JP2020128442A - Zinc acetate hydrate tablet and production method thereof - Google Patents

Abstract

To provide compact granules of zinc acetate hydrate with less occupied volume, in which the disappearance of crystallization water in zinc acetate hydrate in the production process is suppressed, and to provide production methods thereof.SOLUTION: Such granules contain 5 to 200 mg of zinc acetate hydrate (CHOZn-2HO), have a size of 5 to 12 mm in diameter and of 1 to 6 mm in thickness, is a zinc acetate hydrate tablet having the amount of eluted zinc in 15 minutes after measured by Japanese Pharmacopoeia Elution Test Method, paddle method 50 rotations (test solution: 900 mL of water), of 85% or more, and can be obtained by controlling the product temperature to less than 40°C in the granulation step.SELECTED DRAWING: None

Description

The present invention relates to a zinc acetate hydrate tablet containing zinc acetate hydrate as an active ingredient and a method for producing the same.

Wilson's disease is a disease that causes serious damage to the liver, nerves, etc. by the fact that the copper ingested by the diet is not normally excreted from the liver into the bile and intestine, and a large amount of copper accumulates in the liver, brain, kidneys, etc. Is.
As a therapeutic agent for Wilson's disease, capsules containing zinc acetate hydrate (C ₄ H ₆ O ₄ Zn.2H ₂ O) as an active ingredient in 1997 in the United States, 2004 in Europe, and 2008 in Japan. The drug has been approved and is currently in use.

However, the currently used zinc acetate hydrate capsules have a very large total amount of the components packed in the capsule and are a physical mixture, and therefore, when the capsules are filled with the components during the manufacturing process, Poor fluidity causes uneven filling and other problems, which is a major obstacle to continuous production of preparations.
Further, since the capsule has a large drug diameter (for example, No. 1 capsule has an outer diameter of 7 mm and a length of 19 to 20 mm), there is a problem that it is difficult to swallow (difficult to swallow) when taking. Therefore, as an agent containing zinc acetate hydrate as an active ingredient, an agent having a smaller agent diameter (diameter) is required.

In view of the above situation, the present invention controls the drying temperature in the manufacturing process of the granulated product to a product temperature of less than 40° C., thereby suppressing the disappearance of water of crystallization in zinc acetate hydrate in the manufacturing process. An object of the present invention is to provide a compacted granule of zinc acetate hydrate having a small volume and a method for producing the same.

As a method for obtaining a zinc acetate hydrate preparation that has higher production efficiency and is easier to swallow than a capsule preparation, it is possible to fill a capsule with a smaller diameter or change to another dosage form such as a tablet.
On the other hand, zinc acetate hydrate is known as dihydrate, and was recognized as being relatively stable (for example, stable up to about 100° C. even when heated in sulfuric acid). However, when the present inventors conducted extensive research on zinc acetate hydrate, it was found that when zinc acetate hydrate was heated at a relatively low temperature (for example, about 40° C.), water of crystallization in the hydrate was observed. Sometimes disappeared and transferred to an anhydride, resulting in an anhydride not approved as an active ingredient of a therapeutic agent for Wilson's disease.
Therefore, the present inventors, in the production of tablets containing zinc acetate hydrate as an active ingredient, it is necessary to avoid dehydration of zinc acetate hydrate, in wet granulation heating in the drying step, crystal Considering that the disappearance of water was unavoidable, we attempted to produce zinc acetate hydrate tablets with a small diameter by dry granulation. However, the dry granulation method could not obtain zinc acetate hydrate tablets having a small drug size.

As a result of further intensive studies to solve the above-mentioned problems, the present inventors have found that zinc acetate hydrate (C ₄ H ₆ O ₄ Zn.2H ₂ O) is contained in an amount of 5 to 200 mg and has a diameter of Zinc acetate water having a thickness of 5 to 12 mm and a thickness of 1 to 6 mm and having a zinc elution amount of 85% or more after 15 minutes measured by the Japanese Pharmacopoeia dissolution test method paddle method 50 rotations (test liquid: water 900 mL). Surprisingly, it was found that Japanese tablets can be produced by a specific production method (for example, wet granulation method, fluidized bed granulation method).
In addition to the above, the present inventors have obtained various unexpected new findings as described below, and have conducted intensive studies to complete the present invention.

