WO2022210829A1 - Comprimé contenant de l'acétate d'abiratérone - Google Patents

Comprimé contenant de l'acétate d'abiratérone Download PDF

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Publication number
WO2022210829A1
WO2022210829A1 PCT/JP2022/015807 JP2022015807W WO2022210829A1 WO 2022210829 A1 WO2022210829 A1 WO 2022210829A1 JP 2022015807 W JP2022015807 W JP 2022015807W WO 2022210829 A1 WO2022210829 A1 WO 2022210829A1
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Prior art keywords
tablet
mass
abiraterone acetate
content
solubilizer
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PCT/JP2022/015807
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English (en)
Japanese (ja)
Inventor
遼 松田
琢哉 角野
尭彬 城
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ニプロ株式会社
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Priority to JP2023511455A priority Critical patent/JPWO2022210829A1/ja
Publication of WO2022210829A1 publication Critical patent/WO2022210829A1/fr

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/58—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids containing heterocyclic rings, e.g. danazol, stanozolol, pancuronium or digitogenin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/02—Inorganic compounds
    • 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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00—Drugs for disorders of the urinary system
    • A61P13/08—Drugs for disorders of the urinary system of the prostate
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

Definitions

  • the present disclosure relates to tablets containing abiraterone acetate. More specifically, it relates to small tablets containing abiraterone acetate with an improved abiraterone acetate content.
  • Abiraterone acetate has the formula: is rapidly hydrolyzed to abiraterone in vivo, inhibits the activity of androgen synthase 17 ⁇ -hydroxylase/C17,20-lyase (CYP17), castration-resistant prostate cancer, testis, adrenal glands and In prostate tumor tissue, it reduces testosterone and dihydrotestosterone content and suppresses tumor growth.
  • Tablets containing abiraterone acetate as an active ingredient are marketed under names such as "Zytiga (registered trademark) tablet 250 mg" as a therapeutic agent for castration-resistant prostate cancer (Non-Patent Document 1).
  • abiraterone acetate When abiraterone acetate is used as an active ingredient in a therapeutic agent for castration-resistant prostate cancer, 1,000 mg of abiraterone acetate should be orally administered to adults once daily under fasting conditions in combination with prednisolone.
  • tablets containing 250 mg of abiraterone acetate per tablet are used, and 4 tablets are taken daily.
  • This tablet has a low abiraterone acetate content of about 35% by mass, and is a large tablet with a major axis of 16 mm, a minor axis of 9.6 mm, a thickness of 6.3 mm, and a total mass of 736 mg.
  • Abiraterone acetate is a poorly soluble drug with low oral availability.
  • the use of nanoparticles has been disclosed (Patent Document 1).
  • the content of abiraterone acetate in the tablet, which is specifically described in Patent Document 1 is about 15% by mass, which is even lower than that of the commercially available tablet. nothing has been done.
  • Non-Patent Document 1 has a problem of ease of administration due to its large size as described above, and also has a problem that it is difficult to obtain patient compliance because four tablets must be taken a day.
  • small tablets with a high content of abiraterone acetate also have a high content of a solubilizer, which causes gelation and affects the dissolution rate.
  • an object of the present disclosure is to provide a small tablet with a higher content of abiraterone acetate and exhibiting good dissolution characteristics in order to improve ease of administration.
  • the present disclosure [1] 55 to 95 mass%, preferably 55 to 90 mass%, 65 to 95 mass%, 65 to 90 mass%, 75 to 95 mass% of abiraterone acetate as an active ingredient relative to the mass of the whole tablet; or a tablet containing 75-90% by mass, a solubilizer and an aluminometasilicate, [2]
  • the active ingredient abiraterone acetate and the solubilizer together with the metasilicate aluminate as a fluidizing agent, it has good dissolution characteristics, and the active ingredient abiraterone acetate is tableted. It is possible to provide small tablets containing 55 to 95% by mass of the total mass of abiraterone acetate at a high content rate, and improve patient compliance.
  • FIG. 1 is a graph showing the elution rate (%) of abiraterone acetate in Examples 1-3.
  • the tablet of the present disclosure contains 55 to 95% by mass of abiraterone acetate as an active ingredient relative to the mass of the entire tablet, a solubilizer, and a metasilicate aluminate.
  • abiraterone acetate as an active ingredient relative to the mass of the entire tablet
  • a solubilizer and a metasilicate aluminate.
  • metasilicate aluminate as a glidant, gelation during dissolution, which is thought to be caused by the increased content of abiraterone acetate and the solubilizer due to the downsizing of tablets, is suppressed, resulting in good dissolution characteristics.
  • Alumina metasilicate is porous and has the property of drawing water into the tablet.
