U.S. patent application number 11/180913 was filed with the patent office on 2006-01-26 for foam skin cream, use of the foam skin protection cream and a process of its preparation.
This patent application is currently assigned to Stephanie Neubourg. Invention is credited to Fritz Neubourg.
Application Number | 20060018938 11/180913 |
Document ID | / |
Family ID | 7839199 |
Filed Date | 2006-01-26 |
United States Patent
Application |
20060018938 |
Kind Code |
A1 |
Neubourg; Fritz |
January 26, 2006 |
Foam skin cream, use of the foam skin protection cream and a
process of its preparation
Abstract
A foam skin cream can be obtained by preparing a phase I by
melting at 75.degree. C. a mixture containing fatty acids,
especially C.sub.12-C.sub.22 fatty acids, optionally unsaturated
and/or polyunsaturated fatty acids, emulsifiers, coemulsifiers,
such as triceteareth-4-phosphate, followed by metering it with
stirring to a phase II temperature-controlled at 75.degree. C.
obtained from an aqueous mixture containing moisturizers, such as
propylene glycol and/or polyhydric alcohols, especially glycerol,
emulsifiers, such as alkyl sarcosinates, and skin care additives,
such as allantoin; wherein homogeneous mixing of phases I and II is
provided and said metering is performed at a temperature of
75.degree. C.; after the metered addition, the temperature is
maintained at 75.degree. C. for a period of between 5 and 20
minutes; whereupon the temperature of the thus obtained mixture is
lowered to a temperature of between 30 and 40.degree. C. with
constant stirring; the pH value is adjusted to from 7.6 to 8.2,
preferably with a skin-compatible basic organic compound, and the
mixture obtained is filled into dosage forms with the addition of a
propellant.
Inventors: |
Neubourg; Fritz; (Emsdetten,
DE) |
Correspondence
Address: |
JACOBSON HOLMAN PLLC
400 SEVENTH STREET N.W.
SUITE 600
WASHINGTON
DC
20004
US
|
Assignee: |
Neubourg; Stephanie
Emsdetten
DE
|
Family ID: |
7839199 |
Appl. No.: |
11/180913 |
Filed: |
July 14, 2005 |
Related U.S. Patent Documents
|
|
|
|
|
|
Application
Number |
Filing Date |
Patent Number |
|
|
10196726 |
Jul 17, 2002 |
|
|
|
11180913 |
Jul 14, 2005 |
|
|
|
09485930 |
Feb 18, 2000 |
6423323 |
|
|
PCT/EP98/05232 |
Aug 18, 1998 |
|
|
|
10196726 |
Jul 17, 2002 |
|
|
|
Current U.S.
Class: |
424/401 |
Current CPC
Class: |
A61Q 19/00 20130101;
A61K 45/06 20130101; A61K 31/20 20130101; A61K 8/361 20130101; A61K
8/556 20130101; A61K 8/046 20130101; A61K 8/9789 20170801; A61Q
17/00 20130101; A61K 8/37 20130101; A61K 8/342 20130101; A61K 31/20
20130101; A61K 2300/00 20130101 |
Class at
Publication: |
424/401 |
International
Class: |
A61K 8/02 20060101
A61K008/02 |
Foreign Application Data
Date |
Code |
Application Number |
Aug 18, 1997 |
DE |
197 35 591.9 |
Claims
1-17. (canceled)
18. A foam aerosol skin cream, wherein the skin cream does not
contain PTFE, obtained by preparing a phase I by melting at
75.degree. C. a mixture containing one or more C.sub.10-C.sub.22
fatty acids, optionally containing an unsaturated or
polyunsaturated fatty acid, an emulsifier, or a coemulsifier or a
mixture thereof; preparing a phase II, temperature-controlled at
75.degree. C., by aqueous admixture of urea, as a moisture-binding
agent, and two or three ingredients selected from the group
consisting of a moisturizer, an emulsifier, and a skin care
additive, and a combination thereof; metered addition with
homogenous mixing of phase I and phase II at a temperature of
75.degree. C.; followed by maintaining the temperature of the
homogeneous mixture at 75.degree. C. for a period of between 5 and
20 minutes; followed by lowering the temperature of the homogeneous
mixture from 75.degree. C. to a temperature between 30.degree. C.
and 40.degree. C. with constant stirring; followed by adjusting the
pH of the homogeneous mixture at a temperature between 30.degree.
