Composition

Abstract

Provided is an oral composition exhibiting good disintegrability in water and / or good frictional force of a wet powder.　This oral composition includes a heat-resistant substance, a semi-heat-resistant substance, and a non-heat-resistant substance. When the temperature is raised from 25°C to 600°C, the weight residual ratio determined through thermogravimetric analysis is 11% or more. The electromotive force when the temperature is raised from 25°C to 600°C is -4 μV or more. When the temperature is raised from 25°C to 600°C, the weight residual ratio (y) determined through thermogravimetric analysis is represented by the formula y ≥ −2.03x + 23.623 (where x represents the electromotive force when the temperature is raised from 25°C to 600°C), and the tapping density is 0.3 g / cm3 to 5 g / cm3.

Description

composition

[0001] The present disclosure relates to compositions.

[0002] Compositions used in various forms for pharmaceutical and food applications are orally administered or ingested by subjects. Such compositions are required to pass smoothly through the subject's oral cavity and during swallowing, i.e., be easy to swallow. Such properties can be achieved, for example, by the composition having good disintegrability in water and / or good wet powder friction. Similar properties may also be suitable for cosmetics and lubricants. Previously, attempts have been made to adjust the hardness and oral tablet disintegrability 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 manufacturing conditions that allow for accurate control of the fiber length and fiber width contained in the composition.

[0003] International Publication No. 2013 / 180249

[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 encompasses the following aspects: [1] A thermoplastic elastomer comprising a heat-resistant material, a semi-heat-resistant material, and a non-heat-resistant material, wherein the weight residual ratio determined by thermogravimetric analysis when heated from 25°C to 600°C is 11% or more, the electromotive force when heated from 25°C to 600°C is -4 μV or more, the weight residual ratio (y) determined by thermogravimetric analysis when heated from 25°C to 600°C is expressed by the formula: y ≧ -2.03x + 23.623 (x represents the electromotive force when heated from 25°C to 600°C), and the tapped apparent density is 0.3 g / 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.

[0007] 1 is a graph plotting the analysis results of the compositions of Examples and Comparative Examples, with the y-axis representing the weight retention rate determined by thermogravimetric analysis when heated from 25°C to 600°C, and the x-axis representing the electromotive force when heated from 25°C to 600°C. The diagonal line is defined as the boundary that distinguishes between compositions that achieve the effects of disintegrability in water and a good texture on the tongue and those that do not, and is expressed by the formula: y = -2.03x + 23.623. Line A (solid line) represents y = 11 (%), and line B (dotted line) represents x = -4 (μV).

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

[0009] ==First Embodiment (Composition)== The composition (1-1) according to the first embodiment is a composition in which the weight residual ratio determined by thermogravimetric analysis when heated from 25°C to 100°C is 50% or more and 98% or less, and the composition contains a heat-resistant material, a semi-heat-resistant material, and / or a non-heat-resistant material. In the composition, the weight residual ratio determined by thermogravimetric analysis when heated 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 heated from 25°C to 100°C may be within 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 a composition in which the weight retention rate determined by thermogravimetric analysis when heated from 25°C to 200°C is 50% or more and 96% or less, and which 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%, even more preferably 70% to 95%, and even more 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 within 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 a composition in which the weight retention rate determined by thermogravimetric analysis when heated from 25°C to 300°C is 50% or more and 90% or less, and which 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 within a range combining any of the above values ​​as the upper and lower limits.

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

[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 combining any of the above values ​​as the upper and lower limits.

[0017] The composition (1-5) according to this embodiment is a composition in which the weight residual ratio determined by thermogravimetric analysis when heated from 25°C to 500°C is 12% or more and 70% or less, and which contains a heat-resistant substance, a semi-heat-resistant substance, and / or a non-heat-resistant substance.

[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 combining any of the above values ​​as the upper and lower limits.

[0019] The composition (1-6) according to this embodiment has a weight residual ratio of 11% or more as determined by thermogravimetric analysis 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.

[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 combining any of the above values ​​as the upper and lower limits.

[0021] The composition (2-1) 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, in which 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) x 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 combining any of the above values ​​as the upper and lower limits.

[0023] The composition (2-2) 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, in which 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 weight residual ratio (W100) determined by thermogravimetric analysis when heated from 25°C to 100°C is 67 to 93, the weight residual ratio (W300) determined by thermogravimetric analysis when heated from 25°C to 300°C ((W300 / W100) x 100(%)) may be 67, 72, 76, 78, 80, or 93. In one embodiment, the W300 / W100 percentage may be within a range that combines 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, in which the percentage ((W400 / W100)×100(%)) of the weight residual ratio (W400) determined by thermogravimetric analysis when heated from 25° C. to 400° C. relative to the weight residual ratio (W100) determined by thermogravimetric analysis when heated from 25° C. to 100° C. is 15 to 80.

[0026] In the composition, when the weight residual ratio (W400) determined by thermogravimetric analysis when heated from 25°C to 400°C relative to the weight residual ratio (W100) determined by thermogravimetric analysis when heated from 25°C to 100°C ((W400 / W100) x 100(%)) is 15 to 80, it may be 15, 17, 29, 31, 34, 38, 69, or 80. In one embodiment, the W400 / W100 percentage value may be within a range that combines any of the above values ​​as the upper and lower limits.

[0027] The composition (2-4) 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, in which the percentage ((W500 / W100)×100(%)) of 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. is 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) x 100(%)) is 13 to 60, it may be 13, 16, 23, 25, 32, 33, 43, or 60. In one embodiment, the W500 / W100 percentage 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 a composition containing a heat-resistant substance, a semi-heat-resistant substance, and / or a non-heat-resistant substance, in which 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 weight residual ratio (W100) determined by thermogravimetric analysis when heated from 25°C to 100°C is expressed as a percentage of the weight residual ratio (W600) determined by thermogravimetric analysis when heated from 25°C to 600°C ((W600 / W100) x 100(%)), it may be 17, 21, 22, 23, or 30. In one embodiment, the W600 / W100 percentage may be within a range that combines any of the above values ​​as the upper and lower limits.

[0031] The composition (3-1) according to this embodiment 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 substance, a semi-heat-resistant substance, and / or a non-heat-resistant substance.

[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 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 substance, a semi-heat-resistant substance, and / or a non-heat-resistant substance.

[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 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 within a range combining any of the above values ​​as the upper and lower limits.

[0037] The composition (3-4) according to this embodiment 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 within a range combining any of the above values ​​as the upper and lower limits.

[0039] The composition (3-5) according to this embodiment 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. If 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 has an electromotive force of −4 μV 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 within a range combining any of the above values ​​as the upper and lower limits.

[0043] The composition (4-1) according to this embodiment is a composition in which the percentage ((X200 / X100) of the electromotive force (X200) when heated from 25°C to 200°C relative to the electromotive force (X100) when heated from 25°C to 100°C) is 30 to 170, and the composition 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 heated from 25°C to 200°C relative to the electromotive force when heated 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 heated from 25°C to 200°C relative to the electromotive force when heated from 25°C to 100°C may be within a range combining any of the above values ​​as the upper and lower limits.

[0045] The composition (4-2) according to this embodiment is a composition in which the percentage ((X300 / X100) of the electromotive force (X100) when heated from 25°C to 100°C) of the electromotive force (X300) when heated from 25°C to 300°C is -50 to 200, and the composition 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 within a range combining any of the above values ​​as the upper and lower limits.

[0047] The composition (4-3) according to this embodiment is a composition in which the percentage ((X400 / X100) of the electromotive force (X400) when heated from 25°C to 400°C relative to the electromotive force (X100) when heated from 25°C to 100°C) is -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, the ratio 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 within a range combining any of the above values ​​as the upper and lower limits.

[0049] The composition (4-4) according to this embodiment is a composition in which the percentage ((X500 / X100) of the electromotive force (X500) when heated from 25°C to 500°C relative to the electromotive force (X100) when heated from 25°C to 100°C is -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 a composition in which the percentage ((X600 / X100) of the electromotive force (X600) when heated from 25°C to 600°C relative to the electromotive force (X100) when heated from 25°C to 100°C is -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, the ratio 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 has a tapping apparent density of 0.3 g / cm ３ ~5g / cm ３ The composition includes a refractory material, a semi-refractory material, and / or a non-refractory material, wherein

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

[0055] A feature of composition (5) is that the composition can be easily filled into a composition bag or a tablet molding machine, thereby facilitating improved productivity. Studies were conducted to improve composition (5)'s water disintegrability and / or wet powder friction. As a result, it was found that the above-mentioned objectives can be achieved by setting the weight residual rate and electromotive force when heated from room temperature to a specific temperature within specific ranges, and further by specifying the relationship between the weight residual rate and the electromotive force. A composition having the characteristics of composition (5) can be easily filled into a composition bag or a tablet molding machine, thereby facilitating improved productivity. 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 any of the characteristics of compositions (4-1) to (4-5), the composition is likely to exhibit good disintegrability in water and / or good frictional force of a wet powder, and the composition is easily filled into composition bags or tablet molding machines, making it easy to improve productivity.

