Note : Les descriptions sont présentées dans la langue officielle dans laquelle elles ont été soumises.
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A LOTIONED WIPE PRODUCT COMPRISING AN ANTI-STICK AGENT AND A
PERFORMANCE ENHANCING AGENT
FIELD OF THE INVENTION
A lotioned wipe product comprising a substrate and a lotion in contact with
the substrate,
the lotion comprising an anti-stick agent and a performance enhancing agent
may be used for
delivering an improved body cleansing performance. The lotion may help reduce
adhesion of
soils or exudates to the skin.
BACKGROUND OF THE INVENTION
Cleaning the skin is a personal hygiene problem not always easily solved. Dry
tissue
products are the most commonly used cleansing products post-defecation, post-
urination and
during menstruation. Dry tissue products are also commonly used to remove
soils, such as food
and dirt, from the skin. Dry tissue products, such as those commonly used, are
generally referred
to as "toilet paper," "toilet tissue," or "paper towels." In addition to the
use of dry tissue
products, it is becoming increasingly frequent to use moistened substrates,
such as wet wipes, for
the purpose of cleansing the face and body after soiling, and the anus, the
genital area, the
perinea, and the peri-anal area after the voiding of bodily exudates. So
called "wet wipes" are
generally a fibrous structure impregnated with a water or oil-based lotion.
For the purpose of the present document, the anus, the perinea, the perineal
area and the
vulvar area are all terms indicating the body area of the pelvis between,
around and including the
anus and the external genitalia.
Both the perineal area and the vulvar area are marked by the presence of fine
folds/wrinkles (sulci) and hair follicles, both of which make these regions
more difficult
anatomical areas to cleanse. During defecation, fecal matter is excreted
through the anus and
tends to accumulate in hard to reach locations such as around the base of
hairs and in the sulci of
the skin's surface. During menstruation, menses may accumulate on the skin and
hair after the
use of a sanitary napkin. As the fecal or menstrual matter dehydrates upon
exposure to air or
upon contact with an absorbent implement such as tissue paper, diaper, or
sanitary napkin, it
adheres more tenaciously to the skin and hair. Subsequent removal of the
remaining dehydrated
exudates may be even more difficult and may result in inadequate cleansing.
Among those
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negatives associated with the failure of adequate cleansing are irritation,
redness, desquamation,
infections, unpleasant odor, or other kinds of personal discomfort or health
related issues.
People suffering from pathological conditions (such as hemorrhoids, fissures,
cryptitis,
etc.) are even more susceptible to the negatives listed above. Common hygienic
concerns make
the benefits of a good cleansing after defecation, menstruation, and urination
very relevant to
babies, toddlers, children and adults. Cleansing must be efficient in terms of
removal of residues
and gentle in terms of absence of irritation caused by the cleansing. Wet-
wipes bring a response
to that basic need.
In comparison to dry tissue products, wet wipes have several benefits
including:
1 0 - The enabling of a better lubrication during the use of the wipe,
thereby reducing the
abrasiveness of the cleansing operation;
- The hydration of the residues, thus enhancing their removal from the skin
or hair;
- The hydration of the skin tissue; and
- The ability to deliver a soothing or protective lotion to the skin that
can remain on the
skin after the cleansing operation.
Manufacturers of wet wipes have tried to develop wipes products that deliver
the right
balance between normally antagonistic concepts such as:
- Enhancing the removal of soil while protecting the skin from irritation
and abrasion.
- The long lasting feeling of comfortable cleanliness while avoiding a
greasy feeling on
the skin.
There still remains a need not only for a wet wipe that cleans effectively but
that also
simultaneously reduces or prevents the adhesion of soils or exudates to the
skin. Such a wipe
would greatly facilitate cleansing. The facilitation of cleansing by such a
wipe may be reflected
by a reduced deposition of soils or exudates on the skin from subsequent
insults. As a result,
there may be a reduction in the amount of soils or exudates on the skin at the
time of the next
cleaning, easier removal of the soils or exudates from the skin resulting in
less abrasive damage,
reduced smearing of the soils or exudates on the skin, and/or improved
capture/retention of the
soils or exudates on a substrate, such as a wet wipe, or within an absorbent
article. The net
result may be that the time and effort required by the individual to achieve a
satisfactory state of
cleanliness may be minimized.
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There exists a further need for a wet wipe that substantially reduces or
prevents adhesion
of soils or exudates to the skin in a manner that is transparent to the
individual using the wipe,
i.e. does not require a change in habit such as the use of a separate wipe or
leave an undesirable
greasy layer on the skin surface.
SUMMARY OF THE INVENTION
A lotioned wipe product comprising a substrate and a lotion in contact with
the substrate,
the lotion comprising an anti-stick agent and a performance enhancing agent.
The lotion may be
effective at leaving less than about 10% w/w residual soils or exudates as
measured by the Anti-
Stick Screening Method. The anti-stick agent may be present at a concentration
of equal to or
less than about 50% w/w of the lotion composition. The performance enhancing
agent may be
present at a concentration of equal to or less than about 3% w/w of the lotion
composition. The
anti-stick agent may be water soluble.
The anti-stick agent may be selected from the group consisting of non-
polymeric anti-
stick agents, polymeric anti-stick agents, alkoxylated polyols, and
combinations thereof. The
performance enhancing agent may be selected from the group consisting of film
formers,
deposition aids, rheology modifiers and combinations thereof.
The lotion may further comprise an emollient and a surfactant.
An article of commerce may comprise a container housing a lotioned wipe
product.
A method of preventing the adherence of soils or exudates to the skin may
comprise a
step of contacting the lotioned wipe product to the skin.
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DETAILED DESCRIPTION OF THE INVENTION
The ease with which soils and bodily exudates are removed from the skin may be
related
to the strength of the adhesive interactions between the soils or exudates and
the skin surface. A
reduction in the adhesion of the soils or exudates to the skin may enable an
easier removal of the
soils or exudates. A variety of materials (hereinafter referred to as anti-
stick agents) have been
identified that may reduce the strength of adhesion of soils or exudates to
the skin. Additional
materials (hereinafter referred to as "performance enhancing agents") have
been identified that
may improve the efficacy of the anti-stick agents, enabling the use of the
anti-stick agents at a
lower w/w concentration in a lotion composition. A substrate in contact with a
lotion
comprising an anti-stick agent and a performance enhancing agent may reduce
the strength of
adhesion of soils or exudates to the skin. Such a combination of a substrate
and lotion may be a
lotioned wipe product.
As defined herein, "weight/weight" or "w/w" refers to the weight of the
component being
referenced versus the weight of the total material in reference. Therefore,
the use of "w/w" in
substrates refers to the weight of the individual substrate component versus
the weight of the
total substrate. The use of "w/w" in lotions refers to the weight of the
individual lotion
component versus the total weight of the lotion. The use of "w/w" in water
solubility refers to
the weight of the material versus the weight of the total water into which the
material is
dissolved. The use of "w/w" for residual artificial bowel movement (ABM)
refers to the weight
of the remaining artificial bowel movement on the skin versus the total weight
of the artificial
bowel movement applied to the skin.
Substrate
A lotion may be in contact or associated with a substrate for use in the
cleaning and
removal of soils or exudates. "Substrate" is the general term to describe a
piece of material,
generally non-woven material, used in cleansing body parts. In particular,
many currently
available substrates may be intended for the cleansing of the perianal area
after defecation.
Other substrates may be available for the cleansing of the face or other body
parts.
The substrate may be a nonwoven material. "Nonwoven" refers herein to a
fibrous
structure made from an assembly of continuous fibers, coextruded fibers, non-
continuous fibers
and combinations thereof, without weaving or knitting, by processes such as
spunbonding,
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carding, meltblowing, airlaying, wetlaying, coform, or other such processes
known in the art for
such purposes. The nonwoven structure may comprise one or more layers of such
fibrous
assemblies, wherein each layer may include continuous fibers, coextruded
fibers, noncontinuous
fibers and combinations thereof.
