JP5339903B2 - エチニルエストラジオールを含むタナプロゲット組成物 - Google Patents

エチニルエストラジオールを含むタナプロゲット組成物 Download PDF

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Publication number
JP5339903B2
JP5339903B2 JP2008515878A JP2008515878A JP5339903B2 JP 5339903 B2 JP5339903 B2 JP 5339903B2 JP 2008515878 A JP2008515878 A JP 2008515878A JP 2008515878 A JP2008515878 A JP 2008515878A JP 5339903 B2 JP5339903 B2 JP 5339903B2
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Japan
Prior art keywords
composition
tanaproget
product
anhydrous lactose
magnesium stearate
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Expired - Fee Related
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JP2008515878A
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English (en)
Japanese (ja)
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JP2008543758A (ja
JP2008543758A5 (enExample
Inventor
ナギ，アーウィンダー
チャトラパリ，ラマラオ
ハサン，シャミン
アリ，ザファー
ゴラブ，モハメド
Original Assignee
ワイス・エルエルシー
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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
    • 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
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • 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
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/535—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one oxygen as the ring hetero atoms, e.g. 1,2-oxazines
    • A61K31/536—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one oxygen as the ring hetero atoms, e.g. 1,2-oxazines ortho- or peri-condensed with carbocyclic ring systems
    • 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
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/535—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one oxygen as the ring hetero atoms, e.g. 1,2-oxazines
    • A61K31/5375—1,4-Oxazines, e.g. morpholine
    • A61K31/538—1,4-Oxazines, e.g. morpholine ortho- or peri-condensed with carbocyclic ring systems
    • 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
    • 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
    • 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
    • A61K9/14—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
    • 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
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • 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
    • A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A61K9/2077—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
    • 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
    • A61K9/2095—Tabletting processes
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4808—Preparations in capsules, e.g. of gelatin, of chocolate characterised by the form of the capsule or the structure of the filling; Capsules containing small tablets; Capsules with outer layer for immediate drug release
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00—Drugs for disorders of the urinary system
    • A61P13/08—Drugs for disorders of the urinary system of the prostate
    • 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
    • A61P15/12—Drugs for genital or sexual disorders; Contraceptives for climacteric disorders
    • 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
    • A61P35/00—Antineoplastic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • 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
    • 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
    • A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Endocrinology (AREA)
  • Reproductive Health (AREA)
  • Diabetes (AREA)
  • Gynecology & Obstetrics (AREA)
  • Urology & Nephrology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Steroid Compounds (AREA)
JP2008515878A 2005-06-09 2006-06-07 エチニルエストラジオールを含むタナプロゲット組成物 Expired - Fee Related JP5339903B2 (ja)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US68880605P 2005-06-09 2005-06-09
US60/688,806 2005-06-09
PCT/US2006/022150 WO2006135638A2 (en) 2005-06-09 2006-06-07 Tanaproget compositions containing ethinyl estradiol

Publications (3)

Publication Number Publication Date
JP2008543758A JP2008543758A (ja) 2008-12-04
JP2008543758A5 JP2008543758A5 (enExample) 2009-07-23
JP5339903B2 true JP5339903B2 (ja) 2013-11-13

Family

ID=37432377

Family Applications (1)

Application Number Title Priority Date Filing Date
JP2008515878A Expired - Fee Related JP5339903B2 (ja) 2005-06-09 2006-06-07 エチニルエストラジオールを含むタナプロゲット組成物

Country Status (13)

Country Link
US (3) US20060280800A1 (enExample)
EP (1) EP1893217A2 (enExample)
JP (1) JP5339903B2 (enExample)
CN (2) CN101193639A (enExample)
AR (1) AR057060A1 (enExample)
AU (1) AU2006258048A1 (enExample)
BR (1) BRPI0611250A2 (enExample)
CA (1) CA2610767C (enExample)
HN (1) HN2006020928A (enExample)
MX (1) MX2007015571A (enExample)
PE (1) PE20070001A1 (enExample)
TW (1) TW200716137A (enExample)
WO (1) WO2006135638A2 (enExample)

