Oral foamed solid composition
The oral effervescent solid composition with pectin, high HLB surfactants, and protein achieves stable stomach foaming for prolonged satiety by optimizing component ratios, addressing inconsistent gastric raft formation and foaming in existing technologies.
Patent Information
- Authority / Receiving Office
- JP · JP
- Patent Type
- Patents
- Current Assignee / Owner
- Filing Date
- 2021-12-24
- Publication Date
- 2026-03-17
AI Technical Summary
Existing oral compositions either fail to provide sustained satiety or vary in effectiveness due to inconsistent gastric raft formation and foaming, leading to variable feelings of fullness.
An oral effervescent solid composition containing pectin, surfactants with an HLB of 6 or higher, and protein, with specific mass ratios between these components, to stabilize and maintain stomach foaming for an extended period.
The composition effectively produces and maintains stable foam in the stomach, providing sustained satiety and consistent fullness.
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Abstract
Description
Technical Field
[0001] The present invention relates to an oral foaming solid composition.
Background Art
[0002] Obesity has become a serious social problem because it increases the risk of lifestyle-related diseases such as lipid metabolism disorders, hypertension, and hyperglycemia. Effective means for preventing obesity include, for example, a diet that combines exercise therapy and dietary restriction. However, since restricting food intake causes hunger, it does not last in reality.
[0003] Therefore, oral compositions have been developed to eliminate hunger by inducing satiety and restricting food intake. For example, a gastric raft composition containing one or more gel formers selected from the group consisting of alginate, pectin, and xanthan gum, and a certain amount of dextrin with respect to the gel former, wherein the dextrin integrates with the gel former when the gastric raft composition contacts gastric acid to form a raft, has been proposed (Patent Document 1). In addition, a solid composition containing a plant-derived protein and / or peptide in which the amount of insoluble components is a specific amount or more, a surfactant having an HLB of 12 or more, a carbonate, and an organic acid, and in which the total amount and mass ratio of the carbonate and the organic acid are controlled to be constant, is also known (Patent Document 2).
Prior Art Documents
Patent Documents
[0004]
Patent Document 1
Patent Document 2
Summary of the Invention
Problems to be Solved by the Invention
[0006] In view of the above problems, the present inventors conducted research and found that by including pectin, a surfactant with an HLB value above a specific value, and protein, and controlling the mass ratio of pectin to surfactant and the mass ratio of surfactant to protein within a specific range, not only is foaming in the stomach good, but the foaming is also maintained stably in the stomach for a long period of time, thus allowing for a sufficient feeling of fullness.
[0007] In other words, the present invention provides the following [1] to [4]. [1] The following components (A), (B), and (C); (A) Pectin 0.5-18% by mass (B) Surfactants having an HLB of 6 or higher, (C) Protein It contains, The mass ratio of component (A) to component (B) [(B) / (A)] is 0.05 to 4. The mass ratio of component (A) to component (C) [(C) / (A)] is between 0.05 and 9.5. Oral effervescent solid composition. [2] The oral foaming solid composition according to [1], wherein the content of component (B) is 0.1 to 15% by mass. [3] The oral foaming solid composition according to [1] or [2], wherein the content of component (C) is 0.05 to 29% by mass. [4] An oral foaming solid composition according to any one of [1] to [3] above, wherein the mass ratio of component (B) to component (C) [(B) / (C)] is 0.1 to 30. [Effects of the Invention]
[0008] The oral foaming solid composition of the present invention not only foams well in the stomach, but also maintains that foam stably in the stomach for a long period of time, allowing users to fully experience satiety. [Modes for carrying out the invention]
[0009] The oral foaming solid composition of the present invention contains components (A), (B), and (C), and is characterized in that the mass ratio of component (A) to component (B) [(B) / (A)] and the mass ratio of component (A) to component (C) [(C) / (A)] are within a specific range. A detailed explanation follows below.
[0010] The oral effervescent solid composition of the present invention contains pectin as component (A). Herein, "pectin" is a polysaccharide mainly composed of galacturonic acid and methylated galacturonic acid, and is found in the cell walls and mid-leaves of plants such as fruits and vegetables. Component (A) is not particularly limited as long as it is commonly used in food and beverages; for example, it may be a chemically synthesized product or a naturally derived product. Examples of naturally derived products include pectin derived from citrus fruits and pectin derived from apples. Component (A) may contain one or more types.
