CN116471948A

CN116471948A - Food grade thickeners and methods for treating dysphagia

Info

Publication number: CN116471948A
Application number: CN202180072377.6A
Authority: CN
Inventors: M·崔斯特瑞姆; B·莫塞尔; S·克伊格雷
Original assignee: Trisco ICAP Pty Ltd
Current assignee: Trisco ICAP Pty Ltd
Priority date: 2020-09-28
Filing date: 2021-09-28
Publication date: 2023-07-21

Abstract

The present invention provides a method for providing a food grade thickener, the method comprising the steps of: establishing a water continuous phase of the first polysaccharide; adding a second polysaccharide to the continuous phase, thereby forming a gelled mixture; hydrolyzing the gelled mixture to reduce the viscosity of the gelled mixture; and adding the gum to the hydrolyzed gelled mixture under conditions such that the gum only partially expresses its viscosity, thereby forming the food grade thickener. The invention also relates to a method of treating a subject suffering from a chewing and/or swallowing disease, disorder or condition, the method comprising the step of administering to the subject a food, wherein the food comprises the food grade thickener of the present invention. The invention further relates to a storage and delivery system for a food grade thickener, the storage and delivery system comprising: a. ) A container containing the food grade thickener of the present invention; and b.) a pump dispenser sealingly attached to the container, wherein the dispenser comprises a valve for inhibiting or preventing drying of the composition in the container.

Description

Food grade thickeners and methods for treating dysphagia

Priority statement

The present invention claims priority from australian provisional patent applications 2020903490 and 2020903609, each of which is incorporated herein by reference in its entirety.

Technical Field

The present invention relates to a food grade thickener. In particular, the present invention relates to a stable liquid food grade thickener composition comprising a thickener and a viscosity inhibitor composition, wherein the food grade thickener is adapted to increase the viscosity of an aqueous liquid food. The food grade thickener maintains a relatively low viscosity in situ and, in turn, when diluted in an aqueous liquid food or aqueous liquid solid mixture food, the viscosity of the target food increases significantly over a relatively short period of time. Preferably, the viscosity of the food grade thickener of the present invention is released immediately upon dilution of the food grade thickener by allowing one or more of the components of the composition to fully express its viscosity increasing effect. The invention also provides the use of a food grade thickener for the treatment or amelioration or assistance of dysphagia, such as dysphagia and/or dysphagia. Finally, a storage and delivery system is provided, which is a particularly convenient method for delivering the food grade thickener of the present invention. However, it should be understood that the present invention is not limited to these particular fields of use.

Background

The following discussion of the prior art is provided to put the invention in a suitable technical context and to provide a more complete understanding of its advantages. It should be appreciated, however, that any discussion of the prior art throughout the specification should in no way be considered as an expression or suggestion that such prior art is well known or forms part of the common general knowledge in the field.

In the food industry, it is often desirable to add a viscosity enhancing agent to the food formulation to increase the viscosity of the final product. Examples of such end products include yogurt and desserts. It is also generally desirable to provide a viscous thickened liquid, particularly for the geriatric field of view and the rehabilitation market. Thickened liquids need to have a specific known and repeatable viscosity to be suitable for these markets.

Currently, these products are prepared in advance by mixing the food with a viscosity enhancing agent prior to packaging and providing the final thickened product that has been packaged. In some cases, the thickener is provided as a pre-mixed viscous emulsion or gel, which is then added to the food product to be thickened and stirred. It is often difficult to properly mix these gels into food products because the gels do not disperse easily and are prone to clumping, thereby producing a chunk-like end product.

The viscosity enhancing agent may also be provided in a powdered form for the end user to mix into the food product to be thickened. When these viscosity enhancers are dissolved in aqueous solutions, they typically limit the movement of water molecules and increase the viscosity significantly, from thickening to gel formation. This can present problems of non-uniformity in the incorporation of the powder and the possibility of incorporating air into the very thick product. Furthermore, the addition of powdered thickeners often results in a lumpy, inconsistent product, which would be unsafe or undesirable for eating, especially for elderly consumers or patients suffering from chewing and/or swallowing diseases, disorders or conditions, such as dysphagia.

The viscosity enhancing agent may also be added to the food as an aqueous solution or the like. One of the problems with this approach, however, is that the viscosity enhancing agent typically expresses its viscosity in solution, which makes it difficult to dispense the solution unless the concentration of the viscosity enhancing agent is low. This has an effect on the addition of the solution to the food, as the viscosity and concentration of the final product will be affected by the amount of solution added.

Furthermore, such solutions are often unstable and must be used or stored immediately. Thus, this type of composition is not typically prepared, stored or sold in this form, but is typically stored in a powdered form until immediately prior to use in producing a food product. In addition, dispensing powdered viscosity enhancers by volume, as measured using a cup, is inherently inaccurate due to variations in bulk density of the powder.

It is generally desirable to provide a viscous thickened liquid, particularly for the geriatric field of view and the rehabilitation market. Thickened liquids need to have a specific known and repeatable viscosity to be suitable for these markets. Many regulatory authorities have developed predetermined liquid viscosities that are considered to have clinically significant benefits in "slowing" swallowing in dysphagia patients, such that common co-diseases of the condition, such as aspiration pneumonia, are prevented. In view of the varying severity of dysphagia, the following professional guidelines are generally practiced clinically: slightly thick (nectar consistency); moderately thick (honey consistency); and extremely viscous (cloth Ding Choudu). These guidelines are typically associated with 150 mPa-s, 400 mPa-s and 900 mPa-s, respectively. These viscosity grades have now been contained in a relatively new international framework called IDDSI (international dysphagia dietary standardization initiative (International Dysphagia Diet Standardisation Initiative)) and are described as grade 1-slightly viscous, grade 2-slightly viscous, grade 3-medium viscous and grade 4-extremely viscous. The IDDSI framework describes not only the subjective attributes of four consistency classes, but also provides for objective testing (IDDSI flow testing) with a well-defined measurement range to ensure strict compliance with the consistency desired to be achieved. Non-compliance with these consistency parameters increases the risk of dysphagia in persons with dysphagia that may lead to the serious complications mentioned above and may lead to death in frail and elderly patients.

In view of the foregoing, there is a need for improved liquid food-grade thickener compositions that are stable and that can be added in situ to any hot or cold food to produce a thickened liquid food of known and repeatable viscosity that can be used, for example, to feed subjects suffering from chewing and/or swallowing disorders, such as dysphagia.

The inventors are aware of other prior art documents in the field of the present invention, such as JP 2007105018a (i.e. JP 2007) entitled "Highly thickener-containing formulation", which relates to the preparation of thickener compositions that can be used for thickening food.

JP2007 relates to the concept of providing a flowable thickener solution in which there is not enough free water to dissolve a high viscosity thickener (such as xanthan gum) so that it cannot express its complete viscosity in situ, but can express its viscosity quickly when added to an aqueous target food. This is accomplished by adding a high viscosity thickener to an aqueous solution in which low viscosity carboxymethylcellulose (CMC) and/or low viscosity alginate (referred to herein for convenience as a "viscosity inhibitor") is dissolved in water. By suppressing dissolution of the high viscosity thickener, the viscosity of the flowable thickener solution is kept low, and a thickened solution can be obtained when the flowable thickener solution is added to an aqueous target food. The flowable thickener solution disperses rapidly in the target food and rapidly develops viscosity.

In JP2007, the "high viscosity paste" (i.e., thickener) disclosed is: xanthan gum (xanthogen gum), guar gum (guar gum), locust bean gum (locustbean gum), tara gum (tara gum), tamarind gum (tamarind gum), karaya gum (karaya gum), pectin, carrageenan (karagean), gellan gum (gellan gum), alginate, modified starch and high viscosity CMC. The aqueous solution comprises a viscosity inhibitor which is a low viscosity CMC (2-12 wt%, preferably 4-10 wt%) or a low viscosity alginate (2-12 wt%, preferably 4-10 wt%).

JP2007 distinguishes low-viscosity CMC, e.g. less than 100 mPas, from high-viscosity CMC with 10% CMC aqueous solutions having a viscosity of 1000 mPas to 100000 mPas. Example 1 used CMC with a viscosity of 18 mPas (10%, 20 ℃,30rpm type B viscometer), and examples 2 to 5 used sodium alginate with a viscosity of 32.8 mPas (10%, 20 ℃,30rpm type B viscometer). In these examples, when the high viscosity thickener is added to an aqueous solution having a viscosity inhibitor, the resulting viscosity is in the range of 750 mPa-s to 2,100 mPa-s, and when the flowable thickener solution is mixed with 20: when added to a target food at a ratio of 80wt.%, the viscosity is in the range of 2,800 mpa-s to 3,900 mpa-s.

Applicants have attempted to replicate the work disclosed in JP2007 and have surprisingly found that it is not possible to formulate food grade flowable thickener solutions, although JP2007 states that the flowable thickener solutions disclosed therein are food grade thickeners. Thus, in light of the teachings of the present prior art, applicants are unable to formulate food grade flowable thickener solutions that can aid in the treatment of chewing and/or swallowing diseases, disorders or conditions. The applicant hypothesizes that although JP2007 indicates that the resulting flowable thickener solution is food grade, in fact, the viscosity inhibitors utilized in the examples in JP2007 are not food grade, and thus, no disclosure of providing a food grade flowable thickener solution is achieved in JP 2007. In particular, the applicant speculates that the inventors of JP2007 procured industrial grade viscosity inhibitors, rather than food grade viscosity inhibitors, particularly because it is known that the apparent viscosity of industrial grade CMC sodium is lower than that of food grade. This understanding seems to be consistent with the fact that the applicant of JP2007 did not commercialize the product, which suggests that it does not meet the stringent and strict food-grade standards required for this kind of product around the world.

For further explanation, applicants purchased a range of food grade CMC sodium, and found that the lowest molecular weight food grade (i.e., 10,000 daltons) that could be purchased provided a viscosity of 2000cPs in a 10% solution. In contrast, JP2007 describes a sodium CMC for a 10% solution with a viscosity of 18 cPs. This is an important contributor to the differences that applicant has disclosed between JP2007 and the present invention, as will be explained further below. It is also well known that the viscosity of CMC solutions increases rapidly with concentration. The "thumb rule" is that when the concentration is doubled, the viscosity increases 8-to 10-fold, so that a viscosity of 18cPs at 10% solution is not feasible. The use of the lowest viscosity food grade CMC sodium available for the method of JP2007 creates a viscosity that is too high to be flowable or pumpable and will not be readily dispersed in the target food. Additional comparative experimental data can be seen in the experimental section below. For the sake of completeness, it is noted that the applicant has utilized Silverson mixers with universal stators, which are considered equivalent to the "Dispermix" disclosed in JP2007, and thus the differences found by the applicant from this prior art are not merely due to the mixing conditions or the equipment used to prepare the formations discussed herein.

In summary, as further shown in the experimental section below, when food grade ingredients are used in the teachings of JP2007, the produced composition is not flowable, pumpable and/or dispersible in aqueous foods. Thus, the composition of JP2007 is composed of ingredients that are not food grade and thus is not suitable for treating subjects suffering from dysphagia.

Despite what is asserted in JP2007, no food grade thickener is produced in the document. The present invention is an improvement over the prior art in that applicant has been able to prepare thickener solutions that are flowable, pumpable, readily dispersible in the aqueous food of interest, and are food grade, and thus can assist in the treatment of subjects suffering from dysphagia.

What is needed is a method for producing a food grade thickener (using food grade ingredients) that addresses one or more of the following objectives of the present invention. As disclosed herein, applicants have been able to formulate food grade thickeners that exhibit patentable improvements over JP 2007.

It is an object of the present invention to overcome or ameliorate one or more of the disadvantages of the prior art, or at least to provide a useful alternative.

It is an object of a preferred embodiment of the present invention to provide a food grade thickener solution that is flowable and pumpable and dispersible into an aqueous liquid such that the thickened liquid is homogeneous and food grade.

It is an object of further preferred embodiments of the present invention to provide a food grade thickener which also has one or more of the following advantages: is homogeneous (i.e., does not contain undispersed thickener agglomerations or domains); has a sufficient hydration rate so that peak viscosity is reached in a short time frame (i.e., about 30-60 seconds) at low shear (i.e., 30-80BPM with fork/spoon); capable of withstanding shear when delivered with a food-grade pump; no separation or no significant separation was shown over time; is clear/transparent (i.e., imparts little or no color to the target food); and have little or no odor and/or are sufficiently highly concentrated so that relatively little additions can safely change texture without compromising the taste or other desirable attributes of the target food to be thickened.

Disclosure of Invention

According to a first aspect, the present invention provides a method for providing a food grade thickener, the method comprising the steps of:

Providing an aqueous phase;

adding a polysaccharide to the aqueous phase, thereby forming a gelled mixture;

hydrolyzing the gelled mixture to reduce the viscosity of the gelled mixture; and

the gum is added to the hydrolyzed gelled mixture under conditions such that the gum only partially expresses its viscosity, thereby forming the food grade thickener.

In one embodiment, the aqueous phase comprises water, and a polysaccharide (i.e., a first polysaccharide and/or a second polysaccharide as discussed below) is added to the aqueous phase. In another embodiment, a water continuous phase is first established with a first polysaccharide, and a second polysaccharide is added to the water continuous phase to thereby form the gelled mixture.

According to a first aspect, the invention essentially comprises a viscosity inhibitor composition to which a thickener in the form of a gum is added, wherein the viscosity inhibitor composition is formulated such that the gum only partially expresses its viscosity.

The present invention is a significant advancement over the prior art. In some embodiments, in an initial step, the present invention provides an aqueous continuous phase of a first polysaccharide, and then a gelled mixture is formed within the aqueous continuous phase using a second polysaccharide. The gelled aqueous continuous phase is then hydrolyzed to obtain a predetermined viscosity. The hydrolysis conditions are preferably about 80-90 ℃ for a period of time less than 20 hours, but may be shorter or longer than this preferred time and/or at a temperature higher or lower than this preferred temperature range. Preferably, one or more of the steps of the method are performed under low shear conditions, as opposed to prior art techniques that use high shear conditions, as will be further explained below. In a final step, a sufficient amount of gum, such as xanthan gum, is added to the hydrolyzed continuous phase at a concentration of preferably about 4wt.% to 8wt.% to produce a suspension or dispersion of xanthan gum in the hydrolyzed continuous phase to produce an apparent viscosity of about 4,000cp measured at 5RPM using a brookfield viscometer (Brookfield viscometer) spindle number 3 at 20 ℃. The food grade thickener should preferably resist separation of the components of the composition and in turn remain thixotropic and resist shear deformation so as to be dispersible by the delivery pump and retain the ability to rapidly thicken the target food.

Applicants have found that the inventive methods disclosed herein provide control over the "cohesiveness" and "adhesiveness" of what is understood as a thickener system, which are related to the pumpability and pourability of the food grade thickener of the present invention. The "cohesiveness" and "adhesiveness" parameters were measured by the following tests:

·cohesive property-an apparent viscosity of substantially less than about 5,000cps measured at 5RPM using a brookfield viscometer spindle No. 3 at 20 ℃; and

adhesion greater than about 15cm of resistance to flow at 20 ℃ for 30 seconds as measured using a Bostwick consistometer.

It should be understood that other methods may be used to measure the "cohesiveness" and "adhesiveness" parameters of the system or their equivalents.

It has been found that viscosity measurements alone do not provide adequate characterization of the system under investigation. However, the food grade thickeners of the present invention that are prepared to meet these criteria are flowable and pumpable and dispersible into aqueous foods. The food grade thickener of the present invention is also homogenous and does not impart any additional inhomogeneity to the aqueous food to which it is combined. Without wishing to be bound by any theory, the second polysaccharide is initially "tempered" (temper) by the method and has a tertiary structure to accommodate the gum and allow it to hydrate only slightly and allow for the desired cohesive/adhesive properties to be achieved. Utilizing the combination of the first polysaccharides to initially prepare the continuous phase into which the second polysaccharides are dispersed forms a gelled network, and then hydrolyzing the gelled network of the combined polysaccharides appears to disrupt the chemical bonds of the network in such a way as to allow the gum to only partially hydrate upon addition, thereby inhibiting its viscosity expression.

