Drink product and use thereof

Abstract

A drink product having pharmaceutical compositions as an active ingredients of, at least one phosphorylated inositol, optionally Genistein, optionally Ubiquinol, and optionally additional unphosphorylated inositol. Uses for prevention, treatment, and reduction in risk of developing or progression of a number of conditions are disclosed.

Claims

1. An aqueous liquid formulation, comprising: (a) water; (b) at least one phosphorylated inositol isomer selected from myoinositol hexaphosphate or an orally-acceptable salt thereof, at a concentration of about 0.5 to about 4% (w/v); (c) N-Acetyl-L-cysteine; (d) about 0.025 to about 0.05% (w/v) L-Ascorbic acid or L-Ascorbate; (e) Genistein; and (f) a liposomal-encapsulated Ubiquinol, wherein the ratio of the liposomal-encapsulated ubiquinol to the myoinositol hexaphosphate or the orally-acceptable salt thereof is 1:2.5 to 1:25 (w/v).

2. The formulation of claim 1, further comprising at least one unphosphorylated inositol or optical isomer thereof, present in the form as the inositol isomer in the phosphorylated inositol isomer.

3. The formulation of claim 1, further comprising at least one unphosphorylated inositol or optical isomer thereof, present in a different inositol isomeric form from that of the phosphorylated inositol isomer.

4. The formulation of claim 1, further comprising Luteolin.

5. The formulation of claim 1, further comprising Resveratrol.

6. The formulation of claim 1, further comprising Catechin.

7. The formulation of claim 6, wherein the Catechin is (—)-Catechin gallate.

8. The formulation of claim 1, further comprising Rutin.

9. The formulation of claim 8, wherein the Rutin is Rutin hydrate.

10. The formulation of claim 1, wherein the myoinositol hexaphosphate is present in the formulation at about 0.5 to about 4% (w/v).

11. The formulation of claim 1, wherein the molar ratio of myoinositol hexaphosphate to unphosphorylated myoinositol is about 6:1 to 1:6.

12. The formulation of claim 1, wherein the molar ratio of myoinositol hexaphosphate to unphosphorylated myoinositol is about 1:1.

13. The formulation of claim 1, wherein the L-Ascorbic acid is present in the formulation in an amount of about 22.5 to about 90 mg.

14. The formulation of claim 1, wherein the Genistein is present in the formulation in an amount of about 1 to about 5 mg.

15. The formulation of claim 1, further comprising Vitamin B12.

16. The formulation of claim 1, further comprising Vitamin B12 in an amount of 0.12 to 0.48 μg (w/v).

17. The formulation of claim 1, wherein the formulation is a liquid nutritional supplement formulated for oral delivery.

18. An aqueous liquid formulation, comprising: (a) water; (b) at least one phosphorylated inositol isomer selected from myoinositol hexaphosphate or an orally-acceptable salt thereof, at a concentration of 0.5 to 4% (w/v); (c) N-Acetyl-L-cysteine; (d) 0.025 to 0.05% (w/v) L-Ascorbic acid or L-Ascorbate; (e) Genistein; and (f) a liposomal-encapsulated Ubiquinol, wherein the ratio of the liposomal-encapsulated ubiquinol to the myoinositol hexaphosphate or the orally-acceptable salt thereof is 1:2.5 to 1:25 (w/v).

