Composition

Abstract

Provided is a composition that is easy to swallow, has a good texture, has good fillability, has low dispersibility, and / or has high transportability of tablets containing the composition. The composition has specific ranges in parameters of particles such as particle area, Feret diameter, and / or aspect ratio, parameters of the composition such as BS ratio at a height of 30 mm, BS ratio 60 minutes after the start of measurement, powder water absorption rate, angle of repose, difference angle, weight retention rate, and / or electromotive force, and / or parameters of tablets such as disintegration time in water and / or water disintegrability.

Description

Technical Field

[0001] The present disclosure relates to a composition.

Background Art

[0002] Compositions used in various forms for pharmaceutical or food purposes are orally administered or ingested by a subject. Such compositions are required to have good passage in the subject's oral cavity or during swallowing, i.e., ease of swallowing, and / or good taste in the mouth. In addition, it is preferable for the composition to have characteristics such as good fillability, low dusting (low dispersibility), and / or high transportability (resistance to chipping of the powder) in terms of its handling. The above characteristics may also be suitable for compositions for cosmetics or lubricants.

[0003] Conventionally, for example, by adjusting the fiber length, fiber width, etc. of the fibrous substances contained in the composition, attempts have been made to adjust the hardness and in-mouth tablet disintegration properties of tablets containing the composition, and to improve ease of swallowing and good taste in the mouth. However, it has been difficult to set manufacturing conditions for accurately controlling the fiber length and fiber width contained in the composition.

[0004]

Patent Document 1

Summary of the Invention

[0005] A first object of the present disclosure is to provide an easily swallowable composition and / or an easily swallowable tablet containing the composition.

[0006] Another object (a second object) of the present disclosure is to provide a composition with good touch in the mouth and / or a tablet with good touch in the mouth containing the composition.

[0007] Another object (a third object) of the present disclosure is to provide a composition with good fillability.

[0008] Another object (the fourth object) of the present disclosure is to provide a composition with low dispersibility.

[0009] Another object (the fifth object) of the present disclosure is to provide a composition having high transportability of tablets containing the composition and / or tablets having high transportability.

[0010] The present disclosure includes the following aspects. Particles having a particle area of less than 20.0 μm 2 and an aspect ratio of less than 1.40, and any one or more of the following (a) to (d): (a) The Backscatter (BS) ratio at a height of 30 mm from the bottom surface is 11.7% or less, (b) The BS ratio 60 minutes after the start of measurement is less than 21.0%, (c) The frictional force of the wet powder is less than 63%, (d) The water absorption rate of the powder is less than 200%, and wherein the BS ratio at a height of 30 mm from the bottom surface is calculated from the backscattered light measurement value (BS value) obtained at a point 30 mm from the bottom surface of the bottle 1 minute after the start of measurement and the value 5 minutes after the start of measurement when the test bottle containing the sample containing the composition is irradiated with light, according to the following formula: 100×(BS value at the 30 mm point from the bottom surface 1 minute after the start of measurement) / (BS value at the 30 mm point from the bottom surface 5 minutes after the start of measurement) and the BS ratio 60 minutes after the start of measurement is calculated from the backscattered light measurement values (BS values) obtained at a point 40 mm from the bottom surface of the bottle and a point 10 mm from the bottom surface of the bottle when the test bottle containing the sample containing the composition is irradiated with light, according to the following formula: 100×(BS value at the 10 mm point from the bottom surface 60 minutes after the start of measurement) / (BS value at the 40 mm point from the bottom surface 60 minutes after the start of measurement) and the frictional force of the wet powder is the frictional force of the wet powder moving 2 mm, and is obtained by measuring the sample containing the composition at a load of 50 g and a speed of 10 mm / second, from the values of the static frictional force at the time of a moving distance of 0 mm and the static frictional force at the time of a moving distance of 3 mm, according to the following formula: 100×(Static frictional force at the time of 0 mm of moving distance) / (Static frictional force at the time of 3 mm of moving distance) Calculated by Composition

[0011] According to the first aspect of the present disclosure, an easily swallowable composition and / or an easily swallowable tablet containing the composition can be provided.

[0012] According to the second aspect of the present disclosure, a composition having a good texture and / or a tablet having a good texture containing the composition can be provided.

[0013] According to the third aspect of the present disclosure, a composition having good fillability can be provided.

[0014] According to the fourth aspect of the present disclosure, a composition having a low degree of dispersion can be provided.

[0015] According to the fifth aspect of the present disclosure, a composition having a high transportability of a tablet containing the composition and / or a tablet having a high transportability can be provided.

Mode for Carrying Out the Invention

[0016] Hereinafter, an embodiment of the present disclosure will be described in detail. The present disclosure is not limited to the following embodiments, and can be implemented with appropriate modifications within a range that does not inhibit the effects of the present disclosure. Each configuration and their combinations in each embodiment are examples, and within a range not departing from the gist of the present disclosure, addition, omission, substitution, and other changes of the configuration can be made as appropriate. The present disclosure is not limited by the embodiments, but is limited only by the claims. Each aspect disclosed in this specification can be combined with any other features disclosed in this specification. If a specific description given for one embodiment also applies to other embodiments, the description may be omitted for those other embodiments. In the present disclosure, the expression "X to Y" for a numerical range means "X or more and Y or less". If a specific description given for one embodiment also applies to other embodiments, the description may be omitted for those other embodiments. Unless otherwise specified, all numbers representing features, items, amounts, parameters, characteristics, periods, etc. used in this specification and the claims are to be understood as being modified in all cases by the term "about". As used herein, the term "about" means that the feature, item, amount, parameter, characteristic, or period so specified encompasses a range of plus or minus 10 percent of the value of the recited feature, item, amount, parameter, characteristic, or period. Each numerical indicator should be interpreted at least taking into account the number of significant digits reported and applying normal rounding, so as not to limit at least the application of the doctrine of equivalents to the claims. Any numerical range or value inherently includes the range of error necessarily resulting from the standard deviation found in their respective test measurements. Unless otherwise specified, each individual value of a numerical range in this specification is incorporated into the specification in the same manner as if it were individually recited herein.

[0017] As used herein, "comprising" means including at least a part of a certain component, including the case where it consists only of that component.

[0018] [First Embodiment (Composition)] Regarding the composition according to this embodiment, each parameter described below can be measured and adjusted as described in the section "Measurement Method and Adjustment Method of Parameters".

[0019] The composition (1-1) according to the first embodiment is a composition containing particles having a particle area (μm 2 ) of less than 20.0.

[0020] In the composition, 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. When the particle area is 0.22 to 18.3, for example, it may be 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, or 18.3, and may be a range with any one of these as the upper limit and another as the lower limit.

[0021] The composition (1-2) according to the first embodiment is a composition containing particles with a particle area (μm 2 ) less than 20.0.

[0022] In the composition, the particle area is preferably 0.2 or more and less than 20.0, more preferably 2.0 to 18.3. When the particle area is 0.22 to 18.3, for example, it may be 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 as the lower limit.

[0023] The composition (1-3) according to the first embodiment is a composition containing particles with a particle area (μm 2 ) of 20.0 or more.

[0024] In the composition, the particle area is preferably 20.0 to 50.0, more preferably 20.0 to 40.0, and still more preferably 20.0 to 38.0. When the particle area is 20.0 to 38.0, for example, it may be 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 a range with any one of these as the upper limit and another as the lower limit.

[0025] The composition (1-4) according to the first embodiment is a composition containing particles with a particle area (μm 2 ) of 20.0 or more.

[0026] In the composition, 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. When the particle area is 20.0 to 38.0, for example, it may be 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 also be a range with any one of these as the upper limit and another as the lower limit.

[0027] When the particle area is small, the "BS ratio at a height of 30 mm from the bottom surface" 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). When the sedimentation rate is slow and / or the degree of sedimentation is small, when the composition or tablet is orally administered, it is difficult to stay in the mouth, and / or it is easy to achieve good passage during swallowing, that is, it is easy to swallow. Therefore, for example, a composition containing particles with a particle area of less than 20.0, or a tablet containing the composition is likely to be easy to swallow. Furthermore, when the particle area is small, the composition is likely to be compacted. Therefore, for example, a composition containing particles with a particle area of less than 20.0 is easy to fill into a composition bag or a tablet molding machine, and is easy to improve productivity.

[0028] The composition (2-1) according to the first embodiment is a composition containing particles with a Feret diameter (vertical width) (μm) of less than 3.3.

[0029] In the composition, the Feret diameter (vertical width) is preferably 0.10 or more and less than 3.3, more preferably 0.30 or more and less than 3.3, still more preferably 0.40 to 3.2, still more preferably 0.50 to 3.2, still more preferably 0.51 to 3.2, and still more preferably 0.51 to 3.1. When the Feret diameter (vertical) is 0.51 to 3.1, for example, it may be any of 0.51, 0.52, 0.53, 0.54, 0.55, 0.58, 1.5, 1.6, 2.5, 2.6, 3.0, or 3.1, and it may be a range with any one of these as the upper limit and another as the lower limit.

[0030] The composition (2-2) according to the first embodiment is a composition containing particles having a Feret diameter (vertical width) of 3.3 or more and less than 20.0.

[0031] In the composition, the Feret diameter (vertical width) is preferably 3.3 to 10.0, more preferably 3.3 to 5.0. When the Feret diameter (vertical width) is 3.3 to 5.0, for example, it may be any of 3.3, 3.4, 4.9, or 5.0, and it may be a range with any one of these as the upper limit and another as the lower limit.

[0032] The composition (2-3) according to the first embodiment is a composition containing particles having a Feret diameter (vertical width) of 3.3 or more and less than 20.0.

[0033] In the composition, the Feret diameter (vertical width) is preferably 3.3 to 10.0, more preferably 3.3 to 5.0. When the Feret diameter (vertical width) is 3.3 to 5.0, for example, it may be any of 3.3, 3.4, 4.9, or 5.0, and it may be a range with any one of these as the upper limit and another as the lower limit.

[0034] The composition (2-4) according to the first embodiment is a composition containing particles having a Feret diameter (vertical width) of 20.0 or more.

[0035] In the composition, the Feret diameter (vertical width) is preferably 20.0 to 60.0, more preferably 20.0 to 40.0. When the Feret diameter (vertical width) is 20.0 to 40.0, for example, it may be 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, and it may also be a range with any one of these as the upper limit and another as the lower limit.

[0036] When the Feret diameter (vertical width) is small, the particle area of the composition tends to be small. When the particle area is small, the "BS ratio at a height of 30 mm from the bottom surface" 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). When the sedimentation rate is slow and / or the degree of sedimentation is small, when the composition or tablet is orally administered, it is less likely to stay in the mouth and / or it is easier to achieve good passage during swallowing, that is, it is easier to swallow. For example, a composition containing particles with a Feret diameter (vertical width) of less than 3.3, or a tablet containing such a composition is likely to be easy to swallow. Furthermore, when the particle area is small, the composition is likely to be compacted. For example, a composition containing particles with a Feret diameter (vertical width) of less than 3.3 is easier to fill into a composition bag or a tablet molding machine, and it is easier to improve productivity.

[0037] The composition (3-1) according to the first embodiment is a composition containing particles with a Feret diameter (horizontal width) (μm) of 2.4 or less.

[0038] In the composition, the Feret diameter (horizontal width) may be 0.51 to 2.4, may be 0.51 or more and less than 2.3, or may be 0.51 to 2.2.

[0039] When the Feret diameter (vertical width) is 0.51 to 2.4, for example, it may be any of 0.51, 0.52, 0.53, 1.4, 2.1, or 2.4, and it may be a range with any one of these as the upper limit and another as the lower limit.

[0040] The 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.

[0041] When the Feret diameter (vertical width) is 2.3 to 3.1, it may be either 2.3 or 3.1.

[0042] The composition (3-3) according to the first embodiment is a composition containing particles having a Feret diameter (horizontal width) of 2.3 to 3.1.

[0043] When the Feret diameter (horizontal width) is 2.3 to 3.1, for example, it may be either 2.3 or 3.1.

[0044] 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.

[0045] In the composition, 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 still more preferably 20.0 to 36.0. When the Feret diameter (horizontal width) is 20.0 to 36.0, for example, it may be any of 20.0, 22.0, 24.0, 26.0, 27.0, or 36.0, and it may be a range with any one of these as the upper limit and another as the lower limit.

[0046] When the Feret diameter (horizontal width) is small, the particle area of the composition tends to be small. When the particle area is small, the "BS ratio at a height of 30 mm from the bottom surface" 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). When the sedimentation rate is slow and / or the degree of sedimentation is small, when the composition or tablet is orally administered, it is difficult to stay in the mouth, and / or it is easy to achieve good passage during swallowing, that is, it is easy to swallow. For example, a composition containing particles with a Feret diameter (horizontal width) of 2.4 or less, or a tablet containing such a composition is easy to swallow. Furthermore, when the particle area is small, the composition is likely to be compacted. For example, a composition containing particles with a Feret diameter (horizontal width) of 2.4 or less is easy to fill into a composition bag or a tablet molding machine, and it is easy to improve productivity.

[0047] The composition (4-1) according to the first embodiment is a composition containing particles with an aspect ratio of less than 1.40.

[0048] In the composition, the aspect ratio is preferably 1.00 or more and less than 1.40, more preferably 1.00 to 1.35, and still more preferably 1.00 to 1.30. When the aspect ratio is 1.00 to 1.30, for example, it may be any one 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, and it may also be a range with any one of these as the upper limit and another as the lower limit.

[0049] The composition (4-2) according to the first embodiment is a composition containing particles with an aspect ratio of 1.40 or more.

[0050] In the composition, the aspect ratio is preferably 1.40 to 5.00, more preferably 1.40 to 3.00, still more preferably 1.40 to 2.00, and still more preferably 1.40 to 1.63. When the aspect ratio is 1.40 to 1.63, for example, it may be any one of 1.40, 1.41, 1.42, 1.43, 1.45, 1.60, 1.61, 1.62, or 1.63, or it may be a range with any one of these as the upper limit and another as the lower limit.

[0051] The composition (4-3) according to the first embodiment is a composition containing particles having an aspect ratio of 1.40 or more.

[0052] In the composition, the aspect ratio is preferably 1.40 to 5.00, more preferably 1.40 to 3.00, still more preferably 1.40 to 2.00, and even more preferably 1.40 to 1.63. When the aspect ratio is 1.40 to 1.63, for example, it may be any one of 1.40, 1.41, 1.42, 1.43, 1.45, 1.60, 1.61, 1.62, or 1.63, or it may be a range with any one of these as the upper limit and another as the lower limit.

[0053] The composition (4-4) according to the first embodiment is a composition containing particles having an aspect ratio of less than 1.40.

[0054] In the composition, the aspect ratio is preferably 1.00 or more and less than 1.40, more preferably 1.00 to 1.35, still more preferably 1.00 to 1.30, and even more preferably 1.00 to 1.27. When the aspect ratio is 1.00 to 1.27, for example, it may be any one 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 it may be a range with any one of these as the upper limit and another as the lower limit.

[0055] An aspect ratio close to 1.0 indicates that the particles are close to spherical. When the aspect ratio is small, the "BS ratio at a height of 30 mm from the bottom surface" 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). When the sedimentation rate is slow and / or the degree of sedimentation is small, when the composition or tablet is orally administered, it is difficult to stay in the mouth, and / or it is easy to achieve good passage during swallowing, that is, it is easy to swallow. For example, a composition containing particles with an aspect ratio of less than 1.40, or a tablet containing the composition, tends to be easy to swallow. Furthermore, when the aspect ratio is small, the composition is likely to be compacted. For example, a composition containing particles with an aspect ratio of less than 1.40 is easy to fill into a composition bag or a tablet molding machine, and it is easy to improve productivity.

[0056] The composition (5-1) according to the first embodiment is a composition in which the BS ratio (1 minute: 5 minutes) (%) (hereinafter, also referred to as the "BS ratio at a height of 30 mm") at a height of 30 mm from the bottom surface is 11.7 or less.

[0057] In the composition, the BS ratio at the height of 30 mm is preferably 1.0 to 11.7, more preferably 1.0 to 11.0, and still more preferably 1.00 to 10.0. When the BS ratio at a height of 30 mm is 1.0 to 10.0, for example, it may be any one of 1.0, 1.1, 1.2, 1.5, 2.0, 4.0, 6.0, 8.0, or 10.0, or it may be a range with any one of these as the upper limit and another as the lower limit.

[0058] The composition (5-2) according to the first embodiment is a composition in which the BS ratio (%) at a height of 30 mm is 11.8 or more.

[0059] In the composition, the BS ratio at the height of 30 mm is preferably 11.8 to 20.0, more preferably 11.8 to 15.0, and still more preferably 11.8 to 13.0. When the BS ratio at a height of 30 mm is 11.8 to 13.0, for example, it may be any one of 11.8, 12.0, or 13.0, and may also be a range with any one of these as the upper limit and another as the lower limit.

[0060] The composition (5-3) according to the first embodiment is a composition in which the BS ratio (%) at a height of 30 mm is 11.8 or more.

[0061] In the composition, the BS ratio at the height of 30 mm is preferably 11.8 to 20.0, more preferably 11.8 to 15.0, and still more preferably 11.8 to 13.0. When the BS ratio at a height of 30 mm is 11.8 to 13.0, for example, it may be any one of 1.8, 12.0, or 13.0, and may also be a range with any one of these as the upper limit and another as the lower limit.

[0062] The composition (5-4) according to the first embodiment is a composition in which the BS ratio (%) at a height of 30 mm is 11.8 or more.

[0063] In the composition, the BS ratio at the height of 30 mm is preferably 11.8 to 20.0, more preferably 11.8 to 15.0, and still more preferably 11.8 to 13.0. When the BS ratio at a height of 30 mm is 11.8 to 13.0, for example, it may be any one of 11.8, 12.0, or 13.0, and may also be a range with any one of these as the upper limit and another as the lower limit.

[0064] A small BS ratio of the composition at a height of 30 mm means a slow precipitation rate of the composition. When the precipitation rate is slow, when the composition or tablet is orally administered, it is difficult to stay in the mouth, and / or it is easy to achieve good passage during swallowing, that is, it is easy to be swallowed, and / or it is easy to achieve a good feel on the tongue. For example, a composition with a BS ratio of 11.7 or less at a height of 30 mm, or a tablet containing the composition is easy to be swallowed, and / or it is easy to achieve a good feel on the tongue.

[0065] The composition (6-1) according to the first embodiment is a composition in which the BS ratio (10 mm:40 mm) (%) 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.

[0066] In the composition, the BS ratio 60 minutes after the start of measurement is preferably 1.0 or more and less than 21.0, more preferably 1.0 to 20.0, still more preferably 1.5 to 18.0, still more preferably 2.1 to 15.0, and still more preferably 2.1 to 12.0. When the BS ratio 60 minutes after the start of measurement is 1.5 to 12.0, for example, it may be any one of 1.5, 2.1, 2.7, 3.0, 5.2, 6.0, 9.0, or 12.0, and may also be a range with any one of these as the upper limit and another as the lower limit.

[0067] The composition (6-2) according to the first embodiment is a composition in which the BS ratio (%) 60 minutes after the start of measurement is 21.0 or more.

