Note : Les descriptions sont présentées dans la langue officielle dans laquelle elles ont été soumises.
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A STORAGE STABLE TOPICAL COMPOSITION
Backqround of the Invention
The present invention relates to a sugar-containing
composition useful in topical applications having enhanced
storage stability and a method for imparting the storage
stability to the composition.
One of the primary factors which determines the practical
usefulness of a topical cream composition is storage
stability. Lengthening of the "shelf life" of a cream
prior to the onset of composition separation or
crystallization offers obvious advantages such as ease of
inventory management, reduction of waste incurred in
disposing of creams which are no longer active and removal
of the additional burden and uncertainty involved in re-
mixing a composition prior to application in cases where
this procedure is possible. Additionallyr when ~he topical
cream is being utilized as a medicament, a further
advantage of reduction of inadvertent administration of a
composition which can no longer perform its intended
function is obtained.
Storage stability of the presently claimed composition is
particularly difficult due to the presence of relatively
high amounts of sugar in the cream. Sugar compounds are
known to dissolve in almost anything having a high moisture
content. Obviously, a high moisture content is undesirable
for a topical cream composition.
As a result, much effort has been put forth in an attempt
to increase the storage stability of topical compositions.
See, for example, U.S. Patent No. 4,271,143 issued to
Winicov ~t al. on June 2, 1981, U.S. Patent No. 4,401,651
issued to Knutson on August 30, 1983 and British Patent No.
2,084,464 issued to Beta Medical Products Ltd. on April 15,
1982.
Summary of the Invention
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Accordingly, it is an object of the present invention to
provide a topical cream composition which is storage stable
for a long period of time.
It is a further object of the present invention to
provide a method for imparting storage stability to topical
cream compositions by adding a moisture control agent to
the cream.
It is another object of the present invention to provide
an improved topical cream composition by adding a sugar and
a moisture control agent to the composition.
It is a further object of the present invention to
provide a topical cream which can be manufactured in a
continuous or Aiscontinuous manner.
It is another object of the present invention to provide
a crsam base for a topical cream composition comprising wax
compounds, thickness and surfactants.
It is a further object of the present invention to
provide a topical cream composition which is homogenous
throughout.
It is another object of the present invention to provide
a topical cream composition of such a consistency to render
it capable of being applied directly to the skin or to a
dressing material.
Still other objects and features of the present invention
will become apparent to those skilled in the art from the
following detailed description of the present invention.
Detailed Description of the Invention
The present invention contemplates a storage stable
topical composition comprising:
(a) about 5 to about 30% by weight of a cream base
wherein said cream base comprises:
(i~ about 5 to about 10% by weight of one or more
topically acceptable waxes;
(ii) about 0.01 to about 5% by weight of one or more
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topically acceptable thickeners;
(iii) about 0.5 to about 3% by weight of one or more
topically acceptable surfactants; and
tiv) the balance being substantially water;
(b) about 0.1 to about 7% by weight of a topically
active ingredient;
~c) about 50 to about 95~ by weight of a sugar; and
(d) about 0.5 to ahout 2.5~ by weight of a moisture
control agent.
The present invention further contemplates a storage
stable cosmetic composition wherein the sugar level may be
reduced to as low as 20% by weight, with the amount by
weight of the cream base being adjusted upward as
necessary, up to 70% by weight or more. The enhanced
storage stability property of the cream compositions is
derived from the combination of the ingredients therein
which will be discussed in detail below.
The vehicle for the topical composition for the present
invention is a cream base made up of one or more compounds
chosen from each of the categories of waxes, thickeners and
surfactants. Each of the categories and their
contribution(s) to the cream base are detailed below.
~ ax compounds are useful as emollients and humectants in
topical applications. That is, they aid in softening,
moisturizing and lubricating the skin. The presence of
such emollient/humectant materials promotes the production
and application of a cream which will not irritate the skin
through abrasion. The wax compounds preferred, according
to the present invention, are cetyl alcohol, stearyl
alcohol, heeswax, natural or synthetic candelilla,
carnauba, jojoba oil, and ceresine.
Thickening agents, as the name implies, serve to add body
to the composition by increasing the viscosity of the
cream. The presence of such thickeners in a sufficient
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amount promotes the production of a cream composition of a
consistency suitable for topical application. Preferred
thickening agents, according to the present invention, are
synthetic clays, cellulose ether compounds and polyethylene
glycol compounds. Most preferred thickening agents are
Laponite X1~ (a synthetic clay), Methocel (methyl
cellulose), ~thoce~ (ethyl cellulose), Natroso~ (a
cellulose ether compound), carboxymethylcellulose and PEG
400 (polyethylene glycol 400).
