Chewable soft capsule

Abstract

Provided is a chewable soft capsule having a texture closer to that of a gummy.　The chewable soft capsule is such that a capsule film contains 1-35 mass% of (A) a gelatin and 3-25 mass% of (B) an anhydrogalactose-sulfated anhydrogalactose copolymer. The capsule includes, as capsule content, a composition containing (C) a gelatin, (D) glycerins, (E) a sodium salt or potassium salt of an acid selected from citric acid, hydrochloric acid, malic acid, phosphoric acid, gluconic acid, succinic acid, tartaric acid, and lactic acid, and (F) water.

Description

Chewable Soft Capsule

[0001] The present invention relates to a soft capsule that can be chewed in the oral cavity.

[0002] In recent years, due to the expanding use of soft capsules, attempts have been made to develop soft capsule agents with a texture and feel similar to gummy candies. Soft capsules have been studied by incorporating a large amount of plasticizers or by adding starches and saccharides to make the capsule film chewable. For example, Patent Document 1 discloses a soft capsule preparation having a film composed of an oral soft composition containing gelatin, a gelling agent containing a thickening polysaccharide, a polyhydric alcohol, a water-soluble polysaccharide, celluloses, and starch, which is excellent in texture and feel and is less likely to cause caking between compositions and adhesion to a container. Further, Patent Document 2 discloses a chewable soft capsule agent prepared by adding a specific plasticizer to a gelatin agent skin in an amount several times the usually used amount and incorporating water-insoluble celluloses, which has a soft and good chewing texture and low adhesiveness.

[0003] In addition, the present applicant has found that a soft capsule agent molded using a capsule film containing a specific amount of gelatin and anhydrogalactose-sulfated anhydrogalactose copolymer has a texture similar to gummy candies when chewed and suppresses sticking between capsules, adhesion to a container, and discoloration during storage (Patent Document 3).

[0004] On the other hand, regarding soft capsule agents containing a gel-like composition in the capsule contents, for example, a chewable soft capsule agent in which the capsule contents are gelled by a water-soluble gelling agent and exhibit a jelly or gummy form (Patent Document 4), and a chewable soft capsule containing a matrix containing a gel-forming component such as gelatin, a plasticizer such as glycerin, a carboxylic acid such as lactic acid, and water (Patent Document 5) have been reported.

[0005] JP-A-2021-175740 Patent No. 3261331 WO 2024 / 080269 Patent No. 5618402 Patent No. 4995407

[0006] This invention relates to providing a chewable soft capsule with a texture closer to that of gummy candy.

[0007] As a result of various studies, the inventors have discovered that by combining the contents of a soft capsule molded using a capsule coating containing a specific amount of gelatin and anhydrogalactose / sulfated anhydrogalactose copolymer with the sodium or potassium salt of a specific acid along with gelatin and glycerin, a sense of unity is created between the capsule contents and the coating, resulting in a soft capsule with a texture very similar to gummy candy when chewed.

[0008] In other words, the present invention relates to the following 1) to 9). 1) A chewable soft capsule, wherein the capsule shell contains (A) 1 to 35% by mass of gelatin and (B) 3 to 25% by mass of an anhydrogalactose / sulfated anhydrogalactose copolymer, and the capsule contents contain a composition containing (C) gelatin, (D) glycerin, (E) a sodium or potassium salt of an acid selected from citric acid, hydrochloric acid, malic acid, phosphoric acid, gluconic acid, succinic acid, tartaric acid, and lactic acid, and (F) water. 2) The chewable soft capsule according to 1), wherein the content of (C) gelatin in the capsule contents is 1 to 10% by mass of the total amount of capsule contents. 3) The chewable soft capsule according to 1), wherein the content of (D) glycerin in the capsule contents is 5 to 30% by mass of the total amount of capsule contents. 4) The chewable soft capsule according to 1), wherein the content of the sodium salt of the acid indicated by (E) in the capsule contents is 0.05 to 10% by mass of the total amount of capsule contents, and the content of the potassium salt of the acid indicated by (E) is 0.01 to 6% by mass of the total amount of capsule contents. 5) The chewable soft capsule according to any one of 1) to 4), wherein (B) anhydrogalactose / sulfated anhydrogalactose copolymer is a 3,6-anhydrogalactose / 3,6-anhydrogalactose-2-sulfate copolymer. 6) The chewable soft capsule according to 5), wherein the molar ratio of 3,6-anhydrogalactose to 3,6-anhydrogalactose-2-sulfate (3,6-AG-2-S / 3,6-AG) is 25 to 50%. 7) A chewable soft capsule according to any one of 1) to 4), wherein the mass ratio of (A) gelatin to (B) anhydrogalactose / sulfated anhydrogalactose copolymer [(A):(B)] is 1:25 to 13:1. 8) A chewable soft capsule according to any one of 1) to 4), wherein a plasticizer is contained in the capsule shell. 9) A chewable soft capsule according to any one of 1) to 4), which is a rotary die type soft capsule formulation.

