CA2932855C - Orally disintegrating solid dosage unit containing an estetrol component - Google Patents

Orally disintegrating solid dosage unit containing an estetrol component Download PDF

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Publication number
CA2932855C
CA2932855C CA2932855A CA2932855A CA2932855C CA 2932855 C CA2932855 C CA 2932855C CA 2932855 A CA2932855 A CA 2932855A CA 2932855 A CA2932855 A CA 2932855A CA 2932855 C CA2932855 C CA 2932855C
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CA
Canada
Prior art keywords
dosage unit
estetrol
solid dosage
unit according
granules
Prior art date
Legal status (The legal status 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 status listed.)
Active
Application number
CA2932855A
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English (en)
French (fr)
Other versions
CA2932855A1 (en
Inventor
Johannes Jan Platteeuw
Herman Jan Tijmen Coelingh Bennink
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Estetra SRL
Original Assignee
Estetra SRL
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
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First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=49759137&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=CA2932855(C) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Estetra SRL filed Critical Estetra SRL
Publication of CA2932855A1 publication Critical patent/CA2932855A1/en
Application granted granted Critical
Publication of CA2932855C publication Critical patent/CA2932855C/en
Active legal-status Critical Current
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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)
  • 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)
CA2932855A 2013-12-12 2014-12-10 Orally disintegrating solid dosage unit containing an estetrol component Active CA2932855C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP13196904.0 2013-12-12
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 (2)

Publication Number Publication Date
CA2932855A1 CA2932855A1 (en) 2015-06-18
CA2932855C true CA2932855C (en) 2022-07-19

Family

ID=49759137

Family Applications (1)

Application Number Title Priority Date Filing Date
CA2932855A Active CA2932855C (en) 2013-12-12 2014-12-10 Orally disintegrating solid dosage unit containing an estetrol component

Country Status (30)

Country Link
US (2) US9884064B2 (2)
EP (1) EP3079671B1 (2)
JP (1) JP6447931B2 (2)
KR (1) KR102265150B1 (2)
CN (1) CN105979935B (2)
AU (1) AU2014363599B2 (2)
BR (1) BR112016013502B1 (2)
CA (1) CA2932855C (2)
CL (1) CL2016001411A1 (2)
CY (1) CY1119817T1 (2)
DK (1) DK3079671T3 (2)
EA (1) EA032306B1 (2)
ES (1) ES2655076T3 (2)
HR (1) HRP20180129T1 (2)
HU (1) HUE035848T2 (2)
IL (1) IL246082B (2)
LT (1) LT3079671T (2)
MA (1) MA39105B1 (2)
MX (1) MX369035B (2)
NO (1) NO3079671T3 (2)
NZ (1) NZ720906A (2)
PL (1) PL3079671T3 (2)
PT (1) PT3079671T (2)
RS (1) RS56738B1 (2)
SG (1) SG11201604741UA (2)
SI (1) SI3079671T1 (2)
SM (1) SMT201700582T1 (2)
TN (1) TN2016000230A1 (2)
WO (1) WO2015086643A1 (2)
ZA (1) ZA201603903B (2)

Families Citing this family (21)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
PT2714712T (pt) 2011-06-01 2016-11-08 Estetra Sprl Processo para a produção de intermediários de estetrol
SG195118A1 (en) 2011-06-01 2013-12-30 Estetra S A Process for the production of estetrol intermediates
EP2383279A1 (en) 2011-07-19 2011-11-02 Pantarhei Bioscience B.V. Process for the preparation of estetrol
PL2741824T3 (pl) * 2011-08-11 2018-03-30 Estetra S.P.R.L. Zastosowanie estetrolu jako środka antykoncepcji awaryjnej
DK3701944T3 (da) * 2015-06-18 2022-03-14 Estetra Srl Oro-dispergerbar doseringsenhed indeholdende en estetrolkomponent
LT3310346T (lt) 2015-06-18 2021-06-10 Estetra Sprl Burnoje disperguojama tabletė, turinti estetrolio
LT3310345T (lt) * 2015-06-18 2021-06-25 Estetra Sprl Burnoje disperguojama tabletė, turinti estetrolio
CR20180042A (es) 2015-06-18 2018-05-03 Mithra Pharmaceuticals S A Unidad de dosificación orodispersable que contiene un componente estetrol.
KR102712911B1 (ko) 2016-08-05 2024-10-04 에스테트라, 소시에떼 아 레스폰서빌리떼 리미떼 월경통 및 생리통의 관리방법
US20200046729A1 (en) * 2016-08-05 2020-02-13 Estetra Sprl Methods using combined oral contraceptive compositions with reduced cardiovascular effects
SG11202007163WA (en) * 2018-02-07 2020-08-28 Estetra Sprl 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
CN111989105B (zh) * 2018-04-19 2024-07-19 埃斯特拉私人有限责任公司 化合物以及它们在缓解绝经相关症状中的用途
HU231240B1 (hu) 2019-09-03 2022-04-28 Richter Gedeon Nyrt. Ipari eljárás nagytisztaságú ösztetrol hatóanyag előállítására
GB2603868B (en) * 2019-09-27 2023-10-11 Ind Chimica Srl Process for preparing (15ALPHA,16ALPHA,17BETA)-ESTRA-1,3,5(10)-TRIENE-3,15,16,17-tetrol monohydrate (estetrol monohydrate) and intermediates of said process
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
US20230346695A1 (en) 2020-09-29 2023-11-02 Millicent Pharma Limited Orodispersible formulations
AU2023428138A1 (en) 2023-02-02 2025-09-04 Industriale Chimica S.R.L. PROCESS FOR PREPARING (15α,16α,17β)-ESTRA-1,3,5(10)-TRIENE-3,15,16,17-TETROL (ESTETROL) MONOHYDRATE
TW202533830A (zh) 2024-02-28 2025-09-01 比利時商埃斯特拉有限公司 雌四醇多晶型及其生產
HUP2400151A1 (hu) 2024-02-28 2025-09-28 Richter Gedeon Nyrt Ösztetrol-monohidrát kristályosítási eljárás