[0068] In the composition, the BS ratio 60 minutes after the start of measurement is preferably 21.0 to 30.0, more preferably 21.0 to 25.0, and still more preferably 21.0 to 24.4. When the BS ratio 60 minutes after the start of measurement is 21.0 to 24.4, for example, it may be any one of 21.0, 22.0, or 24.4, and may also be a range with any one of these as the upper limit and another as the lower limit.

[0069] The composition (6-3) according to the first embodiment is a composition in which the BS ratio (%) 60 minutes after the start of measurement is 21.0 or more.

[0070] In the composition, the BS ratio 60 minutes after the start of measurement is preferably 21.0 to 30.0, more preferably 21.0 to 25.0, and still more preferably 21.0 to 24.4. When the BS ratio 60 minutes after the start of measurement is 21.0 to 24.4, for example, it may be any one of 21.0, 22.0, or 24.4, and it may also be a range with any one of these as the upper limit and another as the lower limit.

[0071] The composition (6-4) according to the first embodiment is a composition in which the BS ratio (%) 60 minutes after the start of measurement is 21.0 or more.

[0072] In the composition, the BS ratio 60 minutes after the start of measurement is preferably 21.0 to 30.0, more preferably 21.0 to 25.0, and still more preferably 21.0 to 24.4. When the BS ratio 60 minutes after the start of measurement is 21.0 to 24.4, for example, it may be any one of 21.0, 22.0, or 24.4, and it may also be a range with any one of these as the upper limit and another as the lower limit.

[0073] A small BS ratio 60 minutes after the start of measurement of the composition means a small degree of precipitation of the composition. When the degree of precipitation is small, when the composition or tablet is orally administered, it is difficult to stay in the mouth, and / or it is easy to achieve good passage during swallowing, that is, it is easy to swallow and / or it is easy to achieve a good feel on the tongue. For example, a composition in which the BS ratio 60 minutes after the start of measurement is less than 21.0, or a tablet containing the composition is easy to swallow and / or it is easy to achieve a good feel on the tongue.

[0074] The composition (7-1) according to the first embodiment is a composition in which the powder water absorption rate (%) is less than 200.

[0075] In the composition, the powder water absorption rate (%) is preferably 40 to 190, more preferably 50 to 100, still more preferably 50 to 75, and still more preferably 50 to 70. When the powder water absorption rate (%) is 50 to 70, for example, it may be 50, 60, or 70, and it may also be a range with any one of these as the upper limit and another as the lower limit.

[0076] The composition (7-2) according to the first embodiment is a composition having a powder water absorption rate (%) of 200 or more.

[0077] In the composition, the powder water absorption rate (%) is preferably 200 to 300, more preferably 200 to 250. When the powder water absorption rate (%) is 200 to 250, for example, it may be 200, 225, or 250, or may be a range with any one of these as the upper limit and another as the lower limit.

[0078] The composition (7-3) according to the first embodiment is a composition having a powder water absorption rate (%) of 200 or more.

[0079] In the composition, the powder water absorption rate (%) is preferably 200 to 300, more preferably 200 to 250. When the powder water absorption rate (%) is 200 to 250, for example, it may be 200, 225, or 250, or may be a range with any one of these as the upper limit and another as the lower limit.

[0080] The composition (7-4) according to the first embodiment is a composition having a powder water absorption rate (%) of 200 or more.

[0081] In the composition, the powder water absorption rate (%) is preferably 200 to 300, more preferably 200 to 250. When the powder water absorption rate (%) is 200 to 250, for example, it may be 200, 225, or 250, or may be a range with any one of these as the upper limit and another as the lower limit.

[0082] In the composition, when the powder water absorption rate is low, since the powder particles are difficult to expand, the powder particles are likely to loosen, and the "disintegration in water" of the composition or tablets containing the composition is likely to be good. When the water disintegration property is good, when the composition or tablet is orally administered, it is likely to have good intraoral disintegration property, is not likely to stay in the mouth, and / or is likely to achieve good passage of the composition during swallowing, that is, it is likely to be easy to swallow, and / or is likely to achieve good texture. For example, when the powder water absorption rate is less than 200, the composition containing particles or the tablet containing the composition is likely to be easy to swallow, and / or is likely to achieve good texture.

[0083] The composition (8-1) according to the first embodiment is a composition in which the frictional force (gf) of the wet powder at a movement of 2 mm (≒ when the movement distance is zero) (hereinafter also referred to as "frictional force of the wet powder") is less than 63.

[0084] In the composition, the frictional force of the wet powder is preferably 10 or more and less than 63, more preferably 20 to 50, still more preferably 30 to 45, and even more preferably 30 to 32. When the frictional force of the wet powder is 30 to 45, for example, it may be 30, 32, 40, 41, 42, or 45, and it may also be a range with any one of these as the upper limit and another one as the lower limit.

[0085] The composition (8-2) according to the first embodiment is a composition in which the frictional force (%) of the wet powder is 63 or more.

[0086] In the composition, the frictional force of the wet powder is preferably 63 or more and less than 90, more preferably 63 to 70, still more preferably 63 to 65. When the frictional force of the wet powder is 63 to 65, for example, it may be 63, 64, or 65, and it may also be a range with any one of these as the upper limit and another one as the lower limit.

[0087] The composition (8-3) according to the first embodiment is a composition in which the frictional force (%) of the wet powder is 63 or more.

[0088] In the composition, the frictional force of the wet powder is preferably 63 or more and less than 90, more preferably 63 to 70, and still more preferably 63 to 65. When the frictional force of the wet powder is 63 to 65, for example, it may be 63, 64, or 65, and may be a range with any one of these as the upper limit and another as the lower limit.

[0089] The composition (8-4) according to the first embodiment is a composition in which the frictional force (%) of the wet powder is 63 or more.

[0090] In the composition, the frictional force of the wet powder is preferably 63 or more and less than 90, more preferably 63 to 70, and still more preferably 63 to 65. When the frictional force of the wet powder is 63 to 65, for example, it may be 63, 64, or 65, and may be a range with any one of these as the upper limit and another as the lower limit.

[0091] A low frictional force of the wet powder indicates that the powder particles contained in the composition or tablet are smooth, and agglomeration of the powder particles and / or friction between the powder particles are less likely to occur. When the frictional force of the wet powder is low, when the composition or tablet is orally administered, it is less likely to stay in the mouth, and / or it is easy to achieve good passage of the composition during swallowing, that is, it is easy to be swallowed, and / or it is easy to achieve a good feel on the tongue. For example, when the frictional force of the wet powder is less than 63, the composition or the tablet containing the composition is likely to be swallowed and / or is likely to achieve a good feel on the tongue.

[0092] The composition (9-1) according to the first embodiment is a composition in which the disintegration time in water (minutes) of the tablet containing the composition is less than 90.

[0093] In the composition, the disintegration time in water (minutes) is preferably 10 to 80, more preferably 12 to 30, and still more preferably 12 to 15. When the disintegration time in water (in minutes) is 12 to 15, for example, it may be 12, 14, or 15, or it may be a range with any one of these as the upper limit and another as the lower limit.

[0094] The composition (9-2) according to the first embodiment is a composition in which the disintegration time in water (in minutes) of the tablet containing the composition is 90 or more.

[0095] In the composition, the disintegration time in water (in minutes) is preferably 90 to 180, and more preferably 90 to 120. When the disintegration time in water is 90 to 120, for example, it may be 90, 100, 105, 110, or 120, or it may be a range with any one of these as the upper limit and another as the lower limit.

[0096] The composition (9-3) according to the first embodiment is a composition in which the disintegration time in water (in minutes) of the tablet containing the composition is 90 or more.

[0097] In the composition, the disintegration time in water (in minutes) is preferably 90 to 180, and more preferably 90 to 120. When the disintegration time in water is 90 to 120, for example, it may be 90, 100, 105, 110, or 120, or it may be a range with any one of these as the upper limit and another as the lower limit.

[0098] The composition (9-4) according to the first embodiment is a composition in which the disintegration time in water (in minutes) of the tablet containing the composition is 90 or more. In the composition, the disintegration time in water (in minutes) is preferably 90 to 180, and more preferably 90 to 120. When the disintegration time in water is 90 to 120, for example, it may be 90, 100, 105, 110, or 120, or it may be a range with any one of these as the upper limit and another as the lower limit.

[0099] When the disintegration time in water of the composition is short, the "disintegration property in water" of the composition or the tablet containing the composition tends to be good. When the water disintegration property is good, when the composition or tablet is orally administered, it is likely to have good intraoral disintegration property, is not likely to stay in the mouth, and / or is likely to achieve good passage of the composition during swallowing, that is, it is likely to be easy to swallow, and / or is likely to achieve good texture. For example, when the disintegration time (minutes) of the tablet in water is less than 90, the tablet is likely to be easy to swallow, and / or is likely to achieve good texture.

[0100] The composition (10-1) according to the first embodiment is a composition in which the hardness (N) of the tablet containing the composition is 46 or less.

[0101] In the composition, the hardness (N) of the tablet is preferably 10 to 46, more preferably 12 to 46, still more preferably 14 to 46, and still more preferably 14 to 44. When the hardness of the tablet is 14 to 44, for example, it may be 14, 17, 25, 35, 42, 43, or 44, and it may also be a range with any one of these as the upper limit and another as the lower limit.

[0102] The composition (10-2) according to the first embodiment is a composition in which the hardness (N) of the tablet containing the composition is 45 or more.

[0103] In the composition, the hardness (N) of the tablet is preferably 45 to 100, more preferably 45 to 70, and still more preferably 45 to 50. When the hardness of the tablet is 45 to 50, for example, it may be 45, 47, or 50, and it may also be a range with any one of these as the upper limit and another as the lower limit.

[0104] The composition (10-3) according to the first embodiment is a composition in which the hardness (N) of the tablet containing the composition is 45 or more.

[0105] In the composition, the hardness of the tablet is preferably 45 to 100, more preferably 45 to 70, and still more preferably 45 to 50. When the hardness of the tablet is 45 to 50, for example, it may be 45, 47, or 50, or it may be a range with any one of these as the upper limit and another as the lower limit.

[0106] The composition (10-4) according to the first embodiment is a composition containing particles in which the hardness (N) of the tablet containing the composition is 45 or more.

[0107] In the composition, the hardness (N) of the tablet is preferably 45 to 100, more preferably 45 to 70, and still more preferably 45 to 50. When the hardness of the tablet is 45 to 50, for example, it may be 45, 47, or 50, or it may be a range with any one of these as the upper limit and another as the lower limit.

[0108] When the hardness of the tablet is low, the "water disintegrability" of the composition or the tablet containing the composition tends to be good. When the water disintegrability is good, when the composition or tablet is orally administered, it is likely to have good intraoral disintegrability, is less likely to stay in the mouth, and / or is likely to achieve good passage of the composition during swallowing, that is, it is likely to be easy to swallow, and / or is likely to achieve good tongue feel. For example, when the hardness (N) of the tablet is 46 or less, the tablet is likely to be easy to swallow and / or is likely to achieve good tongue feel.

[0109] The composition (11-1) according to the first embodiment is a composition in which the water disintegrability (min / N) (water disintegration time of the tablet / hardness of the tablet) (hereinafter also referred to as "water disintegrability") of the tablet containing the composition is less than 1.9.

[0110] In the composition, the water disintegrability is preferably 0.2 to 1.8, more preferably 0.3 to 1.2, and still more preferably 0.3 to 0.9. When the water disintegrability is 0.3 to 0.9, for example, it may be any of 0.3, 0.4, 0.7, or 0.9, or it may be a range with any one of these as the upper limit and another as the lower limit.

[0111] The composition (11-2) according to the first embodiment is a composition in which the disintegration time in water (min / N) of a tablet containing the composition is 1.9 or more.

[0112] In the composition, the disintegration time 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. When the disintegration time in water is 1.9 to 2.7, for example, it may be any of 1.9, 2.2, 2.3, or 2.7, and may be a range with any one of these as the upper limit and another as the lower limit.

[0113] The composition (11-3) according to the first embodiment is a composition in which the disintegration time in water (min / N) of a tablet containing the composition is 1.9 or more.

[0114] In the composition, the disintegration time 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. When the disintegration time in water is 1.9 to 2.7, for example, it may be any of 1.9, 2.2, 2.3, or 2.7, and may be a range with any one of these as the upper limit and another as the lower limit.

[0115] The composition (11-4) according to the first embodiment is a composition in which the disintegration time in water (min / N) of a tablet containing the composition is 1.9 or more.

[0116] In the composition, the disintegration time 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. When the disintegration time in water is 1.9 to 2.7, for example, it may be any of 1.9, 2.2, 2.3, or 2.7, and may be a range with any one of these as the upper limit and another as the lower limit.

[0117] The lower the value of the disintegration time in water (min / N) of the tablet, the higher the disintegration property. When the tablet has good water disintegrability, it is likely to have good intraoral disintegrability when the composition or tablet is orally administered, is less likely to stay in the mouth, and / or is likely to achieve good passage of the composition during swallowing, that is, is likely to be easy to swallow, and / or is likely to achieve good texture. For example, when the water disintegrability of the tablet is less than 1.9, the tablet is likely to be easy to swallow and / or is likely to achieve good texture.

[0118] The composition (12-1) according to the first embodiment is a composition in which the tapped bulk density (g / cm 3 ) of the powder particles is 0.10 to 8.00.

[0119] In the composition, the tapped bulk density may be 0.50 to 8.00, 0.50 to 5.00, or 0.50 to 4.60. Further, it may be more than 2.00, 2.10 or more, 2.10 to 8.00, or 2.10 to 5.00. When the tapped bulk density is 0.50 to 4.60, for example, it may be any of 0.50, 0.55, 0.60, 0.65, 0.70, 0.80, 2.00, or 4.60, and may be a range with any one of these as the upper limit and another as the lower limit.

[0120] The composition (12-2) according to the first embodiment is a composition in which the tapped bulk density (g / cm 3 ) of the powder particles is 0.35 to 2.00.

[0121] In the composition, the tapped bulk density may be 0.35 or more and less than 0.50. When the tapped bulk density is 0.35 to 2.00, for example, it may be any of 0.35, 0.48, 0.50, 0.80, or 2.00, and may be a range with any one of these as the upper limit and another as the lower limit.

[0122] The composition (12-3) according to the first embodiment is a composition in which the tapped bulk density (g / cm 3) is a composition where it is 0.35 to 2.00.

[0123] In the said composition, the tapped bulk density may be 0.35 or more and less than 0.50. When the tapped bulk density is 0.35 to 2.00, for example, it may be any of 0.35, 0.48, 0.50, 0.80, or 2.00, and may be a range with any one of these as the upper limit and another as the lower limit.

[0124] The composition (12 - 4) according to the first embodiment is a composition where the tapped bulk density (g / cm 3 ) of the powder particles is 0.35 to 2.00.

[0125] In the said composition, the tapped bulk density may be 0.35 or more and less than 0.50. When the tapped bulk density is 0.35 to 2.00, for example, it may be any of 0.35, 0.48, 0.50, 0.80, or 2.00, and may be a range with any one of these as the upper limit and another as the lower limit.

[0126] The higher the tapped bulk density (g / cm 3 ), the easier it is for the composition to be consolidated. For example, a composition where the tapped bulk density (g / cm 3 ) is 0.10 to 8.00 or 0.35 to 2.00 is easy to fill into a composition bag or a tablet molding machine, and is easy to improve productivity.

[0127] The composition (13 - 1) according to the first embodiment is a composition where the bulk density (without tapping) (g / cm 3 ) of the powder particles is 0.10 to 5.00.

[0128] In the said composition, the bulk density (without tapping) is preferably 0.30 to 5.00, more preferably 0.34 to 4.20, and may be more than 1.40 and 4.20 or less. When the apparent density (without tapping) of the powder particles is 0.34 to 4.20, for example, it may be 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, and it may be a range with any one of these as the upper limit and another as the lower limit.

[0129] The composition (13-2) according to the first embodiment is a composition in which the apparent density (without tapping) of the powder particles (g / cm 3 ) is 0.10 to 1.40.

[0130] In the composition, the apparent density (without tapping) is preferably 0.20 to 1.40, and more preferably 0.22 to 1.40. When the apparent density (without tapping) of the powder particles is 0.22 to 1.40, for example, it may be any of 0.22, 0.32, 0.34, 0.50, or 1.40, and it may be a range with any one of these as the upper limit and another as the lower limit.

[0131] The composition (13-3) according to the first embodiment is a composition in which the apparent density (without tapping) of the powder particles (g / cm 3 ) is 0.10 to 1.40.

[0132] In the composition, the apparent density (without tapping) is preferably 0.20 to 1.40, and more preferably 0.22 to 1.40. When the apparent density (without tapping) of the powder particles is 0.22 to 1.40, for example, it may be any of 0.22, 0.32, 0.34, 0.50, or 1.40, and it may be a range with any one of these as the upper limit and another as the lower limit.

[0133] The composition (13-4) according to the first embodiment is a composition in which the apparent density (without tapping) of the powder particles (g / cm 3 ) is 0.10 to 1.40.

[0134] In the composition, the apparent density (without tapping) is preferably 0.20 to 1.40, more preferably 0.22 to 1.40. When the apparent density (without tapping) of the powder particles is 0.22 to 1.40, for example, it may be any of 0.22, 0.32, 0.34, 0.50, or 1.40, and may be a range with any one of these as the upper limit and another as the lower limit.

[0135] The higher the apparent density (without tapping) (g / cm 3 ), the easier it is for the composition to be compacted. For example, a composition with an apparent density (without tapping) (g / cm 3 ) of 0.10 to 5.00 or 0.10 to 1.40 is easy to fill into a composition bag or a tablet molding machine, and is easy to improve productivity.

[0136] The composition (14-1) according to the first embodiment is a composition having a degree of compressibility of 1.0 to 1.5.

[0137] In the composition, the degree of compressibility may be 1.0 or more and less than 1.4, or may be 1.0 to 1.3. When the degree of compressibility is 1.0 to 1.5, for example, it may be any of 1.0, 1.1, 1.2, 1.3, 1.4, or 1.5, and may be a range with any one of these as the upper limit and another as the lower limit.

[0138] The composition (14-2) according to the first embodiment is a composition having a degree of compressibility of 1.4 or more.

[0139] In the composition, the degree of compressibility is preferably 1.4 to 2.0, more preferably 1.4 to 1.6, and may be more than 1.5 and 1.6 or less. When the degree of compressibility is 1.4 to 1.6, for example, it may be any of 1.4, 1.5, or 1.6, and may be a range with any one of these as the upper limit and another as the lower limit.

[0140] The composition (14-3) according to the first embodiment is a composition having a degree of compressibility of 1.4 or more.

[0141] In the composition, the degree of compressibility is preferably 1.4 to 2.0, more preferably 1.4 to 1.6, and may be more than 1.5 and less than or equal to 1.6. When the degree of compressibility is 1.4 to 1.6, for example, it may be any of 1.4, 1.5, or 1.6, and may be a range with any one of these as the upper limit and another as the lower limit.

[0142] The composition (14-4) according to the first embodiment is a composition having a degree of compressibility of 1.4 or more.

[0143] In the composition, the degree of compressibility is preferably 1.4 to 2.0, more preferably 1.4 to 1.6, and may be more than 1.5 and less than or equal to 1.6. When the degree of compressibility is 1.4 to 1.6, for example, it may be any of 1.4, 1.5, or 1.6, and may be a range with any one of these as the upper limit and another as the lower limit.

