Note: Descriptions are shown in the official language in which they were submitted.
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TITLE OF THE INVENTION
Oral Care Regimen
100011
BACKGROUND OF THE INVENTION
100021 Consumers report perceptions of refreshment. contentment,
cleanliness, and
general well-being similar to those experienced post-spa or beauty treatment
after a
professional teeth cleaning carried out by a dentist or hygienist. Thus, there
is a need in the
art for an at-home oral care regimen that permits consumers to re-create the
"extra clean"
mouth feel and associated sense of well-being experienced after a professional
teeth cleaning
and that is coupled with a regimen that preserves the dental surfaces against
caries.
hypersensitivity and other oral care and systemic health benefits.
BRIEF SUMMARY OF THE INVENTION
100031 The invention includes methods of cleaning an oral surface,
maintaining oral
health and/or increasing oral health. Sue'll methods encompass contacting an
oral surface
with a primary oral care composition at least once daily, contacting the oral
surface with a
periodic oral care maintenance composition at least once monthly. The
invention optionally
further comprises contacting the oral surface with a periodic oral care
'cleaning composition
at least once monthly. The periodic oral care maintenance compositions
suitable for use in
the method comprise a basic amino acid in free or salt form. The periodic oral
care cleaning
compositions suitable for use in the method comprise a first abrasive having
an Einlehner
hardness of greater than about 5 rug loss per 100,000 revolutions and a second
abrasive
having an Einlehner hardness of less than about 5 mg loss per 100.000
revolutions. In the
periodic oral care cleaning compositions, the ratio of the first abrasive to
the second abrasive
is about 1:1.6 to about 1.6:1. The periodic oral care cleaning compositions
are characterized
by a pellicle cleaning ratio of greater than about 100 and a radioactive
dentin abrasion of less
than about 200. Additionally or alternatively, the methods may include those
where the
second abrasive comprises silica and has an oil of absorption of greater than
about 90
cm3/100g and/or an Einlehner hardness of less than about 5 mg loss per 100,000
revolutions.
The ratio of the first abrasive to the second abrasive may be about 1:1.6 to
about 1.6:1. The
total amount of the first and second abrasives present in the oral composition
may be greater
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than about 25% by weight of the composition and/or the oral composition has a
pellicle
cleaning ratio of greater than about 100 and a radioactive dentin abrasion of
less than about
200.
[0004] The present invention provides a periodic oral care maintenance
composition
comprising a basic amino acid, in free or salt form, for use in the
therapeutic treatment of an
oral surface, which treatment comprises a. contacting the oral surface with a
primary oral care
composition at least once daily, and b. contacting the oral surface with the
periodic oral care
maintenance composition at least once monthly.
[0005] The present invention further provides a combined preparation
comprising a
periodic oral care maintenance composition and a primary oral care composition
for the
manufacture of a combined preparation for simultaneous, sequential or separate
administration to a subject in the therapeutic treatment of an oral surface,
wherein the oral
surface is:
a. contacted with the primary oral care composition at least once daily, and
b. contacted the with the periodic oral care maintenance composition at least
once
monthly; and
wherein the periodic oral care maintenance composition comprises a basic amino
acid, in free or salt form.
[00061 The present invention further provides the use of a basic amino
acid, in free or salt
form, for the manufacture of a periodic oral care maintenance composition for
the therapeutic
treatment of an oral surface. which treatment comprises a. contacting the oral
surface with a
primary oral care composition at least once daily, and b. contacting the oral
surface with the
periodic oral care maintenance composition at least once monthly.
[0007] The present invention further provides the use of a periodic oral
care maintenance
composition and a primary oral care composition for the manufacture of a
combined
preparation for simultaneous, sequential or separate administration to a
subject in the
therapeutic treatment of an oral surface, wherein the oral surface is:
a. contacted with the primary oral care composition at least once daily, and
b. contacted the with the periodic oral care maintenance composition at least
once
monthly; and
wherein the periodic oral care maintenance composition comprises a basic amino
acid, in free or salt form.
[0008] The present invention further provides a method comprising: a.
contacting an oral
surface with a primary oral care composition at least once daily, and b.
contacting the oral
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surface with a periodic oral care maintenance composition at least once
monthly, wherein the
periodic oral care maintenance composition comprises a basic amino acid, in
free or salt form.
