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1. WO2020066392 - ORALLY ADMINISTERED SOLID PREPARATION AND PRODUCTION METHOD THEREFOR

Publication Number WO/2020/066392
Publication Date 02.04.2020
International Application No. PCT/JP2019/032951
International Filing Date 23.08.2019
IPC
A61K 31/56 2006.01
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
31Medicinal preparations containing organic active ingredients
56Compounds containing cyclopentahydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
A61K 9/20 2006.01
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 47/26 2006.01
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
26Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
A61K 47/38 2006.01
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
A61P 13/08 2006.01
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
13Drugs for disorders of the urinary system
08of the prostate
A61P 17/14 2006.01
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
17Drugs for dermatological disorders
14for baldness or alopecia
CPC
A61K 31/56
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
31Medicinal preparations containing organic active ingredients
56Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives, e.g. steroids
A61K 47/26
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
26Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
A61K 47/38
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
A61K 9/20
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
9Medicinal preparations characterised by special physical form
20Pills, tablets, ; discs, rods
A61P 13/08
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
13Drugs for disorders of the urinary system
08of the prostate
A61P 17/14
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
17Drugs for dermatological disorders
14for baldness or alopecia
Applicants
  • 日新製薬株式会社 NISSIN PHARMACEUTICAL CO., LTD. [JP]/[JP]
Inventors
  • 八鍬 拓士 YAKUWA Takushi
  • 飯澤 紘紀 IIZAWA Koki
  • 石山 毅 ISHIYAMA Tsuyoshi
Agents
  • 辻 茉莉子 TSUJI Mariko
  • 大串 寿人 OHGUSHI Sumito
  • 鈴木 一寿 SUZUKI Motohisa
  • 佐藤 俊彦 SATO Toshihiko
Priority Data
2018-17908225.09.2018JP
Publication Language Japanese (JA)
Filing Language Japanese (JA)
Designated States
Title
(EN) ORALLY ADMINISTERED SOLID PREPARATION AND PRODUCTION METHOD THEREFOR
(FR) PRÉPARATION SOLIDE DESTINÉE À ÊTRE ADMINISTRÉE PAR VOIE ORALE ET PROCÉDÉ DE PRODUCTION S'Y RAPPORTANT
(JA) 経口固形製剤およびその製造法
Abstract
(EN)
The present invention addresses the problem of providing a N-(2,5-bis(trifluoromethyl)phenyl)-3-oxo-4-aza-5α-androst-1-ene-17β-carboxamide (hereinafter referred to as "compound A")-containing orally administered solid preparation that overcomes shortcomings of a soft gelatin capsule formulation or the like containing compound A, has a small total mass per unit preparation, and has a sufficient bioavailability as a medicinal product. An orally administered solid preparation containing compound A and hydroxypropyl cellulose and/or low-substituted hydroxypropyl cellulose is useful as the compound A-containing orally administered solid preparation that solves the abovementioned problem. In addition, the compound A-containing orally administered solid preparation that solves the abovementioned problem can be provided and produced by a method comprising a step for dissolving compound A in an organic solvent, and mixing or granulating compound A with hydroxypropyl cellulose and/or low-substituted hydroxypropyl cellulose.
(FR)
La présente invention a pour objet une préparation solide destinée à être administrée par voie orale contenant du N-(2,5-bis(trifluorométhyl)phényl)-3-oxo-4-aza-5α-androst-1-ène-17β-carboxamide (ci-après appelé « composé A ») qui permet de résoudre les inconvénients d'une formulation de capsule de gélatine molle ou similaire contenant le composé A, qui a une faible masse totale par préparation unitaire et qui a une biodisponibilité suffisante en tant que produit médicinal. À cet effet, l'invention porte sur une préparation solide contenant le composé A destinée à être administrée par voie orale qui est une préparation solide destinée à être administrée par voie orale contenant le composé A et de l'hydroxypropylcellulose et/ou de l'hydroxypropylcellulose faiblement substituée. De plus, la préparation solide contenant le composé A destinée à être administrée par voie orale selon l'invention peut être fournie et produite par un procédé comprenant une étape consistant à dissoudre du composé A dans un solvant organique et mélanger ou granuler le composé A avec de l'hydroxypropylcellulose et/ou de l'hydroxypropylcellulose faiblement substituée.
(JA)
本発明の課題は、N-(2,5-ビス(トリフルオロメチル)フェニル)-3-オキソ-4-アザ-5α-アンドロスタ-1-エン-17β-カルボキサミド(以下、「化合物A」と称する。)を含有する軟質ゼラチンカプセル剤等の欠点を克服し、単位製剤あたりの総質量が小さく、かつ、医薬品として十分な生物学的利用能を有する化合物A含有経口固形製剤を提供することである。 化合物Aならびにヒドロキシプロピルセルロースおよび/または低置換度ヒドロキシプロピルセルロースを含有する経口固形製剤は、上記課題を解決した化合物A含有経口固形製剤として有用である。また、化合物Aを有機溶媒に溶解し、ヒドロキシプロピルセルロースおよび/または低置換度ヒドロキシプロピルセルロースと混合または造粒する工程を含む方法で製造することにより、上記課題を解決した化合物A含有経口固形製剤を提供できる。
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