WO2018101267A1 - Oral agent - Google Patents
Oral agent Download PDFInfo
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- WO2018101267A1 WO2018101267A1 PCT/JP2017/042642 JP2017042642W WO2018101267A1 WO 2018101267 A1 WO2018101267 A1 WO 2018101267A1 JP 2017042642 W JP2017042642 W JP 2017042642W WO 2018101267 A1 WO2018101267 A1 WO 2018101267A1
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- Prior art keywords
- acid
- component
- hlb
- fatty acid
- less
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Classifications
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- 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
- A61K9/4841—Filling excipients; Inactive ingredients
- A61K9/4858—Organic compounds
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/01—Hydrocarbons
- A61K31/015—Hydrocarbons carbocyclic
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/045—Hydroxy compounds, e.g. alcohols; Salts thereof, e.g. alcoholates
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/045—Hydroxy compounds, e.g. alcohols; Salts thereof, e.g. alcoholates
- A61K31/047—Hydroxy compounds, e.g. alcohols; Salts thereof, e.g. alcoholates having two or more hydroxy groups, e.g. sorbitol
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/12—Ketones
- A61K31/122—Ketones having the oxygen directly attached to a ring, e.g. quinones, vitamin K1, anthralin
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
- A61K31/19—Carboxylic acids, e.g. valproic acid
- A61K31/20—Carboxylic acids, e.g. valproic acid having a carboxyl group bound to a chain of seven or more carbon atoms, e.g. stearic, palmitic, arachidic acids
- A61K31/202—Carboxylic acids, e.g. valproic acid having a carboxyl group bound to a chain of seven or more carbon atoms, e.g. stearic, palmitic, arachidic acids having three or more double bonds, e.g. linolenic
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- 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
- 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 an internal medicine.
- An object of the present invention is to provide an internal preparation containing a poorly soluble component, which can exhibit good dispersibility even in the digestive organs of the body.
- the present invention provides the following [1] to [8].
- An internal preparation containing component (A): a poorly soluble component, and component (B): an organic acid monoglyceride.
- Component (C) The agent according to [1], further comprising a hydrophilic emulsifier of HLB 10 or more.
- Component (A) contains at least one selected from the group consisting of lutein, capsanthin, zeaxanthin, ⁇ -cryptoxanthin, docosahexaenoic acid (hereinafter also referred to as “DHA”), astaxanthin and ⁇ -carotene.
- DHA docosahexaenoic acid
- the component (B) contains at least one selected from the group consisting of citric acid monoglyceride, diacetyltartaric acid monoglyceride, lactic acid monoglyceride, and succinic acid monoglyceride.
- Component (D) The agent according to any one of [1] to [4], further comprising a glycerin fatty acid ester or a polyglycerin fatty acid ester having an HLB of less than 10.
- the agent according to any one of [1] to [5] which is a soft capsule.
- composition (A) a hardly soluble component
- Component (B) a step of preparing a content containing an organic acid monoglyceride
- a method of producing a soft capsule comprising the step of including the contents with a coating substrate.
- an internal preparation having good dispersibility of the components (A) and (B) is provided.
- the internal preparation of the present invention contains the following component (A): a hardly soluble component.
- the hardly soluble component is a component that is insoluble or hardly soluble in an aqueous solvent.
- “Insoluble or hardly soluble” means, for example, that when a sample is dissolved in 100 g of water (20 ° C.), the solubility is usually less than 0.2 g / 100 g of water, preferably less than 0.1 g / 100 g of water.
- Examples of hardly soluble components include fatty acids (such as n-3 fatty acids), carotenoids, ubiquinones (such as coenzyme Q10), fat-soluble vitamins (such as vitamin E (such as tocopherol and tocotrienol)), vitamin K, and sterols (such as squalane). Is mentioned.
- the origin of the hardly soluble component is not particularly limited, and may be naturally derived from plants, animals, microorganisms, etc., may be artificially produced such as chemical synthesis, or may be produced by biotechnology such as gene recombination. It may be made, or a commercial product may be used.
- fatty acids examples include saturated fatty acids, unsaturated fatty acids, and polyunsaturated fatty acids (n-3 fatty acids, n-6 fatty acids, n-9 fatty acids), with polyunsaturated fatty acids being preferred, n-3 fatty acids are more preferred.
- the n-3 fatty acid is a fatty acid in which the third carbon atom-carbon bond (n3-position, ⁇ 3-position) from the methyl terminal of the fatty acid is an unsaturated bond.
- the number of carbon atoms contained in the n-3 fatty acid is usually 15 or more, preferably 17 or more, and more preferably 19 or more.
- the upper limit of the number of carbon atoms is usually 30 or less, and preferably 25 or less.
- n-3 fatty acids include docosahexaenoic acid (DHA, (4Z, 7Z, 10Z, 13Z, 16Z, 19Z) -docosa-4,7,10,13,16,19-hexaenoic acid), docosapentaenoic acid (DPA, all-cis-docosa-7,10,13,16,19-pentaenoic acid), ⁇ -linolenic acid, eicosatetraenoic acid (ETA, all-cis-8,11,14,17-eicosa) Tetraenoic acid) and eicosapentaenoic acid (EPA, (5Z, 8Z, 11Z, 14Z, 17Z) -icosa-5,8,11,14,17-pentaenoic acid).
- the n-3 fatty acid is preferably a component (functional component) capable of exerting physiological functions in the body of an organism, and more preferably DHA.
- DHA is often derived from natural products such as animals (for example, fish) and microorganisms (for example, Schizophytrium genus microorganisms), but is not limited thereto. DHA may be in the form of a pharmacologically acceptable salt.
- DHA may be DHA as a free fatty acid or a derivative thereof.
- the derivative include triglyceride type DHA (TG-DHA) and phospholipid type DHA.
