AU2011240102B2 - Very low-dosed solid oral dosage forms for HRT - Google Patents

Very low-dosed solid oral dosage forms for HRT Download PDF

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Publication number
AU2011240102B2
AU2011240102B2 AU2011240102A AU2011240102A AU2011240102B2 AU 2011240102 B2 AU2011240102 B2 AU 2011240102B2 AU 2011240102 A AU2011240102 A AU 2011240102A AU 2011240102 A AU2011240102 A AU 2011240102A AU 2011240102 B2 AU2011240102 B2 AU 2011240102B2
Authority
AU
Australia
Prior art keywords
dosage form
woman
starch
drsp
vasomotor symptoms
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.)
Ceased
Application number
AU2011240102A
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English (en)
Other versions
AU2011240102A1 (en
Inventor
Kerstin Gude
Stephan Mletzko
Rolf Schurmann
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 Intellectual Property GmbH
Original Assignee
Bayer Intellectual Property GmbH
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by Bayer Intellectual Property GmbH filed Critical Bayer Intellectual Property GmbH
Publication of AU2011240102A1 publication Critical patent/AU2011240102A1/en
Application granted granted Critical
Publication of AU2011240102B2 publication Critical patent/AU2011240102B2/en
Ceased legal-status Critical Current
Anticipated expiration legal-status Critical

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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)
AU2011240102A 2010-04-15 2011-04-12 Very low-dosed solid oral dosage forms for HRT Ceased AU2011240102B2 (en)

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 (2)

Publication Number Publication Date
AU2011240102A1 AU2011240102A1 (en) 2012-11-01
AU2011240102B2 true AU2011240102B2 (en) 2015-07-23

Family

ID=44260074

Family Applications (1)

Application Number Title Priority Date Filing Date
AU2011240102A Ceased AU2011240102B2 (en) 2010-04-15 2011-04-12 Very low-dosed solid oral dosage forms for HRT

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 (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2001052857A1 (en) * 2000-01-18 2001-07-26 Schering Aktiengesellschaft Drospirenone for hormone replacement therapy
WO2008122439A2 (en) * 2007-04-05 2008-10-16 Bayer Schering Pharma Aktiengesellschaft Dr0spiren0ne/17beta-estradi0l regimen, pharmaceutical combination product and kit for performing this regimen
WO2009112232A2 (en) * 2008-03-10 2009-09-17 Vladimir Hanes New drospirenone/17beta-estradiol regimen, pharmaceutical combination product and kit for performing this regimen

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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
US20020132801A1 (en) * 2001-01-11 2002-09-19 Schering Aktiengesellschaft Drospirenone for hormone replacement therapy
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
UY29527A1 (es) 2005-05-13 2006-12-29 Schering Ag Composicinn farmaccutica que contienen gestrgenos y/o estrngenos y 5-metil - (6s) - tetrhidrofolato.
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Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2001052857A1 (en) * 2000-01-18 2001-07-26 Schering Aktiengesellschaft Drospirenone for hormone replacement therapy
WO2008122439A2 (en) * 2007-04-05 2008-10-16 Bayer Schering Pharma Aktiengesellschaft Dr0spiren0ne/17beta-estradi0l regimen, pharmaceutical combination product and kit for performing this regimen
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
CN102985070A (zh) 2013-03-20
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
CA2795801C (en) 2018-05-29
EP2558063B1 (en) 2021-09-29
US20110275601A1 (en) 2011-11-10
KR20180018827A (ko) 2018-02-21

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Legal Events

Date Code Title Description
FGA Letters patent sealed or granted (standard patent)
MK14 Patent ceased section 143(a) (annual fees not paid) or expired