WO2025004548A1 - Soft capsule - Google Patents

Abstract

To provide a soft capsule or the like which is chewable, and in which deformation is suppressed.　The soft capsule includes a film, and contents including a first gelling agent, an oil/fat, and an emulsifier.

Description

Softgels

The present invention relates to soft capsules, etc.

　Conventionally, soft capsules have been widely used as dosage forms for medicines, supplements, etc., because they are easy to take, have excellent airtightness, and offer a high degree of design freedom, such as masking and enteric coating. Soft capsules generally contain contents and a coating. Soft capsules have a structure in which the contents are coated with a coating.

In recent years, efforts have been made to give soft capsules elasticity. This makes it possible to provide soft capsules that have a chewy texture and are highly palatable.

As an example of a soft capsule with such chewability, Patent Document 1 describes an invention relating to a chewable soft capsule suitable for chewing, which contains a matrix (contents) containing a gel-forming component, a plasticizer, a polymer modifier, and water. Patent Document 1 describes that the texture and chewability are improved by including a polymer modifier in the soft capsule.

Special Publication No. 2005-529128

However, as in Patent Document 1, if the contents contain a gel-forming component, the water in the soft capsule evaporates over time, which can cause deformation of the soft capsule, such as dents.

The present invention provides a soft capsule that is chewable and prevents deformation.

The present inventors conducted extensive research to solve the above problems. As a result, they discovered that deformation of soft capsules can be suppressed by combining a gelling agent that imparts chewability to the contents with fats and oils. They also discovered that while it was difficult to fill the contents into the shell (capsule filling) by simply adding fats and oils together with a gelling agent to the contents, it became possible to fill the contents into capsules by further adding an emulsifier to the contents.

In other words, the present invention includes, for example, the following aspects:

[1] A soft capsule comprising a content including a first gelling agent, an oil or fat, and an emulsifier, and a shell.
[2] The soft capsule described in [1] above, wherein the first gelling agent contains gelatin.
[3] The soft capsule described in [1] or [2] above, wherein the shell contains a second gelling agent.
[4] The soft capsule described in [3] above, wherein the first gelling agent and the second gelling agent contain gelatin.
[5] The soft capsule according to any one of the above [1] to [4], wherein the oil comprises vegetable oil.
[6] A soft capsule described in any one of [1] to [5] above, wherein the oil or fat contains at least one of medium-chain triglyceride (MCT) and safflower oil.
[7] The soft capsule described in any one of [1] to [6] above, wherein the emulsifier comprises at least one selected from the group consisting of lecithin, enzymatically decomposed lecithin, glycerin fatty acid ester, sucrose fatty acid ester, saponin, and wax.
[8] The soft capsule according to any one of the above [1] to [7], wherein the emulsifier comprises at least one selected from the group consisting of lecithin, liquid enzymatically decomposed lecithin, powdered enzymatically decomposed lecithin, and fractionated enzymatically decomposed lecithin.
[9] The soft capsule according to any one of the above [1] to [8], wherein the emulsifier comprises liquid enzymatically decomposed lecithin.
[10] The content of the first gelling agent is 1 to 20% by mass based on the total mass of the content,
The content of the oil and fat is 0.1 to 35% by mass based on the total mass of the content,
The soft capsule according to any one of the above [1] to [9], wherein the content of the emulsifier is 0.1 to 10% by mass based on the total mass of the content.
[11] The soft capsule described in [10] above, wherein the content of the emulsifier is 0.1 to 4% by mass based on the total mass of the content.
[12] The soft capsule according to any one of [1] to [11] above, wherein the ratio of the content (mass%) of the oil/fat to the content (mass%) of the first gelling agent (oil/fat content) is 0.2 to 10.
[13] The soft capsule according to any one of the above [1] to [12], wherein the ratio of the content (mass%) of the emulsifier to the content (mass%) of the first gelling agent (emulsifier content/first gelling agent content) is 0.05 to 5.

The present invention provides soft capsules and the like that have chewability and suppress deformation.

The following provides a detailed explanation of how to implement the present invention.

1. Soft Capsule The soft capsule according to the present invention comprises a fill material containing a first gelling agent, an oil or fat, and an emulsifier, and a shell.

By including a first gelling agent in the contents, it is possible to obtain a soft capsule that is chewable. Furthermore, by including an oil and an emulsifier in the contents, it is possible to obtain a soft capsule that is less likely to deform.

The shape of the soft capsule according to the present invention is not particularly limited. Specific examples of the shape of the soft capsule according to the present invention include an oval shape (football shape), an oblong shape, a sphere shape, an acorn shape, an elongated eggplant shape, a triangle shape, a diamond shape, a fish shape, a tube shape, a bottle shape, etc.

The average major axis of the soft capsules according to the present invention is preferably 5 to 30 mm, and more preferably 10 to 20 mm. It is preferable that the average major axis of the soft capsules is 5 mm or more, since it provides a stronger chewing sensation. On the other hand, it is preferable that the average major axis of the soft capsules is 30 mm or less, since it is easier to mold the capsules. In this specification, the "major axis" means the maximum distance between two points on the contour line of an object, unless otherwise specified. Also, the "average major axis" means the average value of the maximum major axes of any 10 capsules measured with a dial gauge.

The components of the composition of the present invention are described in detail below.

<Contents>
The contents include a first gelling agent, an oil or fat, and an emulsifier.

The content of the contents is preferably 30-90% by mass, and more preferably 40-80% by mass, based on the total mass of the soft capsule.

[First gelling agent]
The first gelling agent has a function of imparting elasticity to the soft capsule by gelling the contents, thereby imparting elasticity to the soft capsule and providing chewability.

The first gelling agent is not particularly limited, but examples include gelatin, casein, polysaccharides, starches, etc.

Examples of the gelatin include beef gelatin, pork gelatin, chicken gelatin, fish gelatin, and gelatin derivatives.
In this case, examples of the gelatin derivative include crosslinked gelatin crosslinked with an organic compound (methacrylic acid, acrylic acid, (poly)lactic acid, methacrylamide, etc.), gelatin hydrolysates, and the like.

The polysaccharides include carrageenan, agar, sodium alginate, pullulan, glucomannan, gum arabic, welan gum, xanthan gum, gellan gum, tragacanth gum, locust bean gum, pectin, polydextrose, dextrin, maltodextrin, cyclodextrin, resistant dextrin, guar gum, psyllium seed gum, hydroxypropyl cellulose, hydroxypropyl methylcellulose, methylcellulose, carboxymethylcellulose, chitosan, etc.

Starches include, but are not limited to, natural starch and modified starch.

The natural starch is not particularly limited, but examples include potato starch, tapioca starch, glutinous corn starch, glutinous rice starch, sago starch, sweet potato starch, mung bean starch, wheat starch, etc.

The modified starch is a natural starch that has been physically, chemically, or enzymatically processed. Examples of the processing include esterification, etherification, oxidation, cross-linking, hydrolysis, and combinations thereof.

Specific examples of modified starches include esterified starches such as acetylated starch, phosphated starch, and starch octenyl succinate; etherified starches such as hydroxypropylated starch and sodium starch glycolate; oxidized starch; esterified cross-linked starches such as acetylated phosphate cross-linked starch, monoesterified phosphate cross-linked starch, and sodium starch phosphate; etherified cross-linked starches such as hydroxypropylated starch for phosphorylation; esterified oxidized starches such as acetylated oxidized starch; and starch hydrolysates such as glucose, starch syrup, maltodextrin, dextrin, and roasted dextrin.

In one embodiment, the first gelling agent preferably contains gelatin, and more preferably contains gelatin having a bloom of 150 to 300. In this specification, "bloom" means the jelly strength of gelatin, and is measured by the method described in JIS K6503:2001.
In another embodiment, the first gelling agent preferably comprises a polysaccharide, more preferably comprises at least one selected from the group consisting of carrageenan, agar, pullulan, xanthan gum, gellan gum, locust bean gum and pectin, and even more preferably comprises at least one of carrageenan and agar.
In another embodiment, the first gelling agent does not contain gelatin and preferably contains a polysaccharide, more preferably does not contain gelatin and contains at least one selected from the group consisting of carrageenan, agar, pullulan, xanthan gum, gellan gum, locust bean gum, and pectin, and further preferably does not contain gelatin and contains at least one of carrageenan and agar. By not containing gelatin, a soft capsule can be obtained that can be suitably used by subjects who avoid taking gelatin due to religious reasons, vegetarianism, allergies, etc.
In another embodiment, the first gelling agent preferably comprises starches, more preferably comprises modified starch, even more preferably comprises etherified starch, and particularly preferably comprises hydroxypropylated starch.
In another embodiment, the first gelling agent does not contain gelatin and preferably contains starches, more preferably does not contain gelatin and contains modified starch, further preferably does not contain gelatin and contains etherified starch, and particularly preferably does not contain gelatin and contains hydroxypropylated starch. By not containing gelatin, it is possible to obtain a soft capsule that can be suitably used by subjects who avoid taking gelatin for reasons of religion, vegetarianism, allergies, etc.

The first gelling agent may be used alone or in combination of two or more kinds.

