solid components

Abstract

This invention provides a technology for suppressing discoloration during the manufacturing of solid compositions containing tranexamic acids and improving the uniformity of their appearance. [Solution] A solid composition comprising: component (A): at least one selected from the group consisting of tranexamic acid and its salts, and component (B): isomalt.

Description

[Technical Field]

[0001] This invention relates to a solid composition. [Background technology]

[0002] Regarding technologies relating to oral compositions containing tranexamic acid, there is a document described in Patent Document 1 (Japanese Patent Publication No. 2023-105921). The document states that tranexamic acid may lose stability over time and cause discoloration of the formulation depending on the formulation composition (paragraph 0002). Furthermore, it states that an oral composition containing tranexamic acid, at least one selected from the group consisting of neutral amino acids, acidic amino acids, basic amino acids, and salts thereof, and sugar alcohol and / or glycerin (claim 1) can suppress discoloration of the formulation over time, even when tranexamic acid is included, and can provide an oral composition with excellent appearance stability and a pleasant feel (paragraph 0008). [Prior art documents] [Patent Documents]

[0003] [Patent Document 1] Japanese Patent Publication No. 2023-105921 [Overview of the Initiative] [Problems that the invention aims to solve]

[0004] Through the inventors' research, it became clear that the technology described in the above-mentioned patent document has room for improvement in terms of suppressing discoloration during the production of solid compositions containing tranexamic acid and improving the uniformity of appearance.

[0005] This invention provides a technology for suppressing discoloration during the production of solid compositions containing tranexamic acids and improving the uniformity of their appearance. [Means for solving the problem]

[0006] Aspects of the present invention are as follows. [1] A solid composition comprising the following components (A) and (B). (A) At least one selected from the group consisting of tranexamic acid and its salts (B) Isomalt [2] The solid composition according to [1], wherein the mass ratio ((B) / (A)) of the content of component (B) to the content of component (A) in the solid composition is 1.5 or more and 40 or less. [3] The solid composition according to [1] or [2], wherein the content of component (A) in the solid composition per daily dose is 50 mg or more and 3000 mg or less. [4] The solid composition according to any one of [1] to [3], further comprising the following component (C). (C) At least one selected from the group consisting of organic acids and their salts and antioxidants [5] The solid composition according to any one of [1] to [4], which is an oral composition. [6] The solid composition according to any one of [1] to [5], which is a pharmaceutical composition. [7] The solid composition according to any one of [1] to [6], which is a composition for stomatitis. [8] The solid composition according to any one of [1] to [7], which is a composition for pharyngitis. [9] The solid composition according to any one of [1] to [8], which is a composition for whitening.

[10] The solid composition according to any one of [1] to [9], which is a tablet.

[11] The solid composition according to

[10] , wherein the dosage form of the tablet is selected from the group consisting of chewable tablets, troches and lozenges.

[12] The solid composition according to

[10] or

[11] , wherein the arithmetic mean curvature Spc (mm -1 ) of the peak points on the surface of the tablet defined by ISO 25178 is 4.0 or less.

[13] The solid composition according to any one of

[10] to

[12] , wherein the developed area ratio Sdr of the surface of the tablet defined by ISO 25178 is 0.029 or less. The color difference ΔE of the solid composition measured by the following Method 1 * The solid composition according to any one of [1] to

[13] , wherein ab is 25 or more and 75 or less. (Method 1) In accordance with JIS Z 8722, measured with a spectroscopic color difference meter, and the lightness (L * a * b * ), chromaticity (a * ), b * ), of the solid composition defined in the color system are obtained. The color difference (ΔE * ab) is determined by the following formula (1). * ab = ((L ΔE * ab = ((L * -100) 2 + a *2 + b *2 )) 1 / 2 (1)

[15] A discoloration inhibitor for a solid composition containing the following component (A), the discoloration inhibitor containing the following component (B). (A) At least one selected from the group consisting of tranexamic acid and its salts (B) Isomalt

[16] A step of heating a mixture containing the following component (B) and water to 120°C or higher, A step of adding and mixing the following component (A) to the heated mixture, A method for producing a solid composition, comprising. (A) At least one selected from the group consisting of tranexamic acid and its salts (B) Isomalt

[17] The method for producing a solid composition according to

[16] , wherein the step of adding and mixing component (A) includes a step of adding a mixture of component (A) and water.