[0144] The lower the degree of compressibility of the composition, the less likely the composition is to be compressed when vibration is applied to the composition, and the less likely the shape of the bag packaging the composition is to change. As a result, it becomes easier to stack the bags packaging the composition and easier to transport. For example, a composition having a degree of compressibility of 1.0 to 1.5 is easy to stack and transport the bag packaging the composition. Furthermore, the low degree of compressibility of the composition means that when vibration is applied to the powder particles contained in the composition or tablet, the powder layer is less likely to change. When the degree of compressibility of the composition is low, it becomes easier to fill the composition bags or tablet molding machines, and it becomes easier to improve productivity.

[0145] The composition (15-1) according to the first embodiment is a composition having an angle of repose (°) of less than 57.0.

[0146] In the composition, the angle of repose (°) is preferably 40.0 to 56.0, more preferably 45.0 to 50.0, and even more preferably 46.9 to 48.3. When the angle of repose (°) is 46.9 to 48.3, for example, it may be any of 46.9, 47.1, 47.3, 47.5, 47.7, 47.9, 48.1, or 48.3, and it may also be a range with any one of these as the upper limit and another as the lower limit.

[0147] The composition (15-2) according to the first embodiment is a composition having an angle of repose (°) of 57.0 or more.

[0148] In the composition, the angle of repose (°) is preferably 57.0 to 70.0, more preferably 57.0 to 60.0, and even more preferably 57.0 to 59.1. When the angle of repose (°) is 57.0 to 59.1, for example, it may be any of 57.0, 57.8, 58.3, 58.7, or 59.1, and it may also be a range with any one of these as the upper limit and another as the lower limit.

[0149] The composition (15-3) according to the first embodiment is a composition having an angle of repose (°) of 57.0 or more.

[0150] In the composition, the angle of repose (°) is preferably 57.0 to 70.0, more preferably 57.0 to 60.0, and even more preferably 57.0 to 59.1. When the angle of repose (°) is 57.0 to 59.1, for example, it may be any of 57.0, 57.8, 58.3, 58.7, or 59.1, and it may also be a range with any one of these as the upper limit and another as the lower limit.

[0151] The composition (15-4) according to the first embodiment is a composition having an angle of repose (°) of 57.0 or more.

[0152] In the composition, the angle of repose (°) is preferably 57.0 to 70.0, more preferably 57.0 to 60.0, and even more preferably 57.0 to 59.1. When the angle of repose (°) is 57.0 to 59.1, for example, it may be any of 57.0, 57.8, 58.3, 58.7, or 59.1, and it may be a range with any one of these as the upper limit and another as the lower limit.

[0153] 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 less likely to occur. When the angle of repose is small, when the composition or tablet is orally administered, it is less likely to stay in the mouth, and / or it is easy to achieve good passage of the composition during swallowing, that is, it is easier to swallow, and / or it is easy to achieve a good feel on the tongue. Therefore, for example, a composition with an angle of repose (°) less than 57.0, or a tablet containing the composition is likely to be easy to swallow and / or is likely to achieve a good feel on the tongue. Furthermore, when the angle of repose is small, since the powder particles are smooth and friction between the powder particles is less likely to occur, the composition is likely to be compacted. For example, a composition containing particles with an angle of repose (°) less than 57.0 is easy to fill into a composition bag or a tablet molding machine, and it is easy to improve productivity.

[0154] The composition (16-1) according to the first embodiment is a composition having a crumbling angle (°) greater than 31.8.

[0155] In the said composition, the crumbling angle (°) is preferably 32.0 or more, more preferably 32.0 to 44.0, still more preferably 32.0 to 40.0, and even more preferably 33.2 to 35.9. When the crumbling angle (°) is 33.2 to 35.9, for example, it may be any of 33.2, 33.6, 34.0, 34.4, 34.8, 35.3, 35.6, or 35.9, and it may be a range with any one of these as the upper limit and another as the lower limit.

[0156] The composition (16-2) according to the first embodiment is a composition having a crumbling angle (°) less than or equal to 31.8.

[0157] In the composition, the angle of collapse (°) is preferably 20.0 to 31.8, more preferably 25.0 to 31.8, still more preferably 29.9 to 31.8. When the angle of collapse (°) is 29.9 to 31.8, for example, it may be any of 29.9, 30.3, 30.6, 31.1, or 31.8, and may also be a range with any one of these as the upper limit and another one as the lower limit.

[0158] The composition (16-3) according to the first embodiment is a composition having an angle of collapse (°) of 31.8 or less.

[0159] In the composition, the angle of collapse (°) is preferably 20.0 to 31.8, more preferably 25.0 to 31.8, still more preferably 29.9 to 31.8. When the angle of collapse (°) is 29.9 to 31.8, for example, it may be any of 29.9, 30.3, 30.6, 31.1, or 31.8, and may also be a range with any one of these as the upper limit and another one as the lower limit.

[0160] The composition (16-4) according to the first embodiment is a composition having an angle of collapse (°) of 36.0 or more.

[0161] In the composition, the angle of collapse (°) is preferably 36.0 to 50.0, more preferably 36.0 to 45.0.

[0162] When the angle of collapse (°) is 36.0 to 45.0, for example, it may be 45.0.

[0163] When the angle of collapse is more than 31.8, when the composition or tablet is orally administered, it is difficult to stay in the mouth, and / or it is easy to achieve good passage of the composition during swallowing, that is, it is easy to swallow, and / or it is easy to achieve good tongue feel. Furthermore, the larger the collapse angle, the easier it is for the "difference angle" to become smaller. The fact that the "difference angle" is small means that when vibration is applied to the powder particles contained in the composition or tablet, the powder layer is less likely to change, and the composition is likely to be compacted. For example, a composition with a collapse angle (°) exceeding 31.8 is easy to fill into a composition bag or a tablet molding machine, and it is easy to improve productivity. Furthermore, the larger the collapse angle, the lower the dispersibility (degree of powder scattering) of the composition tends to be, and the easier it is to handle. For example, when the collapse angle exceeds 31.8, the dispersibility (degree of powder scattering) of the composition tends to be low, and it is easy to handle. Also, the larger the collapse angle, the easier it is for the composition to be compacted. For example, when the collapse angle of the composition exceeds 31.8, it is easy to fill into a composition bag or a tablet molding machine, and it is easy to improve productivity.

[0164] The composition (17-1) according to the first embodiment is a composition in which the difference angle (°) (angle of repose - collapse angle) (hereinafter also referred to as the "difference angle"), which is the difference between the angle of repose and the collapse angle, is less than 25.2.

[0165] In the composition, 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. When the difference angle (°) is 12.3 to 13.7, for example, it may be any of 12.3, 12.5, 12.7, 12.9, 13.1, 13.3, 13.5, or 13.7, and it may also be a range with any one of these as the upper limit and another as the lower limit.

[0166] The composition (17-2) according to the first embodiment is a composition in which the difference angle (°) is 25.2 or more.

[0167] In the composition, the difference angle (°) is preferably 25.2 to 30.0, more preferably 25.2 to 29.2. When the difference angle (°) is 25.2 to 29.2, for example, it may be any of 25.2, 26.7, 27.7, 28.5, or 29.2, and it may also be a range with any one of these as the upper limit and another as the lower limit.

[0168] The composition (17-3) according to the first embodiment is a composition having a difference angle (°) of 25.2 or more.

[0169] In the composition, the difference angle (°) is preferably 25.2 to 30.0, more preferably 25.2 to 29.2. When the difference angle (°) is 25.2 to 29.2, for example, it may be any of 25.2, 26.7, 27.7, 28.5, or 29.2, and may be a range with any one of these as the upper limit and another as the lower limit.

[0170] The composition (17-4) according to the first embodiment is a composition having a difference angle (°) of less than 25.2.

[0171] In the composition, 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. When the difference angle (°) is 12.0 to 14.1, for example, it may be any of 12.0, 12.8, 13.3, 13.7, or 14.1, and may be a range with any one of these as the upper limit and another as the lower limit.

[0172] The small difference angle (°) indicates that the powder particles contained in the composition or tablet are smooth and friction between the powder particles is less likely to occur. When the difference angle is small, when the composition or tablet is orally administered, it is less likely to stay in the mouth, and / or it is easy to realize good passage of the composition during swallowing, that is, it is easy to be swallowed, and / or it is easy to realize good tongue feel. For example, a composition having a difference angle (°) of less than 25.0, or a tablet containing the composition is easy to be swallowed and / or easy to realize good tongue feel. Furthermore, when the difference angle is small, when vibration is applied to the powder particles contained in the composition or tablet, the powder layer is less likely to change and the composition is easily compacted. For example, a composition having a difference angle (°) of less than 25.0 is easy to fill into a composition bag or a tablet molding machine, and is easy to improve productivity.

[0173] The composition (18-1) according to the first embodiment is a composition in which the stress (kN / m 2 ) at a displacement strain rate of 10% of the tablets containing the composition is 1809 to 2405.

[0174] When the stress (kN / m 2 ) at a displacement strain rate of 10% is 1809 to 2405, for example, it may be 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, and may be a range with any one of these as the upper limit and another as the lower limit.

[0175] The composition (18-2) according to the first embodiment is a composition in which the stress (kN / m 2 ) at a displacement strain rate of 10% of the tablets containing the composition is 1859 to 2319.

[0176] When the stress (kN / m 2 ) at a displacement strain rate of 10% is 1859 to 2319, for example, it may be any of 1859, 1985, 2110, 2193, 2227, 2260, 2294, 2295, 2296, 2297, 2298, 2299, 2300, or 2319, and may be a range with any one of these as the upper limit and another as the lower limit.

[0177] The composition (18-3) according to the first embodiment is a composition in which the stress (kN / m 2 ) at a displacement strain rate of 10% of the tablets containing the composition is 1567 to 1776.

[0178] When the stress (kN / m 2 ) at a displacement strain rate of 10% is 1567 to 1776, for example, it may be any of 1567, 1692, or 1776, and may be a range with any one of these as the upper limit and another as the lower limit.

[0179] The composition (18-4) according to the first embodiment is a composition in which the stress (kN / m 2 ) at a moving strain rate of 10% of the tablet containing the composition is 1483 to 2528.

[0180] When the stress (kN / m 2 ) at a moving strain rate of 10% is 1483 to 2528, for example, it may be any of 1483, 1525, 1609, 1650, 1734, 2444, or 2528, and may be a range with any one of these as the upper limit and another one as the lower limit.

[0181] The composition (19-1) according to the first embodiment is a composition in which the stress (kN / m 2 ) at a moving strain rate of 18% of the tablet containing the composition is less than 1846.

[0182] In the composition, the stress (kN / m 2 ) at a moving strain rate of 18% is preferably 500 to 1845, more preferably 1000 to 1500, still more preferably 1000 to 1200, and even more preferably 1000 to 1100. When the stress (kN / m 2 ) at a moving strain rate of 18% is 1000 to 1100, for example, it may be 1069.

[0183] The composition (19-2) according to the first embodiment is a composition in which the stress (kN / m 2 ) at a moving strain rate of 18% of the tablet containing the composition is more than 1069.

[0184] In the composition, the stress (kN / m 2 ) at a moving strain rate of 18% is preferably 1100 to 2500, more preferably 1200 to 2000, and still more preferably 1500 to 2000. When the stress (kN / m 2 ) at a moving strain rate of 18% is 1500 to 2000, for example, it may be 1846.

[0185] The composition (19-3) according to the first embodiment is a composition in which the stress (kN / m 2 ) at a moving strain rate of 18% of the tablets containing the composition exceeds 1069.

[0186] In the said composition, the stress (kN / m 2 ) at a moving strain rate of 18% is preferably 1100 to 2500, more preferably 1200 to 2000, still more preferably 1500 to 2000. The stress (kN / m 2 ) at a moving strain rate of 18% may be, for example, 1846 when it is 1500 to 2000.

[0187] The composition (19-4) according to the first embodiment is a composition in which the stress (kN / m 2 ) at a moving strain rate of 18% of the tablets containing the composition is 500 to 2500.

[0188] In the said composition, the stress (kN / m 2 ) at a moving strain rate of 18% is preferably 1000 to 2000, more preferably 1069 to 1846. The stress (kN / m 2 ) at a moving strain rate of 18% may be, for example, 1069 or 1846 when it is 1069 to 1846.

[0189] The composition (20-1) according to the first embodiment is the stress resistance (%) of the tablets containing the composition (the ratio (%) of the stress (kN / m 2 ) at a moving strain rate of 18% to the stress (kN / m 2 ) at a moving strain rate of 10%)(100×(the stress (kN / m 2 )) / (the stress (kN / m 2 ))) at a moving strain rate of 10%)) is less than 62.

[0190] In the said composition, the stress resistance (%) of the tablets containing the composition is preferably 20 or more and less than 62, more preferably 30 or more and less than 62, still more preferably 40 to 61, still more preferably 41 to 61, still more preferably 42 to 60, still more preferably 44 to 59. When the stress resistance (%) is 44 to 59, for example, it may be any of 44, 45, 47, 48, 50, 52, 53, 55, 56, or 59, and may be a range with any one of these as the upper limit and another as the lower limit. It may also be.

[0191] The composition (20-2) according to the first embodiment is a composition in which the stress resistance (%) of the tablet containing the composition is more than 76 and less than 104.

[0192] In the composition, the stress resistance (%) is preferably 77 to 100, more preferably 80 to 99. When the stress resistance (%) is 80 to 99, for example, it may be any of 80, 82, 83, 84, 88, 93, or 99, and may be a range with any one of these as the upper limit and another as the lower limit.

[0193] The composition (20-3) according to the first embodiment is a composition in which the stress resistance (%) of the tablet containing the composition is more than 99.

[0194] In the composition, the stress resistance (%) is preferably 100 to 130, more preferably 100 to 120, and even more preferably 104 to 118. When the stress resistance (%) is 104 to 118, for example, it may be any of 104, 109, or 118, and may be a range with any one of these as the upper limit and another as the lower limit.

[0195] The composition (20-4) according to the first embodiment is a composition in which the stress resistance (%) of the tablet containing the composition is more than 59 and less than 80.

[0196] In the composition, the stress resistance (%) is preferably 60 to 79, more preferably 62 to 76. When the stress resistance (%) is 62 to 76, for example, it may be any of 62, 65, 66, 70, 72, 73, or 76, and may be a range with any one of these as the upper limit and another as the lower limit.

[0197] The higher the value of the stress resistance (%) of the tablet, the more flexible the shape can change with respect to external force, and the less likely the tablet is to be damaged by impact or compression. Therefore, when the stress resistance of the tablet is large, the transportability tends to be high. For example, when the stress resistance (%) exceeds 76, the transportability tends to be high.

[0198] The composition (21-1) according to the first embodiment is a composition having a dispersity (%) of less than 44.

[0199] In the composition, the dispersity is preferably 40 or less, more preferably 30 or less, still more preferably 22 or less, and still more preferably 17 to 22. When the dispersity is 18 to 22, for example, it may be any of 17, 18, 19, 20, 21, or 22, and may be a range with any one of these as the upper limit and another one as the lower limit.

[0200] The composition (21-2) according to the first embodiment is a composition having a dispersity (%) of 44 to 49.

[0201] In the composition, the dispersity is preferably 45 to 48, more preferably 46 to 47. When the dispersity is 46 to 47, for example, it may be 46 or 47.

[0202] The composition (21-3) according to the first embodiment is a composition having a dispersity (%) of 44 to 49.

[0203] When the dispersity is 44 to 49, for example, it may be any of 44, 45, 46, 47, 48, or 49, and may be a range with any one of these as the upper limit and another one as the lower limit.

[0204] The composition (21-4) according to the first embodiment is a composition having a dispersity (%) of less than 17.

[0205] In the composition, the degree of dispersion is preferably 5 to 15, more preferably 7 to 10, and even more preferably 9 to 10. When the degree of dispersion is 9 to 10, for example, it may be 9 or 10.

[0206] A composition with a low degree of dispersion (%) has a low degree of powder scattering and is likely to be easy to handle. Therefore, for example, a composition with a degree of dispersion of less than 44, preferably 22 or less, and more preferably less than 17 is likely to be easy to handle.

[0207] The compositions (22-1) to (22-4) according to the first embodiment are compositions having a weight retention rate of 50% or more and 98% or less, preferably 90% to 98%, as determined by thermogravimetric analysis when heated from 25°C to 100°C.

[0208] The compositions (23-1) to (23-4) according to the first embodiment are compositions having a weight retention rate of 50% or more and 98% or less, preferably 80% to 97%, as determined by thermogravimetric analysis when heated from 25°C to 200°C.

[0209] The composition (24-1) according to the first embodiment is a composition having a weight retention rate of 50% or more and 98% or less, preferably 65% to 95%, as determined by thermogravimetric analysis when heated from 25°C to 300°C.

[0210] The compositions (24-2) to (24-4) according to the first embodiment are compositions having a weight retention rate of 50% or more and 98% or less, preferably 90% to 95%, as determined by thermogravimetric analysis when heated from 25°C to 300°C.

[0211] The composition (25-1) according to the first embodiment is a composition having a weight retention rate of 5% or more and 80% or less, preferably 8% to 68%, as determined by thermogravimetric analysis when heated from 25°C to 400°C.

[0212] The compositions (25-2) to (25-4) according to the first embodiment are compositions having a weight residue ratio of 5% or more and 50% or less, preferably 8% to 35%, as determined by thermogravimetric analysis when the temperature is raised from 25°C to 400°C.

[0213] The composition (26-1) according to the first embodiment is a composition having a weight residue ratio of 5% or more and 70% or less, preferably 5% to 45%, as determined by thermogravimetric analysis when the temperature is raised from 25°C to 500°C.

[0214] The compositions (26-2) to (26-4) according to the first embodiment are compositions having a weight residue ratio of 5% or more and 50% or less, preferably 5% to 35%, as determined by thermogravimetric analysis when the temperature is raised from 25°C to 500°C.

[0215] The composition (27-1) according to the first embodiment is a composition having a weight residue ratio of 5% or more and 50% or less, preferably 5% to 45%, as determined by thermogravimetric analysis when the temperature is raised from 25°C to 600°C.

[0216] The compositions (27-2) to (27-4) according to the first embodiment are compositions having a weight residue ratio of 5% or more and 50% or less, preferably 5% to 45%, as determined by thermogravimetric analysis when the temperature is raised from 25°C to 600°C.

[0217] The composition (28-1) according to the first embodiment is a composition having an electromotive force of -10 μV or more and 0 μV or less, preferably -8 μV to -1 μV, when the temperature is raised from 25°C to 100°C.

[0218] The compositions (28-2) to (28-4) according to the first embodiment are compositions having an electromotive force of -5 μV or more and 0 μV or less, preferably -3 μV to -1 μV, when the temperature is raised from 25°C to 100°C.

[0219] The composition (29-1) according to the first embodiment is a composition having an electromotive force of -10 μV or more and 0 μV or less, preferably -8 μV to -1 μV, when the temperature is raised from 25°C to 200°C.

[0220] The compositions (29-2) to (29-4) according to the first embodiment are compositions having an electromotive force of -5 μV or more and 0 μV or less when the temperature is raised from 25°C to 200°C, preferably -3 μV to -1 μV.

