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| United States Patent Application |
20110318291
|
| Kind Code
|
A1
|
|
Marchese; Frank P.
;   et al.
|
December 29, 2011
|
Trehalose-containing topical drying composition and method of using same
Abstract
A topical drying composition is providing containing trehalose as the
effective moisture (sweat) removing ingredient. The composition may be
used in aqueous form or preferably as a cream and in addition to
trehalose it contains several ingredients such as sorbitan monolaurate,
polysorbitan, a moisturizer, a thickener, a softener, an antibacterial
agent and a pH adjusting component to adjust the pH of the composition
between about 5.5 to about 7.5. Sterilized water is used as the carrier
for the composition.
The topical composition can be applied to the area which is vulnerable to
sweating after vigorous exercise in order to moisturize sweating on the
skin.
| Inventors: |
Marchese; Frank P.; (Bronxville, NY)
; Pan; Xinghua; (Hamden, CT)
; Mermelstein; Harold J.; (Bronx, NY)
|
| Serial No.:
|
199543 |
| Series Code:
|
13
|
| Filed:
|
September 2, 2011 |
| Current U.S. Class: |
424/65 |
| Class at Publication: |
424/65 |
| International Class: |
A61K 8/60 20060101 A61K008/60; A61Q 15/00 20060101 A61Q015/00 |
Claims
1. A topical drying composition comprising trehalose as the effective
skin drying ingredient, in an aqueous buffer solution.
2. The composition of claim 1, comprising trehalose in an amount
effective for removal of sweat or moisture from skin.
3. The composition of claim 1, wherein the composition comprises a buffer
to control the pH of the composition.
4. The composition of claim 3, wherein the pH of the composition is
between about 5.5 and about 7.0.
5. A method of removing topical moisture produced on the skin of a person
resulting from perspiration comprising applying to a desired area of the
skin of the person a topical drying composition comprising trehalose as
the effective skin drying ingredient, in an aqueous buffer solution.
6. The method of claim 5, wherein the composition comprises trehalose in
an amount effective for removal of sweat or moisture from skin.
7. The method of claim 5, wherein the composition comprises a buffer to
control the pH of the composition.
8. The method of claim 7, wherein the pH of the composition is between
about 5.5 and about 7.0.
9. The method of claim 5, wherein the perspiration is due to exercise.
10. The method of claim 5, wherein the perspiration is associated with
playing tennis.
11. The method of claim 5, wherein the perspiration is associated with
golfing.
12. The method of claim 5, wherein the perspiration is associated with
aerobics.
13. The method of claim 5, wherein the perspiration is associated with
strenuous sweat-producing activity.
14. The method of claim 5, wherein the topical drying composition is
applied to an area of skin of the person that is vulnerable to sweating.
15. The method of claim 5, wherein the topical drying composition is
applied to the hands of the person.
16. A method of removing topical moisture produced on the hands of a
person resulting from perspiration comprising applying to the hands of
the person a topical drying composition comprising trehalose as the
effective skin drying ingredient.
17. The method of claim 16, wherein the topical drying composition is in
the form of an aqueous buffer solution.
18. The method of claim 16, wherein the topical drying composition is in
the form of a cream.
19. The method of claim 16, wherein the perspiration is due to exercise.
20. The method of claim 16, wherein the perspiration is associated with
playing tennis, golfing, aerobics or other strenuous sweat-producing
activity.
Description
RELATED APPLICATIONS
[0001] This application is a continuation of co-pending application Ser.
No. 12/214,863 filed Jun. 24, 2008.
FIELD OF THE INVENTION
[0002] The present invention relates generally to topical drying
composition and is particularly related to topical drying composition
containing effective amount of trehalose as the drying ingredient. In its
more specific aspect, this invention relates to a topical drying
composition containing an effective amount of trehalose which enhances
drying the skin when it is topically applied to the skin of persons, such
as athletes, after perspiration due to exercise, such as playing tennis,
golf, aerobics or after other strenuous sweat-producing activities.
BACKGROUND OF THE INVENTION
[0003] Trehalose is a known non-reducing disaccharide composed of
D.sub.+glucose units. It is a white, odorless, sweet-tasting powder and,
like maltose, is about 45% as sweet as sugar and has a very low
hydroscopicity (moisture attraction). Trehalose is found in honey, bread,
beer and seafood and there are several prior art patents relating to
various uses of trehalose. For example, U.S. Pat. No. 4,839,164 discloses
cosmetic compositions containing trehalose which increase the penetration
of certain therapeutically beneficial ingredients into the skin thereby
enhancing the therapeutic effects of those ingredients on the skin. The
trehalose is used in a pharmaceutically acceptable carrier and several
trehalose-containing formulations are disclosed in said patent, such as
shampoo formulations, hair-conditioning formulations, skin care gel
formulations, lotions, and skin care creams.
