U.S. patent application number 12/875123 was filed with the patent office on 2011-06-23 for products and methods for reducing malodor from the pudendum.
Invention is credited to Shannon Elizabeth Klingman.
Application Number | 20110150955 12/875123 |
Document ID | / |
Family ID | 44151444 |
Filed Date | 2011-06-23 |
United States Patent
Application |
20110150955 |
Kind Code |
A1 |
Klingman; Shannon
Elizabeth |
June 23, 2011 |
Products and Methods for Reducing Malodor from the Pudendum
Abstract
Products and methods are disclosed for reducing the production
of unwanted odors from the pudendum.
Inventors: |
Klingman; Shannon Elizabeth;
(Chaska, MN) |
Family ID: |
44151444 |
Appl. No.: |
12/875123 |
Filed: |
September 2, 2010 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
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61309831 |
Mar 2, 2010 |
|
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61289992 |
Dec 23, 2009 |
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Current U.S.
Class: |
424/405 ;
514/558; 514/559; 514/570 |
Current CPC
Class: |
A61Q 15/00 20130101;
A61P 31/04 20180101; A61K 31/19 20130101; A61K 31/20 20130101; A61K
8/0208 20130101; A61K 31/192 20130101; A61K 9/0034 20130101; A61K
9/7007 20130101; A61K 8/365 20130101 |
Class at
Publication: |
424/405 ;
514/570; 514/558; 514/559 |
International
Class: |
A01N 25/34 20060101
A01N025/34; A61K 31/192 20060101 A61K031/192; A61K 31/20 20060101
A61K031/20; A61P 31/04 20060101 A61P031/04; A61K 8/02 20060101
A61K008/02; A61Q 90/00 20090101 A61Q090/00 |
Claims
1. A product for application to the pudendum of a user to reduce
fishy odor, the product comprising about 0.5 weight percent or
greater mandelic acid in a viscous lipophilic carrier, the product
being physically associated with indicia specifying that the
product should be applied to the pudendum.
2. The product of claim 1, wherein the product comprises about 1
weight percent or greater mandelic acid, and further comprises
about 1 weight percent or greater lactic acid.
3. The product of claim 1, where the product has an elevated yield
stress allowing the product to readily adhere to substantially
vertical human skin in an applied layer at least 2 millimeters
thick without substantially flowing in response to gravitational
force.
4. The product of claim 1, wherein the product has a pH of about
4.5 or less.
5. The product of claim 1, wherein the container also holds at
least one flexible wipe and wherein the product has a pH of about 5
or lower.
6. The product of claim 5, wherein the at least one flexible wipe
is pretreated with the product.
7. The product of claim 5, wherein the product is disposed in a
discreet portion of the container.
8. The product of claim 1, wherein the indicia provide at least one
of instructions that the product should be applied to and
instructions that the product should be applied to the pudendum
after the pudendum has been exposed to a pH-elevating
substance.
9. The product of claim 8, wherein the pH-elevating substance is at
least one of semen, blood, menses, vaginal discharge, feces, soap
and detergent.
10. A wet wipe product for treating the pudendum of a user
comprising a container having one or more flexible porous wipes
impregnated with an aqueous solution, the solution having a pH
between about 2.8 and 5, the solution comprising about 0.5 weight
percent or greater of mandelic acid or a derivative thereof, the
container further comprising indicia giving directions for use of
the wipes on the pudendum.
11. The wet wipe product of claim 10, wherein a substantial portion
of the mandelic acid or derivative thereof is encapsulated for time
release functionality.
12. A feminine wipe product for reducing the production of unwanted
odor from the pudendum, the product comprising an openable
enclosure containing at least one wipe pretreated with an
acidifying composition, the acidifying composition comprising at
least about 0.5% by weight of a first alpha-hydroxy acid comprising
at least 7 carbons and having a molecular weight in the range of
about 135 to about 400, the alpha-hydroxy also acid having no more
than one carboxylic acid group for every 7 carbons, the acidifying
composition having a pH of from about 3.5 to about 4.5 and further
comprising at least 50% by weight of a viscous lipophilic
carrier.
13. The product of claim 12, wherein the first alpha-hydroxy acid
comprises mandelic acid or derivatives thereof.
14. The product of claim 12, wherein the acidifying composition
comprises about 1% of more of the first alpha-hydroxy acid and
about 0.5% or more of a second alpha-hydroxy acid.
15. A method for reducing or preventing malodor from the pudendum,
comprising: (a) providing a user with a product comprising an
acidifying composition having at least about 0.5% by weight of
mandelic acid, said acidifying composition having a pH between
about 2.8 and 5, and (b) providing directions to the user to apply
the acidifying composition to the pudendum.
16. The method of claim 15, wherein the acidifying composition
further comprises at least about 1% by weight of a second
carboxylic acid component, and wherein the pH of said acidifying
composition is between about 3.2 and 4.5.
17. The method of claim 16, wherein the second carboxylic acid
component comprises lactic acid.
18. The method of claim 15 wherein said acidifying composition has
a non-zero yield stress and wherein the directions are adapted to
cause said acidifying composition to effectively remain in contact
with the human body for a period of at least 10 minutes after
applying said acidifying composition according to the
directions.
19. The method of claim 15, wherein said acidifying composition
comprises a lipophilic carrier.
20. The method of claim 15, wherein said acidifying composition
comprises an aqueous solution.
21. The method of claim 15, further comprising (c) providing one or
more wipes for use with the product, and wherein providing
directions to the user includes providing directions to transfer
the product from at least one of the one or more wipes to the
pudendum.
22. The method of claim 21, wherein the product and the directions
are adapted such that the composition, when applied according to
the directions, will be effectively kept in contact with the
pudendum for a period of at least 60 minutes, and wherein the pH on
the skin in contact with the composition is between about 3.5 and
4.5 during a majority of the at least 60 minutes.
Description
CLAIM TO PRIORITY
[0001] This application claims priority to U.S. Patent Appl. Ser.
No. 61/309,831, "Products and Methods for Reducing Malodor from the
Pudendum," filed Mar. 2, 2010 by Shannon Klingman, and also U.S.
Patent Appl. Ser. No. 61/289,992, "Products and Methods for
Reducing Malodor from the Pudendum," filed Dec. 23, 2009 by Shannon
Klingman, both of which are hereby incorporated by reference in
their entireties for all purposes.
BACKGROUND
[0002] 1. Field of the Invention
[0003] This invention pertains to products and methods for personal
care, particularly for reducing or preventing unwanted odor from
the pudendum.
[0004] 2. Description of Related Art
[0005] Fishy odors from the pudendal region or genitalia of the
female body have long been a source of annoyance and embarrassment
to adult and teenaged women. Women seeking help from physicians are
frequently given antibiotics such as metronidazole, based on the
long-standing belief that vaginal bacteria are the cause of the
problem. Indeed, a fishy odor is commonly considered to be a
symptom for bacterial vaginosis (see, for example, "Bacterial
Vaginosis," Wikipedia,
http://en.wikipedia.org/wiki/Bacterial_vaginosis, accessed Nov. 17,
2009). Others seeking relief have tried a variety of products such
as douches which may provide only short-term decrease in the odor
(if the vagina was the actual source of the odor). In spite of many
medications and feminine hygiene products, there has been a
long-standing unmet need in this area, fueled by lack of
understanding about the causes and the nature of the problem,
especially the assumption that fishy odor only arises from the
vagina due to bacterial imbalance or infectious cause such as
bacterial vaginosis and trichomonas.
[0006] The "Whiff test" for vaginosis involves treating body fluids
with potassium hydroxide (KOH). A resulting fishy odor produced by
an amine reaction is taken as an indicator for the presence of
anaerobic bacteria. However, the amine reaction or related
reactions that result in a fishy odor can take place without
addition of KOH, but under other elevated pH conditions on the
pudendum. The materials serving as a source for the
nitrogen-containing compounds released as fishy odor (e.g.,
trimethylamine) can include semen, blood, urine, cervical mucus and
post menopausal physiologic discharge. When these are brought in
contact with the anaerobic bacteria from the rectum, an unpleasant
fishy odor will result. The odor is known to be associated with
reactions from bacteria, but the historic focus on bacteria in the
vagina and the assumption that vaginitis or more specifically,
bacterial vaginosis, is the cause of the odor may have misled many
in seeking for solutions that treat bacteria in the vagina.
[0007] We have found that for many women, the source of the odor is
more commonly from the pudendum (including the intergluteal folds
and external genitalia), where anaerobic bacteria from the lower
gastrointestinal (Cl) tract or other sources can be found. These
anaerobic bacteria may be especially present on the external skin
around the perianal anatomy.
[0008] The new recognition that vaginal bacteria are not cause of
fishy odor in many women is of special significance, and helps
explain why antibiotic treatments and other standard treatments
have fared so poorly in treating many cases of fishy odor, and why
may women presenting symptoms of fishy odor do not actually have
bacterial vaginosis when thorough testing is conducted (see, for
example, N. K. Lowe et al., "Accuracy of the Clinical Diagnosis of
Vaginitis Compared With a DNA Probe Laboratory Standard,"
Obstetrics & Gynecology, vol. 113, no. 1, January 2009, pp
89-95, abstract available online at
http://journals.lww.com/greenjournal/Abstract/2009/01000/Accuracy_of_the_-
Clinical_Diagnosis_of_Vaginitis.15.aspx and Hope K. Haefner,
"Conquering Resistant Vulvovaginitis," 2007, presentation available
online at
http://www.yellowdocuments.com/12180308-advancements-in-benign-vulvar-and-
). It also points to the long unmet need for improved means of
reducing or preventing fishy odor by better controlling the
activity of anaerobic bacteria on the pudendum, particularly those
interacting with or feeding on nitrogen compounds in body fluids
such as semen, blood, urine, and feces.
[0009] It is believed that a particularly significant discovery is
the recognition that the source of a fishy odor for many women is
not bacteria in the vagina, nor bacteria coming from the vagina,
but anaerobic bacteria from non-vaginal sources such as the
gastrointestinal tract. An understanding of this discovery can be
enhanced in part by consideration of a rare metabolic disorder,
trimethylaminuria, a disorder occurring when humans have an
impaired version of the enzyme flavin-containing monooxygenase 3
(FMO3), which converts trimethylamine to trimethylamine N-oxide
during the metabolism of some nitrogen-containing compounds such as
choline or phosphocholine. With impaired FMO3 activity,
trimethylamine concentrations become elevated and strong fishy odor
can be generated by the sweat and other body fluids of a person,
making life difficult and painful. Foods rich in choline are
especially problematic for those with trimethylaminuria, since it
leads to production of large amounts of trimethylamine. Without
wishing to be bound by theory, it is believed that the release of
trimethyl amine and possibly other nitrogenous compounds produced
by anaerobic bacteria at elevated pH on the pudendum of the human
body is analogous to the production of trimethylamine in the body
when oxidizing enzymes are impaired in those suffering from
trimethylaminuria. Again, without wishing to be bound by theory,
recognition of this analogous condition in light of the newly
recognized mechanisms for fishy odor generation on the skin of the
pudendum also suggests that semen may be an especially important
component in the production of fishy odor in some cases, for semen,
of all body fluids, may be the richest in choline and is among the
richest natural sources of choline and water-soluble choline
compounds, and thus is believed to be a highly significant
potential source for trimethylamine production by certain anaerobic
bacteria on the pudendum.
[0010] Thus, we have discovered that the introduction of semen,
blood, urine, feces, and other body fluids into the pudendum,
including the perineum and adjacent regions, can raise the pH on
the skin and provide the nitrogenous materials and alkaline
conditions for bacterial-assisted production of significant amounts
of volatile amine compounds such as trimethylamine, giving rise to
a fishy odor. While the reactions involved may be similar to those
that occur from bacterial vaginosis, fishy odor can be produced on
the pudendum under benign conditions. In other words, the vagina is
not the key factor when trying to solve the problem of transient
fishy odor for most women.
[0011] For effective prevention of the fishy odor from the amine
reaction, wiping or washing alone is inadequate. The pH of the
environment of the perianal bacteria needs to be maintained in an
acidic state such as at a pH less than about 5.5, or less than
about 5.3, or less than about 5.1, in order to hinder the amine
reaction that causes the unwanted fishy odor. 3.5 to 4.2 is the
normal range of the pH of the vagina, and a pH in this range can be
suitable for the pH of the pudendum. Thus, a suitable range for pH
may be, by way of example, from about 3 to about 5.5, from about
3.2 to about 5, from about 3.5 to 4.5, or from about 3.5 to 5.0.
Without wishing to be bound by theory, our work indicates that the
release of the fishy odor can be triggered by an amine reaction
that occurs when the anaerobic bacteria of the pudendum come into
contact with alkaline bodily fluids such as semen, blood, feces,
and other agents such as soap, in essence, giving a positive Whiff
test on the external genitalia. Possible insight into related
mechanisms may be found, again without wishing to be bound by
theory, in the study of Y. Tsuchiya and E. Endo, "Enzymatic
Reduction of Trimethylamine Oxide," Tohoku Journal of Agricultural
Research, 1952, pp. 127-133, available online at
http://ir.library.tohoku.ac.jp/re/bitstream/10097/29074/1/KJ00000713720.p-
df, which describes how a bacterial enzyme, triamineoxidase,
activates relatively odorless trimethylamine oxide and renders it
susceptible to reduction to the highly malodorous trimethyl amine
by various dehydrogenases. Several potential inhibitors of the
reaction are explored. On page 130 of Tsuchiya and Endo, results
for the reaction rate for trimethylamine production as a function
of pH shows that a pH above 5.5 such as from about 6 to 8 favors
high levels of trimethylamine, whereas a pH of 5.5 or less, or 5.0
or less, favors low levels of trimethylamine.
[0012] An understanding of the importance of maintaining a low pH
in the external environment of the pudendum relative to the issue
of controlling fishy odor appears to be lacking in prior attempts
to deal with fishy odor. For example, some commonly used products
employ baking soda, an alkaline compound, and a recognition of the
role of the environment external to the vagina and its pH appears
to have been lacking in terms of controlling fishy odor.
[0013] The compositions and methods proposed herein for controlling
fishy odor arise in part from the surprising realization that the
real problem in most cases is not bacteria in the vagina, but
conditions arising from an anatomically inevitable consequence of
intercourse, due to semen form intercourse, leaking urine, and
blood from monthly cycles coming in contact with the perianal
bacteria that can inhabit various parts of the pudendum. The close
physical proximity of the vulvar and perianal regions contributes
to the presence of bacteria that can produce or participate in
reactions leading to generation of trimethylamine or related fishy
odor compounds, feeding upon the nitrogenous compounds coming from
intercourse, urine, menstruation, feces, etc.
[0014] With a realization of the nature of the origin of fishy
odors due to elevated pH and associated conditions in the pudendum,
we were able to subsequently develop what is believed to be the
first product that addresses the real problem (for many women) over
a prolonged period of time.
[0015] Vinegar wipes, douches, and other acidic products have been
proposed for personal cleansing, but such products have generally
been developed for rapid cleansing and not for lasting control of
pH. Thus, even highly acidic vinegar wipes only provide a
short-term change in pH, as the acidic components is applied and
then wiped or washed off or otherwise neutralized or quickly
removed from the skin. With the viscous carrier of many embodiments
disclosed herein, acidifying components can be available for a
prolonged period of time to effectively control the pH of the
environment. Further, with larger molecular weight alpha-hydroxy
acids disclosed herein (for many embodiments) that do not rapidly
penetrate the skin, the alpha-hydroxy acids can remain on or above
the skin to effectively maintain the pH in a suitable range for a
prolonged period of time, unlike much lighter acids.
[0016] Thus, there is a need for new products and methods that can
address the surprising discoveries regarding the sources of fishy
odor in many women, and that can overcome the long-standing unmet
needs that have not been adequately addressed by previous products,
formulations, and methods.
[0017] Many retail and prescription products have been marketed are
directed at treating bacteria in the vagina, which again do not
address the issue of the external environment in the pudendum. Most
on the retail side are a cover-up with baking soda and perfumes or
other ingredients that do not address the problem or may even
exacerbate it at the true source (albeit the previously
unrecognized source).
[0018] The recognition that the source of the fishy odor is
frequently from the pudendum and not from the vagina helps explain,
in retrospect, why treatments based on attacking bacteria on the
vagina have been relatively ineffective for so many women for so
long, and may also help explain why misdiagnosis of vaginosis is
such a common problem (see "Throwing the Dice for the Diagnosis of
Vaginal Complaints?" by Andreas Schwiertz et al., Annals of
Clinical Microbiology and Antimicrobials, Vol. 5. No. 4, 2006,
available online at http://www.ann-clinmicrob.com/content/5/1/4).
