DENTURE STABILIZER

STABILISANT DE PROTHESE DENTAIRE

English Abstract

P7283S01/9 PD-3902-03-CAG
ABSTRACT OF THE DISCLOSURE
An improved anhydrous denture adhesive composition is
prepared to contain a mixture of a cationic acrylamide
polymer, sodium carboxymethylcellulose and a mixed,
calcium/sodium partial salt of poly(methyl vinyl
ether/maleic acid). The composition may be formulated as a
powder or anhydrous paste, which when applied to dentures
and exposed to moisture, develops superior adhesive
properties. Suitable cationic acrylamide polymers include a
copolymer of acrylamide and Beta-acryloyloxyethyltrimethyl-
ammonium chloride, or a copolymer of acrylamide and the
reaction product of dimethylaminoethyl methacrylate and
dimethyl sulfate.

Claims

P7283S01/9
What is claimed is:
1. A denture adhesive composition comprising a
substantially anhydrous mixture of:
a) from about 8 to about 30 percent by weight, based on
the total weight of the denture adhesive composition, of a
cationic acrylamide polymer having the formula:
<IMG>
wherein R comprises hydrogen or a lower alkyl having
from 1 to 6 carbon atoms; X- comprises an anion selected
from the group consisting of a halogen ion, perchlorate ion,
hydrogen sulfate ion, methyl sulfate ion and mixtures
thereof; M is an integer between 80-95, inclusive; and N
is an integer between 5-20, inclusive;
(b) from about 10 to about 43 percent by weight, based
on the total weight of the denture adhesive composition, of
sodium carboxymethylcellulose; and
(c) from about 8 to about 30 percent by weight, based
on the total weight of the denture adhesive composition, of
a mixed, calcium/sodium partial salt of poly(methyl vinyl
ether/maleic acid).
2. The denture adhesive composition of claim 1,
wherein said cationic acrylamide polymer comprises a
copolymer of acrylamide and Beta -
acryloyloxyethyltrimethylammonium chloride.

P7283S01/9
3. The denture adhesive composition of claim 2,
further including from about 30 to about 75 percent by
weight, based on the total weight of the denture adhesive
composition, of at least one cream base material selected
from the group consisting of petrolatum, natural and
synthetic oils.
4. The denture adhesive composition of claim 2,
further including from about 30 to about 75 percent by
weight, based on the total weight of the denture adhesive
composition, of a cream base material which is a combination
of mineral oil with a minor amount of a polyethylene wax
having an average molecular weight of 1,000 to 20,000.
5. The denture adhesive composition of claim 2,
further including from about 10 to about 75 percent by
weight, based on the total weight of the denture adhesive
composition, of non-toxic, powdered, excipient materials.
6. The denture adhesive composition of claim 1,
wherein said cationic acrylamide polymer comprises a
copolymer of acrylamide and the reaction product of
dimethylaminoethyl methacrylate and dimethyl sulfate.
7. The denture adhesive composition of claim 6,
further including from about 30 to about 75 percent by
weight, based on the total weight of the denture adhesive
composition, of at least one cream base material selected
from the group consisting of petrolatum, natural and
synthetic oils.
8. The denture adhesive composition of claim 6,
further including from about 30 to about 75 percent by
weight, based on the total weight of the denture adhesive
composition, of a cream base material which is a combination
of mineral oil with a minor amount of a polyethylene wax
having an average molecular weight of 1,000 to 20,000.
9. The denture adhesive composition of claim 6,
further including from about 10 to about 75 percent by
weight, based on the total weight of the denture adhesive
composition, of non-toxic, powdered, excipient materials.

