Note: Descriptions are shown in the official language in which they were submitted.
1
ORAL CARE COMPOSITION AND USE AND METHOD FOR THE PREVENTION
AND CONTROL OF PLAQUE FORMATION, BAD BREATH, GINGIVITIS,
PERIODONTAL DISEASES AND/OR DENTAL CARIES
Technical field
[0001] The invention relates to a new oral care composition for the prevention
and
control of plaque formation, bad breath, gingivitis, periodontal disease
and/or dental
caries. Also, the invention relates to a use of said oral care composition and
to a method
comprising a step involving said oral care composition.
Background of the invention
[0002] It is known that the oral cavity, one of the most densely populated
sites of the
human body with microbial flora, promotes the establishment of distinct
microbial
communities: dental plaque, subgingival plaque and tongue coating. Over 500
microbial
species have been isolated from the oral cavity, many of which are recognized
as
pathogens.
[0003] Self performed mechanical home-care methods (brushing, flossing)
contribute
to the maintenance of oral hygiene and prevention of oral infections. However,
these
procedures require time, motivation and manual dexterity. Also, bacteria are
often left
behind, especially in hard-to-reach areas, such as posterior teeth and
marginal gingiva.
[0004] Pathogenic microorganisms are implicated in the initiation and
progression of
at least oral conditions selected from the group consisting of plaque,
halitosis, gingivitis,
periodontis and dental caries.
[0005] A variety of oral care compositions have been commercialized with
different
microcidal agents. However, they are providing more or less satisfactory
results, but also
side effects.
Plague
[0006] Dental plaque is a host associated biofilm known as soft deposit
adhering on
surfaces of teeth and is considered to be the primary cause of bad breath,
gingivitis,
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periodontitis and dental caries. Therefore, control and reduction of dental
plaque are
essential to a sound oral hygiene and global health.
[0007] More than 500 different types of microorganisms have been found in well-
developed human dental plaque. Some may be important in the pathogenesis of
the oral
disease, and others may not. If not controlled, the normal metabolic activity
of these
plaque organisms can produce various acids, such as acetic, butyric and lactic
acids,
which may react with calcium of dental enamel resulting in decalcifications,
and initiation
and progression of dental caries. Other microbial by-products may attack soft
gum tissue
leading to gingivitis and later on periodontitis.
[0008] The prevention and control of dental plaque remain lingering issues of
high
importance to oral and general health, with a significant social and financial
impact on
modern societies.
Halitosis
[0009] Oral malodor (Halitosis), commonly known as "bad breath" is a condition
that
affects up to 50 % of the global population. In addition to breath odour,
individuals may
have unpleasant taste, described as bitter, dry, fecal, metallic, hot or
pasty. Two of the
most frequent causes of bad breath are:
- Tongue coating, and
- Tonsillolith.
Tongue coating
[0010] Tongue coating is a bacterial whitish or yellowish plaque formed on the
surface
of the posterior part of the tongue. It is composed of epithelial cells peeled
off the oral
mucosa, salivary proteins and food protein remains, which serve as food
subtract to
present bacterial flora, and especially anaerobic proteolytic bacteria. As a
result of
bacterial metabolism unpleasant smell is produced, which is nothing but bad
breath itself.
[0011] Tongue coating is basically formed with a decrease of salivary flow or
an
epithelial desquamation above physiological limits, or even both conditions.
There are
several causes for increasing cell desquamation including oral respiration or
snoring, use
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of orthodontic appliances, the habit of biting lips and cheeks, frequent
ingestion of
alcoholic beverages, or even the use of mouthwashes containing alcohol.
Tonsillolith
[0012] Tonsillolith is a "little paste" that is formed into invaginations
existing in the
tonsils - tonsil crypts. Its content is similar to tongue coating and is
formed by the same
mechanism of epithelial desquamation and reduction of salivary flow.
[0013] It is generally recognized that bad odour, associated with the
tongue coating
and with tonsillolith, is due to the presence of Gram-negative anaerobic
bacteria within
the tongue coating and tonsillolith. These bacteria actively degrade, and the
debris left in
the mouth result in the production of sulfur-containing amino-acids,
methionine and
cysteine, and generate pungent compounds collectively known as volatile sulfur
compounds (VSC). Hydrogen sulfide (H-S-H), methyl mercaptan (CH3-S-H) and
dimethyl
sulfide (CH3-S-CH3), are the principal odour components generated.
[0014] These substances, especially methyl mercaptan, have an unpleasant
odour,
even in a very low concentration, and thus exhalation is perceived as bad
breath.
[0015] It is also recognized that VSC can produce biological effects, such
as altering
the epithelial barrier within the oral cavity, resulting in bleeding and
painful inflammation
of oral tissue. For example, methyl mercaptan enables the penetration of
bacterial toxins
into the underling connecting tissue through the increased permeability of
oral mucosa.
This volatile compound can alter enzymatic and immunologic activities, delay
wound
healing and influence gene activity through the alteration cell shape and
cytoskeleton
pattern.
[0016] An important factor is that, among bacteria present in the tongue
coating and
tonsillolith, there are bacteria that may cause oral and systemic diseases.
Therefore,
removal and control of the tongue coating and tonsillolith are important in
preventing oral
diseases, as well as systemic diseases, such as gastritis and pneumonia.
[0017] In addition to the Gram-negative anaerobic bacteria many individuals
who
complain about bad breath and bad taste, have substantial amounts of yeast.
Among
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them Candida albicans is the species most often responsible for infection in
the oral cavity
and may cause a variety of disorders including gingival bleeding and denture
stomatitis.
Gingivitis
[0018] Gums are pinkish brownish colored soft tissue holding the tooth in bone
sockets
by adhering them firmly throughout periodontal ligaments to periosteum. Gums
are
basically called gingiva and the inflammatory diseases are called gingivitis
in general.
Gingivitis is comprised of different forms of gingival diseases. These
diseases manifest
clinical signs of inflammation and are classified into two main groups:
non-plaque induced, and
plaque-induced.
Non-plaque induced gingivitis
[0019] Gingival conditions not induced by plaque are common and can help
explain
the many different forms of periodontal diseases (Holmstrup, "Non-Plaque-
Induced
Gingival Lesions" Ann Periodontal, vol. 4, No.1, December 1999, pp. 20-28).
[0020] The causes of non-plaque induced gingival disease include, bacterial,
viral and
fungal infections, genetic disorders, mucocutaneous diseases (e.g., Lichen
planus),
traumatic tooth brushing and allergic reaction to drugs.
Plaque-induced gingivitis
[0021] Plaque induced gingivitis is defining as gingival inflammation,
which is confined
to the gingival margin. It is associated with dental plaque and no other local
contributing
factors. Gram-positive and Gram-negative bacteria produce many metabolites
that
induce gingival inflammation. The clinical features of this condition include
redness,
swelling and bleeding on probing. Plaque induced gingivitis is one of the most
frequent
periodontal diseases, affecting more than 90 % of the population, regardless
of age, sex
or race.
Periodontitis
[0022] Periodontitis is defined as an inflammation of the gingiva
extending into the
supporting structure of teeth. The disease is characterized by loss of teeth
attachment,
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due to destruction of the periodontal ligaments and loss of the adjacent
supporting bone.
There is a relative agreement among specialized scientists that at least seven
to eight
organisms are fairly certain to be involved in various types of periodontal
diseases. These
are: Actinomyces viscosus, A. gin givalis, Aggregatibacter
actimomycetemcomitans,
Porphyromonas gin givalis, Tannerella forsythia, Prevotella intermedia, Cam
pylobacter
rectus and Spirochetes. Those, and probably other, not yet identified
organisms, are
considered to be important in gingivitis development, in progression from
gingivitis to
periodontitis, as well as in the advancing lesion of both chronic and
aggressive
periodontitis.
Dental caries
[0023] Dental cavities are generally considered to be caused by microorganisms
such
as Lactobacillus and Streptococcus mutans which adhere to the surface of the
teeth,
especially in pits and crevices, and form dental plaque.
[0024] Glucans produced from sucrose by the S. mutans glucosyltransferases
(GTF)
have been indicated as the primary factor in the adherence of the bacteria to
tooth
surfaces. Dietary sucrose is believed to be the principal material utilized by
the S. mutans
in plaque, resulting in lactic acid production and subsequent enamel
decalcification.
