WO2025225032A1 - 組成物 - Google Patents

組成物

Info

Publication number
WO2025225032A1
WO2025225032A1 PCT/JP2024/016611 JP2024016611W WO2025225032A1 WO 2025225032 A1 WO2025225032 A1 WO 2025225032A1 JP 2024016611 W JP2024016611 W JP 2024016611W WO 2025225032 A1 WO2025225032 A1 WO 2025225032A1
Authority
WO
WIPO (PCT)
Prior art keywords
composition
less
tablet
powder
measurement
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
PCT/JP2024/016611
Other languages
English (en)
French (fr)
Japanese (ja)
Inventor
薫 佐治
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Daicel Corp
Original Assignee
Daicel Corp
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Daicel Corp filed Critical Daicel Corp
Priority to PCT/JP2024/016611 priority Critical patent/WO2025225032A1/ja
Priority to JP2024535224A priority patent/JP7713109B1/ja
Priority to JP2025042212A priority patent/JP2025168242A/ja
Priority to PCT/JP2025/015742 priority patent/WO2025225654A1/ja
Publication of WO2025225032A1 publication Critical patent/WO2025225032A1/ja
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • 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
    • A23L29/00—Foods or foodstuffs containing additives; Preparation or treatment thereof
    • 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
    • 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
    • A61K47/02—Inorganic compounds
    • 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
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/38—Cellulose; Derivatives thereof
    • 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
    • A61K47/46—Ingredients of undetermined constitution or reaction products thereof, e.g. skin, bone, milk, cotton fibre, eggshell, oxgall or plant extracts
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • 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

Definitions

  • This disclosure relates to a composition.
  • compositions used in various forms for pharmaceutical and food applications are orally administered or ingested by subjects, and such compositions are required to have good passage through the oral cavity and during swallowing, i.e., ease of swallowing, and/or a good texture.
  • the composition has the properties of good packing properties, low dusting (low dispersibility), and/or powder that is not easily chipped (high transportability) in terms of handling.
  • the above properties may also be suitable for cosmetic and lubricant compositions.
  • the first objective of the present disclosure is to provide an easy-to-swallow composition and/or an easy-to-swallow tablet containing said composition.
  • Another object (second object) of the present disclosure is to provide a composition that has a pleasant texture on the tongue, and/or a tablet containing said composition that has a pleasant texture on the tongue.
  • Another objective (third objective) of this disclosure is to provide a composition with good filling properties.
  • Another objective (fourth objective) of this disclosure is to provide a composition with low dispersion.
  • Another object (fifth object) of the present disclosure is to provide a composition having high transportability in tablets containing the composition, and/or a tablet having high transportability.
  • the present disclosure includes the following aspects.
  • the particle has an area of less than 20.0 ⁇ m2 and an aspect ratio of less than 1.40, and the particle has one of the following (a) to (d): (a) A backscatter (BS) ratio at a height of 30 mm from the bottom surface is 11.7% or less; (b) BS ratio is less than 21.0% 60 minutes after the start of measurement; (c) the frictional force of the wet powder is less than 63%; (d) powder water absorption rate is less than 200%; Satisfy one or more of the following:
  • the BS ratio at a height of 30 mm from the bottom is calculated by the following formula, based on the backscattered light measurement value (BS value) obtained at a point 30 mm from the bottom of the bottle when a test bottle containing a sample containing a composition is irradiated with light, and the value 1 minute and the value 5 minutes after the start of measurement: 100 x (BS value at 30 mm from the bottom 1 minute after the start
  • an easy-to-swallow composition and/or an easy-to-swallow tablet containing the composition it is possible to provide an easy-to-swallow composition and/or an easy-to-swallow tablet containing the composition.
  • composition having a pleasant texture on the tongue and/or a tablet containing the composition having a pleasant texture on the tongue.
  • composition with good filling properties can be provided.
  • a composition with low dispersion can be provided.
  • the fifth aspect of the present disclosure it is possible to provide a composition having high transportability in tablets containing the composition, and/or a tablet having high transportability.
  • each numerical indicator should be construed in light of the number of reported significant digits and by applying ordinary rounding techniques. Any numerical range or value inherently includes a range of error necessarily resulting from the standard deviation found in their respective testing measurements. Unless otherwise specified, each individual value of a numerical range herein is incorporated herein as if it were individually recited herein.
  • the term "comprise” refers to the inclusion of a certain component as at least a part, and includes cases where the component consists solely of that component.
  • composition for the composition according to this embodiment, the parameters described below can be measured and adjusted as described later in the section "Method for measuring parameters and method for adjusting the parameters.”
  • composition (1-1) according to the first embodiment is a composition containing particles having a particle area ( ⁇ m 2 ) of less than 20.0.
  • the particle area is preferably 0.2 or more and less than 20.0, more preferably 0.22 to 18.3, and may be 0.22 to 12.3.
  • the particle area may be, for example, any of 0.22, 0.23, 2.0, 2.1, 2.3, 4.0, 4.1, 4.3, 6.1, 8.0, 8.1, 8.3, 10.0, 12.0, 12.3, 16.0, 16.1, 16.3, 18.0, 18.1, and 18.3, and may be a range with any one of these as the upper limit and another one as the lower limit.
  • composition (1-2) according to the first embodiment is a composition containing particles having a particle area ( ⁇ m 2 ) of less than 20.0.
  • the particle area is preferably 0.2 or more and less than 20.0, more preferably 2.0 to 18.3.
  • the particle area may be, for example, any of 2.0, 2.1, 2.3, 4.0, 4.1, 4.3, 6.1, 8.0, 8.1, 8.3, 12.0, 12.3, 16.0, 16.1, 16.3, 18.0, 18.1, or 18.3, and may be a range with any one of these as the upper limit and another one as the lower limit.
  • composition (1-3) according to the first embodiment is a composition containing particles having a particle area ( ⁇ m 2 ) of 20.0 or more.
  • the particle area is preferably 20.0 to 50.0, more preferably 20.0 to 40.0, and even more preferably 20.0 to 38.0.
  • the particle area may be, for example, any of 20.0, 20.1, 20.2, 20.3, 21.4, 21.5, 21.6, 36.9, 37.0, 37.1, or 38.0, and may be within a range having any one of these as the upper limit and another one as the lower limit.
  • composition (1-4) according to the first embodiment is a composition containing particles having a particle area ( ⁇ m 2 ) of 20.0 or more.
  • the particle area is preferably 20.0 to 50.0, more preferably 20.0 to 40.0, and even more preferably 20.0 to 38.0.
  • the particle area may be, for example, any of 20.0, 20.1, 20.2, 20.3, 21.4, 21.5, 21.6, 36.9, 37.0, 37.1, or 38.0, and may be within a range having any one of these as the upper limit and another one as the lower limit.
  • the "BS ratio at a height of 30 mm from the bottom" of the composition tends to be small (i.e., the sedimentation rate is slow) and/or the "BS ratio 60 minutes after the start of measurement” tends to be small (i.e., the degree of sedimentation is small).
  • the rate of sedimentation is slow and/or the degree of sedimentation is small, the composition or tablet is less likely to remain in the mouth when administered orally and/or is more likely to pass easily during swallowing, i.e., be easier to swallow.
  • a composition comprising particles having a particle area of less than 20.0, or a tablet comprising said composition, is likely to be easier to swallow.
  • the particle area is small, the composition is easily compacted. Therefore, for example, a composition containing particles with a particle area of less than 20.0 is easily filled into a composition bag or a tablet molding machine, which facilitates improved productivity.
  • composition (2-1) according to the first embodiment is a composition containing particles having a Feret diameter (vertical width) ( ⁇ m) of less than 3.3.
  • the Feret diameter (perpendicular width) is preferably 0.10 or more and less than 3.3, more preferably 0.30 or more and less than 3.3, even more preferably 0.40 to 3.2, even more preferably 0.50 to 3.2, even more preferably 0.51 to 3.2, and even more preferably 0.51 to 3.1.
  • the Feret diameter (perpendicular) is 0.51 to 3.1, it may be, for example, any of 0.51, 0.52, 0.53, 0.54, 0.55, 0.58, 1.5, 1.6, 2.5, 2.6, 3.0, and 3.1, or may be a range having any one of these as an upper limit and another one as a lower limit.
  • Composition (2-2) is a composition containing particles having a Feret diameter (perpendicular width) of 3.3 or more and less than 20.0.
  • the Feret diameter (vertical width) is preferably 3.3 to 10.0, more preferably 3.3 to 5.0.
  • the Feret diameter (vertical width) is 3.3 to 5.0, it may be, for example, any one of 3.3, 3.4, 4.9, or 5.0, or may be within a range having one of these as an upper limit and another as a lower limit.
  • composition (2-3) according to the first embodiment is a composition containing particles having a Feret diameter (perpendicular width) of 3.3 or more and less than 20.0.
  • the Feret diameter (vertical width) is preferably 3.3 to 10.0, more preferably 3.3 to 5.0.
  • the Feret diameter (vertical width) is 3.3 to 5.0, it may be, for example, any one of 3.3, 3.4, 4.9, or 5.0, or may be within a range having one of these as an upper limit and another as a lower limit.
  • Composition (2-4) according to the first embodiment is a composition containing particles having a Feret diameter (vertical width) of 20.0 or more.
  • the Feret diameter (vertical width) is preferably 20.0 to 60.0, more preferably 20.0 to 40.0.
  • the Feret diameter (vertical width) is 20.0 to 40.0, it may be, for example, any of 20.0, 24.0, 24.1, 24.2, 24.5, 24.6, 24.7, 24.8, 24.9, 25.0, 25.6, 25.8, 30.0, 33.0, or 40.0, or may be a range with any one of these as the upper limit and another one as the lower limit.
  • the particle area of the composition tends to be small.
  • the "BS ratio at a height of 30 mm from the bottom" of the composition tends to be small (i.e., the sedimentation rate is slow) and/or the "BS ratio 60 minutes after the start of measurement” tends to be small (i.e., the degree of sedimentation is small). If the rate of sedimentation is slow and/or the degree of sedimentation is small, the composition or tablet is less likely to remain in the mouth when administered orally and/or is more likely to pass easily during swallowing, i.e., be easier to swallow.
  • a composition comprising particles having a Feret diameter (perpendicular width) of less than 3.3, or a tablet comprising said composition, is likely to be easier to swallow. Furthermore, when the particle area is small, the composition is more likely to be compacted. For example, a composition containing particles having a Feret diameter (vertical width) of less than 3.3 is more likely to be filled into a composition bag or a tablet molding machine, which can improve productivity.
  • the composition (3-1) according to the first embodiment is a composition containing particles having a Feret diameter (horizontal width) ( ⁇ m) of 2.4 or less.
  • the Feret diameter (horizontal width) may be 0.51 to 2.4, 0.51 or more and less than 2.3, or 0.51 to 2.2.
  • the Feret diameter (vertical width) is 0.51 to 2.4, it may be, for example, 0.51, 0.52, 0.53, 1.4, 2.1, or 2.4, or it may be within a range with one of these as the upper limit and another as the lower limit.
  • composition (3-2) according to the first embodiment is a composition containing particles having a Feret diameter (horizontal width) of 2.3 to 3.1.
  • the Feret diameter (vertical width) is between 2.3 and 3.1, it may be either 2.3 or 3.1.
  • the composition (3-3) according to the first embodiment is a composition containing particles with a Feret diameter (horizontal width) of 2.3 to 3.1.
  • the Feret diameter (horizontal width) is between 2.3 and 3.1, it may be, for example, either 2.3 or 3.1.
  • the composition (3-4) according to the first embodiment is a composition containing particles having a Feret diameter (horizontal width) of 5.0 or more.
  • the Feret diameter (horizontal width) is preferably 5.0 or more and 50.0 or less, more preferably 10.0 or more and 40.0 or less, and even more preferably 20.0 to 36.0.
  • the Feret diameter (horizontal width) is 20.0 to 36.0, it may be, for example, any one of 20.0, 22.0, 24.0, 26.0, 27.0, or 36.0, or may be a range with any one of these as the upper limit and another one as the lower limit.
  • the particle area of the composition tends to be small.
  • the "BS ratio at a height of 30 mm from the bottom" of the composition tends to be small (i.e., the sedimentation rate is slow) and/or the "BS ratio 60 minutes after the start of measurement” tends to be small (i.e., the degree of sedimentation is small). If the rate of sedimentation is slow and/or the degree of sedimentation is small, the composition or tablet is less likely to remain in the mouth when administered orally and/or is more likely to pass easily during swallowing, i.e., be easier to swallow.
  • a composition containing particles having a Feret diameter (horizontal width) of 2.4 or less, or a tablet containing the composition tends to be easy to swallow. Furthermore, when the particle area is small, the composition is easily compacted. For example, a composition containing particles having a Feret diameter (horizontal width) of 2.4 or less is easily filled into a composition bag or a tablet molding machine, which facilitates improved productivity.
  • composition (4-1) according to the first embodiment is a composition containing particles having an aspect ratio of less than 1.40.
  • the aspect ratio is preferably 1.00 or more and less than 1.40, more preferably 1.00 to 1.35, and even more preferably 1.00 to 1.30.
  • the aspect ratio may be, for example, any of 1.00, 1.01, 1.04, 1.05, 1.06, 1.07, 1.09, 1.11, 1.12, 1.19, 1.20, 1.21, 1.22, 1.25, 1.27, or 1.30, or may be a range with any one of these as the upper limit and another one as the lower limit.
  • Composition (4-2) according to the first embodiment is a composition containing particles with an aspect ratio of 1.40 or more.
  • the aspect ratio is preferably 1.40 to 5.00, more preferably 1.40 to 3.00, even more preferably 1.40 to 2.00, and even more preferably 1.40 to 1.63.
  • the aspect ratio may be, for example, any one of 1.40, 1.41, 1.42, 1.43, 1.45, 1.60, 1.61, 1.62, or 1.63, or may be a range with any one of these as the upper limit and another one as the lower limit.
  • composition (4-3) according to the first embodiment is a composition containing particles having an aspect ratio of 1.40 or more.
  • the aspect ratio is preferably 1.40 to 5.00, more preferably 1.40 to 3.00, even more preferably 1.40 to 2.00, and even more preferably 1.40 to 1.63.
  • the aspect ratio may be, for example, any one of 1.40, 1.41, 1.42, 1.43, 1.45, 1.60, 1.61, 1.62, or 1.63, or may be a range with any one of these as the upper limit and another one as the lower limit.
  • Composition (4-4) according to the first embodiment is a composition containing particles with an aspect ratio of less than 1.40.
  • the aspect ratio is preferably 1.00 or more and less than 1.40, more preferably 1.00 to 1.35, even more preferably 1.00 to 1.30, and even more preferably 1.00 to 1.27.
  • the aspect ratio may be, for example, any of 1.00, 1.03, 1.09, 1.10, 1.11, 1.12, 1.13, 1.14, 1.16, 1.17, 1.20, or 1.27, or may be a range with any one of these as the upper limit and another one as the lower limit.
  • An aspect ratio close to 1.0 indicates that the particles are nearly spherical.
  • the "BS ratio at a height of 30 mm from the bottom" of the composition tends to be small (i.e., the sedimentation rate is slow) and/or the "BS ratio 60 minutes after the start of measurement” tends to be small (i.e., the degree of sedimentation is small).
  • the rate of sedimentation is slow and/or the degree of sedimentation is small
  • the composition or tablet is less likely to remain in the mouth when administered orally and/or is more likely to pass easily during swallowing, i.e., be easier to swallow.
  • a composition comprising particles having an aspect ratio of less than 1.40, or a tablet comprising said composition is likely to be easier to swallow.
  • a small aspect ratio makes the composition more likely to be compacted.
  • a composition containing particles with an aspect ratio of less than 1.40 is more likely to be filled into a composition bag or a tablet molding machine, which makes it easier to improve productivity.