Surface active agents or surfactants serve a multitude of
pu rposes in topical compositions. The
hydrophilic/hydrophobic structural nature of surfactants
cause them to orient at solid/liquid or liquid/liquid
interfaces. The structure of surfactants also functions to
decrease the contractive forces at the juncture of two
liquids, the surface tension, thereby promoting the
dispersion of one liquid in another. Moreover, these
additives promote the dispersion or suspension of solids in
a solution. This feature is important in emulsifying the
wax compounds, dispersing the thickeners and also providing
some assistance in the penetration of the resultant cream
into the skin. Preferred surfactants, according to ~his
invention, are polyethylene glycol ether compounds and
sorbitan monooleate compounds. Most preferred surface
~5 active agents are Tergitol~ 15-s-9 (a polyethylene glycol
ether compound), nonoxynol 9 (nonylphenyl polyethylene
glycol ether), and Polysorbate~ 80 (polyoxyethylene 20
sorbitan mono-oleate).
In addition, some surfactants exhibit anti-microbial
properties. The structural nature of these compounds as
discussed above permits the surfactants to damage or
disrupt the cell membrane of microbes through inactivation
of the enzymes ~hich maintain said membranes or by physical
disorgani~ation of the membranes. Thus, in certain
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pharmaceutical and cosmetic uses, the surfactant
ingredient(s) may enhance act:ivity.
The topically active ingredient found in the composition
is, of course, responsible for the bul~ of the activity or
useful utility of the present invention. Although the
invention is applicable to a cream useful in any topical
application, those of a pharmaceutical or cosmetic nature
are preferred. Examples of suita~le pharmaceutical active
ingredients include povidone iodine, bacteriostatic agents,
antibiotics, anti-inflammatory agents, microbicidal agents
and vitamins, while the cosmQtic active ingredients include
aloe and vitamins.
Suitable bacteriostats according to the claimed invention
are acrisorcin, resorcinol, fluorouracil, benzoyl peroxide,
dichlorindolene and hexachlorophene, for example. Suitable
anti-inflammatory agents include, dimethyl sulfoxide,
hydrocortisone, betamethasone benzoate and
methylsalicylate, for example. Antibiotics usable in the
present invention include Bacitracin, Amphotericin B,
chloramphenicol and polymyzin B sulfate, for example.
Also, vitamins A and E, for example, are capable of being
suspended in a topical cream of the type contemplated by
the present invention in both medicinal and cosmetic
applications. Finally, suitable microbicides include
iodine, gluconate and hydrogen peroxide, for example.
A sugar compound is also present in the topical cream of
the present invention. The sugars contemplated by the
present invention are mono- and di-saccharide compounds,
including their liquid forms and stereoisomers. Preferred
sugar compounds are glucose, fructose and sucrose. These
compounds provide nutrition to the skin to which the cream
is applied, and, in the case of a pharmaceutical use such
as antisept:ic treatment of an open wound, aid in the
healing process. Also, some sugars, such as sucrose,
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exhibit anti-bacterial activity, which enhances the
activity of the resultant topical cream. Thus, the cream
containing sugar with no other active ingredient will be a
useful product.
The moisture control ingredient required by the present
claims is, preferably, selected from the group consisting
of finely divided silicon dioxide (Cab-O-Si~ M-5),
anhydrous lanolin and cholesterol. This component absorbs
any excess moisture in the topical cream composition
thereby maintaining the delicate balance between the
ingredients of the cream. Since the equili~rium which
exists betwePn the components in the cream is able to be
maintained, the tendency for any one of those components to
release from the others is reduced.
The storage stable topical cream formulation contemplated
by the present invention may be manufactured by art-
recognized methodology, with the following set forth as
exemplary.
First, the cream based carrier vehicle must be prepared
using a standard oil-in-water smulsion technique.
Step 1: In a suitable reaction vessel, 20 to 30 weight
~ of the total water needed is heated to a temperature in
the range of 90 - 100~ C. Then 0.175 - 0.4 weight ~ cf a
first thickener is added to the heated water, and the
mixture is subjected to agitation until a product with the
consistency of a paste is obtained. The remainder of the
water necessary (to make up the 100 weight % of the cream
base given the desired weight percentages of the additives)
is added to the paste, and the resultant formulation is
agitated until said paste is completely dissolved in the
solution. Next, 0.5 - 3 weight % o~ a second thickener is
added slowly with concomitant mixing until said second
thickener is also completely dissolved. A first surfactant
is then added, the mixture agitated thoroughly, and the
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resultant solution is set aside.
