Classifications

• • 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
  • A61K31/66—Phosphorus compounds
  • A61K31/683—Diesters of a phosphorus acid with two hydroxy compounds, e.g. phosphatidylinositols
• • 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
• • 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
  • A23L33/115—Fatty acids or derivatives thereof; Fats or oils
• • 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
  • A61K31/66—Phosphorus compounds
  • A61K31/683—Diesters of a phosphorus acid with two hydroxy compounds, e.g. phosphatidylinositols
  • A61K31/688—Diesters of a phosphorus acid with two hydroxy compounds, e.g. phosphatidylinositols both hydroxy compounds having nitrogen atoms, e.g. sphingomyelins
• • 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
  • A61K9/20—Pills, tablets, discs, rods
  • A61K9/2004—Excipients; Inactive ingredients
  • A61K9/2013—Organic compounds, e.g. phospholipids, fats
• • 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
  • A61K9/20—Pills, tablets, discs, rods
  • A61K9/2004—Excipients; Inactive ingredients
  • A61K9/2013—Organic compounds, e.g. phospholipids, fats
  • A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
  • A61P25/00—Drugs for disorders of the nervous system
  • A61P25/28—Drugs for disorders of the nervous system for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
  • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
• • 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
  • A61K9/0012—Galenical forms characterised by the site of application
  • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
  • A61K9/0056—Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals

Definitions

• the present invention relates to a solid supplement containing sphingomyelin.
• Sphingomyelin is a compound having a structure in which phosphocholine is bonded to a ceramide skeleton composed of a sphingoid base and a fatty acid, and is known to exist in the cell membrane, brain and nerve tissue in the body.
• sphingomyelin has been reported to have physiological functions such as memory disorder preventive and therapeutic effects (Patent Document 1), learning ability improving effect (Patent Document 2), and sialomucin secretion promoting effect (Patent Document 3). Expected to be widely applied to food and drinks.
• solid supplements are widely preferred because they are excellent in handleability and storage stability and are easy to take.
• a solid supplement is produced by compression-molding raw material powder and a preparation additive with a tableting machine or the like.
• tableting there may be tableting troubles such as capping where the upper collar side of the supplement peels off in a hat-like shape, or sticking where the raw material powder adheres to the basket and scratches the tablet surface.
• a tableting agent is added to prevent these tableting problems.
• sucrose fatty acid ester, lecithin, stearate, talc and the like are widely used (Patent Documents 4 and 5).
• Patent Document 1 JP-A-2003-146883 (Patent Document 2) JP-A-2007-246404 (Patent Document 3) JP-A-2007-112793 (Patent Document 4) JP-A 2000-139410 (Patent Document 3) Reference 5) Japanese Patent Application Laid-Open No. 2004-155682
• the present invention includes the following components (A) and (B): (A) Sphingomyelin 0.15-7% by mass, (B) phosphatidylinositol or a salt thereof, And the mass ratio [(B) / (A)] of phosphatidylinositol or (B) phosphatidylinositol or its salt to the content of (A) sphingomyelin in the solid supplement is 0.05 to 3 A solid supplement is provided.
• the present invention relates to providing a solid supplement that contains a large amount of sphingomyelin, has good manufacturability, and is excellent in taking feeling.
• the present inventors have included phosphatidylinositol in a certain range, thereby improving manufacturing obstacles at the time of manufacture, and having a rough feeling and less oily odor. It has been found that a solid supplement with excellent feeling can be obtained.
• Sphingomyelin used in the present invention is a compound having a structure in which phosphocholine is bound to a ceramide skeleton composed of a sphingoid base and a fatty acid.
• fatty acids constituting sphingomyelin include saturated or unsaturated linear hydrocarbon chains.
• the ratio of palmitic acid in the total fatty acids constituting sphingomyelin is preferably 50% by mass (hereinafter simply referred to as “%”) or less, more preferably 40% or less, from the viewpoint of production. It is further preferably 30% or less, and further preferably 20% or less.
• the range of such a ratio is preferably 1 to 50%, more preferably 2 to 40%, still more preferably 3 to 30%, still more preferably 5 to 20%, still more preferably 10 to 20%.
• Sphingomyelin can be either chemically synthesized or naturally derived.
