Note: Descriptions are shown in the official language in which they were submitted.
CA 02211382 1997-07-24
METHOD FOR MAINTENANCE AND PRESERVATION OF
DENTAL HEALTH AND ORAL DENTAL HEALTH DIETARY
SUPPLEMENT FOR USE IN SAID METHOD
5FIELD OF THE INVENTION
An oral dietary supplement composition in unit dosage
form specifically designed for maintaining and preserving
dental health and a method for the maintenance and
preservation of dental health by the oral administration
10thereof to a living human being in need of such dietary
supplementation.
BACKGROUND OF THE INVENTION AND PRIOR ART
It is clear that, in the great milieu of vitamin and
mineral supplement compositions presently available on the
15market either over the counter or by prescription,
insufficient emphasis has been placed upon dietary
supplements which are specifically designed for the
attainment, maintenance, and preservation of dental health,
including not only the fortification of the teeth and oral
20cavity so as to provide enhanced resistance to the usual
diseases, avoidance of such ailments and actual recovery
from and elimination of such ailments once they have
commenced within the oral cavity. Although numerous
vitamin, mineral, and other nutritional substances have
25been identified which have a desirable effect in promoting
and maintaining total dental health, up until the present
time there has been no complete oral dietary supplement
which is fortified to fulfill all of the desirable
objectives of a total dental health-care package including
CA 02211382 1997-07-24
the establishment, maintenance, and preservation of dental
health, much less an oral dietary supplement fortified for
just such purpose and to provide the proper nutrition for
fending off common ailments before they cc ~nce as well as
eliminating or ameliorating them and their consequences
once they have com~?nced, even though it is estimated that
up to 98% of the U.S. population have some sort of dental
deficiency or disease. The composition and method of the
present invention are designed for just such multipurpose
nutrition, namely, the establishment, maintenance, and
preservation of dental health by means of a complete oral
dietary supplement designed for just such purpose as well
as for the prevention of numerous common dental diseases
and the elimination or amelioration thereof, as well as
their symptoms and consequences, even though they may have
advanced to a certain stage but yet within the boundaries
and possibilities of recovery through the medium of
nutritional therapy.
To the best of our knowledge, no combination of all of
the essential ingredients put together in the present oral
dietary supplement for dental health have ever been
employed together, much less in unit dosage form, for the
establishment, treatment, and preservation of complete
dental health, nor have any pharmaceutical composition or
nutritional supplement consisting of the same heretofore
been made available for such purpose.
OBJECTS OF THE INVENTION
It is an object of the present invention to provide a
method for the maintenance and preservation of dental
health consisting essentially of the step of orally admini-
stering to a living human being in need of such dietary
supplementation a dietary supplement composition in unit
dosage form consisting essentially of an effective amount
of a plurality of vitamins and minerals for strengthening
gingiva, for strengthening of the immune system and decrea-
CA 02211382 1997-07-24
sing sensitivity, pain, and soreness, and for the strength-
ening of teeth and bone. A further object of the invention
is the provision of an oral dietary supplement composition
for maintaining and preserving dental health, in unit
dosage form, for use in the said method. Additional
objects of the invention will become apparent hereinafter
and still other objects will be obvious to one skilled in
the art to which this invention pertains.
SUMMARY OF THE INVENTION
What we believe to be our invention, then, inter alia,
comprises the following, singly or in combination:
A method for the maintenance and preservation of
dental health consisting essentially of the step of orally
administering to a living human being in need of such
dietary supplementation a dietary supplement composition,
in unit dosage form, consisting essentially of an effective
amount of a plurality of vitamins and minerals for streng-
thening gingiva, an effective amount of a plurality of
vitamins and minerals for strengthening of the immune
system and decreasing sensitivity, pain, and soreness, and
an effective amount of a plurality of vitamins and minerals
for the strengthening of teeth and bone; such a
method wherein the vitamins and minerals include an
effective amount of each of Vitamin C, Vitamin A, and
calcium; such a
method wherein the vitamins and minerals for strength-
ening gingiva include:
Vitamin C, Bioflavanoids, Rutin, Hesperidin,
essential Amino Acids, Iron, and Folic Acid;
the vitamins and minerals for strengthening the immune
system and decreasing sensitivity, pain, and soreness
include:
Zinc, Vitamin E, Vitamin A, Vitamin B1, Vitamin
B2, Vitamin B3, Vitamin B6, Vitamin B12, Biotin,
and Selenium; and
CA 02211382 1997-07-24
the vitamins and minerals for strengthening tooth and
bone include:
Calcium, Vitamin D, Phosphorous, Magnesium,
Vitamin K, Manganese, Iodine, and Copper; such a
method wherein the essential amino acids include all
of the ten essential amino acids; such a
method wherein the formulation range of the vitamins
and minerals comprising the oral dietary supplement
composition includes the following ingredients in the
approximate amounts:
Ingredient Amount
Vitamin A 5,000 to 7,000 IU
Vitamin B1 1.4 to 6 mg.