The applicant has found that the step of first establishing an aqueous continuous phase of a first polysaccharide and then second adding a second polysaccharide to the continuous phase, thereby forming a gelled mixture, and then hydrolyzing the gelled mixture to reduce the viscosity of the gelled mixture to a predetermined range, results in a food grade thickener (e.g. comprising gum) of the present invention having one or more, and in particularly preferred embodiments a plurality of, and in some preferred embodiments all, of the following advantageous properties: is homogeneous (i.e., does not contain undispersed thickener agglomerations or domains); has a sufficient hydration rate so that peak viscosity is reached in a short time frame (i.e., about 30-60 seconds) at low shear (i.e., 30-150BPM with fork/spoon); capable of withstanding shear (i.e., non-newtonian/thixotropic fluids) when delivered with a food grade pump; does not separate over time; clear/transparent (i.e., little or no color) in the target food; and no smell and/or taste, so that no flavor is imparted to the target food to be thickened. The specific steps of the present invention are not predicted or even implied in JP2007 and enable the production of food grade thickeners that cannot be produced by this prior art document. For at least the reasons stated above, the food grade thickener of this invention is an improvement over commercially available products.

As will be shown below, the prior art does not show an apparent viscosity of less than 5000cPs, which is representative of the preferred cohesive properties and is related to dispersibility, as compared to the inventive thickener compositions described herein.

Furthermore, the prior art does not show a resistance to flow of greater than about 15cm measured at 20 ℃ using a Bostwick consistometer at 30 seconds, which is representative of the preferred adhesion properties, in relation to pumpability.

First polysaccharide

In some embodiments, in the first step of the method of the invention, an aqueous continuous phase of the first polysaccharide is established. The first polysaccharide may be a single polysaccharide or a plurality of polysaccharides. The first polysaccharide may be selected from the group consisting of: agar, alginic acid, carrageenan, guar gum, gum tragacanth (gum tragacanth), gum ghatti (gum ghatti), microcrystalline cellulose, sodium carboxymethyl cellulose, methyl cellulose, hydroxypropyl cellulose, methyl ethyl cellulose, karaya gum, locust bean gum, tara gum, psyllium seed gum (psyllium seed gum), quince seed gum (quince seed gum), pectin, furcellaran (furcellelan), gellan gum, konjac, sodium alginate, xanthan gum, and any combination thereof. It should be understood that whatever the first polysaccharide is used, it is food grade. It will be appreciated that some polysaccharides may be modified prior to use, for example, they may be modified to have a higher or lower molecular weight, or to have a different viscosity. In some embodiments, the polysaccharide may also be modified to adjust the gelation temperature. In some embodiments, the gelation temperature is adjusted to 10 ℃ to 100 ℃, or 20 ℃ to 100 ℃, or 30 ℃ to 50 ℃, or 40 ℃ to 60 ℃, or 50 ℃ to 70 ℃, or 60 ℃ to 80 ℃, or 70 ℃ to 90 ℃, or 80 ℃ to 95 ℃, or 90 ℃ to 100 ℃. In one embodiment, the gelling temperature may be modified by the addition of gelling cations. In some embodiments, the polysaccharide may be modified to have lower or higher acylation, or used in a low acyl or high acyl form. It is understood that low acyl refers to a polysaccharide that has been partially deacylated (degree of acylation between 1% and 50%) or fully deacylated (degree of acylation less than 1%), and high acyl refers to a polysaccharide that contains a relatively high number of acyl substituents, e.g., greater than 50% acylated.

To establish the water continuous phase, in a preferred embodiment, the pH of the water is adjusted to pH 3-4 with a food grade acidulant. Any food grade acidulant may be used, but in one embodiment, glucono-delta-lactone (GDL) is used. The first polysaccharide is then added to the acidified water and mixed for incorporation, preferably under high shear conditions. In preferred embodiments, the concentration of the first polysaccharide is 0.01wt.%, or 0.01wt.% to 0.06wt.% or ratio is 1:50 to 1:100. However, it should be understood that other concentrations may be used, such as 0.002wt.%, 0.004wt.%, 0.006wt.%, 0.008wt.%, 0.010wt.%, 0.012wt.%, 0.016wt.%, 0.018wt.%, 0.04wt.%, 0.06wt.%, 0.08wt.%, 0.10wt.%, 0.2wt.%, 0.4wt.%, 0.6wt.%, 0.8wt.%, 1.0wt.%. It will also be appreciated that the concentration used in this step may vary based on the particular first polysaccharide and gelling cation concentration used.

In some embodiments, after the first polysaccharide has been dispersed in the acidified water, gelling cations and optionally one or more preservatives may be added. A suitable gelling cation is 0.001wt% CaCl ₂ . However, it should be understood that other gelling cations may be used at different concentrations. The use of gelling cations may provide additional stability to the final food grade thickener and may help avoid separation of the food grade thickener over time. A suitable preservative is potassium sorbate, which can be incorporated at about 1000 ppm. However, it should be understood that other preservatives may be used at different concentrations.

Preferably, the solution is then heated to "melt" the first polysaccharide and establish a water continuous phase comprising the first polysaccharide. In some embodiments, the solution is heated to a setting temperature of the first polysaccharide. In some embodiments, the solution is heated to the melting temperature of the first polysaccharide. In some embodiments, the solution is heated to between the set temperature and the melting temperature. In other embodiments, the first polysaccharide is heated to a temperature well above one of the setting temperature and the melting temperature. In a preferred embodiment, the solution is heated to 60 ℃, 65 ℃, 70 ℃, 71 ℃, 72 ℃, 73 ℃, 74 ℃, 75 ℃, 76 ℃, 77 ℃, 78 ℃, 79 ℃, 80 ℃, 81 ℃, 82 ℃, 83 ℃, 84 ℃, 85 ℃, 86 ℃, 87 ℃, 88 ℃, 89 ℃, 90 ℃, 91 ℃, 92 ℃, 93 ℃, 94 ℃, 95 ℃, 96 ℃, 97 ℃, 98 ℃, 99 ℃, or 99.5 ℃. It is understood that divalent cations are more effective in promoting the gelation of some polysaccharides than monovalent ions. It is also understood that the gelation temperature and sizing temperature of some polysaccharides may increase with cation concentration.

Second polysaccharide

In a further step of the method of the invention, a second polysaccharide is added to the continuous phase to thereby form a gelled mixture. In some embodiments of the invention, the second polysaccharide comprises one or more materials selected from the group consisting of: agar, alginic acid, carrageenan, guar gum, tragacanth, gellan gum, microcrystalline cellulose, sodium carboxymethyl cellulose, methyl cellulose, hydroxypropyl cellulose, methyl ethyl cellulose, karaya gum, locust bean gum, tara gum, psyllium seed gum, quince seed gum, pectin, furcellaran, gellan gum, konjak, sodium alginate and xanthan gum. In some embodiments of the invention, the second polysaccharide comprises one or more materials selected from the group consisting of: microcrystalline cellulose, sodium carboxymethyl cellulose, methyl cellulose, hydroxypropyl cellulose, and methyl ethyl cellulose.

In some preferred embodiments of the invention, the second polysaccharide is sodium carboxymethyl cellulose (CMC). In some preferred embodiments of the invention, the second polysaccharide is sodium CMC of low molecular weight. Preferably the molecular weight is in the range of 5,000 daltons to 10,000 daltons, 10,000 daltons to 15,000 daltons, 15,000 daltons to 20,000 daltons, 20,000 daltons to 25,000 daltons or 25,000 daltons to 30,000 daltons. In some preferred embodiments, the second polysaccharide is a mixture of low molecular weight CMC sodium. In this embodiment of the invention, the first sodium CMC and the second sodium CMC are used in a ratio of about 1:1. However, it should be appreciated that other ratios may be suitable, such as 10:1, 9:1, 8:1, 7:1, 6:1, 5:1, 4:1, 3:1, 2:1, 1:1, 1:2, 1:3, 1:4, 1:5, 1:6, 1:7, 1:8, 1:9, 1:10. It should be appreciated that the first CMC sodium and the second CMC sodium are food grade.

In some embodiments of the present invention, a sufficient amount of the second polysaccharide is added to the aqueous continuous phase to achieve a target concentration of about 3wt.% to 5 wt.%. However, it should be understood that a range of concentrations may be used, such as 0.5%, 1%, 2%, 3%, 4%, 5%, 6%, 7%, 8%, 9%, 10%, 11%, 12%, 13%, 14%, 15%, 16%, 17%, 18%, 19%, 20%, 21%, 22%, 23%, 24%, 25%, 26%, 27%, 28%, 29% or 30% or any other concentration therebetween. It will also be appreciated that the concentration used in this step may vary based on the particular polysaccharide and polysaccharide used.

It is understood that the products on the market do not use a combination of polysaccharides with different properties. The applicant has found that the use of a combination of polysaccharides can enable fine tuning of the properties of the gelled mixture to achieve a final target concentrate having the desired apparent viscosity (brookfield) and resistance to flow (Bostwick), as well as pumpability and properties such as clarity and dispersibility. It is known that the molecular weight and degree of substitution (DOS) of polysaccharide molecules have a major impact on solution properties. In general, as DOS increases, the clarity of the solution increases, so does the stability, however interactions (via hydrogen bonding) and thixotropic properties may decrease. There is also a competing effect due to molecular weight.

It is desirable to obtain advantageous properties from both the high molecular weight form of the polysaccharide and the low molecular weight form of the polysaccharide. For example, stability and clarity often from the use of high molecular weight polysaccharides are preferred, and almost newtonian behavior (thixotropic) of the continuous phase is preferred, which is oftenCharacteristics of polysaccharide in low molecular weight form. Almost newtonian behaviour is preferred, otherwise it is difficult to introduce sufficient gum and it is also difficult to achieve pumpability, flowability, dispersibility and stability properties over time. When the food grade thickener undergoes shear in the pumping process, the viscosity (resistance to flow) will decrease, which may affect the gum, thus affecting the time that may be required to express its viscosity when added to the target food, and negatively affecting the utility of the food grade thickener of the present invention. A preferred objective of the food grade thickener of the present invention is to provide an International Dysphagia Diet Standardization Initiative (IDDSI) of < 30 seconds. The IDDSI framework consists of 8 consecutive levels (0-7). The levels are identified by numbers, text labels, and color codes. (see also for additional information and details regarding IDDSI frameworkshttps：//iddsi.org/)。

As used herein, the term polysaccharide includes synthetic polysaccharides, naturally occurring polysaccharides, polysaccharide fragments, and any combination thereof. The synthetic polysaccharide is selected from the group consisting of: microcrystalline cellulose, sodium carboxymethyl cellulose, methyl cellulose, hydroxypropyl cellulose, methyl ethyl cellulose, polyvinylpyrrolidone (PVP), carboxyvinyl polymer, methyl vinyl ether, maleic anhydride polymer, ethylene oxide polymer, and any combination thereof. The naturally occurring polysaccharide is selected from the group consisting of: scleroglucan, dextran, elsinan, levan, alternan, inulin, glycooligosaccharide, acacia polysaccharide extract (Acacia tree polysaccharide extract), arabinoxylan (arabinoxylan), curdlan (curdlan), larch polysaccharide extract (Larix occidentalis polysaccharide extract), larch polysaccharide extract (Larix laricina polysaccharide extract), european larch polysaccharide extract (Larix decidua polysaccharide extract), siberian larch polysaccharide extract (Larix sibirica polysaccharide extract), and any combination thereof. The polysaccharide fragment is selected from the group consisting of: pullulan segments, soybean polysaccharide segments, arabinogalactan segments, acacia segments, agar segments, alginic acid segments, carrageenan segments, guar gum segments, tragacanth segments, geon segments, karaya segments, locust bean gum segments, tara gum segments, psyllium seed gum segments, quince seed gum segments, pectin segments, furcellaran segments, gellan gum segments, konjak segments, sodium carboxymethylcellulose segments, sodium alginate segments, xanthan gum segments, and any combination thereof. Also within the scope of the invention is the use of an ionic polysaccharide selected from the group consisting of: sodium alginate fraction, xanthan fraction, pectin fraction, gellan gum fraction, karaya gum fraction, tragacanth gum fraction, sodium carboxymethylcellulose fraction, and any combination thereof.

In the synthesis of synthetic polysaccharides, it will be appreciated that the degree of polymerization of the synthetic polysaccharide, and thus the polymer chain length, may be predetermined or controlled, at least to some extent. Thus, such synthetic polysaccharides may be tailored according to the exact functional requirements desired for the food grade thickener of this invention (e.g., its ability to adequately inhibit the viscosity imparted by the thickener).

The polysaccharide fragments described herein may be produced by any method known in the art. For example, naturally occurring polysaccharides of high average molecular weight (e.g., greater than 500,000) and thus high viscosity can be reduced to their lower average molecular weight fragments (e.g., less than 500000) and thus lower viscosity by hydrolysis (e.g., acid hydrolysis). Any food grade acid such as citric acid, hydrochloric acid, malic acid, tartaric acid, acetic acid, lactic acid, and the like may be used at a concentration sufficient to achieve a pH below 4, preferably between 1.0 and 3.0, and may be heated to about 60 ℃ to about 120 ℃, preferably about 80 ℃ to about 100 ℃, for about 5 hours to 6 hours, preferably 2 hours to 3 hours, until the desired level of hydrolysis is reached. High pressures, such as those above 1 atmosphere, may be used to accelerate the hydrolysis rate and thus reduce overall processing time.

Alternatively, the polysaccharide fragments described herein may be produced by enzymatic digestion of a larger starting polysaccharide. Naturally occurring polysaccharides contain in their basic structure sugars (e.g., glucose, fructose, mannose, arabinose, galactose, rhamnose, glucuronic acid, galacturonic acid, xylose) linked together by various types of glycosidic linkages that are capable of being hydrolyzed by various specific enzymes. It will be appreciated by those skilled in the art that the particular enzyme required to digest the starting polysaccharide will generally depend on the particular sugar/sugar linkage targeted for hydrolysis and thus determine the degree of molecular weight reduction. In addition, the optimal conditions for achieving the most efficient degree of hydrolysis are also specific to the enzyme in question and the type of glycosidic bond that the enzyme can hydrolyze.

The size of the polysaccharide fragment will typically be a function of various factors such as the desire for smaller polysaccharides that conveniently adapt to the inhibition of viscosity imparted by the thickener of the food grade thickener. In specific embodiments, the polysaccharide fragment comprises at least about 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80, 85, 90, 95, 100, 110, 120, 130, 140, 150, 160, 170, 180, 190, 200, 225, 250, 275, 300, 325, 350, 375, 400, 425, 450, 475, 500, 550, 600, 650, 700, 750, 800, 850, 900, 950, 1000, 1050, 1100, 1150, 1200, 1250, 1300, 1350, 1400, 1450, 1550, 1600, 1650, 1750, 1800, 1850, 2000, 1700, 2200, 2150, 245, 50, 2500, or any of the ranges of the larger starting polysaccharides.

Another way to classify cellulosic polysaccharides is by the amount of viscosity that it can produce for a given concentration. This can be explained below with reference to sodium carboxymethyl cellulose (CMC), but applies equally to all cellulose polysaccharides. Sodium carboxymethyl cellulose (CMC) can be classified according to the viscosity fraction produced by a solution of a certain concentration (typically 2 w/w%) into the following groups:

high viscosity CMC-with average molecular weight >250000 for 2w/w% solution from 50000Pa.s to 8000 Pa.s, DP >1000

Medium viscosity CMC-with an average molecular weight of 175000-250000 for 2w/w% solution of 8000Pa.s to 800mPa.s, DP 750-1000

Low viscosity CMC-100-800 mPa.s for 2w/w% solution, DP 500-750, average molecular weight 175000-125000, and

ultralow viscosity CMC-100-1 mPa.s for a 2w/w% solution, DP < 500, average molecular weight < 125000.