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

[0057] Composition (6) according to this embodiment is a composition containing a heat-resistant material, a quasi-heat-resistant material, and / or a non-heat-resistant material, in which the weight residual ratio (y) determined by thermogravimetric analysis when heated from 25°C to 600°C is expressed by the formula: y≧−2.03x + 23.623 (x represents the electromotive force when heated from 25°C to 600°C). Here, composition (6) preferably has at least one of the following characteristics: x is −4 μV or more, and y is 11% or more, and more preferably has both of these characteristics. x is more preferably −4 μV to 20 μV, even more preferably −4 μV to 18 μV, even more preferably −3 μV to 17 μV, and even more preferably 1 μV to 17 μV. y is more preferably 11% to 60%, even 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 x is 1 μV to 17 μV, it may be 1 μV to 6 μV. When y is 20% to 29%, it may be 20% to 25%, or may be 20% to 23%. When composition (6) has both the characteristics of x being −4 μV or greater and y being 11% or greater, 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 being 20% ​​to 29%, or x may be 1 μV to 17 μV and y being 20% ​​to 25% or 20% to 23%.

[0058] Regarding the "formula: y≧−2.03x + 23.623," as shown in FIG. 1 , Examples 1 to 9 (T1 to T3, T6 to T11) in which the weight residual ratio 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 −4 μV or more (to the right of line B) have a disintegration in water of 1.2 (min / N) or less, i.e., good disintegration in water. Furthermore, these compositions have a frictional force of 45 (gf) or less when wetted and a rating of 3 or 4 in the tongue feel sensory test, indicating a good texture. However, the range above line A and to the right of line B includes Comparative Examples 3 to 6 (T12 to T15), which do not exhibit the effects of good disintegration in water and good texture as described above. Therefore, it may be difficult to distinguish between compositions in which the desired effects are achieved and those in which they are not achieved during actual production of the compositions. Therefore, to facilitate this distinction, the formula "y = -2.03x + 23.623" was defined as the boundary line distinguishing between those that achieve the effect and those that do not, based on T2 (Example 2) and T7 (Example 5), and the formula "y ≧ -2.03x + 23.623" was defined to indicate the region above this boundary line. Using this formula as a standard, compositions that achieve no effect or have a low effect can be effectively eliminated. Since the range enclosed by lines A, B, and the formula "y ≧ -2.03x + 23.623" is excluded, compositions that have good disintegrability in water and a good texture on the tongue can be easily identified. Because "formula y ≧ -2.03x + 23.623" is a straight line, it is easy to distinguish, making it even easier to determine whether a composition is effective or not.

[0059] Compositions (1-1) to (1-6), (2-1) to (2-5), (3-1) to (3-6), (4-1) to (4-5), (5), and (6) each exhibit good disintegrability in water and / or good frictional force of a wet powder when formulated into a tablet. Because they exhibit good disintegrability in water, they are more likely to exhibit good oral disintegrability when orally administered to a subject. Furthermore, because these compositions exhibit good frictional force of a wet powder, they are more likely to exhibit the pleasant texture of a powder composition paste when orally administered to a subject. Therefore, because 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 a wet powder, they are more likely to achieve good passage of the composition during swallowing when orally administered, i.e., are more likely to be easy to drink. In particular, when the composition has the characteristics of composition (5), it becomes easier to fill the composition into a composition bag or a tablet molding machine, which makes it 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 achieve the effects of good oral disintegrability based on good disintegrability in water and / or a good texture on the tongue based on good frictional force of the wet powder. In one embodiment, as also explained in the second embodiment, it is preferable that the composition is contained in a food or medicine in the form of a tablet. By being in the form of a tablet, it becomes easier to achieve the effect of good oral disintegrability based on good disintegrability in water and / or the effect of a good texture on the tongue of a disintegrating paste based on good frictional force of the wet powder.

[0061] Furthermore, the fact that the composition exhibits 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 a 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 a composition that combines the characteristics of two or more of these compositions. For example, a composition that has the characteristics of compositions (1-6), (3-6), (5), and (6) and has a weight residual ratio 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 The composition may be a heat-resistant, semi-heat-resistant, and / or non-heat-resistant material composition 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.). By having the characteristics of compositions (1-6), (3-6), and (6), the composition is likely to exhibit good disintegrability in water and / or good frictional force of a wet powder, and by having the characteristics of composition (5), the composition is likely to be filled easily into a composition bag or a tablet molding machine, and productivity is likely to be improved.

[0064] Another example may be a composition comprising a heat-resistant material, a semi-heat-resistant material, and / or a non-heat-resistant material, which has the characteristics of 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, and in which the weight residual ratio determined by thermogravimetric analysis when heated from 25°C to 300°C is 50% or more and 90% or less, and in which 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. For example, it may be a composition having the characteristics of composition (1-4) and composition (1-5), containing a heat-resistant substance, a quasi-heat-resistant substance, and / or a non-heat-resistant substance, in which the weight residual ratio measured by thermogravimetric analysis when heated from 25° C. to 400° C. is 15% or more and 80% or less, and the weight residual ratio measured by thermogravimetric analysis is 12% or more and 70% or less, when heated from 25° C. to 500° C. As yet another example, it may be a composition having the characteristics of composition (3-6) and composition (4-5), containing a heat-resistant substance, a quasi-heat-resistant substance, and / or a non-heat-resistant substance, in which the electromotive force when heated from 25° C. to 600° C. is −4 μV or more and 20 μV or less, and the numerical value ((W600 / W100)×100(%)) calculated as a percentage of the electromotive force when heated from 25° C. to 100° C. is −300 to 100.

[0065] Similarly, a composition having one or more features selected from composition (1-1) and the other compositions, a composition having one or more features selected from composition (1-2) and the other compositions, a composition having one or more features selected from composition (1-3) and the other compositions, a composition having one or more features selected from composition (1-4) and the other compositions, a composition having one or more features selected from composition (1-5) and the other compositions, a composition having one or more features selected from composition (1-6) and the other compositions, a composition having one or more features selected from composition (2-1) and the other compositions, a composition having one or more features selected from composition (2-2) and the other compositions, a composition having one or more features selected from composition (2-3) and the other compositions, a composition having one or more features selected from composition (2-4) and the other compositions, a composition having one or more features selected from composition (2-5) and the other compositions, a composition having one or more features selected from composition (3-1) and the other compositions , a composition having one or more features selected from composition (3-2) and the other compositions above, a composition having one or more features selected from composition (3-3) and the other compositions above, a composition having one or more features selected from composition (3-4) and the other compositions above, a composition having one or more features selected from composition (3-5) and the other compositions above, a composition having one or more features selected from composition (3-6) and the other compositions above, a composition having one or more features selected from composition (4-1) and the other compositions above, a composition having one or more features selected from composition (4-2) and the other compositions above, a composition having one or more features selected from composition (4-3) and the other compositions above, a composition having one or more features selected from composition (4-4) and the other compositions above, a composition having one or more features selected from composition (4-5) and the other compositions above, a composition having one or more features selected from composition (5) and the other compositions above, or a composition having one or more features selected from composition (6) and the other compositions above.Compositions may also be made that combine any two, three, four or more of these features.

[0066] The composition according to this 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 as long as they are acceptable for food compositions or pharmaceutical compositions, and non-limiting examples include magnesium aluminium silicate, magnesium aluminum silicate, magnesium hydroxide, dry sodium carbonate, sodium hydroxide, sodium bicarbonate, sodium carbonate hydrate, Fe-Mg hydrotalcite-like compounds, and Al-Mg hydrotalcite-like compounds. The heat-resistant substance may be one type or a combination of two or more types. When the composition contains naturally occurring components such as plant-derived cellulose, examples of heat-resistant substances may also include inorganic substances contained in the naturally occurring components. In order to adjust the inorganic content, naturally occurring components such as cellulose with an adjusted inorganic content may also be used.

