Compositions and methods for improving hydration of individuals having dysphagia

Abstract

A method of treating or preventing dehydration in an individual having impaired swallowing such as dysphagia can include administering to the individual having the dysphagia an effective amount of a composition containing a salivating agent and a cooling agent in a weight ratio of 1:0.06 to 1:0.2. Optionally the composition includes a tingling agent. The composition can be a powder that is reconstituted before administration, for example at the point of consumption. A thickening or thin cohesive agent can be included in the powder and/or can be included in a liquid in which the powder is reconstituted. The composition can be a beverage containing the salivating agent and the cooling agent in a total amount of at least 3.0 wt. % of the beverage, for example at least 6.0 wt. % of the beverage. The composition can be a ready-to-drink beverage or a frozen dessert on a stick.

Claims

1. A method of treating or preventing dehydration in an individual having impaired swallowing, the method comprising administering to the individual an effective amount of a beverage comprising a salivating agent and a cooling agent in a total amount of at least 3.0 wt. % of the beverage, the beverage further comprising a tingling agent selected from the group consisting of spilanthol, saanshool-I, saanshool-II, sanshoamide, chavicine, piperine, Echinacea extract, Northern Prickly Ash extract, red pepper oleoresin, and mixtures thereof, and the individual is selected from the group consisting of individuals with one or more of fever, vomiting, or viral gastroenteritis; individuals living at high altitudes; and combinations thereof.

2. The method of claim 1 wherein the salivating agent is one or more organic acids selected from the group consisting of adipic, ascorbic, citric, fumaric, lactic, malic and tartaric acids.

3. The method of claim 1 wherein the cooling agent is selected from the group consisting of menthol compounds, acyclic carboxamides, cyclic carboxamides, N-substituted paramenthane carboxamides, phosphine oxides, substituted p-menthanes, menthoxypropane, alpha-keto enamines, N-substituted p-menthane carboxamide, menthyl half acid esters, cubebol and mixtures thereof.

4. The method of claim 1 wherein the beverage comprises a thickening agent and/or cohesive agent.

5. The method of claim 1, wherein the individual has dysphagia.

6. The method of claim 1, wherein the beverage comprises the salivating agent and the cooling agent in a total amount of at least 6.0 wt. % of the beverage.

7. The method of claim 1, wherein the beverage has a viscosity of 35-350 cP.

8. The method of claim 1, wherein the beverage has a viscosity greater than 1,750 cP.

9. The method of claim 1, wherein the beverage comprises a food grade biopolymer selected from the group consisting of botanical hydrocolloids, microbial hydrocolloids, animal hydrocolloids, algae hydrocolloids, and combinations thereof.

10. A method of treating or preventing dehydration in an individual having dysphagia, the method comprising administering to the individual an effective amount of a beverage comprising a salivating agent and a cooling agent in a weight ratio of 1:0.06 to 1:0.2 and a total amount of at least 3.0 wt. % of the beverage, the beverage further comprising a tingling agent selected from the group consisting of spilanthol, saanshool-I, saanshool-II, sanshoamide, chavicine, piperine, Echinacea extract, Northern Prickly Ash extract, red pepper oleoresin, and mixtures thereof, and the individual is selected from the group consisting of individuals with one or more of fever, vomiting, or viral gastroenteritis; individuals living at high altitudes; and combinations thereof.

11. The method of claim 10 wherein the salivating agent is one or more organic acids selected from the group consisting of adipic, ascorbic, citric, fumaric, lactic, malic and tartaric acids.

12. The method of claim 10 wherein the cooling agent is selected from the group consisting of menthol compounds, acyclic carboxamides, cyclic carboxamides, N-substituted paramenthane carboxamides, phosphine oxides, substituted p-menthanes, menthoxypropane, alpha-keto enamines, N-substituted p-menthane carboxamide, menthyl half acid esters, cubebol and mixtures thereof.

13. The method of claim 10 wherein the beverage comprises a thickening agent and/or cohesive agent.

14. The method of claim 10, wherein the beverage comprises the salivating agent and the cooling agent in a total amount of at least 6.0 wt. % of the beverage.