[0008a] Specific aspects of the invention include:
a combination of compositions comprising a periodic oral care maintenance
composition and a primary oral care composition for simultaneous, sequential
or separate
application to a subject in the treatment of an oral surface, wherein: a. the
primary oral care
composition is to be applied at least once daily to the oral surface, and b.
the periodic oral care
maintenance composition is to be applied at least once monthly to the oral
surface; and
wherein the periodic oral care maintenance composition comprises a first
abrasive, a second
abrasive, and a basic amino acid, in free or salt form;
use of a periodic oral care maintenance composition and a primary oral care
composition for the manufacture of a combined preparation for simultaneous,
sequential or
separate application to a subject in the treatment of an oral surface,
wherein: a. the primary
oral care composition is to be applied at least once daily to the oral
surface, and b. the periodic
oral care maintenance composition is to be applied at least once monthly to
the oral surface;
and wherein the periodic oral care maintenance composition comprises a first
abrasive, a
second abrasive, and a basic amino acid, in free or salt form.
DETAILED DESCRIPTION OF THE INVENTION
[00091 The invention provides a regimen method of cleaning an oral
surface to
remove, for example, bacteria, food particles, biofilm, plaque, and/or other
agents that may
result in or contribute to various oral conditions, such as bad breath, poor
oral health,
gingivitis, gum inflammation, or periodontitis. The regimen method of the
invention also
provides the user with a smooth, polished feel and appearance to the tooth
surfaces that may
be perceived as comparable to the "clean feel" experienced after a
professional cleaning.
Methods of maintaining oral health and/or increasing oral health are also
provided.
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[0010] As such the Compositions of the Invention are useful for
treating oral
conditions in the mouth and to clean the oral cavity and provide improved
methods of
promoting oral health.
[0011] Enhancing oral health also provides benefits in systemic
health, as the oral
tissues can be gateways for systemic infections. Good oral health is
associated with systemic
health, including cardiovascular health. The compositions and methods of the
invention
provide particular benefits because basic amino acids, especially arginine,
are sources of
nitrogen which supply NO synthesis pathways and thus enhance microcirculation
in the oral
tissues. Providing a less acidic oral environment is also helpful in reducing
gastric distress
and creates an environment less favourable to Heliobacter, which is associated
with gastric
ulcers. Arginine in particular is required for high expression of specific
immune cell
receptors, for example T-cell receptors, so that arginine can enhance an
effective immune
response. The compositions and methods of the invention are thus useful to
enhance systemic
health including cardiovascular health.
[0012] The primary and the periodic oral care compositions may be effective
upon
application to the oral cavity, e.g., with brushing, to (i) reduce or inhibit
formation of dental
caries, (ii) reduce, repair or inhibit pre-carious lesions of the enamel,
e.g., as detected by
quantitative light-induced fluorescence (QLF) or electrical caries measurement
(ECM), (iii)
reduce or inhibit demineralization and promote remineralisation of the teeth,
(iv) reduce
hypersensitivity of the teeth, (v) reduce or inhibit gingivitis, (vi) promote
healing of sores or
cuts in the mouth, (vii) reduce levels of acid producing bacteria, (viii) to
increase relative
levels of arginolytic bacteria, (ix) inhibit microbial biofilm formation in
the oral cavity, (x)
raise and/or maintain plaque pH at levels of at least pH 5.5 following sugar
challenge.
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(xi) reduce plaque accumulation. (xii) treat. relieve or reduce dry mouth,
(xiii) clean the
teeth and oral cavity (xiv) reduce erosion, (xv) whiten teeth, (xvi) immunize
the teeth
against cariogenic bacteria: and/or (xvii) promote systemic health. including
cardiovascular
health, e.g., by reducing potential for systemic infection via the oral
tissues.
100131 The invention is an oral care regimen that includes contacting an
oral surface with
at least two oral care compositions at differing time increments. The oral
surface to be
treated includes any within the oral cavity. Exemplary surfaces include hard
tissues (e.g.,
teeth) and soft surfaces (e.g., gingiva and tongue).
100141 One of the oral care compositions used in the regimen method of the
invention is a
primary oral care composition. The primary oral care composition may be any
known or to
be developed in the art and can take any form. For example, the primary oral
care
composition may be in the form of a rinse, paste, gel. fluid, suspension,
film, patch, gum.
lozenge, confectionary, or semi-solid pates or stick. The primary oral care
composition may
be a conventional toothpaste, such as those sold under the COLGATE trademark
(Colgate-
Palmolive Company, New York. New York) or under the CREST trademark (Procter
&
Gamble Corporation, Cincinnati, Ohio). Alternatively, the primary oral care
composition
may be any of those described in, e.g., United States Patent Nos. 4,721,614;
4,894,220;
4,986,981: 5,037,635; 5,156,835; 5,288,480; 5,344,641; 5,538,715; 5,776,435
and United
States Patent Application Publication Nos. 2004/0126332. 2004/0136924,
2005/0019273,
2005/0271601. and 2005/0271602.
