Title of Invention

A WASH SOLUTION

Abstract Emulsions containing a dermal anchoring/substantive agent, such as glycerin, in high concentration enhance the activity of active ingredients, such as anti- microbial agents like chlorhexidine gluconate. Kits, compositions and methods pertaining to the same are provided. The invention finds application in cleansers such as hand washes, wound cleansers, body washes, mouthwashes, surgical scrubs, etc., and lotions, creams, foams and ointments. Specifically, one embodiment of the emulsion contains greater than 30% of an anchoring/substantive agent such as glycerin and an effective amount of chlorhexidine gluconate. Additionally, the product produced by the process of combining on the skin high glycerin and an anti-microbial is described.
Full Text BACKGROUND OF THE INVENTION
1. Technical Field of the Invention
The present invention relates to compositions wherein a high concentration of a material
with dermal anchoring/skin mechanical properties, such as high (more than 30%) glycerin, acts to
enhance the effect of active ingredients, such as the anti-microbial agent chlorhexidine gluconate
(CHG).
2. Background of the Invention
A variety of creams, loiions, washes and foams have been developed as an adjunct to
protective gloves to sanitize and protect the skin from both the transmission and the receipt of
infectious agents. These products contain a variety of wetting agents, fatty acids, solvents,
emollients and other agents which act to protect the skin in a variety of ways. However, concern
has been raised about the effect of these additives on a variety of active ingredients such as
germicides (Larson, E., et al., Effects of a Protective Coating Foam on Scrubbing and Gloving,
AMERICAN J. OF INFECTION CONTROL 21(6):297 (1993)). For example, it is taught that
chlorhexidine and its derivative!; are inhibited by a variety of ingredients including anionic
surfactants, soaps, gums, sodium alginate, magnesium aluminum silicate, magnesium trisilicate,
bentonite, talc, kaolin, high pH, 3% lecithin/polysorbate 80 and polysorbate 80 (Interaction
between Cosmetic Ingredients and Preservatives, COSMETICS & TOILETRIES 110:81-86 (1995)).
To address this concern, investigators have performed studies on the effect of various additives on
the efficacy of active ingredients.
Kihara, for example, teaches that the bactericidal activity of chlorhexidine digluconate and
benzalkonium chloride (BAC) decreases in the presence of other ingredients such as serum,
polysaccharides, non-ionic surfactants, powdered milk, dried bovine serum albumin, fish powder
and other organic substances (U.S. Patent No. 5,017,617). Kihara states that most emollients used
in cosmetics are nonionic surfactants or higher alcohols, so it is likely that they decrease the
bactericidal activity of chlorhexidine digluconate and benzalkonium chloride. Therefore, Kihara
tested a variety of emollients, including diesters of dibasic acids, triesters of citric acid or
phosphoric acid, and polyglycerot (2 to 115 monomers), for their effect on chlorhexidine
digluconate. Surprisingly, Kihara found that these di- and tri-esters enhanced, rather than

