WO2009117657A1

WO2009117657A1 - Healthful composition

Info

Publication number: WO2009117657A1
Application number: PCT/US2009/037804
Authority: WO
Inventors: Shikwan Sung; Kim Sang Hyon; Hyop Seung Rhee
Original assignee: Shikwan Sung; Kim Sang Hyon; Hyop Seung Rhee
Priority date: 2008-03-21
Filing date: 2009-03-20
Publication date: 2009-09-24

Abstract

The present application relates to a healthful composition containing a healthful substance, a package containing the healthful composition, a method of making a healthful composition, a machine system and components thereof for making a healthful composition, method of administering a healthful composition, method of treating or preventing at least one disease or condition, preferably in a subject in need thereof, by administration of a healthful composition to the subject, and a liquid composition comprising a liquid, preferably water, and the healthful combination, such that the healthful composition in the liquid composition is in contact with the liquid, but is stable (i.e., does not release the healthful substance) while in contact with the liquid for a finite amount of time.

Description

HEALTHFUL COMPOSITION

Cross Reference to Related Application

This application claims priority to U.S. Provisional Application Number 61/038,616, filed on March 21 , 2008, that is incorporated by reference, herein, in its entirety.

Field of the Invention

The present application relates to a healthful composition containing a healthful substance, a package containing the healthful composition, a method of making a healthful composition, a method of administering a healthful composition, a method of treating or preventing at least one disease or condition, preferably in a subject in need thereof, by administration of a healthful composition to the subject, preferably in an amount sufficient to treat or prevent the at least one disease or condition, and a liquid composition comprising a liquid, preferably water, and the healthful composition, such that the healthful composition in the liquid composition is in contact with the liquid, but is stable (i.e., does not release the healthful substance) while in contact with the liquid for a finite amount of time.

Discussion of the Background

As an approach to the treatment or prevention of diseases or conditions, people consume healthful substances. For example, consumption of the healthful substance vitamin C prevents and, if appropriate, treats scurvy, and consumption of vitamin D prevents rickets. Another example of a healthful substance is fish oil. Fish oil has been employed, for example, to treat and prevent elevated blood triglyceride levels (e.g., see the prescribing information for OMACOR, which is incorporated, by reference, in its entirety).

However, using fish oil as an example, subject compliance with taking fish oil is not optimal. Reasons include forgetfulness, because fish oil is typically stored under refrigerated or freezing conditions, and thus is concealed from view, and thus, does not visually remind the subject to consume the fish oil.

Also, the taste and odor of fish oil, when taken as an oil, are offensive to some subjects, and this offensiveness decreases regular consumption of fish oil.

In an attempt to overcome these offensive fish oil properties, fish oil has been encapsulated in gelatin capsules. However, even if encapsulated, because the fish oil releases, for example, in the stomach, subjects consuming fish oil gelatin capsules have described an undesirable "fish oil burp," that results in the subject tasting and/or smelling the fish oil.

Thus, there remains a need for a delivery system for healthful substances, including fish oil, that does not need to be refrigerated or frozen, that aids in facilitating regular consumption of a healthful substance by visually reminding a subject to consume the healthful substance, that reduces and/or eliminates and offensive sensory properties of the healthful substance, and through ease of consumption, facilitates regular dosing with the healthful substance.

The present inventive embodiments were developed to meet the above described needs. Brief Description of the Drawings

A more complete appreciation of the invention and many of the attendant advantages thereof will be readily obtained as the same become better understood by the reference to the following detailed description when considered in connection with the accompanying drawings, wherein:

Figure 1 shows one method of making a healthful composition inventive embodiment using molds, injection of ingredients into the molds, a machine containing multiple molds and a conveyor belt.

Figure 2 shows one method of making a healthful composition inventive embodiment by injection of a composition into water.

Figure 3 shows another method of making a healthful composition inventive embodiment by injection of a composition into water.

Figure 4 shows a method for microbial testing of inventive healthful composition embodiments of the invention.

Figure 5 shows a method of making a healthful composition inventive embodiment using at least a mold within a base plate, a push pin, a pin for forming cavities, injection nozzles, and a moving knife edge, as well as a healthful composition inventive embodiment.

Figure 6 is a schematic showing an instrumentation diagram of a machine system inventive embodiment useful for, for example, making a healthful composition inventive embodiment.

Figure 7 shows an instrument diagram of a machine system inventive embodiment useful, for, for example, making a healthful composition inventive embodiment. Figure 8 shows a base plate assembly diagram (top and edge views) inventive embodiment useful for, for example, with a machine inventive system inventive embodiment in making a healthful composition inventive embodiment.

Figure 9 shows hole patterns on a base plate inventive embodiment useful for, for example, making a healthful composition inventive embodiment with a machine system inventive embodiment.

Figure 10 shows a push pin plate assembly inventive embodiment useful, for example, with a machine inventive embodiment for making a healthful composition inventive embodiment.

Figure 1 1 shows a pin plate push mechanism assembly inventive embodiment useful, for example, with a machine system inventive embodiment for making a healthful composition inventive embodiment.

Figure 12 shows a liquid filling station inventive embodiment useful, for example, with a machine system inventive embodiment for making a making a healthful composition inventive embodiment.

Figure 13 shows a pin assembly inventive embodiment, useful, for example, with a machine system inventive embodiment for making a healthful composition inventive embodiment.

Figure 14 shows a pellet shear off assembly inventive embodiment, useful, for example, with a machine system inventive embodiment for making a healthful composition inventive embodiment.

It is noted that the inventive embodiments shown in the drawings are not meant to limit the invention, and are depicted for illustrative purposes only. Detailed Description of the Preferred Embodiments

In one inventive embodiment, a healthful composition comprises a mixture of at least one wax, preferably beeswax, at least one filler, preferably calcium carbonate, and at least one anti-oxidant, preferably d-α-tocopherol, with fish oil intermixed throughout this mixture.

In one inventive embodiment, a healthful composition comprises a mixture, preferably a homogeneously mixed, heterogeneous mixture of at least one wax, preferably beeswax, at least one filler, preferably calcium carbonate, fish oil, and at least one anti-oxidant, preferably d-α-tocopherol.

In one inventive embodiment, a healthful composition comprises a mixture, preferably a homogeneously mixed, heterogeneous mixture of at least one wax, preferably beeswax, at least one filler, preferably calcium carbonate, at least one healthful substance, preferably fish oil, and at least one anti-oxidant, preferably d-α- tocopherol, wherein the fish oil has been extracted from the surface of the composition by placing the composition in water and extracting the fish oil from the surface of the composition. In one inventive embodiment, the at least one antioxidant is preferably extracted from the surface of the composition. In one embodiment, the healthful composition is in the shape of a pellet.

The temperature of the water, for the extraction of the at least one healthful substance, preferably fish oil, and/or extraction of the at least one antioxidant, preferably d-α-tocopherol, from the surface of the composition, can range, for example, from I⁰C to 3O⁰C, include all values, ranges, and subranges therein, including for example, 2 ⁰C, 3 ⁰C, 4⁰C, 5 ⁰C, 6 ⁰C, 7 ⁰C, 8 ⁰C, 9 ⁰C, 10 ⁰C, 1 1 ⁰C, 12 ⁰C, 13 ⁰C, 14 ⁰C, 15 ⁰C, 16 ⁰C, 17 ⁰C, 18 ⁰C, 19 ⁰C, 20 ⁰C, 21 ⁰C, 22 ⁰C, 23 ⁰C, 24 ⁰C, 25 ⁰C, 26 ⁰C, 27 ⁰C, 28 ⁰C, 29 ⁰C, and 30 ⁰C. The composition can be subsequently, after the water extraction, dried, for example, at a temperature ranging from 0 ⁰C to 40 ⁰C, including all values, ranges, and subranges therein, including for example, 5 ⁰C, 10 ⁰C, 15 ⁰C, 20 ⁰C, 25 ⁰C, 30 ⁰C, 35 ⁰C, and 40 ⁰C.

In one inventive embodiment, preferably the ratio of at least one wax, preferably beeswax, to at least one filler, preferably calcium carbonate, to at least one antioxidant, preferably d-α-tocopherol, to at least one healthful substance, preferably fish oil, is, by weight of each ingredient: 200 at least one wax: 30 at least one filler: 0.1 at least one antioxidant : 20 healthful substance. The ratio ranges, based on the weight of each ingredient, can be, for example, 100 - 300 at least one wax: 1-60 at least one filler: 0.001-10 at least one antioxidant: 0.01-100 at least one healthful substance; including all ranges, values, and subranges therein. For example, the ratio ranges, based on the weight of each ingredient in the composition, can be, for the ingredient order: at least one wax: at least one filler: at least one antioxidant: at least one healthful substance; as shown in the following Table 1 : Table 1 : Wax Filler Antioxidant Healthful Substance

1 10-300: 2-60: 0.005-10: 0.05-100;

120-300: 3-60: 0.01-10: 0.1 -100;

130-300: 3-60: 0.03-10: 0.1 -100;

140-300: 4-60: 0.05-10: 5-100;

150-300: 5-60: 0.1-10: 10.0-100;

160-300: 10-60: 0.5-10: 15.0-100;

170-300: 15-60: 1.0-10: 20.0-100;

180-300: 20-60: 2.0-10: 25.0-100; 190-300: 25-60: 3.0-10: 30.0-100;

200-300: 30-60: 4.0-10: 35.0-100;

220-300: 35-60: 5.0-10: 40.0-100;

240-300: 40-60: 6.0-10: 50.0-100;

260-300: 45-60: 7.0-10: 75.0-100;

280-300: 50-60: 8.0-10: 85.0-100;

290-300: 55-60: 9.0-10: 95.0-100;

The above values include all values, ranges, and subranges therein.

In one inventive embodiment, the composition is in the form of a pellet that weights between 0.025 g to 0.035 g, including all ranges, subranges, and values therein, including, for example, 0.026g, 0.027g, 0.028 g, 0.029 g, 0.030 g, 0.031 g, 0.032 g, 0.033 g, and 0.034 g.

In one inventive embodiment, the composition is in the shape of a pellet, and comprises at least one pellet, for example, from 1-1000 pellets, from 1-900 pellets, from 1 -800 pellets, from 1-700 pellets, from 1 -600 pellets, from 1 -500 pellets, from 1- 400 pellets, from 1-300 pellets, from 1-200 pellets, from 1-100 pellets, from 1-75 pellets, from 1 -50 pellets, from 1 -25 pellets, from 1-20 pellets, from 1-15 pellets, from 1 -10 pellets, and from 1-5 pellets, including all ranges, subranges, and values therein.

In one inventive embodiment, the composition is in the form of a pellet and the pellet comprises from 0.01 mg to 10 mg of the healthful substance, including all ranges, subranges, and values therein, for example, 0.1 mg, 1.0 mg, 1.5 mg, 2.0 mg, 2.1 mg, 2.2 mg, 2.3 mg, 2.4 mg, 2.5 mg, 2.6 mg, 2.7 mg, 2.8 mg, 2.9 mg, 3.0 mg, 3.5 mg, 4.0 mg, 4.5 mg, 5.0 mg, 5.5 mg, 6.0 mg, 6.5 mg, 7.0 mg, 7.5 mg, 8.0 mg, 8.5 mg, 9.0 mg, and 9.5 mg, including all values, ranges, and subranges therein. In one inventive embodiment, the composition is in the form of pellets, and each pellet, on average, comprises from 0.01 mg to 10 mg of the healthful substance, including all ranges, subranges, and values therein, for example, on average, 0.1 mg, 1.0 mg, 1.5 mg, 2.0 mg, 2.1 mg, 2.2 mg, 2.3 mg, 2.4 mg, 2.5 mg, 2.6 mg, 2.7 mg, 2.8 mg, 2.9 mg, 3.0 mg, 3.5 mg, 4.0 mg, 4.5 mg, 5.0 mg, 5.5 mg, 6.0 mg, 6.5 mg, 7.0 mg, 7.5 mg, 8.0 mg, 8.5 mg, 9.0 mg, and 9.5 mg, including all values, ranges, and subranges therein.

In one inventive embodiment, the composition is in the form of a pellet and comprises a mixed, preferably a homogeneously mixed, heterogeneous mixture of at least one wax, preferably beeswax, at least one filler, preferably calcium carbonate, at least one healthful substance, preferably fish oil, and at least one anti-oxidant, preferably d-α-tocopherol. Preferably, the healthful substance has been extracted or removed or excluded from the surface of the pellet, for example, by placing the pellet in water and extracting the healthful substance from the surface of the pellet. Preferably, the average amount of the healthful substance in the pellet, preferably fish oil, is 2.4 mg. Preferably, the average amount of at least one wax in the pellet, preferably beeswax, is 24 mg. Preferably, the average amount of the at least one filler in the pellet, preferably calcium carbonate, is 3.6 mg. Preferably, the average amount of the at least one antioxidant in the pellet, preferably, d-α-tocopherol, is 0.012 mg. In one inventive embodiment, at the at least one antioxidant is extracted from the surface of the pellet by placing the composition in water and extracting the at least one antioxidant from the surface of the composition / pellet.