100151 The primary oral care composition may contain one or more agents
such as
hurnectants, solvents, thickeners, surfactants, abrasives, flavorants.
colorants, viscosity and/or
rheology modifiers, gums, polymers, sweeteners, etc. Examples of agents that
may be
present in the primary oral care composition include an antibacterial agent, a
plaque
dispersion agent, an antiadhesion agent, an anticaries agent, a desensitizing
agent, a flavorant,
a colorant, a stannous ion agent, triclosan, triclosan monophosphate.
chlorliexidine, alexidine,
hexctidine, sanguinarine, benzalkonium chloride, salicylanilidc. domiphen
bromide.
cetylpyridinium chloride, tetradecylpyridinium chloride, N-tetradecy1-4-
ethylpyriclinium
chloride, octenidine, delmopinol. octapinol, nisin, zinc ion agent, copper ion
agent, essential
oils, furanones. bacteriocins, ethyl lauroyl arginate. extracts of magnolia, a
metal ion source,
arginine bicarbonate, honokiol, magonol. ursolic acid, ursic acid, morin,
extract of sea
buckthorn. a peroxide, an enzyme, a Carnegiet extract, a flavonoid, a llavan,
halogenated
diphenyl ether. creatine, and/or propolis.
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[0016] In the practice of the methods of the invention, the primary oral
care composition
may be applied or contacted to the oral surface at least once daily. In some
embodiments, the
application of the primary oral care composition may be carried out two,
three, four, five, six,
seven times daily, or up to fifteen times daily.
100171 The oral surface may be contacted to the primary oral care
composition using any
means known or to be developed in the art; such means may vary depending on
the form of
the primary oral care composition. Exemplary means of contacting the primary
oral care
composition to the oral surface include application using an implement (such
as a brush,
toothbrush, stick, sponge. cotton swab). lavage. chewing, adjacent placement,
and dissolution
of confectionary.
100181 Another of the oral care compositions used in the methods of the
invention is a
periodic oral care maintenance composition. The oral care maintenance
composition is
generally applied by the consumer. The oral care maintenance composition is in
a form
selected from a mouthrinse, a toothpaste, a tooth gel, a tooth powder, a non-
abrasive gel, a
mousse. a foam, a mouth spray, a lozenge, an oral tablet, a varnish, or a
sealant. The periodic
oral care maintenance composition comprises an effective amount of a basic
amino acid, in
free or salt form, e.g., arginine. The composition may further comprise an
effective amount
of an antibacterial agent, e.g., triclosan and /or Zn+2 ion source, e.g., zinc
citrate; an effective
amount of a fluoride source, e.g., a soluble fluoride salt; and/or a polymer.
100191 In particular, the antibacterial agent may be selected from
halogenated diphenyl
ether (e.g. triclosan), herbal extracts and essential oils (e.g., rosemary
extract, tea extract,
magnolia extract, thymol, menthol, eucalyptol, geraniol, caniacrol. citral,
hinokitol, catechol,
methyl salicylate. epigallocatechin gallate, epigallocatechin. gal lie acid,
miswak extract, sea-
buckthorn extract), bisguanide antiseptics (e.g., chlorhexidine, alexidine or
octenidine),
quaternary ammonium compounds (e.g., cetylpyridinium chloride (CPC),
benzalkonium
chloride, tetradecylpyridinium chloride (TPC), N-tetradecy1-4-ethylpyridinium
chloride
(TDEPC)), phenolic antiseptics, hexetidine. octenidine, sanguinarine, povi
done iodine,
delmopinol, salifluor, metal ions (e.g., zinc salts, for example, zinc
citrate, stannous salts,
copper salts, iron salts), sanguinarine, propolis and oxygenating agents
(e.g., hydrogen
peroxide. buffered sodium peroxyborate or peroxycarbonate), phthalic acid and
its salts,
monoperthalic acid and its salts and esters, ascorbyl stearate, olcoyl
sarcosine, alkyl sulfate,
dioctyl sulfosuccinate, salicylanilide, domiphen bromide, delmopinol,
octapinol and other
piperidino derivatives, nicin preparations, chlorite salts; and mixtures of
any of the foregoing.
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100201 In some embodiments, the application of the oral care maintenance
composition
may be carried out daily, every other day. weekly, monthly or any other
interval based on the
oral care maintenance composition delivery form and desired end benefit. For
example,
when the oral care delivery form is a toothpaste the use is e.g., at least
daily, when the oral
care delivery form is a varnish the use is e.g., weekly or monthly.
