Granules, food product, and method for using granules

Abstract

The present invention provides granules for suppressing rises in water content in an edible capsule, the granules being characterized by containing a diluent and a binder and, in moisture adsorption isotherm analysis of the granules, having a weight change rate of at least 2% when the moisture activity (Aw) is 0.6. Further provided is a method for using granules for suppressing rises in water content, in an edible capsule in a system in which the edible capsule and granules co-exist. The granules contain a diluent and a binder and, in moisture adsorption isotherm analysis of the granules, have a weight change rate of at least 2% when the moisture activity (Aw) is 0.6.

Description

Granules, food products, and methods of using granules

[0001] This invention relates to granules that suppress the increase in moisture content of capsules.

[0002] Capsules, specifically those with a shell (coating) made of gelatin or similar material used in food and medicine, are used to ensure that the contents of the capsule are ingested by the human body through their ability to dissolve in saliva in the oral cavity. However, a drawback of capsules is that their shelf life, especially long-term storage, is compromised by the presence of moisture.

[0003] Japanese Patent Publication No. 2016-74615 (Patent Document 1) discloses a seamless capsule technology that can stably maintain a substance that is incompatible with water by blending the substance with porous fine particle powder (specific example: vapor-phase silica) in the core. However, even with the technology of Patent Document 1, the reduction of moisture content in the seamless capsule is not satisfactory, and it is difficult to avoid softening or deterioration of the capsule due to moisture present outside the seamless capsule.

[0004] Japanese Patent Publication No. 2016-74615

[0005] The present invention aims to enable long-term storage of capsules by developing granules that can suppress the increase in moisture content of capsules when coexisting with them.

[0006] In other words, the present invention provides the following aspects: [1] Granules that suppress the rise in moisture content in an edible capsule, wherein the granules contain an excipient and a binder, and in a moisture adsorption isotherm analysis of the granules, the weight change rate when the water activity (Aw) is 0.6 is 2% or more. [2] A food product containing the granules and the edible capsule. [3] A method for using granules that suppress the rise in moisture content in a capsule in a system in which an edible capsule and granules coexist, wherein the granules contain an excipient and a binder, and in a moisture adsorption isotherm analysis of the granules, the weight change rate when the water activity (Aw) is 0.6 is 2% or more.

[0007] In this invention, we have found that granules that suppress the rise in moisture content of capsules, when composed of excipients and binders as essential components, and when the granules are subjected to moisture adsorption isotherm analysis and the weight change rate is 2% or more at a water activity (Aw) of 0.6, suppress the rise in moisture content within the capsule. In this invention, the rise in moisture content of capsules can be suppressed in a system in which capsules and granules coexist, enabling long-term storage of capsules.

[0008] Figure 1 is a schematic diagram of a manufacturing apparatus used in the capsule manufacturing method according to the present invention. Figure 2 is a graph showing the relationship between water activity (Aw) and weight change rate (%) when the granules of Examples 1 to 3 according to the present invention are exposed to humidified air. Figure 3 is a graph showing the relationship between water activity (Aw) and weight change rate (%) when the granules of Examples 4 to 11 according to the present invention are exposed to humidified air.

[0009] The granules according to the present invention are granules that suppress the rise in moisture content in edible capsules (hereinafter simply referred to as "capsules"), wherein the granules contain an excipient and a binder, and the weight change rate when the water activity (Aw) of the granules is 0.6 is 2% or more in a moisture adsorption isotherm analysis.

[0010] By having a weight change rate of 2% or more, the increase in moisture content within the capsule can be suppressed. There is no particular upper limit to the weight change rate, but the weight change rate may be, for example, 20% or less. The weight change rate may be within the range of any two of the following: 3%, 4%, 5%, 6%, 7%, 8%, 9%, 10%, 12%, 14%, 16%, 18%, and 20%. The weight change rate may be, for example, 3% or more. The weight change rate may be, for example, 10% or less. Here, in this specification, "suppressing the increase in moisture content within the capsule" refers to suppressing the increase in moisture content throughout the entire capsule.

[0011] In this invention, "granules" refer to wet-process granulated materials, which are granular composites formed by binding together particles (including excipients and other components) that constitute powdered granular raw materials with a binder, and these composites have voids. The average particle size of such granules is preferably in the range of 50 μm to 2000 μm. Having the average particle size of the granules within the above range not only suppresses the rise in moisture content inside the capsule, but also suppresses the scattering of granules during use, making them easier to handle. The average particle size of the granules may be within the range of any two of the following: 50 μm, 70 μm, 100 μm, 150 μm, 170 μm, 175 μm, 178 μm, 180 μm, 200 μm, 220 μm, 250 μm, 260 μm, 270 μm, 280 μm, 300 μm, 330 μm, 350 μm, 370 μm, 400 μm, 430 μm, 450 μm, 470 μm, 500 μm, 700 μm, 1000 μm, 1200 μm, 1500 μm, 1700 μm, and 2000 μm. The average particle size of the granules may be, for example, 170 μm or more, or 175 μm or more. Furthermore, the average particle size of the granules may be, for example, 1000 μm or less, or 500 μm or less. The average particle size of the granules can be measured using a laser diffraction particle size distribution analyzer. This analyzer employs the laser diffraction and scattering method, and when a laser beam is shone on a particle, a unique pattern of diffracted and scattered light is generated depending on the size of the particle, and the particle size is measured from the pattern of this diffracted and scattered light.