The new understanding of the need to provide long-term control of
pH on the skin of the pudendum also helps explain, in retrospect,
why previous solutions employing wipes and other means did not
provide lasting or effective solutions. What is needed, then, is an
effective system or method for providing a suitable acidic pH over
a prolonged period of time in the pudendum or portions thereof such
that the amine reactions giving rise to a fishy odor can be
impeded, resulting in a significant decrease in the production of
unpleasant odors.
[0019] In spite of the surprising discovery that a major source for
fishy odor was not from the vagina itself but from the external
skin of the pudendum, particularly when the pH was elevated by the
presence of semen, blood, or other materials or factors, we found
that various efforts to decrease pH were not necessarily adequate
to provide an acceptable solution, for, among other reasons, there
is a risk of skin irritation or other unwanted responses with
prolonged exposure to many acidic compounds. For effective
treatment of the newly appreciated causes of unwanted fish odor for
many women, we have also discovered that a lasting reduction in
fishy odor and associated problems of the inevitable chronic
presence of anaerobic bacteria in the pudendum require new
strategies to provide sustained pH control in ways that do not
irritate the skin. Thus, there is a long-standing need to provide
sustained pH control in non-irritating means to reduce the common
problem of fishy odor production from the pudendum.
SUMMARY
[0020] We have found that relatively non-irritating alpha-hydroxy
acids such as mandelic acid or combinations of mandelic acid and
other alpha-hydroxy acids such as lactic acid, in combination with
a suitable carrier such as a protective lipophilic carrier, a
bioadhesive, or a suitable wipe formulation, can provide acidifying
agents that are effective in controlling the pH in the pudendum
while not irritating the skin. By virtue of the acidic environment
provided by such compositions, the reactions that produce fishy
odor on the pudendum can be controlled such that the odor is
substantially reduced or eliminated. In many embodiments, the
acidifying agents can remain active in the pudendum over a
prolonged period for lasting odor reduction. Such compositions may
be applied to the body in a variety of ways, such as by application
using a pretreated wipe, pad, or absorbent article containing the
acidifying composition that transfers to the body, or by direct
application to the body using a spray or other dispenser or by
application using the fingers or other means to apply the
composition onto the pudendum.
[0021] As used herein, "pudendum" refers to the external genitalia
and surrounding regions of the body, including the interlabial
folds, the clitoral region, the perineum, the perianal region, the
vulvar and perivulvar regions, and the intergluteal folds.
[0022] As used in the description, and in the claims, the term
"alpha-hydroxy acid" refers to compounds represented by the
following generic structure:
(R1)(R2))C(OH)COOH
where R1 and R2 are H, alkyl, aralkyl or aryl groups. In addition,
R1 and R2 may carry OH, CHO, COOH and alkoxy groups. Typical alkyl,
aralkyl and aryl groups for R1 and R2 include methyl, ethyl,
propyl, isopropyl, butyl, pentyl, octyl, lauryl, stearyl, benzyl
and phenyl etc. The alpha-hydroxy acids include, but are not
limited to, lactic acid, mandelic acid, glycolic acid, malic acid,
2-hydroxyoctanoic acid, 2-hydroxydecanoic acid, and citric acid. In
some embodiments, the alpha-hydroxy acid has 13 or fewer carbons,
12 or fewer carbons, 11 or fewer carbons, 10 or fewer carbons, 9 or
fewer carbons, or 8 or fewer carbons, such as between 2 and 14
carbons, between 2 and 11 carbons, between 3 and 11 carbons,
between 3 and 13 carbons, between 7 and 12 carbons, or between 8
and 12 carbons. In one embodiment, the alpha-hydroxy acids comprise
a mixture of 3-carbon and 8-carbon alpha-hydroxy acids.
[0023] To provide an effective quantity of a suitable alpha-hydroxy
acid in the environment on the pudendum, a viscous carrier
substantially more viscous than water can be effective in retaining
the material. As used herein, a material such as a liquid is said
to be "viscous" when it has a viscosity of from about 6 mPas
(millipascal-seconds) to about 300,000 mPas when measured at
25.degree. C., more specifically from 15 mPas to 150,000 mPas, and
more specifically still from 50 mPas to 150,000 mPas. Viscosity
herein is measured on neat composition using a Brookfield RVT, T-C
Spindle at 5 rpms and Heliopath Stand, as described in US Pat.
Application 20060002876, "Personal Care Compositions with Improved
Hyposensitivity," published Jan. 5, 2006 by C. M. Cahen, herein
incorporated by reference to the extent that it is noncontradictory
herewith. In general, a viscous compositions has a viscosity that
is substantially greater than that of water, and typically provides
improved application characteristics when compared with products
having a viscosity similar to that of water when applied directly
by the user using manual (i.e. hand) application.
[0024] A lipophilic viscous carrier such as a cream can further
protect the skin and reduce risks of irritation from the
alpha-hydroxy acid. One or more suitable alpha-hydroxy acids in
combination with a viscous lipophilic carrier can be applied to the
pudendum using the fingers or via a wipe or pad, or can be
transferred from another article such as the pretreated surface of
an absorbent feminine pad such as a pantiliner. In typical
embodiments, the composition is only applied to the pudendum or
other external skin and is not applied to the vagina. Indeed,
indicia or other information associated with compositions within
the scope of the present invention may direct the user to not apply
the composition within the vagina, and may further indicate that
the formulation is intended for application only to the pudendum if
prevention or reduction of fishy odor is desired, or for improved
health of the pudendal region.
[0025] Thus, in one aspect, a product is disclosed for application
to the pudendum of a user to reduce fishy odor, the product
comprising about 0.5 weight percent or greater mandelic acid in a
viscous lipophilic carrier, the product being physically associated
with indicia specifying that the product should be applied to the
pudendum. As used herein, "physically associated with" refers to
indicia on an item physically proximate to the product to enable a
user to obtain the information or directions given by the indicia,
and more specifically refers to indicia such as printed
instructions located on a container that contains the products or
on a label or other printed surface connected to a container of the
product or its associated packaging. Examples can include
instructions disposed on or near a dispenser of the product, a
printed card intended to be distributed with the product and
provided near or attached to the packaging, or a label on a tube or
tub that contains the product. Indicia need not be physically
printed with ink but may be displayed in other ways, including
electronic display on electronic paper or other display means
physically associated with the product.
[0026] Compositions within the scope of the present invention may
be provided in the form of pre-treated wipes, including wet wipes
or wipes pretreated with a viscous lotion, or may be applied to a
wipe shortly before contacting the wipe to the pudendum or any part
thereof. In one embodiment, for example, a cream comprising one or
more suitable alpha-hydroxy acids is applied to a wipe, including a
dry wipe or a wet wipe, prior to use. The wipe may be packaged with
the cream already in contact therewith, or may be packaged with or
marketed in association with a quantity of the cream that can be
manually applied to the wipe prior to contacting the wipe with the
pudendum, such that the cream is transferred to the pudendum. As
used herein, a "cream" is generally an emulsion having a kinematic
viscosity of greater than 500 centistokes, typically in the range
of 10,000-50,000 centistokes.
[0027] The carrier need not be lipophilic and may, for example,
comprise an aqueous gel or other aqueous bioadhesive comprise a
hydrated polymer. Alternatively, a substantially aqueous,
low-viscosity carrier may be used similar to traditional
water-based wet wipe formulations, but comprising a suitable
alpha-hydroxy acid. For the alpha-hydroxy acid to remain effective
on the pudendum for a prolonged period of time after application
with a wet wipe-style product, additional measures may be taken
such as encapsulation of at least a portion of a quantity of an
alpha-hydroxy acid for sustained release thereof, or providing of
delivery means for sustained contact of a low-pH solution with a
portion of the pudendum.
[0028] In some versions, the with one or more suitable
alpha-hydroxy acids is provided in a container or with a kit that
contains or is physically associated with indicia instructing the
user that the composition is to be applied to the pudendum. The
indicia may indicate that the composition should only be applied to
pudendum or more generally that it is intended for use on the
pudendum or should be applied on the pudendum. The indicia may
further specify suggested methods for repeat application, including
time intervals or conditions which would require more frequent
application. In some versions, the indicia indicate that the
product can help control fishy odor arising from the pudendum, and
may indicate the benefit can be obtained by maintaining a suitable
pH range in the environment on the pudendum.
[0029] In one aspect, a composition is disclosed which comprises a
viscous lipophilic carrier and at least 1% by weight of an
alpha-hydroxy acid having a molecular weight of at least 125 or at
least 140 (the molecular weight of mandelic acid is about 152), or
having at least 1% by weight of mandelic acid or a derivative
thereof. In some versions, the alpha-hydroxy acid may have a
solubility in water of at least 1 gram per 10 ml of water (mandelic
acid has a solubility of 1 gram in 6.3 ml of water) at 25.degree.
C., and/or may have an acidity expressed as pKa of at least about
2.0 or at least about 3.0 (larger numbers indicate weaker acids;
mandelic acid has a reported pKa of 3.37 and lactic acid has a
reported pKa of 3.86). The composition may be provided in a
container provided with indicia instructing users to apply the
composition to the external skin of the pudendum, and may further
specify that so doing will help reduce undesirable odor or the
bacteria that cause such odor, and may further indicate that odor
control can thereby be provided over a prolonged period of
time.
[0030] In another aspect, a method is disclosed for reducing
undesirable odors arising from the pudendum of a user, the method
comprising: a) providing a composition comprising at least 0.5% by
weight of mandelic acid or a derivative thereof disposed in a
viscous substantially lipophilic carrier, and b) instructing a user
to apply the composition to the user's pudendum.
[0031] The method may further comprise making a claim that the
composition is effective in reducing fishy odor, and may also
include further instructing the user to repeat application of the
composition to the pudendum after a prolonged period of time has
occurred and/or after exposure to conditions likely to elevate the
pH of the environment of the pudendum, such as intercourse,
contract with blood or feces, or bathing with soap.
[0032] In one aspect, a wipe product is disclosed for reducing the
production of unwanted odor from the pudendum, the product
comprising an openable enclosure containing at least one wipe
pretreated with an acidifying composition, the acidifying
composition comprising at least about 0.5% by weight of a first
alpha-hydroxy acid comprising at least 7 carbons, having a
molecular weight in the range of about 135 to about 400, and having
no more than one carboxylic acid group for every 7 carbons, the
acidifying composition having a pH of from about 3.5 to about 4.5
and further comprising at least 50% by weight of a viscous
lipophilic carrier, wherein upon wiping the pudendum with one of
the at least one wipes, the acidifying composition is adapted to
transfer in part to the pudendum and have a substantial portion
thereof remain in contact with the pudendum for a prolonged period
of time after wiping, thereby effectively lowering the pH on the
treated portion of the pudendum for a prolonged period of time. The
acidifying composition may comprise mandelic acid or its
derivatives, and in related embodiments mandelic acid in an
effective amount is present in combination with one more additional
alpha-hydroxy acids such as lactic acid, in a substantially
lipophilic carrier having rheological properties of a bioadhesive
or otherwise have sufficient non-Newtonian properties (e.g, a
relatively high yield stress) such that it does not readily flow
off the body under the influence of gravity after application to
the body. Other alpha-hydroxy acids that may be considered in
various embodiments.
[0033] As used herein, a material with a relatively high yield
stress may be said to "not substantially flow in response to
gravitational force" or "not readily flow off a surrface under the
influence of gravity" if, when applied uniformly to a vertical
surface such as a vertical sheet of clean sodium glass with the
applied layer having a thickness of 2 millimeters over a 2
cm.times.2 cm area defining a square with top and bottom sides
parallel to the horizontal plane, the effect of gravity in
redistributing the applied material is relatively minor such that
after 30 seconds of exposure to gravity, the upper half of the
square (a 2 cm.times.1 cm region of the coated area) still has at
least 30% of the originally applied mass (with no flow at all, it
would have 50% of the originally applied mass). The test should be
done at 23.degree. C.
[0034] In some embodiments, a first alpha-hydroxy acid such as
mandelic acid and optionally a second alpha-hydroxy acid
composition, such as lactic acid or other acids, is combined to
provide a long-lasting acidifying composition that can control the
pH of the pudendum after application for a prolonged period of time
such as at least about 10 minutes, 30 minutes, 60 minutes, 6 hours,
12 hours, or 24 hours. Indeed, in some embodiments, it has been
found that a single treatment with compositions described herein
can provide effective control in preventing fishy odor for periods
of 24 hours or longer.
[0035] In some embodiments, the carrier can be a lipophilic carrier
such as a cream comprising an oil/water emulsion and having a
finite yield stress to allow substantial quantities to remain in
contact with the body after application over a prolonged period of
time. Yield stress may be measured using a static vane-based test
method with the Brookfield YR-1 of Brookfield Engineering
Laboratories (Boston, Mass.). The yield stress at 25.degree. C. may
be, for example about 2 kPa s or less, or about 1 kP s or less, or
about 0.2 kPa s or less. Other techniques for providing sustained
presence of acids may be considered in various embodiments,
including the use of time-release encapsulation technology or
barriers that release the actives when triggered by moisture, pH,
activity, or other conditions.
[0036] The carrier can be made from a variety of known agents. It
may comprise a viscous, lipophilic base that is substantially water
free or is a mixture of lipophilic components and an aqueous
solution such as an emulsion. The carrier may also be a hydrophilic
base such as a gel, including bioadhesive gels, or a solution such
as the wetting solution of a wet wipe. The carrier may also be a
foam or other forms discussed herein.
[0037] In one version, a composition for preventing fishy odor is
delivered using a wipe. The wipe may be provided with the
composition already present, such as a wet wipe or impregnated wipe
holding the viscous carrier and active ingredients. Alternatively,
the composition may be provided separately for the user to apply
using a wipe or other substrate such as a tissue. In one version, a
single-use pouch or kit comprises a wipe and a separate dose of the
composition that can be released on to the wipe prior to
application.
[0038] Composition according to selected embodiments of the present
invention may have a pH (as measured, for example, with pH test
trips at 22.degree. C.) of about 3.0 to about 5.0, or from about
3.2 to about 4.5, or from about 3.3 to 4.2, such as from about 3.5
to about 4.2.
[0039] Compositions according to selected embodiments of the
present invention can be provided in a wide variety of forms, such
as gels, creams, foams, impregnated pads or strips, and the like,
many of which can be suitable for prolonged contact against the
human body. Prolonged contact can be achieved direct application of
the active ingredients onto the skin by any known means, including
the use of bioadherents, or by mechanical means in which an article
comprising a composition of the present invention is held in place
against the body by, for example, contact with underwear or other
clothing.
[0040] Some forms of useful products are intended for brief contact
with the human body, such as wet wipes or treated pads that may
make brief contact with the skin of the pudendum to deliver active
ingredients, though in such products, the active ingredients may be
provided in a composition that remains on the skin to provide
protection over a prolonged period of time. Compositions of
selected embodiments of the present invention may also be provided
in forms intended for direct application to the human body such as
rinses, washes, sprays, and the like.
[0041] For embodiments in which a formulation is applied using a
wipe, the wipe can serve not only to deliver the active ingredients
to lower the pH on the body over a prolonged time but also to
mechanically remove debris. Methods of use could include daily
treatment such as after bathing to clean and acidify the pudendum.
The treatment could include use of a prepackage, pretreated wipe or
of an ordinary wipe that is wetted or coated with a formulation as
described herein.
[0042] In other embodiments, at least one active ingredient may be
in substantially dry or solid form, such as a powder attached to or
disposed within a pad. When wetted by water or aqueous fluids prior
to, during, or after application of the active ingredient to the
body, the active ingredient may at least partially dissolve to more
effectively control the acidity of the environment (e.g., that of
material on the skin of the pudendum) or to deliver other
benefits.
[0043] In another aspect, a method is disclosed for reducing or
preventing malodor from the pudendum, comprising: (a) providing a
user with a product comprising an acidifying composition having at
least about 0.5% by weight of mandelic acid, said acidifying
composition having a pH between about 3.2 and 4.5, and (b)
providing directions to the user to apply the acidifying
composition to the pudendum. The acidifying composition may further
comprise at least about 1% by weight of a second carboxylic acid
component such as lactic acid. In some embodiments of the method,
the acidifying composition may have a non-zero yield stress and the
directions for use are adapted to cause the acidifying composition
to effectively remain in contact with the human body for a period
of at least 10 minutes after applying the acidifying composition to
the pudendum according to the directions. The acidifying
composition may have a a lipophilic carrier or be in the form of an
aqueous solution or may comprise an aqueous solution, and may be
substantially hydrophilic. The product and the directions may be
adapted such that the composition, when applied according to the
directions, will be effectively kept in contact with the pudendum
for a period of at least 60 minutes, and wherein the pH on the skin
in contact with the composition is between about 3.5 and 4.5 during
a majority of the at least 60 minutes. Skin pH can be measured with
dry pH electrodes, as is known in the art. See, for example, B.