15. A method of treating impaired swallowing in an individual having dysphagia, the method comprising administering to the individual an effective amount of a beverage comprising a salivating agent and a cooling agent in a weight ratio of 1:0.06 to 1:0.2 and a total amount of at least 3.0 wt. % of the beverage, the beverage further comprising a tingling agent selected from the group consisting of spilanthol, saanshool-I, saanshool-II, sanshoamide, chavicine, piperine, Echinacea extract, Northern Prickly Ash extract, red pepper oleoresin, and mixtures thereof, and the individual is selected from the group consisting of individuals with one or more of fever, vomiting, or viral gastroenteritis; individuals living at high altitudes; and combinations thereof.

16. The method of claim 15 wherein the individual has dehydration.

17. The method of claim 15 wherein the individual is at risk of dehydration.

18. The method of claim 15, wherein the beverage comprises the salivating agent and the cooling agent in a total amount of at least 6.0 wt. % of the beverage.

Description

DETAILED DESCRIPTION

(1) All percentages expressed herein are by weight of the total weight of the composition unless expressed otherwise. When reference is made to the pH, values correspond to pH measured at 25° C. with standard equipment. All viscosities herein are values collected at 25° C. and a shear rate of 50 s.sup.−1.

(2) As used in this disclosure and the appended claims, the singular forms “a,” “an” and “the” include plural referents unless the context clearly dictates otherwise. As used herein, “about” is understood to refer to numbers in a range of numerals, for example the range of −10% to +10% of the referenced number, preferably −5% to +5% of the referenced number, more preferably −1% to +1% of the referenced number, most preferably −0.1% to +0.1% of the referenced number. All numerical ranges herein should be understood to include all integers, whole or fractions, within the range. Moreover, these numerical ranges should be construed as providing support for a claim directed to any number or subset of numbers in that range. For example, a disclosure of a range from 1 to 10 should be construed as supporting a range from 1 to 8, from 3 to 7, from 1 to 9, from 3.6 to 4.6, from 3.5 to 9.9, and so forth.

(3) The term “and/or” used in the context of “X and/or Y” should be interpreted as “X,” or “Y,” or “X and Y.” Where used herein, the terms “example” and “such as,” particularly when followed by a listing of terms, are merely exemplary and illustrative and should not be deemed to be exclusive or comprehensive.

(4) The compositions disclosed herein may lack any element that is not specifically disclosed herein. Thus, a disclosure of an embodiment using the term “comprising” includes a disclosure of embodiments “consisting essentially of” and “consisting of” the components identified. Similarly, the methods disclosed herein may lack any step that is not specifically disclosed herein. Thus, a disclosure of an embodiment using the term “comprising” includes a disclosure of embodiments “consisting essentially of” and “consisting of” the steps identified.

(5) “Prevention” includes reduction of risk and/or severity of a condition or disorder. The terms “treatment,” “treat” and “to alleviate” include both prophylactic or preventive treatment (that prevent and/or slow the development of a targeted pathologic condition or disorder) and curative, therapeutic or disease-modifying treatment, including therapeutic measures that cure, slow down, lessen symptoms of, and/or halt progression of a diagnosed pathologic condition or disorder; and treatment of patients at risk of contracting a disease or suspected to have contracted a disease, as well as patients who are ill or have been diagnosed as suffering from a disease or medical condition. The term does not necessarily imply that a subject is treated until total recovery. The terms “treatment” and “treat” also refer to the maintenance and/or promotion of health in an individual not suffering from a disease but who may be susceptible to the development of an unhealthy condition. The terms “treatment,” “treat” and “to alleviate” are also intended to include the potentiation or otherwise enhancement of one or more primary prophylactic or therapeutic measure. The terms “treatment,” “treat” and “to alleviate” are further intended to include the dietary management of a disease or condition or the dietary management for prophylaxis or prevention a disease or condition. A treatment can be patient- or doctor-related.

(6) As used herein, an “effective amount” is an amount that prevents a deficiency, treats a disease or medical condition in an individual or, more generally, reduces symptoms, manages progression of the diseases or provides a nutritional, physiological, or medical benefit to the individual. The relative terms “improved,” “increased,” “enhanced” and the like refer to the effects of the composition comprising a salivating agent, a cooling agent and optionally a tingling agent (disclosed herein) relative to a composition lacking these agents but otherwise identical.

