composition

Abstract

To provide a composition that is easy to swallow, has good texture, has good filling properties, has low dispersibility, and / or has high portability of tablets containing the composition.SOLUTION: This composition has specific ranges in particle parameters including particle area, Feret diameter, and / or aspect ratio; in composition parameters including 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 residual ratio, and / or electromotive force; and / or in tableting parameters including disintegration time in water and / or disintegrability in water.SELECTED DRAWING: None

Description

[Technical Field]

[0001] The present disclosure relates to compositions. [Background technology]

[0002] Compositions used in various forms for pharmaceutical or food applications are orally administered or ingested by subjects, and such compositions are required to pass easily through the oral cavity and during swallowing, i.e., be easy to swallow, and / or have a pleasant texture. In addition, it is preferable that the composition has the properties of good packing properties, low dusting (low dispersibility), and / or powder that is not easily chipped (high transportability) in terms of handling. The above properties may also be suitable for cosmetic and lubricant compositions.

[0003] Conventionally, attempts have been made to adjust the hardness and oral disintegration properties of tablets containing the composition by adjusting, for example, the fiber length, fiber width, etc. of the fibrous material contained in the composition, thereby improving ease of swallowing and a pleasant texture to the palate. However, it has been difficult to set production conditions for accurately controlling the fiber length and fiber width contained in the composition.

[0004] [Patent Document 1] International Publication No. 2013 / 180249 Brochure Summary of the Invention

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

[0006] Another object (second object) of the present disclosure is to provide a composition having a pleasant texture on the tongue, and / or a tablet containing the composition having a pleasant texture on the tongue.

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

[0008] Another object (fourth object) of the present disclosure is to provide a composition having a low degree of dispersion.

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

[0010] The present disclosure includes the following aspects. Particle area is 20.0 μm 2 and comprising particles having an aspect ratio of less than 1.40; (a) to (d) below: (a) Backscatter (BS) ratio at a height of 30 mm from the bottom is 11.7% or less, (b) BS ratio is less than 21.0% 60 minutes after the start of measurement; (c) the frictional force of the wet powder is less than 63%; (d) Powder water absorption rate is less than 200%; Satisfy one or more of the following: Here, the BS ratio at a height of 30 mm from the bottom is calculated by the following formula, based on the backscattered light measurement value (BS value) obtained at a point 30 mm from the bottom of the bottle when a test bottle containing a sample containing a composition is irradiated with light, and the value 1 minute and 5 minutes after the start of measurement: 100 x (BS value at 30 mm from the bottom 1 minute after measurement started) / (BS value at 30 mm from the bottom 5 minutes after measurement started) It is calculated as The BS ratio 60 minutes after the start of measurement was calculated by irradiating a test bottle containing a sample containing the composition with light, and calculating the backscattered light (BS value) measured at a point 40 mm from the bottom of the bottle and a point 10 mm from the bottom from the following formula: 100 x (BS value at 10 mm from the bottom 60 minutes after the start of measurement) / (BS value at 40 mm from the bottom 60 minutes after the start of measurement) It is calculated as The frictional force of the wet powder is the frictional force of the wet powder when it has moved 2 mm, and is calculated from the static frictional force values ​​at a moving distance of 0 mm and 3 mm obtained by measuring a sample containing the composition under a load of 50 g and a speed of 10 mm / sec, using the following formula: 100 x (static friction force at 0 mm travel distance) / (static friction force at 3 mm travel distance) It is calculated as composition.

[0011] According to a first aspect of the present disclosure, an easy-to-swallow composition and / or an easy-to-swallow tablet comprising the composition can be provided.

[0012] According to a second aspect of the present disclosure, it is possible to provide a composition having a pleasant texture on the tongue, and / or a tablet having a pleasant texture on the tongue containing the composition.

[0013] According to the third aspect of the present disclosure, a composition with good filling properties 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 a fifth aspect of the present disclosure, it is possible to provide a composition having high transportability when a tablet containing the composition is administered, and / or a tablet having high transportability. DETAILED DESCRIPTION OF THE INVENTION

[0016] An embodiment of the present disclosure will be described in detail below. The present disclosure is not limited to the following embodiment, and can be implemented by making appropriate modifications within the scope that does not impair the effects of the present disclosure. The configurations and combinations thereof in each embodiment are merely examples, and additions, omissions, substitutions, and other modifications of the configurations are possible as appropriate within the scope of the present disclosure. The present disclosure is not limited by the embodiments, but is limited only by the claims. Each feature disclosed herein may be combined with any other feature disclosed herein. When a specific description given for one embodiment also applies to other embodiments, that description may be omitted in the other embodiments. In this disclosure, the expression "X to Y" regarding a numerical range means "X or more and Y or less." When a specific description given for one embodiment also applies to other embodiments, that description may be omitted in the other embodiments. Unless otherwise specified, all numbers expressing features, items, quantities, parameters, characteristics, periods, etc. used in the specification and claims are understood to be modified in all instances by the term "about." As used herein, the term "about" means that the so-specified feature, item, quantity, parameter, characteristic, or period encompasses a range above and below the stated value of the feature, item, quantity, parameter, characteristic, or period, plus or minus 10 percent. At least, and without limiting the application of the doctrine of equivalents to the scope of the claims, each numerical indicator should be construed in light of the number of reported significant digits and by applying ordinary rounding techniques. Any numerical range or value inherently includes a range of error necessarily resulting from the standard deviation found in their respective testing measurements. Unless otherwise specified, each individual value of a numerical range herein is incorporated herein by reference as if it were individually recited herein.

[0017] In this specification, the term "comprise" refers to containing a certain component as at least a part, and includes cases where the composition consists solely of that component.

[0018] [First embodiment (composition)] For the composition according to this embodiment, the parameters described below can be measured and adjusted as described later in the section "Method for measuring parameters and method for adjusting the parameters."

[0019] The composition (1-1) according to the first embodiment has a particle area (μm 2 ) is 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, it may be, for example, any of 0.22, 0.23, 2.0, 2.1, 2.3, 4.0, 4.1, 4.3, 6.1, 8.0, 8.1, 8.3, 10.0, 12.0, 12.3, 16.0, 16.1, 16.3, 18.0, 18.1, or 18.3, or may be a range with any one of these as the upper limit and another one as the lower limit.

[0021] The composition (1-2) according to the first embodiment has a particle area (μm 2 ) is 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, it may be, for example, any of 2.0, 2.1, 2.3, 4.0, 4.1, 4.3, 6.1, 8.0, 8.1, 8.3, 12.0, 12.3, 16.0, 16.1, 16.3, 18.0, 18.1, or 18.3, and may be a range with any one of these as the upper limit and another one as the lower limit.

[0023] The composition (1-3) according to the first embodiment has a particle area (μm 2 ) is 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 even more preferably 20.0 to 38.0. When the particle area is 20.0 to 38.0, it may be, for example, any of 20.0, 20.1, 20.2, 20.3, 21.4, 21.5, 21.6, 36.9, 37.0, 37.1, or 38.0, or may be within 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 has a particle area (μm 2 ) is 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, it may be, for example, any of 20.0, 20.1, 20.2, 20.3, 21.4, 21.5, 21.6, 36.9, 37.0, 37.1, or 38.0, or may be within 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" of the composition tends to be small (i.e., the sedimentation rate is slow) and / or the "BS ratio 60 minutes after the start of measurement" tends to be small (i.e., the degree of sedimentation is small). If the sedimentation rate is slow and / or the degree of sedimentation is small, the composition or tablet is less likely to remain in the mouth when administered orally and / or is more likely to pass smoothly during swallowing, i.e., be easier to swallow. Thus, for example, a composition comprising particles having a particle area of ​​less than 20.0, or a tablet comprising said composition, is likely to be easier to swallow. Furthermore, when the particle area is small, the composition is easily compacted. Therefore, for example, a composition containing particles with a particle area of ​​less than 20.0 is easily filled into a composition bag or a tablet molding machine, which facilitates improving productivity.

[0028] The composition (2-1) according to the first embodiment is a composition containing particles having 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, even more preferably 0.40 to 3.2, even more preferably 0.50 to 3.2, even more preferably 0.51 to 3.2, and even more preferably 0.51 to 3.1. When the feret diameter (perpendicular) is 0.51 to 3.1, it may be, for example, any of 0.51, 0.52, 0.53, 0.54, 0.55, 0.58, 1.5, 1.6, 2.5, 2.6, 3.0, or 3.1, or may be within 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 (perpendicular 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, it may be, for example, any one of 3.3, 3.4, 4.9, or 5.0, or may be within 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 (perpendicular 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, it may be, for example, any one of 3.3, 3.4, 4.9, or 5.0, or may be within 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 (perpendicular 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, it may be, for example, any of 20.0, 24.0, 24.1, 24.2, 24.5, 24.6, 24.7, 24.8, 24.9, 25.0, 25.6, 25.8, 30.0, 33.0, or 40.0, or may be a range with any one of these as the upper limit and another 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" of the composition tends to be small (i.e., the sedimentation rate is slow) and / or the "BS ratio 60 minutes after the start of measurement" tends to be small (i.e., the degree of sedimentation is small). If the sedimentation rate is slow and / or the degree of sedimentation is small, the composition or tablet is less likely to remain in the mouth when administered orally and / or is more likely to pass smoothly during swallowing, i.e., be easier to swallow. For example, a composition containing particles having a Feret diameter (perpendicular width) of less than 3.3, or a tablet containing the composition, is likely to be easier to swallow. Furthermore, when the particle area is small, the composition is easily compacted. For example, a composition containing particles having a Feret diameter (vertical width) of less than 3.3 is easily filled into a composition bag or a tablet molding machine, which facilitates improved productivity.

[0037] The composition (3-1) according to the first embodiment is a composition containing particles having 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, 0.51 or more and less than 2.3, or 0.51 to 2.2.

[0039] When the feret diameter (vertical width) is 0.51 to 2.4, it may be, for example, 0.51, 0.52, 0.53, 1.4, 2.1, or 2.4, or may be within 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 (perpendicular 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, it may be, for example, 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 even more preferably 20.0 to 36.0. When the feret diameter (horizontal width) is 20.0 to 36.0, it may be, for example, any one of 20.0, 22.0, 24.0, 26.0, 27.0, or 36.0, or may be within 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" of the composition tends to be small (i.e., the sedimentation rate is slow) and / or the "BS ratio 60 minutes after the start of measurement" tends to be small (i.e., the degree of sedimentation is small). If the sedimentation rate is slow and / or the degree of sedimentation is small, the composition or tablet is less likely to remain in the mouth when administered orally and / or is more likely to pass smoothly during swallowing, i.e., be easier to swallow. For example, a composition containing particles having a Feret diameter (horizontal width) of 2.4 or less, or a tablet containing the composition, is likely to be easy to swallow. Furthermore, when the particle area is small, the composition is easily compacted. For example, a composition containing particles having a Feret diameter (horizontal width) of 2.4 or less is easily filled into a composition bag or a tablet molding machine, which facilitates improving productivity.

[0047] The composition (4-1) according to the first embodiment is a composition containing particles having 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 even more preferably 1.00 to 1.30. When the aspect ratio is 1.00 to 1.30, it may be, for example, 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, or may be a range with any one of these as the upper limit and another one as the lower limit.

[0049] The composition (4-2) according to the first embodiment is a composition containing particles having 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, even 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, it may be, for example, any one of 1.40, 1.41, 1.42, 1.43, 1.45, 1.60, 1.61, 1.62, or 1.63, or may be within a range with any one of these as the upper limit and another one 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, even 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, it may be, for example, any one of 1.40, 1.41, 1.42, 1.43, 1.45, 1.60, 1.61, 1.62, or 1.63, or may be within a range with any one of these as the upper limit and another one 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, even 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, it may be, for example, 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 may be within a range with any one of these as the upper limit and another one as the lower limit.

[0055] An aspect ratio close to 1.0 indicates that the particles are nearly spherical. A small aspect ratio tends to result in a small "BS ratio at a height of 30 mm from the bottom" of the composition (i.e., a slow settling rate) and / or a small "BS ratio 60 minutes after the start of measurement" (i.e., a small degree of settling). If the sedimentation rate is slow and / or the degree of sedimentation is small, the composition or tablet is less likely to remain in the mouth when administered orally and / or is more likely to pass smoothly during swallowing, i.e., be easier to swallow. For example, a composition comprising particles having an aspect ratio of less than 1.40, or a tablet comprising said composition, is likely to be easier to swallow. Furthermore, a small aspect ratio makes the composition more easily compacted. For example, a composition containing particles with an aspect ratio of less than 1.40 is more easily filled into a composition bag or a tablet molding machine, which makes it easier to improve productivity.

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

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

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

[0059] In the composition, the BS ratio at a height of 30 mm is preferably 11.8 to 20.0, more preferably 11.8 to 15.0, and even more preferably 11.8 to 13.0. When the BS ratio at a height of 30 mm is 11.8 to 13.0, it may be, for example, 11.8, 12.0, or 13.0, or may be within a range with 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 having a BS ratio (%) at a height of 30 mm of 11.8 or more.

[0061] In the composition, the BS ratio at a height of 30 mm is preferably 11.8 to 20.0, more preferably 11.8 to 15.0, and even more preferably 11.8 to 13.0. When the BS ratio at a height of 30 mm is 11.8 to 13.0, it may be, for example, 1.8, 12.0, or 13.0, or may be within a range with 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 having a BS ratio (%) at a height of 30 mm of 11.8 or more.

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

[0064] A small BS ratio at a height of 30 mm of the composition means that the sedimentation rate of the composition is slow. If the sedimentation rate is slow, the composition or tablet is less likely to remain in the mouth when administered orally and / or is more likely to pass smoothly during swallowing, i.e., be easier to swallow and / or have a good mouthfeel. For example, a composition having a BS ratio of 11.7 or less at a height of 30 mm, or a tablet containing said composition, is likely to be easy to swallow and / or to have a good mouthfeel.

[0065] The composition (6-1) according to the first embodiment is a composition in which the BS ratio (10mm:40mm) (%) 60 minutes after the start of measurement (hereinafter also referred to as "BS ratio 60 minutes after the start of measurement") is less than 21.0.

