COMPOSITION FOR OPTIMIZED DIETARY SUPPLEMENT FORMULATIONS

Abstract

The present invention relates to compositions for human consumption of tailored dietary supplements or nutraceuticals, comprised of various components including, among others, vitamins and minerals, provided in various permutations, in multiple daily doses, based on an individual's age and gender, bioavailability, and synergistic and competing properties of the components, thereby promoting general wellbeing and healthiness.

Claims

1. A method consisting of taking an oral formulation supplement comprising three or more elements from the group consisting of: magnesium citrate, magnesium oxide, calcium carbonate, zinc citrate, vitamin E (D-Alpha tocopheryl acetate), and manganese bisglycinate chelate, taken in the morning.

2. A method consisting of taking an oral formulation supplement comprising three or more elements from the group consisting of: calcium carbonate (with food), copper gluconate, iron (ferrous glycinate), phosphorus (phosphoric acid), molybdenum citrate, vitamin K1 (phylloquinone), MK-4 or MK-7, taken in the afternoon.

3. A method consisting of taking an oral formulation supplement comprising three or more elements from the group consisting of: calcium citrate tetrahydrate (with or without food), potassium citrate, selenium (Selenomethionine with dicalcium phosphate), chromium (yeast), iodine (potassium iodide), vitamin A (beta-carotene), vitamin A (palmitate 250,000 IU/G), vitamin B6 (pyridoxine HCl 81.4%), vitamin D (dry vitamin D3 100 SD/S), vitamin C, (ascorbic acid 99%), thiamin (HCl 87.9%), riboflavin (universal 98%), niacin (USP-FCC), vitamin B12 (methylcobalamin), choline bitartrate, folate (methyltetrahydrofolate), biotin (BITRIT-1 Type A), vitamin B5 (calcium D-pantothenate), taken in the evening.

4. A method consisting of taking an oral formulation supplement of claim 1, wherein, the supplement comprises four or more from the group consisting of: magnesium citrate, magnesium oxide, calcium carbonate, zinc citrate, vitamin E (D-Alpha tocopheryl acetate), and manganese bisglycinate chelate, taken in the morning.

5. A method consisting of taking an oral formulation supplement of claim 2, wherein, the supplement comprises four or more from the group consisting of: calcium carbonate (with food), copper gluconate, iron (ferrous glycinate), phosphorus (phosphoric acid), molybdenum citrate, vitamin K1 (phylloquinone), MK-4 or MK-7, taken in the afternoon.

6. A method consisting of taking an oral formulation supplement of claim 3, wherein, the supplement comprises four or more from the group consisting of: calcium citrate tetrahydrate (with or without food), potassium citrate, selenium (Selenomethionine with dicalcium phosphate), chromium (yeast), iodine (potassium iodide), vitamin A (beta-carotene), vitamin A (palmitate 250,000 IU/G), vitamin B6 (pyridoxine HCl 81.4%), vitamin D (dry vitamin D3 100 SD/S), vitamin C, (ascorbic acid 99%), thiamin (HCl 87.9%), riboflavin (universal 98%), niacin (USP-FCC), vitamin B12 (methylcobalamin), choline bitartrate, folate (methyltetrahydrofolate), biotin (BITRIT-1 Type A), vitamin B5 (calcium D-pantothenate), taken in the evening.

7. A method consisting of taking an oral formulation supplement of claim 1, wherein, the supplement comprises five or more from the group consisting of: magnesium citrate, magnesium oxide, calcium carbonate, zinc citrate, vitamin E (D-Alpha tocopheryl acetate), and manganese bisglycinate chelate, taken in the morning.

8. A method consisting of taking an oral formulation supplement of claim 2, wherein, the supplement comprises five or more from the group consisting of: calcium carbonate (with food), copper gluconate, iron (ferrous glycinate), phosphorus (phosphoric acid), molybdenum citrate, vitamin K1 (phylloquinone), MK-4 or MK-7, taken in the afternoon.

9. A method consisting of taking an oral formulation supplement of claim 3, wherein, the supplement comprises five or more from the group consisting of: calcium citrate tetrahydrate (with or without food), potassium citrate, selenium (Selenomethionine with dicalcium phosphate), chromium (yeast), iodine (potassium iodide), vitamin A (beta-carotene), vitamin A (palmitate 250,000 IU/G), vitamin B6 (pyridoxine HCl 81.4%), vitamin D (dry vitamin D3 100 SD/S), vitamin C, (ascorbic acid 99%), thiamin (HCl 87.9%), riboflavin (universal 98%), niacin (USP-FCC), vitamin B12 (methylcobalamin), choline bitartrate, folate (methyltetrahydrofolate), biotin (BITRIT-1 Type A), vitamin B5 (calcium D-pantothenate), taken in the evening.

10. The method of claim 1 comprising five or more of group one, five or more of group two, and five of more of group three.

