Method for producing rapidly disintegrating compression molded product and rapidly disintegrating compression molded product

Abstract

To provide a method for producing a rapidly disintegrating compression molded product in which a compression molded product can rapidly disintegrate and disperse in a liquid by using a sugar alcohol as an excipient, in a compression molded product containing a thickener: and to provide a rapidly disintegrating compression molded product.SOLUTION: Provided is a method for producing a rapidly disintegrating compression molded product that disintegrates within 120 seconds under stirring conditions of low agitation when a compression molded product containing a thickener in the composition is added to a liquid. It is produced by compression molding of an excipient and a thickener. The composition uses sugar alcohol as an excipient and contains 0.05 to 1 part of the thickening agent per 1 part of the excipient sugar alcohol. The particle size of the thickener was set to 75 μm or more.SELECTED DRAWING: Figure 1

Description

[Technical Field]

[0001] The present invention relates to a method for producing a rapidly disintegrating compression-molded product and a rapidly disintegrating compression-molded product. [Background technology]

[0002] Although tablets, capsules, lozenges, chewable tablets, granules, powders, and the like are known as oral solid preparations in the fields of pharmaceuticals and foods, there are few dosage forms that take into consideration ease of administration by patients. In particular, various preparations that are easy to handle and ingest, suitable for elderly people, children, and patients with swallowing difficulties, have been developed (Patent Documents 1 and 2).

[0003] Incidentally, in hospitals and nursing care facilities, thickening agents (thickeners) such as xanthan gum, carrageenan, galactomacinan, and dielhan gum are sometimes used to impart viscosity to liquids as a measure against swallowing disorders. [Prior art documents] [Patent documents]

[0004] [Patent Document 1] Japanese Patent Application Laid-Open No. 2003-176242 [Patent Document 2] Japanese Patent Application Laid-Open No. 2010-260803 Summary of the Invention [Problem to be solved by the invention]

[0005] Thickeners in powder form have characteristics such as poor dispersibility in liquids, high tendency to form lumps, and tendency to scatter during weighing, making them difficult to handle. Here, lumps refer to, for example, lumps that do not mix with water when dissolved in liquid, forming clumps that are visually observed as floating matter or precipitates in the liquid. Furthermore, in order to disperse the thickener in liquid without lumps, stirring using a mixer such as a homomixer is necessary. To improve this characteristic, granular thickening products are available in which thickener powder is granulated alone or with an excipient. Here, "thickness" refers to a state in which the liquid has some viscosity. However, thickening products still require weighing before use, which places a burden on the operator.

[0006] Here, molded products (e.g., tablets) obtained by compression molding a powder have advantages such as improved handleability, no need for weighing when used, excellent portability, reduced storage space, etc. However, when a thickener is compression molded, the liquid does not penetrate the compression molded product, and only the surface of the compression molded product that comes into contact with the liquid becomes hydrated, which significantly deteriorates dispersibility in the liquid.

[0007] In view of the above circumstances, the present invention has as its technical object to provide a method for producing a rapidly disintegrating compression molded product that can be rapidly disintegrated and dispersed in a liquid by using a sugar alcohol as an excipient in a compression molded product containing a thickener. [Means for solving the problem]

[0008] The present invention, which has been devised to solve the above problems, provides a method for producing a rapidly disintegrating compression-molded product that disintegrates within 120 seconds under low-stirring conditions when a liquid is added to a compression-molded product containing a thickener. The method is produced by compression-molding an excipient and a thickener, using a sugar alcohol as the excipient, and the composition contains 0.05 to 1 part of the thickener per 1 part of the sugar alcohol, and the thickener has a particle size of 75 μm or more. An excipient is an additive added to improve molding and facilitate administration, and is used to produce a formulation with a size that is easy to take. Excipients include sugars, sugar alcohols, starches, celluloses, and inorganic excipients. The excipient used in the method for producing a rapidly disintegrating compression-molded product of the present invention is a sugar alcohol. A thickener is a component used to increase the viscosity of a liquid containing water or an oil phase, and is an additive used to add viscosity. Here, low stirring refers to stirring performed under weak stirring conditions such as 10 revolutions per second or less, such as manual stirring. Manual stirring is, for example, stirring using a spatula (spoon).

