Cleaning compositions for solid surfaces – auxiliary compositions – Cleaning compositions or processes of preparing – For cleaning a specific substrate or removing a specific...
Reexamination Certificate
2000-08-01
2002-07-02
Ogden, Necholus (Department: 1751)
Cleaning compositions for solid surfaces, auxiliary compositions
Cleaning compositions or processes of preparing
For cleaning a specific substrate or removing a specific...
C510S132000, C510S137000, C510S383000, C510S386000, C510S518000
Reexamination Certificate
active
06413921
ABSTRACT:
FIELD OF THE INVENTION
The invention relates to antimicrobial compositions for providing disinfecting treatment and sustained antimicrobial effectiveness to the skin surface with minimized skin irritation. In particular, the invention relates to compositions containing parachlorometaxylenol (PCMX) which are useful in surgical scrub and pre-operative skin disinfecting formulations.
BACKGROUND OF THE INVENTION
Standard surgical procedures require disinfection of skin surfaces of both the surgeon and patient at the surgical site prior to surgery. Effective pre-operative cleansing of skin is critical to reducing the risk of infection to the patient. Surgical scrub and pre-operative skin preparations are therefore important to control the risk of infection.
Microorganisms on the skin can be transient or resident. Transient microorganisms lie on the surface of the skin, whereas resident microorganisms are found at deeper sites in the skin. It is desirable to kill microorganisms on the skin prior to surgery and sustain the antimicrobial activity of the skin surface as effectively as possible through the duration of the surgical procedure.
Effective antiseptic compositions can be produced by combining a surfactant or detergent with an antimicrobial agent. However, many such compositions are unsuitable for contact with human skin, and can cause discomfort and irritation to the skin. The development of formulations containing antimicrobial agents and detergents that provide acceptable antiseptic properties as well as avoid skin irritation has proven difficult, since the effectiveness of the antimicrobial agent is often reduced by the additional ingredients used.
Parachlorometaxylenol (PCMX) has a phenolic chemical structure and is related to compounds such as cresol, carbolic acid, and hexachloroprene. PCMX is a desirable antimicrobial agent and is particularly effective against a wide variety of gram-positive and gram-negative bacteria. PCMX goes by a variety of other names, including chloroxylenol; 4-chloro-3,5 xylenol; 4-chloro-3,5-dimethylphenol; 2-chloro-m-xylenol; 2-chloro-5-hydroxy-m-xylene; 2-chloro-5-hydroxy-m-xylene; 2-chloro-5-hydroxy-1,3-dimethylbenzene; 4-chlor-1-hydroxy-3,5-dimethyl benzene; and 3,5-dimethyl-4-chlorophenol. Antimicrobial formulations containing PCMX as a disinfecting ingredient are well-known in the art and disclosed by Garabedian et al., U.S. Pat. No. 4,632,772; Corti et al., U.S. Pat. No. 5,114,978; Kahn et al., U.S. Pat. No. 5,439,681; and Woodin, Jr. et al., U.S. Pat. No. 5,494,533.
The antimicrobial effectiveness of PCMX is desirable, however, formulations containing PCMX are difficult to prepare due to its incompatibility with many surfactants as well as other types of compounds. The efficacy of PCMX is often compromised by a variety of factors, such as additional ingredients (e.g., surfactants), pH level, and solubility. For example, see Kahn et al., U.S. Pat. No. 5,439,681, which discloses the difficulty of combining surfactants with PCMX while preserving antiseptic efficacy. Dryness and irritation to the skin are also frequently associated with phenolic antimicrobial compounds such as PCMX.
Development of an antimicrobial formulation containing PCMX which demonstrates both a high degree of antimicrobial effectiveness and low skin irritation properties has proven even more difficult. Thus, there exists a need for improved skin disinfecting formulations suitable for surgery containing PCMX.