[0068] Non-limiting examples of semi-thermostable substances include highly crystalline substances. Highly crystalline substances include polymeric carbohydrates. Polymeric carbohydrates are polysaccharides (including oligosaccharides), and non-limiting examples include starch, glycogen, cellulose, etc., formed by polymerization of D-glucose, chitin formed by polymerization of N-acetylglucosamine, and chitosan, which is formed by deacetylation of chitin. Polymeric carbohydrates are not limited by their function or role, and may be carbohydrates that perform or are involved in any function, such as energy storage (starch, glycogen, etc.), biological shaping, immunity, or intercellular communication. In one embodiment, the semi-thermostable substance may be cellulose, or cellulose and one or more of the above-mentioned components. The semi-thermostable substance may be one type or a combination of two or more types.

[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, tetrasaccharide, pentose, or hexose, and may be aldoses having an aldehyde group (including D-glucose, D-ribose, etc.), ketoses having a ketone group (including D-fructose, etc.), etc. The non-thermostable substance may be one type or a combination of two or more types.

[0070] The composition preferably contains heat-resistant materials such as ash and inorganic substances, semi-heat-resistant materials such as cellulose and highly crystalline materials, and non-heat-resistant materials such as proteins and low-molecular-weight carbohydrates. The contents of the heat-resistant material, semi-heat-resistant material, and non-heat-resistant material in the composition are preferably greater than 18% by weight, less than 72% by weight, and greater than 10% by weight, respectively, 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 material is 20% to 40% by weight, the content 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 any range combining any of these values ​​as the upper and lower limits. When the content of the semi-refractory 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 of the range. When the content of the non-refractory 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 of the range. The total content of the refractory material, semi-refractory material, and non-refractory material is preferably 100% by weight. When the content of the refractory material, semi-refractory material, and non-refractory material in the composition is more than 18% by weight, less than 75% by weight, and more than 10% by weight, respectively, the composition is more likely to exhibit good disintegrability in water and / or good frictional force of a wet powder. This makes it easier for the composition to pass through the body smoothly during swallowing when orally administered, making it easier to drink. Here, the inclusion of naturally occurring components such as cellulose in the composition can also include inorganic substances contained in the naturally occurring components. To adjust the content of inorganic substances, naturally occurring components such as cellulose with an adjusted content of inorganic substances can also be used.

[0071] Compositions containing heat-resistant, quasi-heat-resistant, and non-heat-resistant substances in the above-described amounts can be prepared by blending any amount of materials containing one or more selected from heat-resistant, quasi-heat-resistant, and non-heat-resistant substances. Examples of materials containing only heat-resistant substances such as ash include titanium oxide and calcium carbonate. Materials containing heat-resistant, quasi-heat-resistant, and / or non-heat-resistant substances are plant-derived components. Plant-derived components may be components derived from natural plants or plant-derived components prepared by processing plants, such as wheat germ, oats, crystalline cellulose (e.g., Asahi Kasei's Ceolus (registered trademark) PH grade), powdered cellulose (e.g., Nippon Paper Industries Co., Ltd.'s KC Flock W-50), and soybean compositions (soybeans or soybean-derived components). Wheat germ, oats, crystalline cellulose, and powdered cellulose contain heat-resistant substances such as ash, quasi-heat-resistant substances such as cellulose, and non-heat-resistant substances such as hemicellulose. For example, wheat germ contains 5-25 wt% of heat-resistant material, 30-70 wt% of semi-heat-resistant material, and 25-45 wt% of non-heat-resistant material. For example, oats contain 5-20 wt% of heat-resistant material, 45-75 wt% of semi-heat-resistant material, and 20-45 wt% of non-heat-resistant material. For example, crystalline cellulose (Asahi Kasei Ceolus) contains 1-10 wt% of heat-resistant material, 70-98 wt% of semi-heat-resistant material, and 0.1-5 wt% of non-heat-resistant material. For example, powdered cellulose (Nippon Paper Industries Co., Ltd. KC Flock W-50) contains 1-10 wt% of heat-resistant material, 70-90 wt% of semi-heat-resistant material, and 5-20 wt% of non-heat-resistant material. Also, for example, the soybean composition contains 1 to 20% by weight of heat-resistant material, 60 to 90% by weight of semi-heat-resistant material, and 1 to 20% by weight of non-heat-resistant material.

[0072] When preparing a composition, the specific amounts or proportions of thermostable, semi-thermostable, and / or non-thermostable substances contained in the plant-derived components actually used can be determined by methods known to those skilled in the art. For example, the content of thermostable substances such as ash can be measured using a known ash content method. For example, the content of semi-thermostable substances such as cellulose can be measured using a known alpha-cellulose quantification method. For example, the content of non-thermostable substances such as hemicellulose can be calculated by subtracting the value obtained by a known alpha-cellulose measurement from the value obtained using a known holocellulose quantification method. Based on these measurement results, these materials can be mixed to prepare a composition containing thermostable, semi-thermostable, and non-thermostable substances in the desired proportions.

[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 weight residual ratio (y) determined by thermogravimetric analysis when heated from 25°C to 600°C is expressed by the formula: y≧−2.03x + 23.623 (x represents the electromotive force when heated from 25°C to 600°C), and the composition has one or more characteristics selected from the other compositions above. When the composition according to this embodiment satisfies the above formula, it is likely to exhibit good frictional force of a wet powder. Furthermore, it is likely to have a smoother texture on the tongue. This is because the composition is likely to have less aggregation when administered to a subject. Furthermore, when the composition is administered in tablet form, it is likely to have good disintegration 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 has the characteristics of composition (1-6), composition (3-6), composition (5), and composition (6). In one embodiment, the composition is a composition comprising a heat-resistant material, a quasi-heat-resistant material, and a non-heat-resistant material, comprising the characteristics of composition (1-6), composition (3-6), composition (5), and composition (6). In one embodiment, the composition comprises a heat-resistant material, a quasi-heat-resistant material, and a non-heat-resistant material, and has a weight retention 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 as determined by thermogravimetric analysis when heated from 25°C to 600°C, a weight retention rate (y) as determined by thermogravimetric analysis when heated from 25°C to 600°C is expressed by the formula: y ≧ -2.03x + 23.623 (x represents the electromotive force as heated from 25°C to 600°C), and a tapped apparent density of 0.3 g / cm ３ ~5g / cm ３ The composition is:

[0076] When the composition has the characteristics 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, be smoother on the tongue, and, when administered in tablet form, be more likely to have better disintegration properties in water.

[0077] As described in the section "Measurement of Electromotive Force," the electromotive force (x in the formula) of a sample when heated 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 heated 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, 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, the composition can be adjusted to satisfy the above formula. 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 refractory material, the semi-refractory material, and the non-refractory 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 exhibits the desired effect of ease of drinking (good oral disintegration and / or good texture on the tongue).

[0079] At least a portion of the heat-resistant material, at least a portion of the quasi-heat-resistant material, and at least a portion 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 quasi-heat-resistant material contain cellulose. The powder particles of the quasi-heat-resistant material may further contain a soybean-derived component. The shape of the powder particles is not limited, but cellulose and / or components other than cellulose contain fibrous components. The powder composition may be composed of fibrous powder particles. The fibrous powder particles have an average fiber length (length in the fiber direction) of 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 any range combining any of the above values ​​as the upper and lower limits. For example, the average fiber length may be 5 μm or greater. 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 any 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 10-11 μm.

[0080] In one embodiment, any of the compositions described above may further comprise powder particles having an average fiber length of 5 μm or more. The powder particles may be a single fiber or a plurality 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 easier for the powder particles to exhibit appropriate adhesion when prepared into tablets, and / or the prepared tablets can be made to exhibit good disintegration in water and / or good frictional force of a wet powder. As a result, when orally administered, tablets containing the powder composition can be made to exhibit good oral disintegration properties and a good texture to the tongue when the disintegrating paste is formed, and can be made to pass the composition easily during swallowing, i.e., to be easy to swallow.

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

[0083] In one embodiment, any of the above compositions further comprises powder particles 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 wet powder friction. Furthermore, when the number of powder particles contained in the composition is the same, an aspect ratio closer to 1.0 tends to result in a smaller volume. This tends to reduce the risk of clogging in equipment used in the processing or manufacturing of pharmaceuticals, foods, cosmetics, and other products. It is presumed that each of these effects is due to the fact that an aspect ratio close to 1.0 tends to reduce friction between the fibers of the powder particles.

[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 of the powder particles contained in the composition is less than 200%. The water absorption 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 of the powder particles is 50% to 75%, it may be 50%, 60%, 70%, or 75%. In one embodiment, any of the above values ​​may be used as the upper and lower limits to form a range.

[0087] In a composition, when the water absorption rate of the powder particles is low, the powder particles are less likely to expand, so that the powder particles are easily loosened, and the disintegration in water of a tablet containing the composition is likely to be good.When the water absorption rate of the powder particles is less than 200%, the disintegration in water of a tablet containing the composition containing the powder particles is likely to be good.

