JP2011132190A - Intraoral disintegrable tablet - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide an intraoral disintegrable tablet which does not require a special apparatus and is excellent in formability and disintegrability, and a production method thereof. <P>SOLUTION: The intraoral disintegrable tablet includes granulated drug particles and is produced by wet-type granulation by adding an aqueous bonding material solution to a powder including a drug and a dried aluminum hydroxide gel. <P>COPYRIGHT: (C)2011,JPO&INPIT

Description

  The present invention relates to an orally disintegrating tablet that can be easily disintegrated by saliva in the mouth without being chewed to release components.

  As a method for producing an orally disintegrating tablet, as a method using a special production apparatus, a suspension is poured into a mold and dried under reduced pressure or freeze-dried (Patent Document 1: International Publication No. 93-12769, Patent Document 2: Special). (See Japanese Patent Publication No. Sho 62-50445), a method in which a wet granulated product is tableted while wet and dried (Patent Document 3: Japanese Patent Laid-Open No. 8-19589, Patent Document 4: Japanese Patent Laid-Open No. 8-19590) ), And a method of obtaining an orally disintegrating tablet through an aging process that requires temperature control after dry tableting (see Patent Document 5: JP 2001-342128 A, Patent Document 6: JP 11-263723 A), etc. There is. However, when special production equipment is used, many excipients are required, and further capital investment is required. As a method for forming tablets, orally disintegrating tablets can be produced by dry-type tableting, in which a combination of excipients with high disintegration and solubility, and saccharides with low moldability are prepared with highly moldable saccharides. A method is known which is used as an excipient that is granulated and has both moldability and disintegration. However, these methods have a problem in that the tablet mass increases and the tablet size increases in the case of a tablet with a large amount of drug, for example, the amount of excipient increases or a disintegrant is separately required. A method using crystalline cellulose or the like as an excipient is generally known. However, when a large amount of crystalline cellulose or the like is blended, there is a problem that it becomes powdery and the texture becomes worse. From the above, there is a demand for a technique for obtaining an orally disintegrating tablet that does not require a special device, is excellent in moldability and disintegration as an orally disintegrating tablet, has no powdery texture, and has a good texture. It was.

International Publication No. 93-12769 Japanese Examined Patent Publication No. 62-50445 JP-A-8-19589 JP-A-8-19590 JP 2001-342128 A JP-A-11-263723

  The present invention has been made in view of the above circumstances, and an object thereof is to provide an orally disintegrating tablet excellent in moldability and disintegrating property as an orally disintegrating tablet, and a method for producing the same, without requiring a special device. To do.

  As a result of intensive investigations to achieve the above object, the present inventors have obtained drug granulated particles wet-granulated by adding an aqueous binder solution to a powder containing a drug and dry aluminum hydroxide gel. By blending into an internally disintegrating tablet, no special equipment is required, and even tablets with a large amount of drug are excellent in moldability and disintegrating properties as an orally disintegrating tablet, and have a good texture without powderiness. The present inventors have found that an orally disintegrating tablet can be obtained and have made the present invention.

Therefore, the present invention provides the following orally disintegrating tablets and methods for producing the orally disintegrating tablets.
[1]. An orally disintegrating tablet containing drug granulated particles, wherein the drug granulated particles are wet granulated by adding an aqueous binder solution to a powder containing a drug and dry aluminum hydroxide gel. An orally disintegrating tablet characterized by being.
[2]. The orally disintegrating tablet according to [1], wherein the content of the dry aluminum hydroxide gel in the drug particles is 1 to 50% by mass.
[3]. The orally disintegrating tablet according to [1] or [2], wherein the content of the drug is 1 to 70% by mass with respect to the orally disintegrating tablet.
[4]. A step of granulating a powder containing a drug and dry aluminum hydroxide gel while stirring or dropping an aqueous binder solution and then drying to obtain drug granulated particles, and the obtained drug granulated particles or drug The method for producing an orally disintegrating tablet according to [1], comprising a step of tableting a mixture of the granulated particles and other tablet components.

  According to the present invention, there is no need for a special device, and even in tablets with a large amount of drug, it is excellent in moldability and disintegration as an orally disintegrating tablet, and it has no powderiness and has a good texture. A lock and a method for producing the same can be provided.

  Hereinafter, the present invention will be described in detail. The orally disintegrating tablet of the present invention comprises drug granulated particles that are wet granulated by adding an aqueous binder solution to a powder containing a drug and dry aluminum hydroxide gel.