(7) “Animal” includes, but is not limited to, mammals, which includes but is not limited to, rodents, aquatic mammals, domestic animals such as dogs and cats, farm animals such as sheep, pigs, cows and horses, and humans. Where “animal,” “mammal” or a plural thereof is used, these terms also apply to any animal that is capable of the effect exhibited or intended to be exhibited by the context of the passage. As used herein, the term “patient” is understood to include an animal, especially a mammal, and more especially a human that is receiving or intended to receive treatment, as treatment is herein defined. While the terms “individual” and “patient” are often used herein to refer to a human, the present disclosure is not so limited. Accordingly, the terms “individual” and “patient” refer to any animal, mammal or human that can benefit from the treatment. In this regard, animals such as companion animals (i.e., dogs and cats) can suffer from dysphagia.

(8) An animal is considered “elderly” if it has surpassed the first two-thirds of the average expected lifespan in its country of origin, preferably more than the first three-quarters of the average expected lifespan in its country of origin, more preferred at least the first four-fifths of the average expected lifespan in its country of origin. The term “elderly” in the context of a human means an age from birth of at least 60 years, preferably above 63 years, more preferably above 65 years. An elderly cat or dog has an age from birth of at least about 7 years.

(9) As set forth above, the present inventors believe that a refreshing, thirst quenching solution that stimulates swallowing and salivation and increases fluid intake can avoid or mitigate dehydration in a dysphagic patient and/or treat dysphagia. Accordingly, an aspect of the present disclosure is a method comprising administering to an individual having dysphagia an effective amount of a composition comprising a salivating agent and a cooling agent in a weight ratio of 1:0.06 to 1:0.2, preferably 1:0.11 to 1:0.16. These salivating agent: cooling agent ratios provide a refreshing perception identified by physiological markers and do not impart any taste or olfactory perception, contrary to many alleged “cooling agents” which impart a taste or olfactory perception (usually a menthol-type note) and thereby limit the range of applications. In some embodiments, the composition is sugar free and comprises a sweetener (e.g., stevia).

(10) The formulation of the composition provides a refreshing experience to support adequate fluid intake in patients with dysphagia, who rely on thickened fluids for safe swallowing. In this regard, the physiological need of a refreshing sensory experience to support hydration has an outcome of impairment that is inadequate fluid intake, and thus the composition support refreshment by including citric acid; lemon flavor; and tingling, mouth wetting and cooling flavors.

(11) The mixture of citric acid, lemon flavor and tingling and cooling ingredients can provide a multi-sensory experience to dysphagia patients, specifically taste, aroma and trigeminal perception. This mix of ingredients has been tested in adults and demonstrated to moisten the mouth and deliver a cooling sensation, such that dysphagia patients perceive a stimulating, refreshing sensation that is well liked. Furthermore, the mixture can provide a balance of sweetness and sourness to offer a pleasurable and refreshing experience. Moreover, the combination of lemon and citric acid can deliver an intense sensation that amplifies the refreshment, such that dysphagia patients perceive a pleasurable and refreshing drinking experience that promotes good acceptance and supports adequate hydration, helping to meet their target fluid intake.

(12) “Refreshing” sensation has been described as “a complex perception similar to the one experienced during cool water drinking, and corresponding to the relief of unpleasant physical symptoms such as elevated body temperatures or mouth dryness” (Labbe et al. 2011). Sensory properties of foods and beverages that support the delivery of a refreshing sensation have been identified, and these are reflected in the choice of ingredients for the composition.

(13) The refreshing composition can be administered to an individual one or more times per day. In some embodiments, the composition is administered for a time period that is at least one week, preferably for at least one month; and at least one day per week, preferably at least two, three, four, five or six days per week, most preferably seven days per week.

(14) The dysphagia can be oral pharyngeal dysphagia. In some embodiments, the dysphagia is a consequence of at least one of surgery for oral cancer, surgery for throat cancer, a stroke, a brain injury, or a progressive neuromuscular disease, such as Parkinson's disease.

(15) The method can comprise identifying the individual as having dysphagia, e.g., before initial administration of the refreshing composition. The method can comprise identifying the dysphagic individual as having dehydration or being at risk of dehydration, e.g., before initial administration of the refreshing composition. Although dysphagic individuals are generally at risk of dehydration, some dysphagic individuals may have an even greater risk of dehydration than other dysphagic individuals. Non-limiting examples of dysphagic individuals who have a particularly increased risk of dehydration include elderly individuals; individuals with one or more of diabetes, dementia, fever (a body temperature of 38° C. or above), diarrhea, vomiting, or gastroenteritis (viral or bacterial); and individuals living at high altitudes (above about 2,500 meters), patient under chemotherapy or radiotherapy.