[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 When ３ Even if it is 0.32 g / cm ３ Even if it is 0.34 g / cm ３ Even if it is 0.4 g / cm ３ Even if it is 0.45 g / cm ３ Even if it is 0.5 g / cm ３ Even if it is 0.65 g / cm ３ Even if it is 1.6 g / cm ３ Even if 3.8 g / cm ３ Even if ３ Even if 5 g / cm ３In one embodiment, the apparent density (untapped) may be within a range combining any of the above values ​​as upper and lower limits. 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 have a compressibility of less than 1.35. When the compressibility is less than 1.35, it may be 1 to 1.3, such as 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. When the compressibility of the composition is less than 1.35, the composition is less likely to be compressed when subjected to vibration, and the shape of the bag in which the composition is packaged is less likely to change. This makes the bag in which the composition is packaged easier to load and transport.

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

[0093] (Thermogravimetric Analysis) The weight residual ratio 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 ratio is measured by using a thermal analyzer (STA300 manufactured by Hitachi High-Tech Science) to measure N ２This is a value obtained from the remaining weight of the sample at 100°C, 200°C, 300°C, 400°C, and 600°C when the temperature was raised from 25°C to 600°C at 10°C / min in an atmosphere. The weight remaining rate when the sample was heated from temperature a to temperature b is a value expressed as a percentage (%) of the remaining weight at temperature b when the remaining weight at temperature a is set to 100. That is, the weight remaining 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 remaining rate (W ａ→ｃ ) when the sample is heated from temperature a to temperature b, the weight remaining rate (W ａ→ｂ ) is calculated as a percentage using the formula: (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 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, expressed as a percentage. 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 can be expressed in the same way.

[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] When the temperature is increased to 300°C, most of the non-heat-resistant substances contained in the composition disappear (Akira Kuriyama, Materials, Vol. 16, No. 169, pp. 772-776). Therefore, the weight residual ratio determined by thermogravimetric analysis when the temperature is increased from 25°C to 200°C or from 25°C to 300°C indicates the remaining components other than the non-heat-resistant substances contained in the composition. By increasing the content of the non-heat-resistant substances contained in the composition, the weight loss rate when the temperature is increased from 25°C to 200°C or from 25°C to 300°C can be increased and the weight residual ratio can be reduced. Alternatively, by decreasing the content of components other than the non-heat-resistant substances contained in the composition, i.e., the content of the heat-resistant substances and / or non-heat-resistant substances, the weight loss rate when the temperature is increased from 25°C to 200°C or from 25°C to 300°C can be increased and the weight residual ratio can be reduced.

[0097] The weight residual ratio determined by thermogravimetric analysis when the temperature of the composition is raised from 25° C. to 200° C. is measured as described above, and the content of the non-heat-resistant substance contained in the composition can be adjusted so that the weight residual ratio is 50% or more and 96% or less, or any of the desired values ​​listed above. Furthermore, the weight residual ratio determined by thermogravimetric analysis when the temperature of the composition is raised from 25° C. to 300° C. is measured as described above, and the content of the non-heat-resistant substance contained in the composition can be adjusted so that the weight residual ratio is 50% or more and 90% or less, or any of the desired values ​​listed above.

[0098] By adjusting the content of the non-heat-resistant material and / or the content of the heat-resistant material and / or the content of the semi-heat-resistant material in the composition, the weight residual ratio (W100) determined by thermogravimetric analysis when the temperature is raised from 25°C to 600°C, 500°C, 400°C, 300°C, or 200°C can be reduced. ２５→ｄ (d=200, 300, 400, 500 or 600)) as a percentage ((W ２５→ｄ / W100) × 100(%)) can be adjusted. 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 residual amount of components other than water adsorbed in the composition.

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

[0101] The weight retention rate 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 retention rate determined by thermogravimetric analysis when the composition is heated from 25°C to 400°C (W400) relative to the weight retention rate determined by thermogravimetric analysis when the composition is heated from 25°C to 100°C (W100) is adjusted so that the percentage ((W400 / W100) x 100 (%)) of the weight retention rate determined by thermogravimetric analysis when the composition is heated from 25°C to 500°C relative to the weight retention rate determined by thermogravimetric analysis when the composition is heated from 25°C to 100°C (W100) 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 quasi-heat-resistant material and the amount of the heat-resistant material contained in the composition can be adjusted so that the percentage value ((W500 / W100)×100(%)) of the weight residual ratio (W500) determined by thermogravimetric analysis when heated from 25° C. to 100° C., relative to the weight residual ratio (W100) determined by thermogravimetric analysis when heated from 25° C. to 100° C., 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 predetermined temperature is used as a percentage of 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 residual ratio determined by thermogravimetric analysis when the temperature of any of the compositions according to this embodiment is raised to a predetermined temperature can also be adjusted in the same manner as described above.

[0103] (Measurement of Electromotive Force) The electromotive force of a sample at a certain temperature can be obtained by a method well known to those skilled in the art. In the present disclosure, the electromotive force at a certain temperature is measured by measuring the electromotive force of a sample (about 10 mg of a composition) under N ２The electromotive force (μV) of the sample at 100°C, 200°C, 300°C, 400°C, and 600°C when the temperature is increased from 25°C to 600°C at 10°C / min in an atmosphere. The electromotive force (Xa) of the sample when heated from 25°C to temperature a relative to the electromotive force (Xb) of the sample when heated from 25°C to temperature b is expressed as a percentage by the formula: (Xa / Xb) x 100 (%). The electromotive force of the sample when heated from 25°C to temperature a is 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 contents of heat-resistant materials such as ash and inorganic substances, semi-heat-resistant materials such as cellulose and highly crystalline materials, and non-heat-resistant materials such as proteins and low-molecular-weight carbohydrates in the composition. More specifically, by adjusting the contents of the heat-resistant materials, semi-heat-resistant materials, and non-heat-resistant materials to more than 18 wt %, less than 72 wt %, and more than 10 wt %, respectively, the electromotive force when the temperature of the sample is raised from 25° C. to 600° C. can be adjusted to −4 μV or more.

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

[0106] Furthermore, by adjusting the contents of heat-resistant substances such as ash and inorganic substances, quasi-heat-resistant substances such as cellulose and highly crystalline substances, and non-heat-resistant substances such as proteins and low-molecular-weight carbohydrates in the composition, it is possible to adjust the numerical value ((Xa / Xb) x 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 substances, quasi-heat-resistant substances, and non-heat-resistant substances to more than 18% by weight, less than 72% by weight, and more than 10% by weight, respectively, it is possible to adjust the numerical value expressed as a 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 to be between -300 and 100.

[0107] (Measurement of Average Fiber Length and Average Fiber Width of Powder Particles) To remove extremely coarse fibers and aggregated fibers, 1 g of a powder sample of the composition is adjusted to a moisture content of 2 to 3% and then classified using a JIS test sieve (710 μm, manufactured by Tokyo Screen Co., Ltd.) The classified sample is randomly selected under an optical microscope (magnification: 100x), and 100 large and 100 small particles are excluded, leaving 1,000 particles, which are then measured for the fiber length (length in the fiber direction) and fiber width (length perpendicular to the fiber) of the powder particles, and the average values ​​are calculated.

[0108] (Aspect Ratio of Powder Particles) The aspect ratio of 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 measurement 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.). Specifically, all powder particles contained in the composition were measured using a 100 cm ３ After filling the cup and tapping 250 times per minute, the volume of the cup is determined by dividing the weight of the powder sample filled in the cup by the volume of the powder sample.

[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 (without tapping) of the composition is ３ The weight of the powder sample was calculated by roughly filling a glass measuring cylinder of 70 to 100 cm3 with the composition using a quantitative feeder or the like for 2 to 3 minutes, then leveling the top surface of the powder layer with a soft brush to read the volume. ３ The amount of the change 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] (Compressibility) The compressibility is a value calculated by dividing the "tapped apparent density" described above by the "apparent density (without tapping)". The smaller the value, the less likely the composition is to be compressed when vibrated. The compressibility can be adjusted by adjusting the tapped apparent density and / or the apparent density (without tapping) of the composition. The method for adjusting the tapped apparent density and the apparent density (without tapping) is as described above.

[0114] (Water Absorption of Powder Particles) The water absorption of the powder particles contained in the composition is the measured amount of water just before water separation from the fibers is visually confirmed when 2 g of powder particles are placed in a container, water is added dropwise, and the mixture is mixed evenly. This is the average value for n = 100. The water absorption of the powder particles can be adjusted by adjusting the fiber length and / or fiber width of the powder particles. Specifically, increasing the fiber length or width, or both, of the powder particles makes it easier to improve the water absorption of the powder particles. The fiber length and fiber width of the powder particles can be adjusted by adjusting the grinding time, grinding intensity, etc., in the grinding step of the material components when preparing the composition. Specifically, the fiber length and / or fiber width of the powder particles can be increased by shortening the grinding time and / or weakening the grinding intensity.