[0009] According to the present invention, it is possible to provide a chewable soft capsule formulation in which the contents of the capsule and the outer film are integrated, and which has a gummy candy-like texture.

[0010] In the present invention, (A) gelatin, which is a component of the capsule coating, is a base material for the capsule coating and is a denatured collagen obtained by treating a collagen-derived raw material, which is the main protein component of the skin, bones, tendons, etc. of cattle, sheep, pigs, chickens, fish, etc., with acid or alkali and then extracting it with hot water. The origin of the collagen and the processing method are not particularly limited for the gelatin used in the present invention. Furthermore, in the present invention, modified gelatins such as hydrolyzed gelatin, oxygen decomposed gelatin, succinylated gelatin, and phthalated gelatin can also be used, and any type of gelatin can be preferably used.

[0011] The content of (A) gelatin in the capsule coating is 1% by mass or more, preferably 3% by mass or more, more preferably 6% by mass or more, and 35% by mass or less, preferably 25% by mass or less, and more preferably 16% by mass or less, of the total amount of the capsule coating composition, from the viewpoint of capsule moldability and chewability. The capsule coating composition refers to the total amount of components constituting the coating solution before capsule molding.

[0012] The (B) anhydrogalactose / sulfated anhydrogalactose copolymer, which is a component of the capsule coating, is a copolymer of 3,6-anhydrogalactose (3,6-AG) and 3,6-anhydrogalactose-2-sulfate (3,6-AG-2-S), and refers to a copolymer in which the molar ratio of 3,6-anhydrogalactose to 3,6-anhydrogalactose-2-sulfate (3,6-AG-2-S / 3,6-AG) is 25-50%. Such anhydrogalactose / sulfated anhydrogalactose copolymers are also known as kappa-2 carrageenan (R. Falshaw, H. Bixler, K. Johndro, Food Hydrocolloids 15(2001) 441-452; H. Bixler, K. Johndro, R. Falshaw, Food Hydrocolloids 15(2001) 619-630).

[0013] The molecular weight of the anhydrogalactose / sulfated anhydrogalactose copolymer is typically 100,000 daltons or more, preferably 100,000 to 1,000,000 daltons, more preferably 100,000 to 450,000 daltons, and even more preferably 100,000 to 350,000 daltons.

[0014] Anhydrogalactose-sulfated anhydrogalactose copolymers are found in seaweed species belonging to the Gigartinaceae algae (Gigartina radula, Gigartina corymbifera, Gigartina skottsbergii, Iridaea cordata, Sarcothalia crispata, Mazzaella laminarioides, etc.), and can be obtained by separating, recovering, and purifying them. Furthermore, during separation and recovery, the 3,6-AG-2-S moiety can be desulfated and converted to 3,6-AG by alkali treatment (modification treatment), and the proportion of 3,6-AG can be increased as appropriate. These separation and recovery methods and modification treatment methods are well-known and are described in literature such as that by Falshaw, Bixler, and Johndro mentioned above. For example, the denaturation treatment can be carried out by alkaline treatment under heating during recovery from Giartinacean algae. The anhydrogalactose / sulfated anhydrogalactose copolymer is commercially available as "SEAGEL CAP101" (manufactured by FMC).

[0015] The content of (B) anhydrogalactose / sulfated anhydrogalactose copolymer in the capsule coating is 3% by mass or more, preferably 6% by mass or more, more preferably 8% by mass or more, and 25% by mass or less, preferably 20% by mass or less, and more preferably 16% by mass or less, of the total amount of the capsule coating composition, from the viewpoint of the moldability and chewability of the capsule.

[0016] Furthermore, the mass ratio of (A) gelatin to (B) anhydrogalactose / sulfated anhydrogalactose copolymer [(A):(B)] is preferably 1:25 to 13:1, more preferably 1:12 to 6:1, and even more preferably 3:5 to 5:3, from the viewpoint of chewability and storage stability.

