Compositions for improving the absorption of supplements

Abstract

Described is a composition comprising at least one target supplement and at least one rehydration formulation.When at least one target supplement is ingested as part of the composition, the bioavailability of at least one target supplement is improved compared to when it is ingested separately from the composition.When ingested as part of the composition, at least one target supplement is absorbed more rapidly and in greater amounts than when it is ingested separately from the composition.In addition, the composition provides hydration for the subject.

Description

[Background technology]

[0001] This application claims priority to U.S. Provisional Application No. 62 / 607,844, filed December 19, 2017, and U.S. Provisional Application No. 62 / 607,844, filed May 12, 2017, which claims priority to U.S. Provisional Application No. 15 / 925,644, filed March 19, 2018, the entire contents of which are incorporated herein by reference.

[0002] There are a wide variety of supplements available that can be consumed or eaten in the form of over-the-counter medicines. These supplements are used in an attempt to achieve a variety of purposes. For example, humans can use supplements in an attempt to help them sleep, provide nutritional support, provide increased energy, etc.

[0003] Typically, these supplements are taken orally. Although absorption of supplements such as vitamins and minerals can occur at any site in the digestive tract, the small intestine is the primary site in the digestive tract where such absorption occurs. Nutrients are absorbed into the bloodstream in the small intestine via the process of diffusion.

[0004] Thus, supplements taken orally must travel to major parts of the digestive tract and then be absorbed by the body. Therefore, it may take a long time before the effects of the supplement are felt. This delay can lead to difficulties such as frustration, non-compliance with recommendations for taking the supplement, and / or taking more than the recommended dose in hopes of feeling the effects more quickly.

[0005] Thus, there is a need for means to improve the bioavailability of supplements and to enable their effects to be felt more quickly. Summary of the Invention [Means for solving the problem]

[0006] This Summary is provided to introduce a selection of concepts in a simplified form that are further described below in the Detailed Description. This Summary is not intended to identify key or essential features of the claimed subject matter, nor is it intended to be used as an aid in determining the scope of the claimed subject matter.

[0007] This disclosure describes compositions, methods for making compositions, and methods for using compositions.In one embodiment, the composition includes, but is not limited to, at least one rehydration formulation and at least one target supplement that targets a subject's condition, and the target supplement has improved bioavailability when taken by a subject in need as part of the composition, compared to when the target supplement is taken separately from the composition.

[0008] The following detailed description is described with reference to the non-limiting and non-exhaustive embodiments illustrated in the accompanying drawings, in which the left-most digit(s) of a reference number identifies the drawing in which the reference number first appears. The same reference numbers in different drawings refer to similar or identical items. [Brief description of the drawings]

[0009] [Figure 1] 1 is a flow diagram of an exemplary method for making the compositions described herein. [Diagram 2] 1 is a flow diagram of an exemplary method of using the compositions described herein. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0010] (Overview) The following description describes the specific embodiment of the composition for increasing the absorption of target supplements, which comprises the components described in the appended claims, and the related method of making and using the composition.In order to meet statutory requirements, the embodiment is described with specificity.However, the description itself is not intended to limit the scope of this patent.Rather, the inventors intend that the claimed invention can be implemented in another way, include different components, or include the combination of components similar to those described in this document, in cooperation with other existing or future technologies.

[0011] As mentioned above, the present disclosure describes compositions, methods for making compositions, and methods for using compositions.The compositions generally include at least one rehydration formulation and at least one target supplement that targets a condition in a subject, and the target supplement has improved bioavailability when taken by a subject in need as part of the composition than when the target supplement is taken separately from the composition.As used herein, "subject" refers to any mammal, for example, a human mammal or a non-human mammal (e.g., a primate).As used herein, "target supplement" refers to a product that contains at least one ingredient that is intended to target a condition in a subject and is taken orally by a subject.

[0012] Optionally, the composition may contain additional ingredients including, but not limited to, flavors, sweeteners, preservatives, anti-caking agents, gelling agents, antimicrobial agents, citric acid, or excipients.

[0013] Each of the at least one rehydration formulation, the at least one targeted supplement, and the optional additional ingredients is discussed below.

[0014] The rehydration formulation portion of the composition may contain at least five components: sodium, chloride ions, glucose-containing saccharides, potassium, and citrate ions.

[0015] Sodium ions are one component of the rehydration formulations described herein. Generally, rehydration formulations contain sodium at least to prevent hyponatremia that would otherwise result from diluting the blood with large amounts of water. Additionally, sodium may be lost during vomiting or diarrhea. Sodium may be included in the rehydration formulation in the form of a salt cation. Salts include, but are not limited to, sodium chloride, monosodium phosphate, disodium phosphate, trisodium phosphate, sodium citrate (including trisodium citrate), sodium carbonate, sodium bicarbonate, sodium lactate, sodium gluconate, tetrasodium acid pyrophosphate, sodium hydrogen sulfate, or sodium hydroxide.

[0016] In one example of a rehydration formulation described herein, the sodium is in the form of sodium chloride and sodium citrate.

[0017] In one example, sodium chloride has an osmolality of about 35 mmol / L to about 40 mmol / L, or about 37 mmol / L to about 43 mmol / L, or about 40 mmol / L to about 42 mmol / L, or sodium chloride has a weight of about 2.0 g / L to about 2.3 g / L, or about 2.2 g / L to about 2.5 g / L, or about 2.3 g / L to about 2.5 g / L. As used herein, "osmolality" is the concentration of a solution expressed as the total number of solute particles per liter. Osmolality may be expressed in units of milliequivalents per liter (meq / L), with 1 meq being equal to 1 mmol of solute in the solution. In contrast, osmolality is the concentration of a solution expressed as the total number of solute particles per kilogram.

[0018] In one example, the sodium citrate in the rehydration formulations described herein has an osmolality of about 10 mmol / L to about 15 mmol / L, or about 7.0 mmol / L to about 13 mmol / L, or about 8.0 mmol / L to about 10 mmol / L, or a weight of about 0.98 g / L to about 1.5 g / L, or about 0.69 g / L to about 1.3 g / L, or about 0.78 g / L to about 0.98 g / L, or about 2.0 g / L to about 3.0 g / L.

