Disintegration accelerator and tablets
A puffing-treated grain flour from barley, wheat, or rye is used to enhance tablet disintegration, addressing the insufficiencies of conventional natural-derived accelerators by ensuring rapid and stable disintegration.
Patent Information
- Authority / Receiving Office
- JP · JP
- Patent Type
- Applications
- Current Assignee / Owner
- Filing Date
- 2024-09-30
- Publication Date
- 2026-04-09
AI Technical Summary
Conventional disintegration accelerators composed of natural-derived components have insufficient disintegration accelerating effects, particularly when tablets contain hardly disintegrating components, which deteriorate the disintegratability of the tablet.
A disintegration accelerator made from grain flour derived from grains like barley, wheat, rye, or wild oats, subjected to a puffing treatment, is used, with specific viscosity and particle size distribution parameters optimized for effective disintegration.
The solution provides a disintegration accelerator derived from natural materials with improved disintegration properties, promoting rapid tablet disintegration and maintaining stability under accelerated conditions.
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Abstract
Description
Technical Field
[0001] The present invention relates to a disintegration accelerator and a tablet using the same.
Background Art
[0002] In the fields of pharmaceuticals and foods, tablets are applied as solid dosage forms for facilitating ingestion. Generally, tablets are rapidly disintegrated in the body such as in the oral cavity, stomach, and intestine, and a disintegration accelerator is used as an additive for releasing an active ingredient.
[0003] As disclosed in Patent Documents 1 and 2, as disintegration accelerators that can be used in tablets, sodium starch glycolate, semi-synthetic polymers such as sodium carboxymethylcellulose, and natural polysaccharides such as corn starch and pregelatinized starch are known.
Prior Art Documents
Patent Documents
[0004]
Patent Document 1
Patent Document 2
Summary of the Invention
Problems to be Solved by the Invention
[0005] A disintegration accelerator used in tablets has been desired to be composed of a natural-derived component. However, conventional disintegration accelerators composed of natural-derived components have a problem that the disintegration accelerating effect of tablets is still insufficient. In particular, when a tablet contains a hardly disintegrating component that deteriorates the disintegratability of the tablet, the problem becomes prominent.
Means for Solving the Problems
[0006] As a result of research conducted to solve the above-mentioned problems, the inventors of the present invention have found that grain flour derived from a specific grain, after being subjected to a puffing treatment, is suitable as a disintegration accelerator. The following describes various methods for solving the above problems.
[0007] The essence of the disintegration accelerator of Embodiment 1 is that it comprises grain flour derived from at least one grain selected from the genera of barley, wheat, rye, and wild oats, wherein the grain flour has been subjected to a puffing treatment.
[0008] Embodiment 2 is a disintegration accelerator according to Embodiment 1, wherein the grain flour is mixed with water and its viscosity is measured using a rapid viscoanalytic analyzer (RVA) under the following RVA measurement conditions consisting of steps (a) to (d), and the maximum viscosity peak is observed in steps (b) to (c) of steps (a) to (d).
[0009] (a) Stir at 50°C for 1 minute, (b) Stir for 3 minutes and 42 seconds while increasing the temperature from 50°C to 95°C at a rate of 12.2°C / min, (c) Stir for 2 minutes and 30 seconds at 95°C, and (d) Stir for 3 minutes and 48 seconds while decreasing the temperature from 95°C to 50°C at a rate of 11.8°C / min.
[0010] Embodiment 3 is a disintegration accelerator according to Embodiment 1 or 2, wherein the grain flour has a uniformity (D60 / D10) of less than 10, determined by D60 to D10 in a volume-based particle size distribution based on laser diffraction-scattering particle size distribution measurement.
[0011] Embodiment 4 is a disintegration accelerator according to any one embodiment of Embodiments 1 to 3, wherein the grain is of the genus Avena. The gist of the tablet of Embodiment 5 is that it contains a disintegration accelerator described in any one of Embodiments 1 to 4 and a non-disintegrating component.