[0012] Since the granules can be wet-molded granules, the granulation method is not particularly limited, as will be described later. For example, the granules may be fluid-bed granules, extruded granules, or stirred granules.

[0013] In one embodiment of the present invention, the granules contain excipients and binders as described above, but may further contain functional components as needed.

[0014] <Excipients> Excipients are generally known as ingredients added for purposes such as volume increase or dilution, but in this invention, they are powdered ingredients that also affect the weight change rate of the granules. In order to obtain such a weight change rate, the excipient content is 1% by weight or more relative to the dry weight of the granules. There is no particular upper limit to the excipient content, but for the sake of facilitating the production of granules, it may be, for example, 99% by weight or less. The excipient also contains starch. The excipient may consist only of starch, or it may further contain ingredients other than starch. Examples of starch contained in the excipient include starch derived from one or more plants selected from the group consisting of wheat, corn, potato, sweet potato, rice, cassava, kudzu, potato starch, mung bean, and bracken. The excipient preferably contains potato starch.

[0015] Potato starch is derived from the enlarged underground stem (the so-called tuber) of the potato plant. Potato starch used as an excipient is non-gelatinized (non-alpha-formulated) potato starch. The average particle size of non-gelatinized potato starch is, for example, 5 μm to 100 μm. Furthermore, the loose bulk density of non-gelatinized potato starch is, for example, 0.2 g / cm³. ３ ~0.6 g / cm ３ It is within the range. The bulk density of non-gelatinized potato starch can be measured in accordance with the 18th edition of the Japanese Pharmacopoeia. In the 18th edition of the Japanese Pharmacopoeia, "loose bulk density" is described as loosely packed bulk density. Furthermore, in this specification, non-gelatinized potato starch refers to potato starch that has a β-starch crystalline structure. In other words, non-gelatinized potato starch is raw starch.

[0016] The starch content in the granules, particularly ungelatinized potato starch, is preferably 1% by weight or more relative to the dry weight of the granules. When the starch content is 1% by weight or more, it becomes easier to suppress the rise in moisture content in the capsule. There is no particular upper limit to the starch content, and the starch content may be, for example, 99% by weight or less. The starch content may be within the range of any two of the following: 1% by weight, 3% by weight, 5% by weight, 7% by weight, 10% by weight, 15% by weight, 20% by weight, 25% by weight, 30% by weight, 35% by weight, 40% by weight, 45% by weight, 50% by weight, 60% by weight, 70% by weight, 80% by weight, 90% by weight, and 99% by weight. Also, the starch content may be, for example, 5% by weight or more, or 10% by weight or more. The starch content may be, for example, 70% by weight or less.

[0017] The excipient may further contain sugars other than starch. Sugars include monosaccharides, oligosaccharides, polysaccharides, and sugar alcohols. Monosaccharides are components whose molecular structure is represented by a cyclic structure. Examples of such monosaccharides include glucose, fructose, and galactose. Oligosaccharides are components that have a structure in which multiple monosaccharides are linked together, with the number of constituent units in one molecule ranging from 2 to 15. Examples of such oligosaccharides include disaccharides such as maltose, lactose, sucrose, and trehalose; trisaccharides such as raffinose, panose, maltotriose, melegitose, and gentianose; tetrasaccharides such as stachyose; fructooligosaccharides, galactooligosaccharides, isomaltoligosaccharides, xylooligosaccharides, and maltooligosaccharides. Polysaccharides are components that have a structure in which multiple monosaccharides are linked together, with the number of constituent units in one molecule ranging from 16 to 15. Examples of such polysaccharides include water-soluble and water-insoluble dietary fibers. Sugar alcohols are components whose molecular structure is represented by a chain-like structure. Examples of such sugar alcohols include reduced maltose (maltitol), erythritol, sorbitol, and mannitol. Examples of water-soluble dietary fibers include guar gum, glucomannan, and agar. Examples of water-insoluble dietary fibers include cellulose, hemicellulose, and chitin.

[0018] The excipient content is not particularly limited. For example, the excipient content is 1% by weight or more and 99% by weight or less based on the dry weight of the granules. The excipient content may be within the range of any two of the following: 1% by weight, 3% by weight, 5% by weight, 7% by weight, 10% by weight, 15% by weight, 20% by weight, 25% by weight, 30% by weight, 35% by weight, 40% by weight, 45% by weight, 50% by weight, 55% by weight, 60% by weight, 65% by weight, 70% by weight, 75% by weight, 80% by weight, 85% by weight, 90% by weight, 95% by weight, and 99% by weight.

[0019] <Binder> The granules according to the present invention include a binder. The binder is hydrophilic and is added to bind powdered granular raw materials such as excipients. In other words, in the granules, the binder interposes between the particles of the granular raw materials to bind them together, so unlike the powdered raw materials, the binder in the granules does not take the form of particles. Even if the raw material that becomes the binder is in powder form, the binder is first prepared as a solution and therefore does not take the form of particles. Any component can be used as a binder as long as it can bind the particles together in the granules, but the binder preferably contains pregelatinized starch or maltitol. In this case, the binder does not contain ungelatinized starch. Pregelatinized starch is, for example, pregelatinized potato starch.

