KR100580855B1 - 안정화된 티볼론 조성물 - Google Patents

안정화된 티볼론 조성물 Download PDF

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Publication number
KR100580855B1
KR100580855B1 KR1019997009726A KR19997009726A KR100580855B1 KR 100580855 B1 KR100580855 B1 KR 100580855B1 KR 1019997009726 A KR1019997009726 A KR 1019997009726A KR 19997009726 A KR19997009726 A KR 19997009726A KR 100580855 B1 KR100580855 B1 KR 100580855B1
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KR
South Korea
Prior art keywords
starch
tibolone
dosage unit
carrier
weight
Prior art date
Legal status (The legal status 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 status listed.)
Expired - Fee Related
Application number
KR1019997009726A
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English (en)
Korean (ko)
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KR20010020163A (ko
Inventor
데 피터 한
아드리아누스 코넬리스 페트루스 로베르스
후르크 테오도라 안토니아 마리아 람브렉츠-데
조코미누스 안토니우스 마리아 쯔빙켈스
료이치 모리타
Original Assignee
악조 노벨 엔.브이.
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Application filed by 악조 노벨 엔.브이. filed Critical 악조 노벨 엔.브이.
Publication of KR20010020163A publication Critical patent/KR20010020163A/ko
Application granted granted Critical
Publication of KR100580855B1 publication Critical patent/KR100580855B1/ko
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Classifications

    • 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
    • A61K31/565—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol
    • 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
    • A61K31/565—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol
    • A61K31/568—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol substituted in positions 10 and 13 by a chain having at least one carbon atom, e.g. androstanes, e.g. testosterone
    • A61K31/569—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol substituted in positions 10 and 13 by a chain having at least one carbon atom, e.g. androstanes, e.g. testosterone substituted in position 17 alpha, e.g. ethisterone
    • 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
    • A61K31/575—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of three or more carbon atoms, e.g. cholane, cholestane, ergosterol, sitosterol
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
    • 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
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00—Drugs for genital or sexual disorders; Contraceptives
    • 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
    • A61P5/00—Drugs for disorders of the endocrine system
    • A61P5/24—Drugs for disorders of the endocrine system of the sex hormones
    • A61P5/30—Oestrogens
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00—Drugs for disorders of the endocrine system
    • A61P5/24—Drugs for disorders of the endocrine system of the sex hormones
    • A61P5/34—Gestagens

Landscapes

  • Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Medicinal Chemistry (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Endocrinology (AREA)
  • Diabetes (AREA)
  • Reproductive Health (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
KR1019997009726A 1997-04-22 1998-04-20 안정화된 티볼론 조성물 Expired - Fee Related KR100580855B1 (ko)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP97201180.3 1997-04-22
EP97201180 1997-04-22
PCT/EP1998/002361 WO1998047517A1 (en) 1997-04-22 1998-04-20 Stabilized tibolone compositions

Publications (2)

Publication Number Publication Date
KR20010020163A KR20010020163A (ko) 2001-03-15
KR100580855B1 true KR100580855B1 (ko) 2006-05-17

Family

ID=8228228

Family Applications (1)

Application Number Title Priority Date Filing Date
KR1019997009726A Expired - Fee Related KR100580855B1 (ko) 1997-04-22 1998-04-20 안정화된 티볼론 조성물

Country Status (25)

Country Link
US (6) US6399594B2 (https=)
EP (1) EP0975348B1 (https=)
JP (1) JPH10316573A (https=)
KR (1) KR100580855B1 (https=)
CN (2) CN1494908A (https=)
AR (1) AR012480A1 (https=)
AT (1) ATE281836T1 (https=)
AU (1) AU742037B2 (https=)
BR (1) BR9809268A (https=)
CA (1) CA2288070A1 (https=)
DE (1) DE69827484T2 (https=)
DK (1) DK0975348T3 (https=)
ES (1) ES2232949T3 (https=)
HU (1) HUP0001780A3 (https=)
ID (1) ID22763A (https=)
IL (1) IL123984A (https=)
NO (1) NO995127D0 (https=)
NZ (1) NZ338028A (https=)
PL (1) PL190227B1 (https=)
PT (1) PT975348E (https=)
RU (1) RU2207133C2 (https=)
TR (1) TR199902530T2 (https=)
TW (1) TW570798B (https=)
WO (1) WO1998047517A1 (https=)
ZA (1) ZA983169B (https=)