In one inventive embodiment, a healthful composition comprises a core of a mixed, preferably a homogeneously mixed, preferably heterogeneous mixture of at least one wax, preferably beeswax, at least one core filler, preferably calcium carbonate, at least one healthful substance, preferably fish oil, and at least one core antioxidant, preferably d-α-tocopherol, and surface coating of a homogeneously mixed, heterogeneous second mixture of at least one wax, preferably beeswax, at least one coating filler, preferably calcium carbonate, and at least one antixoidant, preferably d-α-tocopherol.

In one inventive embodiment, a healthful composition comprises a coating and a core. The coating comprises at least one coating filler, preferably calcium carbonate, at least one wax, preferably beeswax, and at least one coating antioxidant; and the core comprises at least one core filler, preferably calcium carbonate, at least one wax, preferably beeswax, at least one core antioxidant, and at least one healthful substance, preferably fish oil. The core filler and coating filling may the same or different, and the coating antioxidant and core antioxidant may be the same or different. In one embodiment, the composition comprising the coating and the core is in the shape of a pellet.

In one embodiment, the coating comprises 0.001%-99.999% by weight of the total weight of the composition, and the core comprises 99.999%-0.001% by weight of the total composition, including all values, ranges, and subranges therein, for example: 0.01% by weight of the total weight of the composition, 0.1% by weight of the total weight of the composition, 1% by weight of the total weight of the composition, 5% by weight of the total weight of the composition, 10% by weight of the total weight of the composition, 15% by weight of the total weight of the composition, 20% by weight of the total weight of the composition, 25% by weight of the total weight of the composition, 30% by weight of the total weight of the composition, 35% by weight of the total weight of the composition, 40% by weight of the total weight of the composition, 45% by weight of the total weight of the composition, 50% by weight of the total weight of the composition, 55% by weight of the total weight of the composition, 60% by weight of the total weight of the composition, 65% by weight of the total weight of the composition, 70% by weight of the total weight of the composition, 75% by weight of the total weight of the composition, 80% by weight of the total weight of the composition, 85% by weight of the total weight of the composition, 90% by weight of the total weight of the composition, 95% by weight of the total weight of the composition.

In one inventive embodiment, the ratio of ingredients in the core ranges, by weight of each ingredient in the core, form 50: 1 :0.001 : l - 200:30:5:30 of the at least one wax : the at least one core filler : the at least one core antioxidant : at least one healthful substance; including all values, ranges, and subranges therein. For example, the ratio of ingredients in the coating can have values, as shown in the following Table 2, based on the weight of each ingredient, of: Table 2. Wax Core Filler Core Antioxidant Healthful substance

60 2 0.01 2

100 5 0.1 5

110 7 1.0 7

120 10 1.5 10

130 15 2.0 12

140 17 2.5 15

150 20 3.0 18

170 25 3.5 20

180 27 4.0 22

190 29 4.5 25 including all values, ranges, and subranges therein.

Preferably, the ratio of ingredients in the core ranges, by weight of each ingredient, from 100: 2: 1 : 10 - 100:30: 1 : 10 of the at least one wax : the at least one core filler : the at least one antioxidant : the at least one healthful substance; including all values, ranges, and subranges therein.

In one inventive embodiment, the ratio of ingredients in the coating ranges, by weight of each ingredient in the coating, form 50:2:0.001 - 200:30: 10 of the at least one wax : the at least one coating filler : the at least one coating antioxidant; including all values, ranges, and subranges therein. For example, the ratio of ingredients in the coating can have values, as shown in the following Table 3, based on the weight of each ingredient, of: Table 3.

Wax Coating Filler Coating Antioxidant

50 2 1

60 2 5

70 2 10

80 2 15

90 2 20

100 2 25

100 5 30

100 10 35

100 15 40

100 20 45

100 25 50

125 15 55 150 17 1

200 22 1

225 24 1

250 26 1

275 28 1

300 29 1

100 2 2

100 2 3

100 2 4

100 2 5

100 2 6

100 2 7

100 2 8

100 2 9

100 2 0.001

100 2 0.01

100 2 0.1 including all values, ranges, and subranges therein.

Preferably, the ratio of ingredients in the coating ranges, by weight of each ingredient in the coating, ranges from 100:2: 1 - 100:30: 1 of the at least one wax : the at least one coating filler : the at least one coating antioxidant; including all values, ranges, and subranges therein.

In one inventive embodiment, the weight of the core ranges from 10 mg to 3000 mg, and weight of the coating ranges from 1 mg to 3000 mg; including all ranges, subranges, and values therein, for example, the weight of the core can be 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, 30 mg, 35 mg, 40 mg, 45 mg, 50 mg, 55 mg, 60 mg, 65 mg, 70 mg, 75 mg, 80 mg, 85 mg, 90 mg, 95 mg, 100 mg, 200 mg, 300 mg, 400 mg, 500 mg, 600 mg, 700 mg, 800 mg, 900 mg, 1000 mg, 1 100 mg, 1200 mg, 1300 mg, 1400 mg, 1500 mg, 1600 mg, 1700 mg, 1800 mg, 1900 mg, 2000 mg, 2100 mg, 2200 mg, 2300 mg, 2400 mg, 2500 mg, 2600 mg, 2700 mg, 2800 mg, and 2900 mg, including all values, ranges, and subranges therein; and for example, the weight of the coating can be, for example, 1 mg to 3000 mg, including all ranges, values, and subranges therein; for example, the weight of the coating can be 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, 30 mg, 35 mg, 40 mg, 45 mg, 50 mg, 55 mg, 60 mg, 65 mg, 70 mg, 75 mg, 80 mg, 85 mg, 90 mg, 95 mg, 100 mg, 200 mg, 300 mg, 400 mg, 500 mg, 600 mg, 700 mg, 800 mg, 900 mg, 1000 mg, 1 100 mg, 1200 mg, 1300 mg, 1400 mg, 1500 mg, 1600 mg, 1700 mg, 1800 mg, 1900 mg, 2000 mg, 2100 mg, 2200 mg, 2300 mg, 2400 mg, 2500 mg, 2600 mg, 2700 mg, 2800 mg, and 2900 mg, including all values, ranges, and subranges therein.

The coating of the composition, may optionally, contain a healthful substance which is the same or different from the healthful substance in the core of the healthful composition, when the composition contains both a core and a coating.

It is understood that the shape of core, or if the composition does not contain both a coating and a core, the shape of the composition / pellet thereof, can be definite or amorphous. For example, the core and/or the composition / pellet thereof can be spherical, rod shaped, disk shaped, cone shaped, tear drop shaped, cube shaped, rectangular, triangular, or pyramidal in shape.

In one inventive embodiment, the healthful substance is contained in the healthful composition or pellet thereof in a concentration gradient with the highest concentration of the healthful substance being at the center of the healthful composition, and the concentration of the healthful substance decreasing, continuously or discontinuously, with increasing distance from the center of the healthful composition to the periphery of the healthful composition or pellet thereof.

In one inventive embodiment, the core of the healthful composition, when present, is shaped such that the healthful substance is contained in the healthful composition in a concentration gradient, based on the amount of core material present at a point within the healthful composition, with the highest concentration of the healthful substance being at the center of the healthful composition, and the concentration of the healthful substance decreasing, continuously or discontinuously, with increasing distance from the center of the healthful composition to the end of the core.

It is further understood that when the healthful substance is released from the core, when a core is present, or from the composition, when a core is absent, (e.g., when the healthful composition is placed in an environment that facilitates release of the healthful substance from the healthful composition, such as being administered, preferably orally, to a mammal, preferably a human, more preferably a mammal or human in need of treatment or prevention of a disease or condition by administration of the healthful substance in an amount sufficient to treat or prevent the disease or condition; or in water, in an amount ranging from 100 to 900 ml, including all values, ranges, and subranges therein, for example, 200 ml, 300 ml, 400 ml, 500 ml, 600 ml, 700 ml, and 800 ml, at a temperature ranging from 10 ⁰C to 40 ⁰C, including all ranges, subranges, and values therein, for example, 15 ⁰C, 20 ⁰C, 25 ⁰C, 30 ⁰C, and 35 ⁰C, preferably with stirring, preferably by a paddle, preferably rotating at a range of from 1 to 30 rotations per minute, including all values, ranges, and subranges therein, for example 5 rotations per minute, 10 rotations per minute, 15 rotations per minute, 20 rotations per minute, and 25 rotations per minute), the release rate may be such that a plot of the percent or mass of healthful substance released from the core over time may be linear, or non-linear, and that the release rate of the healthful substance may be constant, continuous, and sustained, or may vary over time, and/or be discontinuous, and/or be of short duration.

When the healthful substance is released from the healthful composition, it is understood that greater than 50%, or 55%, or 60%, or 65%, or 70%, or 75%, or 80%, or 85%, or 90%, or 95% or 100% of the healthful substance, including all values, ranges and subranges between 50% and 100%, may be released from the core of the healthful composition in a time ranging from, for example, 0.5 to 24 hours, including all values, ranges, and subranges therein; for example, 0.5 hours, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 3.5 hours, 4 hours, 4.5 hours, 5 hours, 5.5 hours, 6 hours, 6.5 hours, 7 hours, 7.5 hours, 8 hours, 8.5 hours, 9 hours, 9.5 hours, 10 hours, 10.5 hours, 1 1 hours, 1 1.5 hours, 12 hours, 12.5 hours, 13 hours, 13.5 hours, 14 hours, 14.5 hours, 15 hours, 15.5 hours, 16 hours, 16.5 hours, 17 hours, 17.5 hours, 18 hours, 18.5 hours, 19 hours, 19.5 hours, 20 hours, 20.5 hours, 21 hours, 21.5 hours, 22 hours, 22.5 hours, 23 hours, 23.5 hours, and 24 hours.

The core and/or coating of the healthful composition can contain other materials, for example gelatin, a Bloom gelatin, a Bloom gelatin having a Bloom number less than 50, a plastic, a polymer, a sugar, a polymer substance, a cellulose, a cellulose ether, a gas, a lecithin, stearidonic acid, margarine, processed meat, a protein, a peptide, a polynucleotide, a cooling agent, defined as a chemical compound that, when dissolved in water, feels cool due to an endothermic reaction, mineral oil, ammonia, and emulsifier, for example polyoxethylene 80 sorbitan monolaurate and an acetylated monoglyceride, carnuba wax, sodium bicarbonate, a sterol, a stanol, an absorbing agent, a thermoplastic material, glycerin, water, cholesterol, trans fatty acids, an alcohol, or combinations thereof. In one embodiment, the healthful composition does not contain any of the ingredients listed in this paragraph.

The at least one wax, or where appropriate, at least one coating wax and at least one core wax, can independently be, for example, may be any natural or synthetic wax suitable for oral administration to a human. Examples of edible wax include, but are not limited to, beeswax, castorwax, glycowax, and carmaubawax. In a preferred embodiment, the at least one wax, or where appropriate, the at least one coating wax and at least one core wax, is beeswax.

The healthful composition can be used to treat or prevent a disease or condition, for example, elevated blood triglycerides, ventricular arrhythmia, cardiac arrhythmia, arrhythmogenesis, dyslipidemia, elevated blood cholesterol, inflammation in the lungs, inflammation in the arteries, arthritis, rheumatoid arthritis, Alzheimer's disease, depression, seasonal affective disorder, arteriosclerosis, asthma, chronic bronchitis, emphysema, obesity, mood disorder, macular degeneration, , diabetes, and/or adiposity; or to improve or enhance or support some biological function, for example, for brain development, for brain support, for improvement of postprandial vascular reactivity, for improvement of postprandial vascular reactivity in healthy men, for enhanced cognitive performance in the elderly, for enhanced cognitive performance, for elevated blood pressure, for silent inflammation; and combinations thereof.

Preferably, the healthful substance, and/or the healthful composition, has a mercury concentration of less than 10 parts per billion and/or a concentration of polychlorinated biphenyls of less than 56 parts per billion per gram and/or a concentration of dioxins of less than 1 part per trillion and/or a concentration of furans of less than 2 parts per trillion and/or a peroxide concentration of less than 4 meq/kg and/or concentrations of lead, arsenic, cadmium and nickel of less than 0.1 mg/kg.