[0004] U.S. Pat. No. 5,543,513 discloses the use of anhydrous trehalose as
a desiccant for dehydrating various products such as dehydrated food as
well as dehydrated pharmaceuticals. High-quality food products having
reduced moisture content can be prepared by incorporating anhydrous
trehalose into food products having relatively high moisture content
thereby converting the anhydrous trehalose into hydrous crystalline
trehalose.
[0005] U.S. Pat. No. 6,555,526 discloses an ophthalmic pharmaceutical
composition comprising trehalose as the effective ingredient. As
disclosed in said patent, there are three types of optical isomers of
trehalose, i.e., .varies.,.varies.-trehalose, .varies.,.beta.-trehalose
and .beta.,.beta.-trehalose. All isomers exert therapeutic and/or
prophylactic effect on signs of Sjorgen syndrome.
[0006] U.S. Pat. No. 6,723,170 discloses a crystalline trehalose dihydrate
with low hydroscopicity. Variety of uses are disclosed for the
crystalline trehalose dihydrate, including its use as a sweetener,
taste-improving agent, in feeds and pet foods for animals, in soaps, skin
creams, body
shampoos, hair creams, moisture-controlling agent and a host
of other uses disclosed in said patent.
[0007] Notwithstanding a variety of uses of trehalose disclosed in the
prior art patents, none, so far is known, recognize the efficacy of
trehalose for use in a topical drying composition.
[0008] Therefore, it is an object of the present invention to use
trehalose in a topical drying composition.
[0009] It is a further object of the present invention to provide a
topical drying composition containing trehalose as the effective
ingredient for sweat removal.
[0010] It is also an object of this invention to provide a topical drying
composition containing effective amount of trehalose and a suitable
carrier:
[0011] It is another object of this invention to provide a method of
drying the skin by the topical application of trehalose-containing
composition in which trehalose is the effective skin drying ingredient.
[0012] The foregoing and other objects and features of the present
invention will be more clearly understood from the ensuing description
and illustrative examples.
SUMMARY OF THE INVENTION
[0013] This invention provides a topical drying composition containing an
effective amount of trehalose, in hydrous and/or anhydrous form, in an
acceptable carrier such as sterilized water. The composition further
includes sorbitan monolaurate, polysorbitan and a pH adjuster in an
amount to adjust the pH of the composition between about 5.5 to about
7.5. The pH adjusting ingredient may be sodium chloride, potassium
chloride, sodium hydrogen phosphate and borax, or a mixtures thereof.
[0014] The composition of this invention may be prepared in cream form and
thus may include a thickener such as carbomer Ultrex 10, EDTA softener,
moisturizer such as dimethicone 200, cocoa butter to impart smoothness to
the cream, and antibacterial agent such as sodium benzoate and potassium
benzoate.
[0015] The composition; whether in aqueous solution form or as a cream, is
applied to the skin in the areas which are vulnerable to perspiration
after vigorous exercise. When tested by several volunteers, they
responded with virtually no perspiration after several hours of vigorous
exercise in a gym on a bicycle or treadmill, or even after several miles
of jogging when normally the subjects experienced perspiration in the
past when they did not apply the composition.
DETAILED DESCRIPTION OF THE INVENTION
[0016] The topical drying compositions of this invention are provided as
aqueous solutions or preferably as creams with desirable consistency. The
trehalose ingredient in these compositions may be the hydrous form,
anhydrous form or mixture of the hydrous and anhydrous trehalose, and the
composition may include a "buffer" as hereinafter described in order to
control the pH at a desired level. An antibacterial agent may also be
included in or due to impart antibacterial property to the composition.
[0017] The following illustrative examples describe the preparation of
various trehalose-containing compositions containing various other
necessary and/or desired ingredients in addition to the essential
ingredients. All parts are expressed by weight and weight percent.
Example 1
[0018] 204 grams of distilled water was charged to a reaction vessel
equipped with a stirrer, at room temperature and ambient pressure.
Thereafter, 2.5 grams of a thickener, (Ultrex 10), polyacrylic acid
thickener available from B.F. Goodrich, Co. was added slowly and mixed
with the water in the vessel, followed by addition of 1.5 grams of
ethylene dramine tetra acetic acid (EDTA), with continuous agitation
resulting in mixture A. The clear mixture was then heated to 45.degree.
C.
