BR112018071950A2 - forma polimórfica cristalina a de acetato de 15¿-hidróxi-osaterona, processo para a produção de uma forma polimórfica cristalina a de acetato de 15¿-hidróxi-osaterona, e composição farmacêutica - Google Patents

forma polimórfica cristalina a de acetato de 15¿-hidróxi-osaterona, processo para a produção de uma forma polimórfica cristalina a de acetato de 15¿-hidróxi-osaterona, e composição farmacêutica

Info

Publication number
BR112018071950A2
BR112018071950A2 BR112018071950A BR112018071950A BR112018071950A2 BR 112018071950 A2 BR112018071950 A2 BR 112018071950A2 BR 112018071950 A BR112018071950 A BR 112018071950A BR 112018071950 A BR112018071950 A BR 112018071950A BR 112018071950 A2 BR112018071950 A2 BR 112018071950A2
Authority
BR
Brazil
Prior art keywords
hydroxy
polymorphic form
crystalline polymorphic
osaterone acetate
acetate crystalline
Prior art date
Application number
BR112018071950A
Other languages
English (en)
Inventor
Hayashi Hiroyuki
Miyazaki Koichi
Iwashita Shigeki
Nakagawa Takayoshi
Original Assignee
Aska Pharm Co Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Aska Pharm Co Ltd filed Critical Aska Pharm Co Ltd
Publication of BR112018071950A2 publication Critical patent/BR112018071950A2/pt

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/56Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/58Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids containing heterocyclic rings, e.g. danazol, stanozolol, pancuronium or digitogenin
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07JSTEROIDS
    • C07J73/00Steroids in which the cyclopenta[a]hydrophenanthrene skeleton has been modified by substitution of one or two carbon atoms by hetero atoms
    • C07J73/001Steroids in which the cyclopenta[a]hydrophenanthrene skeleton has been modified by substitution of one or two carbon atoms by hetero atoms by one hetero atom
    • C07J73/003Steroids in which the cyclopenta[a]hydrophenanthrene skeleton has been modified by substitution of one or two carbon atoms by hetero atoms by one hetero atom by oxygen as hetero atom
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00Drugs for disorders of the urinary system
    • A61P13/08Drugs for disorders of the urinary system of the prostate
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00Drugs for dermatological disorders
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00Drugs for disorders of the endocrine system
    • A61P5/24Drugs for disorders of the endocrine system of the sex hormones
    • A61P5/28Antiandrogens
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07JSTEROIDS
    • C07J73/00Steroids in which the cyclopenta[a]hydrophenanthrene skeleton has been modified by substitution of one or two carbon atoms by hetero atoms
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00Drugs for genital or sexual disorders; Contraceptives
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00Drugs for dermatological disorders
    • A61P17/02Drugs for dermatological disorders for treating wounds, ulcers, burns, scars, keloids, or the like
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00Drugs for dermatological disorders
    • A61P17/08Antiseborrheics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00Drugs for dermatological disorders
    • A61P17/14Drugs for dermatological disorders for baldness or alopecia
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00Drugs for skeletal disorders
    • A61P19/08Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease
    • A61P19/10Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease for osteoporosis
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00Antineoplastic agents
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07BGENERAL METHODS OF ORGANIC CHEMISTRY; APPARATUS THEREFOR
    • C07B2200/00Indexing scheme relating to specific properties of organic compounds
    • C07B2200/13Crystalline forms, e.g. polymorphs

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Dermatology (AREA)
  • Urology & Nephrology (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Endocrinology (AREA)
  • Epidemiology (AREA)
  • Rheumatology (AREA)
  • Diabetes (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Reproductive Health (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Steroid Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Organic Low-Molecular-Weight Compounds And Preparation Thereof (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)

Abstract

é fornecida uma forma polimórfica cristalina a de acetato de 15¿-hidróxi-osaterona com uma comprovada estabilidade (estabilidade de armazenamento, estabilidade de pulverização e características de absorção). num espectro de difração de raios-x de pó, os picos de difração característicos da forma polimórfica cristalina a do acetato de 15¿-hidróxi-osaterona aparecem nos ângulos de difração 2¿ de 9,6° ± 0,2°, 17,1° ± 0,2° e 20,2° ± 0,2°. a forma polimórfica cristalina a tem um ponto de fusão de 280 a 283 °c e é um cristal prismático.
BR112018071950A 2016-05-11 2017-05-10 forma polimórfica cristalina a de acetato de 15¿-hidróxi-osaterona, processo para a produção de uma forma polimórfica cristalina a de acetato de 15¿-hidróxi-osaterona, e composição farmacêutica BR112018071950A2 (pt)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP2016095382 2016-05-11
PCT/JP2017/017619 WO2017195804A1 (ja) 2016-05-11 2017-05-10 15β-ヒドロキシ-酢酸オサテロンの結晶多形

Publications (1)

Publication Number Publication Date
BR112018071950A2 true BR112018071950A2 (pt) 2019-02-05

Family

ID=60267316

Family Applications (1)

Application Number Title Priority Date Filing Date
BR112018071950A BR112018071950A2 (pt) 2016-05-11 2017-05-10 forma polimórfica cristalina a de acetato de 15¿-hidróxi-osaterona, processo para a produção de uma forma polimórfica cristalina a de acetato de 15¿-hidróxi-osaterona, e composição farmacêutica