[0011] Component (A) includes HM pectin, in which the proportion of methylated galacturonic acid (degree of esterification: DE) is 50% or more, and LM pectin, in which it is less than 50%, and both can be used. The DE of HM pectin is preferably 52% or more, more preferably 60% or more, even more preferably 65% or more, preferably 80% or less, more preferably 74% or less, and even more preferably 71% or less, from the viewpoint of enhancing foaming and foam retention. The DE is preferably 52-80%, more preferably 60-74%, and even more preferably 65-71%. One or more types of HM pectin can be used. LM pectin tends to have reduced foam retention if the DE is too low. Therefore, a DE of 25% or more is preferred, more preferably 28% or more, and even more preferably 30% or more. The upper limit of such DE is not particularly limited as long as it is less than 50%, but 48% or less is preferred, and 45% or less is even more preferred. Such DE is preferably 25% or more and less than 50%, more preferably 28-48%, and even more preferably 30-45%. One or more types of LM pectin can be used, and they may also be used in combination with HM pectin. In particular, HM pectin is preferred as component (A) from the viewpoint of enhancing foaming and foam retention.
[0012] The content of component (A) in the oral foaming solid composition of the present invention is 0.5 to 18% by mass, but from the viewpoint of enhancing foaming and foam retention, and from the viewpoint of good disintegration of the composition, it is preferably 0.8% by mass or more, more preferably 1.5% by mass or more, even more preferably 2% by mass or more, even more preferably 2.5% by mass or more, and also preferably 16% by mass or less, more preferably 12% by mass or less, even more preferably 7% by mass or less, and even more preferably 4% by mass or less. The content of component (A) in the oral foaming solid composition of the present invention is preferably 0.5 to 16% by mass, more preferably 0.8 to 16% by mass, even more preferably 0.8 to 12% by mass, even more preferably 0.8 to 7% by mass, even more preferably 1.5 to 4% by mass, even more preferably 2 to 4% by mass, and even more preferably 2.5 to 4% by mass. The content of component (A) can be measured using an analytical method suitable for the sample from among commonly known measurement methods, for example, by liquid chromatography. Specifically, this can be done using the method described in the examples below. When measuring, the sample may be freeze-dried to match the detection range of the instrument, or impurities may be removed from the sample to match the separation capabilities of the instrument, or other appropriate treatments may be performed as needed.
[0013] The oral foaming solid composition of the present invention contains a surfactant as component (B) having an HLB of 6 or higher. Component (B) is an edible surfactant commonly used in food and beverages, and any surfactant with an HLB of 6 or higher can be used. It may be prepared using known synthesis methods or a commercially available product may be used. Furthermore, it may be prepared by fractionating and reconstituting a commercially available product as needed. Here, in this specification, "HLB" is an index indicating the degree of affinity of a surfactant to water and oil, and is determined by Griffin's formula. Component (B) can be one or more types, and if two or more surfactants are included, the HLB shall be the weighted average of the HLBs of each surfactant.
[0014] If the HLB of the surfactant is too low, the foaming tendency decreases. Therefore, in the present invention, the HLB is set to 6 or more. From the viewpoints of enhancing foaming and foam retention, and the good disintegrability of the composition, 8 or more is preferable, 10 or more is more preferable, 13 or more is still more preferable. Also, from the viewpoint of enhancing foaming and foam retention, 17 or less is preferable, and 16 or less is still more preferable. And the HLB of the surfactant is preferably 6 to 17, more preferably 8 to 17, still more preferably 10 to 16, and even more preferably 13 to 16.
[0015] As the type of the surfactant, from the viewpoint of enhancing foaming and foam retention, nonionic surfactants are preferably used. For example, sucrose fatty acid esters and polyglycerol fatty acid esters can be mentioned. Among them, from the viewpoint of enhancing foaming and foam retention, sucrose fatty acid esters are preferable.
[0016] Sucrose fatty acid ester is a surfactant in which a fatty acid is ester-bonded to the hydroxyl group of sucrose, and in addition to monoester, diester, triester, and polyester may be contained. Among them, from the viewpoint of flavor, the content of monoester of sucrose fatty acid ester is preferably 60% or more, and more preferably 65% or more.
[0017] [[ID=1十二]]The constituent fatty acid of sucrose fatty acid ester is preferably a saturated or unsaturated fatty acid having 12 to 22 carbon atoms from the viewpoint of being usable in a solid composition, more preferably a saturated or unsaturated fatty acid having 12 to 18 carbon atoms, and still more preferably a saturated or unsaturated fatty acid having 16 to 18 carbon atoms. Among them, the saturated or unsaturated fatty acid having 18 carbon atoms is preferably 60% or more of the total fatty acid amount. As the saturated or unsaturated fatty acid having 18 carbon atoms, stearic acid and oleic acid are preferable, and stearic acid is still more preferable.
