WO2016088816A1 - Comprimé comprenant de l'acétate de zinc hydraté et son procédé de fabrication - Google Patents

Comprimé comprenant de l'acétate de zinc hydraté et son procédé de fabrication Download PDF

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Publication number
WO2016088816A1
WO2016088816A1 PCT/JP2015/083941 JP2015083941W WO2016088816A1 WO 2016088816 A1 WO2016088816 A1 WO 2016088816A1 JP 2015083941 W JP2015083941 W JP 2015083941W WO 2016088816 A1 WO2016088816 A1 WO 2016088816A1
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Prior art keywords
zinc acetate
acetate hydrate
tablet
zinc
present
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PCT/JP2015/083941
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English (en)
Japanese (ja)
Inventor
恒雄 藤居
宏晃 板東
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ノーベルファーマ株式会社
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Priority to JP2016562663A priority Critical patent/JP6716464B2/ja
Publication of WO2016088816A1 publication Critical patent/WO2016088816A1/fr

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00—Medicinal preparations containing inorganic active ingredients
    • A61K33/24—Heavy metals; Compounds thereof
    • A61K33/30—Zinc; Compounds thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating

Definitions

  • 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 severe damage to the liver, nerves, etc., because copper ingested by diet is not normally excreted from the liver into the bile and intestinal tract, and a large amount of copper accumulates in the liver, brain, kidney, etc. It 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 agent has been approved and is currently in use.
  • the zinc acetate hydrate capsules currently used have a very large total amount of ingredients packed in the capsule and are a physical mixture. Therefore, when the ingredients are filled into the capsule in the manufacturing process, The fluidity is poor, causing problems such as uneven filling, which is a major obstacle to continuous production of the preparation.
  • the capsule has a large drug diameter (for example, the 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 (does not swallow) when taken. Therefore, an agent having zinc acetate hydrate as an active ingredient is required to have a smaller agent diameter (diameter).
  • the present invention controls the drying temperature in the production process of the granulated product to a product temperature of less than 40 ° C., thereby suppressing the disappearance of crystal water in the zinc acetate hydrate in the production process.
  • An object of the present invention is to provide a compacted granulated product of zinc acetate hydrate with a small volume and a method for producing the same.
  • zinc acetate hydrate is known as dihydrate and has been recognized to be relatively stable (for example, stable to about 100 ° C. even when heated in sulfuric acid).
  • a relatively low temperature for example, about 40 ° C.
  • Disappeared and metastasized to an anhydride resulting in an anhydride that was not approved as an active ingredient for Wilson's disease treatment.
  • the present inventors have to avoid the anhydrous formation of zinc acetate hydrate in the manufacture of tablets containing zinc acetate hydrate as an active ingredient. Considering that the disappearance of water is inevitable, an attempt was made to produce zinc acetate hydrate tablets with a small drug size by dry granulation. However, the dry granulation method could not obtain a zinc acetate hydrate tablet with a small dosage size.
  • the inventors of the present invention contain 5-200 mg of zinc acetate hydrate (C 4 H 6 O 4 Zn ⁇ 2H 2 O), and the size is a diameter.
  • Zinc acetate water that is 5 to 12 mm, thickness 1 to 6 mm, and zinc elution amount after 15 minutes is measured by 50 rotations of paddle method 50 days (test solution: water 900 mL).
  • test solution water 900 mL
  • Japanese tablets can be produced by a specific production method (for example, wet granulation method, fluidized bed granulation method).
  • the present inventors have obtained various unexpected new findings as described below, and have further conducted intensive studies to complete the present invention.
  • the present invention relates to the following zinc acetate hydrate tablets and the like.
  • test solution water 900 mL
  • 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.
  • the zinc acetate hydrate tablet of the present invention is small in size, it is easier to swallow at the time of taking than the conventional zinc acetate hydrate capsule.
  • the powder for tableting of the zinc acetate hydrate tablet of the present invention can be used as a granule as it is or filled into a capsule.
  • the zinc acetate hydrate tablet of the present invention contains 5-200 mg of zinc acetate hydrate (C 4 H 6 O 4 Zn.2H 2 O), has a size of 5 to 12 mm in diameter and 1 to 6 mm in thickness. Then, the elution amount of zinc after 15 minutes as measured by 50 revolutions of the paddle method of JP (equivalent to 900 mL of water) 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.
  • 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. If it is such a range, the drying after granulation in the manufacturing process of a zinc acetate hydrate tablet can be performed at a temperature of less than 40 ° C., and the crystal water in the zinc acetate hydrate in the manufacturing process can be performed. Since disappearance can be suppressed, it is preferable.
  • 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.
  • the measuring method of the diameter and thickness of a zinc acetate hydrate tablet is not specifically limited, You may follow the measuring method of the conventionally well-known tablet size.
  • the zinc acetate hydrate tablet of the present invention has an elution amount of zinc of 15% or more after 15 minutes measured by the JP dissolution method paddle method 50 rotations (test solution: water 900 mL).
  • the zinc acetate hydrate tablet of the present invention can be dried in the granulated product production process at a temperature of less than 40 ° C., and can suppress the disappearance of crystal water in the zinc acetate hydrate in the production process. Therefore, the zinc elution amount falls within 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 can contain appropriate amounts of additives and pharmaceutically active ingredients generally used in pharmaceuticals. These can be used alone or in combination of two or more.
  • the additive include an excipient, a disintegrant, a lubricant, a binder, a coating agent, a brightener, a coloring agent, a corrigent, a sweetener, and a fragrance, and preferably an excipient.
