Composition

Abstract

To provide an oral composition which exhibits a good in-water disintegrating property and / or good wet powder frictional force.SOLUTION: An oral composition includes a heat-resistant substance, a quasi-heat-resistant substance, and a non-heat-resistant substance. The oral composition exhibits a weight residue percentage determined by thermogravimetric analysis at temperature rising from 25°C to 600°C of 11% or more. The oral composition exhibits an electromotive force at temperature rising from 25°C to 600°C of -4μV or more. The weight residue percentage (y) determined by thermogravimetric analysis at temperature rising from 25°C to 600°C is represented by the expression: y≥-2.03x+23.623 (x represents the electromotive force at temperature rising from 25°C to 600°C). The oral composition exhibits an apparent tapping density of 0.3 g / cm3 to 5 g / cm3.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. Such compositions are required to pass through the oral cavity of a subject or during swallowing, i.e., to be easy to swallow. Such properties can be achieved, for example, by the composition having good disintegrability in water and / or good frictional force of a wet powder. Similar properties may also be suitable for cosmetics and lubricants. Conventionally, attempts have been made to adjust the hardness and intraoral tablet disintegration properties of tablets containing the composition by, for example, adjusting the fiber length, fiber width, etc. of the fibrous material contained in the composition. However, it has been difficult to set production conditions for accurately controlling the fiber length and fiber width contained in the composition.

[0003] [Patent Document 1] International Publication No. 2013 / 180249 Brochure Summary of the Invention

[0004] An object of the present disclosure is to provide a composition that exhibits good disintegrability in water and / or good frictional force of a wet powder.

[0005] The present disclosure includes the following aspects. [1] Includes heat-resistant materials, semi-heat-resistant materials, and non-heat-resistant materials, When heated from 25°C to 600°C, the weight residual rate determined by thermogravimetric analysis is 11% or more, When the temperature rises from 25°C to 600°C, the electromotive force is -4μV or more. When the temperature is increased from 25°C to 600°C, the weight residual ratio (y) determined by thermogravimetric analysis is: Formula: y ≧-2.03x + 23.623 (x represents the electromotive force when the temperature is raised from 25°C to 600°C) It is expressed as Tapping apparent density is 0.3g / cm 3 ~5g / cm 3 The composition.

[0006] According to the present disclosure, it is possible to provide a composition that exhibits good disintegrability in water and / or good frictional force of a wet powder. [Brief description of the drawings]

[0007]

Figure 1

[0008] 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 a range that does not impair the effects of the present disclosure. Each configuration and combination thereof in each embodiment is merely an example, and addition, omission, substitution, and other modifications of the configuration are possible as appropriate within the scope of the present disclosure. The present disclosure is not limited to the embodiments, but is limited only by the claims. Each feature disclosed herein may be combined with any other feature disclosed herein. In cases where a specific description given for one embodiment applies to other embodiments, the description may be omitted in the other embodiments. In this disclosure, the expression "X to Y" for a numerical range means "X or more and Y or less." In cases where a specific description given for one embodiment applies to other embodiments, the description may be omitted in the other embodiments. Unless otherwise specified, all numbers expressing features, items, amounts, parameters, characteristics, periods, etc. used in the specification and claims are understood to be modified in all cases by the term "about". As used herein, the term "about" means that the feature, item, amount, parameter, characteristic, or period so specified encompasses a range above and below the stated feature, item, amount, parameter, characteristic, or period value plus or minus 10 percent. At least, without limiting the application of the doctrine of equivalents to the scope of the claims, each numerical indicator should be interpreted in light of the number of reported significant digits and by applying ordinary rounding techniques. Any numerical range or value inherently includes a range of error necessarily resulting from the standard deviation found in their respective testing measurements. Unless otherwise specified, each individual value of a numerical range herein is incorporated herein as if it were individually recited herein.

[0009] ==First embodiment (composition)== The composition (1-1) according to the first embodiment is The composition has a weight retention rate of 50% or more and 98% or less when heated from 25°C to 100°C as determined by thermogravimetric analysis, and contains a heat-resistant substance, a semi-heat-resistant substance, and / or a non-heat-resistant substance. In the composition, the weight residual ratio determined by thermogravimetric analysis when the temperature is raised from 25° C. to 100° C. is preferably 60% to 98%, more preferably 70% to 98%, and even more preferably 90% to 98%. When the weight residual ratio is 90% to 98%, it may be 95%, 96%, 97%, or 98%. In one embodiment, the weight residual ratio determined by thermogravimetric analysis when the temperature is raised from 25° C. to 100° C. may be in a range combining any of the above values ​​as the upper and lower limits.

[0010] 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).

[0011] The composition (1-2) according to the first embodiment is The composition has a weight retention rate of 50% or more and 96% or less when heated from 25°C to 200°C as determined by thermogravimetric analysis, and contains a heat-resistant substance, a semi-heat-resistant substance, and / or a non-heat-resistant substance.

[0012] In the composition, the weight residual ratio determined by thermogravimetric analysis when the temperature is raised from 25° C. to 200° C. is more preferably 60% to 95%, further preferably 70% to 95%, and further preferably 80% to 95%. When the weight residual ratio is 80% to 95%, it may be 80%, 86%, 92%, 93%, or 95%. In one embodiment, the weight residual ratio determined by thermogravimetric analysis when the temperature is raised from 25° C. to 200° C. may be in a range combining any of the above values ​​as the upper and lower limits.

[0013] The composition (1-3) according to the first embodiment is The composition has a weight retention rate of 50% or more and 90% or less when heated from 25°C to 300°C as determined by thermogravimetric analysis, and contains a heat-resistant substance, a semi-heat-resistant substance, and / or a non-heat-resistant substance.

[0014] In the composition, the weight residual ratio determined by thermogravimetric analysis when the temperature is raised from 25° C. to 300° C. is preferably 55% to 90%, more preferably 60% to 88%, even more preferably 60% to 85%, even more preferably 63% to 80%, and even more preferably 65% ​​to 78%. When the weight residual ratio is 65% to 78%, it may be 65%, 66%, 69%, 72%, 73%, 74%, or 78%. In one embodiment, the weight residual ratio determined by thermogravimetric analysis when the temperature is raised from 25° C. to 300° C. may be a range that combines any of the above values ​​as the upper and lower limits.

[0015] The composition (1-4) according to this embodiment is The composition has a weight retention rate of 15% or more and 80% or less when heated from 25°C to 400°C as determined by thermogravimetric analysis, and contains a heat-resistant material, a semi-heat-resistant material, and / or a non-heat-resistant material.

[0016] In the composition, the weight residual ratio determined by thermogravimetric analysis when the temperature is raised from 25° C. to 400° C. is preferably 15% to 70%, more preferably 16% to 68%, and even more preferably 20% to 60%. When the weight residual ratio determined by thermogravimetric analysis when the temperature is raised from 25° C. to 400° C. is 20% to 60%, it may be 20%, 28%, 29%, 30%, 32%, 37%, or 60%. In one embodiment, the weight residual ratio determined by thermogravimetric analysis when the temperature is raised from 25° C. to 400° C. may be in a range that combines any of the above values ​​as the upper and lower limits.

[0017] The composition (1-5) according to this embodiment is The composition has a weight retention rate of 12% or more and 70% or less when heated from 25°C to 500°C as determined by thermogravimetric analysis, and contains a heat-resistant material, a semi-heat-resistant material, and / or a non-heat-resistant material.

[0018] In the composition, the weight residual ratio determined by thermogravimetric analysis when the temperature is raised from 25° C. to 500° C. is preferably 12% to 60%, more preferably 15% to 55%, and even more preferably 20% to 50%. When the weight residual ratio determined by thermogravimetric analysis when the temperature is raised from 25° C. to 500° C. is 20% to 50%, it may be 20%, 22%, 24%, 31%, or 41%. In one embodiment, the weight residual ratio determined by thermogravimetric analysis when the temperature is raised from 25° C. to 500° C. may be in a range that combines any of the above values ​​as the upper and lower limits.

[0019] The composition (1-6) according to this embodiment is The composition has a weight retention rate of 11% or more when heated from 25°C to 600°C as determined by thermogravimetric analysis, and contains a heat-resistant material, a semi-heat-resistant material, and / or a non-heat-resistant material.

[0020] In the composition, the weight residual ratio determined by thermogravimetric analysis when the temperature is raised from 25° C. to 600° C. is preferably 11% to 60%, more preferably 12% to 50%, even more preferably 13% to 40%, even more preferably 18% to 30%, and even more preferably 20% to 29%. When the weight residual ratio determined by thermogravimetric analysis when the temperature is raised from 25° C. to 600° C. is 20% to 29%, it may be 20%, 21%, 22%, or 29%. In one embodiment, the weight residual ratio determined by thermogravimetric analysis when the temperature is raised from 25° C. to 600° C. may be in a range that combines any of the above values ​​as the upper and lower limits.

[0021] The composition (2-1) according to the first embodiment is The composition contains a heat resistant substance, a semi-heat resistant substance, and / or a non-heat resistant substance, and the weight residual ratio (W200) determined by thermogravimetric analysis when heated from 25°C to 200°C relative to the weight residual ratio (W100) determined by thermogravimetric analysis when heated from 25°C to 100°C ((W200 / W100)×100(%)) is 80 to 98, preferably 85 to 98, and more preferably 88 to 97.

[0022] In the composition, when the weight residual ratio (W200) determined by thermogravimetric analysis when heated from 25° C. to 200° C. relative to the weight residual ratio (W100) determined by thermogravimetric analysis when heated from 25° C. to 100° C. ((W200 / W100)×100(%)) is 88 to 97, it may be 88, 95, 96, or 97. In one embodiment, the W200 / W100 percentage value may be within a range that combines any of the above values ​​as the upper and lower limits.

[0023] The composition (2-2) according to the first embodiment is The composition contains a heat resistant substance, a semi-heat resistant substance, and / or a non-heat resistant substance, and the weight residual ratio (W300) determined by thermogravimetric analysis when heated from 25°C to 300°C relative to the weight residual ratio (W100) determined by thermogravimetric analysis when heated from 25°C to 100°C ((W300 / W100)×100(%)) is 60 to 93, preferably 65 to 93, and more preferably 67 to 93.

[0024] In the composition, when the temperature is raised from 25°C to 100°C, the numerical value in percentage of the weight retention rate (W300) determined by thermogravimetric analysis when the temperature is raised from 25°C to 300°C with respect to the weight retention rate (W100) determined by thermogravimetric analysis ((W300 / W100)×100(%)) is 67 - 93. It may be 67, 72, 76, 78, 80, or 93. In one embodiment, the numerical value in percentage of W300 / W100 may be in a range combined with any of the above values as the upper and lower limits.

[0025] The composition (2 - 3) according to the first embodiment is a composition containing a heat-resistant substance, a semi-heat-resistant substance, and / or a non-heat-resistant substance, wherein the numerical value in percentage of the weight retention rate (W400) determined by thermogravimetric analysis when the temperature is raised from 25°C to 400°C with respect to the weight retention rate (W100) determined by thermogravimetric analysis when the temperature is raised from 25°C to 100°C ((W400 / W100)×100(%)) is 15 - 80.

[0026] In the composition, when the temperature is raised from 25°C to 100°C, the numerical value in percentage of the weight retention rate (W400) determined by thermogravimetric analysis when the temperature is raised from 25°C to 400°C with respect to the weight retention rate (W100) determined by thermogravimetric analysis ((W400 / W100)×100(%)) is 15 - 80. It may be 15, 17, 29, 31, 34, 38, 69, or 80. In one embodiment, the numerical value in percentage of W400 / W100 may be in a range combined with any of the above values as the upper and lower limits.

[0027] The composition (2 - 4) according to the first embodiment is The composition contains a heat-resistant substance, a semi-heat-resistant substance, and / or a non-heat-resistant substance, and has a weight residual ratio (W500) determined by thermogravimetric analysis when heated from 25°C to 500°C as a percentage ((W500 / W100)×100(%)) of 13 to 60.

[0028] In the composition, when the weight residual ratio (W500) determined by thermogravimetric analysis when heated from 25° C. to 500° C. relative to the weight residual ratio (W100) determined by thermogravimetric analysis when heated from 25° C. to 100° C. ((W500 / W100)×100(%)) is 13 to 60, it may be 13, 16, 23, 25, 32, 33, 43, or 60. In one embodiment, the W500 / W100 percentage value may be within a range that combines any of the above values ​​as the upper and lower limits.

[0029] The composition (2-5) according to the first embodiment is The composition contains a heat resistant substance, a semi-heat resistant substance, and / or a non-heat resistant substance, and the weight residual ratio (W600) determined by thermogravimetric analysis when heated from 25°C to 600°C relative to the weight residual ratio (W100) determined by thermogravimetric analysis when heated from 25°C to 100°C ((W600 / W100)×100(%)) is 11 to 45, preferably 15 to 30, and more preferably 17 to 30.

[0030] In the composition, when the percentage value ((W600 / W100)×100(%)) of the weight residual ratio (W600) determined by thermogravimetric analysis when heated from 25° C. to 600° C. relative to the weight residual ratio (W100) determined by thermogravimetric analysis when heated from 25° C. to 100° C. is 17 to 30, it may be 17, 21, 22, 23, or 30. In one embodiment, the percentage value of W600 / W100 may be a range combining any of the above values ​​as the upper and lower limits.

[0031] The composition (3-1) according to this embodiment is The composition has an electromotive force of -10 μV or more and 0 μV or less when heated from 25° C. to 100° C., and contains a heat-resistant material, a semi-heat-resistant material, and / or a non-heat-resistant material.

[0032] In the composition, the electromotive force when the temperature is raised from 25° C. to 100° C. is preferably −8 μV to −1 μV, and more preferably −6 μV to −3 μV. If the electromotive force when the temperature is raised from 25° C. to 100° C. is −6 μV to −3 μV, it may be −6 μV, −5 μV, −4 μV, or −3 μV. In one embodiment, the electromotive force when the temperature is raised from 25° C. to 100° C. may be within a range that combines any of the above values ​​as the upper and lower limits.

