Title of Invention

"ENHANCED ACTIVITY ALCOHOL-BASED ANTIMICROBIAL COMPOSITIONS"

Abstract A composition having antimicrobial properties, comprising: an aliphatic alcohol having from 1 to 8 carbon atoms in an amount from 30 to less than 60 parts; an aromatic alcohol in an amount from 0.5 to 5.0 parts, wherein the hydroxyl group of the aromatic alcohol is connected to a nonaromatic ring carbon atom; a cationic substrate binding activity enhancing substance in an amount from 0.0125 to 0.5 part, wherein the cationic substrate binding activity enhancing substance is behentrimonium methosulfate (docosyl(trimethyl)azanium methyl sulfate), behenalkonium chloride (benzyl-docosyl-dimethylazanium chloride), behenoyl PG-trimonium chloride (3-docosanoyloxy-2-hydroxypropyl), behenamidopropyl PG-trimonium chloride, or combinations thereof; water in an amount from 33 to 65 parts, all said parts based on 100 parts by weight of the compostion, said composition free of a cationic cellulose polymer; and optionally comprises a non-ionic thickner.
Full Text ENHANCED ACTIVITY ALCOHOL-BASED ANTIMICROBIAL COMPOSITIONS
FIELD OF THE INVENTION
[0001] The present invention relates to antimicrobial compositions which can
be used wherever disinfecting compositions are needed, such as in a hospital,
healthcare industry, workplace, recreational facility, home or similar environment.
The antimicrobial compositions are particularly useful as a topical application for
substrate, such as skin and can be used as a hand sanitizer or pre-surgical scrub.
The compositions comprise a synergistic combination of a simple aliphatic alcohol
and an activity enhancing substance, wherein the composition provides,
heretofore unexpected, persistent activity against a broad range of
microorganisms, including gram-negative organisms, while moisturizing the skin.
BACKGROUND OF THE INVENTION
[0002] Various forms of antimicrobial compositions containing alcohols are
known in the art and have been used in the healthcare industry for some time.
The antimicrobial compositions are typically utilized to cleanse the skin and
destroy bacteria and other microorganisms present thereon, especially on the
hands, arms, and face of the user.
[0003] An important use of the antimicrobial composition is to disinfect the
hands and fingers of a person. The composition is generally applied to, and
rubbed into the hands and fingers, and subsequently allowed to evaporate from
the skin. Wiping of the composition from the skin is typically not necessary
because of the alcohol content of the compositions which leads to fast and
essentially complete evaporation of the composition from the skin.
[0004] Antimicrobial compositions in general have been used in the healthcare
industry, food service industry, meat processing industry, and in the private sector
by individual consumers to control and prevent the spread of potentially harmful
microorganisms. The widespread use of antibacterial compositions indicates the
importance of controlling bacteria and other microorganism populations on the
skin or other substrates. It is important, that the antimicrobial compositions
reduce microorganism populations rapidly, without irritating or damaging skin or
having a detrimental toxicity. The prior art antimicrobial compositions generally
contain a high percentage of alcohol, wherein the alcohol acts as a disinfectant
which rapidly evaporates preventing the need to wipe or rinse the composition
from the treated surface. However, it has been found that high amounts of alcohol
generally greater than about 60% dry and/or irritate skin.
[0005] U. S. Patent No. 5,288,486 relates to a process for enhancing the
efficacy of alcohol-based skin antiseptics comprising adding at least one alcoholsoluble
viscosifying agent to an alcohol-based disinfectant, thereby lowering its
alcohol evaporation rate and markedly increasing the exposure time that
disinfecting concentrations of alcohol are present on skin.
[0006] U. S. Patent No. 5,635,462 relates to a reportedly cleansing
composition including a substituted phenol such as para-chloro-meta-xylenol, and
at least one primary surfactant selected from the group consisting of amine
oxides, phospholipids, partially neutralized carboxylic acids and diacids, betaines,
ethoxylated methyglucosides, and mixtures thereof. Other additives such as
viscosifiers or thickeners, emollients, fragrances, perfumes, coloring agents, and
the like may also be added.
[0007] U. S. Patent No. 5,997,893 relates to reportedly antimicrobial
compositions containing high levels of alcohol, carbomer polymers and
antimicrobial agents which provide formulations possessing cosmetic
characteristics.
[0008] U. S. Patent No. 6,022,551 relates to reportedly antimicrobial alcoholcontaining
composition and method of using the composition to reportedly
disinfect surfaces, such as the hands is disclosed.
[0009] U. S. Patent No. 6,136,771 relates to reportedly antibacterial
compositions having a reduced amount of disinfecting alcohol. The antibacterial
compositions contain a phenolic antibacterial agent, a disinfecting alcohol, a
gelling agent, and water, wherein a percent saturation of the antibacterial agent in
a continuous aqueous phase of the composition is at least 25%.
[0010] U. S. Patent No. 6,228,385 relates to a liquid reportedly antimicrobial,
skin moisturizing formulation including: 1) an aqueous alcoholic base; 2) a
humectant; 3) a delivery material adapted to release an emollient when the
formulation is applied to the skin; and 4) an emollient immiscible in the aqueous
alcoholic base and contained by the delivery material. The delivery material
reportedly encapsulates or entraps the emollient for subsequent release.
Desirably, the humectant is glycerin and the emollient is an alkyl-substituted
polysiloxane polymer.
[0011] U. S. Patent No. 6,423,329 relates to compositions and methods of
sanitizing and moisturizing skin surfaces.
[0012] U. S. Patent No. 6,723,689 relates to a reportedly antimicrobial
composition comprising an alcohol in an amount from about 60 to about 95 weight
percent of the total composition, a preservative, a cationic cellulose polymer
thickening agent, a moisturizer and/or a cationic emulsifier, and water in an
amount from about 6 to about 30. weight percent.
[0013] A need exists for antimicrobial compositions which are effective against
a broad spectrum of microorganisms including gram positive and gram negative
bacteria and provide enhanced antimicrobial activity and thus provide a longer
period of protection for the user.
SUMMARY OF THE INVENTION
[0014] Antimicrobial compositions are disclosed which provide enhanced or
prolonged activity against various microorganisms. The aliphatic alcohol
concentration of the compositions is kept at a moderate level in order to prevent
irritation to skin. It has been unexpectedly found that activity enhancing
substances synergistically combine with the aliphatic alcohol in the compositions
of the present invention to provide residual activity on a substrate and prevent
subsequent microorganism growth when compared to alcohol alone. It is believed
that the compositions retard evaporation of the alcohol and/or other antimicrobial