C. and 40.degree. C. to a value of 7.6 to 8.2; followed by
combining the homogeneous mixture with a propellant in a dosage
form, wherein the propellant is butane, propane, or a mixture
thereof.
19. The foam aerosol skin cream according to claim 18, wherein
phase I further contains as a coemulsifier
triceteareth-4-phosphate.
20. The foam aerosol skin cream according to claim 18, wherein the
moisturizer in phase II is propylene glycol, a polyhydric alcohol,
or a combination thereof.
21. The foam aerosol skin cream according to claim 18, wherein the
moisturizer in phase II is glycerol and the emulsifier in phase II
is an alkyl sarcosinate.
22. The foam aerosol skin cream according to claim 18, wherein the
skin care additive in phase II is allantoin.
23. The foam aerosol skin cream according to claim 18, wherein the
pH is adjusted to a value from of 7.6 to 8.2 by adding a
skin-compatible basic organic compound.
24. The foam aerosol skin cream according to claim 18, further
comprising adding a preservative to the homogeneous mixture, with
stirring, at the temperature of 30.degree. C. to 40.degree. C.
25. The foam aerosol skin cream according to claim 18, containing
from 4 to 15% by weight of oil-in-water emulsifier; from 1 to 10%
by weight of the C.sub.10-C.sub.22 fatty acid; from 0.4 to 2.3% by
weight of the coemulsifier; from 1 to 20% urea; from 1 to 10% by
weight of the moisturizer; from 0.5 to 1% by weight of the skin
care additive; and water as the balance to make 100% by weight.
26. A process for making the foam aerosol skin cream comprising:
preparing a phase I by melting at 75.degree. C. a mixture
containing one or more C.sub.10-C.sub.22 fatty acids, optionally
containing an unsaturated or polyunsaturated fatty acid, an
emulsifier, or a coemulsifier or a mixture thereof; preparing a
phase II, temperature-controlled at 75.degree. C., by aqueous
admixture of urea, as a moisture-binding agent, and two or three
ingredients selected from the group consisting of a moisturizer, an
emulsifier, and a skin care additive, and a combination thereof;
metered addition with homogenous mixing of phase I and phase II at
a temperature of 75.degree. C.; followed by maintaining the
temperature of the homogeneous mixture at 75.degree. C. for a
period of between 5 and 20 minutes; followed by lowering the
temperature of the homogeneous mixture from 75.degree. C. to a
temperature between 30.degree. C. and 40.degree. C. with constant
stirring; followed by adjusting the pH of the homogeneous mixture
at a temperature between 30.degree. C. and 40.degree. C. to a value
of 7.6 to 8.2.
27. The foam aerosol skin cream made by the process according to
claim 26.
28. A process of making a container of spray foam aerosol cream
comprising filling the foam aerosol cream of claim 27 together with
a propellant into a spray-can container, wherein the propellant is
butane, propane, or a mixture thereof.
Description
[0001] The present invention relates to a foam skin cream, uses of
the foam skin protection cream and a process for its
preparation.
[0002] The galenic principle of an emulsoid two-phase system having
lipophilic or hydrophobic components and, on the other hand,
hydrophilic components has been known for the production of foam
preparations for skin care. The application of these foam
preparations to the treated skin forms a two-dimensional two-phase
network, the hydrophilic components bind to the keratin of the
horny layer and enable the evaporation of sweat while the
lipophilic components inhibit the permeation of moisture (including
the penetrated sweat) on the skin surface. As the foam, in contrast
to other creams building a barrier, is absorbed in less than a
minute, does not leave any grease traces on the working materials
and prevents heat built-up or even maceration effects from the
action of sweat, the foam has enjoyed rapidly growing popularity as
a protective agent against occupational action of moisture. Further
details about the per se known foam skin creams can be seen, in
particular, from "Haut", issue 4, 1992, by R. Rudolph, L. Bade, B.