[0066] In the composition, the BS ratio 60 minutes after the start of the measurement is preferably 1.0 or more and less than 21.0, more preferably 1.0 to 20.0, even more preferably 1.5 to 18.0, even more preferably 2.1 to 15.0, and even more preferably 2.1 to 12.0. When the BS ratio 60 minutes after the start of measurement is 1.5 to 12.0, it may be, for example, 1.5, 2.1, 2.7, 3.0, 5.2, 6.0, 9.0, or 12.0, or may be within a range with 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 the measurement is preferably 21.0 to 30.0, more preferably 21.0 to 25.0, and even more preferably 21.0 to 24.4. When the BS ratio 60 minutes after the start of measurement is 21.0 to 24.4, it may be, for example, 21.0, 22.0, or 24.4, or may be within a range with one of these as the upper limit and another as the lower limit.

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

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

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

[0073] A small BS ratio of the composition 60 minutes after the start of measurement means that the degree of precipitation of the composition is small. If the degree of sedimentation is small, the composition or tablet is less likely to remain in the mouth when administered orally and / or is more likely to pass smoothly during swallowing, i.e., be easier to swallow and / or have a good texture on the tongue. For example, a composition having a BS ratio of less than 21.0 60 minutes after the start of measurement, or a tablet containing said composition, is likely to be easy to swallow and / or to have a good texture on the tongue.

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

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

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

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

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

[0082] In a composition having low powder water absorption, the powder particles are less likely to expand, so that the powder particles are more likely to break apart, and the "disintegrability in water" of the composition or a tablet containing the composition is more likely to be good. When the disintegrability in water is good, the composition or tablet is likely to have good oral disintegrability when orally administered, is unlikely to remain in the mouth, and / or is likely to achieve good passage of the composition during swallowing, i.e., is likely to be easy to swallow, and / or is likely to have a good texture on the tongue. For example, when the powder water absorption is less than 200, a composition containing the particles or a tablet containing the composition is likely to be easy to swallow and / or have a good mouthfeel.

[0083] The composition (8-1) according to the first embodiment is a composition in which the frictional force (gf) of the wet powder when moved 2 mm (≒ when the moving 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 20-50, even more preferably 30-45, and even more preferably 30-32. When the frictional force of the wet powder is 30 to 45, it may be, for example, 30, 32, 40, 41, 42, or 45, or may be within a range with any one of these as the upper limit and another as the lower limit.

[0085] The composition (8-2) according to the first embodiment is a composition having a frictional force (%) of wet powder of 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 63-70, and even more preferably 63-65. When the frictional force of the wet powder is 63 to 65, it may be, for example, 63, 64, or 65, or may be within a range with one of these as the upper limit and another as the lower limit.

[0087] The composition (8-3) according to the first embodiment is a composition having a frictional force (%) of wet powder of 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 63-70, and even more preferably 63-65. When the frictional force of the wet powder is 63 to 65, it may be, for example, 63, 64, or 65, or may be within a range with one of these as the upper limit and another as the lower limit.

[0089] The composition (8-4) according to the first embodiment is a composition having a frictional force (%) of a wet powder of 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 63-70, and even more preferably 63-65. When the frictional force of the wet powder is 63 to 65, it may be, for example, 63, 64, or 65, or may be within a range with one of these as the upper limit and another as the lower limit.

[0091] A low frictional force of a wet powder indicates that the powder particles contained in the composition or tablet are smooth and are less likely to aggregate and / or cause friction between the powder particles. If the frictional force of the wet powder is low, the composition or tablet is less likely to remain in the mouth when administered orally and / or the composition is more likely to pass through easily during swallowing, i.e., be easier to swallow and / or have a good mouthfeel. For example, if the frictional force of the wet powder is less than 63, the composition or a tablet containing the composition is likely to be easy to swallow and / or provide a good mouthfeel.

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

[0093] In the composition, the disintegration time in water (minutes) is preferably 10 to 80, more preferably 12 to 30, and even more preferably 12 to 15. When the water disintegration time (minutes) is 12 to 15, it may be, for example, 12, 14, or 15, or may be within a range with 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 water disintegration time (minutes) of a tablet containing the composition is 90 or more.

[0095] In the composition, the disintegration time in water (minutes) is preferably 90 to 180, more preferably 90 to 120. When the disintegration time in water is 90 to 120, it may be, for example, 90, 100, 105, 110, or 120, or it may be within 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 water disintegration time (minutes) of a tablet containing the composition is 90 or more.

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

[0099] When the disintegration time of a composition in water is short, the "disintegrability in water" of the composition or a tablet containing the composition tends to be good. When the disintegrability in water is good, the composition or tablet is likely to have good oral disintegrability when orally administered, is unlikely to remain in the mouth, and / or is likely to achieve good passage of the composition during swallowing, i.e., is likely to be easy to swallow, and / or is likely to have a good texture on the tongue. For example, if the disintegration time (minutes) of a tablet in water is less than 90, the tablet is likely to be easy to swallow and / or provide a good mouthfeel.

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

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

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

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

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

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

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

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

[0108] When the tablet hardness is low, the "disintegrability in water" of the composition or a tablet containing the composition tends to be good. When the disintegrability in water is good, the composition or tablet is likely to have good oral disintegrability when orally administered, is unlikely to remain in the mouth, and / or is likely to achieve good passage of the composition during swallowing, i.e., is likely to be easy to swallow, and / or is likely to have a good texture on the tongue. For example, if the hardness (N) of the tablet is 46 or less, the tablet tends to be easy to swallow and / or tends to have a good mouthfeel.

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

[0110] In the composition, the disintegrability in water is preferably 0.2 to 1.8, more preferably 0.3 to 1.2, and even more preferably 0.3 to 0.9. When the disintegrability in water is 0.3 to 0.9, it may be, for example, any one of 0.3, 0.4, 0.7, or 0.9, and may be within 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 water disintegration rate (min / N) of a tablet containing the composition is 1.9 or more.

[0112] In the composition, the disintegrability in water is preferably 1.9 to 5.0, more preferably 1.9 to 3.0, and even more preferably 1.9 to 2.7. When the disintegrability in water is 1.9 to 2.7, it may be, for example, 1.9, 2.2, 2.3, or 2.7, or may be within a range with any one of these as the upper limit and another as the lower limit.

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

[0114] In the composition, the disintegrability in water is preferably 1.9 to 5.0, more preferably 1.9 to 3.0, and even more preferably 1.9 to 2.7. When the disintegrability in water is 1.9 to 2.7, it may be, for example, 1.9, 2.2, 2.3, or 2.7, or may be within a range with any one of these as the upper limit and another as the lower limit.

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

[0116] In the composition, the disintegrability in water is preferably 1.9 to 5.0, more preferably 1.9 to 3.0, and even more preferably 1.9 to 2.7. When the disintegrability in water is 1.9 to 2.7, it may be, for example, 1.9, 2.2, 2.3, or 2.7, or may be within a range with any one of these as the upper limit and another as the lower limit.

[0117] The lower the water disintegration rate (min / N) of a tablet, the higher the disintegration rate. When a tablet has good disintegrability in water, the composition or tablet is likely to have good oral disintegrability when orally administered, is unlikely to remain in the mouth, and / or is likely to achieve good passage of the composition during swallowing, i.e., is likely to be easy to swallow, and / or is likely to have a good texture on the tongue. For example, if the disintegration rate of a tablet in water is less than 1.9, the tablet is likely to be easy to swallow and / or to have a good mouthfeel.

[0118] The composition (12-1) according to the first embodiment has a tapping apparent density (g / cm 3 ) is 0.10 to 8.00.

[0119] In the composition, the tapped apparent density may be 0.50 to 8.00, 0.50 to 5.00, or 0.50 to 4.60, or may be greater than 2.00, 2.10 or greater, 2.10 to 8.00, or 2.10 to 5.00. When the tapping apparent density is 0.50 to 4.60, it may be, for example, any of 0.50, 0.55, 0.60, 0.65, 0.70, 0.80, 2.00, and 4.60, or may be within 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 has a tapping apparent density (g / cm 3 ) is 0.35 to 2.00.

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

[0122] The composition (12-3) according to the first embodiment has a tapping apparent density (g / cm 3) is 0.35 to 2.00.

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

[0124] The composition (12-4) according to the first embodiment has a tapping apparent density (g / cm 3 ) is 0.35 to 2.00.

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

[0126] Tapping apparent density (g / cm 3 The higher the tapping apparent density (g / cm), the easier it is for the composition to be compacted. 3 A composition in which the value of ) is 0.10 to 8.00 or 0.35 to 2.00 can be easily filled into a composition bag or a tablet molding machine, and productivity can be easily improved.

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

[0128] In the composition, the apparent density (without tapping) is preferably 0.30 to 5.00, more preferably 0.34 to 4.20, and may be greater than 1.40 and equal to or less than 4.20. When the apparent density of the powder particles (without tapping) is 0.34 to 4.20, it may be, for example, any of 0.34, 0.40, 0.42, 0.43, 0.44, 0.45, 0.46, 0.50, 0.52, 0.54, 0.55, 0.65, 1.60, or 4.20, or may be within a range 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 has an apparent density of powder particles (without tapping) (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, more preferably 0.22 to 1.40. When the apparent density of the powder particles (without tapping) is 0.22 to 1.40, it may be, for example, any of 0.22, 0.32, 0.34, 0.50, or 1.40, or may be within 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 has an apparent density of powder particles (without tapping) (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, more preferably 0.22 to 1.40. When the apparent density of the powder particles (without tapping) is 0.22 to 1.40, it may be, for example, any of 0.22, 0.32, 0.34, 0.50, or 1.40, or may be within 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 has an apparent density of powder particles (without tapping) (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 of the powder particles (without tapping) is 0.22 to 1.40, it may be, for example, any of 0.22, 0.32, 0.34, 0.50, or 1.40, or may be within a range with any one of these as the upper limit and another as the lower limit.

[0135] Apparent density (without tapping) (g / cm 3 The higher the apparent density (without tapping) (g / cm 3 A composition in which the value of ) is 0.10 to 5.00 or 0.10 to 1.40 can be easily filled into a composition bag or a tablet molding machine, and productivity can be easily improved.

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

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

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

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

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

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

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

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

[0144] The lower the compressibility of the composition, the less the composition is compressed when subjected to vibration, and the less the shape of the bag in which the composition is packaged is changed, which makes the bag in which the composition is packaged easier to load and transport. For example, a composition with a compressibility of 1.0 to 1.5 makes it easier to load a bag containing the composition and to transport it. Furthermore, a low degree of compression of the composition means that the powder layer is less likely to change when the powder particles contained in the composition or tablet are subjected to vibration. When the degree of compression of the composition is low, it becomes easier to fill a composition bag or a tablet molding machine, and productivity can be easily improved.

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

[0146] The angle of repose (°) of the composition is preferably 40.0 to 56.0, more preferably 45.0 to 50.0, and even more preferably 46.9 to 48.3. When the angle of repose (°) is 46.9 to 48.3, it may be, for example, any of 46.9, 47.1, 47.3, 47.5, 47.7, 47.9, 48.1, or 48.3, or may be within a range with 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] The angle of repose (°) of the composition is preferably 57.0 to 70.0, more preferably 57.0 to 60.0, and even more preferably 57.0 to 59.1. When the angle of repose (°) is 57.0 to 59.1, it may be, for example, any of 57.0, 57.8, 58.3, 58.7, or 59.1, or may be within a range with any one of these as the upper limit and another 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] The angle of repose (°) of the composition is preferably 57.0 to 70.0, more preferably 57.0 to 60.0, and even more preferably 57.0 to 59.1. When the angle of repose (°) is 57.0 to 59.1, it may be, for example, any of 57.0, 57.8, 58.3, 58.7, or 59.1, or may be within a range with any one of these as the upper limit and another 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] The angle of repose (°) of the composition is preferably 57.0 to 70.0, more preferably 57.0 to 60.0, and even more preferably 57.0 to 59.1. When the angle of repose (°) is 57.0 to 59.1, it may be, for example, any of 57.0, 57.8, 58.3, 58.7, or 59.1, or may be within a range with any one of these as the upper limit and another 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 unlikely to occur. If the angle of repose is small, the composition or tablet is less likely to remain in the mouth when administered orally, and / or the composition is more likely to pass through easily during swallowing, i.e., be easier to swallow, and / or have a good texture on the tongue. Thus, for example, a composition having an angle of repose (°) of less than 57.0, or a tablet containing said composition, is likely to be easier to swallow and / or provide a good mouthfeel. Furthermore, when the angle of repose is small, the powder particles are smooth and friction between the powder particles is unlikely to occur, making the composition easier to compact. For example, a composition containing particles with an angle of repose (°) of less than 57.0 is easier to fill into a composition bag or a tablet molding machine, making it easier to improve productivity.

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

[0155] In the composition, the collapse angle (°) is preferably 32.0 or more, more preferably 32.0 to 44.0, more preferably 32.0 to 40.0, and even more preferably 33.2 to 35.9. When the collapse angle (°) is 33.2 to 35.9, it may be, for example, any of 33.2, 33.6, 34.0, 34.4, 34.8, 35.3, 35.6, or 35.9, or may be within a range with 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 collapse angle (°) of 31.8 or less.

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

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

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

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

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

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

[0163] If the collapse angle is greater than 31.8, the composition or tablet is less likely to remain in the mouth when orally administered, and / or the composition is more likely to pass through smoothly during swallowing, i.e., be easier to swallow, and / or have a good texture on the tongue. Furthermore, the larger the collapse angle, the smaller the "difference angle" tends to be. A small "difference angle" means that the powder layer is less likely to change when the powder particles contained in the composition or tablet are vibrated, and the composition is more likely to be compacted. For example, a composition with a collapse angle (°) of more than 31.8 is easier to fill into a composition bag or a tablet molding machine, making it easier to improve productivity. Furthermore, the larger the collapse angle, the lower the dispersibility (degree of fluffiness) of the composition and the easier it is to handle. For example, if the collapse angle is greater than 31.8, the dispersibility (degree of fluffiness) of the composition is likely to be low and the easier it is to handle. Furthermore, the larger the collapse angle, the easier it is to compact the composition. For example, if the collapse angle of the composition is greater than 31.8, it becomes easier to fill a composition bag or a tablet molding machine, and productivity is likely to be improved.

[0164] The composition (17-1) according to the first embodiment is a composition in which the difference angle (°) between the angle of repose and the angle of collapse (angle of repose - angle of collapse) (hereinafter also referred to as "difference 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 angle difference (°) is 12.3 to 13.7, it may be, for example, 12.3, 12.5, 12.7, 12.9, 13.1, 13.3, 13.5, or 13.7, or it may be a range with any one of these as the upper limit and another one as the lower limit.