[0020] The binder content is preferably 0.05% by weight or more relative to the dry weight of the granules. In this case, the shape retention of the granules can be improved, and good disintegration properties can be easily obtained. The upper limit of the binder content is set appropriately considering the ease of granule production and is not particularly limited, but the binder content may be, for example, 30% by weight or less. The binder content may be within the range of any two of the following: 0.05% by weight, 0.1% by weight, 0.15% by weight, 0.2% by weight, 0.25% by weight, 0.3% by weight, 0.35% by weight, 0.4% by weight, 0.45% by weight, 0.5% by weight, 0.7% by weight, 1% by weight, 3% by weight, 5% by weight, 7% by weight, 10% by weight, 13% by weight, 15% by weight, 20% by weight, 25% by weight, and 30% by weight.

[0021] <Functional Ingredients> The granules according to the present invention may contain functional ingredients. Functional ingredients refer to ingredients that have an effect on the life activities of a living organism (e.g., a human), including maintaining the health of the organism or mitigating harmful substances. Any ingredient can be used as a functional ingredient as long as it has an effect on the life activities of a living organism. Specifically, functional ingredients are at least one ingredient selected from the group consisting of organic acids, organic acid salts, plant extracts, animal extracts, microbial extracts, microbially produced extracts, microbially fermented extracts, fruit juices, functional polysaccharides, dietary fiber, polyphenols, vitamins, vitamin derivatives, vitamin-like substances, amino acids, microorganisms, anti-inflammatory drugs, omega-3 fatty acids, omega-6 fatty acids, and omega-9 fatty acids. Examples of plants that can be used as raw materials for the above-mentioned plant extracts include olive, cranberry, almond, aloe vera, jasmine, rosehip, rosemary, salacia, blackcurrant, blueberry, raspberry, blackberry, cranberry, cherry, and apple fruit. Examples of Salacia plants mentioned above include Salacia reticulata, Salacia oblonga, Salacia chinensis, Salacia macrophylla, Salacia exculputa, Salacia prinoides, and Salacia undulata. Examples of animals used as raw materials for the animal extracts mentioned above include cattle, horses, pigs, and fish. Functional ingredients also include flavor modifiers and fragrances. Flavor modifiers include, for example, citric acid and sweeteners. Fragrances may be natural or synthetic, and may be used alone or in combination of two or more. Furthermore, there are no particular restrictions on synthetic fragrances as long as they have been conventionally used for the purpose of imparting aroma and flavor. Examples of synthetic fragrances include vanillin, limonene, and hexanal.Natural fragrances are not limited to, but include, for example, rose, jasmine, bitter orange / neroli, chamomile, ylang-ylang, geranium, eucalyptus, tea tree, petitgrain, Satsuma mandarin, orange, lemon, lime, grapefruit, pink grapefruit, bergamot, pepper, juniper, vanilla, sandalwood, pine, cypress, cinnamon, frankincense, myrrh, vetiver, spikenard, orris root, lavender, lemongrass, basil, rosemary, mints (e.g., spearmint, menthol, peppermint, etc.) and berries (e.g., blueberry, cranberry, lingonberry, huckleberry, raspberry, blackberry, loganberry, salmonberry, boysenberry, strawberry, bilberry, elderberry, and kuzuberry, etc.). Fragrances and plant or animal extracts may overlap.

[0022] The content of functional ingredients in the granules can be set appropriately depending on the type of functional ingredient and is not particularly limited. The content of functional ingredients may be, for example, 1% by weight or more relative to the dry weight of the granules. Specific examples of functional ingredient content include 1% by weight, 3% by weight, 5% by weight, 7% by weight, 10% by weight, 12% by weight, 15% by weight, 17% by weight, 20% by weight, 22% by weight, and 25% by weight, and may be within the range of any two of these values.

[0023] <Granulation Method> The granules according to the present invention are produced by a conventional granulation method, specifically by wet granulation. Examples of wet granulation methods include fluidized bed granulation, agitation granulation, rolling granulation, compression granulation, crushing granulation, extrusion granulation, melt granulation, and spray granulation. Wet granulation may be fluidized bed granulation, extrusion granulation, or agitation granulation.

[0024] In the present specification, the granulation method will be described with reference to an example of fluidized bed granulation, but the granulation method is not limited to fluidized bed granulation. Specifically, in fluidized bed granulation, powdery granule raw materials are uniformly mixed, and this mixture is charged into a granulation apparatus (granulation pot). After charging the granule raw materials into the granulation pot, air is fed into the granulation pot under the condition that the supply air temperature is within the range of 50°C to 90°C and the exhaust air temperature is 30°C or higher, thereby causing the granule raw materials to float in the granulation pot. Here, the upper limit of the exhaust gas temperature is the supply air temperature, that is, 50°C or lower. Then, by spraying a binder liquid onto the floating granule raw materials, liquid crosslinks are formed between particles, and powders, or in some cases granules, are allowed to adhere and aggregate to each other (fluidized bed granulation). After the completion of fluidized bed granulation, the granules are air-dried in the granulation pot, and the granules are cooled to room temperature.