[0019] Another component of the at least one rehydration formulation is a glucose-containing saccharide. As used herein, "glucose-containing saccharide" refers to either glucose or a sugar that can be hydrolyzed to form a glucose-containing composition (e.g., glucose, sucrose, dextrose, lactose, maltose, amylase, glycogen, maltodextrin, etc.). For example, stomach acidity converts sucrose into glucose and fructose during digestion. Reference to any saccharide by a single name also includes all forms of the saccharide that may be in equilibrium with the named specific saccharide in an aqueous mixture at room temperature.

[0020] Glucose with an osmolality of 50 mmol / L can increase water and sodium absorption in the small intestine of a human subject by 4-6 fold in the jejunum (the middle portion of the small intestine) and 2-3 fold in the ileum (the distal portion of the small intestine). Glucose in one example has an osmolality of about 50 mmol / L to about 60 mmol / L, or about 50 mmol / L to about 70 mmol / L, or about 45 mmol / L to about 80 mmol / L.

[0021] In one example, the glucose-containing saccharides included in the rehydration formulation include at least glucose and sucrose. In one example, glucose is added at about 8.1 g / L to about 14.4 g / L, about 9.0 g / L to about 12.6 g / L, or about 9.0 g / L to about 10.8 g / L by weight, and sucrose is added at about 12.6 g / L to about 15.7 g / L, about 12.9 g / L to about 14.8 g / L, or about 13.2 g / L to about 13.8 g / L by weight.

[0022] In another example, the glucose-containing saccharides included in the rehydration formulation include dextrose and sucrose. Dextrose is a form of glucose.

[0023] In another example, glucose is the glucose-containing saccharide included in the rehydration formulation. In one example, glucose is added at a weight amount of about 14.5 g / L to about 15.0 g / L, about 14.0 g / L to about 15.6 g / L, or about 12.8 g / L to about 16.8 g / L.

[0024] In yet another embodiment, dextrose is the glucose-containing saccharide included in the rehydration formulation. In one example, dextrose is added at a weight amount of about 14.5 g / L to about 15.0 g / L, about 14.0 g / L to about 15.6 g / L, or about 12.8 g / L to about 16.8 g / L.

[0025] In one embodiment, at least one rehydration formulation described herein has a glucose to sodium molar ratio of about 1:1. Approximately equal amounts of both sodium and glucose (in osmolarity) optimize the glucose-sodium active transport mechanism.

[0026] In one example, chloride ions and citrate ions are two separate components of a rehydration formulation.

[0027] Chloride and citrate ions may help prevent electrolyte imbalance. Chloride ions may be included in the rehydration formulation in the form of salt anions. Chloride ion-containing components may include, but are not limited to, sodium chloride, potassium chloride, calcium chloride, and magnesium chloride.

[0028] In one example, the chloride ion is present in the form of sodium chloride in the amounts previously recited for purposes of sodium content, hi another example, the chloride ion is present in the form of potassium chloride in a weight amount of about 1.50 g / L to about 1.66 g / L, about 1.28 g / L to about 1.88 g / L, or about 1.0 g / L to about 2.0 g / L.

[0029] At the same time, citrate ions may be included in the rehydration formulation. In one example, the citrate ions are in the form of sodium and / or potassium citrate salts (e.g., trisodium citrate, sodium citrate (dehydrate), potassium citrate). The citrate ions may be present as citric acid or as citrate esters (e.g., triethyl citrate) that can be hydrolyzed to citric acid or citrate ions.

[0030] In one example, the citrate ions are present in the form of sodium citrate in the amounts recited above for sodium content purposes, and in the form of potassium citrate in a weight amount of about 1.3 g / L to about 1.7 g / L, or about 1.4 g / L to about 1.6 g / L.

[0031] In another example, the citrate ion is present in the form of sodium citrate at a weight of about 0.98 g / L to about 1.5 g / L, or about 0.69 g / L to about 1.3 g / L, or about 0.78 g / L to about 0.98 g / L, or about 2.0 g / L to about 3.0 g / L. In one example, another component of the rehydration formulation described herein is potassium. As with sodium, potassium may be included in the rehydration formulation because vomiting and diarrhea can result in significant losses of potassium that need to be replaced. As with sodium, potassium may also be present as a salt cation. Potassium salts include, but are not limited to, potassium chloride, potassium phosphate, potassium citrate, potassium carbonate, potassium bicarbonate, and potassium hydroxide.

[0032] In one example, potassium is present in the form of potassium citrate at the weight amounts recited above for purposes of inclusion of citrate ions in the rehydration formulation, and potassium is present in the form of dipotassium phosphate at about 0.3 g / L to about 0.9 g / L, or about 0.5 g / L to about 0.7 g / L by weight.

[0033] In another example, potassium is present in the form of potassium chloride in a weight amount of about 1.50 g / L to about 1.66 g / L, or about 1.28 g / L to about 1.88 g / L, or about 1.0 g / L to about 2.0 g / L.

[0034] In addition, the rehydration formulations described herein (once diluted to the appropriate concentrations as above and with the addition of optional additional ingredients (described below)) have a total osmolality that is within at least one of the standard or "reduced osmolarity ORS" ranges recommended by WHO and UNICEF. See WHO Drug Information Vol. 16, No. 2, 2002, "New formula oral rehydration salts," available at http: / / apps.who.int / medicinedocs / en d / Js4950e / 2.4.html. Also see "Oral Rehydration Salts (ORS) A New Reduced Osmolarity Formulation," available at https: / / www.rehydrate.org / ors / who-unicef-statement.html (May 10, 2002).

[0035] The rehydration formulations described herein are believed to utilize the glucose-sodium active transport mechanism to improve the absorption of water and targeted supplements into the bloodstream. In the small intestine, sodium passes into the intestinal epithelial cells by co-transport with glucose by SGLT1 protein. Two sodium ions and one glucose molecule are transported together across the epithelial cell membrane into the bloodstream by SGLT1 protein. Absorption of glucose and sodium from the small intestine produces an osmotic force. In each transport cycle, water molecules move into the epithelial cells to maintain osmotic equilibrium. Water absorbed from the lumen of the small intestine rather than excreted is available for systemic distribution by the bloodstream for cellular hydration. Thus, the rehydration formulations can deliver hydration to the bloodstream more quickly and in greater quantities than drinking water alone. In one embodiment of the rehydration formulation according to the present disclosure, the relative amounts of components in the rehydration formulation can be as described herein.

