Ready-to-drink electrolyte solution

Abstract

Described is a ready-to-drink electrolyte solution comprising: from 40 mg to 120 mg / 100 ml of sodium, from 50 mg to 100 mg / 100 ml of potassium, from 55 mg to 90 mg / 100 ml of chloride, and from 200 mg to 600 mg / 100 ml of dextrose wherein the osmotic pressure of the ready-to-drink electrolyte solution is less than or equal to 268 mOsm / kg.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims the benefit of priority from Indian provisional application serial number 202311004093 filed on January 20, 2023, the contents of which are hereby incorporated by reference in their entirety. Technical Field

[0003] The present invention generally relates to drinkable solutions, particularly ready-to-drink electrolyte solutions. For example, the present invention relates to a ready-to-drink electrolyte solution comprising sodium, potassium, chloride, and dextrose and having an osmotic pressure of less than or equal to 268 mOsm / kg. The present invention also relates to a method for producing the ready-to-drink electrolyte solution and the use of the ready-to-drink electrolyte solution for human rehydration. Background Art

[0004] Oral rehydration salts (ORS) are well known and are a balanced glucose-electrolyte mixture containing 90 mEq / l of sodium with a total osmotic pressure of 311 mOsm / l (Oral Rehydration Salts, Production of New ORS, World Health Organization (WHO), 2006, WHO / FCH / CAH / 06.1). One approach is to reduce the osmotic pressure of ORS solutions to avoid the possible adverse effects of hypertonicity on net fluid absorption.

[0005] In adults with cholera, hypoosmolar ORS containing 75 mEq / l sodium and 75 mmol / l glucose (total osmolarity 245 mOsm / l) is as effective as standard ORS. However, it is sometimes associated with an increased incidence of transient, asymptomatic hyponatremia.

[0006] Hydration is an important adjunct to recovery from illness. People who are properly hydrated have a faster recovery rate than dehydrated patients with similar illnesses. Hydration can be active (e.g., through sodium-glucose pump activation, resulting in a faster hydration rate) or passive (e.g., through passive water absorption, resulting in a relatively slow hydration rate).

[0007] Active hydration can be achieved via a sodium-glucose pump, in which case typical sodium recommendations for such applications are in the range of 60 mEq / l to 90 mEq / l. However, such sodium recommendations may not be suitable for the elderly or for long-term consumption.

[0008] Similarly, persons with compromised immunity (eg, elderly patients) and / or recurrent infections generally require hydration, preferably active hydration, as well as various minerals and vitamins known to support immune function (eg, zinc, selenium, ascorbic acid).

[0009] Diabetes is a recognized risk factor for dehydration. This increased risk of dehydration in individuals with diabetes is due to increased urinary glucose excretion, increased urination due to osmotic diuresis, use of antihyperglycemic medications, and inadequate fluid intake. Dehydration in individuals with diabetes can cause dizziness, headache, fatigue, dry eyes, dry mouth, increased thirst, dark yellow urine, diabetic ketoacidosis, confusion, hypotension and a weak pulse, and a hyperosmolar, hyperglycemic state. Adequate hydration can help prevent these associated complications.

[0010] Further, patients may experience taste fatigue due to the pill burden (primary therapeutic dose), and the addition of another pill and water administration becomes an unpleasant experience.

[0011] Finally, there is a growing trend among consumers to proactively maintain a healthy lifestyle to boost their immunity and energy levels. These goals are often achieved through proper hydration and food supplementation with minerals and vitamins.

[0012] It would be desirable to provide patients with an electrolyte solution that can promote rehydration while providing immune system support components. It would also be desirable that the electrolyte solution not interfere with pre-existing medical conditions related to salt or sugar metabolism, such as blood pressure or diabetes. It would also be desirable that the electrolyte solution can be consumed daily to proactively boost the immune system.

[0013] Therefore, a formula with low sodium and dextrose content is proposed. Further, the product can provide additional benefits from other minerals such as zinc, selenium and vitamins such as ascorbic acid and / or pyridoxal HCl (B6), folic acid (B9) and cyanocobalamin (B12). Summary of the Invention

[0014] One aspect of the present invention relates to a ready-to-drink electrolyte solution comprising: 40 mg to 120 mg / 100 ml sodium, 50 mg to 100 mg / 100 ml potassium, 55 mg to 90 mg / 100 ml chloride, 200 mg to 600 mg / 100 ml dextrose, and wherein the osmotic pressure of the solution is less than or equal to 268 mOsm / kg.

