CL2016001411A1 - Unidad de dosificación farmacéutica solida de desintegración oral que comprende un componente de estetrol; metodo de preparación; uso para la anticoncepción femenina y en terápia de sustitución hormonal femenina. - Google Patents
Unidad de dosificación farmacéutica solida de desintegración oral que comprende un componente de estetrol; metodo de preparación; uso para la anticoncepción femenina y en terápia de sustitución hormonal femenina.Info
- Publication number
- CL2016001411A1 CL2016001411A1 CL2016001411A CL2016001411A CL2016001411A1 CL 2016001411 A1 CL2016001411 A1 CL 2016001411A1 CL 2016001411 A CL2016001411 A CL 2016001411A CL 2016001411 A CL2016001411 A CL 2016001411A CL 2016001411 A1 CL2016001411 A1 CL 2016001411A1
- Authority
- CL
- Chile
- Prior art keywords
- dosage unit
- female
- weight
- pharmaceutical dosage
- solid pharmaceutical
- Prior art date
Links
- 239000007787 solid Substances 0.000 title abstract 4
- AJIPIJNNOJSSQC-NYLIRDPKSA-N estetrol Chemical compound OC1=CC=C2[C@H]3CC[C@](C)([C@H]([C@H](O)[C@@H]4O)O)[C@@H]4[C@@H]3CCC2=C1 AJIPIJNNOJSSQC-NYLIRDPKSA-N 0.000 title abstract 3
- 229950009589 estetrol Drugs 0.000 title abstract 3
- 238000002657 hormone replacement therapy Methods 0.000 title abstract 2
- 238000002360 preparation method Methods 0.000 title 1
- 239000008187 granular material Substances 0.000 abstract 1
- 239000004615 ingredient Substances 0.000 abstract 1
- 238000000034 method 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
- 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
- A61K31/57—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
- A61K31/573—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 substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/32—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
- A61K47/38—Cellulose; Derivatives thereof
-
- 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
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
- A61K9/0056—Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
-
- 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
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1617—Organic compounds, e.g. phospholipids, fats
- A61K9/1623—Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
-
- 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
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1682—Processes
-
- 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
- A61P15/18—Feminine contraceptives
-
- 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
- A61P5/30—Oestrogens
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)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Zoology (AREA)
- Nutrition Science (AREA)
- Physiology (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Molecular Biology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Biophysics (AREA)
- Inorganic Chemistry (AREA)
- Endocrinology (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Biochemistry (AREA)
- Gynecology & Obstetrics (AREA)
- Diabetes (AREA)
- Reproductive Health (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
unidad de dosificación farmacéutica solida de desintegración oral que tiene un peso de entre 50 y 1.000 mg, la unidad de dosificación consiste de: • 4-95% en peso de gránulos que consisten en: - 3-80% en peso de un componente de estetrol; - 20-97% en peso de alcohol de azúcar C4-C12; - 0-45% en peso de uno o más otros ingredientes farmacéuticamente aceptables; • 5-96% en peso de uno o más excipientes farmacéuticamente aceptables; en donde la unidad de dosificación sólida comprende al menos 0,1 mg del componente de estetrol. Además se divulga un método de preparación de la unidad de dosificación farmacéutica sólida de desintegración oral, y los usos para la anticoncepción femenina y terapia de sustitución hormonal femenina.