Description

DETAILED DESCRIPTION OF THE INVENTION

(1) The present invention is an oral, aqueous liquid formulation containing one or more of a phosphorylated myoinsoitol (or optical isomer thereof), including without limitation the various mono-, di-, tri-, tetra-, penta-, or hexaphosphates or any mono-, di-, tri- or tetra-pyrophosphate groups, (or combinations thereof up to and including 9 phosphate groups, where a pyrophopsphate is counted as 2 phosphate groups). As used herein, when the term “inositol” is used without any designation as to the particular isomer involved it is to be construed as the genus of all 90f the optical isomers thereof unless the context of the particular sentence of paragraph require otherwise. The mono phosphates can be selected from those having the phosphate group at positions 1, 2, 3, 4, 5, or 6 of the inositol 6 member ring. The di-monphosphates can be selected from the those having the 1,2-, 1,3-, 1,4-, 1,5-, 1,6-, 2,3-, 24-, 2,5-, 2,6-, 3,4-, 3,5-, 3,6-, 4,5-, 4,6-, and 5,6-diphosphate substitution pattern. The tri-monophosphates can be selected from those having the 1,2,3-, the 1,2,4-, 1,2,5-, 1,2,6-, 2,3,4-, 2,3,5-, 2,3,6-, 2,4,5-, 2,4,6-, 2,5,6-, 3,4,5-, 3,4,6-, and 4,5,6-trimonophosphate substitution pattern. The tetramonophosphates can be selected from those having the 1,2,3,4- 1,2,3,5-, 1,2,3,6-, 1,2,4,5-, 1,2,4,6-, 1,3,4,5-, 1,3,4,6-, 1,4,5,6-, 2,3,4,5-, 2,3,4,6-, 2,4,5,6-, and 3,4,5,6-tetramonophosphate substitution pattern. The pentamonophosphates can be selected from those having the 1,2,3,4,5-, 1,2,3,4,6-, 1,2,3,5,6-, 1,2,4,5,6-, 1,3,4,5,6-, and 2,3,4,5,6-pentamonophosphate substitution pattern. The pyrophosphated inositols can be selected from those having up 1-4 pyrophosphate groups. The monopyrophosphates can be selected from those having the pyrophosphate group at positions 1, 2, 3, 4, 5, or 6 of the inositol 6 member ring. The di-pyrophosphates can be selected from the those having the 1,2-, 1,3-, 1,4-, 1,5-, 1,6-, 2,3-, 24-, 2,5-, 2,6-, 3,4-, 3,5-, 3,6-, 4,5-, 4,6-, and 5,6-dipyrophosphate substitution pattern. The tri-pyrophosphales can be selected from those having the 1,2,3-, the 1,2,4-, 1,2,5-, 1,2,6-, 2,3,4-, 2,3,5-, 2,3,6-, 2,4,5-, 2,4,6-, 2,5,6-, 3,4,5-, 3,4,6-, and 4,5,6-tripyrophosphate substitution pattern. The tetrapyrophosphates can be selected from those having the 1,2,3,4- 1,2,3,5-, 1,2,3,6-, 1,2,4,5-, 1,2,4,6-, 1,3,4,5-, 1,3,4,6-, 1,4,5,6-, 2,3,4,5-, 2,3,4,6-, 2,4,5,6-, and 3,4,5,6-tetrapyrophsophate substitution pattern. Combinations of monophosphate and pyrophosphate substitutions in a single compound are also possible and may be selected from any of the mono-monophosphates, di-monophosphates, trimonophosphates, tetramonophosphates, and pentamonophosphates mentioned above having pyrophosphate groups on any of the remaining available positions that are not monophosphated so long as the number of monophosphate groups+twice the number of pyrophosphate groups does not exceed 9. Preferably, the phosphorylated compounds are selected from tetra-monophosphate, penta-monophosphate, hexamonophosphate, petamonophosho-monopyrophosphate, and tetrmonophophospho-dipyrophosphate. Particularly preferred are myoinositol hexaphosphate (IPO), myoinositol pentaphosphate, myoinositolpentamonophospho-monopyrophosphate, myoinositoltetramonophospho-dipyrophosphate, the corresponding phosphated (inclusive of pyrophosphorylated) D-chiroinositol analogs thereof, and the corresponding phosphated (inclusive of pyrophosphorylated) scylloinositol analogs thereof. The phosphorylated inositol component is in an effective amount as a nutritional supplement; and/or an effective amount as a medicinal for the treatment of, prevention of, or reduction of the risk of developing a cancer including, without limitation, of the skin, lung, multiple myeloma, leukemia, prostate, ovarian, pancreatic, breast, liver, throat, even viral HPV induced throat cancer, or colon; and/or an effective amount for the treatment of, prevention of, and/or reduction in the risk of damage to cells caused by reactive oxygen species (ROS). Other utilities and aspects of the present invention include protection of those going to high elevations (particularly pilots, extreme mountain climbers, as well as astronauts) as a protectant prophylactically against radiation exposure due to lesser protective effects of the atmosphere against ambient radiation, and environmental toxins. i.e., car exhaust, pollution, radiation, and known toxic free radical generating chemicals. (One particularly troublesome group of compound in the environment includes phthalates, which are known to generate free radical oxygen species in-vivo, and thus, the present invention is useful to offset the undesirable effects thereof.) Similarly, the present invention is also useful as a prophylactic measure against some of the accidental or routine radiation exposure involved with nuclear power plant operators and those involved in mining and refining of radioactive materials. It should be realized that the present invention is not expected to fully cure or fully prevent such effects of radiation exposure, but is of use in minimizing or reducing the effects that would result in the absence of use of the invention or any other preventative measure. Still further utilities for the present invention include usage before, during, or after radiation treatments, which radiation treatments are either for disease treatment (as in radiation for cancer therapy) or diagnostic purposes, such as CAT scans, X-rays, etc., as a partial protectant against at least some of the undesirable effects of such radiation exposure. Human exposure to urban air pollution may trigger toxic responses in brain cells, impacting neurodegenerative disease pathways. As such, the present invention is of use in the prevention and/or treatment of neurodegenerative disease states such as, without limitation, Alzheimer's and brain tumors. A particularly preferred non-limiting embodiment for such neurodegenerative conditions is one which utilizes at least one inositol or inositol phosphate(s) having the scylloinositol optical isomer configuration.

(2) In addition to the phosphorylated inositol (any inoitol isomer) component and water, the formulations optionally may also contain, one or more of (any) unphosphorylated inositol. (in one non-limiting embodiment, the unphosphorylated inositol is myoinositol and the phosphorylated inositol is myoinositol hexaphosphate.) Still further optional components of the present formulation include nutritionally acceptable monovalent electrolytes (including without being limited thereto, cations such as, without limitation sodium, and potassium, and anions such as, without limitation chloride; non-limiting examples of which include sodium chloride, and potassium chloride) as are known in the nutritional supplement arts and/or vitamins (including, without limitation thereto the B vitamins (including without limitation thiamine (vitamin B1); riboflavin (vitamin B2); niacin and/or nicotinamide (vitamin B3); pantothenic acid (vitamin B5); pyridoxine, pyridoxal, pyridoxamine, and/or pyridoxine HCl (vitamin B6); biotin (vitamin B7); folic acid (vitamin 89), and cobalamine (vitamin 812) and vitamin C), as well as herbal extracts. (Nutritionally available salts and esters of the various vitamins may be used in place of the specifically stated vitamin.) The above vitamins and electrolytes are used in amounts such that from 1 to 4 doses (whether as 30 ml, 60 ml, 90 ml, 120 ml, 150 ml, 180 ml, or 240 mil per dose) delivers from %/4 to the full US RDA independently for each one present in a particular formulation (although lesser amounts are acceptable but just not preferred). The formulations of the invention may also optionally contain one or more of flavors (such as without limitation, coconut, grape, blueberry, pomegranate, apple, strawberry, kiwi, dragonftuit, lemon, lime, raspberry, mango, etc), sweeteners (such as without limitation, sucrose, fructose, glucose, stevia, aspartame, rebaudioside A, sucralose, mannitol, xylitol, syrups, etc.), colorings, stabilizers, pH adjusters, preservatives (such as without limitation, sodium benzoate), etc, as well as thickeners and processing aids as may be generally known in the beverage and/or liquid nutritional supplement arts in amounts generally known as acceptable in the art.

