BR112012026115B1 - forma de dosagem oral sólida, seu uso, e unidade de acondicionamento - Google Patents

forma de dosagem oral sólida, seu uso, e unidade de acondicionamento Download PDF

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Publication number
BR112012026115B1
BR112012026115B1 BR112012026115A BR112012026115A BR112012026115B1 BR 112012026115 B1 BR112012026115 B1 BR 112012026115B1 BR 112012026115 A BR112012026115 A BR 112012026115A BR 112012026115 A BR112012026115 A BR 112012026115A BR 112012026115 B1 BR112012026115 B1 BR 112012026115B1
Authority
BR
Brazil
Prior art keywords
dosage form
fact
woman
starch
drsp
Prior art date
Application number
BR112012026115A
Other languages
English (en)
Portuguese (pt)
Other versions
BR112012026115A2 (pt
Inventor
Gude Kerstin
Schürmann Rolf
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 BR112012026115A2 publication Critical patent/BR112012026115A2/pt
Publication of BR112012026115B1 publication Critical patent/BR112012026115B1/pt

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Classifications

    • 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
    • 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
    • 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
    • A61K31/566Compounds 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
    • 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
    • A61K31/57Compounds 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
    • 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
    • A61K31/58Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids containing heterocyclic rings, e.g. danazol, stanozolol, pancuronium or digitogenin
    • A61K31/585Compounds 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
    • 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
    • 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
    • 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
    • A61P5/30Oestrogens
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00Drugs 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)
BR112012026115A 2010-04-15 2011-04-12 forma de dosagem oral sólida, seu uso, e unidade de acondicionamento BR112012026115B1 (pt)

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
BR112012026115A2 BR112012026115A2 (pt) 2016-06-28
BR112012026115B1 true BR112012026115B1 (pt) 2019-12-24

Family

ID=44260074

Family Applications (1)

Application Number Title Priority Date Filing Date
BR112012026115A BR112012026115B1 (pt) 2010-04-15 2011-04-12 forma de dosagem oral sólida, seu uso, e unidade de acondicionamento

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=)

Families Citing this family (25)

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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

Family Cites Families (22)

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Publication number Priority date Publication date Assignee Title
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
ATE442147T1 (de) * 2000-01-18 2009-09-15 Bayer Schering Pharma Ag Pharmazeutische zubereitung enthaltend drospirenon
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.
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
US20090023693A1 (en) * 2007-04-05 2009-01-22 Vladimir Hanes New drospirenone/17beta-estradiol regimen, pharmaceutical combination product and kit for performing this regimen
US20090045024A1 (en) 2007-08-13 2009-02-19 Means Industries, Inc. Overrunning Radial Coupling Assembly Having Dual Bearing Support
WO2009112232A2 (en) * 2008-03-10 2009-09-17 Vladimir Hanes New drospirenone/17beta-estradiol regimen, pharmaceutical combination product and kit for performing this regimen
WO2009138224A1 (en) 2008-05-14 2009-11-19 Helm Ag Pharmaceutical composition comprising drospirenone

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
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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Legal Events

Date Code Title Description
B07D Technical examination (opinion) related to article 229 of industrial property law [chapter 7.4 patent gazette]
B06F Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]
B07E Notification of approval relating to section 229 industrial property law [chapter 7.5 patent gazette]

Free format text: NOTIFICACAO DE ANUENCIA RELACIONADA COM O ART 229 DA LPI

B06T Formal requirements before examination [chapter 6.20 patent gazette]
B06A Patent application procedure suspended [chapter 6.1 patent gazette]
B09A Decision: intention to grant [chapter 9.1 patent gazette]
B16A Patent or certificate of addition of invention granted [chapter 16.1 patent gazette]

Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 12/04/2011, OBSERVADAS AS CONDICOES LEGAIS.

B25G Requested change of headquarter approved

Owner name: BAYER INTELLECTUAL PROPERTY GMBH (DE)