[0012] Embodiment 6 is a tablet according to Embodiment 5, wherein the non-disintegrating component is at least one lipid-soluble component selected from lipid-soluble vitamins, benzoquinone derivatives, polyphenols, materials containing polyphenols, xanthophyll, and materials containing xanthophyll.
[0013] Embodiment 7 is the tablet described in Embodiment 6, wherein the lipid-soluble component is at least one selected from vitamin E, coenzyme Q10, lutein, and turmeric. Embodiment 8 is a tablet according to Embodiment 6 or 7, wherein the content of the lipid-soluble component in the tablet is 30% by mass or less.
[0014] Embodiment 9 is a tablet according to any one embodiment of Embodiments 5 to 8, wherein the non-disintegrating component is at least one selected from polysaccharides, proteins, and beekeeping products. Embodiment 10 is a tablet according to any one embodiment of Embodiments 5 to 9, wherein the non-disintegrating component is at least one selected from hyaluronic acid, proteoglycan, chondroitin, and royal jelly.
[0015] Embodiment 11 is a tablet according to any one embodiment of Embodiments 5 to 10, wherein the hardness change when subjected to an accelerated test for 2 months under conditions of a temperature of 40°C and a relative humidity of 75% is 50N or less. Embodiment 12 is a tablet according to any one embodiment of Embodiments 5 to 11, wherein the increase in disintegration time when subjected to a 2-month accelerated test under conditions of a temperature of 40°C and a relative humidity of 75% is 20 minutes or less. [Effects of the Invention]
[0016] According to the present invention, it is possible to provide a disintegration accelerator that is derived from natural materials and has suitable tablet disintegration properties. [Brief explanation of the drawing]
[0017] [Figure 1]Figure 1 is a graph showing the RVA curves obtained by measuring the viscosities of the expanded oat flour of Example 1 and the oat flour of Comparative Example 1 using a Rapid Visco Analyzer (RVA) under predetermined RVA measurement conditions. [Figure 2] Figure 2 is a flowchart showing the manufacturing process of the expanded oat flour in order.
Mode for Carrying Out the Invention
[0018] An embodiment in which the disintegration accelerator according to the present invention is embodied will be described. The disintegration accelerator contains cereal flour derived from at least one cereal selected from the genus Hordeum, Triticum, Secale, and Avena, and the cereal flour is puffed.
[0019] Examples of those contained in the above cereals include the following. <Cereal> The genus Hordeum, Triticum, Secale, and Avena are cereals belonging to the family Poaceae and are classified as wheat.
[0020] Examples of cereals belonging to the genus Hordeum include barley, etc. Barley is also called naked barley. Examples of cereals belonging to the genus Triticum include wheat, etc.
[0021] Examples of cereals belonging to the genus Secale include rye, etc. Examples of cereals belonging to the genus Avena include coleseed oats, oat, etc. Oat is also called oatmeal, oat.
[0022] In the above-mentioned grain flour, if the particle sizes at which the cumulative volume from the smallest particle size side accounts for 10%, 50%, and 60% of the total particle size distribution based on the laser diffraction / scattering particle size distribution method are D10, D50, and D60, respectively, then the uniformity (D60 / D10) determined by D60 relative to D10 is preferably less than 10, and more preferably 6 or less. A smaller value for uniformity (D60 / D10) indicates higher uniformity. This improves the water-conducting and swelling ability of the tablets during water absorption, thereby efficiently promoting tablet disintegration. The particle size distribution can be measured using a commercially available laser diffraction / scattering particle size distribution analyzer, such as the MT3000II manufactured by Microtrac-Bell. Uniformity can be adjusted by sieving.
[0023] Furthermore, the value of D50 is preferably 50 μm or more and 150 μm or less, more preferably 75 μm or more and 125 μm or less. <Expansion treatment> The disintegration accelerator is made from grain flour derived from the above-mentioned grains, which has been subjected to a puffing process.
[0024] In this invention, the expansion treatment refers to altering the structure of the raw material grain by heating and pressurizing, followed by cooling or drying the raw material grain. The raw material grain may be grains or powder. It may also be a dry process using dried raw materials, or a wet process using hydrated or kneaded materials. After the expansion treatment, it may be powdered if necessary.