[Drug]
The drug of the present invention is not particularly limited, and particulate raw materials (drug particles: single drug, particulate drug such as triturated drug particles, drug-carrying particles carried on supported particles) and the like are used. Can do. Examples of the above-mentioned drugs include noscapine, berberine tannate, funnel extract triple powder, funnel extract powder, funnel extract, engosac powder, dried engosaku extract, aldioxa, berberine chloride, bismuth nitrate nitrate, pseudoephedrine hydrochloride, phenylephrine hydrochloride, d-maleic acid Chlorpheniramine, dl-chlorpheniramine maleate, belladonna total alkaloid, aspirin, acetaminophen, etenzamido, isopropylantipyrine, ibuprofen, ketoprofen, naproxen, loxoprofen sodium, diphenhydramine hydrochloride, carbinoxamine maleate, dexttomethorphan hydrobromide , Anhydrous caffeine, sucralfate hydrate, synthetic hydrotalcite, albumin tannate, grasshopper, ginger Coptis, assembly, loperamide hydrochloride, copper chlorophyllin potassium, Mallotus japonicus, licorice, glycyrrhizic acid and its salts, pseudoephedrine sulfate, Belladonna, and the like, can be used singly or in combination of two or more as appropriate. Among them, since the disintegrating effect is enhanced when the ratio of insoluble particles is high, water-insoluble or poorly water-soluble ones such as berberine tannate, ibuprofen, aldioxa, naproxen, sucralfate hydrate, synthetic hydrotalcite (1 g or 1 mL) The amount of the solvent required to dissolve is preferably 100 mL or more, preferably 1000 mL or more, more preferably 10,000 mL or more; the 15th revised Japanese Pharmacopoeia).

  The content of the drug is not particularly limited, but is preferably 1 to 70% by mass, more preferably 30 to 70% by mass, and still more preferably 35 to 60% by mass with respect to the drug granulated particles. In addition, for the orally disintegrating tablet, in the present invention, an orally disintegrating tablet excellent in moldability and disintegrating property as an orally disintegrating tablet can be obtained even with a small amount of excipient, and the drug is orally disintegrated. The content of the drug is preferably 1% by mass or more, more preferably 30% by mass or more, and preferably 70% by mass or less, preferably 35 to 60% by mass from the viewpoint of tablet moldability. More preferred.

[Dry aluminum hydroxide gel]
By using the dry aluminum hydroxide gel, the wear of the orally disintegrating tablet is improved, and the powdery feeling is reduced and the texture is improved as compared with the case where a large amount of crystalline cellulose or the like is used. However, the dry aluminum hydroxide gel is not wet granulated by adding an aqueous binder solution together with the drug, and even when blended separately from the drug granulated particles in the orally disintegrating tablet, the desired disintegration property can be obtained. Can not.

  The content of the dry aluminum hydroxide gel is not particularly limited, but is preferably 1% by mass or more, preferably 7% by mass or more, and preferably 12% by mass or more with respect to the drug granulated particles from the viewpoint of improving the wear of the orally disintegrating tablet. Is more preferable. In addition, from the viewpoint of disintegration, the content is preferably 50% by mass or less and more preferably 30% by mass or less with respect to the drug granulated particles. Moreover, 1-50 mass% is preferable with respect to an orally disintegrating tablet, and 7-30 mass% is more preferable.

[Binder]
The binder is not particularly limited as long as it can provide a binding force at the time of granulation and a binding force at the time of tableting. However, since the present invention is used as an aqueous binder solution, the following water-soluble binding agent is used. An agent can be used individually by 1 type or in combination of 2 or more types as appropriate. For example, binders include gelatin, agar, alginic acid, sodium alginate, chitansan gum, gum arabic powder, hydroxypropylcellulose, hydroxypropylmethylcellulose, polyvinylpyrrolidone, partially saponified polyvinyl alcohol, methylcellulose, pullulan, partially pregelatinized starch, sugar, sugar Examples include alcohols.

  Among them, the viscosity of the 50% by mass solution is 10000 mPa · s or less (for example, BL type viscometer (eg, RB80L type manufactured by Toki Sangyo Co., Ltd.), 36 ° C. , Rotor No. 2, 30 rpm) and those in which a 50% by mass solution cannot be prepared, a saturated solution having a viscosity of 10000 mPa · s or less (B-type viscometer, 36 ° C.) is preferably used. When a binder having a viscosity too high is used, the disintegration property may be deteriorated. Examples of binders satisfying such conditions include sugars, sugar alcohols, copolypidone, Macrogol 4000 (15th revised Japanese Pharmacopoeia), hydroxypropylcellulose HPC-SSL (trade name: Nippon Soda Co., Ltd.), and the like. In view of the balance between moldability and disintegration, monosaccharides are particularly preferable.

