CN102985070A - 用于hrt的极低剂量的固体口服剂型 - Google Patents

用于hrt的极低剂量的固体口服剂型 Download PDF

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Publication number
CN102985070A
CN102985070A CN2011800282252A CN201180028225A CN102985070A CN 102985070 A CN102985070 A CN 102985070A CN 2011800282252 A CN2011800282252 A CN 2011800282252A CN 201180028225 A CN201180028225 A CN 201180028225A CN 102985070 A CN102985070 A CN 102985070A
Authority
CN
China
Prior art keywords
dosage form
women
drsp
starch
hrt
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
CN2011800282252A
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English (en)
Chinese (zh)
Inventor
S·米尔兹克
R·舒曼恩
K·古德
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Bayer Pharma AG
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Bayer Pharma AG
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Filing date
Publication date
Application filed by Bayer Pharma AG filed Critical Bayer Pharma AG
Publication of CN102985070A publication Critical patent/CN102985070A/zh
Pending legal-status Critical Current

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Classifications

    • 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
    • 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
    • A61K31/58—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids containing heterocyclic rings, e.g. danazol, stanozolol, pancuronium or digitogenin
    • A61K31/585—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids containing heterocyclic rings, e.g. danazol, stanozolol, pancuronium or digitogenin containing lactone rings, e.g. oxandrolone, bufalin
    • 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
    • A61K31/566—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 having an oxo group in position 17, e.g. estrone
    • 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
    • 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
    • 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
    • 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
    • A61P9/00—Drugs for disorders of the cardiovascular system

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)
  • General Chemical & Material Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Engineering & Computer Science (AREA)
  • Endocrinology (AREA)
  • Reproductive Health (AREA)
  • Diabetes (AREA)
  • Cardiology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
CN2011800282252A 2010-04-15 2011-04-12 用于hrt的极低剂量的固体口服剂型 Pending CN102985070A (zh)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP10160072.4 2010-04-15
EP10160072 2010-04-15
PCT/EP2011/055716 WO2011128336A1 (en) 2010-04-15 2011-04-12 Very low-dosed solid oral dosage forms for hrt

Publications (1)

Publication Number Publication Date
CN102985070A true CN102985070A (zh) 2013-03-20

Family

ID=44260074

Family Applications (1)

Application Number Title Priority Date Filing Date
CN2011800282252A Pending CN102985070A (zh) 2010-04-15 2011-04-12 用于hrt的极低剂量的固体口服剂型

Country Status (18)

Country Link
US (3) US20130137664A1 (https=)
EP (1) EP2558063B1 (https=)
JP (1) JP5820465B2 (https=)
KR (2) KR20180018827A (https=)
CN (1) CN102985070A (https=)
AR (1) AR080912A1 (https=)
AU (1) AU2011240102B2 (https=)
BR (1) BR112012026115B1 (https=)
CA (1) CA2795801C (https=)
CO (1) CO6630107A2 (https=)
CR (1) CR20120523A (https=)
EA (1) EA026095B1 (https=)
GT (1) GT201200281A (https=)
IL (1) IL222353A0 (https=)
MX (1) MX356702B (https=)
TW (1) TWI519300B (https=)
UY (1) UY33343A (https=)
WO (1) WO2011128336A1 (https=)

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EP2383279A1 (en) 2011-07-19 2011-11-02 Pantarhei Bioscience B.V. Process for the preparation of estetrol
US9301920B2 (en) 2012-06-18 2016-04-05 Therapeuticsmd, Inc. Natural combination hormone replacement formulations and therapies
BR112014012444B1 (pt) 2011-11-23 2021-12-14 Therapeuticsmd, Inc Composição farmacêutica compreendendo estradiol solubilizado, progesterona e um agente de solubilização, bem como usos desta para tratar um sintoma relacionado à menopausa em uma mulher
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
US9180091B2 (en) 2012-12-21 2015-11-10 Therapeuticsmd, Inc. Soluble estradiol capsule for vaginal insertion
US11266661B2 (en) 2012-12-21 2022-03-08 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
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
US10537581B2 (en) 2012-12-21 2020-01-21 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
RS61777B1 (sr) 2015-06-18 2021-06-30 Estetra Sprl Oralno-disperzibilna tableta koja sadrži estetrol
HUE054589T2 (hu) 2015-06-18 2021-09-28 Estetra Sprl Szájban diszpergálódó esztetrol tartalmú tabletta
MD3310333T2 (ro) 2015-06-18 2020-06-30 Estetra Sprl Unitate de dozare orodispersabilă care conține un component estetrol
CN116077454A (zh) 2015-06-18 2023-05-09 埃斯特拉有限责任公司 含雌四醇组分的口腔分散剂量单位
US10328087B2 (en) 2015-07-23 2019-06-25 Therapeuticsmd, Inc. Formulations for solubilizing hormones
US10286077B2 (en) 2016-04-01 2019-05-14 Therapeuticsmd, Inc. Steroid hormone compositions in medium chain oils
US9931349B2 (en) 2016-04-01 2018-04-03 Therapeuticsmd, Inc. Steroid hormone pharmaceutical composition
CA3178291A1 (en) 2016-08-05 2018-04-12 Estetra Srl Method for the management of dysmenorrhea and menstrual pain
DK3781171T3 (da) 2018-04-19 2022-05-02 Estetra Srl Sammensætninger og deres anvendelser til lindring af menopause-associerede symptomer
TWI801561B (zh) 2018-04-19 2023-05-11 比利時商依思特拉私人有限責任公司 化合物及其用於緩解絕經相關症狀的用途
TWI893101B (zh) 2020-04-16 2025-08-11 比利時商埃斯特拉有限責任公司 具有降低之副作用之避孕組成物

