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1. WO2022003980 - SOLID FORMULATION

Publication Number WO/2022/003980
Publication Date 06.01.2022
International Application No. PCT/JP2020/026275
International Filing Date 03.07.2020
IPC
A61P 35/00 2006.1
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
35Antineoplastic agents
A61K 9/20 2006.1
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
9Medicinal preparations characterised by special physical form
20Pills, lozenges or tablets
A61K 47/04 2006.1
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
47Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
02Inorganic compounds
04Non-metals; Compounds thereof
A61K 47/10 2006.1
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
47Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
08containing oxygen
10Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols ; Poloxamers; PEG/POE alkyl ethers
A61K 47/34 2017.1
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
47Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
34Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
A61K 47/38 2006.1
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
47Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
36Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
38Cellulose; Derivatives thereof
Applicants
  • 富士製薬工業株式会社 FUJI PHARMA CO., LTD. [JP]/[JP]
Inventors
  • 稲田 俊行 INADA, Toshiyuki
  • 清水 隆弘 SHIMIZU, Takahiro
Agents
  • 細田 芳徳 HOSODA, Yoshinori
Priority Data
Publication Language Japanese (ja)
Filing Language Japanese (JA)
Designated States
Title
(EN) SOLID FORMULATION
(FR) FORMULATION SOLIDE
(JA) 固形製剤
Abstract
(EN) Provided are: a solid formulation comprising a coating-treated article obtained by treating abiraterone acetate with a water-soluble coating agent; and a method for producing the solid formulation according to any one of claims 1-12, the method comprising a step for coating-treating abiraterone acetate with a water-soluble coating agent and a step for formulating the obtained coating-treated article. A solid formulation according to the present invention, which contains abiraterone acetate as a drug substance, is a pharmaceutical formulation effective as a therapeutic agent for prostate cancer or the like.
(FR) L'invention concerne : une formulation solide comprenant un article traité par enrobage obtenu par traitement d'acétate d'abiratérone au moyen d'un agent d'enrobage soluble dans l'eau; et un procédé de production de la formulation solide selon l'une quelconque des revendications 1 à 12, le procédé comprenant une étape de traitement d'enrobage d'acétate d'abiratérone au moyen d'un agent d'enrobage soluble dans l'eau et une étape de formulation de l'article traité par enrobage obtenu. Une formulation solide selon la présente invention, qui contient de l'acétate d'abiratérone en tant que substance médicamenteuse, est une formulation pharmaceutique efficace en tant qu'agent thérapeutique dans le cas du cancer de la prostate ou similaire.
(JA) アビラテロン酢酸エステルが、水溶性コーティング剤により処理されてなる被覆処理物を含む、固形製剤、及びアビラテロン酢酸エステルに対し、水溶性コーティング剤により被覆処理する工程、及び得られた被覆処理物を用いて、製剤化する工程を含む、請求項1~12いずれか記載の固形製剤の製造方法。アビラテロン酢酸エステルを原薬として含有する本発明の固形製剤は、前立腺癌等の治療薬として有効な医薬製剤である。
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