JPH11199517A - Intraoral fast disintegrable tablet - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide an intraoral fast disintegrable formulation speedily disintegrable in an oral part, readily producible and combinedly having strength in the manufacturing and in preserving. SOLUTION: This intraoral fast disintegrable formulation combinedly having excellent moldability, strength and disintegrability is obtained by subjecting a mixed and blended material of a medicinal agent, a crystalline cellulose and a sugar alcohol at a specific ratio to compression molding. A mixing weight ratio of the crystalline cellulose to the sugar alcohol is (5/5)-(3.5/6.5) and a disintegrating agent is not contained in the formulation. Preferably, a mixture of one or more than two kinds selected from mannitol, erythritol and xylitol is used as the sugar alcohol.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

The present invention relates to a rapidly disintegrating tablet in the oral cavity which disintegrates in the oral cavity immediately when taken with a small amount of water.

[0002]

2. Description of the Related Art It is difficult for elderly people and children to take tablets because of their low swallowing ability. There is a need for a formulation that can be easily taken by elderly people and children and that can be swallowed quickly even in adults who have the ability to swallow, and that can be taken smoothly without leaving any roughness. Such preparations are known.

For example, Japanese Patent Publication No. 62-50445 discloses drugs,
A rapidly disintegrating oral preparation prepared by preparing a polymer such as gelatin and a solution such as mannitol in advance, placing it in a pocket of PTP, and lyophilizing is described. W
O93 / 12769 describes a rapidly disintegrating oral preparation produced by suspending a drug and a saccharide composed of lactose or mannitol in an aqueous agar solution, filling a mold, solidifying it in a jelly form, and then drying. JP-A-5-27
In 1054, a mixture containing a drug component, a saccharide, and water to such an extent that the particle surface is moistened is subjected to a pressure of 3 to 160 kg / cm ²
Compress with a degree. According to this method, an orally-dissolving tablet having a porous structure with a porosity of about 20 to 80% can be obtained. In Japanese Patent Publication No. 8-30005, in addition to poorly soluble pharmacological active substances and disintegrants, special filler particles (filler particles coated with a layer of colloid or pseudo colloid, or melting, cooling, crushing) Melted granules showing slow solubility obtained by
A disintegrating tablet comprising: WO97 / 386
No. 79 describes a rapidly disintegrating oral preparation produced by preparing a mixed solution of a drug and a filler such as mannitol, a binder and other adjuvants, placing the mixture in a mold, and freeze-drying the mixture. JP-A-9-48726 describes a rapidly disintegrating intraoral tablet obtained by mixing a drug such as a saccharide, a sugar alcohol, and a water-soluble polymer with a drug, humidifying and wetting at a low density, and then drying. However, in the above-mentioned conventional preparations, the strength is insufficient during production and storage,
It is thought that there are some problems such as the complexity of the manufacturing process.

On the other hand, Japanese Patent Application Laid-Open No. Hei 8-27033 describes a solid preparation containing a pharmaceutically active ingredient and erythritol uniformly. Due to the properties of erythritol such as refreshing sweetness, fine powder moldability, low hygroscopicity and good stability, the solid preparation is very stable and easy to take with little moisture absorption. It is described that tablets and the like are easy to produce due to their excellent mechanical suitability. However, the strength of the solid preparation and the disintegrability in the oral cavity have not been studied at all.

[0005]

From the foregoing, it is an object of the present invention to provide a rapidly disintegrating tablet in the oral cavity which rapidly disintegrates in the oral cavity, is easy in the production process, and has both strength during production and storage. Was desired.

[0006]

Means for Solving the Problems The present inventors have intensively studied to solve the above problems. By compressing and molding a mixture of a drug, crystalline cellulose, and a sugar alcohol at a specific ratio, the present inventors have found that it is possible to provide an orally rapidly disintegrating tablet having excellent moldability and strength, and disintegration. The invention has been completed.

