JP6092672B2 - Orally rapidly disintegrating tablets - Google Patents

Description

  The present invention relates to an intraoral rapidly disintegrating tablet.

  In recent years, there has been a demand for the development of tablets that can be taken without water as a dosage form that takes into account the ease of taking by consumers, infants who have difficulty swallowing, and patients with difficulty in behavior. Usually, when taking solid preparations such as tablets, water is required, and there is a problem that it is not convenient. In addition, there is a problem that it is difficult to take a large tablet or a tablet with a large dose. In particular, patients who have difficulty swallowing, children, and elderly people may suffocate by using the throat. On the other hand, chewable tablets do not require water, but are not suitable for children and elderly people with weak chewing ability and teeth. In order to solve these problems, there are dosage forms that disintegrate rapidly in the oral cavity.

Examples of conventional techniques for rapidly disintegrating tablets include those relating to fast disintegrating tablets containing erythritol and mannitol (Patent Document 1 and Patent Document 2). Patent Document 1 relates to a compressed composition imparted with fast disintegration by blending erythritol, and Patent Document 2 relates to a preparation imparted with rapid disintegration by blending mannitol. Thus, although the technique which adds a disintegration promoter is prevailing, erythritol and mannitol have poor moldability, and many excipients are required for formulation, resulting in an increase in the number of grains.
There is also a patent relating to a solid pharmaceutical preparation (Patent Document 3). Patent document 3 gives quick disintegration by blending erythritol, crystalline cellulose, and a disintegrant into a pharmaceutical ingredient, but the disintegrant to be used is crospovidone which is a pharmaceutical additive. I can not use it.
Moreover, there exists a technique (patent document 4) which provides quick disintegration by making a tablet porous. In Patent Document 4, sugar alcohol and starch are kneaded into an infiltrated lump, then rolled and molded, and further dried under reduced pressure to make it porous and impart quick disintegration. However, since the manufacturing method is complicated and a special device is required, it is a technique for versatility.
Further, Patent Document 5 imparts quick disintegration property by adding water to the main ingredient component and saccharide to moisten, imparting the function as a disintegrant to saccharide, and compressing the wet powder, followed by drying. is there. However, it is difficult to use for an active ingredient that deteriorates when coexisting with water, and there is a problem that a special device for drying wet tablets is required.
In order to enhance the disintegration property in the oral cavity, there is a formulation technique that includes a component that reacts with saliva and foams in the oral cavity and imparts quick disintegration more strongly (Patent Document 6). However, preparations prepared by such a technique often have a problem that foaming occurs due to reaction with moisture in the air. Further, Patent Document 6 discloses a technique using an alkali metal carbonate or bicarbonate and fibrin glycolic acid as an acid supply source.
In addition, fast disintegrating tablets are designed to have a low surface hardness so that they can disintegrate quickly in the oral cavity, and they are generally fragile and have the disadvantage of being easily carried and worn out during the packaging process. Yes.
In this way, the manufacture of fast disintegrating tablets does not require complicated processes or special manufacturing equipment, and can be applied to any active ingredient and has excellent disintegration, but easily breaks and wears. There is a need to develop formulations that do not.
In addition, a fast disintegrating tablet is added with a fragrance in order to give a preferred flavor when disintegrating in the oral cavity. Various fragrance | flavor components are used for the fragrance | flavor used in order to provide a flavor. For the fast disintegrating tablet, a powder flavor obtained by spray-drying an emulsion obtained by preparing an oil-soluble flavor with starch or dextrin and various emulsifiers is used. The main component of the powdered fragrance is essential oil and an auxiliary agent for pulverization, such as dextrin, starch, gum arabic, gelatin, and casein (Non-patent Document 1). There is an indication that the disintegration time of a fast disintegrating tablet is delayed when this powder flavor is added.