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20020132801A1 (en) * 2001-01-11 2002-09-19 Schering Aktiengesellschaft Drospirenone for hormone replacement therapy
CN1395488A (zh) * 2000-01-18 2003-02-05 先灵公司 用于激素替代治疗的屈螺酮
WO2009112232A2 (en) * 2008-03-10 2009-09-17 Vladimir Hanes New drospirenone/17beta-estradiol regimen, pharmaceutical combination product and kit for performing this regimen
CN101674837A (zh) * 2007-04-05 2010-03-17 拜耳先灵医药股份有限公司 新的屈螺酮/17β-雌二醇给药方案、用于实施该给药方案的药物组合产品和药盒

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US4826831A (en) 1983-08-05 1989-05-02 Pre Jay Holdings Limited Method of hormonal treatment for menopausal or post-menopausal disorders involving continuous administration of progestogens and estrogens
US4590569A (en) 1983-10-14 1986-05-20 Navigation Sciences Inc. Navigation system including an integrated electronic chart display
DE4426709A1 (de) 1994-07-20 1996-01-25 Schering Ag Steroidale Sexualhormone enthaltende feste Arzneiformen
SI1214076T1 (en) * 1999-08-31 2004-06-30 Schering Aktiengesellschaft Pharmaceutical combination of ethinylestradiol and drospirenone for use as a contraceptive
EP1216712A1 (en) 2000-12-20 2002-06-26 Schering Aktiengesellschaft Cyclodextrin-drospirenone inclusion complexes
EP1216713A1 (en) 2000-12-20 2002-06-26 Schering Aktiengesellschaft Compositions of estrogen-cyclodextrin complexes
JP2004521951A (ja) 2001-07-13 2004-07-22 シエーリング アクチエンゲゼルシャフト Ｈｒｔのためのドロスピレノン及びエストロゲンスルファメートの組み合わせ
HK1079997A1 (zh) * 2002-04-26 2006-04-21 舍林股份公司 治疗接受激素替代疗法之妇女中的高血压的方法
WO2004041288A1 (en) 2002-11-05 2004-05-21 Schering Aktiengesellschaft Hormone replacement therapy with drospirenone
ES2933479T3 (es) 2003-09-29 2023-02-09 Novo Nordisk Healthcare Ag Estabilidad mejorada de formulaciones de progestágenos
WO2005030175A1 (en) 2003-09-29 2005-04-07 Novo Nordisk Femcare Ag Hrt formulations
ATE410171T1 (de) 2003-11-14 2008-10-15 Warner Chilcott Co Inc Graduierte östrogen-kontrazeptiva
GT200500315A (es) * 2004-11-02 2006-06-06 Formas de dosificacion oral solidas que contienen una dosis baja de estradiol
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CN1395488A (zh) * 2000-01-18 2003-02-05 先灵公司 用于激素替代治疗的屈螺酮
US20020132801A1 (en) * 2001-01-11 2002-09-19 Schering Aktiengesellschaft Drospirenone for hormone replacement therapy
CN101674837A (zh) * 2007-04-05 2010-03-17 拜耳先灵医药股份有限公司 新的屈螺酮/17β-雌二醇给药方案、用于实施该给药方案的药物组合产品和药盒
WO2009112232A2 (en) * 2008-03-10 2009-09-17 Vladimir Hanes New drospirenone/17beta-estradiol regimen, pharmaceutical combination product and kit for performing this regimen

Also Published As

Publication number Publication date
AR080912A1 (es) 2012-05-16
US20150094287A1 (en) 2015-04-02
KR20130097073A (ko) 2013-09-02
JP2013523860A (ja) 2013-06-17
CO6630107A2 (es) 2013-03-01
UY33343A (es) 2011-12-01
JP5820465B2 (ja) 2015-11-24
EA201201403A1 (ru) 2013-04-30
MX2012012026A (es) 2013-01-22
IL222353A0 (en) 2012-12-31
US8906890B2 (en) 2014-12-09
CR20120523A (es) 2013-01-09
TW201204368A (en) 2012-02-01
TWI519300B (zh) 2016-02-01
WO2011128336A1 (en) 2011-10-20
BR112012026115A2 (pt) 2016-06-28
GT201200281A (es) 2014-11-26
EP2558063A1 (en) 2013-02-20
US20130137664A1 (en) 2013-05-30
US9592245B2 (en) 2017-03-14
MX356702B (es) 2018-06-11
AU2011240102A1 (en) 2012-11-01
EA026095B1 (ru) 2017-03-31
CA2795801A1 (en) 2011-10-20
BR112012026115B1 (pt) 2019-12-24
AU2011240102B2 (en) 2015-07-23
CA2795801C (en) 2018-05-29
EP2558063B1 (en) 2021-09-29
US20110275601A1 (en) 2011-11-10
KR20180018827A (ko) 2018-02-21

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