ZA201603903B - Orally disintegrating solid dosage unit containing an estetrol component - Google Patents
Orally disintegrating solid dosage unit containing an estetrol componentInfo
- Publication number
- ZA201603903B ZA201603903B ZA2016/03903A ZA201603903A ZA201603903B ZA 201603903 B ZA201603903 B ZA 201603903B ZA 2016/03903 A ZA2016/03903 A ZA 2016/03903A ZA 201603903 A ZA201603903 A ZA 201603903A ZA 201603903 B ZA201603903 B ZA 201603903B
- Authority
- ZA
- South Africa
- Prior art keywords
- dosage unit
- solid dosage
- unit containing
- orally disintegrating
- disintegrating solid
- Prior art date
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
- A61K9/0012—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
- 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
- A61K9/14—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)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Physiology (AREA)
- Zoology (AREA)
- Nutrition Science (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Molecular Biology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Inorganic Chemistry (AREA)
- Biophysics (AREA)
- Endocrinology (AREA)
- Biochemistry (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Reproductive Health (AREA)
- Gynecology & Obstetrics (AREA)
- Diabetes (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP13196904 | 2013-12-12 | ||
| PCT/EP2014/077127 WO2015086643A1 (en) | 2013-12-12 | 2014-12-10 | Orally disintegrating solid dosage unit containing an estetrol component |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| ZA201603903B true ZA201603903B (en) | 2018-07-25 |
Family
ID=49759137
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| ZA2016/03903A ZA201603903B (en) | 2013-12-12 | 2016-06-08 | Orally disintegrating solid dosage unit containing an estetrol component |
Country Status (30)
| Country | Link |
|---|---|
| US (2) | US9884064B2 (enExample) |
| EP (1) | EP3079671B1 (enExample) |
| JP (1) | JP6447931B2 (enExample) |
| KR (1) | KR102265150B1 (enExample) |
| CN (1) | CN105979935B (enExample) |
| AU (1) | AU2014363599B2 (enExample) |
| BR (1) | BR112016013502B1 (enExample) |
| CA (1) | CA2932855C (enExample) |
| CL (1) | CL2016001411A1 (enExample) |
| CY (1) | CY1119817T1 (enExample) |
| DK (1) | DK3079671T3 (enExample) |
| EA (1) | EA032306B1 (enExample) |
| ES (1) | ES2655076T3 (enExample) |
| HR (1) | HRP20180129T1 (enExample) |
| HU (1) | HUE035848T2 (enExample) |
| IL (1) | IL246082B (enExample) |
| LT (1) | LT3079671T (enExample) |
| MA (1) | MA39105B1 (enExample) |
| MX (1) | MX369035B (enExample) |
| NO (1) | NO3079671T3 (enExample) |
| NZ (1) | NZ720906A (enExample) |
| PL (1) | PL3079671T3 (enExample) |
| PT (1) | PT3079671T (enExample) |
| RS (1) | RS56738B1 (enExample) |
| SG (1) | SG11201604741UA (enExample) |
| SI (1) | SI3079671T1 (enExample) |
| SM (1) | SMT201700582T1 (enExample) |
| TN (1) | TN2016000230A1 (enExample) |
| WO (1) | WO2015086643A1 (enExample) |
| ZA (1) | ZA201603903B (enExample) |
Families Citing this family (21)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| PL2714712T3 (pl) | 2011-06-01 | 2017-05-31 | Estetra S.P.R.L. | Metoda wytwarzania półproduktów estetrolu |