[0015] This aspect can be combined with various embodiments in any combination. Therefore, in some embodiments, the ready-to-drink electrolyte solution may also include a vitamin selected from the group consisting of vitamin B6, vitamin B9, vitamin B12, or a combination thereof. In some embodiments, the solution also includes vitamin C. In some embodiments, the solution also includes vitamin D. In some embodiments, the solution also includes zinc. In some embodiments, the solution also includes selenium. In some embodiments, the solution also includes a citrate anion. In some embodiments, the solution also includes an antioxidant and / or a chelating agent. In some embodiments, the solution also includes a chelating agent, an antioxidant, and at least one vitamin, wherein the chelating agent and the antioxidant prevent degradation of at least one vitamin. In some embodiments, the solution also includes a sweetener. In some embodiments, the solution is substantially free of protein. In one or more embodiments, the solution has an energy content of less than 10Kcal / 100ml.

[0016] Another aspect of the present invention relates to a method for making a ready-to-drink electrolyte solution, comprising the steps of mixing a salt, an acid, a sugar, and an optional sweetener in water to produce a mixture; adding vitamins to the mixture; and diluting the mixture with purified water to obtain a ready-to-drink electrolyte solution.

[0017] This aspect can be combined with the various embodiments in any combination. Thus, in some embodiments, the dissolved oxygen level is controlled to remain below 20 ppm during manufacturing. In some embodiments, the method includes an additional packaging step, wherein the ready-to-drink electrolyte solution is conditioned in a sealed package after degassing and nitrogen purging.

[0018] Another aspect of the present invention relates to the use of the ready-to-drink electrolyte solution as described above for rehydration of a human being. The present invention also relates to the use of the ready-to-drink electrolyte solution as described above for rehydration of a human being suffering from diabetes. DETAILED DESCRIPTION

[0019] The terms used in this specification generally have their ordinary meanings in the art within the context of the present disclosure and in the specific context in which each term is used. Certain terms are discussed below or elsewhere in the specification to provide additional guidance when describing the compositions and methods of the present disclosure and how to make and use them.

[0020] As used in this specification and the appended claims, the singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise. Thus, for example, reference to "an ingredient" includes a mixture of ingredients.

[0021] As used herein, the term "about" or "approximately" means within an acceptable error range for a particular value as determined by one of ordinary skill in the art, which will depend in part on how the value is measured or determined (i.e., the limitations of the measurement system). For example, "about" can mean within three or more standard deviations as practiced in the art. Alternatively, "about" can mean a range of at most 10%, at most 5%, at most 3%, at most 1%, or at most 0.5% of a given value. Particularly with respect to systems or processes, the term can mean within an order of magnitude, such as within five times or two times a value.

[0022] As used herein, the terms "comprises," "comprising," or any other variations thereof, are intended to cover a non-exclusive inclusion such that a process, method, article, or apparatus that comprises a list of elements includes not only those elements but may also include other elements not expressly listed or inherent to such process, method, article, or apparatus.

[0023] As used herein, the term " / 100 ml" or "per 100 ml" refers to the amount of an ingredient present in 100 ml of the ready-to-drink electrolyte solution expressed by weight.

[0024] As used herein, when a range of values ​​is provided, the units of measure for the range are similar for both the minimum and maximum values ​​unless otherwise specified. For example, a range of "1 to 100 mg" means "1 mg to 100 mg."

[0025] The ready-to-drink electrolyte solution of the present disclosure can advantageously provide a fluid with low osmotic pressure, low sodium and dextrose content, which is suitable for daily consumption by people who need a palatable solution to restore their hydration level. Advantageously, the ready-to-drink electrolyte solution of the present disclosure will not interfere with pre-existing medical conditions, such as diabetes or hypertension or chronic infections. Advantageously, the ready-to-drink electrolyte solution of the present disclosure will help the human immune system by providing vitamins and minerals known to support immune function. The ready-to-drink electrolyte solution of the present disclosure is also suitable for daily consumption to actively enhance the immune system. The ready-to-drink electrolyte solution of the present disclosure may be particularly suitable for the elderly.

[0026] One aspect of the present invention relates to a ready-to-drink electrolyte solution, comprising:

[0027] 40mg to 120mg / 100ml of sodium,

[0028] 50mg to 100mg / 100ml of potassium,

[0029] 55mg to 90mg / 100ml of chloride, and

[0030] 200mg to 600mg / 100ml of dextrose,

[0031] The osmotic pressure of the solution is less than or equal to 268 mOsm / kg.

