U.S. patent application number 13/006453 was filed with the patent office on 2011-10-13 for methods for improving skin quality.
Invention is credited to Karl Shiqing Wei.
Application Number | 20110250141 13/006453 |
Document ID | / |
Family ID | 44169566 |
Filed Date | 2011-10-13 |
United States Patent
Application |
20110250141 |
Kind Code |
A1 |
Wei; Karl Shiqing |
October 13, 2011 |
Methods For Improving Skin Quality
Abstract
A skin treatment regimen for delivery of a rinse-off personal
skin care composition is provided. The rinse-off personal skin care
composition includes varying ratios of a lathering agent to a
hydrophobic benefit agent. The rinse-off personal skin care
composition can be applied to skin of a user in phases over and/or
in a treatment cycle. Each of the phases of the treatment cycle can
include a ratio of the varying ratios that can be different such as
higher or lower than a ratio of adjacent phase.
Inventors: |
Wei; Karl Shiqing; (Mason,
OH) |
Family ID: |
44169566 |
Appl. No.: |
13/006453 |
Filed: |
January 14, 2011 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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61295732 |
Jan 17, 2010 |
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61295826 |
Jan 18, 2010 |
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Current U.S.
Class: |
424/9.2 ; 435/29;
514/768 |
Current CPC
Class: |
A61K 8/03 20130101; G01N
33/6827 20130101; G01N 2500/04 20130101; A61K 49/0006 20130101;
G06Q 30/0201 20130101; A61K 8/96 20130101; G01N 2800/20 20130101;
A61K 8/31 20130101; G01N 33/62 20130101; G01N 33/6869 20130101;
G01N 33/6881 20130101; G01N 33/92 20130101; A61K 2800/87 20130101;
G01N 2333/545 20130101; G01N 2333/4742 20130101; A61Q 19/10
20130101; G01N 33/6812 20130101; G01N 33/5088 20130101 |
Class at
Publication: |
424/9.2 ; 435/29;
514/768 |
International
Class: |
A61K 49/00 20060101
A61K049/00; A61Q 19/08 20060101 A61Q019/08; A61Q 19/00 20060101
A61Q019/00; C12Q 1/02 20060101 C12Q001/02; A61K 8/92 20060101
A61K008/92 |
Claims
1. A method for identifying a formulation comprising a hydrophobic
benefit agent useful for improving the skin (stratum corneum
barrier) in a human subject, comprising: generating one or more
negative skin profiles for a human subject having dry or damaged
skin; contacting the skin of the human subject with a proposed
rinse-off personal care formulation generating one or more test
profiles comparing the one or more test profiles to the one or more
negative profiles and identifying the proposed formulation as
effective if the test profile is directionally shifted away from
the negative reference profile and shows at least one skin property
selected from (i) reduction of visual dryness, a reduction in
trans-epidermal water loss, increased skin hydration, increased
elastic extension, increased elastic recovery, increased firmness
and (ii) reduction in total protein, an increase in the amount of
one or more of Keratin 1, Keratin 10 and Keratin 11, and a decrease
in cytokine expression.
2. A rinse-off personal skin care composition effective for
improving one or both of stratum corneum barrier maintenance and
repair properties in aged skin, comprising a formulation identified
according to the method of claim 1.
3. A method for improving one or both of stratum corneum barrier
maintenance and repair properties, comprising contacting skin with
the formulation identified according to the method of claim 1.
4. The method according to claim 1, wherein the measurable
improvement is a reduction of visual dryness, wherein the visual
dryness reduction is greater than 0.5 dryness unit vs. water
control after 3 hours of product application.
5. The method according to claim 1, wherein the measurable
improvement is a reduction in trans-epidermal water loss, wherein
the reduction of trans-epidermal water loss is greater than 0.2
TEWL unit vs. water control after 3 hours of product
application.
6. The method according to claim 1, wherein the measurable
improvement is increased skin hydration, wherein the increased skin
hydration is greater than one Corneometer Unit vs. water control
after 3 hours of product application.
7. The method according to claim 1, wherein the measurable
improvement is increased elastic extension, wherein the elastic
extension improvement index is greater than 5 after one hour of
product application.
8. The method according to claim 1, wherein the measurable
improvement is increased elastic recovery, wherein the elastic
recovery improvement index is greater than 5 after one hour of
product application.
9. The method according to claim 1, wherein the measurable
improvement is increased firmness, wherein the skin firmness
improvement index is greater than 4 after one of product
application.
10. The method according to claim 1, wherein the measurable
improvement is reduction in total protein, wherein the total
protein improvement index is greater than 10.
11. The method according to claim 1, wherein the measurable
improvement is an increase in the amount of one or more of Keratin
1, Keratin 10 and Keratin 11, wherein the Keratin improvement index
is greater than 50.
Description
CROSS REFERENCE TO RELATED APPLICATION
[0001] This application claims the benefit of U.S. Provisional
Application No. 61/295,732, filed Jan. 17, 2010 and U.S.
Provisional Application No. 61/295,826, filed Jan. 18, 2010.
FIELD OF THE INVENTION
[0002] The present invention relates to methods for improving skin
quality by delivering personal care articles that provide a premium
product usage experience for the consumer and skin benefits that
persist beyond the application.
BACKGROUND OF THE INVENTION
[0003] Personal care articles are well known and widely used on
hair and skin for delivering actives that provide, for example, one
or more benefits of cleansing, moisturizing, hiding or reducing
imperfections, reducing oiliness, and providing scent to either or
both the shower and the hair or skin. The efficacy of personal care
compositions for cleaning and moisturizing, particularly with
respect to reliving skin dryness and signs of aging, is directly
related to the frequency of use and the level of benefit materials.
And the pleasurable experience of using personal care compositions,
particularly for the benefits of lathering and scenting, are
similarly related to the frequency of use and the level of benefit
materials in the personal care article.
[0004] Consumers typically have limited space to accommodate an
extensive selection of personal care articles, hence they seek
products that deliver the maximum benefits and pleasurable
experience during use. If a treatment regime contains too many
steps or too many packages, consumers often tire of the regime of
personal care compositions over time. Likewise, if a personal care
article contains a balance of actives that are perceived by
consumers to provide an overall non-pleasurable usage experience,
the consumers lose interest in using the product. As a result, in
either case, consumer may decrease, suspend, or even or abandon use
of the personal care article despite what may be significant
benefits gained by the continued compliant use over time.
[0005] The methods of the present invention fulfill this need for a
simplified regime that provides excellent skin benefits.
SUMMARY OF THE INVENTION
[0006] The present invention is directed to methods and regimens
for application of a rinse-off personal care product for treating
and maintaining the quality of skin and to minimize the signs of
aging. Thus, in various embodiments, provided are skin treatment
regimens that comprise applying to the skin of a user a composition
formulated to comprise varying ratios of lathering agent to
hydrophobic benefit agent, said varying ratios being either
continuous or discrete in a treatment cycle comprising at least
first and second phases. The composition applied during the first
phase comprises a first of the varying ratios, and the composition
applied during the second phase comprises a second of the varying
ratios. In some embodiments, said second ratio is lower than the
first ratio. In some embodiments, the treatment cycle comprises a
third phase, and the composition applied therein comprises a third
of the varying ratios. In some embodiments, said third ratio higher
than the second ratio. In some embodiments, the composition is
provided to the user through a delivery article adapted to dispense
the composition in discrete aliquots of approximately equal
volume.
[0007] The present invention is also directed to method of
identifying and providing personal care products that are suitable
for treating and maintaining the quality of skin. In some aspects
the methods are directed to optimizing personal care products for
specific populations of users.
[0008] The present invention is also directed to compositions and
methods for assessing, treating and maintaining the quality of skin
and minimizing the signs of aging by assessing the activity of one
more skin biomarkers that are indicative of skin quality.
[0009] The regimens and methods of the present invention can be
practiced using personal care articles for dispensing a personal
care composition as disclosed herein. The disclosed personal care
article comprises a single chamber package and a personal care
article. The single chamber package comprises a dispensing orifice,
a first zone proximal to the dispensing orifice, a second zone
medial to the dispensing orifice, and a third zone distal to the
dispensing orifice. The personal care article comprises a first
personal care composition, a second personal care composition and a
third personal care composition. The first personal care
composition is substantially within the first zone and comprises a
first concentration of a hydrophobic benefit material. The second
personal care composition is substantially within the second zone
and comprises a second concentration of a hydrophobic benefit
material. The third personal care composition is substantially
within the third zone and comprises a third concentration of a
hydrophobic benefit material. The second concentration is greater
than the first concentration and the third concentration of the
hydrophobic benefit material.
[0010] In another aspect of the present invention, the first
concentration comprises from about 15% to less than 35%, by weight
of the first personal care composition, of hydrophobic benefit
material, the second concentration comprises from about 35% to
about 65%, by weight of the second personal care composition, of
hydrophobic benefit material, and the third concentration comprises
from about 15% to less than 35%, by weight of the third personal
care composition, of hydrophobic benefit material. The first
personal care composition is capable of being substantially
dispensed prior to the second and third personal care composition.
The second personal care composition is capable of being
substantially dispensed prior to the third personal care
composition.
[0011] These and other features, aspects, and advantages of the
present invention will become evident to those skilled in the art
from a reading of the present disclosure with the appended
claims.
BRIEF DESCRIPTION OF THE DRAWINGS
[0012] FIG. 1A and FIG. 1B illustrate a personal care article with
three zones having horizontal interfaces between the compositions
in each zone.
[0013] FIG. 2A is a diagram of the distinguishable layers of a
personal care product after centrifugation which can be measured in
length to calculate the concentration of hydrophobic benefit
material in the personal care product using the Microcentrifugation
Method described below.
[0014] FIG. 2B and FIG. 2C are photographs that exemplify the
measurement of the length of the benefit layer used to calculate
the concentration of the hydrophobic benefit material within in
centrifuged samples tested using the Microcentrifugation Method
described below.
[0015] FIG. 3 is a calibration curve calculated using a formula in
the Microcentrifugation Method described below.
[0016] FIG. 4 illustrates a graphic user interface analysis a
personal care product phase distribution along the radial
dimensions of the package according to the MRI method described
below.
[0017] FIG. 5 illustrates a graphic user interface analysis of a
personal care product phase distribution along the height of the
package according to the MRI method described below.
[0018] FIG. 6A, FIG. 6B, and FIG. 6C are MRI images of hydrophobic
benefit material distribution profiles prior to and after simulated
shipping conditions, as per the Dynamic Stability Shipping Method
described below.
[0019] FIG. 7A, FIG. 7B and FIG. 7C are MRI images of hydrophobic
benefit material distribution profiles of personal care products
described in the examples below.
[0020] FIG. 8 is a chart showing the benefit phase distribution
profile of the hydrophobic benefit material in the personal care
products described in the examples below.
[0021] An appendix of figures is also provided, and includes:
[0022] FIG. 9 is a chart showing the lipid delivery profile
according to an embodiment as described herein wherein the ratio of
lathering agent to hydrophobic benefit agent varies across a
treatment cycle from about 70:30 through about 45:55 to about
80:20.
[0023] FIG. 10 is a graph showing the relative change in visual
dryness using water and a embodiment of personal care composition
having the lipid delivery profile as shown in FIG. 9.
[0024] FIG. 11 is a graph showing the relative change in skin
condition measured with a corneometer using water and a embodiment
of personal care composition having the lipid delivery profile as
shown in FIG. 9.
[0025] FIG. 12 is a graph showing the relative change in skin trans
epidermal water loss using water and a embodiment of personal care
composition having the lipid delivery profile as shown in FIG.
9.
[0026] FIG. 13 is a graph showing the relative change in visual
dryness using water, a personal care composition having a lathering
agent to hydrophobic benefit agent ratio of 44:45 and a embodiment
of personal care composition having the lipid delivery profile as
shown in FIG. 9.
[0027] FIG. 14 is a graph showing the relative change in skin
condition measured with a corneometer using water, a personal care
composition having a lathering agent to hydrophobic benefit agent
ratio of 44:45 and a embodiment of personal care composition having
the lipid delivery profile as shown in FIG. 9.
[0028] FIG. 15 is a graph showing the relative change in skin trans
epidermal water loss using water, a personal care composition
having a lathering agent to hydrophobic benefit agent ratio of
44:45 and a embodiment of personal care composition having the
lipid delivery profile as shown.
[0029] FIG. 16 is a graph showing the change in skin deformation
over time.
[0030] FIG. 17 is a graph showing the relative change in Ue using
water and a embodiment of personal care composition having the
lipid delivery profile as shown in FIG. 9.
[0031] FIG. 18 is a graph showing the relative change in Ur using
water and a embodiment of personal care composition having the
lipid delivery profile as shown in FIG. 9.
[0032] FIG. 19 is a graph showing the relative change in Ue using
water, a personal care composition having a lathering agent to
hydrophobic benefit agent ratio of 44:45 and a embodiment of
personal care composition having the lipid delivery profile as
shown in FIG. 9.
[0033] FIG. 20 is a graph showing the relative change in Ur using
water, a personal care composition having a lathering agent to
hydrophobic benefit agent ratio of 44:45 and a embodiment of
personal care composition having the lipid delivery profile as
shown in FIG. 9.
[0034] FIG. 21 is a graph showing the relative change in total
protein using water and a embodiment of personal care composition
having the lipid delivery profile as shown in FIG. 9
[0035] FIG. 22 is a graph showing the relative change in total
protein using water, a personal care composition having a lathering
agent to hydrophobic benefit agent ratio of 44:45 and a embodiment
of personal care composition having the lipid delivery profile as
shown in FIG. 9
[0036] FIG. 23 is a graph showing the relative change in Keratin 1,
10 and 11 normalized to soluble protein using water and a
embodiment of personal care composition having the lipid delivery
profile as shown in FIG. 9
[0037] FIG. 24 is a graph showing the relative change Keratin 1, 10
and 11 normalized to soluble protein using water, a personal care
composition having a lathering agent to hydrophobic benefit agent
ratio of 44:45 and a embodiment of personal care composition having
the lipid delivery profile as shown in FIG. 9.
[0038] FIG. 25 is a graph showing the lipid delivery profile
according to an embodiment as described herein wherein the ratio of
lathering agent to hydrophobic benefit agent varies across a
treatment cycle from about 70:30 through about 45:55 to about
80:20, wherein the volume of dispensed composition is 250 ml.
[0039] FIG. 26 is a graph showing the lipid delivery profile
according to an embodiment as described herein wherein the ratio of
lathering agent to hydrophobic benefit agent varies across a
treatment cycle from about 70:30 through about 45:55 to about
80:20, wherein the volume of dispensed composition is 450 ml.
DETAILED DESCRIPTION OF THE INVENTION
I. Definitions
[0040] "Ambient conditions" as used herein, refers to surrounding
conditions at one (1) atmosphere of pressure, 50% relative
humidity, and 25.degree. C.
[0041] "Biomarker" as used herein refers to any biological
molecules (genes, proteins, lipids, metabolites) that, singularly
or collectively, reflect the current or predict future state of a
biological system. Thus, as used herein, various biomarkers are
indicators of the quality of skin in terms of elasticity, dryness,
condition, brightness, tone, smoothness, appearance of lines.
Non-limiting examples of biomarkers include, elastic properties,
visual properties of dryness and condition, the presence of
flaking, cohesiveness as evidenced by total protein, lipid content,
trans epidermal water loss, cytokine expression, the presence of
one or more of keratins 1, 10 and 11. One or more modified
biological parameters can be used to screen for materials that
induce a positive or negative effect on skin. The response of skin
to treatment with personal care compositions can also be assessed
by measuring one or more biomarkers.
[0042] "Comprising" as used herein means that other steps and other
ingredients which do not affect the end result can be added. This
term encompasses the terms "consisting of" and "consisting
essentially of." The compositions and methods/processes of the
present invention can comprise, consist of, or consist essentially
of the essential elements and limitations of the invention
described herein, as well as any of the additional or optional
ingredients, components, steps, or limitations described herein
useful in personal cleansing compositions intended for topical
application to the hair or skin.
[0043] "Effective amount" as used herein means an amount of a
compound or composition sufficient to significantly induce a
positive skin benefit, including independently or in combination
with other benefits disclosed herein. This means that the content
and/or concentration of active component in the formulation is
sufficient that when the formulation is applied with normal
frequency and in a normal amount, the formulation can result in the
treatment of one or more undesired skin conditions (e.g., skin
wrinkles). For instance, the amount can be an amount sufficient to
inhibit or enhance some biochemical function occurring within the
skin. This amount of active component may vary depending upon the
type of product, the type of skin condition to be addressed, and
the like.
[0044] "Headspace," as used herein means the void volume that is
located proximal to the dispensing orifice and the interface of the
first zone of the single chamber package. In the alternative, the
headspace can be comprised within the first zone. The headspace of
the personal care articles of the present invention can be
determined by the following method or any other conventional
method. First, an empty package is placed on a balance and weighed.