Attempts to reduce and control dental plaque have been made by inhibiting the
ability of
S. mutans to colonize. However, possibility due to the vitality of S. mutans
when routinely
contacted with food carbohydrate, it has been shown to be very difficult to
inhibit its
growth and thereby promote oral hygiene, without undesirable anti-microbial
side effects.
Prior art
[0025] A variety of available oral care products comprise ingredients selected
from one
or more anti-bacterial agents, buffering agents, humectants, surfactants,
thickeners,
breath fresheners, agents that interfere with or prevent bacterial attachment,
flavoring,
flagrance, coloring, whitening agent, calcium sources, phosphate sources,
potassium
salt, anionic polymers, and others.
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[0026] In U.S. Patent 4,022,880 to Vinson et al., a compound providing zinc
ions as
an anticalculus agent is mixed with an antibacterial agent effective to retard
the growth of
the plaque bacteria.
[0027] Also, a wide variety of antibacterial agents was described in the art
with the zinc
compounds including cationic materials, such as guanides and quaternary
ammonium
compounds, as well as noncationic compounds, such as halogenated
salicylanilides and
halogenated hydroxydiphenyl ethers. Also, a noncationic antibacterial
antiplaque
halogenated hydroxydiphenyl ether-triclosan was disclosed in combination with
zinc
citrate trihydrate in European Patent Publication 161,899 (Saxton et al.) and
in European
patent Publication 271,332 (Davis et al.).
[0028] A mouthwash containing triclosan in a carrier system, containing a
solubilizing
agent, such as propylene glycol, is also disclosed.
[0029] Also, cationic antibacterial agents, such as chlorhexidine,
benzalkonium
chloride and cetylpyridinium chloride have been the subject of investigation
as
antibacterial and anti plaque agents. However, they appear to be generally non-
effective
when used with anionic materials. Noncationic antibacterial materials, on the
other hand,
can be compatible with anionic components in oral composition. US Patent
5,401,496
(Fitzig et al.: March 28, 1995) discloses a preparation comprising a synthetic
oil of a
caprylic/capric triglyceride mixture. US Patent 5,738,840 (Richter; April 14,
1998)
discloses an aqueous composition comprising chloride dioxide and a metal
chloride salt.
[0030] In
a study of microbicidal activity of silver sulfadiazine 657 different types of
bacteria from 22 different bacterial species were exposed. All strains were
inhibited by
levels which can easily be obtained topically. Strains resistant to
sulfadiazine or multiple
antibiotics were sensitive to silver sulfadiazine ("Carr, Howard S.,
Wlodkowski, Theodore
J., and Rosenkranz, Herbert S., November 1973; Silver sulfadiazine: In Vitro
Antibacterial
Activity. Antimicrobial Agents and Chemotherapy, 4(5), 585- 587.
[0031] Also, various rinse preparations are known for treating halitosis. US
Patent
6,132,701 (Perez et al.: October 17, 2000) discloses a method for reducing
halitosis that
includes an aqueous solution of calcium hydroxide for rinsing the oral cavity.
In general,
known anti-halitosis mouthwashes may not remove the often bitter or pasty
taste that
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causes distress to the individual, suggesting that they leave microorganisms
in numbers
large enough to generate by-products that continue to affect the taste
perceptions of the
affected people.
[0032] Salt water rinses are generally considered as excellent short-term
treatment of
wounds in the mouth or after teeth extraction, sore throat or gum sores. US
Patent
4581226A describes a sea water solution that may be used to irrigate eye and
nasal
mucosa, pharyngeal mucosa, external auditory meatus, tissue lining the cavity
of the
mouth and vaginal tissue. Thus, when used for irrigation, the solution may be
applied as
a nose spray, an ear and eyewash, a mouth wash and also a douche.
[0033] Also, QuintonTM Marine Plasma can be used in place of saline solution
in root
canal washings and in cases of periodontal osteoporosis; US 4581226A (DiIon
R.) has
discussed that sea water has exhibited bacteriostatic properties; and US
Patent
6,071,500 (Thislet, June 6, 2000) discloses a breath cleansing spray that
includes xylitol
as a sweetener and calcium hydroxide to raise the pH of the saliva. QuintonTM
Marine
Plasma (QMP), is sea water derived from regions of intense (vortex)
reproduction of
plankton in the Atlantic Ocean. QMP is enriched with various mineral
compounds, trace
elements, and biologically active substances. However, the specific mechanisms
underlying the beneficial effects of the QMP on living organisms remain
unclear.
[0034] It
has been recognized, since ancient times, that salt is not only a natural
disinfectant, but it also removes swelling from tissue and promotes wound
healing. Salt
also promotes isotonic effect which means it contains the same salts and
minerals our
body produces preventing destruction of cells migrating into the area trying
to repair the
wound.
[0035] Recently, a new generation of mouthwash has been produced (Pekovic et
aL,
"Comparative Study Of Antimicrobial Toxicity And Physicochemical Properties Of
The
New Generation Mouthwash OralNetTM' With Common Mouthwashes", EC Microbiology,
Vol. 2, Issue 3, November 2015, pp. 317-327) that contains ultra-pure sea
water and
colloidal silver as active ingredients. However, it has been shown that ultra
pure see water
and colloidal silver have reacted physico-chemically, resulting in turbidity
and
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precipitation, to thereby negatively affect the properties and efficiency of
such a
mouthwash.
[0036] Therefore, there is a strong need for an oral care composition avoiding
drawbacks of existing oral care compositions.
[0037] Also, there is a strong need for use of an anti-microbial oral care
composition,
preferably a mouthwash composition, containing microbicidal agents with a
broad-
spectrum activity, as a supplement to mechanical home-care procedures. Such
agents
should not have properties to induce a microbial resistance, nor to have any
side effects
on oral tissue, cells or teeth.
[0038] Also, there is a strong need for a new oral care composition,
preferably a
mouthwash composition, defining a mile stone in modern dentistry by
controlling and
preventing dental plaque formation and consequent oral diseases conditions.
[0039] Also, there is a strong need for a new oral care composition,
preferably a
mouthwash composition, allowing to reduce dental plaque and promoting oral
hygiene by
reducing dental caries and gingivitis.
[0040] Also, there is a strong need for a new oral care composition, such as a
mouthwash composition, for the prevention and control of plaque formation and
consequent microbial involvement in the etiology of bad breath, gingivitis,
periodontal
disease and dental caries, without drawbacks of existing oral care
compositions.
[0041] Also, there is a strong need for a method for the prevention and
control of
plaque formation and consequent microbial involvement in the etiology of bad
breath,
gingivitis, periodontal disease and dental caries, said method comprising a
step involving
the contact of a new oral care composition, such as a new mouthwash
composition,
which does not present drawbacks of existing oral care compositions.
[0042] Also, with the high incidence of oral diseases, increasing cost of
dental services
and development of antibiotic resistance, there is a global need for
protection of oral
health through safe and effective alternative treatments.
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[0043] The Applicant has now surprisingly discovered a new oral care
composition
allowing to overcome, at least in part, above mentioned drawbacks and to meet
with the
above-mentioned needs.
[0044] According to a preferred aspect, the Applicant has surprisingly
discovered a
new oral care composition, more preferably a new mouthwash, allowing to
overcome the
above-mentioned drawbacks, and allowing to meet the above-mentioned needs. Of
course, the new oral care composition may be under any form, and preferably
under the
form of a mouthwash.
[0045] Also, the Applicant has now surprisingly discovered a new use and a new
method involving the above-mentioned new oral care composition, said use and
method
allowing at least in part to overcome, and preferably allowing to overcome,
the above-
mentioned drawbacks and to meet with the above-mentioned needs.
Summary of the invention
[0046] An embodiment of the present invention relates to an oral care
composition
comprising, but not limited to, two active ingredients:
sodium chloride-free sea water, preferably ultra pure sodium chloride-free sea
water, and
a silver ion solution.
[0047] Another embodiment of the present invention relates to the oral care
composition defined hereinabove, optionally further comprising a
pharmaceutically
acceptable carrier or excipient, said pharmaceutically acceptable carrier or
excipient
being free of chloride ions.