There is a relationship between the viscosity of a 2w/w% solution of CMC and its degree of polymerization (and thus its molecular weight), so it is equally effective to specify the viscosity-inhibiting ability of CMC (and indeed all cellulose polysaccharides) by the effective range of 2% solutions of said CMC. Low viscosity CMC, medium viscosity CMC and high viscosity CMC produce 2% solution viscosity that is too high to produce a flowable liquid thickener solution. Instead, it produces a viscous and non-flowable paste that is difficult to disperse into liquid food products. Fig. 5 shows typical viscosity versus concentration spectra for the four CMC gums described above.

The food grade thickeners provided herein may include one or more polysaccharides comprising synthetic polysaccharides, naturally occurring polysaccharides, polysaccharide fragments, and/or ionic polysaccharides. For example, food grade thickeners may include 1, 2, 3, 4, 5, or more polysaccharides, such as those described herein.

Mixing a second polysaccharide into the continuous phase, thereby forming a gelled mixture

In a preferred embodiment, the second polysaccharide is mixed into the continuous phase under low shear conditions to dissolve the second polysaccharide and form a gelled mixture. Suitable mixing speeds are from 10rpm to 200rpm. However, it should be understood that a variety of devices may be used and that a variety of mixing speeds may be employed. This is preferred if the shear conditions are minimized or kept low. This is in contrast to the prior art, which uses rotor stators understood to be 2000rpm, using high mixing speeds and/or high shear conditions. The use of high mixing speeds and/or high shear conditions may express excessive viscosity from the second polysaccharide, which will increase the apparent viscosity above the target of about 4000cPs to 5000cPs for the food grade thickeners of the present invention, and an irreversible viscosity and/or rheology change for the system. As discussed further below, it is preferred for the food grade thickener of this invention to have an apparent viscosity of about 4000cPs to 5000cPs, which provides rapid dispersion in the target food.

As can be seen in fig. 2, incorporation of polysaccharides under high shear conditions may reduce the clarity of the composition. Fig. 2a shows CMC solutions incorporated using low shear mixing (10-200 rpm) and subsequently hydrolyzed for 0 hours, 8 hours, 10 hours, 12 hours and 14 hours. The text on the back of the label can be clearly seen through the solution, indicating that its clarity is almost the same as water. In contrast, FIG. 2b shows CMC solutions incorporated using high shear mixing (7600-10200 rpm) and subsequently hydrolyzed for 0, 12, 24, 36 and 48 hours. These images clearly show that the clarity of the solutions of fig. 2a is higher than those of fig. 2 b. The text on the back of the label can only be seen through the solution (T-0), indicating that the clarity of the solution is almost the same as water, but for other experiments the solution is completely or substantially opaque.

It will be appreciated that the method of dissolving the second polysaccharide and the degree of agitation (shearing) during dissolution may affect the final viscosity of the food grade thickener of the present invention. In addition, the solvent, the chemical composition of the second polysaccharide, and/or the shear history of the final solution may affect the dissolution characteristics of the second polysaccharide.

Hydrolysis stage

In a further step of the preferred form of the process of the invention, the gelled mixture is hydrolysed to reduce the viscosity of the gelled mixture. The skilled artisan will appreciate that various methods may be used to hydrolyze the gelled mixture. However, in a preferred embodiment, the temperature of the gelled mixture is preferably increased to about 95 ℃, or to about 90 ℃, or to just 90 ℃, or to 89 ℃, 88 ℃, 87 ℃, 86 ℃, 85 ℃, 84 ℃, 83 ℃, 82 ℃, 81 ℃, 80 ℃, 75 ℃, 70 ℃, 65 ℃, 60 ℃, 55 ℃, or 50 ℃. In some preferred embodiments, the gelled mixture is maintained at the temperature for a period of 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, 9 hours, 10 hours, 11 hours, 12 hours, 13 hours, 14 hours, 15 hours, 16 hours, 17 hours, 18 hours, 19 hours, 20 hours, 21 hours, 22 hours, 23 hours, 24 hours, 36 hours, 48 hours, 60 hours, or 72 hours or any time therebetween.

In a preferred embodiment, the hydrolysis stage is carried out for a sufficient time and at a sufficient temperature such that the viscosity is reduced to a predetermined viscosity, preferably in the range of about 80-90cPs (measured at 20 ℃ using a spindle 1 brookfield rotational viscometer at 10 rpm). In other preferred embodiments, the viscosity is in the range of 40-50, 50-60, 60-70, 70-80, 80-90, 90-100, 100-110, 110-120, 120-130, 130-140, or 140-150 cP. Typically, the gelled mixture has a viscosity of about 250-300cPs (measured at 20 ℃ using a spindle 3 brookfield rotational viscometer at 20 rpm), which means that the hydrolysis stage provides a viscosity reduction of about 50%, but can be performed to provide a reduction of 20%, 30%, 40%, 50%, 60%, 70%, 80% or 90% in viscosity. It will be appreciated that the viscosity of the gelled mixture may be above or below about 250-300cPs, and that the hydrolysis stage may be carried out such that a target viscosity of about 60-120cPs is preferably achieved, regardless of the initial viscosity of the gelled mixture.

In a preferred embodiment of the invention, the precondition is that the hydrolyzed material does not precipitate and recover, and then the recovered material is used to create a continuous phase to which gum is added.

It will be appreciated that this is a convenient point in the process of the present invention to provide other food grade additives to the hydrolysed gelled mixture, for example to adjust the pH and add preservatives.

Another potential method for hydrolyzing the second polysaccharide is by enzymatic hydrolysis. There are many enzymes that can cleave specific bonds in polysaccharide molecules. When cleaved by the action of these enzymes, polysaccharides effectively reduce their molecular weight to smaller molecules that bind water and limit its movement, that is, potentially less effective in reducing the apparent viscosity that the polysaccharide can express. Table 1 below shows enzymes capable of cleaving various food polysaccharides.

Table 1: polysaccharides having enzymes capable of hydrolyzing them:

the optimal conditions for enzymatic hydrolysis are different for each enzyme, but are well known to those skilled in the art. The person skilled in the art can select optimal conditions for enzymatic hydrolysis and can monitor the progress of the hydrolysis reaction by monitoring the decrease in viscosity of the polysaccharide solution. Generally, at least a 2-fold reduction in viscosity, typically at least a 3-fold reduction, and potentially up to a 5-fold or 7-fold reduction in viscosity will be observed.

Glue addition

Preferably, the conditions of the hydrolysed gelled mixture are such that the gum expresses its viscosity only partially. In a preferred embodiment, about 4wt.% to 8wt.% of gum is added. It is understood that other concentrations may be used, such as 2wt.%, 3wt.%, 4wt.%, 5wt.%, 6wt.%, 7wt.%, 8wt.%, 9wt.%, 10wt.%, 11wt.%, 12wt.%, 13wt.%, 14wt.%, 15wt.%, 16wt.%, 17wt.%, 18wt.%, 19wt.%, 20wt.%, 21wt.%, 22wt.%, 23wt.%, 24wt.%, 25wt.%, 26wt.%, 27wt.%, 28wt.%, 29wt.%, or 30wt.%.

Preferably, the gum is added to the hydrolyzed gelled mixture under low shear conditions and is incorporated to partially hydrate the gum. Suitable mixing speeds are 10-200rpm. However, it should be understood that a variety of mixing speeds may be employed, which may include low shear conditions to achieve a target final viscosity of about 4000cPs to 5000 cPs.

Without wishing to be bound by theory, the method of the present invention appears to provide optimal tertiary and quaternary structure of the polysaccharide that limits the extent of glue hydration, thereby providing shear resistance or shear resistance during pumping, but at the same time allowing for promotion of rapid dispersion in the target food and allowing the peak viscosity of the glue to be reached under gentle agitation conditions, e.g., 100-150BPM for 30 seconds.

Glue and thickener

According to the method of the invention, gum is added to the hydrolyzed gelled mixture. It should be understood that the terms "gum" and "thickener" are used interchangeably herein. In one embodiment, a single gum is added to the hydrolyzed gelled mixture. However, it should be understood that one or more gums may be added. The glue may be selected from the group consisting of: agar, alginic acid, carrageenan, guar gum, tragacanth gum, gellan gum, microcrystalline cellulose, sodium carboxymethyl cellulose, methyl cellulose, hydroxypropyl cellulose, methyl ethyl cellulose, karaya gum, locust bean gum, tara gum, psyllium seed gum, quince seed gum, pectin, furcellaran, gellan gum, konjak, sodium alginate, galactomannans (coumarone, guar gum, tara gum and locust bean gum), xanthan gum, and any combination thereof.

In some embodiments, the glue is selected from the group consisting of: alginic acid, xanthan gum, sodium carboxymethyl cellulose, pectin, gellan gum, karaya gum, tragacanth gum, and any combination thereof.

An aspect of the invention is that the gum is included in an amount such that the viscosity of the food grade thickener is lower than the viscosity of the food grade thickener comprising only the gum.

Preferably, the gelled continuous phase resulting from the combined action of the first and second polysaccharides that have been hydrolysed enables the addition of gums such that the viscosity of the food grade thickener is at least 50%, 40%, 30%, 20%, 10% or 5% of the viscosity of the composition comprising only the gums.

The ability of thickeners, such as those described herein, to increase the viscosity of an aqueous solution is generally determined at least in part by its ability to bind to water molecules and/or to unfold from a rigid crystalline structure into an entangled random polymer chain network that can form strong and weak associations that resist movement of water. The barrier to free movement of water molecules in solution is manifested as an increase in viscosity. To this end, the present invention predicts, at least in part, about the following findings: the water binding capacity of particular thickeners may be regulated and/or controlled by the addition of one or more polysaccharides, such as those described herein, and/or the extent to which these particular thickeners may unfold from a rigid crystalline structure to an entangled random polymer chain network to produce a particular degree of viscosity inhibition. In addition, these polysaccharides may further control the rate and extent to which their viscosity is inhibited from being released and/or reversed upon dilution of the food grade thickener.

In particular embodiments of the foregoing aspect, the food grade thickener comprises one or more gums. For example, food grade thickeners may include 1, 2, 3, 4, 5, or more thickeners.

Food grade thickener

The food grade thickener of the present invention has one or more of the following characteristics:

a)shelf stability:in hermetically-sealed containers>Shelf life of 6 months.

b)The method comprises the following steps:the apparent viscosity of the concentrate is such that it can be poured.

c)The dispersion is that:food grade thickeners may be incorporated into the target aqueous food under gentle agitation (e.g., < 100BPM in 1 minute) to express viscosity in 30 seconds.

d)Pumpability:the food grade thickener can be pumped (inherently imparting shear) by the dispensing pump without negatively affecting dispersibility. The food grade thickener of the present invention resists shear when pumped.

e)Clarity:the food grade thickener of the present invention is clear and transparent. For example, transmittance of a 7% aqueous solution at 650nm (1 cm path length)>98%. The prior art does not specify clarity and, as shown below, does not have the clarity achieved by the food grade thickener of this invention.

f)Homogenizing: the food grade thickener is substantially homogeneous in that it is substantially uniform, free of agglomerated or highly gelled domains or aggregates within the body 。

Preferably, the food grade thickeners mentioned herein are stable for at least six months up to at least two years at room temperature. Since the thickener composition of the present invention is stable, the performance of the thickener is not significantly degraded, and thus the viscosity remains constant over a commercially reasonable period of time. Thus, the formulation itself may be provided to the end user as a packaged product, such as in a metering pump dispenser. To this end, the end user can reliably calculate the amount of the high grade thickener of the present invention to be added to the food or beverage to achieve the desired final viscosity. The food grade thickener of the present invention is then readily dispensed and readily mixed into food to produce the desired end product. The ability to package and use food grade thickeners in this manner is a result of the presence of the combination of thickener and polysaccharide, which inhibits the expression of viscosity of the thickener and provides significant benefits in terms of use over conventional pouches of powdered or gel-like thickener which are notoriously difficult to accurately measure and difficult to incorporate into liquid foods when the exact package size is not appropriate.

In some embodiments of the present invention, in some embodiments, the viscosity of the food grade thickener is about 100cP, 200cP, 300cP, 400cP, 500cP, 600cP, 700cP, 800cP, 900cP, 1000cP, 1100cP, 1200cP, 1300cP, 1400cP, 1500cP, 1600cP, 1700cP, 1800cP, 1900cP, 2000cP, 2100cP, 2200cP, 2300cP, 2400cP, 2500cP, 2600cP, 2700cP, 2800cP, 2900cP, 3000cP, 3100, 3200cP, 3300cP, 3400cP, 3500cP, 3600cP, 3700cP, 3800cP, 3900cP, 4000cP, 4100cP, 4200cP, 4300cP, 4400cP, 4500cP, 4600cP, 4700cP, 4800cP, 4900cP, 5000cP, 5100cP, 5200cP 5300cP, 5400cP, 5500cP, 5600cP, 5700cP, 5800cP, 5900cP, 6000cP, 6100cP, 6200cP, 6300cP, 6400cP, 6500cP, 6600cP, 6700cP, 6800cP, 6900cP, 7000cP, 7100cP, 7200cP, 7300cP, 7400cP, 7500cP, 7600cP, 7700cP, 7800cP, 7900cP, 8000cP, 8100cP, 8200cP, 8300cP, 8400cP, 8500cP, 8600cP, 8700cP, 8800cP, 8900cP, 9000cP, 9500cP, 10000cP, 11000cP, 12000cP, 13000cP, 14000cP, 15000cP, 16000cP, 17000cP, 18000cP, 19000cP, 20000cP or any range therein. Preferably, the viscosity of the food grade thickener is from about 500cP to about 10000cP. More preferably, the viscosity of the food grade thickener is from about 2000cP to about 8000cP. In a preferred embodiment, the food grade thickener has a viscosity that is dispensable by a pump.

The stability of the liquid food grade thickener of this invention over time may be expressed by retaining the color (if any), flavor (if any), separation (if any), microbial spoilage (if any), viscosity and/or clarity of the food grade thickener. Additionally or alternatively, the stability of the food grade thickener may be determined by the ability of the composition to impart a predetermined level of viscosity when added to food. The stability of the food grade thickener may be determined by using any technique available to those skilled in the food science arts, including microbiological tests for measuring the extent and rate of microbiological spoilage; visual inspection of physical changes such as separation and/or sedimentation; sensory evaluation for determining color, flavor and/or clarity change; and viscosity measurements using a Bostwick consistometer or brookfield viscometer or similar device.

According to a second aspect, the present invention provides a food grade thickener when produced by a method according to the first aspect.

According to a third aspect, the present invention provides a method for increasing the viscosity of an aqueous liquid or aqueous liquid-solid mixture foodstuff, the method comprising the step of adding to the foodstuff the food grade thickener produced by the method according to the first aspect.

According to a fourth aspect, the present invention provides a method of treating a subject suffering from a chewing and/or swallowing disease, disorder or condition, the method comprising the step of administering to the subject a food, wherein the food comprises the food grade thickener produced by the method according to the first aspect.

According to a fifth aspect, the present invention provides the use of the food-grade thickener produced by the method according to the first aspect for the manufacture of a medicament for the treatment or amelioration of a chewing and/or swallowing disease, disorder or condition.

According to a sixth aspect, the present invention provides a method of overcoming or ameliorating dysphagia in a patient in need of such treatment, the method comprising the step of thickening a food or beverage for consumption by the patient with the food grade thickener produced by the method according to the first aspect.

According to a seventh aspect, the present invention provides the use of the food grade thickener produced by the method according to the first aspect for the manufacture of a medicament for overcoming or ameliorating dysphagia in a patient in need of such treatment.

According to an eighth aspect, the present invention provides a storage and delivery system for a food grade thickener, the storage and delivery system comprising:

a. ) A container containing the food grade thickener produced by the method according to the first aspect, and

b. ) A pump dispenser sealingly attached to the container, the dispenser comprising a valve for inhibiting or preventing drying of the composition in the container.

According to a ninth aspect, the present invention provides a kit for a storage and delivery system for food grade thickeners, the kit comprising:

b. ) A pump dispenser attached to the container,

wherein the pump dispenser comprises a valve for inhibiting or preventing drying of the composition in the container.

