Soft capsule

Abstract

The invention provides a novel soft capsule. The soft capsule has a coating film containing gellan gum and satisfies the following (A) and / or (B): (A) the disintegration time measured by the Japan Pharmacopoeia disintegration test method using water as a test solution is 60 minutes or less; (B) The ratio of the rupture strength (g) to the outer diameter (mm) (rupture strength / outer diameter) is 210 or more.

Description

[0001] The present invention is a divisional application of the Chinese patent application with application number 202080071336.0, application date September 25, 2020, and invention name “Soft Capsule”. This application claims the priority of Japanese Patent Application No. 2019-188237 filed in Japan on October 11, 2019. Technical Field

[0002] The present invention relates to a capsule (soft capsule), and more particularly to a capsule used in the fields of medicine, food, industry, etc. Background Art

[0003] Conventionally, various materials such as gelatin are known as film bases for soft capsules. As such a material, gellan gum is being tried.

[0004] For example, Patent Document 1 describes a seamless disintegrating capsule comprising a core and a shell, wherein the shell contains a gelling agent, and the gelling agent contains gellan gum alone or in the form of a mixture with other gelling agents, a filler, and a divalent metal ion blocking agent.

[0005] Prior art literature

[0006] Patent Literature

[0007] Patent Document 1: Japanese Patent No. 5529415 Summary of the invention

[0008] 1. Technical issues to be resolved

[0009] As mentioned above, although attempts are being made to use gellan gum, it appears to leave much to be desired.

[0010] According to the research of the inventors of the present application, gellan gum is a material that is difficult to adjust in terms of quality, physical properties (such as water disintegration, oral disintegration, etc.), and manufacturing and production among coating materials. If it is to be used as a capsule material, many improvements are required.

[0011] In particular, capsules using gellan gum as a coating material (for example, capsules that use little or no gelatin) sometimes require complicated steps such as immersion in an aqueous solution containing a curing agent containing divalent ions (calcium ions, etc.), as described in Patent Document 1, and sometimes the water disintegrability of the obtained capsules deteriorates. Therefore, it is extremely difficult to find capsules that can be effectively produced and used.

[0012] The object of the present invention is to provide a novel capsule containing gellan gum.

[0013] (II) Technical solution

[0014] The inventors of the present application have conducted intensive research to achieve the above-mentioned purpose, and as a result, have found that a new type of capsule can be obtained by adding monovalent metal ions and the like to capsules containing gellan gum, and have found that such capsules have excellent physical properties (for example, while containing gellan gum, they have excellent water disintegrability, have high strength, and can have both of the above-mentioned properties, etc.). The inventors of the present application have further conducted research and have completed the present invention.

[0015] That is, the present invention relates to the following inventions and the like.

[0016] [1] A capsule (soft capsule) having a coating containing gellan gum, wherein the capsule (soft capsule) satisfies the following (A) and / or (B):

[0017] (A) the disintegration time measured by the Japanese Pharmacopoeia disintegration test method using water as the test liquid is within 60 minutes;

[0018] (B) The ratio of the bursting strength (g) to the outer diameter (mm) (bursting strength / outer diameter) is 210 or more.

[0019] In addition, in the capsule, the coating may be free of (substantially free of) gelatin.

[0020] [2] A capsule (soft capsule) having a coating containing gellan gum and a monovalent metal ion.

[0021] In addition, in the capsule, the coating may be free of (substantially free of) gelatin.

[0022] [3] The capsule according to [1] or [2], wherein (A) the disintegration time measured by the Japanese Pharmacopoeia disintegration test method using water as the test liquid is within 60 minutes, and (B) the ratio of the bursting strength (g) to the outer diameter (mm) (bursting strength / outer diameter) is 210 or more.

[0023] [4] The capsule according to any one of [1] to [3], wherein (C) the ratio of the rupture distance (mm) to the outer diameter (mm) (rupture distance / outer diameter) is 0.1 or more.

[0024] [5] The capsule according to any one of [1] to [4], wherein the proportion of gellan gum in the coating is 5% by mass or more.

[0025] [6] The capsule according to any one of [1] to [5], wherein the capsule contains a monovalent metal ion in the form of a monovalent metal compound.

[0026] [7] The capsule according to any one of [1] to [6], wherein the capsule contains a monovalent metal ion in the form of at least one monovalent metal compound selected from the group consisting of alkali metal halides, alkali metal salts of organic acids, and alkali metal salts of sugars or polysaccharides.

[0027] [8] The capsule according to any one of [1] to [6], which contains monovalent metal ions in the form of at least an alkali metal salt of alginate.

[0028] [9] The capsule according to any one of [1] to [8], wherein the ratio of the monovalent metal ion is 0.1 parts by mass or more relative to 100 parts by mass of the gellan gum in terms of metal atoms.

[0029]

[10] The capsule according to any one of [1] to [9], wherein the coating contains another coating base in a ratio of 100 parts by mass or less relative to 100 parts by mass of gellan gum.

[0030]

[11] The capsule according to any one of [1] to

[10] , wherein the coating contains a plasticizer.

[0031]

[12] The capsule according to any one of [1] to

[11] , wherein the coating contains at least one plasticizer selected from polyols, sugar alcohols, disaccharides, polysaccharides and derivatives thereof.

[0032]

[13] The capsule according to any one of [1] to

[12] , wherein the outer diameter of the capsule is 0.1 to 15 mm.

[0033]

[14] The capsule according to any one of [1] to

[13] , wherein the coating ratio of the capsule is 3% by mass or more.

[0034]

[15] The capsule according to any one of [1] to

[14] , wherein the capsule has contents and a coating ratio is 3 to 50% by mass.

[0035]

[16] The capsule according to any one of [1] to

[15] , wherein the standard deviation (SD) value of the rupture strength is 500 g or less, and the standard deviation (SD) value of the rupture distance is 1 mm or less.

[0036]

[17] The capsule according to any one of [1] to

[16] , which is a seamless capsule.

[0037]

[18] A method for manufacturing the capsule described in any one of [1] to

[17] , the method comprising at least: a capsule manufacturing step of obtaining capsules having a water content of 80% by mass or more and a ratio of bursting strength (g) to outer diameter (mm) (bursting strength / outer diameter) of 5.0 or more by a dripping method; and a drying step of drying the capsules obtained by the capsule manufacturing step.

[0038] (III) Beneficial effects

[0039] The present invention can provide a novel capsule (soft capsule) containing gellan gum.

[0040] Another embodiment of the present invention can provide a capsule (soft capsule) having excellent solubility or disintegration in water even if it contains gellan gum. In particular, such a capsule can be a capsule that can disintegrate in a relatively short time (e.g., within 60 minutes, particularly within 20 minutes) in the disintegration test of the Japanese Pharmacopoeia (17th revised edition).

[0041] The capsule (soft capsule) of another embodiment of the present invention can have high strength. For example, such a soft capsule can have high coating strength even when it contains contents.

[0042] Another embodiment of the present invention is a capsule having both excellent strength and water disintegration. According to the research of the inventors of the present application, in capsules containing gellan gum, generally, strength and water disintegration seem to be in a trade-off relationship, but in the present invention, by appropriately selecting the composition and ratio of the capsule, a capsule having both the above-mentioned properties can be unexpectedly obtained efficiently.

