U.S. patent application number 15/294340 was filed with the patent office on 2017-02-02 for systems and methods for bio-matching gels, creams and lotions.
The applicant listed for this patent is Good Clean Love, Inc.. Invention is credited to Wendy Strgar.
Application Number | 20170027894 15/294340 |
Document ID | / |
Family ID | 56128205 |
Filed Date | 2017-02-02 |
United States Patent
Application |
20170027894 |
Kind Code |
A1 |
Strgar; Wendy |
February 2, 2017 |
SYSTEMS AND METHODS FOR BIO-MATCHING GELS, CREAMS AND LOTIONS
Abstract
A method of bio-matching a topical gel, cream or lotion may
comprise selecting a vagina of a living body, identifying a
secretion of the selected vagina, identifying a composition of the
identified secretion, and formulating the topical gel to match the
identified composition of the identified secretion.
Inventors: |
Strgar; Wendy; (Eugene,
OR) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Good Clean Love, Inc. |
Eugene |
OR |
US |
|
|
Family ID: |
56128205 |
Appl. No.: |
15/294340 |
Filed: |
October 14, 2016 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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14636035 |
Mar 2, 2015 |
9470676 |
|
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15294340 |
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62094769 |
Dec 19, 2014 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61K 9/0034 20130101;
A61K 9/00 20130101; A61K 31/191 20130101; A61K 9/06 20130101; A61K
47/36 20130101; G01N 33/50 20130101 |
International
Class: |
A61K 31/191 20060101
A61K031/191; G01N 33/50 20060101 G01N033/50 |
Claims
1. A method of bio-matching a topical gel, the method comprising:
selecting a vagina of a living body; identifying a secretion of the
selected vagina; identifying a composition of the identified
secretion; and formulating the topical gel to match the identified
composition of the identified secretion.
2. The method of claim 1, wherein the body is a human body.
3. The method of claim 1, wherein identifying the secretion
involves identifying a secretion present in a generally healthy
vagina.
4. The method of claim 3, wherein identifying the composition of
the identified healthy secretion involves identifying lactic
acid.
5. The method of claim 4, wherein identifying lactic acid involves
identifying lactic acid having a racemic index in a range of about
50% L/50% D.
6. The method of claim 5, wherein formulating the topical gel
involves selecting lactic acid having an approximately racemic
mixture with between 30% to 70% L and between 70% to 30% D.
7. The method of claim 6, wherein formulating the topical gel
involves formulating the topical gel to include about 1% of the
selected lactic acid.
8. The method of claim 3, wherein formulating the topical gel
involves bio-balancing the topical gel by avoiding inclusion of one
or more ingredients that are toxic to microbiota of the generally
healthy vagina.
9. The method of claim 3, wherein formulating the topical gel
involves using a preselected type and quantity of lactic acid, and
causing the topical gel to have a preselected pH and salt balance
that matches those of a healthy vagina.
10. A topical gel for human use, the gel comprising: a formulation
matched to a composition of a particular part of a human body, the
formulation including lactic acid.
11. The gel of claim 10, wherein the particular part of the human
body is a vagina.
12. The gel of claim 11, wherein the composition is a generally
healthy composition associated with the vagina.
13. The gel of claim 12, wherein the generally healthy composition
includes lactic acid having a racemic index of about 50% L/50%
D.
14. The gel of claim 13, wherein the formulation comprises
approximately 1% lactic acid having a racemic index in a range of
about 30% L/70% D to about 70% L/30% D.
15. The gel of claim 14, wherein the racemic index of the 1% lactic
acid is approximately 50% L/50% D.
16. A vaginal lubricant, comprising: a formulation including lactic
acid having a racemic index that is bio-matched but not
bio-identical to a racemic index of natural lubricants in a healthy
vagina.
17. The lubricant of claim 16, wherein vagina bacteria of the
healthy vagina is dominated by Lactobacillus crispatus which
produce lactic acid that is included in the natural lubricants, the
lactic acid of the natural lubricants having a racemic index of
approximately 50% L/50% D.
18. The lubricant of claim 17, wherein the lactic acid of the
formulation has a racemic index in a range of 80% L/20% D to 20%
L/80% D, thereby resulting in the formulation being bio-matched to
the natural lubricants of the healthy vagina.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation of U.S. patent
application Ser. No. 14/636,035, filed Mar. 2, 2015, which issued
as U.S. Pat. No. 9,470,676, which application is based upon and
claims the benefit under 35 U.S.C. .sctn.119(e) of U.S. Provisional
Patent Application Ser. No. 62/094,769, filed Dec. 19, 2014, which
is incorporated herein by reference in its entirety for all
purposes.
FIELD
[0002] The general field of invention relates to systems and
methods for bio-matching gels, creams and other suitable
formulations to a living body, particularly a human body.