According to a tenth aspect, the present invention provides a method of delivering a food grade thickener to an aqueous liquid or aqueous liquid solid mixture foodstuff, the method comprising the steps of:

a. ) Providing a container containing the food grade thickener produced by the method according to the first aspect; and

b. ) A force is applied to the pump dispenser to thereby deliver one or more doses of a predetermined volume of the food grade thickener into the foodstuff.

According to an eleventh aspect, the present invention provides a composition for assisting or ameliorating dysphagia, the composition comprising a pourable food grade thickener having an apparent viscosity of substantially less than about 5,000cps at 20 ℃ measured using spindle 3 at 5rpm and a resistance to flow of greater than about 12cm at 20 ℃ measured using a Bostwick consistometer at 30 seconds and a light transmittance of >90% measured using a 1cm path length at 650 nm.

According to a twelfth aspect, the present invention provides a method for providing a food grade thickener, the method comprising the steps of:

establishing a water continuous phase of the first polysaccharide;

adding a second polysaccharide to the continuous phase, thereby forming a gelled mixture;

Treatment of dysphagia

Dysphagia generally involves two problems:

a. ) Dysphagia-any throat ataxia that perceives food or liquid to flow back or get stuck in the chest, or that causes coughing or choking upon swallowing, and

b. ) Dysphagia-pain in the throat or chest when swallowing.

Dysphagia may be caused by a lack of ataxia in nerves or muscles, or sometimes by infection and tumors. Symptoms of dysphagia include:

dysphagia feels the food "sticks" in the way down, and it is difficult to transfer food or liquid from the mouth to the esophagus to the stomach,

cough during or immediately after swallowing;

choking-feeling food or liquid sticking to throat or esophagus, then cough,

regurgitation-return of food or liquid to the mouth or pharynx after successful passage.

Nasal reflux food or liquid into the nose; this occurs when the nasopharynx is not normally closed

Other symptoms may include: sore throat, hoarseness, shortness of breath, and chest discomfort or pain.

The food grade thickener of the present invention provides an aid to patients suffering from such dysphagia by the ingestion of an auxiliary food. In particular, the treatment comprises the step of modifying the foodstuff to avoid or substantially avoid one of the more of the symptoms described above. Preferably, the target food having an increased viscosity due to the use of the inventive food grade thickeners disclosed herein is used to feed a subject suffering from a chewing and/or swallowing disease, disorder or condition. Preferably, the chewing and/or swallowing disease, disorder or condition is or includes dysphagia.

Preferably, according to the present invention, the food grade thickener is added to an aqueous liquid or aqueous liquid-solid mixture diet for feeding to a subject suffering from a chewing and/or swallowing disease, disorder or condition. Preferably, the chewing and/or swallowing disease, disorder or condition is or includes dysphagia. In some embodiments, the food grade thickener is separated into suitable individual portions, such as sachets, or is pump dispensable.

It will be readily appreciated that dysphagia is a condition in which the swallowing process is impaired. During feeding, this may cause liquid or solid food to enter the trachea and subsequently the patient's lungs, potentially causing aspiration pneumonia. Dysphagia may occur at any age, but is most common in the elderly, particularly in cases where the elderly suffers from stroke or dementia. One management strategy for dysphagia patients is to eat a modified-texture food (i.e., thickened foods and beverages) that slows the swallowing reflex and leaves the air tube closed for a period of time before the food passes, thereby preventing inhalation.

For food grade thickenersIs a storage and delivery system of (c)

A further aspect of the invention is to provide the food grade thickener of the invention in a container, and wherein the container comprises a pump dispenser sealingly attached to the container to thereby provide a substantially airtight sealed system. The dispenser preferably includes a valve for inhibiting or preventing drying of the composition in the container.

Preferably, the dispenser comprises a dispenser tip comprising a valve disposed therein. Suitably, the aforementioned valve is or comprises a self-sealing valve. In a specific embodiment, the aforementioned valve is selected from the group consisting of: cross slit valves, ball valves, flapper valves, umbrella valves, duckbill valves, reed valves, and any combination thereof. In a specific embodiment of the invention, the valve is biased to a closed position and upon application of a force to the pump dispenser, the valve is actuated to an open position, forcing the composition to flow through the valve.

The storage and delivery system of the present invention preferably comprises a pump dispenser or another sealed delivery system known in the art that: (1) At the time of use and by delivering a consistent dose or volume (e.g., +/-3 to 5% by weight) of food grade thickener throughout the content or volume of the storage and delivery system that it sells; and (2) is capable of protecting the food grade thickener from the drying effects of the atmosphere or the environment having a relative humidity of less than 95% when contained or stored in the storage and delivery system.

The advantage of storing the food grade thickener of this invention in a hermetically sealed container is an improvement in long term stability. For example, the food grade thickeners of the present invention are stable for at least 6 months at room temperature.

In another embodiment of the invention, the food grade thickener of the present invention is stored and/or delivered by a pouch or the like. In one embodiment, the pouch contains a dispenser in the form of a pull-open spout.

In a preferred embodiment of the invention, the food grade thickener maintains a water activity of greater than 95%. It will be readily understood that water activity or aw is defined as the ratio of the partial pressure of water vapor to the standard partial pressure of water vapor in a material at the same temperature. In addition, water typically migrates from areas of high water activity to areas of low water activity until equilibrium is reached. For example, food grade thickeners provided herein have a water activity of greater than 95% (e.g., about or greater than 95.5%, 96%, 96.5%, 97%, 97.5%, 98%, 98.5%, 99%, 99.5% and any ranges therein), which then typically needs to be protected from the atmosphere or environment having a relative humidity of less than 95% to prevent the food grade thickener from drying during storage and prior to delivery or dispensing.

Thus, the storage and delivery system preferably provides a relatively accurate and/or precise dosage or volume of food grade thickener for the desired food. In particular embodiments, delivery of a food grade thickener into a food by a storage and delivery system of the present invention results in a viscosity that is within at least +/-7.5% (e.g., 5+/-0.5%, 1%, 1.5%, 2%, 2.5%, 3%, 3.5%, 4%, 4.5%, 5%, 5.5%, 6%, 6.5%, 7%, 7.5% and any range therein) of the desired or predetermined viscosity of the food. More specifically, delivering a food grade thickener into a food by the storage and delivery system of the present invention results in a viscosity that is within at least +/-3.5% of the desired or predetermined viscosity of the food.

In some embodiments, the storage and delivery system can deliver a volume of 4.5mL, 5mL, 5.5mL, 6mL, 6.5mL, 7mL, 7.5mL, 8mL, 8.5mL, 9mL, 9.5mL, 10mL, 11mL, 12mL, 13mL, 14mL, 15, 16mL, 17mL, 18mL, 19mL, 20mL, 21mL, 22mL, 23mL, 24mL, 25mL, 26mL, 27mL, 28mL, 29mL, 30mL, 31mL, 32mL, 33mL, 34mL, 35mL, 36mL, 37mL, 38mL, 39mL, or 40mL or any amount of food grade thickener therebetween to the target foodstuff.

In some embodiments, the storage and delivery system will be at 50s ^-1 、100s ^-1 、200s ^-1 、300s ^-1 、400s ^-1 、500s ^-1 、600s ^-1 、700s ^-1 、800s ^-1 、900s ^-1 Or 1000s ^-1 Or any shear rate in between. It should be understood thatThe degree of shear experienced by the food grade thickener is related to the internal workings of the pumping equipment and will vary from pumping equipment to pumping equipment.

Use of food grade thickeners to increase the viscosity of food

In some embodiments, a sufficient amount of food grade thickener is added to the target food to achieve a desired target viscosity, e.g., 1wt% to 30wt%. In some embodiments, the amount of food grade thickener added to the food is in the range of 1wt% to 5wt%, 6wt% to 10wt%, 11wt% to 15wt%, 16wt% to 20wt%, 21wt% to 25wt%, or 26wt% to 30wt% (based on the total mass of the solution) or any range therebetween.

In some embodiments, the viscosity of the foodstuff increases to at least 95cP, 100cP, 110cP, 120cP, 130cP, 140cP, 150cP, 175cP, 200cP, 250cP, 300cP, 350, 400cP, 450cP, 500cP, 550cP, 600cP, 650cP, 700cP, 750cP, 800cP, 850cP, 900cP, 950cP, 1000cP, 1050cP, 1100cP, 1150cP, 1200cP, 1250cP, 1300cP, 1350cP, 1400cP, 1450cP, 1500cP, 1550cP, 1600cP, 1650cP, 1700cP, 1750cP, 1800cP, 1850cP, 1900cP, 1950cP, 2000cP, 2050cP, 2100cP, 2150cP, 2250cP, 2300cP, 2350cP, 2400cP, 2450cP, 2500cP, 2550cP, 2600, 2650cP, 2700cP, 2750cP, 2800cP, 2850cP, 3000cP, 2200cP, 1650cP, 3500cP, 3400cP or any range therebetween.

Drawings

Preferred embodiments of the present invention will now be described, by way of example only, with reference to the accompanying drawings, in which:

fig. 1 shows a flow chart of the method of the claimed invention, which indicates the following steps: continuous phase formation, gel formation, hydrolysis and gum addition.

Fig. 2a shows various CMC solutions (pH 3.6) dissolved for 1 hour with minimal shear (10-200 rpm) and then hydrolyzed at 90 ℃ for (L-R) time = 0 (> 10 mL), 8 hours (5.8 mL), 10 hours (5.6 mL), 12 hours (5.0 mL) and 14 hours (4.2 mL). The values in brackets are the corresponding volumes in mL remaining in the flow test according to the IDDSI flow test (10 second flow). Fig. 2b shows various CMC solutions (pH 3.6) dissolved for 1 hour with high shear (7600-10200 rpm) and then hydrolyzed at 90 ℃ for (L-R) time = 0 hours (> 10 mL), 12 hours (3.4 mL), 24 hours (0.8 mL), 36 hours (0.3 mL) and 48 hours (0 mL). The values in brackets are the corresponding volumes in mL remaining in the flow test according to the IDDSI flow test (10 second flow).

Fig. 3 shows the effect of various compositions of the prior art and the present invention when mixed with water in a 1:5 ratio, showing a) the claimed invention and b) -h) comparative example compositions produced using food grade polysaccharides according to the teachings of JP 2007.

Fig. 4 shows the stability of comparative examples 1-8 over a 24 hour period, which shows that none of the compositions of comparative examples 1-8 remained stable over this period.

FIG. 5 is a histogram showing typical viscosity versus concentration spectra for four sets of sodium carboxymethyl cellulose (CMC) gums;

FIG. 6 is a graph showing viscosity of a 5% xanthan solution as a function of sodium carboxymethyl cellulose concentration by acid hydrolysis;

fig. 7 is a graph showing the viscosity of a 5% xanthan solution as a function of sodium alginate concentration for acid hydrolysis;

FIG. 8 is a graph showing viscosity of a 5% xanthan solution as a function of enzymatically hydrolyzed xanthan concentration;

fig. 9 is a graph showing viscosity of a 5% xanthan solution as a function of enzymatically hydrolyzed guar concentration;

fig. 10 is a graph showing viscosity of a 5% xanthan gum solution as a function of methyl ethyl cellulose (dp=250) concentration;

fig. 11 is a graph showing viscosity of a 5% xanthan gum solution as a function of sodium carboxymethyl cellulose (dp=120-150) concentration;

FIG. 12 is a graph showing the viscosity of a 5% xanthan solution as a function of the concentration of the following mixture of low viscosity highly soluble polysaccharides-20 parts enzymatically hydrolyzed xanthan gum; 20 parts of sodium carboxymethylcellulose (dp=120-150); 10 parts of acid hydrolyzed sodium carboxymethylcellulose; 20 parts of acid hydrolyzed sodium alginate; 20 parts of acid hydrolyzed pectin; and is also provided with

FIG. 13 is a graph-8.3 parts acid hydrolyzed pectin showing the viscosity of an 8% sodium alginate solution as a function of the concentration of the following mixture of low viscosity highly soluble polysaccharides; 8.3 parts of hydroxypropyl methylcellulose (dp=200); and 8.3 parts of enzymatically hydrolyzed guar gum.

Definition of the definition

In describing and claiming the present invention, the following terminology will be used in accordance with the definitions set out below. It is also to be understood that the terminology used herein is for the purpose of describing particular embodiments of the invention only and is not intended to be limiting.

Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs.

Throughout the specification and claims, unless the context clearly requires otherwise, the terms "comprise", "comprising", and the like will be construed in an inclusive sense rather than an exclusive or exhaustive sense, that is to say, in the sense of "including but not limited to". For example, a composition, mixture, method, or method that comprises a list of elements is not necessarily limited to only those elements, but may include other elements not expressly listed or inherent to such composition, mixture, method, or method.

The transitional phrase "consisting of …" does not include any unspecified element, step or ingredient. If in the claims this shall close the claims to include those materials set forth except for the impurities normally associated therewith. When the phrase "consisting of …" appears in the subject clause of the claims, rather than immediately following the preamble, it is limited to only the elements set forth in that clause; other elements as a whole are not excluded from the claims.

The transitional phrase "consisting essentially of … (consists essentially of)" is used to define a composition, method, or method that comprises a material, step, feature, component, or element, except those that are literally disclosed, provided that such additional material, step, feature, component, or element does not materially affect the basic and novel characteristics of the claimed invention. The term "consisting essentially of …" occupies an intermediate zone between "comprising" and "consisting of …".

Where applicants have defined the invention or a portion thereof in open terms such as "comprising," it should be readily understood that the description (unless otherwise indicated) should be construed as also describing such invention using the terms "consisting essentially of …" or "consisting of …. In other words, with respect to the terms "comprising," "consisting of …," and "consisting essentially of …," where one of these three terms is used herein, the presently disclosed and claimed subject matter may include the use of either of the other two terms. Thus, in some embodiments not explicitly stated otherwise, any instance of "comprising" may be replaced by "consisting of …" or alternatively by "consisting essentially of …".

Further, unless expressly stated to the contrary, "or" means an inclusive or rather than an exclusive or. For example, the condition a or B is satisfied by any one of the following: a is true (or present) and B is false (or absent), a is false (or absent) and B is true (or present), and both a and B are true (or present).

In addition, the indefinite articles "a" and "an" preceding an element or component of the invention are intended to be non-limiting with respect to the number of instances (i.e., occurrences) of the element or component. Thus, the use of "a" or "an" is to be understood as including one or at least one, and the singular forms of elements or components also include the plural unless the number clearly means a singular.

Except in the operating examples, or where otherwise indicated, all numbers expressing quantities of ingredients or reaction conditions used herein are to be understood as being modified in all instances by the term "about". The examples are not intended to limit the scope of the invention. Hereinafter or otherwise stated, "%" will refer to "% by weight", the "ratio" will refer to "weight ratio", and "part" will refer to "part by weight".

The terms "primary" and "substantially" as used herein shall be meant to include more than 50% by weight unless otherwise indicated.

As used herein, with respect to numbers within a range of numbers, the terms "about", "about" and "substantially" are understood to mean 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, and most preferably-0.1% to +0.1% of the referenced number. Furthermore, with respect to a range of numbers, these terms should be interpreted to provide support for claims directed to any number or subset of numbers within the range. For example, the disclosure of 1 to 10 should be interpreted as supporting ranges of 1 to 8, 3 to 7, 1 to 9, 3.6 to 4.6, 3.5 to 9.9, 8 to 10, etc.

As used herein, wt.% refers to the weight of a particular component relative to the total weight of the referenced composition.

The term "and/or" as used in the context of "X and/or Y" should be interpreted as "X" or "Y" or "X and Y". Similarly, "at least one of X or Y" should be interpreted as "X" or "Y", or "both X and Y".

The terms "preferred" and "preferably" refer to embodiments of the invention that may provide certain benefits in certain circumstances. However, other embodiments may be preferred under the same or other circumstances. Furthermore, the recitation of one or more preferred embodiments does not imply that other embodiments are not useful, and is not intended to exclude other embodiments from the scope of the invention.

The complete disclosures of the patents, patent documents, and publications cited herein are incorporated by reference in their entirety as if each were individually incorporated.

