Note: Descriptions are shown in the official language in which they were submitted.
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Description
Periodontal Composition And Method
Background of Invention
This invention relates generally to periodontal compo-
sitions and methods; and relates more specifically to composi-
tions and methods of this type which are capable of providing
active oxygen in the oral cavity, to thereby inhibit the motility
of harmful oral bacteria.
Recent developments in dental technology, coupled with
topical fluorides, sealants and fluoridization of municipal water
supplies, have fostered a remarkable decrease in tooth decay.
While laymen have associated decay with the main cause of tooth
loss, it is well-known to dental experts that the major cause of
tooth loss after the age of 35, is in fact gum disease. Indeed,
gum disease has now reached epidemic proportions -- over 90~ of
the general population are considered by most such experts to
suffer from some form of gum disease.
Since gum disease is not painful, it is easily un-
detected, and in consequence, untreated. Without the acute
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pain associated with a toothache, most people indeed pay little
or no attention to their gums until the disease has reached an
advanced stage and they are threatened by the loss of teeth.
Recent studies and investigations, however, have con-
clusively demonstrated that the major cause of gum disease is
specific bacteria that live and thrive in the gum crevices.
These bacteria give off toxins that attack the bone, cementum and
gums which support the teeth. If one is able to eliminate the
cause (bacteria), the result is healing of the gums.
Dentists and periodontists have long known that certain
substances can exert powerful cleansing and sanitizing action on
the teeth, the gums and the oral cavity. Hydrogen peroxide, bak-
ing soda (sodium bicarbonate), and salt (sodium chloride) are
examples of such materials. The major recent proponent of an
anti-microbial method based on such knowledge, is Dr. Paul Keyes;
and indeed this new therapy is now widely recognized as the
n Keyes Technique~-
Prior to the popularization of Dr. Keyes methodologymost periodontal cases were referred to periodontists, and the
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method of treatment was often surgery (gingivectomy). This sur-
gery is expensive and painful. Because of the pain, suffering,
and expense associated with gum surgery, a rapidly growing num-
ber of dentists are, however, now adopting the concept of Dr.
Keyes, and his non-surgical approach to gum disease.
Instead of a scalpel, Keyes relies on such ordinary
household items as salt, hydrogen peroxide and baking soda to
create a hostile climate for these troublesome bacteria. The
baking soda neutralizes the acidic toxins given off by the bac-
teria, and the peroxide effectively kills the anerobic bacteriathat cause gum disease. The anerobic bacteria cannot survive in
an oxygenated environment.
Unfortunately baking soda and peroxide must be mixed
daily, because these two elements decompose rapidly when mixed
together. This is a messy, time-consuming and unpleasant daily
chore. As a result, it is very difficult for the potential bene-
ficiaries of such therapy to faithfully adhere to the regimen.
The Keyes method is e.g. described in an article by
Judith E. Randal in A.H. (March/April 1982), at pages 82-85, and
elsewhere. According to the procedure, once a day a patient is
required to perform the following routine:
(a) Two tablespoons or so of baking soda are wet with
enough hydrogen peroxide to form a thick paste;
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(b) A rubber tip, of the kind found on some toothbrush
handles, is employed to massage the paste into the spaces between
the teeth and at the gum margins on both the front and back sides
of the teeth;
S (c) Again using the paste, the patient massages the
gums and gum margins front and back with an electric toothbrush
or a child-sized manual toothbrush;
(d) Enough salt is added to a glass of warm water so
that some remains in the bottom even when the solution is
stirred;
(e) The liquid part of the mixture is poured into a
~ater Pik; and with the device set at moderate speed, the teeth
and gums, front and back are rinsed; and
(f) A glass of plain water is run through the Water
Pik~ to prevent salt damage to its internal parts.
As is readily apparent from the above description of
the Keyes method, it is a relatively complex and burdensome pro-
cedure for an individual patient to employ on a daily basis. It
would clearly be desirable for a patient to be able to perform
the Keyes method or a method similarly effective in an easier
manner, e.g., with a single composition.