[0048] Silver ion solution may be prepared according to any techniques well
known in
the art. Preferably, the silver ion solution may be prepared by electrolysis
procedure of
pure silver (99.9%) in deionized water using a low voltage DC power source (9
to 30
VDC). When electric current passes through the silver electrodes, some silver
atoms, at
the interface with the deionized water, lose an electron and change the atom
into an ion.
Whereas metallic silver is not water soluble, silver ions are water soluble
producing an
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ionic silver solution in deionising water which is free of any other ions of
physic-chemical
substances.
[0049] The Applicant has surprisingly discovered that it is possible to avoid
this color
change, by removing sodium chloride from sea water. Any technics well known in
the art
can be used. Preferably, sodium chloride can be removed by standard inversed-
osmosis
procedure. Following inversed osmosis removal of the sodium chloride from the
sea
water, the contact with ionic silver solution has not generated any detectable
color change
of the mixture.
[0050] Another embodiment of the present invention allows to at least reduce
or allows
to overcome, several of the drawbacks of existing oral care composition,
concerning the
reduction and elimination of harmful microorganisms within the oral cavity.
[0051] Also, another embodiment of the present invention encompasses an oral
care
composition, a use and a method to clean and disinfect an oral cavity and
provide
improved methods of promoting oral health and/or systemic health by reducing
potential
for oral diseases and systemic infection via the oral cavity.
[0052] Also, another embodiment of the present invention provides an oral care
composition and a method allowing to reduce and/or prevent the formation of
plaque and
the etiology of halitosis, gingivitis, periodontitis and dental caries.
[0053] Also, another embodiment of the present invention relates to an oral
care
composition whose primary active microbicidal ingredients comprise sodium
chloride-free
sea water, preferably ultra pure sodium chloride-free sea water, and a silver
ions solution.
[0054] Also, another embodiment of the present invention relates to an oral
care
composition whose primary active microbicidal ingredients comprise sodium
chloride-free
sea water, preferably ultra pure sodium chloride-free sea water, a silver ions
solution, and
optionally a pharmaceutically acceptable carrier or excipient, said
pharmaceutically
acceptable carrier or excipient being free of chloride ions.
[0055] Also, another embodiment of the present invention relates to a new oral
care
composition that is capable of elimination of oral pathogenic bacteria on
contact.
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[0056] Also, another embodiment of the present invention relates to a method
comprising a step of directly contacting an oral care composition according to
the
invention with the oral cavity, e.g. washing the teeth and oral cavity,
optionally in
conjunction with brushing of teeth to reduce plaque formation.
[0057] Also, another embodiment of the present invention relates to a oral
care
composition, use and/or method described herein that can be used for the
prevention and
treatment of halitosis, gingival inflammation or bleeding, and/or periodontal
disease
and/or dental caries, as well as to reduce the pain associated with oral
disease.
[0058] Also, another embodiment of the present invention relates to an oral
care
composition effective in the treatment of mixed bacterial infections that is a
combination
of anaerobes and aerobes consisting of Bacteroides sp., Fusobacterium sp. and
Peptostreptococcus sp., as well as yeast species such as C. albicans.
[0059] Also, another embodiment of the present invention provides oral care
composition containing sea water from which sodium chloride has been removed
and a
silver ions solution, which act in synergy against oral disease and dental
caries etiologic
agents.
[0060] Also, another embodiment of the present invention provides oral care
composition containing sea water from which sodium chloride has been removed,
a silver
ions solution, and optionally a pharmaceutically acceptable carrier or
excipient, said
pharmaceutically acceptable carrier or excipient being free of chloride ions,
which act in
synergy against oral disease and dental caries etiologic agents.
[0061] Without being bound to the theory, the Applicant believes that silver
ion
particles block dentine and openings of dentinal tubuli as a physical barrier
and kill
accumulated bacteria by ions damaging cell membrane and blocking of
respiratory
enzyme of pathogens.
[0062] Also, another embodiment of the invention relates to a synergetic
killing of oral
pathogens with silver ions solution and sodium-chloride free sea water. Also,
said sodium
chloride-free sea water further contributes by its osmolality, based on a rich
content of
minerals and metals, and presence of natural antibiotics.
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[0063] Also, another embodiment of the invention relates to a synergetic
killing of oral
pathogens with silver ions solution, sodium-chloride free sea water, and
optionally a
pharmaceutically acceptable carrier or excipient, said pharmaceutically
acceptable
carrier or excipient being free of chloride ions. Also, said sodium chloride-
free sea water
further contributes by its osmolality, based on a rich content of minerals and
metals, and
presence of natural antibiotics.
[0064] Also, antimicrobial synergy between sodium chloride-free sea water and
silver
ions solution may result in generation of additional microbicidal ingredients
such as silver
diamide fluoride (SDF) (Ag+ (NH3)2 F-) and possibly many others. SDF is known
in
prevention and stopping dental decay. The Applicant believes that this synergy
may
produce positive results in patients that had not found relief from halitosis,
plaque
accumulation, gingivitis, periodontitis and dental caries.
[0065] According to another embodiment of the invention, the oral care
composition
can be used for control of total salivary microbial load by continuous
maintaining pH
around 7.5.
[0066] According to another embodiment of the invention, the oral care
composition,
use and/or method described herein can be used to prevent and treat fungal
infection,
caused by C. alb/cans.
[0067] Another embodiment of the invention relates to the oral care
composition
defined above, with a reduction and/or none of the side effects found in
topical uses of
both sea water and colloidal silver solution.
[0068] Another embodiment of the invention relates to the oral care
composition
optionally further comprising additional ingredients, e.g., selected from but
not limited to
one or more of water, surfactants, solvent, vitamins, minerals, polymers,
enzymes,
humectants, thickeners, additional antimicrobial agents, additional
preservatives,
flavorings, colorings and/or combination thereof.
[0069] The description and specific examples illustrate various embodiments of
the
invention.
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- Recitation of multiple embodiments having stated features that are
not intended to
exclude other oral compositions having additional features or different
combinations of the stated features. Furthermore, the recitation of one or
more
preferred embodiments does not imply that other embodiments are not useful and
are not intended to exclude other embodiments from the scope of the invention.
- Specific examples are provided only for illustrative purposes of how
to make, use
and practice the compositions and methods of this invention.
- The active ingredients of present invention can be delivered in the
form of any oral
care formulations, for example mouthwash, toothpaste, powder, cream, strip,
gum,
or any other formulation known in the art. The oral care compositions of
present
invention preferably are in the form of a mouthwash and disinfectant of
toothbrushes and dentures.
- The term "dentifrice" as used through the description denotes a
paste, gel,
lozenge, gum or liquid formulation. The dentifrice may be in any desired form,
such
as deep stripped, surface stripped, multilayered having a gel surround the
paste,
or any compositions thereof.
- The expressions "pharmaceutically acceptable carrier or excipient",
as used
through this description, represents any safe and effective materials for use
herein. Said "pharmaceutically acceptable carrier or excipient" is free of
chloride
ions. Optionally, such materials may include, for example, thickening agents,
humectants, ionic active ingredients, buffering agents, anticalculus agents,
abrasive polishing materials, peroxide sources, alkali metal bicarbonate,
salts,
surfactants, titanium dioxide, coloring agents, flavor sweetening agents,
antimicrobial agents, herbal agents, desensitizing agents, stain reducing
agents,
and mixtures thereof.
- The expression free of chloride ions means that the concentration
of chloride
ions is lesser than 5 ppm, preferably lesser than 3 ppm, and more preferably
lesser
than 1 ppm.
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- As used herein the words "preferred" and "preferably" are not limiting
and only
refer to the embodiment of the invention that affords certain further
benefits, under
certain circumstances.
The word "include", and its variant is intended to be non-limiting, such that
recitation of items in a list is not to the exclusions of other like items
that may, also
be useful in the materials, compositions, and methods of this invention.
In a similar manner, the description of certain advantages or disadvantages of
known materials and methods is not intended to limit the scope of the
invention.
- As used herein the term "about" indicates a possible variation of up to 5
`)/0 in the
value.
Unless stated otherwise, all percentages of composition components given in
this
specification are by weight based on a total weight of the composition.
The composition and formulation that are provided herein are described and
claimed with reference to their ingredients, as is usual in the art. As would
be
evident to one skilled in the art, the ingredients may in some instances react
with
one another, so that the true composition of the active ingredients of the
final
composition may not correspond exactly to the ingredients listed. Thus, it
should
be understood that the invention extends to the product of the combination and
interaction of the listed ingredients.