P7283S01/9
10. The denture adhesive composition of claim 1,
wherein said cationic acrylamide polymer is present in
amounts of from about 8 to about 27 percent by weight, based
on the total weight of the denture adhesive composition.
11. The denture adhesive composition of claim 1,
wherein said sodium carboxymethylcellulose is present in
amounts of from about 15 to about 43 percent by weight,
based on the total weight of the denture adhesive
composition.
12. The denture adhesive composition of claim 1,
wherein said mixed, calcium/sodium partial salt of
poly(methyl vinyl ether/maleic acid) is present in amounts
of from about 10 to about 27 percent by weight, based on the
total weight of the denture adhesive composition.
13. A method for preparing a denture adhesive
composition comprising:
a) preparing a mixture of:
i) from about 8 to about 30 percent by weight,
based on the total weight of the denture adhesive
composition, of a cationic acrylamide polymer having the
formula:
<IMG>
wherein R comprises hydrogen or a lower alkyl having
from 1 to 6 carbon atoms; X- comprises an anion selected

P7283S01/9
from the group consisting of a halogen ion, perchlorate ion,
hydrogen sulfate ion, methyl sulfate ion and mixtures
thereof; M is an integer between 80-95, inclusive; and N is
an integer between 5-20, inclusive;
ii) from about lo to about 43 percent by weight,
based on the total weight of the denture adhesive
composition, of sodium carboxymethylcellulose; and
iii) from about 8 to about 30 percent by weight,
based on the total weight of the denture adhesive
composition, of a mixed, calcium/sodium partial salt of
poly(methyl vinyl ether/maleic acid);
b) forming a denture adhesive composition including
said mixture; and
c) recovering said denture adhesive composition.
14. The method of claim 13, wherein said cationic
acrylamide polymer comprises a copolymer of acrylamide and
Beta - acryloyloxyethyltrimethylammonium chloride.
15. The method of claim 14, wherein said denture
adhesive composition further includes from about 30 to about
75 percent by weight, based on the total weight of the
denture adhesive composition, of at least one cream base
material selected from the group consisting of petrolatum,
natural and synthetic oils.
16. The method of claim 14, wherein said denture
adhesive composition further includes from about 30 to about
75 percent by weight, based on the total weight of the
denture adhesive composition, of a cream base material which
is a combination of mineral oil with a minor amount of a
polyethylene wax having an average molecular weight of 1,000
to 20,000.
17. The method of claim 14, wherein said denture
adhesive composition further includes from about 10 to about
75 percent by weight, based on the total weight of the
denture adhesive composition, of non-toxic, powdered,
excipient materials.
18. The method of claim 13, wherein said cationic

P7283S01/9
acrylamide polymer comprises a copolymer of acrylamide and
the reaction product of dimethylaminoethyl methacrylate and
dimethyl sulfate.
19. The method of claim 18, wherein said denture
adhesive composition further includes from about 30 to about
75 percent by weight, based on the total weight of the
denture adhesive composition, of at least one cream base
material selected from the group consisting of petrolatum,
natural and synthetic oils.
20. The method of claim 18, wherein said denture
adhesive composition further includes from about 30 to about
75 percent by weight, based on the total weight of the
denture adhesive composition, of a cream base material which
is a combination of mineral oil with a minor amount of a
polyethylene wax having an average molecular weight of 1,000
to 20,000.
21. The method of claim 18, wherein said denture
adhesive composition further includes from about 10 to about
75 percent by weight, based on the total weight of the
denture adhesive composition, of non-toxic, powdered,
excipient materials.