- TG-DHA is a compound in which triglycerol and DHA are ester-bonded. DHA as one or more fatty acids per molecule of triglycerol can bind.
- TG-DHA preferably has two or more DHA molecules bound to one molecule of triglycerol.
- the phospholipid type DHA is a compound in which DHA is bound to a phospholipid such as phosphatidylcholine and phosphatidylserine.
- Carotenoids are usually contained in animals and plants as pigments and have a polyene structure consisting of a conjugated double bond system.
- the number of carbon atoms in the carotenoid is usually 20 or more, preferably 25 or more, more preferably 30 or more, and further preferably 40 or more. It is preferable that the carotenoid can exhibit a physiological function (has functionality) in the body of an organism.
- carotenoids examples include lutein ( ⁇ , ⁇ -carotene-3,3′-diol; C 40 H 56 O 2 ), capsanthin (all-trans-capsanthin, (3R, 3 ′S, 5′R) -3, 3′-dihydroxy- ⁇ , ⁇ -carotene-6′-one; C 40 H 56 O 3 ), zeaxanthin (4- [18- (4-hydroxy-2,6,6-trimethyl-1-cyclohexenyl)- 3,7,12,16-tetramethyl-octadeca-1,3,5,7,9,11,13,15,17-nonaenyl] -3,5,5-trimethyl-3-cyclohexen-1-ol; C 40 H 56 O 2 ), ⁇ -cryptoxanthin ((R) -3,5,5-trimethyl-4- [3,7,12,16-tetramethyl-18- (2,6,6-trimethylcyclohexene) Sa-1-e Le) -
- Lutein is present in the chloroplasts of higher plants (spinach, kale, komatsuna, etc.).
- Capsanthin is present in plants such as paprika and capsicum.
- Zeaxanthin is present in plants (such as corn), egg yolk, and animal fat.
- ⁇ -cryptoxanthin is present in plants such as Satsuma mandarin, physalis, orange, papaya, and apple, dairy products such as egg yolk and butter, and animals such as cows.
- Astaxanthin is present in crustaceans such as shrimps and crabs, and fish such as salmon and red sea bream.
- each carotenoid is not limited to those derived from these. Each carotenoid may be in the form of a pharmacologically acceptable salt.
- Component (A) may be one type of poorly soluble component or a combination of two or more types of poorly soluble components.
- component (A) contains two or more carotenoids, it preferably contains a combination of lutein and capsanthin, or a combination of lutein, capsanthin and zeaxanthin, and is a combination of lutein and capsanthin or a combination of lutein, capsanthin and zeaxanthin. Is more preferable.
- the content of the component (A) is usually 0.1% by mass or more, preferably 0.2% by mass or more with respect to the total amount of the composition.
- the upper limit is usually 50% by mass or less, preferably 40% by mass or less. Therefore, the content of component (A) is usually 0.1 to 50% by mass, preferably 0.2 to 40% by mass, based on the entire composition.
- the internal preparation of this invention can exhibit the physiological function of a component (A) efficiently, and can become an agent excellent in the balance of a dispersibility.
- the upper limit of the content of the carotenoid as the component (A) is 5.0% by mass or less, preferably 4.0% by mass or less, based on the total amount of the composition. Therefore, the content of carotenoid as component (A) is usually 0.1 to 5.0% by mass, preferably 0.2 to 4.0% by mass.
- the internal preparation of the present invention contains component (B): organic acid monoglyceride.
- Organic acid monoglyceride is a compound in which the —OH group at the 3-position of glycerin fatty acid monoester is esterified with an organic acid.
- the number of carbon atoms of the fatty acid contained in the organic acid monoglyceride is usually 8 or more, preferably 14 or more.
- the upper limit is usually 22 or less, preferably 18 or less.
- the number of carbon atoms is preferably 8 to 22, more preferably 8 to 18, and still more preferably 14 to 18.
- the fatty acid may be either an unsaturated fatty acid or a saturated fatty acid.
- fatty acids possessed by glycerin fatty acid esters include caprylic acid, pelargonic acid, capric acid, lauric acid, pentadecylic acid, myristic acid, palmitic acid, margaric acid, stearic acid, oleic acid, linoleic acid, linolenic acid, arachidonic acid, and behenic acid.
- acids such as caprylic acid, pelargonic acid, capric acid, lauric acid, pentadecylic acid, myristic acid, palmitic acid, margaric acid, stearic acid, oleic acid, linoleic acid, and linolenic acid, and palmitic acid, margaric acid, stearin Acid and oleic acid are more preferable.
- Examples of the organic acid that the organic acid monoglyceride has include oxycarboxylic acids such as tartaric acid, lactic acid, malic acid, citric acid, and diacetyltartaric acid; aliphatic saturated dicarboxylic acids such as succinic acid, oxalic acid, adipic acid, and glutaric acid; Monocarboxylic acids composed of lower fatty acids such as propionic acid and butyric acid; aliphatic unsaturated dicarboxylic acids such as maleic acid and fumaric acid; and amino acids such as glycine and aspartic acid; oxycarboxylic acids and aliphatic saturated dicarboxylic acids An acid is preferable, and diacetyltartaric acid, lactic acid, citric acid, and succinic acid are more preferable.
- oxycarboxylic acids such as tartaric acid, lactic acid, malic acid, citric acid, and diacetyltartaric acid
- the HLB of the organic acid monoglyceride is not particularly limited, but usually exceeds 5, preferably 5.5 or more, more preferably 6.0 or more.
- the upper limit is usually less than 10, preferably 9.7 or less, more preferably 9.5 or less. Therefore, it is usually more than 5 and less than 10, preferably 5.5 to 9.7, more preferably 6.0 to 9.5. Thereby, the dispersibility of the internal preparation of this invention can be improved.