Step 2: In a second suitable reaction vessel, the
desired waxes, a third thiclcener and a second surfactant
undergo thorough agitation and heating to a temperature in
the range of 70 - 9o~c.
Step 3: Heat the product of step 1 to a temperature in
the range of 70 - 80C. Under continual agitation, add
t~e produGt of step 2 to the heated product of step 1.
A~ter the addition is completed, agitation is continued
until a cream with a ~irm consistency and uni~orm
composition ~s obtained. The firm and uniform cream is
then cooled to a temperature in the range of 20 - 30Co
Once the preparation of the carrier cream base is
completed, the pharmaceutical cream can be manufactured
using standard mixing procedure. The desired amount of the
active ingredient is added to the cream prepared above and
the mixture is subjected to agitation until the two
-components are well dispersed. Next the sugar component is
added, and the resultant formulation is agitated
thoroughly. Finally, the moisture flow control ingredient
is added and agitation is applied until a homogenous
composition results.
The procedure outlined above is based on production of
the topical cream product on a continuous basis. That is,
the carrier cream base is utilized immediately after its
production in the manufacture of the final product.
However, this need not be the case. The simple addition of
preservative compound in an amount of about 0.05 to about
0.1% by weight of the cream base to the carrier cream base
will allow for discontinuous production of the ultimate
topical cream product. That is, the cream base is capable
of being formulated at a separate time and/or production
facility than the topical cream. Likewise, any combination
of the cream base and some of the other three components
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may be combined separately from the ultimate product. For
example, the cream base, sugar and moisture control agent
may be preserved and shipped to another site where active
ingredient is manufactured. The preservative may be any of
those known in the art to preserve such cream bases,
preferably povidone iodine or a paraben, for example,
methylparaben and butylparaben.
The use of povidone iodine as the active ingredient
provides a pharmaceutically effective cream having anti-
infecti~e properties. Utilizing the povidone iodinecomplex rather than iodine itself offers the advantage of
increased stability of the iodine in the resultant cream
product and enhanced pharmaceutical acceptance without the
sacrifice of the anti-infective properties of th~ elemental
halogen compound. Also, povidone iodine is sugar
compatible which contributes to the overall stability of
the product cream.
A topical anti-infectiva composition of the present
invention may be applied directly to the injured skin or
indirectly to the skin through application to a dressing
material or in any othar manner known in the art for the
juxtaposition of a medicament in cream form with the
affected area of the body.
The combination of anti-infective and tissue growth
promotion activities of a composition of the present
invention renders it useful for treating conditions
involving open wounds or burns. The open wounds can be of
the type resulting from a skin trauma such as gunshot and
knife wounds as well as those induced by other means such
as sores or carbuncles.
The unique combination of ingredients found in
compositions of the present invention also results in
excellent pharmaceutical acceptance. The replacement of
elemental iodine with the povidone iodine complex produces
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drastic improvement in this area. The incidence of skin
irritation and staining as well as the onset of allergic
reactions often brought on by elemental iodine is reduced
very significantly since the PVP-iodine complex is both
non-irritating and non-sensitizing. Also, the sugar and
other additives are safe for use on human skin, inert to
PYP-iodine, i.e., do not react with the complex to release
elemental iodine, and compatible with PVP-iodine and each
- other.
10 The amount of the active ingredient in the composition,
i.e., the dosage required, depends on such factors as the
type of injury or dysfunction, the degree of healing which
has already been induced, if any, and the skin type of the
patient. Those skilled in the art will make an assessment
based on these factors and any others which become apparent
in the specific case and use the appropriate strength
formulation.
When a cosmetic cream is contemplated, the sugar
requirement of said cream is reduced. That is, the cream
may be formulated with a sugar content as low as 20% by
weight of the product cream. This decrease is due to the
reduction in the demand for nutrition supplied to the skin.
Obviously, a cosmetic designed for routine daily use as a
moisturizer or some form of colorant does not require the
tissue regenerative capability of, for example, a
medicament useful for the treatment of open wounds wherein
skin growth is absolutely essential to the healing process.
When the amount of sugar is adjusted, the quantity of cream
base is oppositely altered to complete the cream
composition.
The cosmetic compositions of the present invention may be
applied directly to the skin by hand, applicator or in any
other manner known in the art for the juxtaposition of a
cosmetic in cream form with the desired area of
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application.
