RU2003121240A - Препараты стероидного гормона и способы их получения - Google Patents
Препараты стероидного гормона и способы их получения Download PDFInfo
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- RU2003121240A RU2003121240A RU2003121240/15A RU2003121240A RU2003121240A RU 2003121240 A RU2003121240 A RU 2003121240A RU 2003121240/15 A RU2003121240/15 A RU 2003121240/15A RU 2003121240 A RU2003121240 A RU 2003121240A RU 2003121240 A RU2003121240 A RU 2003121240A
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- Prior art keywords
- steroid hormone
- carrier
- hormone
- mixture
- preparation
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Classifications
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- 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
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- 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
- A61K31/567—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 position 17 alpha, e.g. mestranol, norethandrolone
-
- 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
- A61K31/57—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
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- 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
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- 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
- A61K9/141—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
- A61K9/145—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with organic compounds
-
- 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
- A61K9/1617—Organic compounds, e.g. phospholipids, fats
- A61K9/1623—Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
-
- 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
- A61K9/1682—Processes
- A61K9/1694—Processes resulting in granules or microspheres of the matrix type containing more than 5% of excipient
-
- 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
- A61P15/00—Drugs for genital or sexual disorders; Contraceptives
- A61P15/18—Feminine contraceptives
-
- 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
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Veterinary Medicine (AREA)
- Chemical & Material Sciences (AREA)
- Public Health (AREA)
- Medicinal Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- General Chemical & Material Sciences (AREA)
- Endocrinology (AREA)
- Organic Chemistry (AREA)
- Biophysics (AREA)
- Molecular Biology (AREA)
- Reproductive Health (AREA)
- Diabetes (AREA)
- Gynecology & Obstetrics (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Steroid Compounds (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
Claims (17)
1. Препарат стероидного гормона, обладающий улучшенными параметрами растворения и скорости высвобождения, указанный препарат находится, по существу, в некристаллической форме в смеси с носителем, указанный носитель, стабилизирующий указанный гормон, находится, по существу, в некристаллической форме.
2. Препарат стероидного гормона по п.1, где основной носитель выбран из группы, состоящей из декстрозы, фруктозы, сорбита, ксилита, сахарозы, лактозы, маннита, декстрата, целлюлозы, крахмала и их смесей.
3. Препарат стероидного гормона по п.1, где стероидным гормоном является, по крайней мере, один из прогестина и эстрогена.
4. Препарат стероидного гормона по п.3, где стероидным гормоном является прогестин, выбранный из группы, состоящей из норгестимата, норгестрела, левоноргестрела, норэтиндрона и десогестрела.
5. Препарат стероидного гормона по п.4, где стероидным гормоном является норгестимат и носителем является лактоза.
6. Препарат стероидного гормона по п.3, где препаратом является один из пероральных контрацептивных препаратов и препаратов для заместительной гормональной терапии.
7. Препарат стероидного гормона по п.6, где препаратом является пероральный контрацептивный препарат, содержащий приблизительно от 10 до 50 мкг эстрогена и/или приблизительно от 50 до 300 мкг прогестина.
8. Препарат стероидного гормона по п.7, где прогестином является норгестимат и носителем является лактоза.
9. Способ получения препарата стероидного гормона, обладающего улучшенными параметрами растворения и скорости высвобождения, включающий в себя стадии:
- приготовления смеси, содержащей, по крайней мере, один стероидный гормон и, по крайней мере, один носитель;
- обработки указанной смеси путем приложения достаточного количества механической энергии с целью получения порошковой смеси носитель/гормон, где гормон стабилизирован указанным носителем, в основном, в некристаллической форме; и
- получения указанного препарата из порошковой смеси.
10. Способ по п.9, где смесь обрабатывают путем приложения механической энергии, составляющей, по крайней мере, 0,1 лошадиной силы-мин/кг, с образованием порошковой смеси.
11. Способ по п.9, где стадия обработки смеси путем приложения механической энергии отличается, кроме того, тем, что смесь подвергают смешиванию при высоком уровне энергии.
12. Способ по п.9, где смесь содержит гормон/носитель при соотношении приблизительно от 1/1 до 1/10.
13. Способ по п.9, где основной носитель выбран из группы, состоящей из декстрозы, фруктозы, сорбита, ксилита, сахарозы, лактозы, маннита, декстрата, целлюлозы, крахмала и их смесей.