[0033] The composition (3-2) according to this embodiment is The composition has an electromotive force of -10 μV or more and 0 μV or less when heated from 25° C. to 200° C., and contains a heat-resistant material, a semi-heat-resistant material, and / or a non-heat-resistant material.

[0034] In the composition, the electromotive force when the temperature is raised from 25° C. to 200° C. is preferably −8 μV to −1 μV, and more preferably −6 μV to −2 μV. If the electromotive force when the temperature is raised from 25° C. to 200° C. is −6 μV to −2 μV, it may be −6 μV, −5 μV, −4 μV, −3 μV, or −2 μV. In one embodiment, the electromotive force when the temperature is raised from 25° C. to 200° C. may be within a range that combines any of the above values ​​as the upper and lower limits.

[0035] The composition (3-3) according to this embodiment is The composition has an electromotive force of -9 μV or more and 10 μV or less when heated from 25° C. to 300° C., and contains a heat-resistant material, a semi-heat-resistant material, and / or a non-heat-resistant material.

[0036] In the composition, the electromotive force when the temperature is raised from 25° C. to 300° C. is preferably −8 μV to 8 μV, and more preferably −7 μV to 5 μV. When the electromotive force when the temperature is raised from 25° C. to 300° C. is −7 μV to 5 μV, it may be −7 μV, −5 μV, −3 μV, −2 μV, 0 μV, 1 μV, 3 μV, or 5 μV. In one embodiment, the electromotive force when the temperature is raised from 25° C. to 300° C. may be in a range that combines any of the above values ​​as the upper and lower limits.

[0037] The composition (3-4) according to this embodiment is The composition has an electromotive force of -8 μV or more and 15 μV or less when heated from 25° C. to 400° C., and contains a heat-resistant material, a semi-heat-resistant material, and / or a non-heat-resistant material.

[0038] In the composition, the electromotive force when the temperature is raised from 25° C. to 400° C. is preferably −5 μV to 15 μV, and more preferably −3 μV to 10 μV. When the electromotive force when the temperature is raised from 25° C. to 400° C. is −3 μV to 10 μV, it may be −3 μV, −2 μV, −1 μV, 0 μV, 1 μV, 8 μV, or 10 μV. In one embodiment, the electromotive force when the temperature is raised from 25° C. to 400° C. may be in a range that combines any of the above values ​​as the upper and lower limits.

[0039] The composition (3-5) according to this embodiment is The composition has an electromotive force of -4 μV or more and 20 μV or less when heated from 25° C. to 500° C., and contains a heat-resistant material, a semi-heat-resistant material, and / or a non-heat-resistant material.

[0040] In the composition, the electromotive force when the temperature is raised from 25° C. to 500° C. is preferably −4 μV to 18 μV, and more preferably −2 μV to 14 μV. When the electromotive force when the temperature is raised from 25° C. to 500° C. is −2 μV to 14 μV, it may be −2 μV, −1 μV, 0 μV, 1 μV, 5 μV, or 14 μV. In one embodiment, the electromotive force when the temperature is raised from 25° C. to 500° C. may be within a range that combines any of the above values ​​as the upper and lower limits.

[0041] The composition (3-6) according to this embodiment is The composition has an electromotive force of -4μV or more when heated from 25°C to 600°C, and contains a heat-resistant material, a semi-heat-resistant material, and / or a non-heat-resistant material.

[0042] In the composition, the electromotive force when the temperature is raised from 25° C. to 600° C. is preferably −4 μV to 20 μV, more preferably −4 μV to 18 μV, even more preferably −3 μV to 17 μV, and even more preferably 1 μV to 17 μV. When the electromotive force when the temperature is raised from 25° C. to 600° C. is 1 μV to 17 μV, it may be 1 μV, 2 μV, 5 μV, or 17 μV. In one embodiment, the electromotive force when the temperature is raised from 25° C. to 600° C. may be in a range that combines any of the above values ​​as the upper and lower limits.

[0043] The composition (4-1) according to this embodiment is The composition has an electromotive force (X200) when heated from 25°C to 200°C as a percentage of the electromotive force (X100) when heated from 25°C to 100°C ((X200 / X100)×100(%)) of 30 to 170, and contains a heat resistant material, a semi-heat resistant material, and / or a non-heat resistant material.

[0044] In the composition, the percentage value of the electromotive force when the temperature is raised from 25° C. to 200° C. relative to the electromotive force when the temperature is raised from 25° C. to 100° C. is preferably 35 to 170. When the ratio is 35 to 170, it may be 35, 76, 87, 94, 121, 166, or 170. In one embodiment, the percentage value of the electromotive force when the temperature is raised from 25° C. to 200° C. relative to the electromotive force when the temperature is raised from 25° C. to 100° C. may be a range combining any of the above values ​​as the upper and lower limits.

[0045] The composition (4-2) according to this embodiment is The composition has an electromotive force (X300) when heated from 25°C to 300°C as a percentage of the electromotive force (X100) when heated from 25°C to 100°C ((X300 / X100)×100(%)) of -50 to 200, and contains a heat resistant material, a semi-heat resistant material, and / or a non-heat resistant material.

[0046] In the composition, the percentage value of the electromotive force when the temperature is raised from 25° C. to 300° C. relative to the electromotive force when the temperature is raised from 25° C. to 100° C. is preferably −50 to 180. When the ratio is −50 to 180, it may be −50, −18, −0.4, 49, 51, 120, 172, or 180. In one embodiment, the percentage value of the electromotive force when the temperature is raised from 25° C. to 300° C. relative to the electromotive force when the temperature is raised from 25° C. to 100° C. may be a range combining any of the above values ​​as the upper and lower limits.

[0047] The composition (4-3) according to this embodiment is The electromotive force (X400) when the temperature is raised from 25°C to 400°C relative to the electromotive force (X100) when the temperature is raised from 25°C to 100°C is a percentage ((X400 / X100)×100(%)) of -150 to 100, and the composition contains a heat resistant material, a semi-heat resistant material, and / or a non-heat resistant material.

[0048] In the composition, the percentage value of the electromotive force when the temperature is raised from 25° C. to 400° C. relative to the electromotive force when the temperature is raised from 25° C. to 100° C. is preferably −130 to 70. When the ratio is −130 to 70, it may be −130, −15, −0.4, 2, 27, 36, 61, or 70. In one embodiment, the percentage value of the electromotive force when the temperature is raised from 25° C. to 400° C. relative to the electromotive force when the temperature is raised from 25° C. to 100° C. may be a range combining any of the above values ​​as the upper and lower limits.

[0049] The composition (4-4) according to this embodiment is The electromotive force (X500) when the temperature is raised from 25°C to 500°C relative to the electromotive force (X100) when the temperature is raised from 25°C to 100°C is a percentage ((X500 / X100)×100(%)) of -250 to 50, and the composition contains a heat resistant material, a semi-heat resistant material, and / or a non-heat resistant material.

[0050] In the composition, the percentage value of the electromotive force when the temperature is raised from 25° C. to 500° C. relative to the electromotive force when the temperature is raised from 25° C. to 100° C. is preferably −240 to 40. When the ratio is −240 to 40, it may be −240, −238, −108, −15, 4, 19, or 40. In one embodiment, the percentage value of the electromotive force when the temperature is raised from 25° C. to 500° C. relative to the electromotive force when the temperature is raised from 25° C. to 100° C. may be within a range combining any of the above values ​​as the upper and lower limits.

[0051] The composition (4-5) according to this embodiment is The electromotive force (X600) when the temperature is raised from 25°C to 600°C relative to the electromotive force (X100) when the temperature is raised from 25°C to 100°C is a percentage ((X600 / X100)×100(%)) of -300 to 100, and the composition contains a heat resistant material, a semi-heat resistant material, and / or a non-heat resistant material.

[0052] In the composition, the percentage value of the electromotive force when the temperature is raised from 25° C. to 600° C. relative to the electromotive force when the temperature is raised from 25° C. to 100° C. is preferably −300 to 70. When the ratio is −300 to 70, it may be −300, −284, −205, −108, −103, −58, −28, −19, 20, 62, or 70. In one embodiment, the percentage value of the electromotive force when the temperature is raised from 25° C. to 600° C. relative to the electromotive force when the temperature is raised from 25° C. to 100° C. may be a range combining any of the above values ​​as the upper and lower limits.

[0053] The composition (5) according to this embodiment is Tapping apparent density is 0.3g / cm 3 ~5g / cm 3 The composition includes a refractory material, a semi-refractory material, and / or a non-refractory material,

[0054] The composition has a tapping apparent density of 0.3 g / cm 3 ~5g / cm 3 If it is 0.3 g / cm 3 Even if it is 0.35g / cm 3 Even if it is 0.4g / cm 3 Even if it is 0.45g / cm 3 Even so, 0.48g / cm 3 Even if it is 0.5g / cm 3 Even if it is 0.8g / cm 3 Even if it is 2g / cm 3 Even so, 4.2g / cm 3 Even so, 4.6g / cm 3 Even so, 4.8g / cm 3 Even if it is 5g / cm 3 In one embodiment, the tapping apparent density may be a range combining any of the above values ​​as upper and lower limits.

[0055] The composition (5) has a feature that the composition can be easily filled into a composition bag or a tablet molding machine, and the productivity can be easily improved. As a result of studies on composition (5) to facilitate the exhibiting of better disintegrability in water and / or better frictional force of wet powder, it was found that the above object can be achieved by setting the weight residual rate and the electromotive force in a specific range when the temperature is raised from room temperature to a specific temperature, and further setting the relationship between the weight residual rate and the electromotive force to a specific range. A composition having the characteristics of composition (5) is easy to fill into a composition bag or a tablet molding machine, and productivity is easy to improve. In this composition (5), when the weight residual rate when heated from room temperature (25°C) to a specific temperature is set to be any of the characteristics of compositions (1-1) to (1-6), the electromotive force is set to be within a specific range (any of the characteristics of compositions (3-1) to (3-6)), and the composition has any of the characteristics of compositions (2-1) to (2-5), and / or the composition has any of the characteristics of compositions (4-1) to (4-5), the composition is easy to exhibit good disintegrability in water and / or good frictional force of wet powder, and the composition is easy to fill into a composition bag or a tablet molding machine, and productivity is easy to improve.

[0056] The tapping apparent density is a value measured by the method described below.

[0057] The composition (6) according to this embodiment is When the temperature is increased from 25°C to 600°C, the weight residual ratio (y) determined by thermogravimetric analysis is: The composition is represented by the formula: y≧−2.03x + 23.623 (x represents the electromotive force when the temperature is raised from 25° C. to 600° C.), and includes a heat-resistant material, a semi-heat-resistant material, and / or a non-heat-resistant material. Here, composition (6) preferably has at least one of the characteristics that x is −4 μV or more and that y is 11% or more, and more preferably has both of these characteristics. x is more preferably from −4 μV to 20 μV, even more preferably from −4 μV to 18 μV, even more preferably from −3 μV to 17 μV, and even more preferably from 1 μV to 17 μV. More preferably, y is from 11% to 60%, further preferably from 12% to 50%, further preferably from 13% to 40%, further preferably from 18% to 30%, and further preferably from 20% to 29%. When x is between 1 μV and 17 μV, it may be between 1 μV and 6 μV. When y is between 20% and 29%, it may be between 20% and 25%, or may be between 20% and 23%. When composition (6) has both the characteristics that x is -4 μV or more and y is 11% or more, the combination of the values ​​of x and y may be in any of the above ranges, for example, x may be -3 μV to 17 μV and y may be 20% to 29%, or x may be 1 μV to 17 μV and y may be 20% to 25% or 20% to 23%.

[0058] Regarding the formula: y≧-2.03x+23.623, as shown in Fig. 1, Examples 1 to 5 and 7 to 9 (T1 to T3, T6 to T7, T9 to T11) in which the weight residual rate determined by thermogravimetric analysis when heated from 25°C to 600°C is 11% or more (above line A) and the electromotive force when heated from 25°C to 600°C is -4μV or more (to the right of line B) have a disintegration property in water of 1.2 (min / N) or less, i.e., good disintegration property in water. Furthermore, these compositions have a frictional force of wet powder of 45 (gf) or less and a rating of 3 or 4 in the tongue feel sensory test, and have a good mouth feel. However, the range above line A and to the right of line B includes comparative examples 3 to 6 (T12 to T15) that have poor effects of good disintegrability in water and good texture as described above. Therefore, it may be difficult to distinguish between compositions that have the desired effects and those that do not when actually producing the composition. In order to facilitate this distinction, the formula y=-2.03x+23.623 is defined based on T2 (Example 2) and T7 (Example 5) as a boundary line that distinguishes between compositions that have the effects and those that do not, and the formula y≧-2.03x+23.623 is defined as the region above this boundary line. Using this formula as a reference, compositions that have no or low effects can be effectively eliminated. The range outside the range surrounded by lines A, B, and the formula y≧-2.03x+23.623 is excluded, so that compositions that have good disintegrability in water and good texture can be easily distinguished. Since the formula: y≧−2.03x + 23.623 is a straight line, it is easy to determine, making it easier to determine whether or not the composition is effective.

[0059] Each of the compositions (1-1) to (1-6), (2-1) to (2-5), (3-1) to (3-6), (4-1) to (4-5), (5), and (6) exhibits good disintegrability in water and / or good frictional force of wet powder when made into a tablet form. Since they exhibit good disintegrability in water, they are more likely to exhibit the effect of good oral disintegrability when orally administered to a subject. In addition, since these compositions exhibit good frictional force of wet powder, they are more likely to exhibit the effect of good mouth feel of a powder composition paste when orally administered to a subject. Thus, compositions (1-1) to (1-6), (2-1) to (2-5), (3-1) to (3-6), (4-1) to (4-5), (5), and (6) exhibit good disintegrability in water and / or good frictional force of wet powder, and therefore tend to realize good passage of the composition during swallowing when orally administered, i.e., to be easy to drink. In particular, when a composition has the characteristics of composition (5), it becomes easier to fill the composition into a composition bag or a tablet molding machine, and thus it becomes easier to improve productivity.