[0009] According to the method for producing a rapidly disintegrating compression-molded product of the present invention, the incorporation of a sugar alcohol excipient can prevent the problem that "when a thickener is compressed into a compression-molded product, the liquid does not penetrate the compression-molded product, and only the surface of the compression-molded product that comes into contact with the liquid becomes hydrated, resulting in a significant deterioration in dispersibility in the liquid," thereby achieving a stable disintegration effect. In other words, the use of a sugar alcohol as an excipient allows the compression-molded product to rapidly disintegrate and disperse in liquid (water, etc.). Furthermore, disintegrability can be achieved by using a composition containing 0.05 to 1 part thickener per 1 part excipient. Disintegrability can be achieved when the particle size of the thickener is 75 μm or more.

[0010] The thickener preferably contains one or more selected from the group consisting of xanthan gum, carrageenan, galactomannan, gellan gum, pectin, alginic acids, and starch.

[0011] The method may include a mixing step of mixing an excipient and a thickener, and a compression molding step of compressing and molding the powder obtained in the mixing step. In this way, the method of mixing an excipient and a thickener and then compressing and molding them as is (i.e., direct compression method) has fewer steps and is advantageous in terms of cost.

[0012] The method may also include a granulation step in which an excipient and a thickener are granulated, and a compression molding step in which the granulated product obtained in the granulation step is compressed and molded. Here, granulation refers to the process of forming powdered drug substances, additives, etc. into granules of uniform shape and size. Granulation can be performed using a wet method, a dry method, a spray granulation method, or the like. The wet method involves adding a solution of a binder or the like to a powder to granulate it, and can be performed by directly granulating it or by kneading it and then granulating it. Wet granulation methods include extrusion granulation, stirring granulation, fluidized bed granulation, and tumbling granulation. The dry granulation method involves compressing or melting a powder in a dry state, and then crushing and granulating it. The spray granulation method involves spray-drying a solution containing a powder in a slurry state to granulate it. Granulation and compression molding in this way has the advantages of improving solubility, tableting, and ease of administration, as well as improving handling and flowability, such as preventing scattering.

[0013] The rapidly disintegrating compression molded product according to the present invention is produced by compression molding an excipient and a thickener, and uses a sugar alcohol as the excipient, and has a composition containing 0.05 to 1 part of the thickener per 1 part of the sugar alcohol of the excipient, and the particle size of the thickener is 75 μm or more.When added to a liquid, the product disintegrates within 120 seconds under low stirring conditions.

[0014] The rapidly disintegrating compression molded product of the present invention can be rapidly disintegrated and dispersed in liquid (water, etc.). Furthermore, disintegration properties can be achieved by using a composition containing 0.05 to 1 part thickener per 1 part excipient. Disintegration properties can be achieved when the particle size of the thickener is 75 μm or more. [Effects of the Invention]

[0015] According to the present invention, the rapidly disintegrating compression molded product produced by the method of the present invention, even if it contains a thickener, can be rapidly disintegrated and dispersed in liquid by using a sugar alcohol as an excipient. Furthermore, the rapidly disintegrating compression molded product produced by the method of the present invention has the advantages of improved handleability, no need for weighing at the time of use, excellent portability, and reduced storage space, compared to molded products (e.g., tablets) obtained by compression molding of powder. [Brief explanation of the drawings]

[0016] [Figure 1] FIG. 1 is a simplified block diagram of a method for producing a first disintegratable compression-molded product according to an embodiment of the present invention. [Figure 2] FIG. 2 is a simplified block diagram of a second method for producing a disintegratable compression-molded product according to an embodiment of the present invention. DETAILED DESCRIPTION OF THE INVENTION

[0017] Hereinafter, an embodiment of the present invention will be described with reference to the drawings.

[0018] 1 shows a first method for producing a disintegrative compression-molded product. This method for producing a disintegrative compression-molded product comprises a mixing step 1 in which an excipient and a thickening agent (thickener) are mixed, and a compression-molding step 2 in which the powder (powder) formed in this mixing step 1 is compressed to obtain a tablet. In the mixing step 1, mixing is performed using a publicly known powder mixer, and in the compression-molding step 2, compression-molding can be performed using a publicly known compression-molding machine.