(3) Effective amounts of the phosphorylated inositol component (or optical isomers thereof, when used without other inositol components range from about 0.5 to about 4% (w/v), preferably about 0.75 to about 3% w/v, more preferably about 1 to about 2.5% w/v, still more preferably about 1.1 to about 2% w/v, even more preferably 1.2 to about 1.5% w/v, and most preferably about 1.25% w/v, most preferable & effective dose 2%-4% (w/v) phosphorylated inositol with a daily dosing typically in the range such that about 0.5 to about 18 grams per day, preferably about 1.0 to about 15 grams per day, more preferably about 1.2 to about 10 grams per day, still more preferably about 2.4 to about 8 grams per day, yet more preferably about 3.6 to about 7 grams per day, and most preferably about 4.8 grams to about 5.5 grams per day of phosphorylated inositol is administered. When combined with myoinositol, the phosphorylated component is combined with the unphosphorylated inositols (preferably myoinositol) in a ratio of the phosphorylated component to unphosphorylated inositols (most preferably myoinositol) of about 6:1 to 1:6, preferably about 5:1 to about 1:5, more preferably about 4:1 to about 1:4, still more preferably about 3:1 to about 1:3, even more preferably about 2:1 to about 1:2, most preferably about 1:1, each being a molar ratio. Other suitable ratios include, without limitation, preferably about 4.5:1 to about 1:1, more preferably about 4.25:1 to about 3:1, still more preferably about 4:1 of the phosphorylated inositol component to unphosphorylated inositols (a non-limiting preferred being myoinositol) on a molar basis. Nonetheless, the specific concentration in a given drink may be more or less (including multiple times or fractions thereof (if the volume of the drink per daily dose is properly adjusted to compensate therefore). Thus, for example, for a 1.25% w/v solution of myoinositolhexaphosphate (IP6), where a drink is intended to deliver 3000 mg/240 ml with a serving or dose size of 240 ml (i.e. to deliver a 6 g dose of myoinositol hexaphosphate in two 240 ml doses, typically administered as 240 ml twice daily), an alternate drink having 1500 mg/120 ml with a serving or dose size of 120 ml (either taken 4 times a day or in the situation where a lower dosing is desired, less frequently), or another alternate of 62.5 mg/5 ml where significantly lower amounts are desired. Adjustment of dosings for smaller than average or larger than average adults or for adolescents or children will generally be within the skill of one of ordinary skill in the art given the foregoing ranges for a typical adult. When used in combination with other inositol species, the specific amount of phosphorylated component may be reduced somewhat, but preferably, the other inositol species are added to the above mentioned amounts of the phosphorylated component. In one particularly preferred embodiment, the invention has myoinositolohexaphosphate optionally with or without myoinositol as the only inositol species. When an IP6 is used in combination with an unphosphorylated inositol, the most preferred ratio is stated above is a molar ratio of 1:1 and in a most preferable, but non-limiting embodiment, the total daily dose of such a ratio is about 4.8 grams of the myoIP6 (or isomer thereof) together with 1.32 grams of the unphosphorylated myoinositol (or isomer thereof).

(4) As to the inositol optical isomers that may be used for the invention there are myoinositol, scylloinositol, mucoinositol. D-chiroinositol, L-chiroinositol, neoinositol, alloinositol, epiinositol, and/or cisinositol, with myoinositol, and D-chiroinositol being preferred and myoinositol being most preferred. As to the isomers of the phosphorylated inositol component, one may use the any of the phosphates and pyrophosphates set forth in paragraph 0031 above with any of the inositol optical isomers of the preceding sentence, with myoinositol hexaphosphate, D-chiroinositol hexaphosphate, and scylloinositol hexaphopshate being non-limiting preferred species and myoinositol hexaphosphate being a non-limiting most preferred species.

(5) As the optional free radical scavengers, any orally acceptable free radical scavenger known in the art is a is acceptable for use in the present invention, for example, without limitation, N-Acetyl-L-cysteine. L-Ascorbic acid. Balsalazide (typically available as the disodium salt hydrate), Caffeic acid, (−)-Catechin gallate, Chlorogenic acid, Delphinidin chloride, Diosmin, Ellagic acid, (−)-Epicatechin, Fucoxanthin carotenoid antioxidant. (−)-Gallocatechin, (−)-Gallocatechin gallate, Gallic acid, Ginkgolide B, 3-Hydroxytyrosol, Luteolin, Lycopene, Neochlorogenic acid, Resveratrol, Rutin hydrate, Seleno-L-methionine, Se-(Methyl)selenocysteine hydrochloride, Ubiquinol (liposomal encapsulated Qunol) CoQ10, and Sodium selenite, most preferably L-ascorbic acid. The optional orally acceptable free radical scavengers can be used in amounts generally known as acceptable in the art; when ascorbic acid is used, it is preferably present in amounts of about 30 mg/120 ml of solution (i.e., about 0.025% w/v) or 60 mg/120 ml of solution (about 0.05% w/v). Although, optional, of these, Ubiquinol in an orally administrable, absorbable form is a non-limiting, but particularly preferred species. Such orally administrable and absorbable forms of Ubiquinol are set forth in U.S. Pat. No. 6,455,072 which is incorporated herein in its entirety by reference. When used, the Ubiquinol is present in an amount of up to about 300 mg Ubiquinol per dose, preferably up to about 250 mg, more preferably up to 200 mg. In other embodiments, the Ubiquinol is present in at least 50 mg/dose, at least 100 mg/dose, and most preferably at about 200 mg/dose.