  • the composition (5-1) according to the first embodiment is a composition having a BS ratio (1 min:5 min) (%) at a height of 30 mm from the bottom surface (hereinafter also referred to as "BS ratio at a height of 30 mm") of 11.7 or less.
  • the BS ratio at a height of 30 mm is preferably 1.0 to 11.7, more preferably 1.0 to 11.0, and even more preferably 1.00 to 10.0.
  • the BS ratio at a height of 30 mm is 1.0 to 10.0, it may be, for example, any of 1.0, 1.1, 1.2, 1.5, 2.0, 4.0, 6.0, 8.0, or 10.0, or may be a range with any one of these as the upper limit and another one as the lower limit.
  • the composition (5-2) according to the first embodiment is a composition having a BS ratio (%) at a height of 30 mm of 11.8 or more.
  • the BS ratio at a height of 30 mm is preferably 11.8 to 20.0, more preferably 11.8 to 15.0, and even more preferably 11.8 to 13.0.
  • the BS ratio at a height of 30 mm is 11.8 to 13.0, it may be, for example, 11.8, 12.0, or 13.0, or may be within a range having one of these as an upper limit and another as a lower limit.
  • the composition (5-3) according to the first embodiment is a composition having a BS ratio (%) at a height of 30 mm of 11.8 or more.
  • the BS ratio at a height of 30 mm is preferably 11.8 to 20.0, more preferably 11.8 to 15.0, and even more preferably 11.8 to 13.0.
  • the BS ratio at a height of 30 mm is 11.8 to 13.0, it may be, for example, 1.8, 12.0, or 13.0, or may be within a range having one of these as an upper limit and another as a lower limit.
  • the composition (5-4) according to the first embodiment is a composition having a BS ratio (%) at a height of 30 mm of 11.8 or more.
  • the BS ratio at a height of 30 mm is preferably 11.8 to 20.0, more preferably 11.8 to 15.0, and even more preferably 11.8 to 13.0.
  • the BS ratio at a height of 30 mm is 11.8 to 13.0, it may be, for example, 11.8, 12.0, or 13.0, or may be within a range having one of these as an upper limit and another as a lower limit.
  • a small BS ratio at a height of 30 mm of a composition means that the sedimentation rate of the composition is slow. If the sedimentation rate is slow, the composition or tablet is less likely to remain in the mouth when administered orally and/or is more likely to pass smoothly during swallowing, i.e., be easy to swallow and/or have a good mouthfeel.
  • a composition having a BS ratio of 11.7 or less at a height of 30 mm, or a tablet containing the composition is likely to be easy to swallow and/or to have a good mouthfeel.
  • Composition (6-1) according to the first embodiment is a composition in which the BS ratio (10mm:40mm) (%) 60 minutes after the start of measurement (hereinafter also referred to as "BS ratio 60 minutes after the start of measurement”) is less than 21.0.
  • the BS ratio 60 minutes after the start of the measurement is preferably 1.0 or more and less than 21.0, more preferably 1.0 to 20.0, even more preferably 1.5 to 18.0, even more preferably 2.1 to 15.0, and even more preferably 2.1 to 12.0.
  • the BS ratio 60 minutes after the start of measurement is 1.5 to 12.0, it may be, for example, any one of 1.5, 2.1, 2.7, 3.0, 5.2, 6.0, 9.0, or 12.0, or may be within a range with any one of these as the upper limit and another one as the lower limit.
  • Composition (6-2) is a composition in which the BS ratio (%) 60 minutes after the start of measurement is 21.0 or higher.
  • the BS ratio 60 minutes after the start of the measurement is preferably 21.0 to 30.0, more preferably 21.0 to 25.0, and even more preferably 21.0 to 24.4.
  • the BS ratio 60 minutes after the start of measurement is 21.0 to 24.4, it may be, for example, 21.0, 22.0, or 24.4, or may be within a range with one of these as the upper limit and another as the lower limit.
  • composition (6-3) according to the first embodiment is a composition in which the BS ratio (%) after 60 minutes is 21.0 or higher.
  • the BS ratio 60 minutes after the start of the measurement is preferably 21.0 to 30.0, more preferably 21.0 to 25.0, and even more preferably 21.0 to 24.4.
  • the BS ratio 60 minutes after the start of measurement is 21.0 to 24.4, it may be, for example, 21.0, 22.0, or 24.4, or may be within a range with one of these as the upper limit and another as the lower limit.
  • Composition (6-4) is a composition in which the BS ratio (%) 60 minutes after the start of measurement is 21.0 or higher.
  • the BS ratio 60 minutes after the start of the measurement is preferably 21.0 to 30.0, more preferably 21.0 to 25.0, and even more preferably 21.0 to 24.4.
  • the BS ratio 60 minutes after the start of measurement is 21.0 to 24.4, it may be, for example, 21.0, 22.0, or 24.4, or may be within a range with one of these as the upper limit and another as the lower limit.
  • a small BS ratio of the composition 60 minutes after the start of measurement means that the degree of precipitation of the composition is small. If the degree of sedimentation is small, the composition or tablet is less likely to remain in the mouth when administered orally and/or is more likely to pass smoothly during swallowing, i.e., be easier to swallow and/or have a good mouthfeel. For example, a composition having a BS ratio of less than 21.0 60 minutes after the start of measurement, or a tablet containing said composition, is likely to be easy to swallow and/or to have a good texture on the tongue.
  • composition (7-1) according to the first embodiment is a composition having a powder water absorption rate (%) of less than 200.
  • the powder water absorption (%) is preferably 40 to 190, more preferably 50 to 100, even more preferably 50 to 75, and even more preferably 50 to 70.
  • the powder water absorption rate (%) is 50 to 70, it may be, for example, 50, 60, or 70, or may be within a range with one of these as the upper limit and another as the lower limit.
  • composition (7-2) according to the first embodiment is a composition having a powder water absorption rate (%) of 200 or more.
  • the powder water absorption (%) is preferably 200 to 300, more preferably 200 to 250.
  • the powder water absorption rate (%) is 200 to 250, it may be, for example, 200, 225, or 250, or may be within a range with one of these as the upper limit and another as the lower limit.
  • composition (7-3) according to the first embodiment is a composition having a powder water absorption rate (%) of 200 or more.
  • the powder water absorption (%) is preferably 200 to 300, more preferably 200 to 250.
  • the powder water absorption rate (%) is 200 to 250, it may be, for example, 200, 225, or 250, or may be within a range with one of these as the upper limit and another as the lower limit.
  • composition (7-4) according to the first embodiment is a composition having a powder water absorption rate (%) of 200 or more.
  • the powder water absorption (%) is preferably 200 to 300, more preferably 200 to 250.
  • the powder water absorption rate (%) is 200 to 250, it may be, for example, 200, 225, or 250, or may be within a range with one of these as the upper limit and another as the lower limit.
  • the powder particles are less likely to expand, so that the powder particles are more likely to break apart, and the "disintegrability in water" of the composition or a tablet containing the composition is more likely to be good.
  • the disintegrability in water is good
  • the composition or tablet is likely to have good oral disintegrability when orally administered, is unlikely to remain in the mouth, and/or is likely to achieve good passage of the composition during swallowing, i.e., is likely to be easy to swallow, and/or is likely to have a good texture on the tongue.
  • the powder water absorption is less than 200
  • a composition containing the particles or a tablet containing the composition is likely to be easy to swallow and/or have a good mouthfeel.
  • the composition (8-1) according to the first embodiment is a composition in which the frictional force (gf) of the wet powder when moved 2 mm ( ⁇ when the movement distance is zero) (hereinafter also referred to as the "frictional force of the wet powder") is less than 63.
  • the frictional force of the wet powder is preferably 10 or more and less than 63, more preferably 20 to 50, even more preferably 30 to 45, and even more preferably 30 to 32.
  • the frictional force of the wet powder is 30 to 45, it may be, for example, 30, 32, 40, 41, 42, or 45, or it may be within a range with any one of these as the upper limit and another as the lower limit.
  • the composition (8-2) according to the first embodiment is a composition in which the friction force (%) of the wet powder is 63 or more.
  • the frictional force of the wet powder is preferably 63 or more and less than 90, more preferably 63 to 70, and even more preferably 63 to 65.
  • the frictional force of the wet powder is 63 to 65, it may be, for example, 63, 64, or 65, or may be within a range with one of these as the upper limit and another as the lower limit.
  • the composition (8-3) according to the first embodiment is a composition in which the friction force (%) of the wet powder is 63 or more.
  • the frictional force of the wet powder is preferably 63 or more and less than 90, more preferably 63 to 70, and even more preferably 63 to 65.
  • the frictional force of the wet powder is 63 to 65, it may be, for example, 63, 64, or 65, or may be within a range with one of these as the upper limit and another as the lower limit.
  • Composition (8-4) according to the first embodiment is a composition in which the frictional force (%) of the wet powder is 63 or more.
  • the frictional force of the wet powder is preferably 63 or more and less than 90, more preferably 63 to 70, and even more preferably 63 to 65.
  • the frictional force of the wet powder is 63 to 65, it may be, for example, 63, 64, or 65, or may be within a range with one of these as the upper limit and another as the lower limit.
  • a low frictional force of a wet powder indicates that the powder particles contained in the composition or tablet are smooth and are less likely to aggregate and/or cause friction between the powder particles. If the frictional force of the wet powder is low, the composition or tablet is less likely to remain in the mouth when administered orally and/or the composition is more likely to pass through easily during swallowing, i.e., be easier to swallow and/or have a good mouthfeel. For example, if the frictional force of the wet powder is less than 63, the composition or a tablet containing the composition is likely to be easier to swallow and/or provide a good mouthfeel.
  • Composition (9-1) is a composition in which the water disintegration time (minutes) of a tablet containing the composition is less than 90 minutes.
  • the disintegration time in water is preferably 10 to 80, more preferably 12 to 30, and even more preferably 12 to 15.
  • the water disintegration time (minutes) is 12 to 15, it may be, for example, 12, 14, or 15, or it may be within a range having one of these as the upper limit and another as the lower limit.
  • Composition (9-2) according to the first embodiment is a composition in which the water disintegration time (minutes) of a tablet containing the composition is 90 or more.
  • the disintegration time in water is preferably 90 to 180, more preferably 90 to 120.
  • the water disintegration time is 90 to 120, it may be, for example, 90, 100, 105, 110, or 120, or it may be within a range having one of these as the upper limit and another as the lower limit.
  • Composition (9-3) according to the first embodiment is a composition in which the water disintegration time (minutes) of a tablet containing the composition is 90 or more.
  • the disintegration time in water is preferably 90 to 180, more preferably 90 to 120.
  • the water disintegration time is 90 to 120, it may be, for example, 90, 100, 105, 110, or 120, or it may be within a range having one of these as the upper limit and another as the lower limit.
  • the composition (9-4) according to the first embodiment is a composition in which the water disintegration time (minutes) of a tablet containing the composition is 90 or more.
  • the disintegration time in water (minutes) is preferably 90 to 180, more preferably 90 to 120.
  • the water disintegration time is 90 to 120, it may be, for example, 90, 100, 105, 110, or 120, or it may be within a range having one of these as the upper limit and another as the lower limit.
  • the disintegrability in water of the composition or a tablet containing the composition tends to be good.
  • the composition or tablet is likely to have good oral disintegrability when orally administered, is unlikely to remain in the mouth, and/or is likely to achieve good passage of the composition during swallowing, i.e., is likely to be easy to swallow, and/or is likely to have a good texture on the tongue.
  • the disintegration time (minutes) of a tablet in water is less than 90, the tablet is likely to be easy to swallow and/or provide a good mouthfeel.
  • the composition (10-1) according to the first embodiment is a composition in which the hardness (N) of a tablet containing the composition is 46 or less.
  • the hardness (N) of the tablet is preferably 10-46, more preferably 12-46, even more preferably 14-46, and even more preferably 14-44.
  • the tablet hardness is 14 to 44, it may be, for example, 14, 17, 25, 35, 42, 43, or 44, or may be within a range with any one of these as the upper limit and another as the lower limit.
  • Composition (10-2) according to the first embodiment is a composition in which the hardness (N) of a tablet containing the composition is 45 or more.
  • the hardness (N) of the tablet is preferably 45-100, more preferably 45-70, and even more preferably 45-50.
  • the tablet hardness is 45 to 50, it may be, for example, 45, 47, or 50, or may be within a range with one of these as the upper limit and another as the lower limit.
  • Composition (10-3) according to the first embodiment is a composition in which the hardness (N) of a tablet containing the composition is 45 or more.
  • the hardness of the tablet is preferably 45-100, more preferably 45-70, and even more preferably 45-50.
  • the tablet hardness is 45 to 50, it may be, for example, 45, 47, or 50, or may be within a range with one of these as the upper limit and another as the lower limit.
  • Composition (10-4) according to the first embodiment is a composition containing particles that produce a tablet having a hardness (N) of 45 or more.
  • the hardness (N) of the tablet is preferably 45-100, more preferably 45-70, and even more preferably 45-50.
  • the tablet hardness is 45 to 50, it may be, for example, 45, 47, or 50, or may be within a range with one of these as the upper limit and another as the lower limit.
  • the tablet hardness When the tablet hardness is low, the "disintegrability in water" of the composition or a tablet containing the composition tends to be good.
  • the disintegrability in water When the disintegrability in water is good, the composition or tablet is likely to have good oral disintegrability when orally administered, is unlikely to remain in the mouth, and/or is likely to achieve good passage of the composition during swallowing, i.e., is likely to be easy to swallow, and/or is likely to have a good texture on the tongue.
  • the hardness (N) of the tablet is 46 or less, the tablet tends to be easy to swallow and/or tends to have a good mouthfeel.
  • Composition (11-1) is a composition in which the water disintegration rate (min/N) (water disintegration time of the tablet/tablet hardness) (hereinafter also referred to as "water disintegration rate") of a tablet containing the composition is less than 1.9.
  • min/N water disintegration rate
  • water disintegration rate water disintegration time of the tablet/tablet hardness
  • the disintegrability in water is preferably 0.2 to 1.8, more preferably 0.3 to 1.2, and even more preferably 0.3 to 0.9.
  • the disintegrability in water is 0.3 to 0.9, it may be, for example, any one of 0.3, 0.4, 0.7, or 0.9, or may be within a range having any one of these as the upper limit and another one as the lower limit.
  • Composition (11-2) according to the first embodiment is a composition in which the water disintegration rate (min/N) of a tablet containing the composition is 1.9 or more.
  • the disintegrability in water is preferably 1.9 to 5.0, more preferably 1.9 to 3.0, and even more preferably 1.9 to 2.7.
  • the disintegrability in water is 1.9 to 2.7, it may be, for example, 1.9, 2.2, 2.3, or 2.7, or may be within a range with any one of these as the upper limit and another as the lower limit.
  • Composition (11-3) according to the first embodiment is a composition in which the water disintegration rate (min/N) of a tablet containing the composition is 1.9 or more.
  • the disintegrability in water is preferably 1.9 to 5.0, more preferably 1.9 to 3.0, and even more preferably 1.9 to 2.7.
  • the disintegrability in water is 1.9 to 2.7, it may be, for example, 1.9, 2.2, 2.3, or 2.7, or may be within a range with any one of these as the upper limit and another one as the lower limit.
  • Composition (11-4) according to the first embodiment is a composition in which the water disintegration rate (min/N) of a tablet containing the composition is 1.9 or more.
  • the disintegrability in water is preferably 1.9 to 5.0, more preferably 1.9 to 3.0, and even more preferably 1.9 to 2.7.
  • the disintegrability in water is 1.9 to 2.7, it may be, for example, 1.9, 2.2, 2.3, or 2.7, or may be within a range with any one of these as the upper limit and another one as the lower limit.
  • the disintegration rate (min/N) of the tablet the higher the disintegration rate.
  • the composition or tablet is likely to have good oral disintegrability when orally administered, is unlikely to remain in the mouth, and/or is likely to achieve good passage of the composition during swallowing, i.e., is likely to be easy to swallow, and/or is likely to have a good texture on the tongue.