- HLB Hydrophilicity
- citric acid monoglyceride For example,
- Component (B) may be a single organic acid monoglyceride or a combination of two or more organic acid monoglycerides.
- the content of the component (B) is usually 0.1% by mass or more, preferably 0.3% by mass or more, more preferably 0.5% by mass or more with respect to the total amount of the composition.
- the upper limit is usually 10.0% by mass or less, preferably 8.0% by mass or less, and more preferably 6.0% by mass or less.
- the content of the component (B) is usually 0.1 to 10.0% by mass, preferably 0.3 to 8.0% by mass, more preferably 0.5 to 6%, based on the total amount of the composition. 0.0% by mass.
- the internal use of this invention can exhibit the physiological function of a component (B) efficiently, and can show favorable dispersibility.
- the internal preparation of the present invention may contain, preferably contain, a hydrophilic emulsifier having a component (C): HLB of 10 or more. Thereby, the dispersibility of the internal medicine of this invention can be improved more.
- an organic acid monoglyceride is not contained in a component (C).
- the hydrophilic emulsifier may be an emulsifier exhibiting hydrophilicity.
- the HLB of the hydrophilic emulsifier is usually 10 or more, preferably 12 or more, more preferably 14 or more, and still more preferably 15 or more. Thereby, the dispersibility of the component (A) and component (B) in an internal medicine can be improved more.
- the upper limit of HLB is not specifically limited, Usually, it is 20 or less.
- hydrophilic emulsifiers include nonionic surfactants.
- Nonionic surfactants include sucrose fatty acid ester, polyglycerin fatty acid ester, propylene glycol fatty acid ester, polyglycerin condensed ricinoleic acid ester, sorbitan fatty acid ester, polyoxyethylene sorbitan fatty acid ester, sucrose fatty acid ester, Polyglycerin fatty acid ester, sorbitan fatty acid ester, and polyoxyethylene sorbitan fatty acid ester are preferable, and polyglycerin fatty acid ester, sorbitan fatty acid ester, and polyoxyethylene sorbitan fatty acid ester are more preferable.
- Sucrose fatty acid ester is a fatty acid ester-bonded to at least one of the hydroxy groups of sucrose.
- each fatty acid may be the same as or different from each other.
- the number of carbon atoms of the fatty acid contained in the sucrose fatty acid ester is usually 8 or more, preferably 12 or more, more preferably 14 or more.
- the upper limit is usually 22 or less, preferably 20 or less, more preferably 16 or less.
- the number of carbon atoms is preferably 8 to 22, more preferably 12 to 20, and still more preferably 14 to 16.
- the fatty acid may be either an unsaturated fatty acid or a saturated fatty acid.
- fatty acids possessed by sucrose fatty acid esters include caprylic acid, pelargonic acid, capric acid, lauric acid, pentadecylic acid, myristic acid, palmitic acid, margaric acid, stearic acid, oleic acid, linoleic acid, linolenic acid, arachidonic acid, Examples include behenic acid, lauric acid, pentadecylic acid, myristic acid, palmitic acid, margaric acid, stearic acid, oleic acid, linoleic acid, and linolenic acid are preferable, and palmitic acid, margaric acid, and stearic acid are more preferable.
- sucrose fatty acid esters examples include sucrose dioleate, sucrose distearate, sucrose dipalmitate, sucrose dimyristate, sucrose dilaurate, sucrose monooleate, sucrose mono Examples include stearic acid ester, sucrose monopalmitic acid ester, sucrose monomyristic acid ester, and sucrose monolauric acid ester.
- the polyglycerol fatty acid ester as the component (C) may be any polyglycerol fatty acid ester other than the polyglycerol fatty acid ester as the following component (D).
- the degree of polymerization of polyglycerol is usually 7 or more, preferably 8 or more.
- the upper limit is usually 15 or less, preferably 10 or less.
- the degree of polymerization of polyglycerol is preferably 7 to 15, and more preferably 8 to 10.
- each fatty acid may be the same as or different from each other.
- fatty acids possessed by polyglycerin fatty acid esters For preferred examples of fatty acids possessed by polyglycerin fatty acid esters, caprylic acid, pelargonic acid, capric acid, lauric acid, pentadecylic acid, myristic acid, palmitic acid, margaric acid, stearic acid, oleic acid, linoleic acid, and linolenic acid are preferred. Palmitic acid, margaric acid, and stearic acid are more preferable.
- Sorbitan fatty acid ester is a fatty acid ester-bonded to at least one of the hydroxy groups of sorbitan.
- each fatty acid may be the same as or different from each other.
- Preferable examples of the fatty acid that the sorbitan fatty acid ester has are the same as those mentioned for the fatty acid that the sucrose fatty acid ester has.
- Polyoxyethylene sorbitan fatty acid ester is one in which ethylene oxide is ester-bonded to at least one of the hydroxy groups of sorbitan fatty acid ester. Preferred examples of the sorbitan fatty acid ester are the same as described above.
- the number of moles of ethylene oxide added to the polyoxyethylene sorbitan fatty acid ester is usually 2 or more, preferably 4 or more, more preferably 10 or more.
- the upper limit is usually 100 or less, preferably 50 or less, more preferably 30 or less.
- the added mole number is preferably 2 to 100, more preferably 4 to 50, and still more preferably 10 to 30.
- Component (C) may be one type selected from hydrophilic emulsifiers, or a combination of two or more types.
- the content of the component (C) is usually 0.05% by mass or more, preferably 0.1% by mass or more, more preferably 0.8% by mass relative to the total amount of the composition. It is 15 mass% or more, More preferably, it is 0.3 mass% or more, More preferably, it is 0.5 mass% or more.
- the upper limit is usually 4% by mass or less, preferably 3% by mass or less, and more preferably 2.5% by mass or less. Therefore, the content of the component (C) is usually 0.05 to 4% by mass, preferably 0.1 to 3% by mass, more preferably 0.15 to 2.5% by mass, based on the entire composition.
