The present invention relates to a hydroalcoholic gel that both
provide a sanitizing effect and a moisturizing benefit to the
5 user's skin.
It is well known that one of the best and easiest ways to
defend against harmful bacteria and viruses is washing the
hands thoroughly with soap and water for at least 20 seconds.
10 For instance, in order to prevent the spread of severe acute
respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that
causes COVID-19, hand hygiene is essential, especially in the
absence of a vaccine or effective antiviral drugs.
15 However, handwashing isn't always practical, especially for
healthcare workers. This is due to a lack of access to running
water, and a lack of sufficient time to wash the hands
thoroughly. Alcohol-based hand sanitizers provide a quick,
simple alternative.
20
It is in this respect generally recommend that consumers use an
alcohol-based hand sanitizer that contains at least 60%
alcohol, but preferably higher concentrations of alcohol, as
such hand sanitizers are effective in inactivating/killing most
25 infectious agents, such as microorganisms and viruses. However,
even though alcohol-containing sanitizers are known to possess
good sanitizing activity and prevent infections, use of alcohol
on the skin at high concentrations often severely dries the
skin as the alcohol dissolves the sebum from the skin.
30 Consequently, continuous use of such sanitizers can leave the
user's skin dry, often resulting in red, chapped, and cracked
skin.
As a result, it is common to restrict the alcohol content in
35 hand sanitizers to about 60% percent. However decreasing the
alcohol content in the composition has the unwanted effect of
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decreasing the composition's potency in killing the infectious
agent i.e. bacteria, viruses, fungi, and protozoa.
A problem with the known hand sanitizers is that even though
5 the sanitizer may inactivate/kill most of the infectious agents
accumulated on the users hands, the known sanitizers does not
have a long lasting effect, as the sanitizer easily is ~washed"
10
off, e.g. if the user
washes his/her hands.
sanitizer regularly
is out in the rain, sweat, or simply
Thus, the user has to reapply the hand
in order to obtain the desired
antimicrobial effect, thereby increasing the problems with
dryness/redness of the hands.
Accordingly, there is a requirement for an hydroalcoholic gel
15 with a high percentage of alcohol that will effectively kill
infectious agents, dry quickly, leave no sticky residue, will
not excessively dry the skin and ensure that the composition
has a prolonged sanitising effect, even after subsequent hand
washing.
20
25
These and further aspect are achieved according to the present
invention by providing a hydroalcoholic gel comprising at least
70 weight%
composition,
between than
wherein the
alcohol, between 5 and 10 weight% of an oil
between 0.15 and 6 weight% of a gelling agent and
0.01 and 0.1 weight % of a pH adjusting agent, and
gelling agent consist of between 0. 05 and 2. 0
weight% of a carbomer and between 0 .1 and 4. 5 weight% of a
cellulose polymer composition.
30 Said hydroalcoholic gel is unique in that it comprises a high
concentration of alcohol, thereby effectively killing
microorganisms, virus etc, upon contact, but only low
concentrations of other components, such as gelling agents,
without compromising the moisturising effect or the stability
35 of the product. In fact the hydroalcoholic gel according to the
invention is stable, even after long-term storage. When used,
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the hydroalcoholic gel destroys microorganisms and virus,
moisturizes the skin thereby avoiding red, chapped, and cracked
skin; does not leave an oily residue and a tacky feel on the
skin, and adheres firmly to the skin (even after washing)
5 thereby providing a long-term disinfecting effect. This
prolonged effect may be especially relevant for healthcare
workers and/or other groups that are exposed to infections from
a variety of sources throughout the course of each day.
10 It is generally recognised that an alcohol concentration of 70
% by weight (or above) kills/inactivate microorganisms upon
contact e.g. by denaturating the proteins in the cell membrane
of a bacteria or the proteins in the capsid/envelope of a
virus. The alcohol used in the present hydroalcoholic gel may
15 be any kind of alcohol capable of killing/inactivating the
infectious agent; it is however preferred that said alcohol is
ethanol or isopropanol, or a mixture thereof. For instance,
ethanol at concentration at 70% by weight has shown to be a
potent virucidal agent inactivating all of the lipophilic
20 viruses (e.g., influenza virus) and many hydrophilic viruses
(e.g., rotaviruses).
Even though it is preferred to have an alcohol concentration of
at least 70 % by weight in the hydroalcoholic gel according to
25 the invention, the alcohol content may in some situations be
lower. The inventors have found that alcohol concentrations at
about 65 % by weight in the hydroalcoholic gel is sufficient
for killing/inactivating the relavant infectious agent(s), and
in some situations the alcohol concentrations may be as low as
30 about 45 % by weight in the hydroalcoholic gel.