Vitamin B2 1.7 to 6.8 mg.
Vitamin B3 18 to 45 mg.
Vitamin B6 2 to 6 mg.
Vitamin B12 3 to 18 mg
Folic Acid 400 to 600 mcg.
Biotin 30 to 60 mcg.
Vitamin C 60 to 480 mg.
Vitamin D 200 to 400 IU
Vitamin E 10 to 60 IU
Vitamin K 15 to 50 mcg.
Calcium 150 to 400 mg.
Bioflavanoids 50 to lO0 mg.
Hesperidin 15 to 35 mg.
Rutin 15 to 35 mg.
Phosphorous 20 to 45 mg.
Zinc 5 to 20 mg.
Iron 9 to 27 mg.
Selenium 50 to 150 mcg.
Magnesium 50 to 400 mg.
Manganese 2 to 4 mg.
Iodine (as alkali metal salt) 50 to 150 mcg.
Copper 1 to 3 mg.
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Amino Acids (selected from
the ten essential amino acids) 50 to 150 mg.
Pantothenic Acid 5 to 15 mg
Chromium 15 to 35 mcg
in an appropriate unit dosage form; such a
method wherein the oral dietary supplement composition
is in the form of a compressed tablet or caplet; such a
method wherein the oral dietary supplement composition
is in the form of a compressed tablet or caplet, having a
total weight of 1500-1800 mg.; such a
method wherein the oral dietary supplement composition
is in the form of a compressed tablet, having a total
weight of approximately 1670 mg. plus or minus ten percent;
such a
method wherein the vitamins and minerals comprising
the oral dietary supplement composition include the
following ingredients in the approximate amounts (RDA% in
parentheses; *no established USRDA):
Vitamin A 5000 I.U. All as Beta Carotene (100)
Vitamin Bl (Thiamine) 4.5 mg. (300)
Vitamin B2 (Riboflavin) 5.1 mg. (300)
Vitamin B3 (Niacinamide) 30 mg. (150)
Vitamin B6 3 mg. (150)
Vitamin B12 9 mcg. (150)
Folic acid 400 mcg. (100)
Biotin 30 mcg. (10)
Vitamin C 240 mg. (400)
Vitamin D 200 I.U. (50)
Vitamin E 45 I.U. (150)
Vitamin K 25 mcg. (*)
Calcium (Carbonate) 200 mg. (20)
Bioflavanoids 75 mg. (*)
Hesperidin 25 mg. (*)
Rutin 25 mg. (*)
Phosphorus 35 mg. (10)
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Zinc 15 mg. (100)
Iron 18 mg. (100)
Selenium 100 mcg. (*)
Magnesium 100 mg. (25)
Manganese 3 mg. (*)
Iodine (Potassium iodide) 100 mcg. (66.6)
Copper 1 mg. (50)
Amino Acids (Ovalbumin) 100 mg. (*)
Pantothenic Acid 10 mg. (100)
Chromium 25 mcg. (*)
in an appropriate unit dosage form; such a
method wherein the oral dietary supplement composition
is in the form of a compressed tablet or caplet; such a
method wherein the oral dietary supplement composition
is in the form of a compressed tablet or caplet having a
total weight of 1500-1800 mg; such a
method wherein the oral dietary supplement composition
is in the form of a compressed tablet having a total weight
of approximately 1670 mg. plus or minus ten percent.