[0115] (Sensory test for texture on the tongue) Evaluation was carried out by 30 adult males and 30 adult females. A tablet was placed in the mouth and rolled around on the tongue until it was disintegrated, and the powdery texture on the tongue after the tablet had completely disintegrated was evaluated. The results were evaluated according to the following criteria: 1: Very powdery 2: Powdery 3: Slightly powdery, but moist enough that it was not powdery 4: Not powdery "Powderiness" can be, for example, the feeling that small particles remain on the tongue.

[0116] The closer the evaluation score in the tongue feel sensory test to 4, the less powdery the disintegrating paste of the tablet is, i.e., the better the texture of the disintegrating paste when the tablet is orally administered to a subject. The composition according to this embodiment has an evaluation score of 3 or 4 in the tongue feel sensory test, which indicates that the disintegrating paste of the tablet has a good texture on the tongue, i.e., is an easy-to-swallow tablet or composition.

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

[0118] The tablet hardness (N) is a value measured using a hardness tester (model number: KHT-40N, Fujiwara Seisakusho). A tablet manufactured by the method described in the "Tablet Manufacturing Method" section is placed in the center of the measuring table and the device is started (the AUTO [start] button is pressed). This causes the rod to descend at high speed and the display goes into a peak hold state. When the rod comes into contact with the object to be measured, the speed slows down and the display is monitored approximately every 0.1 seconds. If there is no increase, it is determined to be broken, and the hardness displayed on the hardness tester at that time is taken as the tablet hardness (N).

[0119] The disintegration time in water is measured by placing a tablet in a test tube, adding 20 ml of pure water, shaking it at 37°C in a shaker (reciprocating / rotating shaker MMS-3020, manufactured by Tokyo Rikakikai), and measuring the disintegration time. Measurements are made 50 times, and the average value is used as the disintegration time of the tablet.

[0120] The disintegration in water 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 disintegration in water 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 disintegration in water of the tablet may be within a range combining any of the above values ​​as the upper and lower limits.

[0121] When the tablet has a water disintegration rate of less than 1.9 (min / N), it is easy to realize good oral disintegration when the tablet is ingested as a food or administered as a medicine to a subject, which makes it easy 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 tablets containing the composition, which facilitates the realization of good oral disintegrability as described above. To achieve the above-described favorable water disintegration property, the water disintegration time of the tablet is preferably less than 90 minutes, and more preferably 30 minutes or less. When the water disintegration time of the tablet is 30 minutes or less, it may be 30 minutes, 25 minutes, 15 minutes, 14 minutes, or 12 minutes. In one embodiment, the water disintegration time of the tablet may be within a range that combines any of the above values ​​as the upper and lower limits. The water disintegration time of the tablet may be, for example, 12 to 30 minutes, or 12 to 15 minutes. Furthermore, to achieve the above-described favorable water disintegration property, the tablet hardness is preferably 46 N or less, and more preferably less than 45 N. When the tablet hardness is less than 45 N, it may be 43 N, 42 N, 35 N, 25 N, 17 N, or 14 N. In one embodiment, the tablet hardness may be within a range combining any of the above values ​​as the upper and lower limits, 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 90 μm (JIS Z8801 wire) and recovering it, using a static and dynamic friction measuring device ("Handy Tribomaster TL201Ts" manufactured by Trinity Labs) under measurement conditions of a load of 50 g and a speed of 10 mm / sec. The contactor used was a 5 mm thick sponge sheet ("Gap Tape N-1" manufactured by Cemedine) with artificial skin ("Bioskin" manufactured by Viewlux) attached. Based on the static frictional force (gf) results, the ratio of the movement distances of 0 mm and 3 mm was calculated using the following formula. Formula: Frictional force of wet powder after a movement distance of 2 mm = 100 × (static frictional force at a movement distance of 0 mm / static frictional force at a movement distance of 3 mm)

[0124] The frictional force of the wet powder is preferably less than 65 (gf), and 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 property of the tablet may be within 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). Alternatively, it may be, for example, 30 (gf) to 45 (gf), or 30 (gf) to 34 (gf).

[0125] By making the frictional force of the wet powder less than 65 (gf), it becomes easier to realize a good mouthfeel for the disintegrating paste of the tablet or the paste of the powder composition, which in turn makes it easier to realize good passage of the composition during swallowing, i.e., it becomes easier to obtain a tablet or composition that is 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 Embodiment 2. The composition according to this embodiment can be used as a cosmetic composition or a lubricant composition, as described in Embodiment 3.

[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, it is preferable to use the oral composition according to the first embodiment as a food composition.

[0129] The food compositions can be used alone or in combination of two or more food compositions to prepare foods such as beverages, soups, processed meat products, processed vegetables, processed fruits, seasonings, concentrated foods, and supplements (nutritional supplements, nutritional supplement drinks).

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

[0131] Here, "processed products" 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. From the viewpoint of ease of ingestion, it may be in a fluid form such as a liquid, syrup, paste, gel, jelly, cream, emulsion, spray, mousse, or lotion, or in a solid form such as a powder, granules, tablet, capsule, or soft capsule. The tablet may be any of an orally disintegrating tablet, a chewable tablet, an effervescent tablet, a dispersion, and a dissolving tablet. Considering the effects of good oral disintegration and a good texture of the disintegrating paste due to the good water disintegrability and / or good frictional force of the wet powder resulting from the inclusion of the composition according to the first embodiment, and the resulting 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] The functional ingredient is not limited to any ingredient that is desirable to ingest in addition to a normal diet, but is preferably a substance that can exert some nutritional or physiological activity or effect that is the intended use or purpose of the food containing the food composition in the subject who ingests it. In one embodiment, the functional ingredient is preferably a component that has the effect of improving undesired symptoms and / or poor physical condition in the subject (including functions related to maintaining and improving health). Therefore, the food containing the food composition is preferably a functional food that has the effect of improving undesired symptoms and / or poor physical condition in the subject who ingests it (including functions related to maintaining and improving health). Examples of such functional foods in Japan include general foods, including dietary supplements, health supplements, and nutritionally balanced foods, as well as health functional foods (including foods with nutrient functions, foods for specified health uses (FOSHU), and foods with functional claims), which are labeled according to government standards for safety and efficacy.

[0133] The functional ingredients are not limited in composition, raw materials, origin, or acquisition route, 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 or more functional ingredients. In one embodiment, the functional ingredient may be a soybean-derived ingredient, and the soybean-derived ingredient may be soybean isoflavones and / or equol. Soy isoflavones and equol may each be in the form of glycosides or aglycones. 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 commercially available products, and artificial preparation using equol-producing bacteria, etc.

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

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

[0136] The composition according to the first embodiment can be used as a pharmaceutical composition. The pharmaceutical composition according to this embodiment contains a pharmaceutically active ingredient. In one embodiment, the oral composition according to the first embodiment is preferably used as the 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 treating a disease or condition suitable for the pharmacological effect of the pharmaceutically active ingredient.

[0138] A medicament 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 active pharmaceutical ingredient according to one embodiment is the composition according to the first embodiment, the pharmaceutical composition, or the active pharmaceutical ingredient according to this embodiment for the treatment of a subject in need thereof.

[0142] The pharmaceutical form is not limited, but is preferably a form suitable for oral use. From the viewpoint of ease of administration, it may be in a fluid form such as a liquid, syrup, paste, gel, jelly, cream, emulsion, spray, mousse, or lotion, or in a solid form such as a powder, granules, tablet, capsule, or soft capsule. The tablet may be any of an orally disintegrating tablet, a chewable tablet, an effervescent tablet, a dispersion, and a dissolving tablet. Considering the effects of good oral disintegration and good texture on the tongue due to the moderate water disintegrability and / or good frictional force of the wet powder resulting from the inclusion of the composition according to the first embodiment, and the resulting effect of good passage of the composition during swallowing, the pharmaceutical tablet is preferably an orally disintegrating tablet or a chewable tablet, and more preferably an orally disintegrating tablet.

[0143] The pharmaceutically active ingredient is not limited as long as it is an ingredient that is desired to be administered to a subject having any disease or exhibiting any symptoms, but it is preferably a substance that can exert some physiological activity or effect that is the use or purpose of the pharmaceutically active ingredient in the administered subject.