[0221] The composition (30-1) according to the first embodiment is a composition having an electromotive force of -10 μV or more and 5 μV or less when the temperature is raised from 25°C to 300°C, preferably -8 μV to 3 μV.

[0222] The compositions (30-2) to (30-4) according to the first embodiment are compositions having an electromotive force of -10 μV or more and 0 μV or less when the temperature is raised from 25°C to 300°C, preferably -8 μV to 0 μV.

[0223] The composition (31-1) according to the first embodiment is a composition having an electromotive force of -10 μV or more and 15 μV or less when the temperature is raised from 25°C to 400°C, preferably -10 μV to 10 μV.

[0224] The compositions (31-2) to (31-4) according to the first embodiment are compositions having an electromotive force of -10 μV or more and 0 μV or less when the temperature is raised from 25°C to 400°C, preferably -10 μV to -5 μV.

[0225] The composition (32-1) according to the first embodiment is a composition having an electromotive force of -10 μV or more and 20 μV or less when the temperature is raised from 25°C to 500°C, preferably -10 μV to 15 μV.

[0226] The compositions (32-2) to (32-4) according to the first embodiment are compositions having an electromotive force of -10 μV or more and 0 μV or less when the temperature is raised from 25°C to 500°C, preferably -10 μV to -3 μV.

[0227] The composition (33-1) according to the first embodiment is a composition having an electromotive force of -10 μV or more to 20 μV or less when the temperature is raised from 25°C to 600°C, preferably -8 μV to 18 μV.

[0228] The compositions (33-2) to (33-4) according to the first embodiment are compositions having an electromotive force of -10 μV or more and 5 μV or less when heated from 25°C to 600°C, preferably -8 μV to 3 μV.

[0229] The compositions (34-1) to (34-4) according to the first embodiment are compositions containing a heat-resistant substance, a semi-heat-resistant substance, and / or a non-heat-resistant substance.

[0230] The "heat-resistant substance" is a substance that remains at 400°C or higher when the composition containing it is heated from room temperature (25°C). The "non-heat-resistant substance" is a substance that disappears at less than 300°C when the composition containing it is heated from room temperature (25°C). The "semi-heat-resistant substance" is a substance that disappears between 300°C and 400°C when the composition containing it is heated from room temperature (25°C).

[0231] The compositions (34-1) to (34-4) contain a heat-resistant substance, a semi-heat-resistant substance, and / or a non-heat-resistant substance. Preferably, the composition contains two or more of a heat-resistant substance, a semi-heat-resistant substance, and a non-heat-resistant substance. More preferably, the composition contains a heat-resistant substance, a semi-heat-resistant substance, and a non-heat-resistant substance. Non-limiting examples of heat-resistant substances, semi-heat-resistant substances, and non-heat-resistant substances are as follows.

[0232] Non-limiting examples of heat-resistant substances include inorganic substances. The inorganic substances are not limited within the range acceptable for food compositions or pharmaceutical compositions. Non-limiting examples include magnesium aluminum silicate, aluminum magnesium silicate, magnesium hydroxide, anhydrous sodium carbonate, sodium hydroxide, sodium hydrogen carbonate, sodium carbonate hydrate, Fe-Mg-based hydrotalcite-like compounds, and Al-Mg-based hydrotalcite-like compounds. The heat-resistant substance may be one kind or a combination of two or more kinds. When the compositions (34-1) to (34-4) contain natural-derived components such as plant-derived cellulose, examples of the heat-resistant substances may also include inorganic substances contained in the natural-derived components. In order to adjust the content of the inorganic substances, natural-derived components such as cellulose with the adjusted content of the inorganic substances can also be used.

[0233] Non-limiting examples of the quasi heat-resistant substances include highly crystalline substances. The highly crystalline substances include polymeric carbohydrates. The polymeric carbohydrates are polysaccharides (including oligosaccharides), and non-limiting examples thereof include starch formed by polymerization of D-glucose, glycogen, cellulose, etc., chitin formed by polymerization of N-acetylglucosamine, chitosan obtained by deacetylating chitin, etc. The polymeric carbohydrates are not limited by their functions or roles, and may be carbohydrates that perform any function of energy storage (such as starch, glycogen, etc.), forming a living body, immunity, cell-to-cell communication, or are involved in any function. In one embodiment, the quasi heat-resistant substance may be cellulose, or a combination of cellulose and any one or more of the other above components. The quasi heat-resistant substance may be one type or a combination of two or more types.

[0234] Non-limiting examples of the non heat-resistant substances include proteins, and low molecular weight carbohydrates, etc. The low molecular weight carbohydrates are monosaccharides, and the monosaccharides are not limited by the number of carbon atoms in the carbon chain structure of trioses, tetroses, pentoses, hexoses, and may be aldoses having an aldehyde group (including D-glucose, D-ribose, etc.), ketoses having a ketone group (including D-fructose, etc.), etc. The non heat-resistant substances may be one type or a combination of two or more types.

[0235] The compositions (34-1) to (34-4) preferably contain heat-resistant substances such as ash and inorganic substances, quasi-heat-resistant substances such as cellulose and highly crystalline substances, and non-heat-resistant substances such as proteins and low-molecular carbohydrates. The compositions (34-1) to (34-4) preferably contain the heat-resistant substances, quasi-heat-resistant substances, and non-heat-resistant substances 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 substances, quasi-heat-resistant substances, and non-heat-resistant substances can be appropriately determined by those skilled in the art. The total content of the heat-resistant substances, quasi-heat-resistant substances, and non-heat-resistant substances is preferably 100% by weight. When the composition contains the heat-resistant substances, quasi-heat-resistant substances, and non-heat-resistant substances in amounts of 1% by weight or more, less than 95% by weight, and 5% by weight or more, respectively, the composition is likely to exhibit good swallowability, and / or a good tongue feel effect, and / or effects of good fillability, low dispersibility, and / or high transportability when orally administered. Here, since the composition contains natural-derived components such as cellulose, the inorganic substances and the like contained in the natural-derived components may also be included. In order to adjust the content of the inorganic substances, natural-derived components such as cellulose with the content of the inorganic substances adjusted can also be used.

[0236] The composition containing the heat-resistant substances, quasi-heat-resistant substances, and non-heat-resistant substances in the above-mentioned contents can be prepared by blending a material containing one or more selected from the heat-resistant substances, quasi-heat-resistant substances, and non-heat-resistant substances in an arbitrary amount. Examples of the materials containing only heat-resistant substances such as ash include titanium oxide and calcium carbonate. The materials containing the heat-resistant substances, quasi-heat-resistant substances, and / or non-heat-resistant substances are plant-derived components. The plant-derived components may be components derived from natural plants or plant-derived components produced by subjecting plants to processing treatments. For example, wheat germ, oats, crystalline cellulose (e.g., PH grade of Theolas (registered trademark) of Asahi Kasei), powdered cellulose (e.g., KC Flock W-50 of Nippon Paper Industries Co., Ltd.), soybean compositions (soybeans or soybean-derived components), and truffle-derived compositions (e.g., truffle powder) can be exemplified. 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. For example, wheat germ contains 5 to 25% by weight of heat-resistant substances, 30 to 70% by weight of semi-heat-resistant substances, and 25 to 45% by weight of non-heat-resistant substances. For example, oats contain 5 to 20% by weight of heat-resistant substances, 45 to 75% by weight of semi-heat-resistant substances, and 20 to 45% by weight of non-heat-resistant substances. For example, crystalline cellulose (Ceolus of Asahi Kasei) contains 1 to 10% by weight of heat-resistant substances, 70 to 98% by weight of semi-heat-resistant substances, and 0.1 to 5% by weight of non-heat-resistant substances. For example, powdered cellulose (KC Flock W-50 of Nippon Paper Industries Co., Ltd.) contains 1 to 10% by weight of heat-resistant substances, 70 to 90% by weight of semi-heat-resistant substances, and 5 to 20% by weight of non-heat-resistant substances. Also, for example, the soy composition contains 1 to 20% by weight of heat-resistant substances, 60 to 90% by weight of semi-heat-resistant substances, and 1 to 20% by weight of non-heat-resistant substances. For example, truffle powder contains 0 to 10% by weight of heat-resistant substances, 5 to 50% by weight of semi-heat-resistant substances, and 45 to 95% by weight of non-heat-resistant substances.

[0237] When preparing the composition, the specific amounts or ratios 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. For example, the content of heat-resistant substances such as ash can be measured using a known ash method. For example, the content of semi-heat-resistant substances such as cellulose can be measured using a known method for quantifying α-cellulose. For example, the content of non-heat-resistant substances such as hemicellulose can be calculated by subtracting the value obtained by measuring known α-cellulose from the value obtained by 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 a desired ratio.

[0238] 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 (12-4), (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), (23-1) 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), (32-1) to (32-4), (33-1) to (33-4), (34-1) to (34-4) (hereinafter collectively referred to as the compositions (1-1) to (34-4)) each tend to have good swallowability and / or a good tongue feel when orally administered, and / or tend to have effects of good fillability, low dispersibility, and / or high transportability. Therefore, they are suitable as compositions or tablets for oral administration. Also, based on good fillability, low dispersibility, and / or high transportability, it becomes easier to fill the composition into a composition bag or a tablet molding machine, easier to improve productivity, and / or the composition or tablet tends to be suitable for transportation.

[0239] The above compositions (the compositions (1-1) to (34-4)) may be compositions that combine the characteristics of two or more compositions. For example, it may be a composition comprising the composition (1-1) and the characteristics of one or more other compositions (one or more of the compositions (1-2) to (2-4)). More specifically, for example, it may be a composition having one or more features of the composition (1-1) and the compositions (1-1) to (1-4), or it may be a composition having one or more features of the composition (1-1) and the compositions (2-1) to (33-4). It may also be a composition having one or more features of the composition (1-1) and the compositions (1-1) to (1-4) and one or more features of the compositions (2-1) to (34-4).

[0240] In one embodiment, the composition has the features of the composition (1-1) or (1-2) and the features of the composition (4-1) or (4-4). Such a composition is likely to have good swallowability, good texture, and / or good fillability. In addition, since the degree of dispersion (low degree of powder scattering) is likely to be low, handling is likely to be easy. In one embodiment, the composition has the features of the composition (1-1) or (1-2) and the features of the composition (4-2) or (4-3). Tablets containing such a composition are likely to have high vibration resistance, and thus, high transportability. In one embodiment, the composition has the features of the composition (1-3) or (1-4) and the features of the composition (4-2) or (4-3). Tablets containing such a composition are likely to have high vibration resistance, and thus, high transportability. In one embodiment, the composition has the features of the composition (1-3) or (1-4) and the features of the composition (4-1) or (4-4). Such a composition is likely to have good fillability. In addition, since the degree of dispersion (low degree of powder scattering) is likely to be low, handling is likely to be easy.

[0241] The composition according to the first embodiment is preferably an oral composition. By being used orally, as described above, it can exhibit the effects of good swallowability and / or good texture.

[0242] As will also be described in the second embodiment, the composition according to the first embodiment can take various forms according to its use. In one embodiment, the composition is preferably in the form of a powder composition or a tablet, more preferably in the form of a tablet. By being in the form of a powder composition or a tablet, the composition according to the first embodiment is likely to exhibit good swallowability and / or a good texture effect when in the form of a tablet.

[0243] The composition according to the first embodiment may be in the state of a mixture (for example, a slurry) in which the particles are mixed with a liquid or in the state of a solution in which the particles are dissolved in a solvent, within the range of including or consisting of the particles described above. In that case, the particles do not necessarily 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.

[0244] <Method for Measuring Parameters and Method for Adjusting the Same> In this specification, unless otherwise specified, various parameters are values measured as follows.

[0245] 〔Particle Parameters〕 Put a sample of the composition and ion-exchanged water into a beaker (for example, 2 g of the composition and 20 ml of ion-exchanged water), disperse it with ultrasonic waves (output 90 W) for 2 minutes, and use this as a measurement solution (suspension). For samples with poor dispersibility, after shaking the bottle by hand and standing for 15 minutes, collect the supernatant and put it into the beaker together with ion-exchanged water. Note that a sample prepared to a concentration of 10% by weight is used in advance.

[0246] Using a dynamic image analysis device Parshear Analyzer (manufactured by Hosokawa Micron Corporation), by the flat sheath flow method, form a sample suspension of the composition into a flat sample flow with a sheath liquid, irradiate it with stroboscopic light to capture the particles as still images, and obtain particle parameters and particle shape parameters by image analysis. The measurement conditions are lens magnification standard (10 times), measurement range 0.5 to 300 μm, and the number of detected particles 10,000. The detected particles are regarded as the particles in the composition according to this embodiment. Also, the particles may include bubbles generated in the solvent and the like.

[0247] (Feret diameter) When the particles of the composition imaged as described above are circumscribed by a rectangle, the length of the long side is defined as the "vertical width", and the average value of the values of 1,000 particles with small values among 10,000 measured particles is calculated and defined as the "Feret diameter (vertical width) (μm)". Also, when the particles of the composition imaged as described above are circumscribed by a rectangle, the length of the short side is defined as the "horizontal width", and the average value of the values of 1,000 particles with small values among 10,000 measured particles is calculated and defined as the "Feret diameter (horizontal width) (μm)".

[0248] (Aspect ratio) The aspect ratio of the particles is the value calculated by the following formula from the Feret diameter of the above particles. Aspect ratio of particles = 100 × (Feret diameter (vertical width) of particles) ÷ (Feret diameter (horizontal width))

[0249] (Particle area) Particle area (μm 2 ) represents the area of the particles and is the average value of the values of 1,000 particles with small values among 10,000 measured particles.

[0250] The Feret diameter (vertical and horizontal widths) and the particle area can be adjusted by adjusting the grinding time, grinding strength, etc. in the grinding process of the material components when preparing the composition. Specifically, by reducing the number of grinding steps, shortening the grinding time, and / or weakening the grinding strength, the particle area, the Feret diameter (vertical width) of the particles, and / or the Feret diameter (horizontal width) can be increased. Since the aspect ratio is calculated from the values of the Feret diameter (vertical width) and the Feret diameter (horizontal width), it can be adjusted by adjusting the Feret diameter (vertical and horizontal widths). That is, the aspect ratio can be adjusted by adjusting the grinding time, grinding strength, etc. in the grinding process of the material components when preparing the composition.

[0251] Here, the "Feret diameter (vertical width and horizontal width)" and the "particle area" may be measured independently, that is, the Feret diameter (vertical width and horizontal width) and the particle area may be values based on the measurement of different particles. Therefore, the tendency of the particle area of the particles and the tendency of the Feret diameter (vertical width and / or horizontal width) may not necessarily coincide in the same sample or within the same sample group.

[0252] 〔Backscatter value (BS value)〕 Put 2 g of the sample of the composition and 20 ml of pure water into a test bottle (height 70 mm, diameter 25 mm, capacity 20 ml), set it on a shaker (manufactured by Tokyo Rika Kikai Co., Ltd., MMS-3020), and shake it at 200 times / min for 1 minute. Immediately, set the prepared sample (in the bottle as it is) on a stability tester ST-1 (manufactured by Eihiro Seiki Co., Ltd.), perform light irradiation (light source wavelength: 870 nm), and evaluate the solution stability by measuring the backscattered light (Backscatter value, BS value, %). The measurement conditions are as follows. · Height of the liquid surface to be scanned: 0 to 40 mm from the bottom of the bottle · Scanning frequency: 30 seconds · Measurement time: 1 hour

[0253] Here, a large BS value means that the light is more reflected or scattered by the scattering medium. When this value is large in the measurement of suspended matter in water, it generally indicates a high concentration of dispersed particles.

[0254] (Sedimentation rate: BS ratio at a height of 30 mm) The sedimentation rate (BS ratio (1 minute: 5 minutes) at a height of 30 mm from the bottom (30 mm point from the bottom)) is a value calculated by the following formula based on the above measurement. Sedimentation rate (%) = 100 × (BS value at the 30 mm point from the bottom 1 minute after the start of measurement) ÷ (BS value at the 30 mm point from the bottom 5 minutes after the start of measurement) The larger the BS ratio (1 minute: 5 minutes) at a height of 30 mm from the bottom, the easier it is for the composition to be evaluated to sediment (the sedimentation rate is fast). Note that the bottom surface means the bottom surface of the test bottle.

[0255] (Degree of sedimentation: BS ratio 60 minutes after the start of measurement) The degree of sedimentation (BS ratio (10 mm:40 mm) 60 minutes after the start of measurement) is a value calculated by the following formula based on the above measurement. Degree of sedimentation (%) = 100 × (BS value at a height of 10 mm from the bottom surface (40 mm point on the bottom surface) 60 minutes after the start of measurement) ÷ (BS value at a height of 40 mm from the bottom surface (10 mm point on the bottom surface) 60 minutes after the start of measurement) The larger the BS ratio (10 mm:40 mm) 60 minutes after the start of measurement, the easier it is for the composition to be evaluated to sediment (the degree of sedimentation is large). Note that the bottom surface means the bottom surface of the test bottle.

[0256] The sedimentation rate and the degree of sedimentation can be adjusted by adjusting the particle area and / or the aspect ratio of the particles. The method for adjusting the particle area and the method for adjusting the aspect ratio are as described in the above item of "particle parameters".

[0257] 〔Water absorption rate of powder〕 The water absorption rate (%) of the powder of the composition (water absorption rate of powder particles) is the measured value of the amount of water immediately before the occurrence of water separation from the powder particles is visually confirmed when 2 g of powder particles are placed in a container and water is dropped and mixed evenly. It is the average value of n = 100 (n represents the number of measurements).

[0258] The water absorption rate of the powder can be adjusted by adjusting the particle area, the Feret diameter (vertical width) of the particles, and / or the Feret diameter (horizontal width) of the particles. Specifically, by increasing the particle area, the Feret diameter (vertical width) of the particles, or the Feret diameter (horizontal width) of the particles, or both the Feret diameter (vertical width) and the Feret diameter (horizontal width), it becomes easier to improve the water absorption rate of the powder. The particle area, the Feret diameter (vertical width), and the Feret diameter (horizontal width) of the particles can be adjusted by adjusting the grinding time, the grinding strength, etc. in the grinding process of the material components when preparing the composition. Specifically, by reducing the grinding process, shortening the grinding time, and / or weakening the grinding strength, the particle area, the Feret diameter (vertical width) of the particles, and / or the Feret diameter (horizontal width) can be increased.

[0259] 〔Hardness, Disintegration Time in Water, and Disintegration Property in Water of Tablets〕 The hardness of the tablet (tablet hardness) (N) is the value measured using a hardness tester (model number: KHT-40N, manufactured by Fujiwara Seisakusho). Place the tablet manufactured by the method described in the section "Method for Producing the Composition and Tablet" at the center of the measuring table and start the device (press the AUTO [Start] button). As a result, the rod descends rapidly and the display becomes in the peak hold state. When it contacts the measurement object, it slows down, and the display is monitored approximately every 0.1 second. If it does not increase, it is judged as destruction, and the hardness indicated on the hardness tester at that time is taken as the tablet hardness (N).