Family Cites Families (22)

* Cited by examiner, † Cited by third party
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
PT1390040E (pt) 2001-05-18 2007-04-30 Pantarhei Bioscience Bv Composição farmacêutica para ser utilizado na terapia hormonal de substituição.
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
DE60215224T2 (de) * 2002-02-21 2007-08-23 Schering Aktiengesellschaft Pharmazeutische zusammensetzung, enthaltend ein oder mehrere steroide, eine oder mehrere tetrahydrofolatverbindungen und vitamin 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
WO2007081206A1 (en) 2006-01-09 2007-07-19 Pantarhei Bioscience B.V. A method of treating an acute vascular disorder
US20070286819A1 (en) * 2006-06-08 2007-12-13 Warner Chilcott Company, Inc. Methods to administer ethinyl estradiol and prodrugs thereof with improved bioavailability
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
TW200831139A (en) * 2006-11-29 2008-08-01 Wyeth Corp Estrogen/SERM and estrogen/progestin bi-layer tablets
WO2008079245A2 (en) * 2006-12-20 2008-07-03 Duramed Pharmaceuticals, Inc. Orally disintegrating solid dosage forms comprising progestin and methods of making and use thereof
CN101631536A (zh) * 2007-01-12 2010-01-20 惠氏公司 片中片组合物
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

Also Published As

Publication number Publication date
KR102265150B1 (ko) 2021-06-16
BR112016013502B1 (pt) 2021-05-11
BR112016013502A2 (pt) 2018-07-03
NO3079671T3 (2) 2018-03-24
NZ720906A (en) 2022-04-29
JP6447931B2 (ja) 2019-01-09
CA2932855A1 (en) 2015-06-18
LT3079671T (lt) 2018-02-12
MX369035B (es) 2019-10-25
IL246082A0 (en) 2016-07-31
EA201691226A1 (ru) 2016-10-31
CN105979935A (zh) 2016-09-28
SG11201604741UA (en) 2016-07-28
US9884064B2 (en) 2018-02-06
WO2015086643A1 (en) 2015-06-18
RS56738B1 (sr) 2018-03-30
SMT201700582T1 (it) 2018-03-08
US20160310506A1 (en) 2016-10-27
PL3079671T3 (pl) 2018-03-30
HRP20180129T1 (hr) 2018-02-23
CY1119817T1 (el) 2018-06-27
HUE035848T2 (en) 2018-05-28
ES2655076T3 (es) 2018-02-16
IL246082B (en) 2018-03-29
AU2014363599B2 (en) 2019-10-31
US9987287B2 (en) 2018-06-05
JP2016540021A (ja) 2016-12-22
AU2014363599A1 (en) 2016-06-30
US20180117063A1 (en) 2018-05-03
TN2016000230A1 (en) 2017-10-06
EA032306B1 (ru) 2019-05-31
EP3079671B1 (en) 2017-10-25
PT3079671T (pt) 2017-11-24
CN105979935B (zh) 2019-07-26
KR20160102212A (ko) 2016-08-29
EP3079671A1 (en) 2016-10-19
ZA201603903B (en) 2018-07-25
MX2016007595A (es) 2016-11-28
MA39105A1 (fr) 2017-04-28
DK3079671T3 (en) 2017-12-11
MA39105B1 (fr) 2018-05-31
SI3079671T1 (en) 2018-04-30
CL2016001411A1 (es) 2016-11-11

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