Eberlein-Konig et al., Acta Derm Venereol. 2000, vol. 80, pp.
188-191, available online at
http://adv.medicaljournals.se/files/pdf/80/3/188-191.pdf.
[0044] The method may further comprise (c) providing one or more
wipes for use with the product, and the step of providing
directions to the user may then include providing directions to
transfer the product from at least one of the one or more wipes to
the pudendum.
BRIEF DESCRIPTION OF THE DRAWINGS
[0045] FIGS. 1A, 1B, and 1C show views of a wipe originally sealed
in a pouch, the wipe comprising a formulation for reducing
malodor.
[0046] FIG. 2 shows one version of a container holding multiple
individually sealed wipes for reducing malodor.
[0047] FIG. 3 shows a telescopic view of a tub for wipes and
further comprisinig a container of a cream for application to the
wipes, the cream comprising a formulation for reducing malodor.
[0048] FIG. 4 shows a plan view of a wipe with discrete zones
comprising an active ingredient for reducing malodor.
[0049] FIGS. 5A and 5B show experimental TMA versus time profiles
for liquid samples containing bacteria and choline with and without
a quantity of added material according to an embodiment of the
present invention.
[0050] FIGS. 6A and 6B show experimental TMA versus time profiles
for liquid samples containing bacteria and choline with and without
a quantity of added material according to an embodiment of the
present invention.
[0051] FIGS. 7A and 7B show experimental TMA versus time profiles
for liquid samples containing bacteria and choline with and without
a quantity of added material according to an embodiment of the
present invention, further showing the effect of different
concentrations of the added material.
DETAILED DESCRIPTION OF THE DRAWINGS
[0052] FIG. 1A depicts an individual use product 20 containing a
folded wet wipe 24 sealed within a sealed pouch 22, the wipe 24
comprising a formulation (not shown) for reducing malodor in the
pudendum. The pouch 22 may be made of a film or foil wrap or any
other suitable flexible materials, and generally comprises a front
side 26, a back side 28, a top end 32, and a bottom end 34, the top
end 32 comprising a tear line 30 which may be perforated, for
example, and a tear-away portion 36 which is removed by tearing
along the tear line 30 to open the pouch 22. Of course, many
alternative means may be used to provide for opening the pouch 22,
including resealable flaps (not shown), tear lines along any region
of the pouch 22, slidable or resealable closures (not shown) such
as those commonly used in sandwich bags, and the like. In related
embodiments not shown here, multiple wipes may be disposed in a
pouch 22.
[0053] FIG. 1B depicts the pouch 22 of FIG. 1A after the tear-away
portion 36 thereof has been removed, opening the pouch 36. As
depicted, the wipe 24 has been partially removed from the pouch 22.
The wipe 24 is a folded wipe with a Z-style fold, though any
suitable folded configuration may be used.
[0054] FIG. 1C shows the wipe 24 of FIG. 1B having been fully
removed from the pouch 22 and substantially unfolded. The depicted
wipe 24 is generally rectangular in shape, but any suitable shape
may be used such as oval, elliptical, triangular, irregular shapes,
and so forth (not shown). The wipe 24 may have any suitable
unfolded width and length. For example, the wet wipe may have an
unfolded length of from about 2.0 to about 80.0 centimeters or from
about 10.0 to about 25.0 centimeters and an unfolded width of from
about 2.0 to about 80.0 centimeters or from about 10.0 to about
25.0 centimeters. FIG. 2 shows one version of a container 40
holding multiple individually wrapped products 20 such as those of
FIG. 1A, each having a sealed pouch 22 comprising wet wipes (not
shown) for reducing malodor, further comprising a top end 32, a
tear line 30, and a tear-away portion 36. The container 40 may be
made of paperboard, plastic, foil, foam, or combinations thereof,
and generally comprises a resilient rear panel 42 and a pocket
element 44 defining a pocket 46. A bottom element 48 closed the
bottom of the pocket 46. The pocket 46 can receive a plurality of
the individually wrapped products 20. An optional closure element
(not shown) may be attached to the rear panel 42 or the pocket
element 44 that can be folded or pivoted over the exposed products
20 to close the container 40.
[0055] The wipe 24 may comprise a basesheet with total (dry) basis
weight of from about 25 to about 120 grams per square meter and or
from about 40 to about 90 grams per square meter. The basesheet may
comprise a multilayer structure with, for example, laminated,
bonded, or adjacent layers differing in fibers (e.g., coform with
polyethylene versus coform with polypropylene or differing in the
cellulosic fibers used), fiber treatments, adhesives, etc. Coform
may be used for one or more layers or components, as described in
U.S. Pat. No. 4,100,324 to Anderson et al. which issued Jul. 11,
1978; U.S. Pat. No. 4,604,313 to McFarland et al. which issued Aug.
5, 1986; and U.S. Pat. No. 5,350,624 which issued Sep. 27, 1994;
which are herein incorporated by reference to the extent they are
consistent herewith.
[0056] FIG. 3 shows a telescopic view of a portion of a wipes
container 50 showing a lower body 56 adapted to contain a stack of
wipes 24 and a cream dispenser 52 depicted here as a simple well 54
holding a quantity of cream 56 comprising a composition effective
in controlling malodor on the pudendum. The well 54 may comprise a
resilient material such as a polyolefin plastic or may have
flexible walls. The well 54 may be separable from the lower body 56
of the wipes container 50 or may be unitary therewith, such as a
well 54 formed with the lower body 56 from plastic injection
molding (not shown). The cream dispenser 52, in other embodiments,
may be replaced with other known dispensers of formulations,
including flexible pouches (not shown) that can release a cream by
squeezing, or dispensers with mechanical means for dispensing such
as pumps (not shown).
[0057] The lower body 56 has a floor 62 and side walls 60. The
lower body 56 receives the stack of wipes 24 as shown along the
telescoping axis 64A, and also receives the cream dispenser 52
along the parallel telescoping axis 64B.
[0058] A covering for the container 50 is not shown, but any known
covering may be used such as a removable lid or a hinged lid
connected to or integral with the lower body 56. In use, the
covering (not shown) may be opened to allow a user to remove a wipe
24, apply a quantity of the cream 56 to the wipe 24, and then apply
the wipe to the body.
[0059] FIG. 4 shows a plan view of a wipe 24 with multiple discrete
zones 70 comprising an active ingredient for reducing malodor. The
wipe 24 itself may be a nonwoven web or other flexible porous
substrate, and may be a wet wipe impregnated with an aqueous
solution or may be a dry wipe. The discrete zones 70 in this
embodiment are shown as circles, but they may be in any shape,
size, or arrangement, such as parallel bands, irregular patches,
rectangles, lines and dashes, triangular regions, and combinations
thereof. The discrete zones 70 may comprise a cream, ointment,
lotion, or semi-solid material comprising a composition for
reducing malodor according to various embodiments described herein,
The composition may comprise an acidifying agent and may, for
example, comprise mandelic acid in a viscous lipophilic carrier and
may have a pH from about 2.8 to about 5 or more specifically from
about 3.2 to about 4.5, and more specifically still from 3.2 to
4.5. The discrete zones 70 may be substantially topical relative to
the wipe 24, such that a majority of the mass in the discrete zones
70 is deposited above the upper surface of the substrate of the
wipe 24 (e.g., elevated regions). Alternatively, the discrete zones
70 may be defined by matter that is substantially impregnated into
the wipe 24, or may comprise both elevated regions and impregnated
regions. The wipe 24 may be textured (not shown), with treated
discrete zones 70 corresponding to topographical features on the
wipe such as elevated structures or depressed regions (not
shown).
[0060] FIGS. 5A and 5B, 6A and 6B, and 7A and 7B show experimental
results regarding the suppression of TMA production by bacteria in
the presence of choline as a function of time and as a function of
the presence of a material according to an embodiment of the
present invention. These figures are described in more detail in
the discussion of Example 6 hereafter, but do show that a
formulation according to an embodiment of the present invention is
effective in reducing TMA production by bacterial that are
frequently found on human skin.
FURTHER DETAILED DESCRIPTION
[0061] The acidifying components of the formulation generally
include a first alpha-hydroxy acid such as mandelic acid (also
known as phenylglycolic acid) and optionally a second alpha-hydroxy
acid composition such as lactic acid and/or other carboxylic acids,
including acids such as citric, glycolic, 2-hydroxybutyric acid,
tartaric acid; gluconic acid or other isomers of
pentahydroxyhexanoic acid; hydroxycaprylic acid, leucic acid
(2-hydroxy-4-methylpentanoic acid), ethylglycolic acid, malic acid,
and the like. U.S. Pat. No. 5,091,171, "Amphoteric Compositions and
Polymeric Forms of Alpha Hydroxyacids, and Their Therapeutic Use,"
issued February, 1992 to Yu et al., describes alpha hydroxyl acids
that can be considered for use with various embodiments of the
present invention. The first alpha-hydroxy acid may have at least 7
or at least 8 carbons for each carboxylic acid group and may have a
molecular weight from about 135 to about 400, more specifically
from about 135 to about 250, from about 135 to about 200, or from
145 to 170. The first alpha-hydroxy acid may be monoprotic (a
monocarboxylic acid) or, in some versions, diprotic (a dicarboxylic
acid), though larger numbers of carboxylic acid groups may be
considered. In other versions, the first alpha-hydroxy acid or both
the first and second alpha-hydroxy acid may have a molecular weight
of 90 or greater, 100 or greater, 120 or greater, 150 or greater,
or 160 or greater. The first alpha-hydroxy acid also may have at
least one aromatic ring such as a phenyl group. (Mandelic acid is
the smallest alpha hydroxyl acid with an aromatic ring.) Without
wishing to be bound by theory, it is believed that the first
alpha-hydroxy acid as described is large enough to not rapidly
penetrate into the stratum corneum of the skin, allowing it to
remain present and active on the surface of the skin for a
prolonged period of time, while it is also small enough to be
biologically active to modify the bacterial environment on the skin
and/or to maintain an acidic condition on the surface of the skin.
The relatively high molecular weight and larger number of carbons
per acid group in such acids may also reduce the potential for
irritation to the skin.
[0062] In some embodiments, other alpha-hydroxy acids comprising
aromatic rings may be used, including derivatives of mandelic acid
such as those described in U.S. Pat. No. 6,777,224, "Method for
Producing Optically Active Mandelic Acid Derivatives," issued Aug.
17, 2004 to Mitsuhashi et al., or the dimmers and other derivatives
described in U.S. Pat. No. 5,932,619, "Method for Preventing
Sexually Transmitted Diseases," issued Aug. 3, 1999 to Zaneveld et
al., both of which are herein incorporated by reference to the
extent that it is noncontradictory herewith.
[0063] The second alpha-hydroxy acid composition may, in some
embodiments, help improve the efficacy of the first alpha-hydroxy
acid while also contributing to desired acidity on the skin and
optionally may also have an antimicrobial effect relative to
unwanted bacteria that otherwise could contribute to an undesired
fishy odor. The second alpha-hydroxy acid composition may comprise
alpha-hydroxy acids having, individually or averaged, a molecular
weight of about 170 or less, such as from 75 to 135, from 75 to
125, or from 80 to 85, or from 86 to 92.
[0064] The alpha-hydroxy acids in total may be present in any
suitable concentration, such as 30% by weight or less, 20% by
weight or less, or 10% by weight or less, and more specifically
from about 0.3% to 10% (percentages in reference to chemical
compositions herein will be understood to be weight percent unless
otherwise indicated), from about 0.5% to about 6%, from about 1% to
about 15%, or from about 0.5% to about 3.5%, or from about 0.1% to
about 2.5%.
[0065] In one version, the second alpha-hydroxy acid composition
comprises at least about 30%, at least about 50%, at least about
70% or at least about 93% lactic acid by weight (i.e., weight %) of
lactic acid, such as from about 30% to about 90%, or from about 50%
to about 95%; or from about 50% to about 95% lactic acid by weight.
In one version, the second alpha-hydroxy acid is substantially all
lactic acid.
[0066] Examples of formulations can include lotions, creams, gels,
wipe solutions, sprays, powders, etc., with the following
acidifying compositions, expressed as weight percents: 1.5% lactic
acid and 0.5% mandelic acid; 2.5% lactic acid and 1% mandelic acid;
25% lactic acid and 2% mandelic acid; 10% lactic acid and 10%
mandelic acid; 5% lactic acid and 4% mandelic acid; etc.
[0067] The alpha-hydroxy acids may, at least in part, be provided
in time-release systems that gradually release the alpha-hydroxy
acid to be effective in controlling the pH of the pudendum.
Time-release technology can include microencapsulation and other
systems known in the art. Time-release or other controlled release
means are well known in the art. Some versions, by way of example,
are described in U.S. Pat. No. 5,756,136, "Controlled Release
Encapsulation Compositions," issued May 26, 1998 to Black et al.;
and U.S. Pat. No. 6,835,397, "Controlled Release Encapsulated
Bioactive Substances," issued Dec. 28, 2004 to Lee et al.; both of
which are herein incorporated by reference to the extent that they
are noncontradictory herewith.
[0068] In many embodiments, the formulations and methods disclosed
herein avoid the problems of stinging or other forms of irritation
that are known in some prior products. Sting-free formulations, for
example, may be substantially free of ethanol, propanol, or other
agents that may sting delicate tissues in the pudendal region.
[0069] While the products and methods described herein are
particular suited for controlling unwanted fishy odor from the
pudendum of adult or teenaged females, they may also be adapted for
males in general, such as adult males. They may also be adapted for
children in general, such as infants and toddlers.
Absorbent Articles
[0070] A wide variety of absorbent articles may be used to deliver
formulations or assist in modifying the conditions of the pudendum
to inhibit odor formation and release. Absorbent articles can
include feminine pads, interlabial devices, tampons, incontinence
devices such as diapers and related articles, briefs, panties, and
the like. Description of exemplary products can be found in, by way
of example only, the following: U.S. Pat. No. 7,201,743,
"Incontinence Diaper for Adults," issued Apr. 10, 2007 to Rohrl;
U.S. Pat. No. 6,454,751, "Absorbent Articles Having Hinged
Fasteners," issued Sep. 24, 2002 to Olson; U.S. Pat. No. 5,830,206,
"Pants-Type Diaper or Sanitary Panty," issued Nov. 3, 1998 to
Larsson; U.S. Pat. No. 5,620,432, "Tape tab fasteners for
disposable absorbent articles," issued Apr. 15, 1997 to Goulait et
al.; U.S. Pat. No. 6,620,146, "Adult Incontinence Article with
Body-Shaping Elastics," Sep. 16, 2003 to Gibbs; U.S. Pat. No.
6,375,646, "Absorbent Pants-Type Diaper," issued Apr. 23, 2002 to
Widlund et al.; U.S. Pat. No. 2,092,346, "Catamenial Pad," issued
to Arone on Sep. 7, 1937; U.S. Pat. No. 3,905,372, "Feminine
Hygiene Protective Shield," issued to Denkinger on Sep. 16, 1975;
U.S. Pat. No. 2,662,527, "Sanitary Pad," issued to Jacks on Dec.
15, 1953; U.S. Pat. No. 4,631,062, "Labial Sanitary Pad," issued to
Lassen et al. on Dec. 23, 1986; all of which are herein
incorporated by reference to the extent that it is noncontradictory
herewith.
[0071] Disposable absorbent articles generally have a body facing
intake layer comprising a porous web or film, an absorbent core,
and an impervious backsheet, with other optional components as is
known in the art. In some versions, the intake layer is integral
with the absorbent core or is not present as a distinct separate
component. In some versions, the backsheet is integral with the
absorbent core or similar functionality is provided by treating the
absorbent core with, for example, a hydrophilic material on the
outer surface.
[0072] The absorbent core can be made of any suitable
liquid-absorbent materials such as comminuted wood pulp that is
generally referred to as airfelt, as well as materials such as
cotton; creped cellulose wadding; meltblown polymers including
composites with wood fibers such as coform; chemically modified or
cross-linked cellulosic fibers; synthetic fibers such as
bicomponent spunbond or crimped polyester fibers; peat moss; tissue
materials including tissue wraps and tissue laminates; absorbent
foams; absorbent sponges; superabsorbent polymers; absorbent
gelling materials; or any equivalent material or combinations of
materials, or mixtures of these. The absorbent materials may
comprise folded tissues, woven materials, nonwoven webs, needle
punched rayon, and thin layers of foam. Absorbent portions of the
product may comprise a single material or a combination of
materials, such as a wrapping layer surrounding a central wadding
comprised of a different absorbent material.