[0017] The capsule coating of the present invention preferably contains a plasticizer to improve texture. Examples of plasticizers include glycerin compounds (e.g., glycerin, diglycerin, polyglycerin, etc.), sugar alcohols (sorbitol, xylitol, erythritol, maltitol, mannitol, cyclitol, etc.), glycols (propylene glycol, dipropylene glycol, 1,3-butylene glycol, ethylene glycol, polyethylene glycol, etc.), disaccharides, oligosaccharides, etc. The content of the plasticizer in the capsule coating is preferably 10% by mass or more, more preferably 20% by mass or more, even more preferably 30% by mass or more, and preferably 60% by mass or less, more preferably 50% by mass or less, and even more preferably 45% by mass or less, based on the total amount of the capsule coating composition.

[0018] Furthermore, the capsule coating may contain various additives as needed, such as water-soluble polymers, starches, pigments (natural pigments, synthetic pigments), various sweeteners, preservatives, water activity reducers, and pH adjusters.

[0019] While there are no particular limitations on water-soluble polymers, examples include water-soluble plant fibers derived from plants and seaweed. For instance, pectin, glucomannan, sodium alginate, pullulan, fucoidan, maltodextrin, isomaltodextrin, gellan gum, locust bean gum, xanthan gum, etc.

[0020] Examples of starches include unmodified starch, modified starch, and starch hydrolysates. Examples of source plants include wheat, rice, barley, glutinous rice, glutinous barley, buckwheat, soybeans, potatoes, tapioca, and corn.

[0021] Preferably, the content of water-soluble polymers and starches in the capsule coating is 6% by mass or less of the total amount of solids.

[0022] In this invention, the capsule coating contains (A) gelatin and (B) anhydrogalactose / sulfated anhydrogalactose copolymer, which function as gelling agents. However, this does not preclude the inclusion of other gelling agents as long as they do not affect the chewability and storage stability of the capsule. Examples of other gelling agents include carrageenan, locust bean gum, agar, psyllium seed gum, konjac powder, gellan gum, and xanthan gum.

[0023] In the chewable soft capsule of the present invention, the capsule contents refer to a capsule filling containing an active ingredient that exerts the desired effects, and in addition to the active ingredient, the capsule contains a composition comprising (C) gelatin, (D) glycerin, (E) a sodium or potassium salt of an acid selected from citric acid, hydrochloric acid, malic acid, phosphoric acid, gluconic acid, succinic acid, tartaric acid, and lactic acid, and (F) water. This creates a sense of unity between the capsule contents and the capsule coating, resulting in a texture very similar to gummy candy when chewed. The form of such capsule contents may be liquid or paste, but it is preferable that it be liquid, such as a suspension, emulsified liquid, or viscous liquid.

[0024] (C) Gelatin, like the gelatin in (A) above, is not limited in its collagen origin or processing method. Furthermore, the gelatin may be a modified gelatin such as its hydrolysate, oxygen decomposition product, succinylated gelatin, or phthalated gelatin.

[0025] The content of (C) gelatin in the capsule contents is, from the viewpoint of chewability, 1% by mass or more, preferably 3% by mass or more, more preferably 4% by mass or more, and 10% by mass or less, preferably 8% by mass or less, and more preferably 7% by mass or less, based on the total amount of capsule contents. It is also 1 to 10% by mass, preferably 3 to 8% by mass, and more preferably 4 to 7% by mass.

[0026] Component (D) can be glycerin-based, similar to the plasticizers described above, for example, glycerin, diglycerin, polyglycerin, etc., and is preferably glycerin. The content of glycerin-based (D) in the capsule contents is 5% by mass or more, preferably 10% by mass or more, more preferably 15% by mass or more, and 30% by mass or less, preferably 25% by mass or less, and more preferably 20% by mass or less, from the viewpoint of promoting a sense of unity between the capsule contents and the coating and chewability. Alternatively, it may be 5 to 30% by mass, preferably 10 to 25% by mass, and more preferably 15 to 20% by mass.