The content of the first gelling agent is preferably 0.1% by mass or more, 0.3% by mass or more, 0.5% by mass or more, 0.8% by mass or more, 1% by mass or more, 1.5% by mass or more, 2% by mass or more, 3% by mass or more, 4% by mass or more, 5% by mass or more, or 6% by mass or more, relative to the total mass of the contents.
In addition, the content of the first gelling agent is preferably 20% by mass or less, 18% by mass or less, 15% by mass or less, 12% by mass or less, 10% by mass or less, or 8% by mass or less, relative to the total mass of the contents.
In one embodiment, the content of the first gelling agent is preferably 0.1 to 20% by mass, more preferably 0.3 to 20% by mass, 0.5 to 20% by mass, 0.8 to 20% by mass, or 1 to 20% by mass, even more preferably 1 to 18% by mass, 1 to 15% by mass, 1 to 12% by mass, or 1 to 10% by mass, and particularly preferably 1 to 8% by mass, 1.5 to 8% by mass, 2 to 8% by mass, 3 to 8% by mass, 4 to 8% by mass, 5 to 8% by mass, or 6 to 8% by mass, relative to the total mass of the content.

[Oils and fats]
The oil or fat has the functions of suppressing deformation of the soft capsule, adjusting the viscosity of the contents, dispersing hydrophobic components in the contents, and the like.

Fats and oils include, but are not limited to, vegetable fats and oils, animal fats and oils, etc.

Vegetable oils and fats include, but are not limited to, olive oil, sesame oil, wheat germ oil, safflower oil, perilla oil, soybean oil, camellia oil, corn oil, peppermint oil, castor oil, cottonseed oil, palm oil, peanut oil, refined oils derived from vegetable oils and fats, etc.

Refined oils derived from vegetable fats and oils include medium-chain triglycerides (MCTs). Examples of the medium-chain triglycerides (MCTs) include glyceryl tricaprylate, tri(caprylic acid/capric acid), and tri(caprylic acid/capric acid/lauric acid). Commercially available medium-chain triglycerides (MCT) include Coconard RK (glyceryl tricaprylate), Coconard MT (glyceryl tricaprylate/capricate), Coconard ML (glyceryl tricaprylate/capricate/laurate) (manufactured by Kao Corporation); O.D.O (glyceryl tricaprylate/capricate) (manufactured by Nisshin Oillio Group, Ltd.). In this specification, "medium-chain fatty acid" refers to a saturated fatty acid having 5 to 12 carbon atoms, an unsaturated fatty acid having 5 to 12 carbon atoms, and preferably a saturated fatty acid having 8 to 10 carbon atoms, or an unsaturated fatty acid having 8 to 10 carbon atoms. In addition, "medium-chain triglyceride (MCT)" refers to glycerin to which two or three medium-chain fatty acids are ester-bonded. In one embodiment, medium-chain triglyceride (MCT) is a mixture of non-volatile oily compounds obtained by squeezing the kernels of seeds such as coconut and palm.

Animal fats and oils include, but are not limited to, fish oil, egg yolk oil, beef tallow, lard, refined oils derived from animal fats and oils, etc.

Refined oils derived from animal fats include docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA). DHA is found in large amounts in tuna, monkfish, mackerel, saury, yellowtail, horse mackerel, eel, salmon, sardines, etc. EPA is found in large amounts in tuna, mackerel, saury, yellowtail, horse mackerel, sardines, red sea bream, flounder, etc.

In one embodiment, the oil preferably includes vegetable oil. Also, in one embodiment, it is preferable that the oil includes vegetable oil and does not include animal oil. Vegetable oil has almost no taste and odor compared to animal oil, so that a soft capsule having excellent flavor can be obtained.
In another embodiment, the fat or oil preferably contains at least one of medium-chain triglyceride (MCT) and safflower oil, and more preferably contains medium-chain triglyceride (MCT).

The above-mentioned oils and fats may be used alone or in combination of two or more.

The content of oils and fats, relative to the total mass of the contents, is preferably 0.1 mass% or more, 0.5 mass% or more, 1 mass% or more, 2 mass% or more, 3 mass% or more, 5 mass% or more, 8 mass% or more, 10 mass% or more, 15 mass% or more, 20 mass% or more, 25 mass% or more, 30 mass% or more, or 35 mass% or more.
In addition, the content of oils and fats is preferably 60% by mass or less, 50% by mass or less, 40% by mass or less, 35% by mass or less, 30% by mass or less, 25% by mass or less, 20% by mass or less, 15% by mass or less, 10% by mass or less, or 8% by mass or less, relative to the total mass of the contents.
In one embodiment, the content of the oil or fat is preferably 0.1 to 60% by mass, more preferably 0.1 to 50% by mass, 0.5 to 50% by mass, 1 to 50% by mass, 0.1 to 40% by mass, 0.5 to 40% by mass, or 1 to 40% by mass, and from the viewpoint of reducing the moisture loss rate, it is preferably 1 to 35% by mass, 2 to 35% by mass, 3 to 35% by mass, 5 to 35% by mass, 1 to 30% by mass, 2 to 30% by mass, 3 to 30 ... It is more preferable that the content is 0% by mass, and particularly preferable that the content is 8 to 35% by mass, 10 to 35% by mass, 15 to 35% by mass, 20 to 35% by mass, 25 to 35% by mass, 8 to 30% by mass, 10 to 30% by mass, 15 to 30% by mass, 20 to 30% by mass, 8 to 25% by mass, 10 to 25% by mass, 15 to 25% by mass, 20 to 25% by mass, 8 to 20% by mass, 10 to 20% by mass, 15 to 20% by mass, 8 to 15% by mass, 10 to 15% by mass, or 8 to 10% by mass.

In one embodiment, when the oil contains animal fat, preferably DHA, the content of the animal fat is preferably 50% by mass or less, more preferably 40% by mass or less, or 30% by mass or less, based on the total mass of the contents, and from the viewpoint of suppressing the taste and odor of fish and improving the flavor, it is even more preferable that it is 20% by mass or less, or 15% by mass or less, and particularly preferable that it is 1 to 20% by mass, 1 to 15% by mass, 5 to 20% by mass, or 5 to 15% by mass.

It is preferable that the ratio of the fat/oil content (mass%) to the first gelling agent content (mass%) (fat/oil content/first gelling agent content) is 0.2 or more, 0.5 or more, 0.8 or more, 1.5 or more, 2.5 or more, 3.5 or more, 4.5 or more, or 5.5 or more.
In addition, it is preferable that the ratio of the fat/oil content (mass%) to the first gelling agent content (mass%) (fat/oil content/first gelling agent content) be 10 or less, 8 or less, 6.5 or less, 5.5 or less, 4.5 or less, 3.5 or less, 2.5 or less, or 1.5 or less.
In one embodiment, the ratio of the fat/oil content (mass%) to the first gelling agent content (mass%) (fat/oil content) is preferably 0.2 to 10, 0.5 to 10, 0.5 to 8, 0.5 to 6.5, 0.8 to 10, 0.8 to 8, 0.8 to 6.5, 1.5 to 10, 1.5 to 8, 1.5 to 6.5, 2.5 to 10, 2.5 to 8, 2.5 to 6.5, 3.5 to 10, 3.5 to 8, 3. More preferably, it is 5 to 6.5, 4.5 to 10, 4.5 to 8, 4.5 to 6.5, 5.5 to 10, 5.5 to 8, or 5.5 to 6.5, even more preferably 0.5 to 5.5 or 0.8 to 5.5, and particularly preferably 1.5 to 5.5, 1.5 to 4.5, 1.5 to 3.5, 1.5 to 2.5, 2.5 to 5.5, 2.5 to 4.5, 2.5 to 3.5, 3.5 to 5.5, 3.5 to 4.5, or 4.5 to 5.5.

[emulsifier]
The emulsifier has a function of suppressing phase separation of the contents (for example, phase separation of a gelling agent and an oil or fat) and a function of dispersing hydrophobic components in the contents.

Emulsifiers include, but are not limited to, lecithin, enzymatically hydrolyzed lecithin, glycerin fatty acid esters, sucrose fatty acid esters, saponin, and wax.

Lecithin is a glycerophospholipid containing glycerin, choline, and fatty acids. Examples of the fatty acids include palmitic acid, stearic acid, oleic acid, linoleic acid, and α-linolenic acid. Lecithin is usually a mixture of glycerophospholipids. Lecithin can be obtained by extraction from chicken eggs, soybeans, rapeseed, beef, and the like. Among these, the lecithin is preferably soybean lecithin or egg yolk lecithin, and more preferably soybean lecithin. The composition of the glycerophospholipid contained in lecithin can be appropriately adjusted by, for example, raw material selection, extraction method, purification method, and the like.
Commercially available lecithin products include J Lecithin CL (manufactured by J-Oil Mills Co., Ltd.), SLP Paste, SLP-PI Powder, SLP-PC70, and SLP-White (manufactured by Tsuji Oil Mills Co., Ltd.).

The enzymatically decomposed lecithin is lecithin that has been enzymatically decomposed. The enzyme is, for example, phospholipase A ₁ (PLA ₁ ), phospholipase A ₂ (PLA ₂ ), or phospholipase D (PLD), and preferably PLA ₂ .
PLA ₂ usually cleaves the ester bond between fatty acid and glycerin at the sn-2 position (β position) of lecithin. As a result, the enzymatically decomposed lecithin obtained may contain a decomposition product having a fatty acid ester at the sn-1 position (α position), a hydroxyl group at the sn-2 position (β position), and a choline phosphate ester at the sn-3 position (γ position).
The decomposition rate of the enzymatically decomposed lecithin is preferably 30 to 90%.

