Drug – bio-affecting and body treating compositions – Effervescent or pressurized fluid containing
Patent
1996-08-20
1998-07-07
Jordan, Kimberly R.
Drug, bio-affecting and body treating compositions
Effervescent or pressurized fluid containing
514635, A61K 900, A61K 31155
Patent
active
057764301
DESCRIPTION:
BRIEF SUMMARY
This application is a 371 of PCT/US94/12549, filed Nov. 1, 1994.
BACKGROUND OF THE INVENTION
Chlorhexidine (Rose, Swain, J. Chem. Soc. 1956, 4422, U.S. Pat. No. 2,684,924) and its salts, including the gluconate salt (CHG), is well known as a water soluble topical antimicrobial (G. E. Davies et al. Brit. J. Pharmacol. 9, 192 (1954) and D. M. Foulkes, J. Peridont. Res. 8, Suppl. 12., 55-60 (1973)). Numerous compositions containing CHG as an active ingredient to fight microbial infection after surgery or during wound healing are known. Chlorhexidine and its salts are effective against a wide range of Gram-positive and Gram-negative bacteria. It is also effective against Proteus and against some fungi and viruses. CHG is currently marketed in compositions sold and directly applied at a 4% concentration level e.g., HIBICLENS.TM. (commercially available from Stuart Pharmaceuticals),to achieve an antimicrobial effect.
The combination of an alcohol and CHG is known. For example, the combination of CHG and denatured alcohol containing the denaturant brucine sulfate is known as a composition useful in surgical scrub applications. The combination of a bisbiguanide such as CHG, and an alcohol such as isopropanol or ethanol is also known. See U.S. Pat. Nos. 5,164,107 or 5,089,205. Four percent of isopropanol was added to stock solutions of CHG in the '107 disclosure to prevent the contamination of the stock solution with species of Pseudomonas.
Solutions of 0.5% CHG with 70% isopropanol, and 1.0% CHG with 50% ethanol, were described as skin-disinfectant (see Beeuwkes et al., Acta Therapeutica 11 (1985) pp. 445-451, and Beeuwkes et al., Journal of Hospital Infection 8 (1986) pp. 200-202).
The present invention is a cleanser system of CHG and a denatured alcohol, which is highly effective as an antimicrobial surgical scrub or hand wash composition and is more effective than the prior art compositions.
SUMMARY OF THE INVENTION
The present invention is directed to a composition comprising a cleanser system of between about 0.65 and 0.85 wt. % antimicrobial agent chlorhexidine or a pharmaceutically acceptable salt thereof and between about 50 and 60 wt. % denatured alcohol. The denatured alcohol is Specially Denatured Alcohol SDA 3-C, which is a commercial, non-beverage grade denatured alcohol defined by the Alcohol and Tobacco Tax Division of the Internal Revenue Service as ethanol with a 5% isopropanol denaturant (i.e., 95% ethanol/5% isopropanol). This system has significantly improved and faster-acting antimicrobial properties and may be used in surgical scrubs and in wound dressings. Additional inert or antimicrobial active ingredients may be added to the system. The system is applied, as a foaming scrub or aerosol product, to a patient or organism in order to achieve an antimicrobial affect.
The present invention is also directed to a process for making the CHG/denatured alcohol system which avoids the need for high-temperature processing. Production according to this process obviates the need for explosion-proof facilities which would otherwise be required because of the high alcohol content of the system.
Preferably, the antimicrobial agent is chlorhexidine gluconate, and the system may further comprise a corrosion inhibitor, a pH modifier, an emollient, and a foaming agent.
Preferably, the denatured ethanol is anhydrous denatured ethanol SDA 3-C, the corrosion inhibitor is selected from the group consisting of benzoate salt, a nitrite salt, and a borate salt, the pH modifier is selected from the group consisting of sodium sesquicarbonate, a carbonate salt, a citrate salt, and an acetate, the emollient is selected from the group consisting of cetyl lactate and stearyl lactate, and the foaming agent is selected from the group consisting of an Emulsifying Wax NF, and a blend of stearyl alcohol and cetyl alcohol.
More preferably, the chlorhexidine gluconate is present in a relative weight range of between 0.65 and 0.85 wt. %, anhydrous ethanol SDA 3-C is present in a relative weight range of between 50 and 60 wt.
REFERENCES:
patent: 4915934 (1990-04-01), Tomlinson
Kirchner Fred
Osborne David W.
Calgon Vestal, Inc.
Jordan Kimberly R.
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