- the internal use preparation of this invention can improve dispersibility, and can be made into an agent which does not have a problem also in the safety
- the internal preparation of the present invention may contain, and preferably contain, glycerin fatty acid ester or polyglycerin fatty acid ester having an ingredient (D): HLB of less than 10.
- the component (D) may be a component (d1) having an HLB of 5 or less, or may be a component (d2) exceeding 5 and less than 10.
- the component (d1) and the component (d2) will be described separately.
- the HLB of glycerin fatty acid ester or polyglycerin fatty acid ester as component (D) is usually less than 10, preferably 9.7 or less, more preferably 9.3 or less.
- the lower limit is not particularly limited, and is usually 0 or more.
- Glycerin fatty acid ester is a fatty acid ester-bonded to at least one of the hydroxyl groups of glycerin.
- each fatty acid may be the same as or different from each other.
- the number of carbon atoms of the fatty acid contained in the glycerin fatty acid ester is usually 8 or more, preferably 14 or more.
- the upper limit is usually 22 or less, preferably 18 or less.
- the number of carbon atoms is preferably 8 to 22, more preferably 8 to 18, and still more preferably 14 to 18.
- the fatty acid may be either an unsaturated fatty acid or a saturated fatty acid.
- fatty acids possessed by glycerin fatty acid esters include caprylic acid, pelargonic acid, capric acid, lauric acid, pentadecylic acid, myristic acid, palmitic acid, margaric acid, stearic acid, oleic acid, linoleic acid, linolenic acid, arachidonic acid, and behenic acid.
- acids such as caprylic acid, pelargonic acid, capric acid, lauric acid, pentadecylic acid, myristic acid, palmitic acid, margaric acid, stearic acid, oleic acid, linoleic acid, and linolenic acid, and palmitic acid, margaric acid, stearin Acid is more preferred.
- Polyglycerin fatty acid ester is a fatty acid esterified with at least one of the hydroxyl groups of polyglycerol which is a polymer of glycerin.
- the degree of polymerization of polyglycerol is usually 6 or less, preferably 5 or less, more preferably 4 or less.
- the lower limit is usually 2 or more.
- the degree of polymerization of polyglycerol is preferably 2 to 6, more preferably 2 to 5, and still more preferably 2 to 4.
- each fatty acid may be the same as or different from each other.
- the preferable example of the fatty acid which polyglycerin fatty acid ester has it is the same as that of mentioning about the fatty acid which glycerin fatty acid ester has.
- Component (D) may be any of the following component (d1), component (d2), and a combination of component (d1) and component (d2), and a combination of component (d1) and component (d2) Is preferred: Component (d1): A glycerin fatty acid ester or polyglycerin fatty acid ester component having an HLB of 5 or less. Component (d2): Glycerin fatty acid ester or polyglycerol fatty acid ester having an HLB of more than 5 and less than 10.
- the HLB of glycerin fatty acid ester and polyglycerin fatty acid ester as component (d1) is usually 5 or less, preferably 4.7 or less, more preferably 4.5 or less. Thereby, the stability of the component (A) and the component (B) in the internal medicine can be improved. Although the minimum of HLB is not specifically limited, Usually, it is 0 or more.
- the component (d1) may be one kind selected from glycerin fatty acid esters and polyglycerin fatty acid esters having an HLB of 5 or less, or a combination of two or more kinds.
- the internal preparation of the present invention may contain a component (d2): glycerol fatty acid ester or polyglycerol fatty acid ester having an HLB of more than 5 and less than 10.
- the internal preparation of the present invention preferably contains the component (d2) for the purpose of further improving dispersibility.
- the HLB of the emulsifier as the component (d2) exceeds 5, preferably 5.5 or more, more preferably 6.0 or more.
- the upper limit is usually less than 10, preferably 9.7 or less, more preferably 9.3 or less. Accordingly, the HLB is usually more than 5 and less than 10, preferably 5.5 to 9.7, more preferably 6.0 to 9.3.
- the glycerin fatty acid ester as the component (d2) may be any glycerin fatty acid ester other than the glycerin fatty acid ester as the component (C) and the component (d1).
- glycerol fatty acid ester it is the same as that of mentioning in the glycerol fatty acid ester as a component (C) and a component (d1).
- the polyglycerin fatty acid ester as the component (d2) may be any polyglycerin fatty acid ester other than the polyglycerin fatty acid ester as the component (C) and the component (d1).
- polyglycerol fatty acid ester it is the same as that of mentioning in the polyglycerol fatty acid ester as a component (C) and a component (d1).
- the component (d2) may be one kind selected from glycerin fatty acid esters and polyglycerin fatty acid esters having an HLB exceeding 5 and less than 10, or a combination of two or more kinds.
- the content of the component (D) when the internal preparation contains the component (D) is usually 1% by mass or more, preferably 2% by mass or more, more preferably 3% by mass or more with respect to the total amount of the composition. .
- the upper limit is usually 40% by mass or less, preferably 30% by mass or less, and more preferably 20% by mass or less. Therefore, the content of component (D) is usually 1 to 40% by mass, preferably 2 to 30% by mass, more preferably 3 to 20% by mass, based on the total amount of the composition.
- the internal use preparation of this invention can improve dispersibility, and can be made into an agent which does not have a problem also in the safety
- the content of the component (d1) is usually 1% by mass or more, preferably 2% by mass or more, more preferably 3% by mass or more, further based on the total amount of the composition. Preferably it is 4 mass% or more.
- the upper limit is usually 20% by mass or less, preferably 15% by mass or less, and more preferably 10% by mass or less. Therefore, the content of the component (d1) is usually 1 to 20% by mass, preferably 2 to 15% by mass, more preferably 3 to 10%, and further preferably 4 to 10% by mass with respect to the total amount of the composition. is there.