[18] A method for suppressing discoloration of a solid composition containing the following component (A), A step of heating a mixture containing the following component (B) and water to 120°C or higher, A step of adding and mixing the following component (A) to the heated mixture, A discoloration suppression method, comprising. (A) At least one selected from the group consisting of tranexamic acid and its salts (B) Isomalt [Effects of the Invention]

[0007] According to the present invention, discoloration during the manufacture of solid compositions containing tranexamic acids can be suppressed, and the uniformity of the appearance can be improved. [Modes for carrying out the invention]

[0008] Embodiments of the present invention will be described below. In this embodiment, the composition may contain each component individually or in combination of two or more components. In this specification, the "~" symbol indicating a numerical range represents "greater than or equal to" and "less than or equal to," and includes both of the numbers at either end.

[0009] (solid composition) In this embodiment, the solid composition comprises a combination of tranexamic acids and specific sugars. Specific examples of these sugars include isomalts. More specifically, the isomalts are at least one selected from the group consisting of isomalt, isomaltoligosaccharides, and isomaltodextrin. Of these, isomalt is a mixture composed of α-D-glucopyranoside-1,6-mannitol and α-D-glucopyranose-1,6-sorbitol (isomallitol). Furthermore, both isomaltoligosaccharides and isomaltodextrins contain glucose as a constituent sugar and have α-1,6 links in their structure.

[0010] The solid composition preferably comprises the following components (A) and (B). (A) At least one selected from the group consisting of tranexamic acid and its salts (B) Isomalt

[0011] In this embodiment, since the solid composition contains a combination of components (A) and (B), discoloration during the manufacturing of the solid composition can be suppressed and the homogeneity of its appearance can be improved. More specifically, according to this embodiment, it is also possible to stably suppress browning that may occur during the manufacturing process of the solid composition. Furthermore, for example, it is possible to suppress surface roughness and glossiness of the solid composition, and to obtain a solid composition that is smooth and has a good mouthfeel. Also, when the solid composition is a candy drop, for example, it is possible to obtain a candy drop that is homogeneous, does not discolor, and is less prone to cracking and chipping. The components contained in the solid composition are described below.

[0012] (Component (A)) Component (A) is at least one selected from the group consisting of tranexamic acid (trans-4-aminomethylcyclohexanecarboxylic acid) and its salts. Component (A) can be manufactured by known methods, or a commercially available product can be used. For example, tranexamic acid is listed in the 18th edition of the Japanese Pharmacopoeia.

[0013] Specific examples of salts in tranexamic acid include hydrohalogen salts such as hydrofluoric acid, hydrochloride, hydrobromide, and hydroiodide; Inorganic salts such as nitrates, perchlorates, sulfates, and phosphates; Alkanesulfonates with 1 to 4 carbon atoms, such as methanesulfonates, trifluoromethanesulfonates, and ethanesulfonates; Aryl sulfonates such as benzenesulfonates and p-toluenesulfonates; Organic salts such as acetate, malate, fumarate, succinate, citrate, ascorbate, tartrate, oxalate, and maleate; Alkali metal salts such as sodium salts and potassium salts; Alkaline earth metal salts such as calcium salts and magnesium salts; Organic amine salts such as N-methylmorpholine salt, triethylamine salt, tributylamine salt, diisopropylethylamine salt, dicyclohexylamine salt, N-methylpiperidine salt, pyridine salt, 4-pyrrolidinopyridine salt, picoline salt, and One or more selected from the group consisting of salts with amino acids such as glycine salt, lysine salt, arginine salt, ornithine salt, glutamate, and aspartate.

[0014] Component (A) preferably contains tranexamic acid, and more preferably tranexamic acid. This makes it possible to more stably obtain the discoloration suppression effect and the appearance homogeneity improvement effect during the production of the solid composition.