[0260] The disintegration time in water is the value obtained by putting a tablet (250 mg) containing (including the case consisting of) the composition into a test tube, adding 20 ml of pure water, vibrating it at 37°C with a shaker (reciprocating / rotary shaker MMS-3020, manufactured by Tokyo Rika Kikai Co., Ltd.), and measuring the disintegration time. The measurement is carried out 50 times, and the average value is taken as the disintegration time in water (minutes) of the tablet. When the above lumps disappear, it is judged as disintegration in water. 3 When the above lumps disappeared, it was judged as disintegration in water.

[0261] The disintegration property in water of the tablet is represented by the disintegration time per unit hardness [disintegration time in water (D) / tablet hardness (N) (minutes / N)].

[0262] The disintegration time in water and the tablet hardness can be adjusted by adjusting the particle area, the Feret diameter (vertical width) of the particles, and / or the Feret diameter (horizontal width) of the particles. Specifically, by increasing the particle area, the Feret diameter (vertical width) of the particles, or the Feret diameter (horizontal width) of the particles, or both the Feret diameter (vertical width) and the Feret diameter (horizontal width), it becomes easier to improve the disintegration time in water and / or the tablet hardness. The particle area, the Feret diameter (vertical width), and the Feret diameter (horizontal width) of the particles can be adjusted by adjusting the grinding time, the grinding strength, etc. in the grinding process of the material components when preparing the composition. Specifically, the particle area, the Feret diameter (vertical width) of the particles, and / or the Feret diameter (horizontal width) can be increased by reducing the number of grinding steps, shortening the grinding time, and / or weakening the grinding strength.

[0263] 〔Friction force of wet powder〕 In this specification, the "friction force of wet powder" is the friction force (%) of the wet powder when it moves 2 mm (≒ when the moving distance is zero). The friction force of the wet powder is the value measured under the measurement conditions of a load of 50 g and a speed of 10 mm / sec using a static and dynamic friction measuring instrument ("Handy Tribo Master TL201Ts" manufactured by Trinity Labo), after passing the residue of the sample used in the above-mentioned "disintegration in water" test through a 90 μm (JIS standard Z8801 wire) and collecting it. As the contact, a contact in which artificial skin ("Bioskin" manufactured by Viewlex) is attached to a 5 mm thick sponge sheet ("Tape N-1 for gaps" manufactured by Cemedine) is used. Based on the results of the static friction force (gf), the ratio of the static friction force (gf) at the time of a moving distance of 0 mm and the static friction force (gf) at the time of 3 mm is calculated by the following formula. Friction force (%) of wet powder when moving 2 mm = 100×(static friction force at the time of a moving distance of 0 mm) / (static friction force at the time of a moving distance of 3 mm)

[0264] The frictional force of the wet powder can be adjusted by adjusting the particle area, the Feret diameter (vertical width) of the particles, and / or the Feret diameter (horizontal width) of the particles. Specifically, by increasing the particle area, the Feret diameter (vertical width) of the particles, or the Feret diameter (horizontal width) of the particles, or both the Feret diameter (vertical width) and the Feret diameter (horizontal width), it becomes easier to improve the frictional force of the wet powder. The particle area, the Feret diameter (vertical width), and the Feret diameter (horizontal width) of the particles can be adjusted by adjusting the grinding time, grinding strength, etc. in the grinding process of the material components when preparing the composition. Specifically, by reducing the grinding process, shortening the grinding time, and / or weakening the grinding strength, the particle area, the Feret diameter (vertical width) of the particles, and / or the Feret diameter (horizontal width) can be increased.

[0265] [Apparent tapped density] The apparent tapped density (g / cm 3 ) of the composition is the value measured using a commercially available powder physical property measuring instrument (manufactured by Hosokawa Micron, Powder Tester PT-X type). Specifically, all the 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 obtained by dividing the weight of the powder sample filled in the cup by the volume of the powder sample.

[0266] The apparent tapped density of the composition can be adjusted by adjusting the Feret diameter and / or the shape of the particles. For example, by reducing the particle area and / or the particle diameter (Feret diameter (vertical width or horizontal width)), or reducing the aspect ratio, the apparent tapped density of the powder particles can be increased.

[0267] [Apparent density (without tapping)] The apparent density (without tapping) (g / cm 3 ) of the composition is 3A glass graduated cylinder was roughly filled over 2 - 3 minutes using a quantitative feeder for the composition or the like. After that, the upper surface of the powder layer was leveled horizontally with a soft brush like a pen, and the volume was read. The value was obtained by dividing the weight of the powder sample by the volume. The weight of the powder is appropriately determined so that the volume becomes about 70 - 100 cm 3 to an appropriate level.

[0268] The apparent density (without tapping) of the composition can be adjusted by adjusting the Feret diameter and / or shape of the particles. For example, by reducing the particle area and / or the particle diameter (Feret diameter (vertical width or horizontal width)), or by reducing the aspect ratio, the apparent density (without tapping) of the powder particles can be increased.

[0269] [Compressibility] (Loose bulk density) The loose bulk density is a value measured using a commercially available powder physical property measuring instrument (manufactured by Hosokawa Micron, Powder Tester PT - X type). Specifically, a sample of the composition is dropped through a chute, the cup is filled with the sample, and after the surface is smoothed, the value is obtained by dividing the weight of the powder layer filled in the cup by the volume of the cup.

[0270] (Tapped bulk density) The tapped bulk density is a value measured using a commercially available powder physical property measuring instrument (manufactured by Hosokawa Micron, Powder Tester PT - X type). Specifically, a sample of the composition is dropped through a chute, and while the cup is tapped at a pace of 250 times per minute, the cup is filled with the sample, and after the surface is smoothed, the value is obtained by dividing the weight of the powder layer filled in the cup by the volume of the cup.

[0271] (Compressibility) The compressibility of the composition is a value calculated from the above loose bulk density and tapped bulk density using the following formula. Compressibility (%) = 100×(tapped bulk density - loose bulk density) / tapped bulk density

[0272] The looseness density and / or the compactness density of the composition can be adjusted by adjusting the Feret diameter and / or the shape of the particles. For example, by reducing the particle area and / or the particle diameter (Feret diameter (vertical width or horizontal width)), or reducing the aspect ratio, the looseness density and / or the compactness density can be increased. The compressibility can be adjusted by adjusting the looseness density and / or the compactness density.

[0273] 〔Angle of repose〕 The angle of repose of the composition is the value measured using a commercially available powder physical property measuring instrument (manufactured by Hosokawa Micron, Powder Tester PT-X type). Specifically, the inclination angle (θ1) of the mountain formed when a sample of the composition is supplied onto a circular table through a funnel is read, the angle is calculated, and it is taken as the angle of repose (°).

[0274] The angle of repose of the composition can be adjusted by adjusting the aspect ratio of the particles contained in the composition. For example, by reducing the aspect ratio, the angle of repose can be reduced. The method for adjusting the aspect ratio is as described in the section of "Particle parameters" above.

[0275] 〔Angle of collapse〕 The angle of collapse of the composition is the value measured using a commercially available powder physical property measuring instrument (manufactured by Hosokawa Micron, Powder Tester PT-X type). Specifically, the mountain forming the angle of repose is given three impacts with a dedicated shocker (attached to the Powder Tester), the inclination angle (θ2) of the mountain at the time of collapse is read, the angle is calculated, and it is taken as the angle of collapse (°).

[0276] The angle of collapse 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 the powder water absorption rate of the particles contained in the composition. The method for adjusting the particle area, aspect ratio, and Feret diameter (vertical width and horizontal width) is as described in the section "Particle Parameters" above. The method for adjusting the frictional force of the wet powder is as described in the section "Frictional Force of Wet Powder" above. The method for adjusting the powder water absorption rate is as described in the section "Powder Water Absorption Rate" above.

[0277] [Difference Angle] Based on the values of the angle of repose and the angle of collapse, the value calculated by the following formula is taken as the difference angle (°). Difference angle (°) = Angle of repose (θ1) - Angle of collapse (θ2)

[0278] The difference angle can be adjusted by adjusting the angle of repose and the angle of collapse of the composition. The methods for adjusting the angle of repose and the angle of collapse are as described above.

[0279] [Dispersion Degree (Degree of Powder Fluttering)] The dispersion degree of the composition is the value measured using a commercially available powder physical property measuring instrument (manufactured by Hosokawa Micron, Powder Tester PT-X type). Specifically, 10 g of the sample is dropped from a certain height, and it is calculated by the following formula based on the amount remaining on the watch glass placed below. Dispersion degree (%) = 100 × (Sample input amount - Amount remaining on watch glass) / Sample input amount

[0280] The dispersion degree can be adjusted by adjusting the particle area and / or aspect ratio of the particles contained in the composition. For example, the dispersion degree can be decreased by increasing the particle area. Also, for example, the dispersion degree can be decreased by decreasing the aspect ratio. The methods for adjusting the particle area and aspect ratio are as described in the section "Particle Parameters" above.

[0281] [Stress per Unit of Shear Strain] Using a RHEONERII CREEP METER RE2-33005C (manufactured by Yamaden), measure the stress (kN / m 2 ) with respect to the shear strain (%) for the shear strain of the tableted tablet under the following conditions. · Attachment used: Cylinder (3S) ·Measurement parameters: Storage pitch 0.25 sec, measurement strain rate 40%, measurement speed 0.5 mm / sec, return distance 2.00 mm

[0282] The stress tolerance (%) of the tablet is the value calculated by the following formula. Stress tolerance (%) of tablet = 100×(stress (kN / m at 18% moving strain) 2 ))÷(stress (kN / m at 10% moving strain) 2 ))

[0283] The stress tolerance (%) of the tablet can be adjusted by adjusting the particle area and / or aspect ratio of the particles contained in the tablet. For example, by increasing the particle area and / or increasing the aspect ratio (away from 1.0 and increasing), it becomes easier to increase the stress tolerance. The method for adjusting the particle area and aspect ratio is as described in the section of the above "Particle parameters".

[0284] 〔Thermogravimetric analysis〕 The weight retention rate can be obtained by performing thermogravimetric analysis (TG) according to a method well known to those skilled in the art. In the present disclosure, the weight retention rate is obtained from the residual weight of the sample at 100°C, 200°C, 300°C, 400°C, and 600°C when the sample (about 10 mg of the composition (or the food composition according to the second embodiment, the pharmaceutical composition according to the second embodiment, the cosmetic composition according to the third embodiment, the lubricant composition according to the third embodiment, or a dosage form containing any of these)) is heated from 25°C to 600°C at 10°C / min in an N2 atmosphere using a thermal analyzer (STA300 manufactured by Hitachi High-Technologies Corporation). The weight retention rate when the sample is heated from temperature a to temperature b is the value indicating the residual weight at temperature b as a percentage (%) with the residual weight at temperature a being 100. That is, the weight retention rate is represented by the following formula. Weight retention rate (%) = 100×[residual weight (mg) at temperature b] / [residual weight (mg) at temperature a]

[0285] By adjusting the contents of heat-resistant substances such as ash and inorganic substances, quasi-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, the 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 can be adjusted.

[0286] The weight retention rate determined by thermogravimetric analysis when the temperature is raised from 25 °C to 100 °C indicates the remaining components other than the water adsorbed on the composition. According to the temperature increase up 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 retention rate determined by thermogravimetric analysis when the temperature is raised from 25 °C to 200 °C or from 25 °C to 300 °C indicates the remaining components other than the non-heat-resistant substances contained in the composition. 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 retention rate can be decreased. Alternatively, by decreasing the content of the components other than the non-heat-resistant substances contained in the composition, that is, the content of the heat-resistant substances and / or non-heat-resistant substances, 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 retention rate can be decreased.

[0287] Measure the weight retention rate determined by thermogravimetric analysis when the temperature is raised from 25 °C to 200 °C in the composition as described above, and adjust the content of the non-heat-resistant substances contained in the composition so that it becomes 50% or more and 96% or less, or any desired value listed in this specification. Also, measure the weight retention rate determined by thermogravimetric analysis when the temperature is raised from 25 °C to 300 °C in the composition as described above, and adjust the content of the non-heat-resistant substances contained in the composition so that it becomes 50% or more and 90% or less, or any desired value listed in this specification.

[0288] When the temperature is raised from 25°C to 400°C or higher, between 300°C and 400°C, the semi-heat-resistant substances contained in the composition disappear (Maki Man et al., Bulletin of the Chemical Society of Japan, 1975, (4), pp. 733 - 737). Therefore, when the temperature is raised from 25°C to 400°C or higher, the weight retention rate determined by thermogravimetric analysis indicates the remaining components other than the non-heat-resistant substances (components that disappear when the temperature is raised to 300°C) and the semi-heat-resistant substances (components that disappear between 300°C and 400°C) contained in the composition, that is, the remaining heat-resistant substances. By increasing the contents of the non-heat-resistant substances and semi-heat-resistant substances contained in the composition, the weight loss rate when the temperature is raised from 25°C to 400°C can be increased, and the weight retention rate can be decreased. Alternatively, by decreasing the content of components other than the non-heat-resistant substances and semi-heat-resistant substances contained in the composition, that is, the heat-resistant substances, the weight loss rate when the temperature is raised from 25°C to 400°C or higher can also be increased, and the weight retention rate can be decreased.

[0289] Regarding the weight retention rate determined by thermogravimetric analysis when any composition according to this embodiment is heated to a predetermined temperature, it can be adjusted in the same manner as described above.

[0290] [Measurement of Electromotive Force] The electromotive force of a sample at a certain temperature can be obtained according to a method well known to those skilled in the art. In the present disclosure, the electromotive force at a certain temperature is the electromotive force (μV) of the sample at 100°C, 200°C, 300°C, 400°C, and 600°C when a sample (about 10 mg of the composition) is heated from 25°C to 600°C at 10°C / min in an N2 atmosphere using a thermal analyzer (STA300 manufactured by Hitachi High-Tech Science). By adjusting the contents of heat-resistant substances such as ash and inorganic substances in the composition, semi-heat-resistant substances such as cellulose and highly crystalline substances, and non-heat-resistant substances such as proteins and low-molecular carbohydrates, the electromotive force of the sample at a certain temperature can be adjusted.

[0291] Here, examples of heat-resistant substances, semi-heat-resistant substances, non-heat-resistant substances, etc. are as described in the above "Thermogravimetric Analysis".

[0292] [Manufacturing Method of Composition and Tablet] The tablets of the food or medicine according to this embodiment can be manufactured by methods well-known to those skilled in the art.

[0293] The composition according to the first embodiment can be prepared by using the heat-resistant substance, semi-heat-resistant substance, and non-heat-resistant substance described above as materials and by methods well-known to those skilled in the art. Specifically, the Feret diameter (vertical width) of the sample after primary pulverization is set to 10 μm to 60 μm, the Feret diameter (vertical width) of the sample after secondary pulverization is set to 0.5 μm to 1 μm, and the Feret diameter (vertical width) of the dried composition is about 1 μm to 3 μm and the particle area is 1 to 18 μm 2 is adjusted. Within the range where the particles of the composition can be adjusted in this way, the type and concentration of the sample to be pulverized and each processing condition are not limited to the following examples. Also, preliminary pulverization, replacement of the solvent, granulation, and drying may be appropriately added between each step as appropriate. For example, it can be prepared as follows.

[0294] When the Feret diameter (vertical width) of the material is coarse (specifically, larger than about 10 μm), it is subjected to primary pulverization. For example, using a jet mill (for example, the jet mill STJ-400 manufactured by Seishin), it is pulverized once (primary pulverization) under the condition that the flow rate is 2 kg / hour or more and 12 kg / hour or less (preferably 12 kg / hour), and the Feret diameter (vertical width) is pulverized to about 10 μ to 60 μm (preferably 10 μm) to obtain a powder composition.

[0295] Next, each material is mixed by a predetermined weight (for example, mixed to a total of 100 g with the weights (g) shown in "Materials" in Table 1, wheat germ, titanium oxide, crystalline cellulose (PH-101 of Theolas (registered trademark) of Asahi Kasei), powdered cellulose (KC Flock W-50 of Nippon Paper Industries Co., Ltd.), oats, calcium carbonate, and / or truffle powder). The mixed material is processed 20 times at a processing pressure of 50 MPa using, for example, a homogenizer (manufactured by Gorin, model 15M8AT) equipped with a normal non-destructive homovalve sheet (inner diameter at the downstream end of the hollow cylindrical protrusion / thickness of the ring-shaped end face 1.9 / 1), and pulverized to a Feret diameter (vertical width) of 0.5 μm to 4.0 μm (preferably 0.5 to 1.0 μm) (secondary pulverization).

[0296] Here, it is possible to determine whether to perform only primary pulverization or also secondary pulverization according to the size of the particles constituting the composition.

[0297] As the crusher used for crushing, there are cutting mills: Mesh Mill (manufactured by Horai Co., Ltd.), Atoms (manufactured by Yamamoto Hyakuma Seisakusho Co., Ltd.), Knife Mill (manufactured by Pallmann), Cutter Mill (manufactured by Tokyo Atomizer Co., Ltd.), CS Cutter (manufactured by Mitsui Mining Co., Ltd.), Rotary Cutter Mill (manufactured by Nara Machinery Co., Ltd.), Pulp Crusher (manufactured by Zuiho Co., Ltd.), Shredder (manufactured by Kobe Steel Pantech Co., Ltd.), etc.; hammer mills: Joe Crusher (manufactured by Makino Co., Ltd.), Hammer Crusher (manufactured by Mano Sangyo Co., Ltd.); impact mills: Pulverizer (manufactured by Hosokawa Micron Corporation), Fine Impact Mill (manufactured by Hosokawa Micron Corporation), Super Micron Mill (manufactured by Hosokawa Micron Corporation), Inomizer (manufactured by Hosokawa Micron Corporation), Fine Mill (manufactured by Nippon Pneumatic Mfg. Co., Ltd.), CUM Type Centrifugal Mill (manufactured by Mitsui Mining Co., Ltd.), Ixeed Mill (manufactured by Mano Sangyo Co., Ltd.), Ultra Plex (manufactured by Mano Sangyo Co., Ltd.), Contra Plex (manufactured by Mano Sangyo Co., Ltd.), Colo Plex (manufactured by Mano Sangyo Co., Ltd.), Sample Mill (manufactured by Seishin Co., Ltd.), Bantam Mill (manufactured by Seishin Co., Ltd.), Atomizer (manufactured by Seishin Co., Ltd.), Tornade Mill (manufactured by Nikkiso Co., Ltd.), Near Mill (manufactured by Dalton Co., Ltd.), HT Type Fine Crusher (manufactured by Horai Co., Ltd.), Free Crusher (manufactured by Nara Machinery Co., Ltd.), New Cosmomizer (manufactured by Nara Machinery Co., Ltd.), Gather Mill (manufactured by Nishimura Machinery Co., Ltd.), Spar Powder Mill (manufactured by Nishimura Machinery Co., Ltd.), Blade Mill (manufactured by Nisshin Engineering Co., Ltd.), Super Rotor (manufactured by Nisshin Engineering Co., Ltd.), Npa Crusher (manufactured by Mitsou Ind. Co., Ltd.), Wire Crusher (manufactured by Sanki Seisakusho Co., Ltd.), Pulp Crusher (manufactured by Zuiho Co., Ltd.), Jacobson Fine Crusher (manufactured by Kobe Steel Pantech Co., Ltd.), Universal Mill (manufactured by Tokuju Kousakusho Co., Ltd.); air jet mills: CGS Type Jet Mill (manufactured by Mitsui Mining Co., Ltd.), Micron Jet (manufactured by Hosokawa Micron Corporation), Counter Jet Mill (manufactured by Hosokawa Micron Corporation), Cross Jet Mill (manufactured by Kurimoto Iron Works Co., Ltd.), Supersonic Jet Mill (manufactured by Nippon Pneumatic Mfg. Co., Ltd.), Current Jet (manufactured by Nisshin Engineering Co., Ltd.), Jet Mill (manufactured by Mitsou Ind. Co., Ltd.),Ebara Jet Micronizer (manufactured by Ebara Corporation), Ebara Turbine Jet (manufactured by Ebara Corporation), Selen Mirror (manufactured by Masayuki Sangyo Co., Ltd.), New Micro Cyclo Mat (manufactured by Masuno Seisakusho Co., Ltd.), Krypton (manufactured by Kawasaki Heavy Industries, Ltd.), vertical roller mill: vertical roller mill (manufactured by Sinion Co., Ltd.), vertical roller mill (manufactured by Schaeffler Japan Co., Ltd.), roller mill (manufactured by Kotobuki Giken Kogyo Co., Ltd.), VX mill (manufactured by Kurimoto Iron Works Co., Ltd.), KVM type vertical mill (manufactured by Earth Technica Co., Ltd.), IS mill (manufactured by IHI Plant Engineering Co., Ltd.), pressure type homogenizer (manufactured by SMT Co., Ltd.), etc. are exemplified.