Moreover, an oral dietary supplement composition for
maintaining and preserving dental health, in unit dosage
form, consisting essentially of an effective amount of a
plurality of vitamins and minerals for strengthening
gingiva, an effective amount of a plurality of vitamins and
minerals for strengthening the immune system and decreasing
sensitivity, pain, and soreness, and an effective amount of
a plurality of vitamins and minerals for strengthening
teeth and bones; such an
oral dietary supplement composition wherein the
vitamins and minerals include an effective amount of each
of Vitamin C, Vitamin A, and calcium; such an
oral dietary supplement composition wherein the
vitamins and minerals for strengthening gingiva include:
Vitamin C, Bioflavanoids, Rutin, Hesperidin,
essential Amino Acids, Iron, and Folic Acid;
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CA 02211382 1997-07-24
the vitamins and minerals for strengthening the immune
system and decreasing sensitivity, pain, and soreness
include:
Zinc, Vitamin E, Vitamin A, Vitamin B1, Vitamin
B2, Vitamin B3, Vitamin B6, Vitamin B12, Biotin,
and Selenium; and
the vitamins and minerals for strengthening tooth and
bone include:
Calcium, Vitamin D, Phosphorous, Magnesium,
Vitamin K, Manganese, Iodine, and Copper; such a
composition wherein the essential amino acids include
all of the ten essential amino acids; such a
composition wherein the formulation range of the
vitamins and minerals comprising the oral dietary supple-
ment composition includes the following ingredients in the
approximate amounts:
Inqredient Amount
Vitamin A 5,000 to 7,000 IU
Vitamin B1 1.4 to 6 mg.
Vitamin B2 1.7 to 6.8 mg.
Vitamin B3 18 to 45 mg.
Vitamin B6 2 to 6 mg.
Vitamin B12 3 to 18 mg
Folic Acid 400 to 600 mcg.
Biotin 30 to 60 mcg.
Vitamin C 60 to 480 mg.
Vitamin D 200 to 400 IU
Vitamin E 10 to 60 IU
Vitamin K 15 to 50 mcg.
Calcium 150 to 400 mg.
Bioflavanoids 50 to 100 mg.
Hesperidin 15 to 35 mg.
Rutin 15 to 35 mg.
Phosphorous 20 to 45 mg.
Zinc 5 to 20 mg.
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Iron 9 to 27 mg.
Selenium 50 to 150 mcg.
Magnesium 50 to 400 mg.
Manganese 2 to 4 mg.
Iodine (as alkali metal salt) 50 to 150 mcg.
Copper 1 to 3 mg.
Amino Acids (selected from
the ten essential amino acids) 50 to 150 mg.
Pantothenic Acid 5 to 15 mg
Chromium 15 to 35 mcg
in an appropriate unit dosage form; such a
composition wherein the oral dietary supplement
composition is in the form of a compressed tablet or
caplet; such a
composition wherein the oral dietary supplement
composition is in the form of a compressed tablet or caplet
having a total weight of 1500-1800 mg.; such a
composition wherein the oral dietary supplement
composition is in the form of a compressed tablet having a
total weight of approximately 1670 mg. plus or minus ten
percent; such a
composition wherein the vitamins and minerals
comprising the oral dietary supplement composition include
the following ingredients in the approximate amounts:
Vitamin A 5000 I.U. All as Beta Carotene
Vitamin B1 (Thiamine) 4.5 mg.
Vitamin B2 (Riboflavin) 5.1 mg.
Vitamin B3 (Niacinamide) 30 mg.
Vitamin B6 3 mg.
Vitamin B12 9 mcg.
Folic acid 400 mcg.
Biotin 30 mcg.
Vitamin C 240 mg.
Vitamin D 200 I.U.
CA 02211382 1997-07-24
Vitamin E 45 I.U.
Vitamin K 25 mcg.
Calcium (Carbonate) 200 mg.
Bioflavanoids 75 mg.
Hesperidin 25 mg.
Rutin 25 mg.
Phosphorus 35 mg.
Zinc 15 mg.
Iron 18 mg.
Selenium 100 mcg.
Magnesium 100 mg.
Manganese 3 mg.
Iodine (Potassium iodide) 100 mcg.
Copper 1 mg.
Amino Acids (Ovalbumin) 100 mg.
Pantothenic Acid 10 mg.
Chromium 25 mcg.
in an appropriate unit dosage form; such a
composition wherein the oral dietary supplement
composition is in the form of a compressed tablet or
caplet; such a
composition wherein the oral dietary supplement
composition is in the form of a compressed tablet or caplet
having a total weight of 1500-1800 mg; and such a
composition wherein the oral dietary supplement
composition is in the form of a compressed tablet having a
total weight of approximately 1670 mg. plus or minus ten
percent.