[0060] In one embodiment, the composition is preferably an oral composition. By using it orally, as described above, it becomes easier to obtain the effect of achieving good oral disintegrability based on good disintegrability in water and / or good texture based on good frictional force of wet powder. In one embodiment, the composition is preferably contained in a food or medicine in the form of a tablet, as described in the second embodiment. The tablet form makes it easier to achieve the effect of good oral disintegrability based on good disintegrability in water, and / or makes it easier to achieve the effect of good mouth feel of the disintegrating paste based on the frictional force of the wet powder.

[0061] In addition, the composition exhibiting good disintegrability in water and / or good frictional force of a wet powder is also a suitable property for a cosmetic composition. Therefore, as described in the third embodiment, in one embodiment, the composition may be a cosmetic composition.

[0062] As described above, the composition according to this embodiment has good oral disintegrability based on good disintegrability in water and / or good frictional force of wet powder. Therefore, as described in the third embodiment, in one embodiment, the composition may be a lubricant composition for tablets.

[0063] Compositions (1-1) to (1-6), (2-1) to (2-5), (3-1) to (3-6), (4-1) to (4-5), (5), and (6) may be compositions that combine the respective features of two or more of these compositions. For example, compositions (1-6), (3-6), (5), and (6) are provided, which have the characteristics of a weight residual rate of 11% or more as determined by thermogravimetric analysis when heated from 25° C. to 600° C., an electromotive force of −4 μV or more when heated from 25° C. to 600° C., and a tapping apparent density of 0.3 g / cm. 3 ~5g / cm 3 and the composition may be a heat-resistant material, a semi-heat-resistant material, and / or a non-heat-resistant material composition represented by the formula: y≧−2.03x + 23.623 (x represents the electromotive force when the temperature is increased from 25° C. to 600° C.). The composition, which has the characteristics of compositions (1-6), (3-6), and (6), tends to exhibit good disintegrability in water and / or good frictional force of a wet powder, and the composition, which has the characteristics of composition (5), tends to be easily filled into composition bags or tablet molding machines, and thus tends to improve productivity.

[0064] As another example, the composition may be a composition containing a heat resistant substance, a semi-heat resistant substance, and / or a non-heat resistant substance, which has the characteristics of the compositions (1-2), (1-3), and (2-5), and in which the weight residual ratio determined by thermogravimetric analysis when heated from 25° C. to 200° C. is 50% or more and 96% or less, when heated from 25° C. to 300° C. is 50% or more and 90% or less, and the weight residual ratio determined by thermogravimetric analysis when heated from 25° C. to 600° C. is 11 to 45 as a percentage of the weight residual ratio (W600) determined by thermogravimetric analysis when heated from 25° C. to 600° C. relative to the weight residual ratio (W100) determined by thermogravimetric analysis when heated from 25° C. to 100° C. ((W600 / W100)×100(%)). For example, the composition may be a composition containing a heat resistant substance, a semi-heat resistant substance, and / or a non-heat resistant substance, which has the characteristics of composition (1-4) and composition (1-5), and has a weight residual ratio determined by thermogravimetric analysis when heated from 25° C. to 400° C. of 15% or more and 80% or less, and has a weight residual ratio determined by thermogravimetric analysis when heated from 25° C. to 500° C. of 12% or more and 70% or less. As yet another example, the composition may have the characteristics of composition (3-6) and composition (4-5), and has an electromotive force of -4 μV or more and 20 μV or less when heated from 25° C. to 600° C., and the percentage of the electromotive force when heated from 25° C. to 600° C. relative to the electromotive force when heated from 25° C. to 100° C. ((W600 / W100)×100(%)) is -300 to 100, and may contain a heat resistant material, a semi-heat resistant material, and / or a non-heat resistant material.

[0065] Similarly, a composition having one or more characteristics selected from composition (1-1) and the other compositions, a composition having one or more characteristics selected from composition (1-2) and the other compositions, a composition having one or more characteristics selected from composition (1-3) and the other compositions, a composition having one or more characteristics selected from composition (1-4) and the other compositions, a composition having one or more characteristics selected from composition (1-5) and the other compositions, a composition having one or more characteristics selected from composition (1-6) and the other compositions, a composition having one or more characteristics selected from composition (2-1) and the other compositions, a composition having one or more characteristics selected from composition (2-2) and the other compositions, a composition having one or more characteristics selected from composition (2-3) and the other compositions, a composition having one or more characteristics selected from composition (2-4) and the other compositions, a composition having one or more characteristics selected from composition (2-5) and the other compositions, a composition having one or more characteristics selected from composition (3-1) and the other compositions. a composition having one or more characteristics selected from composition (3-2) and the other compositions, a composition having one or more characteristics selected from composition (3-3) and the other compositions, a composition having one or more characteristics selected from composition (3-4) and the other compositions, a composition having one or more characteristics selected from composition (3-5) and the other compositions, a composition having one or more characteristics selected from composition (3-6) and the other compositions, a composition having one or more characteristics selected from composition (4-1) and the other compositions, a composition having one or more characteristics selected from composition (4-2) and the other compositions, a composition having one or more characteristics selected from composition (4-3) and the other compositions, a composition having one or more characteristics selected from composition (4-4) and the other compositions, a composition having one or more characteristics selected from composition (4-5) and the other compositions, a composition having one or more characteristics selected from composition (5) and the other compositions, or a composition having one or more characteristics selected from composition (6) and the other compositions.The composition may also have a combination of any two, three, four or more of these features.

[0066] The composition according to the present embodiment includes a heat-resistant material, a semi-heat-resistant material, and / or a non-heat-resistant material. Preferably, the composition includes two or more of a heat-resistant material, a semi-heat-resistant material, and a non-heat-resistant material, and more preferably, the composition includes a heat-resistant material, a semi-heat-resistant material, and a non-heat-resistant material. Non-limiting examples of heat-resistant materials, semi-heat-resistant materials, and non-heat-resistant materials are as follows:

[0067] Non-limiting examples of heat-resistant substances include inorganic substances. The inorganic substances are not limited within the range acceptable for food compositions or pharmaceutical compositions, 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 substances may be one type or a combination of two or more types. When the composition contains a naturally derived component such as plant-derived cellulose, examples of the heat-resistant substance may include inorganic substances contained in the naturally derived component. In order to adjust the content of inorganic substances, naturally derived components such as cellulose with an adjusted content of inorganic substances may be used.

[0068] Non-limiting examples of the semi-thermostable substance 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 obtained by deacetylation of chitin. Polymeric carbohydrates are not limited by their function or role, and may be carbohydrates that play or participate in any function, such as energy storage function (starch, glycogen, etc.), function of forming a living body, immunity, intercellular communication, etc. In one embodiment, the semi-thermostable substance may be cellulose, or cellulose and any one or more of the above other components. The semi-thermostable substance may be one type or a combination of two or more types.

[0069] Non-limiting examples of non-thermostable substances include proteins and low molecular weight carbohydrates. Low molecular weight carbohydrates are monosaccharides, and the monosaccharides are not limited by the number of carbon atoms in the carbon chain structure of triose, tetraose, pentose, and 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.

[0070] The composition preferably contains 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. The composition preferably contains heat-resistant substances, semi-heat-resistant substances, and non-heat-resistant substances in amounts of more than 18% by weight, less than 72% by weight, and more preferably 20% to 40% by weight, 30% to 70% by weight, and 10% to 45% by weight, respectively, and even more preferably 20% to 40% by weight, 35% to 55% by weight, and 20% to 35% by weight, respectively. When the heat-resistant substance is 20% to 40% by weight, it may be 20% by weight, 22% by weight, 24% by weight, 28% by weight, 30% by weight, 38% by weight, or 40% by weight, or may be a range combining any of these values ​​as the upper and lower limits. When the content of the quasi-heat resistant material is 30% by weight to 60% by weight, it may be 30% by weight, 35% by weight, 40% by weight, 52% by weight, or 60% by weight, or any combination of these values ​​as the upper and lower limits. When the content of the non-heat resistant material is 20% by weight to 40% by weight, it may be 20% by weight, 24% by weight, 25% by weight, 26% by weight, 27% by weight, 30% by weight, or 32% by weight, or any combination of these values ​​as the upper and lower limits. The total content of the heat resistant material, the quasi-heat resistant material, and the non-heat resistant material is preferably 100% by weight. The composition contains a heat-resistant substance, a semi-heat-resistant substance, and a non-heat-resistant substance in an amount of more than 18% by weight, less than 75% by weight, and more than 10% by weight, respectively, which makes it easier for the composition to exhibit good disintegrability in water and / or good frictional force of a wet powder, which makes it easier to achieve good passage of the composition during swallowing when the composition is orally administered, i.e., makes the composition easier to drink. 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.

[0071] The composition containing the heat resistant material, semi-heat resistant material, and non-heat resistant material in the above-mentioned amounts can be prepared by blending materials containing one or more selected from the heat resistant material, semi-heat resistant material, and non-heat resistant material in any amount. Examples of materials containing only heat-resistant substances such as ash include titanium oxide and calcium carbonate. The material containing the heat-resistant substance, the semi-heat-resistant substance, and / or the non-heat-resistant substance is a plant-derived component. The plant-derived component may be a component derived from a natural plant, or a plant-derived component produced by processing a plant, and examples thereof include wheat germ, oats, crystalline cellulose (e.g., PH grade of Asahi Kasei's Ceolas (registered trademark)), powdered cellulose (e.g., Nippon Paper Industries Co., Ltd.'s KC Flock W-50), and soybean composition (soybean or soybean-derived component). 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 5-25% by weight of heat-resistant material, 30-70% by weight of semi-heat-resistant material, and 25-45% by weight of non-heat-resistant material. For example, oats contain 5-20% by weight of heat-resistant material, 45-75% by weight of semi-heat-resistant material, and 20-45% by weight of non-heat-resistant material. For example, crystalline cellulose (Ceolas, Asahi Kasei) contains 1-10% by weight of heat-resistant material, 70-98% by weight of semi-heat-resistant material, and 0.1-5% by weight of non-heat-resistant material. For example, powdered cellulose (KC Flock W-50, Nippon Paper Industries Co., Ltd.) contains 1-10% by weight of heat-resistant material, 70-90% by weight of semi-heat-resistant material, and 5-20% by weight of non-heat-resistant material. Also, 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.

[0072] When preparing a composition, the specific amount or ratio of heat-resistant, semi-heat-resistant, and / or non-heat-resistant substances contained in the plant-derived components actually used can be determined by a method well known to those skilled in the art. For example, the content of heat-resistant substances such as ash can be measured using a known ash method. For example, the content of semi-heat-resistant substances such as cellulose can be measured using a known alpha-cellulose quantification method. For example, the content of non-heat-resistant substances such as hemicellulose can be calculated by subtracting the value obtained by the 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 heat-resistant, semi-heat-resistant, and non-heat-resistant substances in the desired ratio.

[0073] In one embodiment, the composition has the characteristics of composition (6) and one or more characteristics selected from the other compositions above. That is, in one embodiment, the composition has a weight retention rate (y) determined by thermogravimetric analysis when heated from 25° C. to 600° C.: Formula:y≧-2.03x + 23.623 (x represents the electromotive force when the temperature is raised from 25° C. to 600° C.), and has one or more other characteristics selected from the above compositions. By satisfying the above formula, the composition according to the present embodiment is likely to exhibit good frictional force of wet powder. Furthermore, the texture is likely to be smoother. This is because the composition is likely to have less aggregation when administered to a subject. Furthermore, by satisfying the above formula, when administered in tablet form, the tablet is likely to have good disintegrability in water.

[0074] In one embodiment, the composition preferably has the characteristics of composition (6) and at least one of compositions (1-6), (3-6), and (5), more preferably has two of the characteristics, and even more preferably has three of the characteristics.

[0075] In one embodiment, the composition comprises the features of composition (1-6), composition (3-6), composition (5), and composition (6). In one embodiment, the composition is a composition comprising a refractory material, a semi-refractory material, and a non-refractory material having the characteristics of composition (1-6), composition (3-6), composition (5), and composition (6). In one embodiment, the composition includes a heat resistant material, a semi-heat resistant material, and a non-heat resistant material, and has a weight residual ratio determined by thermogravimetric analysis when heated from 25° C. to 600° C. of 11% or more, an electromotive force when heated from 25° C. to 600° C. of -4 μV or more, and a weight residual ratio (y) determined by thermogravimetric analysis when heated from 25° C. to 600° C. of Formula:y≧-2.03x + 23.623 (x represents the electromotive force when the temperature is raised from 25°C to 600°C), and the tapping apparent density is 0.3 g / cm 3 ~5g / cm 3 The composition is:

[0076] When the composition has the characteristic of composition (6) and at least one, two, or three of the characteristics of compositions (1-6), (3-6), and (5), the composition is likely to exhibit better frictional force of a wet powder, to have a smoother texture on the tongue, and, when administered in tablet form, to have better disintegrability in water.

[0077] As described in the section "Measurement of Electromotive Force", the electromotive force (x in the formula) of the sample when the temperature is raised from 25° C. to 600° C. can be adjusted by adjusting the content of the non-heat-resistant substance, the content of the heat-resistant substance, and / or the content of the quasi-heat-resistant substance in the composition. More specifically, as described in the section "Thermogravimetric Analysis", the weight residual ratio (y in the formula) determined by thermogravimetric analysis when the temperature is raised from 25° C. to 600° C. can be adjusted by adjusting the content of the non-heat-resistant substance, the content of the heat-resistant substance, and / or the content of the quasi-heat-resistant substance in the composition. Therefore, the composition can be adjusted to satisfy the above formula by adjusting the content of the non-heat-resistant material, the content of the heat-resistant material, and / or the content of the semi-heat-resistant material in the composition. More specifically, the electromotive force (where x) when the temperature is raised from 25°C to 600°C can be adjusted to -4 μV or more by adjusting the contents of the heat-resistant material, semi-heat-resistant material, and non-heat-resistant material to more than 18 wt%, less than 72 wt%, and more than 10 wt%, respectively.