[0032] This electrolyte solution is suitable for daily use without causing imbalances in ion or glucose metabolism. This electrolyte solution can participate in the body's active rehydration. This electrolyte solution may be well-balanced for people with high blood pressure and those who need rehydration. Finally, this electrolyte solution may be well-balanced for people with diabetes who need rehydration.

[0033] By "ready-to-drink" is meant that the solution is intended to be drunk or ingested as is, without any further dilution or addition of any solids or liquids.

[0034] Preferably, the amount of sodium in the ready-to-drink electrolyte solution should be kept below 100 mg / 100 ml, or below 80 mg / 100 ml, or below 60 mg / 100 ml, or below 55 mg / 100 ml. For example, the sodium content of the ready-to-drink electrolyte solution may be in the range of 40 mg to 100 mg / 100 ml, or 50 mg to 100 mg / 100 ml, or 40 mg to 80 mg / 100 ml, or 50 mg to 80 mg / 100 ml, or 40 mg to 60 mg / 100 ml, or 45 mg to 55 mg / 100 ml, or 45 mg to 50 mg / 100 ml, or 50 mg to 55 mg / 100 ml.

[0035] Preferably, the amount of potassium in the ready-to-drink electrolyte solution should be kept below 90 mg / 100 ml, or below 80 mg / 100 ml. For example, the potassium content of the ready-to-drink electrolyte solution may be in the range of 50 mg to 90 mg / 100 ml, or 50 mg to 80 mg / 100 ml, or 50 mg to 70 mg / 100 ml, or 60 mg to 100 mg / 100 ml, or 60 mg to 90 mg / 100 ml, or 60 mg to 80 mg / 100 ml.

[0036] It is preferred to have a low content of sodium and / or potassium to provide a ready-to-drink electrolyte solution suitable for people with metabolic diseases related to sodium or potassium salts, or for people who wish to control their sodium or potassium salt intake as part of their daily life. However, a minimum amount of sodium and / or potassium is required to assist in active hydration of the body, for example via a sodium-glucose pump.

[0037] Preferably, the amount of chloride in the ready-to-drink electrolyte solution should be kept below 85 mg / 100 ml, or below 80 mg / 100 ml. For example, the chloride content of the ready-to-drink electrolyte solution may be in the range of 55 mg to 85 mg / 100 ml, or 60 mg to 85 mg / 100 ml, or 65 mg to 85 mg / 100 ml, or 70 mg to 85 mg / 100 ml, or 60 mg to 80 mg / 100 ml, or 65 mg to 80 mg / 100 ml, or 70 mg to 80 mg / 100 ml.

[0038] Preferably, the amount of dextrose in the ready-to-drink electrolyte solution should be kept below 550 mg / 100 ml, or below 500 mg / 100 ml. For example, the dextrose content of the ready-to-drink electrolyte solution may be in the range of 200 mg to 550 mg / 100 ml, or 300 mg to 550 mg / 100 ml, or 400 mg to 550 mg / 100 ml, or 450 mg to 550 mg / 100 ml, or 200 mg to 500 mg / 100 ml, or 300 mg to 500 mg / 100 ml, or 400 mg to 500 mg / 100 ml, or 300 mg to 550 mg / 100 ml, or 300 mg to 500 mg / 100 ml, or 300 mg to 500 mg / 100 ml, or 350 mg to 500 mg / 100 ml.

[0039] The term "dextrose" refers to anhydrous dextrose, not dextrose monohydrate.

[0040] It is preferred to have a dextrose content of less than 550 mg / 100 ml to provide a ready-to-drink electrolyte solution suitable for people with diabetes or other glucose metabolism disorders, or for people who wish to control their carbohydrate intake as part of their daily life. However, a minimum amount of dextrose is required to assist in active hydration of the body, for example via a sodium-glucose pump.

[0041] The molar ratio between dextrose and sodium is preferably from 2:1 to 1:2, preferably about 1:1.

[0042] Preferably, the osmotic pressure of the ready-to-drink electrolyte solution should be higher than 50mOms / kg, or higher than 100mOms / kg, or higher than 150mOms / kg, or higher than 200mOms / kg.

