EA201691226A1 - Орально распадающаяся твердая единица дозирования, содержащая эстетрольный компонент - Google Patents

Орально распадающаяся твердая единица дозирования, содержащая эстетрольный компонент

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Publication number
EA201691226A1
EA201691226A1 EA201691226A EA201691226A EA201691226A1 EA 201691226 A1 EA201691226 A1 EA 201691226A1 EA 201691226 A EA201691226 A EA 201691226A EA 201691226 A EA201691226 A EA 201691226A EA 201691226 A1 EA201691226 A1 EA 201691226A1
Authority
EA
Eurasian Patent Office
Prior art keywords
dosage unit
solid dosage
component
unit containing
disintegrating solid
Prior art date
Application number
EA201691226A
Other languages
English (en)
Other versions
EA032306B1 (ru
Inventor
Йоханнес Ян Платтеу
Херман Ян Теймен Кулинг Беннинк
Original Assignee
Донеста Байосайенс Б.В.
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
Family has litigation
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=EA201691226(A1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Донеста Байосайенс Б.В. filed Critical Донеста Байосайенс Б.В.
Publication of EA201691226A1 publication Critical patent/EA201691226A1/ru
Publication of EA032306B1 publication Critical patent/EA032306B1/ru

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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)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Physiology (AREA)
  • Nutrition Science (AREA)
  • Zoology (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)

Abstract

Настоящее описание относится к орально распадающейся твердой фармацевтической единице дозирования, имеющей массу 50-1000 мг и содержащей по меньшей мере 0,1 мг эстетрольного компонента, выбранного из эстетрола, сложных эфиров эстетрола и их комбинаций. Эта твердая единица дозирования состоит из 4-95 мас.% гранул, состоящих из 3-80 мас.% эстетрольного компонента, выбранного из эстетрола, сложных эфиров эстетрола и их комбинаций; 20-97 мас.% сахарного спирта C-C; 0-45 мас.% одного или более других фармацевтически приемлемых ингредиентов; и 5-96 мас.% одного или более фармацевтически приемлемых вспомогательных веществ. Твердые единицы дозирования настоящего описания особенно подходят для подъязычного, буккального или сублабиального введения эстетрольного компонента.
EA201691226A 2013-12-12 2014-12-10 Орально распадающаяся твердая фармацевтическая единица дозирования, содержащая эстетрольный компонент, ее применение и способ получения EA032306B1 (ru)

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 (2)

Publication Number Publication Date
EA201691226A1 true EA201691226A1 (ru) 2016-10-31
EA032306B1 EA032306B1 (ru) 2019-05-31

Family

ID=49759137

Family Applications (1)

Application Number Title Priority Date Filing Date
EA201691226A EA032306B1 (ru) 2013-12-12 2014-12-10 Орально распадающаяся твердая фармацевтическая единица дозирования, содержащая эстетрольный компонент, ее применение и способ получения

Country Status (29)

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

Families Citing this family (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CA2835979C (en) 2011-06-01 2018-05-01 Estetra S.A. Process for the production of estetrol intermediates
PL2714710T3 (pl) 2011-06-01 2017-03-31 Estetra S.P.R.L. Sposób wytwarzania estetrolowych związków pośrednich
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
SI3310345T1 (sl) * 2015-06-18 2021-05-31 Estetra Sprl Orodisperzibilna tableta, ki vsebuje estetrol
ME03728B (me) * 2015-06-18 2021-01-20 Estetra Sprl Orodisperzibilna dozna jedinica koja sadrži komponentu estetrola
RS61777B1 (sr) 2015-06-18 2021-06-30 Estetra Sprl Oralno-disperzibilna tableta koja sadrži estetrol
MY195019A (en) 2015-06-18 2023-01-03 Estetra Sprl Orodispersible dosage unit containing an estetrol component
US20200046729A1 (en) * 2016-08-05 2020-02-13 Estetra Sprl Methods using combined oral contraceptive compositions with reduced cardiovascular effects
KR20220144885A (ko) * 2016-08-05 2022-10-27 에스테트라, 소시에떼 아 레스폰서빌리떼 리미떼 월경통 및 생리통의 관리방법
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
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