[0078] The composition of this embodiment is preferably a powder composition, considering that when prepared in tablet form and administered or ingested by a subject, it exerts the desired effect of ease of swallowing (good oral disintegrability and / or good texture on the tongue).

[0079] At least a part of the heat-resistant material, at least a part of the semi-heat-resistant material, and at least a part of the non-heat-resistant material contained in the powder composition are powder particles. The powder composition may be composed of powder particles. The powder particles of the semi-heat-resistant material include cellulose. The powder particles of the semi-heat-resistant material may further include a soybean-derived component. The shape of the powder particles is not limited, but the cellulose and / or components other than cellulose may contain fibrous components. The powder composition may be composed of fibrous powder particles. For the fibrous powder particles, the average fiber length (length in the fiber direction) is 1 μm to 500 μm, preferably 5 μm to 500 μm, more preferably 5 μm to 250 μm, even more preferably 5 μm to 100 μm, and even more preferably 5 μm to 50 μm. When the average fiber length is 5 μm to 50 μm, it may be 5 μm, 10 μm, 20 μm, 30 μm, 40 μm, or 50 μm, or may be a range combining any of the above values ​​as the upper and lower limits. For example, the average fiber length may be 5 μm or more. In one embodiment, the average fiber length of the powder particles is 10 to 11 μm. The average fiber width of the powder particles (length in the direction perpendicular to the fibers) is 1 μm to 500 μm, preferably 5 μm to 500 μm, more preferably 5 μm to 250 μm, even more preferably 5 μm to 100 μm, and even more preferably 5 μm to 50 μm. When the average fiber width is 5 μm to 50 μm, it may be 5 μm, 10 μm, 20 μm, 30 μm, 40 μm, or 50 μm, or may be a range combining any of the above values ​​as the upper and lower limits. For example, the average fiber width may be 5 μm or more. In one embodiment, the average fiber width of the powder particles is 10 to 11 μm.

[0080] In one embodiment, any of the above compositions may further be a composition in which the powder particles contained in the composition have an average fiber length of 5 μm or more. The powder particle may be a single fiber or a number of fibers bonded together to form a particle.

[0081] By setting the average fiber length of the powder particles to 1 μm to 500 μm and the average fiber width to 1 μm to 500 μm, it becomes easy to exhibit appropriate adhesion when prepared into a tablet form, and / or it becomes easy to make the prepared tablet exhibit good disintegrability in water and / or good frictional force of a wet powder. As a result, a tablet containing the powder composition, when orally administered, tends to realize good oral disintegrability and a good texture of the disintegrating paste, and tends to realize good passage of the composition during swallowing, that is, it becomes easy to swallow the tablet.

[0082] The average fiber length and average fiber width of the powder particles are values ​​measured by the method described below.

[0083] In one embodiment, any of the above compositions further comprises a powder particle contained in the composition having an aspect ratio (average fiber length / average fiber width) of 1.0 to 100, preferably 1.0 to 5.0, preferably 1.0 to 3.0, more preferably 1.0 to 2.0, and even more preferably 1.0 to 1.5. When the aspect ratio is 1.0 to 1.5, it may be 1.0, 1.1, or 1.5.

[0084] When the aspect ratio of the powder particles contained in the composition is 1.0 to 100, the composition is likely to exhibit good disintegrability in water and good frictional force of a wet powder. In addition, when the number of powder particles contained in the composition is the same, the volume is likely to be smaller when the aspect ratio is closer to 1.0. The risk of clogging in equipment during the process of processing or manufacturing products such as medicines, foods, and cosmetics using the composition is likely to be reduced. It is presumed that each of these effects is due to the fact that the friction between the fibers of the powder particles is likely to be reduced when the aspect ratio is close to 1.0.

[0085] The aspect ratio of the powder particles is a value measured by the method described below.

[0086] In one embodiment, any of the above compositions may further be a composition in which the water absorption rate of powder particles contained in the composition is less than 200%. The water absorption rate of the powder particles is preferably 25% to 150%, more preferably 30% to 100%, even more preferably 40% to 80%, and even more preferably 50% to 75%. When the water absorption rate of the powder particles is 50% to 75%, it may be 50%, 60%, 70%, or 75%. In one embodiment, it may be a range that combines any of the above values ​​as the upper and lower limits.

[0087] In the composition, when the water absorption rate of the powder particles is low, the powder particles are unlikely to expand, so that the powder particles are likely to break apart from each other, and the tablet containing the composition is likely to have good disintegration in water.When the water absorption rate of the powder particles is less than 200%, the tablet containing the composition containing the powder particles is likely to have good disintegration in water.

[0088] The water absorption rate of the powder particles contained in the composition is a value measured by the method described below.

[0089] In one embodiment, any of the above compositions further comprises an apparent density (untapped) of 0.3 g / cm 3 ~5g / cm 3 The composition may have an apparent density (without tapping) of 0.3 g / cm 3 ~5g / cm 3 If it is 0.3 g / cm 3 Even so, 0.32 g / cm 3 Even so, 0.34 g / cm 3 Even if it is 0.4g / cm 3 Even if it is 0.45g / cm 3 Even at 0.5g / cm 3 Even if it is 0.65g / cm 3 Even so, 1.6g / cm 3 Even so, 3.8g / cm 3 Even so, 4.2g / cm 3 Even if it is 5g / cm 3 In one embodiment, the apparent density (without tapping) may be a range combining any of the above values ​​as upper and lower limits. The apparent density of the composition (without tapping) is 0.3 g / cm 3 ~5g / cm 3 This makes it easier to fill the composition into a composition bag or a tablet molding machine, making it easier to improve productivity.

[0090] The apparent density (without tapping) is a value measured by the method described below.

[0091] In one embodiment, any of the above compositions may further be a composition having a compressibility of less than 1.35. When the compressibility is less than 1.35, it may be 1 to 1.3, or may be 1, 1.09, 1.1, 1.11, 1.13, 1.18, 1.2, 1.23, or 1.25. In one embodiment, the compressibility may be within a range combining any of the above values ​​as the upper and lower limits. By making the compressibility of the composition less than 1.35, the composition is less likely to be compressed when the composition is subjected to vibration, and the shape of the bag in which the composition is packaged is less likely to change, which makes it easier to load and transport the bag in which the composition is packaged.

[0092] The compressibility is a value measured by the method described below.

[0093] (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 was measured by measuring N 2 This value was obtained from the remaining weight of the sample at 100°C, 200°C, 300°C, 400°C, and 600°C when the temperature was increased from 25°C to 600°C at 10°C / min in an atmosphere. The weight residual rate when a sample is heated from temperature a to temperature b is the percentage (%) of the remaining weight at temperature b when the remaining weight 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] The weight retention rate (W a→c ) when the sample is heated from temperature a to temperature b, the weight retention rate (Wa→b The percentage value of (W a→b / W a→c ) x 100(%).

[0094] More specifically, for example, the percentage of the weight residual ratio (W600) determined by thermogravimetric analysis when heated from 25°C to 600°C or higher relative to the weight residual ratio (W100) determined by thermogravimetric analysis when heated from 25°C to 100°C ((W600 / W100) x 100(%)) is a percentage value obtained by dividing the weight residual ratio (W600) determined by thermogravimetric analysis when heated from 25°C to 600°C by the weight residual ratio (W100) determined by thermogravimetric analysis when heated from 25°C to 100°C. Note that the weight residual ratio determined by thermogravimetric analysis when heated from 25°C to 100°C is W 25→100 However, in this specification, it is expressed as W100. The weight retention rate for each temperature increase from 25°C to 200°C, 300°C, 400°C, 500°C, 600°C, or d°C is expressed in the same manner.

[0095] 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, it is possible to adjust 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.

[0096] According to the temperature increase up to 300°C, many of the non-heat-resistant substances contained in the composition disappear (Asahi Kuriyama, Materials, Vol. 16, No. 169, pp. 772-776). Therefore, the weight retention rate determined by thermogravimetric analysis when the temperature is increased from 25°C to 200°C, or from 25°C to 300°C, indicates the retention of 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, can be increased, and the weight retention rate can be decreased. Alternatively, by decreasing the content of components other than the non-heat-resistant substances contained in the composition, that is, the content of 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, can be increased, and the weight retention rate can be decreased.

[0097] The weight retention rate determined by thermogravimetric analysis when the temperature of the composition is increased from 25°C to 200°C is measured as described above, and the content of the non-heat-resistant substances contained in the composition can be adjusted so that it is 50% or more and 96% or less, or any desired value listed above. Also, the weight retention rate determined by thermogravimetric analysis when the temperature of the composition is increased from 25°C to 300°C is measured as described above, and the content of the non-heat-resistant substances contained in the composition can be adjusted so that it is 50% or more and 90% or less, or any desired value listed above.

[0098] By adjusting the content of the non-heat-resistant substances, and / or the content of the heat-resistant substances, and / or the content of the semi-heat-resistant substances in the composition, the weight retention rate (W100) determined by thermogravimetric analysis when the temperature is increased from 25°C to 100°C, with respect to the weight retention rate (W 25→d (d = 200, 300, 400, 500 or 600)) expressed as a percentage ((W 25→d / W100)×100(%)) can be adjusted. Here, as described above, W 25→d can also be expressed as Wd.

[0099] The weight residual ratio 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.

[0100] When the temperature is raised from 25°C to 400°C or higher, the semi-heat-resistant substance contained in the composition disappears between 300°C and 400°C (Masaaki Manki et al., Journal of the Chemical Society of Japan, 1975, (4), pp. 733-737). Therefore, the weight residual ratio obtained by thermogravimetric analysis when the temperature is raised from 25°C to 400°C or higher indicates the remaining components other than the non-heat-resistant substance (component that disappears when the temperature is raised to 300°C) and the semi-heat-resistant substance (component that disappears between 300°C and 400°C), i.e., the heat-resistant substance. By increasing the content of the non-heat-resistant substance and the semi-heat-resistant substance contained in the composition, the weight loss rate when the temperature is raised from 25°C to 400°C can be increased and the weight residual ratio can be reduced. Alternatively, by decreasing the content of the non-heat-resistant substance and the component other than the semi-heat-resistant substance contained in the composition, i.e., the heat-resistant substance, the weight loss rate when the temperature is raised from 25°C to 400°C or higher can be increased and the weight residual ratio can be reduced.

[0101] The weight residual ratio determined by thermogravimetric analysis when the composition is heated from 25°C to 400°C or to a temperature higher than 400°C is measured as described above, and the weight residual ratio (W400) determined by thermogravimetric analysis when the composition is heated from 25°C to 400°C relative to the weight residual ratio (W100) determined by thermogravimetric analysis when the composition is heated from 25°C to 500°C is adjusted so that the percentage ((W400 / W100)×100(%)) of the weight residual ratio (W100) determined by thermogravimetric analysis when the composition is heated from 25°C to 100°C is 15 to 80, or any of the desired values ​​listed above. The amount of the non-heat resistant material and / or the amount of the semi-heat resistant material and the amount of the heat resistant material contained in the composition can be adjusted so that the numerical value ((W500 / W100)×100(%)) expressed as a percentage of the weight residual ratio (W500) determined by thermogravimetric analysis when heated from 25° C. to 600° C. relative to the weight residual ratio (W100) determined by thermogravimetric analysis when heated from 25° C. to 100° C. ((W600 / W100)×100(%)) is 15 to 30, or any of the desired values ​​listed above. Here, the weight residual ratio determined by thermogravimetric analysis when the temperature is raised from 25°C to a specified temperature is expressed as a percentage relative to the weight residual ratio determined by thermogravimetric analysis when the temperature is raised from 25°C to 100°C in order to eliminate the influence of water adsorbed in the composition, food composition, pharmaceutical composition, cosmetic composition, or lubricant composition.

[0102] The weight retention rate of any of the compositions according to this embodiment, determined by thermogravimetric analysis when heated to a predetermined temperature, can be adjusted in the same manner as described above.

[0103] (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 was measured using a thermal analyzer (STA300 manufactured by Hitachi High-Tech Science) by measuring the electromotive force of a sample (approximately 10 mg of a composition in N 2 This is the electromotive force (μV) of the sample at 100°C, 200°C, 300°C, 400°C, and 600°C when the temperature was increased from 25°C to 600°C at 10°C / min in an atmosphere. The percentage of the electromotive force (Xa) of a sample when heated from 25°C to temperature a relative to the electromotive force (Xb) of a sample when heated from 25°C to temperature b is expressed by the formula: (Xa / Xb) x 100 (%). Note that the electromotive force of a sample when heated from 25°C to temperature a is X 25→a However, in this specification, it is expressed as Xa. The electromotive force for each temperature rise from 25°C to b°C, 100°C, 200°C, 300°C, 400°C, 500°C, or 600°C can be expressed in the same way.

[0104] 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 matter, 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. More specifically, by adjusting the contents of the heat-resistant material, semi-heat-resistant material, and non-heat-resistant material to more than 18 wt %, less than 72 wt %, and more than 10 wt %, respectively, the electromotive force when the sample is heated from 25°C to 600°C can be adjusted to -4 μV or more.

[0105] Examples of the heat-resistant material, semi-heat-resistant material, non-heat-resistant material, etc. are as explained above in the "Thermogravimetric analysis" section.