- the internal use preparation of this invention can improve dispersibility, and can be made into an agent which does not have a problem also in the safety
- the content of the component (d2) is usually 1% by mass or more, preferably 2% by mass or more, more preferably 3% by mass or more based on the total amount of the composition. .
- the upper limit is usually 20% by mass or less, preferably 18% by mass or less, and more preferably 15% by mass or less. Therefore, the content of the component (d2) is usually 1 to 20% by mass, preferably 2 to 18% by mass, more preferably 3 to 15% by mass with respect to the total amount of the composition.
- the internal use of this invention can improve dispersibility.
- the ratio ((B) / (A)) (%) of the content of the component (B) to the content of the component (A) preferably exceeds 0%, more preferably 10% or more. Although there is no upper limit in particular, it is usually 5000% or less, preferably 4000% or less.
- the ratio of the content of component (A) to the total content of components (B) and (C) ((A) / ((B) + (C)) (%) is usually 5% or more,
- the upper limit is not particularly limited, but is usually 5000% or less, preferably 4000% or less, whereby the internal preparation of the present invention can improve dispersibility as well as stability. it can.
- the internal preparation may contain an emulsifier other than Component (E): Components (A) to (D).
- Examples of the pharmacologically acceptable salt in the present invention include inorganic acid salts such as hydrochloride, hydrobromide, sulfate, hydroiodide, nitrate and phosphate; Acid salts such as acid salts, acetate salts, formates, propionates, benzoates, trifluoroacetates, maleates, tartrates, methanesulfonates, benzenesulfonates or paratoluenesulfonates Inorganic base salts such as sodium salt, potassium salt, calcium salt, magnesium salt and ammonium salt; organic base salts such as triethylammonium salt, triethanolammonium salt, pyridinium salt and diisopropylammonium salt; arginine, aspartic acid, glutamic acid, etc. Examples include amino acid salts.
- inorganic acid salts such as hydrochloride, hydrobromide, sulfate, hydroiodide, nitrate and
- the internal preparation of the present invention may further have components other than those described above and a pharmacologically acceptable base.
- a pharmacologically acceptable base is a component (for example, a storage stabilizer) that mainly ensures stability in storage and distribution.
- one or more components preferably about 1 to 3 types, more preferably about 1 type selected from various components constituting the final product of interest (for example, foods and drinks, pharmaceuticals, quasi drugs) May be contained.
- the pharmacologically acceptable base is not particularly limited as long as the object of the present invention is not impaired.
- the pharmacologically acceptable base may be another component having an inhibitory effect on nitric oxide production.
- oils and fats examples include fatty acid esters other than components (A) to (D), edible oils and fats, hydrocarbons, higher fatty acids, and higher alcohols, and edible oils and fats are preferred.
- fatty acid esters other than components (A) to (D) examples include fatty acid esters other than components (A) to (D), edible oils and fats, hydrocarbons, higher fatty acids, and higher alcohols, and edible oils and fats are preferred.
- the ratio of the total amount of components (A) to (E) (where (C) to (E) is optional) to the total amount of oil components and components (A) to (E) is usually It is 3% by mass or more, preferably 4% by mass or more.
- the upper limit is usually 90% by mass or less, preferably 80% by mass or less.
- excipient examples include cellulose such as hydroxypropylcellulose, hydroxypropylmethylcellulose, methylcellulose, crystalline cellulose, ethylcellulose, low-substituted hydroxypropylcellulose, and pharmacologically acceptable derivatives thereof; polyvinylpyrrolidone, partially saponified polyvinyl alcohol Synthetic polymers such as: gelatin, gum arabic powder, pullulan, agar, alginic acid, sodium alginate, chitansan gum and other polysaccharides: ethanol, glycerin, isobutyl alcohol, isopropyl alcohol, butanol, propanol, 2-pentanol, 2-methylbutanol Lower alcohols such as 3-methyl-2-butanol, 3-methyl-2-butenol, 1-penten-3-ol; hydrogenated rapeseed oil alcohol, laur Higher alcohols such as alcohol, stearyl alcohol, cetyl alcohol, cetostearyl alcohol, lanolin alcohol, o
- disintegrant examples include crospovidone, carmellose calcium, croscarmellose sodium, low-substituted hydroxypropyl cellulose, carboxymethyl cellulose, carboxymethyl cellulose calcium, carboxymethyl starch sodium, hydroxypropyl starch, and partially pregelatinized starch.
- binder examples include hydroxypropylcellulose, hydroxypropylmethylcellulose, methylcellulose, ethylcellulose, polyvinyl alcohol, polyvinylpyrrolidone, gelatin, dextrin, starch, and pregelatinized starch.
- the lubricant examples include calcium stearate, magnesium stearate, sucrose fatty acid esters other than components (C) to (E), light anhydrous silicic acid, sodium stearyl fumarate, polyethylene glycol, talc, and stearic acid. .
- the content of the lubricant with respect to the total amount of the agent is preferably 0.01% by mass or more.
- the upper limit is preferably 25% by mass or less.
- colorant examples include caramel dye, turmeric dye, orange dye, cacao dye, red pepper dye, marigold dye, iron (III) oxide, titanium dioxide, safflower dye, gardenia dye, and copper chlorophyll dye.
- Examples of the internal preparation of the present invention include agents used in oral administration forms (for example, oral administration, sublingual administration). Among these, a less invasive dosage form is preferable, and oral administration (internal use) is more preferable.
- Examples of the dosage form of the oral administration agent (internal use) or the composition for oral administration (composition for internal use) include, for example, liquid (solution), syrup (syrup), tablet (tablet, tablet), capsule (capsule) Agent), powder (granule, fine granule), soft capsule (soft capsule), solid, semi-liquid, cream, and paste.