Examples of the enzymatically decomposed lecithin include liquid enzymatically decomposed lecithin, powdered enzymatically decomposed lecithin, and fractionated enzymatically decomposed lecithin.
The liquid enzymatically decomposed lecithin is a decomposed mixture obtained by enzymatic decomposition.
The powdered enzyme-decomposed lecithin is a powdered decomposed mixture obtained by removing oil from the liquid enzyme-decomposed lecithin and separating and recovering phospholipids.
The fractionated enzymatically decomposed lecithin is a decomposition mixture obtained by fractionating and purifying the powdered enzymatically decomposed lecithin and adjusting the phospholipid concentration.

Glycerol fatty acid esters have a structure in which a fatty acid is ester-bonded to one or two of the three hydroxyl groups of glycerol.
Examples of glycerol fatty acid esters include, but are not limited to, acetate monoglyceride, lactate monoglyceride, citrate monoglyceride, diacetyltartaric acid monoglyceride, succinate monoglyceride, polyglycerol fatty acid esters, and polyglycerol condensed linocylic acid esters.

Sucrose fatty acid ester has a structure in which sucrose is ester-bonded to one to eight, preferably one to three, of the eight hydroxyl groups of sucrose with a fatty acid.
Examples of sucrose fatty acid esters include, but are not limited to, sucrose stearate, sucrose palmitate, sucrose myristic acid ester, sucrose oleate, sucrose laurate, sucrose behenate, sucrose erucate, and sucrose mixed fatty acid (oleate/palmitate/stearate) ester.

Saponins are glycosides that contain sapogenin (aglycone) with a triterpene or steroid skeleton and a sugar chain. There are a variety of molecular species that vary depending on the aglycone structure, sugar chain structure, and the presence or absence of modification of the hydroxyl groups of the sugar chain (acetylation, etc.).

Specific examples of saponins include soybean saponin, onjisaponin, bellflower saponin, senegasaponin, and ginsenoside.

Wax, also called wax, is an ester of fatty acids and alcohols obtained from plants and animals.
Specific examples of wax include beeswax, white beeswax, carnauba wax, rice bran wax, carnauba wax, and lanolin.

In one embodiment, the emulsifier preferably includes at least one selected from the group consisting of lecithin, enzymatically decomposed lecithin, glycerin fatty acid ester, sucrose fatty acid ester, saponin, and wax, more preferably includes at least one selected from the group consisting of lecithin, enzymatically decomposed lecithin, and glycerin fatty acid ester, and from the viewpoint of further suppressing phase separation of the gelling agent and the oil and fat, it is even more preferable that the emulsifier includes at least one selected from the group consisting of lecithin, liquid enzymatically decomposed lecithin, powdered enzymatically decomposed lecithin, and fractionated enzymatically decomposed lecithin, and from the viewpoint of reducing the moisture loss rate of the contents, it is particularly preferable that the emulsifier includes liquid enzymatically decomposed lecithin.
In another embodiment, the emulsifier preferably contains at least one of lecithin and enzymatically decomposed lecithin from the viewpoint of further suppressing phase separation of the gelling agent and the oil and fat, and more preferably contains enzymatically decomposed lecithin from the viewpoint of reducing the moisture loss rate of the contents.

The above emulsifiers may be used alone or in combination of two or more.

The content of the emulsifier is preferably 0.1% by mass or more, 0.3% by mass or more, 0.5% by mass or more, 0.8% by mass or more, 1% by mass or more, 2% by mass or more, 3% by mass or more, 5% by mass or more, or 6% by mass or more, relative to the total mass of the contents.
In addition, the content of the emulsifier is preferably 10% by mass or less, 8% by mass or less, 6% by mass or less, 5% by mass or less, 4% by mass or less, 3% by mass or less, 2% by mass or less, or 1% by mass or less, relative to the total mass of the contents.
In one embodiment, the content of the emulsifier is 0.1 to 10% by weight, 0.1 to 8% by weight, 0.1 to 6% by weight, 0.1 to 5% by weight, 0.3 to 10% by weight, 0.3 to 8% by weight, 0.3 to 6% by weight, 0.3 to 5% by weight, 0.5 to 10% by weight, based on the total weight of the contents. .5-8% by mass, 0.5-6% by mass, 0.5-5% by mass, 0.8-10% by mass, 0.8-8% by mass, 0.8-6% by mass, 0.8-5% by mass, 1-10% by mass, 1-8% by mass, 1-6% by mass, 1-5% by mass, 2-10% by mass, 2-8% by mass, 2-6% by mass, 2-5 From the viewpoint of reducing the moisture loss rate, it is more preferable that it is 0.1 to 4 mass%, 0.3 to 4 mass%, 0.5 to 4 mass%, 0.8 to 4 mass%, 1 to 4 mass%, 2 to 4 mass%, 3 to 4 mass%, and further preferably 0.5 to 3 mass%, 0.8 to 3 mass%, 1 to 3 mass%, 2 to 3 mass%, 0.5 to 2 mass%, 0.8 to 2 mass%, 1 to 2 mass%.

It is preferable that the ratio of the emulsifier content (mass%) to the first gelling agent content (mass%) (emulsifier content/first gelling agent content) be 0.05 or more, 0.1 or more, 0.2 or more, 0.3 or more, 0.5 or more, or 0.8 or more.
In addition, it is preferable that the ratio of the emulsifier content (mass %) to the first gelling agent content (mass %) (emulsifier content/first gelling agent content) be 3 or less, 2.5 or less, 2 or less, 1.5 or less, 1.2 or less, 1 or less, 0.8 or less, 0.5 or less, or 0.3 or less.
In one embodiment, the ratio of the content (mass%) of the emulsifier to the content (mass%) of the first gelling agent (emulsifier content/first gelling agent content) is 0.05 to 3, 0.1 to 3, 0.3 to 3, 0.5 to 3, 0.8 to 3, 0.05 to 2.5, 0.1 to 2.5, 0.3 to 2.5, 0.5 to 2.5, 0.8 to 2.5, 0.05 to 2, 0.1 to 2, 0.3 to 2, 0.5 to 2, 0.8 to 2, 0.05 to 1.5, 0.1 to 1.5, 0.3 to 1.5, It is preferably 0.5 to 1.5, 0.8 to 1.5, 0.05 to 1, 0.1 to 1, 0.3 to 1, 0.5 to 1, or 0.8 to 1, and from the viewpoint of reducing the moisture loss rate, it is more preferably 0.05 to 0.8, 0.05 to 0.5, or 0.05 to 0.3, and further preferably 0.1 to 0.8, 0.2 to 0.8, 0.3 to 0.8, 0.5 to 0.8, 0.1 to 0.5, 0.2 to 0.5, 0.3 to 0.5, 0.1 to 0.3, or 0.2 to 0.3.

[Useful ingredients]
The contents may further contain a useful component. The useful component is not particularly limited as long as it is a component other than the first gelling agent, fats and oils, and emulsifiers, and has a favorable effect on humans when ingested. For example, DHA and EPA are not considered to be "useful components" because they are considered to be fats and oils.

Useful ingredients include, for example, hypnotics, psychotropic drugs, antiepileptic drugs, Parkinson's syndrome drugs, analgesics, Alzheimer's disease drugs, antiallergic drugs, cardiac stimulants, antiarrhythmic drugs, antianginal drugs, antihypertensive drugs, antihyperlipidemic drugs, diuretics, expectorants, antiasthmatic drugs, antacids, peptic ulcer drugs, antithrombotic drugs, thrombolytic drugs, anti-inflammatory drugs, gout drugs, osteoporosis drugs, rheumatoid arthritis drugs, diabetes drugs, anticancer drugs, antibiotics, antifungal drugs, immunosuppressants, and other disease drugs; cinnamon, peony root, apricot kernel, peach kernel, licorice, phellodendron bark, chili pepper, etc. Examples of effective ingredients include herbal medicines such as ginseng, spruce, senega, clove, angelica, gentian, scutellaria, swertia japonica, rehmannia, digitalis, valerian, bellflower, aloe, pinecone, turmeric, and ginger; herbal medicines such as kakkonto, anchusan, goreisan, shoseiryuto, tokishakuyakusan, and mao-to; health-promoting ingredients such as vitamins, minerals, collagen, coenzyme Q10, lutein, blueberries, placenta, soy isoflavones, lactic acid bacteria, and bifidobacteria; and aromatic ingredients such as caryophyllene, menthol, limonene, sesquiterpenes, and vanillin. These active ingredients may be used alone or in combination of two or more.

The amount of useful ingredient contained can be set appropriately depending on the type of useful ingredient and the desired intake amount, etc.

[solvent]
The content may further contain a solvent. The solvent has a function of adjusting the viscosity of the content, a function of dispersing the components in the content, etc.

Specific examples of solvents include water or organic solvents.

The organic solvent is not particularly limited, but examples include ethanol, isopropyl alcohol, acetone, ethyl butyrate, etc.

Among these, it is preferable that the solvent contains water. The above-mentioned solvents may be used alone or in combination of two or more kinds.

The content of the solvent is preferably 1 to 70% by mass, more preferably 1 to 10% by mass, 1 to 20% by mass, 1 to 30% by mass, 1 to 40% by mass, 1 to 50% by mass, or 1 to 60% by mass, even more preferably 5 to 10% by mass, 5 to 15% by mass, 5 to 20% by mass, 5 to 30% by mass, 5 to 40% by mass, 5 to 50% by mass, or 5 to 60% by mass, particularly preferably 5 to 10% by mass, 5 to 15% by mass, or 5 to 20% by mass, very preferably 8 to 15% by mass, and most preferably 7.5 to 12.5% by mass, or 8 to 14% by mass.