As used herein, the term "polysaccharide" generally refers to polymers formed from about 10 to 500, 500 to 1000, 1000 to 2000, 2000 to 5000, 5000 to 10,000, 10,000 to 50,000, 50,000 to 100,000, or more than 100,000 saccharide units, or any range therein, e.g., 10 to more than 100,000 saccharide units, linked to each other by hemiacetal or glycosidic linkages. The polysaccharide may be linear, mono-branched or multi-branched, wherein each branch may have additional secondary branches, and the monosaccharide may be a standard D-or L-cyclic saccharide in the form of pyranose (6-membered ring) or furanose (5-membered ring), respectively, such as D-fructose and D-galactose. In addition, it may be a cyclic sugar derivative, a deoxy sugar, a sugar acid or a poly-derivative sugar. As will be appreciated by those skilled in the art, polysaccharide preparations, and in particular those isolated from nature, typically comprise molecules that are heterogeneous in molecular weight.

As used herein, the term "thickener" refers to any compound used to increase the viscosity of a liquid mixture and/or solution, and particularly those compounds used in food applications, such as edible gums, vegetable gums, and food grade polysaccharides.

As used herein, "synthetic polysaccharide" refers to a polysaccharide that is chemically and/or enzymatically produced, derivatized and/or modified. In specific embodiments, the synthetic polysaccharide is selected from the group consisting of: microcrystalline cellulose, sodium carboxymethyl cellulose, methyl cellulose, hydroxypropyl cellulose, methyl ethyl cellulose, polyvinylpyrrolidone (PVP), carboxyvinyl polymer, methyl cellulose based ether, maleic anhydride polymer, ethylene oxide polymer, and any combination thereof.

As used herein, "naturally occurring polysaccharide" generally refers to a polysaccharide that has not been modified in accordance with how it exists in nature, except as isolated.

For the purposes of the present invention, "isolated" means a material that has been removed from its natural state or otherwise subjected to human manipulation. The isolated material may be substantially or essentially free of components that normally accompany it in its natural state, or may be manipulated so that it is in a manual state with components that normally accompany it in its natural state. The isolated material comprises the material in both natural and recombinant forms. In this regard, naturally occurring polysaccharides may be synthesized so as to effectively replicate the polysaccharides found in nature. The term "isolated" also encompasses terms such as "enriched" and "purified".

By "polysaccharide fragment" is meant any complex carbohydrate formed, for example, by enzymatic and/or chemical digestion of the larger starting polysaccharide. Thus, although fragments are always smaller than the starting polysaccharide from which they are derived, no specific size limitation is implied for the starting polysaccharide or fragment thereof.

As used herein, the term "flowable" and similar terms such as "flowable" refer to the ability of a substance to flow in continuous steam under standard atmospheric conditions and temperatures without undue forces.

As used herein, the term "pumpable" and similar terms such as "pumpability" refer to the ability of a substance to flow through a line, nozzle, and channel of a pump device and/or fittings thereof under pressure without irreversibly deforming or adversely affecting the substance flowing through the line, nozzle, and channel.

As used herein, the term "pourable" and similar terms such as "pourable" refer to the ability of a substance to pour or otherwise flow in continuous steam under standard atmospheric conditions and temperatures without undue force.

As used herein, the term "dispersible" and like terms such as "dispersibility" refer to the ability of a substance to be uniformly and rapidly distributed throughout a medium with minimal force without forming agglomerates or particulates.

As used herein, the units "cP", "cPs", "centipoise", "mpa·s", and "millipascal-seconds" are understood to be interchangeable, and the skilled person will understand to describe the dynamic viscosity of a solution.

As used herein, the term "low shear" refers to conditions in which relatively low speeds (e.g., 2-300 rpm) are used, preferably with low shear agitators, such as hydrofoil impellers. It will be appreciated that a series of agitators will be suitable and the skilled person will be able to select the agitators that impart the least shear to the solution. In some embodiments, the low shear is 1rpm to 1000rpm.

As used herein, the term "high shear" refers to conditions using relatively high mixing speeds (e.g., >1500 rpm) and/or using a high shear stirrer. In some embodiments, the high shear is >1,000rpm to 10000rpm.

All viscosity and apparent viscosity measurements herein were made at 20 ℃ using spindle No. 3 on a brookfield rotational viscometer at 5rpm, unless otherwise indicated.

All anti-flow measurements herein were made using a Bostwick consistometer at 20 ℃ for 30 seconds, unless otherwise indicated.

All light transmittance (clarity) measurements were performed on a Hach DR3900 spectrophotometer using a 1cm path length unless otherwise indicated. However, it should be understood that a range of spectrophotometers are suitable, which would provide equivalent results.

As used herein, a Bostwick consistometer ("Bostwick") is understood to refer to an instrument that determines the consistencies of various materials by measuring the distance a sample flows under its own weight. It should be appreciated that such instruments conform to ASTM standards (ASTM F108093 (2019)).

As used herein, a brookfield viscometer ("brookfield") is understood to refer to an instrument that determines the viscosity of a material by measuring the torque required to rotate an object (e.g., a "spindle").

Detailed Description

Those of skill in the art will understand that the present invention includes the embodiments and features disclosed herein and all combinations and/or permutations of the disclosed embodiments and features.

The compositions produced by the methods of the present invention may provide various advantages, such as one or more of the following, and are a significant advance over the prior art:

flowable;

pumpable;

homogeneous (i.e. without undispersed gum and/or polysaccharide lumps or domains);

dispersible into aqueous liquids such that the thickened liquid is homogeneous;

have sufficient hydration rate so that the peak viscosity of the food is reached in a short time frame (i.e., about 30-60 seconds) at low shear (i.e., 80-160BPM with fork/spoon);

Capable of withstanding shear when delivered with a food-grade pump;

not to separate over time;

clear (no color when dispersed in feed stock); and

imparting little or no odor or taste to the target food.

As discussed above, food grade thickeners are typically used in the patient's home, or in a hospital or geriatric care setting. In this context, it is particularly convenient to provide the container with a pump so that the patient or caregiver can simply dispense a predetermined amount of the thickening agent through the pump into a known amount of the target food to thicken the food. It is important for the thickener to be flowable and have little or no odor or taste so as to negatively affect the food to which it is added. It is also highly preferred for the thickener to be clear and not impart a color to the target food, again so as not to negatively affect the food to which it is added. Furthermore, it is highly preferred that the thickener be readily dispersible into aqueous liquid foods such that the thickened foods are homogeneous and have sufficient hydration rate such that peak viscosity is achieved in a short time frame (i.e., about 30-60 seconds) at low shear (i.e., 80-160BPM with a fork/spoon). When stored in a container/pump storage and delivery system, the thickener must be easily pumpable and must withstand shear so as not to negatively impact the other desired properties mentioned. Still further, it is highly desirable that the thickener be homogeneous, i.e., not contain undispersed agglomerates or domains, either when in situ or when delivered into the target food. Still further, it is highly desirable that the thickener does not separate over time, either when in situ or when delivered into the target food. Designing food grade thickeners to achieve these goals is a very complex task, mainly because there are many competing goals and it is necessary to work within the constraints of the conditions under which the various ingredients are inherently delivered into the composition. The applicant has devised a method that achieves all of the above objects in the preferred embodiments.

In preferred embodiments, the food-grade thickeners described herein, when added to an aqueous liquid or aqueous liquid-solid mixture food in a desired amount, have minimal or negligible impact on particularly desirable attributes thereof, such as the original flavor and/or color of the food, which may be attractive to the consumer. In this regard, the food grade thickener preferably has little or no flavor and/or color contribution to the food when added in the desired amount. In addition, it is preferred that the amount of food grade thickener to be added to the food to achieve the desired viscosity be relatively small to avoid diluting the flavor and/or color characteristics of the food.

In a preferred embodiment, the present invention provides a flowable food grade thickener. Advantageously, the food grade thickener preferably has a viscosity such that it can be easily dispensed, such as from a pump, and is capable of being dispersed with little or no agitation when added to an aqueous liquid or aqueous liquid-solid mixture foodstuff in a desired amount. Preferably, the food grade thickener of this invention is concentrated and can accommodate relatively high percentages of thickener without losing the flow characteristics of the composition. This further enables the food grade thickener to be easily and accurately dispensed into the selected food.

The following compositions list the food grade thickeners of the present invention and provide comparative examples with the prior art which illustrate that the prior art does not achieve the above objectives, either alone or in combination.

Examples

The present invention will now be described with reference to the following examples, which are to be considered in all respects as illustrative and not restrictive.

Example 1: the method of the invention

The inventive food-grade thickener of the present invention is prepared by the following method.

1. The pH of the water was adjusted to pH 3-4 with GDL.

2. The gellan gum is hydrolyzed in water (1:50-100 ratio).

3. The hydrolyzed gellan gum is added to the acidified water. Adding gelling cation (CaCl) to the solution ₂ 0.001%) and potassium sorbate (1000 ppm) preservative.

4. The solution was heated to 80 ℃.

5. About 2wt.% to 8wt.% CMC sodium is added.

6. Mix for 1 hour at low shear of 10-200rpm to dissolve.

7. The temperature is increased to about 90 ℃ for a time sufficient to hydrolyze the CMC sodium solution from a viscosity of about 250-300cPs at 20 ℃ to about 80-90cPs (measured with spindle 1 on a brookfield rotational viscometer at 10 rpm).

8. The pH was adjusted to 3.8-3.9 with GDL.

9. The heat was reduced to 80 ℃ and low shear at 10-200rpm was used to incorporate 4-8% xanthan gum, thereby producing the food grade thickener of the present invention.

In the first step, the pH of the water is adjusted to pH 3-4 with a common food grade acidulant (i.e., glucono delta-lactone; GDL). Gellan gum, gelling salt and potassium sorbate (1000 ppm) were added to the acidified water to preserve the mixture. The solution was then heated to 80 ℃ to activate gellan gum.

After the gellan gum is fully incorporated into the solution, low molecular weight sodium CMC is added. About 2wt.% to 8wt.% CMC sodium is added. After combining, the solutions were mixed under low shear conditions of 10-200rpm to dissolve the CMC.

After dissolution, the viscosity of the solution was about 250-300cPs, and then the temperature was increased to 90 ℃ and maintained for about 10 hours to hydrolyze the CMC sodium solution to obtain a viscosity of about 80-90cPs (measured at 20 ℃ with spindle No. 1 on a brookfield rotational viscometer at 10 rpm).

At this stage, the temperature is increased to the target temperature of 90 ℃, thereby ensuring that no hot spots exceeding the target temperature are formed in the solution. At the end of the heating phase, the pH was adjusted to 3.8-3.9 with GDL and the temperature was reduced to 80℃at which point low shear mixing at 10-200rpm was used for incorporation to add 4-8% xanthan gum, thereby producing the food grade thickener of the present invention.

Example 2: composition 1

Component (A)	Amount (wt.%)
		CMC solution	2 to 8
Xanthan gum	3 to 12
		Gellan gum	0.0325
Potassium sorbate	0.10
		Calcium chloride	0.00325
GDL solution (50 w/w%)	3.00
		Water and its preparation method	Proper amount of

The inventive food-grade thickener produced using the above method and composition 1 is a flowable liquid having an apparent viscosity of less than 5,000 cp. When 10g of food grade thickener was added to 200 g of water and stirred at 150rpm for 30 seconds, the resulting solution reached a viscosity of about 80-100 mPa-s and a light transmittance measured at 650nm as a path length of 1cm was >90%.

Example 3: composition 2

Component (A)	Amount (wt.%)
		CMC solution	0.5 to 7
Sodium alginate	0.1 to 5
		Xanthan gum	6.5
Gellan gum	0.01
		Calcium chloride	0.001
Water and its preparation method	Proper amount of

The inventive food-grade thickener produced using the above method and composition 2 was a flowable liquid with an apparent viscosity of about 14,600cp (measured with spindle 3 on a brookfield rotational viscometer at 5 rpm). When 6g of food grade thickener was added to 100 g of water and stirred at 150rpm for 30 seconds, the resulting solution reached a suitable viscosity and a light transmittance of >90% measured at 650nm at a path length of 1 cm.

Example 4: composition 3

Component (A)	Amount (wt.%)
		Na CMC 30cPs in 2% solution	3
Na CMC 50cPs in 2% solution	0.8
		Xanthan gum	5.7
Potassium sorbate	0.10
		GDL solution (50 w/w%)	3
Water and its preparation method	87.4

The inventive food-grade thickener produced using the above method and composition 3 is a flowable liquid having an apparent viscosity of about 4000 cP. When 20g of food grade thickener was added to 100 g of water and stirred at 75rpm for 30 seconds, the resulting solution reached an apparent viscosity of about 3000cP and a light transmittance of about 84.7% measured at 650nm at a path length of 1 cm.

Example 5: composition 4

Component (A)	Amount (wt.%)
		Na CMC	3.5
Xanthan gum	6.5
		Potassium sorbate	0.10
GDL solution (50 w/w%)	3.0
		Water and its preparation method	86.9

The inventive food-grade thickener produced using the above method and composition 4 is a flowable liquid having an apparent viscosity of about 8200 cP. When 5g of food grade thickener was added to 100 g of water and stirred at 150rpm for 30 seconds, the resulting solution reached a suitable viscosity and the light transmittance measured at 650nm at a path length of 1cm was about 98%.

Example 6: composition 5

Component (A)	Amount (wt.%)
		Na CMC	3.8
Xanthan gum	7
		Gellan gum	0.01
Potassium sorbate	0.10
		Calcium chloride	0.001
GDL solution (50 w/w%)	3.0
		Water and its preparation method	86.089

The inventive food-grade thickener produced using the above method and composition 5 is a flowable liquid having an apparent viscosity of about 14200 cP. When 5g of food grade thickener was added to 100 g of water and stirred at 150rpm for 30 seconds, the resulting solution reached a suitable viscosity and a light transmittance of about 99.1% measured at 650nm at a path length of 1 cm.

Comparative example of JP2007

The following example reproduces the method of JP2007 using commercially available food grade low molecular weight CMC.

Table 2: composition of comparative example

In table 2, the viscosity of food grade CMC 1 at 2% solution was 30cPs and the viscosity of food grade CMC 2 at 2% solution was 50cPs.

The methods of examples 1-3 and 8 were compared.

1. The food grade low molecular weight CMC is dissolved in water.

2. According to JP2007, the mixture is stirred with Silverson at 2000rpm for 5 minutes.

3. No caking was confirmed.

4. Xanthan gum was added and stirred with Silverson at 2000rpm for 1 minute.

5. The viscosity at 30rpm (Brookfield rotational viscometer 20rpm; spindle 5 or 6, depending on the viscosity at 25 ℃ C.) is measured.

The method of example 4 was compared.

1. The food grade low molecular weight CMC is dissolved in water.

2. Stir for 5 minutes with Silverson 2000 rpm.

3. No caking was confirmed.

4. Hydrolysis was carried out at 90℃for 12 hours.

5. Xanthan gum was added and stirred with Silverson at 2000rpm for 1 minute.

6. The viscosity at 30rpm (Brookfield rotational viscometer 20rpm; spindle 5 or 6, depending on the viscosity at 25 ℃ C.) is measured.

Method of comparative example 5

1. Xanthan gum is added to the water.

2. Stir with Silverson at 2000rpm for 5 minutes.

3. The viscosity at 30rpm was measured (30 rpm with a Brookfield rotational viscometer, spindle 5 or 6, depending on the viscosity at 25 ℃).

Method of comparative examples 6 and 7

1. 2 food grade low molecular weight CMC and xanthan gum were blended.

2. The mixture was added to water.

3. Stir for 1 min with Silverson 2000 rpm.

4. The viscosity at 30rpm was measured (30 rpm with a Brookfield rotational viscometer, spindle 5 or 6, depending on the viscosity at 25 ℃).

A silverson mixer with a universal stator is used, which is considered equivalent to the "dispersive mixer" disclosed in JP2007, and since no further information is provided in the specification of JP2007, a universal stator attachment is used.