However, merely combining the components employed by
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Keyes into a rprepackaged" formula will not provide an effective
means for accomplishing the desired results. Specifically, the
hydrogen peroxide and/or sodium bicarbonate can in a combination
decompose rapidly. Hydrogen peroxide (or other peroxide) can
break down in the presence of alkalinity, heat, light and/or
metal ions as follows:
2H2O2--- 2H2 + 2¦ (gas)
Similarly, sodium bicarbonate can break down in the presence of
hydrogen peroxide, heat and/or water as follows:
1~ 2NaHCO3----~~ Na2C3 + H2O + CO2¦ (gas)
Since the active materials are lost or diminished, such a formula
will have a short shelf life. Moreover, the gas evolution is
especially undesirable with a tooth paste or gel, since such gas
evolution can cause swelling and/or bursting of tubes or other
packages containing same. All of these factors are undesirable
for a consumer product.
Summary of Invention
Now in accordance with the present invention, a perio-
dontal composition is provided, which includes a peroxide and a
bicarbonate, in a single highly stable form, which is therefore
susceptible to conventional modern packaging and dispensing sys-
tems, and which can be readily and effectively used by the con-
sumer.
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The composition can be prepared as a non-aqueous paste
or gel dentifrice, and generally comprises a water soluble, non-
aqueous vehicle having dispersed therein an orally acceptable
inorganic peroxide and a bicarbonate salt. The composition is
substantially anhydrous, and the amounts and relative proportions
of the peroxide and bicarbonate are sufficient to provide a
level of bactericidally active oxygen upon breakdown of the
peroxide by tissue contact and by reaction with the bicarbonate in
the oral cavity of the user. The amount of the bicarbonate is
effective to provide a neutral or basic pH upon dissolution of the
composition in water. The composition may be contacted with water
in mouth saliva, a moistened toothbrush, or by contact with water
from an oral irrigating device such as a Water-Pik~. Also the
composition can be directly disolved in a volume of water to pro-
vide a mouth wash.
In our aforementioned Serial No. 002,177 application,at least one of the peroxide or bicarbonate is provided with a
water-soluble barrier coating, which is, however, insoluble in
the non-aqueous vehicle, to prevent reaction therebetween in the
absence of water dissolution of the coating. All of the com-
ponents of the composition are water soluble, whereby upon the
composition being contacted with substantial quantities of
water, including in the oral cavity of a user, dissolution of the
barrier coating enables reaction of the peroxide and bicarbonate
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to augment release of active oxygen, to inhibit the motility of
oral bacteria in said cavity. Dissolution of the bicarbonate
further, enables neutralizing of acid secretions in the oral
cavity.
S In accordance with the present invention, it has
unexpectedly been found, that a periodontal composition including
a peroxide and bicarbonate may be prepared in a single highly
stable form which has all of the advantages of the compositions
disclosed in our aforementioned patent applications, and which
does not require a barrier coating.
More specifically the compositions of the present in-
vention are based upon a combination of calcium peroxide and
sodium bicarbonate, wherein the weight ratios of bicarbonate to
peroxide are in the range of 4:1 to 8:1, and preferably in the
range of 4:1 to 6:1 twhere the expressed quantity of peroxide
is 60~ CaO2). Where combinations as set forth are provided,
the compositions can be readily stored in conventional dispens-
ing containers, e.g., "toothpaste tubes" or the like, for
sustained periods without perceptible instability -- as would,
e.g., cause swelling of the packages. Even after such sustained
storage the compositions when admixed with water, produce
abundant oxygen to enable its use as an effective periodontal
agent.
While we are aware of Mayer, U.S. Patent No. 3,251,780
which discloses a composition including calcium peroxide and
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sodium bicarbonate, such disclosure is directed at a dry
powder for use in the bleaching of wood pulp and textiles, and
has no relation to dentifrice gels or pastes. Maver's powder
indeed provides a pH of from about 9.60 to 12.13, and has a
weight ratio of from about 1.5 to about 3.4 parts sodium bi-
carbonate to each part of calcium peroxide, which characteristics
are very distinct from those of the present invention.
Although not normally necessary, the compositions of the
invention may also include one or more auxiliary stabilizers,
which serve to further reduce the possibility of premature decompo-
sition of the peroxide, or of premature raction between peroxide
and bicarbonate components. These can comprise e.g. dessicants
which remove or absorb any trace water which may find its way into
the compositions. A preferred material for these purposes is
colloidal pyrogenic silica, which also serves in the composition
as a thickener.