The total package volume is determined by completely filling the
package with deionized water and determining the deionized water
weight and recording it as (V.sub.total). The package is then
filled with a personal care composition leaving a headspace. Next,
the package is placed on a balance and re-zero. The headspace
volume is filled with deionized water by a syringe. The weight of
deionized water filled in the headspace is recorded as
(V.sub.headspace). The headspace is calculated as:
V.sub.headspace/V.sub.total*100%.
[0045] "Hydrophobic benefit agent" as used herein, refers to
hydrophobic benefit materials that deliver skin conditioning,
moisturization, and skin health benefits. Preferably, hydrophobic
benefit agents are selected from the group consisting of
petrolatum, lanolin, derivatives of lanolin (e.g. lanolin oil,
isopropyl lanolate, acetylated lanolin, acetylated lanolin
alcohols, lanolin alcohol linoleate, lanolin alcohol riconoleate)
hydrocarbon oils (e.g. mineral oil) natural and synthetic waxes
(e.g. micro-crystalline waxes, paraffins, ozokerite, lanolin wax,
lanolin alcohols, lanolin fatty acids, polyethylene, polybutene,
polydecene, pentahydrosqualene) volatile or non-volatile
organosiloxanes and their derivatives (e.g. dimethicones,
cyclomethicones, alkyl siloxanes, polymethylsiloxanes,
methylphenylpolysiloxanes), natural and synthetic triglycerides
(e.g. castor oil, soy bean oil, sunflower seed oil, maleated soy
bean oil, safflower oil, cotton seed oil, corn oil, walnut oil,
peanut oil, olive oil, cod liver oil, almond oil, avocado oil, palm
oil, sesame oil) and combinations thereof.
[0046] "Liquid" as used herein means that the composition is
generally flowable to some degree. "Liquids", therefore, may
include liquid, semi-liquid, cream, lotion or gel compositions
intended for topical application to skin. The compositions may
exhibit a viscosity of equal to or greater than about 1,500
(centipoise, hereinafter "cps"), equal to or greater than about
5,000 cps, equal to or greater than about 10,000 cps or equal to or
greater than about 20,000 cps and no more than about 1,000,000 cps,
no more than about 500,000 cps, no more than about 300,000 cps, or
no more than about 200,000 cps as measured by the T-Bar Viscosity
Method described hereinafter.
[0047] "Lathering Agent" as used herein refers to a surfactant,
which when combined with water and mechanically agitated generates
a foam or lather sufficient to cause a personal care composition to
provide a lather.
[0048] "Package" includes any suitable container for personal care
compositions exhibiting a viscosity from about 1,500 centipoise
(cP) to about 1,000,000 cP, including but not limited to a bottle,
tottle, tube, jar, non-aerosol pump and mixtures thereof.
[0049] "Personal care composition" as used herein, refers to
compositions intended for topical application to the skin or hair.
The compositions used in accordance with the present invention are
rinse-off formulations, in which the product is applied topically
to the skin or hair and then is subsequently rinsed within minutes
from the skin or hair with water, or otherwise wiped off using a
substrate with deposition of a portion of the composition. The
compositions also may be used as shaving aids. The personal care
composition used in accordance with the present invention is
typically extrudable or dispensible from a single chamber package.
The personal care compositions used in accordance with the present
invention can be in the form of liquid, semi-liquid, cream, lotion
or gel compositions intended for topical application to skin.
Examples of personal care compositions used in accordance with the
present invention can include but are not limited to shampoo,
conditioning shampoo, hair conditioner, body wash, moisturizing
body wash, shower gels, skin cleansers, cleansing milks, hair and
body wash, in shower body moisturizer, pet shampoo, shaving
preparations and cleansing compositions used in conjunction with or
applied to a disposable cleansing cloth. The product forms
contemplated for purposes of defining the compositions and methods
of the present invention are rinse-off formulations by which it is
meant that the product is applied topically to the skin or hair and
then subsequently (i.e., within minutes) rinsed away with water, or
otherwise wiped off using a substrate or other suitable removal
means.
[0050] "Phase" as used herein refers to a distinguishable part in a
cycle of treatment or application of a personal care product
according to the invention. For purposes hereof, a phase need not
be limited to a particular period of time. Phases are distinct from
one another in that the properties, most particularly the ratios of
lathering agent to hydrophobic benefit agent, of a personal care
composition vary between sequential phases. Thus, in a cycle
comprising three phases of treatment or application, each phase may
involve use of personal care compositions that vary relative to one
another, for example wherein the ratios of lathering agent to
hydrophobic benefit agent vary between each of the phases. In
another example, in a cycle comprising three phases of treatment or
application, two of the phases may involve use of personal care
compositions that do not vary relative to one another while a third
phase varies from the other two. In yet another example in a cycle
comprising two phases of treatment or application, each phase may
involve use of personal care compositions that vary relative to one
another, for example wherein the ratios of lathering agent to
hydrophobic benefit agent vary between each of the phases. The
terms "Premium Experience Phase" refers to phases in which the
components in a personal care composition are associated with
delivery of one or more experiential benefits to the user at the
time of use, such as lathering and delivery of scent for excellent
in-use characteristics during cleansing process. The term
"Conditioning Phase" refers to phases in which the components in a
personal care composition are associated with delivery of one or
more benefits during use, for example, deposition of hydrophobic
benefit agent on the skin, that provide long term benefits after
use.
[0051] "Sagging" as used herein means the laxity, slackness, or the
like condition of skin that occurs as a result of loss of, damage
to, alterations to, and/or abnormalities in dermal elastin, muscle
and/or subcutaneous fat.
[0052] "Signs of aging" include, but are not limited to, all
outward visibly and tactilely perceptible manifestations as well as
any other macro or micro effects due to skin aging. Such signs may
be induced or caused by intrinsic factors or extrinsic factors,
e.g., chronological aging and/or environmental damage. These signs
may result from processes which include, but are not limited to,
the development of textural discontinuities such as wrinkles and
coarse deep wrinkles, fine lines, skin lines, crevices, bumps,
large pores (e.g., associated with adnexal structures such as sweat
gland ducts, sebaceous glands, or hair follicles), or unevenness or
roughness, loss of skin elasticity (loss and/or inactivation of
functional skin elastin), sagging (including puffiness in the eye
area and jowls), loss of skin firmness, loss of skin tightness,
loss of skin recoil from deformation, discoloration (including
undereye circles), blotching, sallowness, hyperpigmented skin
regions such as age spots and freckles, keratoses, abnormal
differentiation, hyperkeratinization, elastosis, collagen
breakdown, and other histological changes in the stratum corneum,
dermis, epidermis, the skin vascular system (e.g., telangiectasia
or spider vessels), and underlying tissues (e.g., fat and/or
muscle), especially those proximate to the skin.
[0053] "Skin," as used herein, refers to keratin-containing layers
disposed as the outermost protective covering of mammals (e.g.,
humans, dogs, cats, etc.) which includes, but is not limited to,
skin, mucosa, lips, hair, toenails, fingernails, cuticles, hooves,
etc.
[0054] "Smoothing" and "softening" as used herein mean altering the
surface of the skin such that its tactile feel is improved.
[0055] "Surfactant component" as used herein means the total of all
anionic, nonionic, amphoteric, zwitterionic and cationic
surfactants in a phase. When calculations are based on the
surfactant component, water and electrolyte are excluded from the
calculations involving the surfactant component, since surfactants
as manufactured typically are diluted and neutralized.
[0056] "Statically stable" as used herein, unless otherwise
specified, refers to a personal care article that comprise at least
two compositions that maintain at least two "separate" zones with
at least two separate benefit concentrations zones contained within
a single chamber package at ambient conditions for a period of at
least about 180 days. Alternatively, static stability can be
determined by accelerated protocol at elevated temperature. One
accelerated protocol is based on passing static stability after 10
days at 50.degree. C. By "separate" is meant that there is
substantially no mixing of compositions contained in the zones,
detected by the benefit analysis method, described hereinafter,
prior to dispensing of the composition.
[0057] "Structured," as used herein means having a rheology that
confers stability on the personal care composition. The degree of
structure is determined by characteristics determined by one or
more of the following methods the Yield Stress Method, or the Zero
Shear Viscosity Method or by the Ultracentrifugation Method, all in
the Test Methods below. Accordingly, a surfactant phase of the
composition used in accordance with the present invention is
considered "structured," if the surfactant phase has one or more of
the following properties described below according to the Yield
Stress Method, or the Zero Shear Viscosity Method or by the
Ultracentrifugation Method. A surfactant phase is considered to be
structured, if the phase has one or more of the following
characteristics:
[0058] A. a Yield Stress of greater than about 0.1 Pascal (Pa),
more typically greater than about 0.5 Pa, even more typically
greater than about 1.0 Pa, still more typically greater than about
2.0 Pa, still even more typically greater than about 3 Pa, and even
still even more typically greater than about 5 Pa as measured by
the Yield Stress and Zero Shear Viscosity Method described
hereafter:
[0059] B. a Zero Shear Viscosity of at least about 500
Pascal-seconds (Pa-s), typically at least about 1,000 Pa-s, more
typically at least about 1,500 Pa-s, even more typically at least
about 2,000 Pa-s; or
[0060] C. a Structured Domain Volume Ratio as measured by the
Ultracentrifugation Method described hereafter, of greater than
about 40%, typically at least about 45%, more typically at least
about 50%, more typically at least about 55%, more typically at
least about 60%, more typically at least about 65%, more typically
at least about 70%, more typically at least about 75%, more
typically at least about 80%, even more typically at least about
85%.
[0061] "Topical application", "topically", and "topical", as used
herein, mean to apply (e.g., spread, spray) the compositions used
in accordance with the present invention onto the surface of the
skin.
[0062] "Tottle" as used herein refers to a bottle which rests on
the neck or mouth which its contents are filled in and dispensed
from, but it is also the end upon which the bottle is intended to
rest or sit upon for storage by the consumer and/or for display on
the store shelf, as described in the commonly owned U.S. patent
application Ser. No. 11/067,443 filed on Feb. 25, 2005 to McCall et
al, entitled "Multi-phase Personal Care Compositions, Process for
Making and Providing, and Article of Commerce."
[0063] "Treating" or "treatment" or "treat" as used herein includes
regulating and/or immediately improving skin cosmetic appearance
and/or feel. As used herein, "regulating" or "regulation" means
maintaining or improving the health and/or cosmetic appearance, and
includes both prophylactically regulating and/or therapeutically
regulating. Regulation of skin condition, namely mammalian and in
particular human skin, hair, or nail condition, is often required
due to conditions which may be induced or caused by factors
internal and/or external to the body. Examples include
environmental damage, radiation exposure (including ultraviolet
radiation), chronological aging, menopausal status (e.g.,
post-menopausal changes in skin, hair, or nails), stress, diseases,
disorders, etc. For instance, "regulating skin, hair, or nail
condition" includes prophylactically regulating and/or
therapeutically regulating skin, hair, or nail condition, and may
involve one or more of the following benefits: thickening of skin,
hair, or nails (e.g., building the epidermis and/or dermis and/or
sub-dermal [e.g., subcutaneous fat or muscle] layers of the skin,
and where applicable the keratinous layers of the nail and hair
shaft) to reduce skin, hair, or nail atrophy, increasing the
convolution of the dermal-epidermal border (also known as the rete
ridges), preventing loss of skin or hair elasticity (loss, damage
and/or inactivation of functional skin elastin) such as elastosis,
sagging, loss of skin or hair recoil from deformation; melanin or
non-melanin change in coloration to the skin, hair, or nails such
as under eye circles, blotching (e.g., uneven red coloration due
to, e.g., rosacea) (hereinafter referred to as "red blotchiness"),
sallowness (pale color), discoloration caused by telangiectasia or
spider vessels, and graying hair.
[0064] "Zone" as used herein refers to a domain or region within a
single chamber package which corresponds to a composition of the
personal care article. The interface between the zones can be
distinct or gradual or separated by another zone. The amount
contained within a zone can be defined by a percentage of the
package volume and a zone comprises at least 10% of the package
volume of a given package, excluding the volume of the package
corresponding to the necessary headspace or void volume and the
closure, as shown in FIG. 1A and FIG. 1B of the present invention.
In one aspect, the first personal care composition, the second
personal care composition and third personal care compositions
within a the first zone, second zone or third zone is homogeneous.
In this case, the concentration of hydrophobic benefit material is
constant within the zone. In another aspect, the personal care
composition within the first, second or third zone is
inhomogeneous, such that the concentration of hydrophobic benefit
material varies within the zone. The level of hydrophobic benefit
material can show an increasing or decreasing trend.
[0065] All percentages, parts and ratios are based upon the total
weight of the compositions used in accordance with the present
invention, unless otherwise specified. All such weights as they
pertain to listed ingredients are based on the active level and,
therefore; do not include solvents or by-products that may be
included in commercially available materials, unless otherwise
specified. The term "weight percent" may be denoted as "wt. %"
herein. Except where specific examples of actual measured values
are presented, numerical values referred to herein should be
considered to be qualified by the word "about."
[0066] All molecular weights as used herein are weight average
molecular weights expressed as grams/mole, unless otherwise
specified.
II. Methods and Regimens for Treating Skin
[0067] The personal care compositions used in accordance with the
present invention are used in a conventional manner for cleansing
and conditioning skin. The personal care compositions used in
accordance with the present invention are typically applied
topically to the desired area of the skin in an amount sufficient
to provide effective delivery of the skin cleansing agent,
hydrophobic material, and in some embodiments particles and other
agents and actives to the applied surface. The compositions can be
applied directly to the skin or indirectly via the use of a
cleansing puff, washcloth, sponge or other implement. The
compositions are typically diluted with water prior to, during, or
after topical application, and then subsequently the skin is rinsed
or wiped off, typically rinsed off of the applied surface using
water or a water-insoluble substrate in combination with water.
[0068] The present invention is therefore also directed to methods
of cleansing the skin through the above-described application of
the compositions of the present invention. An effective amount of
the composition for cleansing and conditioning the skin is applied
to the skin, that in some examples has been wetted with water, and
then rinsed off. Such effective amounts generally range from about
1 gm to about 50 gm, and from about 1 gm to about 20 gm.
[0069] In general, a typical method for cleansing and conditioning
the skin comprises the steps of: a) wetting the skin with water, b)
applying an effective amount of the personal care composition to
the skin, and c) rinsing the applied areas of skin with water.
These steps can be repeated as many times as desired to achieve the
desired cleansing and conditioning benefit.
Treatment Regimens
[0070] In various embodiments, the invention provides methods and
regimens for use of a personal care composition having varied
ratios of lathering agent to hydrophobic benefit agent. The
composition is used over a period of time, alternately referred to
as a treatment time, that includes two or more phases. In some
embodiments, the treatment period includes three phases, starting
with first phase in which a high lathering agent (surfactant) is
used that provides a premium user experience through high lather
and fragrance delivery. According to such embodiments, as use
progresses into a second phase, a high lipid "plateau" provides
conditioning through high hydrophobic benefit agent content, and in
a final phase a high lathering agent (surfactant) is used that
provides a premium user experience through high lather and
fragrance delivery. In other embodiment, the order of the phases
may be switched and a treatment period may comprise only two
phases, or it may comprise more than three phases.
[0071] In various embodiments, skin treatment regimens are provided
comprising (i) providing to a user a composition formulated to
comprise varying ratios of lathering agent to hydrophobic benefit
agent, said varying ratios being either continuous or discrete; and
(ii) applying the provided composition to the skin of the user in a
treatment cycle comprising at least first and second phases. The
composition applied during the first phase comprises a first of the
varying ratios, and the composition applied during the second phase
comprises a second of the varying ratios. In some embodiments, said
second ratio is lower than the first ratio. In some embodiments,
the treatment cycle comprises a third phase, and the composition
applied therein comprises a third of the varying ratios. In
accordance with the invention, provided are regimens for the
delivery of a rinse-off personal skin care composition. Some
embodiments include the steps of dispensing from a personal care
article a personal care composition that comprises a lathering
agent and a hydrophobic benefit agent, wherein the article operates
to dispense the composition in aliquots, and wherein the ratio of
lathering agent to hydrophobic benefit agent varies in successively
dispensed aliquots of the composition over the course of dispensing
the article contents such that the amount of hydrophobic benefit
agent in two or more successive aliquots is different. According to
such embodiments, the steps include applying a first aliquot of the
personal care composition to a user's skin together with water,
wherein the lathering agent provides lather when contacted on the
user's skin with water and rinsing the personal care composition
from the user's skin, wherein a portion of the hydrophobic benefit
agent is deposited and remains on the user's skin after
rinsing.