5 The fibers of the substrate may be any natural, cellulosic, and/or
wholly synthetic
material. Examples of natural fibers may include cellulosic natural fibers,
such as fibers from
hardwood sources, softwood sources, or other non-wood plants. The natural
fibers may
comprise cellulose, starch and combinations thereof. Non-limiting examples of
suitable
cellulosic natural fibers include, but are not limited to, wood pulp, typical
northern softwood
Kraft, typical southern softwood Kraft, typical CTMP, typical deinked, corn
pulp, acacia,
eucalyptus, aspen, reed pulp, birch, maple, radiata pine and combinations
thereof. Other sources
of natural fibers from plants include, but are not limited to, albardine,
esparto, wheat, rice, corn,
sugar cane, papyrus, jute, reed, sabia, raphia, bamboo, sidal, kenaf, abaca,
sunn, rayon (also
known as viscose), lyocell, cotton, hemp, flax, ramie and combinations
thereof. Yet other
natural fibers may include fibers from other natural non-plant sources, such
as, down, feathers,
silk, cotton and combinations thereof. The natural fibers may be treated or
otherwise modified
mechanically or chemically to provide desired characteristics or may be in a
form that is
generally similar to the form in which they can be found in nature. Mechanical
and/or chemical
manipulation of natural fibers does not exclude them from what are considered
natural fibers
with respect to the development described herein.
The synthetic fibers can be any material, such as, but not limited to, those
selected from
the group consisting of polyesters (e.g., polyethylene terephthalate),
polyolefins, polypropylenes,
polyethylenes, polyethers, polyamides, polyesteramides, polyvinylalcohols,
polyhydroxyalkanoates, polysaccharides, and combinations thereof. Further, the
synthetic fibers
can be a single component (i.e., single synthetic material or mixture makes up
entire fiber), bi-
component (i.e., the fiber is divided into regions, the regions including two
or more different
synthetic materials or mixtures thereof and may include co-extruded fibers and
core and sheath
fibers) and combinations thereof. It is also possible to use bicomponent
fibers. These
bicomponent fibers can be used as a component fiber of the structure, and/or
they may be present
to act as a binder for the other fibers present in the fibrous structure. Any
or all of the synthetic
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fibers may be treated before, during, or after manufacture to change any
desired properties of the
fibers.
In certain embodiments, it may be desirable to have particular combinations of
fibers to
provide desired characteristics. For example, it may be desirable to have
fibers of certain
lengths, widths, coarseness or other characteristics combined in certain
layers or separate from
each other. The fibers may be of virtually any size and may have an average
length from about 1
mm to about 60 mm. Average fiber length refers to the length of the individual
fibers if
straightened out. The fibers may have an average fiber width of greater than
about 5
micrometers. The fibers may have an average fiber width of from about 5
micrometers to about
50 micrometers. The fibers may have a coarseness of greater than about
5mg/100m. The fibers
may have a coarseness of from about 5mg/100m to about 75mg/100 m.
Additionally, it may be desirable for the fibers to have certain compositional
characteristics. For example, in the instance where the lotion may comprise
hydrophilic (i.e.
water soluble) ingredients that ultimately are intended to be imparted to the
skin during
cleansing, it may be desirable that the fibers comprise hydrophobic materials
to reduce the
tendency of the hydrophilic ingredients to adhere to the fibers, thereby
reducing their availability
to the skin. Without being bound by theory, it is believed that the lotion
ingredients may
partition between the lotion and the fibers during storage and between the
lotion and the fibers
and the skin during cleansing. In the instance where the lotion comprises a
hydrophilic
ingredient that is to be imparted to the skin during cleansing, the use of
hydrophobic fibers in the
substrate favors the partitioning, and subsequent delivery, of the hydrophilic
ingredient to the
skin.
Hydrophobic fibers can be any material, such as, but not limited to, those
selected from
the group consisting of polyesters (e.g., polyethylene terephthalate),
polyolefins, polypropylenes,
polyethylenes, polyethers, polyamides, polyesteramides, and combinations
thereof. Further, the
hydrophobic fibers can be a single component (i.e., single synthetic material
or mixture makes
up entire fiber), bi-component (i.e., the fiber is divided into regions, the
regions including two or
more different synthetic materials or mixtures thereof and may include co-
extruded fibers and
core and sheath fibers) and combinations thereof.
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The fibers may be circular in cross-section, dog-bone shape, delta (i.e.,
triangular cross
section), trilobal, ribbon, or other shapes typically produced as staple
fibers. Likewise, the fibers
can be conjugate fibers such as bicomponent fibers. The fibers may be crimped
and may have a
finish, such as a lubricant, applied.
The substrate materials may also be treated to improve the softness and
texture thereof.
The substrate may be subjected to various treatments, such as, but not limited
to, physical
treatment, such as hydro-molding, hydro-embossing, ring rolling, as described
in U.S. Patent No.
5,143,679 issued to Weber et al. on Sept. 1, 1992; structural elongation, as
described in U.S.
Patent No. 5,518,801 issued to Chappell et al. on May 21, 1996; consolidation,
as described in
U.S. Patent Nos. 5,914,084 issued to Benson et al. on June 22, 1999; 6,114,263
issued to Benson
et al. on Sept 5, 2000; 6,129,801 issued to Benson et al. on Oct. 10, 2000 and
6,383,431 issued
to Dobrin et al. on May 7, 2002; stretch aperturing, as described in U.S.
Patent Nos. 5,628,097
issued to Benson et al. on May 13, 1997; 5,658,639 issued to Curro et al. on
Aug. 19, 1997 and
5,916,661 issued to Benson et al. on June 29, 1999; differential elongation,
as described in US
Publication No. 2003/0028165A1 published on Feb. 6, 2003 by Curro et al.; and
other solid state
formation technologies as described in U.S. Publication No. 2004/0131820A1
published on July
8, 2004 by Turner et al. and U.S. Publication No. 2004/0265534A1 published on
Dec. 30, 2004
by Curro et al., zone activation, and the like; chemical treatment, such as,
but not limited to,
rendering part or all of the substrate hydrophobic, and/or hydrophilic, and
the like; thermal
treatment, such as, but not limited to, thermal-embossing, softening of fibers
by heating, thermal
bonding and the like; and combinations thereof.
Without being bound by theory, it is believed that a textured substrate may
further enable
the ease of removal of the bodily exudates by improving the ability to grip or
otherwise lift the
exudates from the skin during cleansing. Any one of a number of texture
elements may be
useful in improving the ability to grip or otherwise lift the exudates from
the skin during
cleansing such as, but not limited to continuous hydro-molded elements, hollow
molded
element, solid molded elements, circles, squares, rectangles, ovals, ellipses,
irregular circles,
swirls, curly cues, cross hatches, pebbles, lined circles, linked irregular
circles, half circles, wavy
lines, bubble lines, puzzles, leaves, outlined leaves, plates, connected
circles, changing curves,
dots, honeycombs, etc. and combinations thereof. The texture elements may be
hollow
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elements. The texture elements may be connected to each other. The texture
elements may
overlap each other.
The substrate may have a basis weight between about 15, 30, 40 or 45 grams/m2
and
about 65, 75, 85, 95 or 100 grams/m2. A suitable substrate may be a carded
nonwoven
comprising a 40/60 blend of viscose fibers and polypropylene fibers having a
basis weight of 58
grams/m2 as available from Suominen of Tampere, Finland as FIBRELLATm 3160.