- the administration target of the internal preparation may be an animal including a human, and is usually a human, but an animal other than a human (eg, mouse, rat, hamster, dog, cat, sheep, goat, cow, pig, monkey, etc. Mammals).
- the internal preparation of the present invention can be used as a food composition, medicine, or quasi drug.
- food compositions include beverages (soft drinks, carbonated drinks, nutritional drinks, powdered drinks, fruit drinks, milk drinks, jelly drinks, etc.), confectionery (cookies, cakes, gums, candies, tablets, gummies, buns, sheep candy) , Pudding, jelly, ice cream, sherbet, etc.), processed fishery products (kamaboko, chikuwa, hanpen, etc.), processed livestock products (hamburg, ham, sausage, winner, cheese, butter, yogurt, fresh cream, cheese, margarine, fermentation Milk, etc.), soup (powder soup, liquid soup, etc.), staple foods (rice, noodles (dried noodles, raw noodles), bread, cereals, etc.), seasonings (mayonnaise, shortening, dressing, sauce, sauce, soy sauce, etc.) ).
- the dosage form of the internal preparation of the present invention is usually oral administration such as buccal administration and sublingual administration.
- the dosage form of the internal preparation of the present invention can be determined as appropriate depending on whether it is a food or drink, a drug, or a quasi drug, and is not particularly limited.
- dosage forms for oral administration are liquid (liquid), syrup (syrup), tablet, capsule (capsule), powder (granular (granule), fine (powder)) , Soft capsules (soft capsules), solids (solid preparations), semi-liquids, creams, and pastes, with soft capsules (soft capsules) being preferred.
- the method for producing the internal preparation is not particularly limited, and may be followed according to a conventional method based on the dosage form and use. As an example, a production method when the dosage form is a soft capsule is shown below.
- Heating is usually performed at 40 ° C. or higher, preferably 50 ° C. or higher, more preferably 55 ° C. or higher. Although there is no particular upper limit, it is usually 100 ° C. or lower, preferably 90 ° C. or lower, more preferably 80 ° C. or lower. Therefore, the heating is usually performed at 40 to 100 ° C., preferably 50 to 90 ° C., more preferably 55 to 80 ° C.
- the mixing is preferably performed so as to be uniform, and stirred as necessary.
- the cooling temperature is usually 70 ° C.
- the cooling temperature is usually 20 to 70 ° C., preferably 22 to 60 ° C., more preferably 25 to 40 ° C.
- the component (A) is added and mixed (preferably so as to be uniform, stirred if necessary) to obtain the contents of the soft capsule (hereinafter also referred to as “content liquid”).
- the apparatus is not particularly limited, and examples thereof include a high-speed stirrer such as a homomixer and a high-pressure homogenizer, and a high-pressure pulverizer.
- the obtained content liquid is included in the coating substrate.
- the inclusion method include a flat plate method and a rotary die method. The latter is taken as an example, assuming that a medicine tank and a gelatin melting tank are provided, and a filling machine capable of setting a die roll and a tumbler dryer are used. Explained.
- a film substrate for example, a polymer such as gelatin or starch
- a plasticizer for example, glycerin, sorbitol
- purified water or the like
- a film substrate for example, a polymer such as gelatin or starch
- a plasticizer for example, glycerin, sorbitol
- purified water or the like
- the defoaming operation is performed in the same tank, and the viscosity is adjusted to obtain a film stock solution.
- Transfer the undiluted film solution to a small tank (usually warming (50 to 55 ° C)) while filtering, and set it at a predetermined position on the filling machine.
- the drying temperature is usually 20 to 30 ° C. and the relative humidity is 30 to 50%.
- the drying time is usually 24 to 48 hours. For example, when the water content at the time of filling is 30 to 40%, the drying is performed until the water content decreases to 6 to 8%.
- the dried soft capsules may be polished with a tumbler for 2 minutes to 1 hour, if necessary, to finish the soft capsules.
- the oral preparations of the present invention are foods such as health foods, functional foods, dietary supplements (supplements), foods for specified health use, medical foods, foods for the sick, foods for infants, foods for nursing care, foods for the elderly, etc. It can be used as a medicine or quasi-drug.
- Examples 1 to 46 and Comparative Examples 1 to 3 The contents of soft capsules prepared with the compositions described in Tables 1 to 7 were subjected to the following evaluation tests.
- the soft capsule was prepared according to a conventional method. That is, after mixing each component as the contents, each component as a film was coated to obtain a soft capsule.
- Dispersibility of liquid contents Dispersibility in water when disintegrating 6 soft capsules of each example and comparative example in the first liquid of the disintegration test in accordance with the disintegration test method of the general test method listed in the 16th revision Japanese Pharmacopoeia was visually observed. The results of visual observation were evaluated according to the following criteria. A: There is no separation of the oily component containing the hardly soluble component, and the dispersibility to the first liquid of the disintegration test is uniform and good.
- Tables 1-7 The results of the evaluation test are shown in Tables 1-7.
- Table 8 shows information on the components used in each example and comparative example.