inhibited, bactericidal activity. Kihara employs low concentrations of emollient (0.1-1.0%) in 50-
95% ethanol and teaches that higher concentrations of emollient are to be avoided as producing a
sticky feel. The mechanism of enhancement is not provided by Kihara, but it is possible that the
long carbon chain, polar emollent molecules act on the bacterial membranes themselves, thus
assisting the bactericidal effect of chlorhexidine digluconate.
Similarly, in JP 63057502 assigned to Saraya, the inventors found that in alcohol
disinfecting solutions containing ohlorhexidine gluconate (CHG) and an emollient selected from the
group of diisopropyl adipate, diisobutyl adipate, higher fatty acid polyoxethylene glycerol and
polyglycerol, the emollient enhanced the effect of CHG. Again, it may be that the long chain, fatty
acids alone or in combination with CHG act on the bacterial membranes to assist the bactericidal
effect of CHG alone.
Loosemore tested the effect of polyvinyl alcohol and propylene glycol on the germicidal
activity of 0.6% CHG in a teat dip application (U.S. Patent No. 5,641,498). Loosemore reported
that neither ingredient adversely affected the activity of CHG. Although Loosemore's compositions
contained 4% glycerin (also known as glycerol or glycerine), he neglected to compare the effect
of this particular agent on the activity of CHG.
Others, however, havt: studied the effect of glycerin on particular active ingredients.
Mundschenk, for example, studied the effect of glycerin on the efficacy of hydrogen peroxide as
an anti-microbial agent in a dentil cream (U.S. Patent No. 5,512,278). Mundschenk reported that
20% glycerin did not negate the effectiveness of 3% hydrogen peroxide in this particular
application. Similarly, Turck showed that addition of up to 10% glycerin did not decrease the anti-
microbial activity of the disinfectant: N, N-dimethyldodecanamine on liquid cultures of
Streptococcus agalactiae or Escherichia coli (Turck, P.A., et al Mastitis: Effect of pH,
Temperature and emollients on Disinfecting Action of N, N-dimethyldodecanamine J. DAIRY Sci.
65(10): 1987 (1982)), and Hicks showed that up to 6% glycerin did not affect the efficacy of
chlorhexidine digluconate in a teat dip application (Hicks W.G., et ah, Evaluation of a Teat Dip
of Chlorhexidine Digluconate (0.5%) with Glycerin (6%), J. DAIRY Sci. 64(11):2266 (1981)).
Asaka teaches the use of 0.1-15% glycerin as an emollient used in combination with 25-80%
lower alcohol, 0.01-4% cationic disinfectant such as CHG, and 1-40% amphoteric surfactant such
as imidazolinium betaine (Australian Application No. AU-A-74370/94). Asaka notes that the

emollients did not affect the disinfection by the cationic disinfectant, but states that concentrations
higher than 15% may produce stickiness. Asaka's data shows that low levels of glycerin do not
enhance the activity of CHG.
JP 61130210 assigned to San-Star stowed that a paste containing CHG, 0.1-1% citric acid
and 1-5% carrageenan improved the stability of CHG. A sample composition that also contained
30% glycerin was provided.
To date no one has studi ed the effect of high levels of glycerin and similar compounds on
the efficacy of active ingredients such as the anti-microbial chlorhexidine gluconate.
SUMMARY OF THE INVENTION
Broadly speaking, the invention is a wash solution comprising more than 30% of an
anchoring agent and an effective amount of an active ingredient, preferably from about 0.1 to about
10%, wherein unless otherwise specified herein such percents are by weight based on the total
weight of the wash solution. The anchoring agent is a simple polyol or is selected from the group
consisting of 3 to 6 carbon polyols, 3 to 6 carbon aldoses, and 3 to 6 carbon ketoses, and their
combinations and derivatives. Ths active ingredient is selected from the group consisting of anti-
histamines, anti-inflammatory agents, analgesics, anesthetics, anti-perspirants, anti-dandruffs, anti-
microbial agents, astringents, counter irritants, depigmenting agents, bleaching agents, and steroids.
More particularly, the anchoring agent may be selected from the group consisting of
glycerol, propylene glycol, glyceraldehyde, dihydroxyacetone, 1,3-butylene glycol, 2,3-butylene
glycol, erythritol, erythrose, erythrulose, ribose, sorbitol, mannitol, and inositol.
If the active ingredient is an anti-microbial, it may be chlorhexidine or its derivatives, such
as chlorhexidine gluconate, chlorhexidine digluconate, chlorhexidine diacetate, chlorhexidine
dihydrochloride, or it may be selected from the group consisting of nisin, bis-diguanides,
polyhexamethylene biguanide (PHMB), berzalkonium chloride (BAC), benzethonium chloride
(BZC), methylbenzethonium choride, triolosan, triclocarban, tribromsalan, amyltricresols,
parachlorometaxylenol (PCMX), phenol, iodine, nonylphenoxypoly (ethyleneoxy) ethanoliodine,
poloxamer-iodine complex, undecoylium chloride iodine complex, bisquatemary ammonium
compounds, polymeric quaternary ammonium compounds, alcohols, cationic peptides,
organometallic antiseptics, alkyl pyrdinium salts such as cetyl pyridinium chloride (CPC), essential