100211 Another of the oral care composition used in the methods of the
invention is a
periodic oral care cleaning composition. The periodic oral care cleaning
composition
typically has a Pellicle Cleaning Ratio ("PCR") of greater than about 100,
while having a
Radiotracer Dentin Abrasion (-RDA") of less than about 200. In certain
embodiments, the
RDA is less than or equal to about 175, while still having a PCR that exceeds
about 100. In
some embodiments, the RDA is less than about 165. (Methods of performing PCR
and RDA
are described in e.g., United States Patent Nos. 5.939.051 and 6.290.933.
100221 The periodic oral care cleaning composition may include a first
abrasive and a
second abrasive; such abrasives are described in United States Publication No.
2007/0140986.
100231 In certain embodiments, the periodic oral composition comprises a
first abrasive
having an Einlehner hardness of greater than about 5 mg loss per 100,000
revolutions and a
second abrasive having an Einlehner hardness of less than about 5 mg loss per
100.000
revolutions. The first particle having an Einlehner hardness of greater than
about 5 mg loss
per 100,000 revolutions has a primary a polishing function when it is
contacted with an oral
surface. The second particle having an Einlehner hardness of less than about 5
mg loss per
100.000 revolutions has a primary cleaning function, as it is a softer
particle. In certain
embodiments. the second particle has a hardness of greater than about 10 mg
loss per 100.000
revolutions, and in other embodiments, greater than about 15 mg loss per
100,000
revolutions.
100241 The first abrasive of the periodic oral care cleaning composition
may be of a
cleaning abrasive that has a hardness of less than or equal to the oral
surface to be treated,
and the second abrasive is a polishing abrasive that has a hardness of greater
than or equal to
the oral surface to be treated.
100251 Each of the first abrasive and second abrasive of the periodic oral
care cleaning
composition has a particle size. In certain embodiments, the first particle
size is less than the
second particle size. Mean particle size can be measured. e.g.. using a
Malvern Particle Size
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Analyzer, Model Mastersizer S. Malvern Instruments, Inc. of Southborough,
Massachusetts.
U.S.A.
100261 In certain embodiments, the first abrasive has a mean particle size
of less than
about 11 Al11, e.g., less than about 10 pm. For example, examples of suitable
abrasives have
mean particle sizes ranging from about 7 p.m to about 11 pm. Some abrasives
have particle
sizes of less than about 5 pm. In other embodiments, the second abrasive has a
mean particle
size of greater than about 8 pm, e.g., greater than about 10 pm. In some
embodiments, the
second abrasive can have a mean particle size of about 8 pm to about 14 pm.
100271 Any orally or cosmetically acceptable abrasive fulfilling the
requirements set forth
above can be selected for use in the periodic oral care cleaning composition.
Suitable
abrasives include without limitation, silica, silicate, silicon, alumina
(including calcined
aluminum oxide). aluminosilicates, such as bentonite, zeolite, kaolin, and
mica, siliceous or
diatomaceous earth, pumice, calcium carbonate, cuttlebone, insoluble
phosphates. composite
resins, such as melamine resin, phenolic resin, and urea-formaldehyde resin,
polycarbonate,
silicon carbide, boron carbide, microcrystalline wax, microcrystalline
cellulose, including
combinations of colloidal microcrystalline cellulose and
carboxymethylcellulose,
commercially available under the trade name AVICEL from FMC Biopolymer of
Philadelphia, Pennsylvania, U.S.A, and combinations and derivatives of all of
the above. By
"mica" it is meant ally one of a group of hydrous aluminum silicate minerals
with plate
morphology and perfect basal (micaceous) cleavage. Mica can be, for example,
sheet mica,
scrap mica or flake mica, as exemplified by muscovite, biotite or phlogopite
type micas.
Among insoluble phosphates useful as abrasives are orthophosphates,
polymetaphosphates
and pyrophosphates. Illustrative examples are dicalcium orthophosphate
dihydrate.
dicalcium phosphate dihydrate, calcium hydrogen phosphate, calcium
pyrophosphate, 0-
calcium pyrophosphate, tricalcium phosphate, calcium metaphosphate, potassium
metaphosphate, and sodium metaphosphate.
100281 Synthetic silicas include both silica gels and precipitated silicas
which may be
prepared, for example, by the neutralization of aqueous silicate solutions
with a strong
mineral acid. In the preparation of silica gel, a silica hydrogel is formed
which is then
typically washed to low salt content. The washed hydrogel may be milled to the
desired size,
or otherwise dried, ultimately to the point where its stntcture no longer
changes as a result of
shrinkage. When preparing such synthetic silicas, the objective is to obtain
abrasives which
provide maximal cleaning (i.e., removal of stained pellicle) with minimal
damage to the tooth
enamel and other oral tissue.