[0166] The composition (17-2) according to the first embodiment is a composition having a difference angle (°) of 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 angle difference (°) is 25.2 to 29.2, it may be, for example, 25.2, 26.7, 27.7, 28.5, or 29.2, or may be within a range with 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 angle difference (°) is 25.2 to 29.2, it may be, for example, 25.2, 26.7, 27.7, 28.5, or 29.2, or may be within a range with 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 angle difference (°) is 12.0 to 14.1, it may be, for example, any of 12.0, 12.8, 13.3, 13.7, or 14.1, or may be within a range with one of these as the upper limit and another as the lower limit.

[0172] A small difference angle (°) indicates that the powder particles contained in the composition or tablet are smooth and friction between the powder particles is unlikely to occur. If the difference angle is small, the composition or tablet is less likely to remain in the mouth when orally administered, and / or the composition is more likely to pass through easily during swallowing, i.e., be easier to swallow, and / or have a good texture on the tongue. For example, a composition having a difference angle (°) of less than 25.0, or a tablet containing said composition, is likely to be easier to swallow and / or provide a good mouthfeel. Furthermore, when the difference angle is small, the powder layer is less likely to change when the powder particles contained in the composition or tablet are vibrated, and the composition is more likely to be compacted. For example, a composition with a difference angle (°) of less than 25.0 is more easily filled into a composition bag or a tablet molding machine, making it easier to improve productivity.

[0173] The composition (18-1) according to the first embodiment has a stress (kN / m 2 ) is 1809 to 2405.

[0174] Stress at 10% strain rate (kN / m 2 ) is 1809 to 2405, it may be, for example, any of 1809, 1810, 1811, 1812, 1813, 1814, 1815, 1816, 1817, 1900, 1901, 1943, 1944, 2026, 2068, 2069, 2152, 2153, 2235, 2277, 2360, 2361, 2402, 2403, 2404, or 2405, or it may be a range with any one of these as the upper limit and another one as the lower limit.

[0175] The composition (18-2) according to the first embodiment has a stress (kN / m 2 ) is 1859 to 2319.

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

[0177] The composition (18-3) according to the first embodiment has a stress (kN / m 2 ) is 1567 to 1776.

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

[0179] The composition (18-4) according to the first embodiment has a stress (kN / m 2 ) is 1483 to 2528.

[0180] Stress at 10% strain rate (kN / m 2 ) is 1483 to 2528, it may be, for example, any of 1483, 1525, 1609, 1650, 1734, 2444, or 2528, or it 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 has a stress (kN / m 2 ) is less than 1846.

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

[0183] The composition (19-2) according to the first embodiment has a stress (kN / m 2 ) is greater than 1069.

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

[0185] The composition (19-3) according to the first embodiment has a stress (kN / m 2 ) is greater than 1069.

[0186] In this composition, the stress (kN / m 2 ) is preferably 1100 to 2500, more preferably 1200 to 2000, and even more preferably 1500 to 2000. Stress at 18% strain rate (kN / m 2 ) is 1500 to 2000, it may be 1846, for example.

[0187] The composition (19-4) according to the first embodiment has a stress (kN / m 2 ) is 500 to 2500.

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

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

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

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

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

[0194] In the composition, the stress resistance (%) is preferably 100-130, more preferably 100-120, and even more preferably 104-118. When the stress resistance (%) is 104 to 118, it may be, for example, 104, 109, or 118, or may be within a range with 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 a tablet containing the composition is greater than 59 and less than 80.

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

[0197] The higher the stress resistance (%) of a tablet, the more flexibly it can change shape in response to external forces, and the less likely the tablet is to be damaged by impact or compression. Therefore, if a tablet has high stress resistance, it is likely to have high transportability. For example, if the stress resistance (%) is greater than 76, it is likely to have high transportability.

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

[0199] In the composition, the degree of dispersion is preferably 40 or less, more preferably 30 or less, even more preferably 22 or less, and even more preferably 17-22. When the dispersity is 18 to 22, it may be, for example, any of 17, 18, 19, 20, 21, and 22, and may be within a range with any one of these as the upper limit and another 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 degree of dispersion is preferably 45-48, and more preferably 46-47. When the dispersity is 46 to 47, it may be 46 or 47, for example.

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

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

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

[0206] A composition with a low degree of dispersion (%) is less likely to be powdery and is therefore easier to handle. Therefore, for example, a composition having a dispersity of less than 44, preferably 22 or less, more preferably less than 17 tends to be easy to handle.

[0207] Compositions (22-1) to (22-4) according to the first embodiment are compositions whose weight retention rate determined by thermogravimetric analysis when heated from 25°C to 100°C is 50% to 98%, and preferably 90% to 98%.

[0208] Compositions (23-1) to (23-4) according to the first embodiment are compositions whose weight retention rate determined by thermogravimetric analysis when heated from 25°C to 200°C is 50% to 98% and preferably 80% to 97%.

[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] Compositions (24-2) to (24-4) according to the first embodiment are compositions whose weight retention rate determined by thermogravimetric analysis when heated from 25°C to 300°C is 50% to 98% and preferably 90% to 95%.

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

[0212] Compositions (25-2) to (25-4) according to the first embodiment are compositions whose weight residual ratio determined by thermogravimetric analysis when heated from 25°C to 400°C is 5% to 50%, and preferably 8% to 35%.

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

[0214] Compositions (26-2) to (26-4) according to the first embodiment are compositions whose weight residual ratio determined by thermogravimetric analysis when heated from 25°C to 500°C is 5% to 50%, and preferably 5% to 35%.

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

[0216] Compositions (27-2) to (27-4) according to the first embodiment are compositions whose weight residual ratio determined by thermogravimetric analysis when heated from 25°C to 600°C is 5% to 50%, and preferably 5% to 45%.

[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 when heated from 25° C. to 100° C., and preferably -8 μV to -1 μV.

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

[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 when heated from 25° C. to 200° C., and preferably -8 μV to -1 μV.

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

[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 heated from 25° C. to 300° C., and preferably -8 μV to 3 μV.

[0222] The compositions (30-2) to (30-4) according to the first embodiment are compositions that have an electromotive force of -10 μV or more and 0 μV or less when heated from 25° C. to 300° C., and 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 heated from 25° C. to 400° C., and preferably -10 μV to 10 μV.

[0224] The compositions (31-2) to (31-4) according to the first embodiment are compositions that have an electromotive force of -10 μV or more and 0 μV or less when heated from 25° C. to 400° C., and 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 heated from 25° C. to 500° C., and preferably -10 μV to 15 μV.

[0226] The compositions (32-2) to (32-4) according to the first embodiment are compositions that have an electromotive force of -10 μV or more and 0 μV or less when heated from 25° C. to 500° C., and 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 and 20 μV or less when heated from 25° C. to 600° C., and preferably -8 μV to 18 μV.

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

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

[0231] Compositions (34-1) to (34-4) contain a heat-resistant material, a quasi-heat-resistant material, and / or a non-heat-resistant material, preferably a composition contains two or more of a heat-resistant material, a quasi-heat-resistant material, and a non-heat-resistant material, more preferably a composition contains a heat-resistant material, a quasi-heat-resistant material, and a non-heat-resistant material. Non-limiting examples of heat-resistant materials, quasi-heat-resistant materials, and non-heat-resistant materials are as follows:

[0232] Non-limiting examples of heat-resistant substances include inorganic substances. The inorganic substances are not limited as long as they are acceptable for food compositions or pharmaceutical compositions, and non-limiting examples include magnesium aluminosilicate, magnesium aluminum silicate, magnesium hydroxide, dry sodium carbonate, sodium hydroxide, sodium bicarbonate, sodium carbonate hydrate, Fe-Mg hydrotalcite-like compounds, and Al-Mg hydrotalcite-like compounds. The heat-resistant substance may be one type or a combination of two or more types. When compositions (34-1) to (34-4) contain naturally occurring components such as plant-derived cellulose, examples of the heat-resistant substance may also include inorganic substances contained in the naturally occurring components. In order to adjust the content of inorganic substances, naturally occurring components such as cellulose with an adjusted content of inorganic substances may also be used.

[0233] Non-limiting examples of semi-thermostable substances include highly crystalline substances. Highly crystalline substances include polymeric carbohydrates. Polymeric carbohydrates are polysaccharides (including oligosaccharides), and non-limiting examples include starch, glycogen, cellulose, etc., formed by polymerization of D-glucose, chitin formed by polymerization of N-acetylglucosamine, and chitosan, which is obtained by deacetylating chitin. Polymeric carbohydrates are not limited by their function or role, and may be carbohydrates that perform or are involved in any function, such as energy storage (starch, glycogen, etc.), biological shaping, immunity, or intercellular communication. In one embodiment, the semi-thermostable substance may be cellulose, or cellulose and one or more of the above-mentioned components. The semi-thermostable substance may be one type or a combination of two or more types.

[0234] Non-limiting examples of non-thermostable substances include proteins and low-molecular-weight carbohydrates. Low-molecular-weight carbohydrates are monosaccharides, and monosaccharides are not limited by the number of carbon atoms in the carbon chain structure of triose, tetrasaccharide, pentasaccharide, or hexose, 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-thermostable substance may be one type or a combination of two or more types.

[0235] 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-weight carbohydrates. Compositions (34-1) to (34-4) preferably contain the heat-resistant substance, quasi-heat-resistant substance, and non-heat-resistant substance 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 substance, quasi-heat-resistant substance, and non-heat-resistant substance can be determined appropriately by those skilled in the art. The total content of the heat-resistant substance, quasi-heat-resistant substance, and non-heat-resistant substance is preferably 100% by weight. When the composition contains a heat-resistant substance, a semi-heat-resistant substance, and a non-heat-resistant substance in an amount of 1% by weight or more, less than 95% by weight, and 5% by weight or more, respectively, the composition is more likely to exhibit the effects of good ease of swallowing and / or good texture on the tongue when orally administered, and / or good filling properties, low dispersion, and / or high transportability. Here, when the composition contains naturally occurring components such as cellulose, the composition may also contain inorganic substances contained in the naturally occurring components. In order to adjust the content of inorganic substances, naturally occurring components such as cellulose with an adjusted content of inorganic substances may also be used.

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

[0237] When preparing a composition, the specific amounts or proportions of thermostable, semi-thermostable, and / or non-thermostable substances contained in the plant-derived components actually used can be determined by methods known to those skilled in the art. For example, the content of thermostable substances such as ash can be measured using a known ash content method. For example, the content of semi-thermostable substances such as cellulose can be measured using a known alpha-cellulose quantification method. For example, the content of non-thermostable substances such as hemicellulose can be calculated by subtracting the value obtained by a known alpha-cellulose measurement from the value obtained using a known holocellulose quantification method. Based on these measurement results, these materials can be mixed to prepare a composition containing thermostable, semi-thermostable, and non-thermostable substances in the desired proportions.

[0238] Compositions (1-1)~(1-4), (2-1)~(2-4), (3-1)~(3-4), (4-1)~(4-5), (5-1)~(5-4), (6-1)~(6-4) , (7-1)~(7-4), (8-1)~(8-4), (9-1)~(9-4), (10-1)~(10~4), (11-1)~(11-4), (12-1)~(1 2-4), (13-1)~(13-4), (14-1)~(14-4), (15-1)~(15-4), (16-1)~(16-4), (17-1)~(17-4), (18-1)~(18-4), (19-1)~(19-4), (20-1)~(20-4), (21-1)~(21-4), (22-1)~(22-4), (23- Compositions having one or more of the characteristics of 1) to (23-4), (24-1) to (24-4), (25-1) to (25-4), (26-1) to (26-4), (27-1) to (27-4), (28-1) to (28-4), (29-1) to (29-4), (30-1) to (30-4), (31-1) to (31-4), (32-1) to (32-4), (33-1) to (33-4), and (34-1) to (34-4) (hereinafter collectively referred to as compositions (1-1) to (34-4)) tend to have the effects of good ease of swallowing and / or good texture on the tongue when orally administered, and / or tend to have the effects of good filling properties, low dispersion, and / or high transportability, respectively. Therefore, the composition is suitable as a composition or tablet for oral administration, and based on the good filling property, low dispersion, and / or high transportability, the composition can be easily filled into a composition bag or a tablet molding machine, which makes it easy to improve productivity and / or makes the composition or tablet suitable for transport.

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

[0240] In one embodiment, the composition has the characteristics of composition (1-1) or (1-2) and the characteristics of composition (4-1) or (4-4). The composition tends to have good swallowability, a good texture, and / or good filling properties. In addition, the composition tends to have a low degree of dispersion (low degree of dusting), which makes it easy to handle. In one embodiment, the composition has the characteristics of composition (1-1) or (1-2) and the characteristics of composition (4-2) or (4-3). Tablets containing the composition tend to be more vibration-resistant and therefore more transportable. In one embodiment, the composition has the characteristics of composition (1-3) or (1-4) and the characteristics of composition (4-2) or (4-3). Tablets containing the composition tend to be more vibration-resistant and therefore more transportable. In one embodiment, the composition has the characteristics of composition (1-3) or (1-4) and the characteristics of composition (4-1) or (4-4). The composition tends to have good packing properties. In addition, the degree of dispersion (low dustiness) tends to be low, making handling easy.

[0241] The composition according to the first embodiment is preferably an oral composition. By using it orally, as described above, it is possible to achieve the effects of good ease of swallowing and / or a good texture on the tongue.

[0242] As will be explained in the second embodiment, the composition according to the first embodiment can take various forms depending on its intended 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 the effects of good ease of swallowing and / or good texture in the mouth when made into a tablet.

[0243] The composition according to the first embodiment may be a mixture (e.g., slurry) in which the particles are mixed in a liquid, or a solution in which the particles are dissolved in a solvent, to the extent that it contains or consists of the particles described above. In this case, the particles may not maintain the particle area, Feret diameter (vertical width and / or horizontal width), and / or aspect ratio of the particles described above in the mixture or solution.

[0244] <Method of measuring parameters and adjusting them> In this specification, unless otherwise specified, the various parameters are values ​​measured as follows.

[0245] [Particle parameters] A sample of the composition and ion-exchanged water are placed in a beaker (for example, 2 g of composition and 20 ml of ion-exchanged water), and the mixture is dispersed for 2 minutes using ultrasound (90 W output), resulting in a test solution (suspension). For samples with poor dispersibility, the bottle is shaken by hand and allowed to stand for 15 minutes, after which the supernatant is collected and placed in a beaker together with ion-exchanged water. The sample concentration is adjusted to 10% by weight before use.