11. The method of claim 1 consisting essential of five or more from group one, five or more from group two, and five or more from group three.

12. The method of claim 11, tailored for an individual over 65 years of age.

13. The method of claim 1 taken with or just after a meal.

14. The method of claim 2 taken with or just after a meal.

15. The method of claim 3 taken with or just after a meal.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0027] The accompanying drawings, which are included to provide a further understanding of the invention and are incorporated in, and constitute a part of, this specification, illustrate preferred embodiments of the invention and together with the detail description serve to explain the principles of the invention. In the drawings:

[0028] FIG. 1A is an exemplary table of morning components.

[0029] FIG. 1B is an exemplary table of afternoon components.

[0030] FIG. 1C is an exemplary table of evening components.

[0031] FIG. 1D is an additional exemplary table of evening components.

DETAILED DESCRIPTION OF THE INVENTION

[0032] Dietary supplements or nutraceuticals provided in three-a-day permutations and tailored amounts based on an individual's age and gender. The three-a-day vitamin and mineral program is designed to provide optimum nutritional supplementation and absorption of what we have determined are the 26 most essential vitamins and minerals over the period of a 14 to 16-hour waking day, while mitigating compromised absorption due to food, drink and interactions with other nutrients in the program. Such permutations of each supplements or nutraceuticals being comprised of a combination of immediate and slow release components, dependent on improved pharmacodynamics and kinetics. In preferred embodiments, the amount of each nutrient never exceeds the Recommended Daily Allowance, so as not to exceed the body's absorbable limits and, in so doing, waste the excessive nutrients. Form factor and amount of such individual permutation of vitamins or minerals comprising the formulation may also be based on: biological sex and age of consumer; menstrational considerations, absorption and bioavailability of individual and collective mineral and vitamins; individual eating habits in consideration the chronology and contents of individual eating occasions (such as caffeine in the morning, three meals a day, and alcohol in the evening); antagonistic and synergetic properties of individual nutrients relative to other components of composition; Recommended Daily Allowance, Adequate Intake and toxicity quantities; positive and negative interaction of individual and collective nutrients of the composition with food in specific individual's diet. Of particular interest are one or more of the following vitamins and minerals: Calcium, spread among all three occasions in multiple forms and typically omitted from most nutraceutical supplementation programs; Magnesium, provided in a safe amount and in multiple forms in a time-released capsule to prevent inhibitory effects caused by the diet; Zinc, when consumed in excess in a supplement, can inhibit other nutrients' absorption; Iron, which has many contraindications with other nutrients and is separated from those inhibitors; and Vitamin A, where we have taken the reported average daily dietary intake of vitamin A into strong consideration when determining the amount of both carotenoid and retinoid amounts of vitamin A to prevent toxicity levels in all consumer types (pregnant, smokers, etc.). from traditional sleep aids. In some embodiments the components can be put into a single pill with timed release of the relaxant and stimulant or with the coating of the pill forming the initial drug release profile and the inner portion of the pill forming the latter drug release profile.

1. Definitions

[0033] The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting. As used in the specification and the appended claims, the singular forms “a,” “an” and “the” include plural referents unless the context clearly dictates otherwise.

[0034] For recitation of numeric ranges herein, each intervening number there between with the same degree of precision is explicitly contemplated. For example, for the range of 6-9, the numbers 7 and 8 are contemplated in addition to 6 and 9, and for the range 6.0-7.0, the numbers 6.0, 6.1, 6.2, 6.3, 6.4, 6.5, 6.6, 6.7, 6.8, 6.9, and 7.0 are explicitly contemplated.

2. Formulations

[0035] Provided here are exemplary formulation embodiments provided in three-a-day permutations and tailored amounts based on an individual's age and gender. The formulation may be an oral formulation, and may comprise multiple pills or a single pill.

[0036] a. Morning Formulation

[0037] The morning formulation may comprise magnesium citrate, magnesium oxide, calcium carbonate, zinc carbonate, vitamin E (D-alpha tocopheryl acetate), and magnesium bisglycinate chelate.

[0038] b. Afternoon Formulation

[0039] The afternoon formulation may comprise calcium carbonate (with food), copper gluconate, iron (ferrous glycinate), phosphorus (phosphoric acid), molybdenum citrate, vitamin K1 (phylloquinone), MK-4 or MK-7.

[0040] c. Evening Formulation

[0041] The evening formulation may comprise calcium citrate tetrahydrate (with or without food), potassium citrate, selenium (selenometionine with dicalcium phosphate), chromium (yeast), iodine (potassium iodide), vitamin A (beta-carotene), vitamin A (palmitate 250,000 IU/G), vitamin B6 (pyridoxine HCl 81.4%), vitamin D (dry vitamin D3 100 SD/S), vitamin C (ascorbic acid 99%), thiamin (HCl 87.9%), riboflavin (universal 98%), niacin (USP-FCC), vitamin B12 (methylcobalamin), choline bitartrate, folate (methyltetrahydrofolate), biotin (BITRIT-1 Type A), Vitamin B5 (Calcium D-Pantothenate).