• a chemical synthesis method of sphingomyelin 1) a method via phosphoramidite (Weis, Chem Phys Lip, 3, 1999), 2) a method via cyclic phosphate (Dong, Tetrahedron Lett, 5291, 1991) 3)
• a method in which phosphocholine is introduced into the 1-position hydroxyl group of ceramide and converted to sphingomyelin is known by a method (Byun, J Org Chem, 6495, 1994) via a cyclic phosphite.
• lipid components obtained from milk are purified by techniques such as dialysis, ammonium sulfate fractionation, gel filtration, isoelectric precipitation, ion exchange chromatography, solvent fractionation (Sanchez-Juanes, Int Dairy J, 273, 2009). By doing so, high-purity sphingomyelin can be obtained. Moreover, a commercial item can also be used for sphingomyelin.
• the content of (A) sphingomyelin is 0.15 to 7%, but it is possible to take a small amount at a time as an intake form in terms of intake that effectively exhibits physiological effects. From the point of being, 0.2% or more is preferable, 0.3% or more is more preferable, and 0.5% or more is still more preferable. From the viewpoint of maintaining the supplement form, it is preferably 6% or less, more preferably 5% or less, and even more preferably 3% or less. The content range is preferably 0.2 to 6%, more preferably 0.3 to 5%, still more preferably 0.5 to 3%.
• Phosphatidylinositol used in the present invention is one of acidic phospholipids having inositol as a polar group, and is a constituent component of cell membrane, Golgi membrane, endosome and the like.
• fatty acids constituting phosphatidylinositol include saturated or unsaturated linear hydrocarbon chains.
• the salt of phosphatidylinositol may be a pharmaceutically acceptable salt, such as a salt of an alkali metal such as sodium, potassium or lithium, a salt of an alkaline earth metal such as calcium or magnesium, ammonium, etc. And a salt with an inorganic base.
• phosphatidylinositol or a salt thereof either chemically synthesized or naturally derived ones can be used.
• enzymatic and chemical synthesis via phosphatidic acid conjugated with arachidonic acid (Mori, Okayama University Faculty of Agriculture, 9, 2001), extraction from baker's yeast (Trevelyan, J Lipid Res, 445, 1996) Etc. are known.
• Commercial products can also be used.
• the content of (B) phosphatidylinositol or a salt thereof in the solid supplement is preferably 0.02% or more, more preferably 0.05% or more, from the viewpoint of the mouthfeel of the supplement and productivity. % Or more is more preferable, 0.2% or more is more preferable, and 0.3% or more is still more preferable. Moreover, 10% or less is preferable from the point of flavor, 7% or less is more preferable, 5% or less is further more preferable, and 4% or less is still more preferable.
• the range of the content is preferably 0.02 to 10%, more preferably 0.05 to 7%, still more preferably 0.1 to 5%, and still more preferably 0.2 to 4%.
• content of (B) phosphatidylinositol or its salt shall be converted into phosphatidylinositol.
• the content of (B) phosphatidylinositol or a salt thereof in the solid supplement can be measured by an extraction method and a thin layer chromatographic method similar to those of sphingomyelin.
• the mass ratio of (B) phosphatidylinositol or its salt in terms of phosphatidylinositol in the solid supplement to the content of (A) sphingomyelin in the solid supplement [(B) / ( A)] is from 0.05 to 3, preferably from 0.07 or more, more preferably from 0.1 or more, and still more preferably from 0.2 or more, from the viewpoint of the taste and flavor of the supplement.
• 1.6 or less is preferable from the point of flavor, 1.2 or less is more preferable, and 0.8 or less is still more preferable.
• the mass ratio is preferably 0.07 to 1.6, more preferably 0.1 to 1.2, and still more preferably 0.2 to 0.8.
• minerals for example, iron, zinc, chromium, selenium, manganese, molybdenum, copper, iodine, phosphorus, potassium, sodium
• minerals for example, iron, zinc, chromium, selenium, manganese, molybdenum, copper, iodine, phosphorus, potassium, sodium
• Vitamins eg, vitamin A, vitamin B1, vitamin B2, vitamin B6, vitamin B12, vitamin C, folic acid and their salts, or esters thereof
• sweeteners eg, simple sugars, oligosaccharides, synthetic sweeteners
• Acidulants for example, citric acid, malic acid, tartaric acid, lactic acid, succinic acid, adipic acid, glucono delta lactone, gluconic acid, acetic acid, fumaric acid
• flavors coloring agents, preservatives, etc. Also good.