The compositions may also include small amounts of
normal dentrifice adjuvants, such as flavoring agents (typically
0.1 to 5%); cleansing and foaming agents (surfactants), typically
as 0.1 to 10%; normally acceptable dental abrasives or polishing
agents (preferably 1 to 15%, although higher amounts can be
used), such as dicalcium phosphate, suitable calcined kaolins,
etc.; sweetening agents, colorants and the like.
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The compositions may also include fluorine-containing
compounds as are known for use in the dentifrice art, such as
sodium fluoride, sodium monofluorophosphate, stannous fluoride,
and the like.
Detailed Description of Invention
The peroxide component of the compositions of the
invention preferably comprises calcium peroxide, which is readily
available from several commercial sources -- e.g., the FMC grade
which is 60% pure CaO2.
The peroxide component of the compositions of the
invention is included in an amount sufficient to allow release of
sufficient oxygen when the composition is contacted with water,
e.g. during brushing of teeth, to inhibit the motility of oral
bacteria, e.g., in the treatment of gingivitis. Typically, the
peroxide can be employed in the composition of the present inven-
tion in amounts so that at least about 1~ of the composition com-
prises a peroxide. Preferably, the peroxide comprises from about
1 to about 10% by weight of the composition. More preferably,
the peroxide comprises from about 4 to about 6~ by weight of the
composition. A typical calcium peroxide concentration in the
composition is about 4 to 5~ by weight. (In all instances herein
the percentages of calcium peroxide are based upon a commercial
grade including 60~ CaO2).
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The bicarbonate salts employed in the composition of
the invention include any which are sufficiently soluble so that,
when the composition is contacted with water, e.g., in the brush-
ing of teeth, a neutral or basic pH is provided by the bicarbo-
nate. Suitable bicarbonates include alkali metal and alkalineearth metal bicarbonates. Examples of suitable bicarbonates
include sodium bicarbonate, potassium bicarbonate, lithium bicar-
bonate, calcium bicarbonate, magnesium bicarbonate, and the like
or mixtures thereof. A preferred bicarbonate is sodium bicarbo-
nate. If it is desirable, e.g., with a patient having high bloodpressure, etc., sodium-free compositions or low sodium composi-
tions can be employed, such as potassium bicarbonate or magnesium
bicarbonate. Combinations of bicarbonate salts can also be
employed, e.g. sodium and potassium bicarbonates.
The bicarbonate is included in the composition of the
invention in an amount sufficient to provide a neutral and basic
pH when the composition is contacted with water, (as is in the
oral cavity), preferably a pH of from about 7.0 to about 9.5.
The amount of bicarbonate actually employed in the method of the
invention can vary greatly depending upon the form of the compo-
sition and its intended method of application. This is subject
to the weight ratio as between the bicarbonate and the calcium
peroxide, which is critical to assuring release of the peroxygen
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content while yet providing stability to the present composi-
tions. Where the preferred sodium bicarbonate is used, the said
ratio of bicarbonate to calcium peroxide should be in the range
of 4:1 to 8:1, and preferably is in the range of 4:1 to 6:1.
In a further aspect of the invention, it has been found
that by increasing the particle size of the bicarbonate salt,
which decreases its surface area, the stability of the peroxide in
the compositions of the invention is increased. For example, as
among grade numbers 1, 2 and 5 baking soda available from Allied
Chemical (Bulletin No. 513-016 U.S.A.), the No. 5 grade provides
the greatest peroxide stability in the composition of the in-
vention, while the No. 2 grade provides almost the same stahility.
Preferably, the particle size of the bicarbonate salt is such that~
it provides a residual peroxide level of from about 95 to about
99%, more preferably, from about 97.5 to about 99%, when the
composition is stored in a closed container at room temperature
for about 6 weeks. Typical screen analysis of such grades of
baking soda are set forth below:
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GRADE BAKING SODA
Screen
Analysis No. 1 No. 2 No. 5
Cumulative % on
U.S. No. 60
trace 37
100 1 1 72
170 25 68 98
200 38 89 100
325 71 99
Bulk
Density
(lb/ft~ 53 55 46
Preferably, the bicarbonate employed in the composition
e~ 15 of the present invention has an average particle size of from
about 100 to about 2,000 microns, more preferably from about 200
to about 800 microns. The surface area of the bicarbonate
particles in the composition of the invention can be further re-
duced by agglomerating the particles to form aggregates with less
surface area than the component particles.