  • the disintegration rate of a tablet in water is less than 1.9, the tablet is likely to be easy to swallow and/or to have a good mouthfeel.
  • the composition (12-1) according to the first embodiment is a composition in which the tapping apparent density (g/cm 3 ) of the powder particles is 0.10 to 8.00.
  • the tapped apparent density may be 0.50 to 8.00, 0.50 to 5.00, or 0.50 to 4.60, or may be greater than 2.00, 2.10 or greater, 2.10 to 8.00, or 2.10 to 5.00.
  • the tapped apparent density may be 0.50 to 4.60, it may be, for example, any of 0.50, 0.55, 0.60, 0.65, 0.70, 0.80, 2.00, or 4.60, or may be within a range having any one of these as an upper limit and another one as a lower limit.
  • the composition (12-2) according to the first embodiment is a composition in which the tapping apparent density (g/cm 3 ) of the powder particles is 0.35 to 2.00.
  • the tapped apparent density may be 0.35 or more and less than 0.50.
  • the tapped apparent density may be, for example, any of 0.35, 0.48, 0.50, 0.80, and 2.00, and may be within a range having one of these as the upper limit and another as the lower limit.
  • the composition (12-3) according to the first embodiment is a composition in which the tapping apparent density (g/cm 3 ) of the powder particles is 0.35 to 2.00.
  • the tapped apparent density may be 0.35 or more and less than 0.50.
  • the tapped apparent density may be, for example, any of 0.35, 0.48, 0.50, 0.80, and 2.00, and may be within a range having one of these as the upper limit and another as the lower limit.
  • the composition (12-4) according to the first embodiment is a composition in which the tapping apparent density (g/cm 3 ) of the powder particles is 0.35 to 2.00.
  • the tapped apparent density may be 0.35 or more and less than 0.50.
  • the tapped apparent density may be, for example, any of 0.35, 0.48, 0.50, 0.80, and 2.00, and may be within a range having one of these as the upper limit and another as the lower limit.
  • a composition having a tapped apparent density (g/cm 3 ) of 0.10 to 8.00 or 0.35 to 2.00 is easier to fill into a composition bag or a tablet molding machine, making it easier to improve productivity.
  • the composition (13-1) according to the first embodiment is a composition in which the apparent density (without tapping) (g/cm 3 ) of the powder particles is 0.10 to 5.00.
  • the apparent density (without tapping) is preferably 0.30 to 5.00, more preferably 0.34 to 4.20, and may be greater than 1.40 and equal to or less than 4.20.
  • the apparent density (without tapping) of the powder particles is 0.34 to 4.20, it may be, for example, any of 0.34, 0.40, 0.42, 0.43, 0.44, 0.45, 0.46, 0.50, 0.52, 0.54, 0.55, 0.65, 1.60, or 4.20, or may be within a range having any one of these as an upper limit and another one as a lower limit.
  • the composition (13-2) according to the first embodiment is a composition in which the apparent density (without tapping) (g/cm 3 ) of the powder particles is 0.10 to 1.40.
  • the apparent density (without tapping) is preferably 0.20 to 1.40, more preferably 0.22 to 1.40.
  • the apparent density (without tapping) of the powder particles is 0.22 to 1.40, it may be, for example, any one of 0.22, 0.32, 0.34, 0.50, or 1.40, or may be within a range having any one of these as an upper limit and another one as a lower limit.
  • the composition (13-3) according to the first embodiment is a composition in which the apparent density (without tapping) (g/cm 3 ) of the powder particles is 0.10 to 1.40.
  • the apparent density (without tapping) is preferably 0.20 to 1.40, more preferably 0.22 to 1.40.
  • the apparent density (without tapping) of the powder particles is 0.22 to 1.40, it may be, for example, any one of 0.22, 0.32, 0.34, 0.50, or 1.40, or may be within a range having any one of these as an upper limit and another one as a lower limit.
  • the composition (13-4) according to the first embodiment is a composition in which the apparent density (without tapping) (g/cm 3 ) of the powder particles is 0.10 to 1.40.
  • the apparent density (without tapping) is preferably 0.20 to 1.40, more preferably 0.22 to 1.40.
  • the apparent density (without tapping) of the powder particles is 0.22 to 1.40, it may be, for example, any one of 0.22, 0.32, 0.34, 0.50, or 1.40, or may be within a range having any one of these as an upper limit and another one as a lower limit.
  • composition having an apparent density (without tapping) (g/cm 3 ) of 0.10 to 5.00 or 0.10 to 1.40 is easier to fill into a composition bag or a tablet molding machine, making it easier to improve productivity.
  • composition (14-1) according to the first embodiment has a compressibility of 1.0 to 1.5.
  • the compressibility may be 1.0 or more and less than 1.4, or 1.0 to 1.3.
  • the compression degree is 1.0 to 1.5, it may be, for example, any of 1.0, 1.1, 1.2, 1.3, 1.4, or 1.5, or may be within a range with any one of these as the upper limit and another one as the lower limit.
  • composition (14-2) according to the first embodiment is a composition having a compressibility of 1.4 or more.
  • the compressibility is preferably 1.4 to 2.0, more preferably 1.4 to 1.6, and may be greater than 1.5 and not greater than 1.6.
  • the compression degree is 1.4 to 1.6, it may be, for example, 1.4, 1.5, or 1.6, or may be within a range with one of these as the upper limit and another as the lower limit.
  • composition (14-3) according to the first embodiment is a composition having a degree of compression of 1.4 or more.
  • the compressibility is preferably 1.4 to 2.0, more preferably 1.4 to 1.6, and may be more than 1.5 and not more than 1.6.
  • the compression degree is 1.4 to 1.6, it may be, for example, 1.4, 1.5, or 1.6, or may be within a range with one of these as the upper limit and another as the lower limit.
  • composition (14-4) according to the first embodiment is a composition having a degree of compression of 1.4 or more.
  • the compressibility is preferably 1.4 to 2.0, more preferably 1.4 to 1.6, and may be greater than 1.5 and not greater than 1.6.
  • the compression degree is 1.4 to 1.6, it may be, for example, 1.4, 1.5, or 1.6, or may be within a range with one of these as the upper limit and another as the lower limit.
  • a composition having a compressibility of 1.0 to 1.5 makes it easier to load and transport the bag in which the composition is packaged.
  • a low degree of compression of the composition means that the powder layer is less likely to change when the powder particles contained in the composition or tablet are subjected to vibration. When the degree of compression of the composition is low, it becomes easier to fill a composition bag or a tablet molding machine, and productivity can be easily improved.
  • composition (15-1) according to the first embodiment is a composition having an angle of repose (°) of less than 57.0.
  • the angle of repose (°) of the composition is preferably 40.0 to 56.0, more preferably 45.0 to 50.0, and even more preferably 46.9 to 48.3.
  • the angle of repose (°) is 46.9 to 48.3, it may be, for example, any of 46.9, 47.1, 47.3, 47.5, 47.7, 47.9, 48.1, or 48.3, or may be within a range with one of these as the upper limit and another of these as the lower limit.
  • composition (15-2) according to the first embodiment is a composition having an angle of repose (°) of 57.0 or more.
  • the angle of repose (°) of the composition is preferably 57.0 to 70.0, more preferably 57.0 to 60.0, and even more preferably 57.0 to 59.1.
  • the angle of repose (°) is 57.0 to 59.1, it may be, for example, any of 57.0, 57.8, 58.3, 58.7, or 59.1, or may be within a range with one of these as the upper limit and another as the lower limit.
  • composition (15-3) according to the first embodiment is a composition having an angle of repose (°) of 57.0 or more.
  • the angle of repose (°) of the composition is preferably 57.0 to 70.0, more preferably 57.0 to 60.0, and even more preferably 57.0 to 59.1.
  • the angle of repose (°) is 57.0 to 59.1, it may be, for example, any of 57.0, 57.8, 58.3, 58.7, or 59.1, or may be within a range with one of these as the upper limit and another as the lower limit.
  • composition (15-4) according to the first embodiment is a composition having an angle of repose (°) of 57.0 or more.
  • the angle of repose (°) of the composition is preferably 57.0 to 70.0, more preferably 57.0 to 60.0, and even more preferably 57.0 to 59.1.
  • the angle of repose (°) is 57.0 to 59.1, it may be, for example, any of 57.0, 57.8, 58.3, 58.7, or 59.1, or may be within a range with any one of these as the upper limit and another one as the lower limit.
  • a small angle of repose indicates that the powder particles contained in the composition or tablet are smooth and friction between the powder particles is unlikely to occur. If the angle of repose is small, the composition or tablet is less likely to remain in the mouth when administered orally, and/or the composition is more likely to pass through easily during swallowing, i.e., be easier to swallow, and/or have a good texture on the tongue. Thus, for example, a composition having an angle of repose (°) of less than 57.0, or a tablet containing said composition, is likely to be easier to swallow and/or provide a good mouthfeel. Furthermore, when the angle of repose is small, the powder particles are smooth and friction between the powder particles is unlikely to occur, so the composition is easily compacted. For example, a composition containing particles with an angle of repose (°) of less than 57.0 is easy to fill into a composition bag or a tablet molding machine, and productivity is easily improved.
  • composition (16-1) according to the first embodiment is a composition having a collapse angle (°) of greater than 31.8.
  • the collapse angle (°) is preferably 32.0 or more, more preferably 32.0 to 44.0, more preferably 32.0 to 40.0, and even more preferably 33.2 to 35.9.
  • the collapse angle (°) is 33.2 to 35.9, it may be, for example, any of 33.2, 33.6, 34.0, 34.4, 34.8, 35.3, 35.6, or 35.9, or may be within a range with one of these as the upper limit and another of these as the lower limit.
  • composition (16-2) according to the first embodiment is a composition having a collapse angle (°) of 31.8 or less.
  • the collapse angle (°) is preferably 20.0 to 31.8, more preferably 25.0 to 31.8, more preferably 29.9 to 31.8.
  • the collapse angle (°) is 29.9 to 31.8, it may be, for example, any of 29.9, 30.3, 30.6, 31.1, or 31.8, or may be within a range with one of these as the upper limit and another as the lower limit.
  • composition (16-3) according to the first embodiment is a composition having a collapse angle (°) of 31.8 or less.
  • the collapse angle (°) is preferably 20.0 to 31.8, more preferably 25.0 to 31.8, more preferably 29.9 to 31.8.
  • the collapse angle (°) is 29.9 to 31.8, it may be, for example, any of 29.9, 30.3, 30.6, 31.1, or 31.8, or may be within a range with one of these as the upper limit and another as the lower limit.
  • composition (16-4) according to the first embodiment is a composition having a collapse angle (°) of 36.0 or more.
  • the collapse angle (°) is preferably 36.0 to 50.0, more preferably 36.0 to 45.0.
  • the collapse angle (°) is between 36.0 and 45.0, it may be 45.0, for example.
  • the composition or tablet is less likely to remain in the mouth when orally administered, and/or the composition is more likely to pass through smoothly during swallowing, i.e., be easy to swallow, and/or have a good texture on the tongue.
  • the larger the collapse angle the smaller the "difference angle” tends to be.
  • a small “difference angle” means that the powder layer is less likely to change when the powder particles contained in the composition or tablet are vibrated, and the composition is more likely to be compacted.
  • a composition with a collapse angle (°) of more than 31.8 is more easily filled into a composition bag or a tablet molding machine, making it easier to improve productivity.
  • the larger the collapse angle the lower the dispersibility (degree of fluffiness) of the composition and the easier it is to handle.
  • the dispersibility (degree of fluffiness) of the composition is likely to be low and the easier it is to handle.
  • the larger the collapse angle the easier it is to compact the composition.
  • the collapse angle of the composition is greater than 31.8, the composition can be easily filled into a composition bag or a tablet molding machine, which makes it easier to improve productivity.
  • the composition (17-1) according to the first embodiment is a composition in which the difference angle (°) between the angle of repose and the angle of collapse (angle of repose - angle of collapse) (hereinafter also referred to as the "difference angle”) is less than 25.2.
  • the difference angle (°) is preferably 10.0 to 25.0, more preferably 10.0 to 20.0, and even more preferably 12.3 to 13.7.
  • the angle difference (°) is 12.3 to 13.7, it may be, for example, any of 12.3, 12.5, 12.7, 12.9, 13.1, 13.3, 13.5, or 13.7, or it may be a range with any one of these as the upper limit and another one as the lower limit.
  • composition (17-2) according to the first embodiment is a composition having a difference angle (°) of 25.2 or more.
  • the difference angle (°) is preferably 25.2 to 30.0, more preferably 25.2 to 29.2.
  • the angle difference (°) is 25.2 to 29.2, it may be, for example, 25.2, 26.7, 27.7, 28.5, or 29.2, or it may be a range with one of these as the upper limit and another as the lower limit.
  • composition (17-3) according to the first embodiment is a composition having a difference angle (°) of 25.2 or more.
  • the difference angle (°) is preferably 25.2 to 30.0, more preferably 25.2 to 29.2.
  • the angle difference (°) is 25.2 to 29.2, it may be, for example, 25.2, 26.7, 27.7, 28.5, or 29.2, or it may be a range with one of these as the upper limit and another as the lower limit.
  • composition (17-4) according to the first embodiment is a composition having a difference angle (°) of less than 25.2.
  • the difference angle (°) is preferably 10.0 to 25.0, more preferably 10.0 to 20.0, and even more preferably 12.0 to 14.1.
  • the angle difference (°) is 12.0 to 14.1, it may be, for example, 12.0, 12.8, 13.3, 13.7, or 14.1, or may be a range with any one of these as the upper limit and another one as the lower limit.
  • a small difference angle (°) indicates that the powder particles contained in the composition or tablet are smooth and friction between the powder particles is unlikely to occur. If the difference angle is small, the composition or tablet is less likely to remain in the mouth when administered orally, and/or the composition is more likely to pass through easily during swallowing, i.e., be easier to swallow, and/or have a good texture on the tongue. For example, a composition having a difference angle (°) of less than 25.0, or a tablet containing the composition, is likely to be easier to swallow and/or provide a good mouthfeel. Furthermore, when the difference angle is small, when the powder particles contained in the composition or tablet are subjected to vibration, the powder layer is less likely to change and the composition is more likely to be compacted. For example, a composition having a difference angle (°) of less than 25.0 is more likely to be filled into a composition bag or a tablet molding machine, which makes it easier to improve productivity.
  • the composition (18-1) according to the first embodiment is a composition in which the stress (kN/m 2 ) of a tablet containing the composition at a moving strain rate of 10% is 1809 to 2405 kN/m 2 .
  • the stress (kN/m 2 ) at a moving strain rate of 10% is 1809 to 2405, it may be, for example, any of 1809, 1810, 1811, 1812, 1813, 1814, 1815, 1816, 1817, 1900, 1901, 1943, 1944, 2026, 2068, 2069, 2152, 2153, 2235, 2277, 2360, 2361, 2402, 2403, 2404, or 2405, or it may be a range with one of these as the upper limit and another as the lower limit.
  • the composition (18-2) according to the first embodiment is a composition in which the stress (kN/m 2 ) of a tablet containing the composition at a moving strain rate of 10% is 1859 to 2319 kN/m 2 .
  • the stress (kN/m 2 ) at a moving strain rate of 10% is 1859 to 2319, it may be, for example, any of 1859, 1985, 2110, 2193, 2227, 2260, 2294, 2295, 2296, 2297, 2298, 2299, 2300, or 2319, or it may be a range with one of these as the upper limit and another as the lower limit.
  • the composition (18-3) according to the first embodiment is a composition in which the stress (kN/m 2 ) of a tablet containing the composition at a moving strain rate of 10% is 1567 to 1776 kN/m 2 .
  • the stress (kN/m 2 ) at a moving strain rate of 10% is 1567 to 1776, it may be, for example, 1567, 1692, or 1776, or it may be within a range with one of these as the upper limit and another as the lower limit.