oils, and their combinations and derivatives.
Additional agents may be present in the wash solution of the invention including
octadecene-1/maleic anhydride copolymer, organofluorinated modified silicone resins, polyvinyl
pyrrolidone, hydrogenated copolymers of styrene and butadiene, film forming copolymers,
copolymers of eicosene and vinyl pyrrolidone, copolymer of hexadecane and vinyl pyrrolidone,
cellulosic ethers, 2-hydroxyethyl methacrylate homopolymer, cocodimethyl ammonium salt of
hydrolyzate of wheat protein, guar hydroxy propyltrimonium chloride, hydroxypropylcellulose,
lauryldimonium hydroxypropyl hydrolyzed collagen, lauryldimonium hydroxypropyl hydrolyzed
wheat protein, polyquaternium-24 and hyaluronic acid, soluble reticulin and soluble wheat protein,
stearyldimonium hydroxypropyl hydrolyzed collagen, acrylic/acrylate copolymers, behenoxy
dimethicone, dimethicone copolyol phosphate, polydecene/polybutene copolymer,
polymethacrylamidopropyl trimonium chloride, polymethylalkyl siloxane, and the like.
In another embodiment, he invention is a wash solution comprising more than 30% of a
3 to 6 carbon polyol and an effective amount of an anti-microbial agent, preferably from about 0.1
to about 10%. In another embodiment, the polyol has a backbone of 3 to 6 carbons and at least
2 alcohol groups. In a preferred embodiment, the polyol is glycerin and the anti-microbial agent
is chlorhexidine gluconate (CHG). The anchoring agent, for example glycerin, is preferably present
in an amount of at least 40%, for example from about 40 to about 80%, at least 50%, for example
from about 50 to about 75%, or at least (30%. The anti-microbial agent may be present in an
amount ranging from about 0.01 to about: 10%, preferably from about 0.01 to 5%, and more
preferably from about 0.1 to about 2%.
In another embodiment, the invention is a method of improving the efficacy of a polar anti-
microbial agent on the skin, said method comprising the steps of treating the skin with a
composition containing more than 30%, preferably at least 40%, of an anchoring agent; and
washing the skin with an anti-microbial agent or composition containing the anti-microbial agent
in an effective amount. The anchoring agents and anti-microbial agents are as described above.
Although these steps may performed in any order or simultaneously, in a preferred method, the
washing step is performed after the treating step.
The invention also includes kits for the anti-microbial treatment of skin. The kits contain
at least a first container containing a first composition comprising more than 30% of an anchoring

agent, as described above, and a second container containing a second composition comprising
from about 0.1 to about 50 % of an anti-microbial agent, as described above.
Furthermore, the invention includes a product produced by the process of treating the skin
with a first composition containing more than 30% of an anchoring agent, as described above, and
treating the skin with an effective amount of an anti-microbial agent, preferably present in an
amount ranging from about 0.1 tc about 50% wherein the anti-microbials are as described above.
DETAILED DESCRIPTION OF THE INVENTION
To date, no one has studied the effect of high levels of glycerin on a variety of active
ingredients. We have shown that high glycerin does not inhibit and even has a synergistic effect on
a cationic anti-microbial agent, acting to preserve its effectiveness over longer periods of time than
similar compositions without glycerin or with low levels of glycerin.
Though not wishing to be bound to any particular theory, it is hypothesized that high
glycerin acts as a stratum corneum hydrator, creating a reservoir of glycerin in the stratum
corneum. Studies have shown that high glycerin products actually deliver glycerin into the skin and
increase the thickness of the entire stratum corneum (Appa, Y., et al, Clinical Evaluations of
Hand and Body Moisturizers that Heal Skin Dryness, poster presentation at the 1992 American
Academy of Dermatology, San Fnncisco, Dec. 6-7, 1992). It is believed that other materials with
similar anchoring/substantive, hygroscopic and water solubility properties should have a similar
effect, acting to penetrate the stratum corneum, hydrating it and providing a reservoir of water
within which a polar active ingredient can dissolve/reside and be retained to increase its
effectiveness. The effect may be even more pronounced where the active ingredient is both soluble
in water and in the anchoring agent employed. This is true for the combination of CHG and
glycerin because CHG is both water and glycerin soluble.
To test this hypothesis, the effect of similar polyols such as propylene glycol, butylene
glycol, erythritol, xylitol, sorbitol, mannitol, and inositol, etc., and closely related molecules such
as aldoses like glyceraldehyde, erythrose, threose, xylose, ribose, arabinose, lyxose, etc., and
ketoses such as dihydroxyacetone, erythrulose, ribulose, xylulose, etc. were studied. Additional
anchoring agents useful in the invention can be identified in the manner described in Example 1 by
substituting such agent for CHG therein. Anchoring agents that enhance the activity of CHG by