(6) An additional known free radical/reactive oxygen scavenger, for use in the present invention is Genistein. In the present invention, when Genistein is used, it is used in amounts in the range (in mg/kg/day) of from a lower end of about 1 to about 5 mg to an upper range end of about 10 to about 50 mg. Exemplary dosing ranges (in mg/kg/day) include (without limitation) those with a range lower limit of about 1 mg, about 2 mg, about 3 mg, about 4 mg, about 5 mg, about 6 mg, about 7 mg, about 8 mg, about 9 mg, about 10 mg, about 12.5 mg, about 15 mg, about 17.5 mg, about 20 mg, about 25 mg, about 30 mg, about 35 mg, and about 40 mg and having an upper end point of the range selected from about 10 mg, about 12.5 mg, about 15 mg, about 17.5 mg, about 20 mg, about 25 mg, about 30 mg, about 35 mg, about 40 mg, about 45 mg, and about 50 mg. Within these ranges, preferred dosages are in the range (in mg/kg/day) of about 1 to about 30 mg, more preferably about 2 to about 20 mg, still more preferably about 3 to about 15 mg, even more preferably about 5 to about 12.5 mg, most preferably about 10 mg. In the present invention, when Genistein is used, it is used in combination with one or more the other inositiol isomers and/or the inositol hexaphosphate isomers mentioned herein, preferably the Genistein is used in combination with at least one unphosphorylated inositol isomer and at least one phosphorylated inositol isomer, most preferably at least one of a tetramonophosphate, a pentamonophosphate, a hexamonophosphate, a pentamonophospho-monopyrophosphate, a tetramonophospho-dipyrophosphate of at least one inositol isomer. In some particulaily preferred embodiments myoinsitol hexaphosphate and myoinositol is used. In others, the corresponding hexaphosphate and unphosphorylated combination of the other inositol isomers are used in which the phosphphorylated component is the hexaphosphate of the unphosphorylated inositol used. Whether the Genistein is used in combination with inositols which are (a) only phosphorylated inositol isomers, or (b) combinations of unphosphorytlated inositol isomers AND phosphorylated inositol isomers, the benefits of the invention may be obtained. The non-limiting preferred unphosphorpylated inostitol isomers for the Genastein containing embodiments are selected from myoinositol, D-chiroinositol, and scylloinositol. Independently, the preferred phosphorylated inositol isomers for use in the Genistein containing embodiments are selected from myoinositol phosphates, D-chiroinositol phosphates, and scylloinositol phosphates (each inclusive of the full range of monophosphato and pyrophosphate- and mixed monophosphato-pyrophosphato groups set forth above). These Genistein and Insoitol isomeric combinations (whether phosphorylated or unphosphorylated or both) may be used as is or in combination with the other (non-inositol type) components (mentioned herein) in analogous manners as set forth herein with respect to the compositions that do not mention Genistein specifically.

(7) The combination use of Genistein and the inositols and/or the inositol phosphates as described above gives rise to the ability to prevent, delay, modulate, reduce, and treat HIV infections, in a substantially enhanced, substantially non-toxic manner, especially as compared to current medicinal agents for use in the treatment and prophylaxis for HIV. Neither the inositol components nor the Genistein component have the known side effects or associated drug toxicities' and/or drug resistance known to occur with current drugs used to treat HIV and/or AIDS cancers and disseminated diseases due to being plant-based, will likely side step the toxicity issues faced with current drugs, a common occurrence or by product of the everyday and life-long use of the pharmaceutical based regimen faced by HIV positive individuals. This product can be preventive, also an adjunct and/or complementary treatment because patients over time do become resistant to their drugs due to HIV mutant infections known to occur in this disease as well as in cancer. Without being confined to the theory, it is believed that instead of acting directly with the virus, Genistein blocks the many cellular processes that appear to be necessary for the virus to infect cells by inducing a conformational change. This conformational change and signal block works along with the inositol isomer components (whether or not phosphorylated) in a synergistic manner with lesser side effects, and better compliance and better user acceptability to achieve positive outcomes in both cancer and HIV. This allows for impeding viral DNA synthesis and cancer growth and/or impeding viral nuclear migration so that the invention Genistein containing compositions can be used in the prevention, treatment, and amelioration of HIV infection of immune cells, especially resting CD4 T-cells.

(8) The present invention offers phosphorylated inositols in an aqueous oral form as a means to reap the therapeutic benefits of this natural product, particularly in lieu of or in addition to a diet high in fiber. One of the advantages of the present invention is that the delivery of undigested phytate IP6 and the other inositol species are in a form in which they are not captured and broken down as readily as solid forms containing these agents.