The density of the healthful composition can be varied such that, for example, when the healthful composition is placed in a container of water, the healthful composition, or pellct(s) thereof, floats on the water, or sinks to the bottom of the container, or resides somewhere between the surface of the water and bottom of the container, but is fully suspended in the water, or any combination of these. Preferably, the composition, or pellet(s) thereof, floats midway between the surface of the water and the bottom of the container. For example the healthful composition, or pellet(s) thereof, can have a density of > 1.0 g/ml, equal to 1.0 g/ml, less than 1.0 g/ml, or any combination thereof.

In one embodiment of the healthful composition, the density of the healthful composition can be controlled by controlling the amount of core filler and/or coating filler, or if a core and coating are not present, simply filler, relative to the other ingredients in the healthful composition.

Dosing of the healthful substance in the healthful composition can be controlled by controlling the amount of healthful substance in the composition or pellet thereof, in, where applicable, the core mixture, and/or where applicable, controlling the amount of core mixture in the healthful composition, and/or administering more than one unit of the healthful composition at a time, a unit being defined as a self contained discrete piece of healthful composition, such as a pellet, that is not physically joined to any other piece of the healthful composition, such as another pellet.

In one embodiment of the present invention, the healthful composition, is orally ingested in a human. In one embodiment of the present invention, the healthful composition or pellet thereof, is stable (e.g., does not release the healthful substance from the healthful composition) for a period ranging from 1 week to 2 years, including all ranges, values, and subranges therein; for example, 1 week, 2 weeks, 3 weeks, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, 7 months, 8 months, 9 months, 10 months, 1 1 months, 12 months, 13 months, 14 months, 15 months, 16 months, 17 months, 18 months, 19 months, 20 months, 21 months, 22 months, 23 months, and 24 months, including all ranges, values, and subranges therein.

In one embodiment of the invention, wherein the healthful composition, when placed in air at a temperature of 10 ⁰C to 45 ⁰C, including all values, ranges, and subranges therein, preferably 40 ⁰C ± 2 ⁰C, and a relative humidity of 45% to 90%, including all values, ranges, and subranges therein, preferably 75% + 5%, is stable (e.g., , the healthful substance has an odor and no odor of the healthful substance is detectable by sniffing the air, preferably by a human sniffing the air) for a period of time ranging from 1 week to 2 years, including all ranges, values, and subranges therein; for example, 1 week, 2 weeks, 3 weeks, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, 7 months, 8 months, 9 months, 10 months, 1 1 months, 12 months, 13 months, 14 months, 15 months, 16 months, 17 months, 18 months, 19 months, 20 months, 21 months, 22 months, 23 months, and 24 months, including all ranges, values, and subranges therein. This embodiment is hereinafter test condition 1.

In one embodiment of the invention, when the healthful composition contains only one healthful substance, and the healthful substance has an odor, the healthful composition is tested for stability (test condition 1 ) in 12 ounces of pH 7 distilled, deionized water at room temperature (23 ⁰C) in a closed container with a removable and resealable Hd, such as a plastic or glass bottle with a removable screw top cap, by placing the healthful composition into the water in the container, sealing the container, maintaining the container at room temperature, protecting the container from light, and periodically opening the container and smelling the contents to see if the healthful substance has been released by detecting the presence or absence of an odor of the healthful substance, the sniffing preferably conducted by a human). This embodiment is herein after test condition 2.

In another embodiment of the invention, when the healthful composition contains only one healthful substance, and the healthful substance does not have an odor, stability testing of the healthful composition is done in 12 ounces of pH 7 distilled, deionized water at room temperature (23 ⁰C). The healthful composition is placed in the water in a container, the container is sealed, maintained at room temperature, and protected from light. Periodically, the container is opened, an aliquot of the water is removed, and analyzed by HPLC (high performance liquid chromatography) using, for example, normal phase chromatography or reverse phase chromatography, and gradient and/ or isocratic elution with a solvent or solvent system, for example, methanol, water, dimethyl sulfoxide, N, N-dimethyl formamide, or any combination thereof, and analyzed for the presence of healthful substance using a detector, for example, a UV detector, and calibration curve. This embodiment is hereinafter test condition 3.

When the healthful composition contains more than one healthful substance, preferably, the testing method is selected as follows: If at least one of the healthful substances in the healthful composition has an odor, test condition 1 is preferably used for that healthful substance(s). If at least one of the healthful substances in the healthful composition has no odor, preferably test condition 3 is used for that substance. Another inventive embodiment comprises the healthful composition contained in a container or package. Optionally, the container or package is accompanied with instructions for using the healthful composition. Optionally, the instructions are contained on the container or package, or inside of the container or package, or on a writing accompanying the container or package, or any combination thereof.

Another inventive embodiment comprises the healthful composition combined with a liquid, preferably an aqueous solution, more preferably water. When the healthful composition is placed into water, for example a cup of water, a pint of water, a quart of water, a half gallon of water, a gallon of water, 10 ml -1000 ml of water, including all values, ranges, and subranges therein, preferably at pH =7, but at a pH of from 1 to 14, including all values, ranges, and subranges therein, and preferably, at 23⁰C, but at a temperature of from 1 O⁰C to 40 ⁰C, including all values, ranges, and subranges therein, without stirring or agitation, the composition is stable (i.e., does not release the healthful substance from the healthful composition) for a period ranging from 1 week to 2 years, including all ranges, values, and subranges therein.

A further inventive embodiment comprises a method of making a healthful composition comprising mixing the at least one core antioxidant, the at least one core filler, the at least one wax, and the at least one healthful substance, optionally above room temperature, for example, at a temperature ranging from 5O⁰C - 6O⁰C, including all ranges, subranges, and values therein, to form a core mixture, optionally injectable; mixing the at least one coating antioxidant, the at least one coating filler, and the at least one wax, optionally above room temperature, for example, at a temperature ranging from 5O⁰C -6O⁰C, including all ranges, subranges, and values therein, to form a coating mixture, optionally injectable; filling a mold with the coating mixture, optionally above room temperature, for example, at a temperature ranging from 5O⁰C - 6O⁰C, including all ranges, subranges, and values therein, to the point where the mold is from 10% -90% full, by volume of the mold, preferably 50% full by volume of the mold; introducing the core mixture, optionally above room temperature, for example, at a temperature ranging from 5O⁰C - 6O⁰C, including all ranges, subranges, and values therein, into the mold on top of the coating mixture already present in the mold; introducing the coating mixture, optionally above room temperature, for example, at a temperature ranging from 5O⁰C - 6O⁰C, including all ranges, subranges, and values therein, into the mold on top of the core mixture and coating mixture previously introduced into the mold; and removing the resultant coated core from the mold, optionally, with cooling, to form the healthful composition.

Λ further embodiment of the present invention is a method of administering the healthful composition to a mammal, preferably a human, wherein the healthful composition is orally administered to the mammal.

Another embodiment of the present invention is a method of treating at least one disease or condition in a mammal, preferably a human, preferably a human in need thereof, by administering, preferably orally, the healthful composition to the mammal, preferably human, in an amount sufficient to treat the disease or condition.

In one embodiment of the present invention, the at least one healthful substance is fish oil. The fish oil may comprise at least one member selected from the group consisting of eicosapentaenoic acid (EPA), an inorganic salt of EPA, an organic salt of EPA, an ester of EPA, docosahexaenoic acid (DHA), an inorganic salt of DHA, an organic salt of DHA, an ester of DHA, and combinations thereof.

Examples of esters of EPA and/or DHA include methyl ester, ethyl ester, isopropyl ester, tert-butyl ester, and benzyl ester, and the glycerol ester, wherein one, two, or three of the hydroxyl groups of the glycerol are esterified with EPA and/or DHA.

Examples of inorganic salts of EPA and/or DHA include a sodium salt, a potassium salt, a calcium salt, a magnesium salt, a copper salt, and a zinc salt.

Examples of organic salts of EPA and/or DHA include an amino acid salt of EPA and/of DHA, for example, the glycine salt, the valine salt, the leucine salt, the isoleucine salt, the phenylalanine salt, the alanine salt, the arginine salt, the asparagine salt, the aspartic acid salt, the cysteine salt, the glutamine salt, the glutamic acid salt, the histidine salt, the lysine salt, the methionine salt, the praline salt, the serine salt, the threonine salt, the tryptophan salt, and the tyrosine salt. Other organic salts include, for example, the taurine salt and the creatine salt.

If EPA and DHA are both present, the ratio of EPA to DHA, or salt or ester thereof, can range from 1 :99 to 99: 1 by weight total of EPA and DHA, including all values, ranges, and subranges therein.

In certain embodiments, the range of EPA to DHA, or salt or ester thereof, can be from 95:5 to 5:95, 90: 10 to 10:90, 15:85 to 85: 15, 80:20 to 20:80, 25:75 to 75:25, 70:30 to 30:70, 35:65 to 65:35, 40:60 to 60:40, 45:55 to 55:45, and 50:50, and all values, ranges, and subranges therein.

The fish oil can be in liquid or powdered form. The fish oil can be surrounded by spheres or capsules of gelatin with a length ranging from 1 nm to 1000 micrometers, including all ranges, subranges, and values therein. The fish oil, in powdered form, can comprise, for example, a total omega 3 content of from, for example, 150 mg/g - 204 mg/g of omega 3 / g of powder as triglycerides, wherein omega 3 comprises EPA, DHA, or EPA and DHA, preferably in the form of triglycerides. In an inventive embodiment of the present invention, the fish oil, or healthful substance generally, is not encapsulated within a gelatin capsule.

The fish oil can be combined with one or more additional healthful substances or salts thereof.

Other healthful substances useful herein, or where applicable, salts thereof, include, for example, co-enzyme QlO, cod liver oil, vitamin A, vitamin Bl , vitamin B2, vitamin B3, vitamin B4, vitamin B5, vitamin B6, vitamin B7, vitamin B8, vitamin B9 (folic acid and folate forms), vitamin B 12, vitamin C, an ester of vitamin C, such as the calcium ascorbate ester of vitamin C, vitamin D, vitamin E, vitamin K, glucosamine, lycopene, selenium, zinc, ginsing, Echinacea, aloe vera, brewers yeast, astragalus, burdock root, cat's claw, cayenne, chlorella, cranberry berry, grape seed extract, fennel, fenugreek, feverfew, garlic, a garlic extract, odorless garlic, Korean ginsing, Siberian ginsing, American ginsing, golden seal root,green tea, green tea extract, juniper berry, licorice, oregano leaf, pau d'arco, red clover, St. John's Wort, sarsaparilla, caffeine, theobromine, chocolate, alpha linolenic acid, gamma linolenic acid, primrose oil, sea salt, and spirulina.

Any healthful substance, or combination thereof, is encompassed in the present inventive embodiments.

In the inventive embodiments of the present invention, a healthful substance is a solid, liquid, or gas; element, molecule, or salt; taken to maintain health and/or improve health and/or prevent a disease or condition and/or treat a disease or condition.

The composition can also contain a flavorant, a coloring agent, an excipient, preservative, or combinations thereof. Examples of preservatives include sodium citrate, citric acid, methyl paraben, and propyl paraben.

Examples of excipients include silica, silicon dioxide, starch, glucose, fructose, cellulose, hydroxypropyl cellulose, hydroxypropyl methyl cellulose, methyl cellulose, lactose, xylitol, sorbitol, maltitol, gelatin, polyvinyl pyrrolidone, a polyethylene glycol such as PEG 6000, PEG 7000, PEG 8000, PEG 9000, PEG 10,000, PEG 1 1,000, and PEG 12,000.

The shape of composition, or pellet thereof, is not limited, and can be, for example, spherical, tear drop shaped, elongated, oval shaped, football shaped, cylindrical, cone shaped, cube shaped, star shaped, circular, rectangular, rounded rectangular, triangular, pentangular, and hexagonal. In certain examples, the composition or pellet thereof, can be shaped by molding.

The composition, or pellet thereof, can range, for example, in length, from 1 mm to 100 mm in length, including all ranges, subranges, and values therein. For example, the length of the composition or pellet thereof can be 1 mm, or 2 mm, or 3 mm, or 4 mm, or 5 mm, or 6 mm, or 7 mm, or 8 mm, or 9 mm, or 10 mm, or 1 1 mm, or 12 mm, or 13 mm, or 14 mm, or 15 mm, or 20 mm, or 25 mm, 30 mm, 40 mm, 50 mm, 60 mm, 70 mm, 80 mm, and 90 mm in length, including all ranges, subranges, and values therein.