[0043] The capsule of another embodiment of the present invention can be efficiently manufactured even if it contains gellan gum. For example, such capsule can be manufactured even without the impregnation process as described in Patent Document 1. In addition, the capsule can be efficiently prevented from cracking during the manufacture or drying of the capsule. Therefore, such capsule is also excellent in terms of mass productivity. DETAILED DESCRIPTION

[0044] The capsule (soft capsule) of the present invention contains at least gellan gum. Such capsules may contain gellan gum and monovalent metal ions. Such capsules usually have gellan gum (and other components such as monovalent metal ions) in the coating (capsule coating). Specifically, the soft capsule of the present invention includes: a capsule composed of a pure sphere (only a coating) containing gellan gum (and other components such as monovalent metal ions); a capsule containing gellan gum (and other components such as monovalent metal ions) in the coating (a capsule containing contents and a coating, wherein the coating contains gellan gum and monovalent metal ions).

[0045] Gellan gum is a linear heteropolysaccharide produced by the non-pathogenic microorganism Pseudomonas elodea.

[0046] As gellan gum, there are deacylated gellan gum, natural gellan gum, etc. In the present invention, any of them can be used without particular limitation. However, from the viewpoint of the productivity of soft capsules, deacylated gellan gum is preferably used.

[0047] Deacylated gellan gum is a substance obtained by removing the acyl groups (e.g., acetyl and glyceryl) possessed by natural gellan gum. It may be a substance obtained by removing all acyl groups (completely deacylated gellan gum) or a substance obtained by removing some acyl groups (or partially removing) (partially deacylated gellan gum).

[0048] In addition, in the partially deacylated gellan gum, the amount of acyl groups is not particularly limited, and the degree of acylation represented by the ratio of the peak intensity of the acyl groups to the peak intensity of the methyl groups in NMR (Nuclear Magnetic Resonance) measurement (analysis) may be 1.06 or less (e.g., less than 1.06, less than 1.05, less than 1, less than 0.95, less than 0.9, less than 0.8, less than 0.7, less than 0.6, less than 0.5, less than 0.4, less than 0.3, less than 0.2, less than 0.1). In addition, the lower limit of the degree of acylation may be greater than 0, and may be, for example, 0.001, 0.002, 0.003, 0.005, 0.007, 0.01, 0.015, 0.02, 0.025, 0.03, 0.035, 0.04, etc.

[0049] The proportion of gellan gum [or the proportion of gellan gum in the coating (when the capsule contains content, the proportion of gellan gum in the coating)] is not particularly limited, but from the perspective of improving capsule strength, the proportion of gellan gum is 5% by mass or more (for example, 10% by mass or more, 15% by mass or more, 18% by mass or more) in terms of solid content conversion [or in terms of the proportion relative to all components (components constituting the coating) other than solvents such as water], preferably 20% by mass or more, and may be 23% by mass or more, 25% by mass or more, 27% by mass or more, 30% by mass or more, or 33% by mass or more. In addition, the upper limit is not particularly limited, for example, from the perspective of operability during manufacturing and the dryness of the capsule, the proportion of gellan gum may be 80% by mass or less, 70% by mass or less, etc.

[0050] The capsule (film) may contain a monovalent metal ion. By making the capsule (film) contain the monovalent metal ion, a soft capsule having excellent physical properties (for example, strength and water disintegrability) can be easily and efficiently obtained.

[0051] Examples of the monovalent metal ion (or monovalent metal) include alkali metal (eg, lithium, sodium, potassium, rubidium, cesium, and francium) ions.

[0052] The monovalent metal ions may be used alone or in combination of two or more.

[0053] The capsule may contain the monovalent metal ion in the form of a compound containing the monovalent ion.

[0054] Examples of such compounds include inorganic compounds [e.g., alkali metal halides (e.g., lithium chloride, sodium chloride, potassium chloride), etc.], organic compounds {e.g., alkali metal salts of organic acids (e.g., sodium acetate, sodium tartrate, sodium citrate, etc.), alkali metal salts of sugars or polysaccharides [e.g., alkali metal salts of alginates (e.g., sodium alginate, potassium alginate), etc.], etc.}, etc.

[0055] These compounds can be used alone or in combination of two or more.

[0056] From the viewpoint of capsule forming properties, etc., organic compounds (for example, alkali metal salts of polysaccharides such as alkali metal alginate) are preferred over inorganic compounds. Among them, sodium alginate and potassium alginate are more preferred, and sodium alginate is particularly preferred.

[0057] In addition, although gellan gum may contain an alkali metal (for example, contained in the form of an alkali metal salt of a carboxyl group constituting gellan gum), such an alkali metal does not belong to the "monovalent metal ion" (monovalent metal) in the present invention.

[0058] That is, in the present invention (capsule, coating), unless otherwise specified, "monovalent metal ions" refer to monovalent metal ions added or blended separately from gellan gum [monovalent metal (ions) other than alkali metals originally contained in gellan gum].

[0059] When monovalent metal ions are contained, the ratio of the monovalent metal ions [or the ratio of the monovalent metal ions in the film (when the soft capsule contains contents, the ratio of the monovalent metal ions in the film)] is not particularly limited, and can be selected from a range of about 0.01% by mass or more (for example, 0.03% by mass or more) in terms of solid content conversion [or in terms of the ratio relative to all components (components constituting the film) excluding solvents such as water], and can be 0.05% by mass or more (for example, 0.07% by mass or more), preferably 0.1% by mass or more, more preferably 0.3% by mass or more, and particularly 0.5% by mass or more [for example, 0.8% by mass or more (for example, 1% by mass or more, 1.15% by mass or more)], etc. The ratio of the monovalent metal ions can be 30% by mass or less, preferably 20% by mass or less (for example, 18% by mass or less), more preferably 15% by mass or less (for example, 12% by mass or less), and particularly 10% by mass or less (for example, 8% by mass or less, 5% by mass or less), etc.

[0060] When the monovalent metal ion is contained in the form of a compound, the ratio of the monovalent metal compound [or the ratio of the monovalent metal compound in the film (when the capsule contains content, the ratio of the monovalent metal compound in the film)] can be appropriately selected according to the type of compound or the ratio (concentration) of the monovalent metal contained in the compound, and the ratio of the monovalent metal compound can be selected from a range of about 0.01 mass % or more (for example, 0.03 mass % or more) in terms of solid content conversion [or in terms of the ratio relative to all components (components constituting the film) excluding solvents such as water], and can be 0.1 mass % or more (for example, 0.15 mass % or more). The proportion of the monovalent metal compound may be 80 mass % or less (e.g., 70 mass % or less), preferably 60 mass % or less (e.g., 55 mass % or less), further preferably 50 mass % or less (e.g., 45 mass % or less), particularly 40 mass % or less (e.g., 35 mass % or less, 30 mass % or less, 25 mass % or less, 20 mass % or less), etc.