(9) As previously described, the present invention formulation is used for an oral delivery of the active agents therein for the prevention and/or treatment and/or reduction of the risk of developing cancers such as, without limitation, one or more of skin cancer (inclusive of squamous, basal, and melanoma), breast, prostate, ovarian, pancreatic, lung cancer, colon cancer liver cancer, bone cancer, soft tissue cancer, muscular cancer (such as without limitation,) or a blood cancer (such as without limitation a leukemia)(or as described in Table A above) and/or treatment of damage and/or prevention of damage and/or reduction of the risk of damage to cells by reactive oxygen species free radicals that are generated in the body due to environment or metabolic insult. Environmental or metabolic insult may arise from exposure to a wide variety of factors, including radiation, known carcinogens, and known free oxygen radical generating substances (such as in, without limitation, cigarette smoke, pollutants, radiation exposure (whether natural, or created in the workplace, or incident to diagnostic tests and medical treatments, etc.). For the above purposes, a suitable (non-limiting, exemplary) dose of a formulation of the present invention having about 1% to about 4% w/v of myoinositol hexaphosphate (and/or optical isomer thereof) or other phosphorylated species of myoinositol or its isomers as set forth above (mono-nona phosphates) therein in an amount of about 30 ml to about 480 ml, preferably about 60 ml to about 360 ml, more preferably 90 ml to about 270 ml, still more preferably 360 ml, about 120 ml to about 240 ml, most preferably about 180 ml to about 240 ml at least once to 2 times per day, with variations thereon that will be recognized by those of ordinary skill in the art for delivery of about 3 g to about 9 g of myoinositol hexaphosphate (and/or optical isomers thereof) or of the other corresponding phosphates having from 1 to 9 phosphate groups (inclusive of those having pyrophosphate groups in which each pyrophosphate is counted as two of the up to 9 phosphates) on a daily basis for an average adult in 1-2 or 2-4 divided doses a day.

(10) The formulations of the present invention most preferably have the inositol components thereof in solution and preferably are clear, although non-inositol portions of the formulation may make the solution less than completely clear without departing from the invention.

(11) The following non-limiting examples are exemplary only and do not have any limiting effect on the present invention.

Example 1

(12) The following Table I represents a set of inositol hexaphosphate isomers (alone or with an unphosphorylated inositol) for use in the present invention. Table II specifies amounts of the hexaphosphated inositol and the unphosphorylated inositol components, and each is applied independently to the 90 combinations in Table I. For clarity, all of the “A” cells in Table 1 have the respective hexaphosphate mentioned in the left hand column with no unphosphorylated inositol component. All of the “B” cells of Table I have the respective hexaphosphate in combination with unphosphorylated myo-inositol.

(13) TABLE-US-00002 TABLE I Hexaphosphate Unphosphphorylated Component Component A B C D E F G H I J 1. Myo- None Myo- Scyllo- Muco- D-chiro- L-chiro- Neo- Allo- Epi- Cis- inositol inositol inositol inositol inositol inositol inositol inositol inositol inositol Hexaphosphate 2. scyllo- None Myo- Scyllo- Muco- D-chiro- L-chiro- Neo- Allo- Epi- Cis- inositol inositol inositol inositol inositol inositol inositol inositol inositol inositol Hexaphosphate 3. Muco- None Myo- Scyllo- Muco- D-chiro- L-chiro- Neo- Allo- Epi- Cis- inositol inositol inositol inositol inositol inositol inositol inositol inositol inositol Hexaphosphate 4. D-chiro- None Myo- Scyllo- Muco- D-chiro- L-chiro- Neo- Allo- Epi- Cis- inositol inositol inositol inositol inositol inositol inositol inositol inositol inositol Hexaphosphate 5. L-chiro- None Myo- Scyllo- Muco- D-chiro- L-chiro- Neo- Allo- Epi- Cis- inositol inositol inositol inositol inositol inositol inositol inositol inositol inositol Hexaphosphate 6. Neo- None Myo- Scyllo- Muco- D-chiro- L-chiro- Neo- Allo- Epi- Cis- inositol inositol inositol inositol inositol inositol inositol inositol inositol inositol Hexaphosphate 7. allo- None Myo- Scyllo- Muco- D-chiro- L-chiro- Neo- Allo- Epi- Cis- inositol inositol inositol inositol inositol inositol inositol inositol inositol inositol Hexaphosphate 8. epi- None Myo- Scyllo- Muco- D-chiro- L-chiro- Neo- Allo- Epi- Cis- inositol inositol inositol inositol inositol inositol inositol inositol inositol inositol Hexaphosphate 9. Cis- None Myo- Scyllo- Muco- D-chiro- L-chiro- Neo- Allo- Epi- Cis- inositol inositol inositol inositol inositol inositol inositol inositol inositol inositol Hexaphosphate

(14) TABLE-US-00003 TABLE II % are w/v unless noted otherwise I II III IV V VI VII VIII IX Hexaphosphated    1%   2%   4%   1%   2%   4%   1%   2%   4% inositol of Table I Unphosphorylated 0.135% 0.27% 0.54% 0.27% 0.54% 1.08% 0.54% 1.08% 2.16% inositol of Table I When present* Ascorbic acid 0.025% 0.025%  0.025%  0.05% 0.05% 0.05%  0.1%  0.1%  0.1% Water qs to qs to qs to qs to qs to qs to qs to qs to qs to 240 ml. 240 ml. 240 ml. 240 ml. 240 ml. 240 ml. 240 ml. 240 ml. 240 ml. *Molar ratios of hexaphosphates to unphosphorylated inositol in above Table II are either 0.5:1 or 1:1, or 2:1

(15) Each of the 810 formulations resulting from Tables I and II are packaged for introduction into the marketplace. For the sake of clarity, a Table I cell 1B Table II Col I formulation has 1% myoinositol hexaphosphate; 0.135% myoinositol.

Example 2

(16) The following Table 11 utilizes each of the separate formulations of Example 1 except that additional nutritional supplement components are added. The amounts in Table III are expressed as % of the US Recommended Daily Allowance (USRDA) for the particular component in question, or if in mg, then mg/240 ml of solution.

