Classifications

• • A—HUMAN NECESSITIES
  • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
  • A23J—PROTEIN COMPOSITIONS FOR FOODSTUFFS; WORKING-UP PROTEINS FOR FOODSTUFFS; PHOSPHATIDE COMPOSITIONS FOR FOODSTUFFS
  • A23J3/00—Working-up of proteins for foodstuffs
  • A23J3/22—Working-up of proteins for foodstuffs by texturising
  • A23J3/26—Working-up of proteins for foodstuffs by texturising using extrusion or expansion
• • A—HUMAN NECESSITIES
  • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
  • A23L—FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES, NOT OTHERWISE PROVIDED FOR; PREPARATION OR TREATMENT THEREOF
  • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
  • A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
  • A23L33/17—Amino acids, peptides or proteins
  • A23L33/185—Vegetable proteins
• • A—HUMAN NECESSITIES
  • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
  • A23L—FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES, NOT OTHERWISE PROVIDED FOR; PREPARATION OR TREATMENT THEREOF
  • A23L5/00—Preparation or treatment of foods or foodstuffs, in general; Food or foodstuffs obtained thereby; Materials therefor
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
  • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
  • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
  • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
  • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
  • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
  • A61K47/14—Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
  • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
  • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
  • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
  • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
  • A61K47/42—Proteins; Polypeptides; Degradation products thereof; Derivatives thereof, e.g. albumin, gelatin or zein
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K9/00—Medicinal preparations characterised by special physical form
  • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate

Definitions

• the present invention relates to a composition for producing a capsule shell, a method for producing a material for producing a capsule shell, and a capsule shell.
• Patent Document 1 describes the production of a material with a high content of resistant components by treating a plant-derived raw material containing protein with a proteolytic enzyme.
• plant proteins are expected to be used in a variety of applications, such as in food, beverages, and medicines that have health-promoting effects.
• compositions containing vegetable proteins generally have low moldability, which can make it difficult to formulate them.
• the present invention aims to impart new functions to capsule formulations by improving the moldability of capsule shell materials (e.g., soft capsule shell materials) containing vegetable proteins.
• capsule shell materials e.g., soft capsule shell materials
• the capsule shell itself is expected to exert various biological effects.
• DDS_Drug Delivery System a system that delivers the active ingredients of the capsule formulation to the intestine, particularly the large intestine.
• the vegetable proteins contained in the capsule shell material indigestible it is expected to provide a capsule formulation that encapsulates highly reactive contents (highly active substances) in the capsule shell.
• the present invention relates, for example, to a composition for producing a capsule shell.
• a composition for producing a capsule shell comprising at least one member selected from the group consisting of a polyol, a triester, and a trialkylamino acid (collectively referred to as a "formability-imparting component"), and a plant-derived protein.
• a composition for producing a capsule shell comprising at least one member selected from the group consisting of a polyol, a triester, and a trialkylamino acid (collectively referred to as a "formability-imparting component"), and a plant-derived protein.
• the composition described in [1] above, wherein the mass ratio of the moldability-imparting component to the plant-derived protein is 25:75 to 80:20.
• the moldability-imparting component contains glycerin.
• the present invention also relates to a method for producing a composition for producing a capsule shell, for example.
• a method for producing a material for producing a capsule shell comprising a step of pressurizing and heating a composition containing at least one member selected from the group consisting of polyols, triesters, and trialkylamino acids (also referred to as a "formability-imparting component") and a plant-derived protein.
• the method for producing the composition according to the above [6] wherein the mass ratio of the moldability-imparting component to the plant-derived protein is 25:75 to 80:20.
• the present invention further relates to, for example, a capsule shell and a capsule formulation comprising the same.
• a capsule shell comprising at least one member selected from the group consisting of polyols, triesters, and trialkylamino acids (also referred to as "formability-imparting components") and a plant-derived protein.
• the moldability-imparting component contains glycerin.
• the plant-derived protein is a protein that has been subjected to pressure and heat treatment.
• a capsule preparation comprising the capsule shell according to any one of [12] to [16] above and a content encapsulated in the capsule shell.
• a method for reducing digestibility of a protein comprising the steps of pressurizing and heating a composition containing the protein. [19] The method according to [18] above, wherein the composition further contains a polyol.