14. Способ по п.9, где стероидным гормоном является, по крайней мере, один из прогестина и эстрогена.
15. Способ по п.14, где стероидным гормоном является прогестин, выбранный из группы, состоящей из норгестимата, норгестрела, левоноргестрела, норэтиндрона и десогестрела.
16. Способ по п.15, где стероидным гормоном является норгестимат и носителем является лактоза.
17. Способ по п.9, где стадия получения смеси включает в себя стадии:
- приготовления раствора гормона в подходящем растворителе;
- смешивания раствора с носителем с получением однородной смеси; и
- удаления растворителя.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US25566900P | 2000-12-14 | 2000-12-14 | |
| US60/255,669 | 2000-12-14 |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| RU2003121240A true RU2003121240A (ru) | 2005-02-10 |
| RU2286155C2 RU2286155C2 (ru) | 2006-10-27 |
Family
ID=22969374
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| RU2003121240/15A RU2286155C2 (ru) | 2000-12-14 | 2001-12-13 | Препараты стероидного гормона и способы их получения |
Country Status (31)
| Country | Link |
|---|---|
| US (4) | US7867990B2 (ru) |
| EP (2) | EP1361881B1 (ru) |
| KR (1) | KR100899032B1 (ru) |
| CN (1) | CN1290507C (ru) |
| AT (2) | ATE307591T1 (ru) |
| AU (2) | AU2742102A (ru) |
| BG (1) | BG66178B1 (ru) |
| BR (1) | BRPI0116793B8 (ru) |
| CA (1) | CA2431521E (ru) |
| CR (1) | CR7022A (ru) |
| CY (1) | CY1109404T1 (ru) |
| CZ (1) | CZ306435B6 (ru) |
| DE (2) | DE60114467T2 (ru) |
| DK (2) | DK1361881T3 (ru) |
| EC (1) | ECSP034654A (ru) |
| EE (1) | EE05358B1 (ru) |
| ES (2) | ES2253451T3 (ru) |
| HK (2) | HK1057174A1 (ru) |
| HU (1) | HU230400B1 (ru) |
| IL (2) | IL156423A0 (ru) |
| ME (1) | ME00339B (ru) |
| MX (1) | MXPA03005339A (ru) |
| NO (2) | NO334341B1 (ru) |
| NZ (1) | NZ526517A (ru) |
| PT (1) | PT1591121E (ru) |
| RS (1) | RS50414B (ru) |
| RU (1) | RU2286155C2 (ru) |
| SK (1) | SK288222B6 (ru) |
| UA (1) | UA77404C2 (ru) |
| WO (1) | WO2002047693A2 (ru) |
| ZA (1) | ZA200305342B (ru) |
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| AR004178A1 (es) | 1995-07-29 | 1998-11-04 | Smithkline Beecham Plc | Procedimiento para la formulacion de un farmaco, una composicion farmaceutica obtenible mediante este procedimiento y el uso de la misma. |
| DE19616486C5 (de) * | 1996-04-25 | 2016-06-30 | Royalty Pharma Collection Trust | Verfahren zur Senkung des Blutglukosespiegels in Säugern |
| ATE271386T1 (de) * | 1996-07-26 | 2004-08-15 | Wyeth Corp | Orale einstufige empfängnisverhütungsmethode und kombinationspräparat das gestagen und estrogen enthält |
| US5858405A (en) * | 1996-07-26 | 1999-01-12 | American Home Products Corporation | Oral contraceptive |
| US6495532B1 (en) * | 1997-03-19 | 2002-12-17 | Sky High, Llc | Compositions containing lysophosphotidic acids which inhibit apoptosis and uses thereof |
| AU3567699A (en) * | 1998-04-17 | 1999-11-08 | Government Of The United States Of America, As Represented By The Secretary Of The Department Of Health And Human Services, The | Folic acid-containing pharmaceutical compositions, and related methods and delivery systems |
| DE19906152B4 (de) * | 1999-02-10 | 2005-02-10 | Jenapharm Gmbh & Co. Kg | Wirkstoffhaltige Laminate für Transdermalsysteme |
| US6667050B1 (en) * | 1999-04-06 | 2003-12-23 | Galen (Chemicals) Limited | Chewable oral contraceptive |
| PT1591121E (pt) * | 2000-12-14 | 2009-07-20 | Ortho Mcneil Janssen Pharm | Processo para preparar produtos de hormona esteróide compreendendo um agente estabilizante na forma não cristalina |