Comparative example 1 shows the results obtained when food grade CMC sodium (2% solution 30 mpa.s) was used in the process of JP 2007. According to the teachings of JP2007, CMC is first dissolved in water and stirred at 2000 rpm. However, contrary to the teachings of JP2007, the solution must be mixed at 4000rpm for 7 minutes to sufficiently hydrate the CMC, as mixing only at 2000rpm provides a heterogeneous bulk solution. Then, xanthan gum was added and the solution was stirred at 2000rpm for another 1 minute. In comparison to the viscosity of 1364 mPa-s reported in JP2007, the apparent viscosity of the composition using food-grade CMC after allowing the glue to coalesce overnight for a certain time is 8,000 mPa-s, because the product produced is extremely lumpy. The composition is pourable, but viscous and anti-flowing. When used in a pump device as described herein, the composition deteriorates upon dispensing, indicating that the composition has poor shear resistance and is unsuitable for bulk storage and delivery. Specifically, the test was stopped at 1 minute and the solution was hydrated for another 2 minutes as caking was observed. The teachings of JP2007 show that the composition disperses rapidly and expresses its viscosity. However, when using the food grade CMC reproduction method, the composition disperses very slowly and expresses its viscosity. Furthermore, when mixed with water in a ratio of 1:5, the apparent viscosity of the resulting solution was 300 mPas instead of the reported 3496 mPas. The thickened aqueous solution was poor in clarity (47.6% transmittance at 650 nm) and turbid and lumpy, as shown in fig. 3 b. The thickened aqueous solution also showed poor stability and was easily separated within 24 hours (fig. 4 b).

Comparative example 2 shows the results obtained when food-grade CMC sodium (2% solution 50 mPa-s) was used in the process of JP 2007. According to the teachings of JP2007, CMC is first dissolved in water and stirred at 2000rpm for 5 minutes. Similar to comparative example 1, stirring at 4000rpm was required for another 2 minutes to hydrate CMC. Then, xanthan gum was added and the solution was stirred at 2000rpm for another 1 minute. Contrary to the teachings of JP2007, an additional 6 minutes is required to incorporate xanthan gum. The apparent viscosity of the composition using this food grade CMC was 30,000 mPa-s compared to the viscosity of 1364 mPa-s reported in JP 2007. The composition is extremely viscous and is not pourable or flowable. When used in a pump device as described herein, the composition deteriorates upon dispensing, indicating that the composition has poor shear resistance and is unsuitable for bulk storage and delivery. The teachings of JP2007 show that the composition disperses rapidly and expresses its viscosity. However, when reproduced using this food-grade CMC, the composition is not dispersible. Furthermore, when mixed with water in a ratio of 1:5, the apparent viscosity of the resulting solution was 800 mPas instead of the reported 3496 mPas. This thickened aqueous solution also had a medium clarity (71.7% transmittance at 650 nm) and contained undispersed, cloudy thickener composition caking as shown in fig. 3 c. The thickened aqueous solution also showed poor stability and was easily separated within 24 hours (fig. 4 c).

Comparative example 3 shows the results obtained when a combination of food-grade CMC sodium (2% solution 30 mPa-s and 2% solution 50 mPa-s in a ratio of 8:2) was used in the process of JP 2007. According to the teachings of JP2007, CMC is first dissolved in water and stirred at 2000rpm for 5 minutes. However, this method did not adequately incorporate CMC, and therefore the stirring speed was increased to 4000rpm for 5 minutes. Then, xanthan gum was added and the solution was stirred at 2000rpm for another 1 minute. The apparent viscosity of a composition using this combination of food grade CMC is 20000 mPa-s compared to the viscosity of 1364 mPa-s reported in JP2007 (for a composition containing a single CMC). The compositions are viscous and exhibit limited pourability and flowability. When used in a pump device as described herein, the composition deteriorates upon dispensing, indicating that the composition has poor shear resistance and is unsuitable for bulk storage and delivery. The teachings of JP2007 show that the composition disperses rapidly and expresses its viscosity. However, when reproduced using this combination of food-grade CMC, the composition is not dispersible. Furthermore, when mixed with water in a ratio of 1:5, the apparent viscosity of the resulting solution was 150 mPas instead of the reported 3496 mPas (for a 1 CMC composition). This thickened aqueous solution also had poor clarity (64.3% transmittance at 650 nm) and contained undispersed, cloudy thickener composition caking as shown in fig. 3 d. The thickened aqueous solution also showed poor stability and was easy to separate within 24 hours (fig. 4 d).

Comparative example 4 shows the results obtained in the case of an additional step of adding gum after hydrolysis was performed when a combination of CMC was used in the method of JP 2007. Applicants found that despite the hydrolysis of the viscosity inhibitor during the process of JP2007, it failed to obtain a composition with the advantageous qualities of the claimed invention. The food grade CMC was first dissolved in water and stirred at 2000rpm for 5 minutes. Then, the solution was hydrolyzed at 90 ℃ for 12 hours, then xanthan gum was added, and the solution was stirred at 2000rpm for another 1 minute. The apparent viscosity of the composition was 4,000 mPas, but showed poor pourability and flowability. When used in a pump device as described herein, the composition deteriorates upon dispensing, indicating that the composition has poor shear resistance and is unsuitable for bulk storage and delivery. When combined with water at 1:5, the apparent viscosity of the resulting solution was 3650 mPa-s, but showed poor dispersibility and no homogeneous mixture was formed (fig. 4 e). This thickened aqueous solution had a medium clarity (light transmittance at 650nm of 72.4%) and contained undispersed, cloudy thickener composition caking as shown in fig. 3 e.

Comparative example 5 shows the results obtained without first dissolving CMC sodium when xanthan gum (1% in 1% kcl 1300-1700cPs, spindle 3 No. 60 rpm) was used in the process of JP 2007. According to the teachings of JP2007, xanthan gum was added and the solution was stirred at 2000rpm for 5 minutes. As above, the stirring speed was increased to 4000rpm to fully hydrate CMC. Similar to the viscosity of 16,300 mPa-s reported in JP2007, the apparent viscosity of the composition using xanthan gum was 15400 mPa-s. The composition is extremely viscous and is not pourable or flowable. When used in a pump device as described herein, the composition deteriorates upon dispensing, indicating that the composition has poor shear resistance and is unsuitable for bulk storage and delivery. Consistent with the teachings of JP2007, such a composition is non-dispersible. Contrary to the teachings of JP2007, when mixed with water in a 1:5 ratio, the resulting solution has an apparent viscosity of 2250 mPas instead of the reported 242 mPas. The thickened aqueous solution had high clarity (83.9% transmittance at 650 nm) but contained the thickener composition agglomerated as shown in fig. 3 f. Furthermore, this thickened aqueous solution showed very poor dispersibility and did not form a homogeneous mixture (fig. 4 f).

The following comparative examples (6-7) demonstrate the effect of incorporating CMC and xanthan gum into a solution simultaneously rather than by sequential addition. These examples show that the order in which the ingredients are added has a significant impact on the properties of the composition.

Comparative example 6 shows the results obtained when food grade CMC sodium (2% solution 30 mPa-s) was combined with xanthan gum (1% in 1% kcl1300-1700cPs, spindle 3 at 60 rpm) and used in the process of JP 2007. CMC and xanthan were first blended, then dissolved in water, and stirred at 2,000 for 1 minute. The apparent viscosity of the composition using this food grade CMC was 15,000 mpa-s compared to the viscosity of 4,780 mpa-s reported in JP 2007. The compositions are viscous and exhibit limited pourability and flowability. When used in a pump device as described herein, the composition deteriorates upon dispensing, indicating that the composition has poor shear resistance and is unsuitable for bulk storage and delivery. These data are consistent with the teachings of JP2007, i.e., the composition disperses very slowly and expresses its viscosity. When mixed with water in a ratio of 1:5, the resulting solution had an apparent viscosity of 170 mPas instead of the reported 3044 mPas. This thickened aqueous solution also had high clarity (80.3% transmittance at 650 nm) and contained undispersed, cloudy thickener composition caking as shown in FIG. 3 g. Furthermore, the thickened aqueous solution showed very poor dispersibility, did not form a homogeneous mixture and was easy to separate within 24 hours (fig. 4 g).

Comparative example 7 shows the results obtained when food grade CMC sodium (2% solution 50mpa·s) was combined with xanthan gum (1% in 1% kcl1300-1700cPs, spindle 3 No. 60 rpm) and used in the method of JP 2007. CMC and xanthan were first blended, then dissolved in water, and stirred at 2,000 for 1 minute. The apparent viscosity of the composition using this food grade CMC was 17,500 mpa-s compared to the viscosity of 4,780 mpa-s reported in JP 2007. The compositions are viscous and exhibit limited pourability and flowability. When used in a pump device as described herein, the composition deteriorates upon dispensing, indicating that the composition has poor shear resistance and is unsuitable for bulk storage and delivery. When mixed with water in a ratio of 1:5, the resulting solution had an apparent viscosity of 300 mPas. This thickened aqueous solution also had poor clarity (47.8% transmittance at 650 nm) and contained undispersed, cloudy thickener composition caking as shown in fig. 3 h. The thickened aqueous solution also showed poor stability and was easy to separate within 24 hours (fig. 4 h).

Comparative example 8 shows the results obtained when a combination of food-grade CMC was used in the method of JP 2007. According to the teachings of JP2007, CMC is first dissolved in water and stirred at 2000rpm for 5 minutes. Then, xanthan gum was added and the solution was stirred at 2000rpm for another 1 minute. The apparent viscosity of the composition was 7,000 mPas, but showed poor pourability and flowability. When used in a pump device as described herein, the composition deteriorates upon dispensing, indicating that the composition has poor shear resistance and is unsuitable for bulk storage and delivery. When mixed with water in a ratio of 1:5, the resulting solution had an apparent viscosity of 400mPa.s. This solution has high clarity (98.4% transmittance at 650 nm) but contains undispersed, cloudy thickener composition lumps, as shown in FIG. 3 i. The solution also showed poor stability and was easy to separate within 24 hours (fig. 4 i).

As can be seen from the above comparative examples, repeating the prior art process with food grade materials does not produce the following thickeners: flowable, pumpable, homogeneous (i.e., without undispersed gum/polysaccharide/food grade thickener agglomerations or domains), dispersible into aqueous liquids such that the thickened liquid is homogeneous, has sufficient hydration rate to reach peak viscosity in short time frames (i.e., about 30-60 seconds) under low shear (i.e., with a fork/scoop 80-160 BPM), is able to withstand shear when delivered with a food grade pump, does not separate over time, is clear (has no color), and has little or no odor or taste. In all of the above cases related to the prior art, the resulting thickened compositions lack one or more of these desirable properties and are therefore unsuitable for use as thickeners for patients suffering from dysphagia.

Without wishing to be bound by any theory, the inventors postulate that the above results are due to the use of only food grade CMC sodium, rather than the industrial grade known to have lower apparent viscosity. Specifically, for a 2% solution, the lowest food grade that can be purchased in commercial quantities is 10-20 mPa-s. In contrast, JP2007 requires the use of CMC sodium with a viscosity of 18 mPa-s (for a 10% solution). The inventors postulate that this is an important contributor and that this is an industrial purification grade, and therefore JP2007 has no applicability in modifying liquids to treat dysphagia. As shown in table 3, the use of food grade CMC sodium in the process of JP2007 caused the concentrate viscosity to be too high to achieve the readily dispersible flowable, pumpable liquid in the present application. When the teachings of JP2007 are combined with the hydrolysis step (comparative example 4), the resulting composition is still not capable of achieving the dispersibility, flowability, pourability and pumpability of the claimed invention.

Rather, in a preferred embodiment, the claimed invention has each of the aforementioned characteristics. For example, the food grade thickener of example 4 has an apparent viscosity of 4,000 mPas and is homogeneous, flowable and pourable. When water is used in an amount of 1:5, the thickener rapidly disperses and rapidly expresses its viscosity (within about 30 seconds), thickening the solution to 3000 mPa-s. The thickened water was homogeneous and had high clarity (84.7% transmittance at 650 nm) and did not deteriorate when dispensed by a pump device, indicating shear resistance and suitability for bulk storage and delivery.

The data shown herein relating to the method of the claimed invention clearly show that food grade thickeners that achieve the following objectives: food grade, pumpable, pourable, clear. It is further shown herein that repeating the method of JP2007 with food grade polysaccharides does not achieve these objectives. Thus, it is also shown herein that JP2007 uses technical grade polysaccharides to achieve the results claimed herein, and it should be understood that technical grade polysaccharides are not suitable for human consumption. It will be appreciated that a unique combination of first and second polysaccharides is employed with the hydrolysis step, and that the gum is then added to the hydrolyzed mixture under conditions such that the gum only partially expresses its viscosity and thereby forms a food grade thickener. It has been shown herein that the resulting food grade thickener has cohesive and adhesive properties that make it particularly suitable for delivery by pumping equipment, and is flowable, pumpable, dispersible, clear and/or clear in the target food, is homogenous and/or homogeneous in the target food, and has little or no odor or taste and/or imparts little or no odor or taste to the target food.

Table 3: summary of the comparison data.

1. Measured at 25℃using a Brookfield rotational viscometer, 20rpm (spindle No. 5 or 6, depending on the viscosity).

2. Measured using a type B viscometer.

3. Stir at 75rpm for 30 seconds.

4. Stir at 4rpm for 15 seconds.

Experiment and test

Test A1: preparation method

The following general procedure was used to prepare thickener compositions and was used with respect to the following tests A2 and A3.

Dissolving the polysaccharide having a molecular weight of less than 500000 in water with sufficient agitation.

Other additives such as food acids, pigments, flavors and preservatives are added to the solution and mixed until dissolved.

The solution is heated to 60 ℃ to 90 ℃.

Add thickener to the hot solution and mix until dispersed.

The resulting solution is then hot-filled into food packaging at a minimum temperature of 60 ℃.

Test A2: composition 1

Using the method described in test A1, this composition was a 2500cP flowable liquid. When 5g of this liquid was added to 100 ml of orange juice and thoroughly mixed to dispersion, the resulting solution thickened rapidly to a viscosity of 250 cP. The composition is stable and has a shelf life of 10 months when stored at room temperature.

Test A3: composition 2

Using the method described in test A1, this composition was a 1700cP flowable liquid. When 10g of this liquid was added to 100 ml of water and thoroughly mixed to disperse, the resulting solution thickened rapidly to a viscosity of 430 cP. The composition is stable and has a shelf life of 12 months when stored at room temperature.

Test A4: composition 3

Arabinogalactan fragment solutions were obtained from acid hydrolysis (at 80 ℃) of polysaccharides extracted from Acacia tree. A 16% dry solids solution of arabinogalactan fragment solution was obtained by concentrating (removing water) to produce a solution with a viscosity of 55 cP. 9wt.% xanthan gum was then added to produce a thickened concentrate having a viscosity of 1100 cP. The solution was acidified to pH 4.5 with sodium bisulphite and 1000ppm benzoic acid was added as preservative. The solution was then heated to 78 ℃ and hot filled in plastic bottles. When 15g of this thickening concentrate was added to 100 ml of miso soup and thoroughly mixed until dispersed, the resulting solution thickened rapidly to a viscosity of 620 cP. The composition is stable and has a shelf life of 12 months when stored at room temperature.

Test A5: composition 4

A 7wt% solution of xanthan gum was enzymatically hydrolyzed using a xanthan depolymerase (endo-beta-1, 4-glucanase). The viscosity of the resulting solution was 83cP. The enzyme hydrolysate was filtered and purified to remove suspended materials and contaminants, and then 7wt.% of natural unhydrolyzed xanthan gum powder was added to the solution to produce a thickened concentrate having a viscosity of 1650 cP. The solution was acidified to pH 4.5 with citric acid and 1000ppm benzoic acid was added as preservative. The solution was then heated to 75 ℃ and hot filled in plastic bottles. When 5g of this thickened concentrate was added to 100 ml of hot green tea and thoroughly mixed to disperse, the resulting solution thickened rapidly to a viscosity of 110 cP. The composition is stable and has a shelf life of 9 months when stored at room temperature.