[0019] Here, the term "excipient" refers to an additive added to improve molding and facilitate administration, and is used for the purpose of producing a formulation of an easy-to-take size. Excipients include sugars, sugar alcohols, starches, celluloses, and inorganics, and sugar alcohols are used as the excipients used in the method for producing rapidly disintegrating compression-molded products of the present invention. A thickener is a component used to increase the viscosity of a liquid containing water or an oil phase, and is an additive used to add viscosity.

[0020] Sugar alcohols used as excipients include, for example, erythritol and Palatinose (registered trademark) (Mitsui Sugar Co., Ltd.). ,Ma The thickener used may contain one or more selected from the group consisting of xanthan gum, carrageenan, galactomannan, gellan gum, pectin, alginic acids, and starch.

[0021] The composition contains 0.05 to 1 part thickener per 1 part sugar alcohol, and the particle size of the thickener is set to 75 μm or more.

[0022] According to the method for producing a rapidly disintegrating compression-molded product of the present invention, by incorporating a sugar alcohol excipient, it is possible to prevent the problem that "when a thickener is compressed into a compression-molded product, the liquid does not penetrate into the compression-molded product, and only the surface of the compression-molded product that comes into contact with the liquid becomes hydrated, resulting in a significant deterioration in dispersibility in the liquid," thereby achieving a stable disintegration effect. Furthermore, disintegration properties can be obtained by using a composition containing 0.05 to 1 part thickener per 1 part excipient. Disintegration properties can be obtained when the particle size of the thickener is 75 μm or more.

[0023] The rapidly disintegrating compression molded product produced by the method of the present invention, even if it contains a thickener, can be rapidly disintegrated and dispersed in liquid by using a sugar alcohol as an excipient. Furthermore, the rapidly disintegrating compression molded product produced by the method of the present invention has advantages such as improved handleability, no need for weighing at the time of use, excellent portability, and reduced storage space, compared to molded products (e.g., tablets) obtained by compression molding of powder.

[0024] 2 shows a second method for producing a rapidly disintegrating compression-molded product, which includes a granulation step 3 in which an excipient and a thickening agent (thickener) are granulated, and a compression-molding step 4 in which the granules formed in the granulation step 3 are compressed to obtain tablets. In the compression-molding step 4, compression molding can be carried out using a publicly known and commonly used compression molding machine.

[0025] Granulation refers to the process of converting powdered drug substances, additives, etc. into granules of uniform shape and size. Granulation can be performed using a wet method, a dry method, a spray granulation method, or other methods. The wet method involves adding a solution of a binder or other agent to a powder to granulate it. This method can be performed directly or after kneading. Examples of wet granulation methods include extrusion granulation, agitation granulation, fluidized bed granulation, and tumbling granulation. Dry granulation involves compressing or melting powder in a dry state, then crushing and granulating the resulting powder. Spray granulation involves spray-drying a solution containing a powder in a slurry state to form granules. Granulation and compression molding in this way offers advantages such as improved solubility, tabletability, and ease of administration, as well as improved handling and flowability, including preventing scattering.

[0026] Granulators for granulation include extrusion granulators, agitation granulators, fluidized bed granulators, tumbling granulators, dry granulators, etc., and any of these granulators can also be used.

[0027] Thus, the method of granulation shown in Fig. 2 has the same effects as the method of mixing an excipient and a thickener and then compression-molding them as is, as shown in Fig. 1. Furthermore, the rapidly disintegrating compression-molded product produced by the steps shown in Fig. 2 also has the same effects as the rapidly disintegrating compression-molded product produced by the steps shown in Fig. 1.