[0043] Preferably, the osmotic pressure of the ready-to-drink electrolyte solution should be from about 210 mOsm / kg to about 268 mOsm / kg, which corresponds to the WHO standard for low osmotic pressure solutions. However, it is important to note that the ready-to-drink electrolyte solution according to the present invention is not an oral rehydration solution as defined by the WHO.

[0044] The ready-to-drink electrolyte solution according to the present invention may further comprise a vitamin selected from the group consisting of vitamin B6, vitamin B9, vitamin B12 or a combination thereof.

[0045] B vitamins are known to provide many benefits. Vitamin B6 is known to be a key regulator of cell growth and helps restore cell-mediated immunity. Vitamin B6 is known to have anti-inflammatory properties and plays a key role in immune responses. In addition, vitamin B6 supplementation can increase the number / percentage of T lymphocytes, T helper cells, and T suppressor cells in critically ill patients. Vitamin B9 can increase innate immunity in the elderly. Vitamin B9 is also known to modify age-related decreases in NK cell activity. Vitamin B9 may also support Th1 responses. Vitamin B12 is known to increase the number of cells that play a role in cell-mediated immunity. Adequate dietary levels of vitamins B9 and B12 can serve as a preventative measure against inflammation, immune dysfunction, and disease progression.

[0046] The content of the vitamin selected in the group of vitamin B6, vitamin B9, vitamin B12 can be in the range of 0.5mg to 3mg / 100ml, or 0.5mg to 2.5mg / 100ml, or 0.5mg to 2mg / 100ml, or 1mg to 3mg / 100ml, or 1mg to 2.5mg / 100ml, or 1mg to 2mg / 100ml. The content of vitamin B6 (e.g., pyridoxine HCl) can preferably be in the range of 0.8mg to 1.4mg / 100ml, or 0.9mg to 1.3mg / 100ml, or 1mg to 1.2mg / 100ml. The content of vitamin B9 (e.g., folic acid) can preferably be in the range of 0.1mg to 0.3mg / 100ml, or 0.15mg to 0.25mg / 100ml, or 0.18mg to 0.2mg / 100ml. The content of vitamin B12 (e.g., cyanocobalamin) may preferably be in the range of 0.4 mg to 2 μg / 100 ml, or 0.5 mg to 1.7 μg / 100 ml, or 0.6 mg to 1.4 μg / 100 ml. Note that μg may also be expressed as "mcg," which stands for microgram (1 μg = 10 -6 g)

[0047] The ready-to-drink electrolyte solution according to the present invention may further comprise vitamin C.

[0048] The vitamin C content may be in the range of 2 mg to 70 mg / 100 ml, or 2 mg to 60 mg / 100 ml, or 2 mg to 50 mg / 100 ml, or 2 mg to 40 mg / 100 ml, or 10 mg to 70 mg / 100 ml, or 20 mg to 70 mg / 100 ml, or 30 mg to 70 mg / 100 ml, or 30 mg to 60 mg / 100 ml, or 40 mg to 50 mg / 100 ml.

[0049] It would be desirable to have a ready-to-drink electrolyte solution containing vitamin C (eg, ascorbic acid) since this vitamin is known to help boost the immune system.

[0050] The ready-to-drink electrolyte solution according to the present invention may further comprise vitamin D, for example selected from the group consisting of vitamin D2, vitamin D3 or a combination thereof.

[0051] The content of vitamin D in the ready-to-drink electrolyte solution may be in the range of 1 μg to 50 mg / 100 ml, or 1 μg to 10 mg / 100 ml, or 0.1 mg to 50 mg / 100 ml, or 0.1 mg to 10 mg / 100 ml, or 1 mg to 10 mg / 100 ml, or 5 mg to 10 mg / 100 ml, or 6 mg to 8 mg / 100 ml.

[0052] It would be desirable to have a ready-to-drink electrolyte solution containing vitamins D2 and / or D3, as these vitamins are known to play a role in calcium and phosphate metabolism, promote healthy bone structure, have an effect on immune function and reduce inflammation.

[0053] The ready-to-drink electrolyte solution according to the invention may further comprise zinc.

[0054] The zinc content in the ready-to-drink electrolyte solution may be in the range of 0.1 mg to 20 mg / 100 ml, or 0.5 mg to 15 mg / 100 ml, or 1 mg to 10 mg / 100 ml, or 2 mg to 10 mg / 100 ml, or 2 mg to 5 mg / 100 ml, or 1 mg to 2 mg / 100 ml.