[0106] In addition, 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, it is possible to adjust the numerical value ((Xa / Xb)×100(%)) expressed as a percentage of the electromotive force (Xa) when the temperature is raised from 25° C. to temperature a relative to the electromotive force (Xb) when the temperature is raised from 25° C. to temperature b. More specifically, by adjusting the contents of the heat resistant material, the semi-heat resistant material, and the non-heat resistant material to more than 18% by weight, less than 72% by weight, and more than 10% by weight, respectively, the percentage of the electromotive force when the temperature is raised from 25°C to 600°C relative to the electromotive force when the temperature is raised from 25°C to 100°C can be adjusted to a value in the range of -300 to 100.

[0107] (Measurement of average fiber length and average fiber width of powder particles) In order to remove extremely coarse fibers or aggregated fibers, 1 g of powder sample of the composition is classified using a JIS test sieve (Tokyo Screen Co., Ltd.: 710 μm) with the sample adjusted to a moisture content of 2-3%. The classified sample is randomly selected under an optical microscope (magnification: 100 times), and the fiber length (length in the fiber direction) and fiber width (length perpendicular to the fiber) of the powder particles are measured for 1,000 particles, excluding 100 large and 100 small particles, and the average value is calculated.

[0108] (Aspect ratio of powder particles) The aspect ratio of the powder particles is the average value obtained by calculating the fiber length / fiber width using the fiber lengths and fiber widths of 1,000 powder particles obtained by measuring under a microscope as described above.

[0109] (tapping apparent density) The tapping apparent density of the composition is a value measured using a commercially available powder property measuring instrument (Powder Tester PT-T type, manufactured by Hosokawa Micron Co., Ltd.). 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.

[0110] The tapped apparent density of the composition can be adjusted by adjusting the particle size and / or shape of the powder particles. For example, the tapped apparent density of the powder particles can be increased by reducing the particle size (fiber length or fiber width) or the aspect ratio.

[0111] (Apparent density (without tapping)) The apparent density of the composition (without tapping) is 100 cm 3 The weight of the powder is calculated by roughly filling a glass measuring cylinder with the composition for 2 to 3 minutes using a quantitative feeder for the composition, smoothing the top surface of the powder layer with a soft brush, reading the volume, and dividing the weight of the powder sample by the volume. The weight of the powder is calculated by dividing the weight of the powder sample with the volume of the cylinder. 3 The amount will be determined appropriately.

[0112] The apparent density (untapped) of the composition can be adjusted by adjusting the particle size and / or shape of the powder particles. For example, the apparent density (untapped) of the powder particles can be increased by reducing the particle size (fiber length or fiber width) or the aspect ratio.

[0113] (Degree of compression) The degree of compression is a value calculated by dividing the "tapping apparent density" described above by the "apparent density (without tapping)". The smaller the value, the more difficult it is to compress the composition when it is subjected to vibration. The compressibility can be adjusted by adjusting the tapped apparent density and / or apparent density (untapped) of the composition. The method for adjusting the tapped apparent density and apparent density (untapped) is as described above.

[0114] (Water absorption rate of powder particles) The water absorption rate of the powder particles contained in the composition is the measured value of the amount of water just before water separation from the fibers is visually confirmed when 2 g of the powder particles are placed in a container, water is added dropwise and mixed evenly. It is the average value of n=100. The water absorption rate of the powder particles can be adjusted by adjusting the fiber length and / or fiber width of the powder particles. Specifically, the water absorption rate of the powder particles can be easily improved by increasing the fiber length or width, or the fiber length and width, of the powder particles. The fiber length and fiber width of the powder particles 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 fiber length and / or fiber width of the powder particles can be increased by shortening the grinding time and / or weakening the grinding strength.

[0115] (Texture sensory test) The evaluation is conducted by 30 adult males and 30 adult females. The tablet is placed in the mouth, rolled around on the tongue to disintegrate the tablet, and the powdery texture after the tablet has completely disintegrated is evaluated. The results are evaluated according to the following criteria: 1: Very powdery 2: Feels powdery 3: Slightly powdery, but moist enough that it doesn't feel powdery. 4: No powdery feeling "Chalky" can be, for example, the sensation of small grains remaining on the tongue.

[0116] A rating closer to 4 in the texture sensory test indicates that the tablet has a less powdery disintegrating paste, i.e., the tablet exhibits a good disintegrating paste texture when orally administered to a subject. The composition according to this embodiment has a rating of 3 or 4 in the sensory test for texture, which indicates that the disintegrating paste of the tablet provides a good texture on the tongue, i.e., the tablet or composition is easy to swallow.

[0117] (Underwater disintegration) The oral disintegrability of a tablet containing the composition according to this embodiment is evaluated by measuring its disintegrability in water. The disintegration property in water is expressed as the disintegration time per unit hardness [disintegration time in water (D) / tablet hardness (N) (min / N)].

[0118] Tablet hardness (N) is a value measured using a hardness tester (model number: KHT-40N, Fujiwara Manufacturing Co., Ltd.). Place a tablet manufactured using the method explained in the "Tablet Manufacturing Method" section in the center of the measurement table and start the device (press the AUTO [start] button). This causes the rod to descend at high speed and the display goes into peak hold state. When it comes into contact with the object being measured, the speed slows down and the display is monitored approximately every 0.1 seconds. If there is no increase, it is judged to have been destroyed, and the hardness displayed on the hardness tester at that time is taken as the tablet hardness (N).

[0119] The water disintegration time is measured by placing a tablet in a test tube, adding 20 ml of pure water, vibrating it at 37°C with a shaker (reciprocating / rotating shaker MMS-3020, Tokyo Rikakikai Co., Ltd.), and measuring the disintegration time. The measurement is performed 50 times, and the average value is regarded as the water disintegration time of the tablet.

[0120] The water disintegration of the tablet according to this embodiment is preferably less than 1.9 (min / N), more preferably 1.5 (min / N) or less, and even more preferably 1.2 (min / N) or less. When the water disintegration is 1.2 (min / N) or less, it may be 1.2 (min / N), 0.9 (min / N), 0.8 (min / N), 0.7 (min / N), 0.6 (min / N), 0.5 (min / N), 0.4 (min / N), or 0.3 (min / N). In one embodiment, the water disintegration of the tablet may be in a range that combines any of the above values ​​as the upper and lower limits.

[0121] By making the tablet's water disintegration rate less than 1.9 (min / N), it becomes easier to realize good oral disintegration when the tablet is ingested as a food or administered as a medicine to a subject, which makes it easier to realize good passage of the composition during swallowing, i.e., makes the tablet easy to swallow.

[0122] The composition according to this embodiment has a water disintegration property of less than 1.9 (min / N) for a tablet containing the composition, which makes it easier to achieve good oral disintegrability as described above. In order to achieve the above-mentioned suitable disintegrability in water, the disintegration time of the tablet in water is preferably less than 90 minutes, more preferably 30 minutes or less. When the disintegration time of the tablet in water is 30 minutes or less, it may be 30 minutes, 25 minutes, 15 minutes, 14 minutes, or 12 minutes. In one embodiment, the disintegration time of the tablet in water may be a range combining any of the above values ​​as the upper and lower limits. The disintegration time of the tablet in water may be, for example, 12 minutes to 30 minutes, or 12 minutes to 15 minutes. In order to realize the above-mentioned suitable disintegrability in water, the hardness of the tablet is preferably 46N or less, more preferably less than 45N. When the hardness of the tablet is less than 45N, it may be 43N, 42N, 35N, 25N, 17N, or 14N. In one embodiment, the hardness of the tablet may be in a range combining any of the above values ​​as the upper and lower limits. The hardness of the tablet may be, for example, 14N to 46N, or 14N to 43N.

[0123] (Frictional force of wet powder) The frictional force (gf) of the wet powder was measured by passing the residue of the sample used in the above-mentioned "Underwater Disintegrability" test through a 90μm (JIS standard Z8801 wire), collecting it, and measuring it with a static and dynamic friction measuring device (Trinity Lab's "Handy Tribomaster TL201Ts") under the measurement conditions of a load of 50g and a speed of 10mm / sec. The contactor used was a 5mm thick sponge sheet (Cemedine's "Gap Tape N-1") with artificial skin (Viewlux's "Bio Skin") attached. Based on the static friction force (gf) results, calculate the ratio of travel distances of 0 mm and 3 mm using the following formula. Formula: Frictional force of wet powder with a travel distance of 2 mm = 100 x (static frictional force at a travel distance of 0 mm / static frictional force at a travel distance of 3 mm)

[0124] The frictional force of the wet powder is preferably less than 65 (gf), more preferably 45 (gf) or less. When the frictional force of the wet powder is 45 (gf) or less, it may be 42 (gf), 41 (gf), 40 (gf), 34 (gf), 32 (gf), or 30 (gf). In one embodiment, the water disintegration of the tablet may be in a range combining any of the above values ​​as the upper and lower limits. The frictional force of the wet powder may be, for example, 20 (gf) to 60 (gf), 25 (gf) to 55 (gf), or 25 (gf) to 50 (gf). It may also be, for example, 30 (gf) to 45 (gf), or 30 (gf) to 34 (gf).

[0125] The frictional force of the wet powder is less than 65 (gf), which makes it easier to realize a good mouthfeel of the disintegrating paste of the tablet or the paste of the powder composition, which makes it easier to realize good passage of the composition during swallowing, i.e., makes the tablet or composition easy to swallow.

[0126] The composition of this embodiment has a friction force of less than 65 (gf) of the wet powder of the composition, and therefore, as described above, it is easy to achieve good passage of the composition during swallowing, i.e., it is easy to obtain a tablet or composition that is easy to swallow.

[0127] The composition according to this embodiment can be used as a food composition or a pharmaceutical composition, as described in the second embodiment. The composition according to this embodiment can be used as a cosmetic composition or a lubricant composition, as described in the third embodiment.

[0128] ==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.

[0129] The food compositions, either alone or in combination of two or more types of food compositions, can be used in the preparation of foods such as beverages, soups, processed meat products, processed vegetable products, processed fruit products, seasonings, concentrated foods, and supplements (nutritional supplements, nutritional supplement drinks), etc.

[0130] A food product according to one embodiment comprises the food composition according to this embodiment.

[0131] Here, the processed food refers to natural food ingredients that have been processed and / or cooked, and includes frozen foods, retort foods, canned foods, bottled foods, etc. The form of the food is not limited, but is preferably a form suitable for oral use, and from the viewpoint of ease of ingestion, may be a fluid form such as liquid, syrup, paste, gel, jelly, cream, emulsion, spray, mousse, lotion, etc., or may be a solid form such as powder, granules, tablets, capsules, soft capsules, etc. Tablets may be any of orally disintegrating tablets, chewable tablets, effervescent tablets, dispersions, and dissolving tablets. Considering the effect of good oral disintegrability and good texture of the disintegrating paste based on good disintegrability in water and / or good frictional force of the wet powder due to the inclusion of the composition according to the first embodiment, and the effect of 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.

[0132] There is no limitation on the functional ingredient as long as it is an 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 having an effect of improving undesired symptoms and / or poor physical condition in a subject (including functions related to maintaining and promoting health). Therefore, it is preferable that the food containing the food composition is a functional food that has an 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, and health functional foods (including nutritional functional foods, foods for specified health uses (Tokuho), and functional food) that are labeled with functional claims in accordance with national standards for safety and efficacy.

[0133] The composition, raw materials, origin, and acquisition route of the functional ingredients are not limited, and include natural products, natural extracts, chemically synthesized substances, and mixtures of two or more of these. 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 sulfates (isothiacyanates, cysteine ​​sulfoxides, etc.). The food composition may contain one type of functional ingredient, or two or more types. 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 them is not limited, and non-limiting examples of the method include extraction from soybeans according to well-known methods, purchasing a commercially available product, and artificial preparation using equol-producing bacteria, etc.

[0134] In one embodiment, the food product is preferably a functional food in the form of a tablet, more preferably a functional food in the form of an orally disintegrating tablet.

[0135] The amount of food to be used per day is not limited, and can be appropriately determined by one skilled in the art based on the content of functional ingredients in the food and the daily required intake amount for the subject.

[0136] The composition according to the first embodiment can be used as a pharmaceutical composition. The pharmaceutical composition according to this embodiment contains a pharma- ceutical active ingredient. In one embodiment, the oral composition according to the first embodiment is preferably used as a pharmaceutical composition.

[0137] 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 the treatment of a disease or condition for which the pharmacologic effect of the pharmacologic active ingredient is appropriate.

[0138] A pharmaceutical according to one embodiment includes a pharmaceutical composition according to this embodiment.

[0139] In one embodiment, a method of treatment comprises administering the pharmaceutical composition of the present invention to a subject in need thereof.

[0140] 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.

[0141] The composition, pharmaceutical composition, or pharma- ceutical active ingredient according to one embodiment is the composition according to the first embodiment, the pharmaceutical composition, or the pharma- ceutical active ingredient according to this embodiment, for the treatment of a subject in need thereof.

[0142] 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, dispersions, and dissolving tablets. Considering the effects of good oral disintegrability and good texture on the tongue based on the moderate disintegrability in water and / or good frictional force of the wet powder due to the inclusion of the composition of the first embodiment, and therefore the 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.

[0143] The pharma- ceutical 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 pharma-ceutical active ingredient in the administered subject.

[0144] The composition, raw material, origin, and acquisition route of the pharmacologic 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, low molecular weight compounds, and the like. They may be the same substances as these or similar substances having similar functions that are bioengineered substances or chemically synthesized substances (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. The pharmaceutical composition may contain one type of pharmacologic active ingredient, or may contain two or more types.

[0145] The pharmaceutical composition in this embodiment is a pharmaceutical composition for treating or preventing a disease, an undesired symptom, and / or poor physical condition in a subject. "Treatment" includes the reduction, alleviation, or alleviation of symptoms of a disease, and "prevention" includes protection against the onset of a disease or symptom in the future and inhibition of progression. Desirable therapeutic effects of treatment include alleviation of symptoms, improvement of direct or indirect pathological results of a disease, reduction in the rate of progression of the worsening of symptoms, recovery or alleviation of a disease state, and improvement of prognosis.