[0025] In the present granulation method, the granules after ventilation drying may be subjected to vacuum drying. The vacuum drying conditions are preferably such that the degree of vacuum is 50 Pa or less, the drying temperature is 5°C to 80°C, and the drying time is 5 hours to 100 hours. The lower limit of the degree of vacuum is not particularly limited, but the degree of vacuum may be 1 Pa or more. In addition, the granules may be sieved after ventilation drying or vacuum drying. The granules may contain a flavor according to their use; in that case, a flavoring step of adding a flavor to the granules may be performed after ventilation drying or vacuum drying.

[0026] When the granules are fluidized bed granulated products, the loose bulk density of the granules is 0.20 g / cm ３ to 0.65 g / cm ３ It is preferably within the range of . When the bulk density of the granules is within the above range, not only can the increase in moisture content in the capsule be suppressed, but also scattering of the granules during use is suppressed, making handling easier. The bulk density of the granules is, for example, 0.2 g / cm ３ , 0.25 g / cm ３ , 0.3 g / cm ３ , 0.35 g / cm ３ , 0.4 g / cm ３ , 0.45 g / cm ３ , 0.47 g / cm ３ , 0.5 g / cm ３ , 0.55 g / cm ３ , 0.6 g / cm ３ , 0.62 g / cm ３, 0.64 g / cm³ ３ 0.65 g / cm³ ３ It may be within the range of any two of these values. The bulk density of the granules can be measured in accordance with the 18th edition of the Japanese Pharmacopoeia.

[0027] <Weight Change Rate> In this invention, in the isotherm analysis of moisture adsorption of granules, the weight change rate when the water activity (Aw) is 0.6 must be 2% or more. A moisture adsorption / desorption analyzer (METER Group's "AquaLab VSA") is used to measure the moisture absorption capacity of the granules. More specifically, the temperature inside the moisture adsorption / desorption analyzer is set to 25°C, 2000 to 3000 mg of the sample (i.e., granules) is placed in the sample chamber of the moisture adsorption / desorption analyzer, and the measurement is performed using the dynamic dew point isotherm method (DDI method), which involves continuous drying and humidification, with a water activity measurement range of 0.045 Aw to 0.900 Aw and a measurement time of 48 hours. In this DDI method, the sample is dried to 0.045 Aw, then allowed to absorb moisture to 0.900 Aw, and then dried again to 0.045 Aw for measurement. After measurement, an adsorption curve is created with water activity (Aw) on the x-axis and weight change rate (%) on the y-axis, and the weight change rate (%) at a water activity of 0.6 Aw is determined (see Figure 2). This weight change rate is given by the following equation 1: Weight change rate (%) = (W2 - W1) / W1 × 100 ... (Equation 1) W1 is the granule weight when the water activity (Aw) is 0.045, and W2 is the granule weight when the water activity (Aw) is 0.6.

[0028] <Capsules> The granules according to the present invention enable long-term storage of capsules, particularly seamless capsules coated with a water-soluble natural polymer, when they coexist with the capsules, as the moisture contained in the capsules acts as a desiccant due to the granules' desiccant properties. The capsule according to the present invention comprises contents and a coating that covers the contents. Such capsules are not limited to seamless capsules. Furthermore, the present invention may have an intermediate layer between the coating and the contents. The intermediate layer is provided to protect the contents and the coating from each other and to prevent deterioration of the contents' performance.

[0029] <Contents> In a capsule, the state of the contents is not particularly limited, but the contents may be, for example, liquid at room temperature, solid, or semi-solid. Examples of ingredients that can be incorporated into such contents include fatty acids (e.g., caprylic acid, capric acid, eicosapentaenoic acid, docosahexaenoic acid, oleic acid, linoleic acid, etc.), fatty acid esters [e.g., triglycerides (glycerol esters (fats) such as medium-chain triglyceride (MCT, etc.); non-glycerol fatty acid esters such as isopropyl myristate, etc.)], vegetable oils (e.g., olive oil, sunflower oil, corn oil, peanut oil, grape seed oil, wheat germ oil, rapeseed oil, jojoba oil, safflower oil), hydrogenated oils, mineral oils, silicone oils, sucrose fatty acid esters, liquid paraffin, squalane, and fragrances (e.g., esters, alcohols, aldehydes, ketones, phenols, ethers, lactones, hydrocarbons, nitrogen-containing compounds, sulfur-containing compounds, acids, etc.). Functional ingredients that are sometimes incorporated into granules may also be incorporated into the capsule contents. The functional ingredients mentioned above are examples of functional ingredients.

[0030] The contents of the capsule according to the present invention may further contain excipients as described for granules, as well as stabilizers, surfactants, auxiliary agents, or foaming agents as appropriate. The amount of these additives is not particularly limited as long as it does not hinder the effects of the present invention.

[0031] <Coating> The capsule according to the present invention is coated on the outside of its contents with a coating. The coating contains a water-soluble natural polymer. The water-soluble natural polymer is selected from, for example, gelatin, casein, zein, pectin or its derivatives, alginic acid or its salts, agar, gellan gum, carrageenan, fercereran, chitosan, curdlan, starch, modified starch, pullulan, mannan, and mixtures thereof. Of course, the water-soluble natural polymer is not limited to these. These water-soluble natural polymers are preferably in the range of 50% to 90% by weight based on the total solids weight of the coating composition of the seamless capsule. When using alginates, gellan gum, pectin, or carrageenan, alkali metal salts, alkaline earth metal salts, ammonium salts, etc. may be added as appropriate.