[0036] As mentioned above, in one embodiment, the composition described herein comprises at least one rehydration formulation as described above and at least one target supplement that targets a condition in a subject. When ingested by a subject in need thereof, the absorption rate of the target supplement when part of a composition comprising a rehydration formulation ("second absorption rate") is faster than the absorption rate of the target supplement when ingested separately from the composition ("first absorption rate"). In one embodiment, the second absorption rate can be about 10% to about 600% faster than when the target supplement is absorbed by means other than the composition described herein. For example, the second absorption rate can be about 1.1 times to about 6 times faster than the first absorption rate, about 2 times to about 6 times faster than the first absorption rate, or about 2 times to about 3 times faster than the first absorption rate. Furthermore, when part of a composition, a larger amount of the target supplement is absorbed than when ingested separately from the composition.

[0037] For at least these reasons, the bioavailability of the targeted supplement is enhanced when ingested as part of a composition. Furthermore, the compositions described herein rehydrate a subject more quickly and efficiently than water alone.

[0038] In one embodiment, more than one targeted supplement may be included in the composition, depending on the condition being targeted.

[0039] In general, exemplary subject symptoms that may be targeted by a targeted supplement include, but are not limited to, insomnia, drowsiness, weakness, post-exercise fatigue, anticipated post-exercise fatigue, electrolyte deficiency, low energy, protein deficiency, vitamin deficiency, immune deficiency, joint pain, obesity, muscle loss or weakness, inflammation, emotional lability, depression, poor concentration, poor memory, pain, jet lag, and the like.

[0040] In general, examples of types of targeted supplements that can be included in the exemplary compositions described herein include, but are not limited to, vitamins, minerals, amino acids, amino acid analogs, caffeine, proteins, herbal / botanical / plant supplements, functional foods, probiotics, prebiotics, soluble fiber, insoluble fiber, antioxidants, glucosamine, glycosaminoglycans, hormones, etc. Each targeted supplement is suitable for dissolution in water.

[0041] Examples of vitamins that can be included in the compositions described herein are vitamin B1, vitamin B2, vitamin B6, vitamin B 12 , folic acid (vitamin B9), niacin (vitamin B3), pantothenic acid (vitamin B5), biotin (vitamin B7), vitamin C, vitamin D3, vitamin E, vitamin A, and vitamin K.

[0042] Examples of minerals that can be included in the compositions described herein include, but are not limited to, zinc, copper, manganese, nickel, tin, silicon, magnesium, molybdenum, selenium, chromium, vanadium, boron, calcium, iron, iodine, and phosphorus.

[0043] Examples of amino acids that can be included in the compositions described herein include, but are not limited to, branched chain amino acids ("BCAAs") gamma-aminobutyric acid ("GABA"), L-arginine, L-carnitine, acetyl L-carnitine, glutamine, L-lysine, L-tyrosine, taurine, L-cysteine, L-tryptophan, L-theanine, L-carnosine, L-leucine, L-isoleucine, L-valine, beta-alanine, and 5-hydroxytryptophan ("5-HTP").

[0044] Examples of antioxidants that can be included in the compositions described herein include, but are not limited to, carotene, eugenol, lutein, and lycopene.

[0045] Examples of herbal / botanical / plant supplements that can be included in the compositions described herein include, but are not limited to, valerian, chamomile, passionflower, mate tea, ginger, ginseng, or Echinacea purpurea.

[0046] Examples of hormones that can be included in the compositions described herein include, but are not limited to, melatonin.

[0047] Examples of probiotics that can be included in the compositions described herein include, but are not limited to, Lactobacillus reuteri, Lactobacillus acidophilus, and Bifidobacterium bifidum.

[0048] The target supplement may be part of the composition and may be taken as part of the composition. As mentioned above, the rehydration formulation taken by itself causes water and sodium to be drawn more rapidly and in greater quantities across the small intestinal wall into the bloodstream by the action of the glucose-sodium transport system. When taken as part of the composition, the target supplement is absorbed more rapidly and in greater quantities than when taken separately from the composition. In one embodiment, when it is part of the composition, the absorption rate of the target supplement is generally faster than when it is absorbed by means other than the composition described herein. For example, about 1.1 times to about 6 times, or about 2 times to about 6 times, or about 2 times to about 3 times faster. For at least these reasons, when it is part of the composition, the target supplement has improved bioavailability as long as it is in the composition compared to when it is taken separately from the composition.

[0049] In certain embodiments, the target supplement itself may be a raw component of the composition. In other embodiments, the target supplement may be part of another component. For example, vitamin C may be added directly in its raw form or may be included as part of spinach powder. As another example, protein may be included as a target supplement as a protein powder or as soy or whey. Either raw or "bulk" material is referred to herein as a "target supplement."

[0050] As mentioned above, at least one targeted supplement is included in the composition. The selection of the at least one targeted supplement may be determined by the condition to be targeted in the subject.

[0051] In one example, the targeted symptom may be insomnia and at least one of the following targeted supplements may be included in the composition: melatonin, 5-HTP, valerian root, L-theanine, chamomile, L-tryptophan, vitamin C, algae, passionflower, zinc, calcium, or magnesium.

[0052] In another example, the targeted symptom may be electrolyte deficiency (e.g., as may occur during exercise) and at least one of the following targeted supplements may be included in the composition: sodium, potassium, phosphorus, magnesium, selenium, calcium, manganese, or zinc.

[0053] In yet another example, the symptom may be low vitality. In one embodiment, the composition may include at least one of the following target supplements: Matecha, vitamins (e.g., vitamin B2, vitamin B 12 , niacin, B-complex vitamins, or vitamin D), caffeine, coffee bean, green coffee extract, matcha green tea, black tea, white tea, mushrooms (e.g., reishi or cordyceps), ginseng, ashwagandha, or theobromine.

[0054] In yet another example, the condition may be immunosuppression and the composition may include at least one of the following targeted supplements: vitamin C, zinc, Echinacea purpurea, carrot, or ginger.