If the composition or pellet thereof is spherical, for example, the diameter of the composition or pellet thereof can range from, for example, 1 mm to 100 mm in length, including all values, ranges, and subranges therein. For example, the diameter of the composition or pellet thereof can be 1 mm, or 2 mm, or 3 mm, or 4 mm, or 5 mm, or 6 mm, or 7 mm, or 8 mm, or 9 mm, or 10 mm, or 1 1 mm, or 12 mm, or 13 mm, or 14 mm, or 15 mm, or 20 mm, or 25 mm, 30 mm, 40 mm, 50 mm, 60 mm, 70 mm, 80 mm, and 90 mm in length.

If the composition or pellet thereof is spherical, for example, the radius of the composition or pellet thereof can range from, for example, 1 mm to 100 mm in length, including all values, ranges, and subranges therein. For example, the radius of the composition or pellet thereof can be 1 mm, or 2 mm, or 3 mm, or 4 mm, or 5 mm, or 6 mm, or 7 mm, or 8 mm, or 9 mm, or 10 mm, or 1 1 mm, or 12 mm, or 13 mm, or 14 mm, or 15 mm, or 20 mm, or 25 mm, 30 mm, 40 mm, 50 mm, 60 mm, 70 mm, 80 mm, and 90 mm in length.

The composition or pellet thereof can be colored, for example, as a white, red, orange, yellow, green, blue, indigo, violet, black, or grey. The composition or pellet thereof can also contain more than one color, either homogeneous mixed, or separated in different portions of the composition.

In the composition, or pellet thereof, the at least one core antioxidant and the at least one coating antioxidant, which may be the same or different, or if the composition lacks a core and a coating, the at least one antioxidant, can be, for example, L-ascorbic acid, D-ascorbic acid, a salt of L-ascorbic acid, a salt of D- ascorbic acid, an ester of L-ascorbic acid, an ester of D-ascorbic acid, retinol, retinal, retinoic acid, alpha-carotene, beta-carotene, lycopene, an alpha-tocotrienol, a beta- tocotrienol, a gama-tocotrienol, a delta-tocotrienol, an alpha-tocopherol, a beta- tocopherol, a gama-tocopherol, a delta-tocopherol, coenzyme QlO, manganese, melatonin, lutein, zeaxanthin, astaxanthin, canthaxanthin, luteolin, apigenin, tangeritin, quercetin, rutin, kaempferol, myricetin, isohamnetin, a proanthocyanidin, hesperetin, hesperidin, naringenin, naringin, eriodictyol, catechin, gallocatechin, a gallate ester of catechin, a gallate ester of gallocatechin, epicatechin, epigallocatechin, a gallate ester of epicatechin, a gallate ester of epigallocatechin, theaflavin, a gallate ester of theaflavin, a thearubigin, genistein, daidzein, glycitein, resveratrol, pterostilbene, cyaniding, delphinidin, malvidin, pelagronidin, peoidin, petunidin, ellagic acid, gallic acid, salicyclic acid, rosmarinic acid, cinnamic acid, chlorogenic acid, a gallotannin, an ellagitannin, an emblicanin-antioxidant, curcumin, a xanthone, silymarin, eugenol, citric acid, oxalic acid, phytic acid, lignan, bilirubin, uric acid, a lipoic acid, n- acetylsysteine, and combinations thereof.

In the composition or pellet thereof, the at least one core filler, and the at least one coating filler, which may be the same or different, or if the composition or pellet thereof lacks a core and a coating, the at least one filler, can be, for example, the group consisting of apatite, hydroxyapatite, calcium carbonate, calcium disodium EDTA, calcium chloride, calcium citrate, calcium glycerophosphate, calcium gluconate, calcium silicate, calcium oxide, calcium hydroxide, calcium stearate, calcium phosphate tribasic, calcium lactate, calcium pantothenate, calcium oleate, calcium palmirate, calcium D-pantothenate, calcium alginate, calcium phosphate anhydride, calcium hydrogenphosphate, calcium primary phosphate, calcium acetate, calcium saccharate, calcium sulfate, calcium secondary phosphate, calcium para- aminosalicylate, a bio calcilutite compound, magnesium L-aspartate, magnesium chloride, magnesium gluconate, magnesium aluminate silicate, magnesium silicate, magnesium oxide, magnesium hydroxide, magnesium stearate, magnesium carbonate, magnesium aluminate metasilicate, magnesium sulfate, sodium magnesium silicate and synthetic sodium magnesium silicate, silicon oxide hydrate, light silicic anhydride, synthetic hydrotalcite, diatomaceous earth, silicon dioxide, ferrous sulfate, iron carbonate, iron chloride, zinc chloride, zinc stearate, zinc oxide, zinc sulfate, and combinations thereof. In another inventive embodiment, the composition is contained within a package, preferably a display package. The package can be, for example, an envelope, pouch, or box, and can include, for example, directions for administering the composition.

In a further inventive embodiment, the composition can be contained within a a container, such as a bottle. Preferably, the bottle contains a liquid. Preferably, the liquid is present in an amount of, for example, 10 ml to 1000 ml, including all values, ranges and subranges therein. Preferably, the liquid is present in an amount of, for example, a cup, a pint, a quart, a half gallon, or a gallon. Preferably, the liquid is water, for example, spring water, purified water, distilled water, deionized water, mineral water, carbonated water, flavored water, or any combination thereof.

In one inventive embodiment, the composition, or pellet(s) thereof, are not compressed into tablets.

Examples

The present invention is described by way of example in the examples herein after. Obviously, numerous modifications and variations of the present invention are possible in light of the above listed teachings. It is therefore to be understood that, within the scope of the appended claims, the invention may be practiced otherwise than as specifically described herein.

Example 1 :

Beeswax (50.00 kg) was liquefied at 80 ⁰C + 5 ⁰C, and powdered calcium carbonate (10.00 kg), d-α-tocopherol (0.05 kg), and fish oil (20.00 kg) were mixed into the liquefied beeswax, and the resulting mixture, after 20 minutes of mixing, was cooled to 50 "C + 3⁰C and subsequently granulated to form premix compound II.

Separately, beeswax (150.00 kg) was liquefied at 80 ⁰C + 5 ⁰C, and powdered calcium carbonate (20 kg) and d-α-tocopherol (0.05 kg) were mixed into the liquefied beeswax, and the resultant mixture, after 20 minutes of mixing, was cooled to 50 ⁰C + 3⁰C to form premix compound I.

107.05 kg of premix compound I and 80.05 kg of premix compound II were mixed at 50 ⁰C + 3⁰C and the resultant mixture ejected out of a nozzle, as a fine distribution of pellets, at 50 ⁰C ± 3⁰C, into water at a temperature of 15 ⁰C + 3⁰C.

The resultant pellets were dried at 20 ⁰C + 3 ⁰C for 30 minutes, and the dried pellets were subsequently tested for stability as described in Example 2.

Example 2:

A sample of the pellets made in Example 1 above, were placed in air at a temperature of 40 ⁰C ± 2⁰C and a relative humidity of 75% ± 5%. After 6 months, the pellets were tested for stability by smelling, by a human, to detect the presence or absence of the odor of fish oil; for integrity of the EPA and DHA in the fish oil; and for the absence of microbial contamination. The results of these tests are presented in Table 4, below:

Stability Result

Test condition : 40⁰C (± 2°C), 75%RH (± 5%)

Test period : 6 months

Test contents:

1. Descriptions

2. Active analysis

3. Microbiological test

Table 4.

I Specification Initial 1 month 2 month 3 month 4 month 5 month 6 month

Example 3"

1. EPA/DHA GC analysis method EPA, DHA Assay

Test Procedure

Internal standard

Transfer about 400mg of methyl tricosanoate to a 10OmL volumetric flask and dissolve in 0.05g/L butylhydroxytoluene solution dissolved with trimethylpentane and dilute with the same solution to volume.

Test solution

1 ] Transfer l Omg of sample to a test tube and add 2mL of internal standard.

2] Add N₂ gas at 40-50 ^°C to evaporate the solvent.

Add 1.5mL of 20g/L Sodium hydroxide dissolved with methanol and N2 charge and then close with polytetrafluoroethylene-lined stopper and heat under boiling water bath for 7 minutes and mix and then cool down the solution at 40 - 50 ^°C . ] To the solution, add 2mL of Boron trifluoride-methanol solution and N2 charge and close with the stopper and heat under water bath for 30 minutes and mix. Cool down to 40-50 ^°C and then add I mL of trimethylpentane and then close with stopper and vigorously shake for 30 seconds and add 5mL of saturated Sodium chloride solution and N2 charge and then vigorously shake for 15 seconds. Transfer the upper layer to a separate tube and add ImL of trimethylpentane to the methanol layer and shake. Wash the concentrated trimethylpentane with I mL of water in twice and dehydrate with Sodium sulfate, anhydrous. ] Gas chromatograph the solution diluted with trimethylpentane (1 in 5). Standard solution (Prepare at the same time with the test solution) Transfer about 80mg of Docosahexaenoic acid methyl ester, about 90mg of Eicosapentaenoic acid methyl ester to a 100-mL volumetric flask and dissolve in dilute with 0.05g/L butylhydroxytoluene solution (dissolved with trimethylpentane) to volume and mix and then subdivide the standard solution and store in freezer. GC condition: Table 5.

5] Calculation

Assay of EPA and DHA is obtained using following calculation as mg fatty acid/g oil

A3 ml mx,r 1

Ax ^→ → <→ <→ ~ C «→ 1000 m3 Al Ax, r m2 ml= Weight of Internal standard (mg) m2= Weight of sample in test solution (mg) m3= Weight of Internal standard in standard solution (mg) mx,ρ Weight of EPA methyl ester or DHA methyl ester in standard solution (mg) Ax= Peak area of EPA methyl ester or DHA methyl ester obtained from chromatogram of test solution Ax,r= Peak area of EPA methyl ester or DHA methyl ester obtained from chromatogram of standard solution

Al= Peak area of internal standard obtained from chromatogram of test solution

A3= Peak area of internal standard obtained from chromatogram of standard solution

C= Fatty acid conversion factor based on molecular weight of ethyl ester and fatty acid

C_DΠΛ=0.9590

2. Microbiological test procedure embodiments are described, for example, at figure 4. Example 4:

Beeswax (50.00 kg) was liquefied at 80 ⁰C + 5 ⁰C, and powdered calcium carbonate (10.00 kg), d-α-tocopherol (0.5kg), and fish oil and/or powdered fish oil (10.00 kg) were mixed into the liquefied beeswax, and the resulting mixture, after 20 minutes of mixing, was cooled to 50 ⁰C + 3⁰C and subsequently mixed to form premix compound II.

Separately, beeswax (50.00 kg) was liquefied at 80 ⁰C + 5 ⁰C, and powdered calcium carbonate (10 kg) and d-α-tocopherol (0.5 kg) were mixed into the liquefied beeswax to form premix compound I.

60.5 kg of premix compound I, at 80 ⁰C + 5 ⁰C and 70.5 kg of granulated premix compound II at a temperature of 50 ⁰C + 3⁰C, were mixed, and the resultant mixture ejected out of a nozzle, as a fine distribution of pellets, at 50 ⁰C + 3⁰C, into water at a temperature of 15 ⁰C + 3⁰C.

Example 5

Fig. 5 shows a method according to one or more embodiments of the invention. As shown in Fig. 5, a push pin 30 is partially inserted into an aperture 12 formed in a base plate 20. For simplicity, only a single push pin 30 and aperture 12 are shown, however, it is to be understood that a plurality of push pins 30 can be inserted into a corresponding plurality of apertures 12 formed in the base plate 20. As discussed with respect to one or more examples, the apertures 12 are formed in rows and columns forming a 12 x 18 array 13. However, uniformly or non-uniformly spaced plurality of apertures 12 or any number of rows and columns of apertures 12 can be formed as desired.

The base plate 20 is rotated between stations A, B, C, D, E and F to allow for a plurality of process steps to be performed. In an example of the invention, each station-to-station period is twelve seconds. The time period between stations can be higher or lower as desired. In station A, heated liquid wax injector nozzles 70, discussed in more detail with respect to Fig. 12, inject liquid beeswax or beeswax compound (5 mg for example, with a range of, for example, 2 mg to 100 mg, including all values, ranges, and subranges therebetween) into the apertures 12 of base plate 20 and onto a top portion of push pin 30 located within the aperture 12. (The liquid wax can contain additional ingredients, for example, a healthful substance, and /or a filler and/or an antioxidant). The liquid wax is then cooled for a desirable period of time. In an example of the invention, the heated wax is cooled for 8 seconds and solidified in the aperture 12 of the liquid- or air-cooled base plate 20. A metered dispense pump 83 shown in Fig. 12 is used for station A (as well as stations C and D) to ensure that an appropriate amount of wax is injected. The supply lines for the pump 83 are temperature controlled using heater tape, for example mylar, and optionally with insulation.

