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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JP
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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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
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ワイス・エルエルシー
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/56Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/565Compounds 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
    • A61K31/567Compounds 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1617Organic compounds, e.g. phospholipids, fats
    • A61K9/1623Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/535Heterocyclic 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
    • A61K31/536Heterocyclic 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/535Heterocyclic 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
    • A61K31/53751,4-Oxazines, e.g. morpholine
    • A61K31/5381,4-Oxazines, e.g. morpholine ortho- or peri-condensed with carbocyclic ring systems
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/56Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/56Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/565Compounds 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1629Organic macromolecular compounds
    • A61K9/1652Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1682Processes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2013Organic compounds, e.g. phospholipids, fats
    • A61K9/2018Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2072Pills, 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
    • A61K9/2077Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2095Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4808Preparations 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00Drugs for disorders of the urinary system
    • A61P13/08Drugs for disorders of the urinary system of the prostate
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00Drugs for genital or sexual disorders; Contraceptives
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00Drugs for genital or sexual disorders; Contraceptives
    • A61P15/12Drugs for genital or sexual disorders; Contraceptives for climacteric disorders
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00Drugs for genital or sexual disorders; Contraceptives
    • A61P15/18Feminine contraceptives
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00Antineoplastic agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00Drugs for disorders of the endocrine system
    • A61P5/24Drugs for disorders of the endocrine system of the sex hormones
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/205Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Organic Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Molecular Biology (AREA)
  • Endocrinology (AREA)
  • Biophysics (AREA)
  • Reproductive Health (AREA)
  • Urology & Nephrology (AREA)
  • Gynecology & Obstetrics (AREA)
  • Diabetes (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (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
MXPA01011287A (es) * 1999-05-04 2003-07-14 American Home Prod Derivados de ciclotiocarbamato como moduladores de receptor de progesterona.
WO2007030153A2 (en) 2005-04-28 2007-03-15 Wyeth Compositions containing micronized tanaproget
MX2007013469A (es) * 2005-04-28 2008-01-22 Wyeth Corp Forma ii polimorfa de tanaproget.
DE602006012972D1 (de) 2005-04-28 2010-04-29 Wyeth Corp Mikronisierte tanaproget zusammensetzungen und verfahren zu ihrer herstellung
ATE461701T1 (de) * 2005-04-28 2010-04-15 Wyeth Corp Mikronisiertes tanaproget und zusammensetzungen damit
TW200716137A (en) 2005-06-09 2007-05-01 Wyeth Corp Tanaproget compositions containing ethinyl estradiol
CA2710293A1 (en) * 2007-12-20 2009-07-02 Teva Women's Health, Inc. Dosage regimens and pharmaceutical compositions and packages for emergency contraception
JP6203182B2 (ja) * 2011-10-17 2017-09-27 レクシコン ファーマシューティカルズ インコーポレイテッド (s)−エチル2−アミノ−3−(4−(2−アミノ−6−((r)−1−(4−クロロ−2−(3−メチル−1h−ピラゾール−1−イル)フェニル)−2,2,2−トリフルオロエトキシ)ピリミジン−4−イル)フェニル)プロパノエートの固形剤
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
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
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
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
US9180091B2 (en) 2012-12-21 2015-11-10 Therapeuticsmd, Inc. Soluble estradiol capsule for vaginal insertion
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
WO2014159377A1 (en) * 2013-03-14 2014-10-02 Teva Women's Health, Inc. Compositions containing tanaproget and natural estrogens
KR20170005819A (ko) 2014-05-22 2017-01-16 쎄러퓨틱스엠디, 인코퍼레이티드 천연 복합 호르몬 대체 제형 및 요법
US10328087B2 (en) 2015-07-23 2019-06-25 Therapeuticsmd, Inc. Formulations for solubilizing hormones
BR112018070199A2 (pt) 2016-04-01 2019-01-29 Therapeuticsmd Inc composição farmacêutica de hormônio esteroide
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
US6423699B1 (en) * 1999-05-04 2002-07-23 American Home Products Corporation Combination therapies using benzimidazolones
MXPA01011287A (es) * 1999-05-04 2003-07-14 American Home Prod Derivados de ciclotiocarbamato como moduladores de receptor de progesterona.
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
JP2005535624A (ja) * 2002-06-25 2005-11-24 ワイス ホルモン関連症状の治療におけるシクロチオカルバメート誘導体の使用
US7268149B2 (en) 2002-06-25 2007-09-11 Wyeth Cyclothiocarbamate derivatives as progesterone receptor modulators and methods of treating skin disorders
CA2571377C (en) 2004-07-07 2014-03-25 Wyeth Cyclic progestin regimens and kits
US7569679B2 (en) * 2004-08-13 2009-08-04 Wyeth Tanaproget derivatives, metabolites, and uses thereof
MX2007013469A (es) 2005-04-28 2008-01-22 Wyeth Corp Forma ii polimorfa de tanaproget.
WO2006116498A2 (en) 2005-04-28 2006-11-02 Wyeth Purified form of tanaproget
ATE461701T1 (de) 2005-04-28 2010-04-15 Wyeth Corp Mikronisiertes tanaproget und zusammensetzungen damit
DE602006012972D1 (de) 2005-04-28 2010-04-29 Wyeth Corp Mikronisierte tanaproget zusammensetzungen und verfahren zu ihrer herstellung
WO2007030153A2 (en) 2005-04-28 2007-03-15 Wyeth Compositions containing micronized tanaproget
TW200716137A (en) 2005-06-09 2007-05-01 Wyeth Corp Tanaproget compositions containing ethinyl estradiol

Also Published As

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

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