agent if present, and increasing the contact time with the substrate i.e., skin being
treated; or bind with the skin and remain on the surface thereby maintaining
effectiveness against subsequent contact with a microorganism; or combinations
thereof.
[0015] The antimicrobial compositions comprise an aliphatic alcohol, preferably
in an amount of about 50 to about 58 parts by weight, one or more activity
enhancing substances in a range from about 0.0125 to about 10 parts by weight,
and water based on 100 parts by weight of the antimicrobial composition. The
compositions can optionally include other components including, but not limited to,
humectants, skin conditioners, emollients, viscosifying agents, preservatives, and
fragrances.
BRIEF DESCRIPTION OF THE DRAWINGS
[0016] FIG. 1 is a graph plotting residual activity of compositions containing
various additives; and
[0017] FIG. 2 is a graph plotting residual activity of further compositions
containing various additives;
DETAILED DESCRIPTION OF THE INVENTION
[0018] The present invention is directed to enhanced activity alcohol-based
antimicrobial compositions which are preferably utilized as skin disinfectants or
antiseptics which provide the skin or other surface with prolonged antimicrobial
properties. Methods for preparing antimicrobial compositions are also described.
[0019] Alcohol-containing or alcohol-based antimicrobial compositions are
typically drying and even irritating to the skin, especially when utilized repeatedly
as required in the healthcare field. While searching for components which could
increase the moisturizing capabilities of an alcohol-based composition, it was
unexpectedly discovered that compositions could be formulated comprising an
aliphatic alcohol and an activity enhancing substance, which exceeded the activity
of a composition without the latter component. In most cases, the moisturizing
ability of the compositions are improved in addition to providing increased activity
of the composition against microorganisms.
[0020] The compositions of the present invention include an aliphatic alcohol
which has inherent antiseptic properties. Such alcohols are known to kill various
viruses, fungi, mold, and gram positive and gram negative bacteria. Suitable
alcohols are short chain, linear or branched, aliphatic alcohols, and generally have
from 1 to about 8 carbon atoms with 1 to about 4 carbon atoms being preferred.
Examples include, but are not limited to, methanol, ethanol, n-propanol, isopropyl
alcohol, 2-methyl-2 propanol and hexanol, or combinations thereof. Propanol,
isopropyl alcohol and ethanol are preferred.
[0021] The aliphatic alcohol is present in a range generally from 30 parts to
about 90 parts, desirably from about 45 parts to less than about 60 parts, and
preferably from about 50 parts to about 57 or 58 parts by weight per 100 parts by
weight of the composition. It has been unexpectedly found that compositions
having less than 60 parts aliphatic alcohol can be effective antimicrobials having
enhanced activity.
[0022] The alcohol is combined with an activity enhancing substance which
increases the residual activity of the composition and beneficially the effectiveness
of the antibacterial activity as indicated by a log reduction in microorganisms.
TypicaJ prior art antibacterial compositions generally offer a low to moderate
antibacterial activity. Antibacterial activity is assessed against a broad spectrum
of microorganisms, including both gram positive and gram negative bacteria. Log
reduction or alternatively percent reduction, in bacterial populations provided by
the composition correlates to antibacterial activity. Log reductions on skin of
between one and three are desired, and log reductions greater than three are
preferred for a particular contact time which generally ranges from 15 seconds to
about 5 minutes.
[0023] The activity enhancing substance can generally be classified as one of
two types, an aromatic alcohol activity enhancing substance, or a cationic
substrate binding activity enhancing substance. One or preferably both types of
activity enhancing substances are utilized in the compositions of the present
invention. Suitable cationic substrate binding activity enhancing substances
include, but are not limited to, behentrimonium methosulfate, behenalkonium
chloride, behenoyl PG-trimonium chloride, behenoyl PG-dimonium chloride,
behenamidopropyl PG-dimonium chloride, or combinations thereof. The cationic
substrate binding activity enhancing substances are utilized in the antimicrobial
compositions in amounts which range generally from about 0.0125 to about 0.50
parts, desirably from about 0.03 to about 0.10 parts, and preferably from about
0.04 to about 0.075 parts based on 100 parts by weight of the composition. Some
of the substrate binding activity enhancing substances are commercially available
as blends at various concentrations. Often, the substrate binding activity
enhancing substances are blended with one or more long chain aliphatic alcohols
having greater than about 10 carbon atoms such as, but not limited to, cetyl
alcohol, stearyl alcohol, behenyl alcohol or cetearyl alcohol which is generally a
50/50 mixture by weight of cetyl and stearyl alcohol.
[0024] The aromatic alcohol activity enhancing substances include at least one
phenyl group and an alcohol functional group indirectly attached to the phenyl
ring, such as through aliphatic linkage or ether linkage, for example. Suitable
aromatic alcohol activity enhancing substances include, but are not limited to,
phenoxyethanol, 1- phenoxy 2-propanol, and benzyl alcohol. The aromatic
alcohol activity enhancing substances are utilized in the antimicrobial
compositions in amounts which range generally from about 0.5 to about 5.0,
desirably from about 0.75 to about 3.5, and preferably from about 1.0 to about 2.5
parts based on 100 parts by weight of the composition.
[0025] Polyols are optionally but preferably utilized in the antimicrobial
compositions of the present invention. Polyols contain from 2 to about 6 and
desirably 2 or 3 hydroxyl groups. Preferred polyols are water soluble. The polyols
utilized in the present invention are typically skin conditioners such as humectants
or moisturizers. Specific examples of polyols include, but are not limited to,
ethylene glycol, propylene glycol, glycerol, diethylene glycol, triethylene glycol,
dipropylene glycol, tripropylene glycol, hexylene glycol, butylene .glycol, 1,2,6-
hexanetriol, sorbitol, PEG-4 and similar polyhydroxy compounds, and 2-methyl-
1,3-propanediol.
[0026] In addition to the polyols, the antimicrobial compositions of the present
invention can include other skin conditioners such as humectants, emollients,
moisturizers or the like. Emollients are generally thin liquids, oils of various
viscosities, fatty solids or waxes. A function of the skin conditioner is to soften
and soothe the 'skin and to prevent chapping of the same. Preferably the skin
conditioner chosen does not leave a tacky feel on the skin. Examples of such
compounds include, but are not limited to, cyclomethicone, cetyl myristate,