That is, the present invention relates to (1) a drug containing crystalline cellulose and a sugar alcohol and containing no disintegrant, wherein the weight ratio of the crystalline cellulose to the sugar alcohol is 5: 5 to 3.5. : A rapidly disintegrating tablet in the oral cavity which is obtained by compression-molding a mixture mixed in the range of 6.5. (2) The orally rapidly disintegrating tablet according to the above (1), which is obtained by mixing the drug with crystalline cellulose and a sugar alcohol and then directly compression-molding the mixture. (3) The orally rapidly disintegrating tablet according to the above (1), wherein the granules obtained by mixing the drug, crystalline cellulose, and sugar alcohol and then performing wet granulation are compression-molded. (4) The oral cavity according to the above (3), which comprises mixing the drug, a part of crystalline cellulose, and a sugar alcohol, then mixing the granules obtained by wet granulation with the remaining crystalline cellulose, and compression-molding. Internally disintegrating tablets. (5) The rapidly disintegrating tablet in the oral cavity according to the above (1), wherein the granules obtained by mixing the drug and the sugar alcohol and then wet granulation are mixed with crystalline cellulose and compression-molded. (6) The sugar alcohol is mannitol, erythritol,
The orally rapidly disintegrating tablet according to any one of the above (1) to (5), which is one or more kinds selected from xylitol. (7) The above (1) to wherein the sugar alcohol is mannitol
(5) The orally rapidly disintegrating tablet according to any one of (1) to (5). About.

[0008]

BEST MODE FOR CARRYING OUT THE INVENTION The orally rapidly disintegrating tablet of the present invention comprises:
It is characterized by containing microcrystalline cellulose and sugar alcohol at a specific ratio, not containing a disintegrant, and compression molding. The respective features will be described below. First, the sugar alcohol used in the present invention includes mannitol, erythritol, xylitol and the like. One or more of these may be used as a mixture, but mannitol is preferably used.

The above-mentioned crystalline cellulose and sugar alcohol are not particularly limited as long as they are grades generally used in the field of pharmaceuticals. Since these substances have different moldability, excellent formulations can be obtained by appropriately changing the mixing ratio of crystalline cellulose and sugar alcohol and the combination of sugar alcohols. Further, the amounts of these components can be easily determined. For example, after appropriately mixing a desired component with a drug, compression molding is performed, and hardness and disintegration are confirmed, so that suitability can be easily determined.

The orally rapidly disintegrating tablet of the present invention has a weight ratio of crystalline cellulose to sugar alcohol of 5: 5 to 3.5: 6.
5, preferably 5: 5 to 4: 6. When the blending ratio of crystalline cellulose is higher than this, when disintegrated in the oral cavity, the powdery foreign-body sensation due to crystalline cellulose becomes anxious and is not preferable in terms of ingestibility, and when the blending ratio of crystalline cellulose is lower than this, molding is performed. It is not preferable because the molding property is deteriorated and the disintegration property is deteriorated, resulting in poor molding or delayed disintegration time in the oral cavity.

Next, disintegrants will be described. In order to impart desired disintegration and solubility to ordinary tablets, disintegrants (croscarmellose sodium, sodium carboxymethyl starch, low-substituted hydroxypropylcellulose, etc.) are required. It is essential. However, the present inventors surprisingly found that by compressing and molding a mixture of crystalline cellulose and sugar alcohol at a specific ratio, a tablet having sufficient disintegration properties can be obtained without adding a disintegrant. I found it. Conversely, when a general disintegrant is added to the orally rapidly disintegrating tablet of the present invention, the disintegration time is delayed (see Example 6), which is not preferable.

The drug used in the rapidly disintegrating tablet in the oral cavity of the present invention is not particularly limited as long as it is a drug that does not have bitterness, astringency or other discomfort to the extent that it is not difficult to swallow in the oral cavity and can be administered orally. Not done. Such drugs include, for example, antibiotics, chemotherapeutics, hypnotics, sedatives, anxiolytics, antiepileptics, antipyretic analgesics and anti-inflammatory agents, antiparkinson agents, agents for psychiatric nerves, agents for relaxing skeletal muscle, agents for autonomic nerves, agents for stimulating Sedatives, cardiotonic,
Antiarrhythmic, diuretic, antihypertensive, vasoconstrictor, vasoconstrictor, vasodilator, hyperlipidemia, antitussive, bronchodilator, antistatic, intestinal, peptic ulcer, health Gastric digestives, antacids, bile drugs, gastrointestinal drugs, vitamins, nutrient tonics, drugs for liver disease, gout remedies, drugs for diabetes, drugs for oncology, antihistamines, crude drugs, drugs for osteoporosis, etc. .