[Additives]
The contents may further contain additives. Examples of additives include sweeteners (sugar, starch syrup, high fructose glucose liquid sugar, sorbitol, erythritol, xylitol, maltitol, lactitol, sucralose, acesulfame potassium, stevia extract, trehalose, neotame, thaumatin, aspartame, etc.), preservatives, colorants, flavorings, fragrances, antioxidants, pH adjusters, metal sequestering agents, etc. These additives may be used alone or in combination of two or more.

[Contents Composition]
In one embodiment, it is preferred that the content of the first gelling agent is 1 to 20% by mass, the content of the oil or fat is 0.1 to 50% by mass, and the content of the emulsifier is 0.1 to 10% by mass, based on the total mass of the contents.

In one embodiment,
The content of the first gelling agent is 0.1 to 20% by mass based on the total mass of the content,
The content of the oil and fat is 0.1 to 50% by mass based on the total mass of the contents,
The content of the emulsifier is 0.1 to 10% by mass, 0.1 to 8% by mass, 0.1 to 6% by mass, 0.1 to 5% by mass, 0.3 to 10% by mass, 0.3 to 8% by mass based on the total mass of the contents. %, 0.3 to 6 mass%, 0.3 to 5 mass%, 0.5 to 10 mass%, 0.5 to 8 mass%, 0.5 to 6 mass%, 0.5 to 5 mass%, 0.8 to 10 mass%, 0.8 to 8 mass%, 0.8-6% by mass, 0.8-5% by mass, 1-10% by mass, 1-8% by mass, 1-6% by mass, 1-5% by mass, 2-10% by mass, 2-8% by mass, 2-6% by mass, 2-5% by mass, It is preferably 3 to 10% by mass, 3 to 8% by mass, 3 to 6% by mass, 3 to 5% by mass, 5 to 10% by mass, 5 to 8% by mass, 5 to 6% by mass, 6 to 10% by mass, 6 to 8% by mass,
The content of the first gelling agent is 0.3 to 20% by mass, 0.5 to 20% by mass, 0.8 to 20% by mass, or 1 to 20% by mass, based on the total mass of the content;
The content of the oil or fat is 0.1 to 50% by mass, 0.5 to 50% by mass, 1 to 50% by mass, 0.1 to 40% by mass, 0.5 to 40% by mass, or 1 to 40% by mass, based on the total mass of the contents;
The content of the emulsifier is more preferably 0.1 to 4 mass%, 0.3 to 4 mass%, 0.5 to 4 mass%, 0.8 to 4 mass%, 1 to 4 mass%, 2 to 4 mass%, or 3 to 4 mass% relative to the total mass of the content,
The content of the first gelling agent is 1 to 18% by mass, 1 to 15% by mass, 1 to 12% by mass, or 1 to 10% by mass, based on the total mass of the content;
The content of the oil or fat is 1 to 35% by mass, 2 to 35% by mass, 3 to 35% by mass, 5 to 35% by mass, 1 to 30% by mass, 2 to 30% by mass, 3 to 30% by mass, or 5 to 25% by mass, based on the total mass of the contents;
The content of the emulsifier is more preferably 0.5 to 3 mass%, 0.8 to 3 mass%, 1 to 3 mass%, 2 to 3 mass%, 0.5 to 2 mass%, 0.8 to 2 mass%, or 1 to 2 mass% based on the total mass of the content,
The content of the first gelling agent is 1 to 8 mass%, 1.5 to 8 mass%, 2 to 8 mass%, 3 to 8 mass%, 4 to 8 mass%, 5 to 8 mass%, or 6 to 8 mass% relative to the total mass of the content,
The content of fats and oils is 8-35% by mass, 10-35% by mass, 15-35% by mass, 20-35% by mass, 25-35% by mass, 8-30% by mass, 10-3% by mass based on the total mass of the contents. 0% by mass, 15-30% by mass, 20-30% by mass, 8-20% by mass, 10-20% by mass, 15-20% by mass, 8-15% by mass, 10-15% by mass, 8-10% by mass,
The content of the emulsifier is particularly preferably 0.5 to 3 mass%, 0.8 to 3 mass%, 1 to 3 mass%, 2 to 3 mass%, 0.5 to 2 mass%, 0.8 to 2 mass%, or 1 to 2 mass%, relative to the total mass of the contents.

<Coating>
The coating is not particularly limited as long as it can cover the contents and retain them.
In one embodiment, the coating preferably contains a second gelling agent. The coating may further contain other ingredients such as a plasticizer, a solvent, and an additive, as necessary.

The content of the shell is preferably 10-70% by mass, and more preferably 20-60% by mass, of the total mass of the soft capsule.

The thickness of the coating is preferably 150 μm or more, more preferably 200 to 800 μm, even more preferably 250 to 800 μm, and particularly preferably 250 to 500 μm. The thickness of the coating can be measured using a digital microscope (for example, a product name: VHX-900 manufactured by Keyence Corporation, using a 10 μm calibration scale). Specifically, the soft capsule can be cut into equal parts with a sharp blade, and the thickness of the coating on the cross section can be measured using a digital microscope.

[Second gelling agent]
The second gelling agent used should have suitable viscosity and fluidity during production and suitable physical properties such as strength, heat sealability, and crack resistance after the film is formed.

Specific examples of the second gelling agent include gelatin, casein, polysaccharides, starches, etc.

The gelatin, casein, polysaccharides, and starches used are as described above.

In one embodiment, the second gelling agent preferably comprises gelatin, more preferably 150-300 bloom gelatin.
In another embodiment, the second gelling agent preferably contains bovine gelatin and/or porcine gelatin from the viewpoint of versatility and excellent moldability.
In another embodiment, the second gelling agent preferably comprises a polysaccharide, more preferably comprises at least one selected from the group consisting of carrageenan, agar, pullulan, xanthan gum, gellan gum, locust bean gum, and pectin, and even more preferably comprises at least one of carrageenan and agar.
In another embodiment, the second gelling agent does not contain gelatin and preferably contains a polysaccharide, more preferably does not contain gelatin and contains at least one selected from the group consisting of carrageenan, agar, pullulan, xanthan gum, gellan gum, locust bean gum, and pectin, and further preferably does not contain gelatin and contains at least one of carrageenan and agar. By not containing gelatin, a soft capsule can be obtained that can be suitably used by subjects who avoid taking gelatin due to religious reasons, vegetarianism, allergies, etc.
In another embodiment, the second gelling agent preferably comprises starches, more preferably comprises modified starch, even more preferably comprises etherified starch, and particularly preferably comprises hydroxypropylated starch.
In another embodiment, the second gelling agent does not contain gelatin and preferably contains starches, more preferably does not contain gelatin and contains modified starch, further preferably does not contain gelatin and contains etherified starch, and particularly preferably does not contain gelatin and contains hydroxypropylated starch. By not containing gelatin, it is possible to obtain a soft capsule that can be suitably used by subjects who avoid taking gelatin for reasons of religion, vegetarianism, allergies, etc.

The second gelling agent may be used alone or in combination of two or more types.

In one embodiment, the first gelling agent and the second gelling agent may be the same or different, but it is preferable to use the same one. If the first gelling agent and the second gelling agent are the same, it is preferable from the viewpoints of improving the stability of the soft capsule and reducing the feeling of the capsule remaining after chewing.

In one embodiment, it is preferred that the first gelling agent and the second gelling agent comprise gelatin.
In another embodiment, the first gelling agent and the second gelling agent preferably include a polysaccharide, more preferably include at least one selected from the group consisting of carrageenan, agar, pullulan, xanthan gum, gellan gum, locust bean gum, and pectin, and even more preferably include at least one of carrageenan and agar.
In another embodiment, the first gelling agent and the second gelling agent do not contain gelatin and preferably contain a polysaccharide, more preferably do not contain gelatin and contain at least one selected from the group consisting of carrageenan, agar, pullulan, xanthan gum, gellan gum, locust bean gum, and pectin, and even more preferably do not contain gelatin and contain at least one of carrageenan and agar.

The content of the second gelling agent is preferably 1 to 90 mass %, more preferably 5 to 85 mass %, and even more preferably 5 to 80 mass %, based on the total mass of the coating.
In one embodiment, when the second gelling agent is made of gelatin, the content of gelatin is preferably 10 to 90% by mass, more preferably 20 to 80% by mass, even more preferably 30 to 80% by mass, and particularly preferably 50 to 80% by mass, relative to the total mass of the coating.
In another embodiment, when the second gelling agent is a polysaccharide, the content of the polysaccharide is preferably 1 to 60 mass %, more preferably 5 to 50 mass %, even more preferably 5 to 40 mass %, and particularly preferably 10 to 30 mass %, relative to the total mass of the coating.
In another embodiment, when the second gelling agent consists of gelatin and polysaccharides, the total content of the gelatin and polysaccharides is preferably 10 to 90 mass %, more preferably 20 to 80 mass %, and even more preferably 30 to 60 mass %, relative to the total mass of the coating.
In another embodiment, when the second gelling agent is composed of polysaccharides and starches, the total content of the polysaccharides and starches is preferably 10 to 90 mass %, more preferably 20 to 80 mass %, even more preferably 30 to 80 mass %, and particularly preferably 40 to 80 mass %, relative to the total mass of the coating.
In another embodiment, when the second gelling agent consists of gelatin and starch, the total content of the gelatin and starch is preferably 10 to 90% by mass, more preferably 30 to 90% by mass, and even more preferably 50 to 85% by mass, based on the total mass of the coating.
In another embodiment, when the second gelling agent is composed of gelatin, polysaccharides, and starch, the total content of the gelatin, polysaccharides, and starch is preferably 10 to 90% by mass, more preferably 20 to 80% by mass, and even more preferably 40 to 70% by mass, based on the total mass of the coating.