  • the good dissolution characteristics of the resulting tablet are preferably the same as those of tablets containing abiraterone acetate which are already on the market.
  • the dissolution time was 30 minutes. is preferably 30 to 65%, more preferably 35 to 60%, and an elution time of 60 minutes is preferably 70 to 95%, more preferably 75 to 95%.
  • the content of abiraterone acetate in the tablet is 55% by mass or more, preferably 65% by mass or more, more preferably 75% by mass or more, relative to the mass of the entire tablet. If the content of abiraterone acetate is less than 55% by mass relative to the mass of the entire tablet, the tablet cannot be sufficiently miniaturized, and it tends to be difficult to improve the ease of administration.
  • the content of abiraterone acetate in the tablet is 95% by mass or less, preferably 90% by mass or less, relative to the mass of the entire tablet. When the content of abiraterone acetate is more than 95% by mass relative to the mass of the entire tablet, the dissolution rate tends to be delayed due to the high density of abiraterone acetate.
  • the tablet of the present disclosure preferably has a mass of 420 mg or less, more preferably 260 to 420 mg, from the viewpoint of ease of administration.
  • the metasilicate aluminate is not particularly limited, but magnesium aluminometasilicate and the like are used, and Neusilin (registered trademark) manufactured by Fuji Chemical Industry Co., Ltd. can be used as a commercially available product.
  • the content of the metasilicate aluminate in the tablet is not particularly limited, but is generally preferably 0.1% by mass or more, preferably 0.5% by mass, based on the total mass of the tablet from the viewpoint of disintegration. The above is more preferable, and 1.0% by mass or more is even more preferable.
  • the content of metasilicate aluminate in the tablet is usually preferably 20% by mass or less, more preferably 10% by mass or less, and further preferably 5% by mass or less from the viewpoint of fluidity, relative to the total mass of the tablet. preferable.
  • solubilizers include, but are not limited to, anionic surfactants such as sodium lauryl sulfate and sodium dioctylsulfosuccinate, polyoxyethylene glycol sorbitan alkyl esters (eg, polysorbate 80), and polyethylene glycols. and other nonionic surfactants, and various other surfactants.
  • anionic surfactants such as sodium lauryl sulfate are preferred, and sodium lauryl sulfate is more preferred, because they generally have a relatively high solubilizing ability and the active ingredient is a basic drug.
  • the solubilizers may be used alone or in combination of two or more.
  • the content of the solubilizing agent in the tablet varies depending on the content of abiraterone acetate and metasilicate aluminate in the tablet, and is not particularly limited. From the viewpoint of , the content is preferably 0.1% by mass or more, more preferably 0.5% by mass or more, still more preferably 1% by mass or more, and particularly preferably 3% by mass or more. In addition, the content of the solubilizer in the tablet is usually preferably 30% by mass or less, more preferably 20% by mass or less, and further preferably 15% by mass or less from the viewpoint of disintegration, relative to the total mass of the tablet. 10% by mass or less is particularly preferred, and 7% by mass or less is even more preferred.
  • the tablet of the present disclosure contains, in addition to the active ingredients abiraterone acetate, solubilizer, and metasilicate aluminate, for example, disintegrants, binders, excipients, sweeteners, flavors, and metasilicate aluminate. Additives commonly used in this field, such as fluidizing agents, lubricants, flavoring agents, coloring agents, and surfactants, may be included. Tablets of the present disclosure may also be film-coated tablets. When the tablet of the present disclosure is a film-coated tablet, the tablet of the present disclosure can further contain a film coating base that forms a film coating layer in addition to the above excipients.
  • Disintegrants are roughly classified into Swelling type disintegrants and Wicking type disintegrants.
  • Swelling-type disintegrants are insoluble in water, but the disintegrant itself swells by taking in a larger amount of water than the voids of the disintegrant, and the swelling force destroys the structure of the tablet. Since water permeates between the particles one after another, it is thought that the tablet disperses and disintegrates while pulverizing like an eruption.
  • Wicking-type disintegrants have a small contact angle, so water permeates quickly through the surface of the disintegrant and penetrates into the inside of the tablet. thought to collapse.
  • the tablet of the present disclosure is characterized by the use of metasilicate aluminate, and in addition, both Swelling type disintegrant and Wicking type disintegrant can be used, and are not particularly limited.
  • Swelling-type disintegrants include croscarmellose sodium, carmellose calcium, crospovidone, low-substituted hydroxypropyl cellulose, carboxymethyl starch sodium, hydroxypropyl starch, and the like. Among them, it is preferably selected from croscarmellose sodium, crospovidone, and low-substituted hydroxypropylcellulose.
  • Wicking-type disintegrants include partially pregelatinized starch, carmellose, corn starch, microcrystalline cellulose, and the like. These disintegrants may be used alone or in combination of two or more.