As shown in Fig. 5, the top portion of the push pin 30 is substantially planar, however, the top portion could be concave or convex. Additionally, the apertures 12 are substantially circular but could have any desirable shape, for example square, triangular, oval, etc. As such, the push pin 30 would have a matching shape.

In station B, a cavity and opening thereto is formed in the now solidified wax. That is, pins 92, made of for example 316 stainless steel and formed to be 0.050" in diameter, are inserted part way into the warm solid wax to form a cavity. The pins 92 are then retracted. The pins 92 are part of a cavity pin assembly 90 discussed in greater detail with respect to Fig. 13. In an example of the invention, there are a total of 216 (12 x 18) pins press-fit into a temperature-controlled aluminum plate of the pin assembly 90. The pin assembly 90 is used to form all 216 cavities at the same time. The wax, with the cavity and opening formed by the insertion of the pins 92, is now a container that can hold a product, such as a liquid. It should be appreciated that there can be any desirable number of apertures 12 and thus, there will be provided a corresponding number of pins 92 and nozzles 70, 73 and 79.

In station C, liquid omega-3 15% by volume for example, is injected through a plurality of nozzles 78 into the cavities formed in the wax. In an example of the invention, fish oil (0.00 I mL for example, with a range of, for example, from 0.0004 mL to 0.04 mL, including all values, ranges, and subranges therebetween) is injected into the wax and substantially fills the interior space provided by the cavity. The fish oil can contain additional ingredients such as an antioxidant or can contain one or more additional healthful substances). However, a further example of the invention allows for only a part of the cavity to be filled by the fish oil. Another example provides for a different liquid to be injected into the cavity.

Next, at station D, liquid beeswax or beeswax compound (2 mg for example, with a range of, for example, 0.05 mg to 30 mg, including all values, ranges, and subranges therebetween) is injected via a plurality of nozzles 79 into the opening of the cavity and subsequently cooled by the air- or liquid-cooled base plate for 10 seconds for example, to form a cap. The wax can contain additional ingredients, including for example, a filler, an antioxidant, and/or a healthful substance) The container and the cap form a coating that completely surrounds the cavity and the at least one healthful substance contained therein (e.g., the core). At station E, the capped wax pellets 25 are allowed to cool for any adequate amount of time. In an example, the wax pellets 25 are allowed to cool for 10 seconds. No action is applied at station E. Instead, the pellets are cooled at station E before they move to section F.

The composition (e.g., pellet - preferably cylindrical) is then subsequently raised out of the mold by the push pin 30 at station F. That is, the wax pellet 25 is pushed out of the aperture 12 from below by the pin 30. Once pushed out, the pellet 25 is exposed to the scraping blade 40 and is sheared off as discussed in greater detail with respect to Fig. 14. The pellets 25 are then collected by a hopper 52 or other similar collection device. The pellets 25 thus formed can be, for example, 0.10" in diameter and 0.10" high and cylindrical in shape. Next, the push pin is lowered in preparation for returning to wax filling at Station A. In an example of the invention, each station-to-station period is 12 seconds, but longer or shorter time periods are within the spirit and scope of the present invention. The base plate 20 is then rotated and the whole process discussed above is then repeated at each of stations A-F.

Figure 6 is a schematic showing the overall structure of a wax pellet machine according to one or more embodiments of the present invention. The station mounting base 10 includes the five active stations (stations A, B, C, D and F) with one passive station (E), as discussed with respect to Fig. 5, arranged on the round plate forming the base 10. The station mounting base 10 is fixed in position and thus, does not rotate. Each of the stations A-F is connected to a surface of the station mounting base 10.

The base plate 20 is located below the mounting base 10 and is rotatable. The base plate 20 can be made of aluminum for example, and include a plurality of sections each containing an array of apertures 12. In an embodiment of the invention, the base plate 20 includes six aperture array sections 13. In this way, each array section 13 will correspond to and align with one of the stations A-F after each rotation of the base plate 20.

As best shown in Figs. 6-8, the base plate 20 is air- or liquid-cooled to maintain a desired temperature. In a preferred embodiment, water is the coolant. Cooling water flows to the base plate 20 through a water line 33 that includes a temperature sensor 37. Additionally, flowmeters 38 and valves 39 can be associated with the water line 33 to regulate the water flow. As best shown in Fig. 8, the water line 33 can connect with, for example a central region of the base plate 20, and direct water to flow through water tube 34 associated with the base plate 20. In an example of the invention, the water tube 34 is 3/8" Cu tubing brazed to a surface of the base plate 20. The water tube 34 can be formed on any surface of the base plate 20, for example top, bottom and/or side surface and/or be formed in an interior of the base plate 20. The water tube 34 can preferably wind around the areas between the plurality of aperture arrays 13 in order to evenly cool the base plate 20. After the water flows around the area of the base plate 20, the water exits through water line 35. Water flow through water line 35 can be contained by a rotating liquid seal 36.

A DC servomotor 38 with indexer is provided to rotate the rotating base plate 20. The base plate 20 is secured to a telescoping rod 21 to allow a pancake air cylinder 39 with up and down sensors, to move the base plate 20 in an up and down direction. It should be appreciated that any suitable device can be used to move the base plate up and down and rotate the base plate 20. The air cylinder 39 and/or the motor 38 can be fixed to a frame or housing 41 in any suitable manner.

Located under the base plate 20 are a plurality of push pin plate assemblies 60 as shown in Fig. 7 and discussed in more detail with respect to Fig. 10. A push pin assembly 60 is provided for and corresponds to each one of the arrays 13 of apertures 12. Associated with each plate assembly 60 is a 2-position proximity sensor 62 used to determine a pin-up or pin-down position of the pins 30. A proximity sensor 62 is therefore provided for each of stations A-F.

Figure 9 shows an aperture array pattern 13 on the water cooled rotating base plate 20 with respect to an inventive embodiment useful for, for example, making a healthful composition inventive embodiment with a machine system inventive embodiment. As discussed with respect to Figs. 5-6, there are six sets of aperture arrays 13 provided on the base plate 20. The six aperture arrays 13 will correspond to each station A-F. As shown in Fig. 9, the array 13 is formed by 12 columns and 18 rows of apertures 12. However, any number of rows and columns or any aperture arrangement configuration can be used as desired. In an example of the invention, the apertures 12 are 0.100" in diameter with the centers of adjacent apertures 12 formed preferably 0.200" apart. An array formed by this example is approximately 2.200" in width and 3.400" long. It is within the spirit and scope of the invention to provide any sized and shaped aperture 12 and thus form any sized array of apertures 12. An alignment pin 17 is provided at least on one end of the aperture array 13. In Fig. 9, an alignment pin 17 is located at both ends of the array 13 to facilitate alignment at each of stations A-F, for example with the dispenser nozzle plate. Accordingly, the dispenser nozzle plate is spring mounted in an x and y direction and will have matching alignment holes.

Figure 10 is a schematic showing a push pin assembly 60 according to an example of the invention. As shown in Fig. 10, the push pin assembly 60 can be mounted underneath the base plate 20 with a securing device such as with screws or bolts. It should be understood that the pin assembly 60 can be secured in any desirable manner. The push pin assembly 60 is provided for each of the six aperture arrays 13 which also corresponds to the six stations A-F. Each of the push pin assemblies 60 includes mounting plates 63, 64 made of aluminum for example, with the plurality of pins 30 press fit into mounting plate 63 and face the undersides of the base plate. When the pin assembly 60 is mounted on the base plate 20, the pins 30 partially project through the aperture 12. The pins 30 are able to be moved so that they extend the length of the apertures 12 when they are used to push out the pellet 25 as discussed with respect to station F.

Rod 65 projects below the bottom surface of the pin assembly 60 and includes a groove 66 to aid in movement of the pin assembly 60. When the pin assembly 60 is moved up and down, one or more springs 67 are provided between the mounting plate 64 and a lower surface of the base plate 20, to help control the movement of the pin assembly 60 and thus, movement of the pins 30 in the apertures 12. Additionally, one or more stoppers 62 are provided on the mounting plate 63 between the top surface of the mounting plate 63 and the bottom surface of the base plate 20. The stoppers 62 restrict how far the pins 30 can project through the apertures 12. That is, as discussed with respect to Fig. 5 station F, the knife 40 is designed to shear off the pellets 25 from a top surface of the base plate 20. The stoppers 62 prevent the pins 30 from extending too far through the aperture 12 and interfering with the knife 40 during cutting.

As discussed with respect to Fig. 5, once the pellets 25 have been formed in station D and cooled in station E, the pellets 25 are pushed out by the push pins 30 in station F to allow the knife 40 to shear off the pellets 25 which are then collected by the hopper 52. Accordingly, the pin push mechanism 70 shown in Fig. 1 1 is only used with and provided under station F in the process of pushing out the pellets 25 from the apertures 12. Since the pin push mechanism 70 is only provided for station F, the mechanism 70 is not attached to the rotating base plate 20. Instead, the pin push mechanism 70 can be attached to frame 41. The pin push mechanism 70 includes gripper arms 72 configured to engage groove 66 provided with the pin assembly 60 shown in Fig. 10. Movement of gripper arms 72 in a direction parallel to a bottom surface of the pin assembly 60 is controlled by a first air cylinder 73 with double acting rods to move the gripper arms 72 sideways. A second air cylinder 74 is provided to move the gripper arms up and down before and after gripping the rod 65. A third air cylinder 75 is provided to move the pin push mechanism 70 up and down after the rod 65 is gripped, by arms 72 resulting in the movement of the pin assembly 60 up and down. It should be appreciated that any suitable device can be used to grip and move the pin assembly 60 up and down and release the pin assembly 60 after moving it. In accordance with this exemplary method, the pellets 25 can be pushed out from the apertures 12 at station F and be sheared by knife 40.

Figure 12 shows a liquid filling station inventive embodiment useful, for example, with a machine system inventive embodiment for making a healthful composition inventive embodiment. Each of stations A, C and D discussed with respect to Figs. 5-6, includes a similar supply tank 80 provided with either liquid beeswax (or beeswax compound) or liquid omega-3 for example. It should be appreciated that any suitable fluid can be used for injecting into the aperture to form the cavity to hold the healthful compound. The supply tank 80 and/or corresponding structure, such as the dispense nozzles, can be fixed to the station mounting base 10. The supply tank 80 can include a level sensor 81 and a temperature sensor 82. The sensors associated with the examples of the invention can transmit the sensed information to a computer including a microprocessor (not shown) in order to monitor the various readings provided by the sensors. The sensed information can be displayed for a user or operator or transmitted to a remote site for monitoring. The fluid contained in the tank 80 can be transferred along a supply line 84 that is temperature controlled with mylar heater tape for example and optionally with insulation and controlled by a metered dispense pump 83 with suck-back. The temperature of the fluid in supply line 84 can be kept at 1O⁰C above the temperature of the mounting plate for example but can be kept at any other desirable temperature. The liquid can be contained in a dispense reservoir 85 made of aluminum for example, before being dispensed by dispense nozzles 70. The dispense nozzles 70 are press-fit into the aluminum dispense reservoir 85 and can be made of 316 stainless steel and be approximately 1/16" in diameter, as an example. An up and down mechanism is not needed with the supply tank system of stations A, C and D since an up and down movement is provided by the movement of the base plate 20 below the station mounting plate 10 as discussed with respect to Figs. 6-7.

Figure 13 is a schematic showing the cavity pin assembly used at station B. As discussed with respect to Fig. 5, at station B a cavity and opening is formed in the solidified wax by inserting the pins 92 part way into the warm solid wax to form a cavity, which now can be used as a container for holding, for example, omega-3. The cavity pin assembly 90 can be any desirable height, for example 0.300" inches high. The pin assembly 90 can also include 1/8" copper tubing 91 brazed on a top surface thereof to allow temperature controlled coolant flow over one or more surfaces of the pin assembly 90. Water is a preferred coolant. The temperature controlled coolant flow can be a part of the same water flow system discussed with respect to Figs. 7 and 8, or can be a separate water flow system controlled by similar components. As further shown in Fig. 13, the pin assembly 90 of station B is provided on a bottom surface of station mounting base 10 so that the pins 92 project downwardly from the mounting base 10 in a direction of the rotating base plate 20. Pins 92 can be made from 316 stainless steel and be approximately 0.050" in diameter as one example. A distance between the axis of the pins 92 will match the distance between the centers of apertures 12, for example 0.200". However, the distances can be any desirable distance. Further, the pins 92 can be press fit to the pin assembly 90. According to an example of the invention, when the rotating base plate 20 is raised up by the air cylinder 39, the pins 92 on the bottom surface of the cavity pin plate 90 project into the apertures 12 on the rotating base plate 20 to form the cavities in the wax. One or more stoppers 95 are optionally provided on a bottom surface of the pin assembly 90 to prevent the pins 92 from projecting too far into the aperture 12. As an example of the invention, the stoppers 95 will contact the top surface of the base plate 20 so that the pins 92 only project into the apertures 12 a distance of 0.075", for example. It should be appreciated that any desirable depth can be arranged based on the size of the stoppers.