[0061] In particular, when a monovalent metal ion is contained in the form of an organic compound (for example, an alkali metal salt of a sugar or polysaccharide such as an alkali metal salt of alginate), the proportion of the compound calculated as solid content [or as a proportion relative to all components (components constituting the coating) other than solvents such as water] can be 0.1% by mass or more, preferably 1% by mass or more, further preferably 5% by mass or more, and in particular 10% by mass or more, etc. The proportion of the compound can be 80% by mass or less (for example, 70% by mass or less), preferably 60% by mass or less (for example, 55% by mass or less), further preferably 50% by mass or less (for example, 45% by mass or less), and in particular 40% by mass or less, etc.

[0062] In addition, when monovalent metal ions are contained, the ratio of the monovalent metal ions relative to 100 parts by mass of gellan gum can be, for example, 0.01 parts by mass or more (for example, 0.05 parts by mass or more), preferably 0.1 parts by mass or more (for example, 0.3 parts by mass or more), more preferably 0.5 parts by mass or more (for example, 0.8 parts by mass or more), and in particular, it can be 1 part by mass or more (for example, 1.5 parts by mass or more, 2 parts by mass or more, 2.5 parts by mass or more, 3 parts by mass or more), etc. The ratio of the monovalent metal ions can be 100 parts by mass or less (for example, 80 parts by mass or less), preferably 50 parts by mass or less (for example, 40 parts by mass or less), more preferably 30 parts by mass or less (for example, 25 parts by mass or less), etc., and can also be 20 parts by mass or less (for example, 18 parts by mass or less, 15 parts by mass or less), etc.

[0063] When the monovalent metal ion is contained in the form of a compound, the ratio of the monovalent metal compound relative to 100 parts by mass of gellan gum may be, for example, 0.1 parts by mass or more (for example, 0.5 parts by mass or more), preferably 1 parts by mass or more (for example, 2 parts by mass or more), more preferably 3 parts by mass or more (for example, 4 parts by mass or more), and particularly 5 parts by mass or more (for example, 7 parts by mass or more, 8 parts by mass or more, 10 parts by mass or more), etc. The ratio of the monovalent metal compound may be 500 parts by mass or less (for example, 400 parts by mass or less), preferably 300 parts by mass or less (for example, 250 parts by mass or less), more preferably 200 parts by mass or less (for example, 150 parts by mass or less), etc., and may be 120 parts by mass or less (for example, 100 parts by mass or less, 90 parts by mass or less, 80 parts by mass or less, 70 parts by mass or less), etc.

[0064] In particular, when the monovalent metal ion is contained in the form of an organic compound (for example, an alkali metal salt of a sugar or polysaccharide such as an alkali metal salt of alginate), the ratio of the compound relative to 100 parts by mass of gellan gum may be, for example, 0.1 parts by mass or more (for example, 0.5 parts by mass or more), preferably 1 part by mass or more (for example, 3 parts by mass or more), more preferably 5 parts by mass or more (for example, 8 parts by mass or more), and particularly 10 parts by mass or more (for example, 15 parts by mass or more, 20 parts by mass or more, 25 parts by mass or more, 30 parts by mass or more), etc. The ratio of the compound may be 500 parts by mass or less (for example, 400 parts by mass or less), preferably 350 parts by mass or less (for example, 300 parts by mass or less), more preferably 250 parts by mass or less (for example, 200 parts by mass or less), etc., and may be 150 parts by mass or less (for example, 120 parts by mass or less, 100 parts by mass or less), etc.

[0065] By using the monovalent metal ion (compound) in the above ratio, a capsule which is preferred in terms of disintegrability and capsule strength can be easily and efficiently obtained.

[0066] The capsule (or coating) of the present invention may or may not contain polyvalent metal ions (e.g., divalent metal ions such as calcium, etc.) in addition to the monovalent metal ions. When polyvalent metal ions are contained, the content ratio of the polyvalent metal ions (the content ratio in the coating) is not particularly limited, but is preferably small. For example, the polyvalent metal ions (or polyvalent metals) may be 5 parts by mass or less, preferably 3 parts by mass or less, more preferably 1 part by mass or less, and even more preferably 0.1 parts by mass or less, relative to 100 parts by mass of monovalent metal ions (or monovalent metals).

[0067] In addition, gellan gum may contain polyvalent metal ions (for example, contained in the form of alkaline earth metal salts of carboxyl groups constituting gellan gum), but such polyvalent metals do not belong to the above-mentioned "polyvalent metal ions" (polyvalent metals).

[0068] In the capsule (film), gellan gum can be combined with other film bases as needed. As such other film bases, there is no particular limitation, and for example, gelatin, carrageenan, agar, pectin, locust bean gum, xanthan gum, guar gum, thorny gum, Brunei gum, tamarind gum, ghatti gum, psyllium seed gum, tragacanth gum, linseed gum, diutangum, gum arabic, curdlan, furcellaran, pullulan, glucomannan, alginic acid, decomposition products of these film bases (for example, guar gum decomposition products, etc.), salts of these film bases, etc. can be listed.

[0069] The capsule [film (base) constituting the capsule] is particularly preferably of plant origin (with plant ingredients as the main component). From this perspective, when other film bases are used, the other film bases (or films) are also preferably of plant origin (with plant ingredients as the main component), and typically, the capsule [film (base) constituting the capsule] preferably does not contain (substantially does not contain) animal ingredients (such as gelatin, etc.).

[0070] In addition, other coating bases may be used as the component containing monovalent metal ions (monovalent metal compound). For example, the above-mentioned alkali metal alginate may be used as other coating bases.

[0071] Other coating bases may be used alone or in combination of two or more.

[0072] When other film bases are used, the ratio of other film bases is not particularly limited, and it depends on the type of other film bases, etc., and in particular, the film base can be constituted in a manner that gellan gum is the main component. For example, relative to 100 mass parts of gellan gum, the ratio of other film bases can be less than 200 mass parts (for example, less than 150 mass parts), preferably less than 100 mass parts, more preferably less than 80 mass parts (for example, less than 60 mass parts, less than 50 mass parts, less than 40 mass parts, less than 30 mass parts, less than 20 mass parts), etc. When other film bases are used, the lower limit is not particularly limited, for example, relative to 100 mass parts of gellan gum, the ratio of other film bases can be 0.1 mass parts, 0.5 mass parts, 1 mass parts, 2 mass parts, 3 mass parts, 5 mass parts, 8 mass parts, 10 mass parts, 12 mass parts, 15 mass parts, etc.

[0073] In addition, as described above, other coating bases are preferably plant-based. Therefore, even when other coating bases contain animal ingredients (gelatin, etc.), the proportion of animal ingredients (gelatin, etc.) relative to 100 parts by mass of gellan gum can be about 10 parts by mass or less, and can also be substantially free of animal ingredients (gelatin, etc.) [for example, relative to 100 parts by mass of gellan gum, it can be 5 parts by mass or less (for example, 3 parts by mass or less, 2 parts by mass or less, 1 part by mass or less, 0 parts by mass)].