[0025] The expansion process can be carried out using commercially available extrusion molding equipment such as an extruder. An extrusion molding equipment is a device that compresses, mixes, heats, and shears the raw material while extruding it with a screw inside a cylinder.
[0026] The extrusion molding apparatus may be either a single-screw type that extrudes the raw material with one screw, or a multi-screw type that extrudes the raw material with two or more screws. In a twin-screw type that extrudes the raw material with two screws, the two screws interfere with each other to grip and transport the raw material, so the apparatus can be operated without being significantly affected by the characteristics of the processed raw material. There are no particular limitations on twin-screw extrusion molding apparatuses, and commercially available equipment can be used. Examples of extruder manufacturers include Bühler, Buss, GEA, STEER, Wenger, Baker-Perkins, and NP Foods.
[0027] The raw grain may be coarsely ground beforehand to a size that is easy to feed into an extrusion molding machine. Known grinding equipment can be used for coarse grinding. Specifically, this includes grinding equipment such as hammer mills and pin mills, or grinders using media such as bead mills, sand mills, and attritors. These grinding methods may be applied individually or in combination of two or more.
[0028] The raw grain is hydrated after grinding. The mixture obtained by hydration and stirring is fed into an extruder. Further water may be added during the extruding process. The moisture content of the mixture to be extruded is preferably 10% to 50% by mass, and more preferably 20% to 30% by mass. Note that adding water during the process as described above is not mandatory; water may be added only before the extruding process. Alternatively, water may be added only during the extruding process.
[0029] The extruder processing temperature is specified to be between 90°C and 250°C, preferably between 110°C and 200°C, and more preferably between 120°C and 150°C. This temperature range allows for the efficient production of grain flour having the viscosity parameters described later. The extruder processing temperature refers to the highest temperature in the barrel and is referred to as the "heating temperature" in the following description.
[0030] Next, the extruded processed material is pulverized after being dried. For the drying process, known methods can be appropriately adopted. Examples of known drying methods include drum dryers, spray dryers, pneumatic drying methods, freeze-drying methods, etc. Drying and pulverization may be performed simultaneously or continuously using various drying and pulverizing machines. Examples of pulverizers used in the pulverization process include the impact-type pulverizing dryer manufactured by Kitakawa Iron Works Co., Ltd., the Victormill manufactured by Hosokawa Micron Corporation, the Super Powder Mill manufactured by Nishimura Machinery Works Co., Ltd., the SK Jet Omnil mill manufactured by Seishin Enterprise Co., Ltd., etc. In the case of a device capable of performing drying and pulverization simultaneously, the drying process before the pulverization process may be omitted.
[0031] <RVA Measurement> The disintegration accelerator may be one that has a maximum viscosity peak in steps (b) to (c) among steps (a) to (d) when the above cereal powder is mixed with water and the viscosity is measured using the RVA measurement conditions consisting of the following steps (a) to (d) in a Rapid Visco Analyzer (RVA).
[0032] (a) In this step, after stirring at a temperature of 50°C and a paddle rotation speed of 960 rpm for 10 seconds, it is stirred at a paddle rotation speed of 160 rpm for 50 seconds (a total of 一分钟). (b) In this step, while the temperature is raised from 50°C to 95°C at a rate of 12.2°C / min, it is stirred at a rotation speed of 160 rpm for 3 minutes and 42 seconds. (c) In this step, it is stirred at a temperature of 95°C and a rotation speed of 160 rpm for 2 minutes and 30 seconds. (d) In this step, while the temperature is lowered from 95°C to 50°C at a rate of 11.8°C / min, it is stirred at a rotation speed of 160 rpm for 3 minutes and 48 seconds.
[0033] In step (d), it is preferable that the low viscosity state decreased in step (c) is maintained, and it is preferably maintained at a viscosity value lower than the maximum viscosity peak value. As the Rapid Visco Analyzer, commercially available products can be used, for example, RVA4500 (manufactured by Perkin Elmer).