Description

P7283SOl/9
IMPROVE~D DENTrURB 8$ABII~IZBR
B~CKGROUND OF TH}~ INVENTION
1. Field of the Invention
This invention relates to denture adhesives or
stabilizers, and particularly to an improved anhydrous
denture adhesive composition.
2. Description of the Prior Art
Traditionally, adherent powders used to secure dentures
within the mouth were prepared from such materials as finely
powdered natural gums, i.e., karaya, acacia or tragacanth
gum. These materials have the particular property of
swelling to many times their original volume upon the
addition of water to form a gelatinous or mucilaginous mass.
Denture adhesive powders may be a combination of one or more
natural gums, generally flavored with pleasant tasting
volatile oils. Many other additives may also be included,
such as antiseptics, stabilizers, bactericides, special
deodorants, plasticizing agents, fillers, coloring agents,
and the like.
Cream forms of the denture adherent, prepared from
finely ground particles of the natural gums dispersed in a
cream base, are also available and may be used instead of
the powder compositions. In any event, when wet with water,
the natural gum in either the cream or powder formulation,
expands to become a viscous gel which acts as a cushion and
an adherent between the denture plate and the gum tissue.
While these relatively simple formulations are
effective in securing dentures within the oral cavity for a
short period of time, generally more than one application of
adhesive per day is necessary. This is, at best,
inconvenient and therefore, most undesirable.
In recent years, there have been numerous improvements
in the above-described simple denture adhesive formulations.
For example, in U.S. Patent No. 3,003,988, a water
insoluble, water-sensitized copolymer is disclosed as the
adhesive or stabilizing component of a denture composition.
-- 1 --

P7283sol/s ~ 2
More particularly, this patent discloses mixed, partial
salts of copolymers of maleic anhydride with lower alkyl-
vinyl-ethers, and partial esters of these salts, as the
adhesive material. For example, the calcium-sodium partial
salts of a partial isopropyl ester of methyl vinyl
ether/maleic anhydride copolymer is said to provide a
superior denture adhesive.
Another improvement over conventional denture adhesives
is claimed in U.S. Patent No. 3,511,791, which teaches that
copolymers of acrylamide and acrylic acid or homopolymers of
acrylamide can form the principle adhesive component in a
denture adherent to provide sustained adherence in use
without swelling. Whenever a homopolymer of acrylamide,
which is nonionic in character, is used, gum karaya is added
to the formulation in order to provide a synergistic
improvement in gel strength and adhesiveness.
U.S. Patent No. 3,736,274 discloses a denture adhesive
containing three essential ingredients: a maleic anhydride
and/or acid copolymer (with a lower alkyl vinyl ether), a
polymeric N-vinyl lactam, and sodium carboxymethyl
cellulose, preferably incorporated into a diluent such as
petrolatum and/or mineral oil.
U.S. Patent No. 3,919,357 provides anhydrous powders
and creams useful in cosmetic and drug products such as
denture adhesive powders, prepared from an anionic/cationic
adhesive co~bination, toqether with a powdered polyethylene
or powdered polypropylene polymer. Example I shows the
formulation of a denture adhesive powder which includes poly
(methyl vinyl ether/maleic acid) and a copolymer of 85% by
weight acrylamide with 15% by weight Beta-
methacryloyloxyethyltrimethyl ammonium methyl sulfate, as
well as powder polyethylene having an average molecular
weight of 2000 and havinq a particle size such that 99.5% of
the polyethylene powder passes through a 60 mesh screen.
U.S. Patent No. 4,393,080 discloses an adhesive
composition which may include sodium carboxymethylcellulose
-- 2 --

P7283SOl/9 2 ~ ~ ~ 1 2 1
as well as sodium, calcium poly (methyl vinyl ether/maleic
acid), as illustrated in Examples 4, 6, 10, 18 and 19.
U.S. Patent No. 4,514,528 is directed to a hydrophilic
denture adhesive which consists of an admixture of mixed,
partial salts of lower alkyl vinyl ether-maleic anhydride-
type copolymers with either sodium carboxymethylcellulose or
poly (ethylene oxide) homopolymer or both in a hydrophilic
vehicle.
While all of the above denture adhesives provide some
improvement over simple formulations containing only finely
powdered natural gums, it is generally recognized that no
one product has yet been developed which can accommodate,
over a long period of time, the many variations in
temperatures, pH and mechanical agitation which are quite
normal in the oral cavity.
It has now been found that the denture adhesive of this
invention will provide superior adherent properties over
prolonged periods of time and under unusually varied
conditions, without the disadvantages characteristic of
previously known products.
SVMMARY OF ~HE INVENTION
An anhydrous denture adhesive composition exhibiting
superior performance as a denture stabilizer comprises a
mixture of a cationic acrylamide polymer, sodium
carboxymethylcellulose, and a mixed, calcium/sodium partial
salt of poly tmethyl vinyl ether/maleic acid) in an optional
petrolatum-like vehicle. The invention also involves a
method for preparing these novel denture stabilizers.
DESCRIPTION OF THE INVENTION
Applicant has unexpectedly discovered a denture
adhesive composition comprising a substantially anhydrous
mixture of:
~ a) from about 8 to about 30 percent by weight,
based on the total weight of the denture adhesive
composition, of a cationic acrylamide polymer having the
formula:
- 3 -