International Publication Number WO98 / 02185 JP 2001-58944 A Japanese Patent Laid-Open No. 10-182436 JP 2003-137815 A Japanese Patent No. 3069458 JP 2008-127319 A

JPO Standard Technology Fragrance, 328-330 pages, published on March 14, 2006

  It is an object of the present invention to provide a rapidly disintegrating tablet which has a desirable flavor and has a surface hardness required as a tablet.

  The present inventors have investigated the phenomenon that inhibits the disintegration that occurs due to the addition of a powdered fragrance to a fast disintegrating tablet, and it is caused by the essential oil component that is the main component of the powdered fragrance. There was found. Therefore, further research was conducted, and a tablet that does not inhibit disintegration (disintegration delay) even when a powdered fragrance was added and a powdered fragrance used for the tablet were found, and the present invention was completed.

The present invention has the following configuration.
1. Quick disintegration containing saccharides or sugar alcohol and crystalline cellulose as excipients, porous calcium carbonate and sodium bicarbonate as foaming components, citric acid as acid agent, and powdered fragrance adjusted to 300 μm or more tablet.
2. 2. The rapidly disintegrating tablet according to 1 , wherein the fragrance component in the powder fragrance is a citrus essential oil.
3. The rapidly disintegrating tablet according to 1 or 2, wherein the sugar or sugar alcohol is erythritol.
4). The rapidly disintegrating tablet according to any one of 1 to 3 , wherein the citric acid is crystalline citric acid whose surface is coated with sodium citrate.
5. The rapidly disintegrating tablet according to any one of 1 to 4 , wherein the rapidly disintegrating solid preparation has a hardness of 10 kgf or more.
6). The rapidly disintegrating tablet according to any one of 1 to 5 , wherein the tablet having a weight of 750 mg has an oral disintegration time of 40 seconds or less.
7). The rapidly disintegrating tablet according to any one of 1 to 6 , which is a food.

  According to the present invention, there is provided a tablet having a fast disintegrating property while being a tablet which is aromatized and maintains a sufficient tablet hardness with little wear.

It is a figure which shows an example of the manufacturing process of the fast disintegrating tablet of this invention. It is the image which observed the quick disintegration of the tablet of a reference example. It is a graph which shows the result of having tested the influence which the particle diameter of a powder fragrance | flavor has on the disintegration in an oral cavity.

  In the present invention, the saccharides used as the main excipient are monosaccharides and disaccharides that can be used in the technical fields of medicines and food preparations, and sugar alcohols thereof. Specific examples thereof include mannitol, erythritol, xylitol, lactose and glucose, as well as maltose, sorbitol, trehalose, sucrose and fructose. These may be used alone or in combination of two or more. In particular, erythritol is preferable for imparting disintegration properties. When erythritol is contained in the tablet in an amount of 30 to 50% by mass, particularly preferably 40% by mass, the tablet can have appropriate ease of molding and preferable oral disintegration characteristics.

  In general, in order to increase tablet hardness, for example, polyvinylpyrrolidone, hydroxypropylmethylcellulose, methylcellulose, polyvinyl alcohol and the like are used as water-soluble binders. However, tablets obtained in a normal compression molding process are rapidly disintegrating. Not shown. In the present invention, since a suitable amount of modified cellulose is added as crystalline cellulose and a disintegrant without using such a binder, it has an appropriate hardness by a simple direct tableting method that does not require a granulation step. And a tablet with the characteristic of disintegrating rapidly in an oral cavity can be shape | molded. Crystalline cellulose is blended in an amount of 10 to 20% by mass in the tablet. A preferable result can be obtained by containing 2 to 5% of the modified starch in the tablet.

One of the main characteristics of the present invention is to promote the disintegration of a preparation containing a saccharide and a disintegrant by reacting an acid source with one or more foaming sources via water in saliva. Citric acid as the acid source, at least one selected from the group consisting of carbonates and bicarbonates of alkali metals, alkaline earth metals as the foaming source, and 1 tablet as an adjunct to taste masking or fine foaming as necessary Small amounts of other organic acids can be incorporated therein.
In particular, the combined use of sodium bicarbonate and calcium carbonate is preferred as the foaming source. In the present invention, the calcium carbonate is particularly preferably porous calcium carbonate or porous calcium carbonate.