[0055] In a further example, the condition may be a protein deficiency and the composition may include at least one of the following targeted supplements: wheat or soy.

[0056] In a further example, the symptom may be exercise-related joint pain or inflammation, and the composition may include at least one of the following targeted supplements: glucosamine.

[0057] In further examples, the symptom may be pre-exercise warm-up or anticipated post-exercise fatigue, and the composition may include at least one of the following targeted supplements: caffeine, BCAAs, beta-alanine, L-arginine, L-citrulline, or beet root.

[0058] In another example, the symptom may be post-exercise fatigue and the composition may include at least one of the following targeted supplements: whey protein, soy protein, BCAAs, glutamine, beta-alanine, or creatine.

[0059] In yet another example, the condition may be a vitamin deficiency, and the composition may include at least one of the following targeted supplements: Vitamin B1, Vitamin B2, Vitamin B6, Vitamin B7, Vitamin B8, Vitamin B9, Vitamin B10, Vitamin B11, Vitamin B12, Vitamin B13, Vitamin B14, Vitamin B15, Vitamin B16, Vitamin B17, Vitamin B18, Vitamin B19, Vitamin B20, Vitamin B21, Vitamin B22, Vitamin B3, Vitamin B4, Vitamin B5, Vitamin B6, Vitamin B7, Vitamin B8, Vitamin B9, Vitamin B10, Vitamin B11, Vitamin B12, Vitamin B13, Vitamin B14, Vitamin B15, Vitamin B16, Vitamin B17, Vitamin B18, Vitamin B19, Vitamin B20, Vitamin B12, Vitamin B14, Vitamin B15, Vitamin B20, Vitamin B16, Vitamin B17, Vitamin B18, Vitamin B21, Vitamin B19, Vitamin B22, Vitamin B 12 , folic acid (vitamin B9), niacin (vitamin B3), pantothenic acid (vitamin B5), biotin (vitamin B7), vitamin C, vitamin D3, vitamin E, vitamin A, and vitamin K. For example, the condition may be a vitamin deficiency and the composition may include vitamin C, vitamin B3, vitamin B5, vitamin B6, and vitamin B 12 It may contain at least one of the following.

[0060] Other conditions may be targeted by the compositions described herein and other targeted supplements may be used to treat the conditions listed and other conditions.

[0061] In addition to at least one rehydration formulation and at least one target supplement, in one embodiment, the composition may contain optional additional components.Optional additional components may include at least one of natural flavors, artificial flavors, sweeteners (e.g., sodium saccharin, aspartame, acesulfame-K, chlorinated sucrose, erythritol, and / or rebaudioside), colorants, preservatives (e.g., potassium sorbate, sodium benzoate), excipients (e.g., silica, cellulose, cellulose esters, polyethylene glycol, and lecithin), anti-caking agents, gelling agents, antimicrobial agents (e.g., germacrenes), citric acid, or combinations thereof.

[0062] Table 1 shows the amounts of ingredients in one embodiment of the compositions described herein, both by weight and osmolality, when dissolved in 1 liter of water. For purposes of this application, 1 liter of water is assumed to have a weight of 1.0 kg.

[0063] [Table 1]

[0064] Table 2 shows the osmolarity of the individual components of the rehydration formulations along with the total osmolarity of all components for the compositions listed in Table 1.

[0065] [Table 2]

[0066] Table 3 shows the amount of ingredients in another embodiment of the composition described herein, where the target symptom is insomnia. The amount of ingredients is listed by weight and osmolality when dissolved in 8 ounces (236.58 g) of water. The ingredients include (1) components of the rehydration formulation, (2) at least one target supplement, and (3) optional additional ingredients. For the purposes of this application, 1 liter of water is assumed to have a weight of 1.0 kg.

[0067] [Table 3]

[0068] Table 4 shows the osmolarity of the individual components of the rehydration formulations along with the total osmolarity of all components for the compositions listed in Table 3.

[0069] [Table 4]

[0070] 1 and 2, various compositions and methods of making and using the compositions are further described.

[0071] (Exemplary Manufacturing Method) FIG. 1 is a flow diagram of one embodiment of a method 100 for making a composition.

[0072] As mentioned above, the compositions described herein include at least one rehydration formulation and at least one targeted supplement, and may contain optional additional ingredients.

[0073] In step 102, the components of the rehydration formula are combined.

[0074] In one embodiment, the rehydration formulation includes, but is not limited to, at least about 9.0 g to about 12.6 g of glucose per liter of solvent, about 12.9 g to about 14.8 g of sucrose per liter of solvent, about 2.0 g to about 2.3 g of sodium chloride per liter of solvent, about 0.98 g to about 1.5 g of sodium citrate per liter of solvent, about 1.4 g to about 1.6 g of potassium citrate per liter of solvent, and about 0.50 g to about 0.65 g of dipotassium phosphate per liter of solvent.

[0075] In another embodiment, the rehydration formulation includes, but is not limited to, at least about 9.0 g to about 10.8 g of glucose per liter of solvent, about 12.6 g to about 15.7 g of sucrose per liter of solvent, about 2.2 g to about 2.5 g of sodium chloride per liter of solvent, about 0.68 g to about 1.3 g of sodium citrate per liter of solvent, about 1.4 g to about 1.6 g of potassium citrate per liter of solvent, and about 0.50 g to about 0.65 g of dipotassium phosphate per liter of solvent.

[0076] In yet another embodiment, the rehydration formulation includes, but is not limited to, at least about 14.0 g to about 15.6 g of dextrose per liter of solvent, about 2.1 g to about 2.5 g of sodium chloride per liter of solvent, about 2.30 g to about 2.76 g of sodium citrate per liter of solvent, and about 1.28 g to about 1.88 g of potassium chloride per liter of solvent.

[0077] The solvent (e.g., water) may be included as part of the composition or may be added later when preparing a solution containing the composition. The composition may be manufactured as one or more of a powder, gel, emulsion, or liquid.

[0078] In step 104, at least one targeted supplement may be added to at least one rehydration formulation as described above.

[0079] Optional additional ingredients may be added in step 106. The optional additional ingredients may include flavors, preservatives, sweeteners, colorants, anti-caking agents, gelling agents, antimicrobial agents, citric acid, and / or excipients.