  • Disintegrants, binders, lubricants and the like are examples of the additives and pharmaceutically active ingredients generally used in pharmaceuticals. These can be used alone or in combination of two or more.
  • the additive include an excipient, a disintegrant, a lubricant, a binder, a coating agent, a brightener, a coloring agent, a corrigent, a sweetener, and a fragrance, and preferably an excipient.
  • Disintegrants, binders, lubricants and the like are examples of the additives and pharmaceutically
  • excipients include, but are not limited to, sugar alcohols such as mannitol, sorbitol, xylitol, erythritol, maltitol, isomalt; sugars such as lactose hydrate, fructose, sucrose, glucose, trehalose; corn starch , Starches such as potato starch, wheat starch and rice starch; amino acids such as glycine and alanine; silicic acids such as light anhydrous silicic acid, synthetic aluminum silicate, magnesium aluminate metasilicate and calcium silicate; crystalline cellulose, powder Celluloses such as cellulose; talc; titanium oxide and the like.
  • the excipient is preferably crystalline cellulose, corn starch, lactose hydrate or the like. These excipients can 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% by mass with respect to the total mass of the zinc acetate hydrate tablet of the present invention. More preferably, it is about 10 to 50% by mass.
  • the disintegrant is not particularly limited, for example, crospovidone, carmellose calcium, carmellose, croscarmellose, croscarmellose sodium, low-substituted hydroxypropylcellulose, corn starch, potato starch, wheat starch, rice starch, partial Alpha-ized starch, pregelatinized starch, carboxymethyl starch sodium and the like can be mentioned.
  • the disintegrant is preferably crospovidone, carmellose, croscarmellose, low-substituted hydroxypropylcellulose, or the like. These disintegrants can be used alone 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 with respect to the total mass of the zinc acetate hydrate tablet of the present invention. More preferably, it is about 5 to 20% by 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 can 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 weight, more preferably about 0.5 to 10% by weight.
  • the binder is not particularly limited.
  • binders can use 1 type (s) or 2 or more types.
  • water-soluble polymer water-insoluble polymer, gastric polymer, enteric polymer, etc.
  • water-soluble polymers include natural polymers such as gum arabic powder, gelatin pullulan, dextrin, sodium carboxymethyl starch, sodium alginate; polysaccharides; carmellose, carmellose sodium, carmellose calcium, hydroxypropylcellulose, hypromellose , Cellulose derivatives such as hydroxyethyl cellulose, hydroxymethyl cellulose, methyl cellulose, carboxymethyl cellulose; and water-soluble vinyl derivatives such as polyvinyl pyrrolidone and polyvinyl alcohol.
  • water-insoluble polymer examples include ethyl cellulose, vinyl acetate polymer, aminoalkyl methacrylate copolymer, ethyl acrylate / methyl methacrylate copolymer dispersion, and the like.
  • gastric soluble polymer examples include aminoacetal compounds such as polyvinyl acetal and diethylaminoacetate.
  • enteric polymer examples include enteric cellulose esters such as cellulose acetate propionate, hydroxypropylmethylcellulose acetate succinate, hypromellose phthalate, hydroxymethylethylcellulose phthalate, carboxymethylethylcellulose, and cellulose acetate phthalate. Can be mentioned.
  • titanium oxide, polyethylene glycol, talc, etc. can also be used as the coating agent. These coating agents can use 1 type (s) or 2 or more types.
  • the brightening agent is not particularly limited.
  • examples thereof include mixed wax, cetanol, talc, white shellac, paraffin, povidone (polyvinylpyrrolidone), polyethylene glycol 1500, polyethylene glycol 4000, polyethylene glycol 6000, beeswax, glyceryl monostearate, and rosin.
  • 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 sweetening agent include aspartame, acesulfame potassium, saccharin, saccharin sodium, dipotassium glycyrrhizinate, stevia, thaumatin, and sucralose.
  • fragrance examples include fennel oil, orange oil, chamomile oil, spearmint oil, cinnamon oil, clove oil, mint oil, bergamot oil, eucalyptus oil, lavender oil, lemon oil, rose oil, roman chamomile oil, menthol and the like. It is done.
  • the zinc acetate hydrate tablet of the present invention can contain an appropriate amount of a pharmaceutically active ingredient.
  • the active pharmaceutical ingredient is a kind and amount that does not impair the disappearance of crystallization water in the zinc acetate hydrate in the production process of the zinc acetate hydrate tablet of the present invention and the disintegration and moldability of the tablet. Good, not particularly limited.
  • the method for producing a zinc acetate hydrate tablet of the present invention usually 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.
  • a step of granulating and drying to obtain a granulated product (2) tableting the granulated product to obtain an uncoated tablet, and (3) a step of 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 film coating in the step (3), the product temperature is usually 50 ° C. or lower. In the present invention, these steps are usually performed in the order of steps (1) to (3).
  • the method for producing a zinc acetate hydrate tablet of the present invention may include steps other than the steps (1) to (3).
  • a 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.
  • a granulation method, a wet granulation method and the like are preferable. These granulation methods have been well established in the past, and the present invention may also follow 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 an apparatus used for general tablet production.
  • a fluidized bed granulator or the like can be used.
  • the fluidized bed granulation process may be a rolling fluidized bed granulation process.
  • the fluidized bed granulation method includes, for example, mixing zinc acetate hydrate, excipient and disintegrant in a fluidized bed granulator and spraying a solution of a binder and a solvent, It can be carried out.
  • the wet granulation method is a process of mixing a raw material granule with a solvent and then granulating it, and a method and an apparatus used for general tablet production can be used as necessary.
  • the stirring granulation method is preferable among the wet granulation methods.
  • the stirring granulation method can be performed, for example, by putting a mixture of zinc acetate hydrate, excipient, disintegrant, binder and solvent into an agitation granulator and stirring.
  • the solvent used in the fluidized bed granulation method and the wet granulation method is not particularly limited.