-
2001
- 2001-12-13 PT PT05076805T patent/PT1591121E/pt unknown
- 2001-12-13 CA CA2431521A patent/CA2431521E/en not_active Expired - Fee Related
- 2001-12-13 IL IL15642301A patent/IL156423A0/xx unknown
- 2001-12-13 AT AT01996273T patent/ATE307591T1/de active
- 2001-12-13 DK DK01996273T patent/DK1361881T3/da active
- 2001-12-13 EP EP01996273A patent/EP1361881B1/en not_active Expired - Lifetime
- 2001-12-13 KR KR1020037007977A patent/KR100899032B1/ko active IP Right Grant
- 2001-12-13 US US10/022,138 patent/US7867990B2/en not_active Expired - Lifetime
- 2001-12-13 EE EEP200300229A patent/EE05358B1/xx unknown
- 2001-12-13 EP EP05076805A patent/EP1591121B1/en not_active Expired - Lifetime
- 2001-12-13 RU RU2003121240/15A patent/RU2286155C2/ru active
- 2001-12-13 MX MXPA03005339A patent/MXPA03005339A/es active IP Right Grant
- 2001-12-13 DK DK05076805T patent/DK1591121T3/da active
- 2001-12-13 ES ES01996273T patent/ES2253451T3/es not_active Expired - Lifetime
- 2001-12-13 ES ES05076805T patent/ES2327538T3/es not_active Expired - Lifetime
- 2001-12-13 NZ NZ526517A patent/NZ526517A/en not_active IP Right Cessation
- 2001-12-13 AU AU2742102A patent/AU2742102A/xx active Pending
- 2001-12-13 BR BRPI0116793A patent/BRPI0116793B8/pt not_active IP Right Cessation
- 2001-12-13 CZ CZ2003-1896A patent/CZ306435B6/cs not_active IP Right Cessation
- 2001-12-13 ME MEP-2008-488A patent/ME00339B/me unknown
- 2001-12-13 UA UA2003065552A patent/UA77404C2/uk unknown
- 2001-12-13 AT AT05076805T patent/ATE434439T1/de active
- 2001-12-13 DE DE60114467T patent/DE60114467T2/de not_active Expired - Lifetime
- 2001-12-13 WO PCT/US2001/048862 patent/WO2002047693A2/en not_active Application Discontinuation
- 2001-12-13 RS YUP-479/03A patent/RS50414B/sr unknown
- 2001-12-13 DE DE60139087T patent/DE60139087D1/de not_active Expired - Lifetime
- 2001-12-13 AU AU2002227421A patent/AU2002227421B2/en not_active Expired
- 2001-12-13 SK SK880-2003A patent/SK288222B6/sk not_active IP Right Cessation
- 2001-12-13 CN CNB018225578A patent/CN1290507C/zh not_active Expired - Lifetime
- 2001-12-13 HU HU0400646A patent/HU230400B1/hu unknown
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2003
- 2003-06-12 IL IL156423A patent/IL156423A/en active IP Right Grant
- 2003-06-13 NO NO20032708A patent/NO334341B1/no not_active IP Right Cessation
- 2003-06-13 EC EC2003004654A patent/ECSP034654A/es unknown
- 2003-07-01 BG BG107958A patent/BG66178B1/bg unknown
- 2003-07-10 ZA ZA200305342A patent/ZA200305342B/en unknown
- 2003-07-14 CR CR7022A patent/CR7022A/es not_active Application Discontinuation
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2004
- 2004-01-08 HK HK04100131A patent/HK1057174A1/xx not_active IP Right Cessation
-
2006
- 2006-02-09 HK HK06103511.8A patent/HK1083457A1/xx not_active IP Right Cessation
-
2009
- 2009-09-24 CY CY20091101002T patent/CY1109404T1/el unknown
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2010
- 2010-11-02 US US12/917,519 patent/US20110046099A1/en not_active Abandoned
- 2010-11-02 US US12/917,514 patent/US20110046095A1/en not_active Abandoned
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2013
- 2013-10-04 NO NO20131334A patent/NO20131334L/no not_active Application Discontinuation
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2014
- 2014-06-26 US US14/315,738 patent/US20140309204A1/en not_active Abandoned
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