[Plasticizer]
The shell may further contain a plasticizer, which has the function of imparting flexibility to the shell of the soft capsule.

Plasticizers include, but are not limited to, polyhydric alcohols such as glycerin, sorbitol, mannitol, maltitol, ethylene glycol, and propylene glycol; cellulose derivatives such as hydroxymethylcellulose (HPMC), hydroxypropylcellulose (HPC), methylcellulose (MC), and carboxymethylcellulose (CMC); and polymers such as polyvinyl alcohol, polyethylene glycols, and polyvinylpyrrolidone.

Among these, the plasticizer preferably contains a polyhydric alcohol, and more preferably contains glycerin. The above-mentioned plasticizers may be used alone or in combination of two or more kinds.

The plasticizer content is preferably 1 to 80 mass % relative to the total mass of the coating, more preferably 10 to 60 mass %, and even more preferably 20 to 50 mass %.

[solvent]
The coating may contain a solvent. By containing a solvent, the viscosity of the coating can be adjusted, for example.

The solvent used is as described above.

The solvent content is preferably 20% by mass or less, more preferably 17% by mass or less, even more preferably 15% by mass or less, and particularly preferably 8 to 15% by mass, relative to the total mass of the coating.

[Additives]
The coating may further contain an additive, which may be the same as the additive used in the contents.

2. Method for Producing Soft Capsules According to one embodiment of the present invention, there is provided a method for producing a capsule. The method for producing a capsule is not particularly limited, but includes a filling step of filling a coating composition with a composition for filling, and a drying step of drying the resulting filling.

[Filling process]
The filling step is a step of filling the coating composition with the content composition.

(Contents Composition)
The composition for the filling is filled into the composition for the coating, and then dried in a drying step described below to become the content of the soft capsule.
The content composition includes a first gelling agent, an oil and fat, and an emulsifier. The content composition may further include other useful components, solvents, additives, etc., as necessary.

The first gelling agent, oil, emulsifier, useful ingredient, solvent, and additives are the same as those described above.

The content of the first gelling agent is preferably 0.1 mass% or more, 0.3 mass% or more, 0.5 mass% or more, 0.8 mass% or more, 1 mass% or more, 1.5 mass% or more, 2 mass% or more, 3 mass% or more, 4 mass% or more, or 5 mass% or more, relative to the total mass of the composition for the contents.
In addition, the content of the first gelling agent is preferably 20% by mass or less, 18% by mass or less, 15% by mass or less, 12% by mass or less, 10% by mass or less, 8% by mass or less, or 5% by mass or less, relative to the total mass of the composition for contents.
In one embodiment, the content of the first gelling agent is preferably 0.1 to 20% by mass, more preferably 0.3 to 20% by mass, 0.5 to 20% by mass, or 0.8 to 20% by mass, even more preferably 1 to 18% by mass, 1 to 15% by mass, 1 to 12% by mass, or 1 to 10% by mass, and particularly preferably 1 to 8% by mass, 1 to 5% by mass, 1.5 to 8% by mass, 1.5 to 5% by mass, 2 to 8% by mass, 2 to 5% by mass, 3 to 8% by mass, 3 to 5% by mass, 4 to 8% by mass, 4 to 5% by mass, or 5 to 8% by mass, relative to the total mass of the composition for contents.

The content of oils and fats is preferably 0.1% by mass or more, 0.3% by mass or more, 0.5% by mass or more, 0.8% by mass or more, 1% by mass or more, 2% by mass or more, 3% by mass or more, 5% by mass or more, 8% by mass or more, 10% by mass or more, 12% by mass or more, 15% by mass or more, 18% by mass or more, 20% by mass or more, 22% by mass or more, 25% by mass or more, or 28% by mass or more, relative to the total mass of the composition for contents.
In addition, the content of oils and fats is preferably 50% by mass or less, 40% by mass or less, 35% by mass or less, 30% by mass or less, 28% by mass or less, 25% by mass or less, 22% by mass or less, 20% by mass or less, 18% by mass or less, 15% by mass or less, 12% by mass or less, 10% by mass or less, or 8% by mass or less, relative to the total mass of the content composition.
In one embodiment, the content of the oil or fat is preferably 0.1 to 50% by mass, more preferably 0.1 to 40% by mass, 0.3 to 40% by mass, 0.5 to 40% by mass, 0.8 to 40% by mass, 0.1 to 35% by mass, 0.3 to 35% by mass, 0.5 to 35% by mass, 0.8 to 35% by mass, 0.1 to 30% by mass, 0.3 to 30% by mass, 0.5 to 30% by mass, or 0.8 to 30% by mass. From the viewpoint of reducing the moisture loss rate, the content of the oil or fat is preferably 1 to 28% by mass, 2 to 28% by mass, 3 to 28% by mass, 5 to 28% by mass, 1 to 25% by mass, 2 to 25% by mass, 3 to 25% by mass, or 5 to 25% by mass, and even more preferably 8 to 28% by mass, 10 to 28% by mass, or 12 to 28% by mass. , 15-28% by mass, 18-28% by mass, 20-28% by mass, 22-28% by mass, 25-28% by mass, 8-25% by mass, 10-25% by mass, 12-25% by mass, 15- 25% by mass, 18-25% by mass, 20-25% by mass, 22-25% by mass, 8-22% by mass, 10-22% by mass, 12-22% by mass, 15-22% by mass, 18-22% by mass , 20-22% by mass, 8-20% by mass, 10-20% by mass, 12-20% by mass, 15-20% by mass, 18-20% by mass, 8-18% by mass, 10-18% by mass, 12-18 Particularly preferred are 15-18% by weight, 8-15% by weight, 10-15% by weight, 12-15% by weight, 8-12% by weight, 10-12% by weight, and 8-10% by weight.

It is preferable that the ratio of the fat/oil content (mass%) to the first gelling agent content (mass%) (fat/oil content/first gelling agent content) is 0.2 or more, 0.5 or more, 0.8 or more, 1.5 or more, 2.5 or more, 3.5 or more, 4.5 or more, or 5.5 or more.
In addition, it is preferable that the ratio of the fat/oil content (mass%) to the first gelling agent content (mass%) (fat/oil content/first gelling agent content) be 10 or less, 8 or less, 6.5 or less, 5.5 or less, 4.5 or less, 3.5 or less, 2.5 or less, or 1.5 or less.
In one embodiment, the ratio of the fat/oil content (mass%) to the first gelling agent content (mass%) (fat/oil content) is preferably 0.2 to 10, 0.5 to 10, 0.5 to 8, 0.5 to 6.5, 0.8 to 10, 0.8 to 8, 0.8 to 6.5, 1.5 to 10, 1.5 to 8, 1.5 to 6.5, 2.5 to 10, 2.5 to 8, 2.5 to 6.5, 3.5 to 10, 3.5 to 8, 3. More preferably, it is 5 to 6.5, 4.5 to 10, 4.5 to 8, 4.5 to 6.5, 5.5 to 10, 5.5 to 8, or 5.5 to 6.5, even more preferably 0.5 to 5.5 or 0.8 to 5.5, and particularly preferably 1.5 to 5.5, 1.5 to 4.5, 1.5 to 3.5, 1.5 to 2.5, 2.5 to 5.5, 2.5 to 4.5, 2.5 to 3.5, 3.5 to 5.5, 3.5 to 4.5, or 4.5 to 5.5.

The content of the emulsifier is preferably 0.1 mass % or more, 0.3 mass % or more, 0.5 mass % or more, 0.8 mass % or more, 1 mass % or more, 2 mass % or more, 3 mass % or more, or 5 mass % or more, relative to the total mass of the composition for contents.
In addition, the content of the emulsifier is preferably 10% by mass or less, 8% by mass or less, 6% by mass or less, 5% by mass or less, 4% by mass or less, 3% by mass or less, 2% by mass or less, or 1% by mass or less, relative to the total mass of the content composition.
In one embodiment, the content of the emulsifier is 0.1 to 10% by weight, 0.1 to 8% by weight, 0.1 to 6% by weight, 0.1 to 5% by weight, 0.3 to 10% by weight, 0.3 to 8% by weight, 0.3 to 6% by weight, 0.3 to 5% by weight, 0.5 to 10% by weight based on the total weight of the content composition. , 0.5-8% by mass, 0.5-6% by mass, 0.5-5% by mass, 0.8-10% by mass, 0.8-8% by mass, 0.8-6% by mass, 0.8-5% by mass, 1-10% by mass, 1-8% by mass, 1-6% by mass, 1-5% by mass, 2-10% by mass, 2-8% by mass, 2-6% by mass, 2-5 From the viewpoint of reducing the moisture loss rate, it is more preferable that it is 0.1 to 4 mass%, 0.3 to 4 mass%, 0.5 to 4 mass%, 0.8 to 4 mass%, 1 to 4 mass%, 2 to 4 mass%, 3 to 4 mass%, and further preferably 0.5 to 3 mass%, 0.8 to 3 mass%, 1 to 3 mass%, 2 to 3 mass%, 0.5 to 2 mass%, 0.8 to 2 mass%, 1 to 2 mass%, 0.5 to 1 mass%, 0.8 to 1 mass%.

