ZA200305342B - Steroid hormone products comprising a stabilizing agent in non-crystalline form. - Google Patents
Steroid hormone products comprising a stabilizing agent in non-crystalline form. Download PDFInfo
- Publication number
- ZA200305342B ZA200305342B ZA200305342A ZA200305342A ZA200305342B ZA 200305342 B ZA200305342 B ZA 200305342B ZA 200305342 A ZA200305342 A ZA 200305342A ZA 200305342 A ZA200305342 A ZA 200305342A ZA 200305342 B ZA200305342 B ZA 200305342B
- Authority
- ZA
- South Africa
- Prior art keywords
- norgestimate
- lactose
- steroid hormone
- excipient
- product
- Prior art date
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- 239000003270 steroid hormone Substances 0.000 title claims description 47
- 239000003381 stabilizer Substances 0.000 title 1
- 229960000417 norgestimate Drugs 0.000 claims description 116
- KIQQMECNKUGGKA-NMYWJIRASA-N norgestimate Chemical compound O/N=C/1CC[C@@H]2[C@H]3CC[C@](CC)([C@](CC4)(OC(C)=O)C#C)[C@@H]4[C@@H]3CCC2=C\1 KIQQMECNKUGGKA-NMYWJIRASA-N 0.000 claims description 116
- GUBGYTABKSRVRQ-XLOQQCSPSA-N Alpha-Lactose Chemical compound O[C@@H]1[C@@H](O)[C@@H](O)[C@@H](CO)O[C@H]1O[C@@H]1[C@@H](CO)O[C@H](O)[C@H](O)[C@H]1O GUBGYTABKSRVRQ-XLOQQCSPSA-N 0.000 claims description 101
- GUBGYTABKSRVRQ-QKKXKWKRSA-N Lactose Natural products OC[C@H]1O[C@@H](O[C@H]2[C@H](O)[C@@H](O)C(O)O[C@@H]2CO)[C@H](O)[C@@H](O)[C@H]1O GUBGYTABKSRVRQ-QKKXKWKRSA-N 0.000 claims description 100
- 239000008101 lactose Substances 0.000 claims description 96
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- 238000000034 method Methods 0.000 claims description 43
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- 239000005556 hormone Substances 0.000 claims description 9
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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
-
- 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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- 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
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- 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
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- 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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- 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
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- 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
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- 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
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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- A—HUMAN NECESSITIES
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- 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)
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- Endocrinology (AREA)
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- Biophysics (AREA)
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- 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)
Applications Claiming Priority (1)
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| US25566900P | 2000-12-14 | 2000-12-14 |
Publications (1)
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| ZA200305342B true ZA200305342B (en) | 2004-10-11 |
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| ZA200305342A ZA200305342B (en) | 2000-12-14 | 2003-07-10 | Steroid hormone products comprising a stabilizing agent in non-crystalline form. |