INTRODUCTION
[0003] Portions of a human body typically secrete or produce
various substances that may provide various benefits. For example,
a mouth typically secretes saliva, which aids in digestion and
provides lubrication for portions of the mouth. Microflora (e.g.,
including lactobacilli) of a vagina typically produce lactic acid,
which may protect the vagina from various diseases, such as
bacterial vaginosis (BV).
[0004] Often bodily secretions are supplemented with various over
the counter (OTC) and/or prescription secretion supplements. For
example, a person may supplement secretions produced by their lips
with an OTC lip balm. In another example, a female may supplement
secretions produced by her vagina with an OTC or prescription
personal lubricant.
[0005] However, pre-existing secretion supplements often include
components that were presumed to be safe but that actually harm the
portion of the body being supplemented. For example, pre-existing
personal or vaginal lubricants, such as K-Y.RTM. jelly, often
include components that may damage the vagina and/or may make the
vagina more susceptible to disease. For example, pre-existing
vaginal lubricants are often formulated to have pH values of 6-7,
which are much higher than the acidic pH of the healthy vagina,
which has a pH of around 3.5. This may allow sexually transmitted
diseases (STDs) to occur and may lead to other diseases as well,
such as BV.
[0006] Similarly, Pre-seed.RTM., a pre-existing pro-conception
lubricant, also does not have an acidic pH but rather has a
somewhat alkaline pH of 7.29. This high pH alkalizes the vagina to
promote the life of sperm, but by doing so may make the vagina more
susceptible to HIV and other STD pathogens.
[0007] Further, pre-existing personal lubricants are formulated
with an osmolality much greater than an osmolality of a typical
vagina. Using such a personal lubricant may result in the cells of
the vagina releasing fluid to dilute the personal lubricant, which
may result in death of the cells, damage to the vagina, and/or
subsequent dryness of the vagina.
[0008] Moreover, pre-existing vaginal products commonly include
other various ingredients which are harmful to the vagina. For
example, these vaginal products typically include detergents and
surface-active agents, glycerol (glycerine) and other
humectant/solvent excipients, and/or preservatives which typically
include chlorhexidine and/or ethylenediaminetetraacetic acid
(EDTA), among others. Detergents and surface-active ingredients are
harmful because they are markedly toxic to mucosal epithelia,
including that of the vagina. Such detergents and surface-active
ingredients may include nonoxynol-9 and similar detergents, and
glycerol monolaurate (GML). Glycerol (glycerine) and other
humectant/solvent excipients are harmful because they increase
vaginal susceptibility to disease. For example, Moench et al. (BMC
Infectious Diseases 2010, 10:331) reported that the following
excipients markedly increased susceptibility to HSV-2 after a
single exposure: 5% glycerol monolaurate (GML) formulated in
K-Y.RTM. Warming Jelly, 5% GML as a colloidal suspension in
phosphate buffered saline, K-Y Warming Jelly alone, and both of its
humectant/solvent ingredients (neat propylene glycol and neat
polyethylene glycol (PEG-8)).
SUMMARY
[0009] The present disclosure provides systems and methods for
bio-matching formulations (e.g., gels, creams, etc.) to a
particular region (or part) of a living body, such as that of a
human or other animal. Formulations and methods of formulating
thereof may provide compositions that both supplement secretions of
the particular region of the living body and promote the health of
the particular region. In one embodiment, a method of bio-matching
a topical gel is provided. The method may comprise selecting a
vagina of a living female body; identifying a secretion of the
selected vagina; identifying a composition of the identified
secretion; and formulating the topical gel to match the identified
composition of the identified secretion. The matching includes
using a preselected type and quantity of lactic acid, and
formulating to a preselected pH and salt composition.
[0010] In another embodiment, a topical gel for human use is
provided. The gel may comprise a formulation matched to a
composition of a particular part of a human body. The formulation
may include lactic acid, and the particular part may be a
vagina.
[0011] In another embodiment, a topical gel for human use may
comprise a formulation including lactic acid having a racemic index
in a range of about 50% L/50% D. The formulation may be matched to
a composition (or chemistry thereof) of a particular part of a
human body.
[0012] In another embodiment, a vaginal lubricant is provided. The
lubricant may comprise a formulation including lactic acid having a
racemic index that is bio-matched but not bio-identical to a
racemic index of natural lubricants in a generally healthy
vagina.
BRIEF DESCRIPTION OF THE DRAWINGS
[0013] FIG. 1 is a block diagram schematically depicting a
composition of an identified secretion of a selected region of a
living body.
[0014] FIG. 2 is a block diagram schematically depicting a first
formulation bio-matched to the composition of FIG. 1.
[0015] FIG. 3 is a block diagram schematically depicting a second
formulation bio-matched but not bio-identical to the composition of
FIG. 1.