Figure 14 shows a pellet 25 shear off assembly inventive embodiment at station F, useful, for example, with a machine system inventive embodiment for making a healthful composition inventive embodiment. As discussed with respect to Fig. 5, at station E, the capped wax pellet 25 is allowed to cool. At station F, the wax pellets 25 are pushed out of the aperture 12 from below by the pins 30 and sheared off. As shown in Fig. 14, the pellet shear-off assembly includes a plurality of supports 1 10 fixed to the station mounting base 10 to securely hold the pellet shear-off assembly. A support beam 1 12 is provided between the plurality of supports 1 10 so that a DC servo motor 1 15, for example, can be secured thereto. Any other suitable device or mechanism can be used in place of motor 1 15 to move the scraper blade 40. The motor 1 15 provides the power to move the scraper blade 40 via a lead screw 1 18 engaged with the DC motor 1 15. The scraper blade 40 is guided in its movement by a plurality of guide rods 1 17 connected between the support beam 1 12 and the scraper blade support 1 13. Ball bearings 120 are optionally provided on the blade support 1 13 to ensure smooth movement back and forth for the guide rods 1 17. Additionally, nylon rollers 1 19 are optionally connected to the blade support 1 13 to set the height of the scraper blade 40 above the rotating base plate 20.

As best shown in Fig. 6, a cutout 12 is formed in the station mounting base 10 to allow the scraper blade to slide back and forth and contact the rotating surface of the base plate 20. In this way, as the pellets 25 are pushed up from the rotating base plate, the scraper blade 40 is driven away from the center and towards the circumferential edge of the station mounting base 10 to shear off the pellets 25, which are then collected in the pellet hopper 52. After the pellets 25 are sheared by the blade 40, the push pin plate assembly 60 is lowered by action of the pin mechanism 70 and the pins 30 are lowered down into the apertures 12 in preparation for returning to beeswax filling at station A. The whole process discussed above is then repeated.

In accordance with the features of one or more embodiments of the invention, the wax pellet machine to manufacture beeswax pellets filled with liquid omega-3 can be compact in size and have a low cost to manufacture and maintain by using off-the shelf components for example. Further, air cylinders are used with integrated position sensors for linear motion instead of motors to reduce costs and increase efficiency. However, stepper motors, servo motors or other suitable devices can be used in place of air cylinders as desired with substantially the same functionality. The inventive embodiment machine system of this example can make, for example, 10 million pellets per month per machine system, based on 40 hrs per week operation with 20% downtime for maintenance (216 pellets/12 seconds * 3600 seconds/hour * 8 hours/day * 5 days/week * 4 weeks/month * 80% = 10 million pellets/month).

The above written description of the invention provides a manner and process of making and using it such that any person skilled in this art is enabled to make and use the same, this enablement being provided in particular for the subject matter of the appended claims, which make up a part of the original description of the invention. Also fully described and enabled herein are the following embodiments: Embodiment 1. A composition, comprising a) a core, comprising at least one core filler, beeswax, at least one core antioxidant, and at least one healthful substance; and b) at least one coating surrounding the core, comprising at least one coating filler, beeswax, and at least one coating antioxidant; wherein, the at least core one filler may be the same or different from the at least one coating filler, and wherein the at least one core antioxidant may be the same or different from the at least one coating antioxidant. Embodiment 2. The composition of embodiment 1, wherein the at least one healthful substance comprises fish oil, and wherein the fish oil comprises from 1.5% by weight of the composition to 15% by weight of the composition.

Embodiment 3. The composition of embodiment 1 , wherein the at least one healthful substance comprises fish oil, and wherein the fish oil comprises 8% by weight of the composition.

Embodiment 4. The composition of embodiment 1 , wherein the at least one healthful substance comprises fish oil, and wherein the fish oil comprises docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA) in a ratio ranging from 1 :99 EPA:DHA to 99: 1 EPA:DHA.

Embodiment 5. The composition of embodiment 1 , wherein the at least one healthful substance comprises fish oil, and wherein the fish oil comprises at least one member selected from the group consisting of eicosapentaenoic acid (EPA), an inorganic salt of EPA, an organic salt of EPA, an ester of EPA, docosahexaenoic acid (DHA), an inorganic salt of DHA, an organic salt of DHA, an ester of DHA, a triglyceride comprising an ester of DHA, a triglyceride comprising a ester of EPA, a triglyceride comprising and ester of EPA and an ester of DHA, and combinations thereof.

Embodiment 6. The composition of embodiment 1 , wherein the at least one core antioxidant and the at least one coating antioxidant, which may be the same or different, are independently selected from the group consisting of L-ascorbic acid, D- ascorbic acid, a salt of L-ascorbic acid, a salt of D-ascorbic acid, an ester of L- ascorbic acid, an ester of D-ascorbic acid, retinol, retinal, retinoic acid, alpha-carotene, beta-carotene, lycopene, an alpha-tocotrienol, a beta-tocotrienol, a gama-tocotrienol, a delta-tocotrienol, an alpha-tocopherol, a beta-tocopherol, a gama-tocopherol, a delta- tocopherol, coenzyme QlO, manganese, melatonin, lutein, zeaxanthin, astaxanthin, canthaxanthin, luteolin, apigenin, tangeritin, quercetin, rutin, kaempferol, myricetin, isohamnetin, a proanthocyanidin, hesperetin, hesperidin, naringenin, naringin, eriodictyol, catechin, gallocatechin, a gallate ester of catechin, a gallate ester of gallocatechin, epicatechin, epigallocatechin, a gallate ester of epicatechin, a gallate ester of epigallocatechin, theaflavin, a gallate ester of theaflavin, a thearubigin, genistein, daidzein, glycitein, resveratrol, pterostilbene, cyaniding, delphinidin, malvidin, pelagronidin, peoidin, petunidin, ellagic acid, gallic acid, salicyclic acid, rosmarinic acid, cinnamic acid, chlorogenic acid, a gallotannin, an ellagitannin, an emblicanin-antioxidant, curcumin, a xanthone, silymarin, eugenol, citric acid, oxalic acid, phytic acid, lignan, bilirubin, uric acid, a lipoic acid, n-acetylsysteine, and combinations thereof.

Embodiment 7. The composition of embodiment 1 , wherein the at least one core antioxidant and the at least one coating antioxidant each independently comprise at least one member selected from the group consisting of d-alpha-tocopherol, d-beta- tocopherol, d-gama-tocopherol, d-delta-tocopherol, and combinations thereof.

Embodiment 8. The composition of embodiment 1 , wherein the at least one core antioxidant comprises d-alpha-tocopherol, and wherein the at least one coating antioxidant comprises d-alpha-tocopherol.

Embodiment 9. The composition of embodiment 1 , wherein the at least one core filler, and the at least one coating filler, which may be the same or different, are independently selected from the group consisting of apatite, hydroxyapatite, calcium carbonate, calcium disodium EDTA, calcium chloride, calcium citrate, calcium glycerophosphate, calcium gluconate, calcium silicate, calcium oxide, calcium hydroxide, calcium stearate, calcium phosphate tribasic, calcium lactate, calcium pantothenate, calcium oleate, calcium palmirate, calcium D-pantothenate, calcium alginate, calcium phosphate anhydride, calcium hydrogenphosphate, calcium primary phosphate, calcium acetate, calcium saccharate, calcium sulfate, calcium secondary phosphate, calcium para-aminosalicylate, a bio calcilutite compound, magnesium L- aspartate, magnesium chloride, magnesium gluconate, magnesium aluminate silicate, magnesium silicate, magnesium oxide, magnesium hydroxide, magnesium stearate, magnesium carbonate, magnesium aluminate metasilicate, magnesium sulfate, sodium magnesium silicate and synthetic sodium magnesium silicate, silicon oxide hydrate, light silicic anhydride, synthetic hydrotalcite, diatomaceous earth, silicon dioxide, ferrous sulfate, iron carbonate, iron chloride, zinc chloride, zinc stearate, zinc oxide, zinc sulfate, and combinations thereof.

Embodiment 10. The composition of embodiment 1 , wherein the at least one core filler and the at least one coating filler comprise calcium carbonate.

Embodiment 1 1. The composition of embodiment 1 , wherein the at least one core filler and the at least one coating filler comprise calcium carbonate, wherein the at least one healthful substance comprises fish oil, and wherein the at least one core antioxidant and the at least one coating antioxidant comprise d-alpha-tocopherol.

Embodiment 12: The composition of embodiment 1 1 , wherein the ratio of ingredients in the core ranges from 100:2: 1 : 10 to 100:30: 1 : 10 of beeswax: calcium carbonate: d-alpha-tocopherol: fish oil, by weight of ingredients in the core, and wherein the ratio of ingredients in the coating ranges from 100:2: 1 to 100:30: 1 of beeswax: calcium carbonate: d-alpha-tocopherol, by weight of ingredients in the coating.

Embodiment 13. A composition comprising the composition of embodiment 1 1 and a liquid. Embodiment 14. The composition of embodiment 13, wherein the liquid is water.

Embodiment 15. The composition of embodiment 14, wherein the water is selected from the group consisting of tap water, purified water, distilled water, de- ionized water, rain water, spring water, mineral water, sparkling water, vitamin-water, well-water, and combinations thereof.

Embodiment 16. The composition of embodiment 1 , wherein the weight of the core ranges from 10 mg to 3000 mg, and the weight of the coating ranges from 10 mg to 3000 mg.

Embodiment 17. The composition of embodiment 1, wherein the weight of the core comprises from 1% by weight to 99% by weight of the composition, and wherein the weight of the coating comprises from 1% by weight to 99% by weight of the composition.

Embodiment 18. The composition of embodiment 1 , wherein the at least one healthful substance comprises flax seed oil.

Embodiment 19. A method of making a composition, comprising, injecting a first coating mixture into a mold; injecting a core mixture into the mold; and injecting a second coating mixture into the mold, to form the composition, wherein the core mixture comprises at least one core filler, at least one healthful substance, at least one core anti-oxidant, and beeswax, wherein the first coating mixture and the second coating mixture comprise at least one coating filler, at least one coating anti-oxidant, and beeswax, and wherein the ingredients in the first coating mixture and the ingredients in the second coating mixture may be the same or different. Embodiment 20. The method of embodiment 18, wherein the injecting the first coating mixture, the injecting the core mixture, and the injecting the second coating mixture is conducted at a temperature ranging from 35 ⁰C to 85 ⁰C.

Embodiment 21. The method of embodiment 18, wherein the injecting the first coating mixture, the injecting the core mixture, and the injecting the second coating mixture is conducted at a temperature of 60 ⁰C.

Embodiment 22. The method of embodiment 18, further comprising, after the injecting the second core mixture, cooling the composition at a temperature ranging from 1O ⁰C to 40 ⁰C.

Embodiment 23. The method of embodiment 22, further comprising, after the cooling, removing the composition from the mold.

Embodiment 24. A package containing the composition of embodiment 1.

Embodiment 25. A composition formed by the method of embodiment 19.

Embodiment 26. A composition comprising at least one filler, at least one wax, at least one antioxidant, and at least one healthful substance.

Embodiment 27. The composition of embodiment 26, wherein the at least one filler comprises calcium carbonate, the at least one wax comprises beeswax, the at least one antioxidant comprises d-α-tocopherol, and the at least one healthful substance comprises fish oil.

Embodiment 28. The composition of embodiment 26, wherein the ratio ranges, based on the weight of each ingredient, of the at least one filler, the at least one wax, the at least one antioxidant, and the at least one healthful substance, are: 100-300 at least one wax : 1-60 at least one filler : 0.001-10 at least one antioxidant : 0.01 - 100 at least one healthful substance. Embodiment 29. The composition of embodiment 27, wherein the ratio ranges, based on the weight of each ingredient, of the at least one filler, the at least one wax, the at least one antioxidant, and the at least one healthful substance, are: 100-300 the at least one wax : 1-60 the at least one filler : 0.001 -10 the at least one antioxidant : 0.01 - 100 the at least one healthful substance.

Embodiment 30. The composition of embodiment 27, wherein the ratio, based on the weight of each ingredient, of the at least one wax : the at least one filler : the at least one antioxidant : the at least one healthful substance is: 200 the at least one wax : 30 the at least one filler : 0.1 the at least one antioxidant : 20 the at least one healthful substance.