Families Citing this family (17)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1121375B1 (en) * 1998-10-16 2003-05-02 Akzo Nobel N.V. High purity compound (7alpha,17alpha)-17-hydroxy-7-methyl-19-nor-17-pregn-5(10)-en-20-yn-3-one
ES2316350T3 (es) * 1999-02-26 2009-04-16 SHIONOGI & CO., LTD. Capsulas blandas masticables con propiedades mejoradas de administracion y procedimiento para producirlas.
US20040229854A1 (en) * 2000-11-28 2004-11-18 Pieter Haan De Immediate release dosage form for HRT
US20070098784A1 (en) 2001-09-28 2007-05-03 Nutraceutix, Inc. Delivery system for biological component
DK1429802T3 (da) * 2001-09-28 2013-02-18 Tntgamble Inc Tilførselssystem for biologisk komponent
GB0125061D0 (en) * 2001-10-18 2001-12-12 Norton Healthcare Ltd Pharmaceutical composition
TW200418525A (en) * 2002-11-20 2004-10-01 Akzo Nobel Nv Coated pharmaceutical tablets containing Tibolone
CN1324041C (zh) * 2003-04-01 2007-07-04 上海迪赛诺医药科技开发有限公司 替勃龙晶型i的制备方法
BRPI0409860A (pt) * 2003-04-29 2006-05-16 Akzo Nobel Nv processo de solidificação anti-solvente
JP2006514996A (ja) * 2003-05-23 2006-05-18 アクゾ・ノベル・エヌ・ベー 多形性チボロンを含有する即時放出性薬物剤形
EP1742615A2 (en) * 2004-05-05 2007-01-17 Akzo Nobel N.V. Antisolvent emulsion solidification process
WO2005117899A1 (en) * 2004-06-02 2005-12-15 Cipla Limited Pharmaceutical composition comprising tibolone and process for procuding the same
WO2005120517A1 (en) * 2004-06-07 2005-12-22 Strides Arcolab Limited Stable liquid suspension formulation comprising synthetic steroids and process for producing the same
CZ300465B6 (cs) * 2007-07-25 2009-05-27 Zentiva, A. S. Zpusob výroby komprimované farmaceutické formulace s obsahem tibolonu
CN102085193B (zh) * 2009-12-08 2013-11-06 北京以岭生物工程技术有限公司 一种替勃龙口腔崩解片及其制备方法
CN104345098B (zh) * 2013-08-05 2016-04-13 华润紫竹药业有限公司 一种测定替勃龙片剂中抗氧剂含量的方法
MX381207B (es) 2016-05-04 2025-03-12 Novalon S A Uso de alcoholes de azucar en composiciones de tibolona

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0613687A1 (en) * 1993-03-05 1994-09-07 Akzo Nobel N.V. Use of a pregnane derivatives for the treatment of tumours
EP0707848A1 (en) * 1994-10-17 1996-04-24 Akzo Nobel N.V. Solid pharmaceutical composition comprising an excipient capable of binding water

Family Cites Families (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4701450A (en) 1984-03-21 1987-10-20 Akzo N.V. Steroids for use as immunomodulators
CH676470A5 (https=) * 1988-02-03 1991-01-31 Nestle Sa
IE63051B1 (en) * 1989-03-18 1995-03-22 Akzo Nv Pharmaceutical composition which contains a pharmaceutically suitable carrier and the compound having the structure (7alpha, 17alpha)-17-Hydroxy-7-methyl-19-nor-17-pregn-5(10)-en-20-yn- 3-one
AU7719894A (en) * 1993-09-03 1995-03-22 Smithkline Beecham Corporation Stabilized tablet formulation

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0613687A1 (en) * 1993-03-05 1994-09-07 Akzo Nobel N.V. Use of a pregnane derivatives for the treatment of tumours
EP0707848A1 (en) * 1994-10-17 1996-04-24 Akzo Nobel N.V. Solid pharmaceutical composition comprising an excipient capable of binding water

Also Published As

Publication number Publication date
TW570798B (en) 2004-01-11
JPH10316573A (ja) 1998-12-02
DE69827484T2 (de) 2005-03-17
US20040142031A1 (en) 2004-07-22
EP0975348B1 (en) 2004-11-10
PT975348E (pt) 2005-01-31
AU8014698A (en) 1998-11-13
US6514958B1 (en) 2003-02-04
ID22763A (id) 1999-12-09
CN1146424C (zh) 2004-04-21
DE69827484D1 (de) 2004-12-16
US20010005513A1 (en) 2001-06-28
HK1023508A1 (en) 2000-09-15
DK0975348T3 (da) 2005-03-07
PL336658A1 (en) 2000-07-03
ATE281836T1 (de) 2004-11-15
ES2232949T3 (es) 2005-06-01
NO995127L (no) 1999-10-21
CA2288070A1 (en) 1998-10-29
CN1253503A (zh) 2000-05-17
PL190227B1 (pl) 2005-11-30
TR199902530T2 (xx) 2000-05-22
RU2207133C2 (ru) 2003-06-27
ZA983169B (en) 1998-10-20
US6399594B2 (en) 2002-06-04
BR9809268A (pt) 2000-06-27
KR20010020163A (ko) 2001-03-15
WO1998047517A1 (en) 1998-10-29
NO995127D0 (no) 1999-10-21
AU742037B2 (en) 2001-12-13
HUP0001780A3 (en) 2001-02-28
IL123984A (en) 2004-09-27
HUP0001780A2 (hu) 2000-12-28
US20040142028A1 (en) 2004-07-22
US20040142030A1 (en) 2004-07-22
US20030119801A1 (en) 2003-06-26
AR012480A1 (es) 2000-10-18
CN1494908A (zh) 2004-05-12
EP0975348A1 (en) 2000-02-02
NZ338028A (en) 2001-10-26

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