The porous calcium carbonate used in the present invention is a chemically synthesized high-purity light calcium carbonate, and is porous calcium carbonate obtained by multi-stage carbonation of chain-like particles in which fine particles are connected. For example, Porecal-N (Manufactured by Shiraishi Calcium Co., Ltd.) and IK-3000 (manufactured by Shiroishi Central Research Laboratories) It is a preferred embodiment as a foaming source in the present invention to use an equal amount of porous calcium carbonate and sodium bicarbonate. The compounding quantity of the porous calcium carbonate in this invention is 0.5 to 1.5 weight%, and 0.8 to 1.0 weight% is especially preferable. If the blending amount is small, disintegration cannot be promoted. If the blending amount is large, foaming is severe in the oral cavity, making it difficult to ingest, and as a result, disintegration is delayed.
Sodium bicarbonate reacts quickly with citric acid and foams, and calcium carbonate starts foaming later. In this way, the combined use of both increases the foaming time and prevents the foaming feeling from collapsing. It becomes possible to promote. The blending amount of sodium bicarbonate is 0.5 to 1.5% by weight, particularly preferably 0.8 to 1.0% by weight. If the blending amount is small, disintegration cannot be promoted. If the blending amount is large, foaming is severe in the oral cavity, making it difficult to ingest, and as a result, disintegration is delayed.
When sodium bicarbonate and porous sodium carbonate are used in combination, a preferable result can be obtained by setting both to the same amount and 1% by mass or more per tablet.

  When citric acid dissolves in saliva, it reacts with porous calcium carbonate and sodium bicarbonate to cause foaming and disintegrate the tablet with the force from the inside. However, citric acid gradually reacts with the blowing agent via moisture in the air. In order to suppress this, when a raw material in which the surface of citrate granules is coated with sodium citrate is used, such a change with time can be suppressed. CCA (manufactured by San-Ei Gen FFI Co., Ltd.) can be exemplified as the citrate granule coated with such sodium citrate. The amount of citric acid is 0.5 to 1.5% by weight, particularly preferably 0.8 to 1.0% by weight. If the blending amount is small, disintegration cannot be promoted, and if the blending amount is large, the sourness felt in the oral cavity is too strong, which makes it difficult to ingest.

The tablet of this invention mix | blends a powder fragrance | flavor in order to provide a preferable flavor in the case of disintegration in an oral cavity. Powdered fragrance contains essential oil as a flavor component and contains dextrin, starch, gum arabic, gelatin, casein, etc., and is pulverized, and the particle size of the powdered fragrance is sized to 300 μm or more Must be used. When the powdered fragrance | flavor with a particle diameter smaller than this particle diameter mixes, fast disintegration is inhibited. In particular, care is required when using a powdered fragrance containing an essential oil as a fragrance component.
Such a powder flavor can be obtained by sieving a commercially available powder flavor.
Further, in the step of preparing the powdered fragrance, granulation may be performed so that the particle diameter is 300 μm or more. Granulation can be prepared based on a known technique such as wet granulation or dry granulation after powder fragrance is prepared by spray drying.

  The tablet of this invention can mix | blend the lubricant and fluidizing agent required for tableting as materials other than the above. Further, by incorporating a component that promotes the secretion of saliva in the oral cavity, more rapid oral disintegration can be brought about. An example of such a saliva secretion promoter is polyglutamic acid.

  The medicinal component (main drug) applicable in the present invention can include any medicinal component that can be taken orally, or a nutritional component and a functional component. Not only water-soluble but also poorly water-soluble medicinal components can be used. In addition, those having little or no bitterness are preferred, but those having bitterness can also be used after coating. These main ingredient components can be used alone or in combination of two or more. The main drug component can be added to the tableting powder prepared in the mixing step of a mixture of sugar, disintegrant and foaming agent. Moreover, after granulating as needed, it can also be tableted. The blending amount of the active ingredient is preferably 50% by mass or less per tablet. When the content is more than this, problems such as capping may occur in tableting.