[0018] Polyglycerol fatty acid ester is an ester of polyglycerol and fatty acid. The average degree of polymerization of glycerin in this polyglycerol is preferably 7 or more, more preferably 10 or more, preferably 20 or less, and more preferably 15 or less, from the points of being widely used generally and having good foam retention. Here, the average degree of polymerization of glycerin refers to the value obtained by the end group analysis method. Here, the "end group analysis method" refers to the following method. From the relationship between the measured value and the theoretical value of the hydroxyl value (OHV), the degree of polymerization n and the molecular weight (MW) are obtained by the following formula. As the method for measuring the hydroxyl value, there are acetic anhydride·pyridine method or phthalic anhydride·pyridine method.
[0019] MW = 74n+18 OHV = 56110(n+2) / MW
[0020] The constituent fatty acid of the polyglycerol fatty acid ester is preferably a saturated or unsaturated fatty acid having 12 to 22 carbon atoms, more preferably a saturated or unsaturated fatty acid having 12 to 18 carbon atoms, and still more preferably a saturated or unsaturated fatty acid having 16 to 18 carbon atoms, from the point of utilization in a solid composition. Among them, the saturated fatty acid having 18 carbon atoms is preferably 60% or more of the total fatty acid amount.
[0021] The content of component (B) in the oral foaming solid composition of the present invention is preferably 0.1% by mass or more, more preferably 0.3% by mass or more, even more preferably 0.6% by mass or more, and even more preferably 0.8% by mass or more, from the viewpoint of enhancing foam retention. From the viewpoint of enhancing foaming, it is preferably 15% by mass or less, more preferably 12% by mass or less, even more preferably 8% by mass or less, even more preferably 4% by mass or less, even more preferably 2.5% by mass or less, and even more preferably 1.5% by mass or less. The content of component (B) in the oral foaming solid composition of the present invention is preferably 0.1 to 15% by mass, more preferably 0.3 to 12% by mass, even more preferably 0.3 to 8% by mass, even more preferably 0.6 to 4% by mass, even more preferably 0.6 to 2.5% by mass, and even more preferably 0.8 to 1.5% by mass. The content of component (B) can be measured by an analytical method suitable for the condition of the sample from among commonly known measurement methods, for example, it can be analyzed by gas chromatography. Specifically, the methods described in the examples below are examples. Note that, during measurement, appropriate processing may be performed as needed, such as freeze-drying the sample to match the detection range of the instrument, or removing impurities from the sample to match the separation capabilities of the instrument.
[0022] The oral effervescent solid composition of the present invention contains protein as component (C). Component (C) may be of animal or plant origin, and may contain one or more types. Animal-derived proteins can be obtained by employing known methods, for example, by extraction from eggs or milk. Plant-derived proteins can also be obtained by employing known methods, for example, by extraction from plants. Known extraction methods can be employed, and the extraction conditions can be appropriately selected depending on the extraction method. Furthermore, commercially available products may be used as component (C). The molecular weight of the protein is not particularly limited.
[0023] Examples of animal-derived proteins include milk protein, egg protein, animal meat protein, collagen, and gelatin. Milk protein is a protein contained in milk, and examples of milk include cow's milk, goat's milk, sheep's milk, buffalo milk, reindeer's milk, donkey's milk, and camel's milk. Specific examples of milk proteins include whey protein and casein. Whey protein is not particularly limited, but examples include whey powder, whey protein concentrate (WPC), and whey protein isolate (WPI). Egg protein is a protein contained in eggs, and examples include egg yolk protein and egg white protein. Examples of animal meat proteins include proteins derived from livestock such as beef, pork, horse, sheep, and rabbit, as well as poultry such as chicken and turkey, and fish such as tuna. Among animal-derived proteins, milk protein and egg protein are preferred from the viewpoint of enhancing foaming and foam retention, milk protein is more preferred, whey protein is even more preferred, and whey protein isolate (WPI) is even more preferred.
[0024] Examples of plant-derived proteins include soy protein, wheat protein, rice protein, tea protein, and malt protein. Here, "soy protein," "wheat protein," "rice protein," "tea protein," and "malt protein" refer to proteins contained in soybeans, wheat, rice, tea, and malt, respectively. Among the plant-derived proteins, soy protein and wheat protein are preferred from the viewpoint of enhancing foaming and foam retention, with wheat protein being even more preferred.