P7283SOl/9 2 ~ 2 ~
--F CH CIIO ¦_ Cll 2 - C
J H C O
C~2
CH ~ C 13
L
N
wherein R comprises hydrogen or a lower alkyl having
from 1 to 6 carbon atoms; X comprises an anion selected
from the group consisting of a halogen ion, perchlorate ion,
hydrogen sulfate ion, methyl sulfate ion and mixtures
thereof; M is an integer between 80-95, inclusive; and N is
an integer between 5-20, inclusive.
(b) from about 10 to about 43 percent by weight,
based on the total weight of the denture adhesive
composition, of sodium carboxymethylcellulose: and
(c) from about 8 to about 30 percent by weight,
based on the total weight of the denture adhesive
composition, of a mixed, calcium/sodium partial salt of poly
(methyl vinyl ether/maleic acid).
The denture adhesive compositions formed in accordance
with the above-listed combination yield a product which
provides surprising good performance as a denture
stabilizer. Specifically, denture adhesives of the present
invention require fewer applications per day, exhibit
increased holding power and time of holding, and provide
greater consumer confidence of product function.
The invention comprises a unique combination of three
essential components, namely a specific cationic acrylamide
polymer, sodium carboxymethylcellulose and a mixed salt of
poly (methyl vinyl ether/maleic acid). In the absence of
-- 4 --

P7283SOl/9
any of these components from the formulations of this
invention, compositions may be prepared which do not exhibit
the enhanced effect achieved from this combination.
Suitable cationic acrylamide polymers of the invention
have the general formula:
[ N2 c T ~ l2 _~ ~
CH~.-- N --Cll~
~ N
wherein R comprises hydrogen or a lower alkyl having from 1
to 6 carbon atoms; X comprises an anion selected from the
group consisting of a halogen ion, perchlorate ion, hydrogen
sulfate ion, methyl sulfate ion and mixtures thereof; M is
an integer between 80-95, inclusive; and N is an integer
between 5-20, inclusive. Halogen ion is understood to mean
any one of the electronegative elements in Group VII~ of~the
Periodic Table, namely fluorine, chlorine, bromine, iodine
or astatine.
Particularly preferred species of cationic acrylamide
polymers include the copolymers of acrylamide and the
reaction product of dimethylaminoethyl methacrylate and
dimethyl sulfate, and preferably comprises a copolymer of
acrylamide and Beta-acryloyloxyethyltrimethylammonium
chloride. The latter, preferred, cationic acrylamide
polymer is commercially available under the trademark E-
l911Rx (American Cyanamid). The copolymer of acrylamide and
the reaction product of dimethylaminoethyl methacrylate and
-- 5