[0016] FIG. 4 is a block diagram schematically depicting a third
formulation bio-matched but not bio-identical to the composition of
FIG. 1.
[0017] FIG. 5 is a block diagram of a female body, which
schematically depicts a composition of an identified secretion of a
vagina.
[0018] FIG. 6 is a block diagram schematically depicting a first
formulation bio-matched to the composition of FIG. 5.
[0019] FIG. 7 is a block diagram schematically depicting a second
formulation bio-matched but not bio-identical to the composition of
FIG. 5.
[0020] FIG. 8 is a block diagram schematically depicting a third
formulation bio-matched but not bio-identical to the composition of
FIG. 5.
[0021] FIG. 9 is a block diagram schematically depicting the
bio-matched formulation of FIG. 6 being applied to an unhealthy
vagina of a female user.
[0022] FIG. 10 is a block diagram of the female user of FIG. 9
after application of the bio-matched formulation.
[0023] FIG. 11 is a flowchart depicting a method of bio-matching a
topical gel to a living body.
DETAILED DESCRIPTION
[0024] FIG. 1 shows a living body 20, which may be that of a human
or other animal. In some embodiments, body 20 may be a body of a
plant. Body 20 may have one or more regions (or components), such
an eye region, an ear region, a vaginal region, a mouth region, and
a rectal region among others. A selected region 22 of the one or
more regions may produce one or more secretions for one or more
purposes (e.g., to produce one or more desired effects). For
example, a mouth region may produce saliva to lubricate the mouth
region.
[0025] The one or more secretions of the selected region may
include an identified secretion 24. For example, identified
secretion 24 may be a secretion that has been identified as
contributing substantially to producing the desired effect (e.g.,
mouth lubrication, digestion, tartar control, etc.) and/or to
promoting the health of the region.
[0026] As shown in FIG. 1, identified secretion 24 may include
composition 26, which may include one or more chemical
compositions, ionic compositions, molecular structures, and/or
molecular compositions. For example, the composition may include a
first portion of a first type of composition 28, and a second
portion of a second type of composition 30. FIG. 1 shows the first
and second portions including equal amounts of compositions 28 and
30. In some embodiments, composition 26 may include more than two
types of different compositions, and/or may include various ratios
of portions thereof.
[0027] In some embodiments, body 20 may be a generally healthy
body, region 22 may be a generally healthy region, and/or secretion
24 (and/or one or more components of composition 26) may be
identified as contributing to the health of region 22 and/or body
20. For example, the composition of region 22 may correspond to a
generally healthy composition (e.g., associated with flora of a
generally healthy vagina). For example, one or more components of
composition 26 or characteristics or properties thereof may be
associated with (or present in) generally healthy vagina
secretions.
[0028] FIG. 2 shows a first formulation 32 that is bio-matched to
body 20. For example, formulation 32 may be described as being
bio-matched to composition 26. As shown, bio-matched formulation 32
includes a ratio of composition 28 to composition 30 that is equal
to the ratio of composition 28 to composition 30 of secretion 24 in
FIG. 1.
[0029] In some embodiments, formulations bio-matched to secretion
24 may have ratios that are not equal to the ratio of compositions
of secretion 24. For example, FIG. 3 shows a formulation 34 having
a higher ratio of composition 28 to composition 30 than secretion
24, and FIG. 4 shows a formulation 36 including composition 28 but
no composition 30. Formulations 34 and 36 may be described as being
bio-matched but not bio-identical to a chemistry (or a composition)
of secretion 24 (see FIG. 1).
[0030] Formulation 34 and/or formulation 36 may be useful for
promoting the health of region 22 (see FIG. 1) and/or the desired
effect of secretion 24. For example, composition 28 (or a
characteristic of composition 28) may be identified as a
significant contributor to the health of region 22 and/or to the
desired effect of secretion 24. For example, a higher ratio of
composition 28 to composition 30 may be identified as promoting the
health of region 22, in which case formulation 34 and/or
formulation 36 may be applied to region 22 (or to another body
having a corresponding region deficient in composition 28) to
increase a supply of composition 28 in that region.
[0031] Bio-matching a formulation to body 20 may involve
"bio-balancing" the formulation to body 20. For example,
ingredients (or compositions) that may be foreign to, produced by,
or present in body 20 may be identified as possibly (or actually)
detracting from (or harming) the health of region 22 (or body 20 as
a whole). In this case, formulations 32, 34, and/or 36 may be
bio-balanced by avoiding inclusion of one or more of these possibly
or actually harmful ingredients (or compositions).
[0032] In some embodiments of bio-balancing a formulation to a
vagina, harmful ingredients to avoid may include detergents and
surface-active agents, glycerol (or glycerine) and other
humectant/solvent excipients, one or more preservatives such as
chlorhexidine and EDTA, salt in a concentration that makes the
formulation not isotonic in the vagina, and/or acid in a
concentration that does not match that of a healthy vagina.