[0015] The content of component (A) in the solid composition is preferably 0.1% by mass or more, more preferably 1% by mass or more, and even more preferably 3% by mass or more, relative to the total solid composition. This allows for a more reliable anti-inflammatory effect. Furthermore, the content of component (A) in the solid composition is preferably 35% by mass or less, more preferably 20% by mass or less, and even more preferably 10% by mass or less, relative to the total solid composition. This makes it possible to obtain a more homogeneous solid composition.

[0016] The amount of component (A) in the solid composition per day is preferably 50 mg or more, more preferably 400 mg or more, and even more preferably 750 mg or more. This allows for a more reliable anti-inflammatory effect. Furthermore, the content of component (A) in the solid composition per day is preferably 3000 mg or less, more preferably 2000 mg or less, and even more preferably 1500 mg or less. This makes it possible to obtain a more homogeneous solid composition.

[0017] Here, the amount of solid composition to be applied can be appropriately determined considering, for example, the user's gender, age, symptoms, method of application (e.g., administration), number of applications, timing of application, dosage form, etc., and it is preferable to use it within a range that does not cause side effects.

[0018] Furthermore, the number of times the composition is applied per day may be, for example, 1 to 12 times or 1 to 6 times, and preferably 1 to 3 times.

[0019] (Component (B)) Component (B) is the isomalt mentioned above. A commercially available product can be used as component (B).

[0020] Specifically, the content of component (B) in the solid composition can be the remainder after subtracting the amount of components other than component (B) in the solid composition. Furthermore, the content of component (B) in the solid composition is, for example, 55% by mass or more, preferably 65% ​​by mass or more, more preferably 70% by mass or more, and even more preferably 85% by mass or more, relative to the entire solid composition. This makes it possible to more stably obtain the discoloration suppression effect and the appearance homogeneity improvement effect during the production of the solid composition. Furthermore, the content of component (B) in the solid composition is preferably 99.9% by mass or less, more preferably 98% by mass or less, and even more preferably 96% by mass or less, relative to the total solid composition. This allows the effects of component (A) to be obtained more efficiently.

[0021] The mass ratio ((B) / (A)) of the content of component (B) to the content of component (A) in the solid composition is preferably 1.5 or higher, more preferably 3 or higher, even more preferably 5 or higher, and even more preferably 9 or higher. This makes it possible to more stably obtain the discoloration suppression effect and the appearance homogeneity improvement effect during the production of the solid composition. Furthermore, the above mass ratio ((B) / (A)) is preferably 40 or less, more preferably 35 or less, even more preferably 30 or less, and even more preferably 25 or less. This allows the effect of component (A) to be obtained more efficiently.

[0022] (Other ingredients) The solid composition may further contain components other than those described above. For example, the solid composition may further contain the following component (C).

[0023] (Component (C)) Component (C) is at least one selected from the group consisting of organic acids and their salts, and antioxidants. Further inclusion of component (C) in the solid composition can further suppress discoloration of the solid composition over time. Examples of organic acids and their salts include one or more selected from the group consisting of citric acid, tartaric acid, malic acid, succinic acid, fumaric acid, maleic acid, and salts thereof, as well as their hydrates. Specific examples of salts include alkali metal salts such as sodium salts and potassium salts; and alkaline earth metal salts such as magnesium salts and calcium salts. Furthermore, as antioxidants, one or more selected from the group consisting of sodium bisulfite and sodium pyrosulfite may be used.

[0024] The content of organic acids in the solid composition is preferably 0.1% by mass or more, more preferably 1% by mass or more, and even more preferably 3% by mass or more, relative to the total solid composition. This makes it possible to more stably suppress discoloration of the solid composition over time. Furthermore, the content of organic acids in the solid composition is preferably 20% by mass or less, more preferably 15% by mass or less, and even more preferably 13% by mass or less, relative to the total solid composition. This makes it possible to obtain a more homogeneous solid composition.

[0025] The antioxidant content in the solid composition is preferably 0.1% by mass or more, more preferably 0.2% by mass or more, and even more preferably 0.5% by mass or more, relative to the total solid composition. This makes it possible to more stably suppress discoloration of the solid composition over time. Furthermore, the antioxidant content in the solid composition is preferably 5% by mass or less, more preferably 3% by mass or less, and even more preferably 1% by mass or less, relative to the total solid composition. This makes it possible to obtain a solid composition with a better palatability.