[0055] It would be desirable to have a ready-to-drink electrolyte solution containing zinc, as this element is known to help boost the immune system. Zinc is known to have beneficial effects in intestinal immune function, increasing NK cell cytotoxicity, restoring thymine activity, increasing the number of cytotoxic T cells, reducing the number of activated T helper cells (which can lead to autoimmunity), and positively affecting the immune system in the elderly population, thereby preventing or reducing the risk of age-related diseases.

[0056] The ready-to-drink electrolyte solution according to the invention may further comprise selenium.

[0057] The selenium content in the ready-to-drink electrolyte solution may be in the range of 1 μg to 100 μg / 100 ml, or 1 μg to 50 μg / 100 ml, or 1 μg to 20 μg / 100 ml; or 2 μg to 20 μg / 100 ml, or 1 μg to 10 μg / 100 ml, or 2 μg to 10 μg / 100 ml, or 1 μg to 5 μg / 100 ml, or 2 μg to 5 μg / 100 ml, or 2 μg to 10 μg / 100 ml, or 2 μg to 6 μg / 100 ml.

[0058] It would be desirable to have a ready-to-drink electrolyte solution containing selenium, as this element is known to help boost the immune system. Selenium is known to have antioxidant effects, to improve cell-mediated immunity, to improve T helper cell counts, and to enhance immune responses to bacterial and viral infections.

[0059] The ready-to-drink electrolyte solution according to the invention may further comprise citrate anions.

[0060] The content of citrate anions in the ready-to-drink electrolyte solution may be in the range of 0.1 g to 1 g / 100 ml, or 100 mg to 700 mg / 100 ml, or 100 mg to 500 mg / 100 ml, or 200 mg to 1 g / 100 ml, or 200 mg to 700 mg / 100 ml, 200 mg to 500 mg / 100 ml, or 300 mg to 700 mg / 100 ml, or 300 mg to 500 mg / 100 ml, or 150 mg to 400 mg / 100 ml.

[0061] The ready-to-drink electrolyte solution of the present invention may further comprise an antioxidant and / or a chelating agent.

[0062] The antioxidant can be selected from vitamin E or a derivative of vitamin E, such as D-α-tocopheryl polyethylene glycol succinate (vitamin E TPGS), lecithin, gallic acid and its derivatives, tartaric acid, glucose oxidase, 4-hexylresorcinol. Anoxomer, dilauryl thiodipropionate, distearyl thiodipropionate, guaiac resin, isopropyl citrate, butyrated hydroxyanisole. Preferably, the antioxidant is a derivative of vitamin E, such as D-α-tocopheryl polyethylene glycol succinate (vitamin E TPGS). Vitamin E TPGS also provides a source of vitamin E, as vitamin E accounts for about 25% of the total mass of vitamin E TPGS.

[0063] Preferably, the amount of antioxidant in the ready-to-drink electrolyte solution is 1 mg to 50 mg / 100 ml, or 2 mg to 30 mg / 100 ml; or 2 mg to 20 mg / 100 ml, or 5 mg to 20 mg / 100 ml, or 10 mg to 20 mg / 100 ml.

[0064] The chelating agent may be selected from EDTA, trisodium citrate, trisodium orthophosphate, sodium acetate, sodium gluconate, sodium dihydrogen citrate, diacetyltartaric acid and fatty acid esters of glycerol, potassium dihydrogen citrate, potassium gluconate, tripotassium citrate.

[0065] A preferred chelating agent is EDTA.

[0066] Preferably, the amount of chelating agent is 1 mg to 100 mg / 100 ml, or 5 mg to 50 mg / 100 ml, or 10 mg to 50 mg / 100 ml, or 10 mg to 30 mg / 100 ml.

[0067] It has been observed that the presence of antioxidants and chelating agents is particularly beneficial for the stability of vitamin C that may be present in electrolyte solutions.

[0068] EDTA has also been reported to help improve zinc absorption in both children and adults.

[0069] The ready-to-drink electrolyte solution according to the present invention may further comprise a chelating agent, an antioxidant and at least one vitamin, wherein the chelating agent and the antioxidant prevent degradation of the at least one vitamin.

[0070] The ready-to-drink electrolyte solution according to the present invention may further comprise a sweetener.

[0071] For the sake of clarity, the dextrose already present in the electrolyte solution has a sweetening effect, so the solution may contain another sweetener (or sweetener) in addition to the dextrose.