[0028] Although the embodiments of the present invention have been described above, the present invention is not limited to these embodiments and various modifications are possible. For example, the rapidly disintegrating compression-molded product to be produced may be a tablet for pharmaceutical or food use. Furthermore, low agitation may be gentle agitation performed by mixing (propeller agitation, agitation with a mixer) in addition to manual agitation. Incidentally, in addition to excipients and thickeners, disintegrants and lubricants may also be blended as raw materials for the compression-molded product. Disintegrants have the effect of absorbing moisture and making solid tablets more easily crumbled. Examples of disintegrants include crystalline cellulose, low-substituted hydroxypropyl cellulose, carmellose calcium, and croscarmellose sodium. Lubricants are added to prevent raw materials from adhering to the compression device or to prevent chipping due to insufficient tablet hardness caused by compression force, and examples of such lubricants include talc and magnesium stearate. [Example]

[0029] In this case, the disintegration effect of the sugar alcohol was investigated for tablets formed by a mixing step of mixing an excipient and a thickener, and a compression molding step of compressing the powder mixed in the mixing step. In this case, six examples (Examples 1A to 6A) and two comparative examples (Comparative Products 1A to 2A) were investigated, and the results are shown in Table 1. [Table 1]

[0030] Several sugar alcohols (erythritol, palatinose, lactose, and mannitol) were used as excipients for the experimental products. Specifically, granular erythritol was used for Experimental Product 1A, crystalline erythritol for Experimental Product 2A, finely powdered erythritol for Experimental Product 3A, palatinose for Experimental Product 4A, lactose for Experimental Product 5A, and mannitol for Experimental Product 6A. Granular dextrin (DE16) was used for Comparative Product 1A, and finely powdered dextrin (DE16) was used for Comparative Product 2A. Xanthan gum (median diameter d50: 209 μm) was used as a thickener for all Experimental Products 1A to 6A and Comparative Products 1A to 2A. In this case, the ratio of the thickener xanthan gum was 0.5 parts per part of the sugar alcohol excipient.

[0031] The rapidly disintegrating compression molded products of Examples 1A to 6A and Comparative Examples 1A to 2A were manufactured by the manufacturing method shown in Figure 1. That is, an excipient and a thickener were mixed and compressed. Specifically, the excipient sugar alcohol was mixed with the thickener xanthan gum, and then compression molded using a single punch tablet press to obtain each tablet. As mentioned above, three different powder forms of erythritol (granules, crystalline, and fine powder) were tested for the Examples, and two types (granules and fine powder) were tested for the Comparative Examples. Furthermore, the same amounts of disintegrants and lubricants that are commonly used in tableting powders were added to each Example and Comparative Example.

[0032] In the disintegration experiment, one tablet (diameter φ9 mm, 250 ml / tablet) was placed in water (50 cc of city water) and stirred 10 times / second with a stirring tool (e.g., a spoon or spatula) 60 seconds after the addition. This was called manual stirring. The disintegration properties of the tablets were examined 60 seconds after the start of stirring (i.e., 120 seconds after the tablets were added to the water).

[0033] In Table 1, ◯ indicates complete disintegration, and × indicates no disintegration. That is, for each of the Examples 1A to 6A, the tablet shape was lost after 60 seconds of stirring and the tablets were completely disintegrated, whereas the Comparative Examples 1A to 2A remained in tablet form without disintegrating. Therefore, the disintegration effect of the rapidly disintegrating compression molded products of each of the Examples 1A to 6A due to the addition of sugar alcohol was confirmed.

[0034] Specifically, for Products 1A, 3A, 5A, and 6A, disintegration began 10 seconds after addition to water, disintegration progressed 30 seconds after addition to water, nearly disintegrated 60 seconds after addition to water, completely disintegrated immediately after manual mixing, and remained completely disintegrated 120 seconds after addition to water (60 seconds after manual mixing). For Products 2A and 4A, there was no change 10 seconds after addition to water, disintegration began 30 seconds after addition to water, disintegration progressed 60 seconds after addition to water, nearly disintegrated immediately after manual mixing, and completely disintegrated 120 seconds after addition to water (60 seconds after manual mixing). Furthermore, for comparison products 1A and 2A, there was no change 10 seconds or 30 seconds after being placed in water, and 60 seconds after being placed in water, the surface became hydrated (a phenomenon in which a solute molecule or ion in an aqueous solution attracts several water molecules around it and bonds to form a single molecular group), but no disintegration was observed. Immediately after manual stirring, the particles separated slightly, but no disintegration was observed, and the tablet shape remained intact. Even 120 seconds after being placed in water (60 seconds after manual stirring), there was progress in surface hydration, but there was no change in the shape of the tablet.