The amount of active ingredient in the cosmetic topical
cream, depends on such factors as the intended use of the
cosmetic (a corrective moisturizer as opposed to a
fortified colorant, for example) and the nature of the skin
of the recipient (dry, normal, or oily, for example).
Those skilled in the art will make an assessment based on
these factors and any others which become apparent in the
case of a specific cosmetic and provide the appropriate
relative amounts of ingredients.
The topical cream of the present invention exhibits
enhanced storage stability properties. That is, the cream
does not separate or suffer from the crystallization of the
various components susp~nded in the cream for a long period
of time. This results in an increased shelf life and
enhanced usefulness of the topical formulation.
It is believed that the proposed moisture-control
ingredient imparts much of the marked improvement in
storage stability to the composition. This theory is
contemplated due to the properties of the sugar ingredient
of the cream. Sugars will dissolve in almost anything with
a high moisture content. This characteristic is a serious
detriment to the formation of a product with the
consistency of a cream. However, the moisture control
ingredient absorbs the excess moisture and stabilizes the
equilibrium between the components of the product cream.
Thus, cream compositions containing an effective amount of
a moisture control ingredient are capable of maintaining a
high sugar concentration dispersed therein for long periods
of time.
Examples
Example 1: Anti-Infection Cream
A. Preparation of the cream base
Step 1: In a suitable reaction vessel, 174.5 ml of water
13~ 3'~3
is heated to 95C. 2.5 gm Methocel is then added, and the
mixture is agitated until a paste is formed. 698 ml water
cooled to 5C, is added, and agitation is subsequently
applied until the thickener/water paste is completely
dissolved. 15 gm Laponite is then added slowly with
agitation until the thickener is completely dissolved. 10
gm Tergitol is added, and the resulting mixture is blended
and set aside.
Step 2: In a second reaction vessel, 40 gm cétyl
alcohol, 30 gm stearyl alcohol, 20 gm polyethylene glycol
400 and lO gm Polysorbate 80 are heated to 75C while
agitation is supplied.
Step 3: The mixture of Step 1 above is heated to 750C
whereupon the product of Step 2 above is added to the newly
heated product of Step l under conditions of constant
agitation. Agitation is continued until a firm and uniform
cream is obtained. The resultant cream base is cooled to
room temperature.
B. Preparation of a Storage Stable Topical Composition
215 gm of the cream base of A above is mixed with 25 gm
of povidone iodine until the two components are well
dispersed. Next, 750 gm of sucrose is added and the
mixture is agitated thoroughly. 10 gm of finely divided
silicon dioxide is then added, whereupon the composition is
agitated until the final product is homogenous.
Example 2
A. Anti-Infection Cream
Step 1: In a suitable reaction vessel, 174.2 ml of
water is heated to 93C. 3.0 gm Ethocel is then added, and
the mixture is agitated until a paste is formed. 696.8 ml
of water having been cooled to 5C is added, and agitation
is subsequently applied until the thickener/water paste is
completely dissolved. 12 gm of Laponite is then added
slowly with agitation until the thickener is complet~ly
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dissolved. 12 gm nonoxynol 9 is added, and the resulting
mixture is blended and set aside.
Step 2: In a second reaction vessel, 20 gm ceresine, 40
gm cetyl alcohol, 10 gm beeswax and 20 gm polyethylene
glycol 400 and 15 gm Tergitol are heated to 77c while
agitation is supplied.
Step 3: The mixture of Step 1 above is heated to 77C
whereupon the product o~ Step 2 above is added to the newly
heated product of Step 1 under conditions of constant
lo agitation. Agitation is continued until a firm and uniform
cream is obtained. The resultant cream base is cooled to
room temperature.
B. Preparation of a Storage Stable Topical Composition
213 gm of the cream base of A above is mixed with 25 gm
by povidone iodine until the two components are well
dispersed. Next, 750 gm of glucose is added and the
mixture is agitated thoroughly. 12 gm of finely divided
silicon dioxide is then added, whereupon the composition is
agitated until the ~inal product is homogenous.
Example 3: Anti-In~ection Cream
A. Preparation of the cream base
Stap 1: In a suitable r~action vessel, 171.6 ml of
water is heated to 95C. 3.8 gm carboxymethyl cellulose is
then added, and the mixture is agitated until a paste is
formed. 656.6 ml of water having been cooled to 0C is
added, and agitation is subsequently applied until the
thickener/water paste is completely dissolved~ 21 gm of
Ethocel is then added slowly with agitation until the
thickener is completely dissolved. 12 gm Polysorbate~ 80 is
added, and the resulting mixture is blended and set aside.