[0144] The composition, raw material, origin, and route of acquisition of the pharmaceutically active ingredient are not limited, and include natural products, natural extracts, synthetic substances (including bioengineered substances and chemically synthesized substances), and mixtures of two or more of these. Examples of natural products or natural extracts include nucleic acids, proteins (including antibodies and their fragments), culture extracts, and low-molecular-weight compounds. These natural products or natural extracts may be identical to these substances or similar substances with similar functions that are bioengineered or chemically synthesized (chemically synthesized substances). Natural products or natural extracts may be obtained from any organism, such as a microorganism, animal, or plant, and are not limited by the ecology or habitat of the organism. Pharmaceutical compositions may contain one or more pharmaceutically active ingredients.

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

[0146] When two or more food compositions or pharmaceutical compositions are separately formulated to form two or more food or pharmaceutical preparations, the individual foods or pharmaceutical preparations can be ingested or administered simultaneously, separately at a certain time interval, or consecutively. The two or more food or pharmaceutical preparations can also be ingested or administered at different times per day and / or by different routes. Pharmaceutical preparations can be administered systemically or locally.

[0147] In addition to the composition and functional or pharmaceutically active ingredient, a food composition or pharmaceutical composition may further contain one or more non-functional ingredients that are nutritionally or pharmaceutically acceptable as a food. Non-functional ingredients include, for example, acidulants, sweeteners, excipients, surfactants, lubricants, flavorings, fragrances, colorants, stabilizers, preservatives, and other additives. Examples of excipients include mannitol, erythritol, xylitol, trehalose, lactose, maltose, maltitol, glucose, sucrose, fructose, mannose, sorbitol, amylose, light anhydrous silicic acid, hydrous silicon dioxide, anhydrous calcium phosphate, anhydrous calcium hydrogen phosphate, aluminum metasilicate, calcium silicate, magnesium silicate, magnesium oxide, and the like. The surfactant may include a nonionic surfactant, such as sorbitan fatty acid esters such as sorbitan monocaprylate, sorbitan monolaurate, and sorbitan monopalmitate, and glycerin fatty acid esters such as glycerin monocaprylate, glycerin monomyliate, and glycerin monostearate, each having an HLB of 6 to 18. Other non-functional components 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 oil, fatty acid monoglycerides and diglycerides, petroleum esters of fatty acids, hydroxymethylcellulose, and polyvinylpyrrolidone.

[0148] The content of the functional ingredient or pharmaceutically active ingredient in the food composition or pharmaceutical composition is not limited, but may be greater than 10 wt %, greater than 20 wt %, 20-40 wt %, 20-32 wt %, or 20-30 wt %. When the content of the functional ingredient or pharmaceutically active ingredient is 20-30 wt %, the content may be 20 wt %, 24 wt %, 26 wt %, 27 wt %, or 30 wt %. Furthermore, the content of the non-functional ingredient in the food composition or pharmaceutical composition is not limited, but may be 90 wt % or less, 60-90 wt %, 60-80 wt %, 68-80 wt %, or 70-80 wt %. The functional ingredient or pharmaceutically active ingredient may be contained in a non-heat-stable substance in the composition according to this second embodiment, such as a protein or a low-molecular-weight carbohydrate. By having a functional ingredient or pharmaceutically active ingredient content of more than 10% by weight and a non-functional ingredient content of 90% by weight or less, the food composition or food containing the same, or the pharmaceutical composition or medicine containing the same, is more likely to exhibit good wet powder frictional force. Therefore, it is more likely to achieve a good texture on the tongue when ingested, and to achieve good passage of the composition during swallowing, i.e., to make the food or medicine easier to drink. When the food or medicine is in tablet form, it is more likely to exhibit good water disintegration and / or good wet powder frictional force. This makes it more likely that the tablet will achieve good oral disintegration and a good texture of the disintegrating paste on the tongue, and to achieve good passage of the composition during swallowing, i.e., to make the tablet easier to drink. Furthermore, by having a functional ingredient or pharmaceutically active ingredient content of more than 10% by weight, the desired effect of the functional ingredient or pharmaceutically active ingredient is more likely to be exerted in a subject who has ingested the food or administered the medicine.

[0149] The subject to which the food composition or a food containing the same is ingested, or the subject to which the pharmaceutical composition or a medicine containing the same is administered, is not limited as long as it is an animal in need thereof, and may be a human or a non-human animal. Non-human animal species may be, for example, monkeys, dogs, cats, horses, cows, pigs, sheep, goats, rabbits, guinea pigs, hamsters, mice, and / or rats, and are not limited by their use as livestock animals, pet animals, laboratory animals, etc., but are preferably mammals, and more preferably humans.

[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 selected appropriately by a person skilled in the art depending on the dosage form, etc., but examples include blister packs such as PTPs, strip packaging, heat seals, aluminum pouches, film packaging using plastics, synthetic resins, etc., glass containers such as vials, plastic containers such as ampoules, etc.

[0151] (Method for Manufacturing Tablets) 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 manufactured from the powder of the composition according to the first embodiment by wet granulation using a liquid or dry granulation without 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 manufactured using a tablet press, or sheets or ribbons are manufactured by roller compression of the powder of the composition using two rollers. The manufactured slugs, sheets, or ribbons are then pulverized to prepare granules. The granules are then compressed using a tablet press to produce tablets.

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

[0153] Alternatively, for example, the components of the heat-resistant material, semi-heat-resistant material, and non-heat-resistant material, which are the materials for the composition according to the first embodiment, are 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, it is ground once using a jet mill (e.g., a jet mill grinder STJ-400 manufactured by Seishin) at a flow rate of 2 kg / h to 12 kg / h, and ground to approximately 10 μm, thereby obtaining 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 at 3 kN so that the tablet thickness is uniform to approximately 5 mm, and the stress is maintained for 60 minutes to produce tablets with a diameter of 8 mm, R12 punch tablets, and approximately 250 mg. As the compression machine, a HANDTAB-100 manufactured by Enerpac Co., Ltd. can be used. By preparing tablets using powder particles adjusted to about 10 μm by pulverization in this way, the resulting tablets tend to exhibit good disintegrability 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] Tablets produced in this manner are likely to exhibit good disintegrability in water and / or good frictional force of a wet powder, which makes it easier for tablets containing the powder composition to achieve good oral disintegrability and a good texture on the tongue, and to achieve good passage of the composition during swallowing, i.e., to be easy to swallow.

[0155] Third Embodiment (Other Uses) The composition according to the first embodiment can be used in a variety of uses where the properties exhibited by the composition, i.e., good disintegrability in water and / or good frictional force of the wet powder, are favorably utilized. For example, the composition according to the first embodiment can be used as a cosmetic composition. Furthermore, for example, the composition according to the first embodiment can be used as a lubricant composition.

[0156] A cosmetic product according to an embodiment includes the cosmetic composition according to this embodiment. A lubricant according to an embodiment includes the lubricant composition according to this embodiment.

[0157] The cosmetic composition is, for example, a composition intended for the beauty of skin, hair, nails, etc., and can be formulated into a form that allows for the care of these areas to be made into a cosmetic. For example, the cosmetic composition may be a liquid, lotion, cream, patch, oil, spray, liquid cleanser, solid soap, etc. Furthermore, the product may be a cosmetic liquid, beauty serum, moisturizing liquid, moisturizing cream, soap, body soap, skin cleanser, bath salts, sunscreen, shaving lotion, depilatory cream, shampoo, conditioner, hair tonic, hair dye, etc. In particular, from the viewpoint of optimally exerting the effects due to the properties exhibited by the composition according to the first embodiment, lotions, creams, and liquid cleansers are preferred, and commercial forms of liquid cleansers include shampoos, body soaps, and skin cleansers.

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

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

[0161] The lubricant composition may contain one or more functional ingredients and / or one or more non-functional ingredients described in the second embodiment. From the viewpoint of functionality as a lubricant composition, it is preferable to contain one or more lubricants well known to those skilled in the art. Non-limiting examples of such lubricants include titanium oxide, calcium carbonate, hydrous silicon dioxide, hydrous amorphous silicon oxide, glycerin fatty acid esters, magnesium silicate, light anhydrous silicic acid, hydrogenated oil, heavy anhydrous silicic acid, sucrose fatty acid esters, stearyl alcohol, stearic acid, zinc stearate, aluminum stearate, calcium stearate, polyoxyl 40 stearate, magnesium stearate, hydrogenated soybean oil, talc, sodium stearyl fumarate, beeswax, anhydrous silicic acid hydrate, magnesium aluminometasilicate, and glycerin monostearate.

[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 preparation of a medicament containing the pharmaceutical composition.