• the present invention provides a new use for plant-derived proteins as capsule shells.
• the present invention also provides indigestible capsule shells.
• the present invention provides capsule formulations with new functions.
• the plant-derived protein contained in the capsule shell manufacturing composition of the present invention is not particularly limited as long as it is a protein derived from a plant.
• plants from which the protein is derived include grains, beans, nuts and seeds, potatoes, vegetables, fruits, mushrooms, algae, etc.
• the plant-derived proteins of the present invention include proteins contained in fermented products made from plants (for example, rice-derived proteins such as proteins contained in sake lees made from rice) and denatured proteins extracted from plants.
• the plant-derived protein contained in the capsule shell manufacturing composition is preferably made resistant to digestion by, for example, pressurizing and heating (thereby imparting resistant properties to the capsule shell).
• plant-derived proteins that are easily made resistant to digestion include soybean-derived protein, adzuki bean-derived protein, kidney bean-derived protein, cacao bean-derived protein, wheat-derived protein, buckwheat-derived protein, rice-derived protein, etc.
• the plant-derived proteins can be used alone or in combination of two or more kinds.
• the lower limit of the content of the plant-derived protein in the capsule shell manufacturing composition of the present invention is preferably 10% by mass, more preferably 15% by mass, and particularly preferably 20% by mass, based on the total amount of the composition.
• a predetermined function including physiologically active functions and indigestibility due to the plant-derived protein
• the upper limit of the content of the plant-derived protein in the capsule shell manufacturing composition is preferably 85% by mass, more preferably 80% by mass, and particularly preferably 75% by mass, based on the total amount of the composition.
• the capsule shell production composition of the present invention is processed to produce a capsule shell production material, and the formability-imparting component contained in the capsule shell production composition can impart good formability to the capsule shell production material.
• the formability-imparting component can be at least one selected from polyols, triesters, and trialkylamino acids.
• the polyol among the moldability-imparting components is not particularly limited as long as it is an organic compound having a plurality of hydroxyl groups, and may be a diol, a triol, or a polyol having 4 or more hydroxyl groups.
• the polyols may be used alone or in combination of two or more kinds.
• the diol may be, for example, a (poly)alkylene glycol, a monoester of a fatty acid and glycerin, etc.
• examples of the (poly)alkylene glycol include ethylene glycol, propylene glycol, polyethylene glycol, polypropylene glycol, etc.
• Examples of the monoester of a fatty acid and glycerin include glyceryl monocaprylate, glyceryl monobehenate, glyceryl monopalmitate, glyceryl monostearate, glyceryl monobehenate, etc.
• the triol may be, for example, glycerin, a monoester of a fatty acid and diglycerin, etc.
• An example of a monoester of a fatty acid and diglycerin includes a monoester of stearic acid and diglycerin, etc.
• polyols with 4 or more hydroxyl groups examples include chain sugar alcohols such as erythritol, xylitol, sorbitol, and mannitol; chain compounds with 4 or more hydroxyl groups such as polyglycerin; sugar alcohols containing a ring structure such as isomalt, lactitol, and maltitol; and polysaccharides such as trehalose, cellulose derivatives, and chitosan.
• cellulose derivatives include methylcellulose, hydroxypropylcellulose, hydroxypropylcellulose, carboxymethylcellulose, and ethylcellulose with a low ethoxylation rate (preferably an ethoxylation rate of 40% by mass or less).
• the moldability-imparting component may be a triester.
• triesters include triesters of glycerin and carboxylic acids such as triacetin, glycerol tripropionate, glycerol tributyrate, and glycerol trihexanoate; triesters of citric acid such as triethyl citrate, triethyl acetyl citrate, tributyl citrate, triethyl acetyl citrate, and tris(2-ethylhexyl) acetyl citrate; triesters of trimellitate such as tributyl trimellitate and tris(2-ethylhexyl) trimellitate.
• the triesters may be used alone or in combination of two or more.
• the moldability-imparting component may be a trialkylamino acid.
• the trialkylamino acid is not particularly limited as long as it is a compound containing an N,N,N-trialkylammonio group and a -COO- or carboxy group, or a salt thereof.