  • alcohols such as ethanol and isopropanol used for the production of general tablets, water, and the like are used. Can do.
  • a processed product obtained by the granulation is dried to obtain a granulated product.
  • the drying method is not particularly limited. If the drying temperature is less than 40 ° C., a conventionally known drying method in tablet production using a fluidized bed dryer, a shelf dryer or the like may be used.
  • the drying temperature after granulation in the production process of the granulated product is around 60 ° C.
  • water of crystallization in zinc acetate hydrate disappears and transitions to an anhydride.
  • the granulated product is preferably mixed to obtain a tableting powder before the tableting process in order to make it uniform.
  • the mixing method is not particularly limited, and a conventionally known method can be used.
  • the granulated product and the lubricant can be put into a container rotary mixer and mixed.
  • the obtained powder for tableting can be directly used as a granule, or can be filled into a capsule by a conventional method to form 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 the conventional zinc acetate hydrate capsule.
  • the granulated product is compressed and molded to give a plain tablet.
  • the additives and pharmaceutical active ingredients may be mixed and compression molded.
  • the compression molding method is not particularly limited, and for example, a method or an apparatus generally used for tablet formation such as a rotary tableting machine and a single-shot tableting machine can be used.
  • the compression pressure in this compression molding is not specifically 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.
  • the obtained zinc acetate hydrate tablet of the present invention contains 50 mg of zinc, it is about 245 to 255 mg.
  • the uncoated tablet is coated with a film 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 tablet production. Film coating can be performed, for example, by wet spray coating the uncoated tablet with a suspension of a coating agent and a solvent using a coating machine.
  • the solvent for example, alcohols such as ethanol and isopropanol; water can be used.
  • the weight of the tablet after 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.
  • the zinc acetate hydrate tablet contains 50 mg of zinc, it is about 251 to 261 mg.
  • the obtained tablet is dried to obtain the zinc acetate hydrate tablet of the present invention.
  • the drying method is not particularly limited, and the drying method of the coating agent in the production of a conventionally known tablet may be used as long as the drying temperature is 50 ° C. or less.
  • the drying can be performed at a product temperature of 50 ° C. or lower, and the disappearance of crystal water in the zinc acetate hydrate can be suppressed.
  • the product temperature is less than 40 ° C. If the drying temperature after film coating after obtaining the uncoated tablet is 50 ° C or less, the zinc acetate water is used. Disappearance of crystal water in the Japanese product can be suppressed.
  • the zinc acetate hydrate tablet of the present invention obtained by drying may be sprayed with a brightening agent using a conventional method.
  • the zinc acetate hydrate tablet of the present invention obtained as described above can be usually stored 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.
  • the zinc elution amount after 15 minutes is the zinc elution amount after 15 minutes as measured by the JP dissolution method paddle method 50 rotations (test solution: water 900 mL). .
  • Example 1 83.9 g of zinc acetate hydrate, 30.1 g of corn starch (excipient) and 10 g of partially pregelatinized starch (binder) were mixed in a stirring granulator (manufactured by Fukae Kogyo Co., Ltd., high speed mixer) for purification. Granulated by adding water. This was dried at a product temperature of 35 ° C. until the loss on drying (water content) reached 13.8% using a stationary dryer (Advantech, a ventilation dryer). Sized using a sieve (710 ⁇ m).
  • magnesium stearate lubricant
  • mass ratio mass ratio
  • This powder was tableted with a diameter of 6 mm and a tablet mass of 125 mg to give 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 a zinc elution amount of 88% after 15 minutes.
  • 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 POWREC, multiplex), and hydroxypropylcellulose (bonded) Agent) 3 g was dissolved in purified water, and this liquid was sprayed and granulated. This was dried at an air supply temperature of 60 ° C. until the product temperature reached 32 ° C., and then sized using a granulator (Pauleck Co., Comil).
  • magnesium stearate lubricant
  • the mixing ratio mass ratio
  • This powder was tableted with a diameter of 6 mm and a tablet mass of 120 mg to give 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 a zinc elution amount of 98% after 15 minutes.
  • 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), and hydroxypropylcellulose (binder) ) 14 g was dissolved in purified water, and this liquid was added to granulate. This was dried using a fluidized bed dryer (manufactured by POWREC Co., Ltd., multiplex) until the product temperature reached 32 ° C at a supply air temperature of 60 ° C, and the resulting dried product was granulated (Powrec Co., Ltd. ).
  • croscarmellose sodium disintegrant
  • mixture ratio mass ratio
  • magnesium stearate lubricant
  • This powder was tableted with a diameter of 6 mm and a tablet mass of 120 mg to give 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 a zinc elution amount of 95% after 15 minutes.
  • a film coating machine (Freund Sangyo Co., Ltd., High Coater) was used in a solution in which 21 g of hypromellose and 3 g of macrogol 6000 were dissolved in 420 mL of purified water, and 3.6 g of titanium oxide and 2.4 g of talc were further dispersed. Then, the film was coated, and dried at an air supply temperature of 60 ° C. until the drying end temperature (article temperature) reached 50 ° C. to obtain a film-coated tablet.
  • the obtained tablet 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 an elution amount of zinc after 15 minutes: 93%.
  • the zinc acetate hydrate tablet of the present invention has a zinc dissolution amount of 85 after 15 minutes as measured by the JP dissolution paddle method 50 revolutions (test solution: water 900 mL). % Or more, it was confirmed that the tablets were sufficiently compacted and sufficiently containing zinc acetate hydrate.
  • the zinc acetate hydrate tablet of the present invention is small in size and easy to swallow when taken, it can be suitably used as a therapeutic agent for Wilson's disease.