(16) A salivating agent is any agent that induces salivation or a salivating reflex (e.g., mouth watering, mouth wetting or mouth hydrating). Preferably the salivating agent is one or more organic acids selected from the group consisting of adipic, ascorbic, citric, fumaric, lactic, malic and tartaric acids. These compounds stimulate salivary glands and thus enhance salivary flow.

(17) A cooling agent is any agent that imparts a cooling sensation to the skin and mucous membranes of the body, particularly the mouth, nose, throat and gastrointestinal tract during consumption. Preferably the cooling agent is selected from the group consisting of menthol derivative compounds, acyclic and/or cyclic carboxamides, N-substituted paramenthane carboxamides, phosphine oxides, substituted p-menthanes, menthoxypropane, alpha-keto enamine derivatives, N-substituted p-menthane carboxamide, menthyl half acid ester derivatives, cubebol and mixtures thereof. In a particularly preferred embodiment, the cooling agent is a mixture comprising at least a menthol carboxamide compound.

(18) Optionally the refreshing composition further comprises a tingling agent. A tingling agent is any agent that triggers a trigeminal perception, preferably a plant extract from pepper, onion, garlic, radish, horseradish, mustard, chili pepper or ginger. Non-limiting examples of suitable tingling agents include jambu oleoresin or para cress (Spilanthes sp.) in which the active ingredient is spilanthol; Japanese pepper extract (Zanthoxylum peperitum), such as the ingredients known as saanshool-I, saanshool-II and sanshoamide; black pepper extract (Piper nigrum), including the active ingredients chavicine and piperine; Echinacea extract; Northern Prickly Ash extract; red pepper oleoresin; and mixtures thereof.

(19) The refreshing composition may further comprise a mixture of malic acid and citric acid to help provide an organoleptic balance between sweetness and acidity in the final product. In some embodiments, the composition further comprises a mucoadhesive agent such as hydroxypropylmethylcellulose (HPMC) and/or carboxymethylcellulose (CMC) to further enhance the salivating sensation after consumption. The composition may further comprise acidic fruity ingredients to provide fruity olfactory notes, for example pieces of acidic fruits such as citrus fruits, peach or grapefruit; the juice of such fruits; pulp of such fruits; or mixtures thereof.

(20) The refreshing composition can further comprise any number of optional additional ingredients, including conventional food additives, for example one or more proteins, carbohydrates, fats, acidulants, thickeners, buffers or agents for pH adjustment, chelating agents, colorants, emulsifiers, excipients, flavor agents, minerals, osmotic agents, a pharmaceutically acceptable carrier, preservatives, stabilizers, sugars, sweeteners, texturizers, vitamins and/or minerals. The optional ingredients can be added in any suitable amount.

(21) In a preferred embodiment, the refreshing composition is a powder. For example, the composition can be spray-dried, freeze-dried or subjected to any other procedure of drying known in the art. Additionally or alternatively, the composition can be made by dry mixing. Then the powder can be reconstituted with a liquid, for example water or milk, to form a refreshing beverage. The powder can be provided to the consumer in a container (e.g., a sealed container) for reconstitution in the container and/or for allowing the user to pour the powder from the container into a drinking receptacle in which the powder is reconstituted. Non-limiting examples of suitable containers include bags, boxes, cartons, bottles, or combinations thereof. Preferred containers include a sachet/stick pack, i.e., a small disposable pouch, typically of flexible film such as cellophane or paper, preferably capable of being torn open at one or both ends, and containing one serving of the composition.

(22) In an embodiment, the beverage resulting from reconstitution of the composition comprises the salivating agent and the cooling agent in a total amount of at least 3.0 wt. %, and in some embodiments at least 6.0 wt. %. Optionally the beverage can further comprise at least 1.3 wt. % of citric acid and at least 1.0 wt. % tingling agent. In some embodiments, the beverage comprises a flavorant, such as lemon flavor and/or lemon juice flavor.

(23) Preferably the beverage has a nectar consistency, i.e., a viscosity between 35-350 cP (e.g., 50-170 cP). In other embodiments, the viscosity is greater than 1,750 cP. In some embodiments, the beverage may be classified as Slightly Thick, Mildly Thick, Moderately Thick or Extremely thick according to the International Dysphagia Diet Standardization Initiative (IDDSI) criteria (September 2015).