Bruggemann.
[0003] In "hautnah derm" 10 (1994), 344-351, B. Kunze reports
lipid-containing skin protection foams which are indicated for dry
sensitive skin and chronical-rhagadiform eczemas. Ingredients are
also disclosed therein. The skin protection foams described therein
are protective against a lot of occupational noxious matters, such
as acid permanent waving liquids in the hairdresser's trade, lyes,
oils, disinfectants, cleaning and rinsing agents, but also against
water, moisture, sweat, feces, urine and mineral dusts.
[0004] EP 0 598 412 also relates to skin protection foams; PTFE is
described as an active principle.
[0005] DE-C-33 30 628 relates to skin protection and care-lotions
containing silicone oils, partially neutralized stearic acid, fatty
alcohols and their ethoxylated derivatives, ethoxylated wool
alcohols, cetyl/stearyl alcohol, vaseline, thickeners and water.
The lotions disclosed therein are said to be quickly absorbed
without leaving an annoying grease film on the skin for extended
periods of time.
[0006] Information about emulsifiers which can be employed in skin
care agents are found in DE-A-195 42 572. This reference suggests
emulsifiers which contain from 43 to 90% by weight of alkyl and/or
alkenyl oligoglycosides and from 10 to 57% by weight of fatty
alcohols. These emulsifiers are particularly suitable for the
preparation of highly viscous, sensorily light oil-in-water
emulsions having a long shelf life. The German utility model
DE-U-9308050 relates to a skin protection foam used against
skin-aggressive agents. This foam consists of an aqueous emulsion
containing fatty acid esters with good skin compatibility for the
production of a moisture-permeable film, polyhydric alcohol for
stably dispersing the active agents and controlling the humidity of
the film, emulsifiers for improving foam stability, surfactants for
reducing the surface tension and optionally neutralizing agents for
resins and emulsifiers. Gaseous hydrocarbons may be used as
propellants, for example, propane, butane or isobutane and mixtures
thereof. However, the foams described do not contain any free fatty
acids.
[0007] Aerosoles are complicated physical-chemical structures which
do not form under arbitrary circumstances. In Particular, a special
balance between the foam-forming components is important. Slight
shifts in the composition may already result in a collapse of the
foam; thus, a formulation of per se active substances may not be
capable of being formulated as a foam without further
provisions.
[0008] Especially in occupational applications, skin creams are
often found unpleasant because the "fatting" components remain too
long on the skin and lead to annoying finger traces or generally to
an unpleasant feeling. This has been remedied to some extent by the
per se known skin foams since they help preventing or reducing
overload of the skin with the fatting matters. Nevertheless, it is
desirable to find even more acceptance by the user, especially in
the long-term use of skin protection agents.
[0009] It has been the object of the present invention to extend
the application range of skin protection foams by providing a
formulation which is highly accepted by the user, the admixture of
a wide variety of other substances being allowed without destroying
the aerosol employed or deteriorating the properties of the
aerosol.
[0010] The object of the invention is surprisingly achieved by a
base formulation of a foam skin cream having the features of claim
1. Dependent claims 2 to 12 relate to preferred embodiments of the
foam skin cream according to the invention. Claims 13 to 16 relate
to uses of the foam skin cream according to the invention, whereas
claim 17 relates to a process for preparing the base of a foam skin
cream according to the invention.
[0011] The foam skin cream according to the invention can be
obtained by [0012] preparing a phase I by melting at 75.degree. C.
a mixture containing fatty acids, especially C.sub.12-C.sub.22
fatty acids, optionally unsaturated and/or polyunsaturated fatty
acids, emulsifiers, coemulsifiers, such as
triceteareth-4-phosphate, followed by metering it with stirring to
[0013] a phase II temperature-controlled at 75.degree. C. obtained
from an aqueous mixture containing moisturizers, such as propylene
glycol and/or polyhydric alcohols, especially glycerol,
emulsifiers, such as alkyl sarcosinates, and skin care additives,
such as allantoin; [0014] wherein homogeneous mixing of phases I
and II is provided and said metering is performed at a temperature
of 75.degree. C.; [0015] after the metered addition, the
temperature is maintained at 75.degree. C. for a period of between
5 and 20 minutes; whereupon the temperature of the thus obtained
mixture is lowered to a temperature of between 30 and 40.degree. C.
with constant stirring; [0016] the pH value is adjusted to from 7.6
to 8.2, preferably with a skin-compatible basic organic compound,
and the mixture obtained is filled into dosage forms with the
addition of a propellant.