Step 2: In a second reaction vessel, 30 gm stearyl
alcohol, 25 gm jojoba oil, 15 gm ceresine, 20 gm Methocel,
and 15 gm Nonoxyno~ 9 are heated to 75C while agitation is
supplied.
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step 3: The mixture of Step l above is heated to 75C
whereupon the product of Step 2 above is added to the newly
heated product of Step 1 under conditions of constant
agitation.
Agitation is continued until a firm and uniform cream
is obtained. The resultant cream base is cooled to room
temperature.
B. Preparation of a Storage Stable Topical Composition
- 205 gm of the cream base of A above is mixed with 25 gm
of povidone iodine until the two components are well
dispersed. Next, 750 gm of fructose is added and the
mixture is agitated thoroughly. 20 gm o~ finely divided
silicon dioxide is then added, whereupon the composition is
agitated until the final product is homogenous.
Example 4: Anti-Infection Cream
. Preparation of the cream base
Step l: In a suitable reaction vessel, 176.~ ml of
water is heated to 100C. 1.8 gm Natrosol is then added,
and the mixture is agitated until a paste is formed. 705.8
ml of water having b~en cooled to 5~C is added, and
agitation is subsequently applied until the thickener/water
paste is completely dissolved. 13 gm of Laponite is then
added slowly with agitation until the thickener is
completely dissolved. 5.5 gm Tergitol is added, and the
resulting mixture is blended and set aside.
Step 2: In a second reaction vessel, 30 gm cetyl
alcohol, 30 gm synthetic candelilla, 17.5 gm carboxymethyl-
cellulose, and 20.0 gm Polysorbate 80 are heated to 72C
while agitation is supplied.
Step 3: The mixture of Step 1 abov~ is heated to 72C
whereupon the product of Step 2 above is added to the newly
heated product of Step 1 under conditions of constant
agitation. Agitation is continued until a firm and uniform
croam i~ obtain~d. Th~ rQ~ultant or~am ba~o i~ coolQd ~o
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room temperature.
B. Preparation of a storage Stable Topical composition
243 gm of the cream base of A above is mixed with 35 gm
of Vitamin E until the two components are well dispersed.
Next, 700 gm of sucrose is added and the mixture is
agitate~ thoroughly. 22 gm of anhydrous lanolin is then
added, whereupon the composition is agitated until the
final product is homogenous.
- Exam~le 5: Anti-Infection C'ream
A. Preparation of the cream base
Step l: In a suitable reaction vessel, 172.6 ml of
water is heated to 97C. 2.0 gm Methocel is then added,
and the mixture is agitated until a paste is formed. 690.4
ml of water having been cooled to 5C is added, and
agitation is subsequently applied until the thickener/water
paste is completely dissolved. 25 ~n of Methocel is then
added slowly with agitation until the thickener is
-completely dissolved. lO gm Tergitol is added, and the
resulting mixture is blended and set aside.
Step 2: In a second reaction vessel, 40 gm beeswax, 30
~n jojoba oil, 20 gm polyethylen~ glycol 400, and lO gm
Polysorbate 80 are heated to 75~C while agitation is
supplied.
Step 3: The mixture of Step l above is heated to 75~C
whereupon the product of Step 2 above is added to the newly
heated product of Step l under conditions of constant
agitation. Agitation is continued until a firm and uniform
cream is obtained. The resultant cream base is cooled to
room temperature.
B. Preparation of a Storage Stable Topical Composition
295 gm of the cream base of A above is mixed with 25 gm
of Vitamin E until the two components are well dispersed.
Next, 670 ~n of sucrose is added and the mixture is
agitated thoroughly. 10 gm of finely divided silicon
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dioxide is then added, whereupon the composition is
agitated until the final product is homogenous.
Example 6: Anti-Infection Cream
A. Preparation of the cream base
Step 1: In a suitabls reaction vessel, 176 ml of water
is heated to 98C. 2.5 gm Methocel is then added, and the
mixture is agitated until a paste is formed. 704 ml of
water having been cooled to oC is added, and agitation is
subsequently applied until the thickener/water paste is
completely dissolved. 7.5 qm of Laponite is then added
slowly with agitation until the thickener is completely
dissolved. lQ gm Tergitol is added, and the resulting
mixture is blended and set aside.