[0080] Target supplements and other components may be added in various amounts.However, when in solution, the osmolality of glucose and the osmolality of sodium in the composition are at least about 50mmol / L, respectively, and the approximate ratio between each other is maintained at 1:1.In one example, the osmolality of glucose and sodium in the composition is about 50mmol / L to about 80mmol / L, or about 60mmol / L to about 70mmol / L, or about 75mmol / L to about 125mmol / L.In addition, when in solution, the total osmolality of the composition is about 210mmol / L to about 260mmol / L.

[0081] In another embodiment, the dextrose (glucose) in the composition has an osmolarity of about 70 mmol / L to about 90 mmol / L, or about 78 mmol / L to about 84 mmol / L, or about 80 mmol / L to about 82 mmol / L, and the sodium in the composition has an osmolarity of about 67.3 mmol / L to about 69.3 mmol / L, or about 60 mmol / L to about 76 mmol / L, or about 55 mmol / L to about 81 mmol / L. Additionally, when in solution, the total osmolarity of the composition is about 210 mmol / L to about 310 mmol / L, or about 255 mmol / L to about 270 mmol / L.

[0082] In step 108, the composition is converted to the desired state if it is not already in that state. For example, a composition in powder form may be diluted with water to prepare the composition for consumption.

[0083] (Example Usage) Figure 2 is a flow diagram of one embodiment of a method 200 of using the composition described above and shown in Figure 1. Specifically, Figure 2 illustrates an embodiment in which the method of use includes orally administering the targeted supplement in the composition to a subject in need thereof.

[0084] In step 202, a subject in need of a targeted supplement is identified.

[0085] In step 204, a composition is prepared containing at least one rehydration formulation as described herein and at least one targeted supplement as described herein. Optional additional ingredients may be added.

[0086] In step 206, the composition is diluted with water if not already in solution. For example, if the composition is in the form of a powder, gel, or emulsion, the method includes dissolving the composition in an amount of water that is at least sufficient to provide a solution in which the at least one rehydration formulation and one target supplement are substantially dissolved and suitable for consumption by drinking, and the molarity of sodium and glucose is at least 50 mmol / L each.

[0087] In step 208, the solution is orally taken by a subject in need thereof. EXAMPLES

[0088] Example 1: Targeted Supplements: Plasma Concentrations of Melatonin and L-Theanine Pharmacokinetic studies were performed to measure the absorption of melatonin and L-theanine of the test composition in comparison to the reference comparator product by obtaining plasma concentrations of melatonin and L-theanine at times following ingestion of the test composition and the reference comparator, respectively.

[0089] The goal of this study is to compare the pharmacokinetic profile of the test composition with that of an identically labeled reference comparator.

[0090] The study enrolled six healthy adult subjects, including three men and three women.

[0091] Preparation and Administration of Test Compositions and Reference Controls

[0092] Study subjects were instructed to fast for at least 4 hours prior to ingestion of the study product and the start of each study period.

[0093] Subjects received a single dose of the test composition on the first day and a single dose of the reference comparator on the second day after a minimum washout period of about 5 days.

[0094] Both the test composition and the reference comparator contained 3mg melatonin and 50mg L-theanine. The reference comparator product used is a commercial melatonin-based supplement manufactured and sold by Schiff. It is Schiff Knockout® tablet. The reference comparator had a label that was equivalent to the test composition in terms of melatonin and L-theanine dosage. The content of the reference comparator was based on the supplement information panel of the reference comparator.

[0095] A powder mixture was formed from the ingredients listed in Table 3. The mixture was combined with 8 fluid ounces (236.58 g) of water to form the test composition. The resulting osmolarity of the ingredients is listed in Table 3. The resulting osmolarity of dextrose, sodium, chloride ions, potassium, and citrate ions in the test composition is listed in Table 4.

[0096] First, subjects received the test composition. After completion of the test composition, a minimum five day washout period was required before test subjects received the reference comparator.

[0097] Plasma concentrations of the target supplements melatonin and L-theanine in each subject were measured at 15, 30, 60, 90 and 120 minutes after ingestion of the test composition / reference comparator.

[0098] (Plasma concentration 15 minutes after ingestion) Blood samples from each subject were collected within 1 hour before and at 15, 30, 60, 90 and 120 minutes after ingestion of the dose.

[0099] Table 5 (below) lists the plasma concentrations of melatonin (picograms per milliliter) and L-theanine (nanograms per milliliter) measured 15 minutes after ingestion for each of the six subjects 1-6.

[0100] [Table 5]

[0101] Table 5 illustrates that for all six subjects, the L-theanine plasma concentration 15 minutes after ingestion of the test composition was greater than the L-theanine plasma concentration 15 minutes after ingestion of the reference comparator.

[0102] Additionally, Table 5 illustrates that for five of the six subjects, the melatonin plasma concentration 15 minutes after ingestion of the test composition was greater than the melatonin plasma concentration 15 minutes after ingestion of the reference comparator.

[0103] [Table 6]

[0104] Table 6 lists the mean change from baseline (for six subjects) in plasma concentrations of melatonin (in pg / ml) and L-theanine (in ng / ml) for each of six subjects 15 minutes after ingestion of the test composition on the first day and 15 minutes after ingestion of the reference comparator on the second day, based on the data in Table 5 (above).

[0105] As shown in Table 6, the mean change from baseline in L-theanine plasma concentrations 15 minutes after ingestion of the test composition (851 ng / ml) was approximately 3.1-fold greater than the mean change from baseline in L-theanine plasma concentrations 15 minutes after ingestion of the reference comparator (277 ng / ml).

[0106] In addition, as shown in Table 6, the mean change from baseline in melatonin plasma concentrations 15 minutes after ingestion of the test composition (3384 pg / ml) was approximately 3.4 times greater than the mean change from baseline in melatonin plasma concentrations 15 minutes after ingestion of the reference comparator (993 pg / ml).

[0107] Tables 5 and 6 illustrate that the target supplements melatonin and L-theanine are absorbed by the human body more rapidly and to a greater extent (measured 15 minutes after ingestion) when taken as part of a composition described herein (i.e., a test composition comprising at least one target supplement and a rehydration formulation) than when taken as part of a reference control.