20% are considered anchoring igents of this invention.
Likewise, the high anchoring agent content, for example high glycerin content, of this
invention can be combined with and improved by the addition of other agents. Many polymeric
materials with anchoring and substantive properties may be combined with the anchoring agents
described above, for example glycerin, to provide improved retention and slow release of soluble
active ingredients. For example, substantive agents include octadecene-1/maleic anhydride
copolymer, organofluorinated modified silicone resins, polyvinyl pyrrolidone, hydrogenated
copolymers of styrene and butadiene, film forming copolymers, copolymers of eicosene and vinyl
pyrrolidone, copolymer of hexadecane and vinyl pyrrolidone, cellulosic ethers, 2-hydroxyethyl
methacrylate homopolymer, cocodimethyl ammonium salt of hydrolyzate of wheat protein, guar
hydroxy propyltrimonium chloride, hydroxypropylcellulose, lauryldimonium hydroxypropyl
hydrolyzed collagen, lauryldimonium hydroxypropyl hydrolyzed wheat protein, polyquaternium-24
and hyaluronic acid, soluble reticulin and soluble wheat protein, stearyldimonium hydroxypropyl
hydrolyzed collagen, acrylic/acrylate copolymers, Behenoxy dimethicone, dimethicone copolyol
phosphate, polydecene/polybutene copolymer, polymethacrylamidopropyl trimonium chloride,
polymethylalkyl siloxane, and tht like.
However, where the anchoring agent composition is intended to be used where latex gloves
might also be used, for example in a surgical setting, it is preferred that oil-based ingredients be
kept to a minimum if possible. This is because petroleum and mineral oil based additives are known
to compromise the structural integrity of latex. Thus, water soluble ingredients are preferred in this
type of application.
Anti-microbial agents useful in the invention include nisin, bis-diguanides, chlorhexidine
gluconate, chlorhexidine digluconate, chlorhexidine diacetate, chlorhexidine dihydrochloride,
polyhexamethylene biguanide, benzalkonium chloride, benzethonium chloride, methylbenzethonium
chloride, cetyl pyridinium chloride, triclosan, triclocarban, tribromsalan, amyltricresols,
parachlorometaxylenol, phenol, iodine, nonylphenoxypoly (ethyleneoxy) ethanoliodine, poloxamer-
iodine complex, undecoylium chloride iodine complex, bisquatemary ammonium compounds,
polymeric quaternary ammoniun compounds, alcohols, cationic peptides, organometallic
antiseptics, alkyl pyridinium salts, essential oils and their combinations and derivatives. Likewise,
a variety of simple alcohols may function in this regard, including but not limited to, ethanol,