P7283SOl/9 2 ~ 3 1 1 2 ~
dimethyl sulfate is commercially available under the
trademark Polytec 7M (SNF Floerger).
Sodium carboxymethylcellulose, which i8 the second
component in the inventive formulations is a synthetic gum
derived from cellulose, and generally comprises an anionic,
water-soluble, long chain polymer. The preferred sodium
carboxymethylcellulose utilized in the present invention is
commercially available from Hercules Incorporated under the
trademark CMC 7HXF.
The mixed, partial salts of poly(methyl vinyl
ether/maleic acid) employed in the present invention are
preferably the mixed salts of calcium and sodium which are
commercially available under the trademark Gantrez MS955
(General Aniline and Film Corp.).
The three essential components utilized in the present
denture adhesive composition physically interact to form a
two adhesive system which surprisinqly outperforms either
adhesive system taken individually. The first adhesive
system is based on an anionic/cationic interaction between
sodium carboxymethylcellulose and the cationic acrylamide
polymer. The second adhesive system comprises the mixed,
calcium/sodium partial salt of poly(methyl vinyl
ether/maleic acid). When these two systems are combined
according to the present invention, a denture adhesive
composition providing surprising performance as a denture
stabilizer is provided.
In a preferred embodiment of the invention, the
cationic acrylamide polymer is present in amounts of from
about 8% to about 27~ by weight, based on the total weight
of the denture adhesive composition; sodium
carboxymethylcellulose i8 present in amounts of from about
15~ to about 43~ by weight, based on the total weight of the
denture adhesive composition; and the mixed, calcium/sodium
partial salt of poly(methyl vinyl ether/maleic acid) is
present in amounts of ~rom about 10% to about 27% by weight,
based on the total weight of the denture adhesive
- 6 -

P7283S01/9 2
composition.
The denture adhesive compositions of this invention maybe formulated to contain the cationic acrylam~de polymer,
sodium carboxymethylcellulose, and mixed, calcium/sodium
partial salts of poly(methyl vinyl ether/maleic acid) in
either powder or paste form. In the powder formulation, the
components are admixed with conventional flavors and
colorants, together with other non-essential ingredients
such as non-toxic anti-caking agents (silica, magnesium
stearate, talcum powder or the like). The mixture of
ingredients is thoroughly agitated or stirred to yield a
generally homogenous intermixing of all components. In the
past formulations, the cationic acrylamide polymer, sodium
carboxymethylcellulose, and mixed, calcium/sodium partial
salts of poly(methyl vinyl ether/maleic acid) are admixed
with petrolatum, mineral, animal or vegetable oils, and the
like, along with flavors, colorants and certain commonly
used preservatives and fillers.
A particularly preferred paste or cream formulation is
prepared by utilizing as the cream or paste base, the
product of U.S. Patent No. 3,215,599. The cream or paste
base of this patent is characterized as a mixture of white
petroleum oil with a minor amount of a polyethylene wax
having an average molecular weight of 1,000 to 20,000. This
product is described as having emollient properties, useful
in the formulation of medicaments where absorption of the
medicaments by the skin is of paramount importance. Denture
adhesive creams formulated with this petroleum
oil/polyethylene wax blend as the paste or cream base
display unusually good stability, extrudability and product
appearance.
The method for preparing the denture adhesive
compositions according to the present invention, whether
formulated as a powder or paste, employs conventional types
of mixing equipment which are known in the art for blending,
heating and cooling solids and liguids.
-- 7 --

P7283So1/g ~ 3 ~
Whether formulated as a powder or paste, the denture
adhesive mixture of this invention, when applied to dentures
and exposed to moisture, hydrates to form an adhesive
compo~ition which exhibits unexpectedly superior
characteristics in comparison with denture adhesives of the
prior art.
The following examples are given to illustrate the
invention, but are not deemed to be limiting thereof. All
percentages given throughout the specification are based on
the weight of the final denture adhesive composition unless
otherwise indicated.