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100291 Useful abrasive materials for preparing the periodic oral
compositions include
high cleaning, low structure silica abrasives, such as those marketed under
the trade
designation SYLODENT XWA or SYLODENT 783 by Davison Chemical Division of
W. R. Grace & Co. of Baltimore. MD. SYLODENT XWA 650 is a silica hydrogel
composed of particles of colloidal silica. Exemplary silica hydrogels comprise
colloidal
particles of silica having an average particle size of about 3 pm to about 12
pm, and e.g.,
between about 5 p.m to about 10 pm. with a pH range from about 4 to about 10.
e.g., about 6
to about 9 when measured as a 5% by weight slurry. The particles of the XWA
650 contain
about 10 % to about 35% by weight water, have a mean particle size of about 5
p.m to about
12 m, an Einlehner hardness of from greater than or equal to about 5 to about
20 mg loss per
100.000 revolutions, an oil absorption of less than about 90 cm3/100 g. for
example from
between about 40 cm3/100 g to about 90 CM3/100 2. The abrasives have a
Brunauer, Emmett
and Teller (BET) surface area from about 100 to about 700 m2/g. XWA 650 has a
brightness
of about 96.8 technidyne. Such abrasives are disclosed in. e.g., United States
Patent No.
6.290.933.
100301 Another high cleaning silica abrasive that can be included in the
periodic
composition is marketed as SYLODENT XWA 300 and is a silica hydrogel
containing
about 10% to about 25% water by weight, where the mean particles size is about
2 p.m to
about 4 AM. The particles have BET surface area in the range of about 150 to
about 400 m2/g
of silica. The XWA 300 abrasive has an oil absorption of less than about 90
cm3/100 g silica;
and a pH. in a 5% by weight suspension in boiled (CO, free) demineralized
water, equal to or
greater than about 8.5. Such abrasives are disclosed in United States Patent
No. 5,939.051 .
100311 Another suitable high cleaning silica that can be included in the
periodic
composition comprises a silica product, where the particles are about 5 % to
about 35% by
weight water, having a mean particle size of about 7 p.m to about 11 Ani, an
Eirdeliner
hardness of from about 12 to about 19, an oil absorption value of about 50
cm3/100 g to about
65 cm3/100 g. A BET surface area is about 100 to about 700 m2/g of silica. The
brightness is
generally reported to be greater than about 95 technidyne. Such a silica
product is
commercially available as ZEODENT 105 from J.M. Huber of Havre de Grace.
Maryland,
U.S.A.
100321 Other abrasives that can be used include typical cleaning silica
abrasives, such as
precipitated silicas having a mean particle size of up to about 20 p.m.
typically at about 8 to
about 14 ptin. with an oil absorption structure of greater than about 90 to
about 110 cm3/100
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g. such as ZEODENT 115. marketed by J. M. Huber. that has a pH at 5% of the
particles of
about 6.5 ¨ about 7.5 and an Einlehner hardness of about 2 to about 4 mg loss
per 100.000
revolutions. The brightness of such a silica particle is greater than about
95. Such cleaning
abrasives comprise the second abrasive of the oral composition in certain
embodiments.
100331 The silica abrasive polishing materials useful herein, as well as
the other
abrasives, generally have an average particle size ranging between about 0. I
and about 30
microns, about between 5 and about 15 microns. The silica abrasives can be
from
precipitated silica or silica gels, such as the silica xerogels described in
U.S. Pat. No.
3.538,230. to Pader et al. and U.S. Pat. No. 3,862,307, to Digiulio.
Particular silica xerogels are marketed under the trade name Syloid by the W.
R. Grace & Co., Davison Chemical Division. The precipitated silica materials
include those
marketed by the J. M. Huber Corp. under the trade name Zeodent , including the
silica
carrying the designation Zeodent 115 and 119. These silica abrasives are
described in U.S.
Pat. No. 4.340,583.
100341 In certain embodiments, abrasive materials useful in the practice
of the oral care
compositions in accordance with the invention include silica gels and
precipitated amorphous
silica having an oil absorption value of about less than 100 cc/100 g silica
and in the range of
about 45 cc/l00 g to about 70 cc/100 g silica. Oil absorption values are
measured using the
ASTA Rub-Out Method D281. In certain embodiments, the silicas are colloidal
particles
having an average particle size of about 3 microns to about 12 microns, and
about 5 to about
microns.