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
PT1390040E (pt) * 2001-05-18 2007-04-30 Pantarhei Bioscience Bv Composição farmacêutica para ser utilizado na terapia hormonal de substituição.
EP1260225A1 (en) 2001-05-18 2002-11-27 Pantarhei Bioscience B.V. A pharmaceutical composition for use in hormone replacement therapy
US7732430B2 (en) 2001-05-23 2010-06-08 Pantarhei Bioscience B.V. Drug delivery system comprising a tetrahydroxilated estrogen for use in hormonal contraception
ATE449606T1 (de) 2001-05-23 2009-12-15 Pantarhei Bioscience Bv Tetrahydroxylierte estrogen enthaltendes arzneistoffverabreichungssystem zur verwendung in hormonalen kontrazeption
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
WO2003041718A1 (en) 2001-11-15 2003-05-22 Pantarhei Bioscience B.V. Use of estrogenic compounds in combination with progestogenic compounds in hormone-replacement therapy
PL209558B1 (pl) * 2002-02-21 2011-09-30 Bayer Schering Pharma Ag Zestaw zawierający steroid, składnik tetrahydrofolianowy i witaminę B12 do zastosowania w metodzie hormonalnej antykoncepcji lub hormonalnej terapii zastępczej
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
US20070286819A1 (en) 2006-06-08 2007-12-13 Warner Chilcott Company, Inc. Methods to administer ethinyl estradiol and prodrugs thereof with improved bioavailability
EP2029146B8 (en) * 2006-06-08 2018-02-21 Allergan Pharmaceuticals International Limited Methods to administer solid dosage forms of ethinyl estradiol and prodrugs thereof with improved bioavailabilty
EP2086550A2 (en) * 2006-11-29 2009-08-12 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
TW200836773A (en) * 2007-01-12 2008-09-16 Wyeth Corp 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

Also Published As

Publication number Publication date
IL246082A0 (en) 2016-07-31
MX369035B (es) 2019-10-25
US9884064B2 (en) 2018-02-06
JP6447931B2 (ja) 2019-01-09
CN105979935B (zh) 2019-07-26
SI3079671T1 (en) 2018-04-30
SG11201604741UA (en) 2016-07-28
TN2016000230A1 (en) 2017-10-06
US20180117063A1 (en) 2018-05-03
BR112016013502B1 (pt) 2021-05-11
EP3079671A1 (en) 2016-10-19
EA032306B1 (ru) 2019-05-31
MA39105A1 (fr) 2017-04-28
AU2014363599B2 (en) 2019-10-31
HRP20180129T1 (hr) 2018-02-23
RS56738B1 (sr) 2018-03-30
US20160310506A1 (en) 2016-10-27
ES2655076T3 (es) 2018-02-16
NO3079671T3 (ru) 2018-03-24
CL2016001411A1 (es) 2016-11-11
ZA201603903B (en) 2018-07-25
NZ720906A (en) 2022-04-29
CY1119817T1 (el) 2018-06-27
PL3079671T3 (pl) 2018-03-30
BR112016013502A2 (pt) 2018-07-03
KR20160102212A (ko) 2016-08-29
HUE035848T2 (en) 2018-05-28
MA39105B1 (fr) 2018-05-31
IL246082B (en) 2018-03-29
CN105979935A (zh) 2016-09-28
KR102265150B1 (ko) 2021-06-16
CA2932855A1 (en) 2015-06-18
LT3079671T (lt) 2018-02-12
AU2014363599A1 (en) 2016-06-30
EP3079671B1 (en) 2017-10-25
PT3079671T (pt) 2017-11-24
WO2015086643A1 (en) 2015-06-18
MX2016007595A (es) 2016-11-28
JP2016540021A (ja) 2016-12-22
US9987287B2 (en) 2018-06-05
CA2932855C (en) 2022-07-19
DK3079671T3 (en) 2017-12-11

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