[0033] Typically, portions (or regions) of male and female human
bodies secrete various natural substances (or secretions). For
example, a portion of a female human body or a male human body
(e.g., a gland, organ, or flora associated with the portion or an
organ) may secrete or produce one or more particular substances
(e.g., lactic acid, saliva, etc.) for one or more particular
functions (e.g., lubrication, moisturization, cell protection, cell
repair, protection from pathogens or foreign matter such as dust,
etc.).
[0034] For example, the female body may include eyes secreting a
first substance, a scalp secreting a second substance, ears
secreting a third substance, nostrils secreting a fourth substance,
a mouth secreting a fifth substance (e.g., saliva), lips of the
mouth secreting a sixth substance, armpits secreting a seventh
substance, nipples secreting an eighth substance (e.g.,
pheromones), an epidermis secreting a ninth substance, genitalia
secreting a tenth substance (e.g., lactic acid produced by
microflora living in the genitalia), a rectum secreting an eleventh
substance, and feet secreting a twelfth substance.
[0035] The male body may include similar portions secreting (or
producing) similar substances. However, due to differences between
males and females (e.g., hormonal differences, genetic differences,
among others) portions of the male body may differ from portions of
the female body, and portions of the male body may secrete
substances (e.g., pheromones) that are different than the
substances secreted by the female body. For example, the male may
include a penis and a scrotum secreting respective thirteenth and
fourteenth substances, and a mouth of the male may secrete saliva
having a composition that is different than a composition of saliva
from the mouth of the female.
[0036] The genitalia (commonly referred to as a vagina) of the
female human body may include labia majora, labia minora, a vagina,
a cervix, a uterus, a urethra, a clitoris, a mons pubis, a
symphysis pubis, and ovaries. Typically, the labia majora and the
labia minor lead to the vagina, the cervix, and the uterus; and the
urethra leads from the urinary bladder out of the female body
through the labia minora and the labia majora.
[0037] A generally healthy vagina may include (or produce, or have
present therein) various natural lubricants. For example,
microflora (or bacteria) of the vagina (e.g., lactobacilli) may
produce a first anti-microbial lubricant (e.g., lactic acid).
Typically, microflora (e.g., vaginal bacteria) of a generally
healthy vagina is dominated by Lactobacillus crispatus, which
generally produce equal amounts of L-lactic acid and D-lactic acid.
Further, a membrane of a vaginal wall of the vagina may produce a
second lubricant (e.g., moisture), mucus glands of the cervix may
secrete a third lubricant (e.g., different variations of mucus
before and during ovulation), and glands, such as glandula
vestibularis major located near an opening to the vagina, may
secrete a fourth lubricant (e.g., a fluid such as mucus) when the
female is sexually aroused.
[0038] In particular, mucus from the glands of the cervix and/or
moisture from the vaginal wall membrane may provide lubrication
within the vagina, and the fluid from the glandula vestibularis
major may moisten the labial opening of the vagina, which may make
contact with this area more comfortable for the female.
[0039] Typically, the female and/or a sexual partner of the female
may apply an additional lubricant to components of the genitalia
the female, such as the vagina and/or the labia majora and the
labia minora, to increase lubrication of the vagina, which may
enhance the sexual experience and/or prevent breakage of a condom.
For example, the male 70 may roll a condom onto his penis, such
that an inside portion of the condom is in contact with the penis.
The male may then apply a personal lubricant, such as over the
counter K-Y.RTM. jelly, to an outside portion of the condom. The
female and the male may then engage in sexual intercourse, with the
over the counter lubricant providing additional lubrication between
the outside portion of the condom and the vagina. However, as
previously described, pre-existing lubricants often include
components (such as detergents like Nonoxynol-9) that are not
bio-balanced to a healthy vaginal environment, and application of
such components may make the vaginal environment more prone to
disease or damage.
[0040] Accordingly, the applicant has discovered that formulating a
composition (e.g., topical gel, cream, lubricant, etc.) to match a
composition (e.g., chemical composition, and/or characteristics
thereof) of a secretion of a selected region of a human body (e.g.,
a healthy vagina) may provide or enhance a desired effect (e.g.,
lubrication) and promote health.
[0041] For example, FIG. 5 shows a schematic representation of a
female body 40. A vagina 60 of body 40 may secrete one or more
substances (or secretions), as previously described. The one or
more substances may include an identified secretion 80 having a
composition 100. If vagina 60 (and/or body 40) is relatively or
generally healthy, then composition 100 may include L-lactic acid
102 (i.e., L-enantiomers) and D-lactic acid 104 (D-enantiomers),
which are the two optical isomers of lactic acid. For example,
microflora of a generally healthy vagina typically produces lactic
acid comprising approximately 50% L-lactic acid and 50% D-lactic
acid (i.e., lactic acid having a racemic index of about 50% L/50%
D). In contrast, it has been found that BV more commonly occurs in
vaginas with microflora that produce a large percentage of L-lactic
acid and produce only a small percentage (or no percentage) of
D-lactic acid.
