DK0975348T3 - Stabiliserede tibolon-sammensætninger - Google Patents

Stabiliserede tibolon-sammensætninger

Info

Publication number
DK0975348T3
DK0975348T3 DK98928214T DK98928214T DK0975348T3 DK 0975348 T3 DK0975348 T3 DK 0975348T3 DK 98928214 T DK98928214 T DK 98928214T DK 98928214 T DK98928214 T DK 98928214T DK 0975348 T3 DK0975348 T3 DK 0975348T3
Authority
DK
Denmark
Prior art keywords
stabilized
compositions
tibolone compositions
stabilized tibolone
tibolone
Prior art date
Application number
DK98928214T
Other languages
Danish (da)
English (en)
Inventor
Jocominus Antonius Ma Zwinkels
Adrianus Cornelis Petru Rovers
Hurk Theodora Ant Lambregts-De
Ryoichi Morita
De Pieter Haan
Original Assignee
Akzo Nobel Nv
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 Akzo Nobel Nv filed Critical Akzo Nobel Nv
Application granted granted Critical
Publication of DK0975348T3 publication Critical patent/DK0975348T3/da

Links

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)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Endocrinology (AREA)
  • Diabetes (AREA)
  • Reproductive Health (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
DK98928214T 1997-04-22 1998-04-20 Stabiliserede tibolon-sammensætninger DK0975348T3 (da)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP97201180 1997-04-22
PCT/EP1998/002361 WO1998047517A1 (en) 1997-04-22 1998-04-20 Stabilized tibolone compositions
EP98928214A EP0975348B1 (en) 1997-04-22 1998-04-20 Stabilized tibolone compositions

Publications (1)

Publication Number Publication Date
DK0975348T3 true DK0975348T3 (da) 2005-03-07

Family

ID=8228228

Family Applications (1)

Application Number Title Priority Date Filing Date
DK98928214T DK0975348T3 (da) 1997-04-22 1998-04-20 Stabiliserede tibolon-sammensætninger

Country Status (26)

Country Link
US (6) US6399594B2 (zh)
EP (1) EP0975348B1 (zh)
JP (1) JPH10316573A (zh)
KR (1) KR100580855B1 (zh)
CN (2) CN1146424C (zh)
AR (1) AR012480A1 (zh)
AT (1) ATE281836T1 (zh)
AU (1) AU742037B2 (zh)
BR (1) BR9809268A (zh)
CA (1) CA2288070A1 (zh)
DE (1) DE69827484T2 (zh)
DK (1) DK0975348T3 (zh)
ES (1) ES2232949T3 (zh)
HK (1) HK1023508A1 (zh)
HU (1) HUP0001780A3 (zh)
ID (1) ID22763A (zh)
IL (1) IL123984A (zh)
NO (1) NO995127D0 (zh)
NZ (1) NZ338028A (zh)
PL (1) PL190227B1 (zh)
PT (1) PT975348E (zh)
RU (1) RU2207133C2 (zh)
TR (1) TR199902530T2 (zh)
TW (1) TW570798B (zh)
WO (1) WO1998047517A1 (zh)
ZA (1) ZA983169B (zh)

Families Citing this family (17)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
IL141850A (en) * 1998-10-16 2005-11-20 Akzo Nobel Nv High purity composition comprising (7alpha,17alpha)-17-hydroxy-7-methyl-19-nor-17-pregn-5(10)-3n-20-yn-3-one
AU754712B2 (en) * 1999-02-26 2002-11-21 Shionogi & Co., Ltd. Chewable soft capsules having improved administration properties and process for producing the same
US20040229854A1 (en) * 2000-11-28 2004-11-18 Pieter Haan De Immediate release dosage form for HRT
ES2398910T3 (es) * 2001-09-28 2013-03-22 Tntgamble, Inc. Sistema de aporte para componentes biológicos
US20070098784A1 (en) 2001-09-28 2007-05-03 Nutraceutix, Inc. Delivery system for biological component
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
US20060182808A1 (en) * 2003-04-29 2006-08-17 Akzo Nobel N.V. Antisolvent solidification process
MXPA05000824A (es) * 2003-05-23 2005-04-28 Akzo Nobel Nv Forma de dosis farmaceutica de liberacion inmediata que contiene tibolona polimorfa.
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
EP3452019B1 (en) 2016-05-04 2021-06-23 Novalon S.A. Use of sugar-alcohols in tibolone compositions

Family Cites Families (6)

* 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 (zh) * 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
ATE180669T1 (de) * 1993-03-05 1999-06-15 Akzo Nobel Nv Verwendung von pregnanderivaten zur behandlung von tumoren
DE69431662T2 (de) 1993-09-03 2003-09-18 Smithkline Beecham Corp Stabilisierte tablettenformulierung
CA2159419C (en) * 1994-10-17 2006-07-04 Pieter De Haan Solid pharmaceutical composition comprising an excipient capable of binding water

Also Published As

Publication number Publication date
US20030119801A1 (en) 2003-06-26
US20040142028A1 (en) 2004-07-22
DE69827484D1 (de) 2004-12-16
EP0975348B1 (en) 2004-11-10
US6514958B1 (en) 2003-02-04
KR100580855B1 (ko) 2006-05-17
ATE281836T1 (de) 2004-11-15
CN1494908A (zh) 2004-05-12
TR199902530T2 (xx) 2000-05-22
PL336658A1 (en) 2000-07-03
AR012480A1 (es) 2000-10-18
BR9809268A (pt) 2000-06-27
TW570798B (en) 2004-01-11
AU742037B2 (en) 2001-12-13
HUP0001780A2 (hu) 2000-12-28
ZA983169B (en) 1998-10-20
DE69827484T2 (de) 2005-03-17
ES2232949T3 (es) 2005-06-01
CN1146424C (zh) 2004-04-21
KR20010020163A (ko) 2001-03-15
US20010005513A1 (en) 2001-06-28
US20040142030A1 (en) 2004-07-22
PT975348E (pt) 2005-01-31
RU2207133C2 (ru) 2003-06-27
NO995127L (no) 1999-10-21
HUP0001780A3 (en) 2001-02-28
WO1998047517A1 (en) 1998-10-29
IL123984A (en) 2004-09-27
NZ338028A (en) 2001-10-26
CA2288070A1 (en) 1998-10-29
US6399594B2 (en) 2002-06-04
AU8014698A (en) 1998-11-13
EP0975348A1 (en) 2000-02-02
US20040142031A1 (en) 2004-07-22
JPH10316573A (ja) 1998-12-02
HK1023508A1 (en) 2000-09-15
NO995127D0 (no) 1999-10-21
ID22763A (id) 1999-12-09
PL190227B1 (pl) 2005-11-30
CN1253503A (zh) 2000-05-17

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