propanol, butanol, pentanol, 1 -methyl-1-butanol, hexanol, 2-methyl-1-pentanol, 3-methyl-1-
pentanol, 2-ethyl-1-butanol, 3,5,5-dimethyl-1-hexanol, heptanol, octanol, isooctyl alcohol, decanol,
dodecanol, tridecanol, tetradecanol and the like.
Additional active ingredients useful in the invention can be identified in the manner
described in the Example by substituting such active ingredients for CHG and anti-histamines, for
example, diphenylhydramine and phenyltoioxamine; anti-inflammatory agents, for example,
hydrocortisone; analgesics, for example capsaicin; anesthetics, for example benzocaine; anti-
perspirants; anti-dandruffs; astringents, for example calamine, aluminum acetate and zinc oxide;
counter irritants, for example menthol and camphor; depigmenting or bleaching agents; steroids;
and the like. Active ingredients that have at least 20% increased activity when combined with 40%
glycerin are included in this invention.
Active ingredient is defined herein as a pharmaceutically active ingredient that has increased
substantive properties when combined with the anchoring agents below, meaning it penetrates into
the skin, providing long lasting activity even after wash off.
Anchoring agent is defined herein as a hygroscopic agent that penetrates and remains in the upper
layers of the skin (in other words a substantive agent), into which an active ingredient can be
partitioned and retained with the anchoring agent against wash off. The anchoring agent provides
for the slow release of an active ngredient, such as an anti-microbial.
Anti-microbial is defined herein as an agent that inhibits the growth of, or kills, organisms
including bacteria, protozoans, viruses, prions, yeast, fungi, or other infectious agents, and has
increased substantive properties when combined with the anchoring agents above, meaning it
penetrates into the skin providing long lasting anti-microbial activity even after wash off.
High glycerin is defined herein as greater than 30% glycerin, preferably from about 35 to 100%
glycerin, and more preferably frorr about 40 to about 80%. from about 50 to about 75%, or at least
60% glycerin, for example 60 % glycerin (all percentages herein are w/w).

Simple Polyol is defined herein to exclude polymerized polyols, such as polyglycerol, and long
chain (more than 3 carbons) esters of polyols such as fatty acid esters of glycerol.
Wash solution is defined herein as a solution that can be used before, during or after cleansing and
may be hand washes, wound cleansers, body washes, mouthwashes, surgical scrubs, etc. in the form
of liquids, lotions, creams, foams, gels, milks, and the like. Wash solution does not include soap
bars.
Example: The Synergistic Effect of High Glycerin on CHG
High (40%)glycerin and glycerin free formulations were tested for their effect on the
germicidal effectiveness of a 4% solution of CHG per the technique described generally herein and
adapted from Larson (Larson, E., et al, Effects of a Protective Coating Foam on Scrubbing and
Gloving, AMERICAN J. OF INFECT ON CONTROL 21(6):297 (1993)). Ten healthy subjects over the
age of 18 but less than 70 were screened and admitted into the study. Insofar as possible, subjects
were of mixed sex and age. All were free of clinically evident dermatoses or injuries to the hands
or forearms.
During a 14-day pretest period, subjects avoided the use of medicated soaps, lotions,
detergents and shampoos, as well as skin contact with solvents, acids and bases. Non-anti-
microbial products were supplied to the subjects for their use throughout the pre-test period. This
regimen allowed for the stabilization of the normal microbial populations of the hands.
Subjects participated in the study for 5 consecutive days. The first two days subjects had
a baseline microbial count taken of both hands by the Glove Juice Procedure. For the baseline
determination, hands were washed using a liquid nonmedicated baseline soap control (BABY
SAN®, a HUNTINGTON™ product) according to standard surgical scrub procedures.
Subjects clipped fingernails to 2 mm free edge, if necessary. All jewelry was removed from
hands and forearms. Subjects wet their hands, including two thirds (2/3) of the forearms, under
running tap water 40 ± 2°C for thirty seconds. During this rinse, fingernails were cleaned with a
nail cleaner. Hands were maintained higher than elbows during the wash procedure which was as
follows. Hands and forearms were washed with 5 ml of baseline control soap for thirty (30)
seconds using water as required to develop lather. Hands and forearms were rinsed thoroughly,

