U.S. patent application number 10/868149 was filed with the patent office on 2005-10-13 for nutrient system for individualized responsive dosing regimens.
This patent application is currently assigned to Micro Nutrient, LLC. Invention is credited to Klesman, Larry S., Moneymaker, Ricky D., Theus, Jon S..
Application Number | 20050226906 10/868149 |
Document ID | / |
Family ID | 35456160 |
Filed Date | 2005-10-13 |
United States Patent
Application |
20050226906 |
Kind Code |
A1 |
Moneymaker, Ricky D. ; et
al. |
October 13, 2005 |
Nutrient system for individualized responsive dosing regimens
Abstract
Individualized responsive dosing dietary supplement systems,
compositions, methods of dosing, and processes of producing the
same, which allow a consumer to generate individualistic biological
responses/effects. More specifically, a dietary supplement system
for generating individualized biological conditions/responses which
utilizes ultra-low dosage amounts of vitamins, minerals, amino
acids, co-enzymes, and/or other nutrients in a bio-active delivery
system which preferably avoids first pass metabolism, such that an
individual may take multiple doses of the same or different dietary
supplement based on varying desired biological response within each
24 period is also disclosed.
Inventors: |
Moneymaker, Ricky D.;
(Stuarts Draft, VA) ; Klesman, Larry S.; (Lake
Forest, IL) ; Theus, Jon S.; (Gurnee, IL) |
Correspondence
Address: |
MCANDREWS HELD & MALLOY, LTD
500 WEST MADISON STREET
SUITE 3400
CHICAGO
IL
60661
|
Assignee: |
Micro Nutrient, LLC
|
Family ID: |
35456160 |
Appl. No.: |
10/868149 |
Filed: |
June 15, 2004 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
60561097 |
Apr 8, 2004 |
|
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|
Current U.S.
Class: |
424/439 |
Current CPC
Class: |
A61K 33/34 20130101;
A61K 33/00 20130101; A61K 47/183 20130101; A23L 33/16 20160801;
A23L 33/175 20160801; A61K 47/14 20130101; A61K 31/00 20130101;
A61K 45/06 20130101; A61P 3/02 20180101; A61K 31/593 20130101; A61K
33/26 20130101; A23L 33/15 20160801; A61K 31/519 20130101; A61K
33/30 20130101; A61K 31/355 20130101; A61K 31/4415 20130101; A61K
31/07 20130101; A61K 31/525 20130101; A61K 31/375 20130101; A61K
31/714 20130101; A61K 31/51 20130101; A23L 33/30 20160801; A61K
47/02 20130101; A61K 31/00 20130101; A61K 2300/00 20130101; A61K
33/24 20130101; A61K 2300/00 20130101 |
Class at
Publication: |
424/439 |
International
Class: |
A61K 047/00 |
Claims
What is claimed:
1. A process for producing a nutrient system for individualized
responsive dosing comprising the steps of: (a) providing an amount
of water; (b) adding a base composition, wherein i. the base
composition comprises at least two vitamins or minerals; ii. the
base composition is selected from a group of two or more
base-compositions configured to generate one or more pre-determined
biological effects; and iii. optionally at least one amino acid or
co-enzyme; (c) adding a pre-mix composition comprising a blend of
i. at least one vitamin; and ii. at least one mineral; (d)
optionally diluting an intermediate mixture of water, base
composition, and pre-mix composition by a dilution factor; (e)
configuring the mixture comprising the water, base composition, and
pre-mix composition into a final formulation which substantially
avoids first-pass metabolism, wherein the final formulation
comprises between about 1.times.10{circumflex over ( )}-7% of the
RDA, DV, or UL to about 10% of the RDA, DV, or UL of any vitamin,
mineral, amino acid, or co-enzyme; and (f) repeating steps (a)-(e)
one or more times by utilizing i. a different base composition; or
ii. a different dilution factor.
2. The process of claim 1, wherein the base composition contains
the pre-mix.
3. The process of claim 1, wherein the pre-mix composition
components have constant weight percentages in relation to one
another.
4. The process of claim 1, further comprising the step of
multiplying the amount of base mixture by a multiplication factor
before adding it to the mixture.
5. The process of claim 1, wherein the final formulation is
delivered via an oral film, a tablet, a pill, a liquid, a capsule,
a lozenge, a suppository, a nasal spray, or a troche capable of
avoiding first-pass metabolism.
6. The process of claim 5, wherein the final formulation is
delivered via an oral film.
7. The process of claim 1, wherein the pre-determined biological
effect for each of the two or more pre-configured base mixtures is
selected from the group consisting of: stress-relief, cellular
metabolism, energy conservation, energy utilization, enhanced
memory, enhanced cognitive function, calmness, stimulation of the
hypothalamic-pituitary-thyroid axis, fatigue relief, awareness,
enhanced immune response, antioxidation, liver detoxification, and
alcohol metabolism.
8. The process of claim 1, wherein the base mixture and pre-mix
composition in combination comprise an amount of between about
0.01% to about 0.30% by weight of the mixture comprising base
mixture, pre-mix composition, and water.
9. The process of claim 6, wherein the water is selected from a
Shenandoah Valley water source.
10. The process of claim 1, wherein the amount of any vitamin or
mineral in the final formulation is between about 1.times.10'-7% of
the RDA, DV, or UL to about 1% of the RDA or UL.
11. The process of claim 1, wherein the amount of any vitamin or
mineral in the final formulation is between about
1.times.10{circumflex over ( )}-7% of the RDA, DV, or UL to about
0.001% of the RDA or UL.
12. The process of claim 1, wherein the base-mixture comprises at
least two of the members of the group consisting of: magnesium
chloride, sodium chloride, potassium chloride, calcium chloride,
ascorbic acid, caffeine, niacin, potassium benzoate, chromium
picolinate, chromium, polynicolinate, coenzyme Q10, L-glutamine,
potassium sorbate, calcium ascorbate, sodium nitrite, L-arginine,
sodium ascorbate, and combinations and derivatives thereof.
13. The process of claim 12, wherein the base-mixture comprises at
least five of the members of the group consisting of: magnesium
chloride, sodium chloride, potassium chloride, calcium chloride,
ascorbic acid, caffeine, niacin, potassium benzoate, chromium
picolinate, chromium, polynicolinate, coenzyme Q10, L-Glutamine,
potassium sorbate, calcium ascorbate, sodium nitrite, L-arginine,
sodium ascorbate, and combinations and derivatives thereof.
14. The process of claim 3, wherein each of the two or more
pre-configured base-mixtures comprises the components and relative
amounts of a member from the group consisting of Series S, Series
T, Series U, Series V, Series K, Series L, Series M, Series N,
Series X, and Series W.
15. The process of claim 1, wherein the pre-mix composition
comprises two or more of the members of the group consisting of:
vitamin A, vitamin B1, vitamin B2, vitamin B3, vitamin B6, vitamin
B12, vitamin C, vitamin D3, vitamin E, vitamin H, folic acid,
copper, iron, potassium iodide, calcium carbonate, zinc, and
combinations and derivatives thereof.
16. The process of claim 15, wherein the pre-mix composition
comprises five or more of the members of the group consisting of:
vitamin A, vitamin B1, vitamin B2, vitamin B3, vitamin B6, vitamin
B12, vitamin C, vitamin D3, vitamin E, vitamin H, folic acid,
copper, iron, potassium iodide, calcium carbonate, zinc, and
derivatives thereof.
17. The process of claim 1, wherein the base composition further
comprises a stimulant in an amount such that the concentration of
stimulant is less than about 50 milligrams per dose of final
formulation.
18. The process of claim 17, wherein the stimulant is caffeine
present in the final formulation in an amount less than about 5
milligrams per dose.
19. A base mixture for producing an individualized responsive
dosing dietary supplement composition or system wherein, (a) the
base mixture is configured to generate one or more pre-determined
biological effects; (b) the base mixture comprises two or more
vitamins or minerals; (c) the base mixture is configured to provide
no more than about 10% of the RDA, DV, or UL of any vitamin or
mineral in a finished dietary supplement formulation.
20. The base mixture of claim 19, wherein the base mixture is
configured to provide no more than about 0.01% of the RDA, DV, or
UL for any vitamin or mineral in one dose of an individualized
responsive dosing dietary supplement composition or system.
21. The base mixture of claim 19, comprising at least five of the
members of the group consisting of: magnesium chloride, sodium
chloride, potassium chloride, calcium chloride, ascorbic acid,
caffeine, niacin, potassium benzoate, chromium picolinate,
chromium, polynicolinate, coenzyme, L-glutamine, potassium sorbate,
calcium ascorbate, sodium nitrite, L-arginine, sodium ascorbate,
and combinations and derivatives thereof.