It is preferable that the ratio of the emulsifier content (mass%) to the first gelling agent content (mass%) (emulsifier content/first gelling agent content) be 0.05 or more, 0.1 or more, 0.2 or more, 0.3 or more, 0.5 or more, or 0.8 or more.
In addition, it is preferable that the ratio of the emulsifier content (mass %) to the first gelling agent content (mass %) (emulsifier content/first gelling agent content) be 3 or less, 2.5 or less, 2 or less, 1.5 or less, 1.2 or less, 1 or less, 0.8 or less, 0.5 or less, or 0.3 or less.
In one embodiment, the ratio of the content (mass%) of the emulsifier to the content (mass%) of the first gelling agent (emulsifier content/first gelling agent content) is 0.05 to 3, 0.1 to 3, 0.3 to 3, 0.5 to 3, 0.8 to 3, 0.05 to 2.5, 0.1 to 2.5, 0.3 to 2.5, 0.5 to 2.5, 0.8 to 2.5, 0.05 to 2, 0.1 to 2, 0.3 to 2, 0.5 to 2, 0.8 to 2, 0.05 to 1.5, 0.1 to 1.5, 0.3 to 1.5, It is preferably 0.5 to 1.5, 0.8 to 1.5, 0.05 to 1, 0.1 to 1, 0.3 to 1, 0.5 to 1, or 0.8 to 1, and from the viewpoint of reducing the moisture loss rate, it is more preferably 0.05 to 0.8, 0.05 to 0.5, or 0.05 to 0.3, and further preferably 0.1 to 0.8, 0.2 to 0.8, 0.3 to 0.8, 0.5 to 0.8, 0.1 to 0.5, 0.2 to 0.5, 0.3 to 0.5, 0.1 to 0.3, or 0.2 to 0.3.

The amount of useful ingredient contained in the resulting product can be set appropriately depending on the type of useful ingredient and the desired intake amount, etc.

The content of the solvent is preferably 10 to 70% by mass, more preferably 10 to 50% by mass, and even more preferably 20 to 50% by mass, based on the total mass of the content composition.

In one embodiment, it is preferable that the content of the first gelling agent is 1 to 20% by mass relative to the total mass of the content composition, the content of the oil or fat is 0.1 to 35% by mass relative to the total mass of the content composition, and the content of the emulsifier is 0.1 to 10% by mass relative to the total mass of the content composition.

In one embodiment,
The content of the first gelling agent is 0.1 to 20% by mass based on the total mass of the composition for contents,
The content of the oil or fat is 0.1 to 50% by mass based on the total mass of the composition for the filling,
The content of the emulsifier is 0.1 to 10% by mass, 0.1 to 8% by mass, 0.1 to 6% by mass, 0.1 to 5% by mass, 0.3 to 10% by mass, 0 to the total mass of the content composition. .3-8% by mass, 0.3-6% by mass, 0.3-5% by mass, 0.5-10% by mass, 0.5-8% by mass, 0.5-6% by mass, 0.8-10% by mass, 0.8-8% by mass, 0.8-6% by mass, 0.8-5% by mass, 1-10% by mass, 1-8% by mass, 1-6% by mass, 1-5% by mass, 2-10% by mass, 2-8% by mass, 2- Preferably, the content is 6% by mass, 2-5% by mass, 3-10% by mass, 3-8% by mass, 3-6% by mass, 3-5% by mass, 5-10% by mass, 5-8% by mass, 5-6% by mass,
The content of the first gelling agent is 0.3 to 20% by mass, 0.5 to 20% by mass, or 0.8 to 20% by mass, based on the total mass of the composition for contents;
the content of the oil or fat is 0.1 to 40% by mass, 0.3 to 40% by mass, 0.5 to 40% by mass, 0.8 to 40% by mass, 0.1 to 35% by mass, 0.3 to 35% by mass, 0.5 to 35% by mass, 0.8 to 35% by mass, 0.1 to 30% by mass, 0.3 to 30% by mass, 0.5 to 30% by mass, or 0.8 to 30% by mass, relative to the total mass of the composition for contents;
The content of the emulsifier is more preferably 0.1 to 4 mass%, 0.3 to 4 mass%, 0.5 to 4 mass%, 0.8 to 4 mass%, 1 to 4 mass%, 2 to 4 mass%, or 3 to 4 mass% relative to the total mass of the composition for fillings,
The content of the first gelling agent is 1 to 18% by mass, 1 to 15% by mass, 1 to 12% by mass, or 1 to 10% by mass, based on the total mass of the composition for contents;
The content of the oil or fat is 1 to 28% by mass, 2 to 28% by mass, 3 to 28% by mass, 5 to 28% by mass, 1 to 25% by mass, 2 to 25% by mass, 3 to 25% by mass, or 5 to 25% by mass, based on the total mass of the composition for contents;
The content of the emulsifier is more preferably 0.5 to 3 mass%, 0.8 to 3 mass%, 1 to 3 mass%, 2 to 3 mass%, 0.5 to 2 mass%, 0.8 to 2 mass%, 1 to 2 mass%, 0.5 to 1 mass%, or 0.8 to 1 mass% relative to the total mass of the composition for fillings.
the content of the first gelling agent is 1 to 8 mass%, 1 to 5 mass%, 1.5 to 8 mass%, 1.5 to 5 mass%, 2 to 8 mass%, 2 to 5 mass%, 3 to 8 mass%, 3 to 5 mass%, 4 to 8 mass%, 4 to 5 mass%, or 5 to 8 mass%, relative to the total mass of the composition for contents;
The content of fats and oils is 8-28% by mass, 10-28% by mass, 12-28% by mass, 15-28% by mass, 18-28% by mass, 20-28% by mass, 22-28% by mass based on the total mass of the content composition. , 25-28% by mass, 8-25% by mass, 10-25% by mass, 12-25% by mass, 15-25% by mass, 18-25% by mass, 20-25% by mass, 22-25% by mass, 8-22% by mass, 10-22 quality %, 12-22% by mass, 15-22% by mass, 18-22% by mass, 20-22% by mass, 8-20% by mass, 10-20% by mass, 12-20% by mass, 15-20% by mass, 18-20% by mass, 8- 18% by mass, 10-18% by mass, 12-18% by mass, 15-18% by mass, 8-15% by mass, 10-15% by mass, 12-15% by mass, 8-12% by mass, 10-12% by mass, 8-10% by mass,
The content of the emulsifier is particularly preferably 0.5 to 3 mass%, 0.8 to 3 mass%, 1 to 3 mass%, 2 to 3 mass%, 0.5 to 2 mass%, 0.8 to 2 mass%, 1 to 2 mass%, 0.5 to 1 mass%, or 0.8 to 1 mass%, relative to the total mass of the content composition.

The moisture loss rate of the content composition is preferably less than 0.86% by mass, more preferably 0.85% by mass or less, even more preferably 0.75% by mass or less, particularly preferably 0.65% by mass or less, and most preferably 0.30 to 0.65% by mass. In this specification, the "moisture loss rate" is measured by the method described in the Examples.

The viscosity of the content composition is preferably 500 to 10,000 cps, more preferably 1,000 to 6,000 cps, even more preferably 2,000 to 6,000 cps, and particularly preferably 3,000 to 6,000 cps.

(Coating composition)
The coating composition becomes a wet coating when the content composition is filled into the interior in the filling step, and becomes the coating of the soft capsule when dried in the drying step described below.
The coating composition preferably contains a second gelling agent. The coating composition may further contain other ingredients such as a plasticizer, a solvent, and additives, as necessary.

The second gelling agent, plasticizer, solvent, and additives are the same as those described above.

The content of the second gelling agent is preferably 1 to 90% by mass, more preferably 5 to 85% by mass, and even more preferably 5 to 50% by mass, based on the total mass of the coating composition.
In one embodiment, when the second gelling agent is gelatin, the content of gelatin is preferably 10 to 80% by mass, more preferably 20 to 70% by mass, even more preferably 30 to 60% by mass, and particularly preferably 30 to 50% by mass, based on the total mass of the coating composition.
In another embodiment, when the second gelling agent is a polysaccharide, the content of the polysaccharide is preferably 1 to 50 mass %, more preferably 1 to 40 mass %, even more preferably 1 to 30 mass %, and particularly preferably 1 to 20 mass %, relative to the total mass of the coating composition.
In another embodiment, when the second gelling agent is composed of gelatin and polysaccharides, the total content of gelatin and polysaccharides is preferably 10 to 90 mass %, more preferably 20 to 70 mass %, even more preferably 30 to 60 mass %, and particularly preferably 30 to 55 mass %, relative to the total mass of the coating composition.
In another embodiment, when the second gelling agent is composed of polysaccharides and starches, the total content of the polysaccharides and starches is preferably 10 to 90 mass %, more preferably 20 to 80 mass %, even more preferably 20 to 60 mass %, and particularly preferably 20 to 40 mass %, relative to the total mass of the coating composition.
In another embodiment, when the second gelling agent is composed of gelatin and starches, the total content of the gelatin and starches is preferably 10 to 90% by mass, more preferably 20 to 80% by mass, even more preferably 20 to 60% by mass, and particularly preferably 20 to 50% by mass, based on the total mass of the coating composition.
In another embodiment, when the second gelling agent is composed of gelatin, polysaccharides, and starches, the total content of the gelatin, polysaccharides, and starches is preferably 10 to 90% by mass, more preferably 20 to 80% by mass, even more preferably 20 to 60% by mass, and particularly preferably 20 to 40% by mass, based on the total mass of the coating composition.