[0298] Mixing of the materials can be carried out by methods well-known to those skilled in the art. For example, container rotary mixers such as V-type, W-type, double-cone type, and container tack type mixers; stirring mixers such as high-speed stirring type, universal stirring type, ribbon type, pug type, and Nauta type mixers; high-speed fluidized mixers, drum mixers, and fluidized bed mixers may be used. Also, container vibration type mixers such as shakers can be used. Further, as a method for dissolving or dispersing each sample constituting the composition in a medium, there is no particular limitation as long as it is a commonly used dissolution or dispersion method. However, stirring and mixing methods using stirring blades such as one-way rotation type, multi-axis rotation type, reciprocating inversion type, up-and-down movement type, rotation + up-and-down movement type, and pipeline type, such as portable mixers, three-dimensional mixers, and side mixers; jet stirring and mixing methods such as line mixers; stirring and mixing methods of gas injection type; mixing methods using high-shear homogenizers, high-pressure homogenizers, ultrasonic homogenizers, etc., or container vibration type mixing methods using shakers may also be used.

[0299] Granules can be produced from the composition according to the first embodiment by well-known methods such as dry granulation, wet granulation, heat granulation, spray granulation, or microencapsulation, etc., and tablets can be manufactured. However, it is preferable to adopt the wet granulation method. As the wet granulation method, specifically, a fluidized bed granulation method, a stirring granulation method, an extrusion granulation method, a crushing granulation method, or a rolling granulation method is preferable. In the fluidized bed granulation method, in a fluidized bed granulation apparatus, a binding liquid is sprayed onto fluidized powder for granulation. In the stirring granulation method, while adding a binding liquid, by rotating stirring blades in a mixing tank, mixing, kneading, and granulation of the powder are simultaneously performed in a closed structure. In the extrusion granulation method, a wet mass kneaded by adding a binding liquid is granulated by forcibly extruding it from a screen of an appropriate size by a method such as a screw type or a basket type. In the crushing granulation method, a wet mass kneaded by adding a binding liquid is sheared and crushed by a rotating blade of a granulator, and granulated by being repelled from an outer peripheral screen by its centrifugal force. In the rolling granulation method, it rolls by the centrifugal force of a rotating rotor, and at this time, spherical granules with a uniform particle diameter are grown in a snowman shape by the binding liquid sprayed from a spray gun for granulation.

[0300] In one embodiment, the composition according to the first embodiment can be mixed with pure water to prepare a dispersion, and put into a granulator (for example, Granuformer (registered trademark) Gf - 105, etc., Freund Industry Co., Ltd.) to obtain granules. According to the exemplified granulator, drying of the granules can also be performed simultaneously. For example, the supply rate of the dispersion to the granulator can be 2 - 6 L / hour, and the inlet temperature can be 150°C. Here, magnesium stearate (Taihei Chemical Industry Co., Ltd.) may be further added to and mixed with the obtained granules. Using a simple tablet molding machine (HANDTAB - 100, Ichihashi Seiki Co., Ltd.), the granules can be tabletted at a tabletting compression force to obtain tablets with a diameter of 8 mm, a R12 punch tablet, and a weight of about 250 mg.

[0301] The drying method of the granulated product can use any method such as hot air heating type (shelf drying, vacuum drying, fluidized bed drying), conduction heat transfer type (pan type, shelf box type, drum type), or freeze drying. In the hot air heating type, hot air is directly contacted with the additive, and at the same time, the evaporated moisture is removed. In the conduction heat transfer type, the additive is indirectly heated through the heat transfer wall. In freeze drying, the additive is frozen at -10°C or higher and 40°C or lower, and then heated under high vacuum (1.3×10-5 MPa or higher and 2.6×10-4 MPa or lower) to sublimate and remove water. The drying method when drying the aqueous dispersion to obtain the cellulose powder is not particularly limited. For example, any of freeze drying, spray drying, drum drying, shelf drying, pneumatic drying, and vacuum drying may be used, and one type may be used alone, or two or more types may be used in combination. The spraying method during spray drying may be any spraying method such as a disk type, pressure nozzle, pressure two-fluid nozzle, pressure four-fluid nozzle, etc., and one type may be used alone, or two or more types may be used in combination. During the above spray drying, a small amount of water-soluble polymer or surfactant may be added for the purpose of lowering the surface tension of the dispersion, and a foaming agent or gas may be added to the dispersion for the purpose of accelerating the vaporization rate of the medium.

[0302] Before and after pulverization, granulation, and drying, a substitution step of appropriately substituting the solvent may be carried out to improve the efficiency of the treatment. Particularly when the sample contains a large amount of hydrophilic substances, it is subjected to the substitution step. In the substitution step, water, which is the dispersion medium contained in the aqueous dispersion, is substituted with, for example, the following hydrophilic organic solvents. Examples of hydrophilic organic solvents include alcohols (such as C1-4 alkanols like methanol, ethanol, isopropanol, 1-butanol, etc.), alkanediols (such as C2-4 alkanediols like ethylene glycol, propylene glycol, butylene glycol, etc.), cellosolves (such as C1-4 alkyl cellosolves like methyl cellosolve, ethyl cellosolve, etc.), cellosolve acetates (such as C1-4 alkyl cellosolve acetates like ethyl cellosolve acetate, etc.), carbitols (such as C1-4 alkyl carbitols like methyl carbitol, ethyl carbitol, etc.), ketones (such as di-C1-4 alkyl ketones like acetone, methyl ethyl ketone, etc.), ethers (such as cyclic or chain C4-6 ethers like dioxane, tetrahydrofuran, etc.). These solvents may be used alone or in combination of two or more.

[0303] [Second Embodiment (Food Composition · Pharmaceutical Composition)] 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. In one embodiment, it is preferable to use the oral composition according to the first embodiment as a food composition.

[0304] The food composition can be used alone or in combination of two or more food compositions for the preparation of foods such as beverages, soups, processed meats, processed vegetables, processed fruits, seasonings, concentrated foods, supplements (nutritional supplements, nutritional beverages), etc.

[0305] A food according to one embodiment contains the food composition according to this embodiment.

[0306] Here, the processed product means a product obtained by processing and / or cooking natural food ingredients, and includes frozen foods, retort foods, canned foods, bottled foods, etc. The form of the food is not limited, but it is preferably in a form suitable for oral use. From the perspective 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, granule, pellet, tablet, capsule, soft capsule, etc. The tablet may be any of an orally disintegrating tablet, chewable tablet, effervescent tablet, dispersible tablet, and soluble tablet. Considering the good in-mouth disintegration property due to containing the composition according to the first embodiment and / or the good frictional force of the wet powder, the good in-mouth disintegration property and the good tongue feel effect of the disintegrated paste, and thereby the good passing effect of the composition during swallowing, the tablet of the food is preferably an orally disintegrating tablet or a chewable tablet, and more preferably an orally disintegrating tablet.

[0307] The functional ingredient is not limited as long as it is a component that is desired to be ingested in addition to normal diet, but it is preferably a substance that can exert some nutritional or physiological activity or action that is the use or purpose of the food containing the food composition in the subject being ingested. In one embodiment, the functional ingredient is preferably a component having an effect of improving undesired symptoms and / or poor physical condition, etc. in the subject (including functions related to health maintenance and promotion). Therefore, the food containing the food composition is preferably a functional food having an effect of improving undesired symptoms and / or poor physical condition, etc. (including functions related to health maintenance and promotion) in the subject who ingests it. Examples of such functional foods include, for example, in Japan, general foods including dietary supplements, health supplements, nutritional adjustment foods, etc., and health functional foods (including nutritional functional foods, foods for specified health uses (Tokuhos), and foods with functional claims) in which the functional claims of the food are made in accordance with the standards regarding safety and efficacy determined by the state.

[0308] The composition, raw materials, origin, acquisition route, etc. of the functional ingredient are not limited, and include natural products, natural extracts, chemically synthesized substances, mixtures of two or more of these, etc. Non-limiting examples of functional components include vitamins such as vitamin B1, B2, C, minerals such as iron, zinc, amino acids, dietary fiber, DHA, EPA, polyphenols (including anthocyanins, isoflavones (including soy isoflavones and its metabolite equol), flavones, catechins, flavonols, flavanones, etc.), carotenoids (α-catechin, β-catechin, β-cryptoxanthin, lycopene, lutein, zeaxanthin, etc.), sulfur-containing compounds (isothiocyanates, cysteine sulfoxides, etc.). The food composition may contain one or more than two functional components. In one embodiment, the functional component may be a soy-derived component, and the soy-derived component may be soy isoflavone and / or equol. Soy isoflavone and equol may be in the form of glycosides or aglycones, respectively. For example, when the functional component is soy isoflavone or equol, their acquisition methods are not limited. Non-limiting acquisition methods include extraction from soybeans according to well-known methods, purchase of commercial products, and artificial preparation using equol-producing bacteria, etc.

[0309] In one embodiment, the food is preferably a functional food in the form of tablets, and more preferably a functional food in the form of orally disintegrating tablets.

[0310] The daily usage amount of the food is not limited, and those skilled in the art can appropriately determine it based on the content of the functional component in the food and the daily required intake amount for the subject.

[0311] The 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. In one embodiment, it is preferable to use the oral composition according to the first embodiment as a pharmaceutical composition.

[0312] The pharmaceutical composition can be used alone or in combination with two or more pharmaceutical compositions, for example, in the preparation of a medicine for treating diseases and symptoms suitable for the pharmaceutical effects of its pharmaceutically active ingredient.

[0313] The medicine according to one embodiment includes the pharmaceutical composition according to this embodiment.

[0314] The treatment method according to one embodiment includes administering the pharmaceutical composition according to this embodiment to a subject in need thereof.

[0315] The 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 medicine for treating a subject in need thereof.

[0316] The composition, pharmaceutical composition, or pharmaceutically active ingredient according to one embodiment is the composition according to the first embodiment, the pharmaceutical composition according to this embodiment, or the pharmaceutically active ingredient for treating a subject in need thereof.

[0317] The form of the medicine is not limited, but it is preferably in a form suitable for oral use. From the perspective 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, granule, pellet, tablet, capsule, soft capsule, etc. The tablet may be any of an orally disintegrating tablet, chewable tablet, effervescent tablet, dispersible tablet, and soluble tablet. Considering the good orally disintegrating property and good tongue feel effect based on the appropriate water disintegration property and / or good frictional force of the wet powder by including the composition according to the first embodiment, and the good passing effect of the composition during swallowing, the tablet of the medicine is preferably an orally disintegrating tablet or a chewable tablet, and more preferably an orally disintegrating tablet.

[0318] The pharmaceutically active ingredient is not limited as long as it is a component whose administration is desired in a subject having any disease or presenting symptoms, but it is preferably a substance that can exert some physiological activity or action that is the use or purpose of the pharmaceutically active ingredient in the administered subject.

[0319] The composition, raw materials, origin, acquisition route, etc. of the pharmaceutically active ingredient are not limited, and include natural products, natural extracts, synthetic substances (including substances produced by biotechnology and chemically synthesized substances), mixtures of two or more of these, etc. Examples of natural products or natural extracts include nucleic acids, proteins (including antibodies and their fragments), culture fluid extracts, low molecular weight compounds, etc. Substances that are the same as these or similar substances having the same function and are produced by biotechnology, or chemically synthesized substances (chemically synthesized substances) may also be used. Natural products or natural extracts may be obtained from any organisms such as microorganisms, animals, and plants, and are not limited by the ecology or habitat of the organisms. The pharmaceutical composition may contain one kind or two or more kinds of pharmaceutically active ingredients.

[0320] The pharmaceutical composition in this embodiment is a pharmaceutical composition for treating or preventing diseases, unwanted symptoms, and / or physical discomfort, etc. in a subject. "Treatment" includes the reduction, alleviation, and relief of disease symptoms, and "prevention" includes the defense against and suppression of the progression of future diseases or symptoms. Desirable treatment effects by treatment include remission of symptoms, improvement of direct or indirect pathological results of the disease, reduction in the rate of progression of symptom exacerbation, recovery or alleviation of the disease state, and improvement of prognosis.

[0321] When two or more food compositions or pharmaceutical compositions are formulated separately into two or more food or pharmaceutical preparations, the individual foods or pharmaceuticals can be ingested or administered simultaneously, at separate intervals of a certain time, or continuously. The two or more food or pharmaceutical preparations can also be ingested or administered at different frequencies and / or by different routes in a day. The pharmaceutical preparation can be administered systemically or locally.

[0322] A food composition or a pharmaceutical composition may further contain one or more non-functional components that are nutritionally acceptable as food or pharmaceutically acceptable, in addition to the composition and the functional component or the pharmaceutically active ingredient. Examples of the non-functional components include additives such as acidulants, sweeteners, excipients, surfactants, lubricants, flavoring agents, fragrances, coloring agents, stabilizers, and preservatives. Examples of the 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, magnesium oxide, and the like. Examples of the surfactants include nonionic surfactants, such as sorbitan fatty acid esters such as sorbitan monocaprylate, sorbitan monolaurate, sorbitan monopalmitate, and glycerin fatty acid esters such as glycerin monocaprylate, glycerin monomyristate, glycerin monostearate, and the like having an HLB of 6 to 18. Examples of other non-functional components include water, saline, alcohol, silicone, wax, petrolatum, vegetable oil, polyethylene glycol, propylene glycol, liposome, gelatin, magnesium stearate, talc, surfactant, silicic acid, viscous paraffin, essential oil, fatty acid monoglyceride and diglyceride, petroesral fatty acid ester, hydroxymethylcellulose, polyvinylpyrrolidone, and the like.

[0323] The content of the functional ingredient or the pharmaceutically active ingredient in the food composition or the pharmaceutical composition is not limited, but it may be more than 10% by weight, may be 20% by weight or more, may be 20 - 40% by weight, may be 20 - 32% by weight, or may be 20 - 30% by weight. When the content of the functional ingredient or the pharmaceutically active ingredient is 20 - 30% by weight, it may be 20% by weight, 24% by weight, 26% by weight, 27% by weight, or 30% by weight. Also, the content of the non-functional ingredient in the food composition or the pharmaceutical composition is not limited, and it may be 90% by weight or less, may be 60 - 90% by weight, may be 60 - 80% by weight, may be 68 - 80% by weight, or may be 70 - 80% by weight. The functional ingredient or the pharmaceutically active ingredient may be included in the heat-labile substances in the composition according to the second embodiment, and may be, for example, a protein, a low-molecular carbohydrate, or the like. When the content of the functional ingredient or the pharmaceutically active ingredient is more than 10% by weight and the content of the non-functional ingredient is 90% by weight or less, the food composition or the food containing it, or the pharmaceutical composition or the medicine containing it is likely to exhibit good frictional force of the wet powder. Therefore, in its ingestion, it is likely to achieve a good texture on the tongue and a good passage of the composition during swallowing, that is, it is likely to become a food or medicine that is easy to swallow. When the food or medicine is in the form of a tablet, it is likely to exhibit good water disintegrability and / or good frictional force of the wet powder. Thereby, the tablet is likely to achieve good intraoral disintegrability and a good texture of the disintegrated paste on the tongue, and a good passage of the composition during swallowing, that is, it is likely to become a tablet that is easy to swallow. Also, when the content of the functional ingredient or the pharmaceutically active ingredient is more than 10% by weight, in the subject who has ingested the food or has been administered the medicine, the desired effect by the functional ingredient or the pharmaceutically active ingredient is likely to be exerted.

[0324] The subjects of ingestion of a food composition or a food containing the same, or the subjects of administration of a pharmaceutical composition or a medicine containing the same are not limited to animals in need thereof, and may be humans or non-human animals. The non-human animal species may be, for example, monkeys, dogs, cats, horses, cows, pigs, sheep, goats, rabbits, guinea pigs, hamsters, mice, and / or rats, etc., and are not limited by uses such as domestic animals, pet animals, experimental animals, etc., but are preferably mammals, and more preferably humans.

[0325] The packaging form of the food composition or the food containing the food composition, or the pharmaceutical composition or the medicine containing the pharmaceutical composition according to the present embodiment is not particularly limited, and those skilled in the art can appropriately select according to the dosage form, etc. For example, blister packs such as PTP, strip packaging, heat sealing, aluminum pouches, film packaging using plastics or synthetic resins, etc., glass containers such as vials, plastic containers such as ampoules, etc. can be mentioned.

[0326] [Third Embodiment (Other Uses)] The composition according to the first embodiment can be used in various applications where these characteristics can preferably exert their effects based on the characteristics exhibited by the composition and the tablets containing the composition, namely, good swallowability, and / or good tongue feel effect, and / or good fillability, low dispersibility, and / or high transportability effect. For example, the composition according to the first embodiment can be used as a cosmetic composition. Also, for example, the composition according to the first embodiment can be used as a composition for lubricants.

[0327] A cosmetic according to one embodiment contains the cosmetic composition according to the present embodiment. A lubricant according to one embodiment contains the composition for lubricants according to the present embodiment.

[0328] A cosmetic composition is, for example, a composition for the purpose of beautifying the skin, hair, nails, etc., and can be formulated into a form that allows care of these parts to make a cosmetic. For example, it may be a liquid, lotion, cream, patch, oil, spray, liquid detergent, solid soap, etc. Further, as products, it may be a lotion, essence, moisturizing lotion, moisturizing cream, soap, body soap, skin cleansing agent, bath salt for bath, sunscreen, beard shaving lotion, hair removal agent, shampoo, conditioner, hair tonic, hair dye, etc. In particular, from the viewpoint of preferably exerting effects according to the characteristics exhibited by the composition according to the first embodiment, for example, a lotion, cream, or liquid detergent is preferable, and examples of the commercial form of the liquid detergent include shampoo, body soap, skin cleansing agent, etc.

[0329] The cosmetic composition may contain one or more functional components and / or one or more non-functional components described in the second embodiment. Also, examples of the packaging form of the cosmetic containing the cosmetic composition are the same as the packaging forms described in the second embodiment.