22. The base mixture of claim 21, wherein the base mixture
comprises the components and relative amounts of a member from the
group consisting of Series S, Series T, Series U, Series V, Series
K, Series L, Series M, Series N, Series X, and Series W.
23. A pre-mix composition for use in an individualized responsive
dosing dietary supplement composition, wherein (a) the pre-mix
composition comprises two or more compounds selected from the group
consisting of: vitamin A, vitamin B1, vitamin B2, vitamin B3,
vitamin B6, vitamin B12, vitamin C, vitamin D3, vitamin E, vitamin
H, folic acid, copper, iron, potassium iodide, calcium carbonate,
zinc, amino acids, co-enzyme Q-10, and derivatives thereof; and (b)
the pre-mix composition is configured to provide no more than 10%
of the RDA, DV, or UL of any vitamin, mineral, amino acid, or
co-enzyme in each dose of a finished individualized responsive
dosing dietary supplement formulation.
24. The pre-mix composition of claim 23, wherein the pre-mix
composition is a component of an individualized responsive dosing
system, method, or series of compositions which allows for
individualized enhancement of biological functions.
25. The pre-mix composition of claim 23, configured to provide no
more than 0.01% of the RDA, DV, or UL of any vitamin, mineral,
amino acid, or co-enzyme in each dose of a finished individualized
responsive dosing dietary supplement formulation.
26. The pre-mix composition of claim 23, comprising five or more
compounds selected from the group consisting of vitamin A, vitamin
B1, vitamin B2, vitamin B3, vitamin B6, vitamin B12, vitamin C,
vitamin D3, vitamin E, vitamin H, folic acid, copper, iron,
potassium iodide, calcium carbonate, zinc, amino acids, co-enzyme,
combinations and derivatives thereof.
27. An individualized responsive dosing treatment method comprising
selecting from two or more dietary supplement formulations in
delivery systems which substantially avoid first pass metabolism,
wherein each member of a selection of dietary supplement
formulations comprises: (a) five or more vitamins, minerals, amino
acids, or co-enzyme Q-10 in amounts no greater than about 10% of
the RDA, DV, or UL; (b) water containing at least one mineral,
nitrate, and nitrite, each in an amount less than about 10% of the
RDA, DV, or UL; and (c) optionally, a stimulant; wherein, any
selected dietary supplement formulations is separately configured
to generate a pre-determined biological response and wherein, the
dietary supplement formulation may be taken by an individual two or
more times within each day.
28. The method of claim 27, wherein two or more different
selections from the group of two or more dietary supplement
formulations may be taken by an individual each 24 hour period.
29. The method of claim 27, wherein the pre-determined biological
response is selected from the group consisting of: stress-relief,
cellular metabolism, energy conservation, energy utilization,
enhanced memory, enhanced cognitive function, calmness, awareness,
stimulation of the hypothalamic-pituitary-thyroid axis, fatigue
relief, enhanced immune response, antioxidation, liver
detoxification, and alcohol metabolism.
30. The method of claim 27, wherein each delivery for the dietary
supplement formulations is an oral film, a tablet, a pill, a
liquid, a capsule, a lozenge, a nasal spray, a suppository, or a
troche capable of avoiding first-pass metabolism.
31. The method of claim 27, wherein the water is selected from a
Shenandoah Valley water source.
32. The method of claim 27, wherein the dietary supplement
formulation comprises between about 1.times.10{circumflex over (
)}-7% of the RDA, DV, or UL to about 1% of the RDA, DV, or UL of at
least five of the members of the group consisting of: magnesium
chloride, sodium chloride, potassium chloride, calcium chloride,
ascorbic acid, caffeine, niacin, potassium benzo ate, chromium
picolinate, chromium, polynicolinate, coenzyme, L-Glutamine,
potassium sorbate, calcium ascorbate, sodium nitrite, L-Arginine,
sodium ascorbate, and combinations and derivatives thereof.
33. The method of claim 27, wherein the dietary supplement
formulation further comprises between about 0.0001% of the RDA, DV,
or UL to about 1% of the RDA, DV, or UL of five or more of the
members of the group consisting of: vitamin A, vitamin B1, vitamin
B2, vitamin B3, vitamin B6, vitamin B12, vitamin C, vitamin D3,
vitamin E, vitamin H, folic acid, copper, iron, potassium iodide,
calcium carbonate, zinc, and combinations and derivatives
thereof
34. The method of claim 27, wherein the stimulant is caffeine
present in the dietary supplement formulation in an amount less
than 20 milligrams.
35. A product produced by the process of claim 1.
Description
RELATED APPLICATIONS
[0001] This application is a non-provisional application claiming
priority to U.S. provisional application Ser. No. 60/561,097, filed
on Apr. 8, 2004, pending, and incorporated by reference herein in
its entirety.
FIELD OF THE INVENTION
[0002] The present technology relates generally to individualized
responsive dosing dietary supplement systems, compositions, methods
of treatment, and processes of producing the same, which allow a
consumer to target identifiable, individualistic biological
conditions or responses. More specifically, the present technology
relates to a dietary supplement system for targeting individualized
biological conditions or responses which utilizes ultra-low dosage
amounts of vitamins, minerals, amino acids, co-enzymes, stimulants,
and/or similar ingredients in a highly bio-active delivery system,
such that an individual may take multiple doses of the same or
different dietary supplement mixture based on varying biological
need or desired response within each 24 hour period.
BACKGROUND
[0003] Vitamins, minerals, amino acids, and co-enzymes are
compounds required by an animal or human body in small amounts for
metabolism, biophysiological repair, to protect health, and for
proper growth and cellular reproduction. These compounds also
assist in the formation of hormones, blood cells, nervous-system
chemicals, and genetic material. Vitamins, minerals, amino acids,
and co-enzymes are often referred to as nutrients, defined herein
as a substance or ingredient which may be found in food which
imparts a medicinal or health benefit. The various nutrient
compounds are not chemically related, and most differ in their
physiological actions. They generally act as catalysts, combining
with proteins to create metabolically active enzymes that in turn
produce hundreds of important chemical reactions throughout the
body. Without nutrients, many of these reactions would slow down or
cease. The intricate ways in which nutrients act on the body,
however, are still far from clear. The Food and Nutrition Board of
the National Research Council replaced and expanded the Recommended
Dietary Allowances (RDAs) with Dietary Reference Intakes (DRIs) to
provide recommended vitamin, mineral, or other nutrient intakes for
use in a variety of settings for humans. The DRIs are actually a
set of four reference values: Estimated Average Requirements (EAR),
Recommended Dietary Allowances (RDA), Adequate Intakes (AI), and
Tolerable Upper Intake Levels (UL). These values serve as
recommended dosage levels for vitamins, minerals, or other
nutrients. Currently there are no DRI's for intake of caffeine and
other stimulants, or for L-glutamine or L-arginine. However, the
U.S. National Library of Medicine and the National Institute of
Health recommend, for example, that for caffeine, no more than 200
milligrams is taken every three or four hours, and that an adult
should not take more than 1600 mg in twenty-four hours.
Additionally, L-arginine is typically provided in dietary
supplements in dosages of about 100 milligrams, and L-glutamine in
dosages of about 500 milligrams, pursuant to the FDA.
[0004] Dietary supplements are generally nutrient mixtures commonly
taken in single mega-dose dosage forms which contain vitamin,
mineral and other nutrient doses equal to or over the Recommended
Dietary Allowances (RDA) values. Although mega-dose regimens are a
common practice for the prevention of disease, there is a great
deal of debate in the literature regarding the efficacy of such
regimens. Moreover, consuming large doses of vitamins, minerals, or
other nutrients, in the absence of some deficiency or without
proper medical supervision, may cause harmful toxic effects and/or
result in hypervitaminosis.
[0005] Additionally, a consumer usually has little choice in
choosing the variety of ingredients, dosage levels, or dosing
regimens of a conventional dietary supplement, such as a standard
vitamin tablet. Conventional dietary supplements may be effective
for a general purpose, but usually provide an excess of vitamins,
minerals, stimulants, or other compounds which a consumer does not
desire, or those supplements may not adequately target an
individual's specific dietary need or desired biological response.
Additionally, conventional dosage forms of dietary supplements only
allow a consumer to take one or two doses per 24 hour period. As a
result, conventional dietary supplements fail to recognize that the
physiological state and resultant nutrient requirements of any
single individual can depend upon and fluctuate based upon a number
of different biophysical variables during the course of each day or
dosing regimen. For example, individual variations in diet, and the
amount and intensity of physical activity, provide physical and
chemical stimuli that stress various systems of the body to
differing degrees from one person to the next and for each of those
individuals on any given day. Thus, standard "one size fits all"
mega-dose dosage forms/regimens are not amenable to empirical
dosage adjustment to achieve an individualized biophysiological
objective or response.