[0032] To impart flexibility to the capsule film according to the present invention in a dry state, the capsule film may further contain a plasticizer. Examples of the above plasticizer include glycerin, sorbitol and the like. The blending amount of the above plasticizer is 1 to 50% by weight, preferably 5 to 40% by weight, more preferably 15 to 35% by weight, based on the total weight of the dried film. If the blending amount of the above plasticizer is less than 1% by weight, the film cannot withstand vacuum drying, or cannot maintain sufficient flexibility in a dry state, resulting in cracking; if it exceeds 50% by weight, the film softens, causing adhesion and melting at high temperatures.

[0033] If necessary, the capsule film according to the present invention may contain various additives commonly used in this field, such as flavoring agents, sweeteners, coloring agents, preservatives such as parabens, in addition to the above composition. When such additives are used, the total content of all additives is, for example, 0.01 to 10% by weight, preferably 0.1 to 5% by weight, relative to the total solid weight in the composition that forms the capsule film.

[0034] The thickness (film thickness) of the film is not particularly limited because it can be arbitrarily selected according to the purpose of use of the capsule particles. For example, the film thickness may be 10 to 600 µm, may be 30 to 400 µm, or may be 40 to 250 µm.

[0035] <Intermediate layer> If necessary, an intermediate layer may be provided between the capsule content and the capsule film. The intermediate layer is formed by forming the content into multiple layers or forming the film layer into multiple layers. For example, when the content is liquids with different viscosities, a multi-layer structure can be obtained by using a liquid with low viscosity for the inner layer and a liquid with high viscosity for the second layer (the second layer counting from the inner layer); alternatively, when multiple contents with different fat melting points are used, a multi-layer structure can be obtained by setting the melting point of the inner layer to be the lowest and the melting point of the second layer to be higher than that of the inner layer. Similarly, for the film, for example, a film with low oxygen permeability may be used as the outermost layer, and a conventional film of water-soluble natural polymer may be formed on the inner side of the outermost layer as the second layer counting from the outside.

[0036] The particle size (diameter of the sphere) of a capsule varies depending on the contents and intended use, and is not particularly limited. However, it is desirable for the diameter to be 0.3 to 10 mm, preferably 1 to 8 mm. If the diameter of the capsule is less than 0.3 mm, it becomes difficult to contain the contents. Also, while there are no particular problems with capsules with a particle size exceeding 10 mm, they tend to be difficult to swallow when taken orally.

[0037] <Method for Manufacturing Capsules> The method for manufacturing capsules according to the present invention can be carried out using a manufacturing apparatus as shown in Figure 1. Figure 1 is a schematic diagram of a manufacturing apparatus used in the method for manufacturing capsules according to the present invention. This manufacturing apparatus comprises a concentric multilayer nozzle A and a cooling pipe 19 for flowing the solidification liquid down.

[0038] Let's explain Figure 1. Figure 1 shows an apparatus for manufacturing three-layer capsule particles. The contents liquid 14 is discharged from the tip (discharge port) of the inner nozzle 11, and the coating liquid 16 is discharged from the tip (discharge port) of the outer layer nozzle 13. In Figure 1, the case where there is one intermediate layer is shown, so the intermediate layer liquid 14 is discharged from the tip (discharge port) of the intermediate nozzle 12 located between nozzles 11 and 13. Each nozzle is formed in a concentric circle shape with respect to the central axis of the inner nozzle 11. In Figure 1, there is an intermediate layer nozzle 12 that forms the intermediate layer, but the present invention also includes cases where there is no intermediate nozzle or where there are multiple intermediate nozzles.

[0039] The arrows shown in FIG. 1 indicate the flowing direction of the coagulating liquid 18 in the forming tube 19. The coagulating liquid 18 flows downward inside the forming tube 19. Droplets discharged from the concentric multiple nozzle (droplets that form capsule particles) are discharged into the coagulating liquid 18 in the forming tube 19. At first, the discharged liquid forms a long continuous rod-shaped discharged liquid B. While it descends in the forming tube 19, it becomes spherical due to surface tension and coagulates simultaneously to form the capsule 17. The obtained capsule is vacuum-dried in a drying step (not shown). For vacuum drying, it is preferable that the degree of vacuum is 500 Pa or less, the drying temperature is 5°C to 30°C, and the drying time is 5 to 100 hours. The lower limit of the degree of vacuum is not particularly limited, but the degree of vacuum may be, for example, 0.2 Pa or more. Further, the drying time may be 24 to 90 hours.

[0040] <Coexistence System of Capsules and Granules> The above capsules are dried during production to volatilize moisture as described above, but a small amount of moisture remains without being completely dried. In addition, the moisture content in capsules tends to gradually increase due to moisture present in the outside air, and when the moisture content increases, the quality of the capsules may deteriorate. In the present invention, when the aforementioned granules are coexisted with the capsules, the rate of moisture increase in the capsules is reduced, the moisture increase can be suppressed, and long-term storage of the capsules is enabled.