GENERAL DESCRIPTION OF THE INVENTION
The oral dietary supplement composition of the inven-
tion and the method for the maintenance and preservation of
dental health utilizing the same involve, as previously
stated, an effective amount of a plurality of vitamins and
minerals for strengthening gingiva, for strengthening the
immune system and decreasing sensitivity, pain, and
CA 02211382 1997-07-24
soreness, and for the strengthening of teeth and bone, and
the vitamins and minerals included in the compositions
according to the present invention which are used according
to the method of the present invention each have a definite
and positive role to play in dental health, essentially as
set forth in the following:
**Vitamin C - formation of collagen - important for
growth and repair of tissue cells, blood vessels, bones and
teeth - heals wounds and bleeding gums - accelerates
healing after surgery - helps slow healers, receding gums,
and gingival inflammation, may reduce the risk of mouth
cancer - maintains connective tissue - fights infections.
Bioflavonoids, Rutin, and Hesperidin - increase
capillary strength - work synergistically with Vitamin C -
keep connective tissue healthy - increase resistance to
infection - prevention and healing of bleeding gums.
**Calcium - healthy bones and teeth - 20% of bone
calcium is resorbed and replaced each year - 99% of calcium
is in bones and teeth - excess is eliminated daily in urine
- many surveys show calcium intake for many people below
RDA which accelerates bone loss with low calcium intake
causing bone loss from jaw bone and speed up of periodontal
disease - ADA booklet on alveolar (jaw) bone loss advises
increase in calcium - research shows decrease in alveolar
bone resorption for those given calcium and Vitamin D
supplements in double blind studies - not enough calcium
leads to bone disease and brittle bones.
Vitamin D - helps to properly utilize Calcium and
Phosphorus - necessary for strong bones and teeth - defi-
ciencies can lead to osteoporosis, soft bones and teeth,
tooth decay, and gum disease.
Phosphorus - helps calcium formation for bones and
teeth, important for tooth formation, deficiencies can lead
to bone disease and tooth and gum disorders.
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Magnesium - helps bone development, helps Vitamin C,
deficiencies can cause calcium resorption, tooth decay, and
soft bones.
Zinc - regulates the inflammatory process, helps
enzyme systems, aids wound healing - fights bad breath -
deficiencies can lead to poor healing, susceptibility to
infection, slow healing, and loss of taste.
Ovalbumin - contains the ten essential amino acids in
soluble form - goes directly to the stomach and is easily
digested - helps connective tissue repair in the periodon-
tal pocket, nerve dendrites, and bone and muscle healing -
the body cannot make this.
Vitamin K - recent studies show it aids calcium
absorption in bone.
Vitamin E - helps supply oxygen to the oral tissues -
prevents and dissolves blood clots - helps healing - good
for wound healing.
**Vitamin A - strong bones, formation and maintenance
of teeth, and health of gums - Beta Carotene studies show
it may reduce the risk of oral cancer - helps the healing
process - needed for the health of mucous membranes of the
mouth - stimulates the body's defense system and guards
against infection.
Selenium - synergistic with Vitamin E - important for
tissue elasticity - increases resistance to infection -
antioxidant.
B Complex - important for a healthy nervous system to
minimize oral pain - this group includes B 1, 2, 3, 6, and
12.
Vitamin B1 (Thiamine) helps relieve dental postopera-
tive pain - general pain relief.
Vitamin B2 (Riboflavin) - helps eliminate sore mouth,
lips, and tongue - aids healthy skin and healing process in
general - deficiencies can lead to cracks and sores at the
corner of the mouth, sore tongue, and sore mouth.
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Vitamin B3 (Niacinamide) helps the nervous system -
improves circulation - deficiencies can cause canker sores,
bad breath, and swollen tongue.
Vitamin B12 - helps the nervous system - helps form
and regenerate red blood cells.
Manganese - helps bone development.
Folic acid - helps prevent canker sores and red tongue
- analgesic for pain - helps in production of red blood
cells.
Biotin - helps ease muscle pains, alleviate dermati-
tis, and sore tongue.
Iodine - helps dispose of body wastes - aids tooth
development.
Iron - helps in production of red blood cells -
promotes resistance to disease - improves health of teeth,
skin, and bones.
Copper - aids in bone formation and healing.
Pantothenic acid - produces coenzyme A which the body
does not produce on its own - fights cellular toxicity.
Chromium - helps burn free sugar which promotes the
healing of damaged tissue.
** - most important of its group, so the presence of
an effective amount is essential.