[0006] Another drawback with most conventional dietary supplements
is that they suffer from poor degrees and/or rates at which the
various nutrients are absorbed into the systemic circulation of the
body and made available for biophysiological activity (e.g.,
"bioavailability"). These degrees or rates of bioavailability
typically depend upon the dose, dosage form, and method of
administration.
[0007] One particular barrier to efficient nutrient bioavailability
is "first-pass metabolism", which is defined herein to mean a
process in which the nutrient compound(s) are modified, activated,
or inactivated before they enter the systemic circulation, or are
left unchanged and excreted. Alternatively, it may be defined as
the intestinal and hepatic degradation or alteration of a drug or
substance taken by mouth, after absorption, removing some of the
active substance from the blood before it enters the general
circulation.
[0008] For example, it is believed that one significant drawback to
"mega-dosing" of vitamins and minerals is that increased dosages
may not be adequately absorbed into the body, or may actually
decrease absorption. Thus, available transport mechanisms may
become saturated and unable to absorb excess dosage. Additionally,
a drawback to vitamin or mineral delivery via a conventional tablet
or capsule is that differences in luminal pH along the
gastrointestinal tract lining, surface area per luminal volume,
blood perfusion, presence of bile and mucus, and the nature of
epithelial membranes may prevent efficient absorption, activation,
and the like of a nutrient, thereby decreasing its
bioavailability.
[0009] To compensate for first pass metabolism effects, some
previous efforts have been directed to enterically coated tablet or
capsule dosage forms which pass through the stomach unaltered to
disintegrate in the lower intestines. However, aside from a delayed
biophysiologic response as gastric emptying becomes rate-limiting,
gastric irritability, and potential allergic reactions from the
ingestion of such coating materials occurs, and these enterically
coated delayed release dosage forms dissolve and are absorbed
within a narrow time frame. As a result, the body typically
excretes the non-absorbed vitamins or minerals.
[0010] Additional previous attempts have been directed to
continuous or gradual release dosage forms. U.S. Pat. No.
4,882,167, to Jang, discloses dry direct compressed products for
controlled release of actives including vitamins or minerals.
However, the compositions and methods of the Jang patent do not
provide for ultra-low dosage amounts of vitamins or minerals,
dosing flexibility, or systems, compositions, or methods for
individualized responsive dosing based on a desired biological
response.
[0011] WO 99/17753 discloses rapidly dissolving films for delivery
of drugs to be adsorbed in the digestive tract. U.S. Pat. No.
6,596,298, to Leung, discloses consumable oral care films which may
optionally contain active amounts of pharmaceutical drugs. However,
these patents do not utilize vitamins or minerals, and more
specifically, ultra-low dosage amounts of nutrients which would
operate to provide flexibility for individualized dosing. Moreover,
these products or processes do not provide a system or selection
for varying the type or level of dosage depending on a biological
response desired.
[0012] Therefore, there is presently a need for an efficient
process for producing a nutrient dosage and delivery system that is
capable of individualized biological response dosing (i.e., dosing
based upon empirical analysis and adjustment), which is available
in a suitable dosage form, and preferably is efficiently absorbed
and made bioavailable to animal or human tissue. Additionally,
there is presently a need for a treatment method for managing
finely tuned biological needs and responses which utilizes ultra
low dosage amounts, substantially avoids first pass metabolism, and
allows for varied dosage/dosing regimens within each dosing period
(e.g., 24 hours, 6 hours, 1 hour).
SUMMARY OF THE INVENTION
[0013] Embodiments of the presently described technology provide
one or more of the following advantageous features and/or
objects:
[0014] (1) Efficient production of varied and separate nutrient
composition series that are configured to generate discrete types
of biological responses in the body;
[0015] (2) Efficient production of a single series of nutrient
compositions containing varying levels or ranges of ingredients to
generate varying levels or ranges of biological response in an
animal or human body;
[0016] (3) Efficient rate of absorption into an animal or human
body to improve bioavailability, biokinetics, and biodelivery;
[0017] (4) Efficient bioavailability of multiple vitamins,
minerals, amino acids, co-enzymes, and/or other nutrient compounds
in concert;
[0018] (5) Avoidance of first pass metabolism effects, transport
mechanism saturation, or excretion of significant amounts of a
nutrient composition;
[0019] (6) A biological response equivalent dosing unit that does
not approach RDA or UL amounts, but is still effective in enhancing
the overall well being of an individual and generating a biological
response;
[0020] (7) The ability to take multiple doses of a single finely
tuned nutrient composition as need varies within each week, day,
and/or hour; and
[0021] (8) The ability to take multiple doses of different finely
tuned nutrient compositions as different needs develop during each
week, day, and/or hour.
[0022] Other objects and advantages of the presently disclosed
technology will become apparent to those skilled in the art who
have the benefit of this specification and the prior art.
[0023] In preferred embodiments of the presently described
technology, there are provided processes for producing an
individualized responsive dosing nutrient system, the resultant
products of such processes, compositions for use in an
individualized responsive dosing nutrient system, and a method for
generating a biological response utilizing the system.
[0024] The process for producing an individualized responsive
dosing nutrient system preferably first comprises a starting water
source which preferably contains beneficial, but ultra low dosage
levels of at least one nitrate, at least one nitrite, and at least
one mineral. A base mixture is then added containing at least two
vitamins and/or minerals, which is selected from a group of two or
more base compositions configured to generate one or more
pre-determined biological responses. The base mixture is preferably
selected based on a desired biological response for the finished
dietary supplement composition. A pre-mix composition, which is
preferably of a constant compositional make-up during different
runs of the process, is then added or, alternatively, is added as
part of the base mixture.
[0025] Optionally, the mixture comprising the water, base mixture,
and pre-mix, may then be further diluted based on a pre-determined
dilution factor, to vary the ultimate dosage levels in the finished
nutrient composition. Alternatively, the amount of base mixture may
be varied during processing based on a pre-determined
multiplier.
[0026] Then, the mixture containing water, base mixture, and
pre-mix, and optionally further water, is configured into or onto a
delivery system (such as, but not limited to an oral film) which
substantially avoids first-pass metabolism, to form a finished
single nutrient composition. Additionally, it is preferable that
the dosage level of any vitamin, mineral, amino acid, or co-enzyme
contained in the finished nutrient compositions of the presently
described technology be less than 25% of the RDA or UL for such
vitamin, mineral, amino acid, co-enzyme, or other nutrient. More
preferably, the dosage levels are less than 10%, 1%, or 0.1% of RDA
or UL for each nutrient. In the most preferred instances, the
dosage levels are less than 0.001% or less than 0.0001% of RDA or
UL. Preferably, however, the dosage levels are at least
.times.10{circumflex over ( )}-7% of RDA or UL. An illustrative
formulation for a finished single dose (5 drops) of a final
formulation in a liquid delivery system of the present technology
is given in Example 17, below.
[0027] Finally, the foregoing process steps may be repeated one or
more times, more preferably five or more times, and most
preferably, ten or more times, and either a different base mixture
is selected, or a different dilution or base multiplication factor
is selected, to produce a system/series of nutrient compositions
capable of being utilized for individualized biological responsive
dosing.
[0028] Other embodiments of the presently described technology set
forth below illustrate the resultant products of such a process(es)
for the production of an individualized responsive dosing dietary
supplement system, as well as specific base mixtures and set
pre-mix compositions for use in such process and system(s).
[0029] Additionally, there is presently described a method for
individualized responsive dosing to generate a biological response,
comprising the steps of providing a selection of two or more
nutrient formulations in delivery systems which substantially avoid
first pass metabolism and which provide two or more vitamins,
minerals, amino acids, co-enzyme, or other nutrient in amounts
preferably less than 10% or 1% of RDA or UL, more preferably less
than 0.01% of RDA or UL, and most preferably less than 0.0001% of
RDA or UL and a water source comprising at least one mineral,
nitrate, nitrite, and/or other nutrients in amounts preferably less
than 0.001% of RDA or UL. Preferably, however, the dosage levels
are at least 1.times.10{circumflex over ( )}-7% of RDA or UL. The
two or more nutrient compositions are preferably separately
configured to generate one or more pre-determined biological
responses, including, but not limited to: stress-relief, cellular
metabolism, energy conservation, energy utilization, energy
enhancement, enhanced memory, enhanced cognitive function,
calmness, awareness, stimulation of the
hypothalamic-pituitary-thyroid axis, fatigue relief, enhanced
immune response, antioxidation, liver detoxification, and alcohol
metabolism.