[0072] Sweeteners can be selected from natural or artificial sweeteners. Natural sweeteners can be selected from: steviol glucoside (such as stevioside), monk fruit, polyols or sugar alcohols, allulose, glycyrrhizic acid glycoside, thaumatin. Artificial sweeteners can be selected from: saccharin, saccharin sodium, aspartame, acesulfame K, neotame, thaumatin, glycyrrhizic acid glycoside, sucralose, cyclamate, dihydrochalcone, alitame, miraculin and monellin and mixtures thereof. Preferably, the sweetener can be steviol glucoside, such as stevioside. Preferably, the ready-to-drink electrolyte solution according to the present invention can include a sweetener that does not affect osmotic pressure, such as stevioside.

[0073] The content of sweeteners in the ready-to-drink electrolyte solution should be kept below 100 mg / 100 ml, or below 80 mg / 100 ml. For example, the sweetener content of the ready-to-drink electrolyte solution may be in the range of 1 mg to 100 mg / 100 ml, or 10 mg to 100 mg / 100 ml, or 20 mg to 100 mg / 100 ml, 40 mg to 100 mg / 100 ml, or 10 mg to 80 mg / 100 ml, or 20 mg to 80 mg / 100 ml, or 40 mg to 80 mg / 100 ml, or 50 mg to 80 mg / 100 ml, or 50 mg to 70 mg / 100 ml.

[0074] The ready-to-drink electrolyte solution according to the present invention may be substantially free of protein.

[0075] By substantially free of protein is meant that the electrolyte solution may contain less than 10 mg / 100 ml, or less than 1 mg / 100 ml, or less than 0.1 mg / 100 ml of protein.

[0076] The ready-to-drink electrolyte solution according to the present invention may have an energy content of less than 10 Kcal / 100 ml.

[0077] The energy content of ready-to-drink electrolyte solutions should be kept below 8Kcal / 100ml, or below 6Kcal / 100ml, or below 5Kcal / 100ml.

[0078] Another aspect of the present invention relates to a method for producing a ready-to-drink electrolyte solution, the method comprising the following steps:

[0079] - mixing salt, acid, sugar, and optional sweetener in water to produce a mixture;

[0080] - adding vitamins to the mixture; and

[0081] - Dilute this mixture with purified water to obtain a ready-to-drink electrolyte solution.

[0082] Methods for producing ready-to-drink electrolyte solutions may require controlled light conditions while adding the vitamin solution to the mixture. By "controlled light conditions," this means reducing the light intensity compared to normal daylight to prevent photochemical degradation of the vitamins. This can involve operating in low-light environments or with modified light spectra to prevent specific wavelengths from interacting with the vitamin structure.

[0083] The method for manufacturing a ready-to-drink electrolyte solution according to the present invention may require maintaining a controlled dissolved oxygen level in the electrolyte solution below 20 ppm during manufacturing.

[0084] Preferably, during manufacturing, the level of dissolved oxygen in the electrolyte solution should be maintained below 15 ppm, or below 10 ppm, or below 8 ppm, or below 5 ppm, or below 3 ppm, or below 1 ppm.

[0085] For the sake of clarity, 15 ppm is equivalent to 15 mg of oxygen per 1 liter of electrolyte solution.

[0086] It is desirable to keep the level of dissolved oxygen in the electrolyte solution low to prevent oxidation reactions of reactive compounds such as vitamins.

[0087] The method for producing a ready-to-drink electrolyte solution according to the present invention may comprise an additional packaging step, wherein the ready-to-drink electrolyte solution is conditioned in a sealed package after degassing and nitrogen purging.

[0088] Degassing and nitrogen purging are ideal to remove as much oxygen as possible from the packaged electrolyte solution to prevent oxidation reactions of reactive compounds such as vitamins.

[0089] Another aspect of the present invention relates to the use of the ready-to-drink electrolyte solution according to the invention for rehydration of humans.

[0090] In other words, the ready-to-drink electrolyte solution according to the present invention can be used to treat dehydration in humans.

[0091] The person in need of fluid rehydration may be of any age over 2 years old. Preferably, the person may be of any age over 50 years old, or 60 years old, or 70 years old.

[0092] Age groups over 50, 60 or 70 years old are more likely to suffer from health problems, such as diabetes and / or high blood pressure; and a ready-to-drink electrolyte solution with low sugar and sodium content would be particularly desirable to help these people restore their hydration levels.

