JP6447931B2 - エステトロール成分を含有する口腔内崩壊固体単位剤形 - Google Patents

エステトロール成分を含有する口腔内崩壊固体単位剤形 Download PDF

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Publication number
JP6447931B2
JP6447931B2 JP2016539161A JP2016539161A JP6447931B2 JP 6447931 B2 JP6447931 B2 JP 6447931B2 JP 2016539161 A JP2016539161 A JP 2016539161A JP 2016539161 A JP2016539161 A JP 2016539161A JP 6447931 B2 JP6447931 B2 JP 6447931B2
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estetrol
pharmaceutical formulation
solid pharmaceutical
granules
solid
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Expired - Fee Related
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JP2016539161A
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Japanese (ja)
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JP2016540021A5 (enExample
JP2016540021A (ja
Inventor
ヨハネス ヤン プラッテーウ，
ヨハネス ヤン プラッテーウ，
ベニンク， ヘルマン ヤン タイメン コーリング
ベニンク， ヘルマン ヤン タイメン コーリング
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Donesta Bioscience BV
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Donesta Bioscience BV
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    • 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

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  • 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)
JP2016539161A 2013-12-12 2014-12-10 エステトロール成分を含有する口腔内崩壊固体単位剤形 Expired - Fee Related JP6447931B2 (ja)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP13196904 2013-12-12
EP13196904.0 2013-12-12
PCT/EP2014/077127 WO2015086643A1 (en) 2013-12-12 2014-12-10 Orally disintegrating solid dosage unit containing an estetrol component

Publications (3)

Publication Number Publication Date
JP2016540021A JP2016540021A (ja) 2016-12-22
JP2016540021A5 JP2016540021A5 (enExample) 2018-01-25
JP6447931B2 true JP6447931B2 (ja) 2019-01-09

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ID=49759137

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JP2016539161A Expired - Fee Related JP6447931B2 (ja) 2013-12-12 2014-12-10 エステトロール成分を含有する口腔内崩壊固体単位剤形

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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)

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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

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Publication number Publication date
CA2932855C (en) 2022-07-19
NO3079671T3 (enExample) 2018-03-24
KR102265150B1 (ko) 2021-06-16
US9884064B2 (en) 2018-02-06
MA39105B1 (fr) 2018-05-31
PL3079671T3 (pl) 2018-03-30
CN105979935A (zh) 2016-09-28
DK3079671T3 (en) 2017-12-11
BR112016013502A2 (pt) 2018-07-03
ES2655076T3 (es) 2018-02-16
AU2014363599A1 (en) 2016-06-30
SI3079671T1 (en) 2018-04-30
PT3079671T (pt) 2017-11-24
IL246082A0 (en) 2016-07-31
NZ720906A (en) 2022-04-29
TN2016000230A1 (en) 2017-10-06
EP3079671B1 (en) 2017-10-25
CY1119817T1 (el) 2018-06-27
EP3079671A1 (en) 2016-10-19
BR112016013502B1 (pt) 2021-05-11
ZA201603903B (en) 2018-07-25
WO2015086643A1 (en) 2015-06-18
CA2932855A1 (en) 2015-06-18
JP2016540021A (ja) 2016-12-22
CN105979935B (zh) 2019-07-26
EA201691226A1 (ru) 2016-10-31
HUE035848T2 (en) 2018-05-28
SG11201604741UA (en) 2016-07-28
HRP20180129T1 (hr) 2018-02-23
RS56738B1 (sr) 2018-03-30
MX2016007595A (es) 2016-11-28
MA39105A1 (fr) 2017-04-28
IL246082B (en) 2018-03-29
KR20160102212A (ko) 2016-08-29
US9987287B2 (en) 2018-06-05
SMT201700582T1 (it) 2018-03-08
MX369035B (es) 2019-10-25
US20160310506A1 (en) 2016-10-27
CL2016001411A1 (es) 2016-11-11
EA032306B1 (ru) 2019-05-31
AU2014363599B2 (en) 2019-10-31
LT3079671T (lt) 2018-02-12
US20180117063A1 (en) 2018-05-03

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