[0108] (Plasma concentrations 15, 30, 60, 90 and 120 minutes after ingestion) Table 7 shows the mean change in plasma concentration (from baseline for six subjects) at 15, 30, 60, 90 and 120 minutes after ingestion of the test composition and the reference comparator product, respectively.

[0109] [Table 7]

[0110] Table 7 illustrates that the mean L-theanine plasma concentration peaks sooner when included as part of the test composition than when included as part of the reference comparator. That is, the maximum mean L-theanine plasma concentration when included in the test composition was 30 minutes after ingestion (2242 ng / ml), while the maximum mean L-theanine plasma concentration when included in the reference comparator was 60 minutes after ingestion (2942 ng / ml). Table 7 also illustrates the difference between the test composition and the reference comparator in the speed of melatonin absorption, which peaks at 15 minutes after ingestion (3384 pg / ml and 993 pg / ml, respectively).

[0111] (Summary of Example 1) Example 1 provides evidence-based support that there is enhanced absorption (greater and more rapid) of melatonin and L-theanine (measured 15 minutes after ingestion) when included in the compositions described herein than when not included in the compositions. Example 1 also illustrates that L-theanine plasma concentrations peak more quickly when part of the test composition than when part of the reference control.

[0112] (Example clauses) 1. At least one targeted supplement having a first absorption rate and a first absorption amount; At least one rehydration formulation; wherein when the at least one targeted supplement is ingested as part of the composition, the at least one targeted supplement has at least one of a second absorption rate that is greater than the first absorption rate, or a second absorption amount that is greater than the first absorption amount. 2. The composition described in clause 1, wherein the composition is a powder, gel, emulsion or liquid. 3. The composition described in clause 1, wherein the at least one targeted supplement targets a symptom of the subject. 4. The condition is a vitamin deficiency and the at least one targeted supplement is vitamin C, vitamin B3, vitamin B5, vitamin B6 or vitamin B 124. The composition according to claim 3, comprising at least one of: 5. The composition of clause 3, wherein the symptom is insomnia and the at least one targeted supplement comprises at least one of melatonin, L-theanine, valerian root, 5-hydroxytryptophan, or passionflower. 6. The composition of clause 3, wherein the symptom is post-exercise fatigue and the at least one targeted supplement comprises at least one of whey protein, soy protein, branched chain amino acids, glutamine, beta-alanine, or creatine. 7. The composition of clause 3, wherein the symptom is predicted post-exercise fatigue and the at least one targeted supplement comprises at least caffeine, branched chain amino acids, and beta-alanine. 8. The composition of claim 1, wherein the second absorption rate is 2 to 6 times faster than the first absorption rate. 9. The composition of clause 1, wherein the first absorption rate and the second absorption rate include an absorption rate in the ileum, and the second absorption rate is two to three times faster than the first absorption rate. 10. The composition described in clause 1, wherein the first absorption rate and the second absorption rate include an absorption rate in the jejunum, and the second absorption rate is 4 to 6 times faster than the first absorption rate. 11. The at least one rehydration formulation comprises at least about 9.0 g to about 12.6 g of glucose per liter of solvent; about 12.9 g to about 14.8 g of sucrose per liter of solvent; about 2.0 g to about 2.3 g of sodium chloride per liter of solvent; about 0.98 g to about 1.5 g of sodium citrate per liter of solvent; about 1.4 g to about 1.6 g of potassium citrate per liter of solvent; About 0.50 g to about 0.65 g of dipotassium phosphate per liter of solvent 2. The composition according to claim 1, comprising: 12. The at least one rehydration formulation comprises at least about 9.0 g to about 10.8 g of glucose per liter of solvent; about 12.6 g to about 15.7 g of sucrose per liter of solvent; about 2.2 g to about 2.5 g of sodium chloride per liter of solvent; about 0.68 g to about 1.3 g of sodium citrate per liter of solvent; about 1.4 g to about 1.6 g of potassium citrate per liter of solvent; About 0.50 g to about 0.65 g of dipotassium phosphate per liter of solvent 2. The composition according to claim 1, comprising: 13. The composition described in clause 1, wherein the composition has a total osmolality of about 210 mmol / L to about 260 mmol / L. 14. The composition described in clause 1, wherein the osmolarity of sodium in the composition is at least 50 mmol / L and the osmolarity of glucose is at least 50 mmol / L.

[0113] 15. A method of making a composition comprising mixing at least one rehydration formulation with at least one targeted supplement, the at least one targeted supplement has a first absorption rate and a first absorption amount; A method wherein the at least one targeted supplement, when ingested as part of the composition, has at least one of a second absorption rate that is greater than the first absorption rate, or a second absorption amount that is greater than the first absorption amount. 16. The method according to clause 15, wherein the composition is a powder, gel, emulsion or liquid. 17. The method of claim 16, wherein the composition is a powder, the method further comprising dissolving the composition in an amount of water at least sufficient to provide a solution in which the at least one rehydration formulation and the one target supplement are substantially dissolved, making it suitable for consumption by drinking. 18. The method of claim 15, wherein said at least one targeted supplement targets a symptom in a subject. 19. The method of clause 18, wherein the symptom is insomnia and the at least one targeted supplement comprises at least one of melatonin, 5-hydroxytryptophan, valerian root, L-theanine, or passionflower. 20. The method of claim 18, wherein the symptom is predicted post-exercise fatigue and the at least one targeted supplement comprises at least caffeine, branched chain amino acids, and beta-alanine. 21. The method of clause 18, wherein the symptom is post-exercise fatigue and the at least one targeted supplement comprises at least whey protein, soy protein, branched chain amino acids, glutamine, beta-alanine, and creatine. 22. The at least one rehydration formulation comprises at least about 9.0 g to about 12.6 g of glucose per liter of solvent; about 12.9 g to about 14.8 g of sucrose per liter of solvent; about 2.0 g to about 2.3 g of sodium chloride per liter of solvent; about 0.98 g to about 1.5 g of sodium citrate per liter of solvent; about 1.4 g to about 1.6 g of potassium citrate per liter of solvent; About 0.50 g to about 0.65 g of dipotassium phosphate per liter of solvent 16. The method according to claim 15, comprising: 23. The at least one rehydration formulation comprises at least about 9.0 g to about 10.8 g of glucose per liter of solvent; about 12.6 g to about 15.7 g of sucrose per liter of solvent; about 2.2 g to about 2.5 g of sodium chloride per liter of solvent; about 0.68 g to about 1.3 g of sodium citrate per liter of solvent; about 1.4 g to about 1.6 g of potassium citrate per liter of solvent; About 0.50 g to about 0.65 g of dipotassium phosphate per liter of solvent 16. The method according to claim 15, comprising: 24. The method of claim 15, wherein the composition has a total osmolality of about 210 mmol / L to about 260 mmol / L.