[0034] <Tablet> Next, an embodiment of a tablet using the disintegration accelerator according to the present invention will be described. The tablets contain the aforementioned disintegration accelerator and a non-disintegrating component.
[0035] There are no particular restrictions on the content of the disintegration accelerator in the tablets, and it can be set appropriately depending on the purpose, but it is preferably 0.3% by mass or more, more preferably 0.5% by mass or more, even more preferably 2.5% by mass or more and 15% by mass or less, and particularly preferably 5% by mass or more and 10% by mass or less.
[0036] The following describes the non-disintegrating components contained in the tablets. <Difficult-to-disintegrate components> The non-disintegrating components are those listed below.
[0037] Examples of non-disintegrating components include lipid-soluble components, polysaccharides, proteins, and beekeeping products. Examples of the above-mentioned lipid-soluble components include lipid-soluble vitamins, benzoquinone derivatives, polyphenols, materials containing polyphenols, xanthophyll, and materials containing xanthophyll. Specific examples of lipid-soluble components include, for example, vitamin E, coenzyme Q10, lutein, and turmeric. The content of lipid-soluble components in the tablets is not particularly limited, but it is preferably 30% by mass or less.
[0038] Specific examples of the above-mentioned polysaccharides include, for example, hyaluronic acid, proteoglycans, and chondroitin. Specific examples of the above-mentioned proteins include, for instance, collagen and collagen peptides.
[0039] Specific examples of the beekeeping products mentioned above include royal jelly, propolis, and their extracts. These non-disintegrating components may be used individually or in combination of two or more. There are no particular restrictions on the content of non-disintegrating components other than lipid-soluble components in the tablets, and it can be set appropriately depending on the purpose, but 5% by mass or more is preferred, 10% by mass or more is more preferred, 15% by mass or more and 50% by mass or less is even more preferred, and 20% by mass or more and 40% by mass or less is particularly preferred.
[0040] The following describes the application forms of the tablets. <Application form> The shape, structure, and size of the tablets are not particularly limited and can be set as appropriate. The tablet press is not particularly limited and commercially available products can be used as appropriate. Specific examples of tablet presses include single-shot tablet presses and rotary tablet presses. Furthermore, the pressure used during tableting is not particularly limited and the pressure used for general tablet molding can be used as appropriate.
[0041] The form in which tablets can be applied is not particularly limited; for example, they can be applied as powdered foods, nutritional supplements, supplements, pharmaceuticals, etc. The tablets are preferably those whose hardness change after a 2-month accelerated test under conditions of 40°C and 75% relative humidity is 50N or less. For example, the tablets used for measurement are 8mm in diameter tablets obtained by compressing 250mg of tablet powder with a compression pressure of 0.8t.
[0042] Furthermore, it is preferable that the tablets exhibit an increase in disintegration time of 20 minutes or less when subjected to an accelerated test for two months under conditions of 40°C and 75% relative humidity. The tablets used for measurement are those described above. Disintegration time is measured using a disintegration test machine with water as the solvent and a water temperature of 37°C, with 35 up-and-down movements per minute (n=6).
[0043] <Effects and Effects of the Embodiment> The operation and effects of this embodiment will now be described. (1) The disintegration accelerator of this embodiment contains grain flour derived from at least one grain selected from the genera of barley, wheat, rye, and oat, and the grain flour is puffed. Therefore, a disintegration accelerator made from naturally derived materials can be provided.
[0044] (2) The disintegration accelerator of this embodiment has a more favorable disintegration-promoting effect compared to carmellose sodium and pregelatinized starch, which are conventionally known as disintegration accelerators that can be used in tablets. Therefore, it is possible to provide a disintegration accelerator that is derived from natural materials and has favorable tablet disintegration properties.
[0045] (3) When the uniformity of grain flour, as determined by the ratio of D60 to D10 in the volume-based particle size distribution based on the laser diffraction-scattering particle size distribution method (D60 / D10), is less than 10, a highly uniform disintegration accelerator can be provided. This allows for the provision of a superior disintegration accelerator.