• trialkylamino acids examples include betaine (trimethylglycine), triethylglycine, tripropylglycine, triisopropylglycine, trimethyl- ⁇ -aminobutyric acid, N,N,N-trimethylalanine, N,N,N-triethylalanine, N,N,N-triisopropylalanine, N,N,N-trimethylmethylalanine, carnitine, acetylcarnitine, and salts thereof (e.g., hydrochloride, organic acid salt).
• the trialkylamino acid may be used alone or in combination of two or more kinds.
• the capsule shell manufacturing composition of the present invention preferably contains a polyol as a moldability-imparting component. Furthermore, the capsule shell manufacturing composition preferably contains glycerin as a moldability-imparting component in order to increase the moldability of the capsule shell manufacturing material.
• the content of glycerin in the capsule shell manufacturing composition is preferably 30% by mass or more, particularly preferably 50% by mass or more, based on the total of the moldability-imparting components.
• the lower limit of the content of the moldability-imparting component is preferably 10% by mass, more preferably 15% by mass, and even more preferably 25% by mass, based on the total amount of the composition. This is to impart sufficient moldability to the capsule shell manufacturing material.
• the upper limit of the content of the moldability-imparting component in the capsule shell manufacturing composition is preferably 90% by mass, more preferably 85% by mass, and even more preferably 80% by mass, based on the total amount of the composition.
• the mass ratio of the formability-imparting component to the plant-derived protein is preferably 25:75 to 80:20, more preferably 30:70 to 80:20, even more preferably 35:65 to 80:20, and particularly preferably 40:60 to 75:25.
• composition for producing a capsule shell of the present invention may contain other base components, solvents, thickeners, pH adjusters, sequestering agents, shell colorants, flavoring agents, sweeteners, preservatives, fragrances, etc., as necessary.
• the composition for producing a capsule shell may contain, together with the plant-derived protein, base components (other base components) used in conventional capsule shells.
• the other base components may be animal-derived proteins such as gelatin, starch hydrolysates such as starch and dextrin, carrageenan, etc.
• the composition for producing a capsule shell may contain a solvent; the solvent is preferably water, but may contain organic solvents such as ethanol, isopropyl alcohol, acetone, and ethyl butyrate.
• the content of the solvent (preferably water) in the composition for producing a capsule shell of the present invention is preferably less than 20% by mass, more preferably less than 15% by mass, even more preferably less than 10% by mass, and particularly preferably less than 5% by mass, based on the total amount of the composition.
• Water may not be added to the composition for producing a capsule shell, except for water that is added in association with the material components to be added, such as water contained in the raw material of plant-derived protein.
• a material for producing a capsule shell with excellent moldability can be obtained.
• a significant advantage is obtained in that it is possible to shorten or omit the drying process when producing a capsule shell from the material for producing a capsule shell, or when producing a capsule formulation consisting of a capsule shell and a content.
• composition containing protein for example, a composition for producing a capsule shell whose main component is gelatin or polysaccharides, which are animal proteins, or a composition containing a plant-derived protein
• pressure and heat treatment a considerable amount of water was blended into the composition (for example, see JP 2015-8642 A).
• water content can be reduced in the composition for producing a capsule shell of the present invention.
• the composition for producing a capsule shell may contain a thickener, such as gelatin, iota carrageenan, kappa carrageenan, lambda carrageenan, pullulan, agar, alginic acid, sodium alginate, alginic acid esters, gums, etc.
• the thickener may be used alone or in combination of two or more kinds.
• the composition for producing a capsule shell may contain a pH adjuster; the pH adjuster is not particularly limited, but examples thereof include acids such as hydrochloric acid, sulfuric acid, nitric acid, etc.; bases such as sodium hydroxide, potassium hydroxide, etc.; buffers such as phosphate buffers, Tris buffers, etc.
• the pH adjusters may be used alone or in combination of two or more kinds.
• sequestering agents also called metal ion sequestering agents or chelating agents
• sequestering agents include citric acid, tartaric acid, lactic acid, phosphoric acid, acetic acid, gluconic acid, ethylenediaminetetraacetic acid, metaphosphoric acid, salts thereof, glycine, etc.
• the sequestering agents can be used alone or in combination of two or more kinds.