  The powder for tableting may contain various additives generally used for tablet production as long as the effects of the present invention are not adversely affected. Examples of additives other than the binder include acidulants such as citric acid, tartaric acid and malic acid, artificial sweeteners such as aspartame, sodium saccharin and stevia, such as magnesium stearate, sucrose fatty acid ester and talc. Lubricants, for example, edible dyes such as edible yellow No. 5, edible red No. 2 and edible blue No. 2, edible lake dyes, and coloring agents such as iron oxide can be mentioned. These additives can be used alone or in combination of two or more.

An example of the production process of the present invention is shown in FIG. The production method of the present invention is not limited to this step. Further, the lubricant may not be added during the composition but may be used as an external lubricant.
The constitution of the present invention is excellent in that a rapidly disintegrating tablet imparted with the desired flavor can be produced by a very simple method by simple mixing and tableting. In the tableting process, a tableting machine commonly used for powder compression molding, for example, a single tableting machine or a rotary tableting machine can be used. The tableting pressure is usually set to about 200 to 1500 kg, preferably about 500 to 1000 kg, when, for example, 200 mg of tableting powder is tableted using a punch with a diameter (φ) of 8 mm and a single tableting machine. The temperature at the time of tableting may be usually room temperature (about 20 to 30 ° C.), and it is not necessary to adjust in particular. Since the intraoral rapidly disintegrating tablet of the present invention has an appropriate hardness, it can be processed into a desired shape such as a circle or an ellipse. The diameter or major axis of such a tablet is usually 6 to 15 mm, and its weight is usually 80 mg to 1000 mg, but is not limited thereto. Moreover, it is also possible to set it as the split tablet which engraved the dividing line for dividing | segmenting into a tablet.
The tablet according to the present invention has a tablet hardness of 10 mmf with a diameter of 15 mm while having rapid disintegration property in the oral cavity, and has a tablet hardness that can withstand manufacturing, distribution, and storage.

Since the rapidly disintegrating tablet in the oral cavity of the present invention has rapid disintegrating property in the oral cavity, it is easy to drink and easy to handle. Moreover, it becomes easy to drink for children etc. by perfume, and the disintegration inhibition at the time of mix | blending a commercially available powdered fragrance | flavor does not generate | occur | produce.
Therefore, it is suitable for long-term administration to patients applied according to the medicinal properties contained, especially for elderly people, and it can also be used for prevention and treatment of pediatric patients because the taste and odor of drugs can be masked by perfumes. be able to. Furthermore, when taking it to a patient with Sjögren's syndrome or an elderly person with a small amount of saliva, it is convenient because it quickly disintegrates with a minimum amount of water. It is also suitable for patients and children with limited water intake.

  According to the production method of the present invention, since a general-purpose pulverizer, mixer and tablet press can be used, the conventional production apparatus can be used as it is. Furthermore, there is no need to change or add to the manufacturing process depending on the dissolution characteristics of the medicinal ingredients. Therefore, the production method of the present invention is extremely simple without involving complicated steps, and is advantageous from the viewpoint of production cost, production time, and the like, compared to the conventional method for producing an orally rapidly disintegrating tablet. It is. Moreover, it becomes a useful product not only as a medicine but also as a health food and tablet confectionery.

  Reference examples and test examples are shown below, and the present invention will be described in more detail.

Reference example
Production of fast disintegrating tablets without flavoring Manufacture of tablets Quick disintegrating tablets were prepared with the composition shown in Table 1. In addition, N-acetylglucosamine (manufactured by Yaizu Suisan Chemical Co., Ltd.) was used as the main agent, and Porecal-N (manufactured by Shiraishi Calcium Co., Ltd.) was used as the porous calcium carbonate.