[0330] The application targets of the cosmetic composition or the cosmetic containing the same are not limited as long as they are animals that need them, and may be humans or non-human animals. Non-human animal species may be, for example, monkeys, dogs, cats, horses, cows, pigs, sheep, goats, rabbits, guinea pigs, hamsters, mice, and / or rats, etc., and are not limited by uses such as livestock animals, pet animals, experimental animals, etc., but are preferably mammals, and more preferably humans.

[0331] The composition for lubricant is a composition for the purpose of improving the handleability during tableting of tablets and the ease of swallowing during administration of tablets. Since the composition according to the first embodiment has the effects of good swallowability and / or good feel on the tongue, and / or good fillability, low dispersibility, and / or high transportability, it can be preferably used as a composition for lubricant.

[0332] The lubricant composition may contain one or more functional components and / or one or more non-functional components described in the second embodiment. From the perspective of the 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 dioxide, glycerin fatty acid ester, magnesium silicate, light anhydrous silicic acid, hardened oil, heavy anhydrous silicic acid, sucrose fatty acid ester, stearyl alcohol, stearic acid, zinc stearate, aluminum stearate, calcium stearate, polyoxyl 40 stearate, magnesium stearate, hydrogenated soybean oil, talc, sodium stearyl fumarate, beeswax, hydrous silicic acid anhydride, magnesium aluminometasilicate, and glycerin monostearate.

[0333] The lubricant containing the lubricant composition according to this embodiment can be preferably used, for example, in the pharmaceutical composition according to the second embodiment or the pharmaceutical preparation containing the pharmaceutical composition.

[0334] A non-limiting list of exemplary embodiments of the present disclosure and combinations of exemplary embodiments is disclosed below. [1] Particles having a particle area of less than 20.0 μm 2 and an aspect ratio of less than 1.40, and the following (a) to (d): (a) The Backscatter (BS) ratio at a height of 30 mm from the bottom surface is 11.7% or less, (b) The BS ratio 60 minutes after the start of measurement is less than 21.0%, (c) The frictional force of the wet powder is less than 63%, (d) The powder water absorption rate is less than 200%, satisfy any one or more of the following, wherein the BS ratio at a height of 30 mm from the bottom surface is calculated from the backscattered light measurement value (BS value) obtained at a point 30 mm from the bottom surface of the test bottle when irradiating light on the test bottle containing the sample containing the composition, between the value 1 minute after the start of measurement and the value 5 minutes after the start of measurement, by the following formula: 100 × (BS value at the 30 mm point on the bottom surface 1 minute after the start of measurement) / (BS value at the 30 mm point on the bottom surface 5 minutes after the start of measurement) calculated by The BS ratio 60 minutes after the start of measurement is obtained from the backscattered light measurement values (BS values) at the 40 mm point from the bottom of the bottle and the 10 mm point from the bottom of the bottle when light is irradiated onto the test bottle containing the sample containing the composition, according to the following formula: 100 × (BS value at the 10 mm point on the bottom surface 60 minutes after the start of measurement) / (BS value at the 40 mm point on the bottom surface 60 minutes after the start of measurement) calculated by The frictional force of the wet powder is the frictional force of the wet powder moving 2 mm, and is obtained from the static frictional force at the 0 mm point of the moving distance and the static frictional force at the 3 mm point of the moving distance, which are measured with a load of 50 g and a speed of 10 mm / second for the sample containing the composition, according to the following formula: 100 × (static frictional force at the 0 mm point of the moving distance) / (static frictional force at the 3 mm point of the moving distance) calculated by Composition [2] The in-water disintegrability of the tablet containing the composition is 1.9 (min / N), and here, the in-water disintegrability is calculated from the hardness (N) of the tablet measured with a hardness tester and the disintegration time (min) of the tablet in pure water, according to the following formula: In-water disintegration time (D) / Tablet hardness (N) the composition according to [1]. [3] The hardness of the tablet containing the composition is 46 N or less, and the in-water disintegration time of the tablet containing the composition is less than 90 minutes, the composition according to [1] or [2]. [4] Containing particles with a Feret diameter (vertical width) of less than 3.3 μm and a Feret diameter (horizontal width) of 2.4 μm or less, the composition according to any one of [1] to [3].

Examples

[0335] Examples are shown below to further specifically explain the present disclosure, but the interpretation of the present disclosure is not limited by these examples.

[0336] [Preparation of Composition and Tablets] When the Feret diameter (vertical width) of the materials used in the compositions of the Examples and Comparative Examples was coarse (specifically, larger than about 10 μm), they were subjected to primary grinding. Using a jet mill (Jet Mill Pulverizer STJ-400 manufactured by Seishin), they were ground once (primary grinding) under the 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), and ground to a Feret diameter (vertical width) of about 10 μm to 60 μm (Group 1: 10 μm, Group 2: 20 μm, Group 3: 40 μm, Group 4: 60 μm) to obtain a powder composition.

[0337] Next, wheat germ, titanium oxide, crystalline cellulose (PH-101 of Ceolus (registered trademark) manufactured by Asahi Kasei), powdered cellulose (KC Flock W-50 manufactured by Nippon Paper Industries Co., Ltd.), oats, calcium carbonate, and / or truffle powder were mixed to a total of 100 g by weight as shown in "Materials" in Table 1. The mixing was carried out using a fluidized bed mixer.

[0338]

Table 1

[0339] The mixed materials were processed 20 times at a processing pressure of 50 MPa using a homogenizer (manufactured by Gorin, 15M8AT) equipped with a normal non-destructive homovalve sheet (inner diameter of the downstream end of the hollow cylindrical convex part / thickness of the ring-shaped end face 1.9 / 1), and ground to a Feret diameter (vertical width) of about 0.5 μm to 4 μm (Group 1: 0.5 to 1 μm, Group 2: 2 μm, Group 3: 2 μm, Group 4: 4 μm) (secondary grinding).

[0340] The powder composition obtained after primary grinding or secondary grinding was mixed with pure water to prepare a dispersion, which was then fed into a granulator (Granuformer (registered trademark) Gf-105, Freund Industry Co., Ltd.) under the following conditions. By this step, the composition was dried and granulated to obtain granules. · Dispersion supply rate: 2 - 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

[0341] For all the compositions of the examples and comparative examples, the content of the heat-resistant substance was measured by a known ash method, and the content of the semi-heat-resistant substance was measured by a known α-cellulose quantification method. The content of the non-heat-resistant substance was obtained by subtracting the value obtained by measuring the known α-cellulose from the value obtained using a known holocellulose quantification method. They contained heat-resistant substances, semi-heat-resistant substances, and non-heat-resistant substances respectively in the formulations (by weight %) shown in the "Production Examples" of Table 1.

[0342] Also, as a result of analyzing heat-resistant substances, semi-heat-resistant substances, and non-heat-resistant substances in each material in the same way as in the composition, wheat germ contained 5 - 25 wt% of heat-resistant substances, 30 - 70 wt% of semi-heat-resistant substances, and 25 - 45 wt% of non-heat-resistant substances. Oats contained 5 - 20 wt% of heat-resistant substances, 45 - 75 wt% of semi-heat-resistant substances, and 20 - 45 wt% of non-heat-resistant substances. Crystalline cellulose (Theolas of Asahi Kasei) contained 1 - 10 wt% of heat-resistant substances, 70 - 98 wt% of semi-heat-resistant substances, and 0.1 - 5 wt% of non-heat-resistant substances. Powdered cellulose (KC Flock W-50 of Nippon Paper Industries Co., Ltd.) contained 1 - 10 wt% of heat-resistant substances, 70 - 90 wt% of semi-heat-resistant substances, and 5 - 20 wt% of non-heat-resistant substances. Truffle powder contained 93% of non-heat-resistant substances and 5% of semi-heat-resistant substances.

[0343] To prepare tablets containing the compositions of the examples and comparative examples, 250 mg of the granules obtained by the granulator as described above were put into a mortar (manufactured by Ichihashi Seiki Co., Ltd., diameter 8 mm), compressed at 3 kN so that the thickness of the tablets was about 5 mm, and the stress was maintained for 60 minutes to produce tablets with a diameter of 8 mm, R12 pestle tablets, and a weight of about 250 mg (a HANDTAB-100 compressor manufactured by Enapac was used).

[0344] [Evaluation of Composition] The tablets or compositions of the examples and comparative examples were evaluated as follows. The parameters of the particles and the composition were measured for the composition obtained by secondary pulverization in the above "Preparation of Composition and Tablets", and the parameters of the tablets were measured for the tablets obtained by tableting as described above.

[0345] 〔Particle parameters〕 2 g of a sample of the composition and 20 ml of ion-exchanged water were placed in a beaker and dispersed by ultrasonic waves (output 90 W) for 2 minutes to obtain a measurement solution (suspension). For samples with poor dispersibility, the bottle was shaken by hand and allowed to stand for 15 minutes, and then the supernatant was collected and placed in a beaker together with ion-exchanged water. Samples with a concentration previously adjusted to 10% by weight were used.

[0346] Using a dynamic image analyzer Parshear Analyzer (manufactured by Hosokawa Micron Corporation), a sample suspension of the composition was formed into a flat sample stream with a sheath fluid by the flat sheath flow method, and the particles were imaged as still images by irradiating with stroboscopic light. Particle parameters and particle shape parameters were obtained by image analysis. The measurement conditions were a lens magnification of standard (10 times), a measurement range of 0.5 to 300 μm, and 10,000 detected particles. Here, the "Feret diameter (vertical width and horizontal width)" and the "particle area" were measured independently. The 1,000 particles that were the basis of each average value were different particles.

[0347] (Feret diameter) When the particles of the composition imaged as described above were circumscribed by a rectangle, the length of the long side was measured with a Parshear Analyzer as the "vertical width". Among the 10,000 measured particles, the average value of the values of 1,000 particles with small values was calculated and taken as the "Feret diameter (vertical width) (μm)". Also, when the particles of the composition imaged as described above were circumscribed by a rectangle, the length of the shorter side was measured with a Parshear analyzer as the "horizontal width". Among 10,000 measured particles, the average value of the values of 1,000 particles with small values was calculated and taken as the "Feret diameter (horizontal width) (μm)".

[0348] (Aspect ratio) The aspect ratio of the particles was taken as the value calculated by the following formula from the Feret diameter of the above particles. Particle aspect ratio = 100 × (Feret diameter (vertical width) of the particle) ÷ (Feret diameter (horizontal width))

[0349] (Particle area) For particles different from the particles for which the Feret diameter (vertical and horizontal widths) was measured, the area of the particles imaged as described above (particle area (μm 2 )) was measured with a Parshear analyzer. Among 10,000 measured particles, the average value of the values of 1,000 particles with small values was taken as the particle area.

[0350] 〔Backscatter value (BS value)〕 2 g of a sample of the composition and 20 ml of pure water were placed in a test bottle (height 70 mm, diameter 25 mm, capacity 20 ml), set on a shaker (manufactured by Tokyo Rika Kikai Co., Ltd., MMS-3020), and shaken at 200 times / min for 1 minute. Immediately, the prepared sample (still in the bottle) was set on a stability tester ST-1 (manufactured by Eihiro Seiki Co., Ltd.), light irradiation (light source wavelength: 870 nm) was performed, and the solution stability was evaluated by measuring the backscattered light (Backscatter value, BS value, %). The measurement conditions were as follows. · Height of the liquid surface to be scanned: 0 to 40 mm from the bottom of the bottle · Scanning frequency: 30 seconds · Measurement time: 1 hour

[0351] (Sedimentation rate: BS ratio at a height of 30 mm) The sedimentation rate (BS ratio (1 minute: 5 minutes) at a height of 30 mm from the bottom (30 mm point on the bottom surface)) was calculated by the following formula based on the above measurement. Sedimentation rate (%) = 100 × (BS value at 30 mm from the bottom surface after 1 minute of measurement) ÷ (BS value at 30 mm from the bottom surface after 5 minutes of measurement) Here, the bottom surface means the bottom surface of the test bottle.

[0352] (Degree of sedimentation: BS ratio 60 minutes after the start of measurement) The degree of sedimentation (BS ratio (10 mm:40 mm) 60 minutes after the start of measurement) was calculated by the following formula based on the above measurement. Degree of sedimentation (%) = 100 × (BS value at a height of 10 mm from the bottom surface (10 mm from the bottom surface point) 60 minutes after the start of measurement) ÷ (BS value at a height of 40 mm from the bottom surface (40 mm from the bottom surface point) 60 minutes after the start of measurement) Here, the bottom surface means the bottom surface of the test bottle.

[0353] [Water absorption rate of powder] The water absorption rate of the powder of the composition (water absorption rate of powder particles) was measured as follows: 2 g of powder particles were placed in a container, water was dropped and evenly mixed, and the amount of water just before the occurrence of water separation from the powder particles was visually confirmed. The average value of n = 100 (n represents the number of measurements) was obtained.

[0354] [Hardness, disintegration time in water, water disintegrability of tablets] The hardness of the tablet (tablet hardness) (N) was measured using a hardness tester (model number: KHT-40N, Fujiwara Seisakusho). The tablet manufactured in the section of "Preparation of composition and tablet" was placed in the center of the measuring table and the device was started (the AUTO [start] button was pressed). At this time, the hardness in the vertical direction was measured with respect to the compression direction during tablet forming. As a result, when the rod descends rapidly and the display becomes in the peak hold state, and when it contacts the measurement object, it becomes slow and the display is monitored approximately every 0.1 second. If it does not increase, it is judged as destruction, and the hardness indicated by the hardness tester at that time was taken as the tablet hardness (N).

[0355] The disintegration time in water was obtained by putting the tablet (250 g) into a test tube, adding 20 ml of pure water, vibrating it at 37 °C with a shaker (reciprocating / rotary shaker MMS-3020, Tokyo Rika Kikai Co., Ltd.), and measuring the disintegration time. The measurement was performed 50 times, and the average value was taken as the disintegration time in water (minutes) of the tablet. 1 mm 3When the above-mentioned lump disappeared, it was judged as underwater disintegration.

[0356] The underwater disintegration property of the tablet is represented by the disintegration time per unit hardness [underwater disintegration time (D) / tablet hardness (N) (minutes / N)].

[0357] 〔Friction force of wet powder〕 The friction force of the wet powder was obtained by passing the residue of the sample used in the above-mentioned "underwater disintegration property" test through a 90 μm (JIS standard Z8801 wire), collecting it, and using a static and dynamic friction measuring instrument ("Handy Tribo Master TL201Ts" manufactured by Trinity Lab) to measure under the measurement conditions of a load of 50 g and a speed of 10 mm / second. As the contactor, a contactor with artificial skin ("Bioskin" manufactured by Buehlerax) attached to a 5 mm thick sponge sheet ("Tape N-1 for gaps" manufactured by Cemedine) was used. Based on the results of the static friction force (gf), the ratio of the static friction force (gf) at the time when the moving distance is 0 mm and the static friction force (gf) at the time when the moving distance is 3 mm is calculated by the following formula. Formula: Friction force of wet powder for a 2 mm movement (%) = 100×(static friction force at the time when the moving distance is 0 mm / static friction force at the time when the moving distance is 3 mm)

[0358] 〔Tapping apparent density〕 The tapping apparent density (g / cm 3 ) of the composition was measured using a commercially available powder physical property measuring instrument (Powder Tester PT-X type manufactured by Hosokawa Micron). Specifically, all the powder particles contained in the composition were filled into a 100 cm 3 cup, tapped 250 times per minute, and then the volume of the cup was obtained by dividing the weight of the powder sample filled in the cup by the volume of the powder sample.

[0359] 〔Apparent density (without tapping)〕 The apparent density (without tapping) (g / cm 3 ) of the composition is 100 cm 3Into a glass graduated cylinder, using a quantitative feeder for the composition etc., it was roughly filled over 2 - 3 minutes. Then, the upper surface of the powder layer was leveled horizontally with a soft brush like a pen and its volume was read, and the weight of the powder sample was obtained by dividing the weight by the volume. The weight of the powder was appropriately determined so that the volume would be around 70 - 100 cm 3 .

[0360] [Compressibility] (Loose bulk density) A sample of the composition was dropped through a chute, the cup was filled with the sample, and after the surface was smoothed, the value was obtained by dividing the weight of the powder layer filled in the cup by the volume of the cup.

[0361] (Consolidated bulk density) A sample of the composition was dropped through a chute, and while tapping the cup at a pace of 250 times per minute, the cup was filled with the sample. After the surface was smoothed, the value was obtained by dividing the weight of the powder layer filled in the cup by the volume of the cup.

[0362] (Compressibility) The compressibility of the composition was calculated by the following formula from the above loose bulk density and consolidated bulk density. Compressibility (%) = 100×(Consolidated bulk density - Loose bulk density) / Consolidated bulk density

[0363] [Angle of repose] The sieve was vibrated, and when a sample of the composition was supplied onto a circular table through a funnel, the inclination angle (θ1) of the mountain formed was read, the angle was calculated, and it was taken as the angle of repose (°).

[0364] [Angle of collapse] The mountain forming the angle of repose was given three impacts with a dedicated shocker (attached to the powder tester), the inclination angle (θ2) of the mountain when it collapsed was read, the angle was calculated, and it was taken as the angle of collapse (°).

[0365] [Difference angle] Based on the values of the angle of repose and the angle of collapse, the value calculated by the following formula was taken as the difference angle (°). Difference angle (°) = Angle of repose (θ1) - Angle of collapse (θ2)

[0366] [Stress per unit of shear strain] Using a RHEONERII CREEP METER RE2-33005C (manufactured by Yamaden Co., Ltd.), the stress (kN / m 2 ) with respect to the shear strain (%) of the tablet after tableting was measured under the following conditions. · Attachment used: Cylinder (3S) · Measurement parameters: Storage pitch 0.25 sec, measurement strain rate 40%, measurement speed 0.5 mm / sec, return distance 2.00 mm

[0367] The stress tolerance (%) of the tablet (the stress (kN / m 2 ) at 18% shear strain / the stress (kN / m 2 )) at 10% shear strain) was calculated by the following formula. Stress tolerance (%) of the tablet = 100 × (stress (kN / m 2 ) at 18% shear strain) ÷ (stress (kN / m 2 ) at 10% shear strain)

[0368] [Thermogravimetric analysis] Using a thermal analyzer (STA300 manufactured by Hitachi High-Tech Science), the residual weight of the sample (about 10 mg) of the composition was measured at 100°C, 200°C, 300°C, 400°C, and 600°C when the temperature of the sample was raised from 25°C to 600°C at a rate of 10°C / min under a N2 atmosphere. The weight retention rate when the sample is heated from temperature a to temperature b is the value obtained by expressing the residual weight at temperature b as a percentage (%) with respect to the residual weight at temperature a being 100. That is, the weight retention rate is expressed by the following formula. Weight retention rate (%) = 100 × [residual weight (mg) at temperature b] / [residual weight (mg) at temperature a]

[0369] [Measurement of electromotive force] Using a thermal analyzer (STA300 manufactured by Hitachi High-Tech Science), the electromotive force (μV) of the sample (about 10 mg of the composition) was measured at 100°C, 200°C, 300°C, 400°C, and 600°C when the temperature of the sample was raised from 25°C to 600°C at a rate of 10°C / min under a N2 atmosphere.