[0026] Furthermore, the total content of component (C) in the solid composition is preferably 0.1% by mass or more, more preferably 0.2% by mass or more, and even more preferably 0.5% by mass or more, relative to the entire solid composition. This makes it possible to more stably suppress discoloration of the solid composition over time. Furthermore, the total content of component (C) in the solid composition is preferably 25% by mass or less, more preferably 20% by mass or less, and even more preferably 15% by mass or less, relative to the entire solid composition. This makes it possible to obtain a more homogeneous solid composition.

[0027] (water) The solid composition may contain water. The water may be, for example, water added during the manufacture of the solid composition. When the solid composition contains water, its content is specifically greater than 0% by mass relative to the entire solid composition, and may also be 0.1% by mass or more. Furthermore, the water content in the solid composition is preferably 10% by mass or less, more preferably 7% by mass or less, and even more preferably 5% by mass or less, relative to the total solid composition. This allows for a more stable improvement in the uniformity of the appearance of the solid composition during manufacturing.

[0028] Other components included in the solid composition include, for example, sweeteners, acidulants, flavorings, colorings, thickeners, preservatives, and other ingredients.

[0029] The sweetener is one or more components selected from the group consisting of, for example, xylitol, stevia, aspartame, sucralose, sorbitol, l-menthol, acesulfame potassium, and reduced maltose syrup. The acidulant may be added, for example, by incorporating the aforementioned component (C), and more specifically, it may be one or more components selected from the group consisting of malic acid, tartaric acid, lactic acid, and maleic acid. The flavoring is one or more ingredients selected from the group consisting of, for example, natural flavors (such as fruit flavors), mint essence, vanilla essence, cinnamon flavoring, and lemon essence. The coloring agent is, for example, at least one component selected from the group consisting of tar-based dyes and natural coloring agents (beet juice, spirulina, etc.). The thickener is, for example, one or more components selected from the group consisting of gelatin, gum arabic, pectin, xanthan gum, and carboxymethylcellulose. The preservative is, for example, one or more components selected from the group consisting of sorbic acid, parabens, and sodium benzoate. Other components include, for example, one or more components selected from the group consisting of vitamin C (ascorbic acid), vitamin E (tocopherol), magnesium compounds (such as magnesium oxide), calcium compounds (such as calcium lactate), and antioxidants (such as rosemary extract, in addition to the aforementioned component (C)). Next, we will describe the surface properties of the solid composition.

[0030] The solid composition is, for example, a tablet, and the arithmetic mean curvature Spc(mm) of the peaks on the surface of the tablet is defined in ISO 25178. -1 The coefficient of gravity is preferably 5.0 or less, more preferably 4.4 or less, even more preferably 4.2 or less, and even more preferably 4.0 or less. This makes the surface of the solid composition smoother to the touch. For this reason, for example, roughness in the oral cavity can be reduced when the solid composition is an oral composition. Furthermore, the above Spc(mm) of the solid composition -1 ) may be, for example, 0.1 or greater, or for example, 1.0 or greater.

[0031] The solid composition is, for example, a tablet, and the surface area ratio Sdr of the interface as defined in ISO 25178 on the surface of the tablet is preferably 0.050 or less, and more preferably 0.029 or less. This makes the surface of the solid composition smoother to the touch. For this reason, roughness in the oral cavity can be reduced, for example, when the solid composition is an oral composition. Furthermore, the Sdr of the solid composition may be, for example, 0.001 or more, or for example, 0.01 or more.

[0032] Spc(mm) of solid composition -1 ) and Sdr can be measured under the following conditions using a commercially available shape analysis laser microscope or 3D scanner (for example, Keyence's One-Shot 3D Shape Measuring Machine VR-6200). Magnification: 12x Scanning range: Within a 2.5 mm square area from the center of the sample. Measurement frequency, etc.: For each of the three samples, one measurement value was obtained, and the average of these values ​​was used.

[0033] The color difference ΔE of the solid composition is measured by the following method 1. * ab is preferably 75 or less, more preferably 70 or less, and even more preferably 65 or less. This makes it possible to more reliably suppress discoloration during the production of the solid composition. Furthermore, the color difference ΔE of the solid composition * ab may be, for example, 25 or more, or it may also be, for example, 30 or more, or 35 or more.