Step 2: In a second reaction vessel, 20 gm cetyl
alcohol, 40 gm natural candelilla, 10 gm stearyl alcohol,
:~ and 20 gm Nethocel, and 10 gm Tergitol are heated to 75C
while agitation is supplied.
Step 3: The mixture of Step 1 above is heated to 75C
whereupon the product of S*ep 2 above is added to the newly
heated product of Step 1 under conditions of constant
agitation. Agitation is continued until a firm and uniform
cream is obtained. The resultant cream base is cooled to
room temperature.
B. Preparation of a Storage Stable Topical Composition
105 gm of the cream base of A above is mixed with 35 gm
of povidone iodine until the two components are well
dispersed. Next, 850 gm of sucrose is added and the mixture
is agitated thoroughly. 10 gm of cholesterol is th~n
added, whereupon the composition is agitated until the
final product is homogenousO
Example 7: Anti-Infection Cream
A. Preparation of the cream base
Step 1: In a suitable reaction vessel, 174.8 ml of
water is heated to 90C. 2 gm Natrosol is then added, and
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the mixture is agitated until a paste if formed. 699.2 ml
of water having been cooled to 0C is added, and agitation
is subsequently applied until the thickener/water paste is
completely dissolved. 12 gm of Natrosol is then added
slowly with agitation until the thickener is completely
dissolved. lo gm Polysorbate 80 is added, and the
r~sulting mixture is blended and set aside.
Step 2: In a second reaction vessel, 30 gm ceresine, 25
gm carnauba, 15 gm cetyl alcohol, and 20 gm carboxymethyl
cellulose, and 12 gm Polysorbate 80 are heated to 77C
while agitati~n is supplied.
Step 3: The mixture of Step 1 above is heated to 77C
whereupon the product of Step 2 above is heated to 77C
whereupon the product of Step 2 above is added to the newly
heated product of Step l under conditions of constant
agitation. Agitation is continued until a firm and uniform
cream is obtained. The resultant cream base is cooled to
room temperature.
B. Preparation of a Storage Stable Topical Composition
93 gm of the cream base of A above is mixed with 45 gm of
povidone iodine until the two components are well
dispersed. Next, 850 gm of glucose is added and the
mixture is agitated thoroughly. 12 gm of finely divided
silicon dioxide is then added, whereupon the composition is
agitated until the final product is homogenous.
Example 8: Anti-Infection Cream
A. Preparation of the cream base
Step 1: In a suitable reaction vessel, 175 ml of water
is heated to 92DC. 2 gm Ethocel is then added, and the
mixture is agitated until a paste is formed. 702.8 ml of
water having been cooled to 5C is added, and agitation is
subsequently applied until the thickener/water paste is
completely dissolved. 12 gm of Ethocel is then added
slowly with agitation until the thickener is completely
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dissolved. 10 gm Polysorbate 80 i5 added, and the
resulting mixture is blended and set aside.
Step 2: I~ a second reaction vessel, 30 gm stearyl
alcohol, 30 gm natural candelilla, 17.5 gm Me~hocel, and 20
gm Polysorbate 80 are heated to 72C while agitation is
supplied.
Step 3: The mixture of Stlep 1 above is heated to 72C
whereupon the product of Step 2 a-bove is added to the newly
heated product of Step 1 under conditions of constant
agitation. Agitation is continued until a firm and uniform
cream is obtained. The resultant cream base is cooled to
room temperature.
B. Preparation of a Storage Stable Topical Composition
283 gm of the cream base of A above is mixed with 55 gm
of povidone iodine until the two components are well
dispersed. Next, 650 ~m of glucose is added and the
mixture is agitated thoroughly. 12 gm of finely divided
silicon dioxide is then added, whe-reupon the composition is
agitated until the final product is homogenous.
Bxample 9: Anti-Infection Cream
A. Preparation of the cream base
Step 1: In a suitable reaction vessel, 174.8 ml of
water is heated to 91C. 2 gm carboxymethyl cellulose is
then added, and the mixture is agitated until a paste is
formed. 699.2 ml of water having been cooled to 5C is
added, and agitation is subsequently applied until the
thickener/water paste is completely dissolved. 12 ym of
Methocel is then added slowly with agitation until the
thickener is completely dissolved. 12 gm Tergitol is
added, and the resulting mixture is blended and set aside.
Step 2: In a second reaction vessel, 40 -gm cetyl
alcohol, 30 gm stearyl alcohol, 20 gm polyethylene glycol
400, and 10 gm nonoxynol 9 are heated to 79C while
agitation is supplied.