  • the composition (18-4) according to the first embodiment is a composition in which the stress (kN/m 2 ) of a tablet containing the composition at a moving strain rate of 10% is 1483 to 2528 kN/m 2 .
  • the stress (kN/m 2 ) at a moving strain rate of 10% is 1483 to 2528, it may be, for example, any of 1483, 1525, 1609, 1650, 1734, 2444, or 2528, or may be within a range with one of these as the upper limit and another as the lower limit.
  • the composition (19-1) according to the first embodiment is a composition in which the stress (kN/m 2 ) of a tablet containing the composition at a moving strain rate of 18% is less than 1846 kN/m 2 .
  • the stress (kN/m 2 ) at a moving strain rate of 18% is preferably 500 to 1,845, more preferably 1,000 to 1,500, even more preferably 1,000 to 1,200, and still more preferably 1,000 to 1,100.
  • the stress (kN/m 2 ) at a moving strain rate of 18% is 1000 to 1100, it may be 1069, for example.
  • the composition (19-2) according to the first embodiment is a composition in which the stress (kN/m 2 ) of a tablet containing the composition exceeds 1069 at a moving strain rate of 18%.
  • the stress (kN/m 2 ) at a moving strain rate of 18% is preferably 1,100 to 2,500, more preferably 1,200 to 2,000, and even more preferably 1,500 to 2,000.
  • the stress (kN/m 2 ) at a moving strain rate of 18% is 1500 to 2000, it may be 1846, for example.
  • the composition (19-3) according to the first embodiment is a composition in which the stress (kN/m 2 ) of a tablet containing the composition at a moving strain rate of 18% exceeds 1069.
  • the stress (kN/m 2 ) at a moving strain rate of 18% is preferably 1,100 to 2,500, more preferably 1,200 to 2,000, and even more preferably 1,500 to 2,000.
  • the stress (kN/m 2 ) at a moving strain rate of 18% is 1500 to 2000, it may be 1846, for example.
  • the composition (19-4) according to the first embodiment is a composition in which the stress (kN/m 2 ) of a tablet containing the composition at a moving strain rate of 18% is 500 to 2500.
  • the stress (kN/m 2 ) at a moving strain rate of 18% is preferably 1,000 to 2,000, more preferably 1,069 to 1,846.
  • the stress (kN/m 2 ) at a moving strain rate of 18% is 1069 to 1846, it may be 1069 or 1846, for example.
  • Composition (20-1) is a composition in which the stress resistance (%) of a tablet containing the composition (the ratio (%) of stress (kN/m 2 ) at a moving strain rate of 18% to stress (kN/m 2 ) at a moving strain rate of 10% (100 x (stress (kN/m 2 ) at a moving strain rate of 18%)/(stress (kN/m 2 ) at a moving strain rate of 10%)) is less than 62.
  • the stress resistance (%) of a tablet containing the composition is preferably 20 or more and less than 62, more preferably 30 or more and less than 62, even more preferably 40 to 61, even more preferably 41 to 61, even more preferably 42 to 60, and even more preferably 44 to 59.
  • the stress tolerance (%) is 44 to 59, it may be, for example, any of 44, 45, 47, 48, 50, 52, 53, 55, 56, or 59, or it may be a range with any one of these as the upper limit and another one as the lower limit. may be.
  • Composition (20-2) according to the first embodiment is a composition in which the stress resistance (%) of a tablet containing the composition is greater than 76 and less than 104.
  • the stress resistance (%) is preferably 77 to 100, more preferably 80 to 99.
  • the stress tolerance (%) is 80 to 99, it may be, for example, any of 80, 82, 83, 84, 88, 93, or 99, or it may be within a range with any one of these as the upper limit and another one as the lower limit.
  • Composition (20-3) according to the first embodiment is a composition in which the stress resistance (%) of a tablet containing the composition exceeds 99.
  • the stress resistance (%) is preferably 100 to 130, more preferably 100 to 120, and even more preferably 104 to 118.
  • the stress tolerance (%) is 104 to 118, it may be, for example, 104, 109, or 118, or may be within a range having one of these as the upper limit and another as the lower limit.
  • Composition (20-4) according to the first embodiment is a composition in which the stress resistance (%) of a tablet containing the composition is greater than 59 and less than 80.
  • the stress resistance (%) is preferably 60-79, more preferably 62-76.
  • the stress tolerance (%) is 62 to 76, it may be, for example, any of 62, 65, 66, 70, 72, 73, or 76, or it may be within a range with any one of these as the upper limit and another as the lower limit.
  • composition (21-1) according to the first embodiment is a composition having a degree of dispersion (%) of less than 44.
  • the degree of dispersion is preferably 40 or less, more preferably 30 or less, even more preferably 22 or less, and even more preferably 17 to 22.
  • the dispersity is 18 to 22, it may be, for example, any of 17, 18, 19, 20, 21, and 22, and may be within a range having one of these as the upper limit and another as the lower limit.
  • composition (21-2) according to the first embodiment is a composition having a degree of dispersion (%) of 44 to 49.
  • the degree of dispersion is preferably 45-48, more preferably 46-47.
  • the dispersity is 46 to 47, it may be 46 or 47, for example.
  • composition (21-3) according to the first embodiment is a composition having a degree of dispersion (%) of 44 to 49.
  • the dispersity when the dispersity is 44 to 49, it may be, for example, 44, 45, 46, 47, 48, or 49, or it may be within a range with one of these as the upper limit and another as the lower limit.
  • Composition (21-4) according to the first embodiment is a composition having a degree of dispersion (%) of less than 17.
  • the degree of dispersion is preferably 5 to 15, more preferably 7 to 10, and even more preferably 9 to 10.
  • the dispersity is 9 to 10, it may be 9 or 10, for example.
  • a composition with a low degree of dispersion (%) is less powdery and tends to be easier to handle. Therefore, for example, a composition having a dispersity of less than 44, preferably 22 or less, more preferably less than 17 tends to be easy to handle.
  • compositions (22-1) to (22-4) according to the first embodiment are compositions whose weight retention rate determined by thermogravimetric analysis when heated from 25°C to 100°C is 50% to 98%, preferably 90% to 98%.
  • compositions (23-1) to (23-4) according to the first embodiment are compositions whose weight retention rate determined by thermogravimetric analysis when heated from 25°C to 200°C is 50% to 98% and preferably 80% to 97%.
  • the composition (24-1) according to the first embodiment is a composition whose weight retention rate, determined by thermogravimetric analysis when heated from 25°C to 300°C, is 50% or more and 98% or less, preferably 65% to 95%.
  • compositions (24-2) to (24-4) according to the first embodiment are compositions whose weight retention rate determined by thermogravimetric analysis when heated from 25°C to 300°C is 50% to 98% and preferably 90% to 95%.
  • the composition (25-1) according to the first embodiment is a composition whose weight retention rate, as determined by thermogravimetric analysis when heated from 25°C to 400°C, is 5% or more and 80% or less, preferably 8% to 68%.
  • compositions (25-2) to (25-4) according to the first embodiment are compositions whose weight retention rate, determined by thermogravimetric analysis when heated from 25°C to 400°C, is 5% to 50%, preferably 8% to 35%.
  • the composition (26-1) according to the first embodiment is a composition in which the weight retention rate determined by thermogravimetric analysis when heated from 25°C to 500°C is 5% or more and 70% or less, preferably 5% to 45%.
  • compositions (26-2) to (26-4) according to the first embodiment are compositions whose weight retention rate determined by thermogravimetric analysis when heated from 25°C to 500°C is 5% to 50%, preferably 5% to 35%.
  • the composition (27-1) according to the first embodiment is a composition in which the weight retention rate determined by thermogravimetric analysis when heated from 25°C to 600°C is 5% or more and 50% or less, preferably 5% to 45%.
  • compositions (27-2) to (27-4) according to the first embodiment are compositions whose weight retention rate, determined by thermogravimetric analysis when heated from 25°C to 600°C, is 5% to 50%, preferably 5% to 45%.
  • the composition (28-1) according to the first embodiment is a composition whose electromotive force when heated from 25°C to 100°C is between -10 ⁇ V and 0 ⁇ V, preferably between -8 ⁇ V and -1 ⁇ V.
  • compositions (28-2) to (28-4) according to the first embodiment are compositions that have an electromotive force of -5 ⁇ V or more and 0 ⁇ V or less when heated from 25°C to 100°C, and preferably -3 ⁇ V to -1 ⁇ V.
  • the composition (29-1) according to the first embodiment is a composition whose electromotive force when heated from 25°C to 200°C is -10 ⁇ V or more and 0 ⁇ V or less, preferably -8 ⁇ V to -1 ⁇ V.
  • compositions (29-2) to (29-4) according to the first embodiment are compositions that exhibit an electromotive force of -5 ⁇ V or more and 0 ⁇ V or less when heated from 25°C to 200°C, preferably -3 ⁇ V to -1 ⁇ V.
  • the composition (30-1) according to the first embodiment is a composition whose electromotive force when heated from 25°C to 300°C is -10 ⁇ V or more and 5 ⁇ V or less, preferably -8 ⁇ V to 3 ⁇ V.
  • compositions (30-2) to (30-4) according to the first embodiment are compositions that exhibit an electromotive force of -10 ⁇ V or more and 0 ⁇ V or less when heated from 25°C to 300°C, preferably -8 ⁇ V to 0 ⁇ V.
  • the composition (31-1) according to the first embodiment is a composition whose electromotive force when heated from 25°C to 400°C is -10 ⁇ V or more and 15 ⁇ V or less, preferably -10 ⁇ V to 10 ⁇ V.
  • compositions (31-2) to (31-4) according to the first embodiment are compositions that have an electromotive force of -10 ⁇ V or more and 0 ⁇ V or less when heated from 25°C to 400°C, and preferably -10 ⁇ V to -5 ⁇ V.
  • the composition (32-1) according to the first embodiment is a composition whose electromotive force when heated from 25°C to 500°C is -10 ⁇ V or more and 20 ⁇ V or less, preferably -10 ⁇ V to 15 ⁇ V.
  • compositions (32-2) to (32-4) according to the first embodiment are compositions that have an electromotive force of -10 ⁇ V or more and 0 ⁇ V or less when heated from 25°C to 500°C, and preferably -10 ⁇ V to -3 ⁇ V.
  • the composition (33-1) according to the first embodiment is a composition whose electromotive force when heated from 25°C to 600°C is -10 ⁇ V or more and 20 ⁇ V or less, preferably -8 ⁇ V to 18 ⁇ V.
  • compositions (33-2) to (33-4) according to the first embodiment are compositions that have an electromotive force of -10 ⁇ V or more and 5 ⁇ V or less when heated from 25°C to 600°C, and preferably -8 ⁇ V to 3 ⁇ V.
  • compositions (34-1) to (34-4) according to the first embodiment are compositions containing a heat-resistant material, a semi-heat-resistant material, and/or a non-heat-resistant material.
  • a “heat-resistant substance” is a substance that remains at 400°C or higher when a composition containing it is heated from room temperature (25°C).
  • a “non-heat-resistant substance” is a substance that disappears at a temperature below 300°C when a composition containing it is heated from room temperature (25°C).
  • a “semi-heat-resistant substance” is a substance that disappears between 300°C and 400°C when a composition containing it is heated from room temperature (25°C).
  • compositions (34-1) to (34-4) contain a heat-resistant material, a quasi-heat-resistant material, and/or a non-heat-resistant material.
  • the composition contains two or more of a heat-resistant material, a quasi-heat-resistant material, and a non-heat-resistant material. More preferably, the composition contains a heat-resistant material, a quasi-heat-resistant material, and a non-heat-resistant material.
  • heat-resistant materials, quasi-heat-resistant materials, and non-heat-resistant materials are as follows:
  • Non-limiting examples of heat-resistant substances include inorganic substances.
  • the inorganic substances are not limited as long as they are acceptable for food compositions or pharmaceutical compositions, and non-limiting examples include magnesium aluminium silicate, magnesium aluminum silicate, magnesium hydroxide, dry sodium carbonate, sodium hydroxide, sodium bicarbonate, sodium carbonate hydrate, Fe—Mg hydrotalcite-like compounds, and Al—Mg hydrotalcite-like compounds.
  • the heat-resistant substance may be one type or a combination of two or more types.
  • compositions (34-1) to (34-4) contain naturally occurring components such as plant-derived cellulose
  • examples of the heat-resistant substance may also include inorganic substances contained in the naturally occurring components. In order to adjust the content of inorganic substances, naturally occurring components such as cellulose with an adjusted content of inorganic substances may also be used.
  • Non-limiting examples of semi-thermostable substances include highly crystalline substances.
  • Highly crystalline substances include polymeric carbohydrates.
  • Polymeric carbohydrates are polysaccharides (including oligosaccharides), and non-limiting examples include starch, glycogen, cellulose, etc., which are formed by the polymerization of D-glucose, chitin, which is formed by the polymerization of N-acetylglucosamine, and chitosan, which is formed by deacetylating chitin.
  • Polymeric carbohydrates are not limited by their function or role, and may be carbohydrates that perform or are involved in any function, such as energy storage (starch, glycogen, etc.), biological shaping, immunity, intercellular communication, etc.
  • the semi-thermostable substance may be cellulose, or cellulose and one or more of the above-mentioned components.
  • the semi-thermostable substance may be one type or a combination of two or more types.
  • Non-limiting examples of non-heat-resistant substances include proteins and low-molecular-weight carbohydrates.
  • Low-molecular-weight carbohydrates are monosaccharides, and monosaccharides are not limited by the number of carbon atoms in the carbon chain structure of trioses, tetraoses, pentoses, or hexoses, and may include aldoses with aldehyde groups (including D-glucose, D-ribose, etc.), ketoses with ketone groups (including D-fructose, etc.), etc.
  • the non-heat-resistant substance may be one type or a combination of two or more types.
  • Compositions (34-1) to (34-4) preferably contain heat-resistant materials such as ash and inorganic substances, quasi-heat-resistant materials such as cellulose and highly crystalline materials, and non-heat-resistant materials such as proteins and low-molecular-weight carbohydrates.
  • Compositions (34-1) to (34-4) preferably contain the heat-resistant material, quasi-heat-resistant material, and non-heat-resistant material in amounts of 1% by weight or more, less than 95% by weight, and 5% by weight or more, respectively. As shown in Table 1, the contents of the heat-resistant material, quasi-heat-resistant material, and non-heat-resistant material can be determined appropriately by those skilled in the art.
  • the total content of the heat-resistant material, quasi-heat-resistant material, and non-heat-resistant material is preferably 100% by weight.
  • the composition contains a heat-resistant substance, a semi-heat-resistant substance, and a non-heat-resistant substance in an amount of 1% by weight or more, less than 95% by weight, and 5% by weight or more, respectively, the composition is more likely to exhibit the effects of good ease of swallowing and/or good texture on the tongue when orally administered, and/or good filling properties, low dispersion, and/or high transportability.
  • the composition may also contain inorganic substances contained in the naturally occurring components. In order to adjust the content of inorganic substances, naturally occurring components such as cellulose with an adjusted content of inorganic substances may also be used.
  • the composition containing the heat-resistant material, the quasi-heat-resistant material, and the non-heat-resistant material in the amounts described above can be prepared by blending any amount of materials containing one or more selected from the heat-resistant material, the quasi-heat-resistant material, and the non-heat-resistant material.
  • materials containing only heat-resistant substances such as ash include titanium oxide and calcium carbonate.
  • Materials containing heat-resistant, semi-heat-resistant, and/or non-heat-resistant substances are plant-derived ingredients.
  • Plant-derived ingredients may be ingredients derived from natural plants or plant-derived ingredients prepared by processing plants, such as wheat germ, oats, crystalline cellulose (e.g., Asahi Kasei's Ceolus (registered trademark) PH grade), powdered cellulose (e.g., Nippon Paper Industries Co., Ltd.'s KC Flock W-50), soybean compositions (soybeans or soybean-derived ingredients), and truffle-derived compositions (e.g., truffle powder).