(17) TABLE-US-00004 TABLE IIIA Vitamin Or electrolyte a b c d e f g h i B1 5% 10% 15% 20% 5% 10% 15% 20% 5% B2 5% 10% 15% 20% 5% 10% 15% 20% 5% B3 5% 10% 15% 20% 5% 10% 15% 20% 5% B5 5% 10% 15% 20% 5% 10% 15% 20% 5% B6 5% 10% 15% 20% 5% 10% 15% 20% 5% B7 5% 10% 15% 20% 5% 10% 15% 20% 5% B9 5% 10% 15% 20% 5% 10% 15% 20% 5% B12 5% 10% 15% 20% 5% 10% 15% 20% 5% sodium 110 mg 110 mg 110 mg 110 mg 110 mg 110 mg 110 mg 110 mg 110 mg potassium 450 mg 450 mg 450 mg 450 mg 450 mg 450 mg 450 mg 450 mg 450 mg

(18) Each of the formulations in Tables I-IIIA have the further optional electrolytes and supplemental components such as preservatives and stabilizers added in accordance with Table IIIB. Each of the resulting solution is bottled for distribution.

(19) TABLE-US-00005 TABLE IIIB Component i ii iii iv v vi vii viii ix sodium none  55 mg 110 mg 220 none  55 mg 110 mg 220 110 mg potassium none none none none 450 mg 450 mg 450 mg 450 mg 450 mg Sodium benzoate None 0.1% 0.1% 0.1% 0.1% 0.1% 0.1% 0.1% 0.1% malic acid none 250 mg 250 mg 250 mg 500 mg 500 mg 500 mg 500 mg 1000 mg 

Example 3

(20) A single specific formulation of the invention comprises:

(21) distilled water

(22) 1:1 molar ratio Myo-Inositol hexaphosphate (myo-IP6), (4.8 grams) and myo-inositol (1.32 grams),

(23) crystalline fructose,

(24) citric acid (preservative),

(25) vegetable juice (color),

(26) natural flavor,

(27) ascorbic acid (vitamin C),

(28) sodium citrate (electrolyte/antioxidant),

(29) monopotassium phosphate

(30) niacin (13),

(31) pantothenic acid (B5),

(32) pyridoxine hydrochloride (B6),

(33) cyanocobalamine (B12)

(34) The above components are dissolved in the water and bottled for distribution.

Example 4

(35) A particular formulation of the invention comprises

(36) Carbonated water-Carbon dioxide,

(37) Inositol hexaphosphate (4.8 grams) and myo inositol 1.32 grams (1:1 molar ratio),

(38) Erythritol (Rebiana™),

(39) citric acid (preservative),

(40) vegetable juice (color),

(41) natural flavor.

(42) artificial flavors.

(43) ascorbic acid (vitamin C),

(44) sodium citrate (electrolyte),

(45) Monopotassium Phosphate

(46) niacin (B3),

(47) pantothenic acid (B5),

(48) pyridoxine hydrochloride (B6),

(49) cyanocobalamine (B12)

(50) The above components are dissolved in the water and bottled for distribution.

Example 5

(51) A particular formulation of the invention comprises

(52) Distilled and/or sterilized community tap water.

(53) Myo inositol (4.8 grams)

(54) granulated table sugar (14 grams),

(55) citric acid,

(56) high fructose corn syrup,

(57) colors.

(58) glucose,

(59) fructose.

(60) sodium citrate (preservative).

(61) vegetable juice (color).

(62) natural flavor,

(63) ascorbic acid (vitamin C),

(64) natural flavor,

(65) sodium citrate (electrolyte),

(66) monopotassium phosphate (electrolyte),

(67) niacin (B3),

(68) pantothenic acid (B5),

(69) pyridoxine hydrochloride (B6),

(70) cyanocobalamine (B12)

(71) sufficient sodium chloride to bring the sodium content up to 110 mg/240 ml,

(72) The above components are dissolved in the water and bottled for distribution.

Example 6

(73) 800 mg of myoinositol hexaphosphate and 220 mg of myoinositol were dissolved in 240 ml of distilled water to form a drink product of the present invention. The drink product was consumed twice a day.

Example 7: Bottled Water of the Invention

(74) Water, if not already either purified, distilled, or filtered is subjected to an operation to obtain the water in a purified, distilled, or filtered state, and if need be stored for future use. The water is then used to dissolve the components of one of the foregoing formulations, and the result is bottled into appropriate containers.

Example 8: Bottled Carbonated Soft Drink of the Invention

(75) Purified, distilled, or filtered water as obtained in the initial step of Example 7 is used placed in a mixing tank. The various components of the son drink, which typically do not include the inositol components of the present invention, typically sweeteners, “soft drink concentrate”, and flavor are added to the mixing tank. The inositol and hexaphosphate inositol components, either as dry powders or concentrate solutions in water or as a pre-blend is added to the mixing tank in one embodiment before “soft drink components” or thereafter in a second embodiment. The solution is then subjected to a carbonation process and the result is bottled in suitable containers.

Example 9: Bottled Ready to Drink Tea of the Invention

(76) A typical available ready to drink tea of the invention is prepared by preparing such tea in the ordinary fashion for such tea and subjecting the tea to a pasteurization process. The components of the present invention other than the tea are added thereto (as powders) under aseptic bottling conditions or alternatively the components of the present invention other than the tea are dissolved in purified, distilled, or filtered water at high concentrations, subjected to aseptic filtration, and the aseptically filtered solution is added to the pasteurized tea under aseptic conditions.

Example 10: Bottled Juice Drink of the Invention

(77) A bottled fruit juice of the invention can be prepared by merely taking an existing fruit juice drink after it has been pasteurized and fortifying it under asceptic conditions with the inositol hexaphosphate or a mixture of inositol hexaphosphate and inositol and continue to bottle it in appropriate containers under aseptic conditions.