100351 In particular embodiments, the particulate or abrasive materials
comprise a large
fraction of very small particles, e.g., having a d50 less than about 5
microns, for example
small particle silica (SPS) having a d50 of about 3 to about 4 microns. for
example Sorbosil
AC43 (Ineos). Such small particles are particularly useful in formulations
targeted at
reducing hypersensitivity. The small particle component may be present in
combination with
a second larger particle abrasive. In certain embodiments, for example, the
formulation
comprises about 3 to about 8% SPS and about 25 to about 45% of a conventional
abrasive,
100361 Low oil absorption silica abrasives particularly useful in the
practice ofthe
invention are marketed under the trade designation Sylodent XWA by Davison
Chemical
Division of W.R. Grace & Co., Baltimore, Md. 21203. Syloclent 650 XWA , a
silica
hydrogel composed of particles of colloidal silica having a water content of
about 29% by
weight averaging about 7 to about 10 microns in diameter, and an oil
absorption of less than
about 70 cc/100 g of silica is an example of a low oil absorption silica
abrasive useful in the
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practice of the present invention. The abrasive is present in the oral care
composition of the
present invention at a concentration of about 10 to about 60% by weight, in
other
embodiment about 20 to about 45% by weight, and in another embodiment about 30
to about
50% by weight.
100371 In embodiments where the dentifrice is a clear or transparent gel,
an abrasive of
colloidal silica, such as those sold under the trademark SYLOID as SY LOI De
72 and
SYL0fDe 74 or under the trademark SANTOCEL 100 alkali metal alumina-silicate
complexes are particularly useful, since they have refractive indices close to
the refractive
indices of gelling agent-liquid (including water and/or humectant) systems
commonly used in
dentifrices.
100381 In accordance with various embodiments of the present invention, a
first and a
second abrasive are combined in the periodic composition to provide cleaning
capability,
mildness (relatively low abrasivity), and aesthetically acceptable periodic
care compositions.
In various embodiments, an amount of the first abrasive to the second abrasive
can be
expressed by a ratio of the first abrasive to the second abrasive ranging from
about 1:1.6 to
about 1.6:1. For example, a ratio of the first abrasive to the second abrasive
is about 1:1.
The respective amounts of the first abrasive and the second abrasive present
in an oral
composition may be about 13 to about 21% by weight of the oral composition.
100391 In sonic embodiments, the amount of the first abrasive is about 15%
to about 19%,
and the amount of the second abrasive is about 15% to about 19% by weight of
the oral
composition. In certain preferred embodiments, the first abrasive is present
at about 17% by
weight and the second abrasive is present at about 17% by weight of the oral
composition.
Thus, in accordance with various embodiments of the present invention, the
total amount of
abrasive in the periodic oral care cleaning composition, including the first
and second
abrasive is e.g., greater than about 25%, greater than about 30%, and in some
embodiments.
greater than about 35% by total weight of the periodic oral care cleaning
composition.
100401 In some embodiments, the periodic oral composition comprises a first
abrasive
having an Einlehner hardness of greater than about 5 mg loss per 100,000
revolutions and a
second abrasive having an Einlehner hardness of less than about 5 mg loss per
100,000
revolutions. A ratio of the first abrasive to the second abrasive ranges from
about 1:1.6 to
about 1.6:1. Further, the periodic oral composition has a PCR of greater than
about 100 and
an RDA of less than about 200. In certain embodiments, the RDA is less than
about 175. In
certain embodiments, the first abrasive has an oil of absorption of less than
about 90
cm3/100g, and the second abrasive has an oil of absorption of greater than
about 90
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cm3/100g. In some embodiments. the ratio of the first abrasive to the second
abrasive is
about 1:1. The total amount of the abrasives, including both the first and the
second
abrasives, is greater than about 30%. The first abrasive and the second
abrasive are
optionally present at about 17% each, respectively. In some embodiments, the
first and
second abrasives are respectively present in an amount of about 15% to about
19% by weight
of the total periodic oral care cleaning composition. The first and second
abrasives optionally
comprise silica.