That is, the present invention relates to the following zinc acetate hydrate tablets and the like.
[1] 5 to 200 mg of zinc acetate hydrate (C ₄ H ₆ O ₄ Zn.2H ₂ O) was contained, the size was 5 to 12 mm, the thickness was 1 to 6 mm, and the Japanese Pharmacopoeia dissolution test method was used. A zinc acetate hydrate tablet characterized by having a zinc elution amount of 85% or more after 15 minutes as measured by the paddle method 50 times (test liquid: water 900 mL).
[2] The zinc acetate hydrate tablet according to [1], wherein the size is 5 to 10 mm in diameter and 2 to 5 mm in thickness.
[3] The zinc acetate hydrate tablet according to the above [1] or [2], wherein the total mass is not more than twice the zinc acetate hydrate content.
[4] (1) a step of granulating a mixture of zinc acetate hydrate (C ₄ H ₆ O ₄ Zn.2H ₂ O), an excipient, a disintegrating agent and a solvent and then drying to obtain a granulated product, (2) tableting the granulated product to obtain an uncoated tablet, and (3) film coating on the uncoated tablet, followed by drying, wherein the product temperature in the step (1) does not exceed 40°C. In the step (3), the product temperature is 50° C. or lower, and contains 5 to 200 mg of zinc acetate hydrate (C ₄ H ₆ O ₄ Zn.2H ₂ O) and has a diameter of Zinc acetate water having a thickness of 5 to 12 mm and a thickness of 1 to 6 mm and having a zinc elution amount of 85% or more after 15 minutes measured by the Japanese Pharmacopoeia dissolution test method paddle method 50 rotations (test liquid: water 900 mL). Japanese tablet manufacturing method.

According to the present invention, zinc acetate hydrate in which the disappearance of water of crystallization in zinc acetate hydrate in the production process is suppressed by performing drying in the production process of the granulated product at a temperature of the product temperature lower than 40°C You can get a lock.
Moreover, since the zinc acetate hydrate tablet of the present invention has a small size, it can be swallowed more easily when ingested than conventional capsules of zinc acetate hydrate.
The tableting powder of the zinc acetate hydrate tablet of the present invention can be directly used as a granule or can be filled in a capsule.

Hereinafter, the present invention will be described in detail.
<Zinc acetate hydrate tablet>
The zinc acetate hydrate tablet of the present invention contains 5 to 200 mg of zinc acetate hydrate (C ₄ H ₆ O ₄ Zn.2H ₂ O), has a size of 5 to 12 mm and a thickness of 1 to 6 mm. It is characterized in that the amount of zinc eluted after 15 minutes measured by the Japanese Pharmacopoeia Paddle Method 50 revolutions (test solution: water 900 mL) is 85% or more. The zinc acetate hydrate tablet may be an uncoated tablet of zinc acetate hydrate, or a film-coated tablet of the uncoated tablet.

In the zinc acetate hydrate tablet of the present invention, the content of zinc acetate hydrate is usually about 5 to 200 mg, preferably about 50 to 180 mg, more preferably about 80 to 170 mg. Within such a range, the drying after granulation in the manufacturing process of the zinc acetate hydrate tablet can be performed at a temperature of less than 40° C., and the water of crystallization in the zinc acetate hydrate in the manufacturing process can be performed. It is preferable because the disappearance can be suppressed.

The diameter of the zinc acetate hydrate tablet of the present invention is usually about 5 to 12 mm, preferably about 5 to 10 mm, more preferably about 6 to 9 mm.
The thickness of the zinc acetate hydrate tablet of the present invention is usually about 1 to 6 mm, preferably about 2 to 5 mm, more preferably about 3 to 4 mm.
In the present invention, the method for measuring the diameter and thickness of the zinc acetate hydrate tablet is not particularly limited and may be a conventionally known method for measuring tablet size.