[0019] A separate mixture (Mixture B) was prepared containing 40 grams
sorbitan monolaurate (Arlacel 20 available from Ruger Chemical Co., Inc.)
85 grams of polysorbate (Tween 20 available from Ruger Chemical Co.,
Inc.) 23 grams of cocoa butter, 10 grams of dimethicone 200
(polydimethylsiloxane) available from Dow Corning, a moisturizer having a
viscosity of 700 cps, 3 grams of 1% of sodium benzoate and 1.5 grams of
1% potassium sorbate (antibacterial agent), and the resulting mixture was
heated to 60.degree. C. with constant stirring. Mixture B was then slowly
added to the vessel containing mixture A resulting in the formation of
homogeneous cream. The resulting cream was allowed to cool to 35.degree.
C., followed by the addition of aqueous solution of 40 grams of hydrous
trehalose in 100 grams of sterilized water and mixed for 2 hours. The
following table lists the ingredients of the resulting cream.
TABLE-US-00001
TABLE 1
Ingredient Parts by Wt. Wt. %
Sterilized water 204.0 68.74
Carbopol Ultrex 10 .sup.(1) 2.5 0.06
EDTA tetrasodium 1.5 0.04
Sorbitan monolaurate 40 10.3
Cocoa butter 23.0 5.1
Polysorbitan (Tween 20) 8.5 2.18
Dimethicone 200 10.0 2.57
Sodium benzoate 1% 3.0 0.77
Potassium sorbate 1% 1.5 0.04
Hydrous Trehalose 40.0 10.2
TOTAL 334 100.0
.sup.(1) carboxy polymethylene
The pH of the resulting cream was adjusted to 6.5 with 5% solutions of
sodium hydroxide.
Clinical Test on Formula No. 1
[0020] Six male volunteers ages 24, 35, 37, 42, 43 and 50 applied the
cream preparation in Example 1 to the axilla of one arm only. After
exercising in a gym on a bicycle and a treadmill for (4) hours, they all
reported that the axilla to which the cream was applied was completely
dry but the axilla of the other arm to which the cream was not applied
was wet with moisture.
Example 2
[0021] Following a similar procedure as in Example 1, another cream
formulation was prepared having the ingredients listed in the following
table
TABLE-US-00002
TABLE 2
Ingredient Parts by Wt. Wt. %
Sterilized water 203.9 64.9
Carbopol Ultrex 10 2.5 0.7
EDTA 1.5 0.5
Sorbitan monolaurate (Arlacel 20) 27.7 8.8
Cocoa butter 23.1 7.3
Polysorbate 20 (Tween 20) 8.3 2.6
Dimethicone 200 10.0 3.2
Hyamine 0.1 0
Hydrous Trehalose 38.0 12
TOTAL 315.10 100
The pH of the resulting cream was adjusted to 6.4 with 10% sodium
hydroxide solution
Clinical Test on Formula No. 2
[0022] Three female volunteers ages 49, 53 and 59 applied the cream
formulation obtained in Example 2 to both of their armpits. After
exercising vigorously on a treadmill for 2 hours, they reported minimal
wetness compared to their normal experience when they did not use the
cream.
Example 3
[0023] The formulations in the following table was made by the same
general procedure heretofore described and was tested for its efficacy.
TABLE-US-00003
TABLE 3
Ingredient Parts by Wt. Wt. %
Sterilized water 203.9 69.69
Carbomer thickener (Ultra 10) 2.5 .85
Tetra Sodium EDTA 1.5 .51
Sorbitan monolaurate 27.7 9.46
Shea butter 23.1 7.89
Polysorbate 20 (Tween 20) 8.3 2.83
Dimethicone 200 10.0 3.41
Hyamine 0.7 .24
Hydrous Trehalose 15.0 5.12
TOTAL 292.7 100
The pH of the resulting cream was adjusted to 6.4 with 5% sodium
hydroxide solution
Clinical Test on Formula No. 3
[0024] Six male volunteers ages 24, 35, 37, 42, 43 and 50 applied the
cream to the axilla of one arm only. After exercising vigorously in a gym
using a bicycle and treadmill for (4) hours they reported very little
sweating in the armpit to which they applied the cream but the other arm
sweated as normal.
[0025] The same 6 volunteers applied the cream formulation of Example 3
but without including trehalose. All reported significant sweating of the
arm.
Example 4
[0026] In this example the formulation did not contain the dimethicone
moisturizer but contained larger amount of trehalose.