[0030] Additional embodiments are disclosed in the detailed
description provided below. While the presently described
technology will be provided in connection with one or more
preferred embodiments, it will be understood by those skilled in
the art that the presently described technology is not limited to
those embodiments. To the contrary, the presently described
technology includes all alternatives, modifications, and
equivalents as may be included within the spirit and scope of the
appended claims.
DETAILED DESCRIPTION OF THE INVENTION
[0031] It has been unexpectedly and surprisingly discovered that
the dose of a vitamin, mineral, or other nutritional supplement
ingredient, when adapted for delivery via a system that
substantially avoids first pass metabolism, may be significantly
reduced while still producing a desired beneficial
effect/biological response. As a result, the ingredients of a
dietary supplement may be provided at substantially lower levels
(i.e. ultra-low levels) than those recommended by the government as
a raw material standard (RDA, UL, UDA, etc.). Furthermore, it has
been surprisingly discovered that such ultra-low dosage levels and
bioactive delivery systems allow dietary supplement compounds to be
repeatedly and flexibly administered to an animal or human for the
enhancement and augmentation of those biological functions known to
be influenced by any of the individual components. These biological
functions include without limitation those processes associated
with: cellular metabolism including nucleic acid and amino acid
metabolism; energy metabolism including energy conversion,
utilization, and enhancement; mental acuity including memory and
cognitive function; the nervous system including neuromuscular
transmission and propagation; hormone responses including
stimulation of the hypothalamic-pituitary-thyroid axis; management
of peripheral and central fatigue including the enhancement of
antioxidant defense systems; the mitigation of episodic and/or
chronic stress; and detoxification by the liver including increased
alcohol metabolism.
[0032] Specifically, it is believed that due to the ultra-low
dosage levels utilized in the present technology, a specific
composition may be taken by an individual multiple times within
each dosing period (e.g., within each 24 hour, 6 hour, or 1 hour
period). Alternatively, an individual may take multiple, different
compositions within a dosing period to generate varied biological
responses or effects. Thus, the presently described technology may
be utilized in a system which allows an individual to biologically
configure their dietary supplement intake throughout a dosing
period or multiple dosing periods, based on their individual
needs.
[0033] Accordingly, the presently described technology describes
processes for producing an individualized biologically responsive
dosing dietary supplement system, the resulting products of such
processes, compositions for use in an individualized responsive
dosing system, and a method of treatment for generating a
biological response utilizing the individualized responsive dosing
system.
[0034] In one embodiment of the present technology, there is
provided a process for producing an individualized biologically
responsive dosing system that as a dietary supplement, first
comprises a starting water source which preferably contains
beneficial, but ultra-low dosages of at least one nitrate, at least
one nitrite, at least one mineral, and/or other nutrients. A base
mixture which comprises at least two vitamins, minerals, or other
nutrients, more preferably at least three vitamins or minerals, and
most preferably at least five such nutrients is added to the water.
The base mixture is preferably selected from a group of two or more
base mixtures configured to generate one or more pre-determined
biological effects. More preferably, the base mixture is selected
from a group of five or more base mixtures, and most preferably, a
group of 10 or more. The base mixture is preferably selected based
on a desired biological response for the finished nutrient
formulation. Then, a pre-mix composition, which preferably
comprises constant percentage ratios of certain vitamins, minerals,
amino acids, co-enzymes, or other nutrients during processing, is
either added separately or, more preferably, is included as part of
the base mixture during preparation to a final, finished nutrient
formulation. The pre-mix, discussed in detail below, preferably
contains at least three or more, and more preferably, at least five
or more, different vitamins, minerals, amino acids, co-enzymes,
and/or other nutrients.
[0035] Optionally, as an alternative embodiment, an intermediate
mixture comprising the water, base mixture, and pre-mix may be
further diluted based on a preferably pre-determined dilution
factor, to vary the ultimate dosages of the nutrients in the final
formulation. This enables a manufacturer to easily create a range
of dosage formulations. Alternatively, the amount of base mixture
may be varied during processing based on a multiplier. Both the
multiplier or dilution factor are experimentally determined.
Preferably, the multiplier ranges from 20 to 40. Although not
wanting to be bound by any particular theory regarding the
multiplier and/or dilution factor, it is believed that because a
water source is used, preferably from a known, specific source, a
pre-mix, a selection of base mixtures, and a set procedure for
making the strips or liquid, then a multiplier or dilution factor
may be utilized to produce a series of related nutrient
formulations, which can elicit a range of certain biological
effects/responses in an animal or human body (i.e. stimulation,
arousal, drowsiness, energy, etc.) within that single series.
[0036] After any optional dilution step, the mixture containing
water, base mixture, and pre-mix is configured into a final,
finished formulation for delivery to an animal or human which
substantially avoids first-pass metabolism. Suitable and preferred
delivery systems are discussed in detail below. Again, while not
limited to any one theory, it is believed that by utilizing a
delivery system which bypasses first-pass metabolism, the vitamins,
minerals, amino acids, co-enzymes, and/or other nutrients are more
readily made available in the body (e.g., increased
"bioavailability"). It is also believed that the avoidance of
transport mechanism saturation and excretion of excess ingredients
permits the use of much lower amounts/dosages of components than in
conventional dietary supplements, while still providing beneficial
biological effects/responses. Moreover, utilizing lower
amounts/dosages of ingredients allows for multiple uses of a single
or related formulation, or use of another type of formulation, as
an individual's biological need or desired response varies
throughout each dosing period (e.g., each 24 hours, 6 hours, or 1
hour). Furthermore, it is believed that such individualized
responsive dosing is possible in part because the dosage level of
any vitamin, mineral, amino acid, or co-enzyme contained in the
final formulation (i.e. the final oral strip, liquid drops,
capsules, troches, lozenges, etc.) of the instant process are less
than about 25% of the RDA or UL of such vitamin, mineral, amino
acid, or co-enzyme. More preferably, the dosage levels are less
than about 10% or less than 1% of the RDA or UL, and most
preferably, less than about 0.10% or about 0.01% of the RDA or UL.
Some preferred embodiments have dosage levels of less than about
0.001% of the RDA or UL.
[0037] When referred to in the instant technology, the UL is
defined as the maximum level of daily intake of any vitamin,
mineral, amino acid, co-enzyme, or other composition that is likely
to pose no risk of adverse effects, and the RDA is defined as the
Recommended Dietary Allowance. Both values are preferably those
published by the Food and Nutrition Board of the National Research
Council, for Males 19-30 years old. See Example 16: RDA/UL for Some
Nutrients. It will be understood, however, that the present
invention is not limited to those vitamins, minerals, amino acids,
co-enzymes, or other compositions for which RDA values or UL values
have been established by a governing body, and may encompass any
nutrient composition.
[0038] Furthermore, based on known amounts of vitamin, mineral,
amino acid, or co-enzyme amounts in a pre-mix or base composition,
a known dilution factor or multiplication factor, and further based
on a selected, constant process for producing a final formulation,
the final dosage amounts of any components in the final formulation
(i.e. the final oral strip, liquid drops, capsules, troches,
lozenges, etc.), can be calculated.
[0039] After a single form of the nutrient formulation is produced,
the foregoing process steps may be repeated one or more times,
preferably five or more times, and most preferably, ten or more
times to produce different doses of a formulation for a particular
"series" of that formulation, or different types of formulations
for different series. Either a different base mixture is selected,
or a different dilution or multiplication factor is selected, to
produce a system of nutrient compositions capable of being utilized
to generate biological responses.
[0040] For example, a manufacturer may efficiently create a number
of different series, such as illustrative Series S, Series T,
Series U, Series V, Series K, Series L, Series M, Series N, Series
X, and Series W, by utilizing different base mixtures. Examples 4
through 13 describe preferred base compositions for creation of the
foregoing series. Each series may generate a desired and distinct
biological effect or responses, or may overlap slightly in degree
of the same response. Within each series, a manufacturer may
utilize differing dilution or multiplication factors to efficiently
create a gradient of biological responses (i.e. sleep (low energy)
to awake and active high energy). Examples 3 and 15 gives a
examples of a gradient of dilution factors and corresponding
biological effects/responses observed within a given series.
(Series S).
[0041] Below is a detailed description of each of the preferred
steps and components in the presently described technology for
producing an individualized responsive dosing dietary supplement
system. The compositions of the present technology can include any
of the water-soluble and/or fat-soluble vitamins, a coenzyme such
as Q.sub.10, essential and/or non-essential amino acids, and
minerals including without limitation calcium, phosphorus,
magnesium, sodium, potassium, chloride, chromium, copper, fluoride,
iodine, iron, manganese, molybdenum, selenium and zinc. The
presently described technology can also include other ingredients,
for example, nitrate, nitrite, folic acid, and stimulants such as
caffeine. It is also contemplated that the compositions of the
present technology may further include pharmaceutical
compositions.
