PL3079671T3 - Rozpadająca się w jamie ustnej stała jednostka dawkowania zawierająca składnik estetrolowy - Google Patents

Rozpadająca się w jamie ustnej stała jednostka dawkowania zawierająca składnik estetrolowy

Info

Publication number
PL3079671T3
PL3079671T3 PL14814804T PL14814804T PL3079671T3 PL 3079671 T3 PL3079671 T3 PL 3079671T3 PL 14814804 T PL14814804 T PL 14814804T PL 14814804 T PL14814804 T PL 14814804T PL 3079671 T3 PL3079671 T3 PL 3079671T3
Authority
PL
Poland
Prior art keywords
dosage unit
solid dosage
unit containing
orally disintegrating
disintegrating solid
Prior art date
Application number
PL14814804T
Other languages
English (en)
Inventor
Johannes Jan Platteeuw
Bennink Herman Jan Tijmen Coelingh
Original Assignee
Donesta Bioscience B.V.
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=PL3079671(T3) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Donesta Bioscience B.V. filed Critical Donesta Bioscience B.V.
Publication of PL3079671T3 publication Critical patent/PL3079671T3/pl

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/56Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/565Compounds 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/56Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/57Compounds 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
    • A61K31/573Compounds 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/32Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/38Cellulose; Derivatives thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0053Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/0056Mouth 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1617Organic compounds, e.g. phospholipids, fats
    • A61K9/1623Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1682Processes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00Drugs for genital or sexual disorders; Contraceptives
    • A61P15/18Feminine contraceptives
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00Drugs for disorders of the endocrine system
    • A61P5/24Drugs for disorders of the endocrine system of the sex hormones
    • A61P5/30Oestrogens

Landscapes

  • 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)
PL14814804T 2013-12-12 2014-12-10 Rozpadająca się w jamie ustnej stała jednostka dawkowania zawierająca składnik estetrolowy PL3079671T3 (pl)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP13196904 2013-12-12
EP14814804.2A EP3079671B1 (en) 2013-12-12 2014-12-10 Orally disintegrating solid dosage unit containing an estetrol component
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
PL3079671T3 true PL3079671T3 (pl) 2018-03-30

Family

ID=49759137

Family Applications (1)

Application Number Title Priority Date Filing Date
PL14814804T PL3079671T3 (pl) 2013-12-12 2014-12-10 Rozpadająca się w jamie ustnej stała jednostka dawkowania zawierająca składnik estetrolowy

Country Status (30)

