Gentle-acting skin-disinfectants and hydroalcoholic gel formulations

• US 20040247685A1
• Filed: 02/24/2004
• Published: 12/09/2004
• Est. Priority Date: 10/23/2001
• Status: Active Grant

• Current Assignee: Trustees Of Columbia University In The City Of New York (Columbia University)
• Original Assignee: Trustees Of Columbia University In The City Of New York (Columbia University)
• Inventors: Caraos, Lauser, Modak, Shanta, Sampath, Lester, Gaonkar, Trupti A.
• Granted Patent: US 8,436,050 B2
• Time in Patent Office: Days
• US Class Current: 424/488
• CPC Class Codes: A61K 2800/75 Anti-irritant
• CPC Class Codes: A61K 31/79 Polymers of vinyl pyrrolidone
• CPC Class Codes: A61K 8/042 Gels
• CPC Class Codes: A61K 8/347 Phenols
• CPC Class Codes: A61K 8/416 Quaternary ammonium compounds A61K8/35 takes precedence
• CPC Class Codes: A61K 8/43 Guanidines
• CPC Class Codes: A61P 31/00 Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
• CPC Class Codes: A61Q 17/005 Antimicrobial preparations

Abstract

Antimicrobial compositions having synergistic combinations of octoxyglycerin and at least one other antimicrobial agent in formulations which are more effective than prior art compositions without causing increased irritation to the skin of the average user. In certain embodiments, skin irritation may be minimized by low concentrations of antimicrobials and/or the presence of soothing compounds such as zinc. Preferred embodiments include combinations of octoxyglycerin, a quaternary compound, and at least one other antimicrobial agent. Without being bound to any particular theory, it is hypothesized that the unexpected antimicrobial effectiveness of combinations of octoxyglycerin may result from an enhancement of the permeability of microbes to antimicrobials caused by octoxyglycerin. Hydroalcoholic gel composition containing alcohol, water, hydrogel, and emollient or emulsifier, wherein the composition has a viscosity of below 2000 centipoises at between 20 and 40° C. This skin-friendly hydroalcoholic gel composition, which can be further combined with silicone polymer, emollient solvent, thickening agent and antimicrobial agent, enhances rapid and long-term antimicrobial efficacy.

Claims

1. A hydroalcoholic gel composition comprising between 30 and 95 percent (weight/weight) alcohol, 15 and 70 percent (weight/weight) water, 0.05 and 0.5 percent (weight/weight) hydrogel, and 0.2 and 3.0 percent (weight/weight) emollient, wherein said composition has a viscosity below 2000 centipoises.

2. The composition of claim 1 which further comprises between 0.05 and 0.5 percent emulsifier.

3. The composition of claim 1 which further comprises between 0.1 and 1.0 percent silicone polymer.

4. The composition of claim 1 which further comprises between 0.5 and 5.0 percent emollient solvent.

5. The composition of claim 1 which further comprises between 0.1 and 1.0 percent thickening agent.

6. The composition of claim 1 further comprising an antimicrobial agent.

7. The composition of claim 1 wherein the hydrogel is selected from the group consisting of one or more than one of hydroxypropylmethyl cellulose, cationic hydroxyethyl cellulose, ethyl cellulose, hydroxypropyl cellulose, hydroxymethyl cellulose, carboxymethyl cellulose, polymethylene oxide, and chitosan pyrrolidone carboxylate.

8. The composition of claim 1 wherein the emollient is selected from the group consisting of one or more than one of PEG 20 Almond Glycerides, Probutyl DB-10, Glucam P20, Glucam E-10, Glucam P-10, Glucam E-20, Glucam P-20 distearate, Glycerin, Propylene glycol, oxtoxy glycerin, cetyl acetate and acetylated lanolin alcohol, cetyl ether, myristyil ether, hydroxylated milk glycerides, polyquatemium compounds, chitosan, copolymer of dimethyl dialyl ammonium chloride and acrylic acid, dipropylene glycol methyl ethers, and polypropylene glycol ethers.

9. The composition of claim 2 wherein the emulsifier is selected from the group consisting of one or more than one of Incroquat Behenyl TMS-50, Polawax, Stearyl alcohol, and cetearyl alcohol.

