TR199902530T2 - Dayanikli hale getirilmis tibolon terkipleri. - Google Patents
Dayanikli hale getirilmis tibolon terkipleri.Info
- Publication number
- TR199902530T2 TR199902530T2 TR1999/02530T TR9902530T TR199902530T2 TR 199902530 T2 TR199902530 T2 TR 199902530T2 TR 1999/02530 T TR1999/02530 T TR 1999/02530T TR 9902530 T TR9902530 T TR 9902530T TR 199902530 T2 TR199902530 T2 TR 199902530T2
- Authority
- TR
- Turkey
- Prior art keywords
- tibolone
- preparations
- starch
- weight
- stabilized
- Prior art date
Links
- WZDGZWOAQTVYBX-XOINTXKNSA-N tibolone Chemical compound C([C@@H]12)C[C@]3(C)[C@@](C#C)(O)CC[C@H]3[C@@H]1[C@H](C)CC1=C2CCC(=O)C1 WZDGZWOAQTVYBX-XOINTXKNSA-N 0.000 title abstract 3
- 229960001023 tibolone Drugs 0.000 title abstract 3
- 238000002360 preparation method Methods 0.000 title 1
- 229920002472 Starch Polymers 0.000 abstract 2
- 235000019698 starch Nutrition 0.000 abstract 2
- 239000008107 starch Substances 0.000 abstract 2
- 239000004480 active ingredient Substances 0.000 abstract 1
- 239000002775 capsule Substances 0.000 abstract 1
- 239000003937 drug carrier Substances 0.000 abstract 1
- 238000009472 formulation Methods 0.000 abstract 1
- 238000005469 granulation Methods 0.000 abstract 1
- 230000003179 granulation Effects 0.000 abstract 1
- 239000000203 mixture Substances 0.000 abstract 1
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
Bulus, tibolonun etkin bir miktarini (genel olarak, agirlikta %0.1' den 10'a kadar) ve nisasta-ihtiva eden eczacilik ile ilgili olarak kabul edilebilir bir tasiyici (ayni zamanda, temel tanelenme olarak da ifade edilmektedir) ihtiva eden, bir tablet ya da bir kapsül gibi, eczaciliga ait, bir dozaj birimine mahsus olup, ki içinde, tasiyici, nisastanin, agirlikta %10' dan 100'e kadarini ihtiva etmektedir. Böylelikle kuru muhafazaya ve aktif terkip maddesinin daha düsük dozlarina izin veren, daha dayanikli bir tibolon formülasyonu elde edilmektedir.
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 |
|---|---|
| TR199902530T2 true TR199902530T2 (tr) | 2000-05-22 |
Family
ID=8228228
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| TR1999/02530T TR199902530T2 (tr) | 1997-04-22 | 1998-04-20 | Dayanikli hale getirilmis tibolon terkipleri. |
Country Status (25)
| Country | Link |
|---|---|
| US (6) | US6399594B2 (tr) |
| EP (1) | EP0975348B1 (tr) |
| JP (1) | JPH10316573A (tr) |
| KR (1) | KR100580855B1 (tr) |
| CN (2) | CN1494908A (tr) |
| AR (1) | AR012480A1 (tr) |
| AT (1) | ATE281836T1 (tr) |
| AU (1) | AU742037B2 (tr) |
| BR (1) | BR9809268A (tr) |
| CA (1) | CA2288070A1 (tr) |
| DE (1) | DE69827484T2 (tr) |
| DK (1) | DK0975348T3 (tr) |
| ES (1) | ES2232949T3 (tr) |
| HU (1) | HUP0001780A3 (tr) |
| ID (1) | ID22763A (tr) |
| IL (1) | IL123984A (tr) |
| NO (1) | NO995127D0 (tr) |
| NZ (1) | NZ338028A (tr) |
| PL (1) | PL190227B1 (tr) |
| PT (1) | PT975348E (tr) |
| RU (1) | RU2207133C2 (tr) |
| TR (1) | TR199902530T2 (tr) |
| TW (1) | TW570798B (tr) |
| WO (1) | WO1998047517A1 (tr) |
| ZA (1) | ZA983169B (tr) |
Families Citing this family (17)
| 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 |
Family Cites Families (6)
| 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 (tr) * | 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 |
| ES2134313T3 (es) * | 1993-03-05 | 1999-10-01 | Akzo Nobel Nv | Utilizacion de derivados de pregnano para el tratamiento de tumores. |
| AU7719894A (en) * | 1993-09-03 | 1995-03-22 | Smithkline Beecham Corporation | Stabilized tablet formulation |
| 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 |
-
1998
- 1998-04-07 IL IL12398498A patent/IL123984A/en active IP Right Grant
- 1998-04-15 ZA ZA983169A patent/ZA983169B/xx unknown
- 1998-04-20 BR BR9809268-5A patent/BR9809268A/pt not_active Application Discontinuation
- 1998-04-20 KR KR1019997009726A patent/KR100580855B1/ko not_active Expired - Fee Related
- 1998-04-20 AT AT98928214T patent/ATE281836T1/de not_active IP Right Cessation
- 1998-04-20 RU RU99121407/14A patent/RU2207133C2/ru not_active IP Right Cessation
- 1998-04-20 TR TR1999/02530T patent/TR199902530T2/tr unknown
- 1998-04-20 ID IDW991204A patent/ID22763A/id unknown
- 1998-04-20 DE DE69827484T patent/DE69827484T2/de not_active Expired - Fee Related
- 1998-04-20 HU HU0001780A patent/HUP0001780A3/hu unknown
- 1998-04-20 CN CNA2003101026335A patent/CN1494908A/zh active Pending
- 1998-04-20 PT PT98928214T patent/PT975348E/pt unknown
- 1998-04-20 PL PL98336658A patent/PL190227B1/pl not_active IP Right Cessation
- 1998-04-20 EP EP98928214A patent/EP0975348B1/en not_active Expired - Lifetime
- 1998-04-20 DK DK98928214T patent/DK0975348T3/da active
- 1998-04-20 WO PCT/EP1998/002361 patent/WO1998047517A1/en not_active Ceased
- 1998-04-20 ES ES98928214T patent/ES2232949T3/es not_active Expired - Lifetime
- 1998-04-20 NZ NZ338028A patent/NZ338028A/en unknown
- 1998-04-20 CA CA002288070A patent/CA2288070A1/en not_active Abandoned
- 1998-04-20 AU AU80146/98A patent/AU742037B2/en not_active Ceased
- 1998-04-20 CN CNB988044579A patent/CN1146424C/zh not_active Expired - Fee Related
- 1998-04-20 US US09/403,139 patent/US6399594B2/en not_active Expired - Fee Related
- 1998-04-21 AR ARP980101819A patent/AR012480A1/es not_active Application Discontinuation
- 1998-04-22 JP JP10112312A patent/JPH10316573A/ja active Pending
- 1998-05-11 TW TW087107211A patent/TW570798B/zh not_active IP Right Cessation
-
1999
- 1999-10-21 NO NO995127A patent/NO995127D0/no unknown
-
2002
- 2002-04-08 US US10/117,899 patent/US6514958B1/en not_active Expired - Fee Related
- 2002-11-25 US US10/303,494 patent/US20030119801A1/en not_active Abandoned
-
2004
- 2004-01-08 US US10/754,685 patent/US20040142030A1/en not_active Abandoned
- 2004-01-08 US US10/754,733 patent/US20040142031A1/en not_active Abandoned
- 2004-01-08 US US10/754,732 patent/US20040142028A1/en not_active Abandoned
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