* * * * *
Note: The collagen and mucosal epithelial barrier is
dependent on Zinc, Folic acid, Vitamin C, and Iron, which
increase the gingival tissue resistance to bacterial
plaque.
Note: The "Lime Complex" trio of bioflavonoids
potentiates the action of Vitamin C, especially in prevent-
ing capillary permeability and gingival bleeding.
Using Beta Carotene instead of Vitamin A itself takes
advantage of recent Beta Carotene studies which show a
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CA 02211382 1997-07-24
decrease in cancer using Beta Carotene, which would apply
to oral cancer as well.
The compositions of the invention supply all of the
essential Vitamins and Minerals needed for dental health.
In addition, the present formulations include items not
usually found in multivitamin preparations, such as
Ovalbumin, Bioflavonoids, Hesperidin, Rutin, Bone Meal
(Calcium and Phosphorus), and three to four times the usual
amounts of Vitamin C, Bl, and B2.
Some categories of dental diseases for which certain
ingredients of the present dental dietary supplement are
important are as follows:
1) Loose teeth and rece~;ng gums: C, D, Bioflavon-
oids, Calcium, Magnesium, Manganese, A, Selenium, Phospho-
rus, Copper, Hesperidin, Rutin, Ovalbumin.
2) Bleeding gums and flabby gums: C, K, E, A, B2,
B3, B6, B12, Bioflavonoids, Zinc, Selenium, Biotin, Rutin,
Iodine, Iron, Folic acid, Hesperidin, Ovalbumin.
3) Bad breath: Zinc, B2, B3, A, C, B6.
4) Sensitive teeth and sore gums: B6, B2, B1, B3,
B12, Folic acid, Magnesium, Zinc, Biotin, Ovalbumin.
5) Denture and Bridgework wearers: Bioflavonoids, C,
Calcium, Zinc, A, E, B2, Selenium, Ovalbumin.
6) Pyorrhea and gingivitis: Pantothenic acid.
7) Damaged gums: Chromium.
The above-identified active components, considered
separately, have been known to provide certain physiologi-
cal benefits and effects, as described above. However, it
has not been known previously that the combination dietary
supplements of the present invention can provide such
outstanding maintenance and preservation of dental health
when administered to a living human being in need of such
dietary supplementation.
The form of the dietary supplement of the present
invention for oral administration may be in solid or liquid
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form, such as tablets, capsules, granulates, chewable
wafers or tablets, powder packets, syrups, elixirs, disper-
sible drink mixes (with or without effervescence-producing
ingredients), any other liquid form, e.g., emulsion or
suspension, or the like, and is preferably in the form of
tablets or caplets, most especially tablets.
As is usual in the art, compositions according to the
present invention may contain optional preservatives,
sweeteners, or flavorants, which may provide a more
palatable dosage form and assist in long-term patient
compliance, but in general such additional ingredients are
optional. Such additional ingredients and further addita-
ments to be included will be at the discretion of the
formulator. In addition, physiologically-acceptable
buffers or antacids or the like may be incorporated in the
dietary supplements of the present invention at the option
of the formulator.
In the formulations of the invention, the mineral and
vitamin components may be admixed with at least one
pharmaceutically-acceptable diluent (excipient) or carrier
such as cane sugar, lactose, starch, talc, or synthetic or
natural gum, a binder such as gelatin, a lubricant such as
sodium stearate, and/or a disintegrant such as sodium
bicarbonate, calcium carbonate, magnesium carbonate, or
potassium carbonate. To effect a sustained release, a
substance such as a hydrocolloid or other polymer may be
incorporated into the composition. Additional substances
such as lubricants or buffers may also be added, as is
conventional in the art. The tablets, pills, or granules
may be subjected to coatings if desired. Additionally,
agents for the sweetening, flavoring, or for the imparting
of fragrance may be utilized if desired.
In the compositions of the present invention, the
proportions of the active agents, e.g. vitamins and
minerals, in the composition may be varied widely, it being
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CA 02211382 1997-07-24
necessary only that the active ingredients of the present
invention or a prodrug therefor (e.g., betacarotene)
constitute or provide an effective amount such that a
suitable effective dose will be obtained in a single
administration consistent with the dosage form employed.
Obviously, several dosage forms may be administered in the
course of a daily regimen and, of course, a plurality of
individual active components will always be administered in
the same unit dosage of the dietary supplement composition
or formulation, such in fact being of the essence of the
present invention.