[0027] More specifically, the sodium or potassium salt of the acid selected from citric acid, hydrochloric acid, malic acid, phosphoric acid, gluconic acid, succinic acid, tartaric acid, and lactic acid in (E) includes trisodium citrate, sodium chloride, sodium malate, sodium dihydrogen phosphate, disodium hydrogen phosphate, potassium hydrogen phosphate, sodium or potassium gluconate, monosodium succinate, disodium succinate, sodium tartrate, sodium or potassium lactate, and preferably trisodium citrate, sodium chloride, and potassium gluconate. By incorporating such a sodium or potassium salt of the acid, moisture migration to the coating is promoted, and a sense of unity between the contents and the coating is obtained. From the viewpoint of promoting moisture migration to the coating, the content of the sodium salt of the acid shown in (E) in the capsule contents is 0.05% by mass or more, preferably 0.5% by mass or more, more preferably 1% by mass or more, and 10% by mass or less, preferably 8% by mass or less, and more preferably 4% by mass or less, of the total amount of capsule contents. Furthermore, the amount is 0.05 to 10% by mass, preferably 0.5 to 8% by mass, and more preferably 1 to 4% by mass. Also, the content of the potassium salt of the acid indicated by (E) is 0.01% by mass or more, preferably 0.1% by mass or more, more preferably 1% by mass or more, and 6% by mass or less, preferably 4% by mass or less, and more preferably 2% by mass or less, based on the total amount of capsule contents. Furthermore, the amount is 0.01 to 6% by mass, preferably 0.1 to 4% by mass, and more preferably 1 to 2% by mass.

[0028] Furthermore, (F) water is added to the capsule contents to promote gelation. From the viewpoint of promoting gelation, it is preferable to add water in an amount of 15% by mass or more, preferably 20% by mass or more, more preferably 25% by mass or more, and 40% by mass or less, preferably 35% by mass or less, and more preferably 30% by mass or less, of the total amount of capsule contents.

[0029] Active ingredients include various components used in pharmaceuticals, quasi-drugs, cosmetics, and foods (health foods, foods for specified health uses, foods with functional claims, functional oils and fats, supplements, etc.), as well as seasonings, flavorings, and other capsule filling materials that can exert the desired effects when administered or ingested. They may be either water-soluble or oil-soluble substances. Examples of substances that can be used as active ingredients are listed below.

[0030] Examples of functional oils include omega-3 polyunsaturated fatty acids such as DHA, EPA, and alpha-linolenic acid, omega-6 polyunsaturated fatty acids such as linoleic acid and gamma-linolenic acid, and oleic acid, which is an omega-9 monounsaturated fatty acid. Other examples of oils and fats include vegetable oils such as soybean oil, rapeseed oil, safflower oil, rice oil, corn oil, sunflower oil, cottonseed oil, olive oil, sesame oil, peanut oil, Job's tears oil, wheat germ oil, perilla oil, linseed oil, egoma oil, sacha inchi oil, walnut oil, kiwi seed oil, sage seed oil, parsley seed oil, grape seed oil, macadamia nut oil, hazelnut oil, almond oil, pumpkin seed oil, camellia oil, tea seed oil, borage oil, palm oil, palm olein, palm stearin, coconut oil, palm kernel oil, cocoa butter, sal fat, shea butter, and seaweed oil; animal oils such as fish oil, lard, beef tallow, and butter fat; and transesterified oils, hydrogenated oils, and fractionated oils of these.

[0031] Examples of ingredients used in supplements include ginkgo leaf extract, phosphatidylserine, GABA, chicken-derived plasmalogen, anthocyanin-containing bilberry extract and blackcurrant extract, lutein and zeaxanthin-containing marigold pigment, astaxanthin-containing Haematococcus pluvialis extract, crocetin-containing gardenia pigment, carotenoids such as α-carotene, β-carotene, lycopene, and β-cryptoxanthin, vitamin K, coenzyme Q10, quinones such as PQQ, flavonols, isoflavones, tannins, catechins, quercetin, anthocyanins, and flavangenopropyl alcohol. Examples include polyphenols such as sulfates and flavonoids, cannabidiol (a type of cannabinoid), propolis, xylitol, vitamins such as vitamin B1, B2, niacin, pantothenic acid, vitamin B6, vitamin B12, vitamin C, vitamin D3, and vitamin E, minerals such as calcium, phosphorus, sodium, potassium, magnesium, zinc, selenium, chromium, molybdenum, iron, and copper, lactic acid bacteria such as L-92 lactic acid bacteria, plasma lactic acid bacteria, Lactobacillus casei strain Shirota, Lactobacillus gasseri SP strain, and LG-21 lactic acid bacteria, and bifidobacteria such as strains BB-536 and B-3.

[0032] Examples of pharmaceuticals include meclizine hydrochloride, scopolamine hydrobromide hydrate, belladonna extract, berberine tannate, and sodium fluoride.