The mixing ratio of the drug and the mixed powder of crystalline cellulose and sugar alcohol is not particularly limited. However, considering the moldability and disintegration, the drug is added to 1 part by weight of the mixed powder of crystalline cellulose and sugar alcohol. 0.0001
２2 parts by weight, preferably 0.005 parts by weight.
It is preferably contained at 0.1 to 0.1 parts by weight, particularly 0.001 to 0.01 parts by weight.

In the orally rapidly disintegrating tablet of the present invention,
If necessary, the composition may contain various additives commonly used in tablet production. These substances may be used alone or as a mixture at an arbitrary ratio. Examples of the additive include a binder, a fluidizing agent, a lubricant, a flavor, a sweetener, a flavoring agent, and a coloring agent. As the binder, for example, a binder having a weak binding force such as gum arabic powder, gelatin, particularly pullulan, and polyvinyl alcohol are preferable. Examples of the fluidizing agent include hydrous silicon dioxide and light anhydrous silicic acid. Examples of the lubricant include magnesium stearate, calcium stearate, talc, sucrose fatty acid ester and the like. As a flavor, for example, orange, strawberry,
Yogurt, vanilla, menthol and the like. Sweetening agents include aspartame, saccharin, dipotassium glycyrrhizinate, stevia and the like. Examples of the flavoring agent include citric acid, tartaric acid, malic acid, ascorbic acid, sodium citrate, sodium chloride, 1-
Menthol and the like. Examples of the coloring agent include food colors such as Food Red No. 3, Food Yellow No. 5, Food Blue No. 1, and the like. These components can be used in an arbitrary amount alone or in combination as long as the disintegration and the moldability of the orally rapidly disintegrating tablet of the present invention are not impaired. For example, crystalline cellulose / mannitol / Light anhydrous silicic acid / aspartame / strawberry flavor can be mentioned.

As a method for preparing the orally rapidly disintegrating tablet of the present invention, a drug, crystalline cellulose, and a sugar alcohol are mixed and sieved by a conventional method to obtain a powder for compression molding. In the present invention, the particle size of the drug and the additive is not particularly limited, but the smaller the particle size, the better the feeling of taking. If necessary, a wet granulation step can be added. In this case, after mixing the drug, crystalline cellulose, and sugar alcohol by an ordinary method, fluidized bed granulation, high-speed stirring granulation, and the like are performed.
Next, an appropriate lubricant is added to the produced granules to obtain a powder for compression molding. As a result, the flowability is greatly improved without adding a fluidizing agent, and it is possible to eliminate the tableting trouble (see Example 3). The addition of the crystalline cellulose during the wet granulation is not necessarily required to be performed before granulation, and may be partially or entirely added to the granulated granules.

The powder for compression molding thus obtained is placed in a mold and subjected to compression molding by applying a pressure of 200 kg to 1500 kg / punch, preferably 400 kg to 800 kg / punch. If the pressure is lower than this, tablet hardness becomes insufficient and sufficient hardness for handling cannot be secured, and if the pressure is high, disintegration is delayed, which is not preferable. Regarding the molding of the orally rapidly disintegrating tablet of the present invention, any shape can be adopted, and for example, it can be formed into a tablet type, an elliptical shape, a spherical shape, and a rod shape.

The orally rapidly disintegrating tablet of the present invention contains a small amount (5
２０20 ml) of water, it rapidly disintegrates in the oral cavity and can be taken smoothly without leaving any roughness. The dissolution rate of the rapidly disintegrating tablet in the mouth of the present invention is usually 1
~ 30 seconds, preferably 2-20 seconds, more preferably 8 seconds
About 16 seconds. The hardness (measured by a tablet hardness tester) is known to be a problem-free value as long as it is generally about 3.5 to 7 kg, but the orally rapidly disintegrating tablet of the present invention has a hardness of 2 to 20 kg, Preferably, it is about 3 to 15 kg. The friability is generally considered to be 0.8% or less, but the friability of the rapidly disintegrating tablet in the oral cavity of the present invention is a numerical value which is significantly lower than the numerical value (see Example 2).

In the production process of the orally rapidly disintegrating tablet of the present invention, when a wet granulation step (fluid bed granulation step, high-speed stirring granulation step, etc.) is added to the mixed powder of sugar alcohol and crystalline cellulose, erythritol When xylitol is used, disintegration delay with time after tableting is observed. However, when mannitol is used, such a phenomenon does not occur (see Example 4). Most preferred for stability. However, after mixing the drug and some crystalline cellulose, and sugar alcohol, the granules obtained by wet granulation, when the remaining crystalline cellulose is added as the end, or after mixing the drug and sugar alcohol, wet When the whole amount of crystalline cellulose was added to the granules obtained by granulation as a later powder, it was found that even with erythritol or xylitol, there was no delay in disintegration over time (see Example 5). . Here, it is preferable that the amount of crystalline cellulose added later is 75% by weight or more of the total amount of crystalline cellulose.