In the zinc acetate hydrate tablet of the present invention, the amount of zinc eluted after 15 minutes measured by the Japanese Pharmacopoeia dissolution test paddle method 50 times (test liquid: water 900 mL) is 85% or more. The zinc acetate hydrate tablet of the present invention can be dried in the manufacturing process of the granulated product at a temperature of less than 40°C, and can suppress the disappearance of crystal water in the zinc acetate hydrate in the manufacturing process. Therefore, the elution amount of the zinc is in such a range.

The total mass of the zinc acetate hydrate tablet of the present invention is usually about 2 times or less, preferably about 1.6 times or less the zinc acetate hydrate content.

The zinc acetate hydrate tablet of the present invention may contain an appropriate amount of additives and pharmaceutically active ingredients generally used in medicine. These may be used alone or in combination of two or more.
Examples of the additive include an excipient, a disintegrant, a lubricant, a binder, a coating agent, a brightening agent, a coloring agent, a flavoring agent, a sweetening agent, a flavoring agent, and the like, and preferably an excipient , Disintegrants, binders, lubricants and the like.

The excipient is not particularly limited, but examples thereof include sugar alcohols such as mannitol, sorbitol, xylitol, erythritol, maltitol, and isomalt; sugars such as lactose hydrate, fructose, sucrose, glucose, and trehalose; corn starch. , Starches such as potato starch, wheat starch, rice starch; amino acids such as glycine and alanine; silicic acid such as light anhydrous silicic acid, synthetic aluminum silicate, magnesium metasilicate aluminate, calcium silicate; crystalline cellulose, powder Cellulose such as cellulose; talc; titanium oxide and the like. The excipient is preferably crystalline cellulose, corn starch, lactose hydrate or the like. These excipients may be used alone or in combination of two or more.

The content of the excipient contained in the zinc acetate hydrate tablet of the present invention is not particularly limited, but is preferably about 5 to 80 mass% with respect to the total mass of the zinc acetate hydrate tablet of the present invention. And more preferably about 10 to 50% by mass.

The disintegrant is not particularly limited, for example, crospovidone, carmellose calcium, carmellose, croscarmellose, croscarmellose sodium, low-substituted hydroxypropyl cellulose, corn starch, potato starch, wheat starch, rice starch, partial Examples thereof include alpha starch, pregelatinized starch, sodium carboxymethyl starch and the like. The disintegrant is preferably crospovidone, carmellose, croscarmellose, low-substituted hydroxypropyl cellulose, or the like. These disintegrants may be used either individually or in combination of two or more.

The content of the disintegrant contained in the zinc acetate hydrate tablet of the present invention is not particularly limited, but is preferably about 1 to 50% by mass relative to the total mass of the zinc acetate hydrate tablet of the present invention. Yes, and more preferably about 5 to 20 mass %.

The lubricant is not particularly limited, and examples thereof include magnesium stearate, calcium stearate, talc, sucrose fatty acid ester, and sodium stearyl fumarate. The lubricant is preferably talc, magnesium stearate or the like. These lubricants may be used alone or in combination of two or more.

The content of the lubricant contained in the zinc acetate hydrate tablet of the present invention is not particularly limited, but is preferably about 0.1 to 20 relative to the total mass of the zinc acetate hydrate tablet of the present invention. % By mass, more preferably about 0.5 to 10% by mass.

The binder is not particularly limited, for example, povidone, hydroxypropyl cellulose, hypromellose phthalate, hydroxypropylmethyl cellulose acetate succinate, magnesium aluminometasilicate, synthetic aluminum silicate, light anhydrous silicic acid, silicic acid. Calcium, sodium carmellose, ethyl cellulose, methyl cellulose, hypromellose, acacia, sodium alginate, dextrin, corn starch, potato starch, wheat starch, rice starch, partially pregelatinized starch, pregelatinized starch, crystalline cellulose, powdered cellulose, low degree of substitution Examples include hydroxypropyl cellulose, gelatin, pullulan, carboxyvinyl polymer and the like. These binders may be used alone or in combination of two or more.