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| IL (2) | IL156423A0 (sh) |
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| US6787531B1 (en) * | 1999-08-31 | 2004-09-07 | Schering Ag | Pharmaceutical composition for use as a contraceptive |
| US20020132801A1 (en) * | 2001-01-11 | 2002-09-19 | Schering Aktiengesellschaft | Drospirenone for hormone replacement therapy |
| CA2431521E (en) * | 2000-12-14 | 2013-04-16 | Ortho-Mcneil Pharmaceutical, Inc. | Steroid hormone products and methods for preparing them |
| US7858607B2 (en) * | 2003-03-14 | 2010-12-28 | Mamchur Stephen A | System for use by compounding pharmacists to produce hormone replacement medicine customized for each consumer |
| DK1844765T3 (en) * | 2003-06-13 | 2015-04-27 | Skendi Finance Ltd | Slow release estradiol progesterone formulation |
| US8101244B2 (en) | 2004-06-09 | 2012-01-24 | Smithkline Beecham Corporation | Apparatus and method for producing or processing a product or sample |
| TWI547431B (zh) | 2004-06-09 | 2016-09-01 | 史密斯克萊美占公司 | 生產藥物之裝置及方法 |
| EP1625849A1 (en) * | 2004-08-09 | 2006-02-15 | Liconsa, Liberacion Controlada de Sustancias Activas, S.A. | Pharmaceutical composition comprising drospirenone and ethynylestradiol |
| US8486926B2 (en) * | 2006-11-17 | 2013-07-16 | Harbor Therapeutics, Inc. | Steroid tetrol solid state forms |
| CN101939009B (zh) * | 2008-02-05 | 2013-07-17 | 哈博生物科学公司 | 药学固体形式 |
| US8252947B2 (en) * | 2008-04-03 | 2012-08-28 | Harbor Therapeutics, Inc. | Solid state forms of a pharmaceutical |
| EP2172190A1 (en) * | 2008-10-02 | 2010-04-07 | Laboratorios Liconsa, S.A. | Inhalable particles comprising tiotropium |
| US10993879B2 (en) | 2010-02-08 | 2021-05-04 | Shenzhen Evergreen Therapeutics Co., Ltd. | Pulmonary delivery of progestogen |
| ES2773079T3 (es) * | 2010-02-08 | 2020-07-09 | Shenzhen Evergreen Therapeutics Co Ltd | Métodos para el uso de progestágeno como sensibilizador de glucocorticoides |
| US10987361B2 (en) | 2010-02-08 | 2021-04-27 | Shenzhen Evergreen Therapeutics Co., Ltd. | Treating auto-immune and auto-inflammatory diseases |
| US9301920B2 (en) | 2012-06-18 | 2016-04-05 | Therapeuticsmd, Inc. | Natural combination hormone replacement formulations and therapies |
| HUE055562T2 (hu) | 2011-11-23 | 2021-11-29 | Therapeuticsmd Inc | Természetes kombinációjú hormon helyettesítõ kiszerelések, és terápiák ezekkel |
| US10806740B2 (en) | 2012-06-18 | 2020-10-20 | Therapeuticsmd, Inc. | Natural combination hormone replacement formulations and therapies |
| US10806697B2 (en) | 2012-12-21 | 2020-10-20 | Therapeuticsmd, Inc. | Vaginal inserted estradiol pharmaceutical compositions and methods |
| US20130338122A1 (en) | 2012-06-18 | 2013-12-19 | Therapeuticsmd, Inc. | Transdermal hormone replacement therapies |
| US20150196640A1 (en) | 2012-06-18 | 2015-07-16 | Therapeuticsmd, Inc. | Progesterone formulations having a desirable pk profile |
| CN102793929B (zh) * | 2012-09-07 | 2013-12-11 | 上海奥科达生物医药科技有限公司 | 一种制备稳定非晶态药物制剂的方法 |
| US11266661B2 (en) | 2012-12-21 | 2022-03-08 | Therapeuticsmd, Inc. | Vaginal inserted estradiol pharmaceutical compositions and methods |
| US10537581B2 (en) | 2012-12-21 | 2020-01-21 | Therapeuticsmd, Inc. | Vaginal inserted estradiol pharmaceutical compositions and methods |
| US9180091B2 (en) | 2012-12-21 | 2015-11-10 | Therapeuticsmd, Inc. | Soluble estradiol capsule for vaginal insertion |
| US11246875B2 (en) | 2012-12-21 | 2022-02-15 | Therapeuticsmd, Inc. | Vaginal inserted estradiol pharmaceutical compositions and methods |