  • Content in the tablet when using a disintegrant is not particularly limited, relative to the total weight of the tablet, preferably 0.01 wt% or more, more preferably 0.1 wt% or more, 1 % by mass or more is more preferable, and 10% by mass or more is particularly preferable.
  • the disintegrant is preferably 30% by mass or less, more preferably 25% by mass or less, and even more preferably 20% by mass or less, relative to the total mass of the tablet.
  • Binders include, but are not limited to, hydroxypropyl cellulose, povidone, polyvinyl alcohol, hypromellose, methyl cellulose, hydroxyethyl cellulose, gelatin, agar, sodium alginate, dextrin, xanthan gum, gum arabic powder, partially saponified polyvinyl alcohol and and pullulan. Among them, it is preferably at least one selected from the group consisting of hydroxypropyl cellulose, povidone, polyvinyl alcohol and hypromellose, and at least one selected from hydroxypropyl cellulose, povidone and polyvinyl alcohol. Hydroxypropylcellulose is more preferred, and hydroxypropylcellulose is particularly preferred. These may be used independently and may use 2 or more types together.
  • the content in the tablet is not particularly limited, but is preferably 0.01% by mass or more, more preferably 0.1% by mass or more, based on the total mass of the tablet. 1 mass % or more is more preferable.
  • the content of the binder in the tablet is not particularly limited, but is preferably 20% by mass or less, more preferably 10% by mass or less, and even more preferably 5% by mass or less, relative to the total mass of the tablet. .
  • excipients include, but are not limited to, celluloses (crystalline cellulose, ethyl cellulose, etc.) and derivatives thereof, sugars (glucose, lactose, sucrose, refined sucrose, powdered sugar, trehalose, dextran, dextrin, and others). hydrate, etc.), sugar alcohol (D-mannitol, xylitol, sorbitol, erythritol, etc.), glycerin fatty acid ester, inorganic powder (synthetic hydrotalcite), anhydrous calcium phosphate, precipitated calcium carbonate, calcium silicate, hydrogen phosphate Inorganic salts such as calcium hydrate and sodium bicarbonate are included. Celluloses such as crystalline cellulose and sugars such as lactose and lactose hydrate are particularly preferred. Excipients may be used alone or in combination of two or more.
  • the content in the tablet varies depending on the content of abiraterone acetate and other additives in the tablet, and is not particularly limited. .1 to 30% by mass is preferred, and 0.5 to 20% by mass is more preferred.
  • Fluidizing agents other than aluminate metasilicate are not particularly limited, and examples include silicates such as calcium silicate, silicic anhydride such as light anhydrous silicic acid, hydrated silicon dioxide, talc, and titanium oxide. , stearic acid, magnesium stearate, calcium stearate and the like. These may be used alone or in combination of two or more.
  • the content in the tablet varies depending on the content of the aluminate metasilicate, but the above-mentioned powder or abiraterone contained in the granules
  • Acetic acid esters and various additives may be added in an amount that allows smooth flow in the production of tablets, and this varies depending on the type of glidant used, so it is not particularly limited, but usually , with respect to the total weight of the tablet, preferably 0.1 to 10% by weight, more preferably 0.5 to 5% by weight.
  • lubricants include, but are not limited to, stearic acid, sodium stearyl fumarate, magnesium stearate, calcium stearate, sucrose fatty acid esters, polyethylene glycol, hydrogenated oil, glycerol fatty acid esters, and talc. be done.
  • magnesium stearate is preferable because of its high lubricity. These may be used alone or in combination of two or more.
  • the content in the tablet is an amount that can suppress adhesion of the above-mentioned abiraterone acetate and various additives to the tablet manufacturing equipment (punches and dies).
  • the content in the tablet is an amount that can suppress adhesion of the above-mentioned abiraterone acetate and various additives to the tablet manufacturing equipment (punches and dies).
  • it is not particularly limited because it varies depending on the type of lubricant used, it is usually preferably 0.1 to 10% by mass, more preferably 0.5 to 5% by mass, based on the total mass of the tablet. preferable.
  • the tablet of the present disclosure uses a film-coating base, and can be a film-coated tablet in which a film is applied to the surface of the tablet, thereby masking bitterness and malodor, and protecting against external conditions such as moisture, light, or oxygen. It can be expected to have effects such as improved stability of the main drug, improved appearance, and increased commercial value.
  • Film coating bases include, but are not limited to, hydroxypropyl cellulose, hypromellose, carmellose sodium, ethyl acrylate/methyl methacrylate copolymer dispersion, polyvinylpyrrolidone, polyvinyl alcohol, polyoxyethylene polyoxypropylene glycol. Polymers such as can be used. Film coating bases may optionally contain plasticizers such as polyethylene glycol, propylene glycol, triacetin and triethyl citrate, colorants such as titanium oxide, iron sesquioxide and aluminum lake, and brightening agents such as carnauba wax. can be added.
