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
Links
- 239000006186 oral dosage form Substances 0.000 title abstract 2
- 239000007787 solid Substances 0.000 title abstract 2
- 238000002657 hormone replacement therapy Methods 0.000 abstract 3
- METQSPRSQINEEU-UHFFFAOYSA-N dihydrospirorenone Natural products CC12CCC(C3(CCC(=O)C=C3C3CC33)C)C3C1C1CC1C21CCC(=O)O1 METQSPRSQINEEU-UHFFFAOYSA-N 0.000 abstract 2
- 239000002552 dosage form Substances 0.000 abstract 2
- VOXZDWNPVJITMN-ZBRFXRBCSA-N 17β-estradiol Chemical compound OC1=CC=C2[C@H]3CC[C@](C)([C@H](CC4)O)[C@@H]4[C@@H]3CCC2=C1 VOXZDWNPVJITMN-ZBRFXRBCSA-N 0.000 abstract 1
- 101000605827 Homo sapiens Pinin Proteins 0.000 abstract 1
- 206010060800 Hot flush Diseases 0.000 abstract 1
- 102100038374 Pinin Human genes 0.000 abstract 1
- METQSPRSQINEEU-OLKMEILKSA-N drospirenone Chemical compound C([C@]12[C@H]3C[C@H]3C3C4[C@@H]([C@]5(CCC(=O)C=C5[C@@H]5C[C@@H]54)C)CC[C@@]31C)CC(=O)O2 METQSPRSQINEEU-OLKMEILKSA-N 0.000 abstract 1
- METQSPRSQINEEU-HXCATZOESA-N drospirenone Chemical compound C([C@]12[C@H]3C[C@H]3[C@H]3[C@H]4[C@@H]([C@]5(CCC(=O)C=C5[C@@H]5C[C@@H]54)C)CC[C@@]31C)CC(=O)O2 METQSPRSQINEEU-HXCATZOESA-N 0.000 abstract 1
- 229960004845 drospirenone Drugs 0.000 abstract 1
- 229960005309 estradiol Drugs 0.000 abstract 1
- 229930182833 estradiol Natural products 0.000 abstract 1
- 238000012423 maintenance Methods 0.000 abstract 1
- 239000000546 pharmaceutical excipient Substances 0.000 abstract 1
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.
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) |
Families Citing this family (25)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| 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)
| 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 |
-
2011
- 2011-04-12 US US13/641,419 patent/US20130137664A1/en not_active Abandoned
- 2011-04-12 KR KR1020187003598A patent/KR20180018827A/ko not_active Ceased
- 2011-04-12 BR BR112012026115A patent/BR112012026115B1/pt active IP Right Grant
- 2011-04-12 EA EA201201403A patent/EA026095B1/ru not_active IP Right Cessation
- 2011-04-12 MX MX2012012026A patent/MX356702B/es active IP Right Grant
- 2011-04-12 WO PCT/EP2011/055716 patent/WO2011128336A1/en not_active Ceased
- 2011-04-12 CN CN2011800282252A patent/CN102985070A/zh active Pending
- 2011-04-12 AU AU2011240102A patent/AU2011240102B2/en not_active Ceased
- 2011-04-12 CA CA2795801A patent/CA2795801C/en active Active
- 2011-04-12 EP EP11714967.4A patent/EP2558063B1/en active Active
- 2011-04-12 KR KR1020127029796A patent/KR20130097073A/ko not_active Ceased
- 2011-04-12 JP JP2013504242A patent/JP5820465B2/ja active Active
- 2011-04-14 TW TW100113034A patent/TWI519300B/zh not_active IP Right Cessation
- 2011-04-15 UY UY0001033343A patent/UY33343A/es not_active Application Discontinuation
- 2011-04-15 US US13/087,701 patent/US8906890B2/en active Active
- 2011-04-15 AR ARP110101302A patent/AR080912A1/es unknown
-
2012
- 2012-10-11 IL IL222353A patent/IL222353A0/en unknown
- 2012-10-12 CO CO12180903A patent/CO6630107A2/es not_active Application Discontinuation
- 2012-10-15 GT GT201200281A patent/GT201200281A/es unknown
- 2012-10-16 CR CR20120523A patent/CR20120523A/es unknown
-
2014
- 2014-12-08 US US14/564,076 patent/US9592245B2/en active Active
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 |
| 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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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| HH | Correction or change in general | ||
| HH | Correction or change in general | ||
| FG | Grant or registration |