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Step 3: The mixture of Step 1 above is heated to 79C
whereupon the product of Step 2 above is added to the newly
heated product of Step 1 under conditions of constant
agitation. Agitation is continued until a firm and uniform
cream is obtained. The resultant cream base is cooled to
room temperature.
B. Preparation of a Storage Stable Topical Composition
215 gm of the cream base of A above is mixed with 6S gm
`of povidone iodine until the two components are well
dispersed. Next, 700 gm o~ glucose is added and the
mixture is agitated thoroughly. 20 gm o~ ~inely divided
silicon dioxide is then added, whereupon the composition is
agitated until the final product is homo~enous.
Example 10: Cosmetic Cream
A. Preparation of the cream base
Step 1: In a suitable reaction vessel, 174.6 ml of
water is heated to 95C. 2.5 gm Ethocel is then added, and
the mixture is agitated until a paste is formed. 698.4 ml
of water having been cooled to 5~C is added, and agitation
is subsequently applied until the thickener/water paste is
completely dissolved. 12 gm o~ Methocel is then added
slowly with agitation until the thickener is completely
dissolved. 7.5 gm Tergitol is added, and the resulting
mixture is blended and set aside.
25Step 2: In a second reaction vessel, 20 gm ceresine, 40
gm stearyl alcohol, 10 gm beeswax, 20 gm Laponite, and 15
gm Terqitol are heated to 750C while agitation is supplied.
Step 3: The mixture of Step 1 above is heated to 75C
whereupon the product of Step 2 above is added to the newly
heated product of Step 1 under conditions of constant
agitation. Agitation is continued until a firm and uniform
cream is obtained. The resultant cream base is cooled to
room temperature.
B. Preparation of a Storage Stable Topical Composition
, ~
~l3~6~
19
600 gm of the cream hase of A above is mixed with 25 gm
of aloe until the two components are well dispersed. Next,
350 gm of sucrose is added and the mixture is agitated
thoroughly. 25 gm of finely divided silicon dioxide is
then added, whereupon the composition is agitated until the
final product is homogenous.
Fxam~le 11: Cosmetic Cream
A. Preparation of the cream base
Step 1: In a suitable reaction vessel, 172.9 ml of
water to 96C. 3 gm Laponite is then added, and the
mixture is agitated until a paste is formed. 691.6 ml of
water having been cooled to 0C is added, and agitation is
subsequently applied until the thickener/water paste is
completely dissolved. 20 gm of Ethocel is then added
slowly with agitation until the thickener is completely
dissolved. 7.5 gm Polysorbate 80 is added, and the
resulting mixture is blended and sat aside.
Step 2: In a second reaction vessel, 30 gm cetyl
alcohol, 25 gm carnauba, 15 gm beeswax, 20 gm Natrosol, and
gm Tergitol are heated to 75C while agitation is
s~pplied.
Step 3: The mixture of Step 1 above is heated to 75~C
whereupon the product of Step 2 above is added to the newly
heated product of Step 1 under conditions of constant
agitation. Agitation is continued until a firm and uniform
cream is obtained. The resultant cream base is cooled to
room temperature.
B. Preparation of a Storage Stable Topical Composition
545 gm of the cream base of A above is mixed with 35 gm
of aloe until the two components are well dispersed. Next,
400 gm of sucrose is added and the mixture is agitated
thoroughly. 20 gm anhydrous lanolin is then added,
whereupon the composition is agitated until the final
product is homogenous.
:lL3~
Example 12: Cosmetic Cream
A. Preparation of the cream base
Step 1: In a suitable reaction vessel, 173.8 ml of
water is heated to 100C. 3.5 gm Methocel is then added,
and the mixture is agitated until a paste is formed. 695.2
ml of water having heen cooled to 5C is added, and
agitation is subsequently applied until the thickener/water
paste is completely dissolved. 20 gm of Ethocel is then
added slowly with agitation until the thickener is
completely dissolved. 10 gm Tergitol is added, and the
resulting mix~ure is blended and set aside.
Step 2: In a second reaction vessel, 30 gm stearyl
alcohol, 30 gm cetyl alcohol, 17.5 gm carboxymethyl
cellulose, and 20 gm Polysorbate 80 are heated to 75C
while agitation is supplied.
Step 3: The mixture of Step 1 above is heated to 75C
whereupon the product of Step 2 above is added to the newly
heated product of Step 1 under conditions of constant
agitation. Agitation is continued until a firm and uniform
cream is obtained. The resultant cream base is cooled to
room temperature.