[0146] When two or more types of food compositions or pharmaceutical compositions are separately formulated to form two or more types of 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 types of food or pharmaceutical preparations can also be ingested or administered at different times a day and / or by different routes. The pharmaceutical preparations can be administered systemically or locally.

[0147] In addition to the composition and the functional or pharmacoactive ingredient, the food composition or pharmaceutical composition may further contain one or more non-functional ingredients that are nutritionally acceptable or pharmacologic as a food. Examples of the non-functional ingredients include additives such as acidulants, sweeteners, excipients, surfactants, lubricants, flavorings, flavorings, colorants, stabilizers, and preservatives. Examples of the excipients include mannitol, erythritol, xylitol, trehalose, lactose, maltose, maltitol, glucose, sucrose, fructose, mannose, sorbitol, amylose, light anhydrous silicic acid, hydrated silicon dioxide, anhydrous calcium phosphate, anhydrous calcium hydrogen phosphate, aluminum metasilicate, calcium silicate, magnesium silicate, and magnesium oxide. The surfactant may be a nonionic surfactant, for example, a sorbitan fatty acid ester such as sorbitan monocaprylate, sorbitan monolaurate, or sorbitan monopalmitate, or a glycerin fatty acid ester such as glycerin monocaprylate, glycerin monomyriate, or 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 fatty acid esters, hydroxymethylcellulose, polyvinylpyrrolidone, and the like.

[0148] The content of the functional ingredient or pharmacologic active ingredient in the food composition or pharmaceutical composition is not limited, but may be more than 10% by weight, may be 20% by weight or more, may be 20-40% by weight, may be 20-32% by weight, or may be 20-30% by weight. When the content of the functional ingredient or pharmacologic active ingredient is 20-30% by weight, it may be 20% by weight, 24% by weight, 26% by weight, 27% by weight, or 30% by weight. In addition, the content of the non-functional ingredient in the food composition or pharmaceutical composition is not limited, and may be 90% by weight or less, may be 60-90% by weight, may be 60-80% by weight, may be 68-80% by weight, or may be 70-80% by weight. The functional ingredient or pharmacologic active ingredient may be contained in a non-heat-resistant substance in the composition according to the second embodiment, for example, a protein, a low-molecular-weight carbohydrate, or the like. By making the content of functional ingredients or pharma- ceutical active ingredients more than 10% by weight and the content of non-functional ingredients 90% by weight or less, the food composition or the food containing the same, or the pharmaceutical composition or the medicine containing the same, is likely to exhibit good frictional force of wet powder. Therefore, it is easy to realize a good texture when ingested, and it is easy to realize good passage of the composition during swallowing, that is, it is easy to become a food or medicine that is easy to drink. When the food or medicine is in the form of a tablet, it is easy to exhibit good disintegrability in water and / or good frictional force of wet powder. As a result, the tablet is easy to realize good oral disintegrability and good texture of the disintegrated paste, and it is easy to realize good passage of the composition during swallowing, that is, it is easy to become a tablet that is easy to drink. In addition, by having the content of the functional ingredient or pharma- ceutical active ingredient exceed 10% by weight, the functional ingredient or pharma- ceutical active ingredient is more likely to exert the desired effect in a subject who has ingested the food or been administered the medicine.

[0149] 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, etc., and are not limited by their use as livestock animals, pet animals, experimental animals, etc., but are preferably mammals, and more preferably humans.

[0150] The packaging form of the food composition or food containing the food composition, or the pharmaceutical composition or medicine containing the pharmaceutical composition according to this embodiment is not particularly limited and can be appropriately selected 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, synthetic resins, etc., glass containers such as vials, plastic containers such as ampoules, etc.

[0151] (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. For example, granules are produced from the powder of the composition according to the first embodiment by a wet granulation method using a liquid or a dry granulation method not using a liquid. In the wet granulation method, a granulation fluid is used to aggregate the powder using a wet granulator such as a shear granulator, a high shear mixer granulator, a twin screw granulator, or a fluidized bed granulator to produce granules. In the dry granulation method, the powder of the composition is agglomerated by pressure. Specifically, slugs are produced using a tablet press, or sheets or ribbons are produced by roller compression of the powder of the composition with two rollers. The produced slugs, or sheets or ribbons are pulverized to prepare granules. The granules are then compressed by a tablet press to produce tablets.

[0152] More specifically, the composition according to the first embodiment can be put into a fluidized bed granulator (FL-LABO, Freund Corporation) to obtain granules. Furthermore, magnesium stearate (Taihei Chemical Industry Co., Ltd.) is added to the obtained granules, mixed, and compressed using a simple tablet molding machine (HANDTAB-100, Ichihashi Seiki Co., Ltd.) with a tableting compression force to obtain tablets with a diameter of 8 mm, R12 punch tablets, and approximately 250 mg.

[0153] Alternatively, for example, each component of the heat-resistant material, semi-heat-resistant material, and non-heat-resistant material, which are materials for the composition according to the first embodiment, is subjected to a grinding process (milling) in which coarse particles are ground. After the grinding process, the average particle size of the powder particles is confirmed, and if it is less than 60 μm, a jet mill (for example, a jet mill grinder STJ-400 manufactured by Seishin) is used to grind the powder once under conditions of a flow rate of 2 kg / hour to 12 kg / hour, and the powder is ground to about 10 μm to obtain the composition according to the first embodiment (powder composition). 250 mg of this powder composition is placed in a mortar (manufactured by Ichihashi Seiki Co., Ltd., diameter 8 mm), compressed with 3 kN so that the thickness of the tablets is uniform to about 5 mm, and the stress is maintained for 60 minutes to prepare tablets with a diameter of 8 mm, R12 punch tablets, and about 250 mg. As a compressor, a compressor manufactured by Enerpac, HANDTAB-100, can be used. In this way, by preparing tablets using powder particles adjusted to about 10 μm by pulverization, the resulting tablets tend to exhibit good disintegration in water and good frictional force of a wet powder. This is presumably because pulverization tends to make the aspect ratio of the powder particles closer to 1.0, which tends to reduce friction between the fibers of the powder particles.

[0154] The tablets produced in this manner are likely to exhibit good disintegrability in water and / or good frictional force of a wet powder, and thus the tablets containing the powder composition are likely to have good oral disintegrability and good texture on the tongue, and are likely to achieve good passage of the composition during swallowing, i.e., are likely to be easy to swallow.

[0155] ==Third embodiment (other uses)== The composition according to the first embodiment can be used in various applications where the properties exhibited by the composition, i.e., good disintegrability in water and / or good frictional force of the wet powder, are favorably effective. 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.

[0156] 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.

[0157] The cosmetic composition is, for example, a composition intended for the purpose of beauty of the skin, hair, nails, etc., and can be formulated in a form that allows the care of these parts to be made into a cosmetic. For example, it may be a liquid, a lotion, a cream, a patch, an oil, a spray, a liquid cleaner, a solid soap, etc. In addition, the product may be a cosmetic liquid, a beauty essence, a moisturizing liquid, a moisturizing cream, a soap, a body soap, a skin cleansing agent, a bath salt for a bath, a sunscreen, a shaving lotion, a depilatory agent, a shampoo, a conditioner, a hair tonic, a hair dye, etc. In particular, from the viewpoint of exhibiting the effects favorably due to the properties exhibited by the composition according to the first embodiment, for example, a lotion, a cream, and a liquid cleaner are preferable, and examples of the product form of the liquid cleaner include shampoo, a body soap, and a skin cleansing agent.

[0158] 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 of the cosmetic containing the cosmetic composition are similar to the packaging forms described in the second embodiment.

[0159] 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 it, 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.

[0160] The lubricant composition is a composition intended to improve the handling properties during tableting and the ease of swallowing during administration of tablets. The composition according to the first embodiment exhibits good disintegrability in water and / or good frictional force of wet powder, and therefore can be suitably used as a lubricant composition.

[0161] The lubricant composition may contain one or more functional components and / or one or more non-functional components described in the second embodiment. From the 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 ester, magnesium silicate, light anhydrous silicic acid, hardened oil, heavy anhydrous silicic acid, sucrose fatty acid ester, stearyl alcohol, stearic acid, zinc stearate, aluminum stearate, calcium stearate, polyoxyl 40 stearate, magnesium stearate, soybean hardened oil, talc, sodium stearyl fumarate, beeswax, anhydrous silicic acid hydrate, magnesium aluminometasilicate, and glycerin monostearate.

[0162] A lubricant containing the lubricant composition according to this embodiment can be suitably used, for example, in the pharmaceutical composition according to the second embodiment, or in the formulation of a medicament containing the pharmaceutical composition.

[0163] A non-limiting list of exemplary embodiments and combinations of exemplary embodiments of the present disclosure are disclosed below. [1] A method for manufacturing a heat-resistant material, a semi-heat-resistant material, and a non-heat-resistant material, When heated from 25°C to 600°C, the weight residual rate determined by thermogravimetric analysis is 11% or more, When the temperature rises from 25°C to 600°C, the electromotive force is -4μV or more. When the temperature is increased from 25°C to 600°C, the weight residual ratio (y) determined by thermogravimetric analysis is: Formula:y≧-2.03x + 23.623 (x represents the electromotive force when the temperature is raised from 25°C to 600°C) It is expressed as Tapping apparent density is 0.3g / cm 3 ~5g / cm 3 The composition. [2] The composition according to [1], which has a weight residual ratio (W600) determined by thermogravimetric analysis when heated from 25°C to 600°C of 11% to 60%, 12% to 50%, 13% to 40%, 18% to 30%, or 20% to 29%. [3] The composition according to [1] or [2], wherein the weight residual ratio (W100) determined by thermogravimetric analysis when heated from 25°C to 100°C is 50% to 98%, 60% to 98%, 70% to 98%, or 90% to 98%. [4] The composition according to any one of [1] to [3], wherein the weight retention rate (W200) determined by thermogravimetric analysis when heated from 25°C to 200°C is 50% to 96%, 60% to 95%, 70% to 95%, or 80% to 95%. [5] The composition according to any one of [1] to [4], wherein the weight retention rate (W300) determined by thermogravimetric analysis when heated from 25°C to 300°C is 50% to 90%, 55% to 90%, 60% to 88%, 60% to 85%, 63% to 80%, or 65% to 78%. [6] The composition according to any one of [1] to [5], wherein the weight residual ratio (W400) determined by thermogravimetric analysis when heated from 25°C to 400°C is 15% or more and 80% or less, 15% to 70%, 16% to 68%, or 20% to 60%. [7] The composition according to any one of [1] to [6], wherein the weight residual ratio (W500) determined by thermogravimetric analysis when heated from 25°C to 500°C is 12% or more and 70% or less, 12% to 60%, 15% to 55%, or 20% to 50%. [8] The composition according to any one of [1] to [7], wherein (W200 / W100)×100(%) is 80 to 98, 85 to 98, or 88 to 97. [9] The composition according to any one of [1] to [8], wherein (W300 / W100)×100(%) is 60 to 93, 65 to 93, or 67 to 93.

[10] The composition according to any one of [1] to [9], wherein (W400 / W100)×100(%) is 15 to 80.

[11] The composition according to any one of [1] to

[10] , wherein (W500 / W100)×100(%) is 13 to 60.

[12] The composition according to any one of [1] to

[11] , wherein (W600 / W100)×100(%) is 11 to 45, 15 to 30, or 17 to 30.

[13] The composition according to any one of [1] to

[12] , which has an electromotive force (X600) when heated from 25°C to 600°C of -4 μV to 20 μV, -4 μV to 18 μV, or 1 μV to 17 μV.

[14] The composition according to any one of [1] to

[13] , which has an electromotive force (X100) when heated from 25°C to 100°C of -10 μV or more and 0 μV or less, -8 μV to -1 μV, or -6 μV to -3 μV.

[15] The composition according to any one of [1] to

[14] , which has an electromotive force (X200) when heated from 25°C to 200°C of -10 μV or more and 0 μV or less, -8 μV to -1 μV, or -6 μV to -2 μV.

[16] The composition according to any one of [1] to

[15] , wherein the electromotive force (X300) when heated from 25°C to 300°C is -9 μV or more and 10 μV or less, -8 μV to 8 μV, or -7 μV to 5 μV.

[17] The composition according to any one of [1] to

[16] , which has an electromotive force (X400) when heated from 25°C to 400°C of -8 μV to 15 μV, -5 μV to 15 μV, or -3 μV to 10 μV.

[18] The composition according to any one of [1] to

[17] , which has an electromotive force (X500) when heated from 25°C to 500°C of -4 μV to 20 μV, -4 μV to 18 μV, or -2 μV to 14 μV.

[19] The composition according to any one of [1] to

[18] , wherein (X200 / X100)×100(%)) is 30 to 170, or 35 to 170.

[20] The composition according to any one of [1] to

[19] , wherein (X300 / X100)×100(%)) is −50 to 200, or −50 to 180.

[21] The composition according to any one of [1] to

[20] , wherein (X400 / X100)×100(%)) is −150 to 100, or −130 to 70.

[22] The composition according to any one of [1] to

[21] , wherein (X500 / X100)×100(%)) is −250 to 50, or −240 to 40.

[23] The composition according to any one of [1] to

[22] , wherein (X600 / X100)×100(%)) is −300 to 100, or −300 to 70.

[24] Tapping apparent density is 0.35g / cm 3 ~4.6g / cm 3 The composition according to any one of [1] to

[23] ,

[25] The composition according to any one of [1] to

[24] , wherein the heat-resistant material is inorganic.

[26] The composition according to

[25] , wherein the inorganic substance is one or more selected from the group consisting of magnesium aluminium silicate, magnesium aluminum silicate, magnesium hydroxide, dry sodium carbonate, sodium hydroxide, sodium bicarbonate, sodium carbonate hydrate, Fe-Mg hydrotalcite-like compounds, and Al-Mg hydrotalcite-like compounds.