[0034] (Method 1) In accordance with JIS Z 8722, measurements were taken using a spectrophotometer (e.g., SE7700, manufactured by Nippon Denshoku Industries Co., Ltd.) and CIE1976L * a * b * Lightness (L) of a solid composition defined by a color system * ), chromaticity (a * , b * ) is obtained. The color difference (△E) is obtained using the following formula (1). * Find ab). △E * ab=((L * -100) 2 +a *2 +b *2 )) 1 / 2 (1)

[0035] The measurement conditions in Method 1 are specifically as follows. In Method 1, the surface color of the solid composition is measured. Measurement wavelength: 380~780nm Measurement angle: 60° reflection measurement Measurement locations: Average value of two locations

[0036] Furthermore, the brightness (L) of the solid composition measured by Method 1 * The value of ) is preferably 22 or higher, more preferably 25 or higher, and may also be preferably 100 or lower. This can further improve the appearance of the solid composition.

[0037] Similarly, the chromaticity of the solid composition measured by Method 1 (a * ) could be, for example, -2.0 to 0.0. Similarly, the chromaticity of the solid composition measured by Method 1 (b * ) could be, for example, -2.0 to 3.0.

[0038] (Dosage form, etc.) The solid composition may be, for example, a pharmaceutical composition, a quasi-drug composition, or a food composition, and is preferably a pharmaceutical composition. This makes it possible to more reliably obtain the desired efficacy. For example, since the solid composition contains component (A), it can provide one or more effects selected from the group consisting of reducing inflammation such as stomatitis and pharyngitis, and skin whitening. Furthermore, the solid composition is preferably a composition for stomatitis, a composition for pharyngitis, or a whitening composition.

[0039] The solid composition is preferably an oral composition. This allows for excellent ease of ingestion. Similarly, the solid composition is preferably an oral composition.

[0040] The dosage form of the solid composition may be, for example, a tablet, granules, pill, powder, gummy, or jelly, and is preferably a tablet. Examples of tablets include chewable tablets, lozenges, drops, uncoated tablets, sugar-coated tablets, orally disintegrating tablets, and film-coated tablets, and are preferably selected from the group consisting of chewable tablets, lozenges, and drops. This makes it easier to take the solid composition.

[0041] Next, a method for producing the solid composition will be described. A method for producing a solid composition includes, for example, a step of heating a mixture containing component (B) and water to 120°C or higher (step 10), and a step of adding component (A) to the heated mixture and mixing it (step 20). By mixing components (A) and (B) in step 20 after step 10, the discoloration suppression effect and the improvement of appearance homogeneity during the production of the solid composition can be obtained more stably.

[0042] The amount of water added in step 10 can be, for example, 1 to 50 parts by mass per 100 parts by mass of component (B).

[0043] The heating temperature in step 10 is, for example, 120°C or higher, preferably 130°C, more preferably 140°C or higher, and also preferably 180°C or lower, more preferably 160°C or lower. This makes it possible to obtain a solid composition with excellent appearance homogeneity more stably.

[0044] The mixing temperature in step 20 can be, for example, 100 to 150°C. The mixing temperature in step 20 may be lower than the heating temperature in step 10.

[0045] Furthermore, step 20 may include a step of adding a mixture of component (A) and water. This makes it possible to more stably obtain the discoloration suppression effect and the appearance homogeneity improvement effect during the production of the solid composition. The amount of water added at this time can be, for example, 50 to 800 parts by mass per 100 parts by mass of component (A).

[0046] Furthermore, the method for producing the solid composition may further include, after step 20, a step (step 30) in which the mixture obtained in step 20 is poured into a mold and left to stand until it solidifies. The standing temperature in step 30 may be, for example, 20 to 40°C. A solid composition can be obtained through the above process.

[0047] (Method for preventing discoloration) In this embodiment, the discoloration suppression method is a method for suppressing discoloration of a solid composition containing component (A), and includes the steps of heating a mixture containing component (B) and water to 120°C or higher (step 10), and adding and mixing the following component (A) to the heated mixture (step 20). This makes it possible to suppress discoloration when manufacturing solid compositions containing component (A) and improve the uniformity of appearance. Furthermore, the configuration described above for the method of producing the solid composition can be used as appropriate for the method of suppressing discoloration.