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP13196904 | 2013-12-12 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CL2016001411A1 true CL2016001411A1 (es) | 2016-11-11 |
Family
ID=49759137
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CL2016001411A CL2016001411A1 (es) | 2013-12-12 | 2016-06-08 | Unidad de dosificación farmacéutica solida de desintegración oral que comprende un componente de estetrol; metodo de preparación; uso para la anticoncepción femenina y en terápia de sustitución hormonal femenina. |
Country Status (30)
| Country | Link |
|---|---|
| US (2) | US9884064B2 (es) |
| EP (1) | EP3079671B1 (es) |
| JP (1) | JP6447931B2 (es) |
| KR (1) | KR102265150B1 (es) |
| CN (1) | CN105979935B (es) |
| AU (1) | AU2014363599B2 (es) |
| BR (1) | BR112016013502B1 (es) |
| CA (1) | CA2932855C (es) |
| CL (1) | CL2016001411A1 (es) |
| CY (1) | CY1119817T1 (es) |
| DK (1) | DK3079671T3 (es) |
| EA (1) | EA032306B1 (es) |
| ES (1) | ES2655076T3 (es) |
| HR (1) | HRP20180129T1 (es) |
| HU (1) | HUE035848T2 (es) |
| IL (1) | IL246082B (es) |
| LT (1) | LT3079671T (es) |
| MA (1) | MA39105B1 (es) |
| MX (1) | MX369035B (es) |
| NO (1) | NO3079671T3 (es) |
| NZ (1) | NZ720906A (es) |
| PL (1) | PL3079671T3 (es) |
| PT (1) | PT3079671T (es) |
| RS (1) | RS56738B1 (es) |
| SG (1) | SG11201604741UA (es) |
| SI (1) | SI3079671T1 (es) |
| SM (1) | SMT201700582T1 (es) |
| TN (1) | TN2016000230A1 (es) |
| WO (1) | WO2015086643A1 (es) |
| ZA (1) | ZA201603903B (es) |
Families Citing this family (21)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| RS54880B1 (sr) | 2011-06-01 | 2016-10-31 | Estetra Sprl | Postupak proizvodnje intermedijarnih proizvoda estetrola |
| ME02585B (me) | 2011-06-01 | 2017-06-20 | Estetra Sprl | Postupak proizvodnje intermedijara estetrola |
| EP2383279A1 (en) | 2011-07-19 | 2011-11-02 | Pantarhei Bioscience B.V. | Process for the preparation of estetrol |
| CA2843951C (en) * | 2011-08-11 | 2019-08-06 | Wout WOUTERS | Use of estetrol as emergency contraceptive |
| LT3310345T (lt) * | 2015-06-18 | 2021-06-25 | Estetra Sprl | Burnoje disperguojama tabletė, turinti estetrolio |
| CU24523B1 (es) * | 2015-06-18 | 2021-06-08 | Estetra Sprl | Unidad de dosificación orodispersable que contiene un componente estetrol |
| MA44206B1 (fr) | 2015-06-18 | 2021-04-30 | Estetra Sprl | Comprimé orodispersible comprenant estetrol |
| EP3701944B1 (en) | 2015-06-18 | 2021-12-08 | Estetra SRL | Orodispersible dosage unit containing an estetrol component |
| CA3178291A1 (en) * | 2016-08-05 | 2018-04-12 | Estetra Srl | Method for the management of dysmenorrhea and menstrual pain |
| US20200046729A1 (en) * | 2016-08-05 | 2020-02-13 | Estetra Sprl | Methods using combined oral contraceptive compositions with reduced cardiovascular effects |
| IL276584B2 (en) * | 2018-02-07 | 2024-10-01 | Estetra Srl | Contraceptive composition with reduced cardiovascular effects |
| 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 |
| EP3781171B1 (en) * | 2018-04-19 | 2022-02-09 | Estetra SRL | Compounds and their uses for alleviating menopause-associated symptoms |
| HU231240B1 (hu) | 2019-09-03 | 2022-04-28 | Richter Gedeon Nyrt. | Ipari eljárás nagytisztaságú ösztetrol hatóanyag előállítására |