P7283SOl/
EXAMP~ 1
Preparation of Denture Adhesive Cream
A dsnture ~dhesive cream is prepared from the following
ingredients:
Percent
Inqredients w~W
Polyethylene 5.2
Polyisobutylene 4.0
Mineral Oil 30.8
Mixed partial salt of
poly(methyl vinyl ether/maleic acid) 24.2
Sodium carboxymethylcellulose23.42
Cationic acrylamide polymer 12.1
Peppermint Oil O.10
Methyl Paraben 0.05
Propyl Paraben O.10
Color 0.03Q
100 . 000
A. Weigh Polyethylene, Polyisobutylene and Mineral Oil
into a pot (Polyisobutylene is added as a 40% w/w
concentrate in the Mineral Oil) and mix to form a homogenous
mixture while raising the temperature to 90-95 C. Check to
assure complete solution of the wax. With continued mixing,
cool to at least 45 C.
B. Add Peppermint Oil, Methyl Paraben and Propyl
Paraben to the mixture from Step A and continue mixing again
until a homogenous blend is obtained.
C. Preblend the mixed partial salt of poly(methyl
vinyl ether/maleic acid), sodium carboxymethylcellulose,
cationic acrylamide polymer and color; add to the above
mixtùre with continued mixing. After about 5 minutes scrape
down as needed. Reduce pressure to about 28-29 inches
vacuum and mix for about 5-10 additional minutes. The
product is removed and stored for use.
This formulation was subjected to panel testing using
the formulations of this Example with multiple panelists.
The panelists were requested to use the denture adhesive
according to the following instructions:
1. Thoroughly brush away any remaining adhesive and
_ g _

P7283SOl/9
dry dentures. 2. Apply three short strips evenly as shown.
Keep strips away from edges. Use only the amount necessary.
A few trials should indicate the proper amount and best
placement of strips for your individual needs. 3. Press
dentures firmly in place and hold for 20 seconds while cream
sets.
The panelists were then requested to rate the denture
adhesive for the following:
a) number of applications per day,
b) firmness of hold (7=excellent to l=totally
unusable),
c) duration of hold (in hours),
d) confidence of hold (l=very certain dentures would
not hold, to 5=very certain dentures would hold),
and
e) usage intent (l=definitely would not use, to
5=definitely would use).
The results are set forth in Table I, along with the
results of Example 4.
The formulation of Example 1 was then subjected to a
second panel study according to the above-described testing
procedure, in which the panelists were requested to rate the
denture adhesive against the adhesive of a Comparative
Example A. The formulation of Comparative Example A
contained only two of the three essential components of the
invention (cationic acrylamide polymer, sodium
carboxymethylcellulose).
The results of the second panel study are set forth in
Table II.
As evidenced by the data of Table II, the formulation
o~ Example 1 performed significantly better than the
formulation of Comparative Example A, with respect to
holding power (firmness), duration of hold, confidence of
hold and usage intent.
-- 10 --

P7283sol/s 2 ~ 2 ~
EXAMPLE 2
Preparation of a Denture Adhesive Cream
A denture adhesive cream is prepared according to the
procedure of Example 1, using the following ingredients:
Percent
Ingredients w~w
Polyethylene 5.2
Polyisobutylene 4.0
Mineral Oil 30.8
Mixed partial salt of
poly(methyl vinyl ether/maleic acid) 12.259
Sodium carboxymethylcellulose 25.00
Cationic acrylamide polymer 22.461
Peppermint Oil O.10
Methyl Paraben 0.05
Propyl Paraben O.lo
Color 0-030
100. 000
The formulation of this Example would exhibit good
firmness, duration of hold, confidence of hold and usage
intent when used by denture wearers.
,

P7283SO1/9 2~121
- EXAMPLE 3
Preparation of a Denture Adhesive Cream
A denture adhesive cream i~ prepared according to the
procedure of Example l, using the following ingredients:
Percent
Ingredients w/w
Polyethylene 4.0
Polyisobutylene 4.0
Mineral Oil 32.0
Mixed partial salt of
poly(methyl vinyl ether/maleic acid) 18.00
Sodium carboxymethylcellulose 29.72
Cationic acrylamide polymer 12.0
Peppermint Oil O.10
Methyl Paraben 0.05
Propyl Paraben O.lo
Color 0.030
100. ooo
The formulation of this Example would exhibit good
firmness, duration of hold, confidence of hold and usage
int-nt when used by d-nture w-ar-rs.
`
~ ,-
- 12 -

P7283sol/s 2 ~3 ~
EXAMPLE 4
Preparation of a Denture Adhesive Cream
A denture adhesive cream is prepared according to the
procedure of Example 1, using the following ingredients:
Percent
Inaredients w/w
Polyethylene 4.0
Polyisobutylene 4.0
Mineral Oil 32.0
Mixed partial salt of
poly(methyl vinyl ether/maleic acid) 12.00
Sodium carboxymethylcellulose 35.72
Cationic acrylamide polymer 12.0
Peppermint Oil 0.10
Methyl Paraben 0.05
Propyl Paraben 0.10
Color 0.030
100.000
The formulation of this Example would exhibit good
firmness, duration of hold, confidence of hold and usage
intent when used by denture wearers.