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Abstract
Description
〔1〕成分(A):難溶性成分、及び
成分(B):有機酸モノグリセリド、を含む内服剤。
〔2〕成分(C):HLB10以上の親水性乳化剤をさらに含む、〔1〕に記載の剤。
〔3〕成分(A)が、ルテイン、カプサンチン、ゼアキサンチン、β-クリプトキサンチン、ドコサヘキサエン酸(以下、「DHA」ともいう)、アスタキサンチン及びβ-カロテンからなる群より選択される少なくとも1つを含む、〔1〕又は〔2〕に記載の剤。
〔4〕成分(B)が、クエン酸モノグリセリド、ジアセチル酒石酸モノグリセリド、乳酸モノグリセリド、及びコハク酸モノグリセリドからなる群より選択される少なくとも1つを含む、〔1〕~〔3〕のいずれか1項に記載の剤。
〔5〕成分(D):HLBが10未満の、グリセリン脂肪酸エステル又はポリグリセリン脂肪酸エステルをさらに含む、〔1〕~〔4〕のいずれか1項に記載の剤。
〔6〕ソフトカプセル剤である、〔1〕~〔5〕のいずれか1項に記載の剤。
〔7〕成分(A)及び成分(B)を含む内容物と、内容物を包含する皮膜とを有する、〔6〕に記載の剤。
〔8〕成分(A):難溶性成分、及び成分(B):有機酸モノグリセリドを含む内容物を調製する工程、並びに、
内容物を皮膜基材で包含する工程、を有する、ソフトカプセル剤の製造方法。 The present invention provides the following [1] to [8].
[1] An internal preparation containing component (A): a poorly soluble component, and component (B): an organic acid monoglyceride.
[2] Component (C): The agent according to [1], further comprising a hydrophilic emulsifier of HLB 10 or more.
[3] Component (A) contains at least one selected from the group consisting of lutein, capsanthin, zeaxanthin, β-cryptoxanthin, docosahexaenoic acid (hereinafter also referred to as “DHA”), astaxanthin and β-carotene. The agent according to [1] or [2].
[4] In any one of [1] to [3], the component (B) contains at least one selected from the group consisting of citric acid monoglyceride, diacetyltartaric acid monoglyceride, lactic acid monoglyceride, and succinic acid monoglyceride. The agent described.
[5] Component (D): The agent according to any one of [1] to [4], further comprising a glycerin fatty acid ester or a polyglycerin fatty acid ester having an HLB of less than 10.
[6] The agent according to any one of [1] to [5], which is a soft capsule.
[7] The agent according to [6], comprising a content containing the component (A) and the component (B) and a film including the content.
[8] Component (A): a hardly soluble component, and Component (B): a step of preparing a content containing an organic acid monoglyceride, and
A method of producing a soft capsule, comprising the step of including the contents with a coating substrate.
難溶性成分としては、例えば、脂肪酸(n-3系脂肪酸など)、カロテノイド、ユビキノン(コエンザイムQ10など)、脂溶性ビタミン(ビタミンE(トコフェロール、トコトリエノールなど)、ビタミンK、ステロール(スクワランなど)など)が挙げられる。中でも、カロテノイド、脂肪酸が好ましい。難溶性成分の由来は特に限定されず、植物、動物、微生物等の天然由来であってもよいし、化学合成等人工的に製造されたものでもよいし、遺伝子組換え等のバイオテクノロジーにより製造されたものでもよいし、市販品でもよい。 The hardly soluble component is a component that is insoluble or hardly soluble in an aqueous solvent. “Insoluble or hardly soluble” means, for example, that when a sample is dissolved in 100 g of water (20 ° C.), the solubility is usually less than 0.2 g / 100 g of water, preferably less than 0.1 g / 100 g of water. To do.
Examples of hardly soluble components include fatty acids (such as n-3 fatty acids), carotenoids, ubiquinones (such as coenzyme Q10), fat-soluble vitamins (such as vitamin E (such as tocopherol and tocotrienol)), vitamin K, and sterols (such as squalane). Is mentioned. Of these, carotenoids and fatty acids are preferred. The origin of the hardly soluble component is not particularly limited, and may be naturally derived from plants, animals, microorganisms, etc., may be artificially produced such as chemical synthesis, or may be produced by biotechnology such as gene recombination. It may be made, or a commercial product may be used.
成分(d1):HLBが5以下の、グリセリン脂肪酸エステル、又はポリグリセリン脂肪酸エステル成分。
成分(d2):HLBが5を超えて10未満の、グリセリン脂肪酸エステル、又はポリグリセリン脂肪酸エステル。 Component (D) may be any of the following component (d1), component (d2), and a combination of component (d1) and component (d2), and a combination of component (d1) and component (d2) Is preferred:
Component (d1): A glycerin fatty acid ester or polyglycerin fatty acid ester component having an HLB of 5 or less.
Component (d2): Glycerin fatty acid ester or polyglycerol fatty acid ester having an HLB of more than 5 and less than 10.
HLBが5未満のソルビタン脂肪酸エステル、例えば、モノステアリン酸ソルビタン(HLB=4.7)、セスキステアリン酸ソルビタン(HLB=4.2)、トリステアリン酸ソルビタン(HLB=2.0)、セスキイソステアリン酸ソルビタン(HLB=4.5)、オレイン酸ソルビタン(HLB=4.3)、セスキオレイン酸ソルビタン(HLB=3.7)、トリオレイン酸ソルビタン(HLB=2.0)。
HLBが5以上10未満のソルビタン脂肪酸エステル、例えば、モノカプリル酸ソルビタン、モノラウリン酸ソルビタン(HLB=8.6)、イソステアリン酸ソルビタン(HLB=8)。 The internal preparation may contain an emulsifier other than Component (E): Components (A) to (D). Examples of component (E) include the following:
Sorbitan fatty acid esters having an HLB of less than 5, such as sorbitan monostearate (HLB = 4.7), sorbitan sesquistearate (HLB = 4.2), sorbitan tristearate (HLB = 2.0), sesquiisostearic acid Sorbitan (HLB = 4.5), sorbitan oleate (HLB = 4.3), sorbitan sesquioleate (HLB = 3.7), sorbitan trioleate (HLB = 2.0).
Sorbitan fatty acid esters having an HLB of 5 or more and less than 10, for example, sorbitan monocaprylate, sorbitan monolaurate (HLB = 8.6), sorbitan isostearate (HLB = 8).