removing all lather, for 30 seconds under running tap water at 40 ± 2°C. Hands were not dried,
but gloved wet. This was followed by the Glove Juice Procedure.
Glove Juice Procedure Following the prescribed wash and rinse, powder free sterile latex
gloves (FISHERBRAND® POWDER-FREE, STERILE, LATEX SURGICAL GLOVES) were
donned. At the designated Sampling times, 75 ml of sterile Stripping Suspending Fluid with
neutralizes were placed into he glove. The wrist was secured, and an attendant massaged the
hand through the glove in a standardized manner for 60 seconds. Aliquots of the glove juice were
removed and serially diluted, 0°-106, in Butterfields Buffered Phosphate Solution.
Duplicate pour plates were prepared from each of these dilutions on Tryptic Soy Agar with
0.07% (w/v) lecithin and 0.5% Iween 80. Plates were incubated at 30°± 2° C for up to 72 hours.
Those plates providing colony counts between 25 and 250 were counted and used. If the undiluted
(10°) plates gave an average cc unt of 0, the average count was expressed as 1.00. This was done
for mathematical reasons because the log10 of 0 is undefined, but the log10 of 1 is 0. The number
of viable bacteria recovered was 75 X Dilution factor X mean plate count for the duplicate plates.
Subjects followed standard surgical scrub techniques using a solution of 4% CHG for 3
days. On day 3, after scrubbing the subjects applied 350 mg of either High Glycerin (HG) cream,
700 mg Glycerin Free (GF) loton or no cream/lotion control. Microbial sampling was performed
immediately after treatment or at 2 hours after treatment and the log10 reduction recorded as per
Table 1. On day 4, no creams were used and on day 5, creams were applied prior to scrubbing.
The results were as follows:


noteworthy that enhancement of CHG occurs with low amounts of a high glycerin containing
cream, but not with high amounts of a glycerin-free lotion.
The data was evaluated using several Analysis of Variance models and the Students t test.
The data shows that the high (40%) glycerin cream enhanced the effect of CHG activity 2 hours
post scrub on test day S.
Glycerin is a known humetant that has beneficial effects on skin conditioning due to its
effects on the status of water in at least the outer layers of the stratum corneum. This is probably
the result of glycerin interactions with the lipid proteins in the stratum corneum, altering their water
binding and/or hydrophilic properties. Due to this phenomena, as glycerol increases in the skin, so
does water increase to form a reservoir in which water soluble active ingredients, such as CHG,
can be dissolved and retained against wash off. Additionally, where the active ingredient is itself
soluble in glycerin, the enhancement effect is Jurther increased. These effects may explain the mode
of action of glycerin enhancement of CHG activity.
The enhancement is best seen when the skin is first treated with a dermal anchoring agent
before washing with CHG. This is because a reservoir has been created into which the maximum
amount of CHG can diffuse. When the dermal agent is used after the CHG wash, there is less CHG
present to diffuse into the skin with the dermal anchoring agent, most of the CHG having already
been rinsed off due to lack of 2. dermal anchoring agent. However, it is anticipated that the
enhancement effect will occur whether the dermal anchoring agent is used simultaneously with,
before or after the CHG wash, because this is always some amount of CHG retained on the skin
even after rinsing.
The invention has been described in an illustrative manner, and it is to be understood that
the terminology which has been used is intended to be in the nature of description rather than of
limitation.
Obviously, many modifications and variations of the present invention are possible in light
of the above teachings. It is, therefore, to be understood that within the scope of the appended
claims, the invention may be practiced otherwise than as specifically described.

WE CLAIM
1. A wash solution comprising:
(a) more than 30% of an anchoring agent,
wherein the anchoring agent is selected from the group consisting of 3 to 6 carbon
polyols, 3 to 6 carbon aldoses, and 3 to 6 carbon ketoses, and their combinations
and derivatives;
(b) from 0.01% to about 10% active ingredient,
wherein the active ingredient is selected from the group consisting of anti
histamines, anti-inflammatory agents, analgesics, anesthetics, anti-perspirants, anti
dandruffs, anti-microbial agents, astringents, counter-irritants, depigmenting agent
bleaching agents, and steroids.
2. The wash solution as claimed in claim 1, wherein the active ingredient is an anti-microbial agent.
3. The wash solution as claimed in claim 1, wherein the anchoring agent is a 3 to 6 carbon polyol.
4. The wash solution as claimed in claim 3, wherein the polyol is a polyol which has a backbone of 3
6 carbons and at least two hydroxyl groups.
5.) The wash solution as claimed in claim 4, wherein the active agent is an anti-microbial agent.
6. The wash solution as claimed in claim 5,
wherein the polyol is selected from the group consisting of glycerin, propylene
glycol, butylene glycol and combinations thereof; and
wherein the anti-microbial agent is a chlorhexidine derivative.
7. The wash solution as claimed in claim 5,
wherein the polyol is glycerin; and
wherein the anti-microbial agent is chlorhexidine gluconate.
8. The wash solution of claim 3,
wherein the 3 to 6 carbon polyol is selected from the group consisting of glycerin
propylene glycol, 1,3-butylene glycol, 2,3-butylene glycol and combinations thereof; and
wherein the active ingredient is an anti-microbial agent selected from the group
consisting of chlorhexidine gluconate, chlorhexidine digluconate, chlorhexidine diacetat
chlorhexidine dihydrochloride and combinations thereof.