[0025] The content of component (C) in the oral foaming solid composition of the present invention is preferably 0.05% by mass or more, more preferably 0.15% by mass or more, even more preferably 0.3% by mass or more, even more preferably 0.8% by mass or more, even more preferably 1% by mass or more, and even more preferably 1.5% by mass or more, and from the viewpoint of enhancing foaming and foam retention, and from the viewpoint of good disintegration of the composition, it is preferably 29% by mass or less, more preferably 26% by mass or less, even more preferably 18% by mass or less, even more preferably 14% by mass or less, even more preferably 8% by mass or less, and even more preferably 3% by mass or less. The content of component (C) in the oral foaming solid composition of the present invention is preferably 0.05 to 29% by mass, more preferably 0.15 to 26% by mass, even more preferably 0.3 to 18% by mass, even more preferably 0.8 to 14% by mass, even more preferably 1 to 8% by mass, and even more preferably 1.5 to 3% by mass. The content of component (C) can be measured using an analytical method suitable for the sample from among commonly known measurement methods. For example, it is possible to analyze it using the "nitrogen conversion method," which involves measuring the amount of nitrogen (mass%) in the sample by the combustion method and multiplying it by a predetermined "protein conversion factor" for each food product to obtain the protein mass (mass%). The "protein conversion factor" can be found, for example, in the Fifth Revised and Enlarged Standard Tables of Food Composition in Japan, Ministry of Education, Culture, Sports, Science and Technology. Specifically, the method described in the examples below can be used. When measuring, the sample may be freeze-dried to match the detection range of the instrument, or impurities may be removed from the sample to match the separation capacity of the instrument, or other appropriate treatments may be performed as needed.
[0026] The oral foaming solid composition of the present invention requires that the mass ratio of component (A) to component (B) [(B) / (A)] be controlled within a specific range in order to create a feeling of fullness by foaming well in the stomach and maintaining that foam for a sufficient amount of time. Specifically, the mass ratio of component (A) to component (B) [(B) / (A)] is 0.05 to 4, but from the viewpoint of further enhancing foaming and foam retention, and from the viewpoint of good disintegration of the composition, it is preferable to have a ratio of 0.06 or higher, more preferably 0.08 or higher, even more preferably 0.16 or higher, even more preferably 0.24 or higher, and even more preferably 0.30 or higher. Similarly, from the viewpoint of 3.5 or lower, more preferably 2.5 or lower, even more preferably 1.8 or lower, even more preferably 1.2 or lower, even more preferably 1.0 or lower, even more preferably 0.8 or lower, and even more preferably 0.5 or lower. The mass ratio [(B) / (A)] is preferably 0.06 to 3.5, more preferably 0.08 to 2.5, even more preferably 0.16 to 1.8, even more preferably 0.16 to 1.2, even more preferably 0.16 to 1.0, even more preferably 0.24 to 0.8, and even more preferably 0.30 to 0.5.
[0027] Furthermore, in order for the oral foaming solid composition of the present invention to foam well in the stomach and maintain that foam for a sufficient amount of time to induce a feeling of fullness, it is necessary to control the mass ratio of component (A) to component (C) [(C) / (A)] within a specific range. Specifically, the mass ratio of component (A) to component (C) [(C) / (A)] is 0.05 to 9.5, but from the viewpoint of further enhancing foaming and foam retention, 0.06 or higher is preferred, 0.1 or higher is more preferred, 0.3 or higher is even more preferred, and 0.5 or higher is even more preferred. Also, from the viewpoint of further enhancing foaming and foam retention, as well as from the viewpoint of good disintegration of the composition, 8.5 or lower is preferred, 7 or lower is more preferred, 5 or lower is even more preferred, 2.5 or lower is even more preferred, 1.5 or lower is even more preferred, and 0.8 or lower is even more preferred. The mass ratio [(C) / (A)] is preferably 0.06 to 8.5, more preferably 0.06 to 7, even more preferably 0.06 to 5, even more preferably 0.06 to 2.5, even more preferably 0.1 to 1.5, even more preferably 0.3 to 1.5, and even more preferably 0.5 to 0.8.
[0028] Furthermore, in the oral foaming solid composition of the present invention, from the viewpoint of enhancing foaming and foam retention, the mass ratio of component (B) to component (C) [(B) / (C)] is preferably 0.1 or higher, more preferably 0.2 or higher, even more preferably 0.4 or higher, and even more preferably 0.5 or higher. Also, from the viewpoint of enhancing foaming and foam retention, as well as tablet disintegration, it is preferably 30 or less, more preferably 27 or less, even more preferably 20 or less, even more preferably 15 or less, and even more preferably 4 or less. And such mass ratio [(B) / (C)] is preferably 0.1 to 30, more preferably 0.2 to 27, even more preferably 0.4 to 20, even more preferably 0.4 to 15, and even more preferably 0.5 to 4.
[0029] The oral effervescent solid composition of the present invention may contain effervescent components to impart effervescence to the solid composition. The effervescent components are not particularly limited as long as they can impart foam to the solid composition, but for example, (D) carbonates and (E) organic acids may be included. Components (D) and (E) may each be included in one or more types.
[0030] Examples of component (D) include sodium carbonate, sodium bicarbonate, potassium carbonate, potassium bicarbonate, calcium carbonate, magnesium carbonate, and sodium sesquicarbonate. Among these, one or more selected from sodium carbonate and sodium bicarbonate are preferred, and sodium bicarbonate is even more preferred, due to the large amount of foam produced in the stomach and the good texture.