[0035] The following Table 2 shows the state (photographs) of Example Products 1A and 4A, and Comparative Products 1A and 2A in Example 1, 120 seconds after being added to water (60 seconds after manual mixing). Note that Comparative Product 1D was produced by coloring and granulating the excipient dextrin (DE=16) to produce dextrin granules, which were then mixed with a thickener and compression-molded, resulting in colored tablets. [Table 2] [Example]

[0036] In this case, the mixing ratio of excipients and thickeners in tablets formed by a mixing step of mixing excipients and thickeners and a compression molding step of compressing the powders mixed in the mixing step was investigated. In this case, the mixing ratio of excipients and thickeners in tablets formed by a mixing step of mixing excipients and thickeners was investigated. In this case, the mixing ratio of excipients and thickeners in tablets ... each of the excipients and comparative products, erythritol, a sugar alcohol, was used as the excipient, and after mixing with xanthan gum, a typical thickener, rapid disintegration compression molded products (tablets) were obtained by compression molding.

[0037] The ratio of excipient to xanthan gum was 1 part excipient to 0.5 parts xanthan gum for Example 1B, 1 part xanthan gum for Example 2B, and 1.5 parts xanthan gum for Comparative Example 1B. The particle size of the xanthan gum in each of Examples 1B, 2B, and Comparative Example 1B was 250 to 355 μm. Furthermore, similar to Example 1, the same amounts of disintegrant and lubricant commonly used in tableting powders were added.

[0038] The investigation method (disintegration experiment) was the same as in Example 1, in which one tablet (diameter φ9 mm, 250 ml / tablet) was added to water (50 cc of city water), and 60 seconds after addition, the tablet was stirred 10 times / second with a stirring tool (e.g., a spoon). This was so-called manual stirring. The disintegration properties of the tablet were investigated 60 seconds after the start of stirring (i.e., 120 seconds after adding the tablet to the water). The experimental results are shown in Table 3 below. [Table 3]

[0039] In Table 3, ◯ indicates complete disintegration, and △ indicates partial disintegration. That is, in Example 1B and Example 2B, the tablet shape was lost after 60 seconds of stirring and the tablets were completely disintegrated, while in Comparative Example 1B, the tablets were partially disintegrated but not completely disintegrated. Therefore, it was confirmed that disintegration was achieved with a mixing ratio of up to 1 part excipient to 1 part thickener.

[0040] Specifically, for Product 1B, there was no change 10 seconds after being added to water, it began to disintegrate 30 seconds after being added to water, disintegration progressed 60 seconds after being added to water, it was almost completely disintegrated immediately after being manually stirred, and it was completely disintegrated 120 seconds after being added to water (60 seconds after being manually stirred). For Product 2B, there was no change 10 seconds after being added to water, the surface became hydrated 30 seconds after being added to water but no disintegration was observed, it began to disintegrate 60 seconds after being added to water, disintegration progressed immediately after being manually stirred, and it was completely disintegrated 120 seconds after being added to water (60 seconds after being manually stirred). Furthermore, with comparison product 1B, there was no change 10 seconds or 30 seconds after being placed in water, but the surface became hydrated 60 seconds after being placed in water, and although disintegration was observed immediately after manual stirring, the tablet shape remained. Even 120 seconds after being placed in water (60 seconds after manual stirring), the tablet size had decreased to about half of the original size, but the tablet shape remained.

[0041] Table 4 below shows the state (photographs) of Example Product 2B and Comparative Product 1B in Example 2 120 seconds after being placed in water (60 seconds after manual stirring). [Table 4] [Example]

[0042] In this case, the influence of the particle size of the thickener on tablets formed by a mixing step of mixing the excipient and the thickener, and a compression molding step of compressing the powder mixed in the mixing step was investigated. In this case, the effects of the particle size of the thickener on tablets formed by the mixing step were investigated. In this case, the experimental products 1C to 4C and the comparative product 1C were investigated. Each experimental product and the comparative product used erythritol (granules), a sugar alcohol, as the excipient, and mixed with xanthan gum, a typical thickener, and then compressed to obtain a rapidly disintegrating compressed product (tablet).