[0041] As used herein, the "coexistence system of capsules and granules" refers to a state where a mixture of capsules and granules is enclosed in a packaging material such as a stick. After the mixture of capsules and granules is enclosed in the packaging material, the water activity (Aw) of the capsules when the elapsed time is 72 hours or more is preferably 0.14 or less, more preferably 0.13 or less. The lower limit of the water activity (Aw) in this case is not particularly limited, but the water activity (Aw) is, for example, 0.02 or more. Further, in the mixture of capsules and granules, the granules are in contact with the outer surface of the capsules. Such a mixture is suitable for food. Food is usually a solid in a dry state. Examples of such food include foods such as health foods and foods with functional claims, and beverage bases that are dissolved or dispersed in water or the like to prepare beverages.

[0042] In a system where granules and capsules coexist, the amount of granules present is preferably within the range of 30 to 90% by weight relative to the dry weight of the mixture of granules and capsules. By keeping the amount of granules within this range, the increase in moisture content in the capsule can be suppressed, making it easier to achieve long-term storage of the capsule. The amount of granules may be, for example, within the range of any two of 30%, 35%, 40%, 45%, 50%, 55%, 60%, 65%, 70%, 75%, 80%, 85%, and 90% by weight.

[0043] (Examples) The present invention will be described in more detail by reference to examples. The present invention should not be construed as being limited to these examples. In the examples, parts and percentages are based on weight (mass) unless otherwise specified.

[0044] Example 1 (Production of Granules) First, an aqueous solution containing 0.5% by weight of pregelatinized potato starch (Matsunolin M, manufactured by Matsutani Chemical Industry Co., Ltd.) was prepared, and this aqueous solution was used as a binder. Next, rosehip extract (rosehip polyphenol MJ, manufactured by Morishita Jintan Co., Ltd.), maltodextrin (TK-16, manufactured by Matsutani Chemical Industry Co., Ltd.), trehalose, and non-pregelatinized potato starch (Gralow F, manufactured by Nippon Denki Chemical Co., Ltd.; loose bulk density of 0.583 g / cm³) were added. ３ The following were mixed in the proportions shown in Table 1 below, and this mixture was placed in a fluidized bed granulator (Freund FL-MINI). Then, under an air supply temperature of 80°C and an exhaust temperature of 40°C, the mixture in the apparatus was granulated for 30 minutes while spraying the binder solution at a spray rate of 20 ml / h. The product in the apparatus was then air-dried to room temperature. The product after air-drying was obtained as granules (fluidized bed granules). The average particle size and loosened bulk density of the obtained granules are shown in Table 1. The average particle size was measured using a laser diffraction particle size distribution analyzer (Shimadzu SALD-2300), and the loosened bulk density was measured in accordance with the 18th edition of the Japanese Pharmacopoeia. Note that in Table 1, "alpha-gelatinized" is abbreviated as "α-gelatinized" and "non-alpha-gelatinized" as "non-α-gelatinized" for the sake of brevity.

[0045] Example 2 (Preparation of Granules) Granules were prepared in the same manner as in Example 1, except that the amounts of trehalose and non-gelatinized potato starch were changed, as shown in Table 1. The loosened bulk density of the obtained granules is shown in Table 1. The loosened bulk density was measured in accordance with the 18th edition of the Japanese Pharmacopoeia.

[0046] Example 3 (Preparation of Granules) Rosehip extract, maltodextrin, trehalose, and ungelatinized potato starch were mixed in the proportions shown in Table 1 below, and this mixture was placed in a fluidized bed granulator. Then, under an air supply temperature of 80°C and an exhaust temperature of 40°C, the mixture in the apparatus was granulated for 30 minutes while spraying binder solution at a spray rate of 20 ml / h. The product in the apparatus was then air-dried to room temperature. After air-drying, the product was vacuum-dried for 19 hours at a vacuum of 12 Pa and a drying temperature of 50°C. The product after vacuum drying was used as granules (fluidized bed granules). The average particle size and loosened bulk density of the obtained granules are shown in Table 1. The average particle size was measured using a laser diffraction particle size distribution analyzer (Shimadzu SALD-2300), and the loosened bulk density was measured in accordance with the 18th edition of the Japanese Pharmacopoeia.

[0047] Comparative Example 1 (Granule Production) As shown in Table 1, granules were prepared in the same manner as in Example 1, except that the amount of trehalose was changed and non-gelatinized potato starch was not included. The average particle size and loosened bulk density of the obtained granules are shown in Table 1. The average particle size was measured using a laser diffraction particle size distribution analyzer (Shimadzu SALD-2300), and the loosened bulk density was measured in accordance with the 18th edition of the Japanese Pharmacopoeia.

[0048] Example 4 (Preparation of Granules) As shown in Table 2, granules were prepared in the same manner as in Example 2, except that the product after air drying was vacuum-dried for 19 hours at a vacuum of 12 Pa and a drying temperature of 50°C, and the average particle size of the granules was measured.

[0049] Examples 5 and 6 (Preparation of Granules) Granules were prepared in the same manner as in Example 1, except that the amounts of trehalose and non-gelatinized potato starch were changed as shown in Table 2, and the average particle size of the granules was measured.