[0031] The content of component (D) in the oral foaming solid composition of the present invention is preferably 5% by mass or more, more preferably 8% by mass or more, from the viewpoint of producing a large amount of foam in the stomach, and preferably 30% by mass or less, and more preferably 25% by mass or less, from the viewpoint of suppressing moderate acidity. The content of component (D) in the oral foaming solid composition of the present invention is preferably 5 to 30% by mass, and more preferably 8 to 25% by mass.
[0032] In the oral foaming solid composition of the present invention, from the viewpoint of enhancing foaming and foam retention, the mass ratio of component (D) to the total amount of component (C) [[(B)+(C)] / (D)] is preferably 0.04 or higher, more preferably 0.06 or higher, even more preferably 0.08 or higher, even more preferably 0.1 or higher, and also preferably 1.3 or lower, more preferably 1.0 or lower, even more preferably 0.8 or lower, and even more preferably 0.5 or lower. Furthermore, such a mass ratio [[(B)+(C)] / (D)] is preferably 0.04 to 1.3, more preferably 0.06 to 1.0, even more preferably 0.08 to 0.8, and even more preferably 0.1 to 0.5.
[0033] (E) As the organic acid, edible acids can be used. Examples of organic acids include tartaric acid, citric acid, succinic acid, ascorbic acid, acetic acid, gluconic acid, malic acid, fumaric acid, and adipic acid. Among these, one or more selected from tartaric acid, citric acid, and malic acid are preferred, one or more selected from tartaric acid and citric acid are more preferred, and tartaric acid is even more preferred, in terms of producing a moderate sour taste in the mouth.
[0034] The content of component (E) organic acid in the oral foaming solid composition of the present invention is preferably 5% by mass or more, more preferably 8% by mass or more, from the viewpoint of producing a large amount of foam in the stomach, and more preferably 30% by mass or less, more preferably 25% by mass or less, and even more preferably 20% by mass or less, from the viewpoint of suppressing moderate acidity. The content of component (E) in the oral foaming solid composition of the present invention is preferably 5 to 30% by mass, more preferably 8 to 25% by mass, and even more preferably 8 to 20% by mass.
[0035] Furthermore, from the viewpoint of enhancing foaming and foam retention, the mass ratio of component (D) to component (E) [(D) / (E)] of the oral foaming solid composition of the present invention is preferably 0.2 or higher, more preferably 0.4 or higher, even more preferably 0.8 or higher, and even more preferably 1.2 or higher. From the viewpoint of tablet disintegration, it is preferably 3.0 or lower, more preferably 2.7 or lower, even more preferably 2.4 or lower, and even more preferably 2.0 or lower. The mass ratio [(D) / (E)] is preferably 0.2 to 3.0, more preferably 0.4 to 2.7, even more preferably 0.8 to 2.4, and even more preferably 1.2 to 2.0.
[0036] Furthermore, the oral effervescent solid composition of the present invention may optionally contain one or more additives such as amino acids, proteins, vitamins, minerals, flavorings, fruit juices, plant extracts, esters, pigments, emulsifiers, milk components, cocoa powder, seasonings, vegetable oils, antioxidants, preservatives, pH adjusters, quality stabilizers, and nectar extracts. The amount of additives can be appropriately set within a range that does not impair the purpose of the present invention.
[0037] The oral foaming solid composition of the present invention is solid at room temperature (20°C ± 15°C) and is intended exclusively for oral intake. Its forms include, for example, powder, solid, and granules. Specific formulations (dosage forms) include capsules, granules, powders, tablets, pills, and lozenges. Among these, effervescent tablets, granules, powders, pills, and lozenges are preferred due to their ease of administration and the fact that they are taken as food. Tablets, granules, and powders are even more preferred due to their short retention time in the oral cavity.
[0038] The oral foaming solid composition of the present invention may contain carriers as necessary for preparing the solid composition. Examples of carriers include excipients (e.g., maltitol, starch, crystalline cellulose, light anhydrous silicic acid, calcium hydrogen phosphate, etc.), binders (e.g., hydroxypropyl methylcellulose, hydroxypropyl cellulose, gelatin, pregelatinized starch, polyvinylpyrrolidone, polyvinyl alcohol, pullulan, methylcellulose, hydrogenated oil, etc.), disintegrants (e.g., carmellose, carmellose calcium, croscarmellose sodium, crospovidone, corn starch, low-substituted hydroxypropyl cellulose, etc.), lubricants (e.g., calcium stearate, magnesium stearate, stearyl sodium fumarate, talc, silicon dioxide, etc.), bulking agents, dispersants, buffers, diluents, etc.