[0046] (4) Tablets using a disintegration accelerator contain the above-mentioned disintegration accelerator and a non-disintegrating component. Therefore, it is possible to provide tablets that are made from naturally derived materials and contain a disintegration accelerator having suitable tablet disintegration properties.
[0047] <Example of changes> This embodiment can be implemented with the following modifications. This embodiment and the following modifications can be combined with each other to the extent that they do not contradict each other technically.
[0048] The tablets of the above embodiments may be used in combination with lubricants, excipients, sugar alcohols, binders, adhesives, colorants, pH adjusters, buffers, and antioxidants, as long as they do not impair the effects of the present invention. [Examples]
[0049] The following are examples to illustrate the structure and effects of the present invention in more detail, but the present invention is not limited to these examples. (Test Example 1) <Extrusion treatment> The oat flour was subjected to extrusion treatment by the method shown in FIG. 2 to obtain extruded oat flour (hereinafter referred to as "extruded oat flour").
[0050] For the extruded oat flour and oat flour, the uniformity (D60 / D10) determined by D60 with respect to D10 in the volume-based particle size distribution based on the laser diffraction / scattering particle size distribution measurement method was calculated. As a result, the extruded oat flour was 4.63 and the oat flour was 10.71. That is, the extruded oat flour had a higher uniformity than the oat flour. The D50 of the extruded oat flour and oat flour was 105.70 μm and 45.02 μm, respectively.
[0051] [[ID=lo]]<RVA measurement> RVA4500 (manufactured by Perkin Elmer) was used as a Rapid Visco Analyzer. 3 g of the sample and 25 g of water were added to the metal cup for measurement, and the paddle was set (set so that the solid content became 14% taking into account the moisture value of the sample), and viscosity measurement using the RVA measurement conditions consisting of the following steps (a) to (d) was started.
[0052] (a) Stir for 10 seconds at a temperature of 50°C and a paddle rotation speed of 960 rpm, then stir for 50 seconds at a paddle rotation speed of 160 rpm. (b) Heat from a temperature of 50°C to 95°C at a rate of 12.2°C / min while stirring at a rotation speed of 160 rpm for 3 minutes and 42 seconds. (c) Stir at a temperature of 95°C and a rotation speed of 160 rpm for 2 minutes and 30 seconds. (d) Stir at a rotation speed of 160 rpm for 3 minutes and 48 seconds while cooling from a temperature of 95°C to 50°C at a rate of 11.8°C / min.
[0053] The measurement results are shown in FIG. 1. The examination of the RVA measurement was carried out with n = 1. The broken line in FIG. 1 indicates the temperature change. As shown in Figure 1, in the expanded oat flour, it was confirmed that the viscosity increased over time in steps (b) to (c), and then decreased. Furthermore, in step (d), it was confirmed that the low viscosity state that was achieved in step (c) was maintained. In other words, it was confirmed that there was a maximum viscosity peak in steps (b) to (c).
[0054] In the case of oat flour, it was confirmed that the viscosity increased over time in processes (b) to (c), and then decreased thereafter. In addition, it was confirmed that the viscosity increased over time in process (d).
[0055] <Tablet manufacturing> Tables 1 to 5 show the types of disintegration accelerators, non-disintegrating components, and other excipients contained in the tablets of Examples 1 to 11 and Comparative Examples 1 to 23. As shown in Table 2, for Examples 2 and Comparative Examples 4 to 8, grain flours treated with the same expansion process as described above were used as disintegration accelerators. The numerical values indicating the content of each component in the table are in mass percent (the same applies hereafter).
[0056] Regarding carmellose sodium, there is a usage standard that limits its content to 2% by mass or less when used in food. Therefore, in Comparative Example 23, the amount of carmellose sodium used as a disintegrant was set to the upper limit of 2% by mass.
[0057] Each of the components listed in Tables 1-5 was mixed and compressed into tablet powders. Each tablet powder (250 mg) was filled into a hand press jig (manufactured by Mori Machinery Co., Ltd.). Then, using a 10-ton hydraulic press STJ-10P (manufactured by ST Japan Co., Ltd.), each tablet powder was compressed at a pressure of 0.8 ton to obtain tablets with a diameter of 8 mm.