[0042] d. Pill Formation

[0043] The inner portion may comprise a capsule, and the outer portion may comprise a capsule coating. The capsule may be a softgel or a hard-shell capsule. The capsule may comprise a liquid fill, a powder fill, or a semi-solid fill; and a shell.

[0044] 1. Liquid Fill

[0045] The liquid fill may comprise the stimulant, a liquid vehicle, a plasticizer, a surfactant, water, a solubilizing agent, and a suspending agent.

[0046] a. Liquid Vehicle

[0047] The liquid vehicle may comprise a lipophilic liquid or a semi-solid. The lipophilic liquid may comprise a vegetable oil and/or polyether. The semi-solid may comprise a hydrogenated oil, such as castor oil, and/or a wax such as bees wax.

[0048] b. Plasticizer

[0049] The plasticizer may comprise glycerol, glycerin, sorbitol, or propylene glycol, or a combination thereof.

[0050] c. Surfactant

[0051] The surfactant may comprise a lecithin, sorbitol, polysorbate, or sorbitan, or a combination thereof.

[0052] d. Solubilizing Agent

[0053] The solubilizing agent may comprise a beeswax or a mono-, di-, or triglyceride, or a combination thereof.

[0054] e. Suspending Agent

[0055] The suspending agent may comprise maltodextrin, sodium alginate, or xanthan gum, or a combination thereof.

[0056] 2. Powder Fill

[0057] The powder fill may comprise the vitamins and minerals, a diluent, an anti-caking agent, and a lubricant.

[0058] a. Diluent

[0059] The diluent may comprise dicalcium phosphate, lactose, maltodextrin, microcrystalline cellulose, or a starch, or a combination thereof.

[0060] b. Anti-Caking Agent

[0061] The anti-caking agent may comprise magnesium silicate, silica gel, or talc, or a combination thereof.

[0062] c. Lubricant

[0063] The lubricant may comprise hydrogenated vegetable oil, magnesium stearate, mineral oil, or stearic acid, or a combination thereof.

[0064] 3. Semi-Solid Fill

[0065] The semi-solid fill may comprise the vitamins and minerals, a semi-solid vehicle, a surfactant, and an emulsifying agent.

[0066] a. Semi-Solid Vehicle

[0067] The semi-solid vehicle may comprise hydrogenated palm oil, hydrogenated castor oil, cetyl alcohol, cetosteryl alcohol, a stearoyl polyoxylglyceride, a laurolyl polyoxyglyceride, or a combination thereof.

[0068] b. Surfactant

[0069] The surfactant may be a lecithin, sorbitol, polysorbate, or sorbitan, or a combination thereof.

[0070] c. Emulsifying Agent

[0071] The emulsifying agent may be polyethylene glycol, or poloxamer, or a combination thereof.

[0072] 4. Shell

[0073] The shell may comprise a gelling agent, the plasticizer, an opacifier, a colorant, and water.

[0074] a. Gelling Agent

[0075] The gelling agent may comprise gelatin, a plant polysaccharide, a carrageenan, a modified starch, a cellulose or derivative thereof, or a combination of the foregoing. The modified starch may comprise starch hydrolysate. The cellulose derivative may comprise hypromellose or methylcellulose, or a combination thereof.

[0076] b. Opacifier

[0077] The opacifier may comprise titanium dioxide.

[0078] c. Plasticizer

[0079] The plasticizer may comprise glycerol, glycerin, sorbitol, or propylene glycol, or a combination thereof.

[0080] d. Coating

[0081] The coating may comprise a cellulose or derivative thereof, a polyether, a mineral oil, water, a plant resin or protein, and a surfactant. The polyether may comprise a polyethylene glycol, which may comprise a low molecular weight polyethylene glycol such as a PEG 300-600 or PEG 400, or a high molecular weight polyethylene glycol such as a PEG 4000-10,000, or a combination thereof.

[0082] Certain formulation embodiments may comprise the ingredients listed in Table 1.

[0083] Furthermore, although elements of the described aspects and/or embodiments may be described or claimed in the singular, the plural is contemplated unless limitation to the singular is explicitly stated. Additionally, all or a portion of any embodiment may be utilized with all or a portion of any other embodiment, unless stated otherwise.

[0084] While certain exemplary embodiments have been described and shown in the accompanying specification, it is to be understood that such embodiments are merely illustrative of and not restrictive on the broad invention, and that this invention is not be limited to the specific constructions and arrangements shown and described, since various other changes, combinations, omissions, modifications and substitutions, in addition to those set forth in the above paragraphs, are possible. Those skilled in the art will appreciate that various adaptations and modifications of the just described embodiments can be configured without departing from the scope and spirit of the invention. Therefore, it is to be understood that, within the scope of the appended claims, the invention may be practiced other than as specifically described herein.