[0093] The present invention relates to the use of the ready-to-drink electrolyte solution according to the invention for the rehydration of persons suffering from diabetes.

[0094] In other words, the ready-to-drink electrolyte solution according to the present invention can be used to treat dehydration in people suffering from diabetes.

[0095] The person may be suffering from other conditions, such as high blood pressure or recurring infections. The person may also be trying to proactively manage their immune system to prevent any infections or medical conditions.

[0096] Example

[0097] The following examples are intended to illustrate, but not to limit, the disclosed subject matter in any way, shape, or form, whether explicitly or implicitly.

[0098] 1-Preparation of ready-to-drink electrolyte solution

[0099] Table 1 presents Comparative Examples 1 and 2, which are two electrolyte drinks sold by Johnson & Johnson.

[0100] Tables 1 and 2 present inventive examples 3, 4 and 5, which are examples of formulations of ready-to-drink electrolyte solutions according to the present invention.

[0101] Table 1

[0102] Ingredients (g / 100ml) Comparative Example 1 Comparative Example 2 Embodiment 3 of the present invention sucrose 8.800 - - Dextrose monohydrate 2.700 1.000 0.480 ascorbic acid 0.076 0.076 0.048 DL-malic acid - 0.140 - Sodium chloride 0.125 0.180 - Trisodium citrate dihydrate 0.290 0.290 0.240 potassium chloride 0.150 0.150 0.150 Fruit juice concentrate (minimum 68°Brix) 1.420 1.500 - Stevia - 0.022 0.03 Citric acid monohydrate 0.220 - 0.022 Zinc gluconate - - 0.012 Sodium selenate - - 0.0000072 Vitamins (B6, B9, and B12) - - 0.0013 Edetate disodium - - 0.025 Vitamin E TPGS - - 0.007 Flavorings and colorings 0.385 0.06 0.074 purified water Appropriate amount 100ml Appropriate amount 100ml Appropriate amount 100ml

[0103] Table 2

[0104] Ingredients (g / 100ml) Embodiment 4 of the present invention Embodiment 5 of the present invention purified water Appropriate amount 100ml Appropriate amount 100ml Frozen orange juice concentrate - 1.636 Dextrose monohydrate 0.48 0.48 Trisodium citrate dihydrate 0.22 0.22 Citric acid monohydrate 0.22 0.16 potassium chloride 0.15 0.15 ascorbic acid 0.04 0.04 Stevia (Sigma T5) 0.03 0.025 Edetate disodium 0.025 0.025 Zinc gluconate 0.0115 0.0115 Vitamin E-TPGS 0.007 0.007 Flavorings and colorings 0.075 0.039 Sodium selenate 0.000014 0.000014

[0105] The orange juice concentrate of Example 5 has a Brix value between 64° and 66° (refractometer at 20°C), an acidity content between 3 and 7 (as a % of anhydrous citric acid), and a pH between 3 and 4.3. The nutritional value of 100 g of the orange juice concentrate is: 271.1 kcal, 2.3 g protein, 61.1 g carbohydrates (including 54.4 g sugars), 0.3 g fat, 2 g fiber, and 32.8 mg salt.

[0106] 2- Manufacturing process

[0107] Total batch size = 800 liters

[0108] Step 1: Add the ingredients individually to 50% of the batch size of purified water (except vitamins and vitamin ETPGS), and optionally juice concentrate.

[0109] Step 2: Dissolve the Vitamin E TPGS using hot purified water (approximately 80°C) and once a homogeneous solution is observed, allow the solution to cool to ambient conditions (approximately 25°C, room humidity of 60% ± 10%).

[0110] Step 3: Add Step 2 to Step 1 and allow 1 hour of contact time.

[0111] Step 4: Add the vitamin solution to the solution obtained in step 3 under minimal light and ambient conditions.

[0112] Step 5: Adjust the solution obtained in Step 4 to the target volume with sufficient purified water.

[0113] Step 6: Divide the bodies obtained in step 5 into 4 different batches, namely: A, B, C, and D; each batch has different packaging conditions (see below)

[0114] A = Degassed without nitrogen purge (200 ml / bag).

[0115] B = Degassed and nitrogen purged (180 ml / bag).

[0116] C = no degassing and no nitrogen purge (200 ml / bag).

[0117] D = No degassing but nitrogen purging (180 ml / bag).

[0118] The product fill volume for packages using nitrogen purge is 180ml instead of 200ml.