glyceryl dioleate, isopropyl myristate, lanolin, methyl laurate, PPG-9 laurate, soy
stearyl, octyl palmitate, Di-PPG-3 myristyl ether adipate, C12-C15 alkyl
benzoates, PPG-5 lanoate, glucamine and pyridoxine glycol, for example.
Occlusive skin conditioners, for example, cetyl lactate, aluminum lanolate, corn oil,
dimethicone, coconut oil, stearyl stearate, phenyl trimethicone, trimyristin, olive oil,
and synthetic wax, also can be used. Combinations of the classes of skin
conditioners, in addition to miscellaneous skin conditioners known to persons
skilled in the art, alone or in combination can be used. Nonlimiting examples of
miscellaneous skin conditioners include aloe, cholesterol, cystine, keratin, lecithin,
egg yolk, glycine, PPG-12, retinol, salicylic acid, orotic acid, vegetable oil, and
soluble animal collagen. The skin conditioners can be used alone, or in
combination with a skin protectant, like petroleum, cocoa butter, calamine, and
kaolin, for example.
[0027] Still other skin conditioners include alcohol soluble polyquaterniums,
including but not limited to, Merquat 100, which is N,N-dimethyl-N-2-propen-1-
aminium chloride, polyquaternium 22 (acrylic acid-diallyldimethylammonium
chloride polymer) and polyquaternium 47 (1-propanaminium,N,N,N-trimethyl-3-((2-
methyl-1-oxo-2-propenyl)amino)-chloride polymer with methyl 2-propenoate and
2-propenoic acid), all commercially available from ONDEO Nalco of Naperville,
Illinois.
[0028] One or more skin conditioners, emollients, humectants, or the like can
be utilized in the antimicrobial compositions of the present invention in total
amounts which range generally from about 0.25 to about 10 parts, desirably from
about 0.50 to about 5.0 parts, and preferably from about 1.0 to about 3.5 parts
based on 100 parts by weight of the composition.
[0029] Thickening agents are optionally but preferably utilized in the
antimicrobial compositions of the present invention in order to increase the
viscosity thereof. Thickening compounds can be both organic and inorganic. The
antimicrobial compositions of the present invention can be a liquid but typically
contain a sufficient amount of a thickening agent such that the composition is a
viscous liquid or flowable gel that can be easily applied to a substrate such as
skin. The type and amount of thickeners utilized in the composition depend upon
the desired viscosity thereof among other factors. That said, a thickener, when
utilized in the present invention, is present in a range generally from about 0.1 to
about 3.0 parts, desirably from about 0.15 to about 1.0 part, and preferably from
about 0.2 to about 0.75 parts based on 100 parts by weight of the composition.
[0030] The compositions of the present invention have viscosities which range
generally from about 10 to 100,000 centipoise(cp), desirably from about 30 to
about 5,000 centipoise(cp), and preferably from about 60 to about 120 centipoise
(cp) as measured using a low shear viscosity determination method such as the
helipath method using an inverted "t" spindle as known in the art (Brookfield
Method).
[0031] Various thickeners can be utilized to thicken the aqueous and/or nonaqueous
portion of the antimicrobial composition. Examples of suitable thickeners
include, but are not limited to, acacia, acrylates/steareth-20 methacrylate
copolymer, agar, algin, alginic acid, ammonium acrylate copolymers, ammonium
alginate, ammonium chloride, ammonium sulfate, amylopectin, attapulgite,
bentonite, C9-15 alcohols, calcium acetate, calcium alginate, calcium
carrageenan, calcium chloride, caprylic alcohol, carbomer 910, carbomer 934,
carbomer 934P, carbomer 940, carbomer 941, carboxymethyl
hydroxyethylcellulose, carboxymethyl hydroxypropyl guar, carrageenan, cellulose,
cellulose gum, cetearyl alcohol, cetyl alcohol, corn starch, damar, dextrin, i
dibenzylidine sorbitol, ethylene dihydrogenated tallowamide, ethylene dioleamide,
ethylene distearamide, gelatin, guar gum, is guar hydroxypropyltrimonium
chloride, hectorite, hyaluronic acid, hydrated silica, hydroxybutyl methylcellulose,
hydroxyethylcellulose, hydroxyethyl ethylcellulose, hydroxyethyl stearamide-MlPA,
hydroxypropylcellulose, 2-hydroxypropyl ether cellulose, hydroxypropyl guar,
hydroxypropyl methylcellulose, isocetyl alcohol, isostearyl alcohol, karaya gum,
kelp, lauryl alcohol, locust bean gum, magnesium aluminum silicate, magnesium
silicate, magnesium trisilicate, methoxy PEG-22/dodecyl glycol copolymer,
methylcellulose, microcrystallinc cellulose, montmorillonite, myristyl alcohol, oat
flour, oleyl alcohol, palm kernel alcohol, pectin, PEG-2M, PEG-5M, polyacrylic
acid, polyvinyl alcohol, potassium alginate, potassium aluminum polyacrylate,
potassium carrageenan, potassium chloride, potassium sulfate, potato starch,
propylene glycol alginate, sodium acrylate/vinyl alcohol copolymer, sodium
carboxymethyl dextran, sodium carrageenan, sodium cellulose sulfate, sodium
chloride, sodium polymethacrylate, sodium silicoaluminate, sodium sulfate,
stearalkonium bentonite, stearalkonium hectorite, stearyl alcohol, tallow alcohol,
TEA-hydrochloride, tragacanth gum, tridecyl alcohol, tromethamine magnesium
aluminum silicate, wheat flour, wheat starch, xanthan gum, and mixtures thereof.
[0032] The following additional nonlimiting examples of thickening agents act
primarily by thickening the nonaqueous portion of the composition:
abietyl alcohol, acrylinoleic acid, aluminum behenate, aluminum caprylate,
aluminum dilinoleate, aluminum distearate, aluminum
isostearates/laurates/palmitates or stearates, aluminum isostearates/myristates,
aluminum isostearates/palmitates, aluminum isostearates/stearates, aluminum
lanolate, aluminum myristates/palmitates, aluminum stearate, aluminum stearates,
aluminum tristearate, beeswax, behenamide, behenyl alcohol,
butadiene/acrylonitrile copolymer, C29-70 acid, calcium behenate, calcium
stearate, candelilla wax, carnauba, ceresin, cholesterol, cholesteryl
hydroxystearate, coconut alcohol, copal, diglyceryl stearate malate, dihydroabietyl
alcohol, dimethyl lauramine oleate, dodecanedioic acid/cetearyl alcohol/glycol
copolymer, erucamide, ethylcellulose, glyceryl triacetyl hydroxystearate, glyceryl
tri-acetyl ricinoleate, glycol dibehenate, glycol di-octanoate, glycol distearate,
hexanediol distearate, hydrogenated C6-14 olefin polymers, hydrogenated castor
oil, hydrogenated cottonseed oil, hydrogenated lard, hydrogenated menhaden oil,
hydrogenated palm kernel glycerides, hydrogenated palm kernel oil, hydrogenated
palm oil, hydrogenated polyisobutene, hydrogenated soybean oil, hydrogenated
tallow amide, hydrogenated tallow glyceride, hydrogenated vegetable glyceride,
hydrogenated vegetable glycerides, hydrogenated vegetable oil,
hydroxypropylcellulose, isobutylene/isoprene copolymer, isocetyl stearoyl
stearate, Japan wax, jojoba wax, lanolin alcohol, lauramide, methyl
dehydroabietate, methyl hydrogenated rosinate, methyl rosinate,
methylstyrene/vinyltoluene copolymer, microcrystalline wax, montan acid wax,
montan wax, myristyleicosanol, myristyloctadecanol, octadecene/maleic
anhydride copolymer, octyldodecyl stearoyl stearate, oleamide, oleostearine,
ouricury wax, oxidized polyethylene, ozokerite, palm kernel alcohol, paraffin,