B. Preparation of a Storage Stable Topical Composition
545 gm of the cream base of A above is mixed with 45 gm
of aloe until the two components are well dispersed. Next,
400 gm of glucose is added and the mixture is agitated
thoroughly. 10 gm of finely divided silicon dioxide is
then added, whereupon the composition is agitated until the
final product is homogenous.
Example 13: Cosmetic Cream
A. Preparation of the cream base
Step 1: In a suitable reaction vessel, 174.3 ml of
water is heated to 95C. 3.5 gm Ethocel is then added, and
the mixture is agitated until a paste is formed. 697.2 ml
of water having been cooled to 5C is added, and agitation
~3~
21
is subsequently applied until the thickener/water paste is
completely dissolved. 15 gm of Methocel is then added
slowly with agitation until the thickener is completely
dissolved. 10 gm Tergitol is added, and the resulting
mixture is blended and set aside.
Step 2: In a second reaction vessel, 40 gm ceresine, 30
gm stearyl alcohol, 20 gm Methocel, and 10 gm Tergitol are
heated to 72C while agitation is supplied.
Step 3: The mixture of Step 1 above is heated to 72C
whereupon the product of Step 2 above is added to the newly
heated product of Step 1 under conditions of constant
agitation. Agitation is continued until a firm and uniform
cream is obtained. The resultant cream base is cooled to
room temperature.
B. Preparation of a Storage Stable Topical Composition
505 gm of the cream base of A above is mixed with 25 gm
of Vitamin E until the two components are well dispersed.
Next, 450 gm of sucrose is added and the mixture is
agitated thoroughly. 20 gm of finely divided silicon
dioxide is then added, whereupon the composition is
agitated until the final product is homogenous.
Example 14: Cosmetic Cream
A. Preparation of the cream base
Step 1: In a suitable reaction vessel, 177.1 ml of
water is heated to 93C. 1.8 gm of Methoc~l is then added,
and the mixture is agitated until a paste is formed. 708.6
ml of water having been cooled to 5C is added, and
agitation is subsequently applied until the thickener/water
paste is completely dissolved. 15 gm of Ethocel is then
added slowly with agitation until the thickener is
completely dissolved. 10 gm Tergitol is added, and the
resulting mixture is blended and set aside.
Step 2: In a second reaction vessel, 30 ~m cetyl
alcohol, 30 gm stearyl alcohol, 17.5 gm polyethylene glycol
~3~
400, and 10 gm Polysorbate 80 are heated to 75C while
agitation is supplied.
Step 3: The mixture of Step 1 above is heated to 75C
whereupon the product of Step 2 above is added to the newly
heated product of Step 1 under conditions of constant
agitation. Agitation is continued until a firm and uniform
cream is obtained. The resultant cream base is cooled to
room tempsrature.
B. Preparation of a Storage Stable Topical Composition
505 gm of the cream base of A above is mixed with 35 gm
of Vitamin E until the two components are well dispersed.
Next, 450 gm of fructose is added and the mixture is
agitated thoroughly. 10 gm of finely divided silicon
dioxide is then added, whereupon the composition is
agitated until the final product is homogenous.
Example 15: Cream Base Suitable for Discontinuous
Processing
A. Preparation of the cream base
Step 1: In a suitable reaction vessel, 174.35 ml of
water is heated to 95C. 2.5 gm Methocel is then added,
and the mixture is agitated until a paste is formed.
697.40 ml of water having been cooled to 5C is added, and
agitation is subsequently applied until the thickener/water
paste is completely dissolved. 15 gm of Laponite is then
added slowly with agitation until the thickener is
completely dissolved. 10 gm Tergitol is added, and the
resulting mixture is blended and set aside.
Step 2: In a second reaction vessel, 40 gm cetyl
alcohol, 30 gm stearyl alcohol, 20 gm polyethylene glycol
400 and 10 gm Polysorbate 80 are heated to 75C while
agitation is supplied.
Step 3: The mixture of Step 1 above is heated to 75C
whereupon the product of Step 2 above is added to the newly
heated product of Step 1 under conditions of constant
agitation. Agitation is continued until a firm and uniform
cream is obtained. The resultant cream base is cooled to
room temperature.
Step 4: Add 0.75 gm of povidone iodine and agitate
until the resulting, preserved cream base is homogenous
throughout.
It is clear that the above examples are by way of
illustration only and various modifications may be made in
the nature of the composition without departing from the
spirit and scope of the invention.