• an acceptable carrier can be blended as necessary. Especially, it is preferable to mix
• excipient include organic excipients and inorganic excipients.
• examples of the organic excipient include sugars such as lactose, starches, sucrose, maltose, glucose, and crystalline cellulose.
• examples include sugar alcohols such as maltitol, reduced maltose water candy, powdered reduced maltose water candy, erythritol, xylitol, sorbitol, mannitol, lactitol, trehalose, and reduced palatinose.
• inorganic excipients examples include sodium chloride, aluminum silicate, calcium silicate, silicon dioxide, light anhydrous silicic acid, calcium sulfate, and calcium hydrogen phosphate.
• organic excipients are preferred from the viewpoint of the mouthfeel, flavor, ease of chewing, and tablet hardness of the supplement, lactose, starches, and sugar alcohols are preferred, sugar alcohols are more preferred, and maltitol and erythritol. Xylitol is preferable, and maltitol is more preferable. These may be used alone or in combination.
• the sugar alcohol may be either an anhydride or a hydrate.
• the content of the (C) excipient in the solid supplement is preferably 25% or more, more preferably 35% or more, and further preferably 40% or more. Moreover, 99.8% or less is preferable from the point of the mixing
• the content range is preferably 25 to 99.8%, more preferably 35 to 95%, and still more preferably 40 to 90%.
• the content of the sugar alcohol in the excipient is preferably 3% or more, more preferably 5% or more, and still more preferably 8% or more, from the point of mouthfeel of the supplement. Further, from the viewpoint of ease of chewing and tablet hardness, it is preferably 75% or less, more preferably 60% or less, and still more preferably 50% or less. The content range is preferably 3 to 75%, more preferably 5 to 60%, and still more preferably 8 to 50%.
• the content of the (C) sugar alcohol in the solid supplement is preferably 2% or more, more preferably 4% or more, and still more preferably 8% or more in terms of mouthfeel.
• HPLC can be used as a quantification method of sugar alcohol. For example, it can be analyzed by differential refraction detection using an amino column (Fiber Fiber Fundamentals and Applications Supervision: Japan Dietary Fiber Society Editorial: Japan Dietary Fiber Society Editorial Board and others Author: Seiichiro Aoki Publisher: First Publishing (Release date: October 2008).
• a binder for example, hydroxypropylmethylcellulose, hydroxypropylcellulose, gelatin, pregelatinized starch, polyvinylpyrrolidone, polyvinyl alcohol, pullulan methylcellulose
• disintegrating agents eg, carmellose, carmellose calcium, croscarmellose sodium, crospovidone, corn starch, low substituted hydroxypropyl cellulose, etc.
• flavoring agents eg, stevia etc.
• bulking agents examples include carriers such as surfactants, dispersants, buffers, preservatives, and diluents.
• a lubricant other than phosphatidylinositol or a salt thereof can be blended.
• lubricants include calcium stearate, magnesium stearate, sodium stearyl fumarate, sucrose fatty acid ester, talc, silicon dioxide and the like.
• the form of the solid supplement of the present invention is not particularly limited as long as it is solid at room temperature (15 to 25 ° C.).
• Examples of the preparation form of the solid supplement include tablets and lozenges. Of these, chewable tablets and lozenges are preferable and chewable tablets are more preferable from the viewpoint of easy intake.
• it when it is set as a tablet as a supplement, it can also be set as the split tablet which put the score line.
• the shape of the solid supplement may be a round tablet or various deformed tablets having a surface shape such as an oval, an oval, or a quadrangle.
• a diameter of 5 to 15 mm is preferable from the viewpoint of administration.
• the weight per tablet is preferably 0.1 to 2 g, more preferably 0.3 to 1 g from the viewpoint of simplicity and effectiveness.