[0042] Water
[0043] The water can vary from source to source, but preferably
contains at least one nitrate, at least one mineral, and at least
one nitrite. Most preferably, the presently described technology
utilizes water from an Appalachia water source, preferably a water
source from the Eastern slope of the Shenandoah Valley. Different
water sources would require empirical analysis of its constituents
to ensure that the dosage amounts are consistent with spirit of the
presently described technology. For example, the base composition
multiplier could be changed in order to obtain an adjusted base
with a preferred compositional make-up in light of a different
water source.
[0044] The water is preferably filtered to purify and refine it
from the certain, selected water-source. The filter is preferably a
commercially available filter having a pore size of about 0.1
micron. An example of components that the water can include, and
tolerances for the amounts of those components, is set forth
below:
[0045] Nitrate 0-0.10 mg/L+25%
[0046] Nitrite 0-0.01 mg/L+25%
[0047] Calcium 0-12.4 mg/L+25%
[0048] Chromium 0-0.001 mg/L+25%
[0049] Magnesium 0-5.8 mg/L+25%
[0050] Manganese 0-0.001 mg/L+25%
[0051] Potassium 0-1.4 mg/L+25%
[0052] Sodium 0-1.6 mg/L+25%
[0053] Any of these preferred components of the water may range
from 0 to +25%. The pH of the water can range from about 5 to about
7.5. Preferably, the pH of the water is about 7.50 at 25 degrees
Celsius.
[0054] Base Mixture
[0055] Preferably, a selection of base mixtures is provided so that
various base mixtures may be utilized to create different series of
final formulations. It is also preferable that each base mixture is
configured to generate a desired biological response. Either
completely different or overlapping biological responses may be
generated by different base mixtures. Additionally, each of the
base mixtures may already contain a pre-mix with constant
compositional make up. The pre-mix need not be identified as such,
but may merely contain at least two or more vitamins, mineral,
amino acids, or other nutrient which can remain constant (i.e. in
relative proportion to one another) within each base mixture.
[0056] The components of the base mixture preferably comprise at
least two of the following: magnesium chloride, sodium chloride,
potassium chloride, calcium chloride, ascorbic acid, caffeine,
niacin, potassium benzoate, chromium picolinate, chromium,
polynicolinate, coenzyme Q10, L-glutamine, potassium sorbate,
calcium ascorbate, sodium nitrite, L-arginine, or sodium ascorbate.
More preferably, the base mixture comprises at least five of the
foregoing.
[0057] Illustrative examples of base mixtures of the present
technology are embodied in Tables 4 through 13 and have been
designated as series S, T, U, V, K, L, M, N, X and W. Those
examples illustrate the preferred makeup in grams of the individual
ingredients/components of exemplar base compositions, including the
amount of vitamin premix used and the amount of any additional
components admixed with the vitamin premix. For example, Table 4
illustrates that the base composition for the S series comprises
0.02500 grams of vitamin premix admixed with additional components,
including for example 0.06000 grams of magnesium chloride. Also
shown is the adjustment of each component of the base composition
by application of a dilution or multiplication factor to arrive at
the adjusted base composition. For illustrative purposes, the
multiplier is based upon the dissolution of the selected components
in a final volume of 1 gallon of profiled water.
[0058] Any base composition multiplier may be experimentally
determined in regards to a desired biological effect/response, and
is, for illustrative purposes, established relative to that water
characterized in Example 2. A multiplication factor is preferably
empirically determined so as to compensate for variables. The
variables that are taken into consideration can include without
limitation: any additional ingredients/components coming from
selected water sources used for dissolution; any processing
required to arrive a final dosage form; and/or any adjustments
required to achieve a desired biological response/effect. The
multiplier is empirically derived and can range from a factor of
about 20 to about 40. This multiplier is utilized to create a final
adjusted base composition, which will achieve the adequate amount
of each component per base composition, which can then be further
formulated into a specific dosage form and chosen for application
based on desired biological effects/responses on any living system,
human or otherwise.
[0059] For further illustrative purposes, each exemplar series S,
T, U, V, K, L, M, N, X and W may be further divided into sub-series
based on varying dosage amounts. For example, the S-series may
contain subs-series S-1 through S-10 compositional products, which
vary in their solids content with S-1 having less solids than S-10
based upon the dilution rate of the S series adjusted base
composition. See Example 15. The grouping of compositional
products, produced by dilution in the selected water of each of the
representative adjusted base composition mixtures, is illustrated
in Tables 14-22 for each additional exemplar series T, U, V, K, L,
M, N, X and W.
[0060] Pre-Mix
[0061] The general pre-mix formulation is preferably comprised of
pharmaceutical grade vitamins, minerals, amino acids and/or
coenzymes. Each ingredient is preferably on the United States Food
and Drug Administration's Generally Recognized As Safe (GRAS) list.
An illustrative example of a standard premix composition is shown
in Example 1 and includes vitamins A, B1, B2, B3, B6, B12, C, D3, E
and H, in admixture with folic acid, copper, iron, potassium
iodide, calcium carbonate, and zinc. A further embodiment of the
present technology includes base compositions containing the
vitamin premix composition in addition to any further
components/ingredients added to the vitamin premix composition. By
way of example, additional components/ingredients added to the
vitamin premix to form a base composition may include without
limitation magnesium chloride, sodium chloride, potassium chloride,
calcium chloride, ascorbic acid, caffeine, niacin, potassium
benzoate, chromium picolinate, chromium polynicolinate, coenzyme
Q10, L-glutamine, and potassium sorbate, sodium ascorbate,
potassium carbonate, calcium ascorbate, calcium carbonate,
L-arginine, sodium nitrite, and combinations and derivatives
thereof.
[0062] In the preferred embodiments of the presently described
technology, the compositional make-up of the pre-mix formulation
does not vary during processing, or in separate types or series of
finished product. The pre-mix dosage amounts, however, are
preferably adjusted through dilution or multiplication of the base
mixture.
[0063] Delivery System
[0064] For the present technology, any dosage form can be utilized.
Those dosage forms can include, for example, an oral film, tablet,
pill, liquid, capsule, lozenge, troche, suppository, transdermal
patch, nasal sprays, dragus, slurry, suspension, or emulsion. For
this particular technology, dosage administration routes are
preferably those that by-pass first pass metabolism such as buccal,
nasal, transdermal, intradermal, intramuscular, intravenous and
certain rectal routes. This is due to the present technology
believing to have enhanced efficacy by circumventing dosage
administration routes which would undergo first pass metabolism
(oral, in particular).
[0065] Compositions of the present technology can be preferably
formulated for either parenteral or enteric absorption. Parenteral
absorption generally comprises absorption by way other than the
gastrointestinal track and without significant first pass
metabolism. By way of example and without limitation, parenteral
absorption can be pre-gastric, topical, optical, intravenous,
and/or by oral or nasal inhalation. Pre-gastric absorption as used
herein comprises absorption of an ingredient from that part of the
alimentary canal prior to the stomach, and includes without
limitation buccal, sublingual, oropharyngeal and esophageal
absorption. It is envisaged that such pre-gastric absorption will
occur primarily across the mucous membranes in the mouth, pharynx
and oesophagus. The present invention, however, is not limited to
any one method of delivery, and envisions delivery via any tissue
with an adequate rate of absorption, which avoids first pass
metabolism.
[0066] It is preferred that the composition of the present
invention is formulated to promote absorption of
ingredients/components of the final formulation through the buccal,
sublingual, pharyngeal and/or esophageal mucous membranes. Without
being bound by a particular theory, it is believed that pre-gastric
absorption will occur primarily across the mucous membranes in the
mouth or oral cavity, pharynx and esophagus. The oral mucosa has a
thin epithelium and a rich vascularity that favors absorption.
Blood capillaries are extremely close to the surface in these areas
and readily absorb the ingredients into the blood stream. The flow
is from this area of the mouth to the Carotid Artery and it is
envisaged that distribution to the brain and the rest of the body
will be rapid, thereby resulting in greatly enhanced efficacy
and/or rates of response.
[0067] It is also envisaged that the compositions of the present
invention can be formulated to be fast-dispersing and bioadherent
for application to the surface of another product intended for
enteric absorption. Accordingly, any of the compositions of the
present invention upon rapid dissolution from the surface of said
other product can be retained in the oral cavity so as to
facilitate pre-gastric absorption, while the balance of said other
product moves further into the GI tract to undergo enteric
absorption.