[0163] A non-limiting list of exemplary embodiments and combinations of exemplary embodiments of the present disclosure is disclosed below: [1] A thermoplastic elastomer comprising a thermostable material, a semi-thermal material, and a non-thermal material, wherein the weight residual ratio determined by thermogravimetric analysis when heated from 25°C to 600°C is 11% or more, the electromotive force when heated from 25°C to 600°C is -4 μV or more, the weight residual ratio (y) determined by thermogravimetric analysis when heated from 25°C to 600°C is expressed by the formula: y≧−2.03x + 23.623 (x represents the electromotive force when heated from 25°C to 600°C), and the tapped apparent density is 0.3 g / cm ３ ~5g / cm ３[2] The composition according to [1], wherein the weight residual ratio (W600) as determined by thermogravimetric analysis when heated from 25°C to 600°C is 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) as 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 residual ratio (W200) as 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 residual ratio (W300) as determined by thermogravimetric analysis when heated from 25°C to 300°C is 50% to 90% or 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) as determined by thermogravimetric analysis when heated from 25°C to 400°C is 15% to 80% or 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) as determined by thermogravimetric analysis when heated from 25°C to 500°C is 12% to 70% or 12% to 60%, 15% to 55%, or 20% to 50%. [8] The composition according to any one of [1] to [7], wherein (W200 / W100) x 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) x 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) x 100(%) is 15 to 80.

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

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

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

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

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

[12] , wherein the electromotive force (X600) when heated from 25°C to 600°C is -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] , wherein the electromotive force (X100) when heated from 25°C to 100°C is -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] , wherein the electromotive force (X200) when heated from 25°C to 200°C is -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] , wherein the electromotive force (X400) when heated from 25°C to 400°C is -8 μV or more and 15 μV or less, -5 μV to 15 μV, or -3 μV to 10 μV.

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

[17] , wherein the electromotive force (X500) when heated from 25°C to 500°C is -4 μV or more and 20 μV or less, -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] The tapped apparent density is 0.35 g / cm. ３ ~4.6g / cm ３

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

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

[26] The composition according to

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

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

[26] , wherein the semi-heat-resistant substance is a highly crystalline substance.

[28] The composition according to

[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 according to any one 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 according to

[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 thermostable substance in the composition is more than 18% by weight, the content of the semi-thermostable substance in the composition is less than 72% by weight, and the content of the non-thermostable substance in the composition is more than 10% by weight.

[32] The composition according to

[31] , wherein the content of the thermostable substance in the composition is 20% by weight to 40% by weight, the content of the semi-thermostable substance in the composition is 30% by weight to 70% by weight, and the content of the non-thermostable 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 according to any of [1] to

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

[35] The composition according to any 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 powder particles contained in the powder composition have an average fiber width of 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 powder particles contained in the powder composition have an aspect ratio of 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 powder particles contained in the powder composition have a water absorption rate of 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

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

[39] , wherein the degree of compression is less than 1.35, or 1 to 1.3.

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

[40] , wherein a tablet containing the composition has a disintegration time in water of 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] The composition according to any one of [1] to

[43] , which is for oral administration.

[45] The composition according to [1] to

[44] , which is a food composition.

[46] The composition according to [1] to

[44] , which is a pharmaceutical composition.

[47] A functional food comprising the composition according to

[45] .

[48] A medicine comprising the composition according to

[46] .

[49] The functional food according to

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

[50] The medicine according to

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

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

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

[0166] (Examples) (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 6) Powder composition (T8) (Example 7) Powder composition (T9) (Example 8) Powder composition (T10) (Example 9) Powder composition (T11)

[0167] (Comparative Examples) (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)

[0168] [Preparation of Composition and Tablets] The mixture of materials was subjected to a pulverization step (milling) to pulverize coarse particles. After the pulverization step, the average particle size (fiber length) of the powder particles was confirmed. 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) at a flow rate of 2 kg / h to 12 kg / h to obtain a powder composition having a particle size of about 10 μm.

[0169] For the compositions of Examples 1 to 9 and Comparative Examples 1 to 6, the content of the heat-resistant substance was measured by the known ash method, and the content of the semi-heat-resistant substance was measured by the known method for quantifying α-cellulose. The content of the non-heat-resistant substance 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 9 and Comparative Examples 1 to 6 each 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" section of Table 1.

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

[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 (manufactured by Ichihashi Seiki Co., Ltd., diameter 8 mm), compressed at 3 kN so that the tablet thickness was uniform to about 5 mm, and the 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 Composition] 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), a powder composition sample (approximately 10 mg) was subjected to N ２ The sample was heated 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 remaining rate when the sample was heated from temperature a to temperature b is the value expressed as a percentage (%) of the remaining weight at temperature b, assuming that the remaining weight at temperature a is 100. That is, the weight remaining 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 remaining rate (W ａ→ｃ) when the sample is heated from temperature a to temperature b, the weight remaining rate (W ａ→ｂ ) is expressed by the formula: W ａ→ｂ / W ａ→ｃ It is expressed as:

[0174] (Measurement of Electromotive Force) A sample (approximately 10 mg of powder composition) was measured using a thermal analyzer (STA300 manufactured by Hitachi High-Tech Science) 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 the 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] (Disintegrability in Water) Disintegrability in water is expressed as the disintegration time per unit hardness [disintegration time in water (D) / tablet hardness (N) (min / N)]. For the evaluation of disintegrability of tablets in water, 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 it at 37°C in a shaker (reciprocating / rotating shaker MMS-3020, manufactured by Tokyo Rikakikai Co., Ltd.), and measuring the disintegration time. The measurement was carried out 50 times, and the average value was taken as the disintegration time of the tablet in water.

[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 Tablet" was placed on the center of the measuring table and the device was started (the AUTO [start] button was pressed). At this time, the hardness in the direction perpendicular to the compression direction during tablet molding was measured. As a result, the rod descended at high speed and the display entered a peak hold state. When it came into contact with the object to be measured, the speed slowed down and the display was monitored approximately every 0.1 seconds. If there was no increase, it was judged to have broken, and the hardness indicated on the hardness tester at that time was taken as the tablet hardness (N).

[0178] (Frictional Force of Wet Powder) The frictional force (gf) of the wet powder was measured by passing the residue of the sample subjected to the above-mentioned "Underwater Disintegrability" test through a 90 μm (JIS Z8801 wire) and recovering it, using a static and dynamic friction measuring device ("Handy Tribomaster TL201Ts" manufactured by Trinity Labs) under measurement conditions of a load of 50 g and a speed of 10 mm / sec. The contactor used was a 5 mm thick sponge sheet ("Gap Tape N-1" manufactured by Cemedine) with artificial skin ("Bioskin" manufactured by Viewlux) attached. Based on the static frictional force (gf) results, the ratios of the movement distances of 0 mm and 3 mm were calculated using the following formula. Formula: Frictional force of wet powder with a movement distance of 2 mm = 100 × (static frictional force at a movement distance of 0 mm / static frictional force at a movement distance of 3 mm)

[0179] (Measurement of Average Fiber Length and Average Fiber Width of Powder Particles) For 1 g of powder samples of the compositions of the Examples and Comparative Examples, the moisture content was adjusted to 2 to 3% in order to remove extremely coarse fibers and aggregated fibers, and the samples were classified using a JIS test sieve (710 μm, manufactured by Tokyo Screen Co., Ltd.) The classified samples were randomly selected under an optical microscope (magnification: 100x), and 100 large and 100 small particles were excluded, leaving 1,000 particles, for which the fiber length (length in the fiber direction) and fiber width (length in the direction perpendicular to the fiber) of the powder particles were measured, and the average values ​​were calculated.

[0180] (Aspect Ratio of Powder Particles) 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 obtained.

[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-T model, manufactured by Hosokawa Micron Co., Ltd.). Specifically, all the powder particles contained in the composition were measured by tapping the powder particles to a density of 100 cm. 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 (without tapping) of the composition is ３ The powder was roughly filled into a glass measuring cylinder of 70 to 100 cm3 for 2 to 3 minutes using a quantitative feeder for the composition, and then the top surface of the powder layer was leveled with a soft brush such as a paintbrush to read the volume. The weight of the powder sample was calculated by dividing the weight by the volume. ３ It was decided appropriately to be the extent.

[0183] (Water Absorption of Powder Particles) The water absorption of the powder particles contained in the compositions of the Examples and Comparative Examples was measured by placing 2 g of powder particles in a container, adding water dropwise, and mixing uniformly, and measuring the amount of water just before water separation from the fibers was visually confirmed. The average value of n=100 was obtained.

