AU742037B2 - Stabilized tibolone compositions - Google Patents

Stabilized tibolone compositions Download PDF

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Publication number
AU742037B2
AU742037B2 AU80146/98A AU8014698A AU742037B2 AU 742037 B2 AU742037 B2 AU 742037B2 AU 80146/98 A AU80146/98 A AU 80146/98A AU 8014698 A AU8014698 A AU 8014698A AU 742037 B2 AU742037 B2 AU 742037B2
Authority
AU
Australia
Prior art keywords
dosage unit
tibolone
carrier
starch
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.)
Ceased
Application number
AU80146/98A
Other languages
English (en)
Other versions
AU8014698A (en
Inventor
Theodora Antonia Maria Lambregts-De Hurk
Ryoichi Morita
Adrianus Cornelis Petrus Rovers
Jocominus Antonius Maria Zwinkels
Pieter De Haan
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Organon NV
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
Publication of AU8014698A publication Critical patent/AU8014698A/en
Application granted granted Critical
Publication of AU742037B2 publication Critical patent/AU742037B2/en
Assigned to N.V. ORGANON reassignment N.V. ORGANON Alteration of Name(s) in Register under S187 Assignors: AKZO NOBEL N.V.
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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)
  • 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)
AU80146/98A 1997-04-22 1998-04-20 Stabilized tibolone compositions Ceased AU742037B2 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP97201180 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
AU8014698A AU8014698A (en) 1998-11-13
AU742037B2 true AU742037B2 (en) 2001-12-13

Family

ID=8228228

Family Applications (1)

Application Number Title Priority Date Filing Date
AU80146/98A Ceased AU742037B2 (en) 1997-04-22 1998-04-20 Stabilized tibolone compositions

Country Status (25)

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

Families Citing this family (17)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2002527525A (ja) * 1998-10-16 2002-08-27 アクゾ・ノベル・エヌ・ベー （７α，１７α）−１７−ヒドロキシ−７−メチル−１９−ノル−１７−プレグヌ−５（１０）−エン−２０−イン−３−オンを含む高純度組成物
EP1163901B1 (en) * 1999-02-26 2008-09-10 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
US20070098784A1 (en) * 2001-09-28 2007-05-03 Nutraceutix, Inc. Delivery system for biological component
KR100979877B1 (ko) * 2001-09-28 2010-09-02 뉴트라슈틱스 인코포레이티드 생물학적 성분의 전달 시스템
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
KR20060006949A (ko) * 2003-04-29 2006-01-20 아크조 노벨 엔.브이. 반용매 고화 방법
ES2243919T3 (es) * 2003-05-23 2005-12-01 Akzo Nobel N.V. Formulacion solida farmaceutica que contiene tibolona.
WO2005105278A2 (en) * 2004-05-05 2005-11-10 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 (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0389035A1 (en) * 1989-03-18 1990-09-26 Akzo Nobel N.V. 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
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 (3)

* 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 (enExample) * 1988-02-03 1991-01-31 Nestle Sa
ES2185666T3 (es) 1993-09-03 2003-05-01 Smithkline Beecham Corp Formulacion estabilizada para comprimidos.

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0389035A1 (en) * 1989-03-18 1990-09-26 Akzo Nobel N.V. 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
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
EP0975348A1 (en) 2000-02-02
US20040142028A1 (en) 2004-07-22
WO1998047517A1 (en) 1998-10-29
US6399594B2 (en) 2002-06-04
KR20010020163A (ko) 2001-03-15
JPH10316573A (ja) 1998-12-02
NZ338028A (en) 2001-10-26
TW570798B (en) 2004-01-11
ID22763A (id) 1999-12-09
CN1146424C (zh) 2004-04-21
HUP0001780A3 (en) 2001-02-28
US20010005513A1 (en) 2001-06-28
CA2288070A1 (en) 1998-10-29
BR9809268A (pt) 2000-06-27
HUP0001780A2 (hu) 2000-12-28
ATE281836T1 (de) 2004-11-15
DE69827484T2 (de) 2005-03-17
PT975348E (pt) 2005-01-31
NO995127L (no) 1999-10-21
NO995127D0 (no) 1999-10-21
US20030119801A1 (en) 2003-06-26
RU2207133C2 (ru) 2003-06-27
US6514958B1 (en) 2003-02-04
US20040142030A1 (en) 2004-07-22
AR012480A1 (es) 2000-10-18
CN1253503A (zh) 2000-05-17
KR100580855B1 (ko) 2006-05-17
DE69827484D1 (de) 2004-12-16
AU8014698A (en) 1998-11-13
EP0975348B1 (en) 2004-11-10
PL190227B1 (pl) 2005-11-30
PL336658A1 (en) 2000-07-03
US20040142031A1 (en) 2004-07-22
TR199902530T2 (xx) 2000-05-22
IL123984A (en) 2004-09-27
CN1494908A (zh) 2004-05-12
HK1023508A1 (en) 2000-09-15
ZA983169B (en) 1998-10-20
ES2232949T3 (es) 2005-06-01
DK0975348T3 (da) 2005-03-07

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