[0042] To provide improved lubrication and vaginal health,
applicant has formulated a vaginal lubricant that substantially
matches an actual composition and/or characteristic of healthy
vaginal secretions and that avoid inclusion of harmful ingredients
(e.g., detergents, surface-active agents, glycerol, chlorhexidine,
and EDTA). The result is a formulation that is bio-matched (or
bio-balanced) to healthy vaginal secretions. Such a bio-matched
vaginal lubricant should not include (or avoid inclusion of) any
ingredient that might injure healthy vaginal lactobacilli. Rather,
the bio-matched vaginal lubricant may include one or more of the
following components and/or characteristics (or properties) that
are substantially matched to the components and/or characteristics
(or properties) of a healthy vaginal secretions: [0043] an aqueous
gel component--for example, the bio-matched vaginal lubricant may
include a gel that does not include glycerol or other solvents, but
only water (or comprises mainly water), as is true for mucus
secretions of a healthy vagina; [0044] one or more viscoelastic
properties--for example, the bio-matched vaginal lubricant may use
a safe and natural polymer to create a gel with viscoelastic
properties that match those of vaginal secretions (e.g., mucus) of
a healthy vagina, which may include not only matching a viscosity
of the vaginal secretions at a given shear rate, but also across a
broad range of shear rates--more specifically, mucus of the vagina
is a "shear-thinning" lubricant (e.g., a gel that becomes very
slippery, and has a low viscosity when the gel is being sheared, as
in the act of intercourse), and matching the viscoelastic
properties of the vaginal lubricant to the mucus of the vagina may
provide for the gel of the bio-matched vaginal lubricant not
dripping out of the vagina, but remaining in the vagina and
becoming very slippery with a low viscosity only when being
sheared; [0045] an isotonic property--for example, the bio-matched
vaginal lubricant may be formulated to have a salt composition that
makes the bio-matched vaginal lubricant isotonic in the vagina
(e.g., when the bio-matched vaginal lubricant is in the vagina, the
bio-matched vaginal lubricant will not cause water to be secreted
into the vagina, nor cause water to be absorbed out of the vagina);
[0046] an isotonic property that matches as close as possible the
salts present in a vaginal secretion (the salts in a vaginal
secretion include sodium, potassium, calcium, and magnesium).
[0047] a pH property--for example, the pH of the bio-matched
vaginal lubricant may be formulated to closely match the pH of a
healthy vagina (i.e., pH 3.5.+-.0.3%); [0048] a lactic acid
component--for example, the bio-matched vaginal lubricant may be
acidified with .about.1.+-.0.5% lactic acid, which is a
concentration that may match that of a healthy vagina; and [0049] a
racemic lactic acid component--for example, the bio-matched vaginal
lubricant may include lactic acid that is an essentially racemic
(equal) mix of the two optical isomers of lactic acid (i.e., the D-
and L-isomers) to match the mixture of these isomers in a healthy
vagina--more specifically, a healthy vagina is typically acidified
by lactobacilli that produce both D- and L-isomers of lactic acid,
but only a minority of women have these healthy, protective
lactobacilli, and most other women either have few if any
lactobacilli or have strains of lactobacilli that fail to make the
D-isomer, and thus the bio-matched vaginal lubricant may be
formulated to healthy vaginal secretions by including an
approximately even mix of the two isomers (i.e., D- and L-isomers
of lactic acid).
[0050] With respect to achieving the desired biomatching property
recited above, applicant has learned it is particularly important
to biomatch iso-osmolality, pH, and 1% by weight racemic acid. The
isotonic property recited above involves a salt composition that is
isotonic with vaginal fluid. Isotonicity can be achieved with
variations in sodium, and potassium chlorides as well as with other
osmotically active compounds.
[0051] Further, the applicant has found that formulating a vaginal
lubricant to match the vaginal acidity of a healthy vagina,
particularly by including lactic acid in the formulation, and more
specifically by including lactic acid that is substantially
racemic, kills HIV and many other pathogens.