[0370] 〔Evaluation of Ease of Swallowing〕 It was evaluated by 30 adult males and 30 adult females. The tablets were placed in the oral cavity, and the ease of swallowing when the tablets were swallowed 10 seconds later was evaluated. The average value of the 1 - 4 point four - level evaluation of these 60 people was used as the evaluation score for each example and comparative example. The results were evaluated according to the following criteria. ·4 (Very good): It passes through the throat immediately with almost no discomfort. ·3 (Good): It passes through the throat relatively smoothly, but there is a slight discomfort. ·2 (Ordinary): Some effort is required to pass through the throat. ·1 (Bad): Considerable effort is required to swallow, and the discomfort is strong.

[0371] 〔Tactile Sensation Test on the Tongue〕 It was evaluated by 30 adult males and 30 adult females. The tablets were placed in the oral cavity, and the tablets were disintegrated while rolling them with the tongue, and the powdery tactile sensation after the tablets were completely disintegrated was evaluated. The average value of the 1 - 4 point four - level evaluation of these 60 people was used as the evaluation score for each example and comparative example. The results were evaluated according to the following criteria. ·1: A very powdery feeling is felt. ·2: A powdery feeling is felt. ·3: Although a slight powdery feeling is felt, it is moist enough not to feel powdery. ·4: No powdery feeling is felt.

[0372] The closer the evaluation in the tactile sensation test on the tongue is to 4, the lower the powdery feeling of the disintegration paste of the tablets, that is, when the tablets are orally administered to the subject, the disintegration paste exhibits a good tactile sensation on the tongue.

[0373] 〔Evaluation of the Packability (Packing Efficiency) of Particles or Compositions〕 Based on the evaluation of "compressibility" and "angle of difference", it was evaluated as follows. ·4 (Very high (compressibility 1.1 - 1.3, or angle of difference 12 - 24°)): The powder is completely and uniformly filled in the planned volume. ·3 (High (compression degree 1.4 - 1.6 and angle difference 12 - 24°)): The powder is almost completely filled, but there are slight voids. ·2 (Low (compression degree 1.4 - 1.6 and angle difference 25 - 30°)): There are many voids in the filling, lacking uniformity. ·1 (Very low (compression degree 1.4 - 1.6, angle difference 25 - 30°, and large voids are observed by visual inspection during the measurement of the loosened bulk density)): It is hardly filled or large voids are seen.

[0374] 〔Evaluation of dispersibility〕 A 10 - g sample of the composition was dropped from a certain height, and the dispersibility was calculated by the following formula based on the amount remaining on the watch glass placed below. Dispersibility [%] = 100×(Sample input amount - Amount remaining on the watch glass) / Sample input amount

[0375] (Evaluation of the transportability of tablets) The transportability of the tablets was evaluated as follows. Ten tablets (for reference, about 20 ml) obtained by tableting were placed in a test bottle (height 70 mm, diameter 25 mm, capacity 20 ml), and the weight was measured (weight A). The test bottle containing the tablets was set on a shaker (manufactured by Tokyo Rika Kikai Co., Ltd., MMS - 3020) and shaken at 200 times per minute for 1 hour. The powder adhering to the surface of the tablets after the test was removed, and the weight of the recovered powder was measured (weight B).

[0376] Based on weight A and weight B, the chipping condition of the tablets was calculated by the following formula. Chipping condition of tablets (%) = 100×Weight B / Weight A The higher the value of the "chipping condition of tablets", the higher the shock resistance of the tablets and the higher the transportability.

[0377] The results are evaluated according to the following criteria. ·4 (Very high): After the vibration test, no chipping or cracking is observed in the tablets. (Chipping condition of tablets 95% or more) ·3 (High): After the vibration test, very small chips or cracks are slightly observed in the tablets, but the overall shape is maintained. (Degree of chipping of tablets: 90%) ·2 (Moderate): After the vibration test, obvious chips or cracks are seen in the tablets, and there is some deformation in the shape. (Degree of chipping of tablets: 85%) ·1 (Low): After the vibration test, there are many large chips or cracks in the tablets, and the shape is significantly damaged. (Degree of chipping of tablets: 80% or less)

[0378] [Evaluation Results] The measurement results of each parameter for the powder particles, composition, and tablets measured as described above are as shown in Table 2.

[0379] [Table 2] TIFF0007713109000003.tif159170TIFF0007713109000004.tif159170TIFF0007713109000005.tif159170

[0380] [Examination of Evaluation Results] [Ease of Swallowing] When the aspect ratio was less than 1.40 and the particle area was less than 20.0, the evaluation of ease of swallowing was 3 or more. When the aspect ratio was less than 1.40 and the particle area was less than 20.0, it was shown that when the composition or tablet containing the powder particles was orally administered, it was difficult to stay in the mouth and / or it was easy to achieve good passage during swallowing, that is, it was easy to swallow.

[0381] When the powder water absorption rate was less than 200, the evaluation of ease of swallowing was 3 or more. When the powder water absorption rate was less than 200, it was shown that the composition containing the powder particles or the tablet containing the composition was easy to swallow and / or it was easy to achieve good tongue feel.

[0382] When the disintegration time in water is less than 90 minutes, when the hardness of the tablet is 46 or less, when the disintegration property in water is less than 1.9, the evaluation of ease of swallowing was 3 or more. When one or more of these parameters are within the above ranges, it has been shown that when the composition or tablet is orally administered, it is difficult to stay in the mouth, and / or it is easy to achieve good passage of the composition during swallowing, that is, it is easy to swallow.

[0383] When the frictional force of the wet powder was less than 63, the evaluation of ease of swallowing was 3 or more. On the other hand, when the frictional force of the wet powder was 63 or more, the evaluation of ease of swallowing was 2 or less. When the frictional force of the wet powder was less than 63, it has been shown that when the composition or tablet is orally administered, it is difficult to stay in the mouth, and / or it is easy to achieve good passage of the composition during swallowing, that is, it is easy to swallow.

[0384] When the BS ratio at a height of 30 mm was 11.7 or less, the evaluation of ease of swallowing was 3 or more. On the other hand, when the BS ratio at a height of 30 mm was 11.8 or more, the evaluation of ease of swallowing was 2 or less. When the BS ratio at a height of 30 mm was 11.7 or less, it has been shown that when the composition or tablet is orally administered, it is difficult to stay in the mouth, and / or it is easy to achieve good passage of the composition during swallowing, that is, it is easy to swallow.

[0385] When the BS ratio 60 minutes after the start of measurement was less than 21.0, the evaluation of ease of swallowing was 3 or more. On the other hand, when the BS ratio 60 minutes after the start of measurement was 21.0 or more, the evaluation of ease of swallowing was 2 or less. When the BS ratio 60 minutes after the start of measurement was less than 21.0, it has been shown that when the composition or tablet is orally administered, it is difficult to stay in the mouth, and / or it is easy to achieve good passage of the composition during swallowing, that is, it is easy to swallow.

[0386] When the angle of repose of the composition was less than 57.0, the evaluation of ease of swallowing was 3 or more. On the other hand, when the angle of repose of the composition was 57.0 or more, the evaluation of ease of swallowing was 2 or less. When the angle of repose of the composition is less than 57.0, it has been shown that when the composition or tablet is orally administered, it is less likely to stay in the mouth and / or it is easy to achieve good passage of the composition during swallowing, that is, it is easy to swallow.

[0387] When the disintegration angle of the composition is more than 31.8 (preferably 32.0 to 44.0), the evaluation of ease of swallowing was 3 or more. On the other hand, when the disintegration angle of the composition was 31.8 or less or 36.0 (for example, 45.0) or more, the evaluation of ease of swallowing was 2 or less. When the disintegration angle is more than 31.8, it has been shown that when the composition or tablet is orally administered, it is less likely to stay in the mouth and / or it is easy to achieve good passage of the composition during swallowing, that is, it is easy to swallow.

[0388] 〔Palatability test by tongue feel〕 When the aspect ratio was less than 1.40 and the particle area was less than 20.0, the palatability evaluation by tongue feel was 3 or more. When the aspect ratio was less than 1.40 and the particle area was less than 20.0, it has been shown that when the composition or tablet is orally administered, it is less likely to stay in the mouth and / or it is easy to achieve good passage during swallowing, that is, the palatability by tongue feel is likely to be good.

[0389] When the frictional force of the wet powder was less than 63, the palatability evaluation by tongue feel was 3 or more. On the other hand, when the frictional force of the wet powder was 63 or more, the palatability evaluation by tongue feel was 2 or less. When the frictional force of the wet powder was less than 63, it has been shown that when the composition or tablet is orally administered, it is less likely to stay in the mouth and / or it is easy to achieve good passage during swallowing, that is, the palatability by tongue feel is likely to be good.

[0390] When the BS ratio at a height of 30 mm was 11.7 or less, the palatability evaluation by tongue feel was 3 or more. On the other hand, when the BS ratio at a height of 30 mm was 11.8 or more, the evaluation of the palatability by tongue feel was 2 or less. When the BS ratio at a height of 30 mm is 11.7 or less, when the composition or tablet is orally administered, it is difficult to stay in the mouth and / or it is easy to achieve good passage during swallowing, that is, it has been shown that the feel in the mouth tends to be good.

[0391] When the BS ratio 60 minutes after the start of measurement was less than 21.0, the tactile sensation sensory evaluation was 3 or more. On the other hand, when the BS ratio 60 minutes after the start of measurement was 21.0 or more, the tactile sensation sensory evaluation was 2 or less. When the BS ratio 60 minutes after the start of measurement was less than 21.0, when the composition or tablet was orally administered, it was difficult to stay in the mouth and / or it was easy to achieve good passage during swallowing, that is, it has been shown that the feel in the mouth tends to be good.

[0392] When the angle of repose of the composition was less than 57.0, the tactile sensation sensory evaluation was 3 or more. On the other hand, when the angle of repose of the composition was 57.0 or more, the tactile sensation sensory evaluation was 2 or less. When the angle of repose of the composition was less than 57.0, when the composition or tablet was orally administered, it was difficult to stay in the mouth and / or it was easy to achieve good passage during swallowing, that is, it has been shown that the feel in the mouth tends to be good.

[0393] When the crushing angle of the composition was more than 31.8 (preferably 32.0 to 44.0), the tactile sensation sensory evaluation was 3 or more. On the other hand, when the crushing angle of the composition was 31.8 or less or 36.0 or more (for example, 45.0), the tactile sensation sensory evaluation was 2 or less. When the crushing angle was 32.0 or more, when the composition or tablet was orally administered, it was difficult to stay in the mouth and / or it was easy to achieve good passage of the composition during swallowing, that is, it has been shown that the feel in the mouth tends to be good.

[0394] 〔Evaluation of the fillability (filling efficiency) of particles or compositions〕 When the aspect ratio was less than 1.40, the fillability evaluation was 3 or more. On the other hand, when it was 1.40 or more, the fillability evaluation was 2 or less. When the aspect ratio is less than 1.40, the composition is likely to have high fillability and it is likely to improve productivity.

[0395] When the frictional force of the wet powder was less than 63, the fillability evaluation was 4 or more. On the other hand, when the frictional force of the wet powder was 63 or more, the fillability evaluation was 3 or less. When the frictional force of the wet powder was less than 63, the composition was likely to have high fillability and it was likely to improve productivity.

[0396] When the compressibility of the composition was 1.0 to 1.5, the fillability evaluation was 4 or more. On the other hand, when the compressibility of the composition was 1.4 or more, the fillability evaluation was 3 or less. When the compressibility of the composition was 1.0 to 1.5, the composition was likely to have high fillability and it was likely to improve productivity.

[0397] When the angle of repose of the composition was less than 57.0, the fillability evaluation was 4 or more. On the other hand, when the angle of repose of the composition was 57.0 or more, the fillability evaluation was 3 or less. When the angle of repose of the composition was less than 57.0, it was shown that it was likely to have high fillability.

[0398] When the angle of collapse of the composition was more than 31.8, the fillability evaluation was 3 or more. On the other hand, when the angle of collapse of the composition was 31.8 or less, the fillability evaluation was 2 or less. When the angle of collapse of the composition was more than 31.8, the composition was likely to have high fillability and it was likely to improve productivity.

[0399] When the angle difference of the composition was less than 25.2, the fillability evaluation was 3 or more. On the other hand, when the angle difference of the composition was 25.2 or more, the fillability evaluation was 2 or less. When the angle difference was less than 25.2, the composition was likely to have high fillability and it was likely to improve productivity.

[0400] Stress resistance (%) (stress (kN / m at 18% of the moving strain rate × 100)2 )) Stress (kN / m at 10% shear strain 2 )) was less than 80 (preferably less than 62, or more than 59 and less than 80), the filling property evaluation was 3 or more. Furthermore, when the stress tolerance (%) (stress at 18% shear strain / stress at 10% shear strain) was less than 80, the filling property evaluation was 4. It has been shown that when the stress tolerance of the tablet is less than 80, the composition is likely to have high filling property and is likely to improve productivity.

[0401] 〔Evaluation of the dispersibility of particles or composition〕 When the dispersibility (%) is less than 44 (preferably 40 or less), it can be evaluated that the degree of powder scattering of the powder particles contained in the composition is low and the dispersibility is low.

[0402] When the aspect ratio was less than 1.40, the dispersibility (%) was 22 or less. On the other hand, when the aspect ratio was 1.40 or more, the dispersibility (%) was 44 or more.

[0403] The aspect ratio being close to 1.0 indicates that the particles are close to spherical. Therefore, it has been shown that when the aspect ratio is small (for example, less than 1.40), friction between particles is less likely to occur and the dispersibility of the composition is likely to be low.

[0404] When the collapse angle of the composition was more than 31.8, the dispersibility (%) was 22 or less. On the other hand, when the collapse angle was 31.8 or less, the dispersibility (%) was 44 or more. It has been shown that the larger the collapse angle (for example, more than 31.8), the lower the dispersibility of the composition and the easier it is to handle.

[0405] When the difference angle of the composition was less than 25.2, the dispersibility (%) was 22 or less. On the other hand, when the collapse angle was 25.2 or more, the dispersibility (%) was 44 or more. It has been shown that the smaller the difference angle (for example, less than 25.2), the lower the dispersibility of the composition and the easier it is to handle.

[0406] Stress resistance (%) (100 × stress (kN / m at 18% of the moving strain) 2 ) / stress (kN / m at 10% of the moving strain) 2 )) is less than 80 (preferably less than 62, or more than 59 and less than 80), the degree of dispersion (%) was 22 or less. On the other hand, when the stress resistance is more than 76 (for example, more than 76 and less than 104, or more than 99), the degree of dispersion (%) was 44 or more. When the stress resistance is less than 80, it was shown that the degree of dispersion of the composition is low and handling is likely to be easy.

[0407] 〔Evaluation of the transportability of tablets〕

[0408] When the aspect ratio is less than 1.40, the transportability evaluation was 2 or less. On the other hand, when the aspect ratio is 1.40 or more, the transportability evaluation was 3 or more.

[0409] An aspect ratio close to 1.0 indicates that the particles are close to spherical. On the other hand, a large aspect ratio indicates that the particles have a shape deviating from spherical. When the aspect ratio of the particles is 1.40 or more, it was shown that the transportability of the tablets of the composition containing the particles is likely to be high.

[0410] When the collapse angle of the composition is more than 31.8, the transportability evaluation was 2 or less. On the other hand, when the collapse angle is 31.8 or less, the transportability evaluation was 3 or more. When the collapse angle of the composition is 31.8 or less, it was shown that the transportability of the tablets containing the composition is likely to be high.

[0411] When the difference angle of the composition is less than 25.2, the transportability evaluation was 2 or less. On the other hand, when the difference angle is 25.2 or more, the transportability evaluation was 3 or more. When the difference angle of the composition is 25.2 or more, it was shown that the transportability of the tablets containing the composition is likely to be high.

[0412] Stress resistance (%) (100 × stress (kN / m at 18% of the moving strain) 2 ) / stress (kN / m at 10% of the moving strain)2 ) is less than 80 (for example, less than 62, or more than 59 and less than 80), the handling property evaluation was 2 or less. On the other hand, when the stress resistance is more than 76 (preferably 80 to 99, or more than 99), the handling property evaluation was 3 or more. When the stress resistance is more than 76, it was shown that the handling property of the tablets tends to be high.

Industrial Applicability

[0413] Since the composition of this embodiment has characteristics such as being easy to swallow, having a good texture, having good fillability, having low dispersibility, and / or having high handling property of tablets containing the composition, it can be suitably used as a composition for foods, pharmaceuticals, and / or cosmetics, etc. for which such characteristics are desired, and has industrial applicability.

Claims

1. The particle area measured by the dynamic image analysis device is less than 20.0 μm ２ contains particles with an aspect ratio of less than 1.40 and a collapse angle of 32.0 to 44.0°, and The following (a) to (d): (a) The Backscatter (BS) ratio at a height of 30 mm from the bottom surface is 11.7% or less, (b) The BS ratio after 60 minutes from the start of measurement is less than 21.0%, (c) The frictional force of the wet powder is less than 63%, (d) The water absorption rate of the powder is less than 200%, satisfying any one or more of the above, where the BS ratio at a height of 30 mm from the bottom surface is calculated from the value of the backscattered light measurement (BS value) obtained at a point 30 mm from the bottom surface of the test bottle containing the sample containing the composition 1 minute after the start of measurement and the value 5 minutes after the start of measurement using the following formula when light is irradiated on the test bottle containing the sample containing the composition: 100×(BS value at 30 mm from the bottom surface 1 minute after the start of measurement) / (BS value at 30 mm from the bottom surface 5 minutes after the start of measurement) is calculated by The BS ratio 60 minutes after the start of measurement is calculated from the backscattered light measurement values (BS values) obtained at a point 40 mm from the bottom surface and a point 10 mm from the bottom surface of the test bottle when light is irradiated on the test bottle containing the sample containing the composition using the following formula: 100×(BS value at 10 mm from the bottom surface 60 minutes after the start of measurement) / (BS value at 40 mm from the bottom surface 60 minutes after the start of measurement) is calculated by The frictional force of the wet powder is the frictional force of the wet powder moving 2 mm, and is obtained from the values of the static frictional force at the time of 0 mm of the moving distance and the static frictional force at the time of 3 mm of the moving distance measured with a load of 50 g and a speed of 10 mm / second for the sample containing the composition, and is calculated by the following formula: 100×(static frictional force at 0 mm of the moving distance) / (static frictional force at 3 mm of the moving distance) is calculated by containing 60% to 90% by weight of one or more materials selected from the group consisting of wheat germ, oats, calcium carbonate, crystalline cellulose, powdered cellulose, and truffle powder, containing 20% by weight or less of titanium oxide, composition.

2. The in-water disintegration property of the tablet containing the composition is less than 1.9 (min / N), where the in-water disintegration property is calculated from the hardness (N) of the tablet measured with a hardness tester and the disintegration time (min) of the tablet in pure water using the following formula: In-water disintegration time (D) / Tablet hardness (N) The composition according to claim 1.

3. The hardness of the tablet containing the composition is 46 N or less, and The in-water disintegration time of the tablet containing the composition is less than 90 minutes, The composition according to claim 1 or 2.

4. containing particles with a Feret diameter (vertical width) of less than 3.3 μm and a Feret diameter (horizontal width) of 2.4 μm or less, The composition according to claim 1 or 2.

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