  In the procedure shown in Fig. 1, primary mixing is performed for 10 minutes and secondary mixing is performed for 5 minutes using a V-type mixer (Micro-type V-type mixer S-3, manufactured by Tsutsui Richemical Co., Ltd.). N-30E) manufactured by Okada Seiko Co., Ltd. was used to set the tableting pressure (about 1000 kgf) so that the tablet hardness was 10 kgf or more, and tablets with a diameter of 15 mm, a thickness of 3.5 mm, and a weight of 750 mg were produced.

2. Evaluation of tablet (1) Hardness The hardness was measured with a Kiyama hardness tester. It should be noted that, as the hardness that the tablet can withstand manufacture, distribution, and storage, this time, the evaluation condition was that it had a hardness of at least 9 kgf or more, more preferably 10 kfg or more. In the case of this tablet, when expressed in absolute hardness, the evaluation condition is that the tablet has a hardness of 0.17 kgf / mm ² or more, more preferably 0.19 kgf / mm ² or more.
The absolute hardness is calculated by the following formula.
Absolute hardness (kgf / mm ² ) = Tablet hardness (breaking strength, kgf) / Table cross-sectional area (mm ² )
The cross-sectional area of the tablet is a flat tablet like this time,
Tablet cross-sectional area (mm ² ) = tablet diameter (mm) x tablet thickness (mm)
Is calculated by

(2) Friction degree The friability of the tablet was measured using a tablet friability tester manufactured according to the specifications of the 14th Pharmacopoeia reference information. Evaluation was based on 3% or less, which is the friability of chewable tablets (manufactured by FANCL) having the same diameter as the present invention product, which is a normal commercial preparation.

(3) Observation of disintegration situation (petri dish test method)
Put 10g of the test solution (colored red by adding vitamin B12 to water) on the petri dish, and immerse the Kimwipe in one fold. Place the tablet lightly on the soaked Kimwipe and measure the time from placement until the test solution penetrates all the way to the top of the tablet. The tablet touches the Kimwipe only at the bottom, and the test solution is transferred to the tablet only through the Kimwipe. The time when the red color was transferred to the top of the tablet was taken as the disintegration time, and the disintegration state of the preparation at that time was observed. In addition, photographs were taken of the disintegration of the top and side surfaces of the preparation.

(4) Oral disintegration time measurement and sensory evaluation (sensory test method)
Evaluation was made by a panel of 5 healthy adults.
The sample tablet was melted while rolling with the tongue without chewing in the mouth, and the time until the solid matter disappeared was measured.
Moreover, the feeling of administration was evaluated.
Oral disintegration time was defined as the average disintegration time of 5 persons.
The feeling of ingestion was evaluated in consideration of the situation in the oral cavity according to the following criteria based on the discussion of five people. In addition, the defect of each tablet was expressed by an appropriate word.
×: Texture is unpleasant and not acceptable △: Texture is uncomfortable but acceptable ○: Texture is good ◎: Texture is very good

(5) Storage stability test
Store for 7 days in an environment of 40 ° C and 75% humidity, and at the same time store an aluminum bag sealed at 5 ° C. Compare the two and observe the shape and color with the naked eye. Storage stability according to the following evaluation criteria Evaluated.
×: Difference is obvious and product is not established △: Quality is impaired and difference can be recognized ○: Difference is hardly recognized

3. Table 2 shows the evaluation results of the tablets. Moreover, the image which observed the disintegration condition of each tablet is shown in FIG.

As described above, the tablets of Reference Examples 1 and 2 were rapidly penetrated by water, completely dissolved in the oral cavity, and did not leave a foreign body sensation in the oral cavity. Moreover, it had a tablet hardness exceeding the hardness as a fast disintegrating tablet, and was a high level exceeding the level of friability necessary and sufficient as a tablet.
However, when the tablets prepared by adding 1-2% of various commercially available citrus powder fragrances to the formulation of Reference Example 2 to produce a fragrance, either the disintegration time using the petri dish or the disintegration time in the oral cavity was obtained. Was delayed for 2 minutes 30 seconds or more, and it was found that the rapid disintegration was lost. The following tests were conducted to confirm the cause of the disintegrating delay.