[0048] (Discoloration inhibitor) In this embodiment, the discoloration inhibitor is a discoloration inhibitor for a solid composition containing component (A), and also contains component (B). As described above, by providing a discoloration inhibitor that includes component (B), it is possible to suppress discoloration during the manufacturing of the solid composition containing component (A) and improve the uniformity of its appearance.

[0049] The embodiments of the present invention have been described above, but these are merely examples, and various other configurations can also be adopted. [Examples]

[0050] The embodiment will be described in detail below with reference to examples, but this embodiment is not limited to these examples.

[0051] (Examples 1-4, Comparative Examples 1-4) The ingredients were mixed according to the formulations listed in Table 1 or Table 2, and tablets (drops) were prepared using the following procedure.

[0052] (Method for preparing lozenges) Component (B) or (B)' was mixed with 1800 mg of water and heated at 150°C for 1 hour. The temperature was then reduced to 120°C, and an aqueous solution (44.2%) of component (A) was added and mixed. The resulting mixture was poured into a mold (15 mm x 15 mm) and left at room temperature (25°C) until it solidified. After that, it was removed from the mold to obtain the drops for each example. The thickness of the obtained drops was approximately 5 mm.

[0053] (Color measurement) Measurements were taken using a spectrophotometer in accordance with JIS Z 8722 and CIE1976L. * a * b * The lightness (L) of the surface of each example of the dropper as defined by the color system. * ), chromaticity (a * , b * ) was obtained. The color difference (△E) is calculated using the following formula (1). * We calculated ab). The results are shown in Tables 1 and 2. △E * ab=((L * -100) 2 +a *2 +b *2 )) 1 / 2 (1)

[0054] The measuring equipment and conditions are as follows. • Measuring device: SE7700, manufactured by Nippon Denshoku Kogyo Co., Ltd. ·Measurement wavelength: 380~780nm ·Measurement angle: 60° reflection measurement • Measurement locations: Average value of two locations

[0055] (Surface roughness) For examples other than Comparative Examples 3 and 4, the arithmetic mean curvature Spc(mm) of the peaks on the surface of the drop agent as defined in ISO 25178. -1 The surface area ratio Sdr was measured. The results are shown in Tables 1 and 2. The measuring apparatus and conditions are as follows. Comparative Examples 3 and 4 (marked "-" in Table 1) were not measured because they showed significant discoloration in their appearance (visual color), as described later. • Measurement device: 3D scanner (Keyence VR-6200 one-shot 3D shape measuring machine) • Magnification: 12x • Scanning range: Within a 2.5 mm square area from the center of the sample • Number of measurements, etc.: For each of the three samples, a measurement value was obtained at one location, and the average of these values ​​was used.

[0056] (evaluation) The appearance and cracking of the drops obtained in each case were evaluated.

[0057] (exterior) The color (visual color) and surface appearance (visual appearance) of the drops were evaluated visually. The results are shown in Tables 1 and 2.

[0058] (Warekake) For the examples shown in Table 1, 20 samples were placed in 18cm x 12cm resealable aluminum laminate bags, the bags were closed, and the bags were dropped once from a height of 150cm. After dropping, the bags were opened and visually inspected for cracks or chips.

[0059] [Table 1]

[0060] [Table 2]

[0061] The details of the components used in Tables 1, 2, and Table 3 (described below) are shown below. Isomalt: Manufactured by BENEO-Palatinit GmbH Tranexamic acid: Manufactured by AMI LIFESCIENCES PVT. LTD. Citric acid: Manufactured by Fujifilm Wako Pure Chemical Industries, Ltd. Malic acid: Manufactured by Fuso Chemical Industry Co., Ltd. Tartaric acid: Manufactured by Showa Chemical Co., Ltd. Sodium bisulfite: Manufactured by Fujifilm Wako Pure Chemical Industries, Ltd.