Embodiment 31. The composition of embodiment 27, wherein the composition is in the form of a pellet, and wherein the weight of the pellet ranges from 0.025 g to 0.035 g.

Embodiment 32. The composition of embodiment 29, wherein the composition is in the form of a pellet, and wherein the weight of the pellet ranges from 0.025 g to 0.035 g.

Embodiment 33. The composition of embodiment 30, wherein the wherein the composition is in the form of a pellet, and wherein the weight of the pellet ranges from 0.025 g to 0.035 g.

Embodiment 34. The composition of embodiment 31 , wherein the pellet does not comprise the at least one healthful substance on the surface of the pellet.

Embodiment 35. The composition of embodiment 32, wherein the pellet does not comprise the at least one healthful substance on the surface of the pellet.

Embodiment 36. The composition of embodiment 33, wherein the pellet does not comprise the at least one healthful substance on the surface of the pellet. Embodiment 37. The composition of embodiment 27, wherein the at least one healthful substance comprises fish oil, and wherein the fish oil comprises at least one member selected from the group consisting of eicosapentaenoic acid (EPA), an inorganic salt of EPA, an organic salt of EPA, an ester of EPA, docosahexaenoic acid (DHA), an inorganic salt of DHA, an organic salt of DHA, an ester of DHA, a triglyceride comprising an ester of DHA, a triglyceride comprising a ester of EPA, a triglyceride comprising an ester of EPA and an ester of DHA, and combinations thereof.

Embodiment 38. The composition of embodiment 27, wherein the ingredients in the composition are a homogeneously mixed, heterogeneous mixture.

Embodiment 39. A composition comprising at least one filler, at least one wax, at least one antioxidant, and at least one healthful substance.

Embodiment 40. The composition of embodiment 39, wherein the at least one filler comprises calcium carbonate, the at least one wax comprises beeswax, the at least one antioxidant comprises d-α-tocopherol, and the at least one healthful substance comprises fish oil.

Embodiment 41. The composition of embodiment 39, wherein the ratio ranges, based on the weight of each ingredient, of the at least one filler, the at least one wax, the at least one antioxidant, and the at least one healthful substance, are: 100-300 at least one wax : 1-60 at least one filler : 0.001-10 at least one antioxidant : 0.01 - 100 at least one healthful substance.

Embodiment 42. The composition of embodiment 40, wherein the ratio ranges, based on the weight of each ingredient, of the at least one filler, the at least one wax, the at least one antioxidant, and the at least one healthful substance, are: 100-300 the at least one wax : 1-60 the at least one filler : 0.001-10 the at least one antioxidant : 0.01 - 100 the at least one healthful substance.

Embodiment 43. The composition of embodiment 40, wherein the ratio, based on the weight of each ingredient, of the at least one wax : the at least one filler : the at least one antioxidant : the at least one healthful substance is: 200 the at least one wax : 30 the at least one filler : 0.1 the at least one antioxidant : 20 the at least one healthful substance.

Embodiment 44. The composition of embodiment 39, wherein the composition is in the form of a pellet, and wherein the weight of the pellet ranges from 0.025 g to 0.035 g.

Embodiment 45. The composition of embodiment 40, wherein the composition is in the form of a pellet, and wherein the weight of the pellet ranges from 0.025 g to 0.035 g.

Embodiment 46. The composition of claim 44, wherein the pellet does not comprise the at least one healthful substance on the surface of the pellet.

Embodiment 47. The composition of embodiment 45, wherein the pellet does not comprise the at least one healthful substance on the surface of the pellet.

Embodiment 48. The composition of embodiment 39, wherein the at least one healthful substance comprises fish oil, and wherein the fish oil comprises at least one member selected from the group consisting of eicosapentaenoic acid (EPA), an inorganic salt of EPA, an organic salt of EPA, an ester of EPA, docosahexaenoic acid (DHA), an inorganic salt of DHA, an organic salt of DHA, an ester of DHA, a triglyceride comprising an ester of DHA, a triglyceride comprising a ester of EPA, a triglyceride comprising an ester of EPA and an ester of DHA, and combinations thereof. Embodiment 49. The composition of embodiment 39, wherein the composition ingredients are homogeneously mixed.

Embodiment 50. The composition of embodiment 42, wherein the composition is in the form of a pellet, wherein the weight of the pellet ranges from 0.025 g to 0.035 g, wherein the pellet does not comprise the at least one healthful substance on the surface of the pellet, and wherein the composition ingredients are homogeneously mixed.

Embodiment 51. Λ composition, comprising: a) a core, comprising at least one core filler, beeswax, at least one core antioxidant, and at least one healthful substance; and b) at least one coating surrounding the core, comprising: at least one coating filler, beeswax, and at least one coating antioxidant; wherein, the at least core one filler may be the same or different from the at least one coating filler, and wherein the at least one core antioxidant may be the same or different from the at least one coating antioxidant.

Embodiment 52. The composition of embodiment 51 , wherein the at least one healthful substance comprises fish oil, and wherein the fish oil comprises from 1.5% by weight of the composition to 15% by weight of the composition. Embodiment 53. The composition of embodiment 51 , wherein the at least one healthful substance comprises fish oil, and wherein the fish oil comprises 8% by weight of the composition.

Embodiment 54. A method of making a composition, comprising, injecting a first coating mixture into a mold; injecting a core mixture into the mold; and injecting a second coating mixture into the mold, to form the composition, wherein the core mixture comprises at least one core filler, at least one healthful substance, at least one core anti-oxidant, and beeswax, wherein the first coating mixture and the second coating mixture comprise at least one coating filler, at least one coating anti-oxidant, and beeswax, and wherein the ingredients in the first coating mixture and the ingredients in the second coating mixture may be the same or different.

Embodiment 55. A method of making a composition, comprising mixing together at least one filler, at least one wax, at least one antioxidant, and at least one healthful substance.

Embodiment 56. The composition of embodiment 39, wherein the healthful substance is distributed throughout the composition.

Embodiment 57. The composition of embodiment 56, wherein the healthful substance is distributed uniformly throughout the composition.

Embodiment 58. The composition of embodiment 56, wherein the healthful substance is not distributed uniformly throughout the composition.

Embodiment 59. The composition of embodiment 56, wherein the healthful substance is not present on the surface of the composition. Embodiment 60. The composition of embodiment 59, wherein the healthful substance is not present on the surface of the composition, and the healthful substance is further is not present in the composition at a distance, as measured from the outside of the composition toward the center of the composition, of from 0.001% to 50% of the distance from the outside of the composition to the center of the composition, including all values, ranges, and subranges therebetween.

Embodiment 61. The composition of embodiment 60, wherein the healthful substance is present in the composition in pockets containing, minimally, the healthful composition, wherein at least some of the pockets also optionally contain at least one of the at least one wax, the at least one filler, and / or the at least one antioxidant, and wherein the number of pockets ranges from 1 to 10,000, including all values, ranges, and subranges therebetween.

Embodiment 62. A method of making a composition, the method comprising: mixing at least one wax, at least one filler, at least one antioxidant, and at least one healthful substance to form a resultant mixture, and coating the resultant mixture with a coating composition comprising at least one wax, at least one filler, and at least one antioxidant, wherein the at least one filler in the resultant mixture and the at least one filler in the coating composition can be the same or different, and wherein the at least one antioxidant in the resultant mixture and the at least one antioxidant in the coating composition can be the same or different.

Embodiment 63. The method of embodiment 62, wherein the at least one filler in the resultant mixture comprises calcium carbonate, wherein the at least one filler in the coating composition comprises calcium carbonate, wherein the at least one antioxidant in the resultant mixture comprises d-α- tocopherol, wherein the at least one antioxidant in the coating composition comprises d-α- tocopherol, wherein the at least one wax in the resultant mixture comprises beeswax, wherein the at least one wax in the coating composition comprises beeswax, and wherein the at least one healthful substance comprises fish oil.

Embodiment 64. The method of embodiment 63, wherein the at least one wax that is mixed to form the resultant mixture is liquefied.

Embodiment 65. The method of embodiment 64, wherein the resultant mixture is formed at a temperature of 8O⁰C + 5⁰C, and wherein, prior to the coating, the resultant mixture is cooled to 5O⁰C + 3 ⁰C.

Embodiment 66. The method of embodiment 65, wherein the resultant mixture, after cooling, is granulated.

Embodiment 67. The method of embodiment 66, wherein the temperature of the coating composition, when applied to the resultant mixture, is 8O⁰C + 5⁰C.

Embodiment 68. The method of embodiment 67, further comprising, after the coating, ejecting the coated resultant mixture into water.

Embodiment 69. The method of embodiment 68, wherein the ejecting is conducted out of a nozzle.

Embodiment 70. The method of embodiment 69, wherein the temperature of the water is 15 ⁰C + 30 ⁰C. Embodiment 71. The method of embodiment 70, wherein ejecting is conducted such that a fine distribution of pellets are ejected from the nozzle, with an aperture size diameter ranging from 1 nm 10 m, including all values, ranges and subranges therebetween.

Embodiment 72. A composition made by the method of embodiment 62.

Embodiment 73. A composition comprising the composition of embodiment 72 and a liquid.

Embodiment 74. The composition of embodiment 73, wherein the composition comprises water.

Embodiment 75. A method of administering a composition to a mammal, comprising orally administering the composition of embodiment 72 to the mammal.

Embodiment 76. The method of embodiment 75, wherein the mammal is a human.

Embodiment 77. The method of embodiment 76, wherein the orally administering comprises introducing the composition into the mouth of the human.

Embodiment 78. The method of embodiment 63, wherein the calcium carbonate is powdered.

Embodiment 79. The method of embodiment 63, wherein the calcium carbonate is in the form of particles.

Embodiment 80. The method of embodiment 63, wherein the fish oil comprises EPA.

Embodiment 81. The method of embodiment 63, wherein the fish oil comprises DHA.

Embodiment 82. The method of embodiment 63, wherein the fish oil comprises EPA and DHA. Embodiment 83. The method of embodiment 63, wherein the fish oil comprises powdered fish oil.

Embodiment 84. The method of embodiment 79, wherein the particles of calcium carbonate are spherical, and wherein diameters of the particles range from 1 nm to 10 cm, including all values, ranges, and subranges therebetween.

Embodiment 85. The method of embodiment 84, wherein the diameters of the particles range from 10 nm to 10 cm, including all values, ranges, and subranges therebetween.

Embodiment 86. The method of embodiment 84, wherein the diameters of the particles range from 50 nm to 10 cm, including all values, ranges, and subranges therebetween.

Embodiment 87. The method of embodiment 86, wherein the diameters of the particles range is 100 nm to 10 cm, including all values, ranges, and subranges therebetween.

Embodiment 88. The method of embodiment 84, wherein the diameters of the particles range from 500 nm to 10 cm, including all values, ranges, and subranges therebetween.

Embodiment 89. The method of embodiment 84, wherein the diameters of the particles range from 1 mm to 10 cm, including all values, ranges, and subranges therebetween.

Embodiment 90. The method of embodiment 84, wherein the diameters of the particles range from 2 mm to 10 cm, including all values, ranges, and subranges therebetween. Embodiment 91. The method of embodiment 84, wherein the diameters of the particles range from 3 mm to 10 cm, including all values, ranges, and subranges therebetween.

Embodiment 92. The method of embodiment 84, wherein the diameters of the particles range from 4 mm to 10 cm, including all values, ranges, and subranges therebetween.

Embodiment 93. The method of embodiment 84, wherein the diameters of the particles range from 5 mm to 10 cm, including all values, ranges, and subranges therebetween.

Embodiment 94. The method of embodiment 84, wherein the diameters of the particles range from 6 mm to 10 cm, including all values, ranges, and subranges therebetween.

Embodiment 95. The method of embodiment 84, wherein the diameters of the particles range from 7 mm to 10 cm, including all values, ranges, and subranges therebetween.

Embodiment 96. The method of embodiment 84, wherein the diameters of the particles range from 8 mm to 10 cm, including all values, ranges, and subranges therebetween.

Embodiment 97. The method of embodiment 84, wherein the diameters of the particles range from 9 mm to 10 cm, including all values, ranges, and subranges therebetween.

Embodiment 98. The composition of embodiment 72, wherein the composition is in the form of a pellet.

Embodiment 99. The composition of embodiment 72, wherein the composition is in the form of pellets, and wherein the weight of each individual pellet ranges from 0.0001 g to 0.9 g, including all ranges, subranges, and values therebetween.

Embodiment 100. The composition of embodiment 99, wherein the weight of each individual pellet ranges from 0.0005 g to 0.9 g, including all ranges, subranges, and values therebetween.