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The hydrophilic, non-aqueous vehicles employed in the
tooth paste or gel composition of the present invention are water
soluble so that they facilitate the action of the bicarbonate and
peroxide during brushing with the composition. Thus, the vehi-
cles employed in the present invention preferably rapidly dis-
solve with water when used by a consumer, e.g., in mouth rinse
water or the water in a pre-moistened toothbrush in saliva, or in
the post-brushing water rinse. The active species, i.e., the
peroxide and bicarbonate salt, may be dispersed, or suspended in
the vehicle.
Suitable hydrophilic, non-aqueous vehicles for use in
the present invention include polyalkylene glycols, non-ionic
surfactants, anionic surfactants, ampholytic surfactants, cati-
onic surfactants and alkanolamides. Also suitable are glycerol,
propylene glycol or sorbitol in combination with silica, clay,
polymer and/or gum thickeners, and perhaps dicalcium phosphate as
a cleansing agent.
The hydrophilic, non-aqueous vehicles preferably pro-
vide a viscosity for the composition suitable for its use as a
toothpaste or gel, e.g. between about 2,000 cps. to about 200,000
cps. If the selected vehicle does not itself provide the desired
t 334282
viscosity, viscosity modifiers, such as barrier coated dicalcium
phosphate, finely divided pyrogenic silica and the like may be
added, and/or other known and orally acceptable vehicle agents
can be included to provide such desired viscosity.
Typically, the hydrophilic, non-aqueous vehicles
employed in the tooth paste or gel compositions of the invention
are present in an amount of from about 45 to about 90% by weight.
Suitable polyalkylene glycols for use as vehicles in
the present composition include those having molecular weights of
from about 200 to about 20,000. Such materials range in physical
state from thin liquids to pastes to solids with increasing mole-
cular weight.
Preferred polyalkylene glycols for use as vehicles in
the present invention are polyethylene glycols having the general
formula H(OCH2CH2)nOH, where n is greater than or equal to 4.
These liquid and solid polymers are widely known and available
under trademarks such as Carbowax (Union Carbide). In general, v
each polyethylene glycol (PEG) is identified by the manufacturer
by a number which corresponds to its average molecular weight,
e.g. "Carbowax~ 400n. Preferred PEG's for use in the present
invention have a molecular weight in the range of from about 400
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to about 8,000. Mixtures of such polyethylene glycols of differ-
ing molecular weights (and for that matter other vehicles dis-
cussed herein) can be employed to provide desirable viscosity
characteristics for the composition.
Other suitable polyalkylene glycol vehicles include
materials of the formula
CH3 ICH3 ICH3
HO-CH-CH2O(CH2CHO)nCH2CH-OH
or
HO(CH2CH20)a (CHCH20)b (CH2CH20)cH
CH3
Wherein n, a, b and c are integers such that the molecular
weights of such materials are in the range of from about 1,100 to
about 14,000. Also sutiable are the polyoxyalkylene derivatives
of ethylene diamine, e.g., the materials sold under the trademark
TETRONIC.
Suitable non-ionic surfactants for use as the hydro-
philic, non-aqueous vehicle in the tooth paste or gel composition
of the invention include materials such as polyoxyethylene sorbi-
tan fatty acid esters, e.g., materials sold under the trademarkTWEEN. Examples of such materials are polyoxyethylene (20)
sorbitan monolaurate (TWEEN 20), polyoxyethylene (20) sorbitan
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monopalmitate (TWEEN 40), polyoxyethylene (20) sorbitan mono-
stearate (TWEEN 60), polyoxyethylene (4) sorbitan monostearate
(TWEEN 61), polyoxyethylene (20) sorbitan tristerate (TWEEN 65),
polyoxyethylene (20) sorbitan monooleate (TWEEN 80), polyoxyethy-
lene (5) Sorbitan monooleate (TWEEN 81), and polyoxyethylene (20)
sorbitan trioleate (TWEEN 85).
Polyoxyethylene fatty acid esters are also suitable for
use as the vehicle in the tooth paste composition of the inven-
tion. Examples include those materials sold under the trademark
MYRJ such as polyoxyethylene (8) stearate (MYRJ 45) and polyoxy-
ethylene (40) stearate (MYRJ 52).