(24) In an embodiment, the consumer can add the refreshing composition to a thickening or thin cohesive agent and a liquid (e.g., water or milk) to form a beverage at the point of consumption. As used herein, “at the point of consumption” means at the same venue where the refreshing composition is administered to and/or consumed by the individual having dysphagia (e.g., a building such as a home or a care facility) and within thirty minutes before consumption, preferably within fifteen minutes before consumption, more preferably within five minutes of consumption, most preferably within one minute before consumption. In an embodiment, the individual with dysphagia can add the refreshing composition to the thickening agent and the liquid before they consume the resultant beverage. In another embodiment, another person can add the refreshing composition to the thickening agent and the liquid and then administer the resultant beverage to the individual with impaired swallowing such as dysphagia.

(25) The manufacturer can provide a kit comprising a sachet comprising the refreshing composition comprising a salivating agent and a cooling agent, preferably in a weight ratio of 1:0.06 to 1:0.2. The kit can further comprise a thickening or thin cohesive agent, preferably in an additional sachet separate from the refreshing composition. The kit can be employed in the methods disclosed above, for example by the consumer adding the refreshing composition to the thickening or thin cohesive agent and a liquid (e.g., water or milk) to form a beverage at the point of consumption.

(26) In an embodiment, the manufacturer can include the thickening or thin cohesive agent with the refreshing composition and thus provide an agglomerated powder. For example, the manufacturer can package an agglomerated powder comprising the refreshing composition and the thickening or thin cohesive agent in a container such as a sachet/stick pack. In such an embodiment, the beverage can be made at the point of consumption by mere addition of liquid (e.g., water or milk).

(27) The thickening agent can be one or more of xanthan gum, guar gum (e.g., partially hydrolyzed guar gum), carrageenan, native starch, or modified starch. Additionally or alternatively, the thin cohesive agent can comprise a food grade biopolymer selected from the group consisting of botanical hydrocolloids, microbial hydrocolloids, animal hydrocolloids, algae hydrocolloids and combinations thereof. Non-limiting examples of suitable algae hydrocolloids include agar, carrageenan, alginate, and combinations thereof. Non-limiting examples of suitable microbial hydrocolloids are selected from the group consisting of xanthan gum, gellan gum, curdlan gum, and combinations thereof. Non-limiting examples of suitable botanical hydrocolloids include plant-extracted gums, plant-derived mucilages, and combinations thereof. Non-limiting examples of suitable plant-extracted gums include okra gum, konjac mannan, tara gum, locust bean gum, guar gum (e.g., partially hydrolyzed guar gum), fenugreek gum, tamarind gum, cassia gum, acacia gum, gum ghatti, pectins, cellulosics, tragacanth gum, karaya gum, and combinations thereof. Non-limiting examples of suitable plant-derived mucilages include kiwi fruit mucilage (e.g., mucilage is derived from the stem pith of kiwi fruit), cactus mucilage, chia seed mucilage, psyllium mucilage, mallow mucilage, flax seed mucilage, marshmallow mucilage, ribwort mucilage, mullein mucilage, cetraria mucilage, beta-glucan and combinations thereof.

(28) Another embodiment of the refreshing composition is a ready-to-drink beverage. A “ready to drink” beverage is a beverage in liquid form that can be consumed without further addition of liquid. For example, the composition may be a beverage in a can or other container which may be consumed upon opening the can or container without addition of any further ingredients. In some embodiments, the beverage is a gellified water that preferably comprises partially hydrolyzed guar gum. Preferably the ready-to-drink beverage is aseptic.

(29) Another embodiment of the refreshing composition is a frozen dessert on a stick.

(30) Another aspect of the present disclosure is a method of making a food or beverage composition for treating impaired swallowing such as dysphagia, for example a method of enhancing the refreshment of a thickened or thin cohesive beverage. Such methods comprise adding a salivating agent and a cooling agent in a weight ratio of 1:0.06 to 1:0.2, preferably 1:0.11 to 1:0.16, to a composition comprising one or more thickening or thin cohesive agents.

(31) The one or more thickening or thin cohesive agents can maintain elasticity and viscosity of the composition after exposure to pressure of tongue on soft and/or hard palate (e.g., xanthan), which is particularly appropriate for individuals with upper dysphagia; can lose elasticity and viscosity after exposure to pressure of tongue on soft and/or hard palate (e.g., native or modified starch from tapioca, corn, rice, other cereals, or potato), which is particularly appropriate for individuals with upper and lower dysphagia; or can maintain a minimum level of elasticity and viscosity after exposure to pressure of tongue on soft and/or hard palate (e.g., xanthan and starch/modified starch), which is particularly appropriate for individuals with upper dysphagia.