[0074] For example, the capsule (film) may further contain a plasticizer from the viewpoint of adjusting the film strength, etc. As the plasticizer, any plasticizer known in the technical field may be used without particular limitation. Specific examples include polyols (e.g., (poly)alkylene glycols such as ethylene glycol, propylene glycol, polyethylene glycol, and polypropylene glycol; polyols having three or more hydroxyl groups such as glycerol), sugars [e.g., monosaccharides (e.g., glucose, fructose, glucose, galactose, etc.), disaccharides (e.g., sucrose, maltose, trehalose, coupling sugars, etc.), oligosaccharides (e.g., maltooligosaccharides, etc.), sugar alcohols (e.g., sorbitol, maltitol, lactitol, isomalt, xylitol, mannitol, galactitol, erythritol, reduced maltose syrup, etc.), polysaccharides or derivatives thereof [e.g., starch, starch derivatives (e.g., polydextrose, dextrin, maltodextrin, indigestible dextrin, cyclodextrin (α, β or γ)), cellulose derivatives (e.g., hydroxypropyl cellulose, hydroxypropyl methylcellulose, methyl cellulose, carboxymethyl cellulose, etc.)], polyvinyl alcohol, triacetin, etc.

[0075] These plasticizers may be used alone or in combination of two or more.

[0076] Among them, from the perspectives of making the dried capsule elastic and improving water disintegrability, improving the touch or mouthfeel of the coating, improving the operability (ease of operability) of the coating solution, and increasing the solid content concentration in the coating solution by blending a plasticizer to shorten the drying time of the capsule, polyols, sugar alcohols, disaccharides, polysaccharides, and their derivatives (for example, derivatives of polysaccharides such as starch derivatives and cellulose derivatives) are preferred, and glycerol, propylene glycol, sorbitol, erythritol, trehalose, starch, starch derivatives, and cellulose derivatives are more preferred. For example, when the coating contains a plasticizer, the content of the plasticizer in the coating is not particularly limited, and for example, 10 to 50% by mass can be cited.

[0077] The capsule (film) may also contain a component known in the art in addition to the above-mentioned components. As the component, for example, coloring agents (pigment, pigment), aromatics, sweeteners, antioxidants, preservatives, flavoring agents, spicy seasonings, acidulants (for example, citric acid or its salts, etc.), bittering agents, salt, umami ingredients, other components described in the items of the contents described later (for example, physiologically active substances, biologically active substances, etc.) etc. may be listed. These components may be used alone or in combination of two or more. In addition, sweeteners may also be used as the film base, plasticizer according to their type. The content of the component is not particularly limited, for example, may be less than 50% by mass.

[0078] As described above, the capsule may be composed of only the coating, or may be composed of the coating and the contents. In such a capsule having contents, the capsule contents are not particularly limited. The shape of the contents is not particularly limited, for example, it may be liquid, solid, or a mixture of the two states.

[0079] Specific contents include, for example, fragrances, cosmetics, surfactants, detergents, bath agents, fresheners, physiologically active substances (e.g., vitamins, amino acids, collagen, collagen peptides, lipids {fats [oils (e.g., medium-chain fatty acid oils (MCT), olive oil, fish oil, linseed oil, etc.), fats (e.g., butter, margarine, coconut oil, shea butter, etc.)], waxes, etc.}, isoflavones, minerals, enzymes, hormones, etc.), biologically active substances (drugs, etc.), microorganisms (e.g., bacteria such as lactic acid bacteria, bifidobacteria, natto bacteria, yeasts, etc.; fungi such as yeasts, etc.), food and beverages (or their extracts), plants (or their extracts), sweeteners, acidulants, flavorings, tonics, etc.

[0080] These components can be used alone or in combination of two or more.

[0081] The content of the contents in the capsule is not particularly limited and can be appropriately set according to the size of the capsule or its application. For example, the mass ratio of the contents to the coating can be 1 or more if the coating is 1.

[0082] The capsule (soft capsule) may be a seamless capsule. Typical examples of the capsule (soft capsule) include seamless capsules having contents and a film.

[0083] The shape of the capsule is not particularly limited, and may be, for example, spherical (eg, round ball shape) or rugby ball shape.

[0084] The outer diameter of the capsule is not particularly limited, and may be 0.1 mm or more, 0.5 mm or more, 1 mm or more, 1.5 mm or more, 2 mm or more, etc., or 30 mm or less, 25 mm or less, 20 mm or less, 18 mm or less, 15 mm or less, 12 mm or less, 10 mm or less, 8 mm or less, etc., and typically, may be 0.1 to 20 mm (e.g., 0.1 to 15 mm), 1 to 15 mm, 1.5 to 10 mm, 2 to 8 mm, etc. When the plane shape (cross section) of the capsule is circular, the outer diameter refers to the major diameter, and when the plane shape of the capsule is non-circular, the outer diameter refers to the maximum diameter.

[0085] The outer diameter can be measured using, for example, a digital caliper (trade name: Quick-Mini25, model: PK-0510SU, measurement range: 0 to 25 mm, manufactured by Mitutoyo Corporation).

[0086] In addition, when the capsule has no content (or is composed only of a coating), the above-mentioned outer diameter is the diameter of the coating.

[0087] In addition, the outer diameter may also be a measured value under specified conditions (e.g., 40-60% RH, 45% RH, etc.). In the following, unless there is a special provision such as "before drying", the physical properties of the soft capsule (e.g., film thickness, rupture strength, elasticity, etc.) are the same.

[0088] When the capsule has content, the thickness of the film of the capsule is not particularly limited, and may be, for example, about 5 to 120 μm, 10 to 100 μm, 20 to 90 μm, or 20 to 60 μm.

[0089] The thickness (thickness) of the coating film can be measured using, for example, a digital microscope (trade name: VHX-900, manufactured by KEYENCE CORPORATION).

[0090] When the capsule has contents, the mass ratio of the coating to the contents can be selected based on the thickness (outer diameter) of the capsule, etc., and is not particularly limited. For example, relative to 100 parts by mass of the coating, the contents can be selected from a range of about 1 part by mass or more (for example, 10 parts by mass or more), preferably 30 parts by mass or more (for example, 50 parts by mass or more), and more preferably 60 parts by mass or more (for example, 100 parts by mass or more). It can also be 4000 parts by mass or less (for example, 3500 parts by mass or less), preferably 3000 parts by mass or less (for example, 2500 parts by mass or less), and more preferably 2000 parts by mass or less.

[0091] In addition, the coating ratio of the capsule is not particularly limited, and may be, for example, 1% by mass or more, 2% by mass or more, 3% by mass or more, etc. When the capsule has contents, the upper limit of the coating ratio (the ratio of the mass of the coating to the total amount of the coating and the contents) is not particularly limited, and may be, for example, 80% by mass, 70% by mass, 60% by mass, 50% by mass, 40% by mass, 35% by mass, 30% by mass, 25% by mass, 22% by mass, 20% by mass, 18% by mass, etc.

[0092] In particular, when the capsule has contents, the coating ratio may be, for example, 1 to 50 mass % (e.g., 2 to 40 mass %), preferably 3 to 20 mass %, more preferably about 3 to 18 mass %, and usually 3 to 50 mass % (e.g., about 3 to 40 mass %).

[0093] In addition, when the capsule has no content (or is composed of only a coating), the coating ratio is 100% by mass. Of course, the present invention also includes such capsules having no content (capsules with a coating ratio of 100%).

[0094] In addition, the water content of the capsule (the water content of the film) can be appropriately set according to the purpose of the capsule, for example, it can be 30% by mass or less, 25% by mass or less, 20% by mass or less, or 1% by mass or more, 3% by mass or more, 5% by mass or more, 8% by mass or more, etc. From a practical point of view, the water content can be 10 to 18% by mass, etc.