The orally rapidly disintegrating tablet of the present invention is easy to produce, has both strength during production and storage, and is excellent in long-term storage and stability. Also,
As it disintegrates quickly in the oral cavity, it is used as an easy-to-take preparation for the elderly and children, and as a safe preparation for the general public, for treating various diseases as well as conventional oral preparations containing the same drug. Can be used for prevention.

[0020]

The present invention will be described in detail with reference to the following Examples, but it should not be construed that the present invention is limited thereto. Example 1 40 g of crystalline cellulose and sugar alcohol (any of D-mannitol, xylitol and erythritol)
Were mixed and sized by a conventional method. Then the crushed powder 5
00 mg in a mold having a diameter of 11.3 mm,
Compression molding was performed by applying a pressure of kg / punch. A control preparation was obtained by using sucrose instead of sugar alcohol as a control in the same manner. The hardness, disintegration degree and disintegration time in the oral cavity were compared between the two formulations. still,
The hardness is measured using a tablet hardness tester (Schleuniger), the disintegration degree is measured with water according to the thirteenth revised Japanese Pharmacopoeia disintegration test method, and the disintegration time in the disintegrating oral cavity is determined by dissolving one tablet in water 2
It was taken with 0 ml and the time to complete disintegration in the oral cavity was measured.

The results are as shown in Table 1, which shows that the orally rapidly disintegrating tablet of the present invention shows excellent hardness and disintegration.

[0022]

[Table 1]

EXAMPLE 2 120.0 g of crystalline cellulose, D-mannitol 17
After mixing 9.1 g, water granulation was carried out using a fluidized bed granulator and dried sufficiently. To the granulated granules, 0.9 g of magnesium stearate was mixed at the end and 250 mg of granules for tableting were put into a mold having a diameter of 9 mm, and compression molding was performed while changing the pressure. The hardness, disintegration degree, disintegration time in the oral cavity and friability when the pressure (tableting pressure) during this compression molding was changed were compared. The hardness, disintegration degree and disintegration time in the oral cavity were measured in the same manner as in Example 1. The friability was measured in accordance with a conventional method using 20 tablets using a tablet friability tester, and the weight loss due to the friability after 100 rotations was measured.

The results are shown in Table 2. The orally rapidly disintegrating tablet of the present invention has excellent moldability judging from the result of friability and is physically strong. It turned out to be easy.

[0025]

[Table 2]

Example 3 80 g of crystalline cellulose and 120 g of erythritol were mixed, granulated with water using a fluidized bed granulator, and sufficiently dried to obtain a tableting powder. As a control, 80 g of crystalline cellulose and 120 g of erythritol were mixed,
It was sized by a conventional method to give a tableting powder. The fluidity of both tableting powders was compared. The fluidity was measured by an injection angle method using a repose angle measuring device.

The results are as shown in Table 3, and it can be seen that the fluidity is greatly improved by going through the granulation step.

[0028]

[Table 3]

Example 4 98.8 g of crystalline cellulose and sugar alcohol (any of D-mannitol, xylitol and erythritol) 1
48.2 g, aspartame 1 g, ascorbic acid 1 g
Was charged into a fluidized bed granulator, granulated using water, and sufficiently dried. After mixing 249 mg of the granulated granules with 0.75 mg of magnesium stearate and 0.25 mg of lemon flavor, the mixture was placed in a mold having a diameter of 9 mm, and compression-molded by applying a pressure of about 400 kg / punch. Immediately after tableting and at 25 ° C.-61% R.C. H. The hardness and disintegration time in the oral cavity were compared for the tablets stored for one week under the conditions described in (1). The hardness and the disintegration time in the oral cavity were measured in the same manner as in Example 1.

The results are shown in Table 4. In the preparation using D-mannitol, no increase in hardness and no delay in disintegration time were observed, but in the preparation using erythritol or xylitol, a delay in disintegration time was observed. . From this result,
When manufactured by a wet granulation method (fluidized bed granulation method, high-speed stirring granulation method, etc.) using a mixed powder of sugar alcohol and microcrystalline cellulose, a preparation using mannitol is more stable in terms of disintegration. It turned out to be excellent.