Test example 1
Using the composition of the tablet of Reference Example 2 as a basic composition, the disintegration delay when a constituent of a powdered fragrance was added was tested. Part of the formulation has been changed to suit the purpose of this test.
Tablets having the composition shown in Table 5 were prepared in the same manner as in Reference Example 2, using the fragrances having the compositions shown in Tables 3 and 4 as commercially available citrus powder fragrances. The fragrance is lemon flavor powder no. There are two types, 40604 (manufactured by Koken Inc.) and Yuzu C72 (Yuzu flavor powder: manufactured by Sato Foods Co., Ltd.).
The disintegration test was performed on the obtained two kinds of tablets and each tablet of Reference Example 2 by a petri dish test method. Table 6 shows the disintegration time of the petri dish test.

It was confirmed that both the lemon flavor powder and the yuzu flavor powder significantly delayed the disintegration. It was also confirmed that dextrin, which is a common component of both fragrances, and gum arabic added to lemon flavor powder did not delay disintegration in a separately conducted test.
From the test results in Table 6 and the effects of other blending components on the disintegration properties, it was predicted that the essential oil, which is a common component of the two types of powder flavors in Tables 3 and 4, delayed the disintegration properties.

From the results of Test Example 1, it was predicted that the blending of essential oil components inhibited the rapid disintegration property and delayed disintegration. It was expected that it was difficult for the powdered fragrance to be a rapidly disintegrating tablet in the formulation of Reference Example 2.
Then, when this inventor implemented the preliminary test using a powder fragrance | flavor, he found possibility that it could suppress by equalizing the particle diameter of a powder fragrance | flavor.
Therefore, a test for adjusting the particle size of the powdered fragrance and confirming the optimum particle size was conducted.

Test example 2
The influence of the particle size of the powdered fragrance on the disintegration rate was confirmed.
1. Uniformization of particle diameter of powdered fragrances Powdered fragrances with uniform particle diameters were prepared using the commercially available lemon flavor powders and yuzu flavored powders shown in Tables 3 and 4 and used in this test.
Agitation granulation was performed using a food mill 1000 (manufactured by TESCOM). 70% ethanol was used as a binder, and granulation was repeated for about 30 seconds each time ethanol was added. Finally, 70% ethanol, which is about 10% of the weight of the powdered fragrance, was dropped in several portions.
Granules obtained after granulation were sized with a JIS standard 16 mesh sieve. Only the granules passed through the sieve were placed in a dryer DRU600TA (ADVANTEC) and dried overnight at 37 ° C.
After drying, it is sieved using a sieve of mesh size 32, 48, 100, 200, and the resulting granules are 75 μm or less, 75 to 150 μm, 150 to 300 μm for each particle size based on the size of the sieve mesh , 300 to 500 μm, and a powdered fragrance homogenized in five stages of 500 μm or more were obtained.

2. Preparation of fast disintegrating tablet Weigh each ingredient and granulated powdered fragrance so as to have the composition shown in Table 5, then sieve again using a 30-mesh sieve, and form a micro V-shaped mixer S-3 ( And mixed for 10 minutes. The granulated powder flavor was granulated from lemon flavor powder and yuzu flavor powder shown in Tables 3 and 4.
Next, tableting was performed using a single tableting machine N-30E (manufactured by Okada Seiko Co., Ltd.) equipped with a φ15 flat punch to obtain a tablet having a weight of 750 mg. In order to prevent sticking, calcium stearate was used as an external lubricant. Tableting pressure was set at a tablet hardness of 10 kgf (measured with a Kiyama hardness tester) or more. The evaluation results are shown in Tables 7 and 8.