9. The wash solution of claim 5,
wherein the anti-microbial agent is a chlorhexidine derivative.
10. The wash solution as claimed in claim 9,
wherein the chlorhexidine derivative is chlorhexidine gluconate.
11. The wash solution as claimed in claim 5,
wherein the anti-microbial agent is nisin.
12. The wash solution as claimed in claim 5,
wherein the anchoring agent is selected from the group consisting of glycerol,
propylene glycol, glyceraldehyde, dihydroxyacetone, 1,3-butylene glycol, 2,3-butylene
glycol, erythritol, erythrose, erythrulose, sorbitol, mannitol, and inositol; and
wherein the anti-microbial agent is selected from the group consisting of nisin, bis-
diguanides, chlorhexidine gluconate, chlorhexidine digluconate, chlorhexidine diacetate,
chlorhexidine dihydrochlonde, polyhexamethylene biguanide, benzalkonium chloride,
benzethonium chloride, methylbenzethonium chloride, cetyl pyridinium chloride, triclosan,
triclocarban, tribromsalan, amyltricresols, parachlorometaxylenol, phenol, iodine,
nonylphenoxypoly (ethyteneoxy) ethanoliodine, poloxamer-iodine complex, undecoylium
chloride iodine complex, bisquaternary ammonium compounds, polymeric quaternary
ammonium compounds, cationic peptides, organometallic antiseptics, alkyl pyridinium salts,
essential oils, ethanol, propanol, butanol, pentanol, 2-methyl-1-butanol, hexanol, 2-methyl-
1-pentanol, 3-methyl-1-pentanol, 2-ethyl-1-butanol, 3,5,5-trimethyl-10-hexanol, heptanol,
octanol, isooctyl alcohol, decanol, dodecanol, tridecanol, tetradecanol and their
combinations and derivative
13. The wash solution of claim 1, as claimed in comprising an agent selected from the group
consisting of octadecene-1/maleic anhydride copolymer, organofluorinated modified
silicone resins, polyvinyl pyrrolidone, hydrogenated copolymers of styrene and butadiene,
film forming copolymers, copolymers of eicosene and vinyl pyrrolidone, copolymer of
hexadecane and vinyl pyrrolidone, celluiosic ethers, 2-hydroxyethyl methacrylate
homopolymer, cocodimethyi ammonium salt of hydrolyzate of wheat protein, guar hydroxy
propyltrimonium chloride, hydroxypropylcellulose, lauryldimonium hydroxypropyl
hydrolyzed collagen, lauryldimonium hydroxypropyl hydrolyzed wheat protein,

polyquaternium-24 and hyaluronic acid, soluble reticulin and soluble wheat
protein, stearyldimonium hydroxypropyl hydrolyzed collagen, acrylic/acrylate
copolymers, Behenoxy dimethicone, dimethicone copolyol phosphate,
polydecene/polybutene copolymer, polymethacrylamidopropyl trimonium
chloride, and polymethylakyl siloxane.
14. The wash solution as claimed in claim 1, wherein the anchoring agent is
present in an amount of at least 40% of the wash solution.
15. The wash solution as claimed in claim 1, wherein the anchoring agent is
present in an amount ranging from 40% to 80% of the wash solution.
16. The wash solution as claimed in claim 15, wherein the antimicrobial agent
is present in an amount ranging from 0.01% to 5% of the wash solution.
17. The wash solution as claimed in claim 16, wherein the anchoring agent is
glycerin and the anti-microbial agent is chlohexidine gluconate.
18. A kit used for the anti-microbial treatment of skin, said kit comprising:
a first composition comprising more than 30% of an anchoring agent,
wherein the anchoring agent is selected from the group consisting of 3 to 6
carbon polyols, 3 to 6 carbon aldoses,, and 3 to 6 carbon Ketoses, and their
combinations and derivatives; and
a second composition comprising from 0.1% to 50% of an antimicrobial
agent,

