MX356702B - Formas de dosificación sólidas orales con dosis muy bajas para la hrt. - Google Patents

Formas de dosificación sólidas orales con dosis muy bajas para la hrt.

Info

Publication number
MX356702B
MX356702B MX2012012026A MX2012012026A MX356702B MX 356702 B MX356702 B MX 356702B MX 2012012026 A MX2012012026 A MX 2012012026A MX 2012012026 A MX2012012026 A MX 2012012026A MX 356702 B MX356702 B MX 356702B
Authority
MX
Mexico
Prior art keywords
hrt
low
solid oral
oral dosage
dosage form
Prior art date
Application number
MX2012012026A
Other languages
English (en)
Other versions
MX2012012026A (es
Inventor
Schürmann Rolf
Gude Kerstin
Mletzko Stephan
Original Assignee
Bayer Ip 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 Ip Gmbh filed Critical Bayer Ip Gmbh
Publication of MX2012012026A publication Critical patent/MX2012012026A/es
Publication of MX356702B publication Critical patent/MX356702B/es

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)
  • 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)

Abstract

Una forma de dosificación con una dosis muy baja para la terapia de reemplazo de hormonas (HRT), más particularmente una forma de dosificación sólida oral que comprende aproximadamente 0,5 mg de estradiol (que se abrevia "E2") y aproximadamente 0,25 mg de drospirenona (que se abrevia "DRSP"), así como al menos un excipiente farmacéuticamente aceptable. A pesar de las dosis muy bajas de E2 y de DRSP, sorprendentemente se ha descubierto que una proporción elevada de las mujeres que sufren calores moderados a severos de hecho responden a este tratamiento. Por consiguiente, la forma de dosificación de la invención puede usarse como HRT de mantenimiento o puede usarse cuando ya se ha iniciado la HRT.
MX2012012026A 2010-04-15 2011-04-12 Formas de dosificación sólidas orales con dosis muy bajas para la hrt. MX356702B (es)

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
MX2012012026A MX2012012026A (es) 2013-01-22
MX356702B true MX356702B (es) 2018-06-11

Family

ID=44260074

Family Applications (1)

Application Number Title Priority Date Filing Date
MX2012012026A MX356702B (es) 2010-04-15 2011-04-12 Formas de dosificación sólidas orales con dosis muy bajas para la hrt.

Country Status (18)

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

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EP2383279A1 (en) 2011-07-19 2011-11-02 Pantarhei Bioscience B.V. Process for the preparation of estetrol
RS62297B1 (sr) 2011-11-23 2021-09-30 Therapeuticsmd Inc Prirodne kombinovane hormonske supstitucione formulacije i terapije
US9301920B2 (en) 2012-06-18 2016-04-05 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
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
US10806697B2 (en) 2012-12-21 2020-10-20 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
US11266661B2 (en) 2012-12-21 2022-03-08 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
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
US10568891B2 (en) 2012-12-21 2020-02-25 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
WO2016203044A1 (en) 2015-06-18 2016-12-22 Mithra Pharmaceuticals S.A. Orodispersible tablet containing estetrol
NZ737945A (en) 2015-06-18 2023-06-30 Estetra Sprl Orodispersible dosage unit containing an estetrol component
LT3310345T (lt) 2015-06-18 2021-06-25 Estetra Sprl Burnoje disperguojama tabletė, turinti estetrolio
RS57328B1 (sr) 2015-06-18 2018-08-31 Mithra Pharmaceuticals S A Orodisperzibilna dozna jedinica koja sadrži estetrolsku komponentu
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
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
CR20200486A (es) 2018-04-19 2021-01-27 Estetra Sprl Compuestos y sus usos para aliviar los síntomas asociados a la menopausa
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

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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
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DE4426709A1 (de) 1994-07-20 1996-01-25 Schering Ag Steroidale Sexualhormone enthaltende feste Arzneiformen
EP1598069B1 (en) * 1999-08-31 2009-04-22 Bayer Schering Pharma Aktiengesellschaft Pharmaceutical combination of ethinylestradiol and drospirenone for use as a contraceptive
IL150775A0 (en) * 2000-01-18 2003-02-12 Schering Ag Drospirenone for hormone replacement therapy
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
EP1406634A1 (en) 2001-07-13 2004-04-14 Schering Aktiengesellschaft Combination of drospirenone and an estrogen sulphamate for hrt
CA2483554A1 (en) * 2002-04-26 2003-11-06 Schering Aktiengesellschaft Treatment of hypertension in women receiving hormone replacement therapy
AU2002368326A1 (en) 2002-11-05 2004-06-07 Schering Aktiengesellschaft Hormone replacement therapy with drospirenone
PL1670440T3 (pl) 2003-09-29 2014-11-28 Novo Nordisk Healthcare Ag Preparaty HRT
EP2409690B1 (en) 2003-09-29 2022-11-09 Novo Nordisk Health Care AG Improved stability of progestogen formulations
CN1878558A (zh) 2003-11-14 2006-12-13 沃纳奇尔科特公司 梯度雌激素避孕药
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.
US8475838B2 (en) 2005-06-03 2013-07-02 Sandoz Ag Rapidly-dissolving pharmaceutical composition for inhibiting ovulation
CN101489563A (zh) * 2006-07-06 2009-07-22 拜耳先灵医药股份有限公司 用于避孕和预防先天性畸形风险的药物制剂
BRPI0810049A2 (pt) * 2007-04-05 2015-05-05 Bayer Schering Pharma Ag Regime de drospirenona/17beta-estradiol, produto de combinação farmacêutica e kit para realizar esse regime
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TW200946542A (en) * 2008-03-10 2009-11-16 Vladimir Hanes New drospirenone/17β-estradiol regimen, pharmaceutical combination product and kit for performing this regimen
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Also Published As

Publication number Publication date
CA2795801A1 (en) 2011-10-20
EP2558063A1 (en) 2013-02-20
KR20130097073A (ko) 2013-09-02
CA2795801C (en) 2018-05-29
UY33343A (es) 2011-12-01
CO6630107A2 (es) 2013-03-01
IL222353A0 (en) 2012-12-31
MX2012012026A (es) 2013-01-22
EA201201403A1 (ru) 2013-04-30
TWI519300B (zh) 2016-02-01
KR20180018827A (ko) 2018-02-21
EP2558063B1 (en) 2021-09-29
JP5820465B2 (ja) 2015-11-24
AU2011240102B2 (en) 2015-07-23
US20150094287A1 (en) 2015-04-02
US8906890B2 (en) 2014-12-09
TW201204368A (en) 2012-02-01
JP2013523860A (ja) 2013-06-17
WO2011128336A1 (en) 2011-10-20
BR112012026115B1 (pt) 2019-12-24
AU2011240102A1 (en) 2012-11-01
EA026095B1 (ru) 2017-03-31
US20130137664A1 (en) 2013-05-30
GT201200281A (es) 2014-11-26
CR20120523A (es) 2013-01-09
US9592245B2 (en) 2017-03-14
CN102985070A (zh) 2013-03-20
AR080912A1 (es) 2012-05-16
US20110275601A1 (en) 2011-11-10
BR112012026115A2 (pt) 2016-06-28

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