[0058] [Table 1]
[0059] [Table 2]
[0060] [Table 3]
[0061] [Table 4]
[0062] [Table 5] <Measurement> The measured hardness and disintegration time for the tablets of Examples 1-11 and Comparative Examples 1-23 are shown in Tables 1-5 under "Hardness (N)" and "Disintegration Time," respectively.
[0063] Hardness was measured using a load cell type desktop hardness tester DC-50 Desktop Checker (manufactured by Okada Seikou Co., Ltd.). The hardness study was conducted with n=3, and the calculated value was the average value. Disintegration tests were conducted using HC-1 disintegration testers (manufactured by Yazawa Kagaku Co., Ltd.) with 6 tablets of each type, using water as the solvent at a water temperature of 37°C, and with 35 up-and-down movements per minute. The disintegration time of the tablets was measured. Disintegration time was examined with n=6, and the calculated value was the average. In addition, for each example, the time reduction in disintegration time compared to the corresponding comparative example using the same difficult-to-disintegrate component is shown in the "Disintegration Improvement Time" column.
[0064] <Rating> A shorter calculated disintegration time and a longer disintegration improvement time indicate that the tablet was more effectively disintegrated.
[0065] As shown in Table 1, no significant difference in disintegration time was observed between Comparative Examples 1 and 2. On the other hand, Example 1 showed a shorter disintegration time compared to Comparative Examples 1 and 2. These results confirm that puffed oat flour has a disintegration-accelerating effect.
[0066] As shown in Table 2, no significant difference in disintegration time was observed between Comparative Example 3 and Comparative Example 8. In other words, it was confirmed that the puffed oat flour, which belongs to the genus Maize in the grass family, did not have a disintegration-accelerating effect. Example 2 was confirmed to have a shorter disintegration time compared to each comparative example. From these results, it was confirmed that puffed oat flour has a suitable disintegration-accelerating effect on other puffed materials.
[0067] As shown in Table 3, Examples 3-7 were found to have shorter disintegration times compared to their respective comparative examples which had the same non-disintegrating components. These results confirm that puffed oat flour has a suitable disintegration-promoting effect for each non-disintegrating component.
[0068] As shown in Table 4, Examples 8-10 showed shorter disintegration times compared to their respective comparative examples which had the same non-disintegrating components. These results confirm that puffed oat flour has a suitable disintegration-promoting effect for each non-disintegrating component.
[0069] As shown in Table 5, Example 11 was found to have a shorter disintegration time than Comparative Examples 20-23. From these results, it was confirmed that puffed oat flour has a more favorable disintegration-promoting effect than pregelatinized starch, corn starch, agar, and carmellose sodium, which are conventionally known as disintegration-promoting agents that can be used in tablets.
[0070] (Test Example 2) In Test Example 2, the relationship between the amount of puffed oat flour used in the tablets and its disintegration-promoting effect was examined.
[0071] <Tablet manufacturing> The amounts of puffed oat flour used as a disintegration accelerator, the amount of hyaluronic acid used as a non-disintegrating component, and the types and amounts of other excipients contained in the tablets of Examples 12-16 and Comparative Example 24 are shown in Table 6. The puffed oat flour used was obtained in the same manner as in the puffing treatment of Test Example 1.
[0072] Each of the components listed in Table 6 was mixed and compressed into tablet powders. Each tablet powder was compressed in the same manner as in Test Example 1 to obtain tablets with a diameter of 8 mm.
[0073] [Table 6] <Measurement> For the tablets of Examples 12-16 and Comparative Example 24, the measured hardness, disintegration time, and disintegration improvement time are shown in Table 6 under "Hardness (N)", "Disintegration Time", and "Disintegration Improvement Time".
[0074] Hardness, disintegration time, and disintegration recovery time were calculated in the same manner as in Test Example 1. <Rating> As shown in Table 6, Examples 12-16 were found to have shorter disintegration times compared to Comparative Example 24. Furthermore, it was confirmed that the greater the amount of puffed oat flour in the tablets, the shorter the disintegration time.