• the tablet hardness is preferably a hardness that can withstand load, storage, and the like when transporting, extruding from a fully automatic tablet packaging machine (PTP) or extrusion drug packaging machine (PTP), preferably 30N to 140N, preferably 40N to 90N. Is more preferable.
• the solid supplement of the present invention is not particularly limited and is produced according to a conventional method.
• it can be produced by compression molding after preparing a mixture of (A) sphingomyelin, (B) phosphatidylinositol or a salt thereof, and an additive added as necessary.
• Tablets can be molded by directly compressing the mixture (direct powder compression method), or granulated using dry granulation method, wet granulation method, etc. and then compressed (granule compression method) Also good.
• direct powder compression method to make a tablet from the point of simplicity of the process.
• a conventional tableting machine such as a rotary tableting machine or a single-shot tableting machine can be used.
• a tablet is formed after granulation by a granulation method, an extrusion granulation method using a cylindrical granulator, a spherical granulator, a pelleter, etc .; a crushing granulation method using a speed mill, a power mill, etc .;
• a granulated product is produced by dynamic granulation method, stirring granulation method, fluidized bed granulation method, etc., dried and sized, and then the obtained granulated product is compressed by the tableting machine to form tablets. it can.
• the particle size of the granulated product is preferably 45 ⁇ m to 850 ⁇ m, and more preferably 100 ⁇ m to 500 ⁇ m.
• the compression molding pressure at the time of tableting is preferably about 10 to 30 MPa from the viewpoint of maintaining the hardness of the molded product, disintegration, etc.
• the content of (A) sphingomyelin in the solid supplement is preferably 0.2% by mass or more, more preferably 0.3% by mass or more, and further preferably 0.5% by mass or more. Preferably, it is 6% by mass or less, more preferably 5% by mass or less, further preferably 3% by mass or less, preferably 0.2-6% by mass, more preferably 0.3-5% by mass, and still more preferably. Is 0.5 to 3% by mass of the solid supplement according to ⁇ 1>.
• the phosphatidylinositol equivalent amount of (B) phosphatidylinositol or its salt in the solid supplement is preferably 0.02% by mass or more, more preferably 0.05% by mass or more, and further preferably 0.1% by mass or more. More preferably, it is 0.2% by mass or more, more preferably 0.3% by mass or more, preferably 10% by mass or less, more preferably 7% by mass or less, still more preferably 5% by mass or less, still more preferably. Is 4 mass% or less, preferably 0.02 to 10 mass%, more preferably 0.05 to 7 mass%, still more preferably 0.1 to 5 mass%, still more preferably 0.2 to 4 mass%.
• the mass ratio [(B) / (A)] of (B) phosphatidylinositol or its salt converted to phosphatidylinositol with respect to the content of (A) sphingomyelin in the solid supplement is preferably 0.07 or more.
• ⁇ 5> The proportion of palmitic acid in the total fatty acids constituting sphingomyelin is preferably 50% by mass or less, more preferably 40% by mass or less, still more preferably 30% by mass or less, and still more preferably 20% by mass.
• Solid supplement preferably 1% by mass or more, more preferably 2% by mass or more, further preferably 5% by mass or more, further preferably 10% by mass or more, and preferably 1 to 50% by mass or more.
• it is 2 to 40% by mass, more preferably 3 to 30% by mass, still more preferably 5 to 20% by mass, and still more preferably 10 to 20% by mass, according to any one of ⁇ 1> to ⁇ 4>
• Solid supplement ⁇ 6>
• the content of the (C) excipient in the solid supplement is preferably 25% by mass or more, more preferably 35% by mass or more, still more preferably 40% by mass or more, and preferably 99.% by mass. It is 8% by mass or less, more preferably 95% by mass or less, further preferably 90% by mass or less, preferably 25 to 99.8% by mass, more preferably 35 to 95% by mass, and still more preferably 40 to 90%.
• (C) The excipient is preferably an organic excipient, more preferably one or more selected from lactose, starches, and sugar alcohols, more preferably sugar alcohols, and even more preferably multi-components.