[0031]

[Table 4]

Example 5 Sugar alcohol (erythritol, xylitol) 14
8.2 g, 1 g of aspartame, and 1 g of ascorbic acid were charged into a fluidized bed granulator, granulated using water, and sufficiently dried. 98.8 mg of crystalline cellulose and 0.75 m of magnesium stearate were added to 150.2 mg of the granulated granules.
g and 0.25 mg of lemon flavor were mixed, put into a mold having a diameter of 9 mm, and compression-molded by applying a pressure of about 400 kg / punch. Immediately after tableting and at 25 ° C-61% R.
H. The hardness and disintegration time in the oral cavity were compared for the tablets stored for one week under the conditions described in (1). The hardness and the disintegration time in the oral cavity were measured in the same manner as in Example 1.

The results are as shown in Table 5, and it was observed that when crystalline cellulose was added to the granulated granules, no increase in hardness and no delay in disintegration time were observed.

[0034]

[Table 5]

Example 6 200 g of a mixed powder having a mixing ratio of crystalline cellulose: D-mannitol = 4: 6 was subjected to water granulation using a fluidized bed granulator and dried sufficiently. To the granulated granules, 0.3% of magnesium stearate was mixed at the end powder to prepare 250 mg of granules for tableting, and the mixture was placed in a mold having a diameter of 9 mm.
Compression molding was performed by applying the pressure of a punch. As a control, 5.0% of a disintegrating agent (one of croscarmellose sodium, sodium carboxymethyl starch and low-substituted hydroxypropylcellulose) was added to the granulated granules of crystalline cellulose and D-mannitol, and magnesium stearate was further added. A control formulation was obtained by mixing 0.3% at the end and preparing 250 mg of granules for tableting in the same manner. The hardness and disintegration time in the oral cavity of both were measured and compared in the same manner as in Example 1.

The results are as shown in Table 6. The addition of the disintegrant rather delayed the disintegration time, confirming that the addition of the disintegrant was not preferred.

[0037]

[Table 6]

Production Example 1 2 mg of ethyl loflazepate, 140 mg of crystalline cellulose, 205.2 mg of xylitol, 0.7 mg of light anhydrous silicic acid, 1.75 mg of aspartame, and 0.35 mg of strawberry flavor were mixed as main ingredients and then ground in a mortar.
Place 350 mg of the pulverized powder in a 10 mm diameter mold,
By applying a pressure of 0 kg / punch and compression-molding, an orally rapidly disintegrating tablet preparation of the present invention was obtained.

Production Example 2 Rolipram 0.4 mg as the main drug, crystalline cellulose 14
After mixing 0 mg, 206.8 mg of D-mannitol, 0.7 mg of hydrous silica dioxide, 1.75 mg of aspartame, and 0.35 mg of orange flavor, the mixture was ground in a mortar. Place 350 mg of the crushed powder in a mold having a diameter of 10 mm,
By applying a pressure of kg / punch and performing compression molding, an orally rapidly disintegrating tablet of the present invention was obtained.

Production Example 3 2.5 mg of sodium picosulfate, 166.8 mg of crystalline cellulose, and 60 m of D-mannitol as main ingredients
g, erythritol 60 mg, xylitol 60 mg,
After mixing 0.7 mg of light anhydrous silicic acid, the mixture was ground in a mortar. 350 mg of the pulverized powder was placed in a mold having a diameter of 10 mm, and subjected to compression molding under a pressure of about 400 kg / punch to obtain a rapidly disintegrating tablet in the oral cavity of the present invention.

Production Example 4 After mixing 5 g of enalapril maleate, 23.4 g of crystalline cellulose, 140.4 g of erythritol, 5 g of aspartame and 5 g of ascorbic acid as the main agents, water granulation was carried out using a fluid bed granulator, and the mixture was sufficiently mixed. Dried. After mixing 70.2 g of crystalline cellulose, 0.75 g of magnesium stearate, and 0.25 g of a vanilla flavor with 178.8 g of the granulated granules, 250 mg of one tablet was obtained using a rotary tableting machine.
The tablet was rapidly compressed in the oral cavity of the present invention by tableting with a 9 mmφ corner punch at a tableting pressure of 400 kg.