  The content of the binder is not particularly limited, but it is preferably 1% by mass or more based on the drug granulated particles if the amount is too small, and if it is too much, the tablet becomes hard and disintegrating. From the point which worsens, 30 mass% or less is preferable, 2.5-10 mass% is more preferable, 2.5-7 mass% is further more preferable. Moreover, 0.7-30 mass% is preferable with respect to an orally disintegrating tablet, 2.5-10 mass% is more preferable, and 1-7 mass% is further more preferable.

[Binder aqueous solution]
0.01-75 mass% is preferable and, as for content of the binder in binder aqueous solution, 1-55 mass% is more preferable. The viscosity of the aqueous binder solution is 500 mPa · s or less when measured with a BL type viscometer (eg, RB80L type manufactured by Toki Sangyo Co., Ltd.) (measurement conditions: 36 ° C., rotor No. 2, 60 rpm). It is preferable to do. More preferably, it is 300 mPa * s or less, More preferably, it is 100 mPa * s or less.

  As a solvent for the binder aqueous solution, water alone or a mixed solvent of water and a hydrophilic solvent (preferably ethanol) can be used. In this case, the range of water / hydrophilic solvent = 1/0 to 1/1 (mass ratio) is preferable.

  The following mass ratio in the drug granulated particles is preferably 100: 1 to 150, preferably 100: 10 to 100, for the drug: dry aluminum hydroxide gel from the viewpoint of the balance between moldability and disintegration property as an orally disintegrating tablet. More preferably, 100: 10-50 is still more preferable.

[Drug granulated particles]
The drug granulated particles of the present invention are those obtained by wet granulation by adding a binder aqueous solution to a powder containing a drug and dry aluminum hydroxide gel, but within the range not impairing the effects of the present invention, Ordinary optional components may be blended. Optional components include, for example, crystalline cellulose, cellulose such as low-substituted hydroxypropyl cellulose and derivatives thereof, starch and derivatives thereof such as corn starch, potato starch, and hydroxypropyl starch, sugars and sugar alcohols such as lactose and mannitol, etc. Excipients, crospovidone, carmellose calcium, croscarmellose sodium, low-substituted hydroxypropylcellulose, carboxymethylcellulose, carboxymethyl starch sodium, croscarmellose sodium, hydroxypropyl starch and other disintegrants, sodium edetate, Stabilizers such as benzoic acid, pigments such as titanium oxide, iron sesquioxide, food yellow No. 5, aspartame, sucralose, acesulfame potassium, saccharin, saccharinna Sweeteners such as lithium, trehalose and thaumatin, sour agents such as malic acid, tartaric acid, citric acid, succinic acid and fumaric acid, monoterpenes such as menthol, camphor, borneol and limonene, and flavoring agents such as essential oils containing them Is mentioned. These can be used individually by 1 type or in combination of 2 or more types. The method of blending the optional components is not particularly limited, but the powder may be mixed with the powder containing the drug and dry aluminum hydroxide gel, and the one that is soluble in the aqueous solution may be added to the aqueous binder solution, Moreover, you may mix after wet granulation.

  Among them, crystalline cellulose and corn starch are preferably used because the reduced friability is reduced and the moldability is improved. 25 mass% or less is preferable, and 1 mass% or more is preferable from the point of the abrasion improvement of an orally disintegrating tablet, and 4-20 mass% is more preferable. Similarly, 0-25 mass% is preferable with respect to an orally disintegrating tablet, and 4-20 mass% is more preferable. Furthermore, the mass ratio of the dry aluminum hydroxide gel: crystalline cellulose in the drug granulated particles is preferably 1: 8 to 8: 1, and preferably 1: 2 to 3: 1 from the balance of moldability, disintegration property and texture. Is more preferable, and 1: 1 to 1.5: 1 is even more preferable.

  The average particle size of the drug granulated particles is preferably 1-1000 μm, more preferably 500 μm or less. The average particle size is 50% of the mass cumulative particle size distribution, and can be measured by, for example, a laser scattering diffraction particle size distribution analyzer LS 13 320 (manufactured by BECKMAN COULTER). If the average particle size is too small, the particles may be classified and the uniformity may be impaired. If the average particle size is too large, the particles may feel rough when taken.