[0043] In each example, the ratio of the excipient sugar alcohol to the thickener xanthan gum was 1 part. The particle size of the thickener xanthan gum was 355 μm or more for Example 1C, 250-355 μm for Example 2C, 150-250 μm for Example 3C, 75-150 μm for Example 4C, and less than 175 μm for Comparative Example 1C. Furthermore, similar to Example 1, the same amounts of disintegrants and lubricants commonly used in tableting powders were added.

[0044] The investigation method (disintegration experiment) was the same as in Example 1, in which one tablet (diameter φ9 mm, 250 ml / tablet) was added to water (50 cc of city water), and 60 seconds after addition, the tablet was stirred 10 times / second with a stirring tool (e.g., a spoon). This was so-called manual stirring. The disintegration properties of the tablet were investigated 60 seconds after the start of stirring (i.e., 120 seconds after adding the tablet to the water). The experimental results are shown in Table 5 below. [Table 5]

[0045] In Table 5, ◯ indicates complete disintegration, and × indicates no disintegration. Furthermore, for Example Products 1C to 4C, the tablet shape was lost after 60 seconds of stirring, and the tablets were completely disintegrated. In contrast, Comparative Product 1C retained its tablet shape and remained without disintegrating. Therefore, it was confirmed that disintegration was achieved when the particle size of the thickener was 75 μm or more.

[0046] Specifically, for Products 1C, 2C, and 3C, disintegration began 10 seconds after being added to water, continued after 30 seconds, was nearly disintegrated after 60 seconds, completely disintegrated immediately after manual mixing, and remained completely disintegrated 120 seconds after being added to water (60 seconds after manual mixing). Furthermore, for Product 4C, disintegration began 10 seconds after being added to water, disintegration was observed as the surface hydrated after 30 seconds, was nearly disintegrated after 60 seconds, completely disintegrated immediately after manual mixing, and remained completely disintegrated 120 seconds after being added to water (60 seconds after manual mixing). For comparison product 1C, there was no change 10 seconds after being placed in water and 30 seconds after being placed in water, and 60 seconds after being placed in water, hydration of the surface progressed but no disintegration was observed, and even immediately after manual stirring, no disintegration was observed and the tablet shape remained, and even 120 seconds after being placed in water (60 seconds after manual stirring), no disintegration was observed and the tablet shape remained.

[0047] Table 6 below shows the state (photographs) of Example Product 1C, Comparative Product 4C, and Comparative Product 1C in Example 3 120 seconds after being placed in water (60 seconds after manual stirring). [Table 6] [Example]

[0048] In this case, the disintegration effect of the sugar alcohol was investigated for tablets formed by a granulation process in which an excipient and a thickener were granulated, and a compression molding process in which the granules obtained in the granulation process were compressed. Two examples, Example 1D and Example 2D, and one comparative example, Comparative Product 1D, were investigated, and the results are shown in Table 7. [Table 7]

[0049] In Example 1D and Example 2D, erythritol, a sugar alcohol, was used as the excipient and xanthan gum was used as the thickener. Example 1D used granular erythritol (median diameter d50: 219 μm) and xanthan gum (d50 = 209 μm), while Example 2D used crystalline erythritol (250-500 μm) and xanthan gum (d50 = 140 μm). Comparative Example 1D used dextrin (DE16) as the excipient and xanthan gum (d50 = 140 μm) as the thickener. In this case, the ratio of xanthan gum, a thickener, to 1 part erythritol, a sugar alcohol excipient, was 0.33 parts.

[0050] Rapidly disintegrating compression-molded products of Examples 1D and 2D and Comparative Example 1D were manufactured using the manufacturing method shown in Figure 2. Specifically, the excipient and thickener were granulated and then compression-molded. Specifically, the excipient sugar alcohol and the thickener xanthan gum were granulated, and then compressed using a single-punch tablet press to obtain tablets. As mentioned above, three different powder forms of erythritol (granules and crystalline products) were tested for the examples. Each example and comparative example were granulated using a fluidized bed granulator (FD-MP-01, manufactured by Powrex Corporation) with excipient (1 part) and xanthan gum (0.33 parts) and an aqueous potassium chloride solution as a binder. Each example and comparative example were mixed with the same amounts of disintegrant and lubricant typically used in tableting powders, and then compression-molded. After granulation, the granules had a d50% diameter of 274.3 μm for Example Product 1D, a d50% diameter of 371.1 μm for Example Product 2D, and a d50% diameter of 443.0 μm for Comparative Product 1D.