- As indicated throughout the following description, 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.
The examples and other embodiments described herein are indicative and not
intended to be limiting in describing the full scope and methods of this
invention.
Detailed description of the invention
[0070] Another embodiment of the present invention relates to an oral care
composition comprising:
(i) sodium chloride-free sea water; and
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(ii) a silver ions solution.
[0071] Another embodiment of the present invention relates to the oral care
composition defined hereinabove, wherein with respect to the total weight of
the oral care
composition, said cornposition cornprises:
up to 30.00 wt.-% of the sodium chloride-free sea water; and
up to 70.00 wt.-% of the silver ions solution, said silver ions solution
containing in an aqueous medium from 5 ppm to 20 ppm of silver ions.
[0072] Another embodiment of the present invention relates to the oral care
composition defined hereinabove, wherein with respect to the total weight of
the oral care
cornposition, said cornposition cornprises:
up to 32.00 wt.-% of the sodium chloride-free sea water; and
up to 68.00 wt.-% of the silver ions solution, said silver ions solution
containing in an aqueous medium from 5 ppm to 20 ppm of silver ions,
preferably from 10ppm to 15ppm of silver ions.
[0073] Another embodiment of the present invention relates to the oral care
composition defined hereinabove, wherein with respect to the total weight of
the oral care
cornposition, said cornposition comprises:
up to 32.00 wt.-% of the sodium chloride-free sea water; and
up to 68.00 wt.-% of the silver ions solution, said silver ions solution
containing in an aqueous medium from 5 ppm to 20 ppm of silver ions,
preferably from 10ppm to 15ppm of silver ions.
[0074] Another embodiment of the present invention relates to the oral
care
composition defined hereinabove, wherein the aqueous medium of the silver ions
solution
is free of chloride ions. Preferably, the aqueous medium is distilled water,
deionized
water, demineralized water or a mixture thereof, more preferably deionized
water. Much
more preferably, the amount of chloride ions is lesser than 5 ppm, or lesser
than 3 ppm.
[0075] Another embodiment of the present invention relates to the oral care
composition defined hereinabove, further comprising a pharmaceutically
acceptable
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carrier or excipient, said pharmaceutically acceptable carrier or excipient
being free of
chloride ions.
[0076] Another embodiment of the present invention relates to the oral care
composition defined hereinabove, wherein the pharmaceutically acceptable
carrier or
excipient may represent up to 75 wt.- /0 of the total weight of the oral care
composition.
[0077] Another embodiment of the present invention relates to an oral care
composition consisting of:
(I) sodium chloride-free sea water; and
(ii) a silver ions solution.
[0078] Another embodiment of the present invention relates to the oral care
composition defined hereinabove, consisting of:
(i) up to 30.00 wt.-% of the sodium chloride-free sea water;
(ii) up to 70.00 wt.-% of the silver ions solution; and
(iii) from 0 to 75.00 wt.% of the pharmaceutically acceptable carrier or
excipient.
[0079] Another embodiment of the present invention relates to the oral care
composition defined hereinabove, wherein the sodium chloride-free sea water is
obtained
from a synthetic sea water according to ASTM D1141-98, 2013.
[0080] Another embodiment of the present invention relates to the oral
composition
defined hereinabove, wherein the sodium chloride-free sea water is an ultra
pure sodium
chloride-free sea water obtained by inverse osmosis procedure.
[0081] Another embodiment of the present invention relates to the oral care
composition defined hereinabove, wherein said ultra pure sodium chloride-free
sea water
is obtained by mechanical withdrawal of the sodium chloride from sea water. In
this
regard, any processes and/or devices well known to persons skilled in the art
can be used
for the mechanical withdrawal of sodium chloride from sea water.
CA 3050693 2019-07-29
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[0082] Another embodiment of the present invention relates to the oral care
composition defined hereinabove, wherein the ultra pure sodium chloride-free
sea water
contains less than 5 ppm of sodium chloride.
[0083] Another embodiment of the present invention relates to the oral care
composition defined hereinabove, wherein the silver ions solution is an
aqueous solution
of at least one generator of silver ions comprising water, preferably
distilled water,
deionized water or demineralized water, more preferably deionized water.
[0084] Another embodiment of the present invention relates to the oral care
composition defined hereinabove, further comprising at least one additional
ingredient
selected from the group consisting of surfactants, solvent, vitamins,
minerals, polymers,
enzymes, humectants, thickeners, additional antimicrobial agents, additional
preservatives, flavorings, colorings and mixtures thereof. Preferably, said at
least one
additional ingredient is free of chloride ions.
[0085] Another embodiment of the present invention relates to the oral care
composition further comprising at least one additional ingredient selected
from the group
consisting of flavorings agents, colorings agents and mixtures thereof.
[0086] Another embodiment of the present invention relates to the oral care
composition defined hereinabove, wherein the pharmaceutically acceptable
carrier or
excipient comprises distilled water, deionized water, demineralized water or
mixtures
thereof, preferably is deionized water.
[0087] Another embodiment of the present invention relates to the oral care
composition defined hereinabove, wherein the pharmaceutically acceptable
carrier or
excipient represents from 68 wt.-% to 75 wt.-% of the total weight of the oral
care
composition.
[0088] Another embodiment of the present invention relates to the oral care
composition defined hereinabove, wherein 30.00 wt.-% of the sodium chloride-
free sea
water and 70 wt.-% of the silver ions solution represents about 100 wt.-% of
the total
weight of the oral care composition.
CA 3050693 2019-07-29
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[0089] Another embodiment of the present invention relates to the oral care
composition defined hereinabove, wherein the silver ions solution represents
from 110
wt.-% to 125 wt.-% of the total weight of the sodium chloride-free sea water.
[0090] Another embodiment of the present invention relates to the oral care
composition defined hereinabove, further comprising at least one additive
selected from
the group consisting of flavoring agents and coloring agents. Preferably, said
at least one
additive is free of chloride ions.
[0091] Another embodiment of the present invention relates to the oral care
composition defined hereinabove, wherein the flavoring agent is selected from
the group
consisting of menthol, zinc citrate, zinc chloride, tutti-frutti, methyl
salicylate, Eucalyptus
oil, spearmint oil and peppermint oil.
[0092] Another embodiment of the present invention relates to the oral care
composition defined hereinabove, wherein the flavoring agent is menthol, and
wherein
said menthol represents from 0.017 wt.-% to 0.021 wt.-% of the total weight of
the oral
care composition.
[0093] Another embodiment of the present invention relates to the oral care
composition defined hereinabove, wherein the coloring agent is Fast Green (USP-
C.I.
42053).
[0094] Another embodiment of the present invention relates to the oral care
composition defined hereinabove, wherein the Fat Green represents from 0.001
wt.-% to
0.005 wt.-% of the total weight of the oral care composition.
[0095] Another embodiment of the present invention relates to the oral care
composition defined hereinabove, further comprising at least one microbicidal
ingredients
selected from the group consisting of, delmopinol, triclosan, Sanguinaria
Canadensis,
propolis, Aloe vera, sage (salvia officinaffis), lemon (Citrus limon), pine
(Pinus sylvetris),
echinacea (Echinacea purpurea and agustifolia), rathany (Krameria trianda) and
cheeseweed mallow (Melva parviflora L.).
CA 3050693 2019-07-29
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[0096] Another embodiment of the present invention relates to the oral care
composition defined hereinabove, further comprising a source of fluoride ions,
and
wherein the silver ion precursor is silver diamine fluoride (SDF).
[0097] According to another embodiment of the invention, the oral care
composition
may include mouthwashes, mouthrinses, dentifrices, dental gels, lozenges,
beads, gums,
oral stripes, mints, liquid toothpaste, sprays, paint-on gels, lip-balms,
whitening strips,
breathe strips, oral chews, and combinations thereof.
[0098] According to another embodiment of the invention, the oral care
composition
can be used for example for plaque prevention and control of bad odour
formation,
prevention and control of gingivitis, periodontitis and dental caries.