• the content of the sugar alcohol in the excipient is preferably 3% by mass or more, more preferably 5% by mass or more, still more preferably 8% by mass or more, and preferably 75% by mass. Or less, more preferably 60% by mass or less, further preferably 50% by mass or less, preferably 3 to 75% by mass, more preferably 5 to 60% by mass, and further preferably 8 to 50% by mass ⁇
• the solid supplement according to 8> is preferably 3% by mass or more, more preferably 5% by mass or more, still more preferably 8% by mass or more, and preferably 75% by mass. Or less, more preferably 60% by mass or less, further preferably 50% by mass or less, preferably 3 to 75% by mass, more preferably 5 to 60% by mass, and further preferably 8 to 50% by mass ⁇
• the solid supplement according to 8> is preferably 3% by mass
• the content of the sugar alcohol (C) in the solid supplement is preferably 2% by mass or more, more preferably 4% by mass or more, still more preferably 8% by mass or more, and preferably 70% by mass. Or less, more preferably 55% by mass or less, still more preferably 45% by mass or less, and preferably 2 to 70% by mass, more preferably 4 to 55% by mass, still more preferably 8 to 45% by mass ⁇ Solid supplement as described in 8> or ⁇ 9>.
• the solid supplement is preferably a tablet or troche, more preferably a chewable tablet or troche, and even more preferably a chewable tablet.
• Shape supplement is preferably a tablet or troche, more preferably a chewable tablet or troche, and even more preferably a chewable tablet.
• the weight per tablet is preferably 0.1 to 2 g, more preferably 0.3 to 1 g, according to any one of ⁇ 1> to ⁇ 12>.
• (A) A method for preventing tableting failure of the solid supplement by adding (B) phosphatidylinositol or a salt thereof to the solid supplement containing sphingomyelin.
• (B) A method for preventing sticking and capping of the solid supplement by blending (B) phosphatidylinositol or a salt thereof with the solid supplement containing (A) sphingomyelin.
• the mass ratio [(B) / (A)] of (B) phosphatidylinositol or its phosphatidylinositol equivalent to the content of (A) sphingomyelin in the solid supplement is 0.05 to 3.
• Sphingomyelin (SM) COATSOME NM-70, manufactured by NOF Corporation, the proportion of palmitic acid in all constituent fatty acids is about 16% by mass)
• Phosphatidylinositol (PI) L-alpha-Phosphatidylinositol sodium salt, manufactured by Sigma Aldrich, sucrose fatty acid ester: Ryoto Sugar Ester B-370F, manufactured by Mitsubishi Chemical Foods Co., Ltd., calcium stearate: Orlabrite CA-65, NOF Corporation )
• Talc Wako Pure Chemical Industries, Ltd.
• Lactose Laprino Foods Starch: native tapioca, Matsutani Chemical Co., Ltd.
• Examples 1 to 9 and Comparative Examples 1 to 6 [Manufacture of tablets] SM, PI, talc and lactose used were pulverized in a mortar. After each raw material was passed through 50 mesh, each raw material component was mixed with the composition shown in Table 1. Next, using a hydraulic tablet machine (RIKEN CD-10), tablets with a diameter of 13 mm and a weight of 500 mg / tablet and a tableting pressure of 20 MPa were used to obtain circular tablets.
• RIKEN CD-10 hydraulic tablet machine
• Examples 1 to 9 containing a certain amount of phosphatidylinositol had good tableting properties, were smooth and had a good mouthfeel, and had a little oily odor and good flavor.
• Comparative Example 1 in which no lubricant is blended has poor tableting properties and feels rough
• the comparative example 5 with much ratio of the phosphatidylinositol with respect to sphingomyelin and the comparative example 6 with much content of sphingomyelin had a strong oily odor.
• Examples 10 to 13 and Comparative Example 7 Manufacture of tablets] SM, PI and lactose used were pulverized in a mortar. After each raw material was passed through 50 mesh, a circular chewable tablet was obtained in the same manner as in Example 1 except that each raw material component was mixed with the composition shown in Table 2.
• Examples 10 to 13 in which a certain amount of phosphatidylinositol was blended had good tabletability, had a smooth texture, had a less oily odor and a good flavor. Further, the tablets of Examples 10 to 13 had a hardness that was easy to chew, but had a hardness sufficient to prevent damage during transportation or storage before taking. On the other hand, in Comparative Example 7 in which no phosphatidylinositol was blended, a rough feeling was felt.

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