P7283SOl/9 2 ~ ~ 1 1 2 ~
EXAMPLE S
Preparation of a Denture Adhesive Cream
A denture adhesive cream is prepared according to the
procedure of Example 1, using the following ingredients:
Percent
Ingredients w/w
Polyethylene 2.80
Polyisobutylene 1.75
Mineral Oil 30.45
Mixed partial salt of poly
(methyl vinyl ether/maleic acid) 24.20
Sodium carboxymethylcellulose 28.438
Cationic acrylamide polymer 12.1
Peppermint Oil 0.10
Methyl Paraben 0.05
Propyl Paraben 0.10
Color 0.012
100. 000
The formulation of this Example was subjected to panel
testing, following the testing procedure of Example 1. The
panelists were requested to rate the denture adhesive
against a commercially available product A.
The results are set forth in Table III.
As illustrated therein, this adhesive formulation
performed particularly well with respect to number of
applications required per day and performed satisfactorily
with regard to firmness, duration of hold, confidence and
usage.

P7283S01/9 ~i~ 3 ~ 1 2 ~
EXAMPLE 6
Preparation of a Denture Adhesive Cream
A denture adhesive cream is prepared from the following
ingredients:
Percent
Ingredlents w/w
Polyethylene 5.2
Polyisobutylene 4.0
Mineral Oil 30.8
Mixed partial salt of poly
(methyl vinyl ether/maleic acid) 24.2
Sodium carboxymethylcellulose 23.355
Cationic acrylamide polymer 12.1
Peppermint Oil 0.10
Methyl Paraben 0.05
Propyl Paraben 0.10
Color 0-035
Titanium Dioxide 0.060
100 . 000
Follow the procedures of steps A and B, as described in
Example 1.
C. Preblend mixed partial salt of poly(methyl vinyl
ether/maleic acid), sodium carboxymethylcellulose, cationic
acrylamide polymer, color and titanium dioxide, mixing this
preblend with the above mixture until a homogenous product
is obtained. After about 5 minutes scrape down as needed.
Reduce pressure to about 28-29 inches vacuum and mix for
about 5-10 additional minutes.
The formulation of this Example would exhibit good
firmness, duration of hold, confidence of hold and usage
intent when used by denture wearers.

P7283S01/9 2 ~ ~ ~ 1 2 ~
EXAMPLE 7
Preparation of a Denture Adhesive Cream
A denture adhesive cream is prepared from the following
ingredients:
Percent
Ingredient w/w
Petrolatum 23.00
Mineral Oil 17 . 00
Cationic acrylamide polymer - 12.1
Sodium carboxymethylcellulose23.436
Mixed partial salt of poly
(methyl vinyl ether/maleic acid) 24.20
Peppermint Oil 0.10
Methyl Paraben o.OS
Propyl Paraben 0.10
Color 0.014
100. 000
A. Weigh Petrolatum and Mineral Oil into a Versamix
pot. Mix with the anchor set to 75 until uniform.
B. Add Peppermint Oil, Methyl Paraben and Propyl
Paraben with continued mixin~.
C. Preblend cationic acrylamide polymer, sodium
carboxymethylcellulose, mixed partial salt of poly(methyl
vinyl ether/maleic acid) and color by mixing in with the
above mixture. After about 5 minutes scrape down as
needed. Reduce pressure to about 28-29 inches vacuum and
mix for about 5-10 additional minutes.
The formulation of this Example would exhibit good
firmness, duration of hold, confidence of hold and usage
intent when used by denture wearers.
- 16 -