The content of the plasticizer is preferably 1 to 80% by mass, more preferably 5 to 60% by mass, and even more preferably 10 to 40% by mass, based on the total mass of the coating composition.

The solvent content is preferably 90% by mass or less, more preferably 80% by mass or less, even more preferably 70% by mass or less, and particularly preferably 20 to 60% by mass, based on the total mass of the coating composition.

In one embodiment, when the second gelling agent is gelatin, the content of the solvent is preferably 10 to 90% by mass, more preferably 10 to 80% by mass, even more preferably 20 to 60% by mass, and particularly preferably 20 to 40% by mass, based on the total mass of the coating composition.
In another embodiment, when the second gelling agent is a polysaccharide, the content of the solvent is preferably 10 to 90 mass %, more preferably 20 to 80 mass %, even more preferably 30 to 70 mass %, and particularly preferably 40 to 60 mass %, based on the total mass of the coating composition.
In another embodiment, when the second gelling agent is composed of gelatin and a polysaccharide, the content of the solvent is preferably 10 to 90% by mass, more preferably 20 to 80% by mass, even more preferably 30 to 70% by mass, and particularly preferably 40 to 60% by mass, relative to the total mass of the coating composition.
In another embodiment, when the second gelling agent is composed of polysaccharides and starches, the content of the solvent is preferably 10 to 90 mass %, more preferably 20 to 80 mass %, even more preferably 30 to 70 mass %, and particularly preferably 40 to 60 mass %, based on the total mass of the coating composition.
In one embodiment, when the second gelling agent is composed of gelatin and starch, the content of the solvent is preferably 10 to 90% by mass, more preferably 10 to 80% by mass, even more preferably 20 to 60% by mass, and particularly preferably 20 to 40% by mass, based on the total mass of the coating composition.
In another embodiment, when the second gelling agent is composed of gelatin, polysaccharides, and starches, the content of the solvent is preferably 10 to 90% by mass, more preferably 20 to 80% by mass, even more preferably 30 to 70% by mass, and particularly preferably 40 to 60% by mass, based on the total mass of the coating composition.

(filling)
The filling method is not particularly limited, but is preferably a punching method. The punching method is usually carried out using a rotary mold type capsule filling machine. More specifically, the punching method is a method in which two film sheets obtained from a film composition are sandwiched between a pair of cylindrical molds so as to overlap each other, a content composition is injected between the two film sheets, and pressure cutting and pressure bonding are carried out simultaneously by the molds.

When using a content composition containing a first gelling agent, the gelation of the content composition tends to wear down the slide part of the rotary mold type capsule filling machine (the extrusion part for injecting the content composition between the membrane sheets with a pump). This can cause equipment damage, mainly in the slide part. In contrast, according to the manufacturing method of the present invention, the content composition contains a fat as well as the first gelling agent, so the fluidity of the content can be improved and equipment damage can be suppressed.

However, content compositions containing a gelling agent and oil tend to have low compatibility with each other and to undergo phase separation. When attempting to fill a content composition that has undergone phase separation, problems such as being unable to ensure uniformity in the content of the content composition can arise, making it difficult to fill the content composition. In contrast, according to the manufacturing method of the present invention, the content composition contains an emulsifier in addition to a gelling agent and oil. As a result, phase separation of the content composition can be suppressed, and the components in the content composition become uniform, allowing the content composition to be suitably filled.

[Drying process]
The drying step is a step of drying the obtained filling. The obtained filling has a configuration in which the composition for contents is filled in the wet film. In the drying step, for example, the composition for contents becomes the contents by volatilizing at least a part of the solvent contained in the composition for contents, and the wet film becomes a film by removing the moisture contained in the wet film.

There are no particular restrictions on the temperature and relative humidity during drying, but it is best to keep the temperature between 25 and 45°C and the relative humidity below 30% RH.

In one embodiment, the drying step is preferably carried out until the moisture content of the contents falls below 20%, more preferably until it falls to 5-20%, 5-15%, or 8-15%, and even more preferably until it falls to 7.5-12.5%, or 8-14%.
In one embodiment, the drying step is preferably carried out until the moisture content of the coating falls below 15%.

The drying time in the drying process is not particularly limited, but is preferably 1 to 30 days, more preferably 3 to 20 days, and particularly preferably 5 to 15 days.

As described above, the contents and the coating of the soft capsule may be in the form of the contents composition and the coating composition before filling, with at least a portion of the solvent removed.
As for components other than the solvent, whether they are removed by the drying step or not depends on their physical properties, etc.
For example, when the content composition contains a volatile aromatic component as a useful component, a part of the aromatic component may be removed together with the solvent by drying. Therefore, the content of the aromatic component in the content composition can be adjusted so that the content of the aromatic component in the obtained content is a desired value.
On the other hand, the first gelling agent and the oil in the composition for contents, and the second gelling agent in the coating composition, etc. are hardly removed by drying. Therefore, the ratio of the oil content (mass%) to the first gelling agent content (mass%) (oil content/first gelling agent content) and the ratio of the emulsifier content (mass%) to the first gelling agent content (mass%) (emulsifier content/first gelling agent content) can be the same value between the composition for contents and the contents.

The present invention will be explained in detail below with reference to examples, but the present invention is not limited to these.

[Example 1]
(1) Preparation of Content Composition 30 parts by mass of water and 5 parts by mass of BCN200S (gelatin, manufactured by Nitta Gelatin Co., Ltd.) as a first gelling agent were charged into a heating tank equipped with a stirrer and heated and dissolved at 70°C to 80°C. Next, 54 parts by mass of sugar were heated and dissolved at 70°C to 80°C. Furthermore, 10 parts by mass of Coconard ML (medium chain fatty acid triglyceride (MCT), manufactured by Kao Corporation) as an oil and fat, and 1 part by mass of SLP paste (lecithin, manufactured by Tsuji Oil Manufacturing Co., Ltd.) as an emulsifier were mixed at 70°C to 80°C. The obtained mixture was heated at 40°C to 50°C and defoamed using a vacuum defoamer to prepare a content composition. The content composition was stored in a heated container at 35°C to 40°C. The composition of the content composition is shown in Table 1 below.

The prepared content composition was evaluated for viscosity, degree of separation, moisture loss rate, and flavor.

(Evaluation of Viscosity)
40 mL of the composition for contents was placed in a standard glass bottle No. 6 (volume 55 mL) and allowed to stand for 90 minutes at 40° C. The viscosity (cps) was then measured at 40° C. using a digital viscometer LVDV-115 (manufactured by BROOKFIELD Corporation), which is a rotational viscometer (rotation speed: 12 rpm).
The viscosity was evaluated according to the following criteria, and the results are shown in Table 2 below.
A: Viscosity is 6000 cps or less (easy to fill into soft capsules)
B: Viscosity is greater than 6000 cps and less than 50,000 cps (can be filled as a soft capsule)
C: Viscosity exceeds 50,000 cps (cannot be filled into soft capsules)

(Evaluation of the degree of separation)
The content composition was allowed to stand at 40° C., and the solution was visually observed after 3 hours and 5 hours, and the degree of separation was evaluated according to the following criteria. The results are shown in Table 2 below.
A: No separation into two phases after 5 hours. B: No separation into two phases after 3 hours, and separation into two phases after 5 hours. C: Separation into two phases after 3 hours.

(Evaluation of moisture loss rate)
40 mL of the content composition was poured into a standard glass bottle No. 6 (volume 55 mL, mass A), and the content composition was allowed to solidify by placing a lid on the bottle and leaving it in a refrigerator overnight. The standard glass bottle No. 6 containing the content composition was removed from the refrigerator and returned to room temperature (23°C), the lid was removed, and the total mass of the standard glass bottle No. 6 and the content composition was measured (mass B). The bottle was left to stand for 24 hours in an environment of 23±2.0°C and 22±3% RH. The total mass of the standard glass bottle No. 6 and the content after standing was measured (mass C), and the moisture loss rate (mass%) ((mass B-mass C)/(mass B-mass A)×100) was calculated. The results are shown in Table 2 below.

(Flavor evaluation)
40 mL of the content composition was poured into a standard glass bottle No. 6 (volume 55 mL), and the bottle was closed and left to stand overnight in a refrigerator to solidify the content composition. The standard glass bottle No. 6 containing the content composition was removed from the refrigerator and returned to room temperature (23°C). 1 g of the content composition taken out of the standard glass bottle No. 6 was tasted and evaluated for flavor according to the following criteria. The results are shown in Table 2 below.
A: No fishy smell or taste B: Fishy smell and taste, but can be ingested C: Fishy smell and taste, and unpleasant to ingest

(2) Preparation of Coating Composition A coating composition was prepared by mixing 100 parts by weight of BCN200S (gelatin, manufactured by Nitta Gelatin Co., Ltd.) as a second gelling agent, 80 parts by weight of glycerin, 15 parts by weight of a sweetener, and 60 parts by weight of purified water.