[0246] Using a dynamic image analyzer, Pershare Analyzer (manufactured by Hosokawa Micron Corporation), a sample suspension of the composition is formed into a flat sample flow using a sheath liquid using a flat sheath flow method, and particles are captured as still images by irradiating them with a strobe light. Particle parameters and particle shape parameters are obtained by image analysis. Measurement conditions are a standard lens magnification (10x), a measurement range of 0.5 to 300 μm, and a detected particle count of 10,000. The detected particles are considered to be particles in the composition according to this embodiment. Furthermore, the particles may also include air bubbles generated in the solvent.

[0247] (Feret diameter) When the particles of the composition photographed as described above are circumscribed by a rectangle, the length of the long side is taken as the "vertical width," and the average value of the 1,000 smallest particles out of the 10,000 particles measured is calculated to obtain the "Feret diameter (vertical width) (μm)." Furthermore, when the particles of the composition photographed as described above are circumscribed by a rectangle, the length of the short side is taken as the "horizontal width," and the average value of the 1,000 smallest particles out of the 10,000 particles measured is calculated to obtain the "Feret diameter (horizontal width) (μm)."

[0248] (aspect ratio) The aspect ratio of the particle is a value calculated from the Feret diameter of the particle using the following formula. Particle aspect ratio = 100 × (Feret diameter (vertical width) of particle) ÷ (Feret diameter (horizontal width))

[0249] (particle area) Particle area (μm 2 ) represents the particle area and is the average value of the 1,000 smallest particles out of 10,000 particles measured.

[0250] The Feret diameter (vertical width and horizontal width) and particle area can be adjusted by adjusting the grinding time, grinding intensity, etc., during the grinding process of the material components when preparing the composition. Specifically, the particle area, Feret diameter (vertical width), and / or Feret diameter (horizontal width) of the particles can be increased by reducing the number of grinding steps, shortening the grinding time, and / or weakening the grinding intensity. The aspect ratio is calculated from the values ​​of the Feret diameter (vertical width) and the Feret diameter (horizontal width), and therefore can be adjusted by adjusting the Feret diameter (vertical width and horizontal width). In other words, the aspect ratio can be adjusted by adjusting the grinding time, grinding intensity, etc., during 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, i.e., the Feret diameter (vertical width and horizontal width) and the particle area may be values ​​based on measurements of different particles. Therefore, the trend of particle area and the trend of Feret diameter (vertical width and / or horizontal width) may not necessarily coincide within the same sample or the same sample group.

[0252] [Backscatter value (BS value)] A test bottle (height 70 mm, diameter 25 mm, capacity 20 ml) is charged with 2 g of a composition sample and 20 ml of pure water, placed in a shaker (Tokyo Rikaki, MMS-3020), and shaken at 200 rpm for 1 minute. The prepared sample (still in the bottle) is then immediately placed in a Stability Tester ST-1 (Eiko Seiki Co., Ltd.) and irradiated with light (light source wavelength: 870 nm). The solution stability is evaluated by measuring the backscattered light (Backscatter value, BS value, %). The measurement conditions are as follows: Scanning height: 0-40mm from the bottom of the bottle Scan frequency: 30 seconds Measurement time: 1 hour

[0253] Here, a large BS value means that the light is reflected or scattered more by the scattering medium, and when measuring suspensions in water, a large value generally indicates a high concentration of dispersed particles.

[0254] (Settling velocity: BS ratio at a height of 30 mm) The settling rate (BS ratio (1 min:5 min) at a height of 30 mm from the bottom (30 mm from the bottom)) was calculated using the following formula based on the above measurements. Sedimentation rate (%) = 100 × (BS value at 30 mm from the bottom 1 minute after the start of measurement) ÷ (BS value at 30 mm from the bottom 5 minutes after the start of measurement) The larger the BS ratio (1 min:5 min) at a height of 30 mm from the bottom, the easier it is for the composition to settle (the faster the settling rate). The bottom surface means the bottom surface of the test bottle.

[0255] (Degree of precipitation: BS ratio 60 minutes after measurement started) The degree of precipitation (BS ratio (10 mm:40 mm) 60 minutes after the start of measurement) was calculated using the following formula based on the above measurement. Settling rate (%) = 100 x (BS value at a height of 10 mm from the bottom (40 mm from the bottom) 60 minutes after the start of measurement) ÷ (BS value at a height of 40 mm from the bottom (10 mm from the bottom) 60 minutes after the start of measurement) The larger the BS ratio (10 mm:40 mm) 60 minutes after the start of measurement, the more easily the composition to be evaluated precipitates (the greater the degree of precipitation). The bottom surface means the bottom surface of the test bottle.

[0256] The rate and degree of precipitation can be adjusted by adjusting the particle area and / or the aspect ratio of the particles. The methods for adjusting the particle area and the aspect ratio are as described above in the section "Particle Parameters."

[0257] [Powder water absorption rate] The powder water absorption (powder particle water absorption) (%) of a composition is the measured amount of water just before water separation from the powder particles is visually confirmed when 2 g of powder particles are placed in a container, water is added dropwise, and the mixture is mixed evenly. It is the average value of n = 100 (n represents the number of measurements).

[0258] The powder water absorption can be adjusted by adjusting the particle area, the Feret diameter (vertical width), and / or the Feret diameter (horizontal width). Specifically, increasing the particle area, the Feret diameter (vertical width), or the Feret diameter (horizontal width), or both the Feret diameter (vertical width) and the Feret diameter (horizontal width), facilitates improving the powder water absorption. The particle area, Feret diameter (vertical width), and Feret diameter (horizontal width) of the particles can be adjusted by adjusting the grinding time, grinding intensity, etc., in the grinding step of the material components when preparing the composition. Specifically, the particle area, Feret diameter (vertical width), and / or Feret diameter (horizontal width) of the particles can be increased by reducing the number of grinding steps, shortening the grinding time, and / or weakening the grinding intensity.

[0259] [Tablet hardness, water disintegration time, water disintegration property] The tablet hardness (tablet hardness) (N) was measured using a hardness tester (model number: KHT-40N, Fujiwara Seisakusho). A tablet manufactured by the method described in the "Composition and Tablet Manufacturing Method" section was placed on the center of the measuring table, and the device was started (the AUTO [start] button was pressed). This caused the rod to descend at high speed, and the display went into a peak hold state. Upon contact with the object, the speed slowed down, and the display was monitored approximately every 0.1 seconds. If there was no increase, it was deemed to have broken, and the hardness indicated on the hardness tester at that time was taken as the tablet hardness (N).

[0260] The disintegration time in water is a value obtained by placing a tablet (250 mg) containing the composition (including cases where the tablet consists of the composition) in a test tube, adding 20 ml of pure water, shaking it at 37°C in a shaker (reciprocating / rotating shaker MMS-3020, manufactured by Tokyo Rikakikai), and measuring the disintegration time. The measurement is carried out 50 times, and the average value is the disintegration time (minutes) of the tablet in water. 3 The point at which these clumps disappeared was determined to be the point of underwater collapse.

[0261] The disintegration property of a tablet in water is expressed as the disintegration time per unit hardness [disintegration time in water (D) / tablet hardness (N) (min / N)].

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

[0263] [Frictional force of wet powder] In this specification, the "frictional force of wet powder" is the frictional force (%) of wet powder when it moves 2 mm (≈ when the moving distance is zero). The frictional force of the wet powder was measured by passing the residue of the sample used in the "Underwater Disintegrability" test through a 90 μm (JIS Z8801 wire) and collecting it, then measuring it using a static and dynamic friction measuring device (Trinity Lab's "Handy Tribomaster TL201Ts") under the measurement conditions of a load of 50 g and a speed of 10 mm / sec. The contactor used was a 5 mm thick sponge sheet (Cemedine's "Gap Tape N-1") with artificial skin (Viewlux's "Bioskin") attached. Based on the results of the static friction force (gf), the ratio of the static friction force (gf) at the point where the travel distance is 0 mm to the static friction force (gf) at the point where the travel distance is 3 mm is calculated using the following formula. Friction force (%) of wet powder after 2 mm of travel = 100 × (static friction force at 0 mm of travel distance) / (static friction force at 3 mm of travel distance)

[0264] The frictional force of a wet powder can be adjusted by adjusting the particle area, the Feret diameter (vertical width), and / or the Feret diameter (horizontal width). Specifically, increasing the particle area, the Feret diameter (vertical width), or the Feret diameter (horizontal width), or both the Feret diameter (vertical width) and the Feret diameter (horizontal width), facilitates improving the frictional force of a wet powder. The particle area, Feret diameter (vertical width), and Feret diameter (horizontal width) of a particle can be adjusted by adjusting the grinding time, grinding intensity, etc., in the grinding step of the material components when preparing the composition. Specifically, the particle area, Feret diameter (vertical width), and / or the Feret diameter (horizontal width) of a particle can be increased by reducing the number of grinding steps, shortening the grinding time, and / or weakening the grinding intensity.

[0265] [Tapping apparent density] The tapped apparent density (g / cm 3 ) is a value measured using a commercially available powder property measuring instrument (Hosokawa Micron, Powder Tester PT-X type). Specifically, all powder particles contained in the composition were measured using a 100 cm 3 After filling the cup and tapping 250 times per minute, the volume of the cup is determined by dividing the weight of the powder sample filled in the cup by the volume of the powder sample.

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

[0267] [Apparent density (without tapping)] Apparent density of composition (without tapping) (g / cm 3 ) is 100cm 3The weight of the powder sample is calculated by roughly filling a glass measuring cylinder with the composition for 2 to 3 minutes using a quantitative feeder of the composition, then leveling the top surface of the powder layer with a soft brush such as a paintbrush, reading the volume, and dividing the weight of the powder sample by the volume. 3 The amount of the change will be determined appropriately.

[0268] The apparent density (untapped) of the composition can be adjusted by adjusting the Feret diameter and / or shape of the particles. For example, the apparent density (untapped) of the powder particles can be increased by decreasing the particle area and / or particle size (Feret diameter (vertical width or horizontal width)) or the aspect ratio.

[0269] [Compression degree] (Loose bulk density) The loose bulk density is a value measured using a commercially available powder property measuring instrument (Hosokawa Micron, Powder Tester PT-X type). Specifically, a sample of the composition is dropped through a chute, filled into a cup, and the surface is leveled off. The value is then calculated by dividing the weight of the powder layer filled in the cup by the volume of the cup.

[0270] (Packed bulk density) The packed bulk density is a value measured using a commercially available powder property measuring instrument (Hosokawa Micron, Powder Tester PT-X type). Specifically, a sample of the composition is dropped through a chute, and the cup is filled with the sample while tapping the cup at a rate of 250 times per minute. After the surface is leveled, the value is calculated by dividing the weight of the powder layer filled in the cup by the volume of the cup.

[0271] (Compression degree) The compressibility of the composition is a value calculated from the loose bulk density and packed bulk density using the following formula: Compressibility (%) = 100 x (packed bulk density - loose bulk density) / packed bulk density

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

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

[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, the angle of repose can be reduced by reducing the aspect ratio. The method for adjusting the aspect ratio is as described above in the section "Particle Parameters."

[0275] [Collapse angle] The collapse angle of the composition is a value measured using a commercially available powder property measuring instrument (Hosokawa Micron, Powder Tester PT-X type). Specifically, the peaks forming the angle of repose are impacted three times with a special shocker (attached to the powder tester), and the inclination angle (θ2) of the peaks when collapsed is read, and the angle is calculated to be the collapse angle (°).

[0276] The collapse angle of the composition can be adjusted by adjusting the particle area, aspect ratio, Feret diameter (vertical width), Feret diameter (horizontal width), friction force of the wet powder, and / or powder water absorption rate of the particles contained in the composition. The methods for adjusting the particle area, aspect ratio, and Feret diameter (vertical width and horizontal width) are as described above in the section "Particle parameters," the method for adjusting the frictional force of the wet powder is as described above in the section "Frictional force of the wet powder," and the method for adjusting the powder water absorption is as described above in the section "Powder water absorption."

[0277] [Difference angle] The difference angle (°) is calculated using the following formula based on the values ​​of the angle of repose and the angle of collapse. 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 method for adjusting the angle of repose and the angle of collapse is as described above.

[0279] [Dispersion degree (degree of powdering)] The degree of dispersion of the composition is a value measured using a commercially available powder property measuring instrument (Hosokawa Micron, Powder Tester PT-X type). Specifically, 10 g of a sample is dropped from a certain height, and the amount remaining on a watch glass placed below is used to calculate the degree of dispersion according to the following formula: Dispersion degree (%) = 100 x (amount of sample added - amount remaining on watch glass) / amount of sample added

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

[0281] [Stress per moving strain rate] The stress against the moving strain of the tablet was measured using a RHEONER II CREEP METER RE2-33005C (manufactured by Yamaden Co., Ltd.) under the following conditions: stress (kN / m 2 ) is measured. Attachment used: Cylinder (3S) Measurement parameters: storage pitch 0.25sec, measurement distortion rate 40%, measurement speed 0.5mm / sec, return distance 2.00mm

[0282] The stress resistance (%) of the tablet was calculated using the following formula. Tablet stress resistance (%) = 100 × (stress at 18% strain rate (kN / m 2 )) ÷ (Stress at 10% strain rate (kN / m 2 ))

[0283] The stress resistance (%) of a tablet can be adjusted by adjusting the particle area and / or aspect ratio of the particles contained in the tablet. For example, increasing the particle area and / or aspect ratio (away from 1.0) can facilitate increasing stress resistance. The method for adjusting the particle area and aspect ratio is as explained above in the section "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 residual rate is a value obtained from the residual weight of a sample (approximately 10 mg of a composition (or a food composition according to the second embodiment, a pharmaceutical composition according to the second embodiment, a cosmetic composition according to the third embodiment, a lubricant composition according to the third embodiment, or a dosage form containing any of these)) at 10°C / min from 25°C to 600°C in an N2 atmosphere using a thermal analyzer (STA300 manufactured by Hitachi High-Tech Science). The weight residual rate when a sample is heated from temperature a to temperature b is the residual weight at temperature b expressed as a percentage (%), with the residual weight at temperature a being 100. That is, the weight residual rate is expressed by the following formula: Weight remaining rate (%) = 100 × [remaining weight (mg) at temperature b] / [remaining weight (mg) at temperature a]

[0285] By adjusting the contents of heat-resistant substances such as ash and inorganic substances, semi-heat-resistant substances such as cellulose and highly crystalline substances, and non-heat-resistant substances such as proteins and low-molecular-weight carbohydrates in the composition, 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 residual rate determined by thermogravimetric analysis when the temperature is raised from 25°C to 100°C indicates the remaining components other than water adsorbed in the composition. When the temperature is increased to 300°C, most of the non-heat-resistant substances contained in the composition disappear (Akira Kuriyama, Materials, Vol. 16, No. 169, pp. 772-776). Therefore, the weight residual ratio determined by thermogravimetric analysis when the temperature is increased from 25°C to 200°C or from 5°C to 300°C indicates the remaining components other than the non-heat-resistant substances contained in the composition. By increasing the content of the non-heat-resistant substances contained in the composition, the weight loss rate when the temperature is increased from 25°C to 200°C or from 25°C to 300°C increases, and the weight residual ratio can be reduced. Alternatively, by decreasing the content of components other than the non-heat-resistant substances contained in the composition, i.e., the content of the heat-resistant substances and / or non-heat-resistant substances, the weight loss rate when the temperature is increased from 25°C to 200°C or from 25°C to 300°C increases, and the weight residual ratio can be reduced.