[Method for producing drug granulated particles]
The drug granulated particles can be obtained by stirring and granulating a powder containing a drug and dry aluminum hydroxide gel while spraying or dropping an aqueous binder solution and then drying. As the apparatus, a stirring apparatus used for granulation, for example, a high-speed stirring granulator, a rolling fluidized granulator or the like can be used. Suitable production conditions include, for example, when a high-speed agitation granulator high speed mixer FS-10 (manufactured by Fukae Pautech Co., Ltd.) is used, the number of revolutions of agitation is 200 to 500 rpm, preferably 300 to 400 rpm, and the chopper is 1000 to 1000. 4000 rpm, preferably 2000 to 3000 rpm. Spraying or dripping of the binder aqueous solution is performed while adjusting the liquid speed to be 200 to 250 g / min and adding with stirring. Dry after stirring. For drying, methods commonly used for drying, such as shelf-type drying and fluidized bed drying, can be employed, and are not particularly limited. For example, if a shelf-type dryer, the drug granulated particles at 60 to 80 ° C. It is good to dry so that the water content may become 0-5 mass%. Thereafter, using a pulverizer or the like as appropriate, a granulated product having a desired particle size is obtained with a sieve or the like. However, the method for producing drug granulated particles of the present invention is not limited to this, as long as wet granulation is performed by adding an aqueous binder solution to a powder containing a drug and dry aluminum hydroxide gel. And can be produced by methods known to those skilled in the art.

  In addition, as mentioned above, when blending the above-mentioned optional components in the drug granulated particles, the powder may be mixed with the powder containing the drug and dry aluminum hydroxide gel, You may add to binder aqueous solution. Moreover, you may mix after wet granulation.

[Orally disintegrating tablets]
The orally disintegrating tablet of the present invention contains the drug granulated particles. Orally disintegrating tablets refer to those that are chewed and disintegrated in the mouth and the components are released, and those that disintegrate easily by saliva in the mouth without being chewed and the components are released. [In-mouth disintegration time] In the measurement method, the time is preferably less than 40 seconds, more preferably less than 30 seconds. In particular, the content of the drug granulated particles in the orally disintegrating tablet is appropriately selected according to the content of the drug or monosaccharide as described above, but is preferably 50 to 100% by mass, and preferably 70 to 100% by mass. Is more preferable.

  In the orally disintegrating tablet, in addition to the drug granulated particles, other tablet components such as an excipient, a disintegrant imparting disintegration, and a lubricant can be used alone, as long as the effects of the present invention are not impaired. Or 2 or more types can be combined suitably and it can mix | blend an appropriate amount.

  As the excipient, a commonly used excipient can be used. Examples thereof include cellulose such as crystalline cellulose, ethyl cellulose, low-substituted hydroxypropyl cellulose and derivatives thereof, starch and derivatives thereof such as corn starch, potato starch and hydroxypropyl starch, sugars such as lactose and mannitol, sugar alcohols and the like. Especially, it is preferable to mix | blend mannitol from the point which a powderiness reduces and food texture improves. The content of the excipient may be in the range of 0 to 50 mass%, preferably 1 to 30 mass%, with respect to the orally disintegrating tablet. If the content of mannitol is too small, the texture-improving effect becomes insufficient. Therefore, the content is preferably 7% by mass or more and more preferably 10% by mass or more based on the orally disintegrating tablet. On the other hand, if the amount is too large, the disintegration property may be deteriorated.

  The disintegrant may not be contained in the orally disintegrating tablet, but by incorporating the disintegrant, disintegration from the inside of the tablet can be obtained, and the disintegration property of the whole tablet can be improved. Examples of the disintegrant include crospovidone (polyvinylpyrrolidone), carmellose calcium, croscarmellose sodium, low-substituted hydroxypropyl cellulose, carboxymethyl cellulose, carboxymethyl starch sodium, croscarmellose sodium, hydroxypropyl starch, and the like. . Of these, crospovidone is preferred. The content of the disintegrant is preferably 20% by mass or less, more preferably 1.7 to 10% by mass with respect to the orally disintegrating tablet, from the viewpoint of improving the wear resistance of the orally disintegrating tablet and the texture. 10 mass% is more preferable.

  As the lubricant, a commonly used lubricant can be used. For example, magnesium stearate, sucrose fatty acid ester, sodium stearyl fumarate, polyethylene glycol, talc, stearic acid and the like can be mentioned. The content of the lubricant is preferably 0.1 to 1% by mass relative to the orally disintegrating tablet.