Since proteins are denatured more quickly by alcohol in the
presence of water, a preferred embodiment of the hydroalcoholic
gel according to the invention comprises between 5 - 20 % by
35 weight water, preferably between 12 and 18 % by weight water.
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In order to prevent the skin from drying out, due to
defattening by the high alcohol concentration, the
hydroalcoholic gel according to the invention comprises an oil
composition. In this way the hydroalcoholic gel comprises both
5 an aqueous phase and an oily phase, which preferably is
combined into a bigel.
A bigel is a uniform semisolid dispersion system that visually
appear as a single gel, but in which an oleogel and an aqueous
10 gel, are mixed together e.g. by applying a high shear rate.
Bigels are not emulsions, and one of the major advantages of
bigels is the improved stability compared to emulsions (waterin-
oil and oil-in-water), emulgels, hydrogels and oleogels,
which ensures that the hydroalcoholic gel according to the
15 invention remains stable, The enhanced physicochemical
stability of the bigels can be attributed to the formation of
extra fine colloidal dispersions, which is due to the
immobilization of one gel (e.g. the oleogel) in a threedimension
gel network of the other gel (e.g. the aqueous gel).
20 On storage at room temperature, the two components of the bigel
do not get separated and the hydroalcoholic gel according to
the invention therefore remains stable, even after long term
storage, i.e. one year or more.
25 Further, no separation of the aqueous gel and oleogel is
detected when the hydroalcoholic bigel is applied to the skin.
Thus, by converting oleogels and hydrogels into bigels, a good
patient compliance is provided without compromising the
beneficial effects of the individual water and oil phases.
30
35
The oil composition in the hydroalcoholic gel is preferably
selected from mono-, di-, and triglycerides of synthetic, semisynthetic
and natural origin, and mixtures thereof, e.g. a
mixture of capric/caprylic triglycerides.

We Claim:
1. A hydroalcoholic gel comprising at least 70 weight%
alcohol, between 5 and 10 weight% of an oil
5 composition, between 0.15 and 6 weight% of a gelling
agent and between than 0.01 and 0.1 weight % of a pH
adjusting agent, and wherein the gelling agent consist
of between 0.05 and 2.0 weight% of a carbomer and
between 0.1 and 4.5 weight% of a cellulose polymer
10 composition, based on the total weight of the
hydroalcoholic gel, and wherein said alcohol is
ethanol or isopropanol, or a mixture thereof, and
wherein the oil composition is selected from mono-,
di-, and triglycerides of synthetic, semi-synthetic
15 and natural origin, and mixtures thereof.
2. The hydroalcoholic gel according to claim 1, wherein
said hydroalcoholic gel further comprises between 5
and 20 weight% water, preferably between 12 and 18
20 weight% water.
3. The hydroalcoholic gel according to claim 1 or 2,
wherein the hydroalcoholic gel comprises both an
aqueous phase and an oily phase, which is combined
25 into a bigel.
4. The hydroalcoholic gel according to claim 1, 2 or 3
wherein the oil composition in the hydroalcoholic gel
is a mixture of capric/caprylic triglycerides.
30
5. The hydroalcoholic gel according to any of the
preceding claims, wherein the hydroalcoholic gel has a
ARTICLE 34 CLAIMS
41
pH value between 5 and 8, preferably between 6.0 and
7.5.
6. The hydroalcoholic gel according to any of the
5 preceding claims, wherein the pH adjusting agent is
triethanolamine.
7. The hydroalcoholic gel according to claim 6, wherein
the amount of triethanolamine in the hydroalcoholic
10 gel is between 0.02 and 0.08% by weight, such as
between 0.025 and 0.03 by weight or between 0.05 and
0.06 % by weight, based on the total weight of the
final hydroalcoholic gel.
15 8. The hydroalcoholic gel according to any of the
preceding claims, wherein the cellulose polymer
composition comprises ethylcellulose, non-sodium
carboxy methylcellulose, and mixtures thereof.
20 9. The hydroalcoholic gel according to any of the
preceding claims, wherein the hydroalcoholic gel has a
viscosity between 1000 and 150,000 cp, preferably
between 50,000 and 80,000 cP as measured using a Lamy
VRM-08 viscometer with an MS DIN module at a
25 temperature of 23°C and at a shear stress of 0.8 s-1.
10. The hydroalcoholic gel according to any of the
preceding claims, wherein the hydroalcoholic gel
further comprises a disinfecting ingredient.