[27] The composition according to any one of [1] to

[26] , wherein the semi-refractory material is a highly crystalline material.

[28] The composition described in

[27] , wherein the highly crystalline substance is one or more selected from the group consisting of starch, glycogen, cellulose, chitin, and chitosan.

[29] The composition described in any of [1] to

[28] , wherein the non-heat-resistant substance is one or more selected from the group consisting of proteins and low molecular weight carbohydrates.

[30] The composition described in

[29] , wherein the low molecular weight carbohydrate is one or more selected from the group consisting of aldoses and ketoses.

[31] The composition according to any one of [1] to

[30] , wherein the content of the heat resistant material in the composition is greater than 18% by weight, the content of the semi-heat resistant material in the composition is less than 72% by weight, and the content of the non-heat resistant material in the composition is greater than 10% by weight.

[32] The composition according to

[31] , wherein the content of the heat resistant substance in the composition is 20% by weight to 40% by weight, the content of the semi-heat resistant substance in the composition is 30% by weight to 70% by weight, and the content of the non-heat resistant substance in the composition is 10% by weight to 45% by weight.

[33] The composition according to

[31] , wherein the content of the heat resistant substance in the composition is 20% by weight to 40% by weight, the content of the semi-heat resistant substance in the composition is 35% by weight to 55% by weight, and the content of the non-heat resistant substance in the composition is 20% by weight to 35% by weight.

[34] The composition described in any of [1] to

[33] , wherein the composition contains a naturally derived component.

[35] The composition according to any one of [1] to

[34] , wherein the composition is a powder composition, and the average fiber length of powder particles contained in the powder composition is 1 μm to 500 μm, 5 μm to 500 μm, 5 μm to 250 μm, 5 μm to 100 μm, or 5 μm to 50 μm.

[36] The composition according to any one of [1] to

[35] , wherein the composition is a powder composition, and the average fiber width of powder particles contained in the powder composition is 1 μm to 500 μm, 5 μm to 500 μm, 5 μm to 250 μm, 5 μm to 100 μm, or 5 μm to 50 μm.

[37] The composition according to any one of [1] to

[36] , wherein the composition is a powder composition, and the aspect ratio of powder particles contained in the powder composition is 1.0 to 100, 1.0 to 5.0, 1.0 to 3.0, 1.0 to 2.0, or 1.0 to 1.5.

[38] The composition according to any one of [1] to

[37] , wherein the composition is a powder composition, and the water absorption rate of powder particles contained in the powder composition is less than 200%, 25% to 150%, 30% to 100%, 40% to 80%, or 50% to 75%.

[39] Apparent density (without tapping) is 0.3 g / cm 3 ~5g / cm 3 The composition according to any one of [1] to

[38] ,

[40] The composition according to any one of [1] to

[39] , having a compressibility of less than 1.35, or from 1 to 1.3.

[41] The composition according to any one of [1] to

[40] , wherein the water disintegration of a tablet containing the composition is less than 1.9 (min / N), 1.5 (min / N) or less, or 1.2 (min / N) or less.

[42] The composition according to any one of [1] to

[41] , wherein a tablet containing the composition has a disintegration time in water of less than 90 minutes, 30 minutes or less, 12 to 30 minutes, or 12 to 15 minutes.

[43] The composition according to any one of [1] to

[42] , wherein the frictional force of the wet powder is less than 65 (gf), 45 (gf) or less, 20 (gf) to 60 (gf), 25 (gf) to 55 (gf), 25 (gf) to 50 (gf), 30 (gf) to 45 (gf), or 30 (gf) to 34 (gf).

[44] A composition described in any of [1] to

[43] , which is for oral use.

[45] A composition described in [1] to

[44] , which is a food composition.

[46] A composition described in [1] to

[44] , which is a pharmaceutical composition.

[47] A functional food comprising the composition described in

[45] .

[48] ​​A pharmaceutical comprising the composition described in

[46] .

[49] A functional food according to

[47] , in the form of a tablet.

[50] The pharmaceutical composition according to

[48] , which is in the form of a tablet. EXAMPLES

[0164] The present disclosure will be described in more detail below by showing examples, but interpretation of the present disclosure is not limited to these examples.

[0165] [Composition] Wheat germ, titanium oxide, crystalline cellulose (Asahi Kasei's CEOLUS (registered trademark) PH-101), powdered cellulose (Nippon Paper Industries Co., Ltd.'s KC Flock W-50), oats, and / or calcium carbonate were mixed in the amounts (g) shown in the "Materials" section of Table 1 to a total of 100 g to prepare the compositions of Examples 1 to 5, 7 to 9 and Comparative Examples 1 to 6.

[0166] (Example) (Example 1) Powder composition (T1) (Example 2) Powder composition (T2) (Example 3) Powder composition (T3) (Example 4) Powder composition (T6) (Example 5) Powder composition (T7) (Example 7) Powder composition (T9) Example 8 Powder composition (T10) Example 9 Powder composition (T11)

[0167] (Comparative Example) (Comparative Example 1) Powder composition (T4) (Comparative Example 2) Powder composition (T5) (Comparative Example 3) Powder composition (T12) (Comparative Example 4) Powder composition (T13) (Comparative Example 5) Powder composition (T14) (Comparative Example 6) Powder composition (T15) [Table 1]

[0168] Composition and tablet preparation The mixture of materials was subjected to a pulverization process (milling) to pulverize coarse materials. After the pulverization process, the average particle size (fiber length) of the powder particles was confirmed, and if it was less than 60 μm, it was pulverized once using a jet mill (e.g., a jet mill pulverizer STJ-400 manufactured by Seishin) under the condition of a flow rate of 2 kg / hour to 12 kg / hour, and pulverized to about 10 μm to obtain a powder composition.

[0169] For the compositions of Examples 1 to 5, 7 to 9 and Comparative Examples 1 to 6, the content of heat-resistant substances was measured by a known ash method, and the content of semi-heat-resistant substances was measured by a known method for quantifying α-cellulose. The content of non-heat-resistant substances was obtained by subtracting the value obtained by the known measurement of α-cellulose from the value obtained by the known method for quantifying holocellulose. The compositions of Examples 1 to 5, 7 to 9 and Comparative Examples 1 to 6 contained a heat resistant substance, a semi-heat resistant substance, and a non-heat resistant substance in the proportions (wt %) shown in the "Production Examples" in Table 1, respectively.

[0170] In addition, the heat-resistant, semi-heat-resistant, and non-heat-resistant substances of each material were analyzed in the same manner as in the composition. As a result, wheat germ contained 5 to 25% by weight of heat-resistant substances, 30 to 70% by weight of semi-heat-resistant substances, and 25 to 45% by weight of non-heat-resistant substances. Oats contained 5 to 20% by weight of heat-resistant substances, 45 to 75% by weight of semi-heat-resistant substances, and 20 to 45% by weight of non-heat-resistant substances. Crystalline cellulose (Ceolas, Asahi Kasei) contained 1 to 10% by weight of heat-resistant substances, 70 to 98% by weight of semi-heat-resistant substances, and 0.1 to 5% by weight of non-heat-resistant substances. Powdered cellulose (KC Flock W-50, Nippon Paper Industries Co., Ltd.) contained 1 to 10% by weight of heat-resistant substances, 70 to 90% by weight of semi-heat-resistant substances, and 5 to 20% by weight of non-heat-resistant substances.

[0171] To prepare tablets using the powder compositions of the above Examples and Comparative Examples, 250 mg of the sample used to measure the average powder particle diameter (fiber length) was placed in a mortar (Ichihashi Seiki Co., Ltd., diameter 8 mm) and compressed at 3 kN so that the tablet thickness was uniform to about 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.).

[0172] Evaluation of oral compositions The tablets or compositions of the Examples and Comparative Examples were evaluated as follows.

[0173] (Thermogravimetric analysis) Using a thermal analyzer (STA300 manufactured by Hitachi High-Tech Science), the powder composition of the sample (approximately 10 mg) was analyzed with N 2 The temperature was raised from 25°C to 600°C at 10°C / min in an atmosphere, and the remaining 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 remaining weight at temperature b when the remaining weight 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] The weight retention rate (W a→c ) when the sample is heated from temperature a to temperature b, the weight retention rate (W a→b ) is expressed by the formula: W a→b / W a→c It is expressed as:

[0174] (Measurement of electromotive force) Using a thermal analyzer (STA300 manufactured by Hitachi High-Tech Science), a sample (approximately 10 mg of powder composition) was heated with N 2 The electromotive force (μV) of the sample was measured at 100°C, 200°C, 300°C, 400°C, and 600°C when the temperature was increased from 25°C to 600°C at 10°C / min in an atmosphere. The ratio of the electromotive force (Xa) of a sample when heated from 25° C. to temperature a (Xb) of the sample when heated from 25° C. to temperature b is expressed by the formula: Xa / Xb.

[0175] (Underwater disintegration) The disintegration property in water is expressed as the disintegration time per unit hardness [disintegration time in water (D) / tablet hardness (N) (min / N)]. To evaluate the disintegrability of tablets in water, the tablets prepared as described above were used for the compositions of the Examples and Comparative Examples.

[0176] The disintegration time in water was measured by placing a tablet in a test tube, adding 20 ml of pure water, shaking the tablet in a shaker (reciprocating / rotating shaker MMS-3020, Tokyo Rikakikai Co., Ltd.) at 37°C, and measuring the disintegration time. The measurement was performed 50 times, and the average value was regarded as the disintegration time in water of the tablet.

[0177] (Tablet hardness) Tablet hardness (N) was measured using a hardness tester (model number: KHT-40N, Fujiwara Seisakusho). The tablet produced in the section "Preparation of composition and tablets" was placed in the center of the measuring table and the device was started (the AUTO [start] button was pressed). At this time, the hardness in the direction perpendicular to the compression direction during tablet molding was measured. As a result, the rod was rapidly lowered and the display went into a peak hold state, and when it came into contact with the object to be measured, the speed slowed down and the display was monitored approximately every 0.1 seconds. If there was no increase, it was judged to have been destroyed, and the hardness indicated on the hardness tester at that time was taken as the tablet hardness (N).

[0178] (Frictional force of wet powder) The frictional force (gf) of the wet powder was measured by passing the residue of the sample used in the above-mentioned "Underwater Disintegrability" test through a 90μm (JIS standard Z8801 wire), collecting it, and measuring it with a static and dynamic friction measuring device (Trinity Lab's "Handy Tribomaster TL201Ts") under the measurement conditions of a load of 50g and a speed of 10mm / sec. The contactor used was a 5mm thick sponge sheet (Cemedine's "Gap Tape N-1") with artificial skin (Viewlax's "Bio Skin") attached. Based on the results of the static friction force (gf), the ratio of the movement distances of 0 mm and 3 mm was calculated using the following formula. Formula: Frictional force of wet powder with a travel distance of 2 mm = 100 x (static frictional force at a travel distance of 0 mm / static frictional force at a travel distance of 3 mm)

[0179] (Measurement of average fiber length and average fiber width of powder particles) In order to remove extremely coarse fibers or aggregated fibers, 1 g of powder sample of the composition of the examples and comparative examples was classified using a JIS test sieve (Tokyo Screen Co., Ltd.: 710 μm) with the moisture adjusted to 2-3%. The classified samples were randomly selected under an optical microscope (magnification: 100 times), and the fiber length (length in the fiber direction) and fiber width (length perpendicular to the fiber) of the powder particles were measured for 1000 particles, excluding 100 large and 100 small particles, and the average values ​​were calculated.

[0180] (Aspect ratio of powder particles) In order to obtain the aspect ratios of the powder particles of the compositions of the Examples and Comparative Examples, the fiber length and fiber width of 1,000 powder particles obtained by measuring under a microscope as described above were used to calculate the fiber length / fiber width, and the average value was calculated.

[0181] (tapping apparent density) The tapping apparent density of the powder particles of the compositions of the Examples and Comparative Examples was measured using a commercially available powder property measuring instrument (Powder Tester PT type, manufactured by Hosokawa Micron Co., Ltd.). 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.

[0182] (Apparent density (without tapping)) The apparent density of the composition (without tapping) is 100 cm 3The powder was roughly filled into a glass measuring cylinder for 2 to 3 minutes using a quantitative feeder for the composition, and the top surface of the powder layer was leveled with a soft brush, and the volume was read. The weight of the powder sample was then divided by the volume. 3 It was appropriately determined so that

[0183] (Water absorption rate of powder particles) The water absorption rate of the powder particles contained in the compositions of the Examples and Comparative Examples was measured by placing 2 g of the powder particles in a container, dropping water into the container, and mixing the mixture evenly. The water amount just before water separation from the fibers was visually confirmed was measured. The average value of n=100 was obtained.

[0184] (Texture sensory test) The evaluation was carried out by 30 adult males and 30 adult females. The tablets were placed in the mouth and rolled with the tongue until they were disintegrated, and the powdery texture after the tablets were completely disintegrated was evaluated. The average of the four-level evaluation from 1 to 4 by the 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: Slightly powdery, but moist enough that it doesn't feel powdery. 4: No powdery feeling

[0185] (Compression degree) The degree of compression was calculated by dividing the "tapping apparent density" explained above by the "apparent density (without tapping)".