The coating agent is not particularly limited, and examples thereof include water-soluble polymers, water-insoluble polymers, gastric-soluble polymers, enteric-soluble polymers and the like.
Examples of the water-soluble polymer include natural polymers such as gum arabic powder, gelatin pullulan, dextrin, sodium carboxymethyl starch, sodium alginate; polysaccharides; carmellose, carmellose sodium, carmellose calcium, hydroxypropyl cellulose, hypromellose. , Cellulose derivatives such as hydroxyethyl cellulose, hydroxymethyl cellulose, methyl cellulose and carboxymethyl cellulose; and water-soluble vinyl derivatives such as polyvinylpyrrolidone and polyvinyl alcohol.
Examples of the water-insoluble polymer include ethyl cellulose, vinyl acetate polymer, aminoalkyl methacrylate copolymer, ethyl acrylate/methyl methacrylate copolymer dispersion and the like.

Examples of the gastric soluble polymer include aminoacetal compounds such as polyvinyl acetal and diethylaminoacetate.
As the enteric polymer, for example, cellulose acetate propionate, hydroxypropylmethyl cellulose acetate succinate, hypromellose phthalate ester, hydroxymethyl ethyl cellulose phthalate, carboxymethyl ethyl cellulose, cellulose acetate phthalate and other enteric cellulose esters and the like. Can be mentioned.
In addition to the above, titanium oxide, polyethylene glycol, talc and the like can be used as the coating agent.
These coating agents may be used either individually or in combination of two or more.

The brightening agent is not particularly limited, and examples thereof include carnauba wax, hydrogenated oil, vinyl acetate resin, white beeswax, titanium oxide, stearic acid, calcium stearate, polyoxyl 40 stearate, magnesium stearate, purified shellac, and purified paraffin carnauba wax. Examples include mixed wax, cetanol, talc, white shellac, paraffin, povidone (polyvinylpyrrolidone), polyethylene glycol 1500, polyethylene glycol 4000, polyethylene glycol 6000, beeswax, glyceryl monostearate, rosin and the like.

Examples of the colorant include food dyes, food lake dyes, iron sesquioxide, yellow iron sesquioxide, and the like.
Examples of the corrigent include citric acid, tartaric acid, malic acid, ascorbic acid and the like.
Examples of the sweetener include aspartame, acesulfame potassium, saccharin, saccharin sodium, dipotassium glycyrrhizinate, stevia, thaumatin, sucralose and the like.
Examples of the fragrance include fennel oil, orange oil, chamomile oil, spearmint oil, cinnamon oil, clove oil, peppermint oil, bergamot oil, eucalyptus oil, lavender oil, lemon oil, rose oil, Roman chamomile oil, menthol and the like. To be

The zinc acetate hydrate tablet of the present invention may contain an appropriate amount of a pharmaceutically active ingredient. The pharmaceutically active ingredient is a type and amount that does not impair the disappearance of water of crystallization in zinc acetate hydrate in the manufacturing process of the zinc acetate hydrate tablet of the present invention, and the disintegration property and moldability of the tablet. Good and not particularly limited.

<Method for producing zinc acetate hydrate tablet>
The method for producing a zinc acetate hydrate tablet of the present invention generally comprises (1) a mixture of zinc acetate hydrate (C ₄ H ₆ O ₄ Zn.2H ₂ O), an excipient, a disintegrant and a solvent. Granulating and then drying to obtain a granulated product, (2) tableting the granulated product to obtain an uncoated tablet, and (3) film coating the uncoated tablet and then drying. The product temperature in the step (1) usually does not exceed 40°C. In the drying after the film coating in the step (3), the product temperature is usually 50°C or lower. In the present invention, these steps are usually carried out in the order of steps (1) to (3). Further, the method for producing a zinc acetate hydrate tablet of the present invention may include steps other than the steps (1) to (3).