[0114] 25. A method for orally delivering a targeted supplement to a subject in need thereof, said method comprising administering to said subject a composition comprising: at least one targeted supplement having a first absorption rate and a first absorption amount; At least one rehydration formulation; wherein when the at least one targeted supplement is ingested as part of the composition, the at least one targeted supplement has at least one of a second absorption rate that is greater than the first absorption rate or a second absorption amount that is greater than the first absorption amount. 26. The method according to clause 25, wherein the composition is a powder, gel, emulsion or liquid. 27. The method of claim 26, wherein the composition is a powder, the method further comprising dissolving the composition in an amount of water at least sufficient to provide a solution in which the at least one rehydration formulation and the one target supplement are substantially dissolved, making it suitable for consumption by drinking. 28. The method of claim 25, wherein the at least one targeted supplement targets a symptom in the subject. 29. The method of clause 28, wherein the symptom is insomnia and the at least one targeted supplement comprises at least one of melatonin, 5-hydroxytryptophan, valerian root, L-theanine, or passionflower. 30. The method of claim 28, wherein the symptom is predicted post-exercise fatigue and the at least one targeted supplement comprises at least caffeine, branched chain amino acids, and beta-alanine. 31. The method of clause 20, wherein the symptom is post-exercise fatigue and the at least one targeted supplement comprises at least whey protein, soy protein, branched chain amino acids, glutamine, beta-alanine, and creatine. 32. The at least one rehydration formulation comprises at least about 9.0 g to about 12.6 g of glucose per liter of solvent; about 12.9 g to about 14.8 g of sucrose per liter of solvent; about 2.0 g to about 2.3 g of sodium chloride per liter of solvent; about 0.98 g to about 1.5 g of sodium citrate per liter of solvent; about 1.4 g to about 1.6 g of potassium citrate per liter of solvent; About 0.50 g to about 0.65 g of dipotassium phosphate per liter of solvent 26. The method according to claim 25, comprising: 33. The at least one rehydration formulation comprises at least about 9.0 g to about 10.8 g of glucose per liter of solvent; about 12.6 g to about 15.7 g of sucrose per liter of solvent; about 2.2 g to about 2.5 g of sodium chloride per liter of solvent; about 0.68 g to about 1.3 g of sodium citrate per liter of solvent; about 1.4 g to about 1.6 g of potassium citrate per liter of solvent; About 0.50 g to about 0.65 g of dipotassium phosphate per liter of solvent 26. The method according to claim 25, comprising: 34. The method of claim 25, wherein the composition has a total osmolality of about 210 mmol / L to about 260 mmol / L.

[0115] 35. At least one targeted supplement having a first bioavailability value; At least one rehydration formulation; wherein the at least one targeted supplement has a second bioavailability value that is greater than the first bioavailability value when the targeted supplement is ingested as part of the composition. 36. The composition of claim 35, further comprising at least one of a flavoring agent, a sweetener, a coloring agent, a preservative, an excipient, an anti-caking agent, a gelling agent, citric acid, or an antimicrobial agent. 37. The composition of claim 35, wherein the first bioavailability value and the second bioavailability value are based at least on an absorption rate of the target supplement, or the first bioavailability value and the second bioavailability value are based at least on an absorption amount of the target supplement. 38. The at least one rehydration formulation comprises at least about 14.0 g to about 15.6 g of dextrose per liter of solvent; about 2.1 g to about 2.5 g of sodium chloride per liter of solvent; about 2.30 g to about 2.76 g of sodium citrate per liter of solvent; About 1.28g to about 1.88g of potassium chloride per liter of solvent 2. The composition according to claim 1, comprising: 39. The composition described in clause 1, wherein the composition has a total osmolality of about 200 mmol / L to about 310 mmol / L. 40. The composition described in clause 1, wherein the composition has a total osmolality of about 255 mmol / L to about 275 mmol / L.

[0116] 41. The at least one rehydration formulation comprises at least about 14.0 g to about 15.6 g of dextrose per liter of solvent; about 2.1 g to about 2.5 g of sodium chloride per liter of solvent; about 2.30 g to about 2.76 g of sodium citrate per liter of solvent; About 1.28g to about 1.88g of potassium chloride per liter of solvent 16. The method according to claim 15, comprising: 42. The method of claim 15, wherein the composition has a total osmolality of about 200 mmol / L to about 310 mmol / L. 43. The method of claim 15, wherein the composition has a total osmolality of about 255 mmol / L to about 275 mmol / L.

[0117] 44. The at least one rehydration formulation comprises at least about 14.0 g to about 15.6 g of dextrose per liter of solvent; about 2.1 g to about 2.5 g of sodium chloride per liter of solvent; about 2.30 g to about 2.76 g of sodium citrate per liter of solvent; About 1.28g to about 1.88g of potassium chloride per liter of solvent 26. The method according to claim 25, comprising: 45. The method of claim 25, wherein the composition has a total osmolality of about 200 mmol / L to about 310 mmol / L. 46. ​​The method of claim 25, wherein the composition has a total osmolality of about 255 mmol / L to about 275 mmol / L. 47. The composition of clause 3, wherein the symptom is low vitality and the at least one targeted supplement comprises at least one of mate tea, vitamins, caffeine, coffee bean, green coffee extract, matcha green tea, black tea, white tea, ginseng, ashwagandha, or theobromine.

[0118] (Conclusion) Although the subject matter has been described in specific language of structural features and / or methodological acts, it should be understood that the subject matter defined in the appended claims is not necessarily limited to the specific features or acts described. Rather, the specific features and acts are recited as example forms of implementing the claims.