[0073] The backsheet may comprise a woven or nonwoven material,
polymeric films such as thermoplastic films of polyethylene or
polypropylene, or composite materials such as a film-coated
nonwoven material. It may be flexible and adapted to fit into or
attach to undergarments such as panties. It may be provided with
adhesive material and may have tabs for wrapping around the sides
of undergarments. Other attachment means that may cooperate with or
attach to the backsheet may be used such as hook and loop
attachment or other mechanical attachment means, coadhesive
materials, snaps, belts, ligaments, and the like.
[0074] A suitable topsheet may be produced from materials such as
woven or nonwoven webs comprising natural fibers (e.g., wood,
cotton, or other cellulosic fibers), synthetic fibers (e.g.,
polyester, rayon, polypropylene, or polyethylene fibers) or from a
combination of natural and synthetic fibers. Other woven and
nonwoven materials may include apertured formed thermoplastic
films, apertured plastic films, and hydroformed thermoplastic
films; porous foams; reticulated foams; reticulated thermoplastic
films; and thermoplastic scrims.
[0075] The topsheet may comprise an apertured formed film such as
those described in U.S. Pat. No. 3,929,135, "Absorptive Structures
Having Tapered Capillaries", issued to Thompson on Dec. 30, 1975;
U.S. Pat. No. 4,324,246, "Disposable Absorbent Article Having A
Stain Resistant Topsheet", issued to Mullane et al. on Apr. 13,
1982; U.S. Pat. No. 4,342,314, "Resilient Plastic Web Exhibiting
Fiber-Like Properties", issued to Radel et al. on Aug. 3, 1982;
U.S. Pat. No. 4,463,045, "Macroscopically Expanded
Three-Dimensional Plastic Web Exhibiting Non-Glossy Visible Surface
and Cloth-Like Tactile Impression", issued to Ahr et al. on Jul.
31, 1984; and U.S. Pat. No. 5,006,394, "Multilayer Polymeric Film"
issued to Baird on Apr. 9, 1991. The topsheet, for example, may be
similar or identical to the material employed by The Procter &
Gamble Company of Cincinnati, Ohio known as the "DRI-WEAVE.RTM."
topsheet.
[0076] Methods of applying the acidifying compositions to the
absorbent articles include spraying, blade coating, contact
coating, curtain coating, application with metered rods,
flexographic printing, gravure printing, ink-jet printing, other
digital printing techniques, and other known methods.
[0077] Lotioned topsheets and methods of manufacturing them are
described in US 20040064117, "Absorbent Article Having a Lotioned
Topsheet," published Apr. 1, 2004 by Hammons et al., herein
incorporated by reference to the extent that it is noncontradictory
herewith.
[0078] U.S. Pat. No. 6,118,041, "Diaper Having a Lotioned
Topsheet," issued Sep. 12, 2000 to Roe et al., herein incorporated
by reference to the extent that it is noncontradictory herewith,
describes an absorbent article worn next to the skin of a user that
can transfer a lotion on the topsheet of the article to the skin of
the wearer. In one version, the Roe patent describes an absorbent
article with a topsheet having a lotion coating which is semi-solid
or solid at 20.degree. C. and which is partially transferable to
the wearer's skin, the lotion coating comprising from about 10 to
about 95% of a substantially water free emollient having a plastic
or fluid consistency at 20.degree. C., wherein the emollient
contains about 5% or less water and emollient comprising a member
selected from the group consisting of petroleum-based emollients,
fatty acid ester emollients, alkyl ethoxylate emollients, and
mixtures thereof, further comprising from about 5 to about 90% of
an agent capable of immobilizing the emollient on said outer
surface of the topsheet, wherein the immobilizing agent has a
melting point of at least about 35.degree. C. and is miscible with
the emollient.
[0079] The immobilizing agent may comprise a member selected from
the group consisting of waxes, polyhydroxy fatty acid amides,
C14-C22 fatty alcohols, C12-C22 fatty acids, C12-C22 fatty alcohol
ethoxylates having an average degree of ethoxylation of about 2 to
about 30, and mixtures thereof. The natural fats or oils of the
oil-in-water emulsion composition may be selected from the group
consisting of: avocado oil, apricot oil, babassu oil, borage oil,
camellia oil, canola oil, castor oil, coconut oil, corn oil
cottonseed oil, evening primrose oil, hydrogenated cottonseed oil,
hydrogenated palm kernel oil, maleated soybean oil, meadowfoam oil,
palm kernel oil, phospholipids, rapeseed oil, palmitic acid,
stearic acid, linoleic acid, stearyl alcohol, lauryl alcohol,
myristyl alcohol, benenyl alcohol, rose hip oil, sunflower oil,
soybean oil, and mixtures thereof. The amount of said fats or oils
used in the composition may be from about 0.5 to about 10 weight
percent, and more preferably from about 1 to about 5 percent.
[0080] U.S. Pat. No. 5,607,760 to Roe, herein incorporated by
reference to the extent that it is noncontradictory herewith,
describes a lotion coating on the outer surface of the non-woven
top sheet of an absorbent article, such as diapers, pull-on
products, adult incontinence devices, and the like. A waterless
lotion composition is reported to convey a desirable therapeutic or
protective coating benefit and to be effective in reducing the
adherence of bowel movement to the skin. The lotion is solid or
semi-solid at 20.degree. C. with a preferred melting point of about
45.degree. C. In one version of a process for the application of
the lotion to a substrate, the lotion composition is placed in a
heated tank operating at a suitable temperature such as about
63.degree. C., then sprayed onto the substrate by a spray head
operating at a warmer temperature such as about 71.degree. C. In
some versions, the system of Roe can be adapted for application of
formulations to prevent fishy odor described herein.
[0081] Absorbent articles capable of transferring a coated or
impregnated material to the body of the wearer may be made
according to the principles described in any of the following US
patents: U.S. Pat. No. 3,860,003 issued to Buell on Jan. 14, 1975;
U.S. Pat. No. 5,151,092 issued to Buell et al. on Sep. 29, 1992;
U.S. Pat. No. 5,221,274 issued to Buell et al. on Jun. 22, 1993;
U.S. Pat. No. 4,988,344 entitled "Absorbent Articles with Multiple
Layer Absorbent Layers" issued to Reising, et al on Jan. 29, 1991
and U.S. Pat. No. 4,988,345 entitled "Absorbent Articles with Rapid
Acquiring Absorbent Cores" issued to Reising on Jan. 29, 1991. The
topsheet may comprise carded and thermally bonded web made by means
well known to those skilled in the fabrics art. In one version, a
suitable topsheet comprises staple length polypropylene fibers
having a denier from about 1.8 to about 4. As used herein, the term
"staple length fibers" refers to those fibers having a length of at
least about 15.9 mm (0.625 inches). The topsheet may, for example,
have a basis weight from about 14 to about 25 grams per square
meter.
[0082] Absorbent articles with pressure-rupturable capsules may
also be considered, including those of U.S. Pat. No. 3,585,998
issued to Hayford et al. which describes a disposable baby diaper,
an interior liner of which carries an array of pressure-rupturable
capsules containing baby oil. The patent teaches that it is
desirable to break the capsules prior to using the diaper by
applying pressure. The principle of pressure-rupturable capsules is
also used in U.S. Pat. No. 3,464,413 issued to Goldfarb et al. for
making bandages capable of delivering a medicinal material to an
injury.
[0083] U.S. Pat. No. 3,896,807 to Buchalter describes an article
impregnated with a solid oil phase of cream formulation which forms
a cream upon addition of moisture thereto. In related adaptations,
the approach of Buchalter could be used to provide a cream that
becomes further activated by body moisture.
[0084] U.S. Pat. No. 3,489,148 to Duncan et al. teaches a baby
diaper comprising a hydrophobic and oleophobic topsheet wherein a
portion of the topsheet is coated with a discontinuous film of
oleaginous material.
Wipes
[0085] Wipes, whether dry, wet, or in other states, can be made
from any suitable substrate that provide a flexible surface useful
in applying compositions described herein. The wipe may be a
porous, flexible wet wipe capable of retaining and applying a
liquid solution, or may be flexible dry wipe that can apply a
viscous formulation form its surface onto the pudendum. Suitable
materials may include nonwoven or woven fabrics, tissue paper,
composite or multilayered materials, etc, The wipe may be made from
a conventional towelette or wet wipe material or other materials
that have been proposed for wipes such as a nonwoven fabric
including materials such as spunbond webs, meltblown webs,
combinations of polymeric and natural fibers such as spunlace or
coform webs, needlepunched webs, hydroentangled or spunlace
materials, bonded carded webs, electrospun layers, composites or
multilayer fabrics, woven textiles, apertured films, and the like.
Polymeric materials used in the production of nonwoven webs, woven
webs, and films may include polypropylene, polyethylene, PET,
nylons, and the like. Foam pads or layers may be used, including
open cell and closed cell foams, such as polyurethane foams,
regenerated cellulose foams, and the like.
[0086] Examples of materials that may be used in producing wipes as
described herein include those disclosed in any of the following,
alone or in combination: U.S. Pat. No. 5,935,880, "Dispersible
Nonwoven Fabric and Method of Making Same," issued Aug. 10, 1999 to
Wang et al.; U.S. Pat. No. 6,315,864, "Cloth-Like Base Sheet and
Method for Making the Same," issued Nov. 13, 2001 to Anderson et
al.; U.S. Pat. No. 6,416,623, "Method of Producing an Extensible
Paper Having a Three-Dimensional Pattern and a Paper Produced by
the Method," issued Jul. 9, 2002 to Hollmark et al.; U.S. Pat. No.
6,737,068, "Wipe Formulation," May 19, 2004, issued to Durden; U.S.
Pat. No. 7,482,021, "Two-Sided Wipe for Cleaning and Drying a Skin
Surface," issued Jan. 27, 2009 to Tison et al.; US 20020155281,
"Pre-Moistened Wipe Product," published Oct. 24, 2002 by Lang et
al. US; US 20040161991, "Non-Woven Wet Wiping," published Aug. 19,
2004 by Walton et al.; US 20050045293, "Paper Sheet Having High
Absorbent Capacity and Delayed Wet-Out," published Mar. 3, 2005 by
Hermans et al.; all of which are herein incorporated by reference
to the extent that they are noncontradictory herewith.
[0087] Wipes for use with the formulations described herein may
also be made, used, or dispensed according to any of the following:
U.S. Pat. No. 5,292,581, "Wet Wipe," issued Mar. 8, 1994 to
Viazmensky et al.; and U.S. Pat. No. 6,537,631, "Roll of Wet
Wipes," issued Mar. 25, 2003 to Rivera et al., all of which are
herein incorporated by reference to the extent that they are
noncontradictory herewith.
[0088] Wipes may be provided from or in association with dispensers
that provide a quantity of a formulation as described herein useful
in preventing or reducing odor from the pudendum. Such a dispenser
can include a combination of wipe dispenser and spray applicator
for dispensing active ingredients, as described, for example, in US
20090057331, "Wipes Dispenser," published Mar. 5, 2009 by Fryan et
al., herein incorporated by reference to the extent that it is
noncontradictory herewith. Wipes be dispensed from containers such
as plastic or metal tubs or cylinders, from flexible pouches such
as resealable pouches, form cardboard or other cellulosic
containers, and from other known devices for dispensing wipes. U.S.
Pat. No. 6,601,737, "Baby Wipe/Rash Cream Dispenser," issued Aug.
5, 2003 to Gartenberg, herein incorporated by reference to the
extent that it is noncontradictory herewith, can also be adapted to
dispense an effective quantity of a viscous composition comprising
acidifying agents for the reduction of fishy odor when applied to
the pudendum, such that the viscous composition can be applied to a
wipe from the dispenser to assist in application of the formulation
to the pudendum. The wipes may be wet or dry wipes, and may be
pretreated with cleansing compositions, fragrance, and the like,
which can be applied in addition to the acidifying composition as
described herein.
[0089] U.S. Pat. No. 5,971,142, "Absorbent Wipe Dispensing Device,"
issued Oct. 26, 1999 to Jones, describes an absorbent wipe
dispensing device for dispensing absorbent having a wall panel
adapted for removable securement to a wall, which can be adapted
for use with various embodiments described herein. A container for
holding a supply of absorbent wipes is slidably received within the
device which has an opening through it to allow for passage of
absorbent wipes.
[0090] In one embodiment, individually enclosed wipes are provided,
similar to known towelettes such as those discussed in
WO/2003/051227, "Feminine Wipe for Symptomatic Treatment of
Vaginitis," published Jun. 23, 2003 by Syed Rizvi, herein
incorporated by reference to the extent that it is noncontradictory
herewith. Such individual wipes may have dimensions such as
8.times.5.25 inch rectangles, or more generally, rectangles or
other shapes with a first dimension and a second orthogonal
dimension generally aligned with the major axes of the shape (e.g.,
the length of the sides of a rectangle) ranging from about 4 cm to
about 40 cm, or from about 9 cm to about 30 cm. The aspect ratio
(e.g., the length divided by the width, with the longer dimension
being taken as the length) may be about 1, or from about 1 to about
1.6, or from about 1 to about 2.5, or about 1.1 or greater, or less
than 3, by way of example. The wipe may be folded into smaller
dimensions prior to use, and ma be packaged or stored prior to
consumer purchase with individual folded wipe dimensions with first
and second orthogonal dimensions ranging from about 2 cm to about
18 cm, or from about 4 cm to about 12 cm, or less than about 13 cm,
with an aspect ratio of from about 1, or from about 1 to about 1.6,
or from about 1 to about 2.5, or about 1.1 or greater, or less than
about 2. A pouch into which a folded wipe is placed may have
similar but slightly greater dimensions than the wipe itself, with
at least one dimension of the pouch being larger than the
corresponding dimension of the wipe contained therein by no more
than about 5%, about 10%, about 15%, or about 25% of the
corresponding dimension of the wipe. The amount of fluid contained
in the pouch may equal the amount of fluid that a saturated or
less-than-saturated wipe can hold and may be carried completely by
the wipe during manufacturing (i.e., no additional fluid is added
to the pouch beyond what is carried by the wipe itself).
Alternatively, the pouch may contain additional fluid that is
placed in the pouch in addition to what the wipe carries prior to
contact with the pouch, or the wipe may be substantially dry prior
to placement in the pouch and may then be combined with fluid prior
to sealing of the pouch.
[0091] In yet another version, a substantially dry wipe may be
placed in a sealed pouch, after which liquid is injected or
otherwise introduced into the pouch via, for example, a one-way
flow valve or other means, optionally followed by additional
sealing to prevent leakage. The amount of fluid contained in the
pouch may range, by way of example only, from about 1 ml to 50 ml,
from about 2 ml to about 25 ml, or from about 5 ml to about 10 ml.
Alternatively, the amount of liquid present in the pouch or
contained in any wipe may have a mass equal to about 10% or more,
about 30% or more, about 60% or more, about 80% or more, from about
30% to about 300%, from about 50% to about 200%, or from about 70%
to about 150%, of the mass of the dry wipe.
[0092] In one embodiment, the wipes are delivered in a flexible or
rigid container integral with a formulation dispenser for applying
an odor-controlling low-pH formulation on the wipes or the pudendum
directly. The formulation dispenser can be a tab or other closure
element on a pouch that contains a viscous composition that can be
squeezed out through an opening onto a wipe or onto the fingers. In
a related embodiment, the opening of a tab to access the contents
of a container of wipes may also open a seal for a quantity of a
viscous formulation to be applied to the wipe.
Other Product Forms
[0093] A variety of other product forms can be considered.
Single-use sponges in individual wraps can be used, for example,
with instructions and indicia similar to those for wipe products.
The sponge may be polyurethane, regenerated cellulose, and other
known sponge materials. The compositions described herein may be
impregnated in the sponge or applied shortly prior to use. One
example of related materials that can be adapted for use with the
compositions described herein are the vaginal prep sponges marketed
by McKesson. The sponges may be attached to a wand that can be held
by the hand to apply the sponge to the pudendum conveniently. The
wand may be a plastic, paper, or wooden handle. The wand and sponge
may be wrapped in foil or plastic that is removed prior to use. The
dimensions of the sponge may be about 3 cm to 8 cm by about 2 cm to
5 cm by about 1 cm to 3 cm. The sponge may have a raised area for
gripping in the center.
[0094] Sponges on a wand could be used for external use as well as
internal/vaginal use, particular if using a non shedding sponge
material saturated with solution to cleanse the vagina after
intercourse or at the tail end of menses.
[0095] Saturated cotton swabs (i.e., cotton-tipped swabs) can also
be used to deliver the compositions described here. The size of the
swab may be about 2.times.3 cm in size, for example, and may have a
2- to 8-mm diameter applicator stick such as a 3-mm applicator
stick. The swab may packaged in a foil pack with the swab preloaded
with the composition. Swabs may be used, for example, for
convenient application to the interlabial folds, and may be
particularly useful for women that have deep folds. Cotton balls,
textiles, foam pads, or other porous substrates may also be used,
and may be impregnated with a composition effective for controlling
malodor, as described herein, or may be provided with a container
of a composition for controlling malodor, such that the porous
substrate can receive an quantity of the composition and then
transfer it to the pudendal region.
