Composition and method for pre-surgical skin disinfection

Abstract

This invention provides a pre-surgical disinfecting composition that includes at least about 50 percent by weight of a C1-6 alcohol, based upon the total weight of the disinfecting composition, an acid, and a cationic oligomer or polymer. A method for pre-surgical skin disinfection with rapid antiseptic efficacy without the use of secondary antimicrobial compounds is also described.

Description

Claims

1. A pre-surgical disinfecting composition comprising at least about 50 percent by weight of a C1-6 alcohol, based upon the total weight of the disinfecting composition;an acid selected from mineral acids, organic acids, or mixtures thereof; anda cationic oligomer or polymer, wherein said composition provides a log kill of greater than about 3 in less than about 3 minutes against resident and transient skin flora.

2. The composition of claim 1, wherein said C1-6 alcohol comprises ethanol, 2-propanol, n-propanol, or mixtures thereof.

3. The composition of claim 1, wherein said acid comprises hydrochloric acid, nitric acid, sulfuric acid, phosphoric acid, phosphonic acid, boric acid, adipic acid, benzene 1,3,5 tricarboxylic acid, chlorosuccinic acid, choline chloride, cis-aconitic acid, citramalic acid, citric acid, cyclobutane 1,1,3,3 tetracarboxylic acid, cyclohexane 1,2,4,5 tetracarboxylic acid, cyclopentane 1,2,3,4 tetracarboxylic acid, diglycolic acid, fumaric acid, glutamic acid, glutaric acid, glyoxylic acid, isocitric acid, ketomalonic acid, lactic acid, maleic acid, malic acid, malonic acid, nitrilotriacetic acid, oxalacetic acid, oxalic acid, phytic acid, p-toluenesulfonic acid, salicylic acid, succinic acid, tartaric acid, tartronic acid, tetrahydrofuran 2,3,4,5 tetracarboxylic acid, tricarballylic acid, versene acids, 3-hydroxyglutaric acid, 2-hydroxypropane 1,3 dicarboxylic acid, glyceric acid, furan 2,5 dicarboxylic acid, 3,4-dihydroxyfuran-2,5 dicarboxylic acid, 3,4-dihydroxytetrahydrofuran-2,5-dicarboxylic acid, 2-oxo-glutaric acid, d1-glyceric acid, 2,5 furandicarboxylic acid, or mixtures thereof.

4. The composition of claim 1, wherein said cationic oligomer or polymer comprises a cationic polysaccharide, cationic copolymer of saccharide and synthetic cationic monomer, synthetic cationic oligomer or polymer, or mixtures thereof.

5. The composition of claim 4, wherein said synthetic cationic oligomer or polymer comprises a cationic polyalkylene imine, cationic ethoxy polyalkylene imine, cationic poly[N-[3-(dialkylammonio)alkyl]N[3-(alkyleneoxyalkylene dialkylammonio)alkyl]urea dichloride], vinyl caprolactam/VP/dialkylaminoalkyl alkylate copolymer, or polyquaternium polymer.

6. The composition of claim 1, wherein said cationic oligomer or polymer comprises polyquaternium-2, polyquaternium-4, polyquaternium-5, polyquaternium-6, polyquaternium-7, polyquaternium-10, polyquaternium-11, polyquaternium-16, polyquaternium-22, polyquaternium-24, polyquaternium-28, polyquaternium-32, polyquaternium-37, polyquaternium-39, polyquaternium-42, polyquaternium-43, polyquaternium-44, polyquaternium-46, polyquaternium-47, polyquaternium-51, polyquaternium-53, polyquaternium-55, polyquaternium-57, polyquaternium-58, polyquaternium-59, polyquaternium-60, polyquaternium-63, polyquaternium-64, polyquaternium-65, polyquaternium-68, or mixtures thereof.

7. The composition of claim 1, wherein said composition comprises ethanol, citric acid, and polyquaternium-37.

8. The composition of claim 7, wherein said composition comprises at least about 70 percent by weight of ethanol, based upon the total weight of the disinfecting composition; from about 0.012 to about 1 percent by weight of citric acid, based upon the total weight of the disinfecting composition, and from about 0.02 to about 30 percent by weight of polyquaternium-37, based upon the total weight of the disinfecting composition.

9. The composition of claim 1, wherein said composition provides a log kill of greater than about 3 on day 5 of the FDA TFM surgical hand scrub test.

10. The composition of claim 1, wherein said composition provides a log kill of greater than about 3 on day 1 of the FDA TFM surgical hand scrub test.

11. The composition of claim 1, wherein said composition provides a log kill of greater than about 3 in less than about 2 minutes against resident and transient skin flora.

12. The composition of claim 1, wherein said composition provides a log kill of greater than about 3 in less than about 1 minutes against resident and transient skin flora.

13. A method for pre-surgical hand disinfection, the method comprising: contacting the skin with an effective amount of a disinfecting composition comprising at least about 50 percent by weight of a C1-6 alcohol, based upon the total weight of the disinfecting composition; an acid; and a cationic oligomer or polymer.

14. The method of claim 13, wherein said step of contacting provides at least about 3 log kill of resident and transient skin flora in about 1 minute or less, according to the FDA TFM surgical hand scrub test.

15. The method of claim 13, wherein said composition provides a log kill of greater than about 3 in less than about 2 minutes against resident and transient skin flora, according to the FDA TFM surgical hand scrub test.

16. The method of claim 13, wherein said composition provides a log kill of greater than about 3 in less than about 1 minutes against resident and transient skin flora, according to the FDA TFM surgical hand scrub test.

17. The method of claim 13, wherein said composition provides a log kill of greater than about 3 against resident and transient skin flora, on the fifth day of use according to the FDA TFM surgical hand scrub test.