  In addition, the orally disintegrating tablet of the present invention includes stabilizers such as sodium edetate and benzoic acid, pigments such as titanium oxide, iron sesquioxide, and food yellow No. 5, aspartame, sucralose, acesulfame potassium, saccharin, saccharin sodium, Sweeteners such as trehalose and thaumatin, sour agents such as malic acid, tartaric acid, citric acid, succinic acid and fumaric acid, monoterpenes such as menthol, camphor, borneol and limonene, and flavoring agents such as essential oils containing them Can be blended.

  The converted friability of the orally disintegrating tablet is determined by the method shown in the item of converted friability in the examples described later, preferably less than 0.5% by mass, more preferably less than 0.2% by mass, and 0.1% by mass. More preferably less than%.

  The mass of the orally disintegrating tablet depends on the diameter and shape of the tablet, but is preferably 20 to 2000 mg / tablet. Especially, in the tablet with a diameter of φ10.0 mm, from the viewpoint of disintegration, 350 mg / tablet or less is preferable, 320 mg / tablet or less is more preferable, and 280 mg / tablet or less is more preferable. Moreover, from the point of the moldability of a tablet, 150 mg / tablet or more is preferable, 180 mg / tablet or more is more preferable, and 200 mg / tablet or more is further more preferable. The shape of the tablet is not particularly limited, but may be a round shape, a caplet shape, a donut shape, an oblong shape or the like, a laminated tablet, a dry-coated tablet, etc. A secant line may be attached. It is preferable to use a tablet with a diameter based on the amount of powder commonly used in the pharmaceutical preparation field, and tableting is performed so as to achieve the desired tablet strength. The tablet strength can be measured with a tablet breaking strength measuring instrument TH203CP (manufactured by Toyama Sangyo Co., Ltd.).

[Method for producing orally disintegrating tablets]
An orally disintegrating tablet can be obtained by tableting the obtained drug granulated particles or a mixture of the drug granulated particles and other tablet components. For tableting, an apparatus generally used for tablet formation is used. For example, a single tableting machine or a rotary tableting machine is used. The molding pressure at the time of tableting is appropriately selected so as to achieve the target tablet hardness. The hardness varies depending on the tablet size, but is preferably about 3 kgf (tablet hardness measuring device (manufactured by Yamato Scientific Co., Ltd.)) or more. The packaging of the orally disintegrating tablet is not particularly limited, but may be PTP (Press Through Package) packaging for preventing moisture.

  EXAMPLES Hereinafter, although an Example and a comparative example are shown and this invention is demonstrated concretely, this invention is not restrict | limited to the following Example. In addition, the quantity in a table | surface is the quantity of the component described in the case of the component name.

[Examples 1-17, Comparative Examples 1-3]
[Preparation of drug granulated particles]
In advance, the binder described in the binder column in the following table is dissolved in purified water to prepare an aqueous binder solution (binding agent concentration: 10% by mass), and the components described in the drug granulated particle column other than the binder are composed. In a table, 2000 g of the powder having the ratio of 1 is put into a high speed mixer FS-10 (manufactured by Fukae Powtech Co., Ltd.), premixed for 1 minute, and the rotational speed is set to 300 rpm agitator and 2000 rpm chopper. The binder aqueous solution corresponding to the amount of the binder was stirred while being dropped over 4 minutes. Thereafter, high-speed stirring was performed for 2 minutes. The obtained granulated material was spread on a vat and air-dried at 80 ° C. for 5 hours with a shelf dryer DN-93 (manufactured by Yamato Scientific Co., Ltd.) to obtain particles. The obtained particles were sieved with a sieve having an opening of 1000 μm to obtain the desired drug granulated particles (average particle size: 150 to 350 μm).

[Preparation of orally disintegrating tablets]
400 g of the obtained drug granulated particles and other disintegrant / excipient were taken at a predetermined ratio, placed in a plastic bag and shaken by hand about 20 times, then mixed with lubricant and further 10 times. . This mixed powder was tableted with LIBRA2 (manufactured by Kikusui Seisakusho) to obtain circular tablets (φ10.0 mm) having the compositions shown in Tables 1-5. The tableting pressure was adjusted with a tablet hardness measuring device (manufactured by Yamato Scientific Co., Ltd.) so that the hardness was 3 to 5 kgf. (Rotating disk rotation speed: 30 rpm, number of bottles: 12), tablets having the compositions shown in Tables 1 to 5 were obtained. The following evaluation was performed about the obtained tablet. The results are also shown in the table.