[0052] Accordingly, FIG. 6 shows a first formulation 106 that is
bio-matched to a chemistry of body 40 of FIG. 5 (e.g., to a
chemistry of secretion 80 of vagina 60). For example, FIG. 6 shows
formulation 106 including 50% L/50% D racemic lactic acid. In some
embodiments, formulation 106 may include lactic acid having a
racemic index of about 10% L/90% D. In some embodiments,
formulation 106 may include lactic acid having a racemic index of
about 20% L/80% D. In some embodiments, formulation 106 may include
lactic acid having a racemic index of about 30% L/70% D. In some
embodiments, formulation 106 may include lactic acid having a
racemic index of about 40% L/60% D. In some embodiments,
formulation 106 may include lactic acid having a racemic index of
about 60% L/40% D. In some embodiments, formulation 106 may include
lactic acid having a racemic index of about 70% L/30% D. In some
embodiments, formulation 106 may include lactic acid having a
racemic index of about 80% L/20% D. In some embodiments,
formulation 106 may include lactic acid having a racemic index of
about 90% L/10% D. In some embodiments, formulation 106 may include
D-lactic acid, and no L-lactic acid.
[0053] In some embodiments, the racemic lactic acid (or lactic acid
having another suitable racemic index) may comprise about 1% of
formulation 106. For example, the racemic lactic acid may comprise
about 0.5% to about 1.5% of formulation 106. In other embodiments,
the racemic lactic acid (or lactic acid having another suitable
racemic index) may comprise other suitable percentages of
formulation 106. In some embodiments, the racemic lactic acid may
be synthetically-derived. In other embodiments, the racemic lactic
acid may be naturally-derived. Applying formulation 106 to vagina
60 may lubricate vagina 60, and may promote the health of vagina
60.
[0054] FIGS. 7 and 8 show respective formulations 108 and 110,
which may be considered as bio-matched to composition 100 of
secretion 80 of FIG. 5. For example, FIG. 7 shows formulation 108
including lactic acid having a racemic index of 30% L/70% D, which
may be suitable for application to a vagina that is slightly
deficient in D-lactic acid. FIG. 8 shows formulation 110 including
D-lactic acid, but no L-lactic acid, which may be suitable for
application to a vagina that has a greater deficiency of D-lactic
acid (or does not produce any D-lactic acid at all).
[0055] FIG. 9 shows a schematic representation of a female user 112
having a vagina 114 that produces a secretion 116. Secretion 116
may include a composition 118, which may comprise lactic acid
including L-lactic acid 120 and D-lactic acid 122. As shown, the
lactic acid of secretion 116 has a racemic index of 80% L/20% D,
which may be associated with a generally unhealthy condition of
vagina 114 (or a condition prone to disease). Application of
formulation 106 to vagina 114 may both lubricate vagina 114 and
promote the health of vagina 114 (and female user 112). For
example, formulation 106 may be added to secretion 116 to produce a
supplemented secretion 124 (see FIG. 13).
[0056] FIG. 13 shows a schematic representation of female user 112
after application of formulation 106 (see FIG. 12) to vagina 114.
As shown, supplemented secretion 124 of vagina 102 includes lactic
acid having a racemic index of about 62.5% L/37.5% D, which may
more closely match the lactic acid produced by microflora of a
healthy vagina.
[0057] FIG. 14 shows an exemplary method, generally indicated at
200, of bio-matching a topical gel (or cream, lubricant, or other
suitable substance) to a living body.
[0058] Method 200 may include a step 202 of selecting a region of
the body. Step 202 may involve selecting a region including one or
more components, such one or more glands, one or more organs,
and/or flora (e.g., microflora including bacteria) that secrete
various substances. For example, these components may secrete one
or more particular substances (e.g., lactic acid, saliva, etc.) for
one or more particular functions (e.g., lubrication,
moisturization, cell protection, cell repair, excretion of waste,
protection from pathogens or foreign matter such as dust, etc.).
The selected body may be a human body, and the selected region may
be a vagina.
[0059] Method 200 may include a step 204 of identifying a secretion
of the selected region. Step 204 may involve selecting a secretion
produced by (or present in) a generally healthy region, such as a
generally healthy vagina.
[0060] Step 204 may involve identifying a secretion that a
relatively healthy body (or part thereof) produces. For example,
microflora of a generally healthy vagina typically produces lactic
acid comprising approximately 50% L-lactic acid (i.e.,
L-enantiomers) and 50% D-lactic acid (i.e., D-enantiomers). In
contrast, as previously described, BV more commonly occurs in
vaginas with microflora that produce lactic acid with little or no
percentage of D-lactic acid. Accordingly, step 204 may involve
identifying lactic acid having L-enantiomers and D-enantiomers.
[0061] Method 200 may include a step 206 of identifying a
composition (e.g., chemical composition, molecular composition,
ionic composition, or characteristics or properties thereof) of the
identified secretion. Step 206 may involve identifying lactic acid.
Step 206 may involve identifying lactic acid having a racemic index
in a range of about 50L/50% D.