pentaerythrityl hydrogenated rosinate, pentaerythrityl rosinate, pentaerythrityl
tetraabietate, pentaerythrityl tetrabehenate, pentaerythrityl tetraoctanoate,
pentaerythrityl tetraoleate, pentaerythrityl tetrastearate, phthalic
anhydride/glycerin/glycidyl decanoate copolymer, phthalic/trimellitic/glycols
copolymer, polybutene, polybutylene terephthalate, polydipentene, polyethylene,
polyisobutene, polyisoprene, polyvinyl butyral, polyvinyl laurate, propylene glycol
dicaprylate, propylene glycol dicocoate, propylene glycol diisononanoate,
propylene glycol dilaurate, propylene glycol dipelargonate, propylene glycol
distearate, propylene glycol diundecanoate, PVP/eicosene .copolymer,
PVP/hexadecene copolymer, rice bran wax, stearalkonium bentonite,
stearalkonium hectorite, stearamide, stearamide DEA-distearate, stearamide
DIBA-stearate, stearamide MEA-stearate, stearone, stearyl alcohol, stearyl
erucamide, stearyl stearate, stearyl stearoyl stearate, synthetic beeswax,
synthetic wax, trihydroxystearin, triisononanoin, triisostearin, triisononanoin,
triisostearin, tri-isostearyl trilinoleate, trilaurin, trilinoleic acid, trilinolein, trimyristin,
triolein, tripalmitin, tristearin, zinc laurate, zinc myristate, zinc neodecanoate, zinc
rosinate, zinc stearate, and mixtures thereof.
[0033] In a preferred embodiment, the thickener utilized is a non-ionic
thickener such as 2-hydroxypropyl ether cellulose available from Aqualon as
Klucel HF. The compositions of the present invention are preferably free of both
anionic and cationic thickening agents. The use of non-ionic thickeners provides
broad compatibility with the wide range of formulation ingredients utilized.
Antipodally, anionic or cationic thickeners can inactivate antimicrobial agents
utilized in the compositions of the invention.
0034] The antimicrobial compositions of the present invention utilize water,
preferably deionized water, as a carrier. Water is utilized in a range generally
from about 5 or 20 to about 65 parts, desirably from about 33 or 35 to about 50
parts, and preferably from about 37 to about 45 parts based on 100 parts by
weight of the composition.
[0035] The compositions of the present invention optionally include a
preservative component. Examples of suitable preservatives include, but are not
limited to, chlorhexidine gluconate, chlorhexidine acetate, chlorhexidine
isethionate, chloroxylenol, triclosan, methyl paraben, propyl paraben, butyl
paraben, quaternium 15, DMDM hydantoin, iodopropynybutyl carbamate,
diazolindinyl urea, imidazolidinyl urea, parachlormetaxylenol, chlorhexidine
diacetate, glyceryl monolaurate, pyrithione (zinc, sodium, and MDS), 2-bromo-2-
nitropropane-1,3-diol, chloroacetamide, triclocarban, propamidine isethionate,
hexamidine isetnionate, hexetidine, polyhexamethylene biguanide hydrochloride,
alkyltrimethylammonium bromide, benzalkonium chloride and benzethonium
chloride. The preservative is utilized in the present invention in various amounts.
[0036] The antimicrobial compositions of the present invention can contain
optional ingredients which include, but are not limited to, dyes, fragrances, pH
adjusters, buffering agents, antioxidants, emulsifiers and surfactants. The
optional ingredients can be utilized in various amounts to achieve a desired effect
on the composition, as known to those of ordinary skill in the art. Examples of
suitable dyes include, but are not limited to, D&C blue 1, D&C brown 1, D&C
green 5, D&C green 6, D&C green 8, D&C orange 4, D&C orange 5, D&C
orangel 1, D&C orange 12, D&C red 6, D&C red 7, D&C red 17, D&C red 21 D&C
red 27, D&C red 30, D&C red 33 D&C red 34, D&C red 36, D&C violet 2, D&C
yellow 10, D&C yellow 11, D&C yellow 7, D&C yellow 8, FD&C blue 1, FD&C
green 3, FD&C red 4, FD&C red 40, FD&C yellow 5, FD&C yellow 6, or any blend
thereof.
[0037] The pH adjusters can be utilized if desired in order to impart the
compositions of the present invention with a pH of about 4 to about 8, and
preferably from about 4.5 to about 6, if the composition is not already within the
noted ranges. The pH adjusters include, but are not limited to, ammonia, sodium
hydroxide, potassium hydroxide, lithium hydroxide, ethanol amine, triethyl amine,
isopropanol amine, diisopropanol amine, tromethamine, tetrahydroxy propyl
ethylene diamine, isopropyl amine, diethanol amine, triethyanol amine, citric acid,
glycolic acid, lactic acid, hydrochloric acid, nitric acid, phosphoric acid, salicylic
acid, and sulfuric acid.
[0038] In some embodiments, additional antimicrobial compounds can be
utilized in the compositions of the present invention. Suitable antimicrobials
include, but are not limited to, benzalkonium chloride, benzethonium chloride,
CHG or phenols, optionally substituted, such as triclosan, some of which as noted
above, also have other functions such as being a preservative. In most
embodiments however, the compositions of the present invention are free of such
antimicrobials other than the aliphatic alcohol and activity enhancing substances.
[0039] The present invention will be better understood by reference to the
following examples which serve to describe, but not to limit, the present invention.
EXAMPLES:
[0040] Various compounds were tested in the aliphatic alcohol-based
formulation set forth in Table I to determine if moisturization could be improved. It
was unexpectedly discovered during experimentation that one of the components
utilized, behentrimonium methosulfate enhanced activity of the alcohol
composition against Serratia Marcescens ATCC 14756. Following this
unexpected discovery, various other compounds, including quaternary ammonium
compounds, were tested in the formulation of Table I to determine if any
enhanced activity could also be observed. Testing showed that very few
quaternary ammonium compounds offered substantial enhanced activity, whereas
a majority of quaternary ammonium compounds show little or even a negative
effect on antimicrobial activity.
TABLE I
Component
Deionized Water
Polyquaternum 6
Cetyl lactate
Hydroxypropyl cellulose
Fragrance
Isopropyl alcohol
Methylpropanediol
Glycerin
C12-Ci5alkyl benzoate (Finsolv TN)
Total
Weight Percent
40.990
0.480
0.480
0.240
0.024
53.850
1.92
1.92
0.096
100
[0041] Each component listed in Table II was separately added to the above
alcohol-based formulation listed in Table I and tested to determine if antimicrobial
activity could be enhanced. The weight percentages listed in Table II are based
on 100 total parts by weight of the composition in Table I and the listed
component. For example with Experiment A, 5 parts of phenoxyethanol was
tested in 95 parts of the composition listed in Table I.
Additive Components
Phenoxyethanol (ethylene glycol phenyl ether) (90%)
Glyceryl monolaurate (Lauricidin)
Methyl paraben
Propyl paraben
lodopropynyl butylcarbamate
Glydant plus (DMDM Hydantoin/IPBC)
PCMX
Benzethonium chloride
Triclosan
Polyquaternium 6 (40%)
Cocoamidopropyl PG dimonium chloride (40%)
Behentrimonium methosulfate in cetearyl alcohol at 25%
concentrate
Weight %
[0042] The following procedure was utilized to prepare the example