TABLE-US-00004
TABLE 4
Ingredient Parts by Wt. Wt. %
Sterilized water 204.0 64.95
Carbopol Ultrex 10 2.5 0.80
Tetra Sodium EDTA 1.5 0.50
Sorbitan monolaurate 28.0 8.90
Cocoa butter 23.0 7.30
Polysorbate 20 (Tween 20) 8.5 2.70
Sodium Benzoate 1% 3.0 0.95
Potassium Sorbate 1% 1.5 0.50
Hydrous Trehalose 42.0 13.40
TOTAL 314 100
The pH of the resulting cream was adjusted to 6.4 with 5% sodium
hydroxide solution
Clinical Test on Formula No. 4
[0027] Six male volunteers ages 21, 22, 27, 29, 30 and 34 applied the
cream to the axilla of both arms. After exercising vigorously in a gym
using a bicycle and a treadmill for 3.5 hours, all volunteers reported
negligible wetness in their armpits.
Example 5
Part A
[0028] 300 grams of distilled water was combined with 2.5 grams of
carbopol 934 and allowed to form a clear solution. Then 1.5 grams of EDTA
was added and the mixture was stirred until it dissolved. This mixture
was then heated to 55.degree. degrees centigrade with stirring.
Part B
[0029] In a separate vessel 23 grams of cocoa butter was combined with 28
grams of sorbitan monolaurate, 8.5 grams polysorbate 20, and 10 grams of
dimethicone. Then 0.4 grams of sodium chloride, 0.15 grams of potassium
chloride, 0.15 of sodium hydrogen phosphate and 0.1 of borax were added,
and the entire mixture was then heated to 60.degree. degrees centigrade.
Part C
[0030] Part B was then added slowly to Part A with vigorous stirring
forming Part C, a white cream.
Part D
[0031] 68.5 grams of trehalose, 3 grams of 1% sodium benzoate and 1.5
potassium sorbate were added to Part C and the mixed well for several
hours to form a cream having a pH of 7.0
[0032] Table 5 below lists the ingredients and the composition.
TABLE-US-00005
TABLE 5
Ingredient Parts by Wt. Wt. %
Distilled water 300.00 67.11
Carbopol 934 2.5 .56
Tetrasodium EDTA 1.5 .33
Cocoa Butter 23.0 5.14
Sorbitan monolaurate 28.0 6.26
Polysorbate 20 8.5 1.90
Dimethicone 200 10.0 2.23
Sodium Benzoate 1% 3.0 .67
Potassium Sorbate 1% 1.5 .33
Trehalose Anhydrous 68.5 15.30
Sodium Chloride 0.4 0.09
Potassium Chloride 0.15 .03
Sodium hydrogen phosphate 0.15 0.03
Borax 0.1 .02
TOTAL 447.3 100.00
The pH of the resulting cream was adjusted to 6.4 with 5% sodium
hydroxide solution
Clinical Test on Formula No. 5
[0033] The test was conducted on two male volunteers ages 55 and 67. Each
volunteer applied the cream to his face, forehead and one armpit and
entered a sauna. After 1/2 hour they emerged from the sauna and were
examined. Their face and neck showed signs of complete dryness and their
armpits were completely dry. Their back and legs were damp with
perspiration.
[0034] The test was also conducted on three basketball players ages 18, 21
and 23 on an outside court at 82.degree. F. Each covered his hands and
forehead (without band) and armpits with the cream. After playing for 1/2
hour, their hands and forehead were free of moisture. After 2.5 hours
their hands and forehead was still free of moisture.
[0035] The test was also conducted on golfers ages 45, 56, 60 and, 64 on a
very warm day 90.degree. F. Each covered both hands with the cream. After
eight holes of play their hands were dray and they all claimed that the
grip on the club improved with better control and they did not even need
to wear a glove.
[0036] The method of use of the composition simply involves applying by
hand a generous amount to the skin in the area vulnerable to sweating,
and spreading the composition to cover that area. When using the
composition in aqueous solution form, it may be applied similarly, or
from a container with an applicator or a spray nozzle.
[0037] While the aforementioned compositions have been described with
certain degree of specificity, it is obvious to those skilled in the art
of formulating such compositions that several changes or modification may
be made which are nevertheless suggested from the foregoing detailed
description.
[0038] Optionally, other ingredients may be included in the cream
formulation described in the foregoing examples. For example, the
addition of a bovine collagen (1% aqueous solution of alphahydroxy
proline help restore the elasticity in the skin along with 1% aqueous
solution of elastin. Also, while the hydrous trehalose is used as the
effective ingredient, anhydrous trehalose may be used instead, or in
combination with hydrous trehalose. Also aqueous buffer solutions of
trehalose, hydrous and/or anhydrous have been, found effective topical
drying compositions.
* * * * *