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

Families Citing this family (21)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AU2012264602B2 (en) 2011-06-01 2017-03-09 Estetra Srl Process for the production of estetrol intermediates
WO2012164095A1 (en) 2011-06-01 2012-12-06 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
EP2741824B1 (en) * 2011-08-11 2017-05-03 Estetra S.P.R.L. Use of estetrol as emergency contraceptive
HRP20210668T1 (hr) * 2015-06-18 2021-05-28 Estetra Sprl Orodisperzibilna tableta koja sadrži estetrol
MD3310346T2 (ro) 2015-06-18 2021-06-30 Estetra Sprl Comprimată orodispersabilă ce conține estetrol
UA123099C2 (uk) 2015-06-18 2021-02-17 Естетра Спрл Диспергована в порожнині рота одиниця дозування, яка містить естетрольний компонент
US20160367567A1 (en) * 2015-06-18 2016-12-22 Mithra Pharmaceuticals S.A. 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
CA3178181A1 (en) * 2018-02-07 2019-08-15 Estetra Srl Contraceptive composition with reduced cardiovascular effects
JOP20200260A1 (ar) * 2018-04-19 2019-10-19 Estetra Sprl مركبات واستخداماتها للتخفيف من الأعراض المصاحبة لانقطاع الطمث
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
HU231240B1 (hu) 2019-09-03 2022-04-28 Richter Gedeon Nyrt. Ipari eljárás nagytisztaságú ösztetrol hatóanyag előállítására
JP7588140B2 (ja) * 2019-09-27 2024-11-21 インダストリアレ チミカ ソシエタ ア レスポンサビリタ リミタータ (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)および当該製法の中間体を調製するためのプロセス
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
WO2022069956A1 (en) 2020-09-29 2022-04-07 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
ES2278924T3 (es) * 2001-05-18 2007-08-16 Pantarhei Bioscience B.V. Composicion farmaceutica para el uso en terapia de sustitucion hormonal.
EP1260225A1 (en) 2001-05-18 2002-11-27 Pantarhei Bioscience B.V. A pharmaceutical composition for use in hormone replacement therapy
EP1390041B1 (en) * 2001-05-23 2009-11-25 Pantarhei Bioscience B.V. Drug delivery system comprising a tetrahydroxylated estrogen for use in hormonal contraception
PT1390042E (pt) 2001-05-23 2008-03-10 Pantarhei Bioscience Bv Sistema de administração de um medicamento que compreende estrogénio tetrahidroxilado destinado à contracepção 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
AU2002343249B2 (en) * 2002-02-21 2009-02-05 Bayer Schering Pharma Aktiengesellschaft Pharmaceutical compositions comprising one or more steroids one or more tetrahydrofolate components and 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
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
MX2008014941A (es) * 2006-06-08 2008-12-10 Warner Chilcott Co Inc Metodos para administrar formas de dosificacion solida de etinil estradiol y profarmacos del mismo con biodisponibilidad mejorada.
WO2008067387A2 (en) * 2006-11-29 2008-06-05 Wyeth 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
BRPI0806543A2 (pt) * 2007-01-12 2014-04-22 Wyeth Corp Composições de comprimido em comprimido
ATE537833T1 (de) 2007-06-21 2012-01-15 Pantarhei Bioscience Bv Behandlung des mekoniumaspirationssyndroms mit östrogenen
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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
NO3079671T3 (pl) 2018-03-24
CL2016001411A1 (es) 2016-11-11
HUE035848T2 (en) 2018-05-28
WO2015086643A1 (en) 2015-06-18
US20160310506A1 (en) 2016-10-27
CA2932855C (en) 2022-07-19
US20180117063A1 (en) 2018-05-03
PT3079671T (pt) 2017-11-24
EA032306B1 (ru) 2019-05-31
ES2655076T3 (es) 2018-02-16
MA39105B1 (fr) 2018-05-31
KR20160102212A (ko) 2016-08-29
MX2016007595A (es) 2016-11-28
SG11201604741UA (en) 2016-07-28
AU2014363599A1 (en) 2016-06-30
US9884064B2 (en) 2018-02-06
DK3079671T3 (en) 2017-12-11
EP3079671A1 (en) 2016-10-19
CA2932855A1 (en) 2015-06-18
MA39105A1 (fr) 2017-04-28
US9987287B2 (en) 2018-06-05
JP6447931B2 (ja) 2019-01-09
KR102265150B1 (ko) 2021-06-16
LT3079671T (lt) 2018-02-12
TN2016000230A1 (en) 2017-10-06
BR112016013502B1 (pt) 2021-05-11
SI3079671T1 (en) 2018-04-30
IL246082A0 (en) 2016-07-31
HRP20180129T1 (hr) 2018-02-23
MX369035B (es) 2019-10-25
EA201691226A1 (ru) 2016-10-31
NZ720906A (en) 2022-04-29
RS56738B1 (sr) 2018-03-30
EP3079671B1 (en) 2017-10-25
BR112016013502A2 (pt) 2018-07-03
IL246082B (en) 2018-03-29
JP2016540021A (ja) 2016-12-22
AU2014363599B2 (en) 2019-10-31
SMT201700582T1 (it) 2018-03-08
CN105979935A (zh) 2016-09-28
ZA201603903B (en) 2018-07-25
CY1119817T1 (el) 2018-06-27
CN105979935B (zh) 2019-07-26

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