P7283SOl/9 ~ I 2~
EXAMPLE 8
Preparation of a Denture Adhesive Cream
A denture adhesive cream is prepared from the following
ingredients:
Percent
Inaredien~ w~w
Polyethylene 5.2
Polyisobutylene 4.0
Mineral Oil 30.8
Mixed partial salt of poly(methyl vinyl
ether/maleic acid) 24.2
Sodium carboxymethylcellulose23.436
Cationic acrylamide polymer 12.1
Peppermint Oil 0.10
Methyl Paraben 0.05
Propyl Paraben 0.10
Color 0.014
100. 00
Follow the procedures of steps A and B, as described in
Example 1.
C. Preblend mixed partial salt of poly(methyl vinyl
ether/maleic acid), sodium carboxymethylcellulose, cationic
acrylamide polymer and color, mixing in the above mixture.
After about 5 minutes scrape down as needed. Reduce
pressure to about 28-29" vacuum and mix for about 5-lO
additional minutes.
The cationic acrylamide polymer utilized in this
formulation, unlike those of Examples 1-7, was a copolymer
of acrylamide and the reaction product of dimethylaminoethyl
methacrylate and dimethyl sulfate.
The formulation of this Example was subjected to panel
testing, following the testing procedure of Example 1.
The results are set forth in Table IV which shows a
sati~factory number of applications, good firmness and
confidence during use.
- 17 -

P7283S01/9
COMPA~ATIVE EXAMPLE A
Preparation of a Denture Adhesive Cream
A denture adhesive creams is prepared according to the
procedure of Example 7 from the following ingredients:
Percent
Ingredient w~w
Petrolatum 21.9848
Mineral Oil 19.9848
Silica 1.4812
Mixed partial salt of poly
(methyl vinyl ether/maleic acid) 29.6256
Sodium carboxymethylcellulose24.6880
Polyethylene oxide 1.9751
Peppermint Oil 0.0772
Methyl Paraben 0.0493
Propyl Paraben 0.0987
Color 0~0353
100. 0000
The formulation of this Example contains only two of
the three essential components utilized in the invention.
As discussed above, and shown by the panel study results of
Table II, the inventive formulation of Example 1 performed
significantly better than that of Comparative Example A with
respect to holding power (firmness), duration of hold,
confidence of hold and usage intent.
The invention being thus described, it will be obvious
that the same may be varied in many ways. Such variations
are not to be regarded as a departure from the spirit and
- scope of the invention and all such modifications are
intended to be included within the scope of the following
claims.
-- 18 --

P7283S0l/9
TABLE I
ATTRIBUTE R~TINGS ~
~ENTURE CREAM ADHESIVE PANELISTS
Example Example
l 4
#APPLICATIONS l.82 l.86
FIRMNESS 5.l9 4,99
DURATION l0.ll 9.23
CONFIDENCE 3.75 3.52
USAGE 3.86 3.67
19

P7283sol/~ S ~ 2 1
TABLE II
MEAN AT$RIBUT~ RATINGS ~Y
DENTURE CREAM ADH~SIVE PANELISTS
Example 1 Comparative Example A
#APPLICATIONS 1.95 2.075
FIRMNESS 5.27 4.61
DURATION 9.86 8.23
CONFIDENCE 3.82 3.22
USAGE 3.89 3.33

P7283SOl/9 ~ ~ 3
TABLE III
MEAN ATTRIBUTE RATINGS BY
DENTURE CREAM ADHESIVE PANELISTS
Example 5
#APPLICATIONS 1.54
FIRMNESS 5.42
DURATION 11.38
CONFIDENCE 4.08
USAGE 4.13
21

P7 2 8 3 S O 1/ 9
~1 12~
ABLE I_
~a_ ATT~IBUTE RATINGS BY
DENTURE CREAM ADHESIVE PANELISTS
E~ample 8
#APPLICATIONS 1.84
FIRMNESS 5.32
DURATION 12.66
CONFIDENCE 4.58
USAGE 4.26