30
11. The hydroalcoholic gel according to claim 10, wherein
said disinfecting ingredient is quaternary ammonium,
42
a. combine alcohol and optionally water, thereby
providing an aqueous solution
b. disperse the carbomer into the aqueous
solution, thereby providing a first
intermediate composition,
c. mixing the cellulose polymer composition with
the first intermediate composition, thereby
providing a second intermediate composition,
sodium hypochlorite, hydrogen peroxide or a mixture
thereof.
12. The hydroalcoholic gel according to claim 10 or 11,
5 wherein the disinfecting ingredient is added to the
hydroalcoholic gel in an amount between 0.1 and 6 % by
weight, based on the total weight of the final
hydroalcoholic gel.
10 13. The hydroalcoholic gel according to any of the
preceding claims, wherein the hydroalcoholic gel
comprise at least one active ingredient.
14. The hydroalcoholic gel according to claim 13, wherein
15 said active ingredient is selected from hormones;
corticoid and corticoid derivatives; dermatological
active ingredients; antimicrobial agents; antiinflammatory
agents and wound repair agents.
20 15. The hydroalcoholic gel according to claim 13 or 14,
wherein the active ingredient is a hormone, in an
amount between 0.5 and 2.5 wt%, more preferably
between 0.5 and 1.5 wt%, or even more preferred 1 wt%,
based on the total weight of the final hydroalcoholic
25 gel.
16. A method for manufacturing the hydroalcoholic gel
according to any of the claims 1 – 15, said method
comprises the following consecutive steps:
30
43
d. mixing the oil composition with the second
intermediate composition thereby providing a
third intermediate composition, and
e. mixing the pH adjusting agent with the third
intermediate composition, thereby providing
the hydroalcoholic gel.
5
10
15
17. A method according to claim 16, modified in that the
order of step c. and d. are in reverse order, i.e. the
oil composition is mixed with the first intermediate
20 composition thereby providing the second intermediate
composition, and then the cellulose polymer
composition is mixed with the second intermediate
composition, thereby providing the third intermediate
composition, the remaining steps being unchanged.
25
18. The method according to claim 16 or 17, wherein each
added compound is mixed with the previously obtained
solution or intermediate composition under vigorous
stirring.
30
44
19. The method according to claim 16, 17 or 18, wherein
each intermediate composition is stirred for at least
10 minutes.
5 20. A hand sanitizer consisting of the hydroalcoholic gel
according to any of the claims 1 – 13.
21. The hand sanitizer according to claim 20, wherein the
hydroalcoholic gel comprises 70.0 weight% alcohol, 7.0
10 weight% of an oil composition; 2.5 weight% of a
gelling agent and 0.056 weight % of the pH adjusting
agent triethanolamine, and wherein the gelling agent
consist of 0.5 weight% of a carbomer and 2.0 weight%
of a cellulose polymer composition, all based on the
15 total weight of the hydroalcoholic gel.
22. The hand sanitizer according to claim 20, wherein the
hydroalcoholic gel comprises 70.0 weight% alcohol, 7.0
weight% of an oil composition; 2.5 weight% of a
20 gelling agent and 0.028 weight % of the pH adjusting
agent triethanolamine, and wherein the gelling agent
consist of 0.5 weight% of a carbomer and 2.0 weight%
of a cellulose polymer composition, all based on the
total weight of the hydroalcoholic gel.
25
23. The hand sanitizer according to claim 21 or 22,
wherein the alcohol is ethanol, the oil composition is
labrafac WL1349, i.e. a mixture of capric/caprylic
triglycerides, the carbomer is Carbopol 980 NF, and
30 the cellulose polymer composition is Emulfree® CBG or
Emulfree® P.
45
24. A transdermal or mucosal delivery system consisting of
the hydroalcoholic gel according to any of the claims
– 15.
5 25. The transdermal or mucosal delivery system according
to claim 24, wherein the delivery system comprises at
least 1 weight% testosterone, based on the total
weight of the hydroalcoholic gel.
10 26. The delivery system according to claim 25, wherein the
hydroalcoholic gel comprises 1 weight% testosterone,
70.0 weight% alcohol, 7.0 weight% of an oil
composition; 4.5 weight% of a gelling agent and 0.028
or 0.056 weight % of the pH adjusting agent
15 triethanolamine, and wherein the gelling agent consist
of 0.5 weight% of a carbomer and 4.0 weight% of a
cellulose polymer composition, all based on the total
weight of the hydroalcoholic gel.