formulations. The appropriate amount of water was heated to a temperature
sufficient to dissolve any solid components, such as from about 70°C to about
80°C for behentrimonium methosuifate. The solid components such as
behentrimonium methyosuifate were added to the water with mixing utilizing an
impeller mixer. The solution was subsequently cooled to a temperature of about
60° wherein hydroxypropyl cellulose was added with mixing. The solution was
-13-
further cooled to allow the polymer to hydrate. The cetyl lactate, polyquaternium-
6, glycerin, methylpropanediol, phenoxyethanol (in the case of experiment A) or
other noted additive in Table II, and fragrance were added, preferably sequentially
with mixing appropriate to disperse the materials. If necessary, additional water
was added to replace water lost during processing as determined by appropriate
vessel gross and net weights. Next, the appropriate aliphatic alcohol, such as
isopropanol, was added with mixing to complete the composition. It is to be
understood that variations of the above-described process can be utilized. For
example, multi-tank processes can be utilized, and/or various types of dispersing
equipment can replace the higher temperature dispersion of some components,
etc.
[0043] Residual Activity Testing Procedure: Each formulation was tested on
pigskin to evaluate the effect of the compositions on a gram negative organism,
Serratia marcescens ATCC 14756. The gram negative organism was grown for
approximately 24 hours at 30°C and then suspended in Butterfields Buffer to a
count of 1 X 10s. The pigskins were prepared according to the following standard
of procedure. Pigskin hides are collected on the date of slaughter and processed
on the same day by removing adipose tissue and thoroughly cleaning the hide.
Both of these processes are accomplished by spraying both sides of the pig hide
with a high pressure washer. No soap or detergents are used at any time during
the processing of pig hides for laboratory use. After cleaning and de-fatting,
pigskins are placed in water and frozen at the farm from which they were
harvested. When required for laboratory testing, a representative procures the
hides and thaws them for laboratory manipulation. In the laboratory, these hides
are cut into manageable pieces with a scalpel and coarse hair removed with
animal grooming clippers. Disposable razors are further employed to create a
smooth surface without negatively affecting the skin surface. These pieces are
then sterilized by Gamma irradiation and kept frozen until use in a study. Testing
circles were then punched out of the pigskins and glued to a phenolic cap. The
testing samples were placed in a 30°C oven to equilibrate for at least 20 minutes.
Each skin was treated with 150^1 of test product and rubbed for 30 seconds as a
pair, skin to skin. The skins were allowed to dry for 30 seconds and then the test
product was reapplied four times in the same manner. The skins were allowed to
dry in a slightly opened hood for 15 minutes. After drying the skins were
inoculated with 31^1 of the Serratia marcescens inoculum, as prepared above,
rubbed for 15 seconds, and sampled after three minutes. To sample, a sterile 3.5
cm diameter cylinder is placed, lip side down, over the pigskin on the cap. Enough
pressure is applied to the cylinder to prevent any leakage upon the addition of an
appropriate volume of liquid sampling solution to the cylinder. The skin is then
debrided, using a sterile policeman, for 30 seconds by rubbing the surface of the
skin with the flat edge of the policeman with enough pressure to remove any
microorganisms that might be on the surface. Two mL of the sampling solution
are removed using a sterile pipet and are utilized for preparing serial dilutions and
aerobic plate counts to establish the number of Colony Forming Units remaining.
[0044] FIG. 1 illustrates in average log reduction residual activity results of the
testing procedure described above. The quaternary ammonium compound
behentrimonium methosulfate and phenoxyethanol exhibited enhanced
antimicrobial activity when compared to the remaining components listed in Table
[0045] FIG. 1 was derived from the following data which was gathered utilizing
the above described residual activity testing procedure.
[0046] After it was unexpectedly discovered that the quaternary ammonium
compound behentrimonium methosulfate provided increased antimicrobial activity
in the base formulation, additional quaternary ammonium compounds were
screened to determine their effectiveness, if any. The same formulation utilized in
Table I was utilized as the base formulation for testing purposes. The various
quaternary ammonium compounds listed in Table V were added to the base
formulation at a rate of 0.5 parts by weight per 100 parts total composition. The
base formulation and formulations including each quaternary ammonium
compound were tested utilizing the residual activity test procedure described
hereinabove. The results of the experiments are also listed in FIG. 2 and in Table
V.
TABLE IV
Additive Component
Phenoxyethanol
Behentrimonium Methosulfate in cetearyl alcohol at 25%
concentration
Quaternium 26
Babbassuamidopropalkonium Chloride
Centrimonium Chloride
Hydroxyethyl behenamidopropyldimonium chloride
Dioleylamidoethylmonium methosulfate, propylene glycol
Isostearyamidopropyl morpholine lactate
Olealkonium Chloride
Stearamidopropyl dimethylamine lactate
Cinnamidopropyl trimethylammonium chloride
Stearalkonium chloride
Behenalkonium Chloride
Glyceryl caprate
Sodium Coco PG-Dimonium chloride phosphate
Weight %
Base
Base
Phenoxyethanol
Phenoxyethanoi
Behentrimonium methosulfate
Behentrimonium methosulfate
Quaternium 26
Quaternium 26
Babbassuamidopropalkonium chloride
Babbassuamidopropalkonium chloride
Cetrimonium chloride
Cetrimonium chloride
Hydroxyethyl behenamidopropyldimonium chloride
Hydroxyethyl behenamidopropyldimonium chloride
IPEG-3 Dioleylamidoethylmonium methosulfate
IPEG-3 Dioleylamidoethylmonium methosulfate
Isostearyamidopropyl morpholine lactate
Isostearyamidopropyl morpholine lactate
Olealkonium chloride
Olealkonium chloride
Stearamidopropyl dimethylamine lactate
Stearamidopropyl dimethylamine lactate
Cinnamidopropyl trimethylammonium chloride
Cinnamidopropyl trimethylammonium chloride
Stearalkonium chloride
Stearalkonium chloride
Behenalkonium chloride
Behenalkoniurn chloride
Behentrimonium chloride
Behentrimonium chloride
Glyceryl caprate
Glyceryl caprate
Sodium Coco PG-Dimonium chloride phosphate
Sodium Coco PG-Dimonium chloride phosphate
[0047] As illustrated in the above Table V, the quaternary ammonium
compounds behentrimonium methosulfate and behenalkonium chloride containing
compositions exhibited excellent log reduction values and antimicrobial activity
against the microbe Serratia Marcescens. The other quaternary ammonium
compound containing compositions tested exhibited little or no antimicrobial
activity. As evident from the table, the activity is unexpected.
[0048] In accordance with the patent statutes, the best mode and preferred
embodiment have been set forth, the scope of the invention is not limited thereto,
but rather by the scope of the attached claims.