表1~7に記載の組成にて調製したソフトカプセル剤の内容物を以下の評価試験に供した。ソフトカプセル剤の調製は、常法に従って行った。すなわち、内容物としての各成分を混合した後、皮膜としての各成分をコーティングして、ソフトカプセル剤を得た。 Examples 1 to 46 and Comparative Examples 1 to 3
The contents of soft capsules prepared with the compositions described in Tables 1 to 7 were subjected to the following evaluation tests. The soft capsule was prepared according to a conventional method. That is, after mixing each component as the contents, each component as a film was coated to obtain a soft capsule.
第十六改正日本薬局方に収載された一般試験法の崩壊試験法に準拠し、各実施例及び比較例のソフトカプセル6粒を崩壊試験第1液中で崩壊させたときの水への分散性を、目視で観察した。目視観察の結果を以下の基準にて評価した。
A:難溶性成分を含む油性成分の分離がなく、崩壊試験第1液への分散性が均一で良好
B:難溶性成分を含む油性成分の分離がわずかにあるが、崩壊試験第1液への分散性が均一で良好
C:難溶性成分を含む油性成分の分離がみられ、わずかに崩壊試験第1液へ分散する
D:難溶性成分を含む油性成分がほとんど分離し、崩壊試験第1液へ分散しない <Dispersibility of liquid contents>
Dispersibility in water when disintegrating 6 soft capsules of each example and comparative example in the first liquid of the disintegration test in accordance with the disintegration test method of the general test method listed in the 16th revision Japanese Pharmacopoeia Was visually observed. The results of visual observation were evaluated according to the following criteria.
A: There is no separation of the oily component containing the hardly soluble component, and the dispersibility to the first liquid of the disintegration test is uniform and good. B: The oily component containing the hardly soluble component is slightly separated, but the disintegration test goes to the first liquid C: Oily component containing hardly soluble component is separated and slightly dispersed in the first liquid of disintegration test D: Oily component containing hardly soluble component is almost separated, disintegration test first Does not disperse into liquid
Claims (8)
- 成分(A):難溶性成分、及び
成分(B):有機酸モノグリセリド、を含む内服剤。 An internal preparation containing component (A): a poorly soluble component, and component (B): an organic acid monoglyceride. - 成分(C):HLB10以上の親水性乳化剤をさらに含む、請求項1に記載の剤。 Component (C): The agent according to claim 1, further comprising a hydrophilic emulsifier of HLB 10 or more.
- 成分(A)が、ルテイン、カプサンチン、ゼアキサンチン、β-クリプトキサンチン、ドコサヘキサエン酸、アスタキサンチン及びβ-カロテンからなる群より選択される少なくとも1つを含む、請求項1又は2に記載の剤。 The agent according to claim 1 or 2, wherein component (A) comprises at least one selected from the group consisting of lutein, capsanthin, zeaxanthin, β-cryptoxanthin, docosahexaenoic acid, astaxanthin, and β-carotene.
- 成分(B)が、クエン酸モノグリセリド、ジアセチル酒石酸モノグリセリド、乳酸モノグリセリド、及びコハク酸モノグリセリドからなる群より選択される少なくとも1つを含む、請求項1~3のいずれか1項に記載の剤。 The agent according to any one of claims 1 to 3, wherein the component (B) comprises at least one selected from the group consisting of citric acid monoglyceride, diacetyltartaric acid monoglyceride, lactic acid monoglyceride, and succinic acid monoglyceride.
- 成分(D):HLBが10未満の、グリセリン脂肪酸エステル又はポリグリセリン脂肪酸エステルをさらに含む、請求項1~4のいずれか1項に記載の剤。 Component (D): The agent according to any one of claims 1 to 4, further comprising a glycerin fatty acid ester or a polyglycerin fatty acid ester having an HLB of less than 10.
- ソフトカプセル剤である、請求項1~5のいずれか1項に記載の剤。 The agent according to any one of claims 1 to 5, which is a soft capsule.
- 成分(A)及び成分(B)を含む内容物と、内容物を包含する皮膜とを有する、請求項6に記載の剤。 The agent according to claim 6, having a content containing the component (A) and the component (B) and a film containing the content.
- 成分(A):難溶性成分、及び成分(B):有機酸モノグリセリド、を含む内容物を調製する工程、並びに、
内容物を皮膜基材で包含する工程、を有するソフトカプセル剤の製造方法。 A step of preparing a content containing component (A): a poorly soluble component, and component (B): an organic acid monoglyceride, and
A process for producing a soft capsule, comprising the step of including the contents with a coating substrate.
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CN111358000A (en) * | 2018-12-26 | 2020-07-03 | 株式会社芳珂 | Oily composition containing carotene |
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JP6445239B2 (en) | 2014-02-20 | 2018-12-26 | アリメント工業株式会社 | Soft capsule filling composition and soft capsule filled with the soft capsule filling composition |
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JP2007051115A (en) * | 2005-08-19 | 2007-03-01 | Riken Vitamin Co Ltd | Liposoluble medicament composition |
WO2007052738A1 (en) * | 2005-11-04 | 2007-05-10 | Otsuka Pharmaceutical Co., Ltd. | Medicinal composition showing improved drug absorbability |
WO2008044659A1 (en) * | 2006-10-06 | 2008-04-17 | Kaneka Corporation | Highly absorbable composition for oral administration containing oxidized coenzyme q10 |
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JP2020015669A (en) * | 2018-07-23 | 2020-01-30 | 株式会社ファンケル | Oily composition |
JP7032260B2 (en) | 2018-07-23 | 2022-03-08 | 株式会社ファンケル | Oily composition |
CN111358000A (en) * | 2018-12-26 | 2020-07-03 | 株式会社芳珂 | Oily composition containing carotene |
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CN111358000B (en) * | 2018-12-26 | 2023-10-31 | 株式会社芳珂 | Oily composition containing carotene |
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