[0095] The moisture content is not particularly limited and can be determined using a common method [for example, a method of measuring loss on drying (a method using the mass before and after drying)].

[0096] Most of the capsules of the present invention can achieve sufficient water disintegration (excellent water disintegration). At this time, the capsule can be, for example, a capsule having a short disintegration time (for example, within 60 minutes) measured by the disintegration test method of the Japanese Pharmacopoeia (17th revised edition) using water (37±2°C) as the test liquid. The disintegration time can be within 40 minutes, within 30 minutes, etc., and in particular, within 20 minutes, within 10 minutes, etc. The lower limit of the disintegration time is not particularly limited, and can be, for example, 30 seconds, 1 minute, 2 minutes, 3 minutes, 4 minutes, 5 minutes, etc. In the disintegration test, an auxiliary disk can be used as needed.

[0097] The bursting strength of the capsule depends on the outer diameter, etc., and may be, for example, 100 g or more, 200 g or more, 300 g or more, 400 g or more, 500 g or more, 600 g or more, 700 g or more, 800 g or more, 900 g or more, 1000 g or more, etc.

[0098] The upper limit of the burst strength of the capsule is not particularly limited, but may be, for example, 20,000 g or less, 15,000 g or less, 12,000 g or less, or 10,000 g or less.

[0099] The burst strength can be measured using, for example, a rheometer CR-3000EX (manufactured by Sun Scientific Co., Ltd.).

[0100] For capsules (e.g., capsules with contents), the ratio of the bursting strength (g) to the outer diameter (mm) (bursting strength / outer diameter) is not particularly limited, and may be, for example, 200 or more (e.g., greater than 200), preferably 210 or more (e.g., 220 or more), further preferably 230 or more (e.g., 240 or more), and may also be 250 or more, 300 or more, 400 or more, etc.

[0101] The upper limit of the ratio of the burst strength to the outer diameter (burst strength / outer diameter) is not particularly limited, and may be, for example, 20,000, 15,000, 10,000, 8,000, 6,000, or 5,000.

[0102] Since it is conceivable that the capsule is easily broken even if the breaking strength is large (for example, when the outer diameter is large), the ratio of the breaking strength to the outer diameter can be regarded as an index reflecting the actual breaking ease of the capsule.

[0103] The rupture distance of the capsule depends on the outer diameter and the like, but may be, for example, 0.1 mm or more, 0.2 mm or more, 0.5 mm or more, 1.0 mm or more, or the like.

[0104] The upper limit of the rupture distance of the soft capsule is not particularly limited, but may be, for example, 15 mm or less, 10 mm or less, 8 mm or less, or the like.

[0105] The rupture distance can be measured, for example, using a rheometer CR-3000EX (manufactured by Sun Scientific Co., Ltd.).

[0106] The ratio of the rupture distance (mm) to the outer diameter (mm) of the capsule (rupture distance / outer diameter) is not particularly limited, but may be, for example, 0.1 or more, preferably 0.12 or more, more preferably 0.15 or more, and may be 0.18 or more, 0.2 or more, etc.

[0107] The upper limit of the ratio of the rupture distance to the outer diameter (rupture distance / outer diameter) is not particularly limited, and may be, for example, 1.0, 0.98, 0.97, 0.96, 0.95, or the like.

[0108] The ratio of the rupture distance to the outer diameter can reflect the degree of elasticity (ease of deformation until the capsule ruptures), and therefore this ratio can be said to be an index that supplementarily reflects the strength (ease of rupture) of the capsule.

[0109] The capsule of the present invention often has such high (or sufficient) mechanical strength. A particularly preferred embodiment of the capsule of the present invention contains gellan gum and can have both such mechanical strength and the water disintegrability as described above.

[0110] Generally speaking, in order to make the capsules able to withstand the manufacturing process (especially the drying process), it is necessary to increase the film thickness (film coating rate) of the capsules. On the other hand, if the film thickness is increased, the water disintegration is likely to be deteriorated. That is, it is difficult for the capsules to have both sufficient mechanical strength and disintegration. According to the research of the inventors of the present application, this tendency is particularly significant for capsules containing gellan gum in the film.

[0111] However, in the present invention, these properties can be efficiently achieved by adjusting the film formulation and the like.

[0112] Such capsules can be efficiently produced by appropriately selecting components (e.g., monovalent metal ions or metal compounds, other coating bases, other components such as plasticizers) combined with gellan gum and their ratios (further, capsule production conditions), etc.

[0113] In the present invention, a plurality of capsules can be obtained in a relatively uniform form.

[0114] For example, for capsule (plural capsules), the standard deviation (SD) value of the burst strength depends on the burst strength, etc., but can be, for example, 800 g or less, 700 g or less, 600 g or less, 500 g or less, 400 g or less, 350 g or less, etc.

[0115] In addition, for capsule (plural capsules), the standard deviation (SD) value of the rupture distance depends on the rupture strength, etc., but can be, for example, 2 mm or less, 1.5 mm or less, 1 mm or less, 0.8 mm or less, 0.7 mm or less, 0.6 mm or less, 0.5 mm or less, etc.

[0116] Capsules (soft capsules) can be manufactured according to known methods. For example, a solution (filming liquid) containing components corresponding to the capsule (or filming) (for example, gellan gum and other components such as monovalent metal compounds, other filming bases, and plasticizers) can be used to manufacture using a dripping method [using a dripping method using a nozzle (for example, multiple nozzles)].

[0117] In addition, the coating liquid generally uses water as a solvent component in many cases.

[0118] In the coating liquid, the solid content concentration can be, for example, 3 mass % or more (for example, 4 mass % or more), preferably 5 mass % or more, more preferably 6 mass % or more, and can also be 20 mass % or less (for example, 15 mass % or less), preferably 12 mass % or less, more preferably 10 mass % or less, etc.

[0119] The production conditions can be appropriately set according to the composition of the capsule, the size of the capsule diameter, the coating rate, etc. In addition, the cooling temperature, cooling time, drying temperature, and drying time after dripping can also be appropriately set.

[0120] In addition, the dropped capsules may be immersed in an impregnation liquid (for example, a solution containing polyvalent metal ions such as calcium) before drying. However, in the present invention, since the capsules (film) are composed of the above-mentioned components, such impregnation is not necessary, and such impregnation may impair water disintegrability.

[0121] In the present invention, gellan gum is easily and efficiently gelled while being given appropriate strength. Therefore, in the present invention, capsules (soft capsules) having manufacturable appropriate strength and excellent in physical properties (e.g., water disintegrability and mechanical strength) are easily and efficiently obtained.

[0122] In this way, the capsules of the present invention can be efficiently manufactured using the above-mentioned dripping method, and typically, the capsules of the present invention can be manufactured through at least the following steps: a capsule manufacturing step of obtaining capsules (capsules with a high water content) using the dripping method; and a drying step of drying the capsules obtained through the capsule manufacturing step.

[0123] Furthermore, in such a series of steps, by appropriately setting the conditions before drying (capsule before drying step), deformation and cracking after drying can be further suppressed, thereby facilitating efficient production.