[0017] At the one hand, the product obtainable according to this
process can be directly employed as a foam skin cream in the
industrial field for the protection from or reduction of the
absorption of cancerogenic substances, such as polycyclic aromatic
hydrocarbons. This mixture is capable of providing effective
protection for persons whose skin has already been exposed to
cancerogenic substances, such as polycyclic aromatic hydrocarbons.
In addition, the mixture is suitable for providing protection to
persons from the action of acids, lyes (not above pH 11), scouring
agents and detergents, sweat, urine, stool, rubber gloves, dusts,
house dust, machine, drilling and cooling oils, greases,
paints/varnishes, gypsum and other substances and chemicals,
especially aggressive substances and chemicals.
[0018] The foam skin cream according to the invention contains
fatty acids, especially C.sub.12-C.sub.22 fatty acids, and may
optionally additionally contain unsaturated and/or polyunsaturated
fatty acids. Useful fatty acids which are saturated include, in
particular, the naturally occurring C.sub.12-C.sub.22 fatty acids,
especially stearic acid and palmitic acid. Myristic acid may also
be used. Useful unsaturated fatty acids include, in particular,
those having up to three unsaturated bonds in their hydrocarbon
chain. Unsaturated fatty acids are found, for example, in fractions
of coconut fat. Useful coemulsifiers include per se known
coemulsifiers, especially triceteareth-4-phosphate, sodium
laureth-4-phosphate or oleth-3 and other lipophilic emulsifiers
based on fatty alcohols with a low degree of ethoxylation.
[0019] Phase I may additionally contain paraffinum liquidum.
Emulsifiers to be used in phase I may include those based on fatty
alcohols and those based on partial esters of fatty acids.
Particularly preferred fatty alcohols include cetearyl alcohol.
Glyceryl stearate, for example, may be employed as a partial ester
of a fatty acid.
[0020] The moisturizers to be used in phase II include, in
particular, propylene glycol and/or polyhydric alcohols, such as
glycerol. As particular emulsifiers to be used in phase II, there
may be mentioned alkyl sarcosinates, such as lauroyl, lauryl, cetyl
sarcosinates.
[0021] The mixture obtainable according to claim 1 also serves as a
base for other foam skin creams which may be employed in a wide
range of applications for protecting the skin and alleviating
dermatological dysfunctions.
[0022] If desired, one or more preservatives may be added to the
foam skin cream according to the invention. In particular,
substances such as methyldibromoglutaronitrile and/or
phenoxyethanol have proven to be suitable preservatives. These
substances may be added in amounts of from 0.01 to 1% by
weight.
[0023] Preferably, the emulsifiers, fatty acids, coemulsifiers,
moisturizers and skin care agents, especially allantoin, panthenol
etc., are used in the following amounts: [0024] from 4 to 15% by
weight of oil-in-water emulsifier; [0025] from 1 to 10% by weight
of fatty acid, especially from 4 to 7% by weight, preferably from
4.5 to 6% by weight; [0026] from 0.4 to 2.3% by weight of
coemulsifier; [0027] from 1 to 10% by weight of moisturizer; [0028]
from 0.05 to 1% by weight of skin care agent; and [0029] water as
the balance to make 100% by weight.
[0030] A preferable foam skin cream according to the invention
contains: [0031] from 1 to 3% by weight of glyceryl stearate;
[0032] from 3 to 6% by weight of cetearyl alcohol; [0033] from 4 to
6% by weight of stearic acid; [0034] from 0.5 to 2% by weight of
paraffin; [0035] from 0.4 to 2.3% by weight of
triceteareth-4-phosphate; [0036] from 1.5 to 4% by weight of
propylene glycol; [0037] from 1.3 to 4.2% by weight of glycerol;
[0038] from 1 to 3% by weight of cetyl sarcosinate; [0039] from
0.05 to 1% by weight of allantoin; and [0040] water as the balance
to make 100% by weight.