[0062] Method 200 may include a step 208 of formulating the topical
gel to (substantially) match the identified composition of the
identified secretion. Step 208 may involve selecting lactic acid
that is approximately racemic. Step 208 may involve selecting
synthetic acid. Step 208 may involve selecting racemic synthetic
acid. Step 208 may involve selecting pure racemic synthetic acid
having a racemic index of 50% L/50% D. Step 208 may involve
formulating the topical gel to include about 1% lactic acid
(synthetic and/or racemic). In some embodiments, step 208 may
involve bio-balancing the topical gel to avoid (or by avoiding)
inclusion of one or more ingredients that are toxic (or harmful) to
microbiota of the generally healthy vagina (or any vagina).
Examples of ingredients that are toxic (or harmful) to the
microbiota of a vagina include detergents, surface-active agents,
glycerol, many types of preservatives including chloride and EDTA,
salt concentrations/formulations that make the formulation
non-isotonic in the vagina, and acid/base
concentrations/formulations that do not match the pH of the
generally healthy vagina.
[0063] Method 200 may further comprise applying the topical gel to
the selected region of the human body (or a region of another human
body corresponding to the selected region). For example, method 200
may further comprise applying the topical gel to a vagina. For
example, applying the topical gel may involve rolling a condom onto
a penis, such that an inner surface of the condom contacts the
penis; disposing the topical gel onto an outer surface of the
condom; and bringing the vagina into contact with the outer surface
of the condom.
[0064] In some embodiments, the topical gel may be disposed on the
condom prior to the condom being rolled onto the penis. For
example, the topical gel may be disposed on the condom (e.g., the
outer and/or inner surface) during a manufacturing and/or packaging
step of the condom.
[0065] In other embodiments, the topical gel may be provided in a
package or tube that is separate from a package containing a
condom. For example, the topical gel may be provided in a
stand-alone container. The user may open the container and apply
the topical gel directly to the vagina, directly to the penis,
and/or to any suitable surface of a condom.
[0066] In some embodiments, method 200 may further comprise
applying the topical gel to a suitable medical device. For example,
the topical gel may be suitable for lubricating one or more
implements used during a pelvic exam, such as an outer surface of a
glove disposed on a hand of a gynecologist.
EXAMPLE 1
[0067] The following is to prepare a vaginal lubricant according to
a version of the invention, with percentages by weight of the total
formulation shown parenthetically after each component. Certified
organic aloe vera powder (95%), commercially available under the
trademark SD 200X.TM., is hydrated in a separate mixing tank. Agar
(0.2%) is added to hydrated aloe vera powder, and the mixture is
pasteurized by heating it to 160 degrees F. for about thirty (30)
minutes. After allowing the mixture to cool to about 115 degrees
F., Xanthan gum (3.1%) is added. The following inorganic
ingredients are combined in a separate mixing container: potassium
sorbate (0.25%), sodium benzonate (0.20%) and natural flavor
(0.35%). After being suitably mixed, the inorganic ingredients are
added to the aloe vera mixture. Lactic acid (0.9%) is suitably
mixed into the aloe vera mixture to match to the desired pH of
vaginal secretions. The resulting mixture is tested at completion
and prior to dispensing into commercial containers for microbial
count. Microbial count is tested by using commercially recognized
bacterial challenge tests, to meet the standard of no more than ten
colony forming units (CFUs) present. Other quality control tests
are performed, including commercially known 30-day shelf/oven
testing, and freeze/thaw testing.
EXAMPLE 2
[0068] The following is to prepare a vaginal lubricant according to
a version of the invention, with percentages by weight of the total
formulation shown parenthetically after each component. Certified
organic aloe vera powder (95%), commercially available under the
trademark SD 200X.TM., is hydrated in a separate mixing tank. Agar
(0.2%) is added to hydrated aloe vera powder, and the mixture is
pasteurized by heating it to 160 degrees F. for about thirty (30)
minutes. After allowing the mixture to cool to about 115 degrees
F., Xanthan gum (3%) is added. The following inorganic ingredients
are combined in a separate mixing container: potassium sorbate
(0.25%), sodium benzonate (0.20%) and natural flavor (0.35%). After
being suitably mixed, the inorganic ingredients are added to the
aloe vera mixture. Racemic lactic acid (1%) is suitably mixed into
the aloe vera mixture to bring the pH of that mixture within the
range of 3.5-3.9. Microbial count is tested by using commercially
recognized bacterial challenge tests, to meet the standard of no
more than ten colony forming units (CFUs) present. Other quality
control tests are performed, including commercially known 30-day
shelf/oven testing, and freeze/thaw testing.
[0069] The following paragraphs may provide further information
regarding embodiments of the present disclosure.
[0070] A. A method of bio-matching a topical gel, the method
comprising: selecting a region of a living body, wherein selecting
the region involves selecting a vagina; identifying a secretion of
the selected vagina; identifying a composition of the identified
secretion; and formulating the topical gel to match the identified
composition of the identified secretion.
