MA39105A1 - Unité de dosage solide se désintégrant par voie orale contenant un constituant estétrol - Google Patents

Unité de dosage solide se désintégrant par voie orale contenant un constituant estétrol

Info

Publication number
MA39105A1
MA39105A1 MA39105A MA39105A MA39105A1 MA 39105 A1 MA39105 A1 MA 39105A1 MA 39105 A MA39105 A MA 39105A MA 39105 A MA39105 A MA 39105A MA 39105 A1 MA39105 A1 MA 39105A1
Authority
MA
Morocco
Prior art keywords
estetrol
constituent
dosage unit
orally disintegrating
solid dosage
Prior art date
Application number
MA39105A
Other languages
English (en)
Other versions
MA39105B1 (fr
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=MA39105(A1) "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 MA39105A1 publication Critical patent/MA39105A1/fr
Publication of MA39105B1 publication Critical patent/MA39105B1/fr

Links

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

Abstract

La présente invention concerne une unité de dosage pharmaceutique solide se désintégrant par voie orale, ayant un poids de 50 à 1 000 mg et contenant au moins 0,1 mg d'un constituant estétrol choisi parmi l'estétrol, des esters d'estétrol et des combinaisons de ceux-ci. Cette unité de dosage solide est constituée : de 4 à 95 % en poids de granules constitué : de 3 à 80 % en poids d'un constituant estétrol choisi parmi l'estétrol, des esters d'estétrol et des combinaisons de ceux-ci; de 20 à 97 % en poids d'un alcool de sucre en c
MA39105A 2013-12-12 2014-12-10 Unité de dosage solide se désintégrant par voie orale contenant un constituant estétrol MA39105B1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP13196904 2013-12-12
PCT/EP2014/077127 WO2015086643A1 (fr) 2013-12-12 2014-12-10 Unité de dosage solide se désintégrant par voie orale contenant un constituant estétrol

Publications (2)

Publication Number Publication Date
MA39105A1 true MA39105A1 (fr) 2017-04-28
MA39105B1 MA39105B1 (fr) 2018-05-31

Family

ID=49759137

Family Applications (1)

Application Number Title Priority Date Filing Date
MA39105A MA39105B1 (fr) 2013-12-12 2014-12-10 Unité de dosage solide se désintégrant par voie orale contenant un constituant estétrol

Country Status (29)

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

Families Citing this family (15)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EA025511B1 (ru) 2011-06-01 2016-12-30 Эстетра С.П.Р.Л. Способ получения промежуточных соединений эстетрола
CN107266514A (zh) 2011-06-01 2017-10-20 埃斯特拉私人有限责任公司 用于产生雌四醇中间体的方法
EP2383279A1 (fr) 2011-07-19 2011-11-02 Pantarhei Bioscience B.V. Procédé de préparation d'estetrol
PT2741824T (pt) * 2011-08-11 2017-07-06 Estetra Sprl Utilização de estetrol como contracetivo de emergência
EA035687B1 (ru) * 2015-06-18 2020-07-27 Эстетра Спрл Диспергируемая в полости рта единица дозирования, содержащая эстетрольный компонент
UA123098C2 (uk) * 2015-06-18 2021-02-17 Естетра Спрл Диспергована у порожнині рота одиниця дозування, що містить естетрольний компонент
DK3310345T3 (da) * 2015-06-18 2021-05-25 Estetra Sprl Orodispersibel tablet indeholdende estetrol
EP3310346B1 (fr) 2015-06-18 2021-03-24 Estetra SPRL Comprimé orodispersible comprenant estetrol
CA3178291A1 (fr) 2016-08-05 2018-04-12 Estetra Srl Methode de prise en charge de la dysmenorrhee et des douleurs menstruelles
US20200046729A1 (en) * 2016-08-05 2020-02-13 Estetra Sprl Methods using combined oral contraceptive compositions with reduced cardiovascular effects
JP2021513507A (ja) * 2018-02-07 2021-05-27 エステトラ ソシエテ プリーヴ ア レスポンサビリテ リミテ 心臓血管系への影響を低減した避妊薬組成物
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
WO2024160373A1 (fr) 2023-02-02 2024-08-08 Industriale Chimica S.R.L. PROCÉDÉ DE PRÉPARATION DE MONOHYDRATE DE (15α,16α,17β)-ESTRA-1,3,5(10)-TRIÈNE-3,15,16,17-TÉTROL (ESTÉTROL)