[0099] Another embodiment of the present invention relates to the oral care
composition which is a mouthwash composition comprising with respect to the
total
weight of the oral care composition:
Ingredients Concentration* (wt.-%)
Sodium chloride-free sea water 30.0
Solution of silver ions in deionized water (15 ppm 69.98
Ag+)
Flavoring agent (Mint -CAS NO. 2216-51-5) 0.019
Coloring agent (Fast Green C.I. 42053) 0.001
[0100] Another embodiment of the present invention relates to a use of the
oral care
composition defined hereinabove, for cleaning of teeth, treating or reducing
dental
enamel erosion, reducing bacterially-generated biofilm and plaque, gingivitis,
inhibiting
tooth decay and formation of cavities, and/or reducing dentinal
hypersensitivity.
[0101] Another embodiment of the present invention relates to a method for
cleaning
of the teeth, treating or reducing dental enamel erosion, reducing bacterially-
generated
biofilm and plaque, gingivitis, inhibiting tooth decay and formation of
cavities, and/or
CA 3050693 2019-07-29
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reducing dentinal hypersensitivity, said method comprising a step of
contacting the oral
care composition defined hereinabove, with teeth.
[0102] Another embodiment of the present invention relates to a use of the
oral care
composition defined hereinabove, as a vehicle for the addition of bactericide
antibiotics
and for the treatment of inflamed tissue.
Sea water
[0103] On average, according to another embodiment of the invention, sea water
has
a salinity of about 3.5% (35 g/L, or 599 mM), which is a specific gravity of
about 1.025.
This means that every kilogram (roughly one liter by volume) of sea water has
approximately 35 grams (1.2 oz) of dissolved salts (predominantly sodium (Na+
) and
chloride (Cl-) ions). Average density at the surface is 1.025 g/ml. Sea water
is denser
than both fresh water and pure water (density 1.0 g/ml at 4 C) because the
dissolved
salts increase the mass by a larger proportion than the volume. Sea water pH
is limited
to a range between 7.5 and 8.4. Total molar composition of unaltered sea water
(i.e.
before removal of chloride ions), has the following values:
(Salinity = 35 g/1)
H20 53.6
Cl- 0.546
Na + 0.469
Mg2+ 0.0528
S02- 0.0282
Ca2+ 0.0103
K+ 0.0102
Ct* 0.00206
Br- 0.000844 _
Bt** 0.000416
Sr + 0.000091
F- 0.000068
*ct = Carbon total
**Bt =Boron total
[0104] Unaltered sea water is known to possess bactericidal activity against a
variety
of terrestrial organisms.
CA 3050693 2019-07-29
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[0105] The sea water flora is mostly composed of Gram-negative bacteria
suggesting
that it disfavors growth of Gram-positive organisms. However, the Gram-
positive bacteria
are typically pathogens responsible for one-third of all bacterial infections
in humans and
are capable of causing serious and sometime fatal infections in newborn
infants. Many
oral flora pathogens belong to the Gram-positive group of microorganisms such
as
Staphylococcus and Streptococcus genera, Actinomyces viscosus, A. naestundi,
and
others.
[0106] Within recent years emphasis has been placed upon the mechanism of the
observed bactericidal activity of unaltered sea water. Without being bound to
the theory,
the mechanism appears to be selected from the group consisting of:
a) physico-chemical, and
b) biological.
Sodium chloride-free sea water
[0107] According to the present invention, a sodium chloride-free sea water is
a sea
water where the concentration of sodium chloride is lesser than 5 ppm,
preferably lesser
than 3 ppm, and more preferably lesser than 2 ppm.
[0108] Preferably, the sodium chloride-free sea water may be obtained from a
synthetic sea water according to ASTM D1141-98, 2013, or an ultra pure sodium
chloride-
free sea water obtained by inverse osmosis procedure or by any mechanical any
processes and/or devices well known to persons skilled in the art for the
mechanical
withdrawal of sodium chloride from sea water.
Ionic silver solution
[0109] Prior to 1938, colloidal silver was used by physicians as a
mainstream antibiotic
treatment and was considered quite "high-tech." The March 1978 issue of
Science Digest,
in an article, "Our Mightiest Germ Fighter by Jim Powell, pp.1-3, reported:
"Thanks to eye-
opening research, silver is emerging as a wonder of modern medicine. It is
well known
that an antibiotic kills perhaps a half-dozen different disease organisms, but
silver kills
some 650.
CA 3050693 2019-07-29
22
[0110] . Current FDA approved silver-based products include:
- Silver topical ointments for burns,
- Slow replaces silver wound dressing,
- Colloidal silver water purification,
- Silver fabric surgical gowns and drape, and
- Silver sutures.
[0111] Colloidal silver is also currently used by NASA and the World Health
Organization as drinking water disinfectant
(http:/rationalwiki.org/wiki/colloidal-silver).
[0112] The production of silver-based products has evolved over last decades
resulting in modern technologies that allow the manufacturing of ionic silver,
which is
recognized as more efficient in microbial destruction, as compared to
colloidal silver.
[0113] According to another embodiment of the invention, the silver ions
solution is a
suspension of microscopic particles of silver usually in water that has
gained, in recent
years, the reputation of powerful broad-spectrum contact antibiotic, and
preventive
against various infections. Many brands of silver-based products are available
on the
market. The highest grade is produced by the electro-colloidal / non-chemical
method
where the silver ions have been dispersed in water within and bound by an
electric
current. Advantageously, the super-fine silver ions may be suspended for a
very long
period of time in deionized water at concentration of 5 ppm to 20 ppm,
preferably 5 ppm
to 15 ppm, 10 ppm to 15 ppm or 10 ppm to 20 ppm.
[0114] Silver ions are pure metallic ions with a positive electric charge.
Silver ions and
most silver compounds have an oligodynamic effect and are toxic for bacteria,
algae and
fungi in vitro. It is considered that silver ions interfere with the bacteria
in at least three
ways:
- The most frequent description of the mechanism of microbial
destruction is the
damage of microbial membrane by silver ions (Ag+) which are considered to
irreversibly damage cell membrane, as well as key enzyme respiratory systems;
CA 3050693 2019-07-29
23
Binding to the amino acids and nucleic acids of cells, and blocking the
metabolism
of the bacteria;
There is a general consideration that the presence of silver ions near a
bacterium,
fungus or any other single-celled pathogen, disables its oxygen metabolism
enzyme, its chemical lung, so to say. Rapidly, the pathogen suffocates and
dies,
and is cleared out of the body by the immune, lymphatic and elimination
systems.
[0115] Silver, used as a topical antiseptic, is incorporated by bacteria
and it kills them.
Thus, dead bacteria may be the source of silver ions which may continue to
perpetuate
the killing of other microbes.
[0116] Unlike pharmaceutical antibiotics, which destroy beneficial
enzymes, colloidal
silver ions leave these tissue-cell enzymes intact, as they are radically
different from the
enzymes of primitive single-celled life. Thus, silver ions are considered
absolutely safe
for humans, reptiles, plants and all multi-celled living organisms.
[0117] It is known that "super-germs" are resistant to most modern
antibiotics.
Contrarily, it is believed that single-celled germs cannot mutate into silver-
resistant forms,
as happens with conventional antibiotics. Therefore, it is considered that no
tolerance to
silver ions would develop through mutation. Inside the body, silver ions
apparently do not
form toxic compounds or react with anything other than germs.
[0118] One possible precursor of silver ion is silver diamine fluoride
(SDF). The SDF
is postulated to prevent or arrest carries by three mechanisms:
The first of these is through the action of silver ions, damaging microbial
cell
membrane,
The second mechanism is based on the reaction of silver ions with bacterial
amino acids and nucleic acids, which prevent bacterial metabolism and kills
them,
The third mechanism is based on silver ion with enamel structure
precipitations
resulting in formation of a protective layer of insoluble acid resistant
silver apatite
on the surface of dentine.
CA 3050693 2019-07-29
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[0119] Recent studies show that SDF is more effective than fluoride varnish in
prevention and arrest of dental caries (Rosenblatt et al., "Silver Diamine
Fluoride: A
Caries 'Silver-Fluoride Bullet-, J. Dent. Res., 88(2), pp.116-125).
Pharmaceutically acceptable carrier or excipient
[0120] According to another embodiment of the invention, the pharmaceutically
acceptable carrier or excipient may be a liquid, semi-solid or solid. A
liquid, as used herein
can be a fluid or as in other embodiments, a high viscosity liquid such that
flow is
imperceptible under ambient conditions. A liquid can be a thixotropic liquid.