WE CLAIM:
1. A composition having antimicrobial properties, comprising:
an aliphatic alcohol having from 1 to 8 carbon atoms in an amount from 30 to less than 60 parts;
an aromatic alcohol in an amount from 0.5 to 5.0 parts, wherein the hydroxyl group of the aromatic alcohol is connected to a nonaromatic ring carbon atom;
a cationic substrate binding activity enhancing substance in an amount from 0.0125 to 0.5 part, wherein the cationic substrate binding activity enhancing substance is behentrimonium methosulfate (docosyl(trimethyl)azanium methyl sulfate), behenalkonium chloride (benzyl-docosyl-dimethylazanium chloride), behenoyl PG-trimonium chloride (3-docosanoyloxy-2-hydroxypropyl), behenamidopropyl PG-trimonium chloride, or combinations thereof;
water in an amount from 33 to 65 parts, all said parts based on 100 parts by weight of the compostion, said composition free of a cationic cellulose polymer; and
optionally comprises a non-ionic thickner.
2. The composition as claimed in claim 1, wherein the aliphatic alcohol is present in an amount from 45 to less than 60 parts, and wherein the aromatic alcohol is present in an amount from 0.75 to 3.5 parts.
3. The composition as claimed in claim 2, wherein the water is present in an amount from 33 to 50 parts, and wherein the catidnic-substrate binding activity enhancing substance is present in an amount from 0.03 to 0.1 part.
4. The composition as claimed in claim 2, wherein said aliphatic alcohol is methanol, ethanol, n-propanol, isopropyl alcohol, 2-methyl-2 propanol, hexanol, or combinations thereof.