(3) Manufacture of soft capsules The above-prepared content composition and coating composition were used to form football-shaped soft capsules by punching using a rotary mold capsule filling machine. The obtained soft capsules were dried in a rotary tumbler dryer, and then dried on a shelf for 120 hours to manufacture soft capsules. The average major axis of the soft capsules was 17 mm. The water content of the soft capsule contents was 11±3% by weight.
In addition, the components other than water in the composition for the filling, i.e., the first gelling agent (gelatin), the fat (MCT), the emulsifier (lecithin), and the sugar, were not partially removed by drying. Therefore, the content of each component in the soft capsule content can be calculated from the composition of the composition for the filling and the value of the water content in the obtained soft capsule content.
For example, as shown in Table 1, the content of the first gelling agent (gelatin) in the content composition of Example 1 is 5% by weight, the content of fats and oils (MCT) is 10% by weight, the content of emulsifier (lecithin) is 1% by weight, the content of sugar is 54% by weight, and the content of water is 30% by weight. Here, when only water among the components of the content composition is partially removed by drying and the content of water in the soft capsule becomes 11% by weight, the content of the first gelling agent (gelatin) in the soft capsule content can be calculated to be 6.4% by weight, the content of fats and oils (MCT) is 12.7% by weight, the content of emulsifier (lecithin) is 1.3% by weight, and the content of sugar is 68.7% by weight, respectively.

[Examples 2 to 17]
A soft capsule was produced in the same manner as in Example 1, except that the composition for the filling was changed to the composition in Table 1.
In addition, the contents compositions prepared in Examples 2 to 17 were evaluated for viscosity, degree of separation, moisture loss rate, and flavor in the same manner as in Example 1.
The evaluation results for the content compositions are shown in Table 2 below.

[Comparative Example 1]
This is a comparative example in which the composition for the filling does not contain fats or oils and emulsifiers. A soft capsule was produced in the same manner as in Example 1, except that the composition for the filling was changed to the composition in Table 1.
The viscosity, moisture loss rate, and flavor of the content composition prepared in Comparative Example 1 were evaluated in the same manner as in Example 1. Since the content composition in Comparative Example 1 did not contain any oil or fat, the degree of separation was not evaluated. The results are shown in Table 2 below.

[Comparative Example 2]
This is a comparative example in which the composition for the filling does not contain fats and oils and emulsifiers, and the composition for the filling was changed to the composition shown in Table 1. Although an attempt was made to produce soft capsules in the same manner as in Example 1, the viscosity of the composition for the filling was very high, and soft capsules could not be produced.
The content composition prepared in Comparative Example 2 was evaluated for moisture loss rate in the same manner as in Example 1. Note that the viscosity of the content composition in Comparative Example 2 was very high and the viscosity could not be measured. In Comparative Example 2, the content composition did not contain any oil or fat, so the degree of separation was not evaluated. Furthermore, the viscosity of the content composition in Comparative Example 2 was high and encapsulation was impossible, so the flavor was not evaluated. The results are shown in Table 2 below.

[Comparative Examples 3 to 6]
This is a comparative example in which the composition for the filling does not contain an emulsifier, and the composition for the filling was changed to the composition in Table 1. Although an attempt was made to produce a soft capsule in the same manner as in Example 1, the composition for the filling separated into two phases, and therefore the soft capsule could not be produced.
The contents compositions prepared in Comparative Examples 3 to 6 were evaluated for viscosity, degree of separation, and water loss rate in the same manner as in Example 1. In Comparative Examples 3 to 6, the contents compositions were separated, so flavor evaluation was not performed. The results are shown in Table 2 below.

The raw materials used in Examples 1 to 17 and Comparative Examples 1 to 6 are as follows.
(1) First gelling agent and second gelling agent Gelatin: BCN200S (manufactured by Nitta Gelatin Co., Ltd.)
(2) Fats and oils Medium-chain triglyceride (MCT): Coconard ML (manufactured by Kao Corporation)
Safflower oil: Safflower salad oil (manufactured by Nisshin Oillio Group, Ltd.)
DHA: DHA-55MK (manufactured by Maruha Nichiro Corporation)
(3) Emulsifier: Lecithin: SLP Paste (Tsuji Oil Mills Co., Ltd.)
Enzymatically decomposed lecithin: SLP Paste Lyso (Tsuji Oil Mills)
Glycerol fatty acid ester: Poem PR-300 (manufactured by Riken Vitamin Co., Ltd.)
(4) Additives Sugar: Granulated Sugar MG (DM Mitsui Sugar Co., Ltd.)

From the results in Table 2, the content compositions of Examples 1 to 17 contained fats and oils together with the first gelling agent (gelatin), and therefore had a very low moisture loss rate. For this reason, it was considered that in the soft capsules manufactured using the content compositions used in Examples 1 to 17, for example, moisture loss of the content is unlikely to occur over time, and deformation of the soft capsules can be suppressed.
In addition, it was found that the content compositions of Examples 1 to 17 contain an emulsifier, and therefore can suppress phase separation between the first gelling agent (gelatin) and fats and oils, and between the fats and oils and the solvent (water), etc. This makes it possible to use the first gelling agent (gelatin) and fats and oils in combination in the content composition, and can prevent viscosity increase, etc. Therefore, when soft capsules are produced using the content compositions used in Examples 1 to 17, it is believed that the high fluidity of the content compositions can prevent equipment damage in the slide section of a rotary mold type capsule filling machine.
Furthermore, in Examples 13 to 16, the inclusion of DHA, which is an animal fat (fish oil), resulted in a fishy taste and smell, and it was found that the degree of this taste and smell tended to be proportional to the content.

In addition, since the content composition of Comparative Example 2 does not contain fats or oils, it was thought that the soft capsules manufactured using the content composition of Comparative Example 2 were prone to deformation. In addition, since the content of the first gelling agent (gelatin) in Comparative Example 2 is higher than that of Comparative Example 1, it was found that the viscosity of the content composition was high, making filling difficult and making it impossible to manufacture soft capsules.

The content compositions of Comparative Examples 3 to 6 contained fats and oils, resulting in a low moisture loss rate, but did not contain an emulsifier, which caused phase separation and made encapsulation difficult.

[Evaluation of Soft Capsules]
The soft capsules produced in Examples 1 to 17 and Comparative Example 1 were evaluated for dents and equipment breakage. As described above, it was not possible to produce soft capsules in Comparative Examples 2 to 6, and therefore evaluation was not possible.

(dent)
The soft capsules thus produced were allowed to stand for 24 hours in an environment of 23±2° C. and 22±3% RH. After standing, the soft capsules were visually observed to check for the presence or absence of dents, and were evaluated according to the following criteria. The results are shown in Table 3 below.
A: No dents, and the moisture loss rate of the content composition is less than 0.86% by mass B: No dents, and the moisture loss rate of the content composition is 0.86% by mass or more C: Dent present Note that the moisture loss rate of "0.86% by mass" is the moisture loss rate of the content composition in Comparative Example 1. When the moisture loss rate of the content composition is high, it is considered that dents are likely to occur when the soft capsule is left standing for a long period of time.

(Equipment damage)
After producing 10,000 soft capsules, the slide part of the rotary mold type capsule filling machine was visually observed, and the presence or absence of broken pins was evaluated as equipment damage. The results are shown in Table 3 below.

The results in Table 3 show that the soft capsules of Examples 1 to 17, while having chewability due to the inclusion of gelatin, were able to suppress dents, as predicted from the results of the moisture loss rate of the content composition. In addition, as predicted from the results of the formulation, viscosity, and degree of separation of the content composition, no damage occurred to the slide part of the rotary mold type capsule filling machine.

In addition, in Comparative Example 1, although the inclusion of gelatin provided chewability, it was found that dents occurred, as predicted from the results of the moisture loss rate of the content composition. Also, as predicted from the fact that the content composition does not contain fats or oils, it was found that the slide part of the rotary mold type capsule filling machine was damaged.

Claims (13)

A soft capsule comprising a content including a first gelling agent, an oil and an emulsifier, and a shell. The soft capsule of claim 1, wherein the first gelling agent comprises gelatin. The soft capsule of claim 1, wherein the coating contains a second gelling agent. The soft capsule of claim 3, wherein the first gelling agent and the second gelling agent include gelatin. The soft capsule of claim 1, wherein the oil comprises vegetable oil. The soft capsule according to claim 1, wherein the oil or fat comprises at least one of medium chain triglyceride (MCT) and safflower oil. The soft capsule according to claim 1, wherein the emulsifier comprises at least one selected from the group consisting of lecithin, enzymatically decomposed lecithin, glycerin fatty acid ester, sucrose fatty acid ester, saponin, and wax. The soft capsule according to claim 1, wherein the emulsifier comprises at least one selected from the group consisting of lecithin, liquid enzymatically decomposed lecithin, powdered enzymatically decomposed lecithin, and fractionated enzymatically decomposed lecithin. The soft capsule of claim 1, wherein the emulsifier comprises liquid enzymatically decomposed lecithin. The content of the first gelling agent is 1 to 20% by mass based on the total mass of the content,
The content of the oil and fat is 0.1 to 35% by mass based on the total mass of the content,
The soft capsule according to claim 1, wherein the content of the emulsifier is 0.1 to 10% by mass based on the total mass of the fill. The soft capsule according to claim 10, wherein the content of the emulsifier is 0.1 to 4% by mass based on the total mass of the contents. The soft capsule according to claim 1, wherein the ratio of the content (mass%) of the oil to the content (mass%) of the first gelling agent (oil content/first gelling agent content) is 0.2 to 10. The soft capsule according to claim 1, wherein the ratio of the content (mass%) of the emulsifier to the content (mass%) of the first gelling agent (emulsifier content/first gelling agent content) is 0.05 to 5.