| MX341561B (es) | 2011-06-01 | 2016-08-25 | Estetra Sprl | Proceso para la produccion de intermediarios de estetrol. |
| EP2383279A1 (en) | 2011-07-19 | 2011-11-02 | Pantarhei Bioscience B.V. | Process for the preparation of estetrol |
| HUE033590T2 (hu) * | 2011-08-11 | 2017-12-28 | Estetra Sprl | Esztetrol alkalmazása sürgõsségi fogamzásgátlóként |
| MA44206B1 (fr) | 2015-06-18 | 2021-04-30 | Estetra Sprl | Comprimé orodispersible comprenant estetrol |
| JP6866560B2 (ja) | 2015-06-18 | 2021-04-28 | エステトラ ソシエテ プリーヴ ア レスポンサビリテ リミテ | エステトロール成分を含有する口腔内崩壊性投与単位 |
| JP6863547B2 (ja) * | 2015-06-18 | 2021-04-21 | エステトラ ソシエテ プリーヴ ア レスポンサビリテ リミテ | エステトロール成分を含有する口腔内崩壊性投与単位 |
| LT3310345T (lt) * | 2015-06-18 | 2021-06-25 | Estetra Sprl | Burnoje disperguojama tabletė, turinti estetrolio |
| US20200046729A1 (en) * | 2016-08-05 | 2020-02-13 | Estetra Sprl | Methods using combined oral contraceptive compositions with reduced cardiovascular effects |
| CA3178291A1 (en) * | 2016-08-05 | 2018-04-12 | Estetra Srl | Method for the management of dysmenorrhea and menstrual pain |
| MA51733A (fr) * | 2018-02-07 | 2020-12-16 | Estetra Sprl | Composition contraceptive présentant des effets cardiovasculaires réduits |
| 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 |
| JOP20200260A1 (ar) * | 2018-04-19 | 2019-10-19 | Estetra Sprl | مركبات واستخداماتها للتخفيف من الأعراض المصاحبة لانقطاع الطمث |
| HU231240B1 (hu) | 2019-09-03 | 2022-04-28 | Richter Gedeon Nyrt. | Ipari eljárás nagytisztaságú ösztetrol hatóanyag előállítására |
| ES2915058B2 (es) * | 2019-09-27 | 2024-06-21 | Ind Chimica Srl | Proceso para preparar (15alfa,16alfa,17beta)-estra-1,3,5(10)-trieno-3,15,16,17-tetrol (Estetrol) e intermedios de dicho proceso |
| 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 |
| CA3194494A1 (en) | 2020-09-29 | 2022-04-07 | Millicent Pharma Limited | Orodispersible formulations |
| DE112023005720T5 (de) | 2023-02-02 | 2025-12-11 | Industriale Chimica S.R.L | VERFAHREN ZUR HERSTELLUNG VON (15α,16α,17β)-ESTRA-1,3,5(10)-TRIENE-3,15,16,17-TETROL (ESTETROL) MONOHYDRAT |
| WO2025181200A1 (en) | 2024-02-28 | 2025-09-04 | Estetra Srl | Estetrol polymorphic form and production thereof |
| HUP2400151A1 (hu) | 2024-02-28 | 2025-09-28 | Richter Gedeon Nyrt | Ösztetrol-monohidrát kristályosítási eljárás |
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 |
| EP1260225A1 (en) | 2001-05-18 | 2002-11-27 | Pantarhei Bioscience B.V. | A pharmaceutical composition for use in hormone replacement therapy |
| DE60217324T2 (de) * | 2001-05-18 | 2007-04-26 | Pantarhei Bioscience B.V. | Pharmazeutische zusammensetzung für die hormonersatztherapie |
| EP1390042B1 (en) * | 2001-05-23 | 2007-11-28 | Pantarhei Bioscience B.V. | Drug delivery system comprising a tetrahydroxylated estrogen for use in hormonal contraception |
| ES2337129T3 (es) * | 2001-05-23 | 2010-04-21 | Pantarhei Bioscience B.V. | Sistema de administracion de medicamento comprendiendo un estrogeno tetrahidroxilado para el uso en la anticoncepcion hormonal. |
| 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 |
| US8026228B2 (en) | 2001-11-15 | 2011-09-27 | Pantarhei Bioscience B.V. | Estrogenic compounds in combination with progestogenic compounds in hormone-replacement therapy |