Production Example 5 After 5 g of enalapril maleate, 93.6 g of crystalline cellulose, 140.4 g of D-mannitol, 5 g of aspartame and 5 g of citric acid were mixed as main ingredients, water granulation was carried out using a fluid bed granulator. Dry well. Granulated granules 2
After mixing 0.45 g of magnesium stearate and 0.25 g of a vanilla flavor with 49.0 g, a tableting pressure of 400 mg was applied using a rotary tableting machine at 250 mg per tablet and a 9 mmφ corner punch.
By compressing the tablet in kg, a rapidly disintegrating tablet in the oral cavity of the present invention was obtained.

Production Example 6 Simvastatin 5 g as the main drug, crystalline cellulose
6 g, 140.4 g of D-mannitol, 5 g of aspartame, and 5 g of citric acid were charged into a high-speed stirring granulator (high-speed mixer), mixed, granulated with a 90% ethanol aqueous solution, and sufficiently mixed with a hot-air dryer. Dried. Magnesium stearate 0.75 was added to 249 g of the granulated granules.
g, and 0.25 g of orange flavor, and then, using a rotary tableting machine, 250 mg per tablet, and tableting at 400 kg with a 9 mmφ corner punch to obtain a rapidly disintegrating tablet in the oral cavity of the present invention. Was.

Production Example 7 2 g of chlorpheniramine d-maleate, 10 g of phenylephrine hydrochloride, and belladonna total alkaloid 0.1 g as the main ingredients.
After mixing 2 g and 141.78 g of erythritol, water granulation was performed using a fluid bed granulator, and the mixture was sufficiently dried. To 153.98 g of the granulated granules, 94.52 microcrystalline cellulose was added.
g, magnesium stearate 0.75 g and l-menthol 0.75 g, and then, using a rotary tableting machine, 250 mg per tablet, tableting pressure 500 kg with a 9 mmφ corner punch.
To give a rapidly disintegrating tablet in the oral cavity of the present invention.

[0045]

According to the present invention, excellent moldability and strength,
And a rapidly disintegrating tablet in the oral cavity having both disintegration properties. That is, the rapidly disintegrating tablet in the oral cavity of the present invention disintegrates quickly in the oral cavity by taking it with a small amount of water, and can be taken smoothly without leaving any roughness, and is therefore excellent as an oral administration preparation. Also, since it is physically strong, it is easy to handle. Therefore, it can be appropriately used for the treatment and prevention of diseases of patients, particularly elderly or pediatric patients, which are applied according to the contained drug. Further, the orally rapidly disintegrating tablet of the present invention is economical and has high productivity because it can be produced without requiring the addition of a disintegrant and no special production equipment.
Furthermore, since the orally rapidly disintegrating tablet of the present invention contains a sugar alcohol, it has a strong sweetness or a refreshing sweetness, and thus is excellent in ingestibility.

Claims (7)

[Claims] 1. A composition containing a drug, crystalline cellulose, and a sugar alcohol without a disintegrant, wherein the weight ratio of the crystalline cellulose to the sugar alcohol is 5: 5 to 3.5:
A rapidly disintegrating tablet in the oral cavity which is obtained by compression-molding a mixture mixed in the range of 6.5. 2. The method according to claim 1, wherein after the drug is mixed with the crystalline cellulose and the sugar alcohol, the mixture is directly compression molded.
The orally rapidly disintegrating tablet according to the above. 3. The orally rapidly disintegrating tablet according to claim 1, wherein the granules obtained by mixing the drug, crystalline cellulose, and sugar alcohol and then performing wet granulation are compression-molded. 4. The method according to claim 3, comprising mixing the drug, a part of crystalline cellulose, and a sugar alcohol, and then mixing the granules obtained by wet granulation with the remaining crystalline cellulose, followed by compression molding. Oral quick disintegrating tablet. 5. The rapidly disintegrating tablet in the oral cavity according to claim 1, wherein the granules obtained by mixing the drug and the sugar alcohol and then wet granulation are mixed with crystalline cellulose and compression-molded. 6. The orally rapidly disintegrating tablet according to any one of claims 1 to 5, wherein the sugar alcohol is one or more selected from mannitol, erythritol, and xylitol. 7. The orally rapidly disintegrating tablet according to any one of claims 1 to 5, wherein the sugar alcohol is mannitol.