  • wheat germ, oats, crystalline cellulose, and powdered cellulose contain heat-resistant substances such as ash, semi-heat-resistant substances such as cellulose, and non-heat-resistant substances such as hemicellulose.
  • wheat germ contains 5-25 wt% of heat-resistant material, 30-70 wt% of semi-heat-resistant material, and 25-45 wt% of non-heat-resistant material.
  • oats contain 5-20 wt% of heat-resistant material, 45-75 wt% of semi-heat-resistant material, and 20-45 wt% of non-heat-resistant material.
  • crystalline cellulose (Asahi Kasei Ceolus) contains 1-10 wt% of heat-resistant material, 70-98 wt% of semi-heat-resistant material, and 0.1-5 wt% of non-heat-resistant material.
  • powdered cellulose Nippon Paper Industries Co., Ltd.
  • KC Flock W-50 contains 1-10 wt% of heat-resistant material, 70-90 wt% of semi-heat-resistant material, and 5-20 wt% of non-heat-resistant material.
  • the soybean composition contains 1 to 20% by weight of heat-resistant material, 60 to 90% by weight of semi-heat-resistant material, and 1 to 20% by weight of non-heat-resistant material.
  • truffle powder contains 0-10% by weight of heat-resistant material, 5-50% by weight of semi-heat-resistant material, and 45-95% by weight of non-heat-resistant material.
  • the specific amounts or proportions of heat-resistant substances, semi-heat-resistant substances, and/or non-heat-resistant substances contained in the plant-derived components actually used can be determined by methods well known to those skilled in the art.
  • the content of heat-resistant substances such as ash can be measured using a known ash method.
  • the content of semi-heat-resistant substances such as cellulose can be measured using a known method for quantifying alpha-cellulose.
  • the content of non-heat-resistant substances such as hemicellulose can be calculated by subtracting the value obtained by measuring alpha-cellulose from the value obtained using a known method for quantifying holocellulose. Based on these measurement results, these materials can be mixed to prepare a composition containing heat-resistant substances, semi-heat-resistant substances, and non-heat-resistant substances in the desired proportions.
  • compositions (1-1) to (1-4), (2-1) to (2-4), (3-1) to (3-4), (4-1) to (4-5), (5-1) to (5-4), (6-1) to (6-4) ), (7-1) to (7-4), (8-1) to (8-4), (9-1) to (9-4), (10-1) to (10-4), (11-1) to (11-4), (12-1) to (1 2-4), (13-1) to (13-4), (14-1) to (14-4), (15-1) to (15-4), (16-1) to (16-4), (17-1) to (17-4), (18-1) to (18-4), (19-1) to (19-4), (20-1) to (20-4), (21-1) to (21-4), (22-1) to (22-4), (23- Compositions having any one or more of the characteristics of 1) to (23-4), (24-1) to (24-4), (25-1) to (25-4), (26-1) to (26-4), (27-1) to (27-4), (28-1) to (28-4), (29-1) to (29-4), (30-1) to (30-4), (31-1) to (31-4),
  • the composition is suitable as a composition or tablet for oral administration, and based on its good filling properties, low degree of dispersion, and/or high transportability, the composition can be easily filled into a composition bag or a tablet molding machine, which makes it easy to improve productivity and/or makes the composition or tablet suitable for transport.
  • compositions (1-1) to (34-4) may be compositions having the characteristics of two or more compositions in combination.
  • the composition may have the characteristics of the composition (1-1) and one or more other compositions (one or more of the compositions (1-2) to (2-4)). More specifically, for example, the composition may have one or more characteristics of the composition (1-1) and the compositions (1-1) to (1-4), or the composition may have one or more characteristics of the composition (1-1) and the compositions (2-1) to (33-4), or the composition may have one or more characteristics of the composition (1-1) and the compositions (1-1) to (1-4), and one or more characteristics of the composition (2-1) to (34-4).
  • the composition has the characteristics of composition (1-1) or (1-2) and the characteristics of composition (4-1) or (4-4).
  • the composition tends to have good swallowability, good texture, and/or good filling properties.
  • the composition tends to have a low degree of dispersion (low degree of dusting), which makes it easy to handle.
  • the composition has the characteristics of composition (1-1) or (1-2) and the characteristics of composition (4-2) or (4-3). Tablets containing the composition tend to have high vibration resistance and therefore high transportability.
  • the composition has the characteristics of composition (1-3) or (1-4) and the characteristics of composition (4-2) or (4-3). Tablets containing the composition tend to have high vibration resistance and therefore high transportability.
  • the composition has the characteristics of composition (1-3) or (1-4) and the characteristics of composition (4-1) or (4-4).
  • the composition tends to have good packing properties.
  • the degree of dispersion low dustiness
  • the degree of dispersion tends to be low, which tends to make handling easier.
  • composition according to the first embodiment is preferably an oral composition. By using it orally, it is possible to achieve the effects of good swallowability and/or a good texture on the tongue, as described above.
  • the composition according to the first embodiment can take various forms depending on its intended use.
  • the composition is preferably in the form of a powder composition or a tablet, more preferably in the form of a tablet, because the composition according to the first embodiment is in the form of a powder composition or a tablet, and when made into a tablet, it is likely to exhibit the effects of being easy to swallow and/or having a good texture on the tongue.
  • the composition according to the first embodiment may contain or consist of the particles described above, and may be in the form of a mixture in which the particles are mixed with a liquid (e.g., a slurry), or a solution in which the particles are dissolved in a solvent.
  • the particles may not maintain the particle area, Feret diameter (vertical width and/or horizontal width), and/or aspect ratio of the particles described above in the mixture or solution.
  • a sample of the composition and ion-exchanged water are placed in a beaker (for example, 2 g of composition and 20 ml of ion-exchanged water), and the mixture is dispersed for 2 minutes using ultrasound (output 90 W), to prepare a test solution (suspension).
  • a test solution for samples with poor dispersibility, the bottle is shaken by hand and allowed to stand for 15 minutes, after which the supernatant is collected and placed in a beaker together with ion-exchanged water.
  • the sample concentration is adjusted to 10% by weight before use.
  • a sample suspension of the composition is formed into a flat sample flow using sheath liquid using the flat sheath flow method, and particles are captured as still images by irradiating them with strobe light.
  • Particle parameters and particle shape parameters are obtained through image analysis. Measurement conditions are standard lens magnification (10x), measurement range 0.5 to 300 ⁇ m, and number of detected particles 10,000. The detected particles are considered to be particles in the composition of this embodiment. Particles may also include air bubbles generated in the solvent.
  • the particle area ( ⁇ m 2 ) represents the area of a particle, and is the average value of the values of 1,000 smallest particles out of 10,000 particles measured.
  • the Feret diameter (vertical width and horizontal width) and particle area can be adjusted by adjusting the grinding time, grinding intensity, etc. in the grinding process of the material components when preparing the composition.
  • the particle area, Feret diameter (vertical width), and/or Feret diameter (horizontal width) of the particles can be increased by reducing the number of grinding processes, shortening the grinding time, and/or weakening the grinding intensity.
  • the aspect ratio is calculated from the values of the Feret diameter (vertical width) and the Feret diameter (horizontal width), and therefore can be adjusted by adjusting the Feret diameter (vertical width and horizontal width). In other words, the aspect ratio can be adjusted by adjusting the grinding time, grinding intensity, etc. in the grinding process of the material components when preparing the composition.
  • the "Feret diameter (vertical width and horizontal width)" and “particle area” may be measured independently; that is, the Feret diameter (vertical width and horizontal width) and particle area may be values based on measurements of different particles. Therefore, the trend in particle area and the trend in Feret diameter (vertical width and/or horizontal width) may not necessarily match within the same sample or the same sample group.
  • a larger BS value means that the light is being reflected or scattered more by the scattering medium, and when measuring suspensions in water, a large value generally indicates a high concentration of dispersed particles.
  • the bottom surface means the bottom surface of the test bottle.
  • the rate and degree of sedimentation can be adjusted by adjusting the particle area and/or the aspect ratio of the particles. Methods for adjusting the particle area and aspect ratio are as explained in the "Particle Parameters" section above.
  • Powder water absorption can be adjusted by adjusting the particle area, Feret diameter (vertical width), and/or Feret diameter (horizontal width). Specifically, increasing the particle area, Feret diameter (vertical width), or Feret diameter (horizontal width), or increasing the Feret diameter (vertical width) and Feret diameter (horizontal width), makes it easier to improve powder water absorption.
  • the particle area, Feret diameter (vertical width), and Feret diameter (horizontal width) of the particles can be adjusted by adjusting the grinding time, grinding intensity, etc., in the grinding process of the material components when preparing the composition. Specifically, the particle area, Feret diameter (vertical width), and/or Feret diameter (horizontal width) of the particles can be increased by reducing the number of grinding processes, shortening the grinding time, and/or weakening the grinding intensity.
  • the tablet hardness (tablet hardness) (N) is a value measured using a hardness tester (model number: KHT-40N, Fujiwara Seisakusho).
  • a tablet manufactured by the method described in the section "Composition and tablet manufacturing method” is placed on the center of the measuring table, and the device is started (the AUTO [start] button is pressed). This causes the rod to descend at high speed, and the display goes into a peak hold state. When the rod comes into contact with the object to be measured, the speed slows down and the display is monitored approximately every 0.1 seconds. If there is no increase, it is determined to have broken, and the hardness indicated on the hardness tester at that time is taken as the tablet hardness (N).
  • the disintegration time in water is a value obtained by placing a tablet (250 mg) containing the composition (including cases where the tablet consists of the composition) in a test tube, adding 20 ml of pure water, shaking the tablet at 37°C in a shaker (reciprocating/rotating shaker MMS-3020, manufactured by Tokyo Rikakikai), and measuring the disintegration time. The measurement was performed 50 times, and the average value was taken as the disintegration time (minutes) of the tablet in water. Disintegration in water was determined when no agglomerates of 1 mm3 or more were found.
  • the disintegration time of a tablet in water is expressed as the disintegration time per unit hardness [disintegration time in water (D) / tablet hardness (N) (min/N)].
  • the disintegration time in water and tablet hardness can be adjusted by adjusting the particle area, Feret diameter (vertical width) and/or Feret diameter (horizontal width). Specifically, increasing the particle area, Feret diameter (vertical width) or Feret diameter (horizontal width), or both, makes it easier to improve the disintegration time in water and/or tablet hardness.
  • the particle area, Feret diameter (vertical width), and Feret diameter (horizontal width) can be adjusted by adjusting the grinding time, grinding strength, etc., in the grinding step of the material components when preparing the composition. Specifically, the particle area, Feret diameter (vertical width), and/or Feret diameter (horizontal width) can be increased by reducing the number of grinding steps, shortening the grinding time, and/or weakening the grinding strength.
  • the “frictional force of the wet powder” is the frictional force (%) of the wet powder when it has moved 2 mm ( ⁇ when the moving distance is zero).
  • the frictional force of the wet powder was measured by passing the residue of the sample used in the above-mentioned "disintegrability in water” test through a 90 ⁇ m (JIS standard Z8801 wire), recovering it, and measuring it using a static and dynamic friction measuring device ("Handy Tribomaster TL201Ts" manufactured by Trinity Lab) under the measurement conditions of a load of 50 g and a speed of 10 mm/sec.
  • the contactor used was a 5 mm thick sponge sheet ("Gap Tape N-1" manufactured by Cemedine) with artificial skin (“Bioskin” manufactured by Viewlux) attached.
  • the frictional force of a wet powder can be adjusted by adjusting the particle area, Feret diameter (vertical width), and/or Feret diameter (horizontal width). Specifically, increasing the particle area, Feret diameter (vertical width), or Feret diameter (horizontal width), or increasing the Feret diameter (vertical width) and Feret diameter (horizontal width), makes it easier to improve the frictional force of a wet powder.
  • the particle area, Feret diameter (vertical width), and Feret diameter (horizontal width) of a particle can be adjusted by adjusting the grinding time, grinding intensity, etc., in the grinding process of the material components when preparing the composition. Specifically, the particle area, Feret diameter (vertical width), and/or Feret diameter (horizontal width) of a particle can be increased by reducing the number of grinding processes, shortening the grinding time, and/or weakening the grinding intensity.
  • the tapped apparent density (g/cm 3 ) of the composition is a value measured using a commercially available powder property measuring instrument (Hosokawa Micron, Powder Tester PT-X). Specifically, all powder particles contained in the composition are filled into a 100 cm 3 cup, tapped 250 times per minute, and then the volume of the cup is determined by dividing the weight of the powder sample filled in the cup by the volume of the powder sample.
  • the tapped apparent density of the composition can be adjusted by adjusting the Feret diameter and/or shape of the particles.
  • the tapped apparent density of powder particles can be increased by reducing the particle area and/or particle diameter (Feret diameter (vertical width or horizontal width)) or the aspect ratio.
  • the apparent density (without tapping) (g/ cm3 ) of the composition is determined by roughly filling a 100 cm3 glass measuring cylinder with the composition using a quantitative feeder or the like for 2 to 3 minutes, then leveling the top surface of the powder layer with a soft brush such as a paintbrush to read the volume, and dividing the weight of the powder sample by the volume. The weight of the powder is appropriately determined so that the volume is approximately 70 to 100 cm3 .
  • the apparent density (untapped) of the composition can be adjusted by adjusting the Feret diameter and/or shape of the particles.
  • the apparent density (untapped) of the powder particles can be increased by reducing the particle area and/or particle diameter (Feret diameter (vertical width or horizontal width)) or the aspect ratio.
  • the loose bulk density is a value measured using a commercially available powder property measuring instrument (Hosokawa Micron, Powder Tester PT-X). Specifically, a sample of the composition is dropped through a chute, filled into a cup, and the surface is leveled off, and the weight of the powder layer filled in the cup is then divided by the volume of the cup to determine the value.
  • Hosokawa Micron, Powder Tester PT-X powder property measuring instrument
  • the packed bulk density is a value measured using a commercially available powder property measuring instrument (Hosokawa Micron, Powder Tester PT-X). Specifically, a sample of the composition is dropped through a chute, and the cup is filled with the sample while tapping the cup at a rate of 250 times per minute. After the surface is leveled, the value is determined by dividing the weight of the powder layer filled in the cup by the volume of the cup.
  • the loose bulk density and/or packed bulk density of the composition can be adjusted by adjusting the Feret diameter and/or shape of the particles.
  • the loose bulk density and/or packed bulk density can be increased by reducing the particle area and/or particle diameter (Feret diameter (vertical width or horizontal width)) or the aspect ratio.
  • the degree of compression can be adjusted by adjusting the loose bulk density and/or the packed bulk density.
  • the angle of repose of the composition is a value measured using a commercially available powder property measuring instrument (Powder Tester PT-X model, manufactured by Hosokawa Micron Co., Ltd.). Specifically, the inclination angle ( ⁇ 1) of the peak formed when a sample of the composition is supplied onto a circular table through a funnel is read, and the angle is calculated to be the angle of repose (°).
  • the angle of repose of a composition can be adjusted by adjusting the aspect ratio of the particles contained in the composition.
  • the angle of repose can be reduced by reducing the aspect ratio.
  • the method for adjusting the aspect ratio is as explained in the "Particle Parameters" section above.
  • the collapse angle of the composition is a value measured using a commercially available powder property measuring instrument (Hosokawa Micron, Powder Tester PT-X Model). Specifically, the peaks forming the angle of repose are impacted three times with a special shocker (attached to the powder tester), the inclination angle ( ⁇ 2) of the peaks when collapsed is read, and the angle is calculated to be the collapse angle (°).
  • the collapse angle of the composition can be adjusted by adjusting the particle area, aspect ratio, Feret diameter (vertical width), Feret diameter (horizontal width), frictional force of the wet powder, and/or powder water absorption rate of the particles contained in the composition.
  • the methods for adjusting the particle area, aspect ratio, and Feret diameter (vertical width and horizontal width) are as described above in the section "Particle parameters," the method for adjusting the frictional force of the wet powder is as described above in the section “Frictional force of the wet powder,” and the method for adjusting the powder water absorption is as described above in the section "Powder water absorption.”