Country Status (15)

Country Link
US (1) US10508130B2 (pt)
EP (1) EP3456729B1 (pt)
JP (2) JP7210278B2 (pt)
KR (1) KR102383617B1 (pt)
CN (1) CN109153701B (pt)
AU (1) AU2017264187B2 (pt)
BR (1) BR112018071950A2 (pt)
CA (1) CA3021179A1 (pt)
EA (1) EA034965B1 (pt)
ES (1) ES2829578T3 (pt)
MX (1) MX2018013786A (pt)
MY (1) MY195203A (pt)
PH (1) PH12018502365A1 (pt)
SG (1) SG11201809127PA (pt)
WO (1) WO2017195804A1 (pt)

Families Citing this family (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
MY195203A (en) * 2016-05-11 2023-01-11 Aska Pharm Co Ltd Crystalline Polymorph Of 15B-Hydroxy-Osaterone Acetate
CN114502239A (zh) * 2019-10-02 2022-05-13 Aska制药株式会社 排尿障碍改善剂
US20240041899A1 (en) * 2020-12-18 2024-02-08 Aska Pharmaceutical Co., Ltd. Solid preparation

Family Cites Families (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4785103A (en) 1985-03-07 1988-11-15 Teikoku Hormone Mfg. Co., Ltd. 2-oxa- or -aza-pregnane compounds
JPS61204199A (ja) 1985-03-07 1986-09-10 Teikoku Hormone Mfg Co Ltd 2−アザプレグナン化合物
JPS61204198A (ja) 1985-03-07 1986-09-10 Teikoku Hormone Mfg Co Ltd 2−オキサプレグナン化合物
JPS62195398A (ja) 1986-02-21 1987-08-28 Teikoku Hormone Mfg Co Ltd 黄体ホルモン剤
JP2591640B2 (ja) * 1988-02-04 1997-03-19 帝国臓器製薬株式会社 新規な2−オキサプレグナン化合物
JP2980992B2 (ja) 1990-12-28 1999-11-22 帝国臓器製薬株式会社 6−ハロゲノ−2−オキサプレグナ−4,6−ジエン−3−オン化合物の製造方法
JP2591640Y2 (ja) 1993-05-13 1999-03-10 株式会社吉野工業所 液体収納袋
US8473844B2 (en) 2004-03-26 2013-06-25 Harman International Industries, Incorporated Audio related system link management
JP6192228B2 (ja) 2014-05-23 2017-09-06 本田技研工業株式会社 物体認識装置
MY195203A (en) 2016-05-11 2023-01-11 Aska Pharm Co Ltd Crystalline Polymorph Of 15B-Hydroxy-Osaterone Acetate

Also Published As

Publication number Publication date
SG11201809127PA (en) 2018-11-29
ES2829578T3 (es) 2021-06-01
JP2021121645A (ja) 2021-08-26
KR102383617B1 (ko) 2022-04-05
EA201892566A1 (ru) 2019-04-30
CN109153701B (zh) 2021-02-02
US10508130B2 (en) 2019-12-17
EP3456729A1 (en) 2019-03-20
US20190127417A1 (en) 2019-05-02
JPWO2017195804A1 (ja) 2019-03-07
MX2018013786A (es) 2019-03-28
EP3456729A4 (en) 2019-05-22
AU2017264187B2 (en) 2021-02-18
KR20190004787A (ko) 2019-01-14
PH12018502365A1 (en) 2019-09-09
EP3456729B1 (en) 2020-09-02
JP7210278B2 (ja) 2023-01-23
AU2017264187A1 (en) 2018-11-15
JP7241807B2 (ja) 2023-03-17
CA3021179A1 (en) 2017-11-16
EA034965B1 (ru) 2020-04-13
CN109153701A (zh) 2019-01-04
WO2017195804A1 (ja) 2017-11-16
MY195203A (en) 2023-01-11

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B15V Prolongation of time limit allowed

Free format text: TENDO EM VISTA A PORTARIA INPI PR NO 120 DE 16/03/2020, PORTARIA INPI PR NO 161 DE 13/04/2020 E PORTARIA INPI PR NO 166 DE 27/04/2020, QUANTO A SUSPENSAO DOS PRAZOS VENCIDOS ENTRE 16/03/2020 A 15/05/2020, DEVOLVE-SE O PRAZO NESSE PEDIDO COM RELACAO A SOLICITACAO DO PEDIDO DE EXAME.

B350 Update of information on the portal [chapter 15.35 patent gazette]
B15K Others concerning applications: alteration of classification

Free format text: AS CLASSIFICACOES ANTERIORES ERAM: C07J 73/00 , A61K 31/58 , A61P 13/08 , A61P 17/00 , A61P 17/02 , A61P 17/14 , A61P 35/00

Ipc: A61K 31/58 (2006.01), C07J 73/00 (2006.01), A61P 1

B06W Patent application suspended after preliminary examination (for patents with searches from other patent authorities) chapter 6.23 patent gazette]
B06A Patent application procedure suspended [chapter 6.1 patent gazette]