BR9809268A - Unidade de dosagem farmacêutica, processo para fabricação da mesma, e, uso de um produto de amido como um veìculo para unidades de dosagem farmacêutica compreendendo tibolona - Google Patents

Unidade de dosagem farmacêutica, processo para fabricação da mesma, e, uso de um produto de amido como um veìculo para unidades de dosagem farmacêutica compreendendo tibolona

Info

Publication number
BR9809268A
BR9809268A BR9809268-5A BR9809268A BR9809268A BR 9809268 A BR9809268 A BR 9809268A BR 9809268 A BR9809268 A BR 9809268A BR 9809268 A BR9809268 A BR 9809268A
Authority
BR
Brazil
Prior art keywords
pharmaceutical dosage
tibolone
manufacturing
carrier
starch product
Prior art date
Application number
BR9809268-5A
Other languages
English (en)
Inventor
Pieter De Haan
Adrianus Cornelis Petru Rovers
Theodora Ant Lambregts-De-Hurk
Jocominus Antonius Ma Zwinkels
Ryoichi Morita
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 BR9809268A publication Critical patent/BR9809268A/pt

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)

Abstract

"UNIDADE DE DOSAGEM FARMACêUTICA, PROCESSO PARA FABRICAçãO DA MESMA, E, USO DE UM PRODUTO DE AMIDO COMO UM VEìCULO PARA UNIDADES DE DOSAGEM FARMACêUTICA COMPREENDENDO TIBOLONA". A invenção diz respeito a uma unidade de dosagem farmacêutica, tal como um tablete ou uma cápsula, compreendendo uma quantidade eficaz de tibolona (geralmente de 0,1 a 10% em peso) e um veículo farmaceuticamente aceitável contendo amido (também significado como granulado básico), em que o veículo contém de 10 a 100% em peso do amido. Assim uma formulação de tibolona mais estável é obtida, permitindo a armazenagem seca e doses mais baixas do ingrediente ativo.
BR9809268-5A 1997-04-22 1998-04-20 Unidade de dosagem farmacêutica, processo para fabricação da mesma, e, uso de um produto de amido como um veìculo para unidades de dosagem farmacêutica compreendendo tibolona BR9809268A (pt)

Applications Claiming Priority (2)

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

Publications (1)

Publication Number Publication Date
BR9809268A true BR9809268A (pt) 2000-06-27

Family

ID=8228228

Family Applications (1)

Application Number Title Priority Date Filing Date
BR9809268-5A BR9809268A (pt) 1997-04-22 1998-04-20 Unidade de dosagem farmacêutica, processo para fabricação da mesma, e, uso de um produto de amido como um veìculo para unidades de dosagem farmacêutica compreendendo tibolona

Country Status (25)

Country Link
US (6) US6399594B2 (pt)
EP (1) EP0975348B1 (pt)
JP (1) JPH10316573A (pt)
KR (1) KR100580855B1 (pt)
CN (2) CN1146424C (pt)
AR (1) AR012480A1 (pt)
AT (1) ATE281836T1 (pt)
AU (1) AU742037B2 (pt)
BR (1) BR9809268A (pt)
CA (1) CA2288070A1 (pt)
DE (1) DE69827484T2 (pt)
DK (1) DK0975348T3 (pt)
ES (1) ES2232949T3 (pt)
HU (1) HUP0001780A3 (pt)
ID (1) ID22763A (pt)
IL (1) IL123984A (pt)
NO (1) NO995127L (pt)
NZ (1) NZ338028A (pt)
PL (1) PL190227B1 (pt)
PT (1) PT975348E (pt)
RU (1) RU2207133C2 (pt)
TR (1) TR199902530T2 (pt)
TW (1) TW570798B (pt)
WO (1) WO1998047517A1 (pt)
ZA (1) ZA983169B (pt)

Families Citing this family (17)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
SK284569B6 (sk) * 1998-10-16 2005-06-02 Akzo Nobel N.V. Vysoko čistá zlúčenina (7alfa, 17alfa)-17-hydroxy-7-metyl-19-nor- 17-pregn-5(10)-én-20-ín-3-ón, spôsob jej prípravy a farmaceutická dávková jednotka s jej obsahom
WO2000051570A1 (fr) * 1999-02-26 2000-09-08 Shionogi & Co., Ltd. Capsules molles a croquer presentant des proprietes d'administration ameliorees et leur procede de production
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
CA2461708C (en) * 2001-09-28 2012-08-07 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
JP5207432B2 (ja) * 2003-04-29 2013-06-12 エム・エス・ディー・オス・ベー・フェー アンチ溶媒凝固プロセス
AU2004203420B8 (en) * 2003-05-23 2008-02-21 N.V. Organon Immediate-release pharmaceutical dosage form comprising polymorphous tibolone
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
WO2017191266A1 (en) 2016-05-04 2017-11-09 Mithra Pharmaceuticals 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 (pt) * 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
ZA941464B (en) 1993-03-05 1994-09-27 Akzo Nv Use of pregnane derivative
ES2185666T3 (es) 1993-09-03 2003-05-01 Smithkline Beecham Corp Formulacion estabilizada para comprimidos.
IL115445A (en) * 1994-10-17 1999-08-17 Akzo Nobel Nv Solid pharmaceutical compositions comprising low dosage active ingredient oil and excipient capable of binding water and their preparation

Also Published As

Publication number Publication date
HK1023508A1 (en) 2000-09-15
US20040142028A1 (en) 2004-07-22
AU8014698A (en) 1998-11-13
HUP0001780A2 (hu) 2000-12-28
DK0975348T3 (da) 2005-03-07
AU742037B2 (en) 2001-12-13
ID22763A (id) 1999-12-09
DE69827484T2 (de) 2005-03-17
CN1494908A (zh) 2004-05-12
KR100580855B1 (ko) 2006-05-17
US20040142031A1 (en) 2004-07-22
TW570798B (en) 2004-01-11
RU2207133C2 (ru) 2003-06-27
US20010005513A1 (en) 2001-06-28
CA2288070A1 (en) 1998-10-29
NO995127D0 (no) 1999-10-21
PT975348E (pt) 2005-01-31
WO1998047517A1 (en) 1998-10-29
ES2232949T3 (es) 2005-06-01
CN1146424C (zh) 2004-04-21
NZ338028A (en) 2001-10-26
HUP0001780A3 (en) 2001-02-28
AR012480A1 (es) 2000-10-18
US6514958B1 (en) 2003-02-04
CN1253503A (zh) 2000-05-17
ATE281836T1 (de) 2004-11-15
TR199902530T2 (xx) 2000-05-22
US6399594B2 (en) 2002-06-04
EP0975348B1 (en) 2004-11-10
ZA983169B (en) 1998-10-20
US20040142030A1 (en) 2004-07-22
PL190227B1 (pl) 2005-11-30
DE69827484D1 (de) 2004-12-16
IL123984A (en) 2004-09-27
JPH10316573A (ja) 1998-12-02
US20030119801A1 (en) 2003-06-26
PL336658A1 (en) 2000-07-03
KR20010020163A (ko) 2001-03-15
EP0975348A1 (en) 2000-02-02
NO995127L (no) 1999-10-21

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Legal Events

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