| US10568891B2 (en) | 2012-12-21 | 2020-02-25 | Therapeuticsmd, Inc. | Vaginal inserted estradiol pharmaceutical compositions and methods |
| US10471072B2 (en) | 2012-12-21 | 2019-11-12 | Therapeuticsmd, Inc. | Vaginal inserted estradiol pharmaceutical compositions and methods |
| RU2016143081A (ru) | 2014-05-22 | 2018-06-26 | Терапьютиксмд, Инк. | Натуральные комбинированные гормонозаместительные составы и терапии |
| US10328087B2 (en) | 2015-07-23 | 2019-06-25 | Therapeuticsmd, Inc. | Formulations for solubilizing hormones |
| KR20180126582A (ko) | 2016-04-01 | 2018-11-27 | 쎄러퓨틱스엠디, 인코퍼레이티드 | 스테로이드 호르몬 약제학적 조성물 |
| US10286077B2 (en) | 2016-04-01 | 2019-05-14 | Therapeuticsmd, Inc. | Steroid hormone compositions in medium chain oils |
| US20200129438A1 (en) * | 2018-10-31 | 2020-04-30 | Edenbridge Pharmaceuticals, LLC | Finished pharmaceutical dosage form comprising a low dose/high potency active pharmaceutical ingredient and one or more excipients |
| US11633405B2 (en) | 2020-02-07 | 2023-04-25 | Therapeuticsmd, Inc. | Steroid hormone pharmaceutical formulations |
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| US2648700A (en) * | 1946-11-02 | 1953-08-11 | Searle & Co | 2-methyl-2,7-dihydroxy-octahydrophenanthrene-1-propionic acid and derivatives thereof |
| US2636042A (en) * | 1949-07-08 | 1953-04-21 | S B Penick And Company | Water-soluble hormone compounds |
| US2642427A (en) * | 1951-08-01 | 1953-06-16 | Abbott Lab | Piperazine salts of cyclopentanopolyhydrophenanthrene-3-monosulfates |
| US2666066A (en) * | 1951-09-28 | 1954-01-12 | Abbott Lab | Ethylenediamine salts of cyclopen-tanopolyhydrophenanthrene-3-monosulfates |
| US3032469A (en) * | 1958-05-02 | 1962-05-01 | Charles E Frosst & Company | Long acting steroid compounds |
| US3568828A (en) * | 1967-03-01 | 1971-03-09 | Squibb & Sons Inc | Modified sequential oral contraceptive |
| US3691212A (en) * | 1970-04-24 | 1972-09-12 | British Drug Houses Ltd | 17alpha-(1',3'-alkadiynyl)-17beta-acyloxy(17beta-aroyloxy) steroids |
| US4046874A (en) * | 1974-02-13 | 1977-09-06 | Mead Johnson & Company | Soapless shave composition |
| US4511551A (en) * | 1982-11-18 | 1985-04-16 | Unique Technologies, Incorporated | Method and composition for the detection of a precancerous or leukemic condition in mammals |
| US4616006A (en) * | 1983-09-26 | 1986-10-07 | Ortho Pharmaceutical Corporation | Triphasic oral contraceptive |
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| US5407928A (en) * | 1990-08-15 | 1995-04-18 | Schering Aktiengesellschaft | 11β-aryl-gona-4,9-dien-3-ones |
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| FR2668945B1 (fr) * | 1990-11-12 | 1993-02-19 | Theramex | Nouveau procede de cristallisation des substances organiques et les composes ainsi obtenus. |
| IE67345B1 (en) * | 1991-03-12 | 1996-03-20 | Akzo Nv | Low dose dry pharmaceutical preparations |
| DE69207863T2 (de) * | 1991-11-13 | 1996-06-05 | Glaxo Canada | Vorrichtung zur kontrollierten Wirkstoffreigabe |
| US5395627A (en) * | 1992-09-04 | 1995-03-07 | Akzo N.V. | Pharmaceutical granulate |
| DE4229820C2 (de) * | 1992-09-07 | 1998-12-03 | Jenapharm Gmbh | Pharmazeutische Zubereitung auf Gestagen-Basis |
| IT1270831B (it) * | 1993-09-17 | 1997-05-13 | Romano Deghenghi | Composizioni farmaceutiche orali effervescenti contenenti estrone |
| US6290991B1 (en) * | 1994-12-02 | 2001-09-18 | Quandrant Holdings Cambridge Limited | Solid dose delivery vehicle and methods of making same |