wherein the anti-microbial agent is selected from the group consisting of
nisin, bis-diguanides, chlorhexidine gluconate, chlorhexidine digluconate,
chbrhexidine diacetate, chlorhexidine dihydrochloride, polyhexamethylene
biguanide, benzalkonium chloride, benzethonium chloride,
methybenzethonlum chloride, cetyl pyridinium chloride, triclosan,
triclocarban, tribromsalan, amyltricresols, parachbrometaxylenol, phenol,
iodine, nonylphenoxypoly (ethyleneoxy) ethanoliodine, poloxamer-iodine
complex, undecoylium chloride iodine complex, bisquaternary ammonium
compounds, polymeric quaternary ammonium compounds, cationic
peptides, organometallic antiseptics, alkyl pyridinium salts, essential oils,
ethanol, propanol, butano, pentanol, 2-methyt-1-butanol, hexanol, 2-
methyl-1-pentanol, 3-methyl-1-pentanol, 2-ethyl-1-butanol, 3, 5, 5-
trimethyl-10-hexanol, heptanol, octanol, isooctyl alcohol, decanol,
dodecanol, tridecanol, tetradecanol and their combinations and derivatives.
19. The kit as claimed in claim 18, wherein the anchoring agent is glycerin and
the anti-microbial agent is a chlorhexidine derivative or nisin.

Emulsions containing a dermal anchoring/substantive agent, such as glycerin, in
high concentration enhance the activity of active ingredients, such as anti-
microbial agents like chlorhexidine gluconate. Kits, compositions and methods
pertaining to the same are provided. The invention finds application in cleansers
such as hand washes, wound cleansers, body washes, mouthwashes, surgical
scrubs, etc., and lotions, creams, foams and ointments. Specifically, one
embodiment of the emulsion contains greater than 30% of an
anchoring/substantive agent such as glycerin and an effective amount of
chlorhexidine gluconate. Additionally, the product produced by the process of
combining on the skin high glycerin and an anti-microbial is described.

Documents:

2226-CAL-1998-CORRESPONDENCE 1.1.pdf

2226-CAL-1998-CORRESPONDENCE.pdf

2226-CAL-1998-FORM 15.pdf

2226-CAL-1998-FORM-27.pdf

2226-cal-1998-granted-abstract.pdf

2226-cal-1998-granted-assignment.pdf

2226-cal-1998-granted-claims.pdf

2226-cal-1998-granted-correspondence.pdf

2226-cal-1998-granted-description (complete).pdf

2226-cal-1998-granted-examination report.pdf

2226-cal-1998-granted-form 1.pdf

2226-cal-1998-granted-form 18.pdf

2226-cal-1998-granted-form 2.pdf

2226-cal-1998-granted-form 3.pdf

2226-cal-1998-granted-reply to examination report.pdf

2226-cal-1998-granted-specification.pdf

2226-cal-1998-granted-translated copy of priority document.pdf

2226-CAL-1998-PA.pdf


Patent Number 230189
Indian Patent Application Number 2226/CAL/1998
PG Journal Number 09/2009
Publication Date 27-Feb-2009
Grant Date 25-Feb-2009
Date of Filing 29-Dec-1998
Name of Patentee ETHICON, INC.
Applicant Address U S ROUTE 22, SOMERVILLE, NEW JERSEY
Inventors:
# Inventor's Name Inventor's Address
1 HUNUMAN B. JAMPANI 1961 NORTH PORT COURT, GRAPEVINE, TEXAS 76051
2 JERRY L. NEWMAN 4112 PEACHWOOD DR. ARLINGTON, TEXAS 76016
PCT International Classification Number B61
PCT International Application Number N/A
PCT International Filing date
PCT Conventions:
# PCT Application Number Date of Convention Priority Country
1 09/001,020 1997-12-30 U.S.A.