[0124] Generally, the moisture content (moisture content in the film) before drying (capsule before drying) is high, for example, it may be 70% by mass or more, 75% by mass or more, 80% by mass or more, 85% by mass or more, 90% by mass or more, etc., and may be 99% by mass or less, 98% by mass or less, 97% by mass or less, 96% by mass or less, 95% by mass or less, etc.

[0125] The outer diameter of the capsule before drying is not particularly limited, but is usually 0.1 mm or more (eg, 1 to 20 mm), and may be 0.75 to 22.5 mm, 25 mm or less (eg, 0.5 to 25 mm), or the like.

[0126] The outer diameter can be measured, for example, using a digital caliper (trade name: Quick-Mini25, model: PK-0510SU, measurement range: 0 to 25 mm, manufactured by Mitutoyo Corporation).

[0127] The bursting strength of the capsule before drying cannot be determined uniformly according to the outer diameter, but may be 10 g or more (e.g., 50 to 1000 g), 30 to 1500 g, 3000 g or less (e.g., 10 to 3000 g), etc. The bursting strength can be measured using a rheometer CR-3000EX (manufactured by Sun Scientific Co., Ltd.).

[0128] For the capsule before drying, the ratio of the bursting strength (g) to the outer diameter (mm) (bursting strength / outer diameter) can be 3 or more, 3.5 or more, 4 or more, 4.5 or more, and in particular, 5.0 or more. If it is above the above value, the dried capsule has a strength that can be manufactured and can disintegrate in water. From the perspective that the capsule will not break due to drying, the bursting strength / outer diameter can be, for example, 5.5 or more, or 6.0 or more. The upper limit is not particularly limited, and for example, 15 or less can be listed.

[0129] The capsule of the present invention can be manufactured, for example, using the manufacturing method described above, but such a manufacturing method can also refer to a specific known manufacturing method, such as the method described in Japanese Patent Gazette No. 5047285 or Japanese Patent Publication No. 10-506841. Specifically, a dripping method (seamless capsule method) using a double or multiple (three or more) nozzle can be listed. For example, the following manufacturing method can be listed, which includes the process of filling the capsule contents into a capsule coating containing gellan gum (and other components such as monovalent metal ions) to prepare the filler. After preparing the filler, it can also include a molding process and a drying process. In addition, the capsule contents can be the same composition as the capsule coating liquid, and can also be set with reference to the items of the capsule of the present invention described above.

[0130] In the dripping method, for example, a composite nozzle device is used that is appropriately arranged in an approximately concentric circle shape. The composite nozzle device, for example, has an inner nozzle that receives and distributes the capsule content, and an outer nozzle that receives and distributes the capsule coating liquid, and the inner nozzle and the outer nozzle are arranged in an approximately concentric circle shape. Using the composite nozzle device, the capsule content is sprayed out from the spray port of the inner nozzle, and the capsule coating liquid is sprayed out from the spray port of the outer nozzle. The capsule content and the capsule coating liquid can be sprayed from the inner nozzle and the outer nozzle at a specified speed into the oil or gas at the same time by a pump or gravity, respectively, to form a coaxial flow direction in the carrier flow flowing downstream, and physical forces such as vibration are applied to cut off the sprayed liquid at a specified interval, and the cut portion is formed into a spherical shape by using the interfacial tension or surface tension between the oil or gas and the capsule coating liquid, and the film layer is gelled by cooling, thereby manufacturing capsules.

[0131] The interfacial tension or surface tension is not particularly limited, and is preferably 15 to 50 mN / m at the interface between the capsule coating liquid and the content liquid. For example, the interfacial tension or surface tension can be measured using Sigma 702 manufactured by KSV INSTRUMENTS (FINLAND).

[0132] In the present invention, it is preferred to appropriately control the temperature conditions near the multiple nozzles when manufacturing the capsule. It is preferred to set the temperature near the multiple nozzles of the capsule (seamless capsule) manufacturing device within the following range, for example:

[0133] (1) according to the properties of the contents, the temperature of the capsule contents is controlled within a range of ±2°C (more preferably ±1°C) of the set value within a predetermined temperature at which the contents are in a liquid state (or fluidity) {for example, (i) when the contents are in a liquid state (at room temperature), the temperature of the capsule contents is set to 5 to 25°C (more preferably 12 to 22°C); (ii) when the contents are in a solid state at room temperature, the temperature is set to the temperature at which the contents become liquid [for example, when fat (for example, butter, margarine, etc., oil at room temperature below 40°C) is used, the temperature of the capsule contents is set to 30 to 60°C (more preferably 40 to 50°C)], etc.};

[0134] (2) The temperature of the capsule coating liquid is controlled within the range of 50 to 99°C (more preferably 60 to 95°C) to within ±2°C (more preferably ±1°C) of the set value.

[0135] When a lipophilic solvent is added to the oily component of the capsule content and used, it is preferred (3) that the temperature of the lipophilic solvent be controlled within the range of 1 to 25°C (more preferably 5 to 20°C) to be within ±1°C (more preferably ±0.5°C) of the set value.

[0136] Furthermore, in addition to the above conditions, more preferably (4) the difference between the temperature of the capsule content and the temperature of the capsule coating solution is 25° C. to 94° C. (more preferably 38° C. to 85° C.).

[0137] When a lipophilic solvent is added to the oily component of the capsule content, it is more preferred that (5) the difference between the temperature of the capsule coating liquid and the temperature of the lipophilic solvent be 35°C to 94°C (more preferably 49°C to 85°C).

[0138] Furthermore, when the film layer is cooled to gel after passing through the nozzle, cooling is performed using cooling oil. The cooling temperature when using cooling oil is, for example, about 5 to 35°C.

[0139] A person skilled in the art can appropriately select or combine the above temperature conditions (1) to (5) according to the quality level required for the capsule (seamless capsule). For example, by combining PID (Proportional Integral Derivative) control with feedback control, a person skilled in the art can simply perform the above temperature control, but is not limited to these control methods.

[0140] The capsule coating liquid is not particularly limited as long as it contains gellan gum (and further contains other components such as monovalent metal ions as needed), and can be prepared by, for example, dissolving in a solvent. The solvent is not particularly limited as long as it does not hinder the effect of the present invention, and examples thereof include alcohols such as water and ethanol, and water is more suitable.

[0141] Furthermore, when the obtained capsule is cooled, the cooling temperature is not particularly limited, but is usually 20° C. or lower, preferably 10° C. or lower. The cooling time is not particularly limited, but is usually about 10 minutes to 30 hours.

[0142] After the wet capsules are manufactured in the above manner, they can be dried. This drying is usually carried out using, for example, a "drum dryer" with a ventilation device. In addition, for small capsules such as seamless capsules, a flowing type can also be used to dry them while blowing air to make them flow. The drying temperature is not particularly limited and can be around 20 to 50°C.

[0143] Example

[0144] Hereinafter, the present invention will be described in detail using examples, but the present invention is not limited to these examples.

[0145] The obtained capsules were measured or evaluated according to the following methods.

[0146] [Capsule rupture strength and elasticity (rupture distance)]

[0147] The burst strength of the capsule (capsule before and after drying) is a value measured at room temperature (22 to 27° C.) and 40 to 60% RH using a rheometer CR-3000EX manufactured by Sun Scientific Co., Ltd.