SUMMARY OF THE INVENTION
The present invention provides an antimicrobial composition useful for preparing and disinfecting skin prior to surgery. In particular, the composition of the invention can be used as a surgical scrub formulation or pre-surgical skin disinfecting formulation. The pre-operative antimicrobial skin composition comprises parachlorometaxylenol (PCMX) as the antimicrobial agent and an anionic surfactant composition comprising a surfactant having a hydrophobic portion consisting of a linear alkyl and a hydrophilic portion having ethoxylation termination with a sulfonate anionic group; and a sarcosine surfactant. Preferably, the anionic surfactant composition further comprises a foaming anionic surfactant, such as sodium lauryl sulfate. It has now been found that antimicrobial compositions containing PCMX and a combination of certain types of anionic surfactants exhibit both a high degree of initial and persistent antimicrobial efficacy, as well as a low degree of skin irritability.
There is further disclosed an antimicrobial composition for disinfection of a skin surface consisting essentially of:
a) parachlorometaxylenol in an amount of about 3.3% by weight;
b) sodium C
12-15
pareth-15 sulfonate in an amount of about 6.3% by weight;
c) sodium lauroyl sarcosinate in an amount of about 3.0% by weight;
d) sodium lauryl sulfate in an amount of about 1.05% by weight;
e) soy acid in an amount of about 0.3% by weight;
f) propylene glycol in an amount of about 9.0% by weight;
g) PEG-120 methyl glucose dioleate in an amount of about 3.0% by weight;
h) water in an amount of about 72.47% by weight;
i) phenoxyethanol in an amount of about 1.0% by weight;
j) citric acid in an amount of about 0.26% by weight;
k) sodium hydroxide in an amount of about 0.02% by weight; and
l) styrene/PVP co-polymer in an amount of about 0.3% by weight.
The invention also relates to a topical application device containing the antimicrobial composition according to the invention.
The invention further provides for a method of disinfecting skin comprising applying to the surface of the skin to be disinfected an antiseptically effective amount of an antimicrobial composition comprising parachlorometaxylenol; and an anionic surfactant composition comprising a surfactant having a hydrophobic portion consisting of a linear alkyl and a hydrophilic portion having ethoxylation termination with a sulfonate anionic group; and a sarcosine surfactant.
Among the advantages associated with the antimicrobial composition of the invention is that it exhibits the high antimicrobial effectiveness associated with PCMX while also having significantly reduced skin irritability. Another advantage of the invention is that the composition has been formulated to provide a viscous, mild and low odor product without impairing the antimicrobial efficacy of the active ingredient and cleansing properties of the surfactants used in the composition.
DETAILED DESCRIPTION OF THE INVENTION
The antimicrobial composition of the invention comprises a combination of parachlorometaxylenol (PCMX) and additional ingredients including surfactants which when utilized provides the high degree of antiseptic efficacy of PCMX in combination with a low degree of irritation to the skin.
The antimicrobial agent, parachlorometaxylenol, is present in the composition in an antimicrobially effective amount. PCMX can be present in an amount ranging from about 1.0% to about 5.0% by weight. Preferably, PCMX is present in the composition in an amount from about 3.0% to about 4.0% by weight. In one embodiment, PCMX is present in an amount of about 3.3% by weight of the composition. A representative PCMX that can be used in the invention includes NIPACIDE™ PX-R, which is available from Nipa Hardwicke, Inc. of Wilmington, Del.
The composition further comprises a combination of anionic surfactants which function to preserve the antimicrobial activity of PCMX, are compatible with the other surfactants used, and reduce the irritability of the composition. The anionic surfactant composition can collectively comprise between about 5% to about 15% by weight of the composition and includes an anionic surfactant having a hydrophobic portion consisting of a linear alkyl chain and a hydrophilic portion having ethoxylation termination and an sulfonate anionic group; and a sarcosine surfactant. In a preferred embodiment, the anionic surfactant composition further comprises a foaming anionic surfactant, such as sodium lauryl sulfate. The amounts of each surfactant in the surfactant composition can vary slightly, provided the properties contributed by
Childers David
Jeng David
Allegiance Corporation
NIckey Donald O.
Ogden Necholus
Rozycki Andrew G.
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