Another suitable class of non-ionic surfactants for use
in the vehicle in the present invention are polyoxyethylene fatty
ethers, e.g., the materials sold under the trademark BRIJ. Exam-
ples of such materials are polyoxyethylene (4) lauryl ether (BRIJ
30), polyoxyethylene (23) lauryl ether (BRIJ 35), polyoxyethylene
(2) cetyl ether (BRIJ 52), polyoxyethylene (10) cetyl ether (BRIJ
56), polyoxyethylene (20) cetyl ether (BRIJ 58), polyoxyethylene
(2) stearyl ether (BRIJ 72), polyoxyethylene (10) stearyl ether
(BRIJ 76), polyoxyethylene (20) stearyl ether (BRIJ ?8), poly-
oxyethylne (2) oleyl ether (BRIJ 93), polyoxyethylene (10) oleyl
ether, and polyoxyethylene (20) oleyl ether (BRIJ 99).
In one embodiment of the invention, a portion of a non-
ionic surfactant employed in the vehicle in the composition of
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the invention can be substituted with a lipophilic surfactant,
e.g., sorbitan fatty acid esters such as the materials sold under
the trademark ARLACEL. Suitable lipophilic surfactants include
- sorbitan monolaurate (ARLACEL 20), sorbitan monopalmitate
(ARLACEL 40), sorbitan monostearate (ARLACEL 60), sorbitan mono-
oleate (ARLACEL 80), sorbitan sesquioleate (ARLACEL 83), and sor-
bitan trioleate (ARLACEL 85). Typically, from about 10 to about
90% of the non-ionic surfactant can be substituted by a lipo-
philic surfactant, preferably from about 25 to about 50~.
As noted above, other classes of surfactants such as
cationic surfactants, anionic surfactants, ampholytic surfactants
and alkanolamides can also be employed as the vehicle in the com-
position of the present invention. Such materials can be
employed either by themselves as the vehicle or together with a
polyakylene glycol or a non-ionic vehicle as discussed above.
Examples of suitable anionic, cationic, ampholytic and alkamo-
lamide surfactants include di-tallow dimethyl ammonium chloride,
sodium lauryl sulfate, the material
N-CH2
CllH23C
N-CH2
OH CH2CH2ONa
CH2COONa
sold under the trademark MIRANOL, and coconut alkanolamide.
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Typically, when these materials are used as part of the vehicle,
they are substituted for from about 10 to about 90% by weight,
preferably from about 25 to about 50~ by weight, of the main
vehicle used in the composition, e.g., a polyalkalene glycol or a
non-ionic surfactant as discussed above.
Auxiliary stabilizers can also be included in the com-
positions of the invention in order to augment stabilization of
the bicarbonate, and especially of the peroxide component. These
can comprise dessicating agents to absorb trace water, or can
comprise chemical stabilizers.
Any orally acceptable material that stabilizes the
peroxide during storage of the composition in a closed container
can e.g. be employed as an auxiliary stabilizer in the present
composition. Examples of suitable such stabilizing agents
include desicating agents, sequestering agents, colloidal parti-
cles, free radical preventatives, inorganic hardness salts, acid-
ulating agents, and mixtures of such stabilizing agents.
Examples of suitable dessicating agents include magne-
sium sulfate, sodium sulfate, calcium sulfate, calcium chloride
and colloidal silica, e.g., colloidal silica particles sintered
together in chainlike formations having surface areas of from
about 50 to about 400 square meters per gram such as materials
sold under the trademark Cab-O-Sil~ by Cabot Corp. It is
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1 334282
believed that such materials act to stabilize the compositions of
the invention by, for example, absorbing any existing water
either present in or contacted with the composition so as to fur-
ther preclude breakdown of the peroxide and/or bicarbonate.
Colloidal pyrogenic silica serves a further purpose in
the present compositions, i.e. it is a well-recognized thickener,
and is very useful in achieving a desired consistency for both
practical and aesthetic reasons.
Examples of suitable sequestering and/or chelating
10 agents include ethylene diamine tetraacetic acid (EDTA) or its
sodium salts, nitrilotriacetic acid or its sodium salts, diethy-
lene triamine pentaacetic acid (DTPA), or DEQUEST phosphonates
available from Monsanto. It is believed that such chelating or
sequestering agents stabilize the compositions of the invention,
lS for example, by tying up metal ions such as Fe+3, Mn+2, Cu~2,
etc. that can catalyze the decomposition of peroxide in the com-
positions.