[0148] The strength of the dried capsules was measured by leaving the capsules (about 10 to 18% by mass) in an environment with a humidity of 45% RH for a long time (about half a day) (the same shall apply to the dried capsules hereinafter).

[0149] In the above measurement, the deformation distance before the capsule ruptures (the distance the capsule is pressed by the rheometer before ruptures) is used as an index of the elasticity of the capsule.

[0150] Furthermore, n=20 was set and the standard deviation (SD) values ​​of the rupture strength and the rupture distance were calculated.

[0151] [Capsule outer diameter]

[0152] The outer diameter of the capsule was measured using a digital caliper manufactured by Mitutoyo Corporation (trade name: Quick-Mini25, model: PK-0510SU, measurement range: 0 to 25 mm) at room temperature (22 to 27° C.) and 40 to 60% RH.

[0153] [Capsule coating rate]

[0154] The coating ratio was calculated by coating ratio (%)=capsule coating weight / capsule total weight×100.

[0155] The weight was measured using an electronic balance GX-200 manufactured by A&D Company, Ltd.

[0156] [Thickness of capsule coating]

[0157] The thickness of the capsule coating (coating thickness) was measured using a digital microscope manufactured by KEYENCE CORPORATION (trade name: VHX-900, using a calibration scale of 10 μm).

[0158] [Capsule disintegration]

[0159] For the obtained capsules, according to the disintegration test method of the Japanese Pharmacopoeia (17th revised edition), the capsules and auxiliary disks are placed in the tester, and the test is carried out using 37±2°C water as the test liquid. The time when the capsule becomes obviously unable to maintain its original shape or only the capsule film fragments are left is taken as the disintegration time. In addition, for the same formulation, the number of capsules in the test is at least 6, and the average of the disintegration times of these capsules is taken as the disintegration time.

[0160] [Moisture content]

[0161] The moisture content was obtained by measuring the loss on drying represented by the following formula.

[0162] Loss on drying (%) = [capsule weight (mg) - dry capsule weight (mg)] / capsule weight (mg) × 100

[0163] The dry capsule weight refers to the weight of the capsule after the capsule is fully dried (dried at 110° C. for 2 hours).

[0164] [Whether there is cracking after drying]

[0165] If the dried capsules were not cracked, it was evaluated as "none" (0%), and if cracks were present, the crack ratio was evaluated.

[0166] Embodiments 1 to 8

[0167] The coating liquid was prepared according to the following formulation (Table 1), and capsules [content: MCT (Kao: COCONARD ML)] were obtained under the conditions shown in Table 4 by a drop-casting method using a multi-nozzle.

[0168] As gellan gum, deacylated gellan gum (manufactured by CP Kelco, “KELCOGEL”) was used (the same shall apply hereinafter).

[0169] In addition, the ratio of monovalent metal (sodium) ions per 1 g of sodium alginate was 0.0923 g (the same shall apply hereinafter).

[0170] [Table 1]

[0171]

[0172] Comparative Example 1

[0173] The coating liquid was prepared according to the following formulation (Table 2), and capsules [content: MCT (Kao: COCONARD ML)] were obtained under the conditions shown in Table 4 by a drop-casting method using a multi-nozzle.

[0174] [Table 2]

[0175]

[0176] Embodiment 9-10

[0177] The coating liquid was prepared according to the following formulation (Table 3), and capsules [content: MCT (Kao: COCONARD ML)] were obtained by the drop method using a multi-nozzle under the conditions shown in Table 4. In Example 10, the capsules were immersed in a calcium lactate aqueous solution before drying.

[0178] The ratio of monovalent metal (sodium) ions per 1 g of sodium citrate was 0.0891 g (the same shall apply hereinafter).

[0179] [Table 3]

[0180]

[0181] The results are shown in Table 4.

[0182] [Table 4]

[0183]

[0184] As is apparent from the results in the above table, capsules excellent in water disintegrability and mechanical strength were obtained in Examples.

[0185] In particular, the results of Example 9 show that capsules free of cracks after drying can be efficiently obtained by selecting the production conditions of the capsules (conditions before drying).

[0186] Furthermore, the results of Example 10 show that the mechanical strength can be improved by the immersion treatment before drying, but the obtained capsules have poor water disintegrability.

[0187] On the other hand, in Examples 1 to 8, capsules were obtained which were not ruptured and had both water disintegrability and excellent mechanical strength.

[0188] Embodiments 11 to 19

[0189] The coating liquid was prepared according to the following formulation (Table 5), and capsules [content: MCT (Kao: COCONARD ML)] were obtained under the conditions shown in Table 6 by a drop-casting method using a multi-nozzle.

[0190] [Table 5]

[0191]

[0192] In addition, in the coating liquid, the ratio of gellan gum to all solid components is 18.75 mass% (Examples 11 to 12), 31.25 mass% (Examples 13 to 17) or 12.5 mass% (Examples 18 to 19), the ratio of sodium alginate to all solid components is 12.5 mass% (0.092 mass% as monovalent metal), and the ratio of sodium alginate to 100 parts by mass of gellan gum is 66.7 parts by mass (6.15 parts by mass as monovalent metal) [Examples 11 to 12], 40.0 parts by mass (3.69 parts by mass as monovalent metal) [Examples 13 to 17] or 100 parts by mass (9.23 parts by mass as monovalent metal) [Examples 18 to 19].

[0193] The results are shown in Table 6.

[0194] [Table 6]

[0195]

[0196] From the above, it is clear that even if other coating bases (agar, carrageenan, pectin) are blended into gellan gum, capsules having sufficient water disintegrability and mechanical strength can be obtained.

[0197] Among them, from the results of Examples 11 to 17 and Examples 18 and 19, it can be seen that by appropriately selecting the proportion of gellan gum in the entire coating base (so that it is not too small), water disintegrability and mechanical strength can be effectively achieved.

[0198] Furthermore, the results of Example 18 show that even when other film-coating bases are used, capsules free of cracks after drying tend to be efficiently obtained by selecting the production conditions of the capsules (conditions before drying).

[0199] Embodiment 20-26

[0200] The coating liquid was prepared according to the following formulation (Table 7), and capsules [content: MCT (Kao: COCONARD ML)] were obtained by a drop method using a multi-nozzle under the conditions shown in Table 8. In addition, Example 7 is also described for comparison.

[0201] Furthermore, the ratio of monovalent metal (potassium) ions per 1 g of potassium alginate was 0.112 g.

[0202] [Table 7]

[0203]

[0204] In addition, in the coating liquid, the ratio of gellan gum to the total solid content was 37.5% by mass, and the ratio of the monovalent metal compound to the total solid content was 3.75% by mass (1.48% by mass as monovalent metal) [Example 20], 3.75% by mass (1.97% by mass as monovalent metal) [Example 21], 15.0% by mass (2.14% by mass as monovalent metal) [Example 22], 15.0% by mass (2.47% by mass as monovalent metal) [Example 23], 37.5% by mass (3.46% by mass as monovalent metal) [Example 24], 37.5% by mass (3.95% by mass as monovalent metal) [Example 25], 37.5% by mass (4.6% by mass as monovalent metal) [Example 26], and 37.5% by mass (4.95% by mass as monovalent metal) [Example 27]. .20 mass%) [Example 26], the ratio of the monovalent metal compound to 100 parts by mass of gellan gum is 10.0 parts by mass (3.93 parts by mass as monovalent metal) [Example 20], 10.0 parts by mass (5.25 parts by mass as monovalent metal) [Example 21], 40.0 parts by mass (5.70 parts by mass as monovalent metal) [Example 22], 40.0 parts by mass (6.57 parts by mass as monovalent metal) [Example 23], 100 parts by mass (9.23 parts by mass as monovalent metal) [Example 24], 100 parts by mass (10.54 parts by mass as monovalent metal) [Example 25], and 100 parts by mass (11.20 parts by mass as monovalent metal) [Example 26].