5. The composition as claimed in claim 4, wherein said aliphatic alcohol is present in an amount from 50 to 55 parts, and wherein said aromatic alcohol is present in an amount from 1.0 to 2.5 parts, and wherein said cationic substrate binding activity enhancing substance is present in an amount from 0.04 to 0.075 part.
6. The composition as claimed in claim 5, wherein the aliphatic alcohol is propanol, isopropyl alcohol, or ethanol, or combinations thereof, and wherein said aromatic alcohol is phenoxyethanol, benzyl alcohol, l-phenoxy-2-propanol, or combinations thereof.
7. The composition as claimed in claim 1, wherein the cationic substrate binding activity enhancing substance is behentrimonium methosulfate or behenalkonium chloride, and wherein the non-ionic thickener is a cellulose-based thickener in an amount from 0.1 to 3.0 parts.
8. The composition as claimed in claim 7, wherein the composition comprises a polyol, a skin conditioner, or pH adjusters or combinations thereof, wherein the viscosity of the composition is 30 to 120 centipoise, wherein the thickener comprises 2-hydroxypropyl cellulose, and wherein water is present in an amount from 35 to 45 parts.
9. A method for forming an antimicrobial composition, comprising the steps of:
providing from 33 to 65 parts of water to a vessel; wherein water is heated to a temperature sufficient to dissolve any solid components, such as 70"C to 80°C;
adding a cationic substrate binding activity enhancing substance to the water in an amount from 0.0125 to 0.5 part, wherein the cationic substrate binding activity enhancing substrate is behentrirrionium methosulfate, behenalkonium chloride, behenoyl PG-trimonium chloride, behenamidopropyl PG-dimonium chloride, or combinations thereof;
adding an aromatic alcohol to the composition in an amount from 0.5 to 5.0 parts, wherein the hydroxyl group of the aromatic alcohol is connected to a non-aromatic ring carbon atom;