F1BRELLATm 3160 is a 58 grams/m2 nonwoven web comprising 60% w/w 1.5 denier
polypropylene fibers and 40% w/w 1.5 denier viscose fibers. Another suitable
material may be
F1BRELLATm 3100 which is a 62 grams/m2 nonwoven web comprising 50% w/w 1.5
denier
polypropylene fibers and 50% w/w 1.5 denier viscose fibers. In both of these
commercially
available fibrous webs, the average fiber length is about 38 mm. Another
suitable material for
use as a substrate may be SAWATEXTm 2642 as available from Sandler AG of
Schwarzenbach/Salle, Germany. Yet another suitable material for use as a
substrate may have a
basis weight of from about 50 grams/m2 to about 60 grams/m2 and have a 20/80
blend of viscose
fibers and polypropylene fibers. The substrate may also be a 60/40 blend of
pulp and viscose
fibers.
In one embodiment, the surface of the substrate may be essentially flat. In
another
embodiment, the surface of the substrate may optionally contain raised and/or
lowered portions.
These can be in the form of logos, indicia, trademarks, geometric patterns,
images of the surfaces
that the substrate is intended to clean (i.e., infant's body, face, etc.).
They may be randomly
arranged on the surface of the substrate or be in a repetitive pattern of some
form.
In another embodiment, the substrate may be biodegradable. For example the
substrate
could be made from a biodegradable material such as a polyesteramide, or a
high wet strength
cellulose.
Lotion
"Lotion," as used herein, refers to a composition comprising a carrier such as
water. The
lotion further comprises an anti-stick agent and a performance enhancing
agent. Additional
optional ingredients may be added to the lotion as desired, as described
herein, to form a lotion
composition. The lotion may form a film on the surface of the skin and may
provide increased
repellency of residual soils or exudates at a low level of anti-stick agent.
Performance Enhancing Agent
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Performance enhancing agents, as defined herein, refer to materials that
enhance the
deposition, wettability, tenacity, uniformity, stability, or combinations
thereof, of a film that may
be formed on the skin surface after treatment with either an anti-stick agent
alone or a lotion
comprising an anti-stick agent.
Without being bound by theory, it is believed that performance enhancing
agents may
enhance the efficacy of anti-stick agents or lotions comprising anti-stick
agents and thereby
enable lower w/w concentrations of anti-stick agents to be used. It is
surmised this may occur by
enabling the anti-stick agent or the lotion to spread more easily over the
skin surface to form a
film, by enhancing the adherence of the anti-stick agent or lotion to the skin
surface to render it
more durable or resistant to wash-off or rub-off, by enabling the anti-stick
agent or lotion to wet
the skin surface more effectively, by enabling the film that is formed to be
more uniform, by
enabling the film that is formed to be more resistant to rupture, or
combinations thereof.
Performance enhancing agents may include, but are not limited to, materials
that may
generally be known as film formers, deposition aids, rheology modifiers, or
combinations
thereof.
Film formers may include, but are not limited to, polyvinylpyrolidone,
hydroxypropylcellulose, ethylcellulose, methylhydroxypropylcellulose, methyl
ethyl cellulose,
copolymer condensates comprising ethylene oxide and propylene oxide, and
polyethylene glycol.
Other suitable film formers are gums, such as agar, guar gum, gum arabic, gum
arabic uses, gum
ghatti, gum karaya, hydroxypropyl guar gum, and xanthan gum; alginates, such
as calcium
alginate and calcium-sodium alginate; protein film formers such as pectin,
albumen, poly amino
acids (e.g. polylysine), and gelatin; and waxes such as carnauba wax.
Combinations of the
above may also be used.
Rheology modifiers are compounds that may impact the way in which other
materials or
compositions deform and flow. Rheology modifiers may increase the viscosity of
the lotion
composition, may provide "structure" to the lotion composition, may help to
stabilize the lotion
composition on a substrate, may enhance the transfer of the lotion composition
to the skin
surface, and may enhance the uniformity of the film of the lotion composition
on the skin.
Rheology modifiers may also affect the rheological profile of the lotion
composition such
that the viscosity of the lotion composition may change as a function of the
shear that is applied
to the lotion composition. The application of the lotion composition to a
surface (e.g. the skin)
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typically includes a "wiping" or "rubbing" movement. This movement may
increase the shear
and pressure experienced by the lotion composition. In the case of a shear-
thinning rheological
profile (i.e. an increase in shear reduces the viscosity of the lotion
composition), the viscosity of
the lotion may decrease with the increased shear of "wiping" or "rubbing"
thereby enabling a
5 better transfer to the skin as well as a better lubrication effect.
Non-limiting examples of rheology modifiers include, but are not limited to,
rheology
modifiers comprising:
- polysaccharide units, e.g. cellulose, xanthan gum, diutan gum,
carrageenan, gellan
gum, welan gum, pectin, sclerotium gum, starch, galactoarabinan, alginate, and
10 modified-forms thereof;
- homopolymers of acrylic acid;
- acrylic acid cross-linked with a polyfunctional compound, e.g. carbomer
and acrylate
crosspolymer;
- copolymers of acrylic acid, acrylate esters, maleic acid and the like,
generally known as
the alkali swellable emulsions (ASE) group;
- hydrophobically-modified copolymers of acrylic acid, acrylate esters,
maleic acid and
the like, generally known as the hydrophobically-modified alkali swellable
emulsions
(HASE) group;
- polyethylene glycol units of varying length connected by urethane
linkages and
terminated with hydrophobic end groups, generally known as the hydrophobically-
modified ethoxylated urethane resins (HEUR) group; and
- combinations thereof.
In an embodiment, the rheology modifier may be KeltrolTm, as available from CP
Kelco,
San Diego, CA. In an embodiment, the rheology modifier may be TicaxanTm, as
available from
TIC Gums, Belcamp, MD. In an embodiment, the rheology modifier may be
RhodicareTm D, as
available from Rhodia, Cranbury, NJ. Additional examples of rheology modifiers
include, but
are not limited to, UltrezTm-10, a carbomer, and PemulenTm TR-2, an acrylate
crosspolymer,
both of which are available from Noveon, Cleveland OH.
Performance enhancing agents may be used at a weight/weight % (w/w) from about
0.05%, 0.1%, 0.15%, 0.18%, 0.2%, 0.3%, 0.4%, or 0.5% to about 1%, 2%, or 3%.
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It is to be noted that some film formers, deposition aids, and rheology
modifiers can have
multiple functions, e.g. a rheology modifier may enhance both deposition and
film formation.
While particular performance enhancing agents have been illustrated and
described, it
would be obvious to those skilled in the art that various other performance
enhancing agents may
be used without departing from the invention described herein.
Anti-Stick Agent
As used herein, the term "anti-stick agent" refers to water-soluble materials
which may
help reduce or prevent the adherence of soils or exudates to bodily surfaces,
thereby facilitating
subsequent cleanings. "Soils" refers herein to material from a source
extraneous to the body,
such as dirt and food. "Exudates" refers herein to material from a source
internal to the body,
such as urine, menses, feces, and mucus.
Without being bound by theory, it is believed that anti-stick agents may
reduce the
adhesive force between the soils or exudates and the skin surface such that
the adhesive forces
may be smaller than the cohesive forces within the soils or exudates, thereby
allowing the soils
or exudates to detach from the skin surface upon application of a shear force
such as that
generated by wiping. It is not intended that this mechanism describe the means
by which all
anti-stick agents described herein function. Other possible mechanisms of
reducing adhesion to
skin will be obvious to those skilled in the art.
The use of non-water soluble materials to !educe adhesion of soils or exudates
to skin is
known in the art. Materials such as silicones, mineral oil, petrolatum, plant-
derived oils, and
other hydrophobic emollients are known in wet wipes in the form of emulsions.
Examples of
such emulsions may be found in US Patent Nos. 6,083,854 issued July 4, 2000 to
Bogdanski et
al; 5,648,083 issued July 15, 1997 to Blieszner et al.; and 6,440,437 issued
August 27, 2002 to
ICrzysik et al.
While non-water soluble materials such as those described above may deliver
some level
of anti-stick performance, they suffer from several major setbacks including:
- they often leave an undesirable greasy or slippery feel on the skin, and
- they are typically lubricious, reducing interaction of the cleansing
implement and the
soils or exudates, resulting in smearing and poor cleaning.