[0119] "Vitamin E TPGS" stands for D-alpha-tocopheryl polyethylene glycol succinate.

[0120] "Edetate disodium" stands for disodium ethylenediaminetetraacetic acid (or EDTA).

[0121] 3- Stability and analysis

[0122] Four batches of product were produced and packaged according to the above method and analyzed for stability; the results are presented in Table 3 below.

[0123] Example 6 was packaged under degassing but without nitrogen purging (A).

[0124] Example 7 was packaged under degassing and nitrogen purging (B).

[0125] Example 8 was packaged without degassing and without nitrogen purging (C).

[0126] Example 9 was packaged without degassing but with nitrogen purging (D).

[0127] All four embodiments 6 to 9 are inventive according to the present invention.

[0128] Table 3

[0129]

[0130] Example 7 (degassed and nitrogen purged) is the preferred option; it allows for better stability of the vitamins present in the formula.

[0131] Dextrose, stevioside, citrate and vitamin B6 contents were determined by HPLC.

[0132] The sodium, potassium, zinc and selenium contents were determined by ICP OES (Inductively Coupled Plasma-Optical Emission Spectroscopy).

[0133] Carbohydrate content was determined by the differential method according to AOAC 986.25. “AOAC” stands for Association of Official Agricultural Chemists.

[0134] Fat content was determined according to AOAC 986.25.

[0135] Protein content was determined according to AOAC 920.15.

[0136] Vitamin B12 content was determined by LC MS / MS.

[0137] Vitamin B9 content was determined by ELISA.

[0138] Chloride and vitamin C contents were determined according to the FSSAI laboratory manual.

[0139] Energy Kcal content was determined according to Indian Code of Nutritional Parameters (ICMR).

Claims

1. A ready-to-drink electrolyte solution, comprising: 40mg to 120mg / 100ml of sodium; 50mg to 100mg / 100ml of potassium; 55mg to 90mg / 100ml of chloride; and 200mg to 600mg / 100ml of dextrose, wherein the osmotic pressure of the solution is lower than or equal to 268 mOsm / kg. 2 . The ready-to-drink electrolyte solution according to claim 1 , wherein the solution further comprises a vitamin selected from the group consisting of vitamin B6, vitamin B9, vitamin B12, or a combination thereof.

3. The ready-to-drink electrolyte solution according to claim 1 or 2, wherein the solution further comprises vitamin C.

4. The ready-to-drink electrolyte solution according to any one of claims 1 to 3, wherein the solution further comprises vitamin D.

5. The ready-to-drink electrolyte solution according to any one of claims 1 to 4, wherein the solution further comprises zinc.

6. The ready-to-drink electrolyte solution according to any one of claims 1 to 5, wherein the solution further comprises selenium.

7. The ready-to-drink electrolyte solution according to any one of claims 1 to 6, wherein the solution further comprises citrate anions.

8. The ready-to-drink electrolyte solution according to any one of claims 1 to 7, wherein the solution further comprises an antioxidant and / or a chelating agent.

9. The ready-to-drink electrolyte solution according to any one of claims 1 to 8, wherein the solution further comprises a chelating agent, an antioxidant and at least one vitamin, wherein the chelating agent and the antioxidant prevent degradation of the at least one vitamin.

10. The ready-to-drink electrolyte solution according to any one of claims 1 to 9, wherein the solution further comprises a sweetener.

11. The ready-to-drink electrolyte solution according to any one of claims 1 to 10, wherein the solution is substantially free of protein.

12. The ready-to-drink electrolyte solution according to any one of claims 1 to 11, wherein the solution has an energy content of less than 10 Kcal / 100 ml.

13. A method for producing a ready-to-drink electrolyte solution, the method comprising the steps of: - mixing salt, acid, sugar, and optional sweetener in water to produce a mixture; - adding vitamins to the mixture; as well as - Dilute the mixture with purified water to obtain a ready-to-drink electrolyte solution.

14. The method of claim 13, wherein the dissolved oxygen level of the mixture is controlled to remain below 20 ppm during manufacture.

15. The method according to claim 13 or 14, comprising an additional packaging step, wherein the ready-to-drink electrolyte solution is conditioned in a sealed package after degassing and nitrogen purging.

16. Use of the ready-to-drink electrolyte solution according to any one of claims 1 to 12 for rehydration of humans.

17. Use of the ready-to-drink electrolyte solution according to any one of claims 1 to 12 for rehydration of humans suffering from diabetes.

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