EA201201403A1 - Очень низкодозированные твердые пероральные лекарственные формы для гзт - Google Patents

Очень низкодозированные твердые пероральные лекарственные формы для гзт

Info

Publication number
EA201201403A1
EA201201403A1 EA201201403A EA201201403A EA201201403A1 EA 201201403 A1 EA201201403 A1 EA 201201403A1 EA 201201403 A EA201201403 A EA 201201403A EA 201201403 A EA201201403 A EA 201201403A EA 201201403 A1 EA201201403 A1 EA 201201403A1
Authority
EA
Eurasian Patent Office
Prior art keywords
hrt
low
dosage form
dosed
solid
Prior art date
Application number
EA201201403A
Other languages
English (en)
Other versions
EA026095B1 (ru
Inventor
Штефан Млетцко
Рольф Шюрманн
Керстин Гуде
Original Assignee
Байер Интеллекчуал Проперти Гмбх
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 Байер Интеллекчуал Проперти Гмбх filed Critical Байер Интеллекчуал Проперти Гмбх
Publication of EA201201403A1 publication Critical patent/EA201201403A1/ru
Publication of EA026095B1 publication Critical patent/EA026095B1/ru

Links

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
    • A61K31/565—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
    • 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
    • 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)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Endocrinology (AREA)
  • Diabetes (AREA)
  • Reproductive Health (AREA)
  • Cardiology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)

Abstract

Изобретение касается очень низкодозированной лекарственной формы для гормонозаместительной терапии (ГЗТ). Более конкретно, изобретение касается твердой пероральной лекарственной формы, включающей приблизительно 0,5 мг эстрадиола и приблизительно 0,25 мг дроспиренона и как минимум одно фармацевтически приемлемое формообразующее. Несмотря на очень низкие дозы Е2 и DRSP, неожиданно было обнаружено, что большая доля женщин, страдающих от приливов, от умеренных до сильных, фактически реагирует на это лечение. Соответственно, лекарственная форма согласно изобретению может применяться в качестве поддерживающей ГЗТ или может применяться уже после начала ГЗТ.
EA201201403A 2010-04-15 2011-04-12 Очень низкодозированные твердые пероральные лекарственные формы для гормонозаместительной терапии (гзт) EA026095B1 (ru)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
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
EA201201403A1 true EA201201403A1 (ru) 2013-04-30
EA026095B1 EA026095B1 (ru) 2017-03-31

Family

ID=44260074

Family Applications (1)

Application Number Title Priority Date Filing Date
EA201201403A EA026095B1 (ru) 2010-04-15 2011-04-12 Очень низкодозированные твердые пероральные лекарственные формы для гормонозаместительной терапии (гзт)

Country Status (18)

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

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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
ES2885523T3 (es) 2011-11-23 2021-12-14 Therapeuticsmd Inc Formulaciones y terapias de reposición hormonal de combinación naturales
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
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
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
RU2016143081A (ru) 2014-05-22 2018-06-26 Терапьютиксмд, Инк. Натуральные комбинированные гормонозаместительные составы и терапии
ME03728B (me) 2015-06-18 2021-01-20 Estetra Sprl Orodisperzibilna dozna jedinica koja sadrži komponentu estetrola
RS61777B1 (sr) 2015-06-18 2021-06-30 Estetra Sprl Oralno-disperzibilna tableta koja sadrži estetrol
MY195019A (en) 2015-06-18 2023-01-03 Estetra Sprl Orodispersible dosage unit containing an estetrol component
SI3310345T1 (sl) 2015-06-18 2021-05-31 Estetra Sprl Orodisperzibilna tableta, ki vsebuje estetrol
US10328087B2 (en) 2015-07-23 2019-06-25 Therapeuticsmd, Inc. Formulations for solubilizing hormones
US9931349B2 (en) 2016-04-01 2018-04-03 Therapeuticsmd, Inc. Steroid hormone pharmaceutical composition
US10286077B2 (en) 2016-04-01 2019-05-14 Therapeuticsmd, Inc. Steroid hormone compositions in medium chain oils
KR20220144885A (ko) 2016-08-05 2022-10-27 에스테트라, 소시에떼 아 레스폰서빌리떼 리미떼 월경통 및 생리통의 관리방법
JOP20200260A1 (ar) 2018-04-19 2019-10-19 Estetra Sprl مركبات واستخداماتها للتخفيف من الأعراض المصاحبة لانقطاع الطمث
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

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EP1380301B1 (en) * 1999-08-31 2009-01-14 Bayer Schering Pharma Aktiengesellschaft Pharmaceutical combination of ethinylestradiol and dropirenone for use as a contraceptive
US20020132801A1 (en) * 2001-01-11 2002-09-19 Schering Aktiengesellschaft Drospirenone for hormone replacement therapy
DE60113809T2 (de) * 2000-01-18 2006-06-22 Schering Ag Pharmazeutische kombination aus mikronisiertem drospirenon und einen estrogen für die hormonersatztherapie
EP1216713A1 (en) 2000-12-20 2002-06-26 Schering Aktiengesellschaft Compositions of estrogen-cyclodextrin complexes
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Also Published As

Publication number Publication date
AU2011240102B2 (en) 2015-07-23
GT201200281A (es) 2014-11-26
CO6630107A2 (es) 2013-03-01
MX2012012026A (es) 2013-01-22
CA2795801A1 (en) 2011-10-20
US20110275601A1 (en) 2011-11-10
CN102985070A (zh) 2013-03-20
US8906890B2 (en) 2014-12-09
JP5820465B2 (ja) 2015-11-24
AU2011240102A1 (en) 2012-11-01
EP2558063B1 (en) 2021-09-29
JP2013523860A (ja) 2013-06-17
EA026095B1 (ru) 2017-03-31
MX356702B (es) 2018-06-11
EP2558063A1 (en) 2013-02-20
US9592245B2 (en) 2017-03-14
UY33343A (es) 2011-12-01
AR080912A1 (es) 2012-05-16
BR112012026115A2 (pt) 2016-06-28
TW201204368A (en) 2012-02-01
KR20130097073A (ko) 2013-09-02
IL222353A0 (en) 2012-12-31
US20150094287A1 (en) 2015-04-02
CA2795801C (en) 2018-05-29
WO2011128336A1 (en) 2011-10-20
BR112012026115B1 (pt) 2019-12-24
US20130137664A1 (en) 2013-05-30
CR20120523A (es) 2013-01-09
TWI519300B (zh) 2016-02-01
KR20180018827A (ko) 2018-02-21

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MM4A Lapse of a eurasian patent due to non-payment of renewal fees within the time limit in the following designated state(s)

Designated state(s): AM AZ BY KZ KG MD TJ TM