[0072] In accordance with some embodiments of the regimens, the
steps include: application of a composition to skin of a user in
phases over a treatment cycle. It will be understood that a
treatment cycle is described herein as been achieved in phases,
however, the term phrases is intended to be non-limiting with
respect to time or sequence of the steps of a treatment cycle. In
the various embodiments, the composition comprises varying ratios
of a lathering agent to a hydrophobic benefit agent. A treatment
cycle includes a first phase characterized by the application of
the composition having a first ratio of the varying ratios, an
intermediate phase characterized by the application of the
composition having a second ratio of the varying ratios that is
lower than the first ratio, and a final phase characterized by the
application of the composition having a third ratio of the varying
ratios that is higher than the intermediate phase.
[0073] The invention also provides regimens for sustaining consumer
use of a treatment for skin. In various embodiments, the regimen
involves application of the composition to a user's skin in a
treatment cycle having a first phase wherein the ratio of lathering
agent to hydrophobic benefit agent is high and provides a
relatively appealing sensation to the consumer, an intermediate
phase wherein the ratio of lathering agent to hydrophobic benefit
agent is low and provides a relatively less appealing sensation to
the consumer, and a final phase wherein the ratio of lathering
agent to hydrophobic benefit agent is high and provides a
relatively appealing sensation to the consumer.
[0074] The invention also provides regimens for maintaining the
quality of skin with a rinse-off personal care composition which
include the steps of applying the composition to a user's skin on a
daily basis for a period of days, wherein the composition is a
rinse-off personal skin care composition comprising a hydrophobic
benefit agent and a lathering agent, and wherein the ratio of
lathering agent to hydrophobic benefit agent varies over the period
of application, the period of days of application comprising, in
any order, a premium experience phase wherein the ratio of
lathering agent to hydrophobic benefit agent is high, the premium
experience phase characterized by maximal delivery of lather and
scent, and a conditioning phase wherein the ratio of lathering
agent to hydrophobic benefit agent is low, the conditioning phase
characterized by maximal hydrophobic benefit agent deposition. In
some embodiments the sequence of the phases is the premium
experience phase followed by the conditioning phase. In other
embodiments, the sequence of the phases is the conditioning phase
followed by the premium experience phase. In yet other embodiments,
the sequence of the phases is a premium experience phase, followed
by a conditioning phase, followed by a premium experience
phase.
[0075] In some embodiments, said third ratio higher than the second
ratio. In some embodiments, the composition is provided to the user
through a delivery article adapted to dispense the composition in
discrete aliquots of approximately equal volume. In some
embodiments, the composition comprises a continuum of varying
ratios, and at least every other aliquot provided to the user has a
different ratio of lathering agent to hydrophobic benefit agent. In
some embodiments, every aliquot provided to the user has a
different ratio. In some embodiments, at least every other aliquot
provided and applied during the first phase has a lower ratio of
lathering agent to hydrophobic benefit agent.
[0076] In accordance with some embodiments, the composition is
provided in a delivery article that contains sufficient composition
for at least one treatment cycle. According to such embodiments,
the delivery article is adapted to dispense the composition in
discrete aliquots of approximately equal volume, and wherein
aliquots of the composition are applied until the contents of the
delivery article are substantially depleted. In some embodiments
the each aliquot has the same approximate volume. In some
embodiments the volume of each successively dispensed aliquot
increases. In some embodiments a first dispensed aliquot comprises
a first ratio of the varying ratios, and a subsequent dispensed
aliquot comprises a second ratio of the varying ratios that is
different from the ratio of the first aliquot. According to such
embodiments, an aliquot dispensed subsequent to the second aliquot
comprises a third ratio of the varying ratios that is different
from the ratio of the second aliquot. In some embodiments, an
aliquot dispensed subsequent to the second aliquot comprises a
third ratio of the varying ratios that is different from the ratio
of the first aliquot. In some embodiments an aliquot dispensed
subsequent to the second aliquot comprises a third ratio of the
varying ratios that is different from the ratios of the first and
the second aliquots.
[0077] Suitable aliquots for application during the first phase
include, but are not limited to, those having a ratio of lathering
agent to hydrophobic benefit agent from about 90:10 to about 50:50.
Accordingly, non-limiting examples of suitable aliquots for
application during the first phase are those having ratios of
90:10, 85:15, 80:20, 75:25, 70:30, 65:35, 60:40, 55:45, and 50:50.
In some embodiments, at least every other aliquot provided and
applied during the second phase has a lower ratio of lathering
agent to hydrophobic benefit agent. Suitable aliquots for
application during the second phase include, but are not limited
to, those having a ratio of lathering agent to hydrophobic benefit
agent from about 50:50 to about 10:90.
[0078] Accordingly, non-limiting examples of suitable aliquots for
application during the second phase are those having ratios of
50:50, 45:55, 40:60, 35:65, 30:70, 25:75, 20:80, 15:85, and 10:90.
In some embodiments, at least every other aliquot applied during
the third phase has a higher ratio of lathering agent to
hydrophobic benefit agent. Suitable aliquots for application during
the third phase include, but are not limited to, those having a
ratio of lathering agent to hydrophobic benefit agent from about
50:50 to about 90:10. Accordingly, non-limiting examples of
suitable aliquots for application during the third phase are those
having ratios of 50:50, 55:45, 60:40, 65:35, 70:30, 75:25, 80:20,
85:15, and 90:10.
[0079] In some embodiments, the composition comprises discrete
varying ratios, and each aliquot provided to the user during a
phase has the same ratio of lathering agent to hydrophobic benefit
agent. For example, the composition may be in discrete zones within
the delivery article, each zone having a different ratio of
lathering agent to hydrophobic benefit agent. As further example,
each zone may correspond to a phase of the treatment regimen. In
the embodiments wherein the composition comprises discrete ratios
of lathering agent to hydrophobic benefit agent, suitable aliquots
for application during the first phase include, but are not limited
to, those having a ratio from about 90:10 to about 50:50.
Accordingly, non-limiting examples of suitable aliquots for
application during the first phase are those having ratios of
90:10, 85:15, 80:20, 75:25, 70:30, 65:35, 60:40, 55:45, and
50:50.
[0080] In the embodiments wherein the composition comprises
discrete ratios of lathering agent to hydrophobic benefit agent,
suitable aliquots for application during the second phase include,
but are not limited to, those having a ratio from about 50:50 to
about 10:90. Accordingly, non-limiting examples of suitable
aliquots for application during the second phase are those having
ratios of 50:50, 45:55, 40:60, 35:65, 30:70, 25:75, 20:80, 15:85,
and 10:90. In the embodiments wherein the composition comprises
discrete ratios of lathering agent to hydrophobic benefit agent,
suitable aliquots for application during the third phase include,
but are not limited to, those having a ratio from about 50:50 to
about 90:10. Accordingly, non-limiting examples of suitable
aliquots for application during the third phase are those having
ratios of 50:50, 55:45, 60:40, 65:35, 70:30, 75:25, 80:20, 85:15,
and 90:10.
[0081] In accordance with some embodiments, the composition is
applied on a daily basis. It will be appreciated that treatment
times and frequency may vary based upon the user, and as such,
treatment may be on a less than daily basis, or may be more often.
In other embodiments, the treatments may be less frequent, for
example weekly or monthly, or in some other interval of time.
[0082] In accordance with the methods, the composition is provided
in a delivery article that is adapted for use in accordance with a
predetermined time of treatment or a predetermined approximate
number of instances of treatment, or both. Thus, in some
embodiments, the delivery article is adapted to deliver sufficient
composition for one or two or more treatment cycles. In some
embodiments, the delivery article is adapted to deliver the
composition for each treatment cycle in an approximate number of
aliquots or units. In such embodiments, the aliquots may be the
same in volume or may vary. In some embodiments the number of
aliquots or units to be dispensed per phase or in an article is a
predetermined number that defines the approximate number of
instances of use, either in days, weeks or months.
[0083] In some embodiments the composition is applied through a
treatment cycle in a time interval of about thirty days. For
example, the first phase of the treatment cycle may be from about 3
to 7 days, the intermediate phase of the treatment cycle may be
from about 6 to 14 days, and the final phase of the treatment cycle
may be from about 6 to 14 days. In another example, the first phase
of the treatment cycle may be from about 2 to 5 days, the
intermediate phase of the treatment cycle may be from about 3 to 7
days, and the final phase of the treatment cycle may be from about
14 to 21 days.
[0084] In another embodiment, the composition is applied through a
treatment cycle in a time interval of about fifty days. In one
example, the first phase of the treatment cycle may be from about 3
to 7 days, the intermediate phase of the treatment cycle may be
from about 10 to 28 days, and the final phase of the treatment
cycle may be from about 14 to 20 days.
[0085] In another embodiment, the applied through a treatment cycle
in a time interval of about fifty-six days. In one example, the
first phase of the treatment cycle may be from about 2 to 7 days,
the intermediate phase of the treatment cycle may be from about 3
to 28 days, and the final phase of the treatment cycle may be from
about 6 to 21 days
[0086] In accordance with various embodiments, the ratios of
lathering agent to hydrophobic benefit agent may vary in each phase
across a broad possible range. In some embodiments, the ratio of
lathering agent to hydrophobic benefit agent is at a maximum of
about 75:25 during the first phase, and the ratio of lathering
agent to hydrophobic benefit agent is at a minimum of about 45:55
during the intermediate phase, and the ratio of lathering agent to
hydrophobic benefit agent is at a maximum of about 75:25 during the
final phase. In other embodiments, the ratio of lathering agent to
hydrophobic benefit agent is at a maximum of about 70:30 during the
first phase, and the ratio of lathering agent to hydrophobic
benefit agent is at a minimum of about 45:55 during the
intermediate phase, and the ratio of lathering agent to hydrophobic
benefit agent is at a maximum of about 80:20 during the final
phase. In yet other embodiments, the ratio of lathering agent to
hydrophobic benefit agent is at a maximum of about 75:25 during the
first phase, and the ratio of lathering agent to hydrophobic
benefit agent is at a minimum of about 45:55 during the
intermediate phase, and the ratio of lathering agent to hydrophobic
benefit agent is at a maximum of about 75:25 during the final
phase. In some general embodiments, the ratio of lathering agent to
hydrophobic benefit agent is at a maximum in the range from about
50:50 to 90:10 during the first phase, and the ratio of lathering
agent to hydrophobic benefit agent is at a minimum in the range
from about 10:90 to 50:50 during the intermediate phase, and the
ratio of lathering agent to hydrophobic benefit agent is at a
maximum in the range from about 50:50 to 90:10 during the final
phase.
[0087] It will be appreciated that the variations in ratios in each
phase and between the phases may vary independently of the interval
time of treatment, and that the number of days of treatment during
any phase in a described interval may vary. Further, it will be
appreciated that the number of aliquots or units of composition
dispensed or used in a treatment cycle, during any phase, or in any
single application may vary, and that the volume of aliquots may
vary.
[0088] In accordance with some embodiments, a delivery article is
adapted to deliver composition formulated to match a population
profile, wherein the profile reflects preferences in a population
for composition properties selected from maximum hydrophobic
benefit agent content, lathering, scent, color, opalescence,
thickness, and combinations of these. Methods of identifying
population profiles and developing personal care compositions are
described herein.
[0089] In accordance with various embodiments, the composition
formulation used in accordance with the methods may include one or
more additional benefit agents. Non limiting examples of benefit
agents includes vitamins, vitamin derivatives, sunscreens,
desquamation actives, anti-wrinkle actives, anti-atrophy actives,
anti-oxidants, skin soothing agents, skin healing agents, skin
lightening agents, skin tanning agents, anti-acne medicaments,
essential oils, sensates, pigments, colorants, pearlescent agents,
interference pigments, particles, hydrophobically modified
non-platelet particles and combinations thereof. Other benefit
agents and materials as described herein with respect to
representative composition embodiments may also be used. Likewise,
other formulation components, including lathering/surfactant agents
and hydrophobic benefit agents may be selected as described herein.
Additional benefit agents may be provide with either or both the
lathering agent and the hydrophobic benefit agent. Examples of some
specific benefit agents include exfoliating agents, niacinamide,
vitamin E (tocopherol or tocotrieneol), collagen.
[0090] According to the various embodiments, personal care
compositions provide a lathering agent that produces a lather that
varies with the varied ratios of lathering agent and hydrophobic
benefit agent. In some embodiments the lather volume of the
composition is greater than from about 800 ml to 1500 ml by the
cylinder lather method. It will thus be appreciated by those in the
art that in accordance with the cylinder method, the lather volume
provided by a personal care composition may be from about 800, 850,
900, 950, 1000, 1050, 1100, 1150, 1200, 1250, 1300, 1350, 1400,
1450, and 1500 or more ml. Of course it will be appreciated that in
some embodiments, particular with respect to embodiments and phases
wherein the ratio of lathering agent to hydrophobic benefit agent
is low, that the lather volume will be lower or substantially lower
than the above stated range, and that in some embodiments the
lather volume may be from 1500 to 1750 to 1900, to 2000 or more ml.
It will also be appreciated that other methods described or
otherwise known in the art may be used to characterize lather and
lather volume and that the description herein is not limiting, such
that the lather properties of the compositions used as described
herein may be described in other terms.
[0091] In accordance with varying embodiments, the methods and
regimens involve the use of personal care compositions provided in
one or more delivery articles. In some embodiments the ratios of
the lathering agent to hydrophobic benefit agent in the composition
vary as a function of containment location in the single delivery
article. In some embodiments the composition is contained within
discrete zones of the delivery article and wherein ratios of
lathering agent to hydrophobic benefit agent are different in each
zone. According to such embodiments, the discrete zones are
physically separated chambers defined in the delivery article. In
some embodiments the personal care composition is provided in a
delivery article adapted to dispense the composition in discrete
aliquots of approximately equal volume. In some such embodiments,
the delivery article contains sufficient composition for a
predetermined application period. In some embodiments aliquots of
the composition are dispensed and applied until the contents of the
delivery article are substantially depleted
[0092] In some embodiments the ratios of the lathering agent to
hydrophobic benefit agent in the composition vary continuously from
the first phase through the final phase. It will be appreciated
that the variation across a phase or phases may be influenced by
the volume increments of composition provided. In some embodiments,
two or more sequential increments of provided composition may be
the same with respect to the ratios of lathering agent to
hydrophobic benefit agent. In other embodiments, each increment may
be the same.
[0093] According to some embodiments, the quality of the users skin
after the conditioning phase exhibits improvement sufficient to be
detected by measurement of one or more of reduction of visual
dryness, reduction in trans-epidermal water loss, increased skin
hydration, increased elastic extension, increased elastic recovery,
increased firmness, reduction in total protein, increase in the
amount of one or more of Keratin 1, Keratin 10 and Keratin 11, and
decrease in cytokine expression. According to some embodiments the
quality of the users skin is maintained through the premium
experience and conditioning phases as evidenced by no measurable
variation in the properties of visual dryness, trans-epidermal
water loss, skin hydration, elastic extension, elastic recovery,
firmness, total protein, the amount of one or more of Keratin 1,
Keratin 10 and Keratin 11, and cytokine expression as compared with
normal healthy control skin. It will be appreciated that the
indicators of skin quality are not limited to those identified
herein above and that other identifiers or indicators known in the
art may also be assessed to determine improvement of skin quality
according to the methods hereof.
Use of Biomarkers
[0094] One or more potential formulations of personal care
compositions may screened against one or more biomarkers to assess
efficacy of the composition with respect to skin improving benefit.
Graphical data shown in the appendix of figures herein provides
evidence regarding the results using the methods and compositions
described herein.
[0095] Also provided are methods for improving the quality of skin
that are evidenced by measurable improvement in one or more
biomarker indicators. According to such methods, in some
embodiments the steps include dispensing from a personal care
article a personal care composition that comprises a hydrophobic
benefit agent, applying the personal care composition to a user's
skin together with water, rinsing the personal care composition
from the user's skin, wherein a portion of the hydrophobic benefit
agent is deposited and remains on the user's skin after rinsing.
According to such embodiments, the steps further include repeating
the steps of applying and rinsing on at least a once daily basis
over a time interval of successive days, the time interval of use
sufficient to permit detection of measurable improvement in at
least one skin property selected from (i) reduction of visual
dryness, a reduction in trans-epidermal water loss, increased skin
hydration, increased elastic extension, increased elastic recovery,
increased firmness and (ii) reduction in total protein, an increase
in the amount of one or more of Keratin 1, Keratin 10 and Keratin
11, and a decrease in cytokine expression. In some such
embodiments, the composition comprises a lathering agent and
wherein the article operates to dispense the composition in
aliquots, and wherein the ratio of lathering agent to hydrophobic
benefit agent varies in successively dispensed aliquots of the
composition over the course of dispensing the article contents such
that the amount of hydrophobic benefit agent in two or more
successive aliquots is different.