| DE4429374C1 (de) * | 1994-08-12 | 1996-02-01 | Jenapharm Gmbh | Pharmazeutische Präparate zur Kontrazeption/Hormonsubstitution mit biogener Estrogenkomponente |
| 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. |
| DE122010000020I1 (de) * | 1996-04-25 | 2010-07-08 | Prosidion Ltd | Verfahren zur Senkung des Blutglukosespiegels in Säugern |
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| JP2000515890A (ja) * | 1996-07-26 | 2000-11-28 | アメリカン・ホーム・プロダクツ・コーポレイション | プロゲスチンとエストロゲンとの混合剤からなる一相性避妊法およびキット |
| US6495532B1 (en) * | 1997-03-19 | 2002-12-17 | Sky High, Llc | Compositions containing lysophosphotidic acids which inhibit apoptosis and uses thereof |
| US6190693B1 (en) * | 1998-04-17 | 2001-02-20 | Ortho-Mcneil Pharamceutical, Inc. | Pharmaceutical methods of delivering folic acid |
| 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 |
| CA2431521E (en) * | 2000-12-14 | 2013-04-16 | Ortho-Mcneil Pharmaceutical, Inc. | Steroid hormone products and methods for preparing them |
-
2001
- 2001-12-13 CA CA2431521A patent/CA2431521E/en not_active Expired - Fee Related
- 2001-12-13 CN CNB018225578A patent/CN1290507C/zh not_active Expired - Lifetime
- 2001-12-13 UA UA2003065552A patent/UA77404C2/uk unknown
- 2001-12-13 EE EEP200300229A patent/EE05358B1/xx unknown
- 2001-12-13 SK SK880-2003A patent/SK288222B6/sk not_active IP Right Cessation
- 2001-12-13 EP EP05076805A patent/EP1591121B1/en not_active Expired - Lifetime
- 2001-12-13 ES ES01996273T patent/ES2253451T3/es not_active Expired - Lifetime
- 2001-12-13 AT AT01996273T patent/ATE307591T1/de active
- 2001-12-13 DK DK01996273T patent/DK1361881T3/da active
- 2001-12-13 KR KR1020037007977A patent/KR100899032B1/ko active IP Right Grant
- 2001-12-13 DE DE60139087T patent/DE60139087D1/de not_active Expired - Lifetime
- 2001-12-13 DE DE60114467T patent/DE60114467T2/de not_active Expired - Lifetime
- 2001-12-13 RS YUP-479/03A patent/RS50414B/sr unknown
- 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 US US10/022,138 patent/US7867990B2/en not_active Expired - Lifetime
- 2001-12-13 NZ NZ526517A patent/NZ526517A/en not_active IP Right Cessation
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- 2001-12-13 HU HU0400646A patent/HU230400B1/hu unknown
- 2001-12-13 IL IL15642301A patent/IL156423A0/xx unknown
- 2001-12-13 RU RU2003121240/15A patent/RU2286155C2/ru active
- 2001-12-13 WO PCT/US2001/048862 patent/WO2002047693A2/en not_active Application Discontinuation
- 2001-12-13 DK DK05076805T patent/DK1591121T3/da active
- 2001-12-13 CZ CZ2003-1896A patent/CZ306435B6/cs not_active IP Right Cessation
- 2001-12-13 ES ES05076805T patent/ES2327538T3/es not_active Expired - Lifetime
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- 2001-12-13 PT PT05076805T patent/PT1591121E/pt unknown
- 2001-12-13 AT AT05076805T patent/ATE434439T1/de active
- 2001-12-13 EP EP01996273A patent/EP1361881B1/en not_active Expired - Lifetime
- 2001-12-13 ME MEP-2008-488A patent/ME00339B/me unknown
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2003
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- 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
-
2010
- 2010-11-02 US US12/917,514 patent/US20110046095A1/en not_active Abandoned
- 2010-11-02 US US12/917,519 patent/US20110046099A1/en not_active Abandoned
-
2013
- 2013-10-04 NO NO20131334A patent/NO20131334L/no not_active Application Discontinuation
-
2014
- 2014-06-26 US US14/315,738 patent/US20140309204A1/en not_active Abandoned
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