<Granulation>
In the present invention, the method for granulating a mixture of zinc acetate hydrate (C ₄ H ₆ O ₄ Zn.2H ₂ O), an excipient, a disintegrant and a solvent is not particularly limited, but, for example, a fluidized bed A granulation method, a wet granulation method and the like are preferable. These granulation methods have heretofore been well established, and the present invention may also follow the conventionally known methods.

The fluidized bed granulation method is a process of granulating raw material granules while spraying a solvent or a mixed solution of a solvent and a binder, and, if necessary, a method or apparatus used for producing a general tablet. (Fluidized bed granulator etc.) can be used. In the present invention, the fluidized bed granulation treatment may be rolling fluidized bed granulation treatment.
In the present invention, the fluidized bed granulation method, for example, zinc acetate hydrate, excipients and disintegrants, put in a fluidized bed granulator and mixed, by spraying a solution of the binder and solvent, It can be carried out.

The wet granulation method is a treatment in which raw material powder and granules are mixed with a solvent and then granulated, and if necessary, a method and an apparatus used for manufacturing a general tablet can be used. In the present invention, the stirring granulation method is preferable among the wet granulation methods.
In the present invention, the stirring granulation method can be carried out, for example, by adding a mixture of zinc acetate hydrate, an excipient, a disintegrant, a binder and a solvent to a stirring granulator and stirring.

The solvent used in these fluidized bed granulation method and wet granulation method is not particularly limited, but, for example, ethanol used in the production of general tablets, alcohols such as isopropanol, water, etc. may be used. You can

Following the granulation, the treated product obtained by the granulation is dried to obtain a granulated product.
The drying method is not particularly limited, and if the drying temperature is less than 40° C., a conventionally known drying method for tablet production using a fluidized bed dryer, a shelf dryer, etc. may be used.

Generally, the drying temperature after granulation in the manufacturing process of the granulated product is around 60°C. When the zinc acetate hydrate is heated at a temperature of 40° C. or higher, the water of crystallization in the zinc acetate hydrate disappears and the zinc acetate hydrate is transferred to the anhydrous form. By performing drying after granulation at a product temperature of less than 40° C., it is possible to suppress the disappearance of water of crystallization in the zinc acetate hydrate in the manufacturing process of the granule.

Further, after the drying, particle size adjustment using a co-mill, screen mill, jet mill, hammer mill, pin mill and the like; operations necessary for producing tablets such as sieving using a vibrating screen may be further performed.

Prior to the tableting step, the granulated product is preferably mixed for homogenization to obtain a tableting powder. The mixing method is not particularly limited, and a conventionally known method can be used. For example, the mixing can be performed by adding the granulated product and the lubricant to a container rotary mixer and mixing. .. The obtained powder for tableting can be directly used as a granule, or can be filled into a capsule by a conventional method to give a capsule. The capsule filled with the tableting powder of the zinc acetate hydrate tablet of the present invention can be smaller in size than conventional capsules of zinc acetate hydrate.

<Tabletting>
In the production of the zinc acetate hydrate tablet of the present invention, an uncoated tablet is obtained by compression-molding the granulated product following the production process of the granulated product. At the time of compression molding, if necessary, the additives and pharmaceutically active ingredients may be mixed and compression molded.
The compression molding method is not particularly limited, and for example, a method and a device generally used for tablet molding such as a rotary tableting machine and a single shot tableting machine can be used. Moreover, the compression pressure in this compression molding is not particularly limited.
The mass of the uncoated tablet obtained by tableting is, for example, about 120 to 130 mg when the finally obtained zinc acetate hydrate tablet of the present invention contains 25 mg of zinc, and When the obtained zinc acetate hydrate tablet of the present invention contains 50 mg of zinc, it is about 245 to 255 mg.