| RS50909B (sr) * | 2002-02-21 | 2010-08-31 | Bayer Schering Pharma Aktiengesellschaft | Farmaceutske kompozicije koje se sastoje od jednog ili više steroida, jedne ili više tetrahidrofolatne komponente i vitamina b12 |
| 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 |
| SG174785A1 (en) * | 2006-06-08 | 2011-10-28 | Warner Chilcott Co Llc | Methods to administer solid dosage forms of ethinyl estradiol and prodrugs thereof with improved bioavailabilty |
| US20070286819A1 (en) | 2006-06-08 | 2007-12-13 | Warner Chilcott Company, Inc. | Methods to administer ethinyl estradiol and prodrugs thereof with improved bioavailability |
| AU2007325207A1 (en) * | 2006-11-29 | 2008-06-05 | Wyeth | Estrogen/ serm and estrogen/ progestin bi-layer tablets |
| JP5649305B2 (ja) * | 2006-12-20 | 2015-01-07 | テバ ウィメンズ ヘルス インコーポレイテッド | プロゲスチンを含む口腔内崩壊性固体剤形ならびにその製造方法および使用方法 |
| WO2008089087A2 (en) * | 2007-01-12 | 2008-07-24 | Wyeth | Tablet-in-tablet compositions |
| ATE537833T1 (de) * | 2007-06-21 | 2012-01-15 | Pantarhei Bioscience Bv | Behandlung des mekoniumaspirationssyndroms mit östrogenen |
| WO2010033832A2 (en) | 2008-09-19 | 2010-03-25 | Evestra, Inc. | 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 LT LTEP14814804.2T patent/LT3079671T/lt unknown
- 2014-12-10 PL PL14814804T patent/PL3079671T3/pl unknown
- 2014-12-10 SG SG11201604741UA patent/SG11201604741UA/en unknown
- 2014-12-10 BR BR112016013502-4A patent/BR112016013502B1/pt not_active IP Right Cessation
- 2014-12-10 SI SI201430525T patent/SI3079671T1/en unknown
- 2014-12-10 US US15/103,180 patent/US9884064B2/en active Active
- 2014-12-10 EP EP14814804.2A patent/EP3079671B1/en active Active
- 2014-12-10 TN TN2016000230A patent/TN2016000230A1/en unknown
- 2014-12-10 HU HUE14814804A patent/HUE035848T2/en unknown
- 2014-12-10 JP JP2016539161A patent/JP6447931B2/ja not_active Expired - Fee Related
- 2014-12-10 EA EA201691226A patent/EA032306B1/ru unknown
- 2014-12-10 HR HRP20180129TT patent/HRP20180129T1/hr unknown
- 2014-12-10 DK DK14814804.2T patent/DK3079671T3/en active
- 2014-12-10 MA MA39105A patent/MA39105B1/fr unknown
- 2014-12-10 WO PCT/EP2014/077127 patent/WO2015086643A1/en not_active Ceased
- 2014-12-10 SM SM20170582T patent/SMT201700582T1/it unknown
- 2014-12-10 NO NO14814804A patent/NO3079671T3/no unknown
- 2014-12-10 ES ES14814804.2T patent/ES2655076T3/es active Active
- 2014-12-10 RS RS20180016A patent/RS56738B1/sr unknown
- 2014-12-10 PT PT148148042T patent/PT3079671T/pt unknown
- 2014-12-10 MX MX2016007595A patent/MX369035B/es active IP Right Grant
- 2014-12-10 KR KR1020167018146A patent/KR102265150B1/ko not_active Expired - Fee Related
- 2014-12-10 CN CN201480075244.4A patent/CN105979935B/zh not_active Expired - Fee Related
- 2014-12-10 CA CA2932855A patent/CA2932855C/en active Active
- 2014-12-10 AU AU2014363599A patent/AU2014363599B2/en not_active Ceased
- 2014-12-10 NZ NZ720906A patent/NZ720906A/en unknown
-
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 active Active
-
2018
- 2018-01-10 CY CY20181100031T patent/CY1119817T1/el unknown
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