[0287] The weight retention rate of the composition, as determined by thermogravimetric analysis when the temperature is raised from 25°C to 200°C, is measured as described above, and the content of the non-heat-resistant substance contained in the composition can be adjusted so that the weight retention rate is 50% or more and 96% or less, or any of the desired values ​​listed in this specification. Furthermore, the weight retention rate of the composition, as determined by thermogravimetric analysis when the temperature is raised from 25°C to 300°C, is measured as described above, and the content of the non-heat-resistant substance contained in the composition can be adjusted so that the weight retention rate is 50% or more and 90% or less, or any of the desired values ​​listed in this specification.

[0288] When the temperature is raised from 25°C to 400°C or higher, the quasi-heat-resistant substance contained in the composition disappears between 300°C and 400°C (Maki et al., Journal of the Chemical Society of Japan, 1975, (4), pp. 733-737). Therefore, the weight retention rate determined by thermogravimetric analysis when the temperature is raised from 25°C to 400°C or higher indicates the remaining components of the composition other than the non-heat-resistant substance (component that disappears when the temperature is raised to 300°C) and the quasi-heat-resistant substance (component that disappears between 300°C and 400°C), i.e., the heat-resistant substance. Increasing the content of the non-heat-resistant substance and the quasi-heat-resistant substance contained in the composition increases the weight loss rate when the temperature is raised from 25°C to 400°C, thereby decreasing the weight retention rate. Alternatively, decreasing the content of components other than the non-heat-resistant substance and the quasi-heat-resistant substance contained in the composition, i.e., the heat-resistant substance, can also increase the weight loss rate when the temperature is raised from 25°C to 400°C or higher, thereby decreasing the weight retention rate.

[0289] The weight residual ratio determined by thermogravimetric analysis when the temperature of any of the compositions according to this embodiment is raised to a predetermined temperature can also 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 methods 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 a sample (approximately 10 mg of a composition) at 100°C, 200°C, 300°C, 400°C, and 600°C when the sample is heated from 25°C to 600°C at a rate of 10°C / min in a N2 atmosphere using a thermal analyzer (STA300 manufactured by Hitachi High-Tech Science). The electromotive force of a sample at a certain temperature can be adjusted by adjusting the content of heat-resistant materials such as ash and inorganic substances, semi-heat-resistant materials such as cellulose and highly crystalline materials, and non-heat-resistant materials such as proteins and low-molecular-weight carbohydrates in the composition.

[0291] Examples of heat-resistant materials, semi-heat-resistant materials, non-heat-resistant materials, etc. are as explained above in "Thermogravimetric analysis."

[0292] [Composition and tablet manufacturing method] The food or pharmaceutical tablets according to this embodiment can be manufactured by methods well known to those skilled in the art.

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

[0294] If the material has a coarse Feret diameter (vertical width) (specifically, a size exceeding about 10 μm), it is subjected to primary pulverization. For example, using a jet mill (e.g., Seishin Jet Mill Pulverizer STJ-400), the material is pulverized once (primary pulverization) at a flow rate of 2 kg / hour to 12 kg / hour (preferably 12 kg / hour) to obtain a powder composition with a Feret diameter (vertical width) of about 10 μm to 60 μm (preferably 10 μm).

[0295] Next, mix the ingredients in a predetermined weight (for example, mix wheat germ, titanium oxide, crystalline cellulose (Asahi Kasei Ceolus (registered trademark) PH-101), powdered cellulose (Nippon Paper Industries Co., Ltd. KC Flock W-50), oats, calcium carbonate, and / or truffle powder in the weights (g) shown under "Ingredients" in Table 1 to make a total of 100 g). The mixed material is processed 20 times at a processing pressure of 50 MPa using, for example, a homogenizer (15M8AT manufactured by Gaulin) equipped with a conventional non-destructive homogenizing valve seat (inner diameter of downstream end of hollow cylindrical convex portion / thickness of ring-shaped end face: 1.9 / 1) to pulverize the material 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 can be determined whether only primary pulverization is carried out or whether secondary pulverization is also carried out, depending on the size of the particles constituting the composition.

[0297] The mills used for pulverization include cutting mills such as mesh mills (manufactured by HORAI Co., Ltd.), Atoms (manufactured by Yamamoto Hyakuma Manufacturing Co., Ltd.), knife mills (manufactured by Parman Co., Ltd.), cutter mills (manufactured by Tokyo Atomizer Manufacturing Co., Ltd.), CS cutters (manufactured by Mitsui Mining Co., Ltd.), rotary cutter mills (manufactured by Nara Machinery Manufacturing Co., Ltd.), pulp coarse crushers (manufactured by Zuiko Co., Ltd.), shredders (manufactured by Kobe Steel Pantech Co., Ltd.), hammer mills such as jaw crushers (manufactured by Makino Co., Ltd.), hammer crushers (manufactured by Makino Sangyo Co., Ltd.), and impact mills such as Pulverizers (manufactured by Hosokawa Micron Corporation), Fine Impact Mill (Hosokawa Micron Corporation), Super Micron Mill (Hosokawa Micron Corporation), Inomizer (Hosokawa Micron Corporation), Fine Mill (Nippon Pneumatic Mfg. Co., Ltd.), CUM-type centrifugal mill (Mitsui Mining Co., Ltd.), Exceed Mill (Makino Sangyo Co., Ltd.), Ultraplex (Makino Sangyo Co., Ltd.), Contraplex (Makino Sangyo Co., Ltd.), Colloplex (Makino Sangyo Co., Ltd.), Sample Mill (Seishin Co., Ltd.), Bantam Mill (Seishin Co., Ltd.), Tomizer (manufactured by Seishin Co., Ltd.), Tornado Mill (manufactured by Nikkiso Co., Ltd.), Nea Mill (manufactured by Dalton Co., Ltd.), HT-type fine grinder (manufactured by Horai Co., Ltd.), Free Grinding Mill (manufactured by Nara Machinery Works, Ltd.), New Cosmomizer (manufactured by Nara Machinery Works, Ltd.), Gather Mill (manufactured by Nishimura Machinery Works, Ltd.), Super Powder Mill (manufactured by Nishimura Machinery Works, Ltd.), Blade Mill (manufactured by Nisshin Engineering Inc.), Super Rotor (manufactured by Nisshin Engineering Inc.), Npa Crusher (manufactured by Sansho Industry Co., Ltd.), Wheeley Crusher (manufactured by Nisshin Engineering Inc.) Sanki Manufacturing Co., Ltd.), pulp grinder (Zuiko Co., Ltd.), Jacobson fine grinder (Shinko Pantech Co., Ltd.), universal mill (Tokuju Kosakusho Co., Ltd.), airflow mill: CGS type jet mill (Mitsui Mining Co., Ltd.), micron jet (Hosokawa Micron Co., Ltd.), counter jet mill (Hosokawa Micron Co., Ltd.), cross jet mill (Kurimoto Iron Works Co., Ltd.), supersonic jet mill (Nippon Pneumatic Mfg. Co., Ltd.), current jet (Nisshin Engineering Inc.), jet mill (Sansho Industry Co., Ltd.),Examples include Ebara Jet Micronizer (manufactured by Ebara Corporation), Ebara Triad Jet (manufactured by Ebara Corporation), Selenium Mirror (manufactured by Masuko Sangyo Co., Ltd.), New Micro Sictomat (manufactured by Masuno Manufacturing Co., Ltd.), Kryptron (manufactured by Kawasaki Heavy Industries, Ltd.), vertical roller mill: vertical roller mill (manufactured by Chinon Co., Ltd.), vertical roller mill (manufactured by Schaeffler Japan Co., Ltd.), roller mill (manufactured by Kotobuki Giken Kogyo Co., Ltd.), VX Mill (Kurimoto Iron Works Co., Ltd.), KVM type vertical mill (Earth Technica Co., Ltd.), IS Mill (IHI Plant Engineering Co., Ltd.), and pressure homogenizer (SMT Co., Ltd.).

[0298] The materials can be mixed by methods well known to those skilled in the art, such as container rotation mixers such as V-type, W-type, double cone-type, and container tuck-type mixers; stirring mixers such as high-speed stirring, universal stirring, ribbon-type, pug-type, and Nauta-type mixers; high-speed fluid mixers, drum mixers, and fluidized bed mixers. Also, container shaking mixers such as shakers can be used. Furthermore, the method for dissolving or dispersing each sample constituting the composition in a medium is not particularly limited as long as it is a commonly used dissolving or dispersing method. However, stirring and mixing methods using stirring blades such as unidirectional rotation, multi-axis rotation, reciprocating inversion, up-down movement, rotation + up-down movement, and pipeline type stirring blades such as those used in portable mixers, three-dimensional mixers, and side mixers, jet-type stirring and mixing methods such as line mixers, gas-injection stirring and mixing methods, mixing methods using high-shear homogenizers, high-pressure homogenizers, ultrasonic homogenizers, and the like, and container-shaking mixing methods using shakers may also be used.

[0299] The composition according to the first embodiment can be granulated to produce tablets by well-known methods such as dry granulation, wet granulation, heat granulation, spray granulation, or microencapsulation, but it is preferable to use a wet granulation method. Specific examples of wet granulation methods include fluidized bed granulation, agitation granulation, extrusion granulation, crushing granulation, and tumbling granulation. In fluidized bed granulation, a binder liquid is sprayed onto fluidized powder in a fluidized bed granulator to form granules. In agitation granulation, a binder liquid is added while rotating agitator blades in a mixing tank, thereby simultaneously mixing, kneading, and granulating the powder in a sealed structure. In extrusion granulation, a wet mass kneaded by adding a binder liquid is forcibly extruded through an appropriate size screen using a screw or basket method to form granules. In crushing granulation, a wet mass kneaded by adding a binder liquid is sheared and crushed by the rotating blades of a granulator, and then granulated by being ejected from an outer screen by the centrifugal force. In the rolling granulation method, the material is rolled by the centrifugal force of a rotating rotor, and at this time, a binding liquid is sprayed from a spray gun, causing the material to grow into spherical granules with uniform particle size in a snowball-like manner.

[0300] In one embodiment, the composition according to the first embodiment is mixed with purified water to prepare a dispersion, which is then fed into a granulator (e.g., Granuformer (registered trademark) Gf-105, Freund Corporation) to obtain granules. The granulator can also simultaneously dry the granules. For example, the dispersion can be supplied to the granulator at a rate of 2 to 6 L / hour and an inlet temperature of 150°C. At this stage, magnesium stearate (Taihei Chemical Industry Co., Ltd.) may be further added to the obtained granules and mixed. The granules are compressed into tablets using a simple tablet molding machine (HANDTAB-100, Ichihashi Seiki Co., Ltd.) under tableting compression force to obtain tablets with a diameter of 8 mm, R12 punch tablets, and a weight of approximately 250 mg.

[0301] The granulated material can be dried using any of several methods, including hot air drying (shelf drying, vacuum drying, fluidized bed drying), conduction heat transfer (pan drying, tray drying, drum drying), and freeze drying. In the hot air drying method, hot air is directly contacted with the additive, simultaneously removing evaporated water. In the conduction heat transfer method, the additive is indirectly heated through a heat transfer wall. In freeze drying, the additive is frozen at a temperature between -10°C and 40°C, and then heated under high vacuum (1.3 x 10-5 MPa to 2.6 x 10-4 MPa) to sublimate and remove water. There are no particular limitations on the drying method used to dry the aqueous dispersion to obtain cellulose powder. For example, freeze drying, spray drying, drum drying, shelf drying, flash drying, and vacuum drying may be used, either singly or in combination. The spraying method for spray drying may be any of a disk type, a pressure nozzle, a pressure two-fluid nozzle, a pressure four-fluid nozzle, etc., and one type may be used alone or two or more types may be used in combination. During the spray drying, a trace amount of a water-soluble polymer or a surfactant may be added to the dispersion in order to reduce the surface tension of the dispersion, and a foaming agent or gas may be added to the dispersion in order to accelerate the evaporation rate of the medium.

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

[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, the oral composition according to the first embodiment is preferably used as a food composition.

[0304] The food compositions can be used alone or in combination of two or more food compositions to prepare foods such as beverages, soups, processed meat products, processed vegetables, processed fruits, seasonings, concentrated foods, and supplements (nutritional supplements, nutritional supplement drinks).

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

[0306] Here, processed foods refer to natural food ingredients that have been processed and / or cooked, and include frozen foods, retort foods, canned foods, bottled foods, and the like. The form of the food is not limited, but is preferably a form suitable for oral use, and from the viewpoint of ease of ingestion, it may be in a fluid form such as liquid, syrup, paste, gel, jelly, cream, emulsion, spray, mousse, lotion, etc., or in a solid form such as powder, granules, tablets, capsules, soft capsules, etc. Tablets may be any of orally disintegrating tablets, chewable tablets, effervescent tablets, dispersion tablets, and dissolving tablets. Considering the effects of good oral disintegration and a good texture on the tongue of the disintegrating paste due to the good disintegrability in water and / or good frictional force of the wet powder resulting from the inclusion of the composition according to the first embodiment, and the resulting good passage of the composition during swallowing, the food tablet is preferably an orally disintegrating tablet or a chewable tablet, and more preferably an orally disintegrating tablet.