Test B: preparation method

Test B1

4 parts of sodium carboxymethylcellulose of moderate viscosity (degree of polymerization 750-1000) are added to 96 parts of water and mixed to disperse the powder. The viscosity of the solution was measured to be 977 mPas (rotor 3, 30rpm, using an NDJ-5S digital rotary viscometer). The solution was acidified to pH 4.2 using glucono delta lactone and heated to 90 ℃ for 120 minutes. The solution was cooled to room temperature and the viscosity of the acid hydrolyzed solution was measured and found to be 312 mPa-S (rotor 3, 30rpm, using an NDJ-5S digital rotary viscometer). A more than 3-fold reduction in viscosity is achieved by acid hydrolysis.

5 parts of xanthan gum are added with slow mixing to the cooled acid hydrolyzed solution of sodium carboxymethylcellulose. This resulted in a 2160 mPa-S (rotor 1, 30rpm, using NDJ-5S digital rotary viscometer) flowable food grade thickener with a viscosity of 1/9 of that of a 5% xanthan solution in water, demonstrating the effectiveness of acid hydrolyzed sodium carboxymethyl cellulose in inhibiting the viscosity of xanthan gum (see fig. 6).

When 8 parts of the xanthan gum-containing solution prepared above was added to 92 parts of water and gently mixed by hand, the liquid was rapidly dispersed and the viscosity of the water was increased to 727 mPa-S (rotor 2, 30rpm, using NDJ-5S digital rotary viscometer) within 30 seconds of mixing.

This formulation was made shelf stable by adding 700ppm potassium sorbate (or other food preservative allowed) and hot-filling into a hermetically sealed container at 80 ℃, with a shelf life of at least 12 months.

Test B2

6 parts of sodium alginate are added to 94 parts of water and mixed to disperse the powder. The viscosity of the solution was measured to be 3948 mPas (rotor 3, 30rpm, using an NDJ-5S digital rotary viscometer). The solution was acidified to pH 4.4 using citric acid and heated to 90 ℃ for 60 minutes. The solution was cooled to room temperature and the viscosity of the acid hydrolyzed solution was measured and found to be 63 mPa-S (rotor 1, 60rpm, using an NDJ-5S digital rotary viscometer). A more than 63-fold reduction in viscosity is achieved by acid hydrolysis.

5 parts of xanthan gum are added with slow mixing to the cooled acid hydrolyzed solution of sodium alginate. This resulted in 3948 mPa-S (rotor 3, 30rpm, using NDJ-5S digital rotary viscometer) of flowable food grade thickener with a viscosity of almost 1/5 of that of a 5% xanthan solution in water, demonstrating the effectiveness of acid hydrolyzed sodium alginate in inhibiting the viscosity of xanthan gum (see figure 7).

When 8 parts of the xanthan gum-containing solution prepared above was added to 92 parts of water and gently mixed by hand, the liquid was rapidly dispersed and the viscosity of the water was increased to 768 mPa-S within 30 seconds of mixing (rotor 2, 30rpm, using NDJ-5S digital rotary viscometer).

Test B3

2 parts of xanthan gum are added to 98 parts of water and mixed to disperse the powder. The viscosity of the solution was measured to be 3827 mPas (rotor 3, 30rpm, using an NDJ-5S digital rotary viscometer). The xanthan gum depolymerase was combined with 0.4mM MgSO at a concentration of 3.6X10-4 IU/mL ₄ And 0.03mM MnSO ₄ Added together in 0.05M sodium acetate buffer (pH 5.4) and incubated at 32-34℃for 20 min. The enzyme was deactivated by heating to 50 ℃, then the solution was cooled to room temperature, and its viscosity was measured. The viscosity after enzymatic hydrolysis was found to be 94 mPas (rotor 1, 30rpm, using an NDJ-5S digital rotary viscometer). A 40-fold reduction in viscosity was achieved by enzymatic hydrolysis.

5 parts of xanthan gum are added with slow mixing to the cooled enzymatically hydrolyzed solution of xanthan gum. This resulted in 2455 mPa-S (rotor 2, 30rpm, using NDJ-5S digital rotary viscometer) of flowable food grade thickener, which was 1/8 of the viscosity of a 5% xanthan solution in water, demonstrating the effectiveness of enzymatically hydrolyzed xanthan in inhibiting the viscosity of unhydrolyzed xanthan (see figure 8).

When 8 parts of the xanthan gum-containing solution prepared above was added to 92 parts of water and gently mixed by hand, the liquid was rapidly dispersed and the viscosity of the water was increased to 740 mPa-S (rotor 2, 30rpm, using NDJ-5S digital rotary viscometer) within 30 seconds of mixing.

This formulation was made shelf-stable by adding 0.6w/w% glucono delta-lactone (or other allowed food acids) and 700ppm potassium sorbate (or other allowed food preservatives) and hot filling into a hermetically sealed container at 80 ℃, where the shelf life was at least 12 months.

Test B4

2 parts of guar gum was added to 98 parts of water and mixed to disperse the powder. The viscosity of the solution was measured to be 2870 mPas (rotor 3, 30rpm, using an NDJ-5S digital rotary viscometer). Beta-mannanase is added in an amount of 8.3x10 ^-4 Concentration of IU/mLAdded together with phosphate buffer (pH 7.0) and incubated for 30 min at 25 ℃. The enzyme was deactivated by heating to 90 ℃, then the solution was cooled to room temperature, and the viscosity was measured. Viscosity after enzymatic hydrolysis = 410 mpa.s (rotor 1, 30rpm, NDJ-5S digital rotary viscometer). A 7-fold reduction in viscosity is achieved by enzymatic hydrolysis.

5 parts of xanthan gum are added with slow mixing to the cooled enzymatically hydrolyzed solution of guar gum. This resulted in a 3475 mPa-S (rotor 2, 30rpm, using NDJ-5S digital rotary viscometer) flowable food grade thickener with a viscosity of 1/5 of that of a 5% xanthan solution in water, demonstrating the effectiveness of enzymatically hydrolyzed guar in inhibiting the viscosity of xanthan gum (see figure 9).

When 8 parts of the xanthan gum-containing solution prepared above was added to 92 parts of water and gently mixed by hand, the liquid was rapidly dispersed and the viscosity of the water was increased to 790 mPa-S (rotor 2, 30rpm, using NDJ-5S digital rotary viscometer) within 30 seconds of mixing.

This formulation was made shelf stable by adding 0.6% w/w glucono delta-lactone (or other allowed food acids) and 700ppm potassium sorbate (or other allowed food preservatives) and hot filling into a hermetically sealed container at 80 ℃, where the shelf life was at least 12 months.

Test B5

4 parts of methyl ethyl cellulose having an average degree of polymerization of 250 was added to 96 parts of water and mixed to disperse the powder. The viscosity of the solution was measured to be 95 mPas (rotor 1, 30rpm, using an NDJ-5S digital rotary viscometer).

5 parts of xanthan gum are added to the solution of methyl ethyl cellulose with slow mixing. This resulted in 3340 mPa-S (rotor 3, 30rpm, using NDJ-5S digital rotary viscometer) of flowable food grade thickener with a viscosity of about 1/6 of that of a 5% xanthan solution in water, demonstrating the effectiveness of methyl ethyl cellulose with an average degree of polymerization of 250 in suppressing the viscosity of xanthan (see figure 10).

Test B6

2.5 parts of sodium carboxymethylcellulose having an average degree of polymerization of 120 to 150 are added to 97.5 parts of water and mixed to disperse the powder. The viscosity of the solution was measured to be 39 mPas (rotor 1, 30rpm, using an NDJ-5S digital rotary viscometer). 4.5 parts of xanthan gum are added to the solution of sodium carboxymethylcellulose with slow mixing. This resulted in a flowable food grade thickener of 2450mpa.s (rotor 3, 60rpm, using NDJ-5S digital rotary viscometer) at about 1/8 of the viscosity of a 5% xanthan solution in water, demonstrating the effectiveness of sodium carboxymethyl cellulose with an average degree of polymerization of 120-150 in inhibiting the viscosity of xanthan gum (see figure 11).

When 7 parts of the xanthan gum-containing solution prepared above was added to 93 parts of water and gently mixed by hand, the liquid was rapidly dispersed and the viscosity of the water was increased to 747 mPa-S (rotor 2, 30rpm, using NDJ-5S digital rotary viscometer) within 30 seconds of mixing.

Test B7

The following formulation gives examples of how the three types of low viscosity highly soluble polysaccharides mentioned above can be combined to produce a flowable viscosity-inhibiting composition:

water-91 w/w%

Xanthan gum (in its naturally unhydrolyzed form) -5w/w%

Xanthan gum (enzymatically hydrolyzed) -1w/w%

Sodium carboxymethylcellulose (degree of polymerization 120-150) -1.0. 1.0 w/w%

Sodium carboxymethylcellulose (degree of polymerization >500, acid hydrolysed) -0.5w/w%

Sodium alginate (acid hydrolyzed) -1w/w%

Pectin (acid hydrolyzed) -1w/w%

The method comprises the following steps: 1 part of xanthan gum was added to 99 parts of water and mixed to disperse the powder. The xanthan gum depolymerase is mixed with 0.4mM MgSO at a concentration of 3.6X10-4IU/mL ₄ And 0.03mM MnSO ₄ Added together in 0.05M sodium acetate buffer (pH 5.4) and incubated at 32-34℃for 20 min. Three gums to be acid hydrolyzed (0.5 parts sodium carboxymethylcellulose-degree of polymerization greater than 500;1 part sodium alginate; and 1 part pectin) were added with good shear mixing and acidified to pH 4.1 using glucono delta lactone. The solution was heated to 90 ℃ for 60 minutes (this heating step also deactivates the xanthan depolymerase). Finally, 1 part of sodium carboxymethylcellulose (polymerization degree 120 to 150) is added with good shear mixing. The viscosity of the solution was measured to be 76 mPas (rotor 1, 30rpm, using an NDJ-5S digital rotary viscometer).

5 parts of xanthan gum are added with slow mixing to the mixture of low viscosity highly soluble polysaccharides prepared above. This resulted in 1740 mPa-S (rotor 1, 30rpm, using NDJ-5S digital rotary viscometer) of flowable food grade thickener, which is 1/11 of the viscosity of a 5% xanthan solution in water, demonstrating the effectiveness of the mixture in suppressing the viscosity of xanthan gum (see fig. 12). When used alone in the above tests B1-6, the effect was similar and in some cases superior to the low viscosity highly soluble polysaccharide alone.

When 8 parts of the xanthan gum-containing solution prepared above was added to 92 parts of water and gently mixed by hand, the liquid was rapidly dispersed and the viscosity of the water was increased to 705 mPa-S (rotor 2, 30rpm, using NDJ-5S digital rotary viscometer) within 30 seconds of mixing.

Test B8

The following formulation shows how the three types of low viscosity highly soluble polysaccharides mentioned above can be combined to produce a flowable viscosity-inhibiting composition:

water-80 w/w%

Sodium alginate (in its natural unhydrolyzed form) -8w/w%

Pectin (acid hydrolyzed) -1w/w%

Hydroxypropyl methylcellulose (degree of polymerization 200) -1w/w%

Guar gum (enzymatically hydrolyzed) -1w/w%

The method comprises the following steps: 1 part guar gum was added to 99 parts water and mixed to disperse the powder. Beta-mannanase was added together with phosphate buffer (pH 7.0) at a concentration of 8.3X10-4 IU/mL. The solution was incubated at 25℃for 30 minutes. Pectin was then added to carry out acid hydrolysis (1 part) with good shear mixing and the solution was acidified to pH 4.1 using tartaric acid. The solution is then heated to 90 ℃ for 60 minutes (this heating step also deactivates the beta-mannanase). Finally, 1 part of hydroxypropyl methylcellulose (polymerization degree 200) was added with good shear mixing. The viscosity of the solution was measured to be 75 mPas (rotor 1, 30rpm, using an NDJ-5S digital rotary viscometer).

8 parts of sodium alginate were added with slow mixing to the mixture of low viscosity highly soluble polysaccharides prepared above. This resulted in a flowable food grade thickener of 440 mpa.s (rotor 1, 30rpm, using NDJ-5S digital rotary viscometer) with a viscosity of 1/10 of that of an 8% sodium alginate solution in water, demonstrating the effectiveness of the mixture in inhibiting the viscosity of sodium alginate (see figure 13).

When 12 parts of the sodium alginate gel-containing solution prepared above was added to 88 parts of water and gently mixed by hand, the liquid was rapidly dispersed and the viscosity of the water was increased to 610 mPa-S (rotor 2, 30rpm, using NDJ-5S digital rotary viscometer) within 30 seconds of mixing.

Although the invention has been described with reference to specific examples, those skilled in the art will recognize that the invention may be embodied in many other forms, as the specific features of any of the various described examples may be provided in any combination in any other described examples. It will be apparent to those skilled in the art that various modifications and variations can be made to the present invention without departing from the scope or spirit of the invention. It should be understood that the present invention is not intended to be unduly limited by the illustrative embodiments and examples set forth herein and such examples and embodiments are presented by way of example only with the scope of the invention intended to be limited only by the claims set forth herein as follows.

Other embodiments of the invention described herein are defined in the following paragraphs:

1. a method for providing a food grade thickener, the method comprising the steps of:

providing an aqueous phase;

adding a polysaccharide to the aqueous phase, thereby forming a gelled mixture;

2. The method of paragraph 1, wherein the polysaccharide is selected from the group consisting of: agar, alginic acid, carrageenan, guar gum, tragacanth, gellan gum, microcrystalline cellulose, sodium carboxymethyl cellulose, methyl cellulose, hydroxypropyl cellulose, methyl ethyl cellulose, karaya gum, locust bean gum, tara gum, psyllium seed gum, quince seed gum, pectin, furcellaran, gellan gum, konjak, sodium alginate, xanthan gum, or any combination thereof.

3. The method of any one of the preceding paragraphs, wherein the polysaccharide is added to the aqueous phase at a concentration of about 0.5wt% to 30 wt%.

4. The method of any one of the preceding paragraphs, wherein the gelled mixture is hydrolyzed at a temperature of about 50 ℃ to 95 ℃.

5. The method of any of the preceding paragraphs, wherein the gelled mixture is hydrolyzed for a duration of about 2 hours to 72 hours.

6. The method of any one of the preceding paragraphs, wherein the gelled mixture is acid hydrolyzed to produce a hydrolyzed gelled mixture.

7. The method of any one of the preceding paragraphs, wherein the hydrolyzed gelled mixture has a viscosity of about 40-150cP measured at 10RPM using a brookfield viscometer spindle No. 5 at 20 ℃.

8. The method of any one of the preceding paragraphs, wherein the glue is selected from the group consisting of: agar, alginic acid, carrageenan, guar gum, tragacanth gum, gellan gum, microcrystalline cellulose, sodium carboxymethyl cellulose, methyl cellulose, hydroxypropyl cellulose, methyl ethyl cellulose, karaya gum, locust bean gum, tara gum, psyllium seed gum, quince seed gum, pectin, furcellaran, gellan gum, konjak, sodium alginate, coumarone gum, guar gum, tara gum and locust bean gum, xanthan gum, and any combination thereof.

9. The method of any of the preceding paragraphs, wherein the gum is added at a concentration of about 2wt% to 30 wt%.

10. A food grade thickener when produced by the method of any of paragraphs 1 to 9.

11. The food grade thickener of paragraph 10, wherein the food grade thickener is stable for at least six months.

12. The food grade thickener of any of paragraphs 10 to 11, wherein the food grade thickener has a viscosity of about 500 to 10,000cP measured at 5RPM using a brookfield viscometer spindle 3 at 20 ℃.

13. The food grade thickener of any of paragraphs 10 through 12, wherein the food grade thickener has an anti-flow property of greater than about 12cm measured at 20 ℃ using a Bostwick consistometer at 30 seconds.

14. The food grade thickener of any of paragraphs 10 through 13, wherein a 7wt% solution of the food grade thickener and water has a light transmittance of about >90% at 650nm when measured using a 1cm path length.

15. A method for increasing the viscosity of an aqueous liquid or aqueous liquid-solid mixture food, the method comprising the step of adding the food grade thickener of any of paragraphs 10 to 14 to the food.