[0039] In the oral foamed solid composition of the present invention, the moisture content is preferably 5% by mass or less, more preferably 3% by mass or less, even more preferably 2% by mass or less, and even more preferably 0.5% by mass or less, from the viewpoint of suppressing the reaction of the foaming components and improving the storage stability of the solid composition. The moisture content of the oral foamed solid composition can be determined by using an infrared moisture meter FD-610 (Kett Scientific Research Institute Co., Ltd.) and calculating the moisture content on a wet basis under measurement conditions of 70°C and 20 min.
[0040] The oral effervescent solid composition of the present invention effervesce in the presence of saliva or water in the mouth. In particular, after oral ingestion, it reacts rapidly with water in the stomach to effervesce and exhibits excellent foaming properties in the stomach. Therefore, the oral effervescent solid composition of the present invention is suitable as a product that provides an early feeling of fullness or satiety, prevents eating too quickly, and controls the amount of food consumed. The oral foaming solid composition of the present invention is preferably taken orally during or before eating, and more preferably within 5 to 30 minutes before eating, in order to effectively exert its effects. The pH of gastric juice is generally 1.0 to 2.0, although its acidity varies depending on the circumstances.
[0041] The oral foaming solid composition of the present invention preferably has a relative foam volume (%) of 50% or more, more preferably 60% or more, and even more preferably 70% or more, as evaluated using a gastric juice model described in the examples below, after 90 minutes. A higher value indicates superior foaming in the stomach.
[0042] The method for producing the oral foaming solid composition of the present invention is not particularly limited and can be produced according to conventional methods. For example, when manufacturing a powder, components (A), (B), and (C), along with other components as needed, can be blended to adjust the content, mass ratio [(B) / (A)], and mass ratio [(C) / (A)] of component (A). In this case, the mixture may be used as is, or it may be pulverized. It is preferable that the entire powder passes through a No. 18 (850 μm) sieve, and more preferably that 5% or less of the total amount remains on a No. 300 (500 μm) sieve. Granules can be obtained by preparing a mixture by blending components (A), (B), and (C), and other components as needed, adjusting the content, mass ratio [(B) / (A)], and mass ratio [(C) / (A)] of component (A), and then granulating the mixture using a dry granulation method, a wet granulation method, or the like. Examples of granulation methods include extrusion granulation, crushing granulation, rolling granulation, agitation granulation, and fluidized bed granulation. The average particle size of the granules is preferably 45 to 850 μm, and more preferably 100 to 500 μm. When manufacturing tablets, the raw material powder may be compressed and molded directly, or the granules may be granulated using the dry granulation method, wet granulation method, etc., and then compressed and molded. When manufacturing tablets directly or by compressing granules, commonly used tablet presses such as rotary tablet presses or single-stroke tablet presses can be used. For convenience and effectiveness, the weight of each tablet is preferably between 0.05 and 3 g.
[0043] The oral foamed solid composition of the present invention may be contained in a container or bag, for example, in a container or bag made of paper, plastic, glass, or metal. It may also be individually packaged for single oral intake. Among these, individually packaged portions (stick packaging, individual packaging, etc.) are preferred. The packaging material is not limited to those commonly used for food or pharmaceuticals, but for example, a combination of aluminum foil, synthetic resin (polyethylene terephthalate, etc.), laminated paper, etc. may be used. Nitrogen gas may be filled inside the container and packaging material from the viewpoint of maintaining quality. [Examples]
[0044] 1. Analysis of pectin Pectin was analyzed as galacturonic acid and methylated galacturonic acid. The sample was hydrolyzed with sulfuric acid, neutralized, and the filtrate after membrane filtration was analyzed. High-performance liquid chromatography was used for the analysis. The operating conditions were as follows:
[0045] • Model: ICS-6000 [Thermo Fisher Sun-Entific] • Detector; pulsed amperometry detector [Thermo Fisher Sun-Entific] • Column: CarboPac PA1, 4.0mm x 250mm [Thermo Fisher Sun Entity] • Column temperature: 32℃ Mobile phase: A mixture of 0.1 mol / L sodium hydroxide solution and 0.1 mol / L sodium acetate solution (1:1 ratio) ·Injection volume: 5μL
[0046] 2. Analysis of surfactants The analytical method for surfactants in oral foaming solid compositions is as follows: 10-15 mg of the oral foaming solid composition was placed in a screw vial, 500 μL of TMS agent was added, and the mixture was heated in an 80°C water bath for 2 minutes. After cooling, 1.5 mL of hexane was added, the mixture was stirred, and the filtrate was filtered through a 0.45 μm filter. The type and content of surfactants were determined by analysis of the filtrate. A gas chromatograph was used for the analysis, and the operating conditions were as follows.