100411 In certain embodiments, the periodic oral composition comprises a
first abrasive
comprising silica, having an Einlehner hardness of greater than about 5 mg
loss per 100,000
revolutions, and an oil of absorption of less than about 90 cm3/100g. The
periodic oral
composition further comprises a second abrasive comprising silica having an
Einlehner
hardness of less than about 5 mg loss per 100,000 revolutions, and an oil of
absorption of
greater than about 90 cm3/100g. The first abrasive is present at an amount of
about 13% to
about 21% by weight, likewise, the second abrasive is present in an amount of
about 13% to
about 21% by weight of the composition. In some embodiments, the first
abrasive and the
second abrasive are respectively present at about 15 % to about 19% by weight
of the
periodic oral composition. In certain embodiments, the first and second
abrasives are
respectively present in an amount of about 17% by weight of the oral
composition. The PCR
is e.g., greater than about 100 and the RDA is e.g., less than about 200, and
in certain
embodiments, less than about 175. A total amount of the first and second
abrasive present in
the oral composition are e.g., greater than about 25% or e.g., greater than
about 30%.
100421 In certain embodiments, the periodic oral composition comprises a
first abrasive
comprising silica and having an oil of absorption of less than about 90
cm3/100g and an
Einlehner hardness of greater than about 5 mg loss per 100,000 revolutions.
The periodic
oral composition further comprises a second abrasive comprising silica and
having an oil of
absorption of greater than about 90 cm3/100g and an Einlehner hardness of less
than about 5
mg loss per 100,000 revolutions. A ratio of the first abrasive to the second
abrasive is about
1:1.6 to about 1.6:1. Further, a total amount of the first and second
abrasives present in the
oral composition is greater than about 25% by weight of the composition.
100431 In certain embodiments, the periodic oral composition has a ratio of
the first
abrasive to the second abrasive that ranges from about 1:1.6 to about 1.6:1.
In particular
embodiments, the active ingredient comprises a non-ionic antibacterial
ingredient, such as a
halogenated diphenyl ether like triclosan, which will be discussed in more
detail below. In
some embodiments, the first abrasive has an oil of absorption of less than
about 90 cm3/100g
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and an Einlehner hardness of greater than about 5 mg loss per 100.000
revolutions, and the
second abrasive has an oil of absorption of greater than about 90 cm3/100g and
an Einlehner
hardness of less than about 5 mg loss per 100,000 revolutions.
[00441 The periodic oral care cleaning compositions described herein (both
the primary
and the periodic) may comprise an orally acceptable carrier. Conventional
ingredients that
can be used to form the carriers for oral care compositions are well known to
the skilled
artisan. The carrier can be a liquid, semi-solid, or solid phase. Oral
compositions can be in
the form of a dentifrice (including toothpastes, toothpowders, and prophylaxis
pastes).
confectionaries (including gums. beads and chews). film, paint-on gels, or any
other form
known to one of skill in the art where abrasives are employed. Selection of
specific carrier
components is dependant on the desired product form.
(00451 In certain preferred embodiments, the composition(s) are
independently in the
form of a dentifrice, where an exemplary carrier is substantially semi-solid
or solid. The
carrier can be aqueous. in which case the carrier e.g., comprises about 5% to
about 95%
water. In other embodiments, the carrier is substantially non-aqueous. The
carrier optionally
comprises, for example, oral care active ingredients, surface active agents,
such as
surfactants, emulsifiers, and foam modulators, viscosity modifiers and
thickeners,
humectants, diluents, fillers, additional pH modifying agents, colorants,
preservatives,
solvents, and combinations thereof. It is understood that while general
attributes of each of
the above categories of materials may differ: there may be some common
attributes and any
given material may serve multiple purposes within two or more of such
categories of
materials. As recognized by one of skill in the art, the oral composition(s)
optionally include
other materials in addition to those components previously described,
including for example.
emollients, moisturizers, mouth feel agents and the like. Examples of suitable
carriers for
oral compositions are disclosed in United States Patent Nos. 6,669,929,
6,379.654. and
4.894.220.
100461 The oral care active ingredients include for example, anti-bacterial
active agents.
anti-tartar agents. anti-caries agents, anti-inflammatory agents. anti-
sensitivity agents,
enzymes. nutrients, and the like. Active agents among those useful herein are
also disclosed
in United States Patent Nos. 6,290,933 and 6,685,921.
100471 The primary and/or periodic oral care compositions may further
comprise an agent
that interferes with or prevents bacterial attachment, e.g., solbrol or
chitosan.
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(00481 Any suitable fluoride ion source may be present in either or both of
the oral
composition(s), such as those recited in United States Patent No. 5,080.887.
Sources of fluoride ions, acid phosphatases, and =
pyrophosphatase enzyme inhibitors. are well known in the art as anti-caries
agents.