Other effective auxiliary stabilizers for use in the
present composition include in addition to the colloidal parti-
20 cles such as the pyrogenic silica mentioned above, finely divided
clays, zeolites and insoluble metallic oxides, e.g., magnesium
and aluminum oxide. The pyrogenic silica materials are a pre-
ferred auxiliary stabilizing agent in the compositions of the
present invention.
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1 33428~
Also, free radical inhibitors or preventatives such as
butyl hydroxytoluene, butyl hydroxyanisole and beta carotene can
also reduce the instability of peroxide in the composition of the
invention.
S Inorganic hardness salts such as calcium or magnesium
inorganic compounds also reduce peroxide instability. Examples
of such compounds include magnesium carbonate, magnesium chlo-
ride, calcium sulfate, calcium chloride and the like.
The addition of anhydrous acidulating agents or their
salts (powdered or granulated), also provide improvement in
peroxide stability in the compositions of the invention. Exam-
ples of suitable acidulating agents for use in the present inven-
tion include ascorbic acid, tartaric acid, phosphoric acid as
well as the chloride, sulfate or nitrate salts of calcium, mag-
nesium or ammonium.
The inclusion of an auxiliary stabilizing agent in the
composition of the present invention has been found to provide
increased stability of the compositions in comparison to composi-
tions without such stabilizing agent. Typically, the auxiliary
stabilizing material is included in the compositions of the
present invention in an amount of from 0.1 to about 7.5~, prefer-
ably from about 1 to about 5~. For example, when pyrogenic
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colloidal silica materials are used as an auxiliary stabilizing
agent (and thickener), suitable amounts thereof are from 1 to
about 7.5% by weight, preferably from about 3 to about 5% by
weight.
One embodiment of the invention and composition also
includes chloride and/or sulfate salts such as alkali metal chlo-
rides or sulfates, alkaline earth metal chlorides or sulfates, or
mixtures thereof. Suitable chloride salts for use in the compo-
sition of the invention include sodium chloride, potassium chlo-
ride, lithium chloride, calcium chloride, magnesium chloride,
sodium sulfate, potassium sulfate, magnesium sulfate, etc.
Typically, the chloride salts or other salts are
included in the composition of the present invention in amounts
of from about 1 to about 50% by weight of the composition. Pre-
ferably, the chloride or other salts are included in an amount of
from about 1 to about 15% by weight of the composition.
The compositions of the invention can include many
other components which are conventional in the art, again depend-
ing upon the ultimate use to be made of the composition. As with
all the components of the composition, these components should
preferably be of the class generally recognized as safe, espe-
cially for use in the mouth. For example, the composition of the
invention can include conventional adjuvants, e.g., colorants,
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flavors, sanitizing agents, dentally acceptable abrasives,
cleansing agents, and the like.
The compositions of the present invention can be pre-
pared by methodology conventional in the art. For example, the
S peroxide material can be physically mixed with the bicarbonate
salt, and any other materials to be included in the compositions
of the invention, such as a chloride salt or other carriers and/or
adjuvants. The composition can be prepared into a paste or gel
again in a manner conventional for preparing such paste or gels
as is well known in the art by merely including the desired
amount of the peroxide, auxiliary stabilizer (if used) and bicar-
bonate in the desired hydrophilic, non-aqueous vehicle. As noted
above, the paste or gel is non-aqueous.
In a preferred method of preparing a composition of the
present invention, an auxiliary stabilizer an~ thickener (where
used) such as a pyrogenic colloidal silica material, is first
mixed with the hydrophlic, non-aqueous vehicle, such as poly-
alkylene glycol, e.g. of polyethylene glycols such as Carbowax~
400 and Carbowax~ 8,000. Additonal surfactants can also be pre-
sent to provide good foaming when used in the mouth. To suchmixture is added the peroxide with stirring. The bicarbonate
salt is then added to the mixture containing the peroxide. Other
desired adjuvants can be added at the tail end of this process.