adding an aliphatic alcohol having from 1 to 8 carbon atoms to the composition in an amount from 30 to 58 parts;
adding a non-ionic thickener to the composition; and mixing the composition, all parts based on 100 parts by weight of the composition, and wherein the composition is free of a cationic thickener.
10. The method as claimed in claim 9, wherein the cationic substrate binding activity enhancing
substance is present in an amount from 0.03 to 0.1 part, wherein said aromatic alcohol is present
in an amount from 0.75 to 3.5 parts, and wherein the aliphatic alcohol is present in an amount
from 45 to 58 parts.
11. The method as claimed in claim 10, wherein the water is present in an amount from 35 to 50
parts.
12. The method as claimed in claim 11, wherein the cationic substrate binding activity enhancing substance is behentrimonium methosulfate or behenalkonium chloride, and wherein the non-ionic thickener is a cellulose-based thickener in an amount from 0.1 to 3.0 parts, and wherein the composition comprises a polyol, a skin conditioner, pH adjusters or combinations thereof.

Documents:

1306-DELNP-2007-Abstract-(21-06-2012).pdf

1306-DELNP-2007-Abstract-(22-11-2011).pdf

1306-delnp-2007-abstract.pdf

1306-DELNP-2007-Assignment-(09-07-2009).pdf

1306-DELNP-2007-Claims-(21-06-2012).pdf

1306-DELNP-2007-Claims-(22-11-2011).pdf

1306-delnp-2007-claims.pdf

1306-delnp-2007-Correspondence Others-(06-06-2012).pdf

1306-DELNP-2007-Correspondence Others-(21-06-2012).pdf

1306-DELNP-2007-Correspondence Others-(22-11-2011).pdf

1306-DELNP-2007-Correspondence-Others-(08-05-2009).pdf

1306-DELNP-2007-Correspondence-Others-(09-07-2009).pdf

1306-delnp-2007-correspondence-others-1.pdf

1306-DELNP-2007-Correspondence-Others.pdf

1306-delnp-2007-description (complete).pdf

1306-delnp-2007-drawings.pdf

1306-DELNP-2007-Form-1-(21-06-2012).pdf

1306-DELNP-2007-Form-1.pdf

1306-delnp-2007-form-13-(08-05-2009).pdf

1306-delnp-2007-form-18.pdf

1306-DELNP-2007-Form-2-(21-06-2012).pdf

1306-DELNP-2007-Form-2-(22-11-2011).pdf

1306-delnp-2007-form-2.pdf

1306-DELNP-2007-Form-26-(08-05-2009).pdf

1306-DELNP-2007-Form-26-(09-07-2009).pdf

1306-DELNP-2007-Form-3-(22-11-2011).pdf

1306-DELNP-2007-Form-3.pdf

1306-DELNP-2007-Form-5-(21-06-2012).pdf

1306-delnp-2007-form-5.pdf

1306-delnp-2007-form-6-(09-07-2009).pdf

1306-delnp-2007-GPA-(06-06-2012).pdf

1306-DELNP-2007-GPA-(21-06-2012).pdf

1306-delnp-2007-gpa.pdf

1306-delnp-2007-pct-101.pdf

1306-delnp-2007-pct-105.pdf

1306-delnp-2007-pct-210.pdf

1306-delnp-2007-pct-220.pdf

1306-delnp-2007-pct-237.pdf

1306-delnp-2007-pct-301.pdf

1306-delnp-2007-pct-304.pdf

1306-delnp-2007-pct-308.pdf

1306-delnp-2007-pct-311.pdf

1306-DELNP-2007-Petition-137-(22-11-2011).pdf

1306-DELNP-2007-Petition-138-(22-11-2011).pdf


Patent Number 260451
Indian Patent Application Number 1306/DELNP/2007
PG Journal Number 18/2014
Publication Date 02-May-2014
Grant Date 30-Apr-2014
Date of Filing 19-Feb-2007
Name of Patentee AMERICAN STERILIZER COMPANY
Applicant Address 5960, Heisley Road, Mentor, OH 44060-1834
Inventors:
# Inventor's Name Inventor's Address
1 ZACHARIAH C. GRETEN 2667 PIPER HILLS DRIVE,SHILOH, ILLINOIS 62221, USA
2 NANCY-HOPE E. KAISER 115 WILSON COURT, PONTOON BEACH, ILLINOIS 62040, USA
3 DANIEL A. KLEIN 3427 CANTON RUN CROSSING, SHILOH, ILLINOIS 62221, USA
PCT International Classification Number A01N 31/02
PCT International Application Number PCT/US2005/028455
PCT International Filing date 2005-08-11
PCT Conventions:
# PCT Application Number Date of Convention Priority Country
1 10/922,456 2004-08-20 U.S.A.