[0307] The functional ingredient is not limited to any ingredient that is desired to be ingested in addition to a normal diet, but it is preferable that the functional ingredient is a substance that can exert some nutritional or physiological activity or effect that is the use or purpose of the food, including the food composition, in the subject who ingests it. In one embodiment, the functional ingredient is preferably an ingredient that has an effect of improving undesired symptoms and / or poor physical condition in a subject (including functions related to maintaining and improving health). Therefore, it is preferable that the food containing the food composition is a functional food that has the effect of improving undesired symptoms and / or poor physical condition in a subject who ingests it (including functions related to maintaining and improving health). Examples of such functional foods in Japan include general foods, including nutritional supplements, health supplements, and nutritionally adjusted foods, as well as health functional foods (including nutritional functional foods, foods for specified health uses (Tokuho), and foods with functional claims), which are labeled according to national standards for safety and efficacy.

[0308] There are no restrictions on the composition, raw materials, origin, or acquisition route of the functional ingredients, and they include natural products, natural extracts, chemically synthesized substances, and mixtures of two or more of these. Non-limiting examples of functional ingredients include vitamins such as vitamins B1, B2, and C, minerals such as iron and zinc, amino acids, dietary fiber, DHA, EPA, polyphenols (anthocyanins, isoflavones (including soy isoflavones and their metabolite equol), flavones, catechins, flavonols, flavanones, etc.), carotenoids (α-catechin, β-catechin, β-cryptoxanthin, lycopene, lutein, zeaxanthin, etc.), and sulfate-containing substances (isothiacyanates, cysteine ​​sulfoxides, etc.). Food compositions may contain one or more functional ingredients. In one embodiment, the functional ingredient may be a soybean-derived ingredient, and the soybean-derived ingredient may be soybean isoflavones and / or equol. The soybean isoflavones and equol may each be in the form of a glycoside or an aglycone. For example, when the functional ingredient is soy isoflavone or equol, the method for obtaining these is not limited, and non-limiting examples of the method include extraction from soybeans according to well-known methods, purchasing commercially available products, and artificial preparation using equol-producing bacteria, etc.

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

[0310] The daily amount of food to be used is not limited and can be determined appropriately by a person skilled in the art based on the content of functional ingredients in the food and the 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, the oral composition according to the first embodiment is preferably used as a pharmaceutical composition.

[0312] The pharmaceutical compositions, either alone or in combination of two or more pharmaceutical compositions, can be used, for example, in the preparation of a medicament for treating a disease or condition suitable for the pharmacological effect of the pharmaceutically active ingredient.

[0313] A medicament according to one embodiment includes a pharmaceutical composition according to this embodiment.

[0314] In one embodiment, a method of treatment comprises administering the pharmaceutical composition of the present invention to a subject in need thereof.

[0315] A use according to one embodiment is the use of the composition according to the first embodiment or the pharmaceutical composition according to this embodiment in the manufacture of a medicament for the treatment of a subject in need thereof.

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

[0317] The form of the pharmaceutical is not limited, but is preferably a form suitable for oral use, and from the viewpoint of ease of administration, it may be in a fluid form such as liquid, syrup, paste, gel, jelly, cream, emulsion, spray, mousse, lotion, etc., or in a solid form such as powder, granules, tablets, capsules, soft capsules, etc. Tablets may be any of orally disintegrating tablets, chewable tablets, effervescent tablets, dispersion tablets, and dissolving tablets. Considering the effects of good oral disintegration and good texture on the tongue due to the inclusion of the composition according to the first embodiment, which are based on the moderate disintegrability in water and / or the frictional force of the good wet powder, and the resulting effect of good passage of the composition during swallowing, the pharmaceutical tablet 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 an ingredient that is desired to be administered to a subject having any disease or exhibiting any symptoms, but it is preferably a substance that can exert some physiological activity or effect that is the use or purpose of the pharmaceutically active ingredient in the administered subject.

[0319] The composition, raw material, origin, and route of acquisition of the pharmaceutically active ingredient are not limited, and include natural products, natural extracts, synthetic substances (including bioengineered substances and chemically synthesized substances), and mixtures of two or more of these. Examples of natural products or natural extracts include nucleic acids, proteins (including antibodies and fragments thereof), culture extracts, and low-molecular-weight compounds. These natural products or natural extracts may be identical to these substances or similar substances with similar functions that are bioengineered or chemically synthesized (chemically synthesized substances). Natural products or natural extracts may be obtained from any organism, such as a microorganism, animal, or plant, and are not limited by the ecology or habitat of the organism. Pharmaceutical compositions may contain one or more pharmaceutically active ingredients.

[0320] The pharmaceutical composition in this embodiment is a pharmaceutical composition for treating or preventing a disease, undesired symptoms, and / or poor physical condition in a subject. "Treatment" includes the reduction, alleviation, or relief of disease symptoms, and "prevention" includes protection against the onset of future diseases or symptoms and the inhibition of progression. Desirable therapeutic effects of treatment include alleviation of symptoms, improvement of direct or indirect pathological consequences of diseases, reduction in the rate of progression of worsening symptoms, recovery or alleviation of the disease state, and improvement in prognosis.

[0321] When two or more food compositions or pharmaceutical compositions are separately formulated to form two or more food or pharmaceutical preparations, the individual foods or pharmaceutical preparations can be ingested or administered simultaneously, separately at a certain time interval, or consecutively. The two or more food or pharmaceutical preparations can also be ingested or administered at different times per day and / or by different routes. Pharmaceutical preparations can be administered systemically or locally.

[0322] In addition to the composition and functional or pharmaceutically active ingredient, a food composition or pharmaceutical composition may further contain one or more non-functional ingredients that are nutritionally or pharmaceutically acceptable as a food. Non-functional ingredients include additives such as acidulants, sweeteners, excipients, surfactants, lubricants, flavorings, fragrances, colorants, stabilizers, and preservatives. Examples of excipients include mannitol, erythritol, xylitol, trehalose, lactose, maltose, maltitol, glucose, sucrose, fructose, mannose, sorbitol, amylose, light anhydrous silicic acid, hydrous silicon dioxide, anhydrous calcium phosphate, anhydrous calcium hydrogen phosphate, aluminum metasilicate, calcium silicate, magnesium silicate, and magnesium oxide. Examples of surfactants include nonionic surfactants, such as sorbitan fatty acid esters such as sorbitan monocaprylate, sorbitan monolaurate, and sorbitan monopalmitate, and glycerin fatty acid esters such as glycerin monocaprylate, glycerin monomyliate, and glycerin monostearate, each having an HLB of 6 to 18. Other non-functional ingredients include, for example, water, saline, alcohol, silicone, wax, petrolatum, vegetable oil, polyethylene glycol, propylene glycol, liposomes, gelatin, magnesium stearate, talc, surfactants, silicic acid, viscous paraffin, perfume oils, fatty acid monoglycerides and diglycerides, petroleum esters of fatty acids, hydroxymethylcellulose, polyvinylpyrrolidone, etc.

[0323] The content of the functional ingredient or pharmaceutically active ingredient in the food composition or pharmaceutical composition is not limited, but may be greater than 10 wt %, greater than 20 wt %, 20-40 wt %, 20-32 wt %, or 20-30 wt %. When the content of the functional ingredient or pharmaceutically active ingredient is 20-30 wt %, the content may be 20 wt %, 24 wt %, 26 wt %, 27 wt %, or 30 wt %. The content of the non-functional ingredient in the food composition or pharmaceutical composition is not limited, but may be 90 wt % or less, 60-90 wt %, 60-80 wt %, 68-80 wt %, or 70-80 wt %. The functional ingredient or pharmaceutically active ingredient may be contained in a non-heat-resistant substance in the composition according to this second embodiment, such as a protein or a low-molecular-weight carbohydrate. By having a functional ingredient or pharmaceutically active ingredient content of more than 10% by weight and a non-functional ingredient content of 90% by weight or less, the food composition or food containing the same, or the pharmaceutical composition or medicine containing the same, is likely to exhibit good frictional force of a wet powder. Therefore, it is likely to have a good texture on the tongue when ingested, and it is likely to be easy to achieve smooth passage of the composition during swallowing, i.e., it is likely to be a food or medicine that is easy to swallow. When the food or medicine is in tablet form, it is likely to exhibit good disintegrability in water and / or good frictional force of a wet powder. This makes it likely that the tablet will have good oral disintegrability and a good texture on the tongue of a disintegrating paste, and it is likely to be easy to achieve smooth passage of the composition during swallowing, i.e., it is likely to be a tablet that is easy to swallow. Furthermore, by having the content of the functional ingredient or pharmaceutically active ingredient exceed 10% by weight, the desired effect of the functional ingredient or pharmaceutically active ingredient is more likely to be exerted in a subject who has ingested the food or administered the medicine.

[0324] The subject to which the food composition or a food containing it is ingested, or the subject to which the pharmaceutical composition or a medicine containing it is administered, is not limited as long as it is an animal in need thereof, and may be a human or a non-human animal. Non-human animal species may be, for example, monkeys, dogs, cats, horses, cows, pigs, sheep, goats, rabbits, guinea pigs, hamsters, mice, and / or rats, and are not limited by their use as livestock animals, pet animals, laboratory animals, etc., but are preferably mammals, and more preferably humans.

[0325] The packaging form of the food composition or food containing the food composition according to this embodiment, or the pharmaceutical composition or medicine containing the pharmaceutical composition, is not particularly limited and can be selected appropriately by a person skilled in the art depending on the dosage form, etc., and examples include blister packs such as PTPs, strip packaging, heat seals, aluminum pouches, film packaging using plastics or synthetic resins, glass containers such as vials, and plastic containers such as ampoules.

[0326] [Third embodiment (other uses)] The composition according to the first embodiment can be used in various applications where the properties exhibited by the composition and tablets containing the composition, namely, the effects of good ease of swallowing and / or good texture on the tongue, and / or the effects of good packing properties, low dispersion, and / or high transportability, are favorably utilized. 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 lubricant composition.

[0327] A cosmetic product according to one embodiment includes the cosmetic composition according to this embodiment. A lubricant according to one embodiment includes the lubricant composition according to this embodiment.

[0328] The cosmetic composition is, for example, a composition intended for the beauty of skin, hair, nails, etc., and can be formulated into a form that allows for the care of these areas to be made into a cosmetic product. For example, the cosmetic composition may be a liquid, lotion, cream, patch, oil, spray, liquid cleanser, solid soap, etc. Furthermore, the product may be a cosmetic liquid, beauty serum, moisturizing liquid, moisturizing cream, soap, body soap, skin cleanser, bath salts, sunscreen, shaving lotion, depilatory cream, shampoo, conditioner, hair tonic, hair dye, etc. In particular, from the viewpoint of optimally exerting the effects due to the properties exhibited by the composition according to the first embodiment, lotions, creams, and liquid cleansers are preferred, and commercial forms of liquid cleansers include shampoos, body soaps, and skin cleansers.

[0329] The cosmetic composition may contain one or more functional ingredients and / or one or more non-functional ingredients described in the second embodiment. In addition, examples of packaging forms for cosmetics containing the cosmetic composition are the same as the packaging forms described in the second embodiment.

[0330] The subject of application of the cosmetic composition or cosmetics containing the same is not limited as long as it is an animal that requires them, and may be a human or a non-human animal. Non-human animal species may be, for example, monkeys, dogs, cats, horses, cows, pigs, sheep, goats, rabbits, guinea pigs, hamsters, mice, and / or rats, and are not limited by their use as livestock animals, pet animals, or laboratory animals, but are preferably mammals, and more preferably humans.

[0331] The lubricant composition is a composition intended to improve the ease of handling during tableting and the ease of swallowing during administration. The composition according to the first embodiment has the effects of good ease of swallowing and / or good texture on the tongue, and / or good packing properties, low dispersion, and / or high transportability, and therefore can be suitably used as a lubricant composition.

[0332] The lubricant composition may contain one or more functional ingredients and / or one or more non-functional ingredients described in the second embodiment. From the viewpoint of functionality as a lubricant composition, it is preferable to contain one or more lubricants well known to those skilled in the art. Non-limiting examples of such lubricants include titanium oxide, calcium carbonate, hydrous silicon dioxide, hydrous amorphous silicon oxide, glycerin fatty acid esters, magnesium silicate, light anhydrous silicic acid, hydrogenated oil, heavy anhydrous silicic acid, sucrose fatty acid esters, stearyl alcohol, stearic acid, zinc stearate, aluminum stearate, calcium stearate, polyoxyl 40 stearate, magnesium stearate, hydrogenated soybean oil, talc, sodium stearyl fumarate, beeswax, anhydrous silicic acid hydrate, magnesium aluminometasilicate, and glycerin monostearate.

[0333] A lubricant containing the lubricant composition according to this embodiment can be suitably used, for example, in the pharmaceutical composition according to the second embodiment or in the preparation of a medicament containing the pharmaceutical composition.

[0334] A non-limiting list of exemplary embodiments and combinations of exemplary embodiments of the present disclosure are disclosed below. [1] Particle area 20.0 μm 2 and comprising particles having an aspect ratio of less than 1.40; (a) to (d) below: (a) Backscatter (BS) ratio at a height of 30 mm from the bottom is 11.7% or less, (b) BS ratio is less than 21.0% 60 minutes after the start of measurement; (c) the frictional force of the wet powder is less than 63%; (d) Powder water absorption rate is less than 200%; Satisfy one or more of the following: Here, the BS ratio at a height of 30 mm from the bottom is calculated by the following formula, based on the backscattered light measurement value (BS value) obtained at a point 30 mm from the bottom of the bottle when a test bottle containing a sample containing a composition is irradiated with light, and the value 1 minute and 5 minutes after the start of measurement: 100 x (BS value at 30 mm from the bottom 1 minute after measurement started) / (BS value at 30 mm from the bottom 5 minutes after measurement started) It is calculated as The BS ratio 60 minutes after the start of measurement was calculated by irradiating a test bottle containing a sample containing the composition with light, and calculating the backscattered light (BS value) measured at a point 40 mm from the bottom of the bottle and a point 10 mm from the bottom from the following formula: 100 x (BS value at 10 mm from the bottom 60 minutes after the start of measurement) / (BS value at 40 mm from the bottom 60 minutes after the start of measurement) It is calculated as The frictional force of the wet powder is the frictional force of the wet powder when it has moved 2 mm, and is calculated from the static frictional force values ​​at a moving distance of 0 mm and 3 mm obtained by measuring a sample containing the composition under a load of 50 g and a speed of 10 mm / sec, using the following formula: 100 x (static friction force at 0 mm travel distance) / (static friction force at 3 mm travel distance) It is calculated as composition. [2] The water disintegration rate of a tablet containing the composition is 1.9 (min / N), Here, the disintegrability in water is calculated from the hardness (N) of the tablet measured with a hardness tester and the disintegration time (minutes) of the tablet in pure water by the following formula: Disintegration time in water (D) / Tablet hardness (N) The composition according to [1], calculated as follows: [3] The hardness of a tablet containing the composition is 46N or less, and The disintegration time of a tablet containing the composition in water is less than 90 minutes. The composition according to [1] or [2]. [4] Contains 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]. [Example]

[0335] The present disclosure will be explained in more detail below by showing examples, but interpretation of the present disclosure is not limited to these examples.