[0047] <Gas chromatograph operating conditions> • Model: Agilent 7820A GC System [Agilent Technologies] • Detector: Flame ion detector • Column: DB-1HT, length 7m x inner diameter 0.25mm, film thickness 0.1μm [Agilent Technologies] Temperature: 80°C / min → 10°C / min → 340°C / 15 minutes (10°C per minute) ·Inlet: 340℃, • Detector: 350℃ Split ratio: 50:1 ·Injection volume: 1μL • Gas flow rate: 1.0 mL / min (helium)
[0048] 3. Protein analysis The protein content in the oral foamed solid composition was calculated by multiplying the amount of nitrogen quantified by the combustion method by the nitrogen-to-protein conversion factor. The nitrogen-to-protein conversion factor for milk protein is 6.38. The nitrogen-to-protein conversion factors used to calculate the nitrogen content are based on Table 7 of Chapter 1, Section 2) of the Japanese Food Standard Composition Table, revised and expanded fifth edition, published by the Ministry of Education, Culture, Sports, Science and Technology. For foods not listed, conversion factors for other foods are used.
[0049] 4. Analysis of carbonates The analytical method for determining the carbonate content in an oral effervescent solid composition is as follows: 0.1-0.2 g of the oral foaming solid composition was taken, 10 mL of water and 2 mL of 50% phosphoric acid were added, and the container was sealed. After sonication for 10 minutes, it was left to stand for 1 hour, and the headspace gas was subjected to gas chromatography to determine the amount of CO2. The amount of CO2 generated was used to calculate the CO2 content.
[0050] <Gas chromatograph operating conditions> • Model: GC-14B [Shimadzu Corporation] • Detector: TCD • Column: Chromosorb101, 80~100mesh Glass tube, φ3.2mm x 2m Temperature: Column 50°C, Inlet and detector 100°C • Cell current: 75mA • Gas pressure: Helium (carrier gas) 100kPa • Injection volume: 0.2 mL of headspace gas
[0051] 5. Analysis of organic acids The analytical method for determining the organic acid content in an oral foamed solid composition is as follows. 1 g of the oral effervescent solid composition was taken, 20 mL of 5% perchloric acid was added, and extraction was performed by shaking for 10 minutes. The mixture was then diluted to 200 mL with water and sonicated for 10 minutes. After filtration, the mixture was subjected to high-performance liquid chromatography.
[0052] <High-performance liquid chromatography operating conditions> • Model: LC-20AD [Shimadzu Corporation] • Detector: UV-Vis absorbance spectrophotometer SPD-20AV [Shimadzu Corporation] • Column: Shim-pack SCR-102H 300×80 (Length × Inner Diameter (mm)) [Shimadzu Corporation] Column temperature: 40°C ·Mobile phase: 3mmоl / L perchloric acid • Reaction solution: 15 mmol / L containing 0.2 mmol / L bromothymol blue Disodium hydrogen phosphate solution • Flow rate: Mobile phase 1.0 mL / min, reaction solution 1.4 mL / min ·Measurement wavelength: 445nm
[0053] 6. Evaluation of foaming ability and foam retention The foaming and foam retention of the oral foaming solid composition were evaluated in a gastric juice model using the following procedure. (1) Definition and calculation of theoretical foam volume per gram The number of moles of carbon dioxide produced by the reaction of carbonate and organic acid in an oral foaming solid composition is the smallest value (Mi) obtained by dividing the mass of the carbonate by the gram equivalent of the carbonate and dividing the mass of the organic acid by the gram equivalent of the organic acid. On the other hand, the volume of 1 mole of ideal gas is 22.7 liters under standard conditions (0°C, 1 bar). Therefore, in this specification, the value obtained by multiplying Mi by 22.7 liters is taken as the theoretical foam volume (mL) per gram of oral foaming solid composition.
[0054] (2) Gastric juice model solution As a gastric juice model solution, we used the first disintegration test solution (pH 1.2) in accordance with the 16th edition of the revised Japanese Pharmacopoeia (manufactured by Kanto Chemical Co., Ltd.).
[0055] (3) Definition and calculation of relative foam volume The actual amount of foam (measured volume) (mL) generated from 1.02 g of the oral foaming solid composition added to a gastric juice model solution was divided by the theoretical amount of foam (mL) per 1.02 g of the oral foaming solid composition, and the value expressed as a percentage was defined as the relative foam amount (%).
[0056] Relative foam volume (%) = [Measured volume (mL)] / [Theoretical foam volume per 1.02g (mL)] × 100
[0057] The measured volume (mL) in the formula was determined by placing 340 mg x 3 tablets (shape: 9.5φ 2-stage R) of an oral effervescent solid composition sample into a 50 mL graduated cylinder, adding 2 mL of gastric juice model solution, and measuring the foam volume (scale on the top of the foam) after 90 minutes, with the time immediately after addition being defined as 0 minutes.