Water soluble anti-stick agents overcome many of these setbacks. For the
purposes of
the present invention, an anti-stick agent is considered water soluble if
about 0.01%, 0.1%,
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0.5%, or 1.0% w/w or greater dissolves in water at 25 C. Water soluble anti-
stick agents may
have the following advantages:
- they typically do not leave a greasy feeling on the skin, and
- they are typically not as lubricous as non-water soluble anti-stick
agents and may result
in better cleaning and less smearing.
There is a further need for a substrate that may be in contact with a lotion
that may
deliver good repellency of soils or exudates while utilizing low concentration
levels of anti-stick
agent, such as less than or equal to about 10% w/w concentration of anti-stick
agent in the lotion.
Such a lotioned substrate may be cost effective due to the decreased amount of
anti-stick agent
1 0 required to deliver the benefit and due to the ease of incorporation of
the anti-stick agent into the
lotion due to the water solubility of the anti-stick agent. Further, the anti-
stick agent may result
in a cleansing benefit such as the repellency of soils or exudates and may
result in no sensory
negatives on the skin such as a greasy or slippery film. Consumers may prefer
a substrate that
can deliver an anti-stick benefit while being used for routine cleansing, i.e.
consumers may not
prefer an additional step to the process of cleansing, such as the use of one
substrate to clean and
the use of an additional substrate that cleans poorly but provides the anti-
stick benefit. An
example of a wipe containing a hydrophobic anti-stick agent that cleans poorly
and needs to be
used as a separate wipe is described in US 2005/0244480A1.
The strength of adhesion between two materials may be analyzed in a variety of
methods
to determine whether or not the adhesive interactions are impacted by surface
treatments or other
factors. Examples of adhesion tests for determining if a treatment has reduced
adhesion between
two materials (such as by reducing the force of adhesion to less than the
force of cohesion)
include ASTM D2919, ASTM D3528 and related methods referred to or described
therein. Such
methods may test the strength of adhesion through the application of shear.
A method for assessing the adhesion of soils or exudates to the skin surface
has been
detailed herein. It has been discovered that some anti-stick agents, used at a
low level (e.g., in a
lotion), may provide an anti-stick benefit on skin, but the magnitude of this
anti-stick benefit is
greatly reduced on artificial surfaces. Without being bound by theory, it is
believed that factors
such as the wettability, surface energy, and surface chemistry of skin are
critical for the
formation of effective anti-stick films containing certain water soluble anti-
stick agents.
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13
The test for assessing the adhesion of soils or exudates to the skin is
described in detail in
the TEST METHODS section. Briefly, the Anti-Stick Screening Method treats the
skin surface
with a defined amount of anti-stick agent or a lotion comprising the anti-
stick agent. A defined
amount of an artificial pasty bowel movement ("ABM") is applied. The ABM is
covered with a
square piece of paper, and compressed with a defined force for a defined
amount of time. The
paper is then peeled away slowly with forceps. The paper is tared before
application of the ABM
and is re-weighed after removal from the skin. The percent residual ABM on the
skin is
calculated as the weight of the artificial bowel movement (ABM) remaining on
the skin versus
the weight of the artificial bowel movement originally applied to the skin.
The ABM, similar to
real infant BM, fails cohesively, resulting in part of the ABM remaining on
the skin surface and
part of the ABM remaining on the piece of paper. The more efficient the anti-
stick agent or
lotion comprising the anti-stick agent, the less residual ABM on the skin
surface. While
artificial ABM is utilized in the Anti-Stick Screening Method, the artificial
ABM may correlate
in physical properties to soils or exudates. The percent residual artificial
ABM may, therefore,
be utilized as an equivalent measurement of the percent residual soils or
exudates.
An anti-stick agent beneficial for use may leave less than about 10%, 8%, 7%,
5%, 4%,
3% or 2% residual soils or exudates on the skin surface as assessed by the
Anti-Stick Screening
Method. Skin that is not treated with an anti-stick agent, either alone or
within a lotion, but is
otherwise subjected to the above method may serve as a negative control.
Typically, no
treatment of the skin results in about 30 ¨ 35% residual soils or exudates
remaining on the skin
surface.
Conventional substrates comprising a lotion, both aqueous-based and emulsion-
based,
may deliver anti-stick performance in the range of about 15-30% residual soils
or exudates in the
above method. It has been discovered that this level of performance is
insufficient to deliver a
consumer noticeable anti-stick benefit.
The lotion of the present invention may comprise at least about 0.05% w/w of
an anti-
stick agent and at least about 0.01% of a performance enhancing agent. The
lotion may
comprise equal to or less than about 50% w/w of an anti-stick agent and equal
to or less than
about 3% of a performance enhancing agent. The lotion may comprise an anti-
stick agent at a
level from about 0.05%, 0.1%, 0.5%, 1%, 2%, 4% or 5% to about 8%, 10%, 20%,
25% or 50%
w/w of the lotion composition. The lotion may comprise a performance enhancing
agent at a
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14
level from about 0.05%, 0.1%, 0.15%, 0.18%, 0.2%, 0.3%, 0.4%, or 0.5% to about
1%, 2%, or
3% w/w of the lotion composition.
The lotion comprising an anti-stick agent and a performance enhancing agent
may be
effective at leaving less than about 10% residual soils or exudates on the
skin as measured by the
Water-soluble anti-stick agents include, but are not limited to:
- Non-polymeric anti-stick agents such as glycerol and related polyols such
as sorbitol,
maltitol, xylitol, pentaerythitol, sucrose, glucose, maltose, maltotriose,
maltodextrin,
20 maltopentose, maltohexose, and isomaltulose, ethylene glycol, propylene
glycol, butylene
glycol, and the like,
- Polymeric anti-stick agents comprising polyethylene glycol, polypropylene
glycol,
polybutylene glycol, polyglycerol or mixtures thereof, including block
copolymers
comprising ethylene oxide and propylene oxide, and the like,
25 - Alkoxylated polyol compounds,
- Phosphate compounds such as mono-alkyl phosphates and di-alkyl
phosphates,
and combinations of the above.
Non-polymeric anti-stick agents:
Non-polymeric anti-stick agents, such as those listed above, may provide an
anti-stick
CA 02655173 2012-04-13
Polymeric anti-stick agents:
Polymeric anti-stick agents comprising polyethylene glycol, polypropylene
glycol,
polybutylene glycol, polyglycerol or mixtures thereof, including block
copolymers
comprising ethylene oxide and propylene oxide, have been found to be useful as
anti-
stick agents.
Commercially available examples of polymeric anti-stick agents include the
CarbowaxTm and PolyoxTM series as available from The Dow Chemical Company of
Midland, MI, and the PluronicTM, PluronicTM R, Tetroniclm, and TetronicTm R
surfactant
series as available from BASF Corporation of Florham Park, NJ. In one
embodiment, a
=
lotion comprising CarbowaxTM 400 at a level of about 5% w/w and a performance
enhancing agent at a level of about 0.18% w/w may leave less than about 9%
residual
soils or exudates on the skin. In another embodiment, a lotion comprising a
Pluronic,
such as Pluronic F68, at a level of about 2% w/w and a performance enhancing
agent at a
level of about 0.18% w/w may leave less than about 10% residual soils or
exudates on the
skin. In yet another embodiment, a lotion comprising a Pluronic, such as
Pluronic F68, at
a level of about 5% w/w and a performance enhancing agent at a level of about
0.18%
w/w may leave less than about 4% residual soils or exudates on the skin.