  • plasticizers such as polyethylene glycol, propylene glycol, triacetin and triethyl citrate, colorants such as titanium oxide, iron sesquioxide and aluminum lake, and brightening agents such as carnauba wax. can be added.
  • the mass of the film-coating layer is not particularly limited as long as it is an amount that can cover the entire tablet. From the viewpoint of quickly eluting, when the mass of the portion other than the film coating layer in the tablet is 100 parts by mass, it is preferably 0.1 to 5 parts by mass, and 1 to 5 parts by mass. is more preferred.
  • the tablet of the present disclosure is useful for treatment of castration-resistant prostate cancer and endocrine therapy-naive prostate cancer with high-risk prognostic factors.
  • the dose of the tablet of the present disclosure is not particularly limited as long as it is within the scope of common knowledge in the technical field.
  • it is, for example, 1000 mg, and can be administered in 1 to 4 divided doses per day.
  • Tablet manufacturing method As a method for producing tablets, a general method in this technical field can be used, and there is no particular limitation. For example, it can be produced by mixing and granulating abiraterone acetate and a solubilizer, mixing the resulting granules with aluminate metasilicate, and compressing into tablets. At this time, it is preferable to granulate a binder and a disintegrant together with the abiraterone acetate and the solubilizer, and furthermore, it is preferable to mix a lubricant together with the aluminate metasilicate.
  • the granulation method is not particularly limited, and granulation methods commonly used in the pharmaceutical field, such as dry granulation and wet granulation, can be used.
  • the tableting method is not particularly limited. For example, using a tableting die, upper and lower tableting punches, a hydraulic hand press machine, a single-shot tableting machine, a rotary tableting machine, etc. and the like can be used. Tableting may be performed at a tableting pressure such that the resulting tablet has an appropriate hardness, and the tableting pressure is appropriately adjusted according to the tableting method, the equipment used for tableting, the size of the tablet, and the like. .
  • the shape of the tablet to be obtained is not particularly limited, and may be, for example, disk-shaped, doughnut-shaped, polygonal plate-shaped, spherical, elliptical, or caplet-shaped.
  • the size is preferably small.
  • the long axis is about 8 to 15 mm
  • the short axis is about 5 to 12 mm
  • the thickness is about 3 to 8 mm.
  • the diameter is about 5 to 15 mm and the thickness is about 2.5 to 6 mm.
  • a film-coating method As a film-coating method, a conventional film-coated tablet production method used in this technical field can be used. For example, a tablet (uncoated tablet) containing abiraterone acetate is charged into a film coating machine, and the film coating agent and additives are added to an organic solvent such as water or ethanol, or a mixed solution thereof (e.g., water / ethanol mixture). Tablets can be coated by spraying a coating liquid dissolved or dispersed in an appropriate solvent and drying the tablets.
  • an organic solvent such as water or ethanol, or a mixed solution thereof (e.g., water / ethanol mixture). Tablets can be coated by spraying a coating liquid dissolved or dispersed in an appropriate solvent and drying the tablets.
  • Japanese Pharmacopoeia XVII represents the 17th revision of the Japanese Pharmacopoeia.
  • Examples 1-3 According to the formulation in Table 1, abiraterone acetate and low-substituted hydroxypropyl cellulose were put into a stirring granulator (FM-VG-05, manufactured by Powrex Co., Ltd.) to mix the powders. Granulation was carried out by adding a granulation liquid obtained by mixing sodium lauryl sulfate, hydroxypropylcellulose-SL and water. After drying the obtained granules with a fluid bed granulator dryer (FD-MINI, manufactured by Powrex Co., Ltd.) at an air supply temperature of 80 ° C.
  • FD-MINI fluid bed granulator dryer
  • a granule sizing machine (Comil, Powrex Co., Ltd.) (1397 ⁇ m)) to obtain regulated granules.
  • Magnesium aluminometasilicate and magnesium stearate were added to the obtained sized granules, mixed in a plastic bag, and compressed with a rotary tableting machine (VIRG0512SS2AZ, manufactured by Kikusui Seisakusho Co., Ltd.) to give a tablet having a major diameter of 12.8 mm and a minor diameter of 7. It was compressed to 0.7 mm and 5.3 mm thick to give tablets.
  • Test Example 1 Dissolution property test The tablets immediately after production in Examples 1 to 3 were dissolved in a dissolution tester (trade name: NTR-6000 series, manufactured by Toyama Sangyo Co., Ltd.) according to the dissolution test method of the Japanese Pharmacopoeia. The paddle method was used using the Japanese Pharmacopoeia dissolution test liquid 1 (pH 1.2) as the test liquid.
  • the test conditions were a volume of dissolution medium of 900 mL, a temperature of 37 ⁇ 0.5° C., and a paddle speed of 75 rpm. The results are shown in Figure 1 and Table 2 as mean values.
  • the abiraterone acetate tablets containing metasilicate aluminate together with the solubilizer were in the range of 30-65% and 70-95% at the dissolution times of 30 minutes and 60 minutes, respectively, indicating good results. It can be seen that it exhibits excellent elution characteristics.