10. The composition of claim 3 wherein the silicone polymer is selected from the group consisting of one or more than one of polydimethylsiloxane polymer, dimethiconol fluid in dimethicone, cyclomethicone and dimethicone copolyl, and silicone glycol.

11. The composition of claim 4 wherein the emollient solvent is selected from the group consisting of one or more than one of glycidyl ethers having alkyl chains up to and including 18 carbon molecules and ethoxylates and propoxyltes thereof, glyceryl ethers having alkyl chains up to and including 18 carbon molecules and ethoxylates and propoxylates thereof, mono- and diglyceryl ethers having alkyl chains up to and including 18 carbon molecules and ethoxylates and propoxylates thereof, ethoxylate and propoxylate ethers, ethoxy diglycol esters, ethyl hexyl alcohol propoxylate, and propylene glycol esther ethoxylates and propoxylates.

12. The composition of claim 5 wherein the thickening agent is selected from the group consisting of one or more than one of crothix, crodamol and behenyl alcohol.

13. The composition of claim 6 wherein the antimicrobial agent is selected from the group consisting of one or more than one of biguanides, phenols, quaternary ammonium compounds and anti-fungal agents.

14. The composition of claim 13 wherein chlorhexidine gluconate is the biguanide.

15. The composition of claim 13 wherein triclosan is the phenol.

16. The composition of claim 13 wherein benzalkonium chloride is the quaternary ammonium compound.

17. The composition of claim 13 wherein povidone iodine is the anti-fungal agent.

18. The composition of claim 6 wherein phenoxyethanol is the antimicrobial agent.

19. The composition of claim 1 wherein the alcohol is selected from the group consisting of one or more than one of aliphatic alcohol, fatty alcohol and hexanol.

20. The composition of claim 19 wherein the aliphatic alcohol is selected from the group consisting of one or more than one of ethanol, isopropyl alcohol or n-propyl alcohol.

21. The composition of claim 19 wherein the fatty alcohol is elected from the group consisting of one or more than one cetyl, myrstyl, stearyl, octyl, decyl, and lauryl alcohol.

22. The composition of claim 19 wherein the aliphatic alcohol is ethanol at a concentration of between 60 and 95 percent.

23. The composition of claim 19 wherein the fatty alcohol is present at a concentration of between 0.5 and 5%.

24. The composition of claim 19 wherein the hexanol is present at a concentration of between 3 and 5 percent.

25. The composition of claim 19 wherein the aliphatic alcohol is isopropanol at a concentration of between 60 and 95 percent.

26. The composition of claim 9 wherein Incroquat Behenyl TMS and Polawax are present in a 1:

1 ratio.

27. The composition of claim 7 wherein the hydroxypropyl methyl cellulose and cationic hydroxy ethyl cellulose are present in a 1:

1 ratio.

28. The composition of claim 7 wherein hydroxypropyl methyl cellulose and chitosen pyrrolidone carboxylate and present in a 1:

1 ratio.

29. The composition of claim 8 wherein propylene glycol and glycerin are present in a 1:

1 ratio.

30. The composition of claim 8 wherein propylene glycol and octoxyglycerin are present in a 1:

1 ratio.

31. The composition of claim 13 wherein the biguanide is chlorhexidine gluconate at a concentration of between 0.05 and 0.5 percent, wherein the quaternary ammonium compound is benzalkanium chloride at a concentration of between 0.1 and 0.25 percent, and wherein the phenol is phenoxyethanol at a concentration of between 0.1 and 1.0 percent.

32. The composition of claim 25 which further comprises between 5 and 20 percent (weight/weight) of n-propyl alcohol.

33. A method of preparing a hydroalcoholic gel composition comprising the steps of:

dissolving a hydrogel in water at ambient temperature;

dissolving an emulsifier in an alcohol at ambient temperature; and

mixing said dissolved hydrogel and said dissolved emulsifier at an ambient temperature,

wherein said composition has a viscosity below 2000 centipoises at between 20 and 40°

C.

34. The method of claim 33 further comprising a subsequent step of:

adding to the mixture one or more emollients, one or more silicone polymers, one or more emollient solvents, one or more antimicrobial agents, or one or more thickening agents, or mixtures thereof.