Alkoxylated polyol compounds:
Alkoxylated polyol compounds have also been found to deliver an anti-stick
benefit. The alkoxylated polyol compounds useful in the present invention
comprise a
central polyol moiety comprising at least three hydroxyl groups, with at least
one of the
hydroxyl groups being alkoxylated. The alkoxyl group comprises
polyoxyethylene,
polyoxypropylene, polyglycerol and/or mixtures thereof. The average total
degree of
alkoxylation may be from about 1 to about 100. Illustrated below is the
general structure
to which a tris-alkoxylated glycerol may conform wherein:
T2
n A,
-3
D*
A1, A2, and A3 are hydrogen, methyl, or any mixture thereof,
CA 02655173 2012-04-13
16
Di, D2, and D3 are polyoxyethylene, polyoxypropylene, or combinations thereof
as illustrated below. In one embodiment, p may average 4.2 and e may average
13.4.
¨{CH(CH3)CH20}-{"c2H40
The alkoxylated polyol compounds useful in the present invention may further
have at least one of the alkoxy moieties comprising at least one anionic
capping group, as
described in W02005/063847. In one embodiment,
A1, is hydrogen, or methyl,
A2 and A3 are sulfate (S03"),
DI, D2, and D3 are polyoxyethylene, polyoxypropylene, or combinations thereof
as illustrated below. In one embodiment, p may average 4.2 and e may average
13.4.
_tCH(CH3)CH2OHC2'40
e
In another embodiment, a lotion may comprise a tris-alkoxylated glyceryl bis-
sulfate at a level of about 2% w/w and a performance enhancing agent at a
level of about
0.18% and may leave less than about 8% w/w residual soils or exudates on the
skin.
It can be appreciated by one skilled in the art that any appropriate polyol
compound can function as the central polyol moiety, and that any number of
alkoxyl
groups of one or greater, and any number of anionic capping groups can be
used. It can
also be appreciated that the alkoxyl groups can be of any type described, and
need not be
identical. It can also be appreciated that the anionic capping groups can be
of any type
described, and need not be identical.
Phosphate Compounds
Phosphate compounds may include mono-alkyl phosphates and di-alkyl
phosphates.
Mono-alkyl phosphates may have the structural formula as illustrated below
wherein R represents a saturated or unsaturated hydrocarbon group having an
average of
from 8 to 22 carbon atoms, x represents a number from 0 to 20 and each of Y
and Z
represents hydrogen, an alkali metal, ammonium or an alkanol amine.
=
CA 02655173 2012-04-13
16a
0
I1
ROCH2C112),0---P OY
OZ
Di-alkyl phosphates may have the structural formula as illustrated below
wherein
R represents a saturated or unsaturated hydrocarbon group having an average of
from 8 to
22 carbon atoms, x represents a number from 0 to 20 and each of Y and Z
represents
hydrogen, an alkali metal, ammonium or an alkanol amine.
WOCii2C1i2)10
p oy
R(OCH2C112)x0
The saturated or unsaturated hydrocarbon groups having an average of from 8 to
22 carbon atoms can be straight chain, branched or alicyclic hydrocarbons as
are known
to those skilled in the art. In an embodiment, the saturated or unsaturated
hydrocarbon
groups may have an average from 10 to 18 carbon atoms.
Alkali metals and amines may include, but are not limited to, lithium, sodium,
potassium, dimethylmonoethanolamine, methyldiethanolamine, trimethylamine,
triethylamine, dibutylamine, butyldimethylamine, monoethanolamine,
diethanolamine,
triethanolamine, isopropyldimethylamine and isopropylethanolamine.
Optional Lotion Ingredients
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Additional ingredients may be added to the lotion as desired to create a
lotion
composition. The composition may generally comprise any of the following
ingredients:
emollients, surfactants, preservatives, or a combination of preservative
compounds acting
together as a preservative system or other adjunct ingredients. It is to be
noted that some
ingredient compounds can have a multiple function and that all compounds are
not necessarily
present in the composition. The composition may be an aqueous-based solution
or an emulsion.
The pH of the composition may be from about pH 3, 4, or 5 to about pH 7, 7.5,
or 8.
Examples of lotions and lotion compositions that may be used may be found in
the
Examples section as Examples 1 through 12.
Emollient
Emollients may (1) improve the glide of the substrate on the skin, by
enhancing the
lubrication and thus decreasing the abrasion of the skin, (2) hydrate the
residues (for example,
fecal residues or dried urine residues or menses), thus enhancing their
removal from the skin, (3)
hydrate the skin, thus reducing its dryness and irritation while improving its
flexibility under the
wiping movement, and (4) protect the skin from later irritation (for example,
caused by the
friction of an absorbent article) as the emollient is deposited onto the skin
and remains at its
surface as a thin protective layer.
Emollients may include silicone oils, functionalized silicone oils,
hydrocarbon oils, fatty
alcohols, fatty alcohol ethers, fatty acids, esters of monobasic and/or
dibasic and/or tribasic
and/or polybasic carboxylic acids with mono and polyhydric alcohols,
polyoxyethylenes,
polyoxypropylenes, mixtures of polyoxyethylene and polyoxypropylene ethers of
fatty alcohols,
and mixtures thereof. The emollients may be either saturated or unsaturated,
have an aliphatic
character and be straight or branched chained or contain alicyclic or aromatic
rings.
A useful mixture of emollients is caprylic capric triglycerides in combination
with Bis-
PEG/PPG-16/16 PEG/PPG-16/16 dimethicone known as ABIL CARE Tm 85 (available
from
Degussa Care Specialties of Hopewell, VA).
Emollients, when present, may be used in the present invention at a
weight/weight %
from about 0.5%, 1% or 4% to about 0.001%, 0.01%, or 0.02% w/w. Without being
bound by
theory, it is believed that low levels of emollients are desirable as this may
reduce the tendency
of the emollients to form a greasy or oily layer on the skin, which may not be
consumer
preferred.
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18
Surfactant
The surfactant can be an individual surfactant or a mixture of surfactants.
The surfactant
may be a polymeric surfactant or a non-polymeric one. The surfactant may be
employed as an
emulsifier. The surfactant, when present, may be employed in an amount
effective to emulsify
the emollient and any other non-water-soluble oils that may be present in the
composition, such
as an amount ranging from about 0.5%, 1%, or 4% w/w to about 0.001%, 0.01% or
0.02% w/w
(based on the weight surfactant over the weight of the composition).
The composition may include one or more surfactants. The surfactant or
combinations of
surfactants may be mild, which means that the surfactants provide sufficient
cleansing or
detersive benefits but do not overly dry or otherwise harm or damage the skin.
A wide variety of surfactants are useful herein and include those selected
from the group
consisting of anionic surfactants, nonionic surfactants, cationic surfactants,
amphoteric
surfactants, zwitterionic surfactants, and mixtures thereof.
A wide variety of anionic surfactants are useful herein. Non-limiting examples
of
anionic surfactants include those selected from the group consisting of
sarcosinates, sulfates,
sulfonates, isethionates, taurates, phosphates, lactylates, glutamates, and
mixtures thereof.
Amongst the isethionates, the alkoyl isethionates are useful, and amongst the
sulfates, the alkyl
and alkyl ether sulfates are useful. Other anionic materials useful herein are
soaps (i.e., alkali
metal or amine salts, e.g., sodium, potassium or triethanol amine salts) of
fatty acids, typically
having from about 8 to about 24 carbon atoms.
Nonionic surfactants useful herein include, but are not limited to, those
selected from the
group consisting of alkyl glucosides, alkyl polyglucosides, polyhydroxy fatty
acid amides,
alkoxylated fatty acid esters, alkoxylated fatty alcohol ethers, sucrose
esters, amine oxides, and
mixtures thereof.
Suitable amphoteric or zwitterionic surfactants for use in the compositions
herein include
those which are known for use in hair care or other personal care cleansing.
Amphoteric
surfactants suitable for use in the present compositions are well known in the
art and include
those surfactants broadly described as derivatives of aliphatic secondary and
tertiary amines in
which the aliphatic radical can be straight or branched chain and wherein one
of the aliphatic
substituents contains from about 8 to about 18 carbon atoms and one contains
an anionic water
solubilizing group such as carboxy, sulfonate, sulfate, phosphate, or
phosphonate. Useful
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amphoteric surfactants include, but are not limited to, the group consisting
of cocoamphoacetate,
cocoamphodiacetate, lauroamphoacetate, lauroamphodiacetate, and mixtures
thereof.