[0071] A1. The method of paragraph A, wherein the body is a human
body.
[0072] A2. The method of paragraph A, wherein identifying the
secretion involves identifying a secretion present in a generally
healthy vagina.
[0073] A3. The method of paragraph A2, wherein identifying the
composition of the identified healthy secretion involves
identifying lactic acid.
[0074] A4. The method of paragraph A3, wherein identifying lactic
acid involves identifying racemic lactic acid having a racemic
index in a range of about 50% L/50% D.
[0075] A6. The method of paragraph A5, wherein selecting lactic
acid involves choosing an approximately racemic mixture with
between 30% to 70% L and between 70% to 30% D.
[0076] A7. The method of paragraph A6, wherein formulating the
topical gel involves formulating the topical gel to include about
1% of the selected lactic acid.
[0077] A8. The method of paragraph A2, wherein formulating the
topical gel involves bio-balancing the topical gel by avoiding
inclusion of one or more ingredients that are toxic to microbiota
of the generally healthy vagina.
[0078] B. A topical gel for human use, the gel comprising: a
formulation matched to a chemistry of a particular part of a human
body, the formulation including lactic acid.
[0079] B1. The gel of paragraph B, wherein the particular part of
the human body is a vagina.
[0080] B2. The gel of paragraph B1, wherein the chemistry is a
generally healthy chemistry associated with the vagina.
[0081] B3. The gel of paragraph B2, wherein the generally healthy
chemistry includes lactic acid having a racemic index of about 50%
L/50% D.
[0082] B4. The gel of paragraph B3, wherein the formulation
comprises approximately 1% lactic acid having a racemic index in a
range of about 30% L/70% D to 70% L/30% D.
[0083] B5. The gel of paragraph B4, wherein the racemic index of
the 1% lactic acid is approximately 50% L/50% D.
[0084] C. A topical gel for human use, the gel comprising: a
formulation matched to a chemistry of a particular part of a human
body, the formulation including lactic acid having a racemic index
in a range of about 50% L/50% D.
[0085] C1. The gel of paragraph C, wherein the particular part is a
vagina.
[0086] C2. The gel of paragraph C1, wherein the chemistry
corresponds to a generally healthy chemistry associated with flora
of the vagina.
[0087] C3. The gel of paragraph C2, wherein the generally healthy
chemistry includes racemic lactic acid having a racemic index of
about 50% L/50% D.
[0088] C4. The gel of paragraph C3, the lactic acid of the
formulation comprises about 1 % of the formulation.
[0089] D. A vaginal lubricant, comprising: a formulation including
lactic acid having a racemic index that is bio-matched but not
bio-identical to a racemic index of natural lubricants in a healthy
vagina.
[0090] D1. The lubricant of paragraph D, wherein the lactic acid of
the formulation is naturally-derived.
[0091] D2. The lubricant of paragraph D, wherein the lactic acid of
the formulation is synthetically-derived.
[0092] D3. The lubricant of paragraph D, wherein the racemic index
of the lactic acid of the formulation is in a range of about 30%
L/70% D to 70% L/30% D, and the racemic index of the natural
lubricants is about 50% L/50% D.
[0093] D4. The lubricant of paragraph D3, wherein the lactic acid
of the formulation is synthetic lactic acid comprising about 1% of
the formulation, the synthetic lactic acid having a racemic index
of about 50% L/50% D.
[0094] D5. The lubricant of paragraph D, wherein vagina bacteria of
the healthy vagina is dominated by Lactobacillus crispatus which
produce lactic acid that is included in the natural lubricants, the
lactic acid of the natural lubricants having a racemic index of
approximately 50% L/50% D.
[0095] D6. The lubricant of paragraph D5, wherein the lactic acid
of the formulation has a racemic index in a range of 80% L/20% D to
20% L/80% D, thereby resulting in the formulation being bio-matched
to the natural lubricants of the healthy vagina.
[0096] It is believed that the disclosure set forth herein
encompasses multiple distinct inventions with independent utility.
While each of these inventions has been disclosed in its preferred
form, the specific embodiments thereof as disclosed and illustrated
herein are not to be considered in a limiting sense as numerous
variations are possible. Each example defines an embodiment
disclosed in the foregoing disclosure, but any one example does not
necessarily encompass all features or combinations that may be
eventually claimed. Where the description recites "a" or "a first"
element or the equivalent thereof, such description includes one or
more such elements, neither requiring nor excluding two or more
such elements. Further, ordinal indicators, such as first, second
or third, for identified elements are used to distinguish between
the elements, and do not indicate a required or limited number of
such elements, and do not indicate a particular position or order
of such elements unless otherwise specifically stated.
* * * * *