[0096] Spray bottles may be used, for example, for application of
the compositions described herein for post intercourse or bowel
movement and also for postpartum treatments after childbirth. For
example, an accordion pleated plastic bottle could be provided with
a tablet inside with an effervescent composition that rapidly
dissolves when water is added. After adding water, the product
could function like a bidet in a bottle. Such a bottle could be
collapsed when empty for convenience storage and reuse. The "bidet
tablets" and bottles could be provided separately (e.g., the
tablets could be provided in a blister pack).
[0097] In another embodiment, the compositions describes herein
could be provided on a porous web such as a nonwoven web or paper
web, including substrates similar to those used for dryer sheets in
clothing care. The thin, weblike substrate pretreated with the
active ingredients useful for controlling fishy odor may be dry
initially but activated with moisture, or may be provided in an
emulsion or ointment that does not require significant moisture to
become effective in controlling pH on the pudendum. Such a sheet
may be wrapped around, placed in, or otherwise attached to a
feminine pad, underwear or other article that is placed adjacent to
the pudendum.
[0098] In one version, active ingredients described herein are
applied to tissue paper marketed as toilet paper, such as a toilet
paper for female use. In wiping, small quantities of pH controlling
agents can be left on the pudendum to assist on controlling the pH
thereon and in preventing fishy odor or other malodors. In one
related embodiment, "his and hers" rolls of toilet paper can be
marketed in which the "hers" rolls are pretreated with a
composition for delivering one or more alpha-hydroxy acids such as
mandelic acid for use in controlling malodor arising from the
pudendum.
[0099] Feminine pads or wipes can also be provided that can be held
or placed in contact with the pudendum for a short period of time
such as about 2 hours or less, about 1 hour or less, about 30
minutes or less, or about 10 minutes or less, such as about 10
minutes to 60 minutes or about 15 minutes to about 45 minutes. Such
pads or wipes may be adapted to fit into the folds of the pudendum
to deliver active ingredients for pH control. A pretreated wipe may
be placed on another pad or other article for improved contact.
[0100] Active ingredients in powder form may be delivered in a
spray such as a propellant-delivered powder spray may be directed
to spray an article such as the crotch of underwear or the
pudendum-contacting portion of an absorbent article, or may be used
to spray directly on the body. Propellant-free application using a
manually operated pump may be considered, wherein air, for example,
entrains particulates in the dry powder.
[0101] Tampons may also be considered. Such tampons may be provided
with powder in the core of the tampon.
Further Embodiments
[0102] Numerous known compounds may also be present in various
formulations that are within the scope of the present invention.
For example, botanical extracts may be present in effective or
trace amounts. Such extracts may include, for example, extracts
from Yucca schidigera extract, aloe vera, avocado, grapeseed,
lavender, lemon, and the like. The products of the present
invention may also comprise enzymes such as digestive enzymes. Also
present may be useful bacteria in, for example, pro-biotic
formulations. In some embodiments, microencapsulated beneficial
microorganisms may be present, including lactic-acid producing
microbes.
[0103] The products and methods of the present invention may also
be adopted in combination with other known treatments, such as the
treatments for vulvar dystrophy described in U.S. Pat. No.
4,150,128, "Method of Treating Atrophic Vulvar Dystrophy," issued
Apr. 17, 1979 to Jasionowski, herein incorporated by reference to
the extent that it is noncontradictory herewith. Jasionowski
describes pharmaceutical formulations comprising a pharmaceutically
acceptable hydrophilic ointment base containing a suspension of
progesterone (Pregn-4-ene, 3, 20-dione) or other progestins
dissolved in vegetable oil is topically applied to an area
afflicted with vulvar dystrophy. Plant estrogens, including those
obtained from soy and black cohosh, may also be considered.
[0104] Many alternate product formats can be considered. For
example, the compositions of the present invention may be provided
not only in wipes or creams, but also as vaginal suppositories to
provide ongoing release of active ingredients for the pudendal
area. The compositions of the present invention may also be applied
to absorbent articles such as sanitary napkins, feminine pads,
incontinence pads, pantiliners, tampons, and the like. The
compositions of the present invention may be delivered via wet
wipes, wetted sponges, strips of nonwoven materials or other
flexible materials attached to the underwear or temporarily held or
wiped against the body, etc. The compositions may also be delivered
by means of an aerosol spray, a non-aerosol spray such as a
manually pumped spray bottle, a roller with a rolling head that
delivers liquid ingredients from a liquid reservoir, a gel stick,
and the like, including, for example, a tubular delivery device
with a twist-click elevator mechanism in which turning of a lower
portion of the device ratchets up an elevator that expels a cream
or gel from an orifice on a delivery head for application to the
body, similar to the delivery pen used for the Willow-Bark-to-Go
anti-acne treatment of Boscia (Yokohama, Japan).
[0105] The feminine treatment composition may be applied in a
variety of means to deliver active ingredients to the exterior
surface of the user. These delivery means may include feminine pads
(a term intended to comprise sanitary napkins, pantiliners, thong
liners, and a variety of menstrual pads and incontinence products).
The delivery means may also comprise wipes, particularly wet wipes,
that are used to deliver active ingredients in a formulation to the
exterior body of the user in the pudendum or adjacent regions.
Moist or pretreated liners may also be placed in contact with the
body for a period of time, similar to or in conjunction with the
use of feminine pads (e.g., pantiliners). These may be applied
during the day, including throughout the day or for brief periods
of time, such as for 1 minute or longer, 5 minutes or longer, or 20
minutes or longer, including, for example from 10 minutes to 12
hours, from 1 hour to 6 hours, or for about 1 hour to 24 hours, or
less than about any of the following: 24 hours, 6 hours, 2 hours, 1
hours, 10 minutes, 5 minutes, 1 minute, 30 seconds, or 15
seconds.
[0106] The feminine treatment composition may be generally applied
in any known form such as in the form of a spray or a viscous
formulation for application by means other than conventional
spraying. Such a viscous formulation may comprise a cream
(generally understood to comprise an emulsion such as an oil/water
emulsion, including oil-in-water and water-in-oil emulsions) such
as those that may be described as a moisturizer, lotion, liniment,
ointment, salve, etc. The viscous formulation may also appear to be
a jelly, including a single-phase or multi-phase viscous fluid such
as a gel optionally displaying viscoelasticity. The viscous
formulation may be characterized by being flowable under shear
stress, but may have a yield stress such that at very low shear
stress levels, the formulation substantially does not flow. In some
cases, the yield stress may be sufficiently high such that a
quantity of the viscous formulation at room temperature (22.degree.
C.) maybe applied to a substantially vertical section of human skin
without immediately and noticeably flowing under the influence of
gravity alone (specifically, the quantity may be sufficient to coat
a 3 cm diameter circular section of dry, glabrous skin such as skin
on the upper thigh to a depth of about 2 mm without visible
migration of the viscous formulation after 3 minutes of gravitation
pull while the skin is held substantially still in a vertical
orientation). The viscous formulation may also comprise a
substantial quantity of void space or gaseous bubbles and may be in
the form of a foam, a multiphase gel, etc. The formulation may also
be provided as a solid or semisolid material such as a soluble
polymeric film or other film capable of releasing active
ingredients in use, including films comprising slow-release
polymeric substrates. Slow-release polymers for releasing active
ingredients may be used in any other known form as well. The
formulation may also be provided as a wash, as a douche product, as
a suppository, as a coating, liquid, vaginal capsule, vaginal
tablet, vaginal film, vaginal sponge, vaginal ovule, etc., provided
that it is adapted to release active ingredients to the exterior
skin of the user. The formulation may also be applied to a vaginal
insert, tampon, wipe or pad, and then administered to the vagina,
provided that active ingredients can be delivered therefrom to the
exterior surfaces of the body adjacent the vagina.
[0107] For formulations comprising gels, although a variety of
compounds may be employed, water is usually employed as the
dispersion medium for the gel to optimize biocompatibility. Other
possible dispersion mediums include non-aqueous solvents, including
glycols, such as propylene glycol, butylene glycol, triethylene
glycol, hexylene glycol, polyethylene glycols, ethoxydiglycol, and
dipropyleneglycol; alcohols, such as ethanol, n-propanol, and
isopropanol; triglycerides; ethyl acetate; acetone; triacetin; and
combinations thereof. Typically, the dispersion medium (e.g.,
water) constitutes greater than about 75 wt/vol %, in some
embodiments greater than about 90 wt/vol %, and in some
embodiments, from about 95 wt/vol % to about 99 wt/vol % of the
vaginal treatment composition.
[0108] The disperse phase of the gel may be formed from any of a
variety of different gelling agents, including temperature
responsive ("thermogelling") compounds, ion responsive compounds,
and so forth. Thermogelling systems, for instance, respond to a
change in temperature (e.g., increase in temperature) by changing
from a liquid to a gel. Generally speaking, the temperature range
of interest is from about 25.degree. C. and 40.degree. C., in some
embodiments from about 35.degree. C. and 39.degree. C., and in one
particular embodiment, at the human body temperature (about
37.degree. C.). Compositions that change state at about this
temperature are useful because they will remain in a body cavity,
for example, after they have been delivered. Any of a variety of
thermogelling compounds that are capable of gelling when applied to
the vagina may be used in the present invention. In some cases,
thermogelling block copolymers, graft copolymers, and/or
homopolymers may be employed. For example, polyoxyalkylene block
copolymers may be used in some embodiments of the present invention
to form a thermo-gelling composition. The term "polyoxyalkylene
block copolymers" refers to copolymers of alkylene oxides, such as
ethylene oxide and propylene oxide, which form a gel when dispersed
in water in a sufficient concentration. Some suitable
polyoxyalkylene block copolymers include polyoxybutylene block
copolymers and polyoxyethylene/polyoxypropylene block copolymers
("EO/PO" block copolymers), such as described in U.S. Patent
Application Publication No. 2003/0204180 to Huang, et al., which is
incorporated herein in its entirety by reference thereto for all
purposes. For instance, exemplary polyoxyalkylene block copolymers
include polyoxyethylene/polyoxypropylene block copolymers (EO/PO
block copolymers), etc.
[0109] Any suitable gelling agent, including gellan and other
polymers and polysaccharides, may be used, including those
described in U.S. Pat. No. 7,619,008, "Xylitol for Treatment of
Vaginal Infections," issued Nov. 17, 2009 to Yang et al., herein
incorporated by reference to the extent that it is noncontradictory
herewith.
Preservatives and Antimicrobial Agents
[0110] Additional preservatives or antimicrobial agents may be
provided in the formulations and systems described herein. Such
agents may include cetylpyridinium chloride, parabens e.g., (methyl
paraben, ethyl paraben), imidazolidinyl urea, propyl benzoate,
sodium benzoatre, potassium sorbate, and the like. Other
antimicrobial or bacteriostatic agents that may be considered
include, by way of example only, biguanide, chitosan derivatives,
silver nanoparticles or other silver-based compositions and
products capable of releasing silver ions, and the like. Nisin, a
polycyclic peptide antibacterial agent, may also be incorporate in
some embodiments of the formulations of the present invention.
Rheology Modifying Ingredients
[0111] Many known rheology modifiers can be considered to obtain
desired properties, particularly the bioadhesive properties of some
embodiments. Gums such as guar gum or xanthan gum or other
industrial gums, polyvinyl alcohols, polyacrylates,
cellulose-derived polymers such as carboxymethylcellise or
hydroxyalkylcellulose polymers, Laponite, clays, carboxomer
polymers, and numerous other compounds can be considered. Silicone
elastomers can be considered, including those described in U.S.
Ser. No. 09/613,266 (P&G).
[0112] Known bioadhesive polymers may be used as part of the
carrier system, including polyolprepolymers from Barnet Products
Group (Englewood Cliffs, N.J.) and related compounds such as
Barnet's Topicare.RTM. Delivery Compounds and related liquid
polymers. Barnet's polyolprepolymers are polyalkalene glycol-based
polyurethane polymers suitable for use as skin care agents that can
hold active ingredients on the surface of the skin. They do not
absorb substantially into the skin and can remain in place for a
prolonged period of time, being capable of forming a liquid
reservoir on the skin. Specific products include polyolprepolymer-2
(PP-2), polyolprepolymer-14 (PP-14), and polyolprepolymer-15
(PP-15). PP-2 is a lipophilic mixture of liquid hydroxy-terminated
polymers in polypropylene glycol having oligomers with a molecular
weight range of 1,500 to 10,000 and an average molecular weight of
about 4,000 and an HLB in the range of 12-14. At 35.degree. C., it
has a reported viscosity of about 2500 to 4000 cps. PP-14 is
similar but has a higher molecular weight of about 18,000 and is
more lipophilic. It has an HLB of about 11-13. At 35.degree. C., it
has a reported viscosity of about 2500 to 6000 cps. PP-15 is a
mixture of liquid hydroxy-terminated polymers in polyethylene
glycol. It has a molecular weight of about 1,800 and is soluble in
water and alcohol and can be used in aqueous systems with
hydrophilic components. At 35.degree. C., it has a reported
viscosity of about 2500 to 5000 cps. See "Polyolprepolymers:
Properties and Use in Cosmetic Products--Technical Manual," Bertek
Pharmaceuticals, a subsidiary of Mylan Laboratories (Englewood
Cliffs, N.J.), 1996.
[0113] The aforementioned polyolprepolymers are believed to be
particularly useful in enhancing the efficacy of active ingredients
such as alpha-hydroxy acids by holding them on the epidermis level
and reducing irritation.
[0114] Bioadhesive materials useful for some of the embodimenst
described herein may include those discussed in U.S. Pat. No.
6,479,045, "Vaginal pH Buffering for Preventing Miscarriage and
Premature Labor, by Treating or Preventing Bacterial Vaginosis,"
published Nov. 12, 2002 by Bologna et al. The Bologna patent
discusses water-insoluble but water-swellable cross-linked
polycarboxylic acid polymers that may be used in vaginal
treatments. For some versions of the present materials and methods,
the bioadhesives may be modified to comprise suitable alpha hydroxy
acids and other agents, and then marketed as a solution for the
problem of fishy odor by application to the pudendum as opposed to
the vagina.
Skin Benefit Agents
[0115] Non-limiting examples of skin benefit agents that may be
considered for use herein are described in The CTFA Cosmetic
Ingredient Handbook, 2nd Edition (1992), which includes a wide
variety of ingredients commonly used in the skin care industry, and
which may be suitable for use in various embodiments of the present
invention. Non-limiting examples of skin benefit agents include
absorbents, aesthetic components such as fragrances, pigments,
natural extractives such as witch hazel or aloe vera,
colorings/colorants, essential oils, skin sensates, astringents,
etc. (e.g., clove oil, menthol, camphor, eucalyptus oil, eugenol,
menthyl lactate, witch hazel distillate), anti-caking agents,
antimicrobial agents (e.g., iodopropyl butylcarbamate),
antioxidants, colorants, cosmetic astringents, cosmetic biocides,
drug astringents, external analgesics, opacifying agents, pH
adjusters, skin-conditioning and/or moisturizing agents, i.e.
glycerine, skin soothing and/or healing agents (e.g., panthenol and
derivatives (e.g., ethyl panthenol), pantothenic acid and its
derivatives, allantoin, bisabolol, and dipotassium
glycyrrhizinate), retinoids, (e.g. retinol palmitate), tocopheryl
nicotinate, skin treating agents, vitamins and derivatives thereof.
It is to be understood that the actives useful herein can in some
instances provide more than one benefit or operate via more than
one mode of action. Therefore, classifications herein are made for
the sake of convenience and are not intended to limit the active to
that particular application or applications listed.
[0116] Moisturizers may include urea, which may also be used in
combination with lactic acid for effective moisturizing
activity.
Foam Embodiments
[0117] In some embodiments, the active ingredients are delivered to
the body while in a foam state, such as stable foam, for example,
that is produced with or without a propellant. In some versions, a
foam is dispensed from a dispenser such as a propellant-free
dispenser with pumping action to create the foam from a composition
in a foamable carrier, and then applied to a wipe or other
substrate, or applied to the hand of the user or otherwise
delivered to the pudendum. Propellant-driving foam generators may
also be used to deliver the composition in the form of a foam.
[0118] Active ingredients in a foam may be dispensed for subsequent
placement on a dry wipe, a pre-moistened wipe, or other soft,
flexible applicator (e.g., an object about 3-fingers wide or 4 to
10 cm wide) or a finger condom wipe or other object to used for
application of the foam-based composition to the pudendum. The foam
can be a non-propellant foam. A foam with a suitable stiffness of
yield stress can be applied to the pudendum in any manner of
methods for sustained adherence and contact with the body.