<Film coating>
Following the tableting step for obtaining the uncoated tablet, the uncoated tablet is film-coated and then dried to obtain the zinc acetate hydrate tablet of the present invention.
The film coating method is not particularly limited and may be a method generally used in the production of tablets. The film coating can be performed, for example, by wet-spraying the plain tablet with a suspension of a coating agent and a solvent using a coating machine. As the solvent, for example, alcohols such as ethanol and isopropanol; water can be used.

The mass of the tablet after the film coating is, for example, about 124 to 134 mg when the finally obtained zinc acetate hydrate tablet of the present invention contains 25 mg of zinc, and the mass of the tablet of the present invention finally obtained. When the zinc acetate hydrate tablet contains 50 mg of zinc, it is about 251 to 261 mg.

The zinc acetate hydrate tablet of the present invention can be obtained by drying the obtained tablet after the film coating.
The drying method is not particularly limited and may be a conventionally known method for drying a coating agent in the production of tablets as long as the drying temperature is 50° C. or lower.
In the present invention, the drying can be performed at a product temperature of 50° C. or less, and the disappearance of water of crystallization in zinc acetate hydrate can be suppressed. In the step (1) of obtaining the granulated product, the product temperature is lower than 40°C, but the drying temperature after the film coating after obtaining the uncoated tablet is zinc acetate water if the product temperature is 50°C or lower. It is possible to suppress the disappearance of the water of crystallization in the Japanese product.
The zinc acetate hydrate tablet of the present invention obtained by drying may be sprayed with a brightening agent by a conventional method.

The zinc acetate hydrate tablet of the present invention obtained as described above can be usually housed in a container or a bag by a conventional method. The container or bag is not particularly limited as long as it can be used as a tablet container or bag, and conventionally known ones can be used.

Hereinafter, the present invention will be described in more detail with reference to Examples, but the present invention is not limited to these Examples, and various changes and modifications can be made without departing from the technical scope of the present invention.
In Examples 1 to 3 below, the zinc elution amount after 15 minutes is the zinc elution amount after 15 minutes measured by the Japanese Pharmacopoeia Paddle Method 50 revolutions (test solution: water 900 mL). ..

<Production of zinc acetate hydrate tablets>
(Example 1)
Purification by mixing 83.9 g of zinc acetate hydrate, 30.1 g of corn starch (excipient) and 10 g of partially pregelatinized starch (binder) with a stirring granulator (Fukae Industry Co., Ltd., High Speed Mixer). Granulation was carried out by adding water. This was dried at a product temperature of 35°C using a static dryer (ventilation dryer manufactured by Advantech) until the loss on drying (water content) reached 13.8%, and the obtained dried product was No. 22. The particles were sized with a sieve (710 μm). Magnesium stearate (lubricant) was mixed with this sized product so that the mixing ratio (mass ratio) was sized product/magnesium stearate=124/1 to produce tableting powder. .. This powder was tabletted with a diameter of 6 mm and a tablet weight of 125 mg to obtain zinc acetate hydrate tablets. The obtained zinc acetate hydrate tablet had a thickness of 3.4 mm, a disintegration time of 7 to 15 minutes, and an elution amount of zinc after 15 minutes was 88%.

(Example 2)
83.9 g of zinc acetate hydrate, 20.1 g of corn starch (excipient) and 12 g of carmellose (disintegrant) were mixed in a fluid bed granulator (manufactured by Paulec, multiplex), and hydroxypropyl cellulose (bonded) was mixed. 3 g of the agent) was dissolved in purified water, and this solution was sprayed for granulation. This was dried at an air supply temperature of 60° C. until a product temperature of 32° C. was reached, and then sized by a sieving machine (Powrec Co. Ltd., Comill). Manufacture a tableting powder by mixing magnesium stearate (lubricant) with this sized product so that the mixing ratio (mass ratio) is sized product/magnesium stearate = 119/1. did. This powder was tabletted with a diameter of 6 mm and a tablet weight of 120 mg to obtain zinc acetate hydrate tablets. The obtained zinc acetate hydrate tablet had a thickness of 3.4 mm, a disintegration time of 4 to 7 minutes, and an elution amount of zinc after 15 minutes: 98%.