[0096] According to the various embodiments, evidence of
improvement using biomarkers is determined using methods known in
the art. For example, one or more such measurable improvement can
include a reduction of visual dryness, a reduction in
trans-epidermal water loss, increased skin hydration, wherein
visual dryness is measured using corneometer and other known
devices and techniques. In another example a measurable improvement
is one or more of increased elastic extension, increased elastic
recovery, increased firmness, measured using a cutometer and other
known devices and techniques. In another example a measurable
improvement is one or more of reduction in total protein, increase
in the amount of one or more of Keratin 1, Keratin 10 and Keratin
11, decrease in one or more inflammatory cytokine expression, as
measured from tissue or cell samples that may be obtained using
known techniques such as skin strip methods described herein,
biopsy, or other method of sampling. Measurements of total protein,
specific proteins may be made using conventional techniques, and
may include one or more affinity agents and assays as described
herein and otherwise known in the art.
[0097] Also provided are methods for identifying a formulation
comprising a hydrophobic benefit agent useful for improving the
skin (stratum corneum barrier) in a human subject. Embodiments of
such methods include generating one or more negative skin profiles
for a human subject having dry or damaged skin; contacting the skin
of the human subject with a proposed rinse-off personal care
formulation by generating one or more test profiles and comparing
the one or more test profiles to the one or more negative profiles
and identifying the proposed formulation as effective if the test
profile is directionally shifted away from the negative reference
profile and shows at least one skin property selected from (i)
reduction of visual dryness, a reduction in trans-epidermal water
loss, increased skin hydration, increased elastic extension,
increased elastic recovery, increased firmness and (ii) reduction
in total protein, an increase in the amount of one or more of
Keratin 1, Keratin 10 and Keratin 11, and a decrease in cytokine
expression.
[0098] In one embodiment, the screening step comprises: (1) placing
potential formulations of personal care composition in contact with
skin or skin cells that exhibit need for improvement in terms of
exhibiting any one or more signs of dryness or aging, the contact
for a period of time sufficient to enable action on the skin tissue
or cell. Typically, the time of action will be commensurate with
the typical time of application of a rinse-off product as used
conventionally; (2) repeating the treatment in parallel with
control cells or tissue; (3) repeating the treatment in parallel
with one or more control compositions, including, for example,
water; (4) isolating samples from the skin or cells for analysis;
(5) performing proteomic analysis and/or transcriptomic analysis
and/or genomic analysis, partial or complete, for assessing the
effect of the test composition; and (6) comparing the results with
the controls.
Optimizing Compositions and Methods for Populations
[0099] It will be appreciated that the methods hereof are useful
for benefiting users from a variety of populations. Accordingly,
also provided are methods for developing personal care compositions
and regimens of treatment for members of various populations. The
methods involve understanding the preferences of the target
populations. For example, North American consumers are accustomed
to thicker personal care compositions and heavier skin feel than
consumers in China. Accordingly, when designing a premium
anti-aging body wash and methods of use, the personal care
compositions must comply with regional expectations balanced with
delivery of the consumer desired skin benefits. Thus, for example,
for one target population, the personal care composition lipid
profile varies from 25% to 55%, giving consumers not only improved
personal care composition aesthetics and in-use experience, but
optimal performance in terms of conditioning. For another target
population, personal care composition lipid profile varies from
10-15% lipid. Similar preferences exist with respect to personal
care composition texture, consistency, lather character and primary
benefit focus. For example, while some eastern consumers expect
personal care compositions that are of thinner consistency and
lighter skin feel, other consumers are more similar to American
consumers--expecting more from their personal care compositions,
enjoying thicker consistencies and are more open to heavier skin
feels. Thus, methods are provided for providing a range of personal
care compositions (a global menu) for the consumers in various
populations, such as populations that are defined
geographically.
[0100] The various embodiments include identifying a target
population and developing a population profile with respect to a
rinse-off personal care composition used for cleansing and
moisturizing comprising the steps of determining the population
preferences for maximum amount of hydrophobic benefit agent, and
determining the population preferences for lather volume, lather
texture, and lathering speed, composition thickness, color,
translucence, opalescence, and scent. Such embodiments further
include the steps of formulating a personal care composition
reflecting a population profile, wherein the composition comprises
varying ratios of a lathering agent to a hydrophobic benefit agent,
configuring a delivery article adapted to dispense the composition
in discrete aliquots of approximately equal volume, and adapted to
contain the composition so as to dispense the composition in phases
comprising at least a first phase comprising a first ratio of the
varying ratios of lathering agent to hydrophobic benefit agent, and
a second phase comprising a second ratio of the varying ratios of
lathering agent to hydrophobic benefit agent that is different than
the first ratio. In some such embodiments, the steps further
include manufacturing the composition for the target population;
and providing the composition in the delivery article. It will be
appreciated that the method may be repeated for a different target
population.
III. Treatment Examples
Example 1
Personal Care Composition Features and Benefits
TABLE-US-00001 [0101] Factors Benefits 1. Skin Enhancement
Minimizing lines Improving skin tone Helping skin look younger 2.
Rinsing/Clean Feel Not leaving skin greasy or coated Rinsing easily
from skin Leaving skin feeling clean 3. Moisturization Not leaving
skin dry/cracked Leaving skin soft/smooth Hydrating and locking in
Moisture 4. Scent Having a pleasant scent during use Having a
pleasant scent in bottle Leave long lasting scent on skin 5. Lather
Providing right lather amount Lathering quickly and easily
Providing rich, creamy lather
Example 2
Clinical Study: Evaluation of Skin Indicator Response
[0102] A study was undertaken to evaluate the response of a variety
of skin indicators using an array of different personal care
compositions and water. The study was 29 days in duration, with a 7
day interval of preconditioning, 21 days of treatment and 1
regression day. Skin was analyzed at various points from the
beginning through the end of the study period. The objective of the
study was to characterize the dry skin improvement profile of
several body wash prototypes and to generate samples to assess
treatment's effects on stratum corneum indicators (also referred to
as biomarkers).
[0103] Leg wash studies are used to evaluate the beneficial effects
of personal care products on dry leg skin. Leg wash studies are
designed to approximate consumer-relevant exposure levels, e.g.
washing frequency. The technique used in this study is a
modification of a published procedure (Ertel, et al, 1999).
[0104] The study was conducted over 29 consecutive days, including
a 7-day preconditioning phase, a 21-day treatment phase and 1 day
of regression. This randomized study employed an incomplete block
design in which 4 of the 5 treatments was evaluated on each
subject, 2 treatments on each leg.
[0105] After the 7-day preconditioning phase, subjects returned to
the test facility to have the skin on their lower legs evaluated by
an expert grader. Only subjects which exhibited sufficient dryness
on all of the treatment sites qualified to continue into the
treatment phase.
[0106] Technicians treated each qualified subjects' lower legs in a
controlled manner with the assigned treatments once daily for 21
days. Subjects' legs were visually evaluated for dryness and
redness at several pre and post-treatment times as outlined in the
following study schedule. Non-invasive instrumental measurements of
stratum corneum hydration (Corneometer 825), barrier function
(Dermalab TEWL (trans epidermal water loss)), and viscoelasticity
(Cutometer) were made on the treatment sites following visual
evaluations.
Preconditioning Phase Procedure
[0107] Prospective subjects were selected on the basis of their
ability to meet the inclusion and exclusion criteria on DCF 1 and
must have provided written informed consent. During
preconditioning, enrolled subjects used a bar of Olay.RTM. with no
exfoliating beads provided by the test facility in place of their
usual product(s) for bathing and showering. They continued to use
this product throughout their participation. Subjects also received
a set of instructions to be followed during the study.
Treatment Phase Procedure
[0108] Before initial grading on Study Day 8, test facility
personnel marked off the leg application areas [two 70 cm.sup.2
areas (7 cm across.times.10 cm down)] on the outer aspect of the
subjects' lower legs using a template and laboratory marking pen
(corner brackets are sufficient to delineate each area). Trained
clinical assistants treated each subject's legs according to the
procedure outlined in the Treatment Procedure. In general, the
following should be noted:
[0109] The "No Treatment" site (code A) was wetted initially,
rinsed, and dried per the normal wash procedure. During the
"product application" portion of the procedure, the site was timed
for the 90 sec. "residence" but did not have product or additional
water applied, nor underwent any of the physical manipulation
(i.e., rubbing with fingers or implement).
[0110] Clinical Assistants wore disposable gloves during wash
procedure, changed them between treatments and between
subjects.
[0111] Clinical Assistants verified the correct treatment sequence
and documented such before treating each subject.
[0112] The procedure was conducted once each day for 21 consecutive
days.
[0113] The body wash products were applied using puffs. Puffs were
pre-labeled with subject number and treatment code, and used
accordingly throughout the treatment phase.
[0114] The puff treatment procedure for all puffs was conducted
daily after all product treatments were completed on each subject
(except on the final day of treatment).
Product/Puff Preparation and Placement
[0115] The Sponsor provided puffs for use in application of body
washes. All of the puffs were treated with 9.3 ml of the
appropriate treatment code each day after treatment (except on the
final day of treatment.) according to the procedure outlined in the
Treatment/Puff Treatment Procedure. All body wash products were
dispensed at 0.7 ml (dose targeted at 10 .mu.l/cm.sup.2). Products
were mixed according to the procedures outlined in the Test Product
Mixing Procedure. Briefly Code C was prepared by weighing out 10 g
of product from individual bottles and then mixed. A sample of
unused Code C was transferred to a jar, sealed, and sent to the
Sponsor weekly for analysis. Two of the body wash products (codes B
& E) were swirled dual component products that are supplied in
a single container. A sufficient amount of each swirled product for
all subjects for one day was dispensed into a dosing container and
then stirred with a spatula until the product is well mixed. The
mixed product was drawn into syringes at the 0.7 ml dosage.
Evaluations
[0116] At each evaluation, subjects acclimated for a minimum of 30
minutes in a room with the environment maintained at 70.degree.
F..+-.2 and 30-45% relative humidity prior to visual grading and
non-invasive instrumental measurements being made on their
legs.
[0117] All evaluations were made in the controlled environment
described above. Instrumental measurements were made according to
procedures outlined in the Sponsor's instructions or published
guidelines. The same instruments and operators were used throughout
the study.
Visual Grading
[0118] Each subject's lower legs were visually evaluated by a
qualified grader for dryness and redness at baseline (Study Day 8,
prior to the first treatment) as a prerequisite for qualification
into the treatment phase.
[0119] The same grader was used throughout the study. Qualifying
subjects were graded at the following 9 additional times during the
course of the study:
[0120] Study Day 8--Baseline and approximately 3 hours post
treatment #1;
[0121] Study Day 10--approximately 3 hours post treatment #3;
[0122] Study Days 12 & 21--approximately 24 hours post
treatments #4 and #13 and approximately 3 hours post treatments #5
and #14;
[0123] Study Day 28--approximately 3 hours post treatment #21;
[0124] Study Day 29--approximately 24 hours post treatment #21;
Corneometer Skin Capacitance
[0125] Non-invasive skin capacitance measurements were taken in
duplicate on each site of the subjects' legs after every visual
grading during the study using a Corneometer CM825 instrument. Data
was recorded electronically using the Sponsor's direct data entry
and data capture programs. The same instrument and operator were
used throughout the study
Trans-Epidermal Water Loss (TEWL)
[0126] TEWL was measured with the DermaLab.RTM. Evaporimeter
equipped with dual probes. Each measurement consists of readings
collected for 60 seconds with the mean of the last 20 seconds
recorded from both probes (Channel A and Channel B). One
measurement was taken at each treatment site and recorded on DCF 2
(DermaLab TEWL Measurements Log) on each evaluation day for both
probes as Channel A and Channel B, respectively. The same
instrument and operator were used throughout the study. These
measurements were made according to procedures outlined in the
Sponsor's instrument SOP or published guidelines. Measurements were
taken 8 times during the course of the study;
[0127] Study Day 8--Baseline;
[0128] Study Day 10--approximately 3 hours post treatment #3;
[0129] Study Day 12--approximately 24 hours post treatment #4 and
approximately 3 hours post treatment #5;
[0130] Study Day 21--approximately 24 hours post treatment #13 and
approximately 3 hours post treatment #14;
[0131] Study Day 28--approximately 3 hours post treatment #21;
[0132] Study Day 29--approximately 24 hours post treatment #21.
Cutometer Measurements of Elasticity
[0133] Non-invasive skin viscoelasticity measurements were taken
with a Cutometer SEM 575 equipped with an 8 mm probe. Data was
recorded electronically using the data capture program accompanying
the instrument. Two Cutometer instruments were used due to the
number of subjects enrolled in the study. Subjects were assigned to
the same instrument throughout the study on the basis of there
subject number. The same instruments and operators were used
throughout the study. These measurements were made according to the
procedures outlined in the Sponsor's instrument SOPs or published
guidelines. Measurements were taken 5 times during the course of
the study;
[0134] Study Day 8--Baseline;
[0135] Study Day 10--approximately 1 hour post treatment #3;
[0136] Study Day 12--approximately 1 hour post treatment #5;
[0137] Study Day 21--approximately 1 hour post treatment #14;
[0138] Study Day 28--approximately 1 hour post treatment #21;
Imaging
[0139] Digital images were taken of full length, lower legs. Both
left and right outer calves were taken for each subject. Images
were captured with under both parallel and cross polarized
lighting.
[0140] The leg imaging system (LIS) uses a combination of two
cameras to capture both study images and repositioning images.
Study images are captured with a Fuji F2 Pro digital SLR camera
with a 60 mm Nikor lens. Repositioning images are captured with a
SuperCircuits PC-33C CCD video camera with a Computar 8.5-40 mm
f1.3 CS-mount lens. Using proprietary imaging software (UltraGrab),
both the study and repositioning digital images are captured and
stored on a portable personal computer while simultaneously being
backed-up to an external USB hard drive or another networked
workstation designated for backup file storage. Image illumination
is provided by 1 JTL Versalight D 1000 flash unit with a color
temperature around 5600 K provides the illumination for the study
images. The camera and flash unit are mounted onto the imaging
platform of the LIS, which also incorporates a fixed color chart
used for the "on-the-fly" color calibration and color correction of
study images. A changeable filter holder system is attached in
front of the imaging camera which allows for the selection of the
correct combination of filter alignment to capture both parallel
and cross polarized images.
[0141] To capture an image each subject sat at the end of the
imaging system with the leg positioning frame. Two leg rests are
positioned (one each near the ankle and knee) such that the subject
can easily place either of their outer legs (left or right) against
each rest allowing the leg to be positioned such that it was in the
center of the imaging area. The system was placed in a dedicated
room at least 8.times.8 square feet or a curtained off area of a
larger room. One electric circuit and wall outlet provided power to
the image capturing system using one outlet power strip and a UPS
power backup system. Measurements were taken 6 times during the
course of the study;
[0142] Study Day 8--Baseline;
[0143] Study Day 10--approximately 3 hours post treatment #3;
[0144] Study Day 12--approximately 3 hours post treatment #5;
[0145] Study Day 21--approximately 3 hours post treatment #14;
[0146] Study Day 28--approximately 3 hours post treatment #21;
[0147] Study Day 29--approximately 24 hours post treatment #21
Tape Stripping
[0148] Tape stripping was performed throughout the study for dry
skin sampling. D-Squames was always collected following all other
evaluations scheduled to take place at the same time point.
Clinical assistants wore disposable gloves while collecting
D-Squames. At each collection time point a series of 6 D-Squames
were used to sample the same spot within the treatment area. The
technician used forceps to place a D-Squames sampling disc toward
the edges of each site (away from the region being evaluated by
other instrumentation) and applied pressure using the D-Squames
disc applicator (push the D-Squames applicator down and then
release). The technician removed the sampling disc with forceps and
placed the disc into a pre-labeled 12 well culture plate. Each
subject had two 12 well culture plates for sampling disc
collection; one for each leg. Wells 1-6 of each plate were for the
site nearest the knee, while wells 7-12 were used for the site
nearest the ankle. D-Squames sample plates were placed in shipping
boxes with labels corresponding to the subjects' samples enclosed
and placed in a cooler with dry ice. The samples were couriered to
the Sponsor's designee once all samples for the day have been
collected. D-Squames was collected 4 times at the following time
points:
[0149] Study Day 8--Baseline;
[0150] Study Day 12--approximately 24 hours post treatment #4;
[0151] Study Day 21--approximately 24 hours post treatment #13;
[0152] Study Day 29--approximately 24 hours post treatment #21;
[0153] References: Ertel, K. D., Neumann, P. B., Hartwig, P. M.,
Rains, G. Y., and Keswick, B. H., Leg Wash protocol to assess the
skin moisturization potential of personal cleansing products. Int.
J. Cosmet. Sci. 21: 383-397 (1999); Fitzpatrick, T. B., The
validity and practicality of sun-reactive skin types I through VI.
Arch. Dermatology, 124: 869-871 (1988).
Cytokine, Keratin and Soluble Protein Analyses
[0154] Samples were collected for analysis using D-Squame Tape
Strips. D-Squame tapes were applied on the site of interest (Scalp,
Leg, Face, Underarm, Forearm) with constant pressure/time, and
removed to collect samples of the stratum corneum. Alternative
sampling methods using Sebutape and Cup Scrubs can also be
accommodated. Tape strip samples were placed in a 12 well plate
under frozen conditions (-80.degree. C.) until analysis. Tape
samples were extracted for analysis by placing the tapes inside a
polypropylene tube (2 ml) and adding extraction buffer (PBS, pH
7.4, 0.04% SDS, Protease Inhibitors) and sonicating for 30 min at
4.degree. C. The samples were then centrifuged to remove any
insoluble material and the supernatant is transferred into two deep
well plates.