[0119] Examples of foam-based systems are described in U.S. Pat.
No. 6,818,204, "Stable Foam for Use in Disposable Wipe," issued to
Lapidus on Nov. 16, 2004, herein incorporated by reference to the
extent that it is noncontradictory herewith. The Lapidus patent,
whose teachings may be adapted for use with the present products
and processes, discusses the use of compatible surfactants, e.g.,
nonionic, anionic, amphoteric, for use in human hygienic products.
The surfactant should be capable of forming a foam when mixed with
air in a finger actuated, mechanical pump foamer. Such surfactants
are said to include, without limitation, those which do not
irritate mucous membranes such as polyethylene 20 cetyl ether (Brij
58).TM., a nonionic surfactant; sodium lauroyl sarcosinate
(Hamposyl L-30).TM., sodium lauryl sulfoacetate (Lathanol LAL).TM.
and sodium laureth sulfate (Sipon ESY).TM.--anionic surfactants;
lauramidopropyl betaine (Monateric LMAB.TM.), an amphoteric
surfactant, as well as polysorbate 20, TEA-cocoyl glutamate,
disodium cocoamphodiacetate and combinations thereof. Typically,
the surfactant is said to present in an amount from about 2% to
about 35% by weight, or from about 5% to about 15% by weight.
[0120] At least one foam stabilizing agent may also be present in
certain foamable embodiments. Suitable foam stabilizing agents may
include, without limitation, natural or synthetic gums such as
xanthan gum, polyalkylene glycols such as polyethylene glycol,
alkylene polyols such as glycerine and propylene glycol and
combinations thereof. Typically, the foam stabilizers may be
present in an amount from about 0.10% to about 5%, or from about 2%
to about 4%.
[0121] In the Lapidus patent (U.S. Pat. No. 6,818,204), alkylene
polyols are said to be typically employed in amounts from about
0.1% to about 10%, gums are employed in amounts ranging from about
0.05% to about 1%, and/or polyalkylene glycols are present in
amounts ranging from about 0.05% to about 2%.
[0122] Preferably, the foam is produced using the F2 Finger Pump
Foamer.TM. manufactured by AirSpray International Inc. of Pompano
Beach, Fla. Such a spring-loaded valve system operates without the
use of gas propellants or the like. Upon actuation, precise amounts
of air and liquid are mixed, and a foam capable of maintaining its
structure for a substantial length of time is dispensed. In
addition, the dispenser can deliver a variable amount of foam,
thereby reducing waste of the wipe agent contained therein.
[0123] A suitable foamer, by way of example, is the F2 Finger Pump
Foamer.TM. made by AirSpray. Details of exemplary propellantless
defoamers are described in U.S. Pat. No. 5,443,569, issued on Aug.
22, 1995, and U.S. Pat. No. 5,813,576, issued Sep. 29, 1998, herein
incorporated by reference to the extent that it is noncontradictory
herewith.
Other Ingredients
[0124] Many other ingredients may be used in the formulation
provided they are not antagonistic to the intended function of the
product. Such ingredients may include chelating agents such as
EDTA, fragrances, viscosity modifiers, colors, opacifiers such as
titanium oxide, sensory agents such as menthol or other known
agents capable of producing a cooling or warming sensation on the
skin; essential oils, fatty acids, proteins including various
enzymes; probiotic agents to enhance growth of lactobaccili or
other desirable bacteria, and the like.
[0125] Humectants and solubilizers may be used, such as butylene
glycol.
[0126] In various embodiments, the formulation may be substantially
free of any or all of the following: ethanol, methanol, propanol,
alcohols, alcohols having 3 our fewer carbons, alcohols having 2 or
fewer carbons, glycolic acid, acetic acid, critic acid, latex,
spermicides, Octoxynol-9, TEA (triethylamine, a compound which may
contribute to unwanted odor) or derivatives of TEA, TMA
(trimethylamine), ammonia or complexes thereof, amines, protein,
polyhydroxy fatty acids, polyhydroxy acids, alpha-hydroxy acids
having 14 or greater carbons, fatty acids, polyhydroxy fatty acid
esters (or polyhydroxy fatty acid derivatives such as esters,
amides, and alcohols), benzoic acid, preservatives, perfumes,
artificial colors, sodium bicarbonate, bicarbonates in solid or
ionic form, retinol, or Retin-A. "Substantially free" in this
context may mean lacking an effective quantity. For alcohols and
acids this may be taken as less than 0.1%. In some cases, the
concentration may be less than 0.05%. Xylitol or other 5-carbon
sugars may be used to enhance the antimicrobial benefits of the
composition. See, for example, U.S. Pat. No. 7,619,008, "Xylitol
for Treatment of Vaginal Infections," issued Nov. 17, 2009 to Yang
et al., previously incorporated by reference.
[0127] U.S. Pat. No. 6,440,437, "Wet Wipes Having Skin Health
Benefits," issued Aug. 27, 2002 to Krzysik et al., herein
incorporated by reference to the extent that it is noncontradictory
herewith, describes a soft wet wipe or wipe-type product, such as a
baby wipe, an adult wipe, hand wipe, a face wipe, a cosmetic wipe,
a household wipe, an industrial wipe, a personal cleansing wipe,
cotton balls, cotton tipped swabs, and the like, that can be made
by combining the wipe or wipe-type product with an oil-in-water
emulsion composition comprising a natural fat or oil, sterol or
sterol derivative, humectant, emulsifying surfactant, and water.
Krzysik discuss a wet wipe or wipe-type product with an
oil-in-water emulsion composition comprising a natural fat or oil,
sterol or sterol derivative, humectant, emulsifying surfactants and
surfactant combinations having an HLB range of about 7 to about 18,
and water. The composition is said to readily transfer from the wet
wipe or wipe-type sheet onto the skin being contacted with the
sheet to provide enhanced skin barrier benefits. The natural fat or
oil used in the composition may include borage oil, avocado oil, or
sunflower oil. The sterol or sterol derivative used in the
composition may include soy sterol, avocado sterols, or
cholesterol. The humectant used in the composition may include
glycerin, sorbitol, or propylene glycol. The emulsifying surfactant
used in the composition may include glyceryl stearate SE,
emulsifying wax NF, or propylene glycol oleate SE. The composition
may further comprise from about 0.1 to about 30 weight percent
petrolatum or mineral oil.
[0128] One embodiment drawing upon the Krzysik et al. patent is a
wet wipe or wipe-type product that enhances skin barrier functions
having at least one layer and an oil-in-water emulsion composition.
The oil-in-water emulsion composition may comprise from about 0.1
to about 30 weight percent of natural fats or oils, from about 0.1
to about 10 weight percent of sterol or sterol derivative, from
about 0.1 to about 30 weight percent of humectant, from about 0.5
to about 20 weight percent of emulsifying surfactant having an HLB
range from about 7 to about 18, and from about 45 to about 99.5
weight percent of water. The amount of the oil-in-water emulsion
composition contained within each wet wipe or wipe-type product may
range from about 150 to about 600 weight percent based on the
weight of the product. This formulation can be modified according
to the discoveries disclosed previously to be useful in preventing
unwanted odor, including the use of suitable alpha hydroxy
acids.
[0129] The lists of fats and oils, fatty acids, fatty alcohols,
essential oils, and emulsifying surfactants in the Krzysik et al.
patent (U.S. Pat. No. 6,440,437, previously incorporated by
reference) are in particular incorporated herein by reference and
may be used for various embodiments herein.
[0130] Suitable humectants may include, but are not limited to, the
followingmaterials: acetamide MEA, Aloe Vera Gel, arginine PCA,
chitosan PCA, copper PCA, corn glycerides, dimethyl
imidazolidinone, fructose, glucamine, glucose, glucose glutamate,
glucuronic acid, glutamic acid, glycereth-7, glycereth-12,
glycereth-20, glycereth-26, glycerin, honey, hydrogenated honey,
hydrogenated starch hydrolysate, hydrolyzed corn starch, lactamide
MEA, lactic acid, lactose lysine PCA, mannitol, methyl gluceth-10,
methyl gluceth-20, PCA, PEG-2 lactamide, PEG-10 propylene glycol,
polyamino sugar condensate, potassium PCA, propylene glycol,
propylene glycol citrate, saccharide hydrolysate, saccharide
isomerate, sodium aspartate, socium lactate, sodium PCA, sorbitol,
TEA-Lactate, TEA-PCA, urea, xylitol, and the like, as well as
mixtures thereof.
[0131] Non-ionic silicone surfactants may also be used, according
to US20070141127, "Wet Wipes with Natural Antimicrobial Agents,"
herein incorporated by reference to the extent that it is
noncontradictory herewith. Suitable natural antimicrobial agents
discussed therein may also be combined with the formulations
described here.
[0132] U.S. Pat. No. 5,665,426 to Krzysik et al., herein
incorporated by reference to the extent that it is noncontradictory
herewith, describes a lotion formula that can be applied to a
tissue which will remain available for transfer to the user's skin
to reduce skin irritation and redness. The lotion composition
includes from about 30 to about 90 weight percent of oil, from
about 10 to about 40 weight percent wax, and from about 5 to about
40 weight percent of a fatty alcohol. The melting point of the
lotion composition is from about 30.degree. C. to about 70.degree.
C. The lotion was applied to the tissue via a heated rotogravure
printing process.
[0133] Specifically, the formulation was pre-melted at about
56.degree. C. and the press supply system (supply hose, doctor
application head, and gravure roll) was pre-heated to about
50.degree. C. The deposit solidified almost instantaneously on the
surface of the treated tissue. Such a system can be adapted for
versions of the present system to apply a lotion to a tissue, a
wipe, a topsheet, or other suitable surface for subsequent transfer
to the skin of a user.
[0134] In general, whether applied from a treatment on an absorbent
article, from a wipe of any kind, by a spray, sponge, pads, by the
fingers, or by any other means, the formulation may have the
characteristics of a semi-solid at both 20.degree. C. and at
37.degree. C. (normal internal body temperature). For example, at
20.degree. C., the portion of the formulation that is liquid may be
from about 2% to about 60% by weight, or from about 5% to about 50%
by weight, or from about 5% to about 30% by weight. Upon heating to
37.degree. C., the liquid fraction may be from about 5% to about
80%, or from about 10% to about 75%, or from about 15% to about
70%, which may, for example, represent an increase in the relative
amount of liquid present, wherein the ratio of the liquid weight
percent at 37.degree. C. to the liquid weight percent at 20.degree.
C. may be greater than 1, greater than 1.05, greater than 1.1, or
greater than 1.2, such as from about 1.05 to about 20, from about
1.05 to about 10, from about 1.05 to about 6, or from about 1.20 to
about 10.
[0135] In one version, the formulation may have substantially
liquid properties at room temperature prior to being applied to a
substrate. U.S. Pat. No. 7,169,400, "Waterless Lotion and
Lotion-Treated Substrate," issued Jan. 30, 2007 to Luu et al.,
herein incorporated by reference to the extent that it is
noncontradictory herewith, describes lotion compositions that are
substantially liquid at room temperature (defined by Luu et al. as
being from 20.degree. C. to 25.degree. C.) but which become
semi-solid or substantially more viscous after application to a
substrate such as a cellulosic or other polymeric web as a
component of the composition is absorbed by the substrate. In one
version, Luu et al. describe a lotion including a micro-emulsion,
which comprises a polar emollient, a non-polar emollient, a
non-ionic surfactant, and a co-surfactant wherein at least one of
the emollients has substantial solubility in either cellulosic or
synthetic fiber. For example, at least the polar emollient may be
soluble in cellulosic fibers and the non-polar emollient may be
soluble in synthetic fibers. Polar emollients may include a
polyhydroxy emollient such as propylene glycol, glycol, glycerol,
sorbitol, diethylene glycol, methylene glycol, poly propylene
glycol, poly ethylene glycol, and the like.
[0136] Non-polar emollients may include an aromatic or linear
ester, Guerbet ester, mineral oil, squalane, squalene, liquid
paraffin and the like. The polar or non-polar emollient is either
in the continuous outer phase or in the discontinuous internal
phase of the micro-emulsion. Co-surfactants may include fatty
alcohols. Preferred fatty alcohols include C12 to C18 fatty
alcohols, behenyl alcohol, iso cetyl alcohol, and iso stearyl
alcohol.
[0137] Non-ionic surfactants may include PEG-20 methyl glucose
sesquistearate, PPG-20 methyl glucose ether, PPG-20 methyl glucose
ether distearate, PEG-20 methyl glucose distearate, PEG-120 methyl
glucose dioleate, ethoxylated methyl glucose having from about 10
to about 20 repeating ethoxy units, and the like. The lotion may
comprise, for example, at least 10% polyalkoxy or polyhydroxy
emollient; an aromatic ester, such as C.sub.12 to C.sub.15 alkyl
benzoate ester or mineral oil; and may further comprise myristyl
alcohol and, for example, PEG-20 methylglucose sesquistearate. Such
lotions may be adapted for use with other formulations described
herein and may, for example, further comprise mandelic acid.
[0138] The formulation may also comprise a plurality of other
acidifying agents such as acetic acid, fumaric acid, ascorbic acid,
and the like. Known medicaments may also be included, such as
compositions in pharmaceutically effective concentrations for
treating infections, skin disorders, and other known health
conditions.
Packaging and Dispensing
[0139] Products made according to any of the embodiments of the
present invention may be packaged and/or dispensed in any known way
suitable for any particular product format. Wet wipes, for example,
may be packaged in perforated rolls contained within flexible
pouches or rigid dispensers of any kind. Wipes may also be cut and
folded into known configurations such as C-folds, L-folds, M-folds,
quarter folds, and the like., for dispensing wipes from various
known containers. In some embodiments, each individual wet wipe is
arranged in a folded configuration and stacked one on top of the
other to provide a stack of wet wipes. The stack of folded wet
wipes may be placed in the interior of a container, such as a
plastic tub, to provide a package of wet wipes for eventual sale to
the consumer. Alternatively, the wet wipes may include a continuous
strip of material which has perforations between each wipe and
which may be arranged in a stack or wound into a roll for
dispensing.
[0140] Wipe dispensers and dispensers for other product forms may
include mounted and stand-alone dispensers such as those of Klein
Environmental Supplies, (Englewood Cliffs, N.J.).
[0141] Wipes or absorbent articles used within the scope of the
present invention may be packaged using any known wrapper, pouch,
casing, or other packaging system, such as those described in U.S.
Pat. No. 6,010,001, "Individual Packaging for Hygienic Wiping,"
issued Jan. 4, 2000 to Osborn; U.S. Pat. No. 3,062,371, "Internally
Sterile Composite Package," issued to D. Patience on Nov. 6, 1962;
U.S. Pat. No. 3,698,549, "Packages for Small Articles," issued to
J. A. Glassman on Oct. 17, 1972; all of which herein incorporated
by reference to the extent that they are noncontradictory herewith.
Systems that can be adapted for use with certain embodiments of the
present invention include U.S. Pat. No. 5,180,059, "Package of a
Sanitary Tampon," issued to S. Shimatani and K. Shimatani on Jan.
19, 1993, which describes packaging sheets that help protect the
user's hands during application of the product.
[0142] Wipes and other products may be provided in sterile heat
sealable pouches. Sterilization, if desired, may be provided by
gamma irradiation, microwave radiation, e-beam radiation,
ultraviolet light, steam autoclaving, ethylene oxide treatment, or
any other known method.
[0143] Pouches may substantially consist or comprise foil, foil
laminates, polymeric films, and the like.
[0144] Wipes may also be dispensed from sealable jars such as glass
or plastic jars or other resilient containers. Any known dry or wet
wipe container may also be considered, including resilient plastic
tubs with openings for dispensing of wipes in a pop-up manner, such
as Cottonelle.RTM. wipes from Kimberly-Clark Corporation (Dallas,
Tex.).
[0145] In one version, wipes may be co-packaged with single-use
dispensers of a formulation in the form of a lotion, cream, or
solution, wherein a cardboard or plastic container for wipes (e.g.,
a rectangular container holding plurality of wipes) is connected to
a lid element by a hinge, in which the underside of the lid
contains a plurality of single-use formulation containers such as
pouches that can be opened by squeezing or tearing. The single-use
formulation containers may be held by a pocket on the underside of
the lid element, allowing them to be visible when the lid element
is placed in an upright or open position, allowing both the wipes
and the single-use containers to be visible and readily selected
and taken by a user, as desired. This packaging embodiment may have
a lid element that resembles several popular chewing gum packages
such as those described in US20090150231, "Package Assembly for
Multi-Modality Functional Ingredients in Chewing Gum Compositions,"
published Jun. 11, 2009 by Jani et al.