  • the difference angle can be adjusted by adjusting the angle of repose and angle of collapse of the composition.
  • the method for adjusting the angle of repose and angle of collapse is as explained above.
  • the degree of dispersion can be adjusted by adjusting the particle area and/or aspect ratio of the particles contained in the composition. For example, the degree of dispersion can be reduced by increasing the particle area. Alternatively, the degree of dispersion can be reduced by decreasing the aspect ratio. Methods for adjusting the particle area and aspect ratio are as explained above in the "Particle Parameters" section.
  • the stress resistance (%) of a tablet can be adjusted by adjusting the particle area and/or aspect ratio of the particles contained in the tablet. For example, increasing the particle area and/or aspect ratio (away from 1.0) tends to increase stress resistance.
  • the method for adjusting the particle area and aspect ratio is as explained above in the section "Particle parameters.”
  • the weight retention rate can be obtained by performing thermogravimetric analysis (TG) according to a method well known to those skilled in the art.
  • the weight residual rate is a value obtained from the residual weight of a sample (approximately 10 mg of a composition (or a food composition according to the second embodiment, a pharmaceutical composition according to the second embodiment, a cosmetic composition according to the third embodiment, a lubricant composition according to the third embodiment, or a dosage form containing any of these)) at 10°C/min from 25°C to 600°C in an N2 atmosphere using a thermal analyzer (STA300 manufactured by Hitachi High-Tech Science).
  • STA300 manufactured by Hitachi High-Tech Science
  • heat-resistant substances such as ash and inorganic substances, semi-heat-resistant substances such as cellulose and highly crystalline substances, and non-heat-resistant substances such as proteins and low-molecular-weight carbohydrates in the composition
  • weight retention rate determined by thermogravimetric analysis when the temperature is raised from 25°C to 200°C, 300°C, 400°C, 500°C, or 600°C.
  • the weight residual ratio determined by thermogravimetric analysis when the temperature is raised from 25° C. to 100° C. indicates the residual amount of components other than water adsorbed in the composition.
  • the temperature is raised to 300°C, most of the non-heat-resistant substances contained in the composition disappear (Akira Kuriyama, Materials, Vol. 16, No. 169, pp. 772-776). Therefore, the weight residual ratio determined by thermogravimetric analysis when the temperature is raised from 25°C to 200°C or from 5°C to 300°C indicates the remaining components other than the non-heat-resistant substances contained in the composition.
  • the weight loss rate when the temperature is raised from 25°C to 200°C or from 25°C to 300°C increases, and the weight residual ratio can be reduced.
  • the content of the heat-resistant substances and/or non-heat-resistant substances By increasing the content of the non-heat-resistant substances contained in the composition, the weight loss rate when the temperature is raised from 25°C to 200°C or from 25°C to 300°C increases, and the weight residual ratio can be reduced.
  • the weight residual ratio of the composition determined by thermogravimetric analysis when the temperature is raised from 25°C to 200°C is measured as described above, and the content of the non-heat-resistant substance contained in the composition can be adjusted so that the weight residual ratio is 50% or more and 96% or less, or any of the desired values listed in this specification. Furthermore, the weight residual ratio of the composition determined by thermogravimetric analysis when the temperature is raised from 25°C to 300°C is measured as described above, and the content of the non-heat-resistant substance contained in the composition can be adjusted so that the weight residual ratio is 50% or more and 90% or less, or any of the desired values listed in this specification.
  • the quasi-heat-resistant substances contained in the composition disappear between 300°C and 400°C (Maki Tadashi et al., Journal of the Chemical Society of Japan, 1975, (4), pp. 733-737). Therefore, the weight retention rate determined by thermogravimetric analysis when the temperature is raised from 25°C to 400°C or higher indicates the remaining components of the composition other than the non-heat-resistant substances (components that disappear when the temperature is raised to 300°C) and the quasi-heat-resistant substances (components that disappear between 300°C and 400°C), i.e., the heat-resistant substances.
  • Increasing the content of the non-heat-resistant substances and quasi-heat-resistant substances contained in the composition increases the weight loss rate when the temperature is raised from 25°C to 400°C, thereby reducing the weight retention rate.
  • decreasing the content of components other than the non-heat-resistant substances and quasi-heat-resistant substances contained in the composition, i.e., the heat-resistant substances can also increase the weight loss rate when the temperature is raised from 25°C to 400°C or higher, thereby reducing the weight retention rate.
  • the weight retention rate determined by thermogravimetric analysis when heated to a specified temperature for any of the compositions according to this embodiment can also be adjusted in the same manner as described above.
  • the electromotive force of a sample at a certain temperature can be obtained according to methods well known to those skilled in the art.
  • the electromotive force at a certain temperature is the electromotive force ( ⁇ V) of a sample (approximately 10 mg of a composition) at 100°C, 200°C, 300°C, 400°C, and 600°C when the sample is heated from 25°C to 600°C at a rate of 10°C/min in an N2 atmosphere using a thermal analyzer (STA300 manufactured by Hitachi High-Tech Science).
  • the electromotive force of a sample at a certain temperature can be adjusted by adjusting the content of heat-resistant materials such as ash and inorganic substances, semi-heat-resistant materials such as cellulose and highly crystalline materials, and non-heat-resistant materials such as proteins and low-molecular-weight carbohydrates in the composition.
  • heat-resistant materials such as ash and inorganic substances
  • semi-heat-resistant materials such as cellulose and highly crystalline materials
  • non-heat-resistant materials such as proteins and low-molecular-weight carbohydrates in the composition.
  • composition and tablet manufacturing method The food or pharmaceutical tablets according to this embodiment can be manufactured by methods well known to those skilled in the art.
  • the composition according to the first embodiment can be prepared using the above-described heat-resistant, semi-heat-resistant, and non-heat-resistant materials by methods well known to those skilled in the art. Specifically, the Feret diameter (vertical width) of the sample after primary pulverization is adjusted to 10 ⁇ m to 60 ⁇ m, the Feret diameter (vertical width) of the sample after secondary pulverization is adjusted to 0.5 ⁇ m to 1 ⁇ m, and the Feret diameter (vertical width) of the composition after drying is adjusted to approximately 1 ⁇ m to 3 ⁇ m and a particle area of 1 to 18 ⁇ m2.
  • the type and concentration of the sample to be pulverized and the processing conditions are not limited to the examples below.
  • preliminary pulverization, solvent substitution, granulation, and drying may be added as appropriate between each process.
  • it can be prepared as follows.
  • the material has a coarse Feret diameter (vertical width) (specifically, a size greater than approximately 10 ⁇ m), it is subjected to primary pulverization.
  • a jet mill such as the Seishin Jet Mill Pulverizer STJ-400
  • a flow rate of 2 kg/hour to 12 kg/hour preferably 12 kg/hour
  • a Feret diameter (vertical width) of approximately 10 ⁇ m to 60 ⁇ m (preferably 10 ⁇ m), yielding a powder composition.
  • each ingredient is mixed in a predetermined weight (for example, wheat germ, titanium oxide, crystalline cellulose (Asahi Kasei Ceolus (registered trademark) PH-101), powdered cellulose (Nippon Paper Industries Co., Ltd. KC Flock W-50), oats, calcium carbonate, and/or truffle powder are mixed in the weights (g) shown under "Ingredients" in Table 1 to make a total of 100 g).
  • a predetermined weight for example, wheat germ, titanium oxide, crystalline cellulose (Asahi Kasei Ceolus (registered trademark) PH-101), powdered cellulose (Nippon Paper Industries Co., Ltd. KC Flock W-50), oats, calcium carbonate, and/or truffle powder are mixed in the weights (g) shown under "Ingredients" in Table 1 to make a total of 100 g).
  • the mixed material is processed 20 times at a processing pressure of 50 MPa using, for example, a homogenizer (15M8AT manufactured by Gaulin) equipped with a normal non-destructive homogenizing valve seat (inner diameter of downstream end of hollow cylindrical convex portion/thickness of ring-shaped end face: 1.9/1) to be pulverized to a Feret diameter (vertical width) of 0.5 ⁇ m to 4.0 ⁇ m (preferably 0.5 to 1.0 ⁇ m) (secondary pulverization).
  • a homogenizer 15M8AT manufactured by Gaulin
  • a normal non-destructive homogenizing valve seat inner diameter of downstream end of hollow cylindrical convex portion/thickness of ring-shaped end face: 1.9/1
  • Feret diameter vertical width
  • 0.5 ⁇ m to 4.0 ⁇ m preferably 0.5 to 1.0 ⁇ m
  • the crushers used for crushing include cutting mills: mesh mill (manufactured by Horai Co., Ltd.), Atoms (manufactured by Yamamoto Hyakuma Manufacturing Co., Ltd.), knife mill (manufactured by Parman), cutter mill (manufactured by Tokyo Atomizer Manufacturing Co., Ltd.), CS cutter (manufactured by Mitsui Mining Co., Ltd.), rotary cutter mill (manufactured by Nara Machinery Manufacturing Co., Ltd.), pulp coarse crusher (manufactured by Zuiko Co., Ltd.), shredder (manufactured by Kobe Steel Pantech Co., Ltd.), etc.; hammer mills: jaw crusher (manufactured by Makino Co., Ltd.), hammer crusher (manufactured by Makino Sangyo Co., Ltd.); impact mills: pulverizer (manufactured by Hosokawa Micron Corporation), fine impact mill (manufactured by Hosokawa Micron Corporation
  • the materials can be mixed by a method well known to those skilled in the art, and examples of such mixers include container rotary mixers such as V-type, W-type, double cone-type, and container tuck-type mixers; agitation mixers such as high-speed agitation, universal agitation, ribbon-type, pug-type, and Nauta-type mixers; a high-speed fluid mixer, a drum mixer, and a fluidized bed mixer.
  • a container shaking mixer such as a shaker can also be used.
  • the method for dissolving or dispersing each sample constituting the composition in a medium is not particularly limited as long as it is a commonly used dissolving or dispersing method.
  • Examples of methods that may be used include stirring and mixing methods using stirring blades such as unidirectional rotation, multi-axis rotation, reciprocating inversion, up-down movement, rotation + up-down movement, and pipeline type blades of a portable mixer, a three-dimensional mixer, and a side mixer; jet-type stirring and mixing methods such as a line mixer; gas-blowing stirring and mixing methods; mixing methods using a high-shear homogenizer, a high-pressure homogenizer, an ultrasonic homogenizer, and the like; and container-shaking mixing methods using a shaker.
  • stirring blades such as unidirectional rotation, multi-axis rotation, reciprocating inversion, up-down movement, rotation + up-down movement, and pipeline type blades of a portable mixer, a three-dimensional mixer, and a side mixer
  • jet-type stirring and mixing methods such as a line mixer
  • gas-blowing stirring and mixing methods mixing methods using a high-shear homogenizer, a high-pressure homogenizer, an ultrasonic homogen
  • the composition according to the first embodiment can be granulated to produce tablets by known methods such as dry granulation, wet granulation, heat granulation, spray granulation, or microencapsulation, but it is preferable to use a wet granulation method.
  • wet granulation methods include fluidized bed granulation, agitation granulation, extrusion granulation, crushing granulation, and tumbling granulation.
  • fluidized bed granulation a binder liquid is sprayed onto fluidized powder in a fluidized bed granulator to form granules.
  • a binder liquid is added while rotating agitator blades in a mixing tank, thereby simultaneously mixing, kneading, and granulating the powder in a sealed structure.
  • extrusion granulation a wet mass kneaded by adding a binder liquid is forcibly extruded through an appropriate size screen using a screw or basket method to form granules.
  • crushing granulation a wet mass kneaded by adding a binder liquid is sheared and crushed by the rotating blades of a granulator, and then granulated by being ejected from an outer screen by the centrifugal force.
  • the material is rolled by the centrifugal force of a rotating rotor, and at this time, a binding liquid is sprayed from a spray gun, causing the material to grow into spherical granules with uniform particle size in a snowball-like manner.
  • the composition according to the first embodiment is mixed with pure water to prepare a dispersion, which is then introduced into a granulator (e.g., Granuformer (registered trademark) Gf-105, Freund Corporation) to obtain granules.
  • a granulator e.g., Granuformer (registered trademark) Gf-105, Freund Corporation
  • the granulator can also simultaneously dry the granules.
  • the dispersion can be supplied to the granulator at a rate of 2 to 6 L/hour and an inlet temperature of 150°C.
  • magnesium stearate (Taihei Chemical Industry Co., Ltd.) may be further added to the obtained granules and mixed.
  • the granules are compressed into tablets using a simple tablet molding machine (HANDTAB-100, Ichihashi Seiki Co., Ltd.) under tableting compression force to obtain tablets with a diameter of 8 mm, R12 punch tablets, and a weight of approximately 250 mg.
  • HANDTAB-100 Ichihashi Seiki Co., Ltd.
  • the granulated product can be dried using any of a variety of methods, including hot air heating (shelf drying, vacuum drying, fluidized bed drying), conduction heat transfer (pan type, tray box type, drum type), and freeze drying.
  • hot air heating method hot air is directly brought into contact with the additive, and evaporated water is simultaneously removed.
  • conduction heat transfer method the additive is indirectly heated through a heat transfer wall.
  • freeze drying the additive is frozen at a temperature of -10°C to 40°C, and then heated under high vacuum (1.3 x 10-5 MPa to 2.6 x 10-4 MPa) to sublimate and remove water.
  • high vacuum 1.3 x 10-5 MPa to 2.6 x 10-4 MPa
  • freeze drying, spray drying, drum drying, shelf drying, flash drying, and vacuum drying may be used, and one method may be used alone, or two or more methods may be used in combination.
  • the spraying method for spray drying may be any of a disk type, a pressure nozzle, a pressure two-fluid nozzle, a pressure four-fluid nozzle, etc., and one type may be used alone or two or more types may be used in combination.
  • a trace amount of a water-soluble polymer or a surfactant may be added to the dispersion in order to reduce the surface tension of the dispersion, and a foaming agent or gas may be added to the dispersion in order to accelerate the evaporation rate of the medium.
  • a solvent substitution step may be carried out as appropriate to increase the efficiency of the treatment.
  • a sample contains a large amount of hydrophilic substances, it is subjected to a substitution step in which the water, which is the dispersion medium contained in the aqueous dispersion, is substituted with, for example, the hydrophilic organic solvent described below.
  • hydrophilic organic solvents examples include alcohols (C1-4 alkanols such as methanol, ethanol, isopropanol, and 1-butanol), alkanediols (C2-4 alkanediols such as ethylene glycol, propylene glycol, and butylene glycol), cellosolves (C1-4 alkyl cellosolves such as methyl cellosolve and ethyl cellosolve), cellosolve acetates (C1-4 alkyl cellosolve acetates such as ethyl cellosolve acetate), carbitols (C1-4 alkyl carbitols such as methyl carbitol and ethyl carbitol), ketones (di-C1-4 alkyl ketones such as acetone and methyl ethyl ketone), and ethers (cyclic or chain C4-6 ethers such as dioxane and tetrahydrofuran). These solvents may be used
  • the composition according to the first embodiment can be used as a food composition.
  • the food composition according to this embodiment contains a functional ingredient.
  • the oral composition according to the first embodiment is preferably used as a food composition.
  • the food compositions can be used to prepare foods such as beverages, soups, processed meat products, processed vegetables, processed fruit products, seasonings, concentrated foods, and supplements (nutritional supplements and nutritional supplement drinks).
  • a food product according to one embodiment includes the food composition according to this embodiment.
  • processed foods refer to natural food ingredients that have been processed and/or cooked, and include frozen foods, retort foods, canned foods, bottled foods, etc.
  • the form of the food is not limited, but is preferably a form suitable for oral use, and from the viewpoint of ease of ingestion, it may be in a fluid form such as liquid, syrup, paste, gel, jelly, cream, emulsion, spray, mousse, lotion, etc., or in a solid form such as powder, granules, tablets, capsules, soft capsules, etc. Tablets may be any of orally disintegrating tablets, chewable tablets, effervescent tablets, dispersion tablets, and dissolving tablets.