[0205] The results are shown in Table 8.

[0206] [Table 8]

[0207]

[0208] The results in the above table show that capsules excellent in water disintegrability and mechanical strength can be obtained even when various monovalent alkali metal salts are used.

[0209] Embodiments 27 to 31

[0210] The coating liquid was prepared according to the following formulation (Table 9), and capsules [content: MCT (Kao: COCONARD ML)] were obtained by the drop method using a multi-nozzle under the conditions shown in Table 10. In addition, Example 24 is also described for comparison.

[0211] [Table 9]

[0212]

[0213] In addition, in the coating liquid, the ratio of gellan gum to all solid components is 30.0 mass %, the ratio of sodium alginate to all solid components is 30.0 mass % (2.77 mass % as monovalent metal), and the ratio of sodium alginate to 100 parts by mass of gellan gum is 100 parts by mass (9.23 parts by mass as monovalent metal).

[0214] The results are shown in Table 10.

[0215] [Table 10]

[0216]

[0217] The results in the above table show that capsules excellent in water disintegrability and mechanical strength can be obtained even when various plasticizers are used.

[0218] Embodiment 32-33

[0219] The coating liquid was prepared according to the following formulation (Table 11), and a capsule (pure sphere) having only a coating and no content was obtained by a drop-casting method using a single nozzle.

[0220] [Table 11]

[0221]

[0222] In addition, in the coating liquid, the ratio of gellan gum to all solid components was 20.0 mass%, the ratio of sodium alginate to all solid components was 26.7 mass%, and the ratio of sodium alginate to 100 mass parts of gellan gum was 133 mass parts (12.31 mass parts as monovalent metal).

[0223] The results are shown in Table 12.

[0224] [Table 12]

[0225]

[0226] The results in the above table show that capsules excellent in water disintegrability and mechanical strength can be obtained even without having any contents.

[0227] Embodiment 34-35

[0228] The coating liquid was prepared according to the same recipe as in Example 24 (Table 9), and the capsules were obtained under the conditions shown in Table 13 by the drop method using a multi-nozzle [Contents of Example 34: purified olive oil (Dcoop S. Coop. And.: Olive Oil Refining); Contents of Example 35: fish oil (Maruha Nichiro Corporation: DHA-46MK) 80% by mass and MCT (Kao: COCONARD ML) 20% by mass]. In addition, Example 24 is also described for comparison.

[0229] The results are shown in Table 13.

[0230] [Table 13]

[0231]

[0232] The results in the above table show that capsules excellent in water disintegrability and mechanical strength can be obtained even when the contents are changed.

[0233] Embodiments 36 to 43

[0234] The coating solution was prepared according to the following formulation (Table 14) (in Table 1 (Examples 1 to 8), sodium alginate was not used, and the total amount of sodium alginate and guar gum decomposition products was set to guar gum decomposition products), and capsules [content: MCT (Kao: COCONARD ML)] were obtained under the conditions shown in Table 15 by a drop method using a multi-nozzle. In addition, Examples 1 to 8 are also described for comparison.

[0235] [Table 14]

[0236]

[0237] The results are shown in Table 15.

[0238] [Table 15]

[0239]

[0240] Industrial Applicability

[0241] The capsule of the present invention can be applied to fields such as medicine, food, and industry.

Claims

1. A soft capsule having a coating substantially free of gelatin and containing gellan gum, wherein the soft capsule satisfies the following (A) and / or (B): (A) the disintegration time measured by the Japanese Pharmacopoeia disintegration test method using water as the test liquid is within 60 minutes; (B) The ratio of the bursting strength (g) to the outer diameter (mm) (bursting strength / outer diameter) is 210 or more.

2. A soft capsule having a coating substantially free of gelatin and containing gellan gum and a monovalent metal ion.

3. The capsule according to claim 1 or 2, wherein: (A) the disintegration time measured by the Japanese Pharmacopoeia disintegration test method using water as the test liquid is within 60 minutes, and (B) the ratio of the bursting strength (g) to the outer diameter (mm) (bursting strength / outer diameter) is 210 or more.

4. The capsule according to any one of claims 1 to 3, wherein (C) The ratio of the rupture distance (mm) to the outer diameter (mm) (rupture distance / outer diameter) is 0.1 or more.

5. The capsule according to any one of claims 1 to 4, wherein The ratio of gellan gum in the coating film is 5% by mass or more.

6. The capsule according to any one of claims 1 to 5, wherein The capsule contains monovalent metal ions in the form of monovalent metal compounds.

7. The capsule according to any one of claims 1 to 6, wherein The capsule contains a monovalent metal ion in the form of at least one monovalent metal compound selected from the group consisting of alkali metal halides, alkali metal salts of organic acids, and alkali metal salts of sugars or polysaccharides.

8. The capsule according to any one of claims 1 to 6, comprising at least a monovalent metal ion in the form of an alkali metal salt of alginate.

9. The capsule according to any one of claims 1 to 8, wherein The ratio of the monovalent metal ion is 0.1 parts by mass or more relative to 100 parts by mass of the gellan gum in terms of metal atom.

10. The capsule according to any one of claims 1 to 9, wherein The coating film contains other coating base agents in a ratio of 100 parts by mass or less relative to 100 parts by mass of the gellan gum.

11. The capsule according to any one of claims 1 to 10, wherein The coating contains a plasticizer.

12. The capsule according to any one of claims 1 to 11, wherein The coating contains at least one plasticizer selected from the group consisting of polyols, sugar alcohols, disaccharides, polysaccharides, and derivatives thereof.

13. The capsule according to any one of claims 1 to 12, wherein The outer diameter of the capsule is 0.1~15 mm.

14. The capsule according to any one of claims 1 to 13, wherein The capsule has a coating ratio of 3% by mass or more.

15. The capsule according to any one of claims 1 to 14, wherein The capsule has contents and a coating rate of 3 to 50% by mass.

16. The capsule according to any one of claims 1 to 15, wherein The standard deviation (SD) value of the rupture strength is 500 g or less, and the standard deviation (SD) value of the rupture distance is 1 mm or less.

17. The capsule according to any one of claims 1 to 16, which is a seamless capsule.

18. A method for manufacturing the capsule according to any one of claims 1 to 17, the method comprising at least: a capsule manufacturing step of obtaining capsules having a water content of 80% by mass or more and a ratio of a bursting strength (g) to an outer diameter (mm) (bursting strength / outer diameter) of 5.0 or more by a dripping method; and a drying step of drying the capsules obtained by the capsule manufacturing step.

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