A semi-solid
can be a gel, a colloid, or a gum. In other embodiments, the carrier or
excipient may be
substantially non-aqueous.
[0121] As a non-limiting example, in the case the oral care composition is a
mouthwash, the pharmaceutically acceptable carrier or excipient may be water.
[0122] According to another embodiment of the invention, the specific
composition of
the pharmaceutically acceptable carrier or excipient preferably depends on the
intended
use of the composition. Non-limiting examples of pharmaceutically acceptable
carrier or
excipient may include ultra pure distilled or deionized water.
[0123] According to another embodiment of the invention, the oral care
composition
may further comprise additives. Non-limiting examples of such additives may
comprise
at least one of negative fluor ions, preservative agents, flavoring agents,
sweeteners,
anticalculus agents, pH adjusters, thickening agents, surfactants, colorants,
chelating
agents and eventually any other additives well known in the art of oral care
composition.
[0124] According to another embodiment of the invention, the pharmaceutically
acceptable carrier or excipient in the present invention may also comprise
thickeners,
gelling agents or combination thereof. Thickeners or gelling agents useful
herein may
include inorganic, natural or synthetic thickeners or gelling agents. Examples
of
thickeners and gelling agents include inorganic thickening silicas such as: an
amorphous
silica, for example Zeodent 165; Irish moss, iota-carrageenan, gum tragacanth
or
polyvinyl pyrrolidone. In certain embodiments, the pharmaceutically acceptable
carrier or
CA 3050693 2019-07-29
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'excipient may comprise a polishing agent, such as silica, a calcined alumina,
sodium
bicarbonate, calcium carbonate, dicalcium phosphate or calcium pyrophosphate.
Negative fluor ion (Fluoride)
[0125]
Fluoride (F¨) is negative ion of the element fluorine. Fluoride interacts with
hydroxyapatite in order to form a stronger compound that is less susceptible
to acid attack
on teeth. Precursors of fluoride ions, or fluoride-providing components are
known as anti
caries agents.
[0126] According to another embodiment of the invention, the oral care
composition
may further include one or more fluoride precursors. In addition to sea water,
a wide
variety of ion-yielding material can be employed as soluble fluoride
precursors in the
present oral care compositions. Preferably, representative ion fluoride
precursors include,
but are not limited to, stannous fluoride, sodium fluoride, potassium
fluoride, sodium
monofluorophosphate, sodium fluorosilicate, ammonium fluorosilicae, amine
fluoride,
ammonium fluoride, and combination thereof.
[0127] Where the oral care composition contains calcium salts, the fluoride
salts are
preferably salts wherein the fluoride is covalently bound to another atom,
e.g., as in
sodium monofluorophosphate, rather than merely ionically bound, e.g., sodium
fluoride.
The preservative agents
[0128] According to another embodiment of the invention, the preservative
agents are
usually comprised by substances added to oral hygiene and personal hygiene
products,
cosmetics and perfumes, having as primary purpose to preserve them from damage
and/or deterioration caused by microorganisms during manufacture and storage,
as well
as to protect consumers from inadvertent contamination during use of the
product.
Flavoring agents
[0129] According to another embodiment, the flavoring agents are those known
in the
art, such as natural and artificial flavoring agents. They provide the oral
care composition
with a pleasant flavor and consequently to the breath of the mouthwash user.
Good
flavoring agents not only enhances product acceptability, but also attracts
consumers to
buy it again. Also, flavoring agents provide a sensation of taste on the
tongue and also a
CA 3050693 2019-07-29
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key signal which, when perceived by the brain, becomes closely linked to
product
characteristics and performance to influence the perceptions of the consumer.
[0130] According to another embodiment of the invention, the flavoring agents
may be
chosen from synthetic flavors oils or flavoring aromatics, and/or oils, oleo
resins and
extracts derived from plants, leaves, flowers, fruits and so forth, and
combination thereof.
Preferably, commonly used flavoring agents include, but are not limited to,
mints such as
peppermint, artificial vanilla, cinnamon derivatives and various fruit
flavors, whether
employed individually or in admixture. More preferably, flavoring agent in the
oral care
composition according to the present invention is, but not limited to, mint at
a
concentration of 0.01 % to 0.05 "Yo by weight of the total weight.
Sweeteners
[0131] According to another embodiment of the invention, sweeteners may
include
water-soluble sweetening agents i.e. monosaccharides, disaccharides and
polysaccharides, such as xylose, ribose, glucose (dextrose), mannose,
galatose, fructose
(levulose), sucrose or maltose.
Anticalculus agents
[0132] According to another embodiment of the invention, anticalculus agent
(tartar
control) agent) may include, without limitation, phosphates and
polyphosphates. As non-
limiting examples, phosphate may encompass orally acceptable mono and
polyphosphates, for example P16 phosphates, monomeric phosphates such as
monobasic, dibasic or tribasic phosphate, dimeric phosphates such as
pyrophosphates,
and multimeric phosphates, e.g. sodium hexametaphosphate.
[0133] In
particular other non-limiting examples, phosphate may be selected from the
group consisting of alkali dibasic phosphate and alkali pyrophosphate salts
selected from
the group consisting of dibasic sodium phosphate, dibasic potassium phosphate,
dicalcium phosphate dehydrate, calcium pyrophosphate, tetrasodium
pyrophosphate,
sodium tripolyphosphate and mixture of any of the two or more of these.
CA 3050693 2019-07-29
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[0134] In other embodiments, the anticalculus agents may also include
polyaminopropanesulfonic acid, hexamethaphosphate salts, zinc citrate
trihydrate,
polypeptides, polyolefin sulfonatem polyolefin phosphates, diphosuphionates.
[0135] According to another embodiment of the invention, the anticalculus
agent may
also comprise phosphate salts. In particular embodiments, these salts may be
alkali
phosphate salts, i.e., salts of alkali metal hydroxides or alkali earth
hydroxides, for
example, sodium, potassium or calcium salts which are abundant in sea water.
pH/pH adjuster/buffer
[0136] According to another embodiment of the invention, the oral care
composition
may have a pH generally in the range of from 7 to 8. Preferably, the pH is
about 7.5 and
may be characterized as being isotonic.
[0137] According to another embodiment of the invention, the pH can be
controlled
with a pH adjuster. Non-limiting examples of possible pH adjuster may be an
acid or a
base. Preferably, a pH adjuster may be an acid such as citric acid or benzoic
acid, or a
base such as sodium hydroxide or a buffer such as sodium citrate, benzoate,
carbonate
or bicarbonate, disodium hydrogen phosphate, sodium dihydrogen phosphate, etc.
Thickening agent
[0138] According to another embodiment of the invention, the oral care
composition
may comprise at least one thickening agent. According to another embodiment of
the
invention, thickening agents may be any thickening agent well known in the art
of oral
care compositions. As a non-limiting example, when the oral care composition
is a
dentifrice, the at least one thickening agent provides required rheological
properties, so
that the dentifrice can be stored in dispensing container over a period of
time and
thereafter reliably dispensed there from by the user. It should have the
adequate viscosity
not only to be dispensed but also to exhibit an acceptable consistency within
the mouth
during tooth brushing.
[0139] According to another embodiment of the invention, when the oral care
composition is selected from the group consisting of toothpaste, creams and
gels typically
CA 3050693 2019-07-29
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contain a natural or synthetic thickener or gelling agent in proportion of 0.1
wt.-% to 10
wt.-% with respect to the total weight of the oral care composition.
[0140] According to another embodiment of the invention, the thickening agents
may
include modified cellulose, such as carboxymethyl cellulose (CMC), and other
polysaccharide or gum components.
[0141] According to another embodiment of the invention, a polysaccharide
thickening
agent may consist consists of at least one xanthan gum which is present in an
amount of
from 0.1 to 1.5 wt.-% based on the total weight of the composition.
Optionally, minor
amounts of additional thickeners may also be present, for example carrageenan
gum,
tragacanth, starch, polyvinylpirollidone, hydroxyethypropyl cellulose,
hydroxybutyl, ethyl
cellulose, hydroxypropyl methylcellulose, hydroxyethyl cellulose, sodium CMC
and
colloidal silica.