[0068] It is also believed that ingredients absorbed by pre-gastric
absorption will pass straight into the systemic circulatory system
and thereby avoid the gastrointestinal track and first pass
metabolism in the liver. Accordingly, bioavailability of an active
ingredient delivered in this way may also be increased.
Additionally, the bioavailability of a number of vitamins,
minerals, amino acids, co-enzymes, and/or other nutrients in
concert can also be increased. It is desired that the dose of an
ingredient may be minimized, while still producing the desired
beneficial effects, with close to zero order kinetics (immediate
efficacy) thereby decreasing the required dose. These
concentrations may vary and will be selected primarily on the
desired biological response and dosage form selected.
[0069] U.S. Pat. Nos. 6,596,298; 6,569,463; 5,948,430; 6,592,887;
5,629,003; 6,419,903; and 6,316,029 disclose various delivery
systems which may be utilized in the present technology.
[0070] One particularly preferred method of delivery, although not
limited to any one method, is a consumable oral strip. The dosage
form can include by way of example and without limitation, a
starch, pectin, and/or cellulose based strip or film that adheres
to and dissolves in a mouth of a consumer. A strip formulation is
made utilizing conventional film formulation processing and
technology. The preferred film formulation is a starch-based film
formulation or matrix. Other film formulation matrixes can be
utilized such as pectin and other film bases (cellophane tape).
[0071] Based on selected amounts of vitamin, mineral, amino acid,
co-enzyme, and/or other nutrients in a selected pre-mix or base
composition, a selected dilution factor or multiplication factor,
and further based on a selected, constant process for producing a
final formulation, a final dosage amount of components/ingredients
in a finished oral strip may be determined. The dosage level will
be determined therefore, by the number of strips made per gallon of
the mixture comprising water, base mixture, and pre-mix.
Preferably, this rate of strips per gallon of mixture is a constant
during processing, such that variation in the finished product is
achieved through the afore-mentioned multiplication and dilution
factors. Optionally, the rate of strips per gallon may also be
adjusted to vary finished nutrient formulation properties. A
conventional oral strip processing method is disclosed in U.S. Pat.
No. 6,596,298 to Leung ("the Leung patent").
[0072] In preferred methods of strip formulation, approximately
2020 grams of the mixture comprising water, base mixture, and
pre-mix (regardless of the dilution factor and/or multiplication
factor) is used per 454 grams of strip matrix. Additionally,
preferred oral strips have dimensions of approximately 35.356
mm.sup.3 with a tolerance of +/-5%. As one illustrative example, in
preferred strip formulation processing, when utilizing a K-16
formulation, approximately 19,500 strips may be made from
approximately one gallon of K-16.
[0073] Individualized Responsive Dosing
[0074] Additional embodiments of the present technology include
individualized responsive dosing methods, wherein an individual may
select from different series or types of nutrient components within
a series based on varying need or desired biological response
needed throughout each 24 hour period (or in some embodiments, each
6 hour or 1 hour period). The preferred method of dosing provides a
selection of three or more nutrient formulations in delivery
systems which substantially avoid first pass metabolism, and each
member of the selected nutrient formulations comprises: (a) at
least five or more vitamins, minerals, amino acids, co-enzyme, or
other nutrients in amounts no greater than about 25% of the
Recommended Daily Allowance (RDA) or Upper Limit (UL); (b) water
containing at least one mineral, nitrate, and nitrite, each in an
amount less than about 25% of the RDA or UL for that component; and
(c) optionally, a stimulant. Furthermore, each of the three or more
nutrient formulations is separately configured to generate a
specific, pre-determined biological response/effect.
[0075] The different formulations of the present technology may be
configured to generate the following pre-determined biological
responses: cellular metabolism including nucleic acid and amino
acid metabolism; energy metabolism, including energy conversion and
utilization; mental acuity, including memory and cognitive
function; nerve signaling including neuromuscular transmission and
propagation; hormone signaling including stimulation of the
hypothalamic-pituitary-thyroid axis; management of peripheral and
central fatigue, including the enhancement of antioxidant defense
systems; the mitigation of episodic and/or chronic stress; and
detoxification by the liver including increased alcohol
metabolism.
[0076] Preferably, each formulated series has a different
biological effect/response which can be graded within the series.
In other words, a series such as exemplary Series S may be
anecdotally shown to produce varying levels of energy or relaxation
per composition/formulation within the series. Thus, for
illustration purposes, the gradient of Example 15 may be
observed.
[0077] Although not wanting to be bound be any particular theory,
it is believed that a series such as the exemplary S series may
enhance biochemical signal processing within cellular tissues to
cause a gradient of energy levels observed which are dependent upon
the concentration (i.e., solids content) of the composition within
the series utilized (i.e., S-1 biological effects v. S-10
biological effects). It is further believed that such energy
enhancement effects are due to enhanced cellular radical
scavenging, oxygenation, or utilization of GABA as well as tissue
responses such as vasodilation or enhanced glomerular
filtration.
[0078] Additionally, as previously described, the administration of
these formulations to the body in a delivery system which
preferably avoids first pass metabolism increases bioavailability
of the formulations to the body, which in turn enhances component
ingredient capacity or concentrations at a cellular level to the
tissues, which in turn again with increased capacity improves
cellular absorptive capacity of the component/ingredient leading to
a biochemical signal being generated to those tissues and a
biological/biochemical response produced.
[0079] Therefore, an individual may select one of the series to
begin with and attempt to achieve a particular desired biological
response. For example, the patient may select the S-series to
achieve enhanced levels of energy or drowsiness depending upon
which composition within the S-series is selected. If the patient
selects an illustrative S-1 composition, then the patient could
preferably take 1 strip or 1 drop of the composition at a time to
try and achieve the "energy" effect desired. If the effect is not
achieved, then the patient may continue with a strip by strip or
drop by drop approach to try and achieve the particular biological
effect desired with that particular composition of the series. This
particular dosage methodology is an individualized responsive
dosing or titration approach. For a liquid formulation, an
individual may preferably begin with 5 drops and continue to
titrate drop by drop to attempt to achieve the desired biological
response/effect. For comparison purposes, 120 drops equal 1
Teaspoon.
[0080] If the composition of the series still does not provide the
biological response/effect the individual desires, then the
individual can select a high solids content formulation within the
series such as, for example, S-2 to S-10 to try and achieve the
desired effect (or change of effect, i.e., from sleep to energy) on
a strip by strip or drop by drop basis again.
[0081] Finally, if the individual still does not achieve the
desired biological response/effect with that particular
series/formulation, then the individual may select another series
and continue with the foregoing approaches again to see if the
desired biological response/effect can be achieved. A different
series/formulation may generate completely different biological
responses/effects (i.e. calmness versus enhanced memory), or may
overlap in its response/effect. For example, in illustrative
examples S and K, the only differences are that S starts at a lower
energy level than K where K starts at a higher energy level
immediately at the K-1 sub-series. In contrast, S-1 is more
suitably directed to sleep promotion. Likewise, a T-1 formulation
will have a different biological effect than an S-1 formulation,
although certain T Series formulations may have similar biological
effects to certain S Series formulations (i.e., effect/response
overlap). Yet, the same individualized responsive dosing approach
is utilized.
[0082] As previously described, the overall dosing methodology
above is referred to as individualized responsive dosing since the
individual is dosing his or herself in a stepwise fashion to
attempt to achieve the desired biochemical signal and resultant
biological effect, response, or condition. Conventional vitamin
regimens do not allow patients to variably and individually dose
themselves based upon their biological responses and biochemical
signals because conventional vitamin/mineral compositions are a one
mega-dose/one dosing regimen fits all type approach which would be
counter to the presently described technology's individualized
responsive dosing approach.
[0083] The following examples describe some of the preferred
embodiments of the present technology without limiting the
technology thereto. Other embodiments include, but are not limited
to, those described in the above written description, including
additional or alternative components, alternative concentrations,
and additional or alternative properties and uses.