Examples ofsuch sources are inorganic metal and/or ammonium fluoride salts and
compounds, such as, for example: sodium fluoride, potassium fluoride, ammonium
fluoride,
amine fluoride, calcium fluoride: a copper fluoride, such as cuprous fluoride;
zinc fluoride.
barium n fluoride: sodium silicafluoride, sodium fluorosilicate. ammonium
fluorosilicate,
sodium fluorozirconate; and sodium monofluorophosphate. aluminum mono- and di-
fluorophosphate. and fluorinated sodium calcium pyrophosphate. and
combinations thereof.
The fluoride source can also be an amine fluoride, such as olaflur
(N'octadecyltrimethylendiamine-N,N.N'-tris(2-ethanol)-dihydrofluoride). Sodium
fluoride,
amine fluoride, stannous fluoride, sodium monofluorophosphate (MFP), and
mixtures
thereof, are preferred. In certain embodiments the fluoride ion source
includes stannous
fluoride, sodium fluoride, sodium monofluorophosphate as well as mixtures
thereof.
100491 In certain embodiments, the periodic and/or primary oral care
compositions of the
invention may also contain a source of fluoride ions or fluorine-providing
ingredient in
amounts sufficient to supply about 25 ppm to 25,000 ppm of fluoride ions,
generally at least
about 500 ppm, e.g., about 500 to about 2000 ppm, e.g., about 1000 to about
1600 ppm, e.g.,
about 1450 ppm. The appropriate level of fluoride will depend on the
particular application.
A mouthwash, for example, would typically have about 100 to about 250 ppm
fluoride. A
toothpaste for general consumer use would typically have about 1000 to about
1500 ppm,
with pediatric toothpaste having somewhat less. A dentifrice or coating for
professional
application could have as much as 5,000 or even 25,000 ppm fluoride.
100501 The periodic and/or primary oral care compositions of the invention
may comprise
a calcium phosphate abrasive, e.g.. tricalcium phosphate (Ca3(PO4)2),
hydroxyapatite
(Ca10(PO4)40H)2), or dicalcium phosphate dihydrate (CaHPO4 = 2H20, also
sometimes
referred to herein as DiCal) or calcium pyrophosphate.
100511 Either or both oral composition(s) optionally comprise an
anticalculus component.
such as one or more of the anti-calculus components recited in United States
Patent No.
5,292,526. In various
embodiments. the anti-calculus component includes one or more polyphosphates.
The anti-
calculus composition can include at least one wholly or partially neutralized
alkali metal or
ammonium tripolyphosphate or hexametaphosphate salt present in the oral
composition at an
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effective anti-calculus amount. The anti-calculus component can also include
at least one
water soluble. linear, molecularly dehydrated polyphosphate salt effective in
an anticalculus
amount. The anti-calculus component can also include a mixture of potassium
and sodium
salts. at least one of which is present in an effective anti-calculus amount
as a polyphosphate
anti-calculus agent. Other useful anticalculus agents include polycarboxylate
polymers and
polyvinyl methyl ether/maleic anhydride (PVM/MA) copolymers, such as GANTREZ .
100521 All other substances or molecules known to be useful in oral care
compositions
may be included in either or both of the daily or the periodic compositions.
For example.
such additional molecules may include antibacterial agents, antiplaque agents.
desensitizing
agents, anti-inflammation agents. colorants, thickeners, flavorants.
surfactants, abrasives,
anti-adhesion agents, an anti-caries agent. a sensate. and/or vitamins.
100531 Other components that may be added to either or both composition
include a
stannous ion agent; triclosan; triclosan monophosphate; chlorhexidine;
alexidine: hexetidine;
sanguinarine; benzalkoni urn chloride; salicylanilide; domiphen bromide;
cetylpyridinium
chloride (CPC); tctradecylpyridinium chloride (TPC); N-tetradecy1-4-
ethylpyridinium
chloride (TDEPC); octenidine; delmopinol; octapinol; nisin; zinc ion agent;
copper ion agent;
essential oils; furanones; bacteriocins, ethyl latiroyl arginate, extracts of
magnolia, a metal
ion source, arginine bicarbonate. honokiol, magonol, ursolic acid. ursic acid,
morin, extract of
sea buckthorn, a peroxide, an enzyme, a Camellia extract, a flavonoid, a
flavan, halogenated
diphenyl ether, creatine, chitosan and propolis.
100541 As used throughout, ranges are used as shorthand for describing each
and every
value that is within the range. Any value within the range can be selected as
the terminus of
the range. In the event of a conflict in a definition in the present
disclosure and that of a
cited reference, the present disclosure controls. It is understood that when
formulations are
described, they may be described in terms of their ingredients, as is common
in the art,
notwithstanding that these ingredients may react with one another in the
actual formulation as
it is made. stored and used. and such products are intended to be covered by
the formulations
described.
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