[0062] Tables 1 and 2 show that in each example, the inclusion of components (A) and (B) in combination effectively suppressed browning that occurred during the production of the drops, and a homogeneous surface was obtained. Furthermore, as shown in Table 1, cracking due to dropping was also suitably suppressed, indicating excellent impact resistance during transportation.

[0063] (Examples 5-8) The ingredients were mixed according to the formulations listed in Table 3, and tablets (drops) were prepared using the following procedure.

[0064] (Method for preparing lozenges) Component (B) was mixed with 1800 mg of water and heated at 150°C for 1 hour. The temperature was then reduced to 120°C, and a mixture of component (A), component (C), and water was added. The resulting mixture was poured into a mold (15 mm x 15 mm) and left at room temperature (25°C) until solidified. Afterward, it was removed from the mold to obtain the drops for each example.

[0065] The color of the drops obtained in each example was visually evaluated immediately after production and after storage at 40°C for 1 month (1M). The results for each example are shown in Table 3 along with those for Example 1.

[0066] [Table 3]

[0067] Table 3 shows that by further incorporating component (C), discoloration during storage, in addition to discoloration immediately after manufacturing, was more effectively suppressed.

Claims

1. A solid composition comprising the following components (A) and (B). (A) At least one selected from the group consisting of tranexamic acid and its salts (B) Isomalt

2. The solid composition according to claim 1, wherein the mass ratio ((B) / (A)) of the content of component (B) to the content of component (A) in the solid composition is 1.5 or more and 40 or less.

3. The solid composition according to claim 1 or 2, wherein the content of component (A) in the solid composition per day is 50 mg or more and 3000 mg or less.

4. The solid composition according to claim 1 or 2, further comprising the following component (C). (C) At least one selected from the group consisting of organic acids and their salts and antioxidants.

5. A solid composition according to claim 1 or 2, which is an oral composition.

6. A solid composition according to claim 1 or 2, which is a pharmaceutical composition.

7. A solid composition according to claim 1 or 2, which is a composition for treating stomatitis.

8. A solid composition according to claim 1 or 2, which is a composition for pharyngitis.

9. A solid composition according to claim 1 or 2, which is a whitening composition.

10. A solid composition according to claim 1 or 2, which is a tablet.

11. The solid composition according to claim 10, wherein the dosage form of the tablet is selected from the group consisting of chewable tablets, lozenges, and drops.

12. The arithmetic mean curvature Spc (mm) of the peaks on the surface of the tablet as defined in ISO 25178. -1 The solid composition according to claim 10, wherein the ratio is 4.0 or less.

13. The solid composition according to claim 10, wherein the surface area ratio Sdr of the tablet as defined in ISO 25178 is 0.029 or less.

14. The color difference ΔE of the solid composition is measured by the following method 1. ＊ The solid composition according to claim 1 or 2, wherein ab is 25 or more and 75 or less. (Method 1) Conforming to JIS Z 8722, measured with a spectroscopic color difference meter, and in the CIE 1976 L * a * b * The lightness (L ＊ ) and chromaticity (a ＊ , b ＊ ) of the solid composition defined in the color system are obtained. The color difference (ΔE ＊ ab) is determined by the following formula (1). △E ＊ ab=((L ＊ -100) ２ +a ＊２ +b ＊２ )) １ / ２ (1)

15. A discoloration inhibitor for a solid composition containing the following component (A), wherein the discoloration inhibitor also contains the following component (B). (A) At least one selected from the group consisting of tranexamic acid and its salts (B) Isomalt

16. A step of heating a mixture containing the following component (B) and water to 120°C or higher, The process involves adding the following component (A) to the heated mixture and mixing it, A method for producing a solid composition containing the above. (A) At least one selected from the group consisting of tranexamic acid and its salts (B) Isomalt

17. The method for producing a solid composition according to claim 16, wherein the step of adding and mixing component (A) includes the step of adding a mixture of component (A) and water.

18. A method for suppressing discoloration of a solid composition containing the following component (A): A step of heating a mixture containing the following component (B) and water to 120°C or higher, The process involves adding the following component (A) to the heated mixture and mixing it, A method for suppressing discoloration, including the method described above. (A) At least one selected from the group consisting of tranexamic acid and its salts (B) Isomalt

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