AR012480A1 - Una unidad de dosis farmaceutica que comprende tibolona, un metodo para elaborarla y el uso de un producto de almidon como vehiculo en unidades dedosis farmaceuticas que comprenden tibolona - Google Patents

Una unidad de dosis farmaceutica que comprende tibolona, un metodo para elaborarla y el uso de un producto de almidon como vehiculo en unidades dedosis farmaceuticas que comprenden tibolona

Info

Publication number
AR012480A1
AR012480A1 ARP980101819A ARP980101819A AR012480A1 AR 012480 A1 AR012480 A1 AR 012480A1 AR P980101819 A ARP980101819 A AR P980101819A AR P980101819 A ARP980101819 A AR P980101819A AR 012480 A1 AR012480 A1 AR 012480A1
Authority
AR
Argentina
Prior art keywords
tibolone
vehicle
pharmaceutical
units
dedosis
Prior art date
Application number
ARP980101819A
Other languages
English (en)
Original Assignee
Organon 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 Organon Nv filed Critical Organon Nv
Publication of AR012480A1 publication Critical patent/AR012480A1/es

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)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • General Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Endocrinology (AREA)
  • Diabetes (AREA)
  • Reproductive Health (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

Una unidad de dosis farmacéutica, por ejemplo una tableta o una cápsula, que comprende una cantidad efectiva de tibolona (que varía, por lo general,entre el 0,1 y el 10% en peso) y un vehículo farmacéticamente aceptable que contiene almidon(t ambién denominado granulado básico) donde el vehículocontiene entre el 10 y el 100% en peso de almidon. De esta manera se obtiene una formulacion de tibolona más estable, que se puede almacenar en lugar seco yque permite dosis más pequenas deling rediente activo. Un método para elaborar la unidad de dosis farmacéutica que comprende: suministrar un vehículo con lacomposicion deseada, mezclar la tibolona y, opcionalmente los estabilizadores, con una parte del vehículo, obtener una pre-mezcla, tamizar la pre-mezcla,volver a mezclar con la porcion restante del vehículo y finalmente mezclar con el lubricante. Uso de un producto de almidon como vehículo en unidades de dosisfarmacéuticas.
ARP980101819A 1997-04-22 1998-04-21 Una unidad de dosis farmaceutica que comprende tibolona, un metodo para elaborarla y el uso de un producto de almidon como vehiculo en unidades dedosis farmaceuticas que comprenden tibolona AR012480A1 (es)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
EP97201180 1997-04-22

Publications (1)

Publication Number Publication Date
AR012480A1 true AR012480A1 (es) 2000-10-18

Family

ID=8228228

Family Applications (1)

Application Number Title Priority Date Filing Date
ARP980101819A AR012480A1 (es) 1997-04-22 1998-04-21 Una unidad de dosis farmaceutica que comprende tibolona, un metodo para elaborarla y el uso de un producto de almidon como vehiculo en unidades dedosis farmaceuticas que comprenden tibolona

Country Status (26)

Country Link
US (6) US6399594B2 (es)
EP (1) EP0975348B1 (es)
JP (1) JPH10316573A (es)
KR (1) KR100580855B1 (es)
CN (2) CN1146424C (es)
AR (1) AR012480A1 (es)
AT (1) ATE281836T1 (es)
AU (1) AU742037B2 (es)
BR (1) BR9809268A (es)
CA (1) CA2288070A1 (es)
DE (1) DE69827484T2 (es)
DK (1) DK0975348T3 (es)
ES (1) ES2232949T3 (es)
HK (1) HK1023508A1 (es)
HU (1) HUP0001780A3 (es)
ID (1) ID22763A (es)
IL (1) IL123984A (es)
NO (1) NO995127L (es)
NZ (1) NZ338028A (es)
PL (1) PL190227B1 (es)
PT (1) PT975348E (es)
RU (1) RU2207133C2 (es)
TR (1) TR199902530T2 (es)
TW (1) TW570798B (es)
WO (1) WO1998047517A1 (es)
ZA (1) ZA983169B (es)

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
US7763276B1 (en) * 1999-02-26 2010-07-27 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
KR100979877B1 (ko) * 2001-09-28 2010-09-02 뉴트라슈틱스 인코포레이티드 생물학적 성분의 전달 시스템
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
CA2523883C (en) * 2003-04-29 2012-01-03 Akzo Nobel N.V. Antisolvent solidification process
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
BR112018072371B1 (pt) 2016-05-04 2024-04-30 Novalon S.A. Uso de um açúcar-álcool, composição farmacêutica, método para preparar uma forma de dosagem sólida compreendendo tibolona e uso de uma composição farmacêutica

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 (es) * 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
AU671706B2 (en) * 1993-03-05 1996-09-05 Akzo N.V. Use of a Pregnane Derivative
ATE227122T1 (de) * 1993-09-03 2002-11-15 Smithkline Beecham Corp Stabilisierte tablettenformulierung
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
US20010005513A1 (en) 2001-06-28
CA2288070A1 (en) 1998-10-29
US6514958B1 (en) 2003-02-04
NO995127D0 (no) 1999-10-21
PL336658A1 (en) 2000-07-03
PT975348E (pt) 2005-01-31
HK1023508A1 (en) 2000-09-15
US20040142030A1 (en) 2004-07-22
NO995127L (no) 1999-10-21
WO1998047517A1 (en) 1998-10-29
KR20010020163A (ko) 2001-03-15
CN1253503A (zh) 2000-05-17
ES2232949T3 (es) 2005-06-01
IL123984A (en) 2004-09-27
AU8014698A (en) 1998-11-13
TW570798B (en) 2004-01-11
AU742037B2 (en) 2001-12-13
US20030119801A1 (en) 2003-06-26
DK0975348T3 (da) 2005-03-07
US20040142028A1 (en) 2004-07-22
ID22763A (id) 1999-12-09
JPH10316573A (ja) 1998-12-02
DE69827484T2 (de) 2005-03-17
HUP0001780A3 (en) 2001-02-28
ZA983169B (en) 1998-10-20
DE69827484D1 (de) 2004-12-16
PL190227B1 (pl) 2005-11-30
NZ338028A (en) 2001-10-26
TR199902530T2 (xx) 2000-05-22
US6399594B2 (en) 2002-06-04
HUP0001780A2 (hu) 2000-12-28
EP0975348A1 (en) 2000-02-02
CN1146424C (zh) 2004-04-21
CN1494908A (zh) 2004-05-12
ATE281836T1 (de) 2004-11-15
EP0975348B1 (en) 2004-11-10
RU2207133C2 (ru) 2003-06-27
KR100580855B1 (ko) 2006-05-17
BR9809268A (pt) 2000-06-27
US20040142031A1 (en) 2004-07-22

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