[0033] The chewable soft capsule of the present invention may be a rotary die type soft capsule formulation in which a capsule coating composition is stretched on a pair of rotating drums using a rotary die type soft capsule molding machine to form a coating sheet, an appropriate temperature is applied to the surface of the coating sheet with segments, and the coating sheet is molded into a predetermined shape using a rotating die roll while the contents are filled and the coating sheet is bonded to it; a flat plate type soft capsule formulation in which a coating sheet is placed on one of a pair of flat plate molds, the contents are placed on top of it, another coating sheet is placed over it, and finally the other mold is placed on top and pressed to form a predetermined shape; or a seamless type soft capsule formulation formed by simultaneously discharging a capsule coating composition and contents from two concentric nozzles into a cooling liquid flowing at a constant speed. However, a rotary die type soft capsule formulation is preferred from the viewpoint of a wide range of contents that can be manufactured, a high degree of freedom in selecting the shape and size, and productivity.

[0034] A rotary die-type soft capsule formulation, which is encapsulated using a rotary die, can be preferably exemplified by injecting the capsule contents between sheets of capsule coating formed into a sheet shape and then compressing and molding from both sides. The capsule coating composition can be prepared by stirring and dispersing (A) gelatin and (B) anhydrogalactose / sulfated anhydrogalactose copolymer, and various additives as needed, in water, stirring and dissolving at 70 to 98°C, and then vacuum degassing.

[0035] Furthermore, the contents of the capsule can be prepared, for example, by dissolving a water-soluble active ingredient and the sodium or potassium salt of the acid shown in (E), and (D) glycerin in heated water, adding (C) gelatin and mixing to obtain an aqueous gelatin solution. Separately, an oil-soluble active ingredient can be mixed with heated oil (for example, medium-chain triglyceride), and the dispersed mixture can be added to the aforementioned aqueous gelatin solution. The mixture can then be mixed using a stirrer or grinder, and the mixture can be degassed in an incubator to prepare an emulsified or suspended form.

[0036] The chewable soft capsule agent thus obtained is excellent in storage stability and is packaged and stored in various packaging forms such as bottled packaging, PTP packaging, and pouches, and is distributed.

[0037] Hereinafter, the present invention will be specifically described with reference to examples, but the present invention is not limited thereto. 1. Preparation of capsule contents (1) Raw materials

[0038]

[0039] (2) Examples 1 to 7, Comparative Examples 1 to 3 Purified water was heated to 40 to 80°C, and a water-soluble raw material, a sodium salt or a potassium salt, and glycerin were added and dissolved, and then gelatin was added and mixed to obtain an aqueous gelatin solution. Separately, medium-chain fatty acid triglyceride was heated to 30 to 70°C and mixed with an oil-soluble raw material, and the resulting mixture was added to the aqueous gelatin solution, mixed using a stirrer and a grinder, and degassed using an incubator to obtain a content liquid composition.

[0040] (3) Comparative Example 4 Gelatin, a gel hydrolyzate, glycerin, sorbitol, and a sweetener (sucralose) were mixed and dissolved at about 60°C. Next, citric acid was added and the mixture was modified by incubating at 60°C for 12 hours.

[0041] 2. Preparation of capsule coating (1) Raw materials

[0042]

[0043] (2) Examples 1 to 7, Comparative Examples 1 to 3 Glycerin was weighed into a predetermined container, and an anhydrogalactose / sulfated anhydrogalactose copolymer was added little by little while stirring to obtain an anhydrogalactose / sulfated anhydrogalactose copolymer dispersion. Purified water and the anhydrogalactose / sulfated anhydrogalactose copolymer dispersion were charged into a blending tank and dissolved while stirring. Then, gelatin was added and dissolved while stirring, and degassing was performed by stirring and defoaming to obtain a capsule film composition.

[0044] (3) Comparative Example 4 Gelatin, glycerin, water, sorbitol, and citric acid were weighed into a specified container, dissolved while stirring, and degassed by stirring and defoaming to obtain a capsule film composition.

[0045] 3. Capsule Molding by Rotary Die Soft Capsule Filling Machine (B) Examples 1 to 7, Comparative Examples 1 to 4 The film solution was filled into the spray box of a rotary die soft capsule filling machine, stretched on a rotating drum to form a thin film of about 0.8 mm, and cooled to obtain a film sheet. Using the film sheet obtained at this stage, a sheet evaluation was carried out. Next, the film sheet was heated with a segment and adhered, and the content liquid was filled immediately before punching. The punched and molded product was dried to produce a soft capsule agent.