[0050] Example 7 (Preparation of Granules) As shown in Table 2, granules were prepared in the same manner as in Example 1, except that the amount of non-gelatinized potato starch was changed and trehalose was not included, and the average particle size of the granules was measured.

[0051] Example 8 (Preparation of Granules) As shown in Table 2, granules were prepared in the same manner as in Example 1, except that Salacia extract was used instead of rosehip extract, and the average particle size of the granules was measured.

[0052] Example 9 (Production of Granules) First, an aqueous solution containing 0.5% by weight of maltitol (Amalti MR-50, manufactured by Mitsubishi Corporation Life Sciences Co., Ltd.) was prepared and used as the binder solution. Next, rosehip extract, maltodextrin, trehalose, and ungelatinized potato starch were mixed in the proportions shown in Table 2 below, and this mixture was put into a fluidized bed granulator. Then, under an air supply temperature of 80°C and an exhaust temperature of 40°C, the mixture in the apparatus was granulated for 30 minutes while spraying the binder solution at a spray rate of 20 ml / h. The product in the apparatus was then air-dried to bring it to room temperature. The product after air-drying was obtained as granules (fluidized bed granules). The average particle size of the obtained granules was measured.

[0053] Example 10 (Production of Granules) Using 85% ethanol as a solvent, a solution containing 0.75% by weight of pregelatinized potato starch was prepared, and this solution was used as the binder. Next, rosehip extract, maltodextrin, trehalose, and unpregelatinized potato starch were added to a mixing container in the amounts shown in Table 2 below. Then, the binder was added so that the amount of pregelatinized potato starch in the resulting granules matched the amount shown in Table 2. These components were then thoroughly mixed in the container. The resulting mixture was loaded into a basket-type blade extruder and extruded at a screen diameter of 1 mmφ and a blade rotation speed of 20 rpm. The extruded material was then air-dried at 60°C for 3 hours. The product after air-drying was obtained as granules (extruded granules), and the average particle size of the granules was measured. To measure the average particle size of the extruded granules, the same laser diffraction particle size distribution analyzer as in Example 1 was used.

[0054] Example 11 (Preparation of Granules) Using 85% ethanol as a solvent, a solution containing 0.375% by weight of pregelatinized potato starch was prepared, and this solution was used as the binder. Next, rosehip extract, maltodextrin, trehalose, and unpregelatinized potato starch were added to a stirring granulator in the amounts shown in Table 2 below. Then, the binder was added so that the amount of pregelatinized potato starch in the resulting granules matched the amounts shown in Table 2. After that, the components were stirred and mixed in the apparatus so that the granules were sufficiently formed. The resulting granules were air-dried at 60°C for 3 hours. The product after air-drying was used as granules (stir-fried granules), and the average particle size of the granules was measured. To measure the average particle size of the stirred granules, a laser diffraction particle size distribution analyzer similar to that used in Example 1 was used.

[0055] <Evaluation of Moisture Adsorption Characteristics of Granules> The moisture adsorption characteristics were evaluated for granules containing starch with different proportions of non-gelatinized potato starch (granules of Examples 1 to 11) and granules that did not contain non-gelatinized potato starch (granules of Comparative Example 1). The moisture adsorption characteristics were measured using a moisture adsorption / desorption measuring device ("AquaLab VSA" manufactured by METER Group).

[0056] Specifically, 2000-3000 mg of the sample (granules to be measured) was placed in the chamber of the moisture adsorption / desorption measuring device. The temperature inside the measuring device was set to 25°C, and the water activity measurement range was set to 0.045 (Aw) to 0.900 (Aw). The measurement was performed for 48 hours using the dynamic dew point isotherm method (DDI method), which involves continuous drying and humidification (the sample was dried to 0.045 (Aw), then allowed to absorb moisture to 0.900 (Aw), and then dried again to 0.045 (Aw)). The measurement results are shown in Figure 2 as a graph with water activity (Aw) on the x-axis and weight change rate (%) on the y-axis. The weight change rate (%) when the water activity (Aw) is 0.6 is listed in Tables 1 and 2 below.

[0057]

[0058]

[0059] The granules of Examples 1 to 11 showed a higher weight change rate of 2% or more when the water activity (Aw) was 0.6 compared to the granules of Comparative Example 1. This suggests that the granules of Examples 1 to 11 have high hygroscopic properties.

[0060] <Evaluation experiment of a system in which capsules and granules coexist> Manufacturing example 1 (Capsule manufacturing) (a) Content liquid: 19.0 parts by weight of Bifidobacterium powder was dispersed in 81.0 parts by weight of melted palm kernel oil (unhydrogenated oil) with a melting point of 40°C to form the content liquid. (b) Protective layer liquid: 93.0 parts by weight of palm kernel oil (unhydrogenated oil, melting point 43°C) and 7.0 parts by weight of lecithin were mixed to form the protective layer liquid. (c) Coating liquid: 18.0 parts by weight of gelatin [jelly strength: 240 bloom], 6.0 parts by weight of concentrated glycerin as a food additive, 1.0 part by weight of low methoxyl (LM) pectin and 75.0 parts by weight of purified water were mixed to form the coating liquid.