Zwitterionic surfactants suitable for use herein include those surfactants
broadly
described as derivatives of aliphatic quaternary ammonium, phosphonium, and
sulfonium
compounds, in which the aliphatic radicals can be straight or branched chain,
and wherein one of
the aliphatic substituents contains from about 8 to about 18 carbon atoms and
one contains an
anionic group such as carboxy, sulfonate, sulfate, phosphate or phosphonate.
Useful zwitterionic
detersive surfactants are the betaines, amphoacetates and sulfobetaines, e.g.,
cocoamidopropylbetaine, sodiumlaurylamphoacetate and
cocoamidopropylhydroxysultaine.
Preservative
Controlling microbiological growth may be beneficial in water based products
such as
lotion compositions intended for application to substrates in forming wipes.
The lotion
composition may comprise a preservative or a combination of preservatives
acting together as a
preservative system. Preservatives and preservative systems are used
interchangeably in the
present document to indicate one unique or a combination of preservative
compounds. A
preservative may be understood to be a chemical or natural compound or a
combination of
compounds reducing the growth of microorganisms, thus enabling a longer shelf
life for a
package of substrates (opened or not opened) as well as creating an
environment with reduced
growth of microorganisms when transferred to the skin during the wiping
process.
The spectrum of activity of the preservative may include bacteria, molds and
yeast. Each
of such microorganisms may be killed by the preservative. Another mode of
action to be
contemplated may be the reduction of the growth rate of the microorganisms
without active
killing. Both actions however result in a drastic reduction of the population
of microorganisms.
Materials useful as preservatives include, but are not limited to: methylol
compounds,
iodopropynyl compounds, simple aromatic alcohols, paraben compounds, chelators
such as
ethylenediamine tetraacetic acid, and combinations thereof.
In one embodiment, the preservative system may comprise a methylol compound or
its
equivalent, an iodopropynyl compound and mixtures thereof. Methylol compounds
may release
a low level of formaldehyde when in a water solution that has an effective
preservative activity.
Exemplary methylol compounds include, but are not limited to, diazolidinyl
urea (GERMALL
11 as is available from International Specialty Products of Wayne, NJ), N41,3-
bis(hydroxy-
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methyl)-2,5-dioxo-4-imidazolidinyll-N,N'-bis(hydroxymethyl) urea, imidurea
(GERMALL 115
as is available from International Specialty Products of Wayne, NJ), 1,1-
methylene bis[343-
(hydroxymethyl)-2,5-dioxo-4-imidazolidinyllureal, 1,3-dimethylo1-5,5-dimethyl
hydantoin
(DMDMH), sodium hydroxymethyl glycinate (SUTTOCIDE A as is available from
5 International Specialty Products of Wayne, NJ), and glycine anhydride
dimethylol (GADM).
Methylol compounds can be used at concentrations between about 0.025% and
about 0.50%
w/w. In another embodiment, the concentration may be about 0.075% w/w. The
iodopropynyl
compound may provide antifungal activity. An exemplary material may be
iodopropynyl butyl
carbamate as is available from Clariant UK, Ltd. of Leeds, The United Kingdom
as
10 NIPACIDETm IPBC. Another exemplary material may be 3-iodo-2-
propynylbutylcarbamate.
Iodopropynyl compounds can be used effectively at a concentration between
about 0.001% and
about 0.05% w/w. The concentration may be about 0.009% w/w. A preservative
system of this
type may comprise a blend of a methylol compound at a concentration of about
0.075% w/w and
an iodopropynyl compound at a concentration of about 0.009% w/w.
15 In another embodiment, the preservative system may comprise simple
aromatic alcohols
(e.g. benzyl alcohol). Materials of this type may have effective antibacterial
activity. Benzyl
alcohol is available from Symrise, Inc. of Teterboro, NJ.
In another embodiment, the preservative may comprise at least one paraben
antimicrobial. The preservative may be a paraben antimicrobial selected from
the group
20 consisting of methylparaben, ethylparaben, propylparaben, butylparaben,
isobutylparaben or
combinations thereof. The total concentration of paraben antimicrobial may be
lower than about
0.3%, 0.5%, or 1% w/w. The minimum amount of paraben antimicrobial may be any
amount
sufficient to obtain the desired preservation of the composition, such as more
than about 0.001%.
In another embodiment, acidic compounds used in sufficient amount to reduce
the pH of
the lotion composition (e.g. pH of less than about 5) may be useful as the
preservative, or as a
potentiator for other preservative ingredients.
In another embodiment, chelators, such as ethylenediamine tetraacetic acid and
its salts,
may also be used in preservative systems as a potentiator for other
preservative ingredients.
Adjunct Ingredients
The lotion composition may optionally include other adjunct ingredients.
Possible
adjunct ingredients may be selected from a wide range of additional
ingredients such as, but not
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21
limited to perfumes and fragrances, texturizers, colorants, soothing agents
and medically active
ingredients, such as healing actives and skin protectants.
Article of Commerce
In one embodiment, an article of commerce may be provided. The article of
commerce
may comprise a container as described herein and at least one substrate as
described herein.
Containers useful may include, but are not limited to, PET tubs, flow wrap
pouches,
precut sachets for individually packed cleansing mitts, and other packaging
known in the art as
suitable for nonwoven articles. Additionally, the container may also be
manufactured to
facilitate removal of individual cleansing substrates.
The container may be made of any suitable material or materials and can be
manufactured in any suitable manner. For example, the container can be made of
polystyrene,
polypropylene, PET, POET, polyethylene, polyester, polyvinyl alcohol, or the
like. The
containers may also be made of a mixture of the above materials. The
containers may be
manufactured by, for example, a vacuum molding process or an injection molding
process, or
any suitable process.
Additional information on containers, as well as additional optional
components for
containers, including, but not limited to: container bodies, lids, container
features, such as, but
not limited to, attachment of lids, hinges, zippers, securing aids, and the
like, can be found in
U.S. Patent Nos. Des. 451,279; Des. 437,686; Des. 443,508; Des 443,451; Des
421,901; Des
421,902; Des 416,794; Des 414,637; Des 445,329; 3,982,659; 3,967,756;
3,986,479; 3,994,417;
6,269,970; 5,785,179; 5,366,104; 5,322,178; 5,050,737; 4,971,220; 6,296,144;
6,315,114;
4,840,270; 4,471,881; 5,647,506; 6,401,968; 6,269,969; 6,412,634; 5,791,465;
6,092,690; U.S.
Patent Application Publication No. 2002/0064323 published on May 30, 2002,
issued to Chin;
and WO 00/27268 published on May 18, 2000 and assigned to The Procter & Gamble
Company;
WO 02/14172 published on February 21, 2002 and assigned to The Procter &
Gamble Company;
and WO 99/55213 published on November 4, 1999 and assigned to The Procter &
Gamble
Company.
Anti-Stick Screening Method
This method may be used for assessing the adhesion of soils or exudates to the
skin by
quantifying the percentage of residual artificial pasty bowel movement ("ABM")
left on the skin
surface after treatment. The ABM, similar to real infant BM, fails cohesively,
resulting in part of
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the ABM remaining on the skin surface and part of the ABM being removed. The
more efficient
the anti-stick agent or lotion comprising the anti-stick agent and the
performance enhancing
agent, the lower the percentage of residual ABM on the skin surface.
At least eight healthy adults participate in a single screening study. Each of
the panelists
completes a four-day washout period during which they use Olay unscented
moisturizing soap,
as distributed by The Procter and Gamble Company, Cincinnati, OH, to wash
their forearms.