[0046] 4. Drying (B) Examples 1 to 7, Comparative Examples 1 to 4 The molded soft capsule agent was fed into a tumbler dryer connected to the filling machine and dried at a temperature of 20 to 30°C and a relative humidity of 5 to 70% for 8 to 60 hours to obtain the target soft capsule agent.

[0047] 5. Evaluation (1) Capsule Moldability It was judged whether a soft capsule could be molded using a rotary die soft capsule filling machine. ○: Molded successfully ×: Could not be molded

[0048] (2) Chewability It was carried out by 4 expert panelists and evaluated in 3 levels: "soft and chewable", "chewable but slightly hard", and "too hard to chew". ○: Soft and chewable △: Chewable but slightly hard ×: Too hard to chew

[0049] (3) Texture It was carried out by 4 expert panelists and evaluated in 2 levels: "the film and the content have a sense of unity and a gummy-like texture" and "the film and the content have no sense of unity". ○: The film and the content have a sense of unity and a gummy-like texture ×: The film and the content have no sense of unity

[0050]

[0051] 6. Results and Discussion The soft capsule formulations of the present invention in Examples 1 to 7 exhibited excellent capsule moldability and, when chewed, had a soft texture and good chewability. Furthermore, the promotion of moisture transfer from the contents to the capsule coating resulted in a sense of unity between the capsule contents and the coating, giving it a gummy-like texture. On the other hand, Comparative Example 1, which did not contain a sodium or potassium salt of a specific acid in the capsule contents, had good capsule moldability and chewability, but lacked a sense of unity between the capsule contents and the coating, resulting in a problematic texture. Comparative Example 2, which contained sodium acetate in the capsule contents, had good capsule moldability, but had problems with chewability and texture. Comparative Example 3, which contained calcium chloride in the capsule contents, had good capsule moldability, but was hard and difficult to chew, lacked a sense of unity between the capsule contents and the coating, and had problems with chewability and texture. Therefore, it was found that calcium salts are not suitable for formulation. Based on these results, it was found that including a sodium or potassium salt of a specific acid in the capsule contents is important for creating a gummy-like texture where the contents and the outer film feel integrated.

[0052] Comparative Example 4, which did not contain anhydrogalactose / sulfated anhydrogalactose copolymer in the coating and did not contain sodium salts in the capsule contents, had good moldability, but was hard and difficult to chew, lacked a sense of unity between the contents and the coating, and had problems with chewability and texture.

Claims

1. A chewable soft capsule, wherein the capsule shell contains (A) 1 to 35% by mass of gelatin and (B) 3 to 25% by mass of an anhydrogalactose / sulfated anhydrogalactose copolymer, and the capsule contents contain a composition containing (C) gelatin, (D) glycerins, (E) a sodium or potassium salt of an acid selected from citric acid, hydrochloric acid, malic acid, phosphoric acid, gluconic acid, succinic acid, tartaric acid, and lactic acid, and (F) water.

2. The chewable soft capsule according to claim 1, wherein the content of (C) gelatin in the capsule contents is 1 to 10% by mass of the total amount of capsule contents.

3. The chewable soft capsule according to claim 1, wherein the content of (D) glycerin in the capsule contents is 5 to 30% by mass of the total amount of capsule contents.

4. The chewable soft capsule according to claim 1, wherein the content of the sodium salt of the acid represented by (E) in the capsule contents is 0.05 to 10% by mass of the total amount of the capsule contents, and the content of the potassium salt of the acid represented by (E) is 0.01 to 6% by mass of the total amount of the capsule contents.

5. (B) The chewable soft capsule according to any one of claims 1 to 4, wherein the anhydrogalactose / sulfated anhydrogalactose copolymer is a 3,6-anhydrogalactose / 3,6-anhydrogalactose-2-sulfate copolymer.

6. The chewable soft capsule according to claim 5, wherein the molar ratio of 3,6-anhydrogalactose to 3,6-anhydrogalactose-2-sulfate (3,6-AG-2-S / 3,6-AG) is 25 to 50%.

7. A chewable soft capsule according to any one of claims 1 to 4, wherein the mass ratio of (A) gelatin to (B) anhydrogalactose / sulfated anhydrogalactose copolymer [(A):(B)] is 1:25 to 13:

1.

8. A chewable soft capsule according to any one of claims 1 to 4, wherein a plasticizer is contained in the capsule shell.

9. A chewable soft capsule formulation according to any one of claims 1 to 4, wherein the soft capsule formulation is a rotary die type.

Images