[Mouth disintegration time]
Oral disintegration was evaluated by 10 adult males. The tablet was placed in the mouth, and the tablet was disintegrated while rolling with the tongue, and the time until the tablet was completely disintegrated was measured. Evaluation was made based on the following criteria from the average value of the decay time of 10 people. △ or more is the allowable range.
<Standard>
◎: Less than 20 seconds ○: 20 seconds or more and less than 30 seconds △: 30 seconds or more and less than 40 seconds ×: 40 seconds or more

[Equivalent friability]
The test was conducted in accordance with JP Reference Information and the friability test method for tablets. In parallel with the friability test, the tablets were separately left in the same time and in the same measurement test room, and the change in mass was measured. The mass change rate was subtracted from the friability to calculate the converted friability and evaluated according to the following criteria. △ or more is the allowable range.
<Standard>
A: Less than 0.1% by mass O: 0.1% by mass or more and less than 0.2% by mass Δ: 0.2% by mass or more and less than 0.5% by mass x: 0.5% by mass or more

[Food texture]
The texture was evaluated by 10 adult men. The tablet was put into the oral cavity, the tablet was disintegrated while rolling with the tongue, and the texture until the tablet was completely disintegrated was evaluated. Judgment is based on the following criteria, and the answer with the most responses is shown. 3 or more is an allowable range.
<Standard>
5: Does not feel powdery 4: Feels slightly powdery 3: Feels a little powdery 2: Feels powdery 1: Very feels powdery

  As is clear from the results of Comparative Example 1, when dry aluminum hydroxide gel was not used and crystalline cellulose was used instead of dry aluminum hydroxide gel, the texture was inferior to that of the present invention. . Further, as is clear from the results of Comparative Example 2, when the dry aluminum hydroxide gel was contained outside the drug granulated particles, the disintegration time in the mouth was inferior to that of the present invention.

The raw materials used in the above examples are shown below.
1. 1. Berberine tannate: manufactured by Alps Pharmaceutical Co., Ltd. Rohto extract 3 times powder: Alps Pharmaceutical Co., Ltd. (trade name: Rohto extract 3 times powder C)
2. 36.7% by weight of funnel extract impregnated with 66.7% by weight of corn starch Loot extract granule: 66.6% by mass of funnel extract adsorbed to 33.4% by mass of crospovidone CL-SF Dry aluminum hydroxide gel: manufactured by Kyowa Chemical Industry Co., Ltd. (trade name: dry aluminum hydroxide gel S-100)
5. Mannitol: Rocket Japan Co., Ltd. (trade name: Pearitol 100SD)
6). Crospovidone: BASF Japan K.K. (trade name: Kollidon CL-SF), Crospovidone: BASF Japan K.K. (brand name: Kollidon CL)
7). Magnesium stearate: Taihei Chemical Industry Co., Ltd. (trade name: Magnesium stearate)
8). Fructose: manufactured by Kyowa Hakko Kogyo Co., Ltd. (trade name: fructose)
9. Crystalline cellulose: manufactured by Asahi Kasei Chemicals Corporation (trade name: Theolas KG-1000)
10. Hydroxypropyl cellulose: Nippon Soda Co., Ltd. (trade name: HPC-SSL)
11. Anhydrous caffeine: manufactured by Shizuoka Caffeine Co., Ltd. (trade name: anhydrous caffeine)
12 Aldioxa: Made by Permachem Asia (trade name: Aldioxa)
13. Noscapine: manufactured by Shiratori Pharmaceutical Co., Ltd. (trade name: Noscapine)
14 Synthetic hydrotalcite: manufactured by Kyowa Chemical Industry Co., Ltd. (trade name: synthetic hydrotalcite)

Claims (4)

  An orally disintegrating tablet containing drug granulated particles, wherein the drug granulated particles are wet granulated by adding an aqueous binder solution to a powder containing a drug and dry aluminum hydroxide gel. An orally disintegrating tablet characterized by being.   The orally disintegrating tablet according to claim 1, wherein the content of the dry aluminum hydroxide gel in the drug particles is 1 to 50% by mass.   The orally disintegrating tablet according to claim 1 or 2, wherein the drug content is 1 to 70 mass% with respect to the orally disintegrating tablet.   A step of granulating a powder containing a drug and dry aluminum hydroxide gel while stirring or dropping an aqueous binder solution and then drying to obtain drug granulated particles, and the obtained drug granulated particles or drug The method for producing an orally disintegrating tablet according to claim 1, further comprising the step of tableting a mixture of the granulated particles and other tablet components.