KR102265150B1 - 에스테트롤 성분을 함유하는 구강 붕해성 고체 투여 단위 - Google Patents

에스테트롤 성분을 함유하는 구강 붕해성 고체 투여 단위 Download PDF

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KR102265150B1
KR102265150B1 KR1020167018146A KR20167018146A KR102265150B1 KR 102265150 B1 KR102265150 B1 KR 102265150B1 KR 1020167018146 A KR1020167018146 A KR 1020167018146A KR 20167018146 A KR20167018146 A KR 20167018146A KR 102265150 B1 KR102265150 B1 KR 102265150B1
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estetrol
weight
granules
orally disintegrating
sugar alcohol
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Expired - Fee Related
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Korean (ko)
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KR20160102212A (ko
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요하네스 잔 플라테에위
헤르만 잔 티즈멘 코엘링 베닌크
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에스테트라 에스.피.알.엘.
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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)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Zoology (AREA)
  • Physiology (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)
KR1020167018146A 2013-12-12 2014-12-10 에스테트롤 성분을 함유하는 구강 붕해성 고체 투여 단위 Expired - Fee Related KR102265150B1 (ko)

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 (2)

Publication Number Publication Date
KR20160102212A KR20160102212A (ko) 2016-08-29
KR102265150B1 true KR102265150B1 (ko) 2021-06-16

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ID=49759137

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KR1020167018146A Expired - Fee Related KR102265150B1 (ko) 2013-12-12 2014-12-10 에스테트롤 성분을 함유하는 구강 붕해성 고체 투여 단위

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)

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HRP20161369T1 (hr) 2011-06-01 2016-12-02 Estetra S.P.R.L. Postupak za proizvodnju intermedijera estetrola
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
PT2741824T (pt) * 2011-08-11 2017-07-06 Estetra Sprl Utilização de estetrol como contracetivo de emergência
EP3310333B1 (en) 2015-06-18 2020-04-29 Estetra SPRL Orodispersible dosage unit containing an estetrol component
PL3106148T3 (pl) * 2015-06-18 2018-08-31 Mithra Pharmaceuticals S A Jednostka dawkowania ulegająca rozpadowi w jamie ustnej zawierająca składnik estetrolowy
MD3310346T2 (ro) 2015-06-18 2021-06-30 Estetra Sprl Comprimată orodispersabilă ce conține estetrol
US10894014B2 (en) 2015-06-18 2021-01-19 Estetra Sprl Orodispersible tablet containing 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
UA126746C2 (uk) * 2018-02-07 2023-01-18 Естетра Спрл Композиція контрацептива зі зниженими ефектами щодо серцево-судинної системи
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
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
EP4221693A1 (en) 2020-09-29 2023-08-09 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
CL2025000553A1 (es) 2024-02-28 2025-08-29 Estetra Srl Forma polimórfica de estetrol y producción de la misma
HUP2400151A1 (hu) 2024-02-28 2025-09-28 Richter Gedeon Nyrt Ösztetrol-monohidrát kristályosítási eljárás

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KR20160102212A (ko) 2016-08-29
TN2016000230A1 (en) 2017-10-06
MX2016007595A (es) 2016-11-28
PL3079671T3 (pl) 2018-03-30
EA032306B1 (ru) 2019-05-31
AU2014363599A1 (en) 2016-06-30
HUE035848T2 (en) 2018-05-28
DK3079671T3 (en) 2017-12-11
IL246082A0 (en) 2016-07-31
CA2932855C (en) 2022-07-19
SG11201604741UA (en) 2016-07-28
HRP20180129T1 (hr) 2018-02-23
EA201691226A1 (ru) 2016-10-31
SI3079671T1 (en) 2018-04-30
MX369035B (es) 2019-10-25
BR112016013502B1 (pt) 2021-05-11
CY1119817T1 (el) 2018-06-27
MA39105A1 (fr) 2017-04-28
WO2015086643A1 (en) 2015-06-18
CN105979935B (zh) 2019-07-26
IL246082B (en) 2018-03-29
US20180117063A1 (en) 2018-05-03
CL2016001411A1 (es) 2016-11-11
US9884064B2 (en) 2018-02-06
AU2014363599B2 (en) 2019-10-31
LT3079671T (lt) 2018-02-12
JP2016540021A (ja) 2016-12-22
NO3079671T3 (enExample) 2018-03-24
ES2655076T3 (es) 2018-02-16
NZ720906A (en) 2022-04-29
RS56738B1 (sr) 2018-03-30
US9987287B2 (en) 2018-06-05
SMT201700582T1 (it) 2018-03-08
ZA201603903B (en) 2018-07-25
JP6447931B2 (ja) 2019-01-09
CN105979935A (zh) 2016-09-28
EP3079671A1 (en) 2016-10-19
BR112016013502A2 (pt) 2018-07-03
EP3079671B1 (en) 2017-10-25
US20160310506A1 (en) 2016-10-27
CA2932855A1 (en) 2015-06-18
MA39105B1 (fr) 2018-05-31
PT3079671T (pt) 2017-11-24

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