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The compositions of the present invention as noted
above can be used to treat periodontal disease. In such treat-
ment, it is believed that the composition of the invention
attacks the anerobic bacteria that cause such periodontal
disease. In the method of the present invention, the composi-
tions described above are applied to the gums of the patient,
e.g., a mammal such as man, in an amount effective to inhibit the
bacterial motility of the oral anerobic bacteria and other bacte-
rial types.
The invention is further illustrated by the following
Examples, which are, however, intended to be illustrative, and
not delimitive of the invention which is otherwise set forth:
Example I
A composition in accordance with the present invention
was prepared in the form of a paste or gel. A high molecular
weight polyethylene glycol, Carbowax~ 8,000, was warmed and com-
bined with a low molecular weight polyethylene glycol, Carbowaxt
400. Baking soda is added with stirring. A foaming agent,
MAPROFI ~ 63, was added to and mixed with the resulting mixture.
The mentioned surfactant is a purified oral grade of sodium
lauryl sulfate. The weight percent of the respective ingredients
in the composition of this Example are listed below:
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Ingredient % by ~Jeight
Polyethylene glycol 8,000
(Carbowax 8,000) 10.33
Polyethylene glycol 400
(Carbowax~ 400) 56.75
Calcium peroxide (FMC grade -
-60% CaO2) 4.54
NaHCO3, fine grade #3 27.24
Surfactant - sodium lauryl sulfate
(Maprofix 563 - Onyx-Chemical Co. 1.14
Flavoring agents (e.g., 0.5~ by weight) may be added
to this composition to enhance palatability.
This toothpaste (or "gel") is a cosmetically accept-
able dentifrice which produces bactericidally active oxygen in
use. When lg of this composition was dispersed and substantially
dissolved in about 159 of water -- deemed to approximately corre-
spond to use in the mouth -- a pH of 9.0 was measured. The
composition is "package stable" (as generally recognized) under
reasonable conditions of storage when packaged in a squeeze tube
or pump-type of container; i.e. the formation of gases (CO2 and
2) that would otherwise occur in a single phase unstabilized
composition of peroxide and bicarbonate is effectively inhibited.
Typical test procedures for confirming such package stability
involves subjecting the composition in a closed container to
sustained storage at elevated temperatures. Samples of the
composition of this Example were found to be stable for at
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least 2 1/2 months, when subjected to such storage at 120~F. and
at 105F. The packages thus tested exhibited no perceptible
swelling, and the product taken from the container showed avail-
able peroxide when subjected to testing in a potassium iodide
solution.
Example II
In this Example, a further paste or gel similar to
that of Example I was prepared, wherein the respective ingredi-
ents were as follows:
10 Ingredient % by ~eight
Polyethylene glycol 8,000 9.3
(Carbowax~ 8,000)
Polyethylene glycol 400
(Carbowax~ 400) 51.0
Calcium peroxide (FMC grade - 60% to CaO2 4.1
Baking Soda (Church & Dwight)
Grade 3, 24.6
Calcium carbonate 10.0
Surfactant foaming agent - sodium
20 lauryl sulfate 1.0
The calcium carbonate in this composition serves as a
dental abrasive (as does to some extent the NaHCO3. Other
dentally acceptable abrasives, such as 1 to 15% of dicalcium
phosphate, can be used. Once again small quantities of flavor-
ing agents can be added if desired. ~hen lg of this compositionwas dispersed and substantially dissolved in 15g of water as in
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Example I, the pH was again measured at 9Ø The final composi-
tion is again a package stable, cosmetically acceptable denti-
~frice which produces bactericidally active oxygen in use. The
composition of this Example displayed the same excellent stability
and continued peroxide activity after 2 1/2 months storage at 105
and at 120F., as the samples of Example I.
The flavoring agents can include known dentifrice
adjuvants, such as mint flavor and other dentifrice flavors,
methyl salicilate, menthol, sodium sacharin (or other sweeteners,
e.g. Nutrisweet~). Also, other conventional dentifrice compo-
nents such as dentifrice abrasives, fluorine-containing com-
pounds, colorants, etc. can be provided.
- While the present invention has been particularly set
forth in terms of specific embodiments thereof, it will be under-
lS stood in view of the instant disclosure, that numerous variations
upon the invention are now enabled to those skilled in the art,
which variations yet reside within the scope of the present
teaching. Accordingly, the invention is to be broadly construed,
and limited only by the scope and spirit of the claims now
appended hereto.