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Abstract

La présente invention concerne : un granulat de taille compacte d'acétate de zinc hydraté, dans lequel la perte d'eau de cristallisation est supprimée pendant un processus de fabrication par régulation de la température de matériau du granulat à moins de 40 °C pendant le processus de fabrication qui a un faible volume occupé ; et son procédé de fabrication.<sp /> Le granulat est sous la forme d'un comprimé comprenant de l'acétate de zinc hydraté, ledit comprimé contenant 5 à 200 mg d'acétate de zinc hydraté (C4H6O4Zn·2H2O), ayant un diamètre de 5 à 12 mm et une épaisseur de 1 à 6 mm, et présentant un rapport d'élution de zinc de 85 % ou plus après 15 minutes lorsqu'il est mesuré selon la méthode d'élution de la pharmacopée japonaise (méthode à palettes : 50 r/min, liquide d'essai : eau 900 ml).
PCT/JP2015/083941 2014-12-03 2015-12-02 Comprimé comprenant de l'acétate de zinc hydraté et son procédé de fabrication WO2016088816A1 (fr)

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JP2019534046A (ja) * 2016-11-01 2019-11-28 ジロニックス・アイピー・ホールディングス・ピーティーイー．リミテッド ガンマ−ポリグルタミン酸および亜鉛組成物
JP2020128442A (ja) * 2014-12-03 2020-08-27 ノーベルファーマ株式会社 酢酸亜鉛水和物錠及びその製造方法
US11944640B2 (en) 2016-11-01 2024-04-02 Xylonix PTE. LTD. Zinc-[gamma]-PGA compositions and methods for treating cancer

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WO2011053917A2 (fr) * 2009-11-01 2011-05-05 Adeona Pharmaceuticals, Inc. Préparations orales gastrorétentives à teneur élevée en zinc
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JP2020128442A (ja) * 2014-12-03 2020-08-27 ノーベルファーマ株式会社 酢酸亜鉛水和物錠及びその製造方法
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