Example 11

(78) Inositol hexaphosphate and inositol enriched soft and hard drinks

(79) Myo-inositol hexaphosphate and myo-inositol in a 1:1 molar ratio are added to known bottled soft (including bottled water) and/or hard drinks, including those marketed under various trade names including those products made or distributed under various Coco-Cola™ brands, Aquapure, Aquarius, Bacardi Mixers. Bacardi Premium Mixers, Barq's, Barrilitos, Beverly, Bright And Early, caffeine free Barq's, caffeine free Coca-cola, caffeine free Coke light/Diet Coke, Campbells, Cascal, cherry Coke, Chippewa, Citra, Coca-cola, Coca-Cola Zero, Cumberland Gap, DANNON*, DASANI, Delaware Punch, diet_Barq's, Diet cherry Coke, Diet Coke/Coca-Cola light, Diet Coke/Coca-Cola light with Lime, diet Fanta, diet Inca Kola, diet Mello Yello/Mello Yello Zero, Diet NESTEA*, diet Vanilla Coke, Dr Pepper. Evian, Fanta, Five Alive, Flavor Rage, Fresca, Fruitopia, FUZE, Georgia, glacéau smart water, glacéau vitamin water, glacéau vitamin water zero, Gold Peak. H2OK, Hi-C, Honest, Illy*, Inca Kola, Java Monster, Juan Valder, Krest, Lift, Master Chill, Master Pour, McCafe, Mello Yello, Mero Mix. Minute Maid, Minute Maid Enhanced, Minute Maid Juices To Go, Minute Maid Soft Drink, Monster, NESTEA*, NESTEA COOL*, Northern, Neck, NOS, Odwalla, Peace, Pepe Rico, Pibb, POWERADE, POWERADE LIGHT, POWERADE PLAY, Red Flash, Simply Orange, Smart, Sokenbicha, Southern Sun, Sprite, Sprite Remix, Sprite Zero/diet Sprite/Sprite light, Sunfill, TaB, Vanilla Coke, VAULT, Vegitabeta, Worx, Energy. Zico, all Pepsi brands and Gatorade brands.

(80) Inositol phosphates and/or analogs described herein are excellent candidates for chemoprevention due to cell permeability, solubility, low toxicity, and demonstrated efficacies inhibiting tumor growth.

Example 12: Genistein Containing Compositions

(81) Examples 1-5 and 7-11 are repeated except that 1 mg (Example 12a), 5 mg (Example 12b), 10 mg (Example 12c), 15 mg (Example 12d), 20 mg (Example 12e), 25 mg (example 12f), 30 mg (Example 12g), 35 mg (Example 12h), 40 mg (Example 12i), 45 mg (Example 12j) or 50 mg (Example 12k) of Genistein are added to the compositions. Each subpart of Example 12 is to be understood as a repetition of each of Examples 1-11 with the particular amount of Genistein mentioned for that subpart.

Example 13

(82) 500 mg of myoinositol hexaphosphate and 1.67 grams myoinositol, 20 mg's of Genistein were dissolved in 20 oz of distilled water to form a drink product of the present invention. The drink product was consumed twice a day.

Example 14

(83) 500 mg of myoinositol hexaphosphate and 1.67 grams myoinositol, 20 mg's of Genistein, 200 mgs of pharmaceutical grade water soluble liposomal encapsulated Ubiquinol (Qunol Liquid Co Q10) (U.S. Pat. No. 6,455,072) were dissolved in 20 oz of distilled water to form a drink product of the present invention. The drink product was consumed twice a day.

Example 15

(84) 500 mg of myoinositol hexaphosphate and 1.67 grams myoinositol, 20 mg's of Genistein, pharmaceutical grade water soluble liposomal encapsulated-Ubiquinol (Qunol Liquid Co Q10) (U.S. Pat. No. 6,455,072) were dissolved in 20 oz of Acai blueberry Pomegranate juice to form a drink product of the present invention. B1 1.1 mg. B5 5 mg B6-1.7 mg. B12-2.4 mcg, ascorbic acid-500 mg tablets were crushed and added to the drink- and the drink product was consumed twice a day.

Example 16

(85) Examples 1-5 and 7-12 are repeated except that the hexaphosphate of the respective inositol is replaced by the phosphate in the following table.