16. The method of paragraph 15, wherein the amount of food-grade thickener added is about 1wt% to 30wt%.

17. The method of paragraph 15 or paragraph 16, wherein adding the food-grade thickener to the food increases the viscosity of the food to at least about 95cP.

18. A method of treating a subject suffering from a chewing and/or swallowing disease, disorder or condition, the method comprising the step of administering to the subject a food, wherein the food comprises a food grade thickener according to any of paragraphs 10 to 14.

19. Use of a food grade thickener according to any of paragraphs 10 to 14 for the manufacture of a medicament for the treatment or amelioration of a chewing and/or swallowing disease, disorder or condition.

20. A method of overcoming or ameliorating dysphagia in a patient in need of such treatment, the method comprising the step of thickening a food or beverage for consumption by the patient with a food grade thickener according to any of paragraphs 10 to 14.

21. Use of a food grade thickener according to any of paragraphs 10 to 14 for the manufacture of a medicament for overcoming or ameliorating dysphagia in a patient in need of such treatment.

22. A storage and delivery system for a food grade thickener, the storage and delivery system comprising: a container containing a food grade thickener according to any of paragraphs 10 to 14; and a pump dispenser sealingly attached to the container, the dispenser comprising a valve for inhibiting or preventing drying of the composition in the container.

23. A kit for a storage and delivery system for food grade thickeners, the kit comprising:

a container containing a food grade thickener according to any of paragraphs 10 to 14; and a pump dispenser for attachment to the container, wherein the pump dispenser comprises a valve for inhibiting or preventing drying of the composition in the container.

24. A method of delivering a food grade thickener to an aqueous liquid or aqueous liquid-solid mixture food, the method comprising the steps of:

providing a container containing the food grade thickener of any of paragraphs 10 to 14; and applying a force to the pump dispenser to thereby deliver one or more doses of the predetermined volume of the food-grade thickener into the foodstuff.

25. The system of paragraph 22, or the kit of paragraph 23, or the method of paragraph 24, wherein a predetermined volume of one, two, and three doses of the food-grade thickener increases the viscosity of the food to a first viscosity level, a second viscosity level, and a third viscosity level, respectively, and wherein a non-linear relationship exists between the first viscosity level, the second viscosity level, and the third viscosity level.

26. The system of paragraph 22 or 25, or the kit of paragraph 23 or paragraph 25, or the method of paragraph 24 or 25, wherein the pump dispenser comprises a valve for inhibiting or preventing the composition in the container from drying.

27. The system of any one of paragraphs 22 or 25 to 26, or the kit of any one of paragraphs 23 or 25 to 26, or the method of any one of paragraphs 24 to 26, wherein the valve is or comprises a self-sealing valve.

28. The system of paragraph 27, or the kit of paragraph 27, or the method of paragraph 27, wherein the valve is selected from the group consisting of: cross slit valves, ball valves, flapper valves, umbrella valves, duckbill valves, reed valves, and any combination thereof.

29. The system of paragraph 27, or the kit of paragraph 27, or the method of paragraph 27, wherein the valve is biased to a closed position and upon application of a force to the pump dispenser, the valve is actuated to an open position, thereby forcing the composition to flow through the valve.

30. The system of any one of paragraphs 22 or 25 to 29, or the kit of any one of paragraphs 23 or 25 to 29, or the method of any one of paragraphs 24 to 29, wherein the pump dispenser comprises a dispenser tip comprising the valve disposed therein.

31. A composition for assisting or ameliorating a swallowing disorder, the composition comprising a pourable food grade thickener having an apparent viscosity of substantially less than about 5,000cps measured at 20 ℃ using a spindle No. 3 at 5rpm and a resistance to flow of greater than about 12cm measured at 20 ℃ using a Bostwick consistometer at 30 seconds, and wherein a 7wt% solution of the food grade thickener and water has a light transmittance of >90% at 650nm when measured with a path length of 1 cm.

32. A method for providing a food grade thickener, the method comprising the steps of:

A water continuous phase of the first polysaccharide is established,

adding a second polysaccharide to the continuous phase, thereby forming a gelled mixture,

hydrolyzing the gelled mixture to reduce the viscosity of the gelled mixture, and

33. The method of paragraph 32, wherein the first polysaccharide is selected from the group consisting of: agar, alginic acid, carrageenan, guar gum, tragacanth, gellan gum, microcrystalline cellulose, sodium carboxymethyl cellulose, methyl cellulose, hydroxypropyl cellulose, methyl ethyl cellulose, karaya gum, locust bean gum, tara gum, psyllium seed gum, quince seed gum, pectin, furcellaran, gellan gum, konjak, sodium alginate or xanthan gum, and any combination thereof.

34. The method of any one of paragraphs 32 to 33, wherein the aqueous continuous phase comprises about 0.002wt.% to 1.0wt.% of the first polysaccharide.

35. The method of any one of paragraphs 32 to 34, wherein the aqueous continuous phase is heated to melt the first polysaccharide.

36. The method of any one of paragraphs 32 to 35, wherein the second polysaccharide is selected from the group consisting of: agar, alginic acid, carrageenan, guar gum, tragacanth, gellan gum, microcrystalline cellulose, sodium carboxymethyl cellulose, methyl cellulose, hydroxypropyl cellulose, methyl ethyl cellulose, karaya gum, locust bean gum, tara gum, psyllium seed gum, quince seed gum, pectin, furcellaran, gellan gum, konjak, sodium alginate, xanthan gum, or any combination thereof.

37. The method of any one of paragraphs 32 to 36, wherein the second polysaccharide is added to the aqueous phase at a concentration of about 0.5wt% to 30 wt%.

38. The method of any one of paragraphs 32 to 37, wherein the gelled mixture is hydrolyzed at a temperature of about 50 ℃ to 95 ℃.

39. The method of any one of paragraphs 32 to 38, wherein the gelled mixture is hydrolyzed for a duration of about 2 to 72 hours.

40. The method of any one of paragraphs 32 to 39, wherein the gelled mixture is acid hydrolyzed to produce a hydrolyzed gelled mixture.

41. The method of any one of paragraphs 32 to 40, wherein the hydrolyzed gelled mixture has a viscosity of about 40-150cP measured at 10RPM using a brookfield viscometer spindle 1 at 20 ℃.

42. The method of any one of paragraphs 32 to 41, wherein the glue is selected from the group consisting of: agar, alginic acid, carrageenan, guar gum, tragacanth gum, gellan gum, microcrystalline cellulose, sodium carboxymethyl cellulose, methyl cellulose, hydroxypropyl cellulose, methyl ethyl cellulose, karaya gum, locust bean gum, tara gum, psyllium seed gum, quince seed gum, pectin, furcellaran, gellan gum, konjak, sodium alginate, coumarone gum, guar gum, tara gum and locust bean gum, xanthan gum, and any combination thereof.

43. The method of any one of paragraphs 32 to 42, wherein the gum is added at a concentration of about 2wt% to 30 wt%.

Claims

providing an aqueous phase;

adding a polysaccharide to the aqueous phase, thereby forming a gelled mixture;

2. The method of claim 1, wherein the polysaccharide is selected from the group consisting of: agar, alginic acid, carrageenan (guar gum), guar gum (gum), gum tragacanth (gum tragacanth), gellan gum (gum ghatti), microcrystalline cellulose, sodium carboxymethyl cellulose, methyl cellulose, hydroxypropyl methylcellulose, hydroxypropyl cellulose, methyl ethyl cellulose, karaya gum (gum karaya), locust bean gum (locustbean gum), tara gum (tara gum), psyllium seed gum (psyllium seed gum), quince seed gum (essential seed gum), pectin, furcatenin (furcatelan gum), gellan gum, konjak, sodium alginate, xanthan gum (xanthan gum), or any combination thereof.

3. The method of any one of the preceding claims, wherein the polysaccharide is added to the aqueous phase at a concentration of about 0.5wt% to 30 wt%.

4. The method of any one of the preceding claims, wherein the gelled mixture is hydrolyzed at a temperature of about 50 ℃ to 95 ℃.

5. The method of any one of the preceding claims, wherein the gelled mixture is hydrolyzed for a duration of about 2 hours to 72 hours.

6. The method of any one of the preceding claims, wherein the gelled mixture is acid hydrolyzed to produce a hydrolyzed gelled mixture.

7. The method of any one of the preceding claims, wherein the hydrolyzed gelled mixture has a viscosity of about 40-150cP measured at 10rpm using a brookfield viscometer (Brookfield viscometer) spindle 1 at 20 ℃.

8. The method of any one of the preceding claims, wherein the glue is selected from the group consisting of: agar, alginic acid, carrageenan, guar gum, tragacanth gum, gellan gum, microcrystalline cellulose, sodium carboxymethyl cellulose, methyl cellulose, hydroxypropyl cellulose, methyl ethyl cellulose, karaya gum, locust bean gum, tara gum, psyllium seed gum, quince seed gum, pectin, furcellaran, gellan gum, konjak, sodium alginate, coumarone gum (fenugreek gum), guar gum, tara gum and locust bean gum, xanthan gum, and any combination thereof.

9. The method of any of the preceding claims, wherein the gum is added at a concentration of about 2wt% to 30 wt%.

10. A food grade thickener when produced by the method of any of claims 1 to 9.

11. The food grade thickener of claim 10, wherein the food grade thickener is stable for at least six months.

12. The food grade thickener of any of claims 10 to 11, wherein the food grade thickener has a viscosity of about 500cP to 10,000cP measured at 20 ℃ using a brookfield viscometer spindle number 5 at 10 rpm.

13. The food grade thickener of any of claims 10 to 12, wherein the food grade thickener has an anti-flow property of greater than about 12cm measured at 20 ℃ using a Bostwick consistometer at 30 seconds.

14. The food grade thickener of any of claims 10 to 13, wherein a 7wt% solution of the food grade thickener and water has a light transmittance of approximately >90% at 650nm when measured using a 1cm path length.

15. A method for increasing the viscosity of an aqueous liquid or aqueous liquid-solid mixture food, the method comprising the step of adding to the food a food grade thickener according to any of claims 10 to 14.

16. The method of claim 15, wherein the amount of food grade thickener added is about 1wt% to 30wt%.

17. The method of claim 15 or claim 16, wherein adding the food-grade thickener to the food increases the viscosity of the food to at least about 95cP.

18. A method of treating a subject suffering from a chewing and/or swallowing disease, disorder or condition, the method comprising the step of administering to the subject a food, wherein the food comprises the food grade thickener according to any one of claims 10 to 14.

19. Use of a food grade thickener according to any of claims 10 to 14 for the manufacture of a medicament for the treatment or amelioration of chewing and/or swallowing diseases, disorders or conditions.

20. A method of overcoming or ameliorating dysphagia in a patient in need of such treatment, the method comprising the step of thickening a food or beverage with a food grade thickener according to any one of claims 10 to 14 for consumption by the patient.

21. Use of a food grade thickener according to any of claims 10 to 14 for the manufacture of a medicament for overcoming or ameliorating dysphagia in a patient in need of such treatment.

22. A storage and delivery system for a food grade thickener, the storage and delivery system comprising:

a container containing a food grade thickener according to any of claims 10 to 14; and

a pump dispenser sealingly attached to the container, the dispenser comprising a valve for inhibiting or preventing drying of the composition in the container.

a pump dispenser for attachment to the container, wherein the pump dispenser comprises a valve for inhibiting or preventing drying of the composition in the container.

providing a container containing a food grade thickener according to any of claims 10 to 14; and

a force is applied to the pump dispenser to thereby deliver one or more doses of a predetermined volume of the food grade thickener into the foodstuff.

25. The system of claim 22, or the kit of claim 23, or the method of claim 24, wherein predetermined volumes of one, two, and three doses of the food grade thickener increase the viscosity of the food to a first viscosity level, a second viscosity level, and a third viscosity level, respectively, and wherein a non-linear relationship exists between the first viscosity level, the second viscosity level, and the third viscosity level.

26. The system of claim 22 or 25, or the kit of claim 23 or claim 25, or the method of claim 24 or claim 25, wherein the pump dispenser comprises a valve for inhibiting or preventing drying of the composition in the container.

27. The system of any one of claims 22 or 25 to 26, or the kit of any one of claims 23 or 25 to 26, or the method of any one of claims 24 to 26, wherein the valve is or comprises a self-sealing valve.

28. The system of claim 27, or the kit of claim 27, or the method of claim 27, wherein the valve is selected from the group consisting of: cross slit valves, ball valves, flapper valves, umbrella valves, duckbill valves, reed valves, and any combination thereof.

29. The system of claim 27, or the kit of claim 27, or the method of claim 27, wherein the valve is biased to a closed position and upon application of a force to the pump dispenser, the valve is actuated to an open position, forcing the composition to flow through the valve.

30. The system of any one of claims 22 or 25 to 29, or the kit of any one of claims 23 or 25 to 29, or the method of any one of claims 24 to 29, wherein the pump dispenser comprises a dispenser tip comprising the valve disposed therein.

31. A composition for assisting or ameliorating a swallowing disorder, the composition comprising a pourable food grade thickener having an apparent viscosity of substantially less than about 5,000cps measured at 20 ℃ using spindle 3 at 5rpm and a resistance to flow of greater than about 12cm measured at 20 ℃ using a Bostwick consistometer at 30 seconds, and wherein a 7wt% solution of the food grade thickener and water has a light transmittance of >90% at 650nm when measured with a path length of 1 cm.

a water continuous phase of the first polysaccharide is established,

33. The method of claim 32, wherein the first polysaccharide is selected from the group consisting of: agar, alginic acid, carrageenan, guar gum, tragacanth, gellan gum, microcrystalline cellulose, sodium carboxymethyl cellulose, methyl cellulose, hydroxypropyl cellulose, methyl ethyl cellulose, karaya gum, locust bean gum, tara gum, psyllium seed gum, quince seed gum, pectin, furcellaran, gellan gum, konjak, sodium alginate or xanthan gum, and any combination thereof.

34. The method of any one of claims 32 to 33, wherein the aqueous continuous phase comprises about 0.002wt.% to 1.0wt.% of the first polysaccharide.

35. The method of any one of claims 32 to 34, wherein the aqueous continuous phase is heated to melt the first polysaccharide.

36. The method of any one of claims 32 to 35, wherein the second polysaccharide is selected from the group consisting of: agar, alginic acid, carrageenan, guar gum, tragacanth, gellan gum, microcrystalline cellulose, sodium carboxymethyl cellulose, methyl cellulose, hydroxypropyl cellulose, methyl ethyl cellulose, karaya gum, locust bean gum, tara gum, psyllium seed gum, quince seed gum, pectin, furcellaran, gellan gum, konjak, sodium alginate, xanthan gum, or any combination thereof.

37. The method of any one of claims 32 to 36, wherein the second polysaccharide is added to the aqueous phase at a concentration of about 0.5wt% to 30 wt%.

38. The method of any one of claims 32 to 37, wherein the gelled mixture is hydrolyzed at a temperature of about 50 ℃ to 95 ℃.

39. The method of any one of claims 32 to 38, wherein the gelled mixture is hydrolyzed for a duration of about 2 hours to 72 hours.

40. The method of any one of claims 32 to 39, wherein the gelled mixture is acid hydrolyzed to produce a hydrolyzed gelled mixture.

41. The method of any one of claims 32 to 40, wherein the hydrolyzed gelled mixture has a viscosity of about 40-150cP measured at 20 ℃ using a brookfield viscometer spindle 1 at 10 rpm.

42. The method of any one of claims 32 to 41, wherein the glue is selected from the group consisting of: agar, alginic acid, carrageenan, guar gum, tragacanth gum, gellan gum, microcrystalline cellulose, sodium carboxymethyl cellulose, methyl cellulose, hydroxypropyl cellulose, methyl ethyl cellulose, karaya gum, locust bean gum, tara gum, psyllium seed gum, quince seed gum, pectin, furcellaran, gellan gum, konjak, sodium alginate, coumarone gum, guar gum, tara gum and locust bean gum, xanthan gum, and any combination thereof.

43. The method of any one of claims 32 to 42, wherein the gum is added at a concentration of about 2wt% to 30 wt%.