• capsule coating components substances that have traditionally been used as capsule coating components can also be used.
• composition for producing capsule shell The method for producing the composition for producing the capsule shell is not particularly limited, and the composition can be produced by a known means.
• the composition can be produced by mixing the plant-derived protein, the component for imparting moldability, and other components as necessary, using a mixer or the like. Mixing may be performed while heating or cooling as necessary.
• the material for producing a capsule shell according to one embodiment of the present invention can be obtained from a composition for producing a capsule shell. More specifically, the material for producing a capsule shell can be obtained by pressurizing and heating the composition for producing a capsule shell (pressurized and heated). By pressurizing and heating the composition for producing a capsule shell, the plant-derived protein contained therein becomes indigestible, and a material for producing a capsule shell having excellent moldability can be produced.
• Methods for pressurizing the capsule shell manufacturing composition include, for example, A) a method of kneading the capsule shell manufacturing composition, and B) a method of statically pressurizing the capsule shell manufacturing composition.
• Kneading as a method of applying pressure means mixing the capsule shell manufacturing composition while applying pressure, and is different from simply mixing.
• the capsule shell manufacturing composition can be kneaded using any kneading machine, but the kneading machine is preferably equipped with a kneading function using a screw, blade, roll, etc., and a heating function.
• the capsule shell manufacturing composition can be kneaded by melt kneading under heating conditions.
• the capsule shell manufacturing composition is preferably kneaded using an extruder equipped with a twin screw (twin-screw extruder). With a twin-screw extruder, kneading and molding can be performed continuously.
• the screw rotation speed is preferably 2 to 20 rpm, more preferably 4 to 16 rpm.
• Static pressurization a method of applying pressure, applies pressure to a mass (bulk) of the capsule shell manufacturing composition that is left stationary.
• Static pressurization of the capsule shell manufacturing composition can be carried out, for example, using a heat press.
• the pressing pressure is preferably 5 to 50 MPa, and particularly preferably 10 to 30 MPa.
• the lower limit of the temperature (heating temperature) for heating the composition for producing a capsule shell is preferably 50°C, more preferably 70°C, and particularly preferably 115°C.
• the upper limit of the temperature (heating temperature) for heating the composition for producing a capsule shell is preferably 200°C, more preferably 190°C, and even more preferably 180°C.
• the temperature (heating temperature) at which the capsule shell manufacturing composition is heated can be set so as to render the plant-derived proteins contained in the composition indigestible (denaturing them), and for this purpose, it is usually preferable to set the heating temperature at 120 to 160°C.
• the heating temperature refers to the temperature of the extruder's feeder (raw material input section) or barrel (the section inside which the screw rotates and kneads the raw materials).
• the extruder has a feeder (raw material input section) and a barrel (the section inside which the screw rotates and kneads the raw materials); the barrel is usually divided along the direction from just below the feeder to the extrusion outlet, and is configured so that the heating temperature can be set for each of the multiple regions.
• the heating temperature of the capsule shell manufacturing composition pressurized and heated using an extruder refers to the heating temperature in at least one of the multiple regions, and it is not necessarily necessary to adjust the heating temperature in all regions.
• the capsule shell manufacturing material is characterized by high moldability; for example, the moldability can be indicated by tensile strength.
• the capsule shell manufacturing material preferably has a tensile strength of 2.0 N/mm2 or more , more preferably 3.0 N/mm2 or more, and more preferably 10 N/mm2 or less , as measured based on the test method specified in JIS-K7127.
• the capsule shell of one embodiment of the present invention may be a molded product of a material for producing a capsule shell. That is, the capsule shell contains a moldability imparting component and a plant-derived protein, and may contain other components as necessary, similar to the composition for producing a capsule shell and the material for producing a capsule shell. Each component and its content are as described above in "1. Composition for producing a capsule shell".
• the plant-derived protein contained in the capsule shell of the present invention is preferably a denatured product of a protein extracted from a plant, or a denatured product of a protein contained in a fermented product made from a plant.
• the denatured product may be a heat-denatured product, a pressure-denatured product, or a heat-pressure-denatured product.
• the capsule shell of the present invention can be used as the capsule shell of a capsule formulation; in the capsule formulation, the capsule shell can be filled (encapsulated) with contents.