3. Evaluation Each prepared tablet was evaluated by the following method.
(1) Hardness Hardness was measured by compressing in the tablet diameter direction with a Kiyama digital hardness meter. The evaluation condition was that the tablet has a hardness that can withstand the manufacture, distribution, and storage, at least 9 kgf or more, more preferably 10 kgf or more this time. In the case of this tablet, when expressed in absolute hardness, the evaluation condition is that the tablet has a hardness of 0.17 kgf / mm ² or more, more preferably 0.19 kgf / mm ² or more.
The absolute hardness is calculated by the following formula.
Absolute hardness (kgf / mm ² ) = Tablet hardness (breaking strength, kgf) / Table cross-sectional area (mm ² )
The cross-sectional area of the tablet is a flat tablet like this time,
Tablet cross-sectional area (mm ² ) = tablet diameter (mm) x tablet thickness (mm)

(2) Friction degree The friability of the tablet was measured using a tablet friability tester manufactured according to the specifications of the 14th Pharmacopoeia reference information.

(3) Measurement of oral disintegration time and sensory evaluation (sensory test method)
Evaluation was made by a panel of 5 healthy adults.
The sample tablet was melted while rolling with the tongue without chewing in the mouth, and the time until the solid matter disappeared was measured.
Moreover, the feeling of administration was evaluated.
Oral disintegration time was defined as the average disintegration time of 5 persons.
The feeling of ingestion was evaluated in consideration of the situation in the oral cavity according to the following criteria based on the discussion of five people. Moreover, it was decided to express the defects of each preparation with appropriate reviews.
×: Texture is unpleasant and not acceptable △: Texture is uncomfortable but acceptable ○: Texture is good ◎: Texture is very good

(4) Evaluation results The hardness of the tablets showed measured values of 10 kgf or more. The degree of friability was 3% or less in all cases.
The evaluation results of the oral disintegration time and the oral sensory test are shown in Table 7, Table 8, and FIG.

As shown in Table 7 and FIG. 3, all tablets had a disintegration time of 1 minute or less, and the disintegration time in the oral cavity was dramatically shortened by granulating and sizing the powdered fragrance. Moreover, the disintegration time in the oral cavity could be shortened within 40 seconds by setting the particle size of the powdered fragrance to 300 μm or more. Furthermore, when the particle size of the powdered fragrance was 500 μm or more, the oral disintegration time could be shortened to about 30 seconds. In addition, the texture in the oral cavity was favorably evaluated because the discomfort of the texture disappeared when the particle size was 500 μm.
From the above test results, in order to suppress the disintegration delay due to the essential oil contained in the powder fragrance, the particle size of the powder fragrance may be adjusted to 300 μm or more, and if the particle size is adjusted to 500 μm or more, the functional surface will be improved Became clear.
Moreover, it became clear that the formulation prepared using such a powder fragrance | flavor has also improved the food texture at the time of an oral disintegration.
That is, the rapidly disintegrating tablet obtained by carrying out the present invention has an appropriate hardness as a tablet, disintegrates rapidly in the oral cavity, and has a preferred flavor.

Claims (7)

Quick disintegration containing saccharides or sugar alcohol and crystalline cellulose as excipients, porous calcium carbonate and sodium bicarbonate as foaming components, citric acid as acid agent, and powdered fragrance adjusted to 300 μm or more tablet. The rapidly disintegrating tablet according to claim 1 , wherein the fragrance component in the powder fragrance is a citrus essential oil. The rapidly disintegrating tablet according to claim 1 or 2 , wherein the saccharide or sugar alcohol is erythritol. The rapidly disintegrating tablet according to any one of claims 1 to 3 , wherein the citric acid is crystalline citric acid whose surface is coated with sodium citrate. The rapidly disintegrating tablet according to any one of claims 1 to 4 , wherein the fast disintegrating solid preparation has a hardness of 10 kgf or more. The rapidly disintegrating tablet according to any one of claims 1 to 5 , wherein the tablet having a weight of 750 mg has an oral disintegration time of 40 seconds or less. The rapidly disintegrating tablet according to any one of claims 1 to 6 , which is a food.