(Example 3)
839 g of zinc acetate hydrate, 101 g of corn starch (excipient) and 116 g of crystalline cellulose (excipient) were mixed with a stirring granulator (manufactured by Fukae Kogyo Co., Ltd., High Speed Mixer) to give hydroxypropyl cellulose (binder ) 14 g was dissolved in purified water, and this solution was added for granulation. This was dried using a fluidized bed dryer (manufactured by Paulec, Multiplex) at an air supply temperature of 60° C. until a product temperature of 32° C. was reached, and the obtained dried product was a sizing machine (manufactured by Paulec, Comill). ). Croscarmellose sodium (disintegrant) was added to this sized product so that the mixing ratio (mass ratio) was sized product/croscarmellose sodium/magnesium stearate=107/12/1. After mixing well, magnesium stearate (lubricant) was mixed to produce a tableting powder. This powder was tabletted with a diameter of 6 mm and a tablet weight of 120 mg to obtain zinc acetate hydrate tablets. The obtained zinc acetate hydrate tablet had a thickness of 3.3 mm, a disintegration time of 8 to 9 minutes, and an elution amount of zinc after 15 minutes: 95%. To this tablet, 21 g of hypromellose and 3 g of macrogol 6000 were dissolved in 420 mL of purified water, and a solution in which 3.6 g of titanium oxide and 2.4 g of talc were dispersed was used with a film coating machine (Freund Industrial Co., Ltd., High Coater). Film coating was performed and dried at an air supply temperature of 60° C. until a drying end temperature (product temperature) of 50° C. was reached to obtain a film coated tablet. The obtained tablets had a tablet weight of 123 mg, a diameter of 6 mm, a thickness of 3.4 mm, a disintegration time of 9 to 11 minutes, and a zinc elution amount after 15 minutes: 93%.

From the results of Examples 1 to 3, in the zinc acetate hydrate tablet of the present invention, the zinc elution amount after 15 minutes measured by the Japanese Pharmacopoeia Paddle Method 50 revolutions (test solution: water 900 mL) was 85. % Or more, and it was confirmed that the tablet was compact and sufficiently contained zinc acetate hydrate.

Since the zinc acetate hydrate tablet of the present invention is small in size and easy to swallow when ingested, it can be suitably used as a therapeutic agent for Wilson's disease.

Claims (4)

(1) A step of granulating a mixture containing zinc acetate hydrate (C ₄ H ₆ O ₄ Zn.2H ₂ O), an excipient, a binder and a solvent and then drying the mixture to obtain a granulated product, (2) ) A step of tableting the granulated product to obtain an uncoated tablet, wherein the product temperature in the step (1) is less than 40°C.
Method for producing zinc acetate hydrate tablet. (1) A step of granulating a mixture containing zinc acetate hydrate (C ₄ H ₆ O ₄ Zn.2H ₂ O), an excipient, a binder and a solvent and then drying the mixture to obtain a granulated product, (2 ) A step of tableting the granulated product to obtain an uncoated tablet, and (3) a step of film-coating the uncoated tablet and then drying, wherein the product temperature in the step (1) is less than 40° C., A method for producing a zinc acetate hydrate tablet, wherein the product temperature in the step (3) is 50° C. or lower. The method for producing a zinc acetate hydrate tablet according to claim 1 or 2, wherein the mixture in the step (1) further contains a disintegrant. The zinc acetate hydrate tablet contains 5-200 mg of zinc acetate hydrate (C ₄ H ₆ O ₄ Zn.2H ₂ O),
The size is 5 to 12 mm in diameter and 1 to 6 mm in thickness,
The zinc acetate according to any one of claims 1 to 3, wherein the dissolution amount of zinc after 15 minutes measured by the Japanese Pharmacopoeia dissolution test paddle method 50 times (test liquid: water 900 mL) is 85% or more. Method for producing hydrate tablet.