[0155] Supernatant samples for Cytokine/keratin analysis were
fortified with 2.0% Bovine Serum Albumin (BSA) before freezing. The
remaining supernatants were transferred to a second deep well plate
for Soluble Protein analysis. Samples were analyzed for Cytokines
(IL-1.sup..alpha., IL-1ra, IL-8) and Skin analytes (Human Serum
Albumin, Keratin 1, 10, 11) using validated Millipore.TM. Multiplex
immunoassay methods with a Bio-Plex Protein Array Reader system.
Soluble protein determinations of the supernatants were performed
using the Pierce BCA.TM. Protein assay kit with the aliquot
designated for soluble protein using a validated method. The values
obtained for soluble proteins were used to normalize the Cytokine
and Keratin data. Cytokine and Skin analyte concentrations were
reported as pg/mL or ng/mL and the soluble proteins were reported
as .mu.g/mL. Methods have been validated to demonstrate accuracy,
precision, bench top stability, freeze thaw stability, short and
long term storage stability of the extracts. Extraction efficiency
of the methods have been shown to be >70% and reproducible with
a single extraction of the tape strips.
TABLE-US-00002 Expected Biomarker Outcome for Endpoints Biomarkers
Rationale Benefit Benefit Stratum Corneum Total Protein More
cohesiveness .dwnarw. Strengthening Cohesiveness in healthy stratum
strateum corneum corneum. Less Improving skin cohesiveness in
barrier. damaged skin. Differentiation Keratin 1, 10 Higher .uparw.
Improving skin 11 differentiation in health normal/healthy skin.
Irritation/ Cytokines Elevated in .dwnarw. Reducing skin
Inflammation IL-1.sup..alpha., IL-1ra, diseased/irritated
irritation. IL-8 skin.
[0156] Keratin 1, 10, 11 Results: The results of Keratin 1, 10, 11
were normalized to total soluble protein. The results are plotted
below. A significant increase of normalized Keratin 1, 10 11 as
compared to water control at day 7 (100% increase) was observed.
The normalized Keratin 1, 10, 11 level is further increased to 150%
vs. water at day 14 and 22. The data is consistent with literature
reports that dry skin dry skin is a condition characterized by
hyperproliferation and decreased differentiation. (See Engeke,
Jensen, Ekanayake-Mudiyanselage and Proksch "Effects of xerosis and
aging on epidermal proliferation and differentiation", Br. J.
Dermatology, 137: 219-225 (1997).)
[0157] Total Protein Results: The results of the total protein from
six consecutive tape strips as measured by SquameScan 850 were
obtained. Treatment according to the variable lipid method showed
improved cohesiveness at day 7.0, 14.0, and 22.0 measurement points
vs. water control.
Example 3
Improvements in Skin Elasticity and Cohesion from a Petrolatum
Depositing Bodywash
[0158] Aging skin is frequently characterized by an increase in
dryness and subsequent flaking, as well as a general loss of
elasticity. Daily activities such as bathing can exacerbate some of
these issues, particularly if skin drying products such as soap are
used. While moisturizing bodywashes are readily available in the
market, few purport to make improvements in skin condition beyond
skin dryness.
Objective
[0159] In an effort to improve the overall condition, health and
viability of aging skin, we have developed a petrolatum depositing
bodywash that is aesthetically pleasing to use and will deliver
benefits beyond typical moisturization.
Method
[0160] Standard Leg Controlled-Application Test (LCAT) methodology
was used. Treatment was conducted over a 3 week period; women with
dry leg skin had their legs washed once daily with the randomly
assigned body wash products and water alone treatment as control
(.about.50 per treatment). Typical moisturization measures were
taken, including expert dryness grading, corneometer and TEWL.
[0161] Non-invasive skin viscoelasticity measurements were taken
with a Cutometer SEM 575. Tape-strip analysis of biomarkers was
also conducted to gain insight into how the product affected the
skin health and integrity. Six successive D-squame tapes were taken
from virgin areas within each treatment site at baseline and at the
end of each treatment week. The strips were then analyzed for total
protein with a SquameScan 850 as a measure of stratum corneum
cohesiveness. The method is based on a well established D-Squame
tape strip procedure. Tape strip samples are subsequently extracted
in appropriate buffer solution by sonication followed by
centrifugation. The resulting supernatant samples are analyzed for
relevant skin biomarkers (total proteins, cytokines, and keratin)
by validated analytical methods (Multiplex ELISA and LC/MS/MS).
Results
[0162] Results indicate that the body wash delivers significant
improvements in all standard moisturization measures (dryness
grades, corneometer hydration, and TEWL). For the first time in the
rinse-off context, the results show significant improvement in skin
elasticity as compared to the water treatment control. The total
protein results further reveal significant improvement in stratum
corneum cohesiveness. Taken together, these findings support the
conclusion that the petrolatum depositing bodywash improves the
overall condition of skin.
Example 4
Test of Inventive Composition Example A
[0163] The following test of Inventive Composition Example A
further demonstrates the benefits of articles, methods, and/or
compositions used in accordance with the present invention.
[0164] Step A) Preconditioning Phase Procedure [0165] During
preconditioning, enrolled subjects used a bar of Olay.RTM. with no
exfoliating beads provided by the test facility in place of their
usual product(s) for bathing and showering. They continued to use
this product throughout their participation.
[0166] Step B). Treatment Phase Procedure [0167] Before initial
grading on Study Day 8, test facility personnel marked off the leg
application areas [two 70 cm.sup.2 areas (7 cm across.times.10 cm
down)] on the outer aspect of the subjects' lower legs using a
template and laboratory marking pen (corner brackets are sufficient
to delineate each area). Trained clinical assistants treated each
subject's legs according to the procedure outlined in the Treatment
Procedure. In general, the following should be noted:
[0168] Treatment Procedure: [0169] Begin with the LEFT leg: [0170]
1. A Clinical Assistant wets the treatment area for 5 seconds with
95-100.degree. F. running tap water. [0171] 2. The Clinical
Assistant applies the test product assigned to that site, using the
appropriate procedure as follows: [0172] "No Treatment" (water
only): [0173] No product is applied to this site. Wait
approximately 10 seconds, then continue as below with Step #3.
[0174] [The "No Treatment" site is wetted initially (#1), rinsed
(#5), and dried (#6) per the normal wash procedure. The site is
timed for the 90 sec. "residence" (#3) but does not have product
applied nor undergo any of the physical manipulation (i.e., rubbing
with fingers or implement).] [0175] Body Wash Products: [0176]
While holding the appropriately labeled puff in one hand, wet the
puff for 5 seconds under the running tap, then allow the excess
water to drain off the puff for 10 seconds without shaking or
squeezing the puff. [0177] Dispense 0.7 ml of body wash product
from the syringe onto the center of the treatment area. [0178]
Place the wet puff over the dispensed product and gently rub the
puff back and forth within the appropriate site for 10 seconds.
[0179] 3. The lather (or water only) remains on the application
site for 90 seconds. [0180] 4. When the residence time for a
particular application site has expired, the Clinical Assistant
will rinse the site for 15 seconds under a running tap, taking care
not to rinse the adjacent sites. [0181] 5. After the application
area has been rinsed, the Clinical Assistant gently pats the area
dry with a disposable paper towel. [0182] 6. Using the appropriate
treatments, this entire procedure (#1-5) is repeated on the lower
site on the left leg before conducting the entire procedure (#1-5)
on the right leg. [0183] Puff Treatment Procedure [0184] 1. While
holding the appropriately labeled puff in one hand, wet the puff
for 5 seconds under the running tap, then allow the excess water to
drain off the puff for 10 seconds without shaking or squeezing the
puff. [0185] 2. Dispense 9.3 ml of appropriate body wash product
onto the puff in a broad circular pattern. [0186] 3. Hold puff in
one hand. Squeeze puff until you just feel the core. Do 10
rotations forward alternating hands, then repeat in the opposite
direction for 10 rotations alternating hands, for a total of 20
rotations [0187] 4. Following the wash, while holding the puff in
one hand, rinse the puff for 20 seconds under the running tap, then
allow the excess water to drain off then hang to dry.
[0188] Step C). Evaluations [0189] At each evaluation, subjects
were acclimated for a minimum of 30 minutes in a room with the
environment maintained at 70.degree. F..+-.2 and 30-45% relative
humidity prior to visual grading and non-invasive instrumental
measurements being made on their legs. All evaluations were made in
the controlled environment described above. [0190] 1. Visual
Grading: [0191] Each subject's lower legs were visually evaluated
by a qualified grader for dryness at baseline (Study Day 8, prior
to the first treatment) as a prerequisite for qualification into
the treatment phase. The minimum entrance criteria are >2.5 in
initial dryness at the start of the treatment phase (Step B).
[0192] 2. Cutometer Measurement of Skin Elasticity [0193] The first
cutometer measurement was performed before the initial product
treatment phase as baseline. The second set of cutometer
measurement was made at 90 mins after the seventh product
treatment. All non-invasive skin viscoelasticity measurements were
taken with a Cutometer.RTM. SEM 575 (Courage & Khazaka,
Electronic GmbH, Koeln, Germany) equipped with an 8 mm probe at 200
mbar pressure. The same instruments and operators were used
throughout the study. The following elastic parameters are
typically used: elastic extension U.sub.e, elastic recovery
U.sub.r, and elasticity R.sub.7. [0194] The cutometer's operating
principles and applications are described in reference below: A. O,
Barel, W. Courage, P. Clarys; Suction Method for Measurement of
Skin Mechanical Properties, the Cutometer.RTM.; Handbook of
Non-Invasive Methods and the Skin, J. Serup G. B. E. Jemec, 1995;
335-340. [0195] 3. Tape Stripping Procedure and Total Stratum
Corneum Protein Measurement [0196] A first set of tape stripping
was performed before the initial product treatment phase as
baseline. The second set of tape stripping was performed at 24
hours after the sixth product treatment. Clinical assistants wore
disposable gloves while collecting D-Squames.RTM.. At each
collection time point a series of 6 D-Squames were used to sample
the same spot within the treatment area. The technician used
forceps to place a D-Squame.RTM. sampling disc toward the edges of
each site (away from the region being evaluated by other
instrumentation) and apply pressure using the D-Squame disc
applicator (push the D-Squame applicator down and then release).
The technician then removed the sampling disc with forceps and
placed the disc into a pre-labeled 12 well culture plate. Each
subject had two 12 well culture plates for sampling disc
collection; one for each leg. [0197] The total stratum corneum
proteins are analyzed by infrared densitometry (model number
SquameScan.RTM. 850A, Heiland Electronic, Wetzlar, Germany). The
results are reported as protein absorptance at 850 nm. The method
is described in reference: R. Voegeli, J. Heiland, S. Doppler, A.
V. Rawlings and T. Schreier; Efficient and simple quantification of
stratum corneum proteins on tape strippings by infrared
densitometry, Skin Research and Technology 2007; 13; 242-251.
[0198] Step D). Calculation of Skin Elasticity Improvement Index
and Stratum Corneum Cohesiveness Improvement Index [0199] 1)
Calculation of Skin Elasticity Improvement Index [0200] a) Elastic
Extension (U.sub.e) Improvement Index is calculated as:
[0200]
[(U.sub.e).sup.P.sub.end-(U.sub.e).sup.C.sub.end]/(U.sub.e).sup.C-
.sub.end*100-[(U.sub.e).sup.P.sub.ini-(U.sub.e).sup.C.sub.ini]/(U.sub.e).s-
up.C.sub.ini*100 [0201] wherein [0202] (U.sub.e).sup.C.sub.ini is
the initial elastic extension parameter at the beginning of the
water control leg; [0203] (U.sub.e).sup.P.sub.ini is the initial
elastic extension parameter at the beginning of the test product
leg; [0204] (U.sub.e).sup.C.sub.end is the final elastic extension
parameter at the end of the water control leg; [0205]
(U.sub.e).sup.P.sub.end is the final elastic extension parameter at
the end of the test product leg. [0206] b) Elastic Recovery
(U.sub.r) Improvement Index is calculated as:
[0206]
[(U.sub.r).sup.P.sub.end-(U.sub.r).sup.C.sub.end]/(U.sub.r).sup.C-
.sub.end*100-[(U.sub.r).sup.P.sub.ini-(U.sub.r).sup.C.sub.ini]/(U.sub.r).s-
up.C.sub.ini*100 wherein [0207] (U.sub.r).sup.C.sub.ini is the
initial elastic recovery parameter at the beginning of the water
control leg; [0208] (U.sub.r).sup.P.sub.ini is the initial elastic
recovery at the beginning of the test product leg; [0209]
(U.sub.r).sup.C.sub.end is the final elastic recovery at the end of
the water control leg; [0210] (U.sub.r).sup.P.sub.end is the final
elastic recovery at the end of the test product leg. [0211] c)
Elasticity (R.sub.7) Improvement Index is calculated as:
[0211]
[(R.sub.7).sup.P.sub.end-(R.sub.7).sup.C.sub.end]/(R.sub.7).sup.C-
.sub.end*100-[(R.sub.7).sup.P.sub.ini-(R.sub.7).sup.C.sub.ini]/(R.sub.7).s-
up.C.sub.ini*100 [0212] wherein [0213] (R.sub.7).sup.C.sub.ini is
the initial elasticity at the beginning of the water control leg;
[0214] (R.sub.7).sup.P.sub.ini is the initial elasticity at the
beginning of the test product leg; [0215] (R.sub.7r).sup.C.sub.end
is the final elasticity at the end of the water control leg; [0216]
(R.sub.7).sup.P.sub.end is the final elasticity at the end of the
test product leg.
[0217] 2) Calculation of Stratum Corneum Cohesiveness Improvement
Index [0218] a) Stratum Corneum Cohesiveness Improvement Index is
calculated as:
[0218]
[(Protein).sup.C.sub.end-(Protein).sup.P.sub.end]/(Protein).sup.C-
.sub.end*100-[(Protein).sup.C.sub.ini-(Protein).sup.P.sub.ini]/(Protein).s-
up.C.sub.ini*100 wherein [0219] (Protein).sup.C.sub.ini is the sum
of initial protein absorption of tape 1 to tape 6 at the beginning
of the water control leg; [0220] (Protein .sub.e).sup.P.sub.ini is
the sum of initial protein absorption of tape 1 to tape 6 at the
beginning of the test product leg; [0221] (Protein).sup.C.sub.end
the sum of final protein absorption of tape 1 to tape 6 at the end
of the water control leg; [0222] (Protein).sup.P.sub.end is the sum
of final protein absorption of tape 1 to tape 6 at the end of the
test product leg.
[0223] 3) Calculation of Keratin 1, 10, 11 Improvement Index [0224]
Keratin 1, 10, 11 Improvement Index is calculated as:
[0224]
[(Keratin).sup.C.sub.end-(Keratin).sup.P.sub.end]/(Keratin).sup.C-
.sub.end*100-[(Keratin).sup.C.sub.ini-(Keratin).sup.P.sub.ini]/(Keratin).s-
up.C.sub.ini*100 wherein [0225] (Keratin).sup.C.sub.ini is the
initial Keratin 1, 10, 11 normalized to total soluble protein at
the beginning of the water control leg; [0226]
(Keratin).sup.P.sub.ini is the initial Keratin 1, 10, 11 normalized
to total soluble protein at the beginning of the test product leg;
[0227] (Keratin).sup.C.sub.end is the final Keratin 1, 10, 11
normalized to total soluble protein at the end of the water control
leg; [0228] (Keratin).sup.P.sub.end is the final Keratin 1, 10, 11
normalized to total soluble protein at end of the test product leg.
Results of Inventive Composition Example A vs. Water Control
TABLE-US-00003 [0228] Inventive p value Example A (base size n =
50) a) Skin Elastic Extension (Ue) 16 p = 0.003 Improvement Index
b) Skin Elastic Recovery (Ur) 21 p = 0.0004 Improvement Index c)
Skin Elasticity (R7) Improvement 4 p = 0.05 Index d) Stratum
Corneum Cohesiveness 23 p < 0.0001 Improvement Index e) Keratin
Improvement Index 172 p < 0.0001
IV. Personal Care Articles and Personal Care Compositions
[0229] The present invention contemplates use of personal care
compositions and articles comprising personal care compositions. In
some embodiments, personal care articles for dispensing a personal
care compositions comprises a single chamber package and a personal
care article. It will be appreciated that other embodiments of
personal care articles and personal care compositions are
contemplated for use according to the invention, and the following
descriptions regarding possible embodiments is non-limiting.