Surfactants
[0142] According to another embodiment of the invention, the oral care
composition
may contain any type of surfactant well known in the art of oral care
composition,
preferably anionic surfactants, such as for example:
- Higher alkyl sulfates, such as sodium lauryl sulfate,
_ Higher alkyl ether sulfates, e.g., of formula CH3(CH2)mCH2
(OCH2CH2)30S03X,
wherein m is 6-16, e.g., 10, n is 1-6, e.g., 2,3 or 4, and X is Na or K, for
example
sodium laureth-2 sulfate (CH3(CH2)10CH2(OCH2CH2)20S03Na),
- Higher alkyl aryl sulfonate such as sodium benzene sulfonate (sodium
lauryl
benzene sulfonate),
- Higher alkyl sulfoacetates, such as sodium laudryl sulfoacetate
(dodecyl sodium
sulfoacetate), higher fatty acids esters of 1,2-dihydroxy propane sulfonate,
sulfocolaurate (N-2-ethyl laurate potassium sulfoacetamide) and sodium lauryl
sarcosinate,
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Water-soluble salt of higher fatty acid monosulfates, such as the sodium salt
of
the monosulfated monoglyceride of hydrogenated coconut oil fatty acids, such
as
sodium N-methyl N-cocoyl taurate, sodium cocomonoglyceride sulfate.
Colorant
[0143] According to another embodiment of the invention, the oral care
composition
may comprise at least one colorant.
[0144] The at least one colorant may be any colorant known in the art of food
and oral
hygiene products. The group of ingredients with colorant action includes, but
is not limited
to all colorant, for food or oral hygiene products, available on the market.
Preferably
different ingredients with colorant action may be used to provide product with
a gamma
of color options. More preferably, the group of ingredients with colorant
action is present
in an amount from about 0.0001 wt.- /0 to about 1wt.- /0 of the total weight
of the oral care
composition, much more preferably about 0.0001 wt.-%.
[0145] According to another embodiment of the invention, the at least one
colorant
may be Fast Green at concentration of 0.001 % to 0.005 `)/0 by weight of the
total weight
of the oral care composition.
Chelating
[0046] According to another embodiment of the invention, the oral care
composition
may also include one or more chelating agents able to complex calcium found in
the cell
walls of the bacteria, binding of this calcium weakens the bacterial cell wall
and facilitates
bacterial lysis.
Water
[0147] According to another embodiment of the invention, water may be
preferably
deionized and free of organic impurities. More preferably, water commonly
makes up the
balance of the oral care composition and includes, e.g., 40 wt.-% to 75 wt.-%
by weight
of the total weight of the oral care composition. Much more preferably, amount
of water
may include the free water which is added plus that amount which is introduced
with other
materials such sea water, ionic silver solution, water, or any components of
the oral care
composition according to the invention.
CA 3050693 2019-07-29
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Other optional ingredients
[0148] According to another embodiment of the invention, oral care composition
may
contain a variety of known ingredients including, but not limited to,
whitening agents,
preservative silicones, chlorophyll compounds and/or ammoniated materials,
such as
urea, diammonium phosphate adhesives, sudsing agents, flooring agents,
additional
antiplaque agents and abrasive agents. Those ingredients, when present, are
incorporated in the proportion which do not substantially adversely affect the
properties
and characteristics desired. Also, other optional components are further
described in U.S.
Pat. No. 5,004,597, to Majeti; U.S. Pat. No. 3,959,458, to Agricola et at. and
U.S. Pat.
No. 3,937,807, to Haefele.
[0149] The embodiments described herein will be further understood by
reference to
the following non-limiting examples:
Examples of preferred compositions
[0150] As mentioned above, the oral care composition of the present invention
may be
applied to a variety of oral care products. Here are some examples of
preferred
formulations showing concentration of ingredients:
1. Mouthwash
Ingredients Concentration wt.-%
Sodium-chloride free sea water 30.0
Silver ions solution (15ppm Ag+ in 69.98
deionized water)
Mint (CAS N 2216-51-5) 0.019
Colorant (Fast Green C.I. 42053) 0.001
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2. Oral care composition for disinfection of toothbrushes and dentures
Ingredients Concentration wt.-%
Sodium-chloride free sea water 28.0
Silver ions solution (15ppm Ag+ in 71.98
deionized water)
Mint (CAS N 2216-51-5) 0.019
Colorant (Fast Green C.I. 42053) 0.001
[0151] Table 1. EVALUATION OF EFFICACY OF THE MOUTHWASH ON PLAQUE
- INVOLVED BACTERIA
[0152] A. Experimental treatment with the content of mouthwash
Microbs Initial suspension Contact time, in minutes: (% of reduction)
*TCM/ml 0.5 1 2
S. mills 1.3x 105 52.1 92.5 99.9
S. oralis 1.3x 105 60.8 91.0 99.9
S. mitor 1.3x 105 63.5 94.3 99.9
S. sanguis 1.3x 105 59.9 93.7 99.9
*TMC= total microbial count
[0153] B. Control treatment with PBS*
Microbs Initial suspension Contact time, in minutes: (% of reduction)
**TCM/ml 0.5 1 2
S. mitts 1.3 x 105 0.8 0.9 0.9
S. oralis 1.3x 105 0.6 0.6 0.7
S. mitor 1.3x 105 0.9 1.1 1.0
S. sanguis 1.3x 105 0.4 0.5 0.6
*PBS = Phosphate buffered solution
**TMC= Total microbial count
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[0154] Table 2. EVALUATION OF EFFICACY OF THE MOUTHWASH ON
BACTERIA INVOLVED IN THE ETIOLOGY OF HALITOSIS
[0155] A. Experimental treatment with the content of mouthwash
Microbs Initial suspension Contact time, in minutes: (% of
*TCM/ml reduction)
0.5 1 2
Porphyromonas gin givalis 1.3 x 105 59.6 91.1 99.9
Prevotella intermedia 1.3x 105 66.1 94.6 99.9
Fusobacterium nucleatum 1.3 x 105 54.7 92.8 99.9
Treponema dent/cola 1.3 x 105 57.0 93.9 99.9
*TMC= total microbial count
[0156] B. Control treatment with PBS*
Microbs Initial suspension Contact time, in minutes: (% of
**TCM/ml reduction)
0.5 1 2
P. gingivalis 1.3 x 105 0.2 0.3 0.5
P. intermedia 1.3 x 105 0.2 0.3 0.4
F. nucleatum 1.3 x 105 0.1 0.2 0.5
T. dent/cola 1.3 x 105 0.3 0.3 0.5
*PBS = Phosphate buffered solution
**TMC= Total microbial count
[0157] Table 3. EVALUATION OF EFFICACY OF THE MOUTHWASH ON
BACTERIA INVOLVED IN THE ETIOLOGY OF GINGIVITIS
[0158] A. Experimental treatment with the content of mouthwash
Microbs Initial suspension Contact time, in minutes: (% of
reduction)
*TCM/ml 0.5 1 2
Actinomyces viscosus 1.3 x 105 49.5 89.0 99.9
A. gingival 1.3x 105 51.6 91.6 99.9
P. rectus 1.3x 105 52.8 90.3 99.9
*TMC= total microbial count
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[0159] B. Control treatment with PBS**
Microbs Initial suspension Contact time, in minutes: (% of
*TC Mimi reduction)
0.5 1 2
Actinomyces viscosus 1.3 x 105 0.1 0.2 0.3
A. gingival 1.3x 105 0.1 0.3 0.3
P. rectus 1.3x 105 0.2 0.2 0.3
*TMC= total microbial count
**PBS = Phosphate buffered solution
[0160] Table 4. EVALUATION OF EFFICACY OF THE MOUTHWASH ON
BACTERIA INVOLVED IN THE ETIOLOGY OF PERIODONTITIS
[0161] A. Experimental treatment with the content of mouthwash
Microbs Initial suspension Contact time, in minutes:
*TC Mimi (% of reduction)
0.5 1 2
Aggregatibacter 1.3 x 105 56.3 92.9 99.9
actinomicetemcomitans
Porfiromonas gin givalis 1.3 x 105 58.7 94.1 99.9
Compilobacter rectus 1.3 x 105 58.5 93.8 99.9
*TMC= total microbial count
[0162] B. Control treatment with PBS*
Microbs Initial suspension Contact
time, in minutes:
**TCM/ml (% of reduction)
0.5 1 2
Aggregatibacter 1.3 x 105 0.1 0.2 0.3