• the capsule formulation is preferably a soft capsule, and can be filled with liquid or paste-like contents.
• the thickness of the capsule shell of the present invention is preferably 200 ⁇ m or more. This is to ensure that the contents contained in the capsule shell are securely sealed. There is no particular upper limit to the thickness, but it is usually several thousand ⁇ m or less. The thickness of the capsule shell can be measured using a digital microscope.
• the capsule shell of the present invention can be manufactured by molding a material for manufacturing a capsule shell.
• the material for manufacturing a capsule shell of the present invention can be molded into a capsule shell by injecting it from an extruder into a mold having a desired capsule shape and cooling it.
• the capsule shell manufacturing material can be shaped into a film, tube, pellet, etc., when it is extruded from an extruder; then, the capsule shell can be formed by a known method.
• the capsule shell manufacturing material of the present invention when it is extruded into a film, it can then be formed into a capsule shell by a punching method, and the capsule preparation can be produced using the film.
• the capsule shell manufacturing material of the present invention can be extruded into a pellet, and the capsule shell can be produced by melting the pelletized capsule shell manufacturing material; in this case, the above-mentioned [1-3. Other components] can be added to the melt.
• a capsule formulation (preferably a soft capsule formulation) having the capsule shell of the present invention can be produced by a known method.
• the contents encapsulated in the capsule shell are not particularly limited, and known active ingredients and additives can be selected.
• the shape of the capsule formulation is also not particularly limited, and can be any shape, such as spherical or ellipsoidal.
• the capsule formulation having the capsule shell of the present invention contains a plant-derived protein in the capsule shell, and therefore can impart various desirable physiological activities to the capsule formulation, such as an anti-inflammatory effect based on the plant-derived protein.
• the capsule preparation having the capsule shell of the present invention can contain indigestible plant-derived protein in the capsule shell, it may be possible to deliver active ingredients contained in the contents of the capsule preparation to the large intestine, or to realize a DDS that targets the large intestine. In other words, it may be preferable that the contents of the capsule preparation contain active ingredients that should be absorbed in the large intestine.
• the capsule preparation having the capsule shell of the present invention can contain indigestible plant-derived protein in the capsule shell, it may be possible to encapsulate highly reactive contents.
• a composition for producing a capsule shell containing a plant-derived protein is provided, and by pressurizing and heating the composition, a material for producing a capsule shell having resistance to digestion and good moldability can be provided.
• the present invention also provides a method for reducing the digestibility of proteins in general (e.g., animal-derived proteins, etc.) in addition to plant-derived proteins. The reduction in digestibility can be confirmed by a general artificial digestion test method. The method can be carried out by pressurizing and heating a composition containing a protein.
• the composition containing the protein may contain water and other components similar to the formability-imparting component in the capsule shell manufacturing composition.
• the formability-imparting component is preferably a polyol, and more preferably glycerin.
• the ratio of the protein to the formability-imparting component may also be set in the same manner as in the capsule shell manufacturing composition.
• the pressurization and heat treatment of the protein-containing composition can be carried out under the same conditions as the pressurization and heat treatment of the capsule shell manufacturing composition.
• the protein-containing composition can be treated by kneading or static pressurization; a kneading machine such as a twin-screw extruder or a heat press can be used.
• the material obtained by subjecting a composition containing a protein and a moldability-imparting component to pressure and heat treatment preferably has good moldability similar to the above-mentioned capsule shell manufacturing material, and may have, for example, the same tensile strength as the capsule shell manufacturing material.
• Example 1 (Production of Composition for Producing Capsule Shell and Material for Producing Capsule Shell) 20 g of Wilpro N10 (manufactured by Wilmar, protein content 86.4% by mass, moisture content 5.6% by mass) containing soy protein was added to 20 g of glycerin and mixed to prepare a composition for producing a capsule shell. The obtained composition for producing a capsule shell was then fed to a twin-screw extruder, heated and pressurized, and the kneaded mixture was extruded from the tip of the barrel under normal pressure to obtain a material for producing a capsule shell.
• Wilpro N10 manufactured by Wilmar, protein content 86.4% by mass, moisture content 5.6% by mass
• the barrel temperature was set to 90°C at the feed section (directly below the raw material feed section), 130°C at the center, and 130°C at the tip.