Panelists must refrain from using any topical product, such as ointments,
creams or lotions, on
their forearms during this washout-out period and also on the day of the
screening study. On the
day of testing, panelist's arms are inspected to ensure they are free of cuts,
scratches, and rashes.
If any skin abnormalities are present, the panelist cannot participate.
A template and a fine-tip marker are used to mark-off up to ten 3 cm by 3 cm
sites on the
volar forearms, i.e. up to ten sites per panelist. All but one of these sites
are treated with an anti-
stick agent or a lotion comprising an anti-stick agent. The remaining site
receives no anti-stick
treatment, i.e. serves as a negative control. The locations of the various
treatments, including the
no-treatment site, may be randomized among the sites on each panelist. Testing
starts at the site
closest to the elbow on the left arm and, as testing on each site is
completed, progresses to the
site closest to the wrist on the left arm, then to the site closest to the
elbow on the right arm, and
finally to the site closest to the wrist on the right arm. Testing on each
site requires
approximately 4 minutes, for a total time per panelist of approximately 40
minutes.
For each site that is treated, 1 ill/cm2 or 9 ill/site of anti-stick agent or
lotion comprising
an anti-stick agent and a performance enhancing agent is applied in the center
of the site using a
standard or positive displacement pipettor. The applied agent or lotion is
then spread over the
entire site (the boundary of which is defined by the marks made using the
template) using a
powder-free finger cot, Catalog # 56613-413 as available from VWR Scientific
of West Chester,
PA, by placing the finger cot on top of the agent or lotion droplet and
lightly rubbing the finger
cot over the skin surface using several side-to-side and up-and-down movements
for a total
elapsed time of 10-15 seconds. Examining the site from an oblique angle, the
person conducting
the test needs to ensure that a uniform film has been formed over the entire
area of the site. The
film is left exposed to air, untouched, for approximately 1 minute prior to
proceeding with the
subsequent steps.
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A 1 ml syringe, such as Catalog # BD-309628 as available from VWR Scientific
of West
Chester, PA, that has been filled with room temperature ABM and is devoid of
air bubbles, is
placed onto a tared four-place analytical balance. The weight is recorded. The
syringe with
ABM is held over the center of the test site on the forearm, in reasonably
close proximity to the
skin surface, and approximately 0.2 ml of ABM is dispensed onto the skin by
pressing the
plunger and by watching the gradations on the syringe. The ABM should form a
reasonably
uniform, compact mound in the center of the test site. The syringe is re-
weighed on the
analytical balance, and the weight is recorded. The quantity of ABM that was
delivered to the
forearm is calculated by subtracting the second weight from the first.
A 4 cm x 4 cm piece of weigh paper, Catalog # 12578-201 as available from VWR
Scientific of West Chester, PA, is tared on the four place analytical balance,
centered over the
ABM mound on the forearm test site, and gently lowered onto the ABM using
forceps. The
weigh paper must not be touched with fingertips, as this may transfer oils
onto its surface. Next,
a 500 g bottle-shaped weight, such as Catalog # 12766-518 as available from
VWR Scientific of
West Chester, PA, that exerts approximately 0.5 psi of downward force is
placed over the weigh
paper such that the mound of ABM under the weigh paper is approximately
centered under the
weight. The weight may be gently held in place or balanced on the forearm by
the panelist for
30 seconds. After 30 seconds have elapsed, two fingers are placed gently on
either side of the
weigh paper to hold it in place, and the 500 g weight is slowly lifted. Using
a pair of forceps, the
weigh paper is slowly and gently peeled from the test site. The forceps are
placed at the lower
right corner of the weigh paper, and the weigh paper is slowly peeled upwards
in the direction of
the upper left corner of the weigh paper. It should take approximately 1-2
seconds to remove the
weigh paper. Once removed, the weigh paper is placed back onto the analytical
balance that it
was tared on, and the weight is recorded to determine the amount of ABM
removed.
The above steps are repeated until all sites per panelist have been tested,
i.e. the steps
consisting of application of anti-stick agent or lotion comprising an anti-
stick agent and a
performance enhancing agent, application of ABM, application of weigh paper,
application of
weight, and removal of weigh paper. For the no-treatment control, application
of agent or lotion
is skipped and ABM is applied directly to the skin site.
An example of a spreadsheet to collect the various weight measurements and to
calculate
the percent (%) residual ABM left on the arm is as follows:
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24
Sub Site Trtmnt Syringe Syringe After ABM Applied ABM Removed % ABM Arm
101 1 I 7.8561 7.6351 0.2210 0.1678 24.07
101 2 J 7.6343 7.4241 0.2102 0.1967 6.42
101 3 H 7.4223 7.2208 0.2015 0.1473 26.90
101 4 A 7.2200 7.0090 0.2110 0.1754 16.87
101 5 G 7.0080 6.8087 0.1993 0.1755 11.94
101 6 B 7.8082 7.5957 0.2125 0.2042 3.91
101 7 F 7.5943 7.3862 0.2081 0.1536 26.19
101 8 C 6.9643 6.7592 0.2051 0.1526 25.60
101 9 E 7.3840 7.1725 0.2115 0.1984 6.19
101 10 D 7.1711 6.9678 0.2033 0.1788 12.05
Wherein:
- Sub refers to the subject number, which is minimally 101 to 108 and
ideally 101 to 110,
i.e. the above chart would be replicated 8 to 10 times to cover all panelists.
- Site refers to arm location, starting with the left arm near the elbow (Site
1) and
proceeding to the right arm near the wrist (Site 10).
- Trtmnt refers to the code of the treatment applied, typically a letter
from A-J.
- Syringe refers to the initial weight of the syringe containing ABM.
- Syringe After refers to the final weight of the syringe containing ABM
once
approximately 0.2 ml of ABM has been dispensed onto a treatment site.
- ABM Applied is a calculated value obtained from the equation Syringe -
Syringe After =
ABM Applied.
- ABM Removed refers to the weight of the ABM that has been captured on the
tared
weight paper after the weigh paper has been peeled from a treatment site.
- % ABM Arm is a calculated value obtained from the equation ((ABM Applied -
ABM
Removed)/ABM Applied) x 100. This is a measure of the percent (%) residual ABM
on
the skin surface after treatment.
The mean and standard error of the mean ("SEM") for each treatment, e.g. A-J,
for all
panelists, e.g. 101-110, is calculated and graphed.
When the method is run correctly, the no treatment control may yield a value
between
approximately 30% to 35% residual ABM.
This method may also be used to assess expressed lotion compositions from
commercially available wipe products. Expressed lotion compositions are
prepared by inserting
the entire wipe stack of a non-expired marketed product into a pre-cleaned
press capable of
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exerting about 80 psi downward force on the stack. Ideally, the lower plate of
the press contains
a channel into which the expressed lotion may collect, and a hole through
which the expressed
lotion may flow into a clean storage container. An example of a suitable
storage container is
Catalog # 83008-666 as available from VWR Scientific of West Chester, PA. All
expressed
5 lotions are stored at room temperature prior to use.
On the day prior to the study, 10 ml of each anti-stick agent or lotion
composition is
transferred into a glass scintillation vial such as Catalog # 66022-060 as
available from VWR
Scientific of West Chester, PA. Each vial is labeled with the treatment code,
e.g. A-J. On the
day of the study, the anti-stick agent or lotion composition is drawn from the
scintillation vial
10 with the standard or positive displacement pipettor and applied to the
respective treatment site as
described in the method. By having the various treatments in the scintillation
vials, it is very
easy to rearrange the vials in between panelists to accommodate the
randomization scheme for
the study.
To ensure reproducible results, the Anti-Stick Screening Method should be run
at a room
15 temperature of 21 C 2 C and at a relative humidity of 30-50%.
Preparation of Artificial Pasty Bowel Movement (ABM)
The following equipment is required:
- an analytical balance accurate to 0.001g
- a homogenizer capable of stirring the ingredients to homogeneity, such as
an Ika
20 LabortechnikTm T25 basic or equivalent as available from Ika-Werke GmbH
and Co. KG
of Staufen, Germany.