actinomicetemcomitans
Porfiromonas gingivalis 1.3 x 105 0.1 0.2 0.2
Compilobacter rectus 1.3x 105 0.2 0.2 0.2
* PBS = Phosphate buffered solution
**TMC= Total microbial count
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[0163] Table 5. EVALUATION OF EFFICACY OF THE MOUTHWASH ON
BACTERIA INVOLVED IN THE ETIOLOGY OF DENTAL CARIES
[0164] A. Experimental treatment with the content of mouthwash
Microbs Initial suspension Contact time, in minutes: (% of
reduction)
*TCM/ml
0.5 1 2
Streptococcus mutans 1.3 x 105 61.6 94.0 99.9
Lactobacilus 1.3x 105 65.3 96.2 99.9
*TMC= total microbial count
[0165] B. Control treatment with PBS*
Microbs Initial suspension Contact time, in minutes: (% of reduction)
**TCM/m I 0.5 1 2
S. mutans 1.3x 105 0.1 0.1 0.2
Lactobacilus 1.3 x 105 0.1 0.1 0.2
* PBS = Phosphate buffered solution
**TMC= Total microbial count
[0166] Table 6. EVALUATION OF EFFICACY OF THE MOUTHWASH ON
BACTERIAL SPECIES AND C. ALBICANS THAT ARE INVOLVED IN MIXED
ORAL INFECTIONS
[0167] A. Experimental treatment with the content of mouthwash
Microbs Initial suspension Contact time, in minutes: (% of
reduction)
*TC Mimi
0.5 1 2
Bacteroides gingivalis 1.3 x 105 59.6 91.8 99.9
Fusobacterium 1.3 x 105 54.1 93.4 99.9
Peptosteptococcus 1.3 x 105 60.2 95.0 99.9
C. albicans 1.3 x 105 58.3 90.3 99.9
*TMC= total microbial count
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[0168] B. Control treatment with PBS*
Microbs Initial suspension Contact time, in minutes: (% of
reduction)
**TCM/ml 0.5 1 2
B. gin givalis 1.3 x 105 0.2 0.2 0.3
Fusobacterium 1.3 x 105 0.1 0.2 0.4
Peptosteptococcus 1.3 x 105 0.1 0.2 0.3
C. albicans 1.3x 105 0.2 0.3 0.3
*PBS = Phosphate buffered solution
**TMC= Total microbial count
[0169] Table 7. EVALUATION OF EFFICACY OF THE SYNERGETIC EFFECT OF
THE ACTIVE INGREDIENTS OF MOUTHWASH ON ORAL DISEASES
INVOLVED IN BACTERIA
[0170] A. Experimental treatment with the Sodium chloride-free sea water
Microbs Initial suspension Contact time, in minutes: (% of
reduction)
*TC M/m I 0.5 1 2
A. viscosus 1.3 x 105 40.8 80.5 90.8
C. albicans 1.3x 105 51.0 82.1 93.1
B. gingivalis 1.3x 105 50.2 84.3 94.9
F. nucleatum 1.3 x 105 48.6 83.5 96.1
S. mutans 1.3x 105 47.3 80.9 91.3
*TMC= total microbial count
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[0171] B. Experimental treatment with ionic silver solution
Microbs Initial suspension Contact time, in minutes: (% of reduction)
*TCM/ml
0.5 1 2
A. viscosus 1.3 x 105 42.6 83.9 93.6
C. albicans 1.3x 105 53.0 84.7
95.0
B. gingivalis 1.3x 105 52.3 86.8 98.2
F. nucleatum 1.3 x 105 50.7 85.2 99.9
S. mutans 1.3x 105 49.5 81.9 94.7
*TMC= total microbial count
[0172] C. Experimental treatment with the whole content of mouthwash
Microbs Initial suspension Contact time, in minutes: (% of reduction)
*TC Mimi
, 0.5 1 2
A. viscosus 1.3 x 105 49.9 89.8 99.9
C. albicans 1.3x 105 58.3 ' 40.3 99.9
B. gingivalis 1.3x 105 . 59.6 . 91.8 99.9
F. nucleatum 1.3 x 105 - 54.1 93.4 99.9
S. mutans 1.3x 105 - 52.1 - 92.5 99.9
*TMC= total microbial count
[0173] D. Control treatment with PBS*
Microbs Initial suspension Contact time, in minutes: (% of
reduction)
**TC Mimi 0.5 1 2
A. viscosus 1.3x 105 0.2 0.2 0.2
C. albicans 1.3x 105 0.1 0.2 0.3
B. gingivalis 1.3x 105 0.1 0.2
0.3
F. nucleatum 1.3 x 105 0.2 0.3 0.3
S. mutans 1.3x 105 0.2 0.2 0.3
*PBS = Phosphate buffered solution
**TMC= Total microbial count
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[0174] Table 8. COMPARATIVE EVALUATION OF TURNIDITY OF ORALNETTm
MOUTHWASH AND THE MOUTHWASH BASED ON PRESENT
INVENTION
Mouthwash Turbidity in NTU* during time after
manufacturing
lh 1 day 2 days 5 days
OralNetTM 12 16 18 18
Present invention mouthwash 4 4 4 4
*NTU = Nephelometric turbidity unit
Microbicidal efficacy of the present invention
[0175] A new generation of mouthwash, called "OralNet", is commercially
available on
the market in the province of Quebec, Canada. According to the technical
specifications,
OralNet is based on ultrapure Arctic Ocean water supplemented with colloidal
silver. The
study reports the microbicidal efficacy against salivary flora of healthy
individuals, toxicity,
endogenous pH and physicochemical content of OralNet as evaluated in
comparison with
7 over-the-counter (OTC) mouthwashes (Pekovic et al., "Comparative Study Of
Antimicrobial Toxicity And Physicochemical Properties Of The New Generation
Mouthwash 'OralNetTM' With Common Mouthwashes", EC Microbiology, Vol. 2, Issue
3,
November 2015, pp. 317-327). The obtained results show that OralNet displayed
the
highest microbicidal activities in vitro exceeding 99.9 % after 30 seconds of
contact with
test organisms and the lowest toxicity in vitro (3.69 %), as compared to the
standard
mouthwashes studied. In addition, OralNet has well balance endogenous pH
(7.5), as
well as a simple chemical structure composed of two natural active
ingredients.
[0176] However, it was noticed that sodium-chloride from sea water reacted
with
colloidal silver solution, resulting in a substantial change of the color and
increased
turbidity level.
[0177] According to a preferred embodiment of the invention, the Applicant has
surprisingly discovered that by the use of sodium chloride-free water, silver
ion solution
and deionized water for preparing the oral care composition according to the
invention,
the change of color and increase of turbidity has been avoided. Also, the
microbicidal
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activity of each ingredient, as well as the synergetic microbial effect of
both active
ingredients, has been significantly increased, as illustrated in the above
Tables 1 ¨ 8.
Antimicrobial Preservation Effectiveness Test
[0178] The Antimicrobial Preservation Effectiveness test is used to determine
the
antimicrobial preservation effectiveness of the water-based product
compositions by
means of a double challenge test. Products compositions are developed to
withstand
microbial challenges introduced by normal consumer use. The test is run on
aged
samples (13 weeks, 40 C). The test used two pools of microorganisms:
bacteria/yeast
and mold. The product is challenged at 1% level at day 0 and at day 7.
Reduction of the
inoculum is monitored over a 28-day period. The following are the accepted
criteria for
the mouthwash formulas.
-
Bacteria and yeast must show a 99.9 % reduction (3 logs) of the inoculum as
determined by plate count at day 7 following each inoculation. No increase
after 7
days of the second inoculation and for the remainder of the test within normal
variation data;
-
Mold must show a 90 % reduction (1 log) of the inoculum as determined by the
plate count on day 14 following the second inoculation (day 21). No increase
from
day 14 to day 21 of the second inoculation of the test within normal variation
of the
data;
[0179] The content of the present invention is in compliance with the
requirement of
antimicrobial preservation effectiveness test.
[0180]
Equivalent changes, modifications and variations of specific embodiments,
materials, compositions and methods may be made within the scope of the
present
invention, with substantially similar results.
[0181] Many modifications and variations are possible and would be apparent to
a
person skilled in the light of art of present invention. It is therefore to be
understood that
the invention can be practiced otherwise than as specifically described herein
and still
will be within the spirit and scope of the appended claims.
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