| DE112020004564T5 (de) * | 2019-09-27 | 2022-06-15 | Industriale Chimica S.R.L. | VERFAHREN ZUM HERSTELLEN VON (15α,16α,17β)-ESTRA-1,3,5(10)-TRIEN-3,15,16,17-TETROL (ESTETROL) UND ZWISCHENSTUFEN DES VERFAHRENS |
| 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 |
| CN113552768B (zh) | 2020-04-24 | 2025-06-17 | 爱天思株式会社 | 感光性着色组合物、彩色滤光片及图像显示装置 |
| AU2021351921A1 (en) | 2020-09-29 | 2023-04-06 | Millicent Pharma Limited | Orodispersible formulations |
| JP2026503158A (ja) | 2023-02-02 | 2026-01-27 | インダストリアーレ キミカ エッセ．エッレ．エッレ． | （１５α，１６α，１７β）－エストラ－１，３，５（１０）－トリエン－３，１５，１６，１７－テトロール（エステトロール）一水和物の調製方法 |
| HUP2400151A1 (hu) | 2024-02-28 | 2025-09-28 | Richter Gedeon Nyrt | Ösztetrol-monohidrát kristályosítási eljárás |
| WO2025181200A1 (en) | 2024-02-28 | 2025-09-04 | Estetra Srl | Estetrol polymorphic form and production thereof |
Family Cites Families (22)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO1997004752A1 (en) * | 1995-07-26 | 1997-02-13 | Duramed Pharmaceuticals, Inc. | Pharmaceutical compositions of conjugated estrogens and methods for their use |
| US6117446A (en) | 1999-01-26 | 2000-09-12 | Place; Virgil A. | Drug dosage unit for buccal administration of steroidal active agents |
| DE60217324T2 (de) * | 2001-05-18 | 2007-04-26 | Pantarhei Bioscience B.V. | Pharmazeutische zusammensetzung für die hormonersatztherapie |
| EP1260225A1 (en) | 2001-05-18 | 2002-11-27 | Pantarhei Bioscience B.V. | A pharmaceutical composition for use in hormone replacement therapy |
| DE60234515D1 (de) | 2001-05-23 | 2010-01-07 | Pantarhei Bioscience Bv | Tetrahydroxylierte estrogen enthaltendes arzneistoffverabreichungssystem zur verwendung in hormonalen kontrazeption |
| DK1390042T3 (da) * | 2001-05-23 | 2008-03-31 | Pantarhei Bioscience Bv | System for administration af et lægemiddel omfattende tetrahydroxyleret östrogen til anvendelse i hormonal svangerskabsforebyggelse |
| WO2003018026A1 (en) | 2001-08-31 | 2003-03-06 | Pantarhei Bioscience B.V. | Use of estrogenic compounds in combination with progestogenic compounds in hormone-replacement therapy |
| DE60216630T2 (de) | 2001-11-15 | 2007-09-20 | Pantarhei Bioscience B.V. | Verwendung von östrogen in kombination mit progestogen für die hormonsubstitutiionstherapie |
| JP5037779B2 (ja) * | 2002-02-21 | 2012-10-03 | バイエル ファーマ アクチエンゲゼルシャフト | １又は複数のステロイド、１又は複数のテトラヒドロ葉酸成分およびビタミンｂ１２を含む医薬組成物 |
| GB0410616D0 (en) | 2004-05-13 | 2004-06-16 | Unilever Plc | Antiperspirant or deodorant compositions |
| US20070048369A1 (en) | 2005-08-26 | 2007-03-01 | National Starch And Chemical Investment Holding Corporation | Mucosal delivery tablet |
| US20090221540A1 (en) | 2006-01-09 | 2009-09-03 | Pantarhei Bioscience B.V. | Method of Treating An Acute Vascular Disorder |
| MX2008014941A (es) * | 2006-06-08 | 2008-12-10 | Warner Chilcott Co Inc | Metodos para administrar formas de dosificacion solida de etinil estradiol y profarmacos del mismo con biodisponibilidad mejorada. |
| US20070286819A1 (en) * | 2006-06-08 | 2007-12-13 | Warner Chilcott Company, Inc. | Methods to administer ethinyl estradiol and prodrugs thereof with improved bioavailability |