[0119] Those skilled in the art will appreciate that a virtually unlimited number of variations on the above description are possible and that the accompanying drawings are merely intended to illustrate one or more example embodiments or implementations.

[0120] Those skilled in the art will recognize that various other modifications can be made and equivalents can be substituted without departing from the claimed subject matter. Additionally, many modifications can be made to the teachings of the claimed subject matter to adapt to a particular situation without departing from the central concepts described herein. Accordingly, it is not intended that the claimed subject matter be limited to the specific embodiments disclosed, but rather that the claimed subject matter includes all embodiments that fall within the scope of the appended claims and equivalents thereof.

[0121] In the foregoing detailed description, numerous specific details are set forth to provide a thorough understanding of the claimed subject matter. However, those skilled in the art will understand that the claimed subject matter may be practiced without these specific details. Other examples, methods, devices, or systems that will be known to those skilled in the art have not been described in detail so as not to obscure the claimed subject matter.

[0122] Throughout this specification, reference to "one embodiment" or "embodiment" can mean that a specific feature, structure, or characteristic described in connection with a specific embodiment can be included in at least one embodiment of the claimed subject matter. Thus, the references to "one embodiment" or "embodiment" in various places throughout this specification are not necessarily intended to refer to the same embodiment, or to the one specific embodiment described. Furthermore, it should be understood that the specific features, structures, or characteristics described can be combined in various ways with one or more embodiments. Of course, these or other aspects will generally vary depending on the specific context of use. Thus, the specific context of the description or use of these terms can provide useful guidance on the implications of those contexts.

[0123] Conditional statements such as "can," "could," "might," and "may," among others, are to be understood in the context of providing that a particular example or embodiment includes certain features, components, and / or steps that another example or embodiment does not include, unless specifically stated otherwise. Thus, such conditional statements are not necessarily intended to imply that a particular feature, component, and / or step is somehow required in one or more examples, or that one or more examples or embodiments include logic (with or without user input or guidance) that determines that a particular feature, component, and / or step is included or should be performed in those particular examples or embodiments. Conjunctive statements such as "at least one of X, Y, or Z" should be understood to indicate that an item, statement, etc. may be X, Y, Z, or any combination thereof, unless specifically stated otherwise.

Claims

1. 1. A composition comprising: at least one targeted supplement targeting a symptom in a subject, the targeted supplement having a first absorption rate when taken separately from the composition; At least one rehydration formulation; Including, The targeted supplement includes at least one of melatonin or L-theanine; the rehydration formulation comprises sodium ions, chloride ions, a glucose-containing saccharide, potassium ions and citrate; In said composition, the osmolality of glucose is greater than the osmolality of sodium ions; when the at least one target supplement is ingested as part of the composition, the at least one target supplement has a second absorption rate that is greater than the first absorption rate, the second absorption rate being measured less than 30 minutes after ingestion; The at least one rehydration formulation comprises at least 8.1 g to 16.8 g of glucose per liter of solvent; 12.6 g to 15.7 g of sucrose per liter of solvent; 2.0 to 2.5 g of sodium chloride per liter of solvent; 0.68 g to 3 g of sodium citrate per liter of solvent; 1.3 g to 1.7 g of potassium citrate per liter of solvent; 0.3 to 0.9 g dipotassium phosphate per liter of solvent; Including, composition.

2. A composition comprising: at least one targeted supplement targeting a symptom in a subject, the targeted supplement having a first absorption rate when taken separately from the composition; At least one rehydration formulation; Including, The targeted supplement includes at least one of melatonin or L-theanine; the rehydration formulation comprises sodium ions, chloride ions, a glucose-containing saccharide, potassium ions and citrate; In said composition, the osmolality of glucose is greater than the osmolality of sodium ions; when the at least one target supplement is ingested as part of the composition, the at least one target supplement has a second absorption rate that is greater than the first absorption rate, the second absorption rate being measured less than 30 minutes after ingestion; The at least one rehydration formulation comprises at least 9.0 g to 10.8 g of glucose per liter of solvent; 12.6 g to 15.7 g of sucrose per liter of solvent; 2.2 to 2.5 g of sodium chloride per liter of solvent; 0.68 g to 1.3 g of sodium citrate per liter of solvent; 1.4 to 1.6 g of potassium citrate per liter of solvent; 0.50 g to 0.65 g dipotassium phosphate per liter of solvent; Including, composition.

3. A composition comprising: at least one targeted supplement targeting a symptom in a subject, the targeted supplement having a first absorption rate when taken separately from the composition; At least one rehydration formulation; Including, The targeted supplement includes at least one of melatonin or L-theanine; the rehydration formulation comprises sodium ions, chloride ions, a glucose-containing saccharide, potassium ions and citrate; In said composition, the osmolality of glucose is greater than the osmolality of sodium ions; when the at least one target supplement is ingested as part of the composition, the at least one target supplement has a second absorption rate that is greater than the first absorption rate, the second absorption rate being measured less than 30 minutes after ingestion; The at least one rehydration formulation comprises at least 14.0 g to 15.6 g of dextrose per liter of solvent; 2.1 to 2.5 g of sodium chloride per liter of solvent; 2.30 g to 2.76 g of sodium citrate per liter of solvent; 1.28g to 1.88g of potassium chloride per liter of solvent; Including, composition.

4. 4. The composition of any of claims 1 to 3, wherein the symptom is insomnia and the composition further comprises at least one of valerian root, 5-hydroxytryptophan, or passionflower, or comprises both melatonin and L-theanine.

5. 4. The composition of claim 1, wherein the second absorption rate is from 2 to 6 times faster than the first absorption rate.

6. 4. The composition of claim 1, wherein the osmolarity of sodium in the composition is at least 50 mmol / L and the osmolarity of glucose is at least 50 mmol / L.

7. 4. The composition of claim 1, wherein the composition has a total osmolality of 200 mmol / L to 310 mmol / L.

8. 4. The composition of claim 1, wherein the composition has a total osmolality of 255 mmol / L to 275 mmol / L.

9. A method for producing a composition according to any one of claims 1 to 8, comprising the steps of: The method comprises the step of mixing at least one rehydration formulation with at least one targeted supplement.

Images