(32) In an embodiment, the one or more thickening agents comprise carrageenan and starch. For example, the beverage can comprise about 0.03 wt. % to about 0.05 wt. % carrageenan and about 1.5 wt. % to about 4.0 wt. % starch, preferably about 0.03 wt. % to about 0.05 wt. % carrageenan and about 1.7 wt. % to about 1.9 wt. % starch, more preferably about 0.04 wt. % carrageenan and about 1.8 wt. % starch.

(33) In an embodiment, the one or more thin cohesive agent comprise beta glucan. The composition can comprise beta-glucan in a concentration of from 0.01 wt % to 25 wt % capable of providing to the beverage: a shear viscosity of less than 200 mPas, when measured at a shear rate of 50s−1, a relaxation time, determined by a Capillary Breakup Extensional Rheometry (CaBER) experiment, of more than 10 ms (milliseconds) at a temperature of 20° C.

(34) For flavor, a sweetener such as a sugar or sugar substitute, e.g., maltodextrin or steviol, can be included with the thickening or thin cohesive agent.

EXAMPLES

(35) The following non-limiting examples support the concept of compositions and methods for improving hydration of individuals having dysphagia.

Example 1

(36) The table below has two example formulations. A flavour block formulation is a lemon-flavored refreshing blend in powder form that can be provided in a sachet/stick pack. The flavour block is used at the point of consumption by addition of the powder to another powder containing a thickening agent. For reconstitution into a beverage, water is also added. Another formulation involves the thickening agent being agglomerated with the lemon-flavored refreshing blend and present together in the sachet/stick pack such that only addition to water is needed to form a beverage at the point of consumption (“all-in-one”). The beverages have a nectar consistency.

(37) TABLE-US-00001 TABLE 1A All-in-one Flavour block (agglomerated) Water l,500 g 1,500 g Thickening Agent Powder 0 g 18 g Citric Acid 100% 2 g 2 g Lemon Juice flavor 1.5 g 1.5 g Tingling agent 1.5 g 1.5 g Sweetener 10.5 g 10.5 g Mouthwatering/cooling agent 4.5 g 4.5 g

(38) The table below has another flavour block formulation.

(39) TABLE-US-00002 TABLE 1B g per Portion g per 100 g Citric Acid 100% 0.13 8.030 Lemon flavor powder 0.08 4.950 Tingling agent powder 0.1 6.180 Cooling agent powder 0.3 18.541 Sweetener powder 1.0 61.805 Curcumin 0.008 0.494

Example 2

(40) The table below has a formulation that can be used to make ready-to-drink beverages that are gellified waters to be administered to and/or consumed by individuals having dysphagia.

(41) TABLE-US-00003 TABLE 2A Ingredient Amount Potassium Chloride 2 kg Calcium Citrate 4.2 kg Xanthan and Guar Gum 7.5 kg Sweetener 2 kg Carrageenan 110 kg Anhydrous Citric Acid 0.13 kg Colorants 1.05 kg Aroma 4.4 kg Partially Hydrolyzed Guar 400 kg Gum (PHGG) Tingling agent 10 kg Mouthwatering/cooling agent 30 kg

(42) The table below has another formulation that can be used to make ready-to-drink beverages that are gellified waters.

(43) TABLE-US-00004 TABLE 2B Ingredient Amount Potassium Hydroxide 0.0090 kg Calcium Citrate 0.0420 kg Xanthan and Guar Gum 0.0900 kg Sweetener 0.0225 kg Carrageenan 1.0000 kg Cooling Agent 0.1780 kg Non-Lemon Flavor (e.g., Peach) 0.1200 kg Lemon Flavor 0.0600 kg Partially Hydrolyzed 4.0000 kg Guar Gum (PHGG) Tingling agent 0.0560 kg Colorants 0.0075 kg

(44) It should be understood that various changes and modifications to the presently preferred embodiments described herein will be apparent to those skilled in the art. Such changes and modifications can be made without departing from the spirit and scope of the present subject matter and without diminishing its intended advantages. It is therefore intended that such changes and modifications be covered by the appended claims.