[0230] Single chamber package comprises a dispensing orifice, a
first zone proximal to the dispensing orifice, a second zone medial
to the dispensing orifice, and a third zone distal to the
dispensing orifice. The personal care article comprises a first
personal care composition, a second personal care composition and a
third personal care composition. The first personal care
composition is substantially within the first zone and comprises a
first concentration of a hydrophobic benefit material. The second
personal care composition is substantially within the second zone
and comprises a second concentration of a hydrophobic benefit
material. The third personal care composition is substantially
within the third zone and comprises a third concentration of a
hydrophobic benefit material. The second concentration is greater
than the first concentration and the third concentration of the
hydrophobic benefit material. The first personal care composition
is capable of being substantially dispensed prior to the second
personal care composition and the third personal care composition.
The second personal care composition is capable of being
substantially dispensed prior to the third personal care
composition.
[0231] The personal care article used in accordance with the
present invention, in most embodiments, is statically stable. In
most embodiments, the personal care article used in accordance with
the present invention is dynamically stable according to the
Dynamic Stability Shipping Method disclosed in the Test Methods
below.
[0232] In some embodiments, the first personal care composition is
in physical contact with the second personal care composition
within the single chamber package. The second personal care
composition, in another embodiment, is in physical contact with the
third personal care composition within the single chamber
package.
[0233] In one embodiment, the first zone, second zone and/or third
zone of the present invention comprises from about 10% to about
70%, by volume, of the package. The first zone, second zone and/or
third zone of the present invention comprise from about 10% to
about 60%, from about 10% to about 50%, from about 10% to about
40%, from about 10% to about 30%, from about 10% to about 20%, by
volume, of the package. In other embodiments, the first zone,
second zone and/or third zone of the present invention comprises
from about 20% to about 70%, from about 20% to about 60%, from
about 20% to about 50%, from about 20% to about 40%, from about 20%
to about 30%, by volume, of the package. In other embodiments, the
first second and/or third zone of the present invention comprises
from about 30% to about 70%, from about 30% to about 60%, from
about 30% to about 50%, from about 30% to about 40%, by volume, of
the package.
[0234] The personal care article used in accordance with the
present invention comprises a single chamber package can contain
any number or zones and compositions, such as for example, four
zones and four compositions, five zones and five compositions, six
zones and six compositions, twelve zones and twelve compositions,
and so on. Each of these compositions is capable of substantially
dispensing prior to the composition before it in a substantially
sequential manner. For example, the fourth personal care
composition substantially within the fourth zone is capable of
dispensing prior to the fifth personal care composition within the
fifth zone, etc. In some embodiments, a dual-chamber delivery
article having side-by-side chambers with a control valve or cap to
regulate dispensing from each chamber may be used. In other
embodiments, a dual-chamber delivery article with end-to-end
chambers may be selected, where product is dispensed separately
from each chamber. In yet other embodiments, a kit of two or more
separate bottles that may nest or stack or otherwise inter-fit may
be used for dispensing the personal care compositions.
[0235] The personal care article used in accordance with the
present invention is filled to comprise a headspace. In some
embodiments, the personal care article used in accordance with the
present invention comprises a headspace that is less than 10%, is
less than 6%, less than 5% and less than 4%. In other embodiments,
the personal care article used in accordance with the present
invention comprises a headspace that is less than 3%, less than 2%
and less than 1%.
[0236] In another aspect, each personal care composition comprises
a dye, colorant or the like, such that each personal care
composition is a distinct color or hue. For example, the first
personal care composition is a yellow color, the second personal
care composition is an orange color and the third personal care
composition is a purple color.
[0237] The amount or concentration of hydrophobic benefit materials
in the first personal care composition, second personal care
composition and third personal care composition are usually
formulated, by weight of the composition, at less than about 75%,
less than about 65%, less than about 60%, less than about 60%, less
than about 55%, less than about 50%, less than about 45%, less than
about 40%, less than about 35%, less than about 30%, less than
about 25%, less than about 20%, less than about 10%, less than
about 5%, less than about 4%, less than about 3%, less than about
2%, less than about 1%. The first personal care composition, second
personal care composition and third personal care composition
comprises from about 1.0% to about 60%, from about 5% to about 60%,
from about 10% to about 50%, from about 20% to about 45%, by weight
of the personal care composition, of a hydrophobic benefit
material.
[0238] In some embodiments, the first concentration can comprise
from about 10% to less than about 50% or, from about 10% to about
40%, by weight of the first personal care composition. The first
concentration of hydrophobic material, in other embodiments,
comprise from about 15% to less than 45% or 15% to less than 35% by
weight of the first personal care composition, of hydrophobic
benefit material. The first concentration, in some embodiments,
comprise from about 20% to about 40% and from about 25% to about
40%, by weight of the first personal care composition.
[0239] In some embodiments, the second concentration comprises from
greater than 30% to about 70%, greater than about 35% to about 65%,
by weight of the second personal care composition, of hydrophobic
benefit material. In another embodiment, the second concentration
comprises from about 40 to about 60% and about 55% by weight of the
second personal care composition.
[0240] In some embodiments, the third concentration can comprise
from about 10% to less than about 50% or, from about 10% to about
40%, by weight of the third personal care composition. The third
concentration of hydrophobic material, in other embodiments,
comprise from about 15% to less than 45% or 15% to less than 35% by
weight of the third personal care composition, of hydrophobic
benefit material. The third concentration, in some embodiments,
comprise from about 20% to about 40% and from about 25% to about
40%, by weight of the third personal care composition.
[0241] In one embodiment, the first personal care composition,
second personal care composition and third personal care
composition used in accordance with the present invention are
multi-phase compositions and comprise one of more phases or one or
more of the components described in the phases below:
[0242] The personal care compositions used in accordance with the
present invention comprise a benefit phase or benefit phase
components. The benefit phase in the present invention, in most
embodiments, is anhydrous and is substantially free of water. In
some embodiments, the benefit phase is substantially free or free
of surfactant.
[0243] Hydrophobic benefit materials suitable for use in the
present invention typically have a Vaughan Solubility Parameter of
from about 5 (cal/cm.sup.3).sup.1/2 to about 15
(cal/cm.sup.3).sup.1/2, as defined by Vaughan in Cosmetics and
Toiletries, Vol. 103. The Vaughan Solubility Parameter (VSP) as
used herein is a parameter used to define the solubility of
hydrophobic materials. Vaughan Solubility parameters are well known
in the various chemical and formulation arts and typically have a
range of from 5 to 25. Non-limiting examples of hydrophobic benefit
materials having VSP values ranging from about 5 to about 15
include the following: Cyclomethicone 5.92, Squalene 6.03,
Petrolatum 7.33, Isopropyl Palmitate 7.78, Isopropyl Myristate
8.02, Castor Oil 8.90, Cholesterol 9.55, as reported in Solubility,
Effects in Product, Package, Penetration and Preservation, C. D.
Vaughan, Cosmetics and Toiletries, Vol. 103, October 1988.
[0244] The hydrophobic benefit materials for use in the benefit
phase of the composition have a preferred rheology profile as
defined by Consistency value (k) and Shear Index (n). The term
"Consistency value" or "k" as used herein is a measure of lipid
viscosity and is used in combination with Shear Index, to define
viscosity for materials whose viscosity is a function of shear. The
measurements are made at 35.degree. C. and the units are poise
(equal to 100 cps). The term "Shear Index" or "n" as used herein is
a measure of lipid viscosity and is used in combination with
Consistency value, to define viscosity for materials whose
viscosity is a function of shear. The measurements are made at
35.degree. C. and the units are dimensionless. Consistency value
(k) and Shear Index (n) are more fully described in the Test
Methods below. Preferred Consistency value ranges are 1-10,000
poise (1/sec).sup.n-1, typically 10-2000 poise (1/sec).sup.n-1 and
more typically 50-1000 poise (1/sec).sup.n-1. Shear Index ranges
are 0.1-0.8, typically 0.1-0.5 and more typically 0.20-0.4. These
preferred rheological properties are especially useful in providing
the personal cleansing compositions with improved deposition of
benefit agents on skin.
[0245] In one embodiment, the benefit phase is comprised of the
hydrophobic benefit materials selected from the group consisting of
petrolatum, lanolin, derivatives of lanolin (e.g. lanolin oil,
isopropyl lanolate, acetylated lanolin, acetylated lanolin
alcohols, lanolin alcohol linoleate, lanolin alcohol riconoleate)
hydrocarbon oils (e.g. mineral oil) natural and synthetic waxes
(e.g. micro-crystalline waxes, paraffins, ozokerite, lanolin wax,
lanolin alcohols, lanolin fatty acids, polyethylene, polybutene,
polydecene, pentahydrosqualene) volatile or non-volatile
organosiloxanes and their derivatives (e.g. dimethicones,
cyclomethicones, alkyl siloxanes, polymethylsiloxanes,
methylphenylpolysiloxanes), natural and synthetic triglycerides
(e.g. castor oil, soy bean oil, sunflower seed oil, maleated soy
bean oil, safflower oil, cotton seed oil, corn oil, walnut oil,
peanut oil, olive oil, cod liver oil, almond oil, avocado oil, palm
oil, sesame oil) and combinations thereof. In one aspect, at least
about 50% by weight of the hydrophobic benefit materials are
selected from the groups of petrolatum, mineral oil, paraffins,
polyethylene, polybutene, polydecene, dimethicones, alkyl
siloxanes, cyclomethicones, lanolin, lanolin oil, lanolin wax. In
one embodiment, the remainder of the hydrophobic benefit material
is selected from: isopropyl palmitate, cetyl riconoleate, octyl
isononanoate, octyl palmitate, isocetyl stearate, hydroxylated milk
glyceride and combinations thereof. The benefit phase of the
personal care composition, in some embodiments, comprises a
combination of petrolatum and mineral oil.
[0246] In some embodiments, the personal care composition used in
accordance with the present invention comprises a surfactant phase.
The personal care composition typically comprises from about 1% to
about 100%, by weight of the composition; from about 5% to about
85%; by weight of the composition, from about 10% to 80%, by weight
of the composition; from about 20 to 70%, by weight of the
composition; from about 25% to 60%, by weight of the composition,
from about 30% to about 50%, by weight of the composition, of a
surfactant phase.
[0247] In some embodiments, the surfactant phase comprises a
structured domain that is comprised of a mixture of surfactants.
The presence of structured domain enables the incorporation of high
levels of hydrophobic benefit materials in a separate phase which
is not emulsified within composition. In one aspect, the structured
domain in the composition is characterized as, or is, an opaque
structured domain. In one aspect, the opaque structured domain is
characterized as, or is, a lamellar phase. The lamellar phase
produces a lamellar gel network. The lamellar phase provides
resistance to shear, adequate yield to suspend particles and
droplets and at the same time provides long term stability, since
it is thermodynamically stable. The lamellar phase tends to have a
higher viscosity thus minimizing the need for viscosity
modifiers.
[0248] In one aspect, the surfactant phase comprises a domain that
is comprised of a mixture of surfactants and is a micellar phase. A
micellar phase is optically isotropic. Micelles are approximately
spherical in shape. Other shapes such as ellipsoids, cylinders, and
bilayers are also possible. In one aspect, the micellar phase is
structured to enhance viscosity and to suspend particles. This can
be accomplished using viscosity modifiers such as those defined
below as water structurants.
[0249] In some embodiments, the surfactant phase comprises a
surfactant component which comprises of a mixture of surfactants
including lathering surfactants or a mixture of lathering
surfactants. The surfactant phase comprises surfactants suitable
for application to the mammalian skin or hair and is compatible
with water and the other ingredients of the composition used in
accordance with the present invention. These surfactants include
anionic, nonionic, cationic, zwitterionic, amphoteric, soap, or
combinations thereof. Typically, anionic surfactant comprises at
least 40% of the surfactant component. The personal care
composition, in some embodiments, comprises the surfactant
component at concentrations ranging from about 2% to about 40%,
from about 4% to about 25%, about 1% to about 21%, about 3 to 15%,
by weight of the composition, of the surfactant component.
[0250] Suitable surfactants are described in McCutcheon's,
Detergents and Emulsifiers, North American edition (1986),
published by allured Publishing Corporation; and McCutcheon's,
Functional Materials, North American Edition (1992); and in U.S.
Pat. No. 3,929,678 issued to Laughlin, et al on Dec. 30, 1975.
[0251] Preferred linear anionic surfactants for use in the
surfactant phase of the personal care composition include ammonium
lauryl sulfate, ammonium laureth sulfate, sodium lauryl sulfate,
sodium laureth sulfate, potassium laureth sulfate, sodium lauryl
sarcosinate, sodium lauroyl sarcosinate, lauryl sarcosine, cocoyl
sarcosine, ammonium cocoyl sulfate, potassium lauryl sulfate, and
combinations thereof.
[0252] Branched anionic surfactants and monomethyl branched anionic
surfactants suitable for the present invention are described in a
commonly owned U.S. Publication No. 60/680,149 entitled "Structured
Multi-phased Personal Cleansing Compositions Comprising Branched
Anionic Surfactants" filed on May 12, 2005 by Smith, et al.
Branched anionic surfactants include but are not limited to the
following surfactants: sodium trideceth sulfate, sodium tridecyl
sulfate, sodium C.sub.12-13 alkyl sulfate, and C.sub.12-13 pareth
sulfate and sodium C.sub.12-13 pareth-n sulfate.
[0253] In one aspect of the personal care compositions used in
accordance with the present invention comprise an amphoteric
surfactant, a zwitterionic surfactant and combinations thereof. In
one embodiment, the personal care composition comprises at least
one amphoteric surfactant. Amphoteric surfactant suitable for use
in the present invention include those that are 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,
e.g., carboxy, sulfonate, sulfate, phosphate, or phosphonate.
Examples of compounds falling within this definition are sodium
3-dodecyl-aminopropionate, sodium 3-dodecylaminopropane sulfonate,
sodium lauryl sarcosinate, N-alkyltaurines such as the one prepared
by reacting dodecylamine with sodium isethionate according to the
teaching of U.S. Pat. No. 2,658,072, N-higher alkyl aspartic acids
such as those produced according to the teaching of U.S. Pat. No.
2,438,091, and the products described in U.S. Pat. No. 2,528,378.
In one aspect, the personal care composition comprises an
amphoteric surfactant that is selected from the group consisting of
sodium lauroamphoacetate, sodium cocoamphoactetate, disodium
lauroamphoacetate disodium cocodiamphoacetate, and combinations
thereof. Moreover, Amphoacetates and diamphoacetates are also used
in some embodiments of the present invention.
[0254] Zwitterionic surfactants suitable for use include those that
are 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, e.g., carboxy,
sulfonate, sulfate, phosphate, or phosphonate. Zwitterionic
surfactants suitable for use in the personal care composition
include alkyl betaines, including cocoamidopropyl betaine.
[0255] The personal care composition used in accordance with the
present invention is typically free of alkyl amines and
alkanolamide to ensure mildness of the composition to the skin.
[0256] An electrolyte can be added per se to the personal care
composition or it can be formed in situ via the counterions
included in one of the raw materials. The electrolyte typically
includes an anion comprising phosphate, chloride, sulfate or
citrate and a cation comprising sodium, ammonium, potassium,
magnesium or combinations thereof. Some preferred electrolytes are
sodium chloride, ammonium chloride, sodium or ammonium sulfate. The
electrolyte is typically added to the surfactant phase of the
composition in the amount of from about 0.1% to about 6%; from
about 1% to about 5%, more typically from about 2% to about 4%,
more typically from about 3% to about 4%, by weight of the personal
care composition.
[0257] In one embodiment, the first personal care composition
comprise a first concentration of surfactant, the second personal
care composition comprises a second concentration of surfactant and
the third personal care composition comprises a third concentration
of surfactant. The first concentration of surfactant is different
from the second concentration of surfactant and the third
concentration of surfactant, in some embodiments. In one aspect,
the first personal care composition has a first concentration of
surfactant that is a greater that the second concentration of
surfactant in the second personal care compositions and is the same
as or greater than the third concentration of surfactant in the
third personal care compositions. In one aspect, the first personal
care composition has a lower concentration of surfactant than the
second and the third personal care compositions.
[0258] In some embodiments, the personal care compositions used in
accordance with the present invention comprise a structured aqueous
phase. The structured aqueous phase, in one embodiment, comprises a
water structurant and water. The structured aqueous phase has a pH
in the range from about 5 to about 9.5, or in one aspect have a pH
of about 7. In one embodiment, the structured aqueous phase is
hydrophilic. In one aspect, the structured aqueous phase is a
hydrophilic, non-lathering gelled water phase.
[0259] In some embodiments, the structured aqueous phase comprises
less than about 5%, less than about 3%, less than about 1%, by
weight of the structured aqueous phase, of a surfactant component.
In one aspect, the structured aqueous phase is free of lathering
surfactants in the composition. In one embodiment, the structured
aqueous phase of the present invention comprises from about 30% to
about 99%, more than about 50%, more than about 60%, more than
about 70%, more than about 80%, by weight of the structured aqueous
phase, of water.