| JP2010511062A (ja) * | 2006-11-29 | 2010-04-08 | ワイス エルエルシー | エストロゲン／ｓｅｒｍおよびエストロゲン／プロゲスチン二層錠剤 |
| RU2465907C2 (ru) * | 2006-12-20 | 2012-11-10 | Тева Вимен'С Хелс, Инк. | Распадающиеся в полости рта твердые дозированные формы, содержащие прогестин, и способы получения и применение указанных дозированных форм |
| EP2117518A2 (en) * | 2007-01-12 | 2009-11-18 | Wyeth a Corporation of the State of Delaware | Tablet-in-tablet compositions |
| EP2155205B1 (en) * | 2007-06-21 | 2011-12-21 | Pantarhei Bioscience B.V. | Treatment of meconium aspiration syndrome with estrogens |
| US20110250274A1 (en) | 2008-09-19 | 2011-10-13 | Shaked Ze Ev | Estriol formulations |
| DE102009007771B4 (de) * | 2009-02-05 | 2012-02-16 | Bayer Schering Pharma Aktiengesellschaft | Bukkales Applikationssystem, 17α-Estradiol enthaltend |
| CN102058604A (zh) * | 2009-11-17 | 2011-05-18 | 北京万全阳光医学技术有限公司 | 一种含有地诺孕素和戊酸雌二醇的药物组合物及其制备方法 |
| WO2014159377A1 (en) | 2013-03-14 | 2014-10-02 | Teva Women's Health, Inc. | Compositions containing tanaproget and natural estrogens |
-
2014
- 2014-12-10 DK DK14814804.2T patent/DK3079671T3/en active
- 2014-12-10 SG SG11201604741UA patent/SG11201604741UA/en unknown
- 2014-12-10 NZ NZ720906A patent/NZ720906A/en unknown
- 2014-12-10 CA CA2932855A patent/CA2932855C/en active Active
- 2014-12-10 PT PT148148042T patent/PT3079671T/pt unknown
- 2014-12-10 KR KR1020167018146A patent/KR102265150B1/ko not_active Expired - Fee Related
- 2014-12-10 RS RS20180016A patent/RS56738B1/sr unknown
- 2014-12-10 SM SM20170582T patent/SMT201700582T1/it unknown
- 2014-12-10 HU HUE14814804A patent/HUE035848T2/en unknown
- 2014-12-10 CN CN201480075244.4A patent/CN105979935B/zh not_active Expired - Fee Related
- 2014-12-10 SI SI201430525T patent/SI3079671T1/en unknown
- 2014-12-10 MA MA39105A patent/MA39105B1/fr unknown
- 2014-12-10 JP JP2016539161A patent/JP6447931B2/ja not_active Expired - Fee Related
- 2014-12-10 HR HRP20180129TT patent/HRP20180129T1/hr unknown
- 2014-12-10 TN TN2016000230A patent/TN2016000230A1/en unknown
- 2014-12-10 WO PCT/EP2014/077127 patent/WO2015086643A1/en not_active Ceased
- 2014-12-10 US US15/103,180 patent/US9884064B2/en not_active Expired - Fee Related
- 2014-12-10 EP EP14814804.2A patent/EP3079671B1/en active Active
- 2014-12-10 PL PL14814804T patent/PL3079671T3/pl unknown
- 2014-12-10 LT LTEP14814804.2T patent/LT3079671T/lt unknown
- 2014-12-10 AU AU2014363599A patent/AU2014363599B2/en not_active Ceased
- 2014-12-10 NO NO14814804A patent/NO3079671T3/no unknown
- 2014-12-10 ES ES14814804.2T patent/ES2655076T3/es active Active
- 2014-12-10 EA EA201691226A patent/EA032306B1/ru unknown
- 2014-12-10 BR BR112016013502-4A patent/BR112016013502B1/pt not_active IP Right Cessation
- 2014-12-10 MX MX2016007595A patent/MX369035B/es active IP Right Grant
-
2016
- 2016-06-07 IL IL246082A patent/IL246082B/en active IP Right Grant
- 2016-06-08 CL CL2016001411A patent/CL2016001411A1/es unknown
- 2016-06-08 ZA ZA2016/03903A patent/ZA201603903B/en unknown
-
2017
- 2017-12-22 US US15/852,187 patent/US9987287B2/en not_active Expired - Fee Related
-
2018
- 2018-01-10 CY CY20181100031T patent/CY1119817T1/el unknown
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