[0075] (Test Example 3) Accelerated stability testing was conducted to evaluate changes in the tablet's properties. In Example 17, the same tablets used in Example 6 were used. In Comparative Example 25, the same tablets used in Comparative Example 13 were used. These tablets were placed in aluminum resealable bags, sealed, and then subjected to accelerated testing under the following conditions.
[0076] Accelerated testing conditions: 40°C, 75%RH. Accelerated testing period: 0.2 months Items to check: Tablet disintegration time, tablet hardness, and the intensity of the odor of the non-disintegrating component.
[0077] Disintegration time and hardness were measured in the same manner as in Test Example 1. Disintegration time was investigated with n=6, and the calculated value was the average value. Hardness was investigated with n=5, and the calculated value was the average value. The intensity of the odor of the non-disintegrating component was evaluated by panelists who directly smelled the tablets, and the turmeric-derived odor was rated on a three-point scale: strong, medium, and weak.
[0078] [Table 7] <Rating> As shown in Table 7, in Example 17, the change in hardness before and after the accelerated test was smaller compared to Comparative Example 25, confirming that the tablets were more stable.
[0079] Furthermore, in Example 17, the change in disintegration time before and after the accelerated test was smaller compared to Comparative Example 25, confirming that the tablet was more stable. From the above, it was found that by adding the puffed oat flour of the present invention as a disintegration accelerator to tablets containing a difficult-to-disintegrate component, not only is a disintegration-accelerating effect obtained, but deterioration of tablet disintegration properties such as a decrease in tablet hardness over time and an extension or delay in disintegration time are suppressed.
Claims
1. A disintegration accelerator for tablets comprising grain flour derived from at least one grain selected from the genera Barley, Wheat, Rye, and Avena, wherein the grain flour is puffed.
2. The tablet disintegration accelerator according to claim 1, wherein when the grain flour is mixed with water and its viscosity is measured using a rapid viscoanalytic analyzer (RVA) under the following RVA measurement conditions (a) to (d), the maximum viscosity peak is observed in steps (b) to (c) of steps (a) to (d). (a) Stir at 50°C for 1 minute, (b) Stir for 3 minutes and 42 seconds while increasing the temperature from 50°C to 95°C at a rate of 12.2°C / min, (c) Stir for 2 minutes and 30 seconds at 95°C, and (d) Stir for 3 minutes and 48 seconds while decreasing the temperature from 95°C to 50°C at a rate of 11.8°C / min.
3. The tablet disintegration accelerator according to claim 1, characterized in that the grain flour has a uniformity (D60 / D10) of less than 10, determined by D60 to D10 in a volume-based particle size distribution based on laser diffraction / scattering particle size distribution measurement.
4. The tablet disintegration accelerator according to claim 1, wherein the grain is of the genus Avena.
5. A tablet containing a disintegration accelerator according to any one of claims 1 to 4 and a poorly disintegrating component.
6. The tablet according to claim 5, wherein the non-disintegrating component is at least one lipid-soluble component selected from lipid-soluble vitamins, benzoquinone derivatives, polyphenols, materials containing polyphenols, xanthophyll, and materials containing xanthophyll.
7. The tablet according to claim 6, wherein the lipid-soluble component is at least one selected from vitamin E, coenzyme Q10, lutein, and turmeric.
8. The tablet according to claim 6, wherein the content of the lipid-soluble component in the tablet is 30% by mass or less.
9. The tablet according to claim 5, wherein the non-disintegrating component is at least one selected from polysaccharides, proteins, and beekeeping products.
10. The tablet according to claim 9, wherein the non-disintegrating component is at least one selected from hyaluronic acid, proteoglycan, chondroitin, and royal jelly.
11. The tablet according to claim 5, wherein the hardness change when subjected to an accelerated test for two months under conditions of a temperature of 40°C and a relative humidity of 75% is 50N or less.
12. The tablet according to claim 5, wherein the increase in disintegration time when subjected to an accelerated test for two months under conditions of a temperature of 40°C and a relative humidity of 75% is 20 minutes or less.
Citation Information
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