Directions for Use
[0146] Inidicia placed on or otherwise associated with packaging
may inform users of the benefits of the product, call attention to
the relationship between fishy odor and the non-pathological
environment of the pudendum, provide information about the
importance of maintaining the right pH in that region, and give
instructions for use. Instructions for use may include, by way of
example, information similar to the following:
[0147] "Directions for use. For best product performance, after
showering, blow dry your bottom on a low warm setting until skin is
dry. Apply the cream to the folds between your labia, up onto your
clitoral hood, perineum and between your buttocks including the
area around your anus.
[0148] "For best results, use the wipe to cleanse the areas of your
bottom after urination, bowel movements, intercourse and rigorous
activity. Reapply the cream if needed for added protection
especially after showering."
[0149] Indicia may be placed on the packaging material holding a
container of a composition such as an outer cardboard box, or may
be placed on the container that directly holds the composition
(e.g., a squeezable tube, a plastic or glass jar, a spray bottle, a
foam dispenser, a tube of wipes, etc.). Alternatively or in
addition, instructions for use may be associated with the product
in a variety of ways other that directly printing on a package. The
instructions may be provided on printed material that is
distributed with the product but physically detached therefrom, or
may be on a website or other information source that is associated
with the product (e.g., accessible via a QR code, barcode, RFID
tag, or URL printed on the package). Information about the product
and its use may also be approved in promotional media such as in
television commercials promoting the product. Such information may
point to the surprising discovery that many cases of fishy odor are
not due to pathological conditions in the vagina but are a result
of proximity of sources of anaerobic bacteria to the pudendum
coupled with pH lowering conditions, calling for care in
maintaining a suitable pH in the pudendum.
EXAMPLES
Example 1
[0150] A viscous cream comprising lactic acid, mandelic acid, and
an oil/water emulsion carrier was formulated using the following
ingredients:
[0151] Water
[0152] Lactic acid 8.0%
[0153] Mandelic acid 4.0%
[0154] Glycerin
[0155] Xanthan gum thickener
[0156] Polyquaternium 10
[0157] Aloe vera extract
[0158] Oat extract
[0159] Allantoin
[0160] Chamomile extract
[0161] Sodium hydroxide
[0162] Methylisothiazolinone (preservative)
[0163] Capryl glycol
[0164] The pH of the formulation was 4.0.
[0165] This formulation was then tested with female subjects using
an external test agency. Seventeen product summaries were collected
from test subjects. The summaries are formatted on a 5 point scale
with 5 being the most favorable to 1 being the least. The product
was evaluated on the properties as follows, texture, feel after
applied to the skin, irritability to the application area,
reduction or blocked odor, how well the women liked the product and
whether or not they would use the product again or recommend it to
a friend. Most of the women fell between the ages of 20-50 with the
exception on both extremes, the youngest being nineteen and the
oldest aged sixty-five. One women was pregnant in her third
trimester.
[0166] Each of 5 parameters are separately considered. All 17 gave
the product a 5/5 rating in terms of texture and consistency.
[0167] The product was not irritating to the area of application.
Thirteen of the 17 (76%). gave it a 5/5. Three of the 17 gave it a
4/5 or 18%. Combined 4-5/5 rating is 16/17 or 94%. One woman gave
it a 3/5 rating and then explained that she had stinging upon
initial application that went away quickly. She stated that overall
the product worked and she would buy the product and use in the
future. A point was made by several women that they had a warming
sensation upon initial application that they felt meant it was
working or one woman verbalized that it felt like K-Y warming gel.
None of the women felt that this was a negative. Some said that
they felt that it must be working.
[0168] The product reduced or blocked odor. Thirteen of the 17
(76%) gave the product a 5/5 rating for odor reduction. Three of
the 17 gave a 4/5 or 18%. Combined rating of 4-5/5 is 16/17 or 94%.
Of the women who gave a 4/5 in this category, there were no
additional comments about why they felt it was less than a 5. One
woman gave the product a 3/5. She said that it only made her feel
more wet and she did not like the product. Others stated that they
felt that the product helped with odor during menses, after
intercourse or after working out.
[0169] For overall approval of the product, fourteen of the 17
(82%) gave it 5/5. One woman gave it a 4/5. Combined rating of
4-5/5 is 15/17 or 88%. One woman gave it a 2/5. (the one who did
not like the product because it made her feel more wet). The same
positive numbers were obtained when the subjects were asked if they
would use this product again and recommend it to others.
Example 2
[0170] Another version of a viscous cream was made with the
following ingredients:
[0171] Water
[0172] Lactic acid 10.0%
[0173] Safflower oil
[0174] Mandelic acid 2.0%
[0175] Tricontyl PVP (water proofing agent)
[0176] Glyceryl Stearate
[0177] PEG-100 Stearate
[0178] Emulsifing Wax
[0179] Caprylic Capric Triglyceride
[0180] Cetyl alcohol
[0181] Dimethicone
[0182] Polyacryamide
[0183] C13 C14 Isoparaffin
[0184] Laureth-7
[0185] Aloe vera
[0186] Allantoin
[0187] Oat extract
[0188] Chamomile extract
[0189] Sodium Hydroxide
[0190] Phenoxyrthanol (preservative)
[0191] Chlorphenensin (preservative)
[0192] Benzoic acid (preservative)
[0193] Sorbic acid (preservative)
[0194] Butylene Glycol
Example 3
[0195] A composition for treating fishy odor arising from the
pudendum was prepared using the ingredients and weight percents
shown in Table 1:
TABLE-US-00001 TABLE 1 Ingredients in a composition for treating
fishy odor. % Sequence INCI Names Trade Names W/W Suppliers 1 Water
D.I. Water 49.60 Open 1 Disodium EDTA Versene Na2 0.100 Open 1
Glycerin 99 vegetable Glycerin 99 5.00 Open 1 Lactic Acid 70% Purac
10.00 Purac America 1 DL Mandelic acid Mandelic Acid 2.00 Orient
Star 310/7016402 1 Allantoin Allantoin 0.10 Open 2 Glyceryl
Stearate & PEG Arlacel 165 3.50 Open 100 Stearate 2 Cetyl
Alcohol Cetyl Alcohol 2.00 Open 2 Dimethicone Dow Corning 1.00 Dow
Corning 200/100 2 Caprylic/Capric Liponate CG 3.50 Lipo chemical
Triglyceride 2 Emulsifying Wax Polawax 3.00 Croda 2 Tricontyl PVP
Ganez WP660 3.00 ISP 2 Carthamus Tinctorius High oleic 8.50 Open
(safflower) Seed Oil Safflower oil 3 Germazide PSB 1.00 3 50%
Sodium Hydroxide Sodium 2.500 Open Hydroxide 3 Aloe Barbadensis
leaf Aloe 10 Fold 0.50 Active organic extract 3 Avena Sativa (oat)
kernel Oat extract 0.10 """" extract 3 Chamomilla Recutita
Chamomile 0.10 """"" (Matricaria Matricaria) extract flower extract
4 Sepigel 305 2.50 Seppic 4 PPG-12/SMDI Copolymer
Polyolperpolymer-2 2.00 Barnet
[0196] Procedures: [0197] 1. In a clean sanitized stainless steel
tank, Sequence 1 ingredients were combined and mixed thoroughly to
form a first mixture. [0198] 2. The first mixture was heated to
75.degree. C. while mixing continued. [0199] 3. In a separate
stainless steel tank, Sequence 2 ingredients were combined and
heated to 75.degree. C. to form a second mixture. [0200] 4. After
slight cooling, when both mixtures were at 70.degree. C., the
second mixture was added gradually to the first mixture while
mixing. Mixing continued for another 15 minutes to form a third
mixture. [0201] 5. A cooling cycle was then started as the third
mixture was cooled to 40.degree. C. Then the Sequence 3 ingredients
were added one at time in the listed order while mixing to form a
fourth mixture. [0202] 6. The ingredients from Sequence 4 were then
blended into the fourth mixture to form the final composition.
[0203] The final composition had a pH less than 4 and was then
tested for efficacy in terms of preventing malodor. Relative to
similar compositions without the PP-12 prepolymer (PPG-12), the
composition was found to be surprisingly effective in preventing
fishy odor from the pudendum, with a prolonged effect lasting over
24 hours. Without wishing to be bound by theory, it is believed
that the prepolymer compound assists in holding the alpha-hydroxy
acids of the composition off the skin and in an environment where
they can be effective in maintaining a low pH and reducing the
activity of anaerobic bacteria on the pudendum.
[0204] The product apparently not only diminishes existing odor on
contact, but has a lasting effect that is believed to due at least
in part to the combination of alpha-hydroxy acids in a lipophilic
carriers. In a formulation without the prepolymer, the efficacy on
the pudendum was estimated to have a duration of about 6 to 8
hours, such that fishy odor was substantially reduced or prevented
after application, but would begin to return after about 8 hours.
With a change in formulation to include the prepolymer from Barnet,
the lasting odor control exceeded expectations and lasted upwards
of 24 hours. Another surprise was the observation of an apparent
cumulative effect with daily use over time, such that the interval
required before the return of malodor could be detected increased
significant over time beyond what was expected based on experience
with related formulations without the prepolymer. In particular,
the interval of time before the return of fishy odor after
activities like intercourse, menses, and exercise and leaking urine
was extended significantly and the intensity of the fishy odor when
it did return appeared to be significantly less than expected as
well. Without wishing to be bound by theory, it may be that the
bacterial load is well controlled on the pudendum long after
application of the product, and thus the amount of "work" to be
done by reapplication of the product is lessened with regular
use.
Example 4
[0205] In one prophetic example, a feminine care product is treated
with the formulations previously described. The feminine care
product is an absorbent disposable article that may comprise a
breathable stretched elastomeric film, such as that described in
U.S. Pat. No. 6,461,457, "Dimensionally Stable, Breathable,
Stretch-Thinned, Elastic Films," issued Oct. 8, 2002 to Taylor et
al., herein incorporated by reference to the extent that it is
noncontradictory herewith, the breathable film serving as at least
a portion of the skin-contacting side of the absorbent article
(e.g., as an intake layer or cover layer on the article). The
article may comprise a cellulosic absorbent core, an impervious
film as a back layer, and other components known in the art, as
described in any of the following: U.S. Pat. No. 5,795,349,
"Absorbent Articles Having Panty Covering Components that Naturally
Wrap the Sides of Panties," issued Aug. 18, 1998 to Lavash et al.;
U.S. Pat. No. 4,738,676, "Pantiliner," issued Apr. 19, 1988 to
Osborn; U.S. Pat. No. 7,601,415, "Absorbent Device Using an
Apertured Nonwoven as an Acquisition Distribution Layer," issued
Oct. 13, 2009; U.S. Pat. No. 6,213,993, "Self-Adhering Absorbent
Article," issued Apr. 10, 2001 to Zacharias et al.; and so forth.
The porous skin-contacting layer on the article may be treated, at
least in part, with a formulation comprising a viscous, semisolid,
or solid lipophilic components blended with an acidifying compound
comprising a gentle aliphatic acid such as mandelic acid or
derivatives thereof and a low-molecular weight carboxylic acid such
as lactic acid. The formulation may be prepared by blending a
heated molten lipophilic component (e.g., at a temperature of about
40.degree. C. or higher, or between about 40.degree. C. and
70.degree. C.) with about 1% to about 20% by weight, or from about
3% to about 10% by weight, of an aqueous solution comprising the
acidifying compounds, such that after blending with the lipophilic
component, the resulting mixture has about 0.5% to about 3% by
weight of acids. Emulsifying or stabilizing components maybe added
in effective amounts to enhance the blending. The formulation may
then be coated on or otherwise applied the porous web of the cover
layer by known means such as impregnation, cast coating, gravure
printing, flexographic printing, and the like, with an effective
basis weight of the applied material corresponding to about 10 gsm
(grams per square meter) or greater, such as about 50 gsm, about
100 gsm, about 250 gsm, or about 500 gsm or greater, such as from
about 50 gsm to about 700 gsm, or from about 100 gsm to about 400
gsm. In contact with the body, the acidying components may be
release onto the skin to elevate the pH there to an acceptable
range that hinders the formation of fish odor compounds. Other
components in the treatment on the absorbent article may also
contribute toward that end, including antimicrobial agents.
Example 5
[0206] In a prophetic embodiment related to that of Example 4, the
active ingredients are not necessarily directly on or in the
body-contacting materials, but may be present in an underlying
layer which can release the active ingredients to alter the
environment on the skin of the wearer to reduce the formation in
unwanted odors. Thus, a viscous formulation may be present beneath
the body contacting material, where the body-contacting material
may be a porous layer such as an apertured film or fibrous layer,
and wherein the formulation may be present immediately below the
body contacting material for release during use of the absorbent
article. Release may be due to diffusion or migration, or may be
triggered by physical or thermal means, in which case the active
ingredients may be encapsulated in microcapsule or large
encapsulating layers that rupture under physical compression or
stress, or upon warming to some temperature above room temperature
and below body temperature.
Example 6
[0207] In a report conducted and prepared by BioScreen Testing
Services (Torrance, Calif.), various compositions were evaluated in
terms of their effectiveness in suppressing the liberation of
trimethylamine from gut bacteria (Report No. 644705, May 10, 2010).
The report notes that BioScreen was asked to evaluate a Feminine
Hygiene Cream/Solution product for its potency to inhibit the
formation of trimethylamine (TMA).
[0208] A viable method was developed for the assay of
trimethylamine (TMA). The method utilizes triethylamine and
methanol together as internal standards and choline as the
substrate for generating TMA from the bacterial species. The
bacterial culture for these studies was Clostridium sporogenes,
which was grown in house at BioScreen.
[0209] Common bacterial species present in the lower
gastrointestinal tract include Acidaminococcus, Bacteroides,
Bifidobacterium, Clostridium, Coprococcus, Enterobacter,
Enterococcus Escherichia, Eubacterium, Fusobacterium, Klebsiella,
Lactobacillus, Megamonas, Megasphaera, Peptostreptococcus, Proteus,
Ruminococcus, and Veillonella. Of these, Clostridium sporogenes was
chosen due to its reported propensity for generating TMA from
substrates carrying trimethylamino moeties.
[0210] Tests were conducted with a headspace gas chromatograph to
verify that Clostridium sporogenes bacterial could actively
generating trimethylamine from a choline substrate.
[0211] Equipment for the testing included a Trace GC Ultra gas
chormoatograph and a Varian CP-Volamine column. An FID detector was
used with 2.5 mL/min helium flow. Other details of operation are
given in Table 2 below:
TABLE-US-00002 TABLE 2 Other settings for the GC testing. Detector:
FID Range: 10 Carrier Gas Flow: 2.5 mL/min Carrier Gas Helium Split
ratio: 50 Detector temperature: 260.degree. C. Injector
temperature: 140.degree. C. Injector liner: Split 5 mm with no
glasswool plug Injection volume: 1.0 mL Integrator: Xcalibur 2.0
Initial column temperature: 40.degree. C. Hold time: 5.0 min
Program rate: 15.degree. C./min Final column temperature:
260.degree. C. Agitator temperature: 60.degree. C. Syringe
temperature: 80.degree. C. Final Hold time: 5.0 min Incubation
time: 10.0 min
[0212] The bacterial species C. sporogenes, a species found in the
lower GI tract. was inoculated into 100 mL of Fluid Thioglycolate
medium and incubated at 35.+-.2.degree. C. for a minimum of 16
hours. At the end of incubation, the concentration of the bacterial
suspension was confirmed by serial dilution in 9 mL PBS up to
10.sup.-7 and anaerobic incubation at 32.5.+-.2.5.degree. C. for a
minimum of 48 hours. Counts were recorded from dilution plates with
25 to 250 colonies. The average counts were multiplied by the
reciprocal of the dilution factor to furnish the CFU/mL of the
bacterial species.
[0213] The formation of TMA from Clostridium sporogenes by
interaction with choline substrate with the addition of 0.1 mL and
0.3 mL of Hygiene Product Solution was also investigated to arrive
at the minimum amount of the Product needed for suppression of TMA
formation.
[0214] Extensive testing was done to verify that TMA or methanol
could be used as standards.
[0215] In results shown below, solvents, reagents and standards
used are described in Table 3. Triethylamine (0.5 mL), along with
methanol (0.5 mL), was dissolved in an aqueous 1% benzalkonium
chloride solution in a 100 mL volumetric flask and this solution
used as the dual internal standard mix.
TABLE-US-00003 TABLE 3 Solvents, Reagents and Standards Compounds
Description Source Choline bicarbonate 80% in water Spectrum
Trimethylamine 35% in ethanol Aldrich Trimethylamine 99.9% Burdick
and Jackson Benzalkonium chloride 52.48% Spectrum Methanol 97%
purity EMD Dimethylsulfoxide 99.98% VWR/BDH DI Water In house
[0216] Results for the evaluation of TMA suppression by a Hygiene
Product Solution (the composition from Example 1) according to
various embodiments of the present invention are shown in Table
4.