[0041] In another preferred embodiment, the foam skin cream
according to the invention additionally contains a
silicone-containing substance, such as dimethicone. This substance
is added to phase I. Preferably, it is present in amounts of from
0.05 to 1% by weight.
[0042] In addition, the foam skin cream according to the invention
may additionally contain one or more refatting substances in phase
I, such as decyl oleate, isohexadecane, stearic acid glycol ester,
coconut fatty acid ethanolamide, corn oil, peanut oil, almond oil,
sesame oil, olive oil, jojoba oil, soybean oil, wool wax alcohols,
paraffin, medium-chain triglycerides, oleic acid oleyl esters,
white petrolatum, macrogol-glycerol hydroxystearate, hydrogenated
castor oil, castor oil from Ricinus communis, avocado oil, wheat
germ oil, palmitic acid isopropyl ester, cetyl palmitate, myristic
acid myristyl ester and/or octyldodecanol.
[0043] In particular, the foam skin cream contains amounts of from
0.5 to 2% by weight of decyl oleate and/or from 0.5 to 2% by weight
of octyldecanol, or another of the refatting substances mentioned,
if the product is to be used for normal skin. The total amount of
refatting substances is to be such that the skin protection foam is
not destroyed. An amount of about 4% by weight of refatting
substances is sufficient for normal to slightly dry skin. If dry
skin is to be treated with the foam skin cream according to the
invention, amounts of from 3 to 6% by weight of a component of the
refatting substances, such as, in particular, decyl oleate and/or
octyldecanol, are recommendable. If more than one component is
used, the total amount of refatting components is to be about 12%
at most for slightly dry skin. If even more severely dry skin is
treated, the amount of refatting substances is from about 6 to 9%
by weight if a component such as decyl oleate is used, and from 6
to 9% by weight if octyldecanol is used. The amount of refatting
substance may then be up to 20% by weight.
[0044] Like the products without silicone-containing substances,
the latter foam skin creams are suitable for the care and
protection of the skin, especially from aggressive substances, such
as scouring agents and detergents, sweat, urine, stool, rubber
gloves, dusts, house dust, machine, drilling and cooling oils,
greases, paints/varnishes, gypsum and other substances and
chemicals, especially aggressive substances and chemicals.
[0045] The foam skin creams are also suitable for the treatment or
alleviation of dermatological diseases. This includes, in
particular, dermatological diseases such as allergic contact
dermatitis type I and IV, cumulative-subtoxic eczema,
toxic-irritative eczema, microbial-dysregulative eczema, atopic
dermatitis, atopic palmoplantar eczema, dyshidrosis, hyperhidrosis,
contact urticaria, intertriginous eczema in connection with
hemorrhoids, various weeping fungal infections, e.g., interdigital
mycosis, perleches, psoriasis vulgaris, ulcus cruris, cholinergic
urticaria, diaper dermatitis.
[0046] It may be indicated to include substances which can increase
the moisture content of the skin, in addition to refatting
substances. Such hydratizing substances include, in particular,
urea, ethoxydiglycol, sodium chloride, magnesium chloride,
sorbitol, dexpanthenol, sodium lactate, allantoin, hyaluronic acid,
vitamin E, linolenic acid. The amount of those substances can be
from 1 to 20% by weight or more of the respective substances,
depending on the severity of the disease to be treated. These
quantities also apply, in particular, to urea which may also be
present in amounts of from 3 to 15% by weight or from 12.5 to 15%
by weight. The foam skin cream according to the invention may also
be used for psoriasis.
[0047] One particularly important field of application concerns the
prophylaxis and treatment of diabetic foot. Due to accompanying
symptoms of diabetes, diabetics suffer from dry skin which in the
course of the diseases favors damage to the extremities, up to an
extent where amputation becomes necessary in the case of those
having been diabetic for many years. Prophylactic application of
skin protection agents which provide an improvement of the skin
parameters in diabetics can prevent the development of diabetic
foot.