[0260] In one embodiment, the structured aqueous phase comprises a
water structurant. The water structurant is selected from the group
consisting of inorganic water structurants (e.g. silicas,
polyacrylates, polyacrylamides, modified starches, crosslinked
polymeric gellants, copolymers) charged polymeric water
structurants (e.g. Acrylates/Vinyl Isodecanoate Crosspolymer
available, STABYLEN 30.RTM. available from 3V SIGMA S.P.A of
Bergamo Italy), Acrylates/C10-30 Alkyl Acrylate Crosspolymer (e.g.
PEMULEN.TM. TR1 and TR2 polymers available from NOVEON.RTM.),
Carbomers, Ammonium Acryloyldimethyltaurate/VP Copolymer (e.g.
Aristoflex.RTM. AVC available from Clariant), Ammonium
Acryloyldimethyltaurate/Beheneth-25 Methacrylate Crosspolymer (e.g.
ARISTOFLEX.RTM. HMB available from Clariant), Acrylates/Ceteth-20
Itaconate Copolymer (e.g. STRUCTURE.RTM. 3001 available from
National Starch), Polyacrylamide (e.g. SEPIGEL.TM. 305 available
from SEPPIC), water soluble polymeric structurants (e.g. cellulose
gums and gel, and starches), associative water structurants (e.g.
xanthum gum, gellum gum, pectins, alginates such as propylene
glycol alginate), and combinations thereof. In some embodiments,
the structured aqueous phase comprises from about 0.1% to about
30%, from about 0.5% to about 20%, from about 0.5% to about 10%,
and from about 0.5% to about 5%, by weight of the structured
aqueous phase, of a water structurant. In some embodiments, a water
structurant for the structured aqueous phase has a net cationic
charge, net anionic charge, or neutral charge.
[0261] While not essential for the purposes of the present
invention, the non-limiting list of optional materials, illustrated
hereinafter are suitable for use in personal care compositions, and
may be incorporated in certain embodiments, for example to assist
or enhance cleansing performance, for treatment of the skin, or to
modify the aesthetics of the personal care composition. Optional
materials useful in the products herein are described by their
cosmetic and/or therapeutic benefit or their postulated mode of
action or function. These descriptions are non-limiting and made
for the sake of convenience because it is understood that these
materials can provide more than one benefit, function or operate
via more than one mode of action. The precise nature of these
optional materials, and levels of incorporation thereof, will
depend on the physical form of the composition and the nature of
the cleansing operation for which it is to be used. The amount of
optional materials in compositions are usually formulated, by
weight of the composition, at less than about less than about 6%,
less than about 5%, less than about 4%, less than about 3%, less
than about 2%, less than about 1%, less than about 0.5%, less than
about 0.25%, less than about 0.1%, less than about 0.01%, less than
about 0.005%.
[0262] In some embodiments of the present invention, comprise
optional ingredients, which are selected from the group consisting
of thickening agents, low density microspheres (e.g. EXPANCEL.RTM.
microspheres available from 091 WE40 d24, Akzo Nobel and others
described in commonly owned and assigned U.S. Patent Publication
No. 2004/0092415A1 published on May 13, 2004), preservatives,
antimicrobials, fragrances, chelators (e.g. such as those described
in U.S. Pat. No. 5,487,884 issued to Bisset et al.), sequestrants,
vitamins (e.g. Retinol), vitamin derivatives (e.g. tocophenyl
actetate, niacinamide, panthenol), sunscreens, desquamation actives
(e.g. such as those described in U.S. Pat. Nos. 5,681,852 and
5,652,228 issued to Bisset), anti-wrinkle/anti-atrophy actives
(e.g. N-acetyl derivatives, thiols, hydroxyl acids, phenol),
anti-oxidants (e.g. ascorbic acid derivatives, tocophenol), skin
soothing agents/skin healing agents (e.g. panthenoic acid
derivatives, aloe vera, allantoin), skin lightening agents (e.g.
kojic acid, arbutin, ascorbic acid derivatives), skin tanning
agents (e.g. dihydroxyacteone), polymeric phase structurant (e.g.
naturally derived polymers, synthetic polymers, crosslinked
polymers, block copolymers, copolymers, hydrophilic polymers,
nonionic polymers, anionic polymers, hydrophobic polymers,
hydrophobically modified polymers, associative polymers, and
oligomers); a liquid crystalline phase inducing structurant (e.g.
trihydroxystearin available from Rheox, Inc. under the trade name
THIXCIN.RTM. R), organic cationic deposition polymer (e.g.
Polyquaternium 10 available from Amerchol Corp., guar
hydroxypropyltrimonium chloride available as JAGUAR.RTM. C-17 from
Rhodia Inc., and N-HANCE.RTM. polymer series commercially available
from AQUALON), pH regulators (e.g. triethanolamine), anti-acne
medicaments, essential oils, sensates, pigments, colorants,
pearlescent agents, interference pigments (e.g. such as those
disclosed in U.S. Pat. No. 6,395,691 issued to Liang Sheng Tsaur,
U.S. Pat. No. 6,645,511 issued to Aronson et al., U.S. Pat. No.
6,759,376 issued to Zhang et al., U.S. Pat. No. 6,780,826 issued to
Zhang et al.) particles (e.g. talc, kolin, mica, smectite clay,
cellulose powder, polysiloxane, silicas, carbonates, titanium
dioxide, polyethylene beads) hydrophobically modified non-platelet
particles (e.g. hydrophobically modified titanium dioxide and other
materials described in a commonly owned, patent application
published on Aug. 17, 2006 under Publication No. 2006/0182699A by
Taylor, et al.) and combinations thereof. Other optional
ingredients are most typically those materials approved for use in
cosmetics and that are described in the CTFA Cosmetic Ingredient
Handbook, Second Edition, The Cosmetic, Toiletries, and Fragrance
Association, Inc. 1988, 1992.
V. Methods Related to Personal Care Articles and Personal Care
Compositions Measuring Lather Volume
[0263] Lather volume of a personal skin care composition can be
measured using a graduated cylinder and a tumbling apparatus. A
1,000 ml graduated cylinder is chosen which is marked in 10 ml
increments and has a height of 14.5 inches at the 1,000 ml mark
from the inside of its base (for example, Pyrex No. 2982).
Distilled water (100 grams at 23.degree. C.) is added to the
graduated cylinder. The cylinder is clamped in a rotating device
which clamps the cylinder with an axis of rotation that transects
the center of the graduated cylinder. One gram of the total
personal cleansing composition with specified cleansing phase to
benefit phase ratio (0.75 g of the cleansing phase and 0.25 g of
the benefit phase, or 0.45 g of the cleansing phase and 0.55 g of
the benefit phase) is added into the graduated cylinder and the
cylinder is capped. The cylinder is rotated at a rate of 10
revolutions in about 20 seconds, and stopped in a vertical position
to complete the first rotation sequence. A timer is set to allow 30
seconds for the lather thus generated to drain. After 30 seconds of
such drainage, the first lather volume is measured to the nearest
10 ml mark by recording the lather height in ml up from the base
(including any water that has drained to the bottom on top of which
the lather is floating).
[0264] If the top surface of the lather is uneven, the lowest
height at which it is possible to see halfway across the graduated
cylinder is the first lather volume (ml). If the lather is so
coarse that a single or only a few foam cells ("bubbles") reach
across the entire cylinder, the height at which at least 10 foam
cells are required to fill the space is the first lather volume,
also in ml up from the base. Foam cells larger than one inch in any
dimension, no matter where they occur, are designated as unfilled
air instead of lather. Foam that collects on the top of the
graduated cylinder but does not drain is also incorporated in the
measurement if the foam on the top is in its own continuous layer,
by adding the ml of foam collected there using a ruler to measure
thickness of the layer, to the ml of foam measured up from the
base. The maximum foam height is 1,000 ml (even if the total foam
height exceeds the 1,000 ml mark on the graduated cylinder). One
minute after the first rotation is completed, a second rotation
sequence is commenced which is identical in speed and duration to
the first rotation sequence. The second lather volume is recorded
in the same manner as the first, after the same 30 seconds of
drainage time. A third sequence is completed and the third lather
volume is measured in the same manner, with the same pause between
each for drainage and taking the measurement.
[0265] The lather result after each sequence is added together and
the Total Lather Volume determined as the sum of the three
measurements, in ml. The Flash Lather Volume is the result after
the first rotation sequence only, in ml, i.e., the first lather
volume. Compositions according to the present invention perform
significantly better in this test than similar compositions in
conventional emulsion form.
Microcentrifugation Method:
[0266] The Microcentrifugation Method determines the variation of
the percent of hydrophobic benefit material per dose in a package
that comprises a personal care article. As an overview, the
personal care articles being tested are dispensed in 10.0 mL sample
sizes and these samples are centrifuged. Centrifugation separates
the sample size of personal care articles into distinguishable
layers. The first personal care composition, second personal care
composition and third personal care composition have multiple
distinguishable layers, for example a microsphere layer, a
surfactant layer, and a benefit layer that comprises hydrophobic
benefit material, as shown in FIG. 2B and FIG. 2C. After
centrifugation, the volume percentage of the benefit phase for each
sample is determined and plotted per dose of personal care article
to obtain the hydrophobic benefit material distribution profile of
the personal care article throughout the product package.
TABLE-US-00004 TABLE 1 Description of Apparatus used in the
Microcentrifugation Method Apparatus: Description: Micro-centrifuge
VWR Galaxy 16DH 2 mL Micro-centrifuge VWR cat. No. 20170-170 clear
tubes Disposable syringes 1 mL, VWR cat. No. BD309602 Top Load
balance Capable of weighing to 2 decimal cases. Clear plastic cups
207 mL Solo Plastic cup Centrifuge tube stand capacity to hold at
least 24 tubes Electronic Digital Caliper capable of measuring 2
decimal cases in mm
[0267] To prepare the samples for a 295 mL package of a personal
care article, label 24 clear plastic cups 1-24. Place cup 1 on top
of balance and tare. Open package containing the personal care
article, dispense 8.80 g.+-.0.50 g of product in cup 1, and record
the weight of each sample. Repeat these instructions for all 24
cups, or for as many doses you can get from one package. If
composition gets stuck in the package, tap the package in
descending motion for four times.
[0268] Next, label 24 centrifuge tubes 1-24 doses. Then, mix the
sample in cup 1 well by stirring the sample with a stirrer by hand
and then draw the sample into a syringe. Insert the syringe all the
way to the bottom of the centrifuge tube. Slowly push the plunger
as you withdraw the syringe form the centrifuge tube, making sure
no air bubbles or gaps are formed. Check for air bubbles, if any
air bubble is found tap the centrifuge tube until sample fills the
gaps left by the air bubbles. Load the syringe with more sample of
the product and bring the extremity of the syringe to the top of
the sample of the product that is inside the centrifuge tube.
Slowly push the plunger while withdrawing the syringe from the
centrifuge tube. Check for air bubbles, and eliminate them by
tapping down the centrifuge tube. Fill the centrifuge tube to its
maximum capacity with the sample of the product (i.e. all the way
to the rim), cap the centrifuge tube and place in the centrifuge
tube rack. Repeat these steps until all 24 centrifuge tubes are
filled.
[0269] Load the centrifuge as described in the manufacturer's
instrument operation section of the instruction manual. Centrifuge
each of the samples for 15 minutes at 13,000 rpm. Once
centrifugation is done, remove each centrifuge tube from
centrifuge. Next, use a caliper to measure the length of benefit
phase to 1/100 of mm. Record the length of benefit phase for each
sample.
[0270] FIG. 2A is a diagram of the layers of a personal care
composition after centrifugation. FIG. 2B and FIG. 2C are
photographs that exemplify the measurement of the benefit phase
comprising hydrophobic benefit material within in the centrifuged
samples.
[0271] The volume of each dispensed sample is calculated by convert
the weight of each sample to volume using product density (0.88
g/mL).
Volume ( sample ) = Weight Density ##EQU00001##
The total volume dispensed is calculated by adding the volume of a
sample to the sum of the volumes of all previous samples. The
percent hydrophobic benefit material is calculated using equation
of calibration curve, below. In this equation, y=length of benefit
layer and x=the percentage hydrophobic benefit material in the
sample.
X = y + 3.0416 0.3867 ##EQU00002##
[0272] FIG. 3 depicts a calibration curve that was generated from
20 to 70% concentration of hydrophobic benefit material. This curve
was used to transform mm of hydrophobic benefit material to percent
of hydrophobic benefit material in the composition.
[0273] Finally, plot the percentage of hydrophobic benefit material
versus the total volume dispensed to obtain the hydrophobic benefit
material distribution profile of the personal care article
throughout the package.
Magnetic Resonance Imaging (MRI) Method:
[0274] The MRI Method is used to obtain images and quantitatively
describe the benefit distribution in 3-Dimension. The Instrument
used is a 4.7T Magnex Scientific magnet with a 60 cm horizontal
bore. The data is collected using a Bruker 25 cm imaging coil and
Bruker Paravision 3.0.2. The data is collected using a spin-echo
pulse sequence, repetition time of 1000 ms and echo time of 15
ms.
[0275] Images were acquired of 32 of 2 mm thick slices were
acquired along the flat surface of the package or bottle. The
fields of view were 22 cm.times.10 cm with data size of
256.times.128, which results in in-plane pixel resolutions of 86
um.times.78 um.
[0276] The customized imaging analysis software used to analyze the
MRI images is a Matlab based graphical user interface program,
hereinafter referred to as "GUI program". This GUI program was
developed in order to quantitatively describe benefit layer
distribution in 3-dimensions. The GUI program sets thresholds based
on MRI intensity to segment background and/or void region, benefit
region and surfactant region. The distribution of hydrophobic
benefit material along the height and radial are summed and plotted
as FIG. 4 and FIG. 5. FIG. 4 illustrates GUI based analysis of
personal care composition phase distribution along the radial
dimensions of the package. FIG. 5 illustrates GUI based analysis of
personal care composition phase distribution along the height of
the package.
Dynamic Shipping Stability Method:
[0277] The dynamic shipping stability method is a simulated
shipping test that is conducted to illustrate the impact of the
amount headspace on the distribution profile of hydrophobic benefit
material in a personal care article used in accordance with the
present invention. The method is conducted on a vibration table,
such as a MTS Vibration Table, available from Lansmont TTV of
Monterrey, Calif.
[0278] The method tests shipping cases of personal care articles.
There are 6 personal care articles or packages that are comprised
within a shipping case. The personal care articles are filled with
inventive example B using inventive filler profile B with various
headspaces at 16%, 10% and 3%, of the volume of the personal care
article, respectively. The shipping cases are submitted to
simulated shipping conditions. The temperature of the shipping
cases of personal care articles can be varied to simulate shipping
conditions from cold to warm climate regions.
[0279] Prior to submitting the shipping cases to simulated shipping
conditions, MRI images of each personal care articled are obtained
by the MRI method at 25.degree. C. Next, the shipping cases are
subjected to simulated shipping conditions
[0280] There are four steps to induce the simulated shipping
conditions:
[0281] Step 1: The shipping cases are dropped once at each of the
six orientations for a total of six times. The "six orientations,"
of the shipping cases used are up, down, and on each of the four
sides.
[0282] Step 2: The ASTM D4169 Truck Level 2 method is performed on
the shipping cases in upright positions for three hours.
[0283] Step 3: The ASTM D4728 Truck method is performed with
shipping cases at the six orientations for thirty minutes for each
orientation.
[0284] Step 4: The shipping cases are dropped once at each of the
six orientations for a total of six times.
[0285] After submitting the shipping cases to simulated shipping
conditions, MRI images are taken for each personal care article by
the MRI method at 25.degree. C.
[0286] The MRI images prior to and after simulated shipping
conditions are visually compared and graded of the shipping
stability. The MRI images are compared on the amount of phase
mixing, the presence of a zone of high concentration of hydrophobic
benefit material, the orientation of the concentration of
hydrophobic benefit material medial to the dispensing orifice, the
amount of void volume and an orientation of the void volume at the
end proximal to the dispensing orifice. If after submitting the
shipping cases to simulated shipping conditions, the MRI images
that show an excessive amount of mixing, the absence of a zone of
high concentration of hydrophobic benefit material, an excessive
amount of void volume and/or the volume is located medial or distal
to the dispensing orifice; the personal care article would fail the
dynamic stability shipping method. Conversely, if after submitting
the shipping cases to simulated shipping conditions, the MRI images
that show only a slight amount of mixing, the presence of a zone of
high concentration of hydrophobic benefit material which is located
medial to the dispensing orifice, a small amount of void volume
located proximal to the dispensing orifice; the personal care
article would pass the dynamic stability shipping method.