TABLE-US-00004 TABLE 4 Set up for Evaluation of Hygiene Product
Potency at 1.0 mL concentration Culture Bacterial DI BAC/TEA/
Medium Choline Culture Water Methanol No. of Sample ID (mL) (mL)
(mL) (mL) IS (mL) injections Bacterial Culture without addition of
Hygiene Product Blank IS 3.0 0.1 1.0 1 Time 0 hrs 0.1 3.0 1.0 1.0 3
Time 2 hrs 0.1 3.0 1.0 1.0 3 Time 3 hrs 0.1 3.0 1.0 1.0 3 Time 4
hrs 0.1 3.0 1.0 1.0 3 Time 6 hrs 0.1 3.0 1.0 1.0 3 Bacterial
Culture with addition of Hygiene Product Solution (1.0 mL) Time 0
hrs 0.1 3.0 1.0 1.0 3 Time 2 hrs. 0.1 3.0 1.0 1.0 3 Time 3 hrs 0.1
3.0 1.0 1.0 3 Time 4 hrs 0.1 3.0 1.0 1.0 3 Time 6 hrs 0.1 3.0 1.0
1.0 3 System Suitability Standards (TMA, amount in mg) Culture TMA
Std TMA Std BAC/TEA/ Medium Choline 9.75 mg/ 0.975 mg/ Methanol No.
of Sample ID (mL) (mL) mL (mL) mL (mL) IS (mL) injections Blank IS
3.0 0.1 1.0 1 Std 9.75 2.0 0.1 1.0 1.0 1 Std 4.875 2.5 0.1 0.5 1.0
1 Std. 1.95 2.8 0.1 0.2 1.0 7 Std 0.975 2.0 0.1 1.0 1.0 1 Std
0.4875 2.5 0.1 0.5 1.0 1 Std 0.195 2.8 0.1 0.2 1.0 1 Std 0.0975 2.9
0.1 0.1 1.0 1 BAC = benzalkonium chloride; TEA = triethylamine
[0217] During the method development stage, it was found that
addition of benzalkonium chloride, a known antibacterial compound,
to the culture solution stops further reactivity of the bacterial
culture with choline and hence, any experimental errors due to
continued evolution of TMA before and between GC measurements is
avoided.
[0218] It was observed that TMA liberation at measurable amounts
commences around 2 hours after the addition of choline to the
clostridium sporogenes culture and steadily increases up to 6
hours. Further follow up of the reaction up to 24 hours indicated
that little additional TMA was obtained after the 6 hour
period.
[0219] The approach for evaluating the efficiency of the Hygiene
Product Solution included utilizing a comparative experimental set
up with the bacterial culture/choline mixture with and without the
addition of the Hygiene Product Solution. Simultaneously, system
suitability and linearity measurements employing working standards
of TMA were also set up. The culture/choline reaction was followed
from the time of addition of the choline reagent, at intervals of
2, 3, 4 and 6 hours from this commencement time.
[0220] At first, the effect of addition of the Hygiene Product
Solution at a concentration 1.0 mL to 3.0 mL of the bacterial
culture containing 0.1 mL of choline bicarbonate solution (80%
aqueous) was investigated. The results of this study, using
triethylamine (TEA) and methanol as internal standards, are
presented in Tables 5 and 6, respectively.
TABLE-US-00005 TABLE 5 Screening of Hygiene Product for Suppression
of Trimethylamine (TMA) formation at a Concentration of 1.0 mL/Vial
(TEA Int. Std.) Peak Area Peak Area Conc. of Sample of TMA Int. Std
TEA Response TMA Average Identity from GC/FID from GC/FID Factor
(RF) (mg/vial) (% RSD) Blank culture/choline samples (without
Hygiene Product Solution) 0 hours 22034 2291934 0.0096 0.1763 0
hours 6262 1344977 0.0047 0.1621 0 hours 5636 1289738 0.0044 0.1612
0.1665 (5.1) 2 hours 57243 1001257 0.0672 0.3409 2 hours 90416
894695 0.1011 0.4379 2 hours 72682 795520 0.0914 0.4102 0.3964
(12.6) 3 hours 446165 972667 0.4587 1.4614 3 hours 811460 1095777
0.7405 2.2680 3 hours 317356 672981 0.4716 1.4983 1.7426 (26.1) 4
hours 715862 946742 0.7561 2.3126 4 hours 907439 944506 0.9608
2.8982 4 hours 862656 707466 1.2194 3.6383 2.9497 (22.5) 6 hours
1358933 715723 1.8987 5.5824 6 hours 14434782 617313 2.3388 6.8419
6 hours 1539396 694965 2.2151 6.4878 6.3040 (10.3) Culture
medium/choline with Hygiene Product Solution (1 mL) added 0 hours
20600 52415 0.3930 1.2734 0 hours 6208 179952 0.0345 0.2475 0 hours
9876 90641 0.1090 0.4605 0.6605 (82.0) 2 hours 0.00 7803 0.0000
0.1487 2 hours 0.00 54727 0.0000 0.1487 2 hours 0.00 48231 0.0000
0.1487 0.1487 (0.0) 3 hours 0.00 54556 0.0000 0.1487 3 hours 0.00
28354 0.0000 0.1487 3 hours 0.00 120728 0.0000 0.1487 0.1487 (0.0)
4 hours 0.00 169343 0.0000 0.1487 4 hours 4753 246984 0.0192 0.2038
4 hours 0.00 33644 0.0000 0.1487 0.1671 (19.0) 6 hours 0.00 18870
0.0000 0.1487 6 hours 0.00 36781 0.0000 0.1487 6 hours 0.00 11594
0.0000 0.1487 0.1487 (0.0)
TABLE-US-00006 TABLE 6 Screening of Hygiene Product for Suppression
of Trimethylamine (TMA) formation at a Concentration of 1.0 mL/Vial
(Methanol as Internal Standard) Peak Area Peak Area Int. Std Conc.
of Sample of TMA (MeOH) from Response TMA Average Identity from
GC/FID GC/FID Factor (RF) (mg/vial) (% RSD) Blank culture/choline
samples (Hygiene Product Solution) 0 hours 22034 1515332 0.0145
0.1904 0 hours 6262 1255936 0.0050 0.1630 0 hours 5636 1152265
0..0049 0.1627 0.1720 (9.2) 2 hours 57243 1179564 0.0570 0.3119 2
hours 90416 1246735 0.0725 0.3563 2 hours 72682 1259827 0.0577
0.3138 0.3273 (7.7) 3 hours 446165 1349463 0.3306 1.0949 3 hours
811460 1087570 0.7461 2.2840 3 hours 317356 1291792 0.2457 0.8518
1.4102 (54.3) 4 hours 715862 1118001 0.6403 1.9812 4 hours 907439
998037 0.9092 2.7507 4 hours 862656 622357 1.3861 4.1155 2.9491
(36.7) 6 hours 1358933 1036260 1.3114 3.9016 6 hours 1443782
1145409 1.2605 3.7560 6 hours 1539396 1033086 1.4901 4.4131 4.0236
(8.6) Culture medium/choline with Hygiene Product Solution (1 mL)
added 0 hours 20600 854008 0.0241 0.2178 0 hours 6208 880909 0.0070
0.1689 0 hours 9876 831714 0.0119 0.1827 0.1896 (13.3) 2 hours 0.00
914941 0.0000 0.1487 2 hours 0.00 1190919 0.0000 0.1487 2 hours
0.00 902057 0.0000 0.1487 0.1487 (0.0) 3 hours 0.00 1026409 0.0000
0.1487 3 hours 0.00 866272 0.0000 0.1487 3 hours 0.00 966337 0.0000
0.1487 0.1487 (0.0) 4 hours 0.00 761454 0.0000 0.1487 4 hours 4753
1193731 0.0040 0.1601 4 hours 0.00 867308 0.0000 0.1487 0.1525
(4.3) 6 hours 0.00 968836 0.0000 0.1487 6 hours 0.00 791448 0.0000
0.1487 6 hours 0.00 958889 0.0000 0.1487 0.1487 (0.0)
[0221] The data in Tables 5 and 6 show that formation of TMA from
Clostridium sporogenes is completely suppressed at the Hygiene
Product Solution concentration of 1.0 mL per test vial. FIGS. 5A
and 5B, 6A and 6B, and 7A and 7B show graphical representations.
FIGS. 5A and 5B show TMA versus time profiles for testing done
without (FIG. 5A) and with (FIG. 5B) the Hygiene Product (1.0 mL
concentration) of Example 1 added to vials containing bacterial
culture and choline (for TEA internal standards). FIGS. 6A and 6B
show TMA versus time profiles for testing done without (FIG. 6A)
and with (FIG. 6B) the Hygiene Product (1.0 mL concentration) of
Example 1 added to vials containing bacterial culture and choline
(for methanol internal standards).
[0222] FIGS. 7A and 7B show the response factor (RF) for TMA versus
time from experimental in testing of TMA concentration in vials of
a bacteria-containing solution with choline with different
concentrations of added material according to an embodiment of the
present invention as described in Example 1. FIGS. 7A and 7B show a
concentration effect for the Hygiene Product Solution in terms of
its ability to suppress the formation of TMA from the bacteria. At
a level of 0.1 mL Hygiene Product per vial, there was only minor
suppression of TMA formation. On the other hand, at 0.3 mL level
per vial, a suppression of over 60% could be observed. See Tables 7
and 8 for further details.
TABLE-US-00007 TABLE 7 Screening of Hygiene Product for Suppression
of Trimethylamine (TMA) formation at a Concentration of 0.1 and 0.3
mL/Vial (TEA as Internal Standard) Peak Area Peak Area Conc. of
Sample of TMA Int. Std TEA Response TMA Average Identity from
GC/FID from GC/FID Factor (RF) (mg/vial) (% RSD) Blank
culture/choline samples (without Hygiene Product Solution) 0 hours
0.0 1199841 0.0000 0.0553 0 hours 0.0 0.0000 0.0553 0.0553 (0.) 2
hours 226372 1333681 0.1697 0.5466 2 hours 179204 845562 0.2119
0.6887 0.6076 (14.2) 3 hours 613063 530878 1.1548 3.3978 3 hours
670989 626892 1.0703 3.1533 3.2755 (5.3) 4 hours 1342568 825947
1.6255 4.7601 4 hours 1009090 506876 1.9908 5.8175 5.2888 (14.1) 6
hours 2372390 756959 3.1341 9.1267 6 hours 2191528 751315 2.9169
8.4981 8.8124 (5.0) Culture medium/choline with Hygiene Product
Solution (0.1 mL) added 0 hours 8719 681568 0.0128 0.0923 0 hours
5122 599566 0.0085 0.0800 0.0862 (10.1) 2 hours 90411 463373 0.1951
0.6200 2 hours 90673 510613 0.1776 0.5693 0.5947 (6.0) 3 hours
399678 374049 1.0685 3.1480 3 hours 719013 949924 0.7569 2.2461
2.6971 (23.6) 4 hours 1044789 599985 1.7414 5.0955 4 hours 697939
446236 1.5641 4.5823 4.8389 (7.5) 6 hours 1891991 625092 3.0267
8.8159 6 hours 2340351 800392 2.9240 8.5186 8.6672 (2.4) Culture
medium/choline with Hygiene Product Solution (0.3 mL) added 0 hours
0.00 402517 0.0000 0.0553 0 hours 14759 529344 0.0279 0.1360 0.0956
(59.7) 2 hours 12506 193472 0.0646 0.2424 2 hours 16007 254549
0.0629 0.2373 0.2398 (1.5) 3 hours 72904 182075 0.4004 1.2142 3
hours 79132 175308 0.4514 1.3618 1.2880 (8.1) 4 hours 142789 135796
1.0515 3.0987 4 hours 236737 270125 0.8764 2.5919 2.8453 (12.6) 6
hours 306515 170779 1.7948 5.2502 6 hours 399887 195678 2.0436
5.9703 5.6102 (9.1)
TABLE-US-00008 TABLE 8 Screening of Hygiene Product for Suppression
of Trimethylamine (TMA) formation at a Concentration of 0.1 and 0.3
mL/Vial (Methanol as Internal Standard) Peak Area Peak Area Int.
Std Conc. of Average Sample of TMA Methanol Response TMA Identity
from GC/FID from GC/FID Factor (RF) (mg/vial) (% RSD) Blank
culture/choline samples (without Griffiths Hygiene Product
Solution) 0 hours 0.00 1289617 0.0000 0.0553 0 hours 0.00 1280270
0.0000 0.0553 0.0553 (0.0) 2 hours 226372 1246744 0.1816 0.5808 2
hours 179204 1288664 0.1391 0.4578 0.5193 (16.8) 3 hours 613063
1201500 0.5102 1.5322 3 hours 670989 1236759 0.5425 1.6256 1.5789
(4.2) 4 hours 1342568 1153926 1.1635 3.4229 4 hours 1009090 1169900
0.8625 2.5518 2.9874 (20.6) 6 hours 2372390 1064687 2.2283 6.5048 6
hours 2191528 794532 2.7583 6.0388 7.2718 (14.9) Culture
medium/choline with Griffiths Hygiene Product Solution (0.1 mL)
added (#644705) 0 hours 6719 1240176 0.0070 0.0756 0 hours 5122
1259125 0.0041 0.0671 0.0713 (8i.5) 2 hours 90411 1193595 0.0757
0.2745 2 hours 90674 1223364 0.0741 0.2698 0.2722 (1.2) 3 hours
399678 1217900 0.3282 1.0051 3 hours 719013 1237478 0.5810 1.7370
1.3711 (37.7) 4 hours 1044789 1054053 0.9912 2.9243 4 hours 697939
1174383 0.5943 1.7754 2.3499 (34.6) 6 hours 1891991 757336 2.4976
7.2843 6 hours 2340351 961501 2.4341 7.1005 7.1924 (1.8) Culture
medium/choline with Griffiths Hygiene Product Solution (0.3 mL)
added (#644705) 0 hours 0.00 931217 0.0000 0.0553 0 hours 5122
1155357 0.0128 0.0923 0.0738 (35.4) 2 hours 90411 1084704 0.0115
0.0887 2 hours 90674 1087286 0.0147 0.0979 0.0933 (7.0) 3 hours
399678 1061919 0.0687 0.2540 3 hours 719013 1088146 0.0727 0.2658
0.2599 (3.2) 4 hours 1044789 1082015 0.1320 0.4372 4 hours 697939
1174717 0.2015 0.6386 0.5379 (26.5) 6 hours 1891991 1053974 0.2861
0.8891 6 hours 2340351 1076652 0.3714 1.1303 1.0097 (16.9)
[0223] The report from BioScreen offered these conclusions: [0224]
Griffiths Feminine Hygiene Product Solution (Accession #644705) is
effective in suppressing the formation of trimethylamine (TMA), the
main foul odor causing nitrogenous material, completely at a
concentration of 1.0 mL per 3.0 mL of clostridium sporogenes
culture which is at a concentration of 9.6.times.10.sup.8 CFU/mL.
[0225] The Hygiene Product Solution is ineffective at a
concentration of 0.1 mL for 3.0 mL of the same bacterial culture.
[0226] At a concentration of 0.3 mL per 3.0 mL of the bacterial
culture, around 60% suppression of TMA was observed.
[0227] It should be noted, however, that even when extremely dilute
at the concentration of 0.1 mL of added material to a much larger
amount of bacteria-rich liquid in a vial, the added material did
not some strictly ineffective but may have had a dramatically
weakened effect compared to the much stronger effect of higher
doses of the material according to an embodiment of the present
invention.
REMARKS
[0228] When introducing elements of aspects of the invention or the
embodiments thereof, the articles "a," "an," "the," and "said" are
intended to mean that there are one or more of the elements. The
terms "comprising," "including," and "having" are intended to be
inclusive and mean that there may be additional elements other than
the listed elements.
[0229] Having described aspects of the invention in detail, it will
be apparent that modifications and variations are possible without
departing from the scope of aspects of the invention as defined in
the appended claims. As various changes could be made in the above
compositions, products, and methods without departing from the
scope of aspects of the invention, it is intended that all matter
contained in the above description shall be interpreted as
illustrative and not in a limiting sense.
[0230] While the foregoing description makes reference to
particular illustrative embodiments, these examples should not be
construed as limitations. The inventive system, methods, and
products can be adapted for other uses or provided in other forms
not explicitly listed above, and can be modified in numerous ways
within the spirit of the present disclosure. Thus, the present
invention is not limited to the disclosed embodiments, but is to be
accorded the widest scope consistent with the claims below.
* * * * *
References