18. A method for skin disinfection, the method comprising: contacting the skin with an effective amount of a disinfecting composition comprising at least about 50 percent by weight of a C1-6 alcohol, based upon the total weight of the disinfecting composition; an acid; and a cationic oligomer or polymer.

19. The method of claim 18, wherein said step of contacting provides at least about 3 log kill of resident and transient skin flora in about 1 minute or less.

20. The method of claim 18, wherein said composition provides a log kill of greater than about 3 in less than about 2 minutes against resident and transient skin flora.

21. The method of claim 18, wherein said composition provides a log kill of greater than about 3 in less than about 1 minutes against resident and transient skin flora.

22. The method of claim 18, wherein said organic acid comprises hydrochloric acid, nitric acid, sulfuric acid, phosphoric acid, phosphonic acid, boric acid, adipic acid, benzene 1,3,5 tricarboxylic acid, chlorosuccinic acid, choline chloride, cis-aconitic acid, citramalic acid, citric acid, cyclobutane 1,1,3,3 tetracarboxylic acid, cyclohexane 1,2,4,5 tetracarboxylic acid, cyclopentane 1,2,3,4 tetracarboxylic acid, diglycolic acid, fumaric acid, glutamic acid, glutaric acid, glyoxylic acid, isocitric acid, ketomalonic acid, lactic acid, maleic acid, malic acid, malonic acid, nitrilotriacetic acid, oxalacetic acid, oxalic acid, phytic acid, p-toluenesulfonic acid, salicylic acid, succinic acid, tartaric acid, tartronic acid, tetrahydrofuran 2,3,4,5 tetracarboxylic acid, tricarballylic acid, versene acids, 3-hydroxyglutaric acid, 2-hydroxypropane 1,3 dicarboxylic acid, glyceric acid, furan 2,5 dicarboxylic acid, 3,4-dihydroxyfuran-2,5 dicarboxylic acid, 3,4-dihydroxytetrahydrofuran-2,5-dicarboxylic acid, 2-oxo-glutaric acid, d1-glyceric acid, 2,5 furandicarboxylic acid, or mixtures thereof.

23. The method of claim 18, wherein said cationic polymer comprises a cationic polysaccharide, cationic copolymer of saccharide and synthetic cationic monomer, synthetic cationic oligomer or polymer, or mixtures thereof.

24. The method of claim 18, wherein said synthetic cationic oligomer or polymer comprises a cationic polyalkylene imine, cationic ethoxy polyalkylene imine, cationic poly[N-[3-(dimethylammonio)propyl]N′[3-(ethyleneoxyethylene dimethylammonio)propyl]urea dichloride], vinyl caprolactam/VP/dimethylaminoethyl methacrylate copolymer, or polyquaternium polymer.

25. The method of claim 18, wherein said cationic oligomer or polymer comprises polyquaternium-2, polyquaternium-4, polyquaternium-5, polyquaternium-6, polyquaternium-7, polyquaternium-10, polyquaternium-11, polyquaternium-16, polyquaternium-22, polyquaternium-24, polyquaternium-28, polyquaternium-32, polyquaternium-37, polyquaternium-39, polyquaternium-42, polyquaternium-43, polyquaternium-44, polyquaternium-46, polyquaternium-47, polyquaternium-51, polyquaternium-53, polyquaternium-55, polyquaternium-57, polyquaternium-58, polyquaternium-59, polyquaternium-60, polyquaternium-63, polyquaternium-64, polyquaternium-65, polyquaternium-68, or mixtures thereof.

26. The method of claim 18, wherein said disinfecting composition comprises: ethanol;an acid selected from the group consisting of citric acid, lactic acid, malic acid, tartaric acid, salicylic acid, oxalic acid, and mixtures thereof; anda cationic polymer selected from the group consisting of polyquaternium-2, polyquaternium-4, polyquaternium-6, polyquaternium-7, polyquaternium-10, polyquaternium-1, polyquaternium-16, polyquaternium-22, polyquaternium-24, polyquaternium-28, polyquaternium-37, polyquaternium-39, polyquaternium-46, polyquaternium-47, polyquaternium-53, polyquaternium-55, and mixtures thereof.

27. The method of claim 18, wherein said disinfecting composition comprises: at least about 50 percent by weight of a C1-6 alcohol, based upon the total weight of the disinfecting composition;from about 0.012 to about 1 percent by weight of an acid selected from the group consisting citric acid, lactic acid, malic acid, tartaric acid, salicylic acid, oxalic acid, and mixtures thereof, based upon the total weight of the disinfecting composition; andfrom about 0.02 to about 30 percent by weight of a cationic polymer selected from the group consisting of polyquaternium-2, polyquaternium-4, polyquaternium-6, polyquaternium-7, polyquaternium-10, polyquaternium-11, polyquaternium-16, polyquaternium-22, polyquaternium-24, polyquaternium-28, polyquaternium-37, polyquaternium-39, polyquaternium-46, polyquaternium-47, polyquaternium-53, polyquaternium-55, and mixtures thereof, based upon the total weight of the disinfecting composition.

28. The method of claim 18, wherein said composition comprises ethanol, citric acid, and polyquaternium-37.

29. The method of claim 18, wherein said composition comprises at least about 70 percent by weight of ethanol, based upon the total weight of the disinfecting composition; from about 0.012 to about 1 percent by weight of citric acid, based upon the total weight of the disinfecting composition, and from about 0.02 to about 30 percent by weight of polyquaternium-37, based upon the total weight of the disinfecting composition.

30. The method of claim 18, wherein said composition further comprises one or more of a humectant, ester, emulsifying agent, thickener, and stabilizer.