[0061] A 2.5 mm diameter triple-layered seamless capsule containing Bifidobacterium was fabricated by simultaneously dropping the above contents liquid from the inner nozzle of a concentric triple nozzle, the protective layer liquid from the outermost intermediate nozzle, and the above coating liquid from the outermost nozzle into cooled, flowing oil. The resulting triple-layered seamless capsule was air-dried at 20°C for 8 hours. After air-drying, the seamless capsule was vacuum-dried at 20 Pa and a drying temperature of 20°C for 24 hours. The resulting seamless capsule was then used in the following tests.

[0062] Changes in water activity over time: The granules from Example 3 and Comparative Example 1 were mixed with the capsules from Production Example 1 in a uniform 1:1 weight ratio. This mixture was then airtightly sealed in an aluminum zipper bag (Lamizip AL-9, manufactured by Seisan Nippon Co., Ltd.), and the changes in water activity of the granules and capsules over time were evaluated. Similarly, for Examples 2, 7, 8, and 9, the granules were mixed with the capsules from Production Example 1, and the changes in water activity of the granules and capsules over time were evaluated. Evaluation 1 was the combination of the granules of Example 3 and the capsules of Production Example 1, Evaluation 2 was the combination of the granules of Comparative Example 1 and the capsules of Production Example 1, Evaluation 3 was the combination of the granules of Example 2 and the capsules of Production Example 1, Evaluation 4 was the combination of the granules of Example 7 and the capsules of Production Example 1, Evaluation 5 was the combination of the granules of Example 8 and the capsules of Production Example 1, and Evaluation 6 was the combination of the granules of Example 9 and the capsules of Production Example 1. Here, once a bag was sealed, it was not used for evaluation at subsequent elapsed times after opening. The aluminum zipper bags were opened at 0 hours and 72 hours after sealing. After opening the aluminum zipper bags, the contents were separated into granules and capsules, and the water activity (Aw) of each was measured. In this measurement, the water activity of the granules was measured using a water activity analyzer (Hyglob 2, manufactured by Rotronic), and the water activity of the capsules was measured using a water activity analyzer (LabMaster-aw neo, manufactured by Novasina).

[0063] Tables 3 and 4 show the evaluation results regarding the change in water activity (Aw) in a system where capsules and granules coexist. Note that the reason why evaluations 1 to 7 differ for the water activity (Aw) at 0 hours after capsule encapsulation is that even capsules manufactured using the same method have different initial values ​​(water activity at 0 hours after capsule encapsulation).

[0064]

[0065]

[0066] In Evaluation 2 (the coexistence system of granules from Comparative Example 1 and capsules from Production Example 1), an increase in water activity was observed in the capsules after 72 hours. However, in all of Evaluations 1 (the coexistence system of granules from Example 3 and capsules from Production Example 1), 3 (the coexistence system of granules from Example 2 and capsules from Production Example 1), 4 (the coexistence system of granules from Example 7 and capsules from Production Example 1), 5 (the coexistence system of granules from Example 8 and capsules from Production Example 1), and 6 (the coexistence system of granules from Example 9 and capsules from Production Example 1), a decrease in water activity was observed in the capsules after 72 hours. From these results, it can be concluded that in the coexistence system of granules and capsules according to the present invention, the water activity (Aw) of the capsules remains low even after at least 72 hours. Therefore, since it is a sealed system, it is expected that the water activity will remain low even if the elapsed time is extended further.

[0067] <Additional aspects of the present invention> [1] Granules that suppress the rise in moisture content in an edible capsule, wherein the granules contain an excipient and a binder, and in a moisture adsorption isotherm analysis of the granules, the weight change rate when the water activity (Aw) is 0.6 is 2% or more. [2] The granules according to [1], wherein the granules are wet granulated. [3] The granules according to [1] or [2], wherein the content of the excipient is 1% by weight or more with respect to the dry weight of the granules. [4] A food product containing the granules according to any one of [1] to [3] and the edible capsule. [5] A method for using granules that suppress the rise in moisture content in an edible capsule in a system in which an edible capsule and granules coexist, wherein the granules contain an excipient and a binder, and in a moisture adsorption isotherm analysis of the granules, the weight change rate when the water activity (Aw) is 0.6 is 2% or more.

[0068] 11...Contents nozzle 12...Intermediate nozzle 13...Coating nozzle 14...Contents liquid 15...Intermediate layer liquid 16...Coating liquid 17...Seamless capsule 18...Coagulation liquid 19...Forming tube A...Concentric multiple nozzle B...Forming section

Claims

1. Granules for suppressing moisture increase in edible capsules, characterized in that the granules contain an excipient and a binder, and in a moisture adsorption isotherm analysis of the granules, the weight change rate when the water activity (Aw) is 0.6 is 2% or more.

2. The granules according to claim 1, wherein the granules are wet-process granulated material.

3. The granules according to claim 1, wherein the content of the excipient is 1% by weight or more relative to the dry weight of the granules.

4. A food product comprising the granules described in any one of claims 1 to 3 and the edible capsule.

5. A method for using granules in a system in which edible capsules and granules coexist, wherein the granules contain an excipient and a binder, and the weight change rate when the water activity (Aw) of the granules is 0.6 is 2% or more, as determined by isotherm analysis of the water adsorption of the granules.

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