Embodiment 101. The composition of embodiment 99, wherein the weight of each individual pellet ranges from 0.001 g to 0.9 g, including all ranges, subranges, and values therebetween.

Embodiment 102. The composition of embodiment 99, wherein the weight of each individual pellet ranges from 0.003 g to 0.9 g, including all ranges, subranges, and values therebetween.

Embodiment 103. The composition of embodiment 99, wherein the weight of each individual pellet ranges from 0.005 g to 0.9 g, including all ranges, subranges, and values therebetween.

Embodiment 104. The composition of embodiment 99, wherein the weight of each individual pellet ranges from 0.01 g to 0.9 g, including all ranges, subranges, and values therebetween.

Embodiment 105. The composition of embodiment 99, wherein the weight of each individual pellet ranges from 0.05 g to 0.9 g, including all ranges, subranges, and values therebetween.

Embodiment 106. The composition of embodiment 99, wherein the weight of each individual pellet ranges from 0.1 g to 0.9 g, including all ranges, subranges, and values therebetween. Embodiment 107. The composition of embodiment 99, wherein the weight of each individual pellet ranges from 0.2 g to 0.9 g, including all ranges, subranges, and values therebetween.

Embodiment 108. The composition of embodiment 99, wherein the weights of the pellets range from 0.3 g to 0.9 g, including all ranges, subranges, and values therebetween.

Embodiment 109. The composition of embodiment 99, wherein the weight of each individual pellet ranges from 0.4 g to 0.9 g, including all ranges, subranges, and values therebetween.

Embodiment 1 10. The composition of embodiment 99, wherein the weight of each individual pellet ranges from 0.5 g to 0.9 g, including all ranges, subranges, and values therebetween.

Embodiment 1 1 1. The composition of embodiment 99, wherein the weight of each individual pellet ranges from 0.6 g to 0.9 g, including all ranges, subranges, and values therebetween.

Embodiment 1 12. The composition of embodiment 99, wherein the weight of each individual pellet ranges from 0.7 g to 0.9 g, including all ranges, subranges, and values therebetween.

Embodiment 1 13. The composition of embodiment 99, wherein the weight of each individual pellet ranges from 0.8 g to 0.9 g, including all ranges, subranges, and values therebetween.

Embodiment 1 14. The composition of embodiment 72, wherein the composition is in the form of a pellet, and wherein the pellet comprises from 0.0001 mg to 1000 mg of the at least one healthful substance, including all values, ranges, and subranges therebetween, or a healthful effective amount. Embodiment 1 15. The composition of embodiment 1 14, wherein the pellet comprises from 0.0005 mg to 1000 mg of the at least one healthful substance, including all values, ranges, and subranges therebetween.

Embodiment 1 16. The composition of embodiment 1 14, wherein the composition is in the form of a pellet, and wherein the pellet comprises from 0.001 mg to 1000 mg of the at least one healthful substance, including all values, ranges, and subranges therebetween.

Embodiment 1 17. The composition of embodiment 1 14, wherein the composition is in the form of a pellet, and wherein the pellet comprises from 0.005 mg to 1000 mg of the at least one healthful substance, including all values, ranges, and subranges therebetween.

Embodiment 1 18. The composition of embodiment 1 14, wherein the composition is in the form of a pellet, and wherein the pellet comprises from 0.01 mg to 1000 mg of the at least one healthful substance, including all values, ranges, and subranges therebetween.

Embodiment 1 19. The composition of embodiment 1 14, wherein the composition is in the form of a pellet, and wherein the pellet comprises from 0.05 mg to 1000 mg of the at least one healthful substance, including all values, ranges, and subranges therebetween.

Embodiment 120. The composition of embodiment 1 14, wherein the composition is in the form of a pellet, and wherein the pellet comprises from 0.1 mg to 1000 mg of the at least one healthful substance, including all values, ranges, and subranges therebetween.

Embodiment 121. The composition of embodiment 1 14, wherein the composition is in the form of a pellet, and wherein the pellet comprises from 0.5 mg to 1000 mg of the at least one healthful substance, including all values, ranges, and subranges therebetween.

Embodiment 122. The composition of embodiment 1 14, wherein the composition is in the form of a pellet, and wherein the pellet comprises from 1.0 mg to 1000 mg of the at least one healthful substance, including all values, ranges, and subranges therebetween.

Embodiment 123. The composition of embodiment 1 14, wherein the composition is in the form of a pellet, and wherein the pellet comprises from 5.0 mg to 1000 mg of the at least one healthful substance, including all values, ranges, and subranges therebetween.

Embodiment 124. The composition of embodiment 1 14, wherein the composition is in the form of a pellet, and wherein the pellet comprises from 10.0 mg to 1000 mg of the at least one healthful substance, including all values, ranges, and subranges therebetween.

Embodiment 125. The composition of embodiment 1 14, wherein the composition is in the form of a pellet, and wherein the pellet comprises from 15 mg to 1000 mg of the at least one healthful substance, including all values, ranges, and subranges therebetween.

Embodiment 126. The composition of embodiment 1 14, wherein the composition is in the form of a pellet, and wherein the pellet comprises from 20 mg to 1000 mg of the at least one healthful substance, including all values, ranges, and subranges therebetween.

Embodiment 127. The composition of embodiment 1 14, wherein the composition is in the form of a pellet, and wherein the pellet comprises from 30 mg to 1000 mg of the at least one healthful substance, including all values, ranges, and subranges therebetween.

Embodiment 128. The composition of embodiment 1 14, wherein the healthful substance is distributed discontinuously throughout the composition.

Embodiment 129. A commercial package comprising the composition of embodiment 74.

Embodiment 130. The composition of embodiment 74, wherein the composition comprises a core and a coating.

Embodiment 131. The composition of embodiment 130, wherein the ratio of ingredients in the coating, by weight of each ingredient, ranges from 10: 1 :0.1 to 100:20: 1 of the at least one wax : the at least one filler: the at least one antioxidant, including all values, ranges, and subranges therebetween.

Embodiment 132. The composition of embodiment 131 , wherein the ratio of the ingredients in the coating, by weight of each ingredient, is 50: 10:0.5 of the at least one wax : the at least one filler : the at least one antioxidant.

Embodiment 133. The method of embodiment 62, wherein the ratio of ingredients in the coating composition, by weight of each ingredient, ranges from 10: 1 :0.1 to 100:20: 1 of the at least one wax : the at least one filler: the at least one antioxidant, including all values, ranges, and subranges therebetween.

Embodiment 134. The method of embodiment 62, wherein the ratio of the resultant mixture to the coating composition, by weight, ranges from 1 : 100 to 100: 1 , including all values, ranges, and subranges therebetween.

Embodiment 135. The method of embodiment 62, wherein the ratio of the resultant mixture to the coating composition, by weight, ranges from 10: 1 to 1 : 10 including all values, ranges, and subranges therebetween. Embodiment 136. The method of embodiment 62, wherein the ratio of the resultant mixture to the coating composition, by weight, ranges from 5: 1 to 1 :5, including all values, ranges, and subranges therebetween.

Embodiment 137. The method of embodiment 62, wherein the ratio of the resultant mixture to the coating composition, by weight, ranges from 2: 1 to 1 :2, including all values, ranges, and subranges therebetween.

Embodiment 138. The method of embodiment 62, wherein the ratio of the resultant mixture to the coating composition, by weight, is 1.165: 1.

Embodiment 139. The method of embodiment 62, wherein the ratio of the ingredients in the resultant mixture, by weight of each ingredient, is 50: 10:0.5: 10 of the at least one wax : the at least one filler : the at least one antioxidant : at least one healthful substance.

Embodiment 140. The composition of embodiment 130, wherein the ratio of ingredients in the core, by weight of each ingredient, is 50:10:0.5: 10 of the at least one wax : the at least one filler : the at least one antioxidant : at least one healthful substance.

Embodiment 141. The composition of embodiment 130, wherein the ratio of ingredients in the core, by weight of each ingredient, ranges from 5: 1 :0.5:0.1 to 250:50:5: 1 , including all values ranges, and subranges therebetween.

Embodiment 142. The method of embodiment 62, wherein the ratio of ingredients in the resultant mixture, by weight of each ingredient, ranges from 5: 1 :0.5:0.1 to 250:50:5: 1 , including all values ranges, and subranges therebetween. Embodiment 143. The method of embodiment 62, wherein the at least one wax in the resultant mixture and the at least one wax in the coating composition can be the same or different. Embodiment 144. A method of making a composition, comprising mixing together at least one filler, at least one wax, at least one antioxidant, and at least one healthful substance, where the ingredients are contacted/added in any order, singly, some at once, all at once, or any combination thereof, and are mixed at any or all of before, after, or during contacting/adding of the ingredients.

The present specification includes the accompanying claims and the accompanying figures.

Λs used in the present specification, the phrases "selected from the group consisting of," "chosen from," and the like include mixtures of specified materials.

All references, patents, applications, tests, standards, documents, publications, brochures, texts, articles, etc. mentioned herein are incorporated herein by reference. Where a numerical range or limit is stated, the endpoints are included. Also, all values and subranges within a numerical limit or range are specifically included as if explicitly written out. Terms such as "contain(s)" and the like as used herein are open terms meaning 'including at least' unless otherwise specifically noted.

Terms such as "a" or "an" mean one or more, unless otherwise specifically noted.

The specification is presented to enable a person skilled in the art to make and use the invention, and is provided in the context of a particular application and its requirements. Various modifications to the preferred embodiments will be readily apparent to those skilled in the art, and the generic principles defined herein may be applied to other embodiments and applications without departing from the spirit and scope of the invention. Thus, this invention is not intended to be limited to the embodiments shown, but is to be accorded the widest scope consistent with the principles and features disclosed herein.

Claims

Claim 1. A composition, comprising a container comprising a first wax, wherein the container contains a cavity, wherein the container partially surrounds the cavity, wherein the container has an opening to the cavity; at least one healthful substance that at least partially fills the cavity; and a container cap comprising a second wax, wherein the container cap seals the opening to the container such that the container cap in combination with the container form a coating that completely surrounds the cavity and the at least one healthful substance contained therein.

Claim 2. The composition of claim 1 , wherein the first wax and the second wax are beeswax, and wherein the at least one healthful substance comprises fish oil.

Claim 3. The composition of claim 1, wherein at least one of the first wax and the second wax further comprises, independently of each other, at least one filler.

Claim 4. The composition of claim 1 , wherein at least one of the first wax, the second wax, and the at least one healthful substance further comprises, independently of each other, at least one antioxidant. Claim 5. The composition of claim 1 , wherein the first wax and the second wax comprise beeswax, wherein the at least one healthful substance comprises liquid fish oil, wherein the first wax is provided in an amount ranging from 2 mg to 100 mg; wherein the amount of the second wax in the container cap ranges from 0.

5 mg to 30 mg; and wherein the amount of the at least one healthful substance that fills at least part of the cavity ranges from 0.0004 mL to 0.04 mL.

Claim 6. The composition of claim 5, wherein the first wax is provided in an amount of 5 mg, wherein the amount of the second wax in the container cap is 2 mg, and wherein the amount of fish oil that fills at least part of the cavity is 0.001 mL.

Claim 7. The composition of claim 1 , wherein the composition is in the form of a cylindrical pellet, wherein the cylindrical pellet has an outer diameter ranging from 0.06 inches to 0.40 inches, and wherein the cylindrical pellet has a length ranging from 0.06 inches to 0.40 inches.

Claim 8. A method of treating a disease or condition in a human, the method comprising, orally administering the composition of claim 1 to the human in an amount sufficient to treat the disease or condition.

Claim 9. A method of administering a composition to a human, the method comprising orally administering the composition of claim 1 to the human.

Claim 10. The method of claim 9, wherein the composition is administered to the human along with a liquid.

Claim 1 1. A method of making the composition of claim 1 , the method comprising , providing a first wax; creating a cavity, with an opening thereto, in the first wax to form the container; filling at least part of the cavity with at least one healthful substance; and sealing the opening to the cavity with the container cap.

Claim 12. The method of claim 1 1 , wherein the providing the first wax comprises injecting the first wax, in liquid form, into a mold, and cooling the injected first wax to form a solid first wax.

Claim 13. The method of claim 1 1 , wherein the creating a cavity with an opening thereto comprises pushing a pin part way into the first wax and then withdrawing the pin.

Claim 14. The method of claim 1 1 , wherein the filling the at least part of the cavity with the at least one healthful substance comprises injecting the at least one healthful substance into the cavity via the opening.

Claim 15. The method of claim 1 1 , wherein the sealing the opening to the container with the container cap comprises, filling the opening by injecting the second wax, in liquid form, into the opening and then cooling the injected second wax so that the injected second wax solidifies thereby forming the container cap.