(86) TABLE-US-00006 Type of phosphate Example material Species of phosphate Example 16A monophosphate 1-monophosphate; 2-monophosphate; 3-monophosphate; 4-monophosphate; 5-monophosphate; 6-monophosphate Example 16B di-monophosphate 1,2-dimonophosphate; 1,3-dimonophosphate; 1,4-dimonophosphate; 1,5-dimonophosphate; 1,6-dimonophosphate; 2,3-dimonophosphate; 2,4-dimonophosphate; 2,5-dimonophosphate; 2,6-dimonophosphate; 3.4-dimonophosphate; 3,5-dimonophosphate; 3,6-dimonophosphate; 4,5-dimonophosphate; 4,6-dimonophosphate; 5,6-dimonophosphate Example 16C Tri-monophosphate 1,2,3-trimonophosphate; 1,2,4-trimonophosphate; 1,2,5-trimonophosphate; 1,2,6-trimonophosphate; 2,3,4-trimonophosphate; 2,3,5-trimonophosphate; 2,3,6-trimonophosphate; 2,4,5-trimonophosphate; 2,4,6-trimonophosphate; 2,5,6-trimonophosphate; 3,4,5-trimonophosphate; 3,4,6-trimonophosphate; 4,5,6-trimonophosphate Example 16D Tetra-monophosphate 1,2,3,4-tetramonophosphate; 1,2,3,5-tetramonophosphate; 1,2,3,6-tetramonophosphate; 1,2,4,5-tetramonophosphate; 1,2,4,6-tetramonophosphate; 1,3,4,5-tetramonophosphate; 1,3,4,6-tetramonophosphate; 1,3,5,6-tetramonophosphate; 2,3,4,5-tetramonophosphate; 2,3,4,6-tetramonophosphate; 2,4,5,6-tetramonophosphate; 3,4,5,6-tetramonophosphate; Example 16E Penta-monophosphate 1,2,3,4,5-pentamonophosphate 1,2,3,4,6-pentamonophosphate 1,2,3,5,6-pentamonophosphate 1,2,4,5,6-pentamonophosphate 1,3,4,5,6-pentamonophosphate 2,3,4,5,6-pentamonophosphate Example 16F Pentamonophospho- 1,2,3,4,5- monopyrophosphate pentamonophosphate-6- pyrophosphate 1,2,3,4,6- pentamonophosphate-5- pyrophosphate 1,2,3,5,6- pentamonophosphate-4- pyrophosphate 1,2,4,5,6- pentamonophosphate-3- pyrophosphate 1,3,4,5,6- pentamonophosphate-2- pyrophosphate 2,3,4,5,6- pentamonophosphate-1- pyrophosphate Example 16G Tetramonophospho- 1,2,3,4-tetramonophosphate- dipyrophosphate 5,6-dipyrophosphate; 1,2,3,5-tetramonophosphate- 4,6-dipyrophosphate; 1,2,3,6-tetramonophosphate- 4,5-dipyrophosphate; 1,2,4,5-tetramonophosphate- 3,6-dipyrophosphate; 1,2,4,6-tetramonophosphate- 3,5-dipyrophosphate; 1,3,4,5-tetramonophosphate- 2,6-dipyrophosphate; 1,3,4,6-tetramonophosphate- 2,5-dipyrophosphate; 1,3,5,6-tetramonophosphate- 2,4-dipyrophosphate; 2,3,4,5-tetramonophosphate- 1,6-dipyrophosphate; 2,3,4,6-tetramonophosphate- 1,5-dipyrophosphate; 2,4,5,6-tetramonophosphate- 1,3-dipyrophosphate; 3,4,5,6-tetramonophosphate- 1,2-dipyraphosphate; Example 16H Trimonophospho- 1,2,3-trimonophosphate-4,5,6- tripyrophosphate tripyrophosphate; 1,2,4-trimonophosphate-3,5,6- tripyrophosphate; 1,2,5-trimonophosphate-3,4,6- tripyrophosphate; 1,2,6-trimonophosphate-3,4,5- tripyrophosphate; 2,3,4-trimonophosphate-1,5,6- tripyrophosphate; 2,3,5-trimonophosphate-1,4,6- tripyrophosphate; 2,3,6-trimonophosphate-1,4,5- tripyrophosphate; 2,4,5-trimonophosphate-1,3,6- tripyrophosphate; 2,4,6-trimonophosphate-1,3,5- tripyrophosphate; 2,5,6-trimonophosphate-1,3,4- tripyrophosphate; 3,4,5-trimonophosphate-1,2,6- tripyrophosphate; 3,4,6-trimonophosphate-1,2,5- tripyrophosphate; 4,5,6-trimonophosphate-1,2,3- tripyrophosphate Example 16 I Mono-monophosphate- 1-monophosphate-2- monopyrophosphate monopyrophosphate; 1-monophosphate-3- monopyrophosphate; 1-monophosphate-4- monopyrophosphate; 1-monophosphate-5- monopyrophosphate; 1-monophosphate-6- monopyrophosphate; 2-monophosphate-1- monopyrophosphate; 2-monophosphate-3- monopyrophosphate; 2-monophosphate-4- monopyrophosphate; 2-monophosphate-5- monopyrophosphate; 2-monophosphate-6- monopyrophosphate; 3-monophosphate-1- monopyrophosphate; 3-monophosphate-2- monopyrophosphate; 3-monophosphate-4- monopyrophosphate; 3-monophosphate-5- monopyrophosphate; 3-monophosphate-6- monopyrophosphate; 4-monophosphate-1- monopyrophosphate; 4-monophosphate-2- monopyrophosphate; 4-monophosphate-3- monopyrophosphate; 4-monophosphate-5- monopyrophosphate; 4-monophosphate-6- monopyrophosphate; 5-monophosphate-1- monopyrophosphate; 5-monophosphate-2- monopyrophosphate; 5-monophosphate-3- monopyrophosphate; 5-monophosphate-4- monopyrophosphate; 5-monophosphate-6- monopyrophosphate; 6-monophosphate-1- monopyrophosphate 6-monophosphate-2- monopyrophosphate 6-monophosphate-3- monopyrophosphate 6-monophosphate-4- monopyrophosphate 6-monophosphate-5- monopyrophosphate

(87) One skilled in the art will readily appreciate that the present invention is well adapted to carry out the objectives and obtain the ends and advantages mentioned, as well as those inherent therein. The embodiments, methods, procedures and techniques described herein are presently representative of the preferred embodiments, are intended to be exemplary and are not intended as limitations on the scope. Changes therein and other uses will occur to those skilled in the art which are encompassed within the spirit of the invention and are defined by the scope of the appended claims. Although the invention has been described in connection with specific preferred embodiments, it should be understood that the invention as claimed should not be unduly limited to such specific embodiments. Indeed, various modifications of the described modes for carrying out the invention which are obvious to those skilled in the art are intended to be within the scope of the following claims.

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