• the screw rotation speed was 8 rpm.
• a dynamic viscoelasticity measuring device (Ares-G2 manufactured by Waters)
• a 25 mm parallel plate fixture was used to measure the temperature dependence of the storage modulus G' at an angular velocity of 6.28 rad/sec, a gap of 1 mm, and a heating rate of 0.1°C/sec.
• the obtained material for producing a capsule shell showed a rubber-like plateau in the range of 70 to 170°C.
• Pancreatin manufactured by Fujifilm Wako Pure Chemical Industries, Ltd.
• a digestive enzyme was dissolved in purified water adjusted to pH 9 with 0.1 mol/L NaOH to prepare a test solution with a pancreatin concentration of 0.3 mass%.
• 100 mg of capsule shell manufacturing material was added to 50 mL of the prepared test solution, and the solution was left to stand at 45°C for 5 hours, after which the residue was collected by centrifugation and dried at 50°C for 16 hours. The dried residue was divided by the solid mass of the specimen to obtain a percentage.
• Table 1 The larger this value, the more indigestible the sample is.
• Examples 2 to 20 [Reference Examples], [Comparative Examples 1 to 3]
• the capsule shell manufacturing material was manufactured and evaluated in the same manner as in Example 1, except that the type and amount of each component was changed as shown in Tables 1 to 6. The evaluation results are shown in Tables 1 to 6.
• Comparative Example 3 a simple mixture of Wilpro N10 and glycerin was simply mixed and the digestibility was evaluated.
• Comparative Example 1 when a composition containing a specified ratio of plant-derived protein (soy protein) and a moldability-imparting agent, glycerin, was processed without heating in a twin-screw extruder, a material with a poor moldability rating was obtained. Also, as shown in Comparative Example 3 (Table 6), a composition (untreated material) containing a specified ratio of plant-derived protein (soy protein) and a moldability-imparting agent, glycerin, did not show a decrease in digestibility.
• Comparative Example 2 when a composition containing plant-derived protein (soy protein) and water was pressurized and heated in a twin-screw extruder, a material with a poor moldability rating was obtained, although a decrease in digestibility was observed.
• Example 20 As shown in Example 20 (Table 5), when a composition containing a plant-derived protein (soy protein) and the main component glycerin as well as HPC (hydroxypropyl cellulose) and Poem J-2081V (monoester of stearic acid and diglycerin) as moldability-imparting components was pressurized and heated in a twin-screw extruder, a material with good moldability was obtained. This shows that a variety of moldability-imparting components can be combined.
• a plant-derived protein a plant-derived protein
• HPC hydroxypropyl cellulose
• Poem J-2081V monoester of stearic acid and diglycerin
• Example 21 (Production of materials for capsule shell production using a heat press) A capsule shell manufacturing composition was prepared by mixing 12 g of Wilpro N10 and 8 g of glycerin. The capsule shell manufacturing composition was then fed to a heat press and heated and pressed at 15 MPa and 129° C. for 120 seconds to obtain a film having a thickness of about 0.8 mm.
• the digestibility of the obtained film was evaluated in the same manner as in Example 1, and was found to be 70%.
• the tensile strength of the obtained film was measured with reference to the plastics-tensile property test method (JIS K7127), and was found to be 3.28 ⁇ 0.34 N/ mm2 .
• the film obtained above was molded into a pocket shape using a mold to obtain two capsule shells.
• One of the obtained capsule shells was manually filled with the contents (medium chain fatty acid triglyceride), and the upper and lower capsule shells were joined using another mold. When joining, they were heated at 140°C for 10 seconds. No leakage of the contents was observed in the obtained capsule formulation.
• the composition for producing the capsule shell of the present invention provides a capsule formulation with new functions, expanding the applications of the capsule formulation. Specifically, for example, it is possible to impart a biological effect to the capsule shell itself, to impart a drug delivery function (DDS function) to the large intestine, etc., or to make the capsule contents into highly active drugs.
• DDS function drug delivery function

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• 2024
  • 2024-06-12 JP JP2025531450A patent/JPWO2025009342A1/ja active Pending
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