[0051] The investigation method (disintegration experiment) was the same as in Example 1, in which one tablet (diameter φ9 mm, 250 ml / tablet) was added to water (50 cc of city water), and 60 seconds after addition, the tablet was stirred 10 times / second with a stirring tool (e.g., a spoon). This was so-called manual stirring. The disintegration properties of the tablet were investigated 60 seconds after the start of stirring (i.e., 120 seconds after adding the tablet to the water).

[0052] In Table 7, ◯ indicates complete disintegration, and × indicates no disintegration. Furthermore, for Example Products 1D and 2D, the tablet shape was lost after 60 seconds of stirring, and the tablets were completely disintegrated. In contrast, Comparative Product 1D retained its tablet shape and remained without disintegrating.

[0053] Specifically, for Example 1D, there was no change 10 seconds after being placed in water, disintegrated and lost its tablet shape 30 seconds after being placed in water, nearly disintegrated 60 seconds after being placed in water and after manual agitation, and completely disintegrated 120 seconds after being placed in water (60 seconds after manual agitation). For Example 2D, there was disintegration 10 seconds after being placed in water, disintegrated and lost its tablet shape 30 seconds after being placed in water, completely disintegrated 60 seconds after being placed in water, and remained completely disintegrated immediately after manual agitation and 120 seconds after being placed in water (60 seconds after manual agitation). For Comparative Example 1D, there was no change 10 seconds after being placed in water and 30 seconds after being placed in water, and even after 60 seconds and 120 seconds after being placed in water (60 seconds after manual agitation), the surface was slightly hydrated but the tablet shape remained unchanged.

[0054] Therefore, the disintegration effect of the sugar alcohol was confirmed. In this case, the state (photograph) of Example Product 2D and Comparative Product 1D in Example 4 120 seconds after being placed in water (60 seconds after manual mixing) is shown in Table 8 below. [Table 8] [Explanation of symbols]

[0055] 1 Mixing process 2. Compression molding process 3 Granulation process 4. Compression molding process

Claims

1. A method for producing a rapidly disintegrating compression-molded product that disintegrates within 120 seconds under low stirring conditions when a compression-molded product containing a thickener in its composition is added to a liquid, the method comprising: A method for producing a rapidly disintegrating compression-molded product, which is produced by compressing a raw material powder that does not contain any medicinal ingredients and contains at least an excipient and a thickener among excipients, thickeners, disintegrants, and lubricants, wherein a sugar alcohol is used as the excipient, the composition contains 0.33 to 1 part of the thickener per 1 part of the sugar alcohol of the excipient, and the particle size of the thickener is 209 μm to 355 μm.

2. The method for producing a fast-disintegrating compression molded product described in claim 1, characterized in that the thickener contains one or more selected from the group consisting of xanthan gum, carrageenan, galactomannan, gellan gum, pectin, alginic acids, and starches.

3. A method for producing a fast-disintegrating compression molded product as described in claim 1 or claim 2, characterized in that it comprises a mixing process for mixing the raw material powders, and a compression molding process for compression molding the mixed powder of the raw material powders mixed in the mixing process.

4. A method for producing a rapidly disintegrating compressed molded product as described in claim 1 or claim 2, characterized in that it comprises a granulation process for granulating the raw material powder, and a compression molding process for compressing and molding the granulated product of the raw material powder granulated in the granulation process.

5. A fast-disintegrating compression-molded product which does not contain any medicinal ingredients and is produced by compressing and molding a raw material powder which contains at least an excipient and a thickener from among excipients, thickeners, disintegrants, and lubricants, wherein a sugar alcohol is used as the excipient, and the composition contains 0.33 parts to 1 part of the thickener for 1 part of the sugar alcohol of the excipient, the particle size of the thickener being 209 μm to 355 μm, and which disintegrates within 120 seconds when added to a liquid under low agitation conditions.

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