[0184] (Sensory test for texture on the tongue) Evaluation was carried out by 30 adult males and 30 adult females. A tablet was placed in the mouth and rolled around on the tongue until it was disintegrated, and the powdery texture on the tongue after the tablet had completely disintegrated was evaluated. The average of the four-level evaluations from 1 to 4 by these 60 people was used as the evaluation score for each Example and Comparative Example. The results were evaluated according to the following criteria: 1: Very powdery 2: Powdery 3: Slightly powdery, but moist enough that it is not powdery 4: Not powdery

[0185] (Compressibility) The compressibility was calculated by dividing the "tapping apparent density" explained above by the "apparent density (without tapping)".

[0186] (Functional Formula of Weight Residual Ratio (y)) The weight residual ratio (y) determined by thermogravimetric analysis when the temperature was raised from 25°C to 600°C was shown as a function using the electromotive force (x) when the temperature was raised from 25°C to 600°C. First, the weight residual ratios when the temperature was raised from 25°C to 600°C were plotted for the compositions of the Examples and Comparative Examples shown in Table 2. As shown in FIG. 1 , Examples 1 to 9 (T1 to T3, T6 to T11) in which the weight residual ratio determined by thermogravimetric analysis when the temperature was raised from 25°C to 600°C was 11% or more (above line A) and the electromotive force when the temperature was raised from 25°C to 600°C was -4 μV or more (to the right of line B) had a water disintegration property of 1.2 (min / N) or less, i.e., exhibited good water disintegration property. Furthermore, these compositions had a wet powder friction force of 45 (gf) or less and a rating of 3 or 4 in the tongue feel sensory test, indicating a good mouthfeel. However, the range above line A and to the right of line B included Comparative Examples 3 to 6 (T12 to T15), which had poor effects of providing good disintegrability in water and a good texture to the tongue. To facilitate the difficulty of distinguishing between compositions that provide the desired effects and those that do not during actual production of the compositions, the formula "y≧−2.03x + 23.623" was defined as the boundary line distinguishing between compositions that provide the desired 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 only a low effect could be effectively eliminated. Because the range enclosed by lines A, B, and "formula: y≧−2.03x + 23.623" is excluded, compositions with good disintegrability in water and a good texture to the tongue can be easily identified. Because "formula: y≧−2.03x + 23.623" is a straight line, it is easy to distinguish, making it easier to determine whether or not a composition has an effect.

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

[0193] Table 3 shows 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 relative to the weight residual ratio (W100) determined by thermogravimetric analysis when the temperature is raised from 25°C to 100°C, as expressed as a percentage ((Wd / W100) x 100 (%)).

[0194] For example, the weight residual ratio (W600) determined by thermogravimetric analysis when the temperature is raised from 25°C to 600°C relative to the weight residual ratio (W100) determined by thermogravimetric analysis when the temperature is raised from 25°C to 100°C ((W600 / W100) x 100(%)) was 14 to 42 in the Examples.

[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 -6 μV to -2 μV for all the compositions of the Examples and Comparative Examples. In the Examples, the electromotive force was -6 μV to -4 μV. In particular, in the Examples in which 20% high-purity cellulose powder was mixed, the electromotive force was -5 μV to -4 μV. On the other hand, in the Comparative Examples, the electromotive force was -2 μV to -1 μV.

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

[0197] When the temperature was raised from 25°C to 300°C, the electromotive force was -8µV to +3µV for all the 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 -9 μV to +8 μV for all the compositions of the Examples and Comparative Examples. In the Examples, the electromotive force was -2 μV to +8 μV. In the Examples in which 20% high-purity cellulose powder was mixed, the electromotive force was -2 μV to -1 μV. On the other hand, in the Comparative Examples, the electromotive force was -9 μV to -7 μV.

[0199] When the temperature was raised from 25°C to 500°C, the electromotive force was -8µV to +14µV for all the 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 for all compositions in 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 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, as expressed as a percentage ((Xd / X100) x 100 (%)).

[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.

[0203] (Disintegrability in Water) The disintegrability values ​​in water for the compositions of the Examples and Comparative Examples are shown in Table 2. In the Examples, the disintegrability in water was less than 1.9 (min / N). The tablets of the compositions of the Examples had a disintegration in water of less than 1.9 (min / N), and therefore exhibited good oral disintegrability, 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 values ​​of the frictional force of the wet powder 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). Since the frictional force of the wet powder of the compositions of the Examples was less than 65 (gf), the disintegrating paste of the tablet or the paste of the powder composition had a good texture on the tongue.

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

[0206] (Aspect Ratio of Powder Particles) The aspect ratios (average fiber length / average fiber width) of the powder particles for the compositions of the Examples and Comparative Examples are shown in Table 2. In the Examples, the aspect ratios were 1.0 to 1.1. When the powder particles contained in the composition have such aspect ratios, the composition according to the present disclosure is more likely to exhibit good disintegrability in water and good wet powder friction. Furthermore, when the number of powder particles contained in a composition is the same, an aspect ratio closer to 1.0 tends to result in a smaller volume. This tends to reduce the risk of clogging in equipment used in the processing or manufacturing of products such as pharmaceuticals, foods, and cosmetics. It is presumed that each of these effects is due to the fact that an aspect ratio closer to 1.0 tends to reduce friction between the fibers of the powder particles.

[0207] (Tapped apparent density) The tapped apparent density of the compositions of the Examples and Comparative Examples is shown in Table 2. In the Examples, the tapped apparent density was 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 productivity can be easily improved.

[0208] (Apparent Density (without tapping)) The apparent density (without tapping) of the compositions of the Examples and Comparative Examples is shown in Table 2. In the Examples, the apparent density was 0.32 g / cm ３ ~4.2 g / 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) The water absorption rate of powder particles (powder water absorption rate) for the compositions of the Examples and Comparative Examples is shown in Table 2. The powder water absorption rate of the compositions of the Examples was 75% or less. When the water absorption rate of powder particles in a composition is low, the powder particles are less likely to expand, so the powder particles tend to loosen together, and tablets containing the composition tend to have good disintegration in water. When the water absorption rate of powder particles in the composition according to the present disclosure is 75% or less, tablets containing a composition composed of the powder particles had good disintegration in water.

[0210] (Compressibility) The compressibility of the compositions of the Examples and Comparative Examples is shown in Table 2. The compressibility of the compositions of the Examples was 1.09 to 1.25. When the composition has such a compressibility, the composition is less likely to be compressed when 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 and transport the bag in which the composition is packaged.

[0211] (Sensory Test for Texture) The results of the sensory test for texture on the tongue of tablets of the compositions of the Examples and Comparative Examples are shown in Table 2. The evaluation of the sensory test for texture on the tongue of the compositions of the Examples was 3 (3: slightly powdery, but moist enough to not feel powdery) or 4 (4: not powdery). It was revealed that the compositions of the Examples had a good texture on the tongue.

[0212] (Relationship between Water-Disintegratability and Frictional Force of Wet Powder and Composition Characteristics) From the above results, it was found that compositions 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 exhibit good water-disintegratability and good wet powder frictional force. Each weight residual ratio is an index that comprehensively indicates, for example, [1] the degree of heat resistance of the heat-resistant substance, quasi-heat-resistant substance, and non-heat-resistant substance, and [2] the content of the heat-resistant substance, quasi-heat-resistant substance, and non-heat-resistant substance in the composition. Regarding each weight residual ratio, when a composition contains a sufficient amount of high-density heat-resistant substance, such as an inorganic substance (i.e., low fiber content), fiber aggregation was low, and tablets formed into tablets were likely to have a smooth texture. Furthermore, such compositions also exhibited excellent water-disintegratability when formed into tablets due to low fiber aggregation. Furthermore, electromotive force is an indicator of the degree of heat absorption and heat generation, and by achieving a specific ratio of electromotive force, i.e., by adjusting the balance of crystalline and amorphous components in the composition, it is possible to reduce the rigid fibers specific to the highly crystalline component, which leads to suppression of friction between the components and makes it easier to present a good texture to the tongue 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 suppression of fiber aggregation and to the disintegration property of the tablet in water. It has been revealed that by combining the above, it is possible to exhibit effects related to a better texture to the tongue and disintegration property in water.

[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. A thermogravimetric material containing a heat-resistant material, a semi-heat-resistant material, and a non-heat-resistant material, the weight residual ratio determined by thermogravimetric analysis when heated from 25°C to 600°C is 11% or more, the electromotive force when heated from 25°C to 600°C is -4μV or more, the weight residual ratio (y) determined by thermogravimetric analysis when heated from 25°C to 600°C is expressed by the formula: y ≧ -2.03x + 23.623 (x represents the electromotive force when heated from 25°C to 600°C), and the tapping apparent density is 0.3g / cm ３ ~5g / cm ３ The composition.

2. The composition according to claim 1, which is for oral administration.

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 according to claim 3.

6. A medicine 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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