[0186] (Function of weight residual rate (y)) The weight retention rate (y) determined by thermogravimetric analysis when the temperature is increased from 25°C to 600°C is shown as a function using the electromotive force (x) when the temperature is increased from 25°C to 600°C. First, the weight retention rates when the temperature was raised from 25° C. to 600° C. for the compositions of the examples and comparative examples shown in Table 2 were plotted. As shown in Fig. 1, Examples 1 to 5, 7 to 9 (T1 to T3, T6 to T7, T9 to T11) in which the weight residual rate determined by thermogravimetric analysis when heated from 25°C to 600°C was 11% or more (above line A) and the electromotive force when heated from 25°C to 600°C was -4µV or more (to the right of line B) had a disintegration property in water of 1.2 (min / N) or less, i.e., good disintegration property in water. Furthermore, these compositions had a frictional force of wet powder of 45 (gf) or less and a rating of 3 or 4 in the tongue feel sensory test, indicating that they had a good feel on the tongue. However, the range above line A and to the right of line B included Comparative Examples 3 to 6 (T12 to T15), which had little effect of providing good disintegrability in water and good texture on the tongue as described above. In order to facilitate the distinction between compositions that provide the desired effects and those that do not during the actual production of compositions, the formula "y≧-2.03x + 23.623" was defined as the boundary line for distinguishing between compositions that provide the effects and those that do not, based on T2 (Example 2) and T7 (Example 5). Using this formula as a standard, compositions that provide no or low effects can be effectively eliminated. Since the range enclosed by lines A, B, and the straight line "formula: y≧-2.03x + 23.623" is excluded, compositions with good disintegrability in water and good texture can be easily identified. Since "formula: y≧-2.03x + 23.623" is a straight line, it is easy to distinguish, making it easier to determine whether a composition is effective or not.

[0187] [Evaluation results] (Thermogravimetric analysis) As shown in Table 2, the weight residual rate was 95% or more for all compositions in the Examples and Comparative Examples when the temperature was raised from 25° C. to 100° C. The weight loss when the temperature was raised from 25° C. to 100° C. was due to the reduction in water adsorbed in the tablet or powder composition, and the remaining matter was the tablet or powder composition excluding water.

[0188] When the temperature was raised from 25°C to 200°C, the weight residual ratio was 85% or more in all compositions of the Examples and Comparative Examples. In the Examples, the weight residual ratio was 85% to 93%. In particular, in the Examples (Examples 2 and 3) in which 20% high purity cellulose powder was mixed, the weight residual ratio was 92% to 93%. On the other hand, in the Comparative Examples, the weight residual ratio was 96% or more.

[0189] When the temperature was raised from 25°C to 300°C, the weight residual ratio was 65% or more in all compositions of the Examples and Comparative Examples. In the Examples, the weight residual ratio was 65% to 88%. In particular, in the Examples in which 20% high purity cellulose powder was mixed, the weight residual ratio was 72% to 73%. On the other hand, in the Comparative Examples, the weight residual ratio was 91% or more.

[0190] When the temperature was raised from 25°C to 400°C, the weight residual ratio was 9% or more in all compositions of the Examples and Comparative Examples. In the Examples, the weight residual ratio was 16% to 66%. In particular, in the Examples in which 20% high-purity cellulose powder was mixed, the weight residual ratio was 28% to 30%. On the other hand, in the Comparative Examples, the weight residual ratio was 9% to 33%.

[0191] When the temperature was raised from 25°C to 500°C, the weight residual ratio was 7% or more in all compositions of the Examples and Comparative Examples. In the Examples, the weight residual ratio was 15% to 41%. In particular, in the Examples in which 20% high purity cellulose powder was mixed, the weight residual ratio was 21% to 23%. On the other hand, in the Comparative Examples, the weight residual ratio was 7% to 31%.

[0192] When the temperature was raised from 25 to 600°C, the weight residual ratio was 6% or more in all compositions of the Examples and Comparative Examples. In the Examples, the weight residual ratio was 13 to 40%. In particular, in the Examples in which 20% high purity cellulose powder was mixed, the weight residual ratio was 20% to 21%. On the other hand, in the Comparative Examples, the weight residual ratio was 6 to 29%. [Table 2]

[0193] Table 3 shows the percentage ((Wd / W100) x 100 (%)) of the weight residual ratio (W100) determined by thermogravimetric analysis when the temperature is raised from 25°C to 100°C, relative to the weight residual ratio (Wd (d = 200, 300, 400, 500 or 600)) determined by thermogravimetric analysis when the temperature is raised from 25°C to 200°C, 300°C, 400°C, 500°C or 600°C.

[0194] For example, the percentage ((W600 / W100)×100(%)) of the weight residual ratio (W100) determined by thermogravimetric analysis when the temperature is raised from 25° C. to 100° C. was 14 to 42 in the examples. [Table 3]

[0195] (Evaluation of electromotive force) As shown in Table 2, when the temperature was raised from 25°C to 100°C, the electromotive force was -6μV to -2μV in all compositions of the Examples and Comparative Examples. In the Examples, the electromotive force was -6μV to -4μV. In particular, in the Examples in which 20% high purity cellulose powder was mixed, the electromotive force was -5μV to -4μV. On the other hand, in the Comparative Examples, the electromotive force was -2μV to -1μV.

[0196] When the temperature was raised from 25°C to 200°C, the electromotive force was -6μV to -2μV in all the compositions of the Examples and Comparative Examples. In the Examples, the electromotive force was -6μV to -2μV. In the Examples in which 20% high purity cellulose powder was mixed, the electromotive force was -6μV to -4μV. On the other hand, in the Comparative Examples, the electromotive force was -3μV to -2μV.

[0197] When the temperature was raised from 25°C to 300°C, the electromotive force was -8μV to +3μV in all compositions of the Examples and Comparative Examples. In the Examples, the electromotive force was -2μV to +3μV. In the Examples in which 20% high purity cellulose powder was mixed, the electromotive force was -6μV to -2μV. On the other hand, in the Comparative Examples, the electromotive force was -8μV to -5μV.

[0198] When the temperature was raised from 25°C to 400°C, the electromotive force was -9μV to +8μV in all compositions of the Examples and Comparative Examples. In the Examples, the electromotive force was -2μV to +8μV. In the Examples in which 20% high purity cellulose powder was mixed, the electromotive force was -2μV to -1μV. On the other hand, in the Comparative Examples, the electromotive force was -9μV to -7μV.

[0199] When the temperature was raised from 25°C to 500°C, the electromotive force was -8μV to +14μV in all compositions of the Examples and Comparative Examples. In the Examples, the electromotive force was -2μV to +14μV. In the Examples in which 20% high purity cellulose powder was mixed, the electromotive force was -2μV to +1μV. On the other hand, in the Comparative Examples, the electromotive force was -8μV to -4μV.

[0200] When the temperature was raised from 25°C to 600°C, the electromotive force was -6μV to +17μV in all compositions of the Examples and Comparative Examples. In the Examples, the electromotive force was -3μV to +17μV. In the Examples in which 20% high purity cellulose powder was mixed, the electromotive force was +1μV to +5μV. On the other hand, in the Comparative Examples, the electromotive force was -6μV to +2μV.

[0201] Table 4 shows the percentage ((Xd / X100) x 100 (%)) of the electromotive force (Xd (d = 200, 300, 400, 500 or 600)) when the temperature is increased from 25°C to 200°C, 300°C, 400°C, 500°C, or 600°C, relative to the electromotive force (X100) when the temperature is increased from 25°C to 100°C.

[0202] For example, the percentage (X600 / X100) of the electromotive force (X600) when the temperature is raised from 25°C to 600°C relative to the electromotive force (X100) when the temperature is raised from 25°C to 100°C was -284 to 62 in the examples. [Table 4]

[0203] (Underwater disintegration) The values ​​of disintegrability in water for the compositions of the Examples and Comparative Examples are shown in Table 2. In the examples, the disintegration in water was less than 1.9 (min / N). The tablets of the compositions of the examples had a water disintegration rate of less than 1.9 (min / N), and therefore exhibited good oral disintegration rate, which resulted in good passage of the composition during swallowing, i.e., the tablets were easy to swallow.

[0204] (Frictional force of wet powder) The wet powder frictional force values ​​for the compositions of the examples and comparative examples are shown in Table 2. In the examples, the frictional force of the wet powder was less than 65 (gf). The compositions of the examples had a frictional force of less than 65 (gf) for the wet powder, and thus exhibited a good mouthfeel of a disintegrating paste of a tablet or a paste of a powder composition.

[0205] (Measurement of the average major and minor diameters of powder particles) Table 2 shows the major and minor axis values ​​of the powder particles (fibers) for the compositions of the Examples and Comparative Examples. In the examples, the powder particles (fibers) had a major axis of 10 to 11 μm and a minor axis of 10 to 11 μm. By having such major and minor axes, when the composition according to the present disclosure is used to prepare a tablet, it becomes easy to exhibit appropriate adhesion, and / or it becomes easy to make the prepared tablet exhibit good disintegrability in water and / or good frictional force of a wet powder.

[0206] (Aspect ratio of powder particles) Table 2 shows the aspect ratios (average fiber length / average fiber width) of the powder particles for the compositions of the examples and comparative examples. In the examples, the aspect ratio was 1.0 to 1.1. When the powder particles contained in the composition have such an aspect ratio, the composition according to the present disclosure is likely to exhibit good disintegrability in water and good frictional force of wet powder. In addition, when the number of powder particles contained in the composition is the same, the volume is likely to be smaller when the aspect ratio is closer to 1.0. The risk of clogging in equipment during the process of processing or manufacturing products such as medicines, foods, and cosmetics using the composition is likely to be reduced. It is presumed that each of these effects is due to the fact that the friction between the fibers of the powder particles is likely to be smaller when the aspect ratio is closer to 1.0.

[0207] (tapping apparent density) The tapped apparent densities of the compositions of the examples and comparative examples are shown in Table 2. In the embodiment, 0.35 g / cm 3 ~4.6g / cm 3 When the composition has such a tapping apparent density, it becomes easy to fill a composition bag or a tablet molding machine, and therefore it becomes easy to improve productivity.

[0208] (Apparent density (without tapping)) Table 2 shows the apparent densities (without tapping) of the compositions of the examples and comparative examples. In the embodiment, 0.32 g / cm 3 ~4.2g / cm 3 When the composition has such an apparent density (without tapping), the composition can be easily filled into a composition bag or a tablet molding machine, and productivity can be easily improved.

[0209] (Water absorption rate of powder particles) Table 2 shows the powder particle water absorption (powder water absorption) of the compositions of the examples and comparative examples. The powder water absorption of the compositions of the examples was 75% or less. In a composition, when the water absorption rate of the powder particles is low, the powder particles are unlikely to expand, so that the powder particles are likely to break apart from each other, and the tablet containing the composition is likely to have good disintegration in water. When the water absorption rate of the powder particles of the composition according to the present disclosure is 75% or less, the tablet containing the composition composed of the powder particles has good disintegration in water.

[0210] (Degree of compression) The compression ratios for the compositions of the examples and the comparative examples are shown in Table 2. The degree of compression of the compositions in the examples was 1.09 to 1.25. When the composition has such a degree of compression, the composition is less likely to be compressed when the composition is subjected to vibration, and the shape of the bag in which the composition is packaged is less likely to change. This makes it easier to load the bag in which the composition is packaged, and easier to transport.

[0211] (Texture sensory test) The results of the sensory test on the texture of tablets of the compositions of the Examples and Comparative Examples are shown in Table 2. The composition of the examples was evaluated in a sensory test for texture to the tongue as 3 (3: slightly powdery, but moist enough that it does not feel powdery) or 4 (4: not powdery). It was found that the compositions of the examples had a good mouth feel.

[0212] (Relationship between water disintegration and frictional force of wet powder and composition characteristics) From the above results, it was found that a composition having at least the characteristics of compositions (1-1) to (1-6), (2-1) to (2-5), (3-1) to (3-6), (4-1) to (4-5), (5) and / or (6) according to the present disclosure exhibits good disintegrability in water and good frictional force of a wet powder. Each weight residual rate is an index that comprehensively indicates the degree of heat resistance of the heat-resistant substance, semi-heat-resistant substance, and non-heat-resistant substance against heat, and the content of the heat-resistant substance, semi-heat-resistant substance, and non-heat-resistant substance in the composition, etc. Regarding each weight residual rate, when the composition contains a sufficient amount of high-density heat-resistant substance such as inorganic matter (i.e., the amount of fiber is small), there is little fiber aggregation, and the texture of the tablet when made into a tablet is likely to be smooth. In addition, such a composition has excellent disintegration in water when made into a tablet because there is little fiber aggregation. In addition, the electromotive force is an index of the degree of heat absorption and generation, and by adjusting the electromotive force to a specific ratio, that is, by adjusting the balance between the crystals and non-crystals of the composition, it is possible to reduce the rigid fibers specific to the highly crystalline component, which leads to the suppression of friction between the components, and makes it easier to present a good texture when made into a tablet. Furthermore, by not excessively increasing the highly crystalline component, it is possible to reduce the rigid fibers, which contributes to the suppression of fiber aggregation and the disintegration of the tablet in water. It was revealed that by combining the above, it is possible to achieve better texture and better disintegration in water. [Industrial Applicability]

[0213] The composition of the present embodiment exhibits good disintegrability in water and / or good frictional force of a wet powder, and therefore can be suitably used as a composition for food, pharmaceutical, cosmetic, etc., where such properties are desired, and has industrial applicability.

Claims

1. The present invention includes a heat-resistant material, a semi-heat-resistant material, and a non-heat-resistant material, When the temperature is raised from 25° C. to 600° C., the weight residual rate determined by thermogravimetric analysis is 11% or more, The electromotive force is -4 μV or more when the temperature is increased from 25 ° C to 600 ° C. The weight residual ratio (y) determined by thermogravimetric analysis when the temperature is increased from 25° C. to 600° C. is Formula: y ≧−2.03x + 23.623 (x represents the electromotive force when the temperature is raised from 25°C to 600°C) It is expressed as Tapping apparent density is 0.3 g / cm ３ ~5g / cm ３ The composition.

2. The composition of claim 1 , which is for oral use.

3. 3. The composition according to claim 1 or 2, which is a food composition.

4. The composition according to claim 1 or 2, which is a pharmaceutical composition.

5. A functional food comprising the composition of claim 3.

6. A medicament comprising the composition according to claim 4.

7. The functional food according to claim 5, which is in the form of a tablet.

8. The pharmaceutical composition according to claim 6, which is in the form of a tablet.

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