[0048] In addition, skin care substances, such as polyunsaturated
fatty acids (PUFA), may be added to the foam skin cream according
to the invention. These include, in particular, omega-6 fatty acids
as known, for example, from evening primrose oil and borage oil.
Both synthetic omega-6 fatty acids and those obtained from the
mentioned plant extracts may be employed.
[0049] Further, there may be used soothing substances, such as
chamomile extract, as another fraction which may be admixed with
the foam skin cream according to the invention.
[0050] Skin-active vitamins, such as vitamins A, E and F, may be
admixed with the foam skin cream according to the invention in
effective amounts. Especially for the treatment and prevention of
diaper dermatitis, admixing the following substances has proven
useful: from 3 to 7% by weight of Calendula extract, from 3 to 7%
by weight of Hamamelis extract, from 3 to 7% by weight of chamomile
extract, from 3 to 7% by weight of tea tree oil extract, from 1 to
5% by weight of decyl oleate, from 1 to 5% by weight of
octyldodecanol.
[0051] The process according to the invention for the preparation
of the foam skin protection cream according to the invention
comprises the following steps: [0052] preparing a phase I by
melting at 75.degree. C. a mixture containing fatty acids,
especially C.sub.12-C.sub.22 fatty acids, optionally unsaturated
and/or polyunsaturated fatty acids, coemulsifiers, such as
triceteareth-4-phosphate, followed by metering this phase with
stirring to [0053] a phase II molten at 75.degree. C. obtained from
an aqueous mixture containing moisturizers, such as propylene
glycol and/or polyhydric alcohols, especially glycerol,
emulsifiers, such as alkyl sarcosinates, and skin care additives,
such as allantoin; [0054] wherein homogeneous mixing of phases I
and II is provided and said metering is performed at a temperature
of 75.degree. C.; [0055] after the addition of phase I to phase II,
the temperature is maintained at 75.degree. C. for a period of
between 5 and 20 minutes; whereupon the temperature of the thus
obtained mixture is lowered to a temperature of between 30 and
40.degree. C. with constant stirring; [0056] adjusting the pH value
to from 7.6 to 8.2, preferably with a skin-compatible basic organic
compound, and filling into containers with the addition of a
propellant.
[0057] The invention will be further illustrated by the following
Example.
EXAMPLE
[0058] The skin protection cream according to the invention is
prepared in a heatable and coolable closed apparatus with a
self-withdrawing homogenisator and a heatable metering funnel
(preferably in a Koruma multipurpose apparatus).
[0059] The preparation of phase I is effected in a heatable
metering funnel by melting at 75.degree. C. a mixture containing 2%
by weight of glyceryl stearate, 4% by weight of cetearyl alcohol,
5% by weight of stearic acid, 1% by weight of paraffin and 1% by
weight of triceteareth-4-phosphate, followed by metering this phase
with stirring to phase II previously prepared in the heatable and
coolable closed apparatus with a self-withdrawing homogenisator.
Phase II consists of an aqueous mixture containing 2.5% by weight
of propylene glycol, 2.5% by weight of glycerol, 2% by weight of
sodium lauroylsarcosinate and 0.3% by weight of allantoin. The
amount of water is 79.7% by weight. Homogeneous mixing of phases I
and II is to be provided.
[0060] The metering of phase I is performed at a temperature of
75.degree. C. Both phases are combined with constant stirring at a
medium stirring speed, and care must be taken that homogenization
is effected uniformly. The temperature is maintained at 75.degree.
C. for between 5 and 20 min. The mixture obtained is cooled to a
temperature of between 30 and 40.degree. C. with constant
stirring.
[0061] Then, after a temperature of 40.degree. C. has been reached,
the further substances may be added. This may include adjusting the
pH value to between 7.8 and 8.0. For this purpose,
2-amino-2-methyl-1-propanol is used. Stirring is continued for a
sufficient period of time until the pH value has stabilized,
followed by filling into suitable storage tanks or into the
corresponding spraying containers. In the latter case, 91% of drug
is filled together with 9% of butane/propane.
* * * * *