Families Citing this family (27)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR100732692B1 (ko) * 1999-05-04 2007-06-27 와이어쓰 프로게스테론 수용체 조절인자인 시클로티오카르바메이트유도체
US7767668B2 (en) * 2005-04-28 2010-08-03 Wyeth Llc Micronized tanaproget, compositions, and methods of preparing the same
WO2006116596A2 (en) * 2005-04-28 2006-11-02 Wyeth Micronized tanaproget and compostions containing same
BRPI0610438A2 (pt) 2005-04-28 2012-10-23 Wyeth Corp composição farmacêutica, cápsula, conjunto farmacêutico, e, processo para preparar uma composição
MX2007013469A (es) * 2005-04-28 2008-01-22 Wyeth Corp Forma ii polimorfa de tanaproget.
MX2007015571A (es) 2005-06-09 2008-03-06 Wyeth Corp Composiciones de tanaproget que contienen etinilestradiol.
US20090170823A1 (en) * 2007-12-20 2009-07-02 Duramed Pharmaceuticals, Inc. Dosage Regimens and Pharmaceutical Compositions and Packages for Emergency Contraception
WO2013059146A1 (en) * 2011-10-17 2013-04-25 Lexicon Pharmaceuticals, Inc. Solid dosage forms of (s)-ethyl 2-amino-3-(4-(2-amino-6-((r)-1-(4-chloro-2-(3-methyl-1h-pyrazol-1-yl)phenyl)-2,2,2-trifluoroethoxy)pyrimidin-4-yl)phenyl)propanoate
EP2782584B1 (en) 2011-11-23 2021-06-09 TherapeuticsMD, Inc. Natural combination hormone replacement formulations and therapies
US9301920B2 (en) 2012-06-18 2016-04-05 Therapeuticsmd, Inc. Natural combination hormone replacement formulations and therapies
US20130338122A1 (en) 2012-06-18 2013-12-19 Therapeuticsmd, Inc. Transdermal hormone replacement therapies
US10806740B2 (en) 2012-06-18 2020-10-20 Therapeuticsmd, Inc. Natural combination hormone replacement formulations and therapies
US20150196640A1 (en) 2012-06-18 2015-07-16 Therapeuticsmd, Inc. Progesterone formulations having a desirable pk profile
US10806697B2 (en) 2012-12-21 2020-10-20 Therapeuticsmd, Inc. Vaginal inserted estradiol pharmaceutical compositions and methods
US20140006315A1 (en) * 2012-07-02 2014-01-02 Stèphane Etheve Method of marketing oregano capsules containing thymoquinone
US9326997B2 (en) 2012-09-24 2016-05-03 Ahlam E. Elakkad Composition and method for treation Oligoovulation, Oligomenorrhea and Amenorrhea
US10568891B2 (en) 2012-12-21 2020-02-25 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
US10471072B2 (en) 2012-12-21 2019-11-12 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
US11266661B2 (en) 2012-12-21 2022-03-08 Therapeuticsmd, Inc. Vaginal inserted estradiol pharmaceutical compositions and methods
WO2014159377A1 (en) * 2013-03-14 2014-10-02 Teva Women's Health, Inc. Compositions containing tanaproget and natural estrogens
AR100562A1 (es) 2014-05-22 2016-10-12 Therapeuticsmd Inc Composición farmacéutica de estradiol y progesterona para terapia de reemplazo hormonal
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
WO2017173044A1 (en) 2016-04-01 2017-10-05 Therapeuticsmd Inc. Steroid hormone compositions in medium chain oils

Family Cites Families (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR100732692B1 (ko) * 1999-05-04 2007-06-27 와이어쓰 프로게스테론 수용체 조절인자인 시클로티오카르바메이트유도체
US6423699B1 (en) * 1999-05-04 2002-07-23 American Home Products Corporation Combination therapies using benzimidazolones
UA73119C2 (en) 2000-04-19 2005-06-15 American Home Products Corpoir Derivatives of cyclic thiocarbamates, pharmaceutical composition including noted derivatives of cyclic thiocarbamates and active ingredients of medicines as modulators of progesterone receptors
EP1531824A4 (en) * 2002-06-25 2005-09-21 Wyeth Corp CYCLOTHIOCARBAMATE DERIVATIVES AS PR-MODULATORS AND THEIR USE IN THE TREATMENT OF SKIN DISEASES
AU2003247608A1 (en) * 2002-06-25 2004-01-06 Wyeth Use of cyclothiocarbamate derivatives in treatment of hormone-related conditions
AR049707A1 (es) * 2004-07-07 2006-08-30 Wyeth Corp Regimenes y kits de progestina ciclica
AU2005272854B2 (en) * 2004-08-13 2012-04-26 Wyeth Tanaproget derivatives, metabolites, and uses thereof
BRPI0610438A2 (pt) 2005-04-28 2012-10-23 Wyeth Corp composição farmacêutica, cápsula, conjunto farmacêutico, e, processo para preparar uma composição
ES2431324T3 (es) 2005-04-28 2013-11-26 Wyeth Llc Forma purificada de tanaproget
WO2006116596A2 (en) 2005-04-28 2006-11-02 Wyeth Micronized tanaproget and compostions containing same
US7767668B2 (en) 2005-04-28 2010-08-03 Wyeth Llc Micronized tanaproget, compositions, and methods of preparing the same
MX2007013469A (es) 2005-04-28 2008-01-22 Wyeth Corp Forma ii polimorfa de tanaproget.
MX2007015571A (es) 2005-06-09 2008-03-06 Wyeth Corp Composiciones de tanaproget que contienen etinilestradiol.

Also Published As

Publication number Publication date
AU2006258048A1 (en) 2006-12-21
US8664208B2 (en) 2014-03-04
EP1893217A2 (en) 2008-03-05
CN103989687A (zh) 2014-08-20
US20060280800A1 (en) 2006-12-14
TW200716137A (en) 2007-05-01
AR057060A1 (es) 2007-11-14
BRPI0611250A2 (pt) 2011-02-15
PE20070001A1 (es) 2007-01-29
JP2008543758A (ja) 2008-12-04
CA2610767A1 (en) 2006-12-21
CN101193639A (zh) 2008-06-04
WO2006135638A2 (en) 2006-12-21
HN2006020928A (es) 2011-02-16
MX2007015571A (es) 2008-03-06
US20120114748A1 (en) 2012-05-10
US20140194398A1 (en) 2014-07-10
WO2006135638A3 (en) 2007-03-15
CA2610767C (en) 2014-09-23

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