EXAMPLES
Example 1
[0084]
1 Component Amount Component Amount Vitamin A 6000 usp Vitamin
D.sub.3 480 usp Vitamin B.sub.1 0.00519 mg Vitamin E 35 usp Vitamin
B.sub.2 0.00392 mg Vitamin H 0.00045 ug Vitamin B.sub.3 0.05 mg
Folic Acid 0.00048 ug Vitamin B.sub.6 0.05 Copper 0.0022 mg Vitamin
B.sub.12 0.000015 ug Iron 0.0191 mg Vitamin C 0.15 mg Potassium
Iodide 0.000165 ug Zinc 16.1 mg Calcium carbonate 0.1 mg
Example 2
Water Composition
[0085]
2 Analyte Result Units Nitrate <0.10 mg/L Nitrite <0.01 mg/L
Calcium 12.4 mg/L Chromium <0.001 mg/L Magnesium 5.8 mg/L
Manganese <0.001 mg/L Potassium 1.4 mg/L Sodium 1.6 mg/L
Example 3
Typical Method for Optional Dilution
[0086]
3 Dilution rate to 1 gallon mixture Sub-series for processing into
final product S-1 0.5 oz to 1 gallon S-2 1 oz to 1 gallon S-3 2 oz
to 1 gallon S-4 3 oz to 1 gallon S-5 4 oz to 1 gallon S-6 5 oz to 1
gallon S-7 6 oz to 1 gallon S-8 7 oz to 1 gallon S-9 8 oz to 1
gallon S-10 9 oz to 1 gallon S-11 10 oz to 1 gallon S-16 15 oz to 1
gallon S-21 20 oz to 1 gallon S-26 25 oz to 1 gallon Dilution
Method for all S Series products - Mix initial proscribed amount of
Base Mixture with the same quantity of profiled water. Agitate for
1 minute per dilution. Repeat until 1 gallon of finished mixture is
produced. For example, 8 such steps are required for S-1.
Preferably, wait about 8 hours between dilution steps.
Example 4
Base Composition for Series S
[0087]
4 Adjusted Base Composition (Dissolved in 1 gallon Select Water =
Adjusted Base Base Base Amount Mul- Composition Composition (grams)
tiplier Mixture) Magnesium 0.06000 g 23 1.38 g chloride Sodium
0.09000 g 23 2.07 g chloride Potassium 0.09000 g 23 2.07 g chloride
Calcium 0.06000 g 23 1.38 g chloride Ascorbic acid 0.50000 g 23
11.5 g (ester C) Caffeine 0.04750 g 23 1.0925 g Niacin 0.01000 g 23
0.23 g Potassium 0.04500 g 23 1.035 g benzoate Vitamin 0.02500 g 23
0.575 g Premix Chromium 0.0001870 g 23 0.004301 g picolinate
Chromium 0.0001870 g 23 0.004301 g polynicolinate Coenzyme Q10
0.03125 g 23 0.71875 g L-Glutamine 0.25000 g 23 5.75 g Potassium
0.10000 g 23 2.3 g sorbate
Example 5
Base Composition for Series T
[0088]
5 Adjusted Base Composition (Dissolved in 1 gallon Select Water =
Adjusted Base Base Amount Mul- Base Composition Composition (grams)
tiplier Mixture) Magnesium 0.06000 g 23 1.38 g chloride Sodium
0.09000 g 23 2.07 g ascorbate Potassium 0.09000 g 23 2.07 g
carbonate Calcium 0.06000 g 23 1.38 g ascorbate Ascorbic acid
0.50000 g 23 11.5 g (ester C) Caffeine 0.04750 g 23 1.0925 g Niacin
0.01000 g 23 0.23 g Potassium 0.04500 g 23 1.035 g benzoate Vitamin
0.02500 g 23 0.575 g Premix Chromium 0.0001870 g 23 0.004301 g
picolinate Chromium 0.0001870 g 23 0.004301 g polynicolinate
Coenzyme Q10 0.03125 g 23 0.71875 g L-Glutamine 0.25000 g 23 5.75 g
Potassium 0.10000 g 23 2.3 g sorbate
Example 6
Base Composition for Series U
[0089]
6 Adjusted Base Composition (Dissolved in 1 gallon Select Water =
Adjusted Base Base Amount Mul- Base Composition Composition (grams)
tiplier Mixture) Magnesium 0.06000 g 23 1.38 g chloride Sodium
0.09000 g 23 2.07 g chloride Potassium 0.09000 g 23 2.07 g chloride
Calcium 0.06000 g 23 1.38 g chloride Ascorbic acid 0.50000 g 23
11.5 g (ester C) Caffeine 0.04750 g 23 1.0925 g Niacin 0.01000 g 23
0.23 g Potassium 0.04500 g 23 1.035 g benzoate Vitamin 0.02500 g 23
0.575 g Premix Chromium 0.0001870 g 23 0.004301 g picolinate
Chromium 0.0001870 g 23 0.004301 g polynicolinate Coenzyme Q10
0.03125 g 23 0.71875 g L-Glutamine 0.25000 g 23 5.75 g Potassium
0.10000 g 23 2.3 g sorbate Sodium nitrite 0.07250 g 23 1.6675 g
Example 7
Base Composition for Series V
[0090]
7 Adjusted Base Composition (Dissolved in 1 gallon Select Water =
Adjusted Base Base Amount Mul- Base Composition Composition (grams)
tiplier Mixture) Magnesium 0.06000 g 23 1.38 g chloride Sodium
0.09000 g 23 2.07 g ascorbate Potassium 0.09000 g 23 2.07 g
carbonate Calcium 0.06000 g 23 1.38 g ascorbate Ascorbic acid
0.50000 g 23 11.5 g (ester C) Caffeine 0.04750 g 23 1.0925 g Niacin
0.01000 g 23 0.23 g Potassium 0.04500 g 23 1.035 g benzoate Vitamin
0.02500 g 23 0.575 g Premix Chromium 0.0001870 g 23 0.004301 g
picolinate Chromium 0.0001870 g 23 0.004301 g polynicolinate
Coenzyme Q10 0.03125 g 23 0.71875 g L-Glutamine 0.25000 g 23 5.75 g
Potassium 0.10000 g 23 2.3 g sorbate Sodium nitrite 0.07250 g 23
1.6675 g
Example 8
Base Composition for Series K
[0091]
8 Adjusted Base Composition (Dissolved in 1 gallon Select Water =
Adjusted Base Base Amount Mul- Base Composition Composition (grams)
tiplier Mixture) Magnesium 0.06000 g 23 1.38 g chloride Sodium
0.09000 g 23 2.07 g chloride Potassium 0.09000 g 23 2.07 g chloride
Calcium 0.06000 g 23 1.38 g chloride Ascorbic acid 0.50000 g 23
11.5 g (ester C) Caffeine 0.09500 g 23 2.185 g Niacin 0.01000 g 23
0.23 g Potassium 0.04500 g 23 1.035 g benzoate Vitamin 0.02500 g 23
0.575 g Premix Chromium 0.0001870 g 23 0.004301 g picolinate
Chromium 0.0001870 g 23 0.004301 g polynicolinate Coenzyme Q10
0.06250 g 23 1.4375 g L-Glutamine 0.25000 g 23 5.75 g Potassium
0.10000 g 23 2.3 g sorbate
Example 9
Base Composition for Series L
[0092]
9 Adjusted Base Composition (Dissolved in 1 gallon Select Water =
Adjusted Base Base Amount Mul- Base Composition Composition (grams)
tiplier Mixture) Magnesium 0.06000 g 23 1.38 g chloride Sodium
0.09000 g 23 2.07 g ascorbate Potassium 0.09000 g 23 2.07 g
carbonate Calcium 0.06000 g 23 1.38 g ascorbate Ascorbic acid
0.50000 g 23 11.5 g (ester C) Caffeine 0.09500 g 23 2.185 g Niacin
0.01000 g 23 0.23 g Potassium 0.04500 g 23 1.035 g benzoate Vitamin
0.02500 g 23 0.575 g Premix Chromium 0.0001870 g 23 0.004301 g
picolinate Chromium 0.0001870 g 23 0.004301 g polynicolinate
Coenzyme Q10 0.06250 g 23 1.4375 g L-Glutamine 0.25000 g 23 5.75 g
Potassium 0.10000 g 23 2.3 g sorbate
Example 10
Base Composition for Series M
[0093]
10 Adjusted Base Composition (Dissolved in 1 gallon Select Water =
Adjusted Base Base Amount Mul- Base Composition Composition (Grams)
tiplier Mixture) Magnesium 0.06000 g 23 1.38 g chloride Sodium
0.09000 g 23 2.07 g chloride Potassium 0.09000 g 23 2.07 g chloride
Calcium 0.06000 g 23 1.38 g chloride Ascorbic acid 0.50000 g 23
11.5 g (ester C) Caffeine 0.09500 g 23 2.185 g Niacin 0.01000 g 23
0.23 g Potassium 0.04500 g 23 1.035 g benzoate Vitamin 0.02500 g 23
