropanol or n-propanol.

16. - A composition according to claim 15, further characterized in that the lower alkyl alcohol is isopropanol or n-propanol or a combination thereof.

17. A composition according to any of the preceding claims, further characterized in that the alcohol content is not greater than 70% w / v.

18. A composition according to any of the preceding claims, further characterized in that the alcohol content is between 55-70% w / v.

19. A composition according to claim 17, further characterized in that alcohol is present in an amount of 3 to 10% w / v.

20. A composition according to claim 19, further characterized in that the alcohol is present in an amount of 4 to 8% w / v.

21. A composition according to any of the preceding claims, further characterized in that the aryl alcohol is selected from the group consisting of benzyl alcohol, a phenylethyl alcohol, a phenoxyethanol, a phenoxypropanol or a chlorinated derivative thereof.

22. A composition according to claim 21, further characterized in that the aryl alcohol is selected from the group consisting of phenoxyethanol and phenoxypropanol.

23. - A composition according to any of the preceding claims, further characterized in that the aryl alcohol does not exceed 3% w / v.

24. A composition according to any of the preceding claims, further characterized in that it includes an inert vehicle.

25. A composition according to claim 24, further characterized in that the inert vehicle is water.

26. A composition according to claim 24, further characterized in that the inert carrier is a lower alcohol.

27. A composition according to claim 26, further characterized in that the inert carrier is an ethanol.

28. A composition according to any of the preceding claims, further characterized in that it includes one or more of the ingredients that are selected from the group consisting of a) a solubilizing agent, b) a foaming agent, c) a further modifying agent, viscosity, d) preservatives, e) other conventional additives, f) additional surfactants.

29. A composition according to claim 28, further characterized in that the solubilizing agent is propylene glycol, a hydrotrope or mixtures thereof.

30. A composition according to claim 29, further characterized in that the hydrotrope is selected from the group consisting of urea, cumenesulfonate, toluenesulfonate, xylene sulfonate and the ethanolamine salts of citric acid and other hydroxycarboxylic acids.

31.- A composition according to any of claims 28 to 30, further characterized in that the foaming agent is an alkylamine, alkyl monono or diethanolamide oxide.

32. A composition according to claim 31, further characterized in that the foaming agent is selected from the group consisting of lauryl condensates, cocodiethanolamide condensates, monoethanolamide condensates, lauryl dimethylamine oxides and cetyldimethylamine oxides.

33. A composition according to any of claims 28 to 32, further characterized in that the viscosity modifier is selected from the group consisting of cellulose derivatives, guar resins and carbopol resins.

A composition according to any of claims 28 to 33, further characterized in that the preservative is selected from the group consisting of imidazolidinyl derivatives, urea derivatives (germabenes), methylparabens (esters of p-hydroxybenzoic acid) or propylparabens (esters) of p-hydroxybenzoic acid).

35. A composition according to any of claims 28 to 34, further characterized in that the conventional additives are selected from the group consisting of coloring agents, fragrances, antioxidants, emollients, stabilizing agents and thickeners.

36. - A composition according to claim 35, further characterized in that the thickener is carboxymethylcellulose.

37. A composition according to any of claims 28 to 36, further characterized in that the additional surfactant is selected from the group consisting of amphoteric surfactants, anionic surfactants and ionic surfactants.

38.- A composition according to claim 37, further characterized in that the additional surfactant includes a quaternary ammonium compound or an anionic high foaming surfactant.

39. A composition according to claim 38, further characterized in that the high foaming anionic surfactant is selected from the group consisting of laurylethoxysulfonate, a sarcosinate and sodium 2-lauryl ether sulphate.

40.- A composition according to any of claims 28 to 39, further characterized in that the additional ingredients are selected to avoid possible incompatibilities with any of the other ingredients of the composition and especially with respect to the antimicrobial agent.

41. A composition according to any of the preceding claims, further characterized in that the pH is 8 or less.

42. - A composition according to any of the preceding claims, further characterized in that the pH is in the range of 5 to 7.

43.- A composition according to claim 40, further characterized in that the pH is 5.5.

44. A composition according to any of claims 1 to 40, further characterized in that the pH is controlled to avoid precipitation of the ingredients.

45.- A composition according to any of the preceding claims, further characterized in that the pH is adjusted by an organic acid.

46. A composition according to claim 45, further characterized in that the organic acid is selected from the group consisting of lactic acid, acetic acid, citric acid and gluconic acid.

47. A composition according to claim 46, further characterized in that the organic acid is gluconic acid.

48. A method for decontaminating surfaces contaminated with bacteria including pseudomonas, which method comprises contacting the surface with a disinfecting cleaning composition according to any of the preceding claims.

49.- A cleaning disinfectant composition substantially as that described herein with reference to any of the examples.

50. - A method for decontaminating surfaces substantially as described herein with reference to any of the examples.