- a homogenizer probe to be used with the homogenizer, such as Catalog #
525N 25F as
available from Ika-Werke GmbH and Co. KG of Staufen, Germany.
The following reagents are required:
25 - FecloneTm Powder #4, available from SiliClone Studio, Valley Forge,
PA, as Catalog
Number Feclone BFPS-4.
- FecloneTm Powder #6, available from SiliClone Studio, Valley Forge, PA,
as Catalog
Number BFPS-6.
- FecloneTm Powder #7, available from SiliClone Studio, Valley Forge, PA,
as Catalog
Number BFPS-7.
- CarbopolTm 981, available from BF Goodrich, Cleveland, OH.
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26
- Deionized water.
The following quantities of the above reagents are required:
Ingredient Grams
Deionized water for CarbopolTm solution 78.78
FecloneTm powder #4 6.600
FecloneTm powder #6 6.600
FecloneTm powder #7 6.600
Carbopol TM 981 0.900
The procedure to prepare the ABM consists of the following steps:
A. Preparation of CarbopolTm Solution
1. Weigh 78.78 g 0.01 g of deionized water in a 250 ml beaker.
2. Weigh 0.900 g 0.001 g of CarbopolTm on weigh paper.
3. Put beaker on a magnetic stirrer and set speed at 400 rpm.
4. Add CarbopolTm powder slowly to the water, over the span of about 5
minutes. While
adding the CarbopolTm, increase the stirring speed slowly to 600 rpm.
5. Once the CarbopolTm powder has been added to the water, cover the beaker
and continue
mixing at 600 rpm for 15 minutes. The CarbopolTm powder must be completely
dispersed, i.e. a transparent gel without any agglomerates.
6. Set up a hot plate at 150 C. Place the CarbopolTm solution on the hot plate
and continue
mixing at 600 rpm until the solution is heated to 81 C to 83 C.
B. Preparation of ABM Mixture
1. Weigh 6.600 g 0.01 g each of Feclone powders #4, #6, and #7 into a beaker
and mix
well.
2. Using a T25 basic or equivalent homogenizer with a homogenizer probe, stir
the
CarbopolTm solution at 8000 rpm for about 30 seconds before proceeding with
Step 3.
3. To the CarbopolTm solution that is being stirred, slowly add the FecloneTm
powder
mixture, about one quarter of the total at a time. Ensure that the FecloneTm
powder
mixture gets pulled through the homogenizer probe during addition, i.e. is
thoroughly
mixed into the pasty composition that is forming. If necessary, use a spatula
to facilitate
incorporation of the FecloneTm powder mixture into the composition.
4. After all of the FecloneTm powder mixture has been added, continue mixing
with the
homogenizer at 8000 rpm for an additional 5 minutes, using the spatula to push
the pasty
CA 02655173 2010-12-02
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composition towards the homogenizer probe. The composition should be
thoroughly
mixed and appear homogeneous.
The finished ABM may be placed in a container, such as Catalog # 14233-954 as
available from VWR Scientific of West Chester, PA, and stored in the
refrigerator for up to 30
days. After 30 days, a new sample should be prepared for further experiments.
The container
must be tightly sealed to avoid drying out of the ABM.
Prior to using the ABM in the Anti-Stick Screening Method, the ABM must be
removed
from the refrigerator and allowed to adjust back to room temperature. An easy
way to
accomplish this is to fill a 10 ml syringe, such as Catalog # BD301604 as
available from VWR
Scientific of West Chester, PA, with cold ABM and then allow the syringe to
equilibrate to room
temperature on a counter top. Equilibration typically takes about 15 minutes.
The 10 ml syringe
can then be used to fill the 1 ml syringe described in the Anti-Stick
Screening Method.
Examples
The lotion compositions of Examples 1 through 12 are contacted as described
earlier
with a substrate such as FibreIla 3160, a 58 grams/m2 nonwoven comprising a
blend of 40%
viscose fibers and 60% polypropylene fibers as is available from Suominen of
Tampere, Finland
or any other substrate deemed suitable for use.
In the Examples, "Q.S" refers herein to "quantum sufficit" and is a sufficient
percentage
of water added to the composition to bring the overall composition to 100%.
Weight Percent
Components Examplel Example2 Example3 Example4
Water Q.S. Q.S. Q.S. Q.S.
Disodium EDTA 0.100 0.100 0.100 0.100
Iodopropynylbutylcarbamate 0.009 0.009 0.009 0.009
Benzyl Alcohol 0.500 0.500 0.500 0.500
Suttocide A 50% Solution 0.150 0.150 0.150 0.150
Xanthan Gum 0.180 0.180 0.180 0.180
PEG40 Hydro. Castor Oil 0.550 0.550 0.550 0.550
Abil Care 85T 0.100 0.100 0.100 0.100
Citric Acid 0.055 0.055 0.055 0.055
Perfume 0.070 0.070 0.070 0.070
CarbowaxO 400 5.000
Pluronic F68 2.000
Pluronic F68 5.000
Tris-Alkoxylated Glyceryl Bis-Sulfate 2.000
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28
Weight Percent
Components Example5 Example6 Example7 Example8
Water Q.S. Q.S. Q.S. Q.S.
Disodium EDTA 0.100 0.100 0.100 0.100
PEG40 Hydrog. Castor Oil 0.400 0.400 0.400 0.400
Propylene Glycol 1.500 1.500 1.500 1.500
Phenoxyethanol 0.800 0.800 0.800 0.800
Methyl Paraben 0.150 0.150 0.150 0.150
Ethyl Paraben 0.050 0.050 0.050 0.050
Propyl Paraben 0.050 0.050 0.050 0.050
Xanthan Gum 0.180 0.180 0.180 0.180
Abil Care 85 0.100 0.100 0.100 0.100
Trilaureth-4 Phosphate 0.400 0.400 0.400 0.400
Monobasic Sodium Phosphate 0.180 0.180 0.180 0.180
Perfume 0.0'70 0.070 0.070 0.070
Cartowax 400 5.000
Pluronic F68 2.000
Pluronic F68 5.000
Tris-Alkoxylated Glyceryl Bis-Sulfate 2.000
Weight Percent
Components Example9 Example10 Example 1 1 Example12
Water Q.S. Q.S. Q.S. Q.S.
Disodium EDTA 0.100 0.100 0.100 0.100
Xanthan Gum 0.180 0.180 0.180 0.180
Abil care 85uvi
0.100 0.100 0.100 0.100
Sodium Benzoate 0.120 0.120 0.120 0.120
PEG40 Hydmg. Castor Oil 0.440 0.440 0.440 0.440
Citric Acid 0.530 0.530 0.530 0.530
Trisodium Citrate 0.390 0.390 0.390 0.390
Benzyl Alcohol 0.300 0.300 0.300 0.300
Perfume 0.070 0.070 0.070 0.070
liuxyl PE9010 0.300 0.300 0.300 0.300
Carbowax(R) 400 5.000
Pluronic F68 2.000
Pluronic F68 5.000
'fris-Alkoxylated Glyceryl Bis-Sulfate 2.000
As available from Schuelke and Mayr GmbH of Norderstedt, Germany.
The dimensions and values disclosed herein are not to be understood as being
strictly
limited to the exact numerical values recited. Instead, unless otherwise
specified, each such
dimension is intended to mean both the recited value and a functionally
equivalent range
CA 02655173 2011-08-17
29
surrounding that value. For example, a dimension disclosed as "40nun" is
intended to mean
"about 40mm".
All documents cited in the Detailed Description of the Invention are
not to be construed as an
admission that it is prior art with respect to the present invention. To the
extent that any
meaning or definition of a term in this written document conflicts with any
meaning or definition
of the term in a document cited herein, the meaning or definition assigned
to the
term in this written document shall govern.