[0287] The results of the dynamic shipping stability method are
shown below in FIG. 6A, FIG. 6B and FIG. 6C. As shown in FIG. 6A,
the packages with 16% headspace shows extensive co-mixing of the
two phases and thus, failed the shipping dynamic shipping stability
method. As shown in FIG. 6B, the packages with 10% headspace shows
improved dynamic shipping stability method as the zone of high
concentration of hydrophobic benefit material is still apparent in
the MRI image. As shown in FIG. 6C, the packages with 3% headspace
shows the best shipping stability as the variable concentrations of
hydrophobic benefit material is maintained after shipping
protocol.
Ultracentrifugation Method:
[0288] The Ultracentrifugation Method is used to determine the
percent of a structured domain or an opaque structured domain that
is present in a personal care composition that comprises a
surfactant phase or a surfactant component. The method involves the
separation of a composition by ultracentrifugation into separate
but distinguishable layers. The first personal care composition,
second personal care composition and third personal care
composition have multiple distinguishable layers, for example a
non-structured surfactant layer, a structured surfactant layer, and
a benefit layer.
[0289] First, dispense about 4 grams of personal care composition
into Beckman Centrifuge Tube (11.times.60 mm). Next, place the
centrifuge tubes in an Ultracentrifuge (Beckman Model L8-M or
equivalent) and ultracentrifuge using the following conditions:
50,000 rpm, 18 hours, and 25.degree. C.
[0290] After ultracentrifuging for 18 hours, determine the relative
phase volume by measuring the height of each layer visually using
an Electronic Digital Caliper (within 0.01 mm). First, the total
height is measured as H.sub.a which includes all materials in the
ultracentrifuge tube. Second, the height of the benefit layer is
measured as H.sub.b. Third, the structured surfactant layer is
measured as H. The benefit layer is determined by its low moisture
content (less than 10% water as measured by Karl Fischer
Titration). It generally presents at the top of the centrifuge
tube. The total surfactant layer height (H.sub.a) can be calculated
by this equation:
H.sub.s=H.sub.a-H.sub.b
[0291] The structured surfactant layer components may comprise
several layers or a single layer. Upon ultracentrifugation, there
is generally an isotropic layer at the bottom or next to the bottom
of the ultracentrifuge tube. This clear isotropic layer typically
represents the non-structured micellar surfactant layer. The layers
above the isotropic phase generally comprise higher surfactant
concentration with higher ordered structures (such as liquid
crystals). These structured layers are sometimes opaque to naked
eyes, or translucent, or clear. There is generally a distinct phase
boundary between the structured layer and the non-structured
isotropic layer. The physical nature of the structured surfactant
layers can be determined through microscopy under polarized light.
The structured surfactant layers typically exhibit distinctive
texture under polarized light. Another method for characterizing
the structured surfactant layer is to use X-ray diffraction
technique. Structured surfactant layer display multiple lines that
are often associated primarily with the long spacings of the liquid
crystal structure. There may be several structured layers present,
so that H.sub.c is the sum of the individual structured layers. If
a coacervate phase or any type of polymer-surfactant phase is
present, it is considered a structured phase.
[0292] Finally, the structured domain volume ratio is calculated as
follows:
Structured Domain Volume Ratio=H.sub.c/H.sub.s*100%
[0293] If there is no benefit phase present, use the total height
as the surfactant layer height, H.sub.s=H.sub.a.
Yield Stress and Zero Shear Viscosity Method:
[0294] The Yield Stress and Zero Shear Viscosity of a composition
contained within a zone, can be measured either prior to combining
the phases in a composition, or after combining the phases in a
composition by separating the phases by suitable physical
separation means, such as centrifugation, pipetting, cutting away
mechanically, rinsing, filtering, or other separation means. In the
case of testing from a product package, two zones can be selected
from the package that contains at least two compositions that
contain separate hydrophobic benefit material concentrations. In
order to separate the zones, the product can be frozen at a
temperature of at least -20.degree. C. for a period of at least 24
hours. The zones are then cut using a cutting implement such as a
bandsaw. The cut portions are collected separately and allowed
equilibrate to ambient conditions.
[0295] A controlled stress rheometer, such as a TA Instruments
AR2000 Rheometer, is used to determine the Yield Stress and Zero
Shear Viscosity. The determination is performed at 25.degree. C.
with the 4 cm diameter parallel plate measuring system and a 1 mm
gap. The geometry has a shear stress factor of 79580 m.sup.-3 to
convert torque obtained to stress. Serrated plates can be used to
obtain consistent results when slip occurs.
[0296] First a sample of the composition is obtained and placed in
position on the rheometer base plate, the measurement geometry
(upper plate) moving into position 1 mm above the base plate.
Excess phase at the geometry edge is removed by scraping after
locking the geometry. If the phase comprises particles discernible
to the eye or by feel (beads, e.g.) which are larger than about 150
microns in number average diameter, the gap setting between the
base plate and upper plate is increased to the smaller of 4 mm or
8-fold the diameter of the 95.sup.th volume percentile particle
diameter. If a phase has any particle larger than 5 mm in any
dimension, the particles are removed prior to the measurement.
[0297] The determination is performed via the programmed
application of a continuous shear stress ramp from 0.1 Pa to 1,000
Pa over a time interval of 4 minutes using a logarithmic
progression, i.e., measurement points evenly spaced on a
logarithmic scale. Thirty (30) measurement points per decade of
stress increase are obtained. Stress, strain and viscosity are
recorded. If the measurement result is incomplete, for example if
material flows from the gap, results obtained are evaluated and
incomplete data points excluded. The Yield Stress is determined as
follows. Stress (Pa) and strain (unitless) data are transformed by
taking their logarithms (base 10). Log(stress) is graphed vs.
log(strain) for only the data obtained between a stress of 0.2 Pa
and 2.0 Pa, about 30 points. If the viscosity at a stress of 1 Pa
is less than 500 Pa-sec but greater than 75 Pa-sec, then
log(stress) is graphed vs. log(strain) for only the data between
0.2 Pa and 1.0 Pa, and the following mathematical procedure is
followed. If the viscosity at a stress of 1 Pa is less than 75
Pa-sec, the zero shear viscosity is the median of the 4 highest
viscosity values (i.e., individual points) obtained in the test,
the yield stress is zero, and the following mathematical procedure
is not used. The mathematical procedure is as follows. A straight
line least squares regression is performed on the results using the
logarithmically transformed data in the indicated stress region, an
equation being obtained of the form:
Log(strain)=m*Log(stress)+b (1)
[0298] Using the regression obtained, for each stress value (i.e.,
individual point) in the determination between 0.1 and 1,000 Pa, a
predicted value of log(strain) is obtained using the coefficients m
and b obtained, and the actual stress, using Equation (1). From the
predicted log(strain), a predicted strain at each stress is
obtained by taking the antilog (i.e., 10.sup.x for each x). The
predicted strain is compared to the actual strain at each
measurement point to obtain a % variation at each point, using
Equation (2).
%variation=100*(measured strain-predicted strain)/measured strain
(2)
[0299] The Yield Stress is the first stress (Pa) at which %
variation exceeds 10% and subsequent (higher) stresses result in
even greater variation than 10% due to the onset of flow or
deformation of the structure. The Zero Shear Viscosity is obtained
by taking a first median value of viscosity in Pascal-seconds
(Pa-sec) for viscosity data obtained between and including 0.1 Pa
and the Yield Stress. After taking the first median viscosity, all
viscosity values greater than 5-fold the first median value and
less than 0.2.times. the median value are excluded, and a second
median viscosity value is obtained of the same viscosity data,
excluding the indicated data points. The second median viscosity so
obtained is the Zero Shear Viscosity.
VI. Method of Manufacture
[0300] In one embodiment, the personal care articles of the present
invention are manufactured by a dual phase filler. The dual phase
filler is associated with storage vessels, a combiner, a blender
and nozzle for filling multiple personal care compositions. An
example of a dual phase filler and associated software is
manufactured by Antonio Mengibar Packaging Machinery of Barcelona,
Spain. The surfactant phase and benefit phase of the personal care
compositions are stored in separate storage vessel; each vessel
equipped with a pump and a hose assembly. A programmed filler
profile of the dual-phase filler controls the pumping of specific
ratios of the two phases of the personal care compositions which
result in the zones within a package. The two phases of the
personal care compositions are pumped from the storage tanks into a
combiner where the two phases are combined. After the phases are
combined; they are mixed in a blender. From the blender, the
resultant product is pumped via a hose into a single nozzle. The
nozzle is placed into a container and fills a product package with
a single resulting product. In some embodiments, the resultant
product exhibits a distinct pattern of the phases which are
visually distinct. In other embodiments, the resultant product
exhibits a uniform appearance without a pattern. If a pattern is
present, the pattern is selected from the group consisting of
striped, marbled, geometric, and combinations thereof.
[0301] In another embodiment, the personal care compositions used
in accordance with the present invention are manufactured according
to the method disclosed in U.S. patent application Ser. No.
10/837,214 Publication No. 2004/0219119 A1 entitled "Visually
distinctive multiple liquid phase compositions" filed by Wei et al.
on Apr. 30, 2004, published on Nov. 18, 2004. Alternatively, it may
be effective to combine toothpaste-tube filling technology with a
spinning stage design. In still another embodiment, the personal
care compositions are prepared by the method and apparatus as
disclosed in U.S. Pat. No. 6,213,166 issued to Thibiant et al. on
Apr. 10, 2001. The method and apparatus allow two or more
compositions to be filled with a spiral configuration into a single
product package. The method requires that at least two nozzles be
employed to fill the compositions into a package. The package is
placed on a moving stage and spun as the composition is introduced
into the package.
[0302] Non-limiting examples of the personal care compositions,
ratios of phases and filler profiles are disclosed in the examples
below.
VII. Composition and Articles Examples
Example 1
Exemplary Personal Care Articles
[0303] Table 2 shows non-limiting examples of the personal care
articles of the present invention and a comparative example. These
personal care articles are made and filled in a single chamber
package. The personal care compositions used in accordance with the
present invention comprise various concentrations of hydrophobic
benefit material through out the package. These personal care
compositions used in accordance with the present invention are
filled in a package within multiples zones. The comparative example
comprises uniform concentration of hydrophobic benefit material
through out the package.
TABLE-US-00005 TABLE 2 Examples of the Present Invention and
Comparative Example Inventive Inventive Comparative Example A
Example B Example C Surfactant Phase Composition Sodium
Lauroamphoacetate.sup.1. 4.9 4.9 4.9 Sodium Trideceth
Sulfate.sup.2. 8.4 8.4 8.4 Sodium Lauryl Sulfate 8.4 8.4 8.4
Trideceth-3.sup.3. 2.0 2.0 2.0 Sodium Chloride 4.75 4.75 4.75 Guar
0.6 0.6 0.6 hydroxypropyltrimonium chloride.sup.4.
Polyethyleneoxide.sup.5. 0.15 0.15 0.15 Xanthan gum.sup.6. 0.2 0.2
0.2 Hollow microspheres.sup.7. 0.36 0.3 0.3 Methyl chloro
isothiazolinone 0.0005 0.0005 0.0005 and methyl
isothiazolinone.sup.8. EDTA.sup.9. 0.15 0.15 0.15 Sodium Benzoate
0.2 0.2 0.2 Citric Acid, titrate pH = pH = pH = 5.7 .+-. 0.2 5.7
.+-. 0.2 5.7 .+-. 0.2 Perfume 1.3 1.3 1.3 Water Q.S. Q.S. Q.S.
Benefit Phase Composition Petrolatum .sup.10. 70 70 70 Mineral
Oil.sup.11. 30 30 30 Filler Profile Inventive Inventive Comparative
Profile A Profile B Profile C .sup.1.available from Cognis Chemical
Corp. .sup.2.sulfanated to >95% sulfate from ICONOL .RTM. TDA-3
available from BASF Corp., .sup.3.ICONOL .RTM. TDA-3 available from
BASF Corp., .sup.4.N-HANCE .RTM. 3196 Polymer from Aqualon of
Wilmington, DE, .sup.5.POLYOX .TM. WSR-301 available from DOW .RTM.
Chemical Corp., .sup.6.KELTRO .TM. 1000 available from CP Kelco,
.sup.7.EXPANCEL .RTM. microspheres available from 091 WE40 d24,
Akzo Nobel, .sup.8.KATHON .RTM. CG available for Rohm & Haas,
.sup.9.DISSOLVINE .RTM. NA 2x available from Akzo Nobel,
.sup.10.G2218 petrolatum from Sonneborn, .sup.11.HYDROBRITE .RTM.
1000 White Mineral Oil available from Sonneborn.
[0304] The compositions described above can be prepared by
conventional formulation and mixing techniques. The surfactant
phase composition is made by first preparing a citric acid premix
and then a polymer pre-mix. The citric acid premix is prepared by
adding citric acid into water at a ratio of 1:3. The polymer premix
is prepared by adding polyethyleneoxide and xanthan gum into
trideceth-3. The following ingredients are then added into the main
mixing vessel in the following sequence with agitation: water, guar
hydroxypropyltrimonium chloride, hollow microspheres, sodium
lauroamphoacetate, sodium trideceth sulfate, sodium lauryl sulfate,
sodium chloride, sodium benzoate, and disodium EDTA. The citric
acid premix is added into the main mixing vessel and the pH of the
composition is adjusted to 5.7.+-.0.2. The polymer premix is next
added into the main mixing vessel with continuous agitation.
Perfume and methyl chloro isothiazolinone and methyl
isothiazolinone are added while continuing the agitation until the
composition is homogeneous. The resultant surfactant phase
composition is fed into the dual-phase filler through a
hose-assembly.
[0305] The benefit phase composition is prepared by first adding
petrolatum into a mixing vessel. The mixing vessel has been heated
to 82.2.degree. C. Mineral oil is added into the mixing vessel with
agitation. The benefit phase composition is cooled to 44.degree. C.
through a scraped-wall heat-exchanger, such as that manufactured by
Waukesha Cherry-Burrell, Delavan, Wis. After cooling, the resultant
benefit phase composition is fed into the dual-phase filler through
a second hose-assembly.
[0306] The filler profiles A, B and C are examples of filling
programs that specify the ratios of the surfactant and benefit
phases within packages filled by a dual phase filler. Filler
profiles A and B specify variable hydrophobic benefit material
concentrations throughout the zones of the personal care articles
of the present invention. Whereas filler profile C specifies
uniform hydrophobic benefit material concentrations in the
resultant personal care article within the package.
TABLE-US-00006 TABLE 3 Dual Phase Filler Profiles for Example A and
B Filler Profile A Filler Profile B Benefit Sur- Benefit Sur- Dose
Material factant Dose Material factant Step (mL) % % Step (mL) % %
1 33.6 24 76 1 33.2 30 70 2 61.4 42 58 2 61.7 50 50 3 70.6 52 48 3
71.2 60 40 4 104.2 63 37 4 104.4 70 30 5 133.2 63 37 5 132.9 60 40
6 155.2 52 48 6 154.7 50 50 7 174.9 42 58 7 194.6 40 60 8 194.5 32
68 8 223.1 20 80 9 223.5 15 85 9 248.7 10 90 10 249.0 7 93 10 280.0
20 80 11 280.2 15 85 11 289.5 30 70 12 289.5 27 73 -- -- -- --
TABLE-US-00007 TABLE 4 Dual Phase Filler Profiles for Example C
Filler Profile C Step Dose (mL) Benefit Material % Surfactant % 1
11 45 55 2 20 45 55 3 35 45 55 4 52 45 55 5 75 45 55 6 108 45 55 7
148 45 55 8 188 45 55 9 229 45 55 10 265 45 55 11 280 45 55
[0307] FIG. 7 depicts MRI images that illustrate the surfactant and
hydrophobic benefit material distribution in a package of examples
A, B and C. These images were taken by the MRI Method, described in
detail in the Test Methods above. As shown in FIG. 7, the
comparative example C shows a uniform hydrophobic benefit material
distribution throughout the package. Inventive examples A and B, in
FIG. 7 show a variable hydrophobic benefit material distribution
profile with higher benefit zones are highlighted with arrows.
[0308] FIG. 8 is a chart of the hydrophobic benefit material
distribution in examples A and B of the present invention. The
Micro centrifugation Method, described in detail in the Test
Methods above, was used to quantify the hydrophobic benefit
material distribution in the inventive examples A and B. Profile A
and profile B, shown in FIG. 8 clearly show a variable benefit
distribution from the beginning, middle, and end of the
dispensing.
[0309] 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 surrounding that value. For example, a dimension
disclosed as "40 mm" is intended to mean "about 40 mm."
[0310] All documents cited in the Detailed Description of the
Invention are, in relevant part, incorporated herein by reference;
the citation of any document is 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 document
conflicts with any meaning or definition of the same term in a
document incorporated by reference, the meaning or definition
assigned to that term in this document shall govern.
[0311] While particular embodiments of the present invention have
been illustrated and described, it would be obvious to those
skilled in the art that various other changes and modifications can
be made without departing from the spirit and scope of the
invention. It is therefore intended to cover in the appended claims
all such changes and modifications that are within the scope of
this invention.
* * * * *