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Abstract

L'invention concerne un comprimé : contenant entre 55 et 95 % en masse d'acétate d'abiratérone, en tant que principe actif, par rapport à la masse totale du comprimé, un agent de solubilisation et un métasilicate d'aluminate ; étant un petit comprimé dont la teneur en acétate d'abiratérone est davantage augmentée afin d'améliorer les propriétés de dosage ; et présentant de bonnes caractéristiques de dissolution.
PCT/JP2022/015807 2021-04-01 2022-03-30 Comprimé contenant de l'acétate d'abiratérone WO2022210829A1 (fr)

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Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2005139168A (ja) * 2003-10-15 2005-06-02 Fuji Chem Ind Co Ltd 口腔内速崩壊性錠剤用の組成物
WO2020004630A1 (fr) * 2018-06-29 2020-01-02 中外製薬株式会社 Composition pharmaceutique contenant un médicament basique faiblement soluble
JP2020169143A (ja) * 2019-04-04 2020-10-15 ニプロ株式会社 アジルサルタンを含有する錠剤
JP2021024865A (ja) * 2019-08-07 2021-02-22 沢井製薬株式会社 アビラテロン酢酸エステル含有製剤

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2005139168A (ja) * 2003-10-15 2005-06-02 Fuji Chem Ind Co Ltd 口腔内速崩壊性錠剤用の組成物
WO2020004630A1 (fr) * 2018-06-29 2020-01-02 中外製薬株式会社 Composition pharmaceutique contenant un médicament basique faiblement soluble
JP2020169143A (ja) * 2019-04-04 2020-10-15 ニプロ株式会社 アジルサルタンを含有する錠剤
JP2021024865A (ja) * 2019-08-07 2021-02-22 沢井製薬株式会社 アビラテロン酢酸エステル含有製剤

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