0.575 g Premix Chromium 0.0001870 g 23 0.004301 g picolinate
Chromium 0.0001870 g 23 0.004301 g polynicolinate Coenzyme Q10
0.06250 g 23 1.4375 g L-Glutamine 0.25000 g 23 5.75 g Potassium
0.10000 g 23 2.3 g sorbate Sodium 0.07250 g 23 1.6675 g nitrite
Example 11
Base Composition for Series N
[0094]
11 Adjusted Base Composition (Dissolved in 1 gallon Select Water =
Adjusted Base Base Base Amount Mul- Composition Composition (Grams)
tiplier Mixture) Magnesium 0.06000 g 23 1.38 g chloride Sodium
0.09000 g 23 2.07 g ascorbate Potassium 0.09000 g 23 2.07 g
carbonate Calcium 0.06000 g 23 1.38 g ascorbate Ascorbic acid
0.50000 g 23 11.5 g (ester C) Caffeine 0.09500 g 23 2.185 g Niacin
0.01000 g 23 0.23 g Potassium 0.04500 g 23 1.035 g benzoate Vitamin
0.02500 g 23 0.575 g Premix Chromium 0.0001870 g 23 0.004301 g
picolinate Chromium 0.0001870 g 23 0.004301 g polynicolinate
Coenzyme Q10 0.06250 g 23 1.4375 g L-Glutamine 0.25000 g 23 5.75 g
Potassium 0.10000 g 23 2.3 g sorbate Sodium 0.07250 g 23 1.6675 g
nitrite
Example 12
Base Composition for Series W
[0095]
12 Adjusted Base Composition (Dissolved in 1 gallon Select Water =
Adjusted Base Base Amount Mul- Base Composition Composition (grams)
tiplier Mixture) Magnesium 0.06000 g 23 1.38 g chloride Sodium
0.09000 g 23 2.07 g ascorbate Potassium 0.09000 g 23 2.07 g
carbonate Calcium 0.06000 g 23 1.38 g ascorbate Ascorbic acid
0.50000 g 23 11.5 g (ester C) Caffeine 0.04750 g 23 1.0925 g Niacin
0.01000 g 23 0.23 g Potassium 0.04500 g 23 1.035 g benzoate Vitamin
0.02500 g 23 0.575 g Premix Chromium 0.0001870 g 23 0.004301 g
picolinate Chromium 0.0001870 g 23 0.004301 g polynicolinate
Coenzyme Q10 0.03125 g 23 0.71875 g L-Glutamine 0.25000 g 23 5.75 g
L-Arginine 0.25000 g 23 5.75 g Potassium 0.10000 g 23 2.3 g sorbate
Sodium 0.07250 g 23 1.6675 g nitrite
Example 13
Base Composition for Series X
[0096]
13 Adjusted Base Composition (Dissolved in 1 gallon Select Water =
Adjusted Base Base Amount Mul- Base Composition Composition (grams)
tiplier Mixture) Magnesium 0.06000 g 23 1.38 g chloride Sodium
0.09000 g 23 2.07 g ascorbate Potassium 0.09000 g 23 2.07 g
carbonate Calcium 0.06000 g 23 1.38 g ascorbate Ascorbic acid
0.50000 g 23 11.5 g (ester C) Caffeine 0.04750 g 23 1.0925 g Niacin
0.01000 g 23 0.23 g Potassium 0.04500 g 23 1.035 g benzoate Vitamin
0.02500 g 23 0.575 g Premix Chromium 0.0001870 g 23 0.004301 g
picolinate Chromium 0.0001870 g 23 0.004301 g polynicolinate
Coenzyme Q10 0.03125 g 23 0.71875 g L-Glutamine 0.25000 g 23 5.75 g
L-Arginine 0.25000 g 23 5.75 g Potassium 0.10000 g 23 2.3 g
sorbate
Example 14
Typical Oral Strip Ingredients
[0097]
14 Component Results (mg/strip) Nitrate <0.002 Nitrite
<0.0002 Calcium 0.1279 Chromium 0.000055 Magnesium 0.037
Manganese 0.00001 Potassium 0.23 Sodium 2.442
Example 15
Dosage Gradient Within a Series
[0098]
15 S-1 Generates a biochemical signal for sleep (almost
unconscious) S-2 Generates a biochemical signal for relaxation S-3
Generates a biochemical signal for calmness S-4 Generates a
biochemical signal for decreased anxiety S-5 Generates a
biochemical signal for increased mental alertness S6-S7 Generates a
biochemical signal for increased mental acuity and focus S-8
Generates a biochemical signal for increased energy S-9 Generates a
biochemical signal for further increased energy without the
sensation of a lactic acid burn S-10 Generates a biochemical signal
for enhanced energy sensation.
Example 16
RDA/UL Values for Some Nutrients
[0099]
16 Nutrient RDA (mg/day) UL (mg/day) Folate 0.4 1 Niacin 16 35
Pantothenic Acid 5 ND Vitamin B2 1.3 ND Vitamin B1 1.2 ND Vitamin A
0.9 3 Vitamin B6 1.3 100 Vitamin B12 2.4 ND Vitamin C 75 2000
Vitamin D 5 50 Vitamin E 15 1000 Vitamin K 0.12 ND Calcium 1000
2500 Chromium 0.035 ND Copper 0.9 10 Fluoride 4 10 Iodine 0.15 1.1
Iron 8 45 Magnesium 320 350 Manganese 2.3 11 Molybdenum 0.045 2
Phosphorus 700 4000 Selenium 0.055 0.4 Vanadium ND 1.8 Zinc 11
40
Example 17
Typical RDA/UL Percentages of Final Formulation (5 Drops)
[0100]
17 US Dietary Guidelines Percentage Diluted (For Men 25-50
Difference between Base Amounts Per Amount in years old) Dosage and
the US Ingredients amounts (g) Gallon (g) 5 drops (g) (g) Dietary
Guidelines Magnesium 1.3800 5.39E-03 2.77E-07 0.35 RDA 0.00007920%
Chloride Sodium Chloride 2.0700 8.09E-03 4.16E-07 2.4 RDA
0.00001733% Potassium 2.0700 8.09E-03 4.16E-07 4 DV 0.00001040%
Chloride Calcium Chloride 1.3800 5.39E-03 2.77E-07 1.2 RDA
0.00002310% Ascorbic Acid 11.5000 4.49E-02 2.31E-06 2 UL
0.00011551% (ester C) Caffeine 1.0925 4.27E-03 2.19E-07 0.24
0.00009144% Niacin 0.2300 8.98E-04 4.62E-08 0.035 UL 0.00013201%
Potassium 1.0350 4.04E-03 2.08E-07 4 DV 0.00000520% Benzoate
Chromium 0.0043 1.68E-05 8.64E-10 0.00012 DV 0.00071999% Picolinate
Chromium 0.0043 1.68E-05 8.64E-10 0.00012 DV 0.00071999%
Polynicolinate Coenzyme Q10 0.7188 2.81E-03 1.44E-07 N/A
L-Glutamine 5.7500 2.25E-02 1.16E-06 N/A Potassium Sorbate 2.3000
8.98E-03 4.62E-07 4 DV 0.00001155% Vitamin A 0.2371 9.26E-04
4.76E-08 2 0.00000238% Vitamin B1 0.0041 1.62E-05 8.33E-10 0.0011
RDA 0.00007569% Vitamin B2 0.0031 1.22E-05 6.29E-10 0.0013 RDA
0.00004837% Vitamin B3 0.0399 1.56E-04 8.02E-09 0.035 UL
0.00002292% Vitamin B6 0.0399 1.56E-04 8.02E-09 0.1 UL 0.00000802%
Vitamin B12 0.0000 4.68E-08 2.41E-12 0.0000024 RDA 0.00010027%
Vitamin C 0.1198 4.68E-04 2.41E-08 2 UL 0.00000120% Vitamin D3
0.0190 7.41E-05 3.81E-09 0.00005 UL 0.00762078% Vitamin E 0.0014
5.40E-06 2.78E-10 1 UL 0.00000003% Vitamin H 0.0004 1.40E-06
7.22E-11 0.00003 AI 0.00024064% Folic Acid 0.0004 1.50E-06 7.70E-11
0.001 RDA 0.00000770% Copper 0.0018 6.86E-06 3.53E-10 0.002 DV
0.00001765% Iron 0.0153 5.96E-05 3.06E-09 0.01 RDA 0.00003064%
Potassium Iodide 0.0001 5.12E-07 2.64E-11 4 DV 0.00000000% Calcium
0.0799 3.12E-04 1.60E-08 1.2 RDA 0.00000134% Carbonate Zinc 0.0129
5.02E-05 2.58E-09 0.015 RDA 0.00001722%
[0101] The invention has now been described in such full, clear,
concise and exact terms as to enable any person skilled in the art
to which it pertains, to practice the same. It is to be understood
that the foregoing describes preferred embodiments and examples of
the invention and that modifications may be made therein without
departing from the spirit or scope of the invention as set forth in
the claims.
* * * * *