  • the food tablet is preferably an orally disintegrating tablet or a chewable tablet, and more preferably an orally disintegrating tablet.
  • the functional ingredient is not limited to any ingredient that is desired to be ingested in addition to a normal diet, but it is preferable that the functional ingredient is a substance that can exert some nutritional or physiological activity or effect that is the use or purpose of the food, including the food composition, in the subject who ingests it.
  • the functional ingredient is preferably an ingredient that has an effect of improving undesired symptoms and/or poor physical condition in a subject (including functions related to maintaining and improving health). Therefore, it is preferable that the food containing the food composition is a functional food that has the effect of improving undesired symptoms and/or poor physical condition in a subject who ingests it (including functions related to maintaining and improving health).
  • Examples of such functional foods in Japan include general foods, including nutritional supplements, health supplements, and nutritionally adjusted foods, as well as health functional foods (including nutritional functional foods, foods for specified health uses (Tokuho), and foods with functional claims), which are labeled with functional food claims in accordance with national standards for safety and efficacy.
  • composition, raw materials, origin, and acquisition route of the functional ingredients are not limited, and include natural products, natural extracts, chemically synthesized substances, and mixtures of two or more of these.
  • functional ingredients include vitamins such as vitamins B1, B2, and C, minerals such as iron and zinc, amino acids, dietary fiber, DHA, EPA, polyphenols (anthocyanins, isoflavones (including soy isoflavones and their metabolite equol), flavones, catechins, flavonols, flavanones, etc.), carotenoids ( ⁇ -catechin, ⁇ -catechin, ⁇ -cryptoxanthin, lycopene, lutein, zeaxanthin, etc.), and sulfate-containing substances (isothiacyanates, cysteine sulfoxides, etc.).
  • the food composition may contain one type of functional ingredient, or two or more types.
  • the functional ingredient may be a soybean-derived ingredient
  • the soybean-derived ingredient may be soybean isoflavones and/or equol.
  • the soybean isoflavones and equol may each be in the form of a glycoside or an aglycone.
  • the method for obtaining these is not limited, and non-limiting examples of the method include extraction from soybeans according to well-known methods, purchasing commercially available products, and artificial preparation using equol-producing bacteria, etc.
  • the food is preferably a functional food in the form of a tablet, and more preferably a functional food in the form of an orally disintegrating tablet.
  • the daily amount of food to be used is not limited and can be determined appropriately by a person skilled in the art based on the content of functional ingredients in the food and the required daily intake for the subject.
  • composition according to the first embodiment can be used as a pharmaceutical composition.
  • the pharmaceutical composition according to this embodiment contains a pharmaceutically active ingredient.
  • the oral composition according to the first embodiment is preferably used as a pharmaceutical composition.
  • the pharmaceutical composition either alone or in combination with two or more pharmaceutical compositions, can be used, for example, to prepare a medicine for treating a disease or symptom suitable for the pharmacological effect of the pharmaceutically active ingredient.
  • a pharmaceutical according to one embodiment includes a pharmaceutical composition according to this embodiment.
  • a treatment method includes administering the pharmaceutical composition of this embodiment to a subject in need thereof.
  • a use according to one embodiment is the use of the composition according to the first embodiment or the pharmaceutical composition according to this embodiment in the manufacture of a medicament for the treatment of a subject in need thereof.
  • composition, pharmaceutical composition, or pharmaceutically active ingredient of one embodiment is the composition of the first embodiment, the pharmaceutical composition, or the pharmaceutically active ingredient of this embodiment for the treatment of a subject in need thereof.
  • the form of the pharmaceutical is not limited, but is preferably a form suitable for oral use, and from the viewpoint of ease of administration, it may be in a fluid form such as liquid, syrup, paste, gel, jelly, cream, emulsion, spray, mousse, lotion, etc., or in a solid form such as powder, granules, tablets, capsules, soft capsules, etc. Tablets may be any of orally disintegrating tablets, chewable tablets, effervescent tablets, dispersion tablets, and dissolving tablets.
  • the pharmaceutical tablet is preferably an orally disintegrating tablet or a chewable tablet, and more preferably an orally disintegrating tablet.
  • the pharmaceutically active ingredient there are no restrictions on the pharmaceutically active ingredient, so long as it is an ingredient that is desired to be administered to a subject with any disease or symptom, but it is preferable that it is a substance that can exert some physiological activity or effect that is the intended use or purpose of the pharmaceutically active ingredient in the administered subject.
  • compositions include natural products, natural extracts, synthetic substances (including bioengineered substances and chemically synthesized substances), and mixtures of two or more of these.
  • natural products or natural extracts include nucleic acids, proteins (including antibodies and fragments thereof), culture extracts, and low molecular weight compounds. They may be identical substances or similar substances with similar functions that are bioengineered or chemically synthesized substances (chemically synthesized substances).
  • Natural products or natural extracts may be obtained from any living organism, such as a microorganism, animal, or plant, and are not limited by the ecology or habitat of the organism.
  • Pharmaceutical compositions may contain one or more pharmaceutically active ingredients.
  • the pharmaceutical composition in this embodiment is a pharmaceutical composition for treating or preventing a disease, unwanted symptoms, and/or poor physical condition in a subject.
  • Treatment includes the reduction, alleviation, or mitigation of disease symptoms, and “prevention” includes protection against the future onset of a disease or symptom and the inhibition of its progression. Desirable therapeutic effects of treatment include alleviation of symptoms, improvement of direct or indirect pathological consequences of a disease, reduction in the rate of progression of worsening symptoms, recovery or alleviation of the disease state, and improvement in prognosis.
  • the individual foods or pharmaceuticals can be ingested or administered simultaneously, separately at a certain time interval, or consecutively.
  • the two or more types of food or pharmaceutical preparations can also be ingested or administered at different times per day and/or by different routes.
  • Pharmaceutical preparations can be administered systemically or locally.
  • a food composition or pharmaceutical composition may further contain one or more non-functional ingredients that are nutritionally or pharmaceutically acceptable as a food.
  • Non-functional ingredients include additives such as acidulants, sweeteners, excipients, surfactants, lubricants, flavorings, fragrances, colorants, stabilizers, and preservatives.
  • excipients include mannitol, erythritol, xylitol, trehalose, lactose, maltose, maltitol, glucose, sucrose, fructose, mannose, sorbitol, amylose, light anhydrous silicic acid, hydrous silicon dioxide, anhydrous calcium phosphate, anhydrous calcium hydrogen phosphate, aluminum metasilicate, calcium silicate, magnesium silicate, and magnesium oxide.
  • the surfactant may include a nonionic surfactant, for example, a sorbitan fatty acid ester such as sorbitan monocaprylate, sorbitan monolaurate, or sorbitan monopalmitate, or a glycerin fatty acid ester such as glycerin monocaprylate, glycerin monomyliate, or glycerin monostearate, which has an HLB of 6 to 18.
  • a nonionic surfactant for example, a sorbitan fatty acid ester such as sorbitan monocaprylate, sorbitan monolaurate, or sorbitan monopalmitate, or a glycerin fatty acid ester such as glycerin monocaprylate, glycerin monomyliate, or glycerin monostearate, which has an HLB of 6 to 18.
  • non-functional ingredients include, for example, water, saline, alcohol, silicone, wax, petrolatum, vegetable oil, polyethylene glycol, propylene glycol, liposomes, gelatin, magnesium stearate, talc, surfactants, silicic acid, viscous paraffin, perfume oils, fatty acid monoglycerides and diglycerides, petroleum esters of fatty acids, hydroxymethylcellulose, polyvinylpyrrolidone, etc.
  • the content of the functional ingredient or pharmaceutically active ingredient in the food composition or pharmaceutical composition is not limited, but may be greater than 10 wt %, greater than 20 wt %, 20-40 wt %, 20-32 wt %, or 20-30 wt %.
  • the content of the functional ingredient or pharmaceutically active ingredient is 20-30 wt %, the content may be 20 wt %, 24 wt %, 26 wt %, 27 wt %, or 30 wt %.
  • the content of the non-functional ingredient in the food composition or pharmaceutical composition is not limited, but may be 90 wt % or less, 60-90 wt %, 60-80 wt %, 68-80 wt %, or 70-80 wt %.
  • the functional ingredient or pharmaceutically active ingredient may be contained in a non-heat-stable substance in the composition according to this second embodiment, such as a protein or a low-molecular-weight carbohydrate.
  • the composition during swallowing i.e., it is likely to be a food or medicine that is easy to swallow.
  • the food or medicine is in tablet form, it is likely to exhibit good disintegrability in water and/or good wet powder frictional force. This makes it likely that the tablet will achieve good oral disintegration and a good texture on the tongue as a disintegrating paste, and it is likely to achieve good passage of the composition during swallowing, i.e., it is likely to be a tablet that is easy to swallow.
  • the content of the functional ingredient or pharmaceutically active ingredient exceed 10% by weight, the desired effect of the functional ingredient or pharmaceutically active ingredient is more likely to be exerted in a subject who has ingested the food or administered the medicine.
  • the subject to which the food composition or food containing it is ingested, or the subject to which the pharmaceutical composition or medicine containing it is administered is not limited to any animal in need thereof, and may be a human or a non-human animal.
  • Non-human animal species may be, for example, monkeys, dogs, cats, horses, cows, pigs, sheep, goats, rabbits, guinea pigs, hamsters, mice, and/or rats, and are not limited by their use as livestock, pets, or laboratory animals, but are preferably mammals, and more preferably humans.
  • the packaging form of the food composition or food containing the food composition, or the pharmaceutical composition or medicine containing the pharmaceutical composition according to this embodiment is not particularly limited and can be selected appropriately by a person skilled in the art depending on the dosage form, etc., but examples include blister packs such as PTPs, strip packaging, heat seals, aluminum pouches, film packaging using plastic or synthetic resin, glass containers such as vials, and plastic containers such as ampoules.
  • composition according to the first embodiment can be used in various applications where the properties exhibited by the composition and tablets containing the composition, i.e., the effects of good ease of swallowing and/or good texture on the tongue, and/or the effects of good packing properties, low dispersion, and/or high transportability, are favorably utilized.
  • the composition according to the first embodiment can be used as a cosmetic composition.
  • the composition according to the first embodiment can be used as a lubricant composition.
  • a cosmetic product according to one embodiment includes the cosmetic composition according to this embodiment.
  • a lubricant according to one embodiment includes the lubricant composition according to this embodiment.
  • the cosmetic composition is, for example, a composition intended for the beauty of the skin, hair, nails, etc., and can be formulated into a form that allows for the care of these areas to be made into a cosmetic product.
  • a cosmetic product may be a liquid, lotion, cream, patch, oil, spray, liquid cleanser, solid soap, etc.
  • the product may be a cosmetic liquid, beauty serum, moisturizing liquid, moisturizing cream, soap, body soap, skin cleanser, bath salts, sunscreen, shaving lotion, depilatory cream, shampoo, conditioner, hair tonic, hair dye, etc.
  • lotions, creams, and liquid cleansers are preferred, and commercial forms of liquid cleansers include shampoo, body soap, and skin cleansers.
  • the cosmetic composition may contain one or more functional ingredients and/or one or more non-functional ingredients described in the second embodiment.
  • examples of packaging forms for cosmetics containing the cosmetic composition are the same as the packaging forms described in the second embodiment.
  • the subject of application of the cosmetic composition or cosmetics containing the same is not limited to any animal that requires them, and may be either a human or a non-human animal.
  • Non-human animal species may be, for example, monkeys, dogs, cats, horses, cows, pigs, sheep, goats, rabbits, guinea pigs, hamsters, mice, and/or rats, and are not limited by their use as livestock, pets, or laboratory animals, but are preferably mammals, and more preferably humans.
  • a lubricant composition is a composition intended to improve the handling properties of tablets during tableting and the ease of swallowing when administering them.
  • the composition of the first embodiment has the effects of being easy to swallow and/or having a good texture on the tongue, and/or having good packing properties, low dispersion, and/or high transportability, and therefore can be suitably used as a lubricant composition.
  • the lubricant composition may contain one or more functional ingredients and/or one or more non-functional ingredients described in the second embodiment. From the standpoint of functionality as a lubricant composition, it preferably contains one or more lubricants well known to those skilled in the art. Non-limiting examples of such lubricants include titanium oxide, calcium carbonate, hydrous silicon dioxide, hydrous amorphous silicon oxide, glycerin fatty acid esters, magnesium silicate, light anhydrous silicic acid, hydrogenated oil, heavy anhydrous silicic acid, sucrose fatty acid esters, stearyl alcohol, stearic acid, zinc stearate, aluminum stearate, calcium stearate, polyoxyl 40 stearate, magnesium stearate, hydrogenated soybean oil, talc, sodium stearyl fumarate, beeswax, anhydrous silicic acid hydrate, magnesium aluminometasilicate, and glycerin monostearate.
  • lubricants include titanium oxide, calcium
  • a lubricant containing the lubricant composition according to this embodiment can be suitably used, for example, in the pharmaceutical composition according to the second embodiment or in the formulation of a drug containing the pharmaceutical composition.
  • the BS ratio at a height of 30 mm from the bottom is calculated by the following formula, based on the backscattered light measurement value (BS value) obtained at a point 30 mm from the bottom of the bottle when a test bottle containing a sample containing a composition is irradiated with light, and the value 1 minute and the value 5 minutes after the start of measurement: 100
  • the water disintegration rate of a tablet containing the composition is 1.9 (min/N),
  • the disintegrability in water is calculated from the hardness (N) of the tablet measured with a hardness tester and the disintegration time (minutes) of the tablet in pure water by the following formula: Disintegration time in water (D)/tablet hardness (N)
  • the composition according to [1] wherein the calculated [3]
  • the hardness of a tablet containing the composition is 46 N or less, and the disintegration time of a tablet containing the composition in water is less than 90 minutes.
  • the particle has a Feret diameter (vertical width) of less than 3.3 ⁇ m and a Feret diameter (horizontal width) of 2.4 ⁇ m or less.
  • the Feret diameter (vertical width) of the material used in the compositions of the Examples and Comparative Examples was large (specifically, greater than about 10 ⁇ m), it was subjected to primary pulverization.
  • a jet mill Jet Mill Pulverizer STJ-400 manufactured by Seishin
  • the mixture was pulverized once (primary pulverization) under conditions of a flow rate of 2 kg/hour or more and 12 kg/hour or less (Group 1: 12 kg/hour, Group 2: 8 kg/hour, Group 3: 2 kg/hour, Group 4: 2 kg/hour) to a Feret diameter (vertical width) of approximately 10 ⁇ m to 60 ⁇ m (Group 1: 10 ⁇ m, Group 2: 20 ⁇ m, Group 3: 40 ⁇ m, Group 4: 60 ⁇ m), thereby obtaining a powder composition.
  • the mixed material was processed 20 times at a processing pressure of 50 MPa using a homogenizer (Gaulin, 15M8AT) equipped with a conventional non-destructive homogenizing valve seat (inner diameter of downstream end of hollow cylindrical convex portion / thickness of ring-shaped end face 1.9 / 1), and crushed to a Feret diameter (vertical width) of approximately 0.5 ⁇ to 4 ⁇ m (Group 1: 0.5-1 ⁇ m, Group 2: 2 ⁇ m, Group 3: 2 ⁇ m, Group 4: 4 ⁇ m) (secondary crushing).
  • a homogenizer Gaulin, 15M8AT
  • a conventional non-destructive homogenizing valve seat inner diameter of downstream end of hollow cylindrical convex portion / thickness of ring-shaped end face 1.9 / 1
  • a Feret diameter vertical width
  • Dispersion liquid supply rate 2 to 6 L/hour (Group 1: 2 L/hour, Group 2: 6 L/hour, Group 3: 6 L/hour, Group 4: 2 L/hour) ⁇ Inlet temperature 150°C, ⁇ Outlet temperature 70°C
  • compositions in the Examples and Comparative Examples the content of heat-resistant materials was measured by the known ash method, the content of semi-heat-resistant materials was measured by the known alpha-cellulose quantification method, and the content of non-heat-resistant materials was obtained by subtracting the value obtained by the known alpha-cellulose measurement from the value obtained by the known holocellulose quantification method.