[0058] The raw materials used in this example are as follows: (1) Pectin Pectin (DE72): GEMU HM Pectin YM-150-LJ (manufactured by Sansho Co., Ltd.) Pectin (DE70): GEMU HM Pectin JM-150-J (manufactured by Sansho Co., Ltd.) Pectin (DE58): GEMU HM Pectin 121-J slow set (manufactured by Sansho Co., Ltd.) Pectin (DE55): GEMU HM Pectin BETA BI-J (manufactured by Sansho Co., Ltd.) Pectin (DE52): GEMU HM Pectin AS confectionery-J (manufactured by Sansho Co., Ltd.) Pectin (DE40): GEMU LM Pectin LM-105AS-J (manufactured by Sansho Co., Ltd.) Pectin (DE35): GEMU LM Pectin LM-101AS-J (manufactured by Sansho Co., Ltd.) (2) Protein Whey protein isolate (WPI895, Fonterra) (3) Surfactants (sucrose fatty acid esters) Sucrose sugar ester HLB15 (S-1570, manufactured by Mitsubishi Chemical Foods) Sucrose sugar ester HLB11 (S-1170F, manufactured by Mitsubishi Chemical Foods) Sucrose sugar ester HLB3 (S-370F, manufactured by Mitsubishi Chemical Foods) (4) Carbonates Sodium bicarbonate: Baking soda (food additive C), manufactured by Tosoh Corporation. (5)Organic acid Tartaric acid: Anhydrous citric acid MS, manufactured by Fuso Chemical Industries Co., Ltd. (6) Excipients Maltitol: Amalti MR-50, manufactured by Mitsubishi Corporation Foodtech Co., Ltd. Furthermore, the purity of the active ingredients listed above is 95% by mass for pectin and 98% by mass or higher for the other components.
[0059] Examples 1-14 and Comparative Examples 1-6 Each component shown in Table 1 was mixed, and then compressed using a single-shot tablet press (RIKEN CDM-5PA) with a punch shape of 9.5φ, 2-stage R, and a tablet weight of 340 mg / tablet to obtain tablets of an oral effervescent solid composition. The obtained oral effervescent solid composition was then analyzed, and the amount of foam was evaluated, the results of which are shown in Table 1. The raw materials were mixed so that the active amounts of each component matched the values in the table. Maltitol was used as a balancing component so that the total amount of the mixed composition was 100% by mass.
[0060] [Table 1]
[0061] Examples 15-24 and Comparative Examples 7, 8 Except for the incorporation of the components shown in Table 2, oral effervescent solid composition tablets were obtained using the same procedure as in Example 1. The obtained oral effervescent solid composition was then analyzed, and the amount of foam was evaluated. The results, along with those of Example 2, are shown in Table 2.
[0062] [Table 2]
[0063] Example 25 and Comparative Example 9 Except for the incorporation of the components shown in Table 3, oral effervescent solid composition tablets were obtained using the same procedure as in Example 1. The obtained oral effervescent solid composition was then analyzed, and the amount of foam was evaluated. The results, along with those of Example 2, are shown in Table 3.
[0064] [Table 3]
[0065] Examples 26-30 Except for the incorporation of the components shown in Table 4, oral effervescent solid composition tablets were obtained using the same procedure as in Example 1. The obtained oral effervescent solid composition was then analyzed, and the amount of foam was evaluated. The results, along with those of Example 2, are shown in Table 4.
[0066] [Table 4]
[0067] Tables 1-4 show that by incorporating pectin, a surfactant with an HLB of 6 or higher, and protein, and controlling the mass ratio of pectin to surfactant and the mass ratio of surfactant to protein within a specific range, not only is foaming in the stomach good, but the foaming is also maintained stably in the stomach for a long period of time. Therefore, the oral effervescent solid composition of the present invention provides a sufficient feeling of fullness. Furthermore, the tablet form of the oral effervescent solid composition exhibits excellent disintegration properties.
Claims
1. The following components (A), (B), and (C); (A) Pectin 0.5-18% by mass (B) Surfactants having an HLB of 11 or more and 16 or less, (C) Protein It contains, The mass ratio of component (A) to component (B) [(B) / (A)] is between 0.05 and 4. The mass ratio of component (A) to component (C) [(C) / (A)] is between 0.05 and 9.
5. Oral effervescent solid composition.
2. The oral foaming solid composition according to claim 1, wherein the content of component (B) is 0.1 to 15% by mass.
3. An oral foaming solid composition according to claim 1 or 2, wherein the content of component (C) is 0.05 to 29% by mass.
4. An oral foaming solid composition according to any one of claims 1 to 3, wherein the mass ratio of component (B) to component (C) [(B) / (C)] is 0.1 to 30.
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