As noted above, inactive components or excipients
which are well known in the art, may optionally be provided
as fillers to place the active ingredients, vitamins and
minerals into tablet or caplet form. For example, the
fillers may include binders, lubricants, and disintegrants,
which can for example optionally include cellulose,
gelatin, silica, and the like. Additionally, anticaking
and flow-enhancing agents, for example anhydrous dicalcium
phosphate and magnesium oxide may be employed if desired,
as well as flavors and sweeteners, for example aspartame,
natural orange flavor, or the like.
The active ingredients or components are either simply
a~ix~ together or granulated and mixed together, either
by dry or wet granulation, together with usual excipients,
and tabletted or encapsulated according to conventional
procedure.
DETAILED DESCRIPTION OF THE INVENTION
The following Examples are given by way of illustra-
tion only, and are not to be construed as limiting.
Example 1 - Preferred Unit Dosage Form
The ingredients and amounts for the formulation of a
unit dosage form of the oral dietary supplement composition
of the present invention for maintaining and preserving
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dental health consist essentially of the following ingredi-
ents in the following amounts:
Vitamin A 5000 I.U. All as Beta Carotene (100)
Vitamin B1 (Thiamine) 4.5 mg. (300)
Vitamin B2 (Riboflavin) 5.1 mg. (300)
Vitamin B3 (Niacinamide) 30 mg. (150)
Vitamin B6 3 mg. (150)
Vitamin B12 9 mcg. (150)
Folic acid 400 mcg. (100)
Biotin 30 mcg. (10)
Vitamin C 240 mg. (400)
Vitamin D 200 I.U. (50)
Vitamin E 45 I.U. (150)
Vitamin K 25 mcg. (*)
Calcium (Carbonate) 200 mg. (20)
Bioflavanoids 75 mg. (*)
Hesperidin 25 mg. (*)
Rutin 25 mg. (*)
Phosphorus 35 mg. (10)
Zinc 15 mg. (100)
Iron 18 mg. (100)
Selenium 100 mcg. (*)
Magnesium 100 mg. (25)
Manganese 3 mg. (*)
Iodine (Potassium iodide) 100 mcg. (66.6)
Copper 1 mg. (50)
Amino Acids (Ovalbumin) 100 mg. (*)
Pantothenic Acid 10 mg. (100)
Chromium 25 mcg. (*)
All formulated into a unit dosage form, preferably a
caplet or a tablet, and most especially a tablet, having a
total weight of approximately 1670 mg., plus or minus ten
percent.
Note: * No U.S. RDA established
I.U. = International Units
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CA 02211382 1997-07-24
**The ten essential amino acids are well known to be
Isoleucine, Leucine, Lysine, Methionine, Phenylalanine,
Threonine, Tryptophan, Valine, Arginine, and Histidine.
The above-identified active ingredients are blended
with additional inactive ingredients or excipients in
stainless steel containers using stainless steel mixers or
otherwise in standard equipment and the ultimate blend of
all ingredients is transferred to usual equipment for
encapsulation or compression tableting. Preferred excipi-
ents employed in minor amounts, up to a maximum of two (2)
percent w/w of the total formulation, are as follows:
microcrystalline cellulose as binder, croscarmellose sodium
as a disintegrant, magnesium stearate as lubricant, stearic
acid as lubricant, and hydroxypropylmethylcellulose as a
tablet coating, with an optional artificial coloring
incorporated in the tablet coating, such artificial color
as usual selected from a GRAS and/or FDA-approved artifi-
cial coloring, when employed. After simple admixture, or
after wet or dry granulation and admixture, tablets are
produced on semiautomatic or high-speed automation
compression machines and capsules are filled on semiauto-
matic or high-speed automatic encapsulation equipment
according to the usual procedure of the art and packages
are checked in process for tablet or capsule count and
product uniformity. Example 2 - Formulation Range
The ingredients and amounts for the formulation of a
unit dosage form of the oral dietary supplement composition
of the present invention for maintaining and preserving
dental health consist essentially of the following ingredi-
ents in the following amounts, given by ranges:
Inqredient Amount
Vitamin A 5,000 to 7,000 IU
Vitamin B1 1.4 to 6 mg.
Vitamin B2 1.7 to 6.8 mg.
Vitamin B3 18 to 45 mg.
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CA 02211382 1997-07-24
Vitamin B6 2 to 6 mg.