[0336] [Preparation of Compositions and Tablets] When the Feret diameter (vertical width) of the material used in the compositions of the Examples and Comparative Examples was coarse (specifically, greater than about 10 μm), it was subjected to primary pulverization. Using a jet mill (Seishin Jet Mill Pulverizer STJ-400), the mixture was pulverized once (primary pulverization) under conditions of a flow rate of 2 kg / hour to 12 kg / hour (Group 1: 12 kg / hour, Group 2: 8 kg / hour, Group 3: 2 kg / hour, Group 4: 2 kg / hour) to a Feret diameter (vertical width) of approximately 10 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 (Asahi Kasei Ceolus (registered trademark) PH-101), powdered cellulose (Nippon Paper Industries Co., Ltd. KC Flock W-50), oats, calcium carbonate, and / or truffle powder were mixed to a total of 100 g in the weights (g) shown under "Materials" in Table 1. Mixing was carried out using a fluidized bed mixer.

[0338] [Table 1]

[0339] The mixed material was processed 20 times at a processing pressure of 50 MPa using a homogenizer (Gaulin, 15M8AT) equipped with a conventional non-destructive homogenizing valve seat (inner diameter of the downstream end of the hollow cylindrical convex part / thickness of the ring-shaped end face 1.9 / 1), and crushed to a Feret diameter (vertical width) of approximately 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 crushing).

[0340] The powder composition obtained after the primary or secondary pulverization was mixed with pure water to prepare a dispersion, which was then placed in a granulator (Granuformer® Gf-105, Freund Corporation) under the following conditions: This step resulted in drying and granulation of the composition, yielding granules. Dispersion liquid supply rate: 2 to 6 L / hour (Group 1: 2 L / hour, Group 2: 6 L / hour, Group 3: 6 L / hour, Group 4: 2 L / hour) ·Inlet temperature 150℃, ·Outlet temperature 70℃

[0341] For all compositions in the Examples and Comparative Examples, the content of heat-resistant materials was measured by the known ash method, the content of semi-heat-resistant materials was measured by the known alpha-cellulose quantification method, and the content of non-heat-resistant materials was obtained by subtracting the value obtained by the known alpha-cellulose measurement from the value obtained by the known holocellulose quantification method. The compositions (wt %) shown in "Production Examples" in Table 1 contained heat-resistant materials, semi-heat-resistant materials, and non-heat-resistant materials.

[0342] In addition, the heat-resistant, semi-heat-resistant, and non-heat-resistant substances of each material were analyzed in the same manner as for the composition. Results showed that wheat germ contained 5-25 wt% heat-resistant substances, 30-70 wt% semi-heat-resistant substances, and 25-45 wt% non-heat-resistant substances. Oats contained 5-20 wt% heat-resistant substances, 45-75 wt% semi-heat-resistant substances, and 20-45 wt% non-heat-resistant substances. Crystalline cellulose (Asahi Kasei Ceolus) contained 1-10 wt% heat-resistant substances, 70-98 wt% semi-heat-resistant substances, and 0.1-5 wt% non-heat-resistant substances. Powdered cellulose (Nippon Paper Industries KC Flock W-50) contained 1-10 wt% heat-resistant substances, 70-90 wt% semi-heat-resistant substances, and 5-20 wt% non-heat-resistant substances. The truffle powder contained 93% non-thermostable material and 5% semi-thermostable material.

[0343] To prepare tablets containing the compositions of the Examples and Comparative Examples, 250 mg of granules obtained by the granulator as described above were placed in a mortar (manufactured by Ichihashi Seiki Co., Ltd., diameter 8 mm) and compressed at 3 kN so that the tablet thickness was uniform to approximately 5 mm. This stress was maintained for 60 minutes to produce tablets with a diameter of 8 mm, R12 punch tablets, and approximately 250 mg (the compression machine used was a HANDTAB-100 manufactured by Enerpac Co., Ltd.).

[0344] [Evaluation of the composition] The tablets or compositions of the Examples and Comparative Examples were evaluated as follows. Measurement of parameters for the particles and composition was carried out for the composition obtained by secondary grinding in the above "Preparation of Composition and Tablets", and measurement of parameters for the tablets was carried out for the tablets obtained by tableting as described above.

[0345] [Particle parameters] 2 g of a composition sample and 20 ml of ion-exchanged water were placed in a beaker and dispersed for 2 minutes using ultrasound (output 90 W), resulting in a test solution (suspension). For samples with poor dispersibility, the bottle was shaken by hand and allowed to stand for 15 minutes, after which the supernatant was collected and placed in a beaker together with ion-exchanged water. The sample concentration was adjusted to 10 wt% before use.

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

[0347] (Feret diameter) The particle of the composition photographed as above was circumscribed in a rectangle, and the length of the long side was measured as the "vertical width" using a Pershare analyzer. Of the 10,000 particles measured, the average value of the 1,000 smallest particles was calculated and used as the "Feret diameter (vertical width) (μm)." Furthermore, when the particles of the composition photographed as described above were circumscribed in a rectangle, the length of the short side was measured as the "horizontal width" using a Pershare analyzer. Of the 10,000 particles measured, the average value of the 1,000 smallest particles was calculated and used as the "Feret diameter (horizontal width) (μm)."

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

[0349] (particle area) For particles other than those for which the Feret diameter (vertical width and horizontal width) was measured, the area of ​​the particle imaged as above (particle area (μm 2 )) was measured using a Pershare analyzer. The particle area was calculated by averaging the values ​​of the 1,000 smallest particles out of 10,000 particles measured.

[0350] [Backscatter value (BS value)] A test bottle (height 70 mm, diameter 25 mm, capacity 20 ml) was charged with 2 g of a composition sample and 20 ml of pure water, placed in a shaker (Tokyo Rikaki, MMS-3020), and shaken at 200 rpm for 1 minute. The prepared sample (still in the bottle) was immediately placed in a Stability Tester ST-1 (Eiko Seiki Co., Ltd.) and irradiated with light (light source wavelength: 870 nm). The solution stability was evaluated by measuring the backscattered light (Backscatter value, BS value, %). The measurement conditions were as follows: Scanning height: 0-40mm from the bottom of the bottle Scan frequency: 30 seconds Measurement time: 1 hour

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

[0352] (Degree of precipitation: BS ratio 60 minutes after measurement started) The degree of precipitation (BS ratio (10 mm:40 mm) 60 minutes after the start of measurement) was calculated using the following formula based on the above measurements. Settling rate (%) = 100 x (BS value at a height of 10 mm from the bottom (10 mm from the bottom) 60 minutes after the start of measurement) ÷ (BS value at a height of 40 mm from the bottom (40 mm from the bottom) 60 minutes after the start of measurement) The bottom surface means the bottom surface of the test bottle.

[0353] [Powder water absorption rate] The powder water absorption of the composition (water absorption of powder particles) was measured by placing 2 g of powder particles in a container, adding water dropwise, and mixing evenly. The amount of water just before water separation from the powder particles was visually confirmed was measured. The average value of n = 100 (n represents the number of measurements) was obtained.

[0354] [Tablet hardness, water disintegration time, water disintegration property] The tablet hardness (tablet hardness) (N) was measured using a hardness tester (model number: KHT-40N, Fujiwara Seisakusho). The tablets manufactured in the "Preparation of Composition and Tablets" section were placed on the center of the measuring table and the device was started (the AUTO [start] button was pressed). At this time, the hardness in the direction perpendicular to the compression direction during tablet molding was measured. As a result, the rod descended at high speed, and the display entered a peak hold state. When it came into contact with the object to be measured, the speed slowed down and the display was monitored approximately every 0.1 seconds. If there was no increase, it was considered to be fractured, and the hardness displayed on the hardness tester at that time was taken as the tablet hardness (N).

[0355] The disintegration time in water was measured by placing a tablet (250 g) in a test tube, adding 20 ml of pure water, and shaking it at 37°C in a shaker (reciprocating / rotating shaker MMS-3020, manufactured by Tokyo Rikakikai) to measure the disintegration time. The measurement was carried out 50 times, and the average value was taken as the disintegration time (minutes) of the tablet. 3The point at which these clumps disappeared was determined to be the point of underwater collapse.

[0356] The disintegration property of a tablet in water is expressed as the disintegration time per unit hardness [disintegration time in water (D) / tablet hardness (N) (min / N)].

[0357] [Frictional force of wet powder] The frictional force of the wet powder was measured by passing the residue of the sample used in the "Underwater Disintegrability" test through a 90 μm wire (JIS Z8801 standard wire), collecting it, and measuring it with a static and dynamic friction measuring device (Trinity Lab's "Handy Tribomaster TL201Ts") under the conditions of a load of 50 g and a speed of 10 mm / sec. The contactor used was a 5 mm thick sponge sheet (Cemedine's "Gap Tape N-1") with artificial skin (Viewlux's "Bioskin") attached. Based on the results of the static friction force (gf), the ratio of the static friction force (gf) at the point where the travel distance is 0 mm to the static friction force (gf) at the point where the travel distance is 3 mm is calculated using the following formula. Formula: Friction force (%) of wet powder after 2 mm of movement = 100 x (static friction force at 0 mm of movement distance / static friction force at 3 mm of movement distance)

[0358] [Tapping apparent density] The tapped apparent density (g / cm 3 ) was measured using a commercially available powder property measuring instrument (Hosokawa Micron, Powder Tester PT-X type). 3 After filling the cup and tapping 250 times per minute, the volume of the cup was determined by dividing the weight of the powder sample filled in the cup by the volume of the powder sample.

[0359] [Apparent density (without tapping)] Apparent density of composition (without tapping) (g / cm 3 ) is 100cm 3The weight of the powder sample was calculated by dividing the weight of the powder sample by the volume. 3 It was decided appropriately to be the extent.

[0360] [Compression degree] (Loose bulk density) A sample of the composition was dropped through a chute, filled into a cup, and the surface was leveled off, after which the weight of the powder layer filled in the cup was divided by the volume of the cup to determine the value.

[0361] (Packed bulk density) A sample of the composition was dropped through a chute, and the cup was filled with the sample while tapping the cup at a rate of 250 times per minute. After the surface was leveled, the weight of the powder layer filled in the cup was divided by the volume of the cup to determine the value.

[0362] (Compression degree) The compressibility of the composition was calculated from the loose bulk density and packed bulk density using the following formula: Compressibility (%) = 100 x (packed bulk density - loose bulk density) / packed bulk density

[0363] [Angle of repose] The sieve was vibrated, and a sample of the composition was fed onto the round table through a funnel. The inclination angle (θ1) of the peak formed when the sieve was vibrated was read, and the angle was calculated to be the angle of repose (°).

[0364] [Collapse angle] The peaks forming the angle of repose were impacted three times with a special shocker (attached to the powder tester), and the inclination angle (θ2) of the peaks when they collapsed was read, and the angle was calculated as the collapse angle (°).

[0365] [Difference angle] The difference angle (°) was calculated from the values ​​of the angle of repose and the angle of collapse using the following formula. Difference angle (°) = Angle of repose (θ1) - Angle of collapse (θ2)

[0366] [Stress per moving strain rate] The stress against the moving strain of the tablet was measured using a RHEONER II CREEP METER RE2-33005C (manufactured by Yamaden Co., Ltd.) under the following conditions: stress (kN / m 2 ) was measured. Attachment used: Cylinder (3S) Measurement parameters: storage pitch 0.25sec, measurement distortion rate 40%, measurement speed 0.5mm / sec, return distance 2.00mm

[0367] Tablet stress resistance (%) (stress at 18% strain rate (kN / m 2 ) / Stress at 10% strain rate (kN / m 2 )) was calculated using the following formula. Tablet stress resistance (%) = 100 × (stress at 18% strain rate (kN / m 2 )) ÷ (Stress at 10% strain rate (kN / m 2 ))

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

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

[0370] [Easy to swallow] The evaluation was carried out by 30 adult males and 30 adult females. The tablets were placed in the mouth and swallowed 10 seconds later, and the ease of swallowing was evaluated. The average of the 4-point evaluation from 1 to 4 by 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): Goes down the throat quickly with almost no discomfort. 3 (Good): Passes through the throat relatively smoothly, but there is a slight discomfort. 2 (normal): Takes some effort to pass through the throat. · 1 (bad): Swallowing requires considerable effort and is very uncomfortable.

[0371] [Tongue feel sensory test] The evaluation was carried out by 30 adult males and 30 adult females. The tablets were placed in the mouth and rolled around on the tongue until they were disintegrated, and the powdery texture after the tablets were completely disintegrated was evaluated. The average of the 4-point evaluations (1 to 4) by 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: Very powdery. ·2: Feels powdery. 3: It feels slightly powdery, but is moist enough that it doesn't feel powdery. ·4: Does not feel powdery.

[0372] The closer the rating in the tongue texture sensory test is to 4, the less powdery the disintegrating paste of the tablet is, i.e., the better the disintegrating paste will be on the tongue when the tablet is orally administered to a subject.

[0373] [Evaluation of packing properties (packing efficiency) of particles or compositions] Based on the evaluation of "compressibility" and "angle difference", the evaluation was made as follows. ·4 (Very high (compressibility 1.1-1.3, or difference angle 12-24°)): The powder is completely and uniformly packed into the planned volume. 3 (High (compression degree 1.4-1.6 and difference angle 12-24°)): The powder is almost completely packed, but there are some voids. ·2 (Low (compression degree 1.4-1.6 and difference angle 25-30°)): There are many voids in the filling and it lacks uniformity. ·1 (Very low (compressibility 1.4-1.6, difference angle 25-30°, and large voids visible by visual observation during loose bulk density measurement)): Almost not filled, or large voids visible.