  • the compositions (wt %) shown in "Production Examples" in Table 1 contained a heat-resistant material, a semi-heat-resistant material, and a non-heat-resistant material.
  • the heat-resistant, semi-heat-resistant, and non-heat-resistant substances of each material were analyzed in the same manner as the composition. Results showed that wheat germ contained 5-25% by weight of heat-resistant substances, 30-70% by weight of semi-heat-resistant substances, and 25-45% by weight of non-heat-resistant substances. Oats contained 5-20% by weight of heat-resistant substances, 45-75% by weight of semi-heat-resistant substances, and 20-45% by weight of non-heat-resistant substances. Crystalline cellulose (Asahi Kasei's Ceolus) contained 1-10% by weight of heat-resistant substances, 70-98% by weight of semi-heat-resistant substances, and 0.1-5% by weight of non-heat-resistant substances.
  • Powdered cellulose (Nippon Paper Industries Co., Ltd.'s KC Flock W-50) contained 1-10% by weight of heat-resistant substances, 70-90% by weight of semi-heat-resistant substances, and 5-20% by weight of non-heat-resistant substances.
  • the truffle powder contained 93% non-heat-stable material and 5% semi-heat-stable material.
  • a sample suspension of the composition was formed into a flat sample flow using a sheath liquid using a flat sheath flow method, and particles were captured as still images by irradiating them with a strobe light, and particle parameters and particle shape parameters were obtained by image analysis.
  • the measurement conditions were a standard lens magnification (10x), a measurement range of 0.5 to 300 ⁇ m, and a detected particle count of 10,000.
  • the "Feret diameter (vertical width and horizontal width)" and the "particle area” were measured independently. The 1,000 particles that formed the basis of each average value were different particles.
  • particle area The particle area ( ⁇ m 2 ) of the particles photographed as described above was measured using a Pershare analyzer, other than the particles whose Feret diameters (vertical and horizontal widths) were measured. The particle area was determined as the average value of the values of the 1,000 smallest particles out of the 10,000 particles measured.
  • the bottom surface means the bottom surface of the test bottle.
  • the tablet hardness (tablet hardness) (N) was measured using a hardness tester (model number: KHT-40N, Fujiwara Seisakusho). The tablet produced in the section "Preparation of Composition and Tablet" was placed on the center of the measuring table and the device was started (the AUTO [start] button was pressed). At this time, the hardness in the direction perpendicular to the compression direction during tablet molding was measured. As a result, the rod descended at high speed and the display entered a peak hold state. When it came into contact with the object to be measured, the speed slowed down and the display was monitored approximately every 0.1 seconds. If there was no increase, it was judged to have broken, and the hardness indicated on the hardness tester at that time was taken as the tablet hardness (N).
  • the disintegration time in water was measured by placing a tablet (250 g) in a test tube, adding 20 ml of pure water, and shaking it at 37°C in a shaker (reciprocating/rotating shaker MMS-3020, manufactured by Tokyo Rikakikai) to measure the disintegration time. The measurement was performed 50 times, and the average value was used as the disintegration time (minutes) of the tablet in water. The tablet was judged to have disintegrated in water when no agglomerates of 1 mm3 or more had disappeared.
  • the disintegration time of a tablet in water is expressed as the disintegration time per unit hardness [disintegration time in water (D) / tablet hardness (N) (min/N)].
  • Friction force (%) of wet powder after 2 mm of movement 100 ⁇ (static friction force at 0 mm of movement distance / static friction force at 3 mm of movement distance)
  • the tapped apparent density (g/cm 3 ) of the composition was measured using a commercially available powder property measuring instrument (Hosokawa Micron, Powder Tester PT-X). Specifically, all powder particles contained in the composition were filled into a 100 cm 3 cup, and the cup was tapped 250 times per minute. The volume of the cup was then determined by dividing the weight of the powder sample filled in the cup by the volume of the powder sample.
  • the apparent density (without tapping) (g/ cm3 ) of the composition was determined by roughly filling a 100 cm3 glass measuring cylinder with the composition using a quantitative feeder or the like over a period of 2 to 3 minutes, then leveling the top surface of the powder layer with a soft brush such as a paintbrush to read the volume, and dividing the weight of the powder sample by the volume. The weight of the powder was appropriately determined so that the volume would be approximately 70 to 100 cm3 .
  • Thermogravimetric analysis Using a thermal analyzer (STA300 manufactured by Hitachi High-Tech Science), a sample (approximately 10 mg) of the composition was heated from 25°C to 600°C at a rate of 10°C/min in a N2 atmosphere, and the residual weight of the sample was measured at 100°C, 200°C, 300°C, 400°C, and 600°C.
  • Dispersity [%] 100 x (amount of sample added - amount remaining on watch glass) / amount of sample added
  • the transportability of the tablets was evaluated as follows. Ten compressed tablets (approximately 20 ml) were placed in a test bottle (height 70 mm, diameter 25 mm, capacity 20 ml) and their weight was measured (weight A). The test bottle containing the tablets was placed in a shaker (Tokyo Rikakikai, MMS-3020) and shaken at 200 rpm for 1 hour. After the test, the powder on the surface of the tablets was brushed off and the weight of the collected powder was measured (weight B).
  • Tablet chipping rate (%) 100 x weight B / weight A The higher the value of "tablet chipping", the more vibration-resistant the tablet is, and the easier it is to transport.
  • the results are evaluated according to the following criteria: 4 (Very high): After the vibration test, no chipping or cracking was observed in the tablets. (95% or more of the tablets were chipped.) 3 (high): After the vibration test, very small chips or cracks were observed on the tablet, but the overall shape was maintained (90% of the tablet was chipped). 2 (medium): After the vibration test, the tablets had obvious chips or cracks, and were slightly deformed. (85% of tablets were chipped.) 1 (low): After the vibration test, the tablets have many large chips and cracks, and their shape is significantly damaged (less than 80% of the tablets are chipped).
  • the swallowability rating was 3 or higher. It has been shown that when the powder water absorption rate is less than 200, a composition containing powder particles or a tablet containing the composition is likely to be easy to swallow and/or to have a good mouthfeel.
  • the swallowability rating was 3 or more. It has been shown that when one or more of these parameters are within the above ranges, the composition or tablet is less likely to remain in the mouth when orally administered and/or the composition is more likely to pass through easily during swallowing, i.e., is more likely to be easy to swallow.
  • the swallowability rating was 3 or higher.
  • the swallowability rating was 2 or lower. It has been shown that when the frictional force of the wet powder is less than 63, the composition or tablet is less likely to remain in the mouth when orally administered and/or the composition is more likely to pass through easily during swallowing, i.e., is more likely to be easily swallowed.
  • the swallowability rating was 3 or more.
  • the BS ratio at a height of 30 mm was 11.8 or more, the swallowability rating was 2 or less.
  • the BS ratio at a height of 30 mm is 11.7 or less, it has been shown that the composition or tablet is less likely to remain in the mouth when orally administered and/or is more likely to achieve good passage of the composition during swallowing, i.e., is more likely to be easy to swallow.
  • the swallowability rating was 3 or higher.
  • the swallowability rating was 2 or lower. If the BS ratio 60 minutes after the start of measurement is less than 21.0, it indicates that the composition or tablet is less likely to remain in the mouth when orally administered and/or is more likely to pass through the composition easily during swallowing, i.e., is more likely to be easily swallowed.
  • the swallowability rating was 3 or higher.
  • the swallowability rating was 2 or lower. It has been shown that when the angle of repose of a composition is less than 57.0, the composition or tablet is less likely to remain in the mouth when orally administered and/or the composition is more likely to pass through easily during swallowing, i.e., is more likely to be easily swallowed.
  • the collapse angle of the composition When the collapse angle of the composition was greater than 31.8 (preferably 32.0 to 44.0), the ease of swallowing was rated at 3 or higher. On the other hand, when the collapse angle of the composition was 31.8 or lower or 36.0 or higher (e.g., 45.0), the ease of swallowing was rated at 2 or lower. It has been shown that when the collapse angle is greater than 31.8, the composition or tablet is less likely to remain in the mouth when orally administered and/or the composition is more likely to pass through easily during swallowing, i.e., is more likely to be easily swallowed.
  • the frictional force of the wet powder was less than 63
  • the sensory evaluation of the texture on the tongue was 3 or more.
  • the frictional force of the wet powder was 63 or more
  • the sensory evaluation of the texture on the tongue was 2 or less. It has been shown that when the frictional force of the wet powder is less than 63, the composition or tablet is less likely to remain in the mouth when orally administered and/or is more likely to pass smoothly during swallowing, i.e., it is more likely to have a good texture on the tongue.
  • the sensory evaluation of the texture on the tongue was rated at 3 or more.
  • the BS ratio at a height of 30 mm was 11.8 or more
  • the sensory evaluation of the texture on the tongue was rated at 2 or less. It has been shown that when the BS ratio at a height of 30 mm is 11.7 or less, the composition or tablet is less likely to remain in the mouth when orally administered and/or is more likely to pass smoothly during swallowing, i.e., it is more likely to have a good texture on the tongue.
  • the sensory evaluation of texture on the tongue was 3 or more.
  • the sensory evaluation of texture on the tongue was 2 or less. If the BS ratio 60 minutes after the start of measurement is less than 21.0, it was shown that the composition or tablet is less likely to remain in the mouth when orally administered and/or is more likely to pass smoothly during swallowing, i.e., is more likely to have a pleasant texture on the tongue.
  • the angle of repose of the composition When the angle of repose of the composition was less than 57.0, the sensory evaluation of the feel on the tongue was 3 or more. On the other hand, when the angle of repose of the composition was 57.0 or more, the sensory evaluation of the feel on the tongue was 2 or less. It has been shown that when the angle of repose of a composition is less than 57.0, the composition or tablet is less likely to remain in the mouth when orally administered and/or is more likely to pass smoothly during swallowing, i.e., it is more likely to have a good texture on the tongue.
  • the collapse angle of the composition was more than 31.8 (preferably 32.0 to 44.0), the sensory evaluation of the texture on the tongue was 3 or more.
  • the collapse angle of the composition was 31.8 or less or 36.0 or more (for example, 45.0)
  • the sensory evaluation of the texture on the tongue was 2 or less. It has been shown that when the collapse angle is 32.0 or more, the composition or tablet is less likely to remain in the mouth when orally administered, and/or the composition is more likely to pass through smoothly during swallowing, i.e., the texture is more likely to be pleasant on the tongue.
  • the packing property was evaluated as 4 or more.
  • the packing property was evaluated as 3 or less. It has been shown that when the frictional force of the wet powder is less than 63, the composition tends to have high packing properties and productivity tends to be improved.
  • the packing property was rated at 4 or higher.
  • the packing property was rated at 3 or lower. It has been shown that when the compressibility of the composition is 1.0 to 1.5, the composition tends to have high packing properties and productivity tends to be improved.
  • the packing property was evaluated as 4 or higher.
  • the packing property was evaluated as 3 or lower. It has been shown that when the angle of repose of the composition is less than 57.0, the composition is likely to have high packing properties.
  • the filling property was evaluated as 3 or higher.
  • the filling property was evaluated as 2 or lower. It has been shown that when the collapse angle of the composition is greater than 31.8, the composition tends to have high filling properties and productivity tends to be improved.
  • the filling property was evaluated as 3 or more.
  • the difference angle of the composition was 25.2 or more, the filling property was evaluated as 2 or less. It has been shown that when the difference angle is less than 25.2, the composition tends to have high filling properties and productivity tends to be improved.
  • the fillability rating was 3 or more. Furthermore, when the stress tolerance (%) (stress at a moving strain rate of 18% / stress at a moving strain rate of 10%) was less than 80, the fillability rating was 4. It has been shown that when the stress resistance of the tablet is less than 80, the composition tends to have high packing properties and productivity tends to be improved.
  • the degree of dispersion (%) was 22 or less.
  • the degree of dispersion (%) was 44 or more.
  • An aspect ratio close to 1.0 indicates that the particles are nearly spherical. Therefore, when the aspect ratio is small (for example, less than 1.40), friction between particles is less likely to occur, and the degree of dispersion of the composition is likely to be low.
  • the dispersity (%) was 22 or less.
  • the dispersity (%) was 44 or more. It was shown that the larger the collapse angle (for example, greater than 31.8), the lower the degree of dispersion of the composition and the easier it was to handle.
  • the dispersity (%) was 22 or less.
  • the collapse angle was 25.2 or more, the dispersity (%) was 44 or more. It was shown that the smaller the difference angle (for example, less than 25.2), the lower the degree of dispersion of the composition and the easier it is to handle.
  • the stress tolerance (%) (100 ⁇ stress (kN/m 2 ) at a moving strain rate of 18% / stress (kN/m 2 ) at a moving strain rate of 10%) was less than 80 (preferably less than 62, or more than 59 and less than 80), the dispersity (%) was 22 or less.
  • the stress tolerance was more than 76 (for example, more than 76 and less than 104, or more than 99), the dispersity (%) was 44 or more.
  • the stress resistance is less than 80, it was shown that the degree of dispersion of the composition was low and handling was likely to be easy.
  • the transportability rating was 2 or less.
  • the transportability rating was 3 or more.
  • An aspect ratio close to 1.0 indicates that the particles are nearly spherical, whereas a large aspect ratio indicates that the particles have a shape that is far from spherical. It has been shown that when the aspect ratio of the particles is 1.40 or more, the transportability of tablets containing the particles tends to be improved.
  • the transportability rating was 2 or less.
  • the transportability rating was 3 or more. It has been shown that when the collapse angle of a composition is 31.8 or less, the transportability of tablets containing the composition tends to be improved.
  • the transportability rating was 2 or less.
  • the transportability rating was 3 or more. It was shown that when the difference angle of a composition is 25.2 or more, the transportability of a tablet containing the composition tends to be improved.
  • the transportability rating was 2 or less.
  • the stress tolerance was more than 76 (preferably 80 to 99, or more than 99)
  • the transportability rating was 3 or more. It was shown that when the stress resistance is greater than 76, the transportability of the tablet tends to be high.
  • composition of this embodiment has the properties of being easy to swallow, having a pleasant texture, good packing properties, low dispersibility, and/or high transportability of tablets containing the composition, and therefore can be suitably used as a composition for food, pharmaceutical, and/or cosmetic applications where such properties are desired, and has industrial applicability.

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Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2011019045A1 (ja) * 2009-08-11 2011-02-17 富士化学工業株式会社 崩壊性粒子組成物及び口腔内速崩壊錠
WO2011019046A1 (ja) * 2009-08-11 2011-02-17 富士化学工業株式会社 崩壊性粒子組成物及び口腔内速崩壊錠
JP2018083923A (ja) * 2016-11-25 2018-05-31 旭化成株式会社 セルロース分散液、セルロース分散液の製造方法、成形体組成物、成形体、及び成形体組成物の製造方法
JP7478914B1 (ja) * 2023-11-13 2024-05-07 株式会社ダイセル 組成物

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2011019045A1 (ja) * 2009-08-11 2011-02-17 富士化学工業株式会社 崩壊性粒子組成物及び口腔内速崩壊錠
WO2011019046A1 (ja) * 2009-08-11 2011-02-17 富士化学工業株式会社 崩壊性粒子組成物及び口腔内速崩壊錠
JP2018083923A (ja) * 2016-11-25 2018-05-31 旭化成株式会社 セルロース分散液、セルロース分散液の製造方法、成形体組成物、成形体、及び成形体組成物の製造方法
JP7478914B1 (ja) * 2023-11-13 2024-05-07 株式会社ダイセル 組成物

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