Vitamin B12 3 to 18 mg
Folic Acid 400 to 600 mcg.
Biotin 30 to 60 mcg.
Vitamin C 60 to 480 mg.
Vitamin D 200 to 400 IU
Vitamin E 10 to 60 IU
Vitamin K 15 to 50 mcg.
Calcium 150 to 400 mg.
Bioflavanoids 50 to 100 mg.
Hesperidin 15 to 35 mg.
Rutin 15 to 35 mg.
Phosphorous 20 to 45 mg.
Zinc 5 to 20 mg.
Iron 9 to 27 mg.
Selenium 50 to 150 mcg.
Magnesium 50 to 400 mg.
Manganese 2 to 4 mg.
Iodine (as alkali metal salt) 50 to 150 mcg.
Copper 1 to 3 mg.
Amino Acids (selected from
the ten essential amino acids) 50 to 150 mg.
Pantothenic Acid 5 to 15 mg
Chromium 15 to 35 mcg
All formulated into a unit dosage form, preferably a
caplet or tablet, not exceeding a total weight of 1800 mg.,
preferably about 1500 to 1800 mg. and most especially a
tablet of about 1670 mg. plus or minus ten percent.
The above-identified active ingredients are blended
with additional inactive ingredients or excipients in
stainless steel containers using stainless steel mixers or
otherwise in standard equipment and the ultimate blend of
all ingredients is transferred to usual equipment for
encapsulation or compression tableting. Preferred excipi-
ents employed in minor amounts, up to a maximum of two (2)
CA 02211382 1997-07-24
percent w/w of the total formulation, are as follows:
microcrystalline cellulose as binder, croscarmellose sodium
as a disintegrant, magnesium stearate as lubricant, stearic
acid as lubricant, and hydroxypropylmethylcellulose as a
tablet coating, with an optional artificial coloring
incorporated in the tablet coating, such artificial color
as usual selected from a GRAS and/or FDA-approved artifi-
cial coloring, when employed. After simple admixture, or
after wet or dry granulation and admixture, tablets are
produced on semiautomatic or high-speed automation
compression machines and capsules are filled on semiauto-
matic or high-speed automatic encapsulation equipment
according to the usual procedure of the art and packages
are checked in process for tablet or capsule count and
product uniformity.
* * * * *
The exact time of administration or ingestion of the
oral dental health dietary supplement of the present
invention is immaterial, but is preferably at any time
after a period of fasting, e.g., in the morning, at or
before breakfasttime, and especially when a healthy
breakfast is not eaten, since fasting from proper vitamins
and minerals has been taking place during the night since
the ingestion of foods from dinner many hours ago, and
ingestion of the dietary supplement of the present
invention in the morning brings the fast from the proper
vitamins and minerals to an end essentially instantaneously
by providing the superb combination of minerals and
vitamins present in the dietary supplement of the inven-
tion, which is especially designed to help maintain and
preserve dental health.
* * * * *
It is therefore seen that the present invention
provides a novel and effective dietary supplement composi-
tion, in unit dosage form, for the maintenance of complete
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CA 02211382 1997-07-24
dental and oral health and for preventing periodontal
disease and tooth loss, by providing effective amounts of
components for strengthening the gingiva, for strengthening
the immune system and decreasing sensitivity, pain, and
soreness, and for strengthening teeth and bone, and a
method for the maintenance and preservation of dental
health by the oral administration of such an oral dental
health dietary supplement composition to a living human
being in need of such dietary supplementation. The
composition and method of the invention have the unpredict-
able and highly advantageous characteristics and effects of
preventing periodontal disease and tooth loss by the
building of resistance to gum diseases which cause flabby
and inflamed gums and tooth loss, by helping the body to
combat bleeding gums, swollen gums, loosening teeth, decay,
bad breath, and the like, through the provision of
effective amounts of minerals and vitamins for the streng-
thening of gingiva, for the strengthening of the immune
system and decrease of sensitivity, pain, and soreness, and
for the strengthening of teeth and bone, all as more fully
set forth in the foregoing, and whereby all of the
objectives of the present invention are attained.
It is to be understood that the present invention is
not to be limited to the exact details of operation, or to
the exact compounds, compositions, methods, procedures, or
embod;rents shown and described, as various modifications
and equivalents will be apparent to one skilled in the art,
wherefore the present invention is to be limited only by
the full scope which can be legally accorded to the
appended claims.
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