[0374] [Evaluation of Dispersion Degree] A 10 g sample of the composition was dropped from a certain height, and the degree of dispersion was calculated using the following formula based on the amount remaining in a watch glass placed underneath. Dispersity [%] = 100 x (amount of sample added - amount remaining on watch glass) / amount of sample added

[0375] (Evaluation of tablet transportability) The transportability of the tablets was evaluated as follows. Ten compressed tablets (approximately 20 ml) were placed in a test bottle (height 70 mm, diameter 25 mm, capacity 20 ml) and their weight was measured (weight A). The test bottle containing the tablets was placed in a shaker (Tokyo Rikakikai, MMS-3020) and shaken at 200 times per minute for 1 hour. After the test, the powder on the surface of the tablets was wiped off and the weight of the collected powder was measured (weight B).

[0376] Based on weight A and weight B, the degree of chipping of the tablet was calculated using the following formula. Tablet chipping rate (%) = 100 x weight B / weight A The higher the value of "tablet chipping", the more vibration-resistant the tablet is, and the easier it is to transport.

[0377] The results are evaluated according to the following criteria: 4 (Very high): No chipping or cracking of tablets was observed after the vibration test. (95% or more of tablets were chipped.) 3 (High): After the vibration test, very small chips or cracks are observed on the tablets, but the overall shape is maintained (90% of the tablets are chipped). 2 (Medium): After the vibration test, obvious chips and cracks were observed in the tablets, and the shape was slightly deformed (85% of the tablets were chipped). 1 (low): After the vibration test, the tablets have many large chips and cracks, and their shape is significantly damaged (less than 80% of the tablets are chipped).

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

[0379] [Table 2] TIFF2025168242000003.tif232170TIFF2025168242000004.tif228170TIFF2025168242000005.tif232170

[0380] [Consideration 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 swallowability rating was 3 or higher. It has been shown that when the aspect ratio is less than 1.40 and the particle area is less than 20.0, the composition or tablet is less likely to remain in the mouth when orally administered and / or is more likely to pass through easily during swallowing, i.e., is more likely to be easily swallowed.

[0381] When the powder water absorption rate was less than 200, the swallowability rating was 3 or higher. It has been shown that when the powder water absorption rate is less than 200, a composition containing powder particles or a tablet containing the composition is likely to be easy to swallow and / or to have a good mouthfeel.

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

[0383] When the frictional force of the wet powder was less than 63, the ease of swallowing was rated as 3 or higher. On the other hand, when the frictional force of the wet powder was 63 or higher, the ease of swallowing was rated as 2 or lower. It has been shown that when the frictional force of the wet powder is less than 63, the composition or tablet is less likely to remain in the mouth when orally administered and / or the composition is more likely to pass through easily during swallowing, i.e., is more likely to be easily swallowed.

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

[0385] When the BS ratio 60 minutes after the start of measurement was less than 21.0, the ease of swallowing was rated at 3 or higher. On the other hand, when the BS ratio 60 minutes after the start of measurement was 21.0 or higher, the ease of swallowing was rated at 2 or lower. If the BS ratio 60 minutes after the start of measurement is less than 21.0, it indicates that the composition or tablet is less likely to remain in the mouth when orally administered and / or that the composition is more likely to pass through smoothly during swallowing, i.e., is more likely to be easily swallowed.

[0386] When the angle of repose of the composition was less than 57.0, the ease of swallowing was rated at 3 or higher. On the other hand, when the angle of repose of the composition was 57.0 or higher, the ease of swallowing was rated at 2 or lower. It has been shown that when the angle of repose of a composition is less than 57.0, the composition or tablet is less likely to remain in the mouth when orally administered and / or the composition is more likely to pass smoothly during swallowing, i.e., is more likely to be easy to swallow.

[0387] When the collapse angle of the composition was greater than 31.8 (preferably 32.0 to 44.0), the ease of swallowing was rated at 3 or higher. On the other hand, when the collapse angle of the composition was 31.8 or lower or 36.0 or higher (e.g., 45.0), the ease of swallowing was rated at 2 or lower. It has been shown that when the collapse angle is greater than 31.8, the composition or tablet is less likely to remain in the mouth when orally administered and / or the composition is more likely to pass through easily during swallowing, i.e., is more likely to be easily swallowed.

[0388] [Tongue feel sensory test] When the aspect ratio was less than 1.40 and the particle area was less than 20.0, the sensory evaluation of the texture on the tongue was 3 or higher. It has been shown that when the aspect ratio is less than 1.40 and the particle area is less than 20.0, the composition or tablet is less likely to remain in the mouth when orally administered and / or is more likely to pass smoothly during swallowing, i.e., it is more likely to have a good texture on the tongue.

[0389] When the frictional force of the wet powder was less than 63, the sensory evaluation of the texture on the tongue was 3 or more. On the other hand, when the frictional force of the wet powder was 63 or more, the sensory evaluation of the texture on the tongue was 2 or less. It has been shown that when the frictional force of the wet powder is less than 63, the composition or tablet is less likely to remain in the mouth when orally administered and / or is more likely to pass smoothly during swallowing, i.e., it is more likely to have a good texture on the tongue.

[0390] When the BS ratio at a height of 30 mm was 11.7 or less, the sensory evaluation of texture on the tongue was rated at 3 or more. On the other hand, when the BS ratio at a height of 30 mm was 11.8 or more, the sensory evaluation of texture on the tongue was rated at 2 or less. It has been shown that when the BS ratio at a height of 30 mm is 11.7 or less, the composition or tablet is less likely to remain in the mouth when orally administered and / or is more likely to pass smoothly during swallowing, i.e., it is more likely to have a good texture on the tongue.

[0391] When the BS ratio 60 minutes after the start of measurement was less than 21.0, the sensory evaluation of texture on the tongue was 3 or higher. On the other hand, when the BS ratio 60 minutes after the start of measurement was 21.0 or higher, the sensory evaluation of texture on the tongue was 2 or lower. If the BS ratio 60 minutes after the start of measurement is less than 21.0, it indicates that the composition or tablet is less likely to remain in the mouth when orally administered and / or is more likely to pass smoothly during swallowing, i.e., is more likely to have a pleasant texture on the tongue.

[0392] When the angle of repose of the composition was less than 57.0, the sensory evaluation of the texture on the tongue was 3 or higher. On the other hand, when the angle of repose of the composition was 57.0 or higher, the sensory evaluation of the texture on the tongue was 2 or lower. It has been shown that when the angle of repose of a composition is less than 57.0, the composition or tablet is less likely to remain in the mouth when orally administered and / or is more likely to pass smoothly during swallowing, i.e., it is more likely to have a good texture on the tongue.

[0393] When the collapse angle of the composition was more than 31.8 (preferably 32.0 to 44.0), the sensory evaluation of the texture on the tongue was 3 or more. On the other hand, when the collapse angle of the composition was 31.8 or less or 36.0 or more (for example, 45.0), the sensory evaluation of the texture on the tongue was 2 or less. It has been shown that when the collapse angle is 32.0 or more, the composition or tablet is less likely to remain in the mouth when orally administered, and / or the composition is more likely to pass through smoothly during swallowing, i.e., the texture is more likely to be pleasant on the tongue.

[0394] [Evaluation of packing properties (packing efficiency) of particles or compositions] When the aspect ratio was less than 1.40, the packing evaluation was 3 or higher. On the other hand, when the aspect ratio was 1.40 or higher, the packing evaluation was 2 or lower. It has been shown that when the aspect ratio is less than 1.40, the composition tends to have high filling properties and productivity tends to be improved.

[0395] When the frictional force of the wet powder was less than 63, the packing property was evaluated as 4 or more. On the other hand, when the frictional force of the wet powder was 63 or more, the packing property was evaluated as 3 or less. It has been shown that when the frictional force of the wet powder is less than 63, the composition tends to have high packing properties and productivity tends to be improved.

[0396] When the compressibility of the composition was 1.0 to 1.5, the packing property was evaluated as 4 or higher. On the other hand, when the compressibility of the composition was 1.4 or higher, the packing property was evaluated as 3 or lower. It was shown that when the compressibility of the composition is 1.0 to 1.5, the composition tends to have high packing properties and productivity tends to be improved.

[0397] When the angle of repose of the composition was less than 57.0, the packing property was evaluated as 4 or higher. On the other hand, when the angle of repose of the composition was 57.0 or higher, the packing property was evaluated as 3 or lower. It has been shown that when the angle of repose of the composition is less than 57.0, the composition tends to have high packing properties.

[0398] When the collapse angle of the composition was greater than 31.8, the fillability rating was 3 or higher. On the other hand, when the collapse angle of the composition was 31.8 or lower, the fillability rating was 2 or lower. It has been shown that when the collapse angle of the composition is greater than 31.8, the composition tends to have high fillability and productivity tends to be improved.

[0399] When the difference angle of the composition was less than 25.2, the filling property was evaluated as 3 or more. On the other hand, when the difference angle of the composition was 25.2 or more, the filling property was evaluated as 2 or less. It has been shown that when the difference angle is less than 25.2, the composition tends to have high filling properties and productivity tends to be improved.

[0400] Stress resistance (%) (100 x stress at 18% strain rate (kN / m2 ) / Stress at 10% strain rate (kN / m 2 When the stress tolerance (%) (stress at a moving strain rate of 18% / stress at a moving strain rate of 10%) was less than 80 (preferably less than 62, or more than 59 and less than 80), the fillability rating was 3 or higher. Furthermore, when the stress tolerance (%) (stress at a moving strain rate of 18% / stress at a moving strain rate of 10%) was less than 80, the fillability rating was 4. It has been shown that when the stress resistance of the tablet is less than 80, the composition tends to have high packing properties and productivity tends to be improved.

[0401] [Evaluation of the Dispersibility of Particles or Compositions] When the degree of dispersion (%) is less than 44 (preferably 40 or less), the powder particles contained in the composition have a low degree of dusting, and can be evaluated as having low dispersibility.

[0402] When the aspect ratio was less than 1.40, the dispersity (%) was 22 or less, whereas when the aspect ratio was 1.40 or more, the dispersity (%) was 44 or more.

[0403] An aspect ratio close to 1.0 indicates that the particles are nearly spherical. Therefore, when the aspect ratio is small (for example, less than 1.40), friction between particles is unlikely to occur, and the degree of dispersion of the composition is likely to be low.

[0404] When the collapse angle of the composition was greater than 31.8, the dispersity (%) was 22 or less. On the other hand, when the collapse angle was 31.8 or less, the dispersity (%) was 44 or more. It was shown that the larger the collapse angle (for example, greater than 31.8), the lower the degree of dispersion of the composition, making it easier to handle.

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

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

[0407] [Evaluation of tablet transportability]

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

[0409] An aspect ratio close to 1.0 indicates that the particles are nearly spherical, while a large aspect ratio indicates that the particles have a shape that is far from spherical. It has been shown that when the aspect ratio of the particles is 1.40 or more, the transportability of tablets containing the particles tends to be improved.

[0410] When the collapse angle of the composition was greater than 31.8, the transportability rating was 2 or less. On the other hand, when the collapse angle was 31.8 or less, the transportability rating was 3 or more. It has been shown that when the collapse angle of a composition is 31.8 or less, the transportability of tablets containing the composition tends to be improved.

[0411] When the difference angle of the composition was less than 25.2, the transportability rating was 2 or less. On the other hand, when the difference angle was 25.2 or more, the transportability rating was 3 or more. It was shown that when the difference angle of a composition is 25.2 or more, the transportability of a tablet containing the composition tends to be improved.

[0412] Stress resistance (%) (100 x stress at 18% strain rate (kN / m 2 ) / Stress at 10% strain rate (kN / m2 ) was less than 80 (for example, less than 62, or more than 59 and less than 80), the transportability rating was 2 or less. On the other hand, when the stress tolerance was more than 76 (preferably 80 to 99, or more than 99), the transportability rating was 3 or more. It was shown that when the stress resistance is greater than 76, the transportability of the tablet tends to be high. [Industrial Applicability]

[0413] The composition of the present embodiment has the properties of being easy to swallow, having a good texture, good filling properties, low dispersibility, and / or high transportability of tablets containing the composition, and therefore can be suitably used as a composition for food, pharmaceutical, and / or cosmetic purposes where such properties are desired, and has industrial applicability.

Claims

1. Particle area is 20.0 μm ２ and comprising particles having an aspect ratio of less than 1.40; The following (a) to (d): (a) A backscatter (BS) ratio at a height of 30 mm from the bottom surface is 11.7% or less; (b) BS ratio is less than 21.0% 60 minutes after the start of measurement; (c) the frictional force of the wet powder is less than 63%; (d) powder water absorption rate is less than 200%; Satisfy one or more of the following: Here, the BS ratio at a height of 30 mm from the bottom is calculated by the following formula, based on the backscattered light measurement value (BS value) obtained at a point 30 mm from the bottom of the bottle when a test bottle containing a sample containing a composition is irradiated with light, and the value 1 minute and the value 5 minutes after the start of measurement: 100 x (BS value at 30 mm from the bottom 1 minute after the start of measurement) / (BS value at 30 mm from the bottom 5 minutes after the start of measurement) It is calculated as The BS ratio 60 minutes after the start of measurement was calculated by the following formula, based on the backscattered light measurement values ​​(BS values) obtained at points 40 mm and 10 mm from the bottom of the bottle when a test bottle containing a sample containing the composition was irradiated with light: 100 × (BS value at 10 mm from the bottom 60 minutes after the start of measurement) / (BS value at 40 mm from the bottom 60 minutes after the start of measurement) It is calculated as The frictional force of the wet powder is the frictional force of the wet powder when it has moved 2 mm, and is calculated from the static frictional force values ​​at a moving distance of 0 mm and 3 mm obtained by measuring a sample containing the composition under a load of 50 g and a speed of 10 mm / sec, using the following formula: 100 × (static friction force at travel distance of 0 mm) / (static friction force at travel distance of 3 mm) It is calculated as composition.

2. The disintegration rate of a tablet containing the composition in water is 1.9 (min / N), Here, the disintegrability in water is calculated from the hardness (N) of the tablet measured with a hardness tester and the disintegration time (minutes) of the tablet in pure water by the following formula: Disintegration time in water (D) / tablet hardness (N) The composition of claim 1, wherein the calculated

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

4. The particles have 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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