Family Cites Families (22)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1997004752A1 (fr) * 1995-07-26 1997-02-13 Duramed Pharmaceuticals, Inc. Compositions pharmaceutiques d'oestrogenes conjugues et leurs modes d'emploi
US6117446A (en) 1999-01-26 2000-09-12 Place; Virgil A. Drug dosage unit for buccal administration of steroidal active agents
EP1260225A1 (fr) 2001-05-18 2002-11-27 Pantarhei Bioscience B.V. Compositions pharmaceutiques pour le traitement hormonal substitutif
US8048869B2 (en) * 2001-05-18 2011-11-01 Pantarhei Bioscience B.V. Pharmaceutical composition for use in hormone replacement therapy
ATE449606T1 (de) 2001-05-23 2009-12-15 Pantarhei Bioscience Bv Tetrahydroxylierte estrogen enthaltendes arzneistoffverabreichungssystem zur verwendung in hormonalen kontrazeption
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 (fr) 2001-08-31 2003-03-06 Pantarhei Bioscience B.V. Utilisation de composes oestrogeniques combines avec des composes progestogeniques dans une hormonotherapie substitutive
WO2003041718A1 (fr) 2001-11-15 2003-05-22 Pantarhei Bioscience B.V. Utilisation de composes oestrogenes combines a des composes progestogenes en therapie de substitution hormonale
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
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WO2014159377A1 (fr) 2013-03-14 2014-10-02 Teva Women's Health, Inc. Composition contenant du tanaproget et des œstrogènes naturels

Also Published As

Publication number Publication date
KR20160102212A (ko) 2016-08-29
HUE035848T2 (en) 2018-05-28
MX2016007595A (es) 2016-11-28
JP2016540021A (ja) 2016-12-22
BR112016013502B1 (pt) 2021-05-11
US20160310506A1 (en) 2016-10-27
IL246082A0 (en) 2016-07-31
TN2016000230A1 (en) 2017-10-06
US20180117063A1 (en) 2018-05-03
US9987287B2 (en) 2018-06-05
JP6447931B2 (ja) 2019-01-09
HRP20180129T1 (hr) 2018-02-23
EP3079671B1 (fr) 2017-10-25
MX369035B (es) 2019-10-25
SG11201604741UA (en) 2016-07-28
AU2014363599B2 (en) 2019-10-31
CY1119817T1 (el) 2018-06-27
PT3079671T (pt) 2017-11-24
SI3079671T1 (en) 2018-04-30
LT3079671T (lt) 2018-02-12
DK3079671T3 (en) 2017-12-11
MA39105B1 (fr) 2018-05-31
EA201691226A1 (ru) 2016-10-31
CA2932855A1 (fr) 2015-06-18
EP3079671A1 (fr) 2016-10-19
NO3079671T3 (fr) 2018-03-24
NZ720906A (en) 2022-04-29
EA032306B1 (ru) 2019-05-31
CN105979935B (zh) 2019-07-26
PL3079671T3 (pl) 2018-03-30
AU2014363599A1 (en) 2016-06-30
KR102265150B1 (ko) 2021-06-16
WO2015086643A1 (fr) 2015-06-18
CA2932855C (fr) 2022-07-19
IL246082B (en) 2018-03-29
RS56738B1 (sr) 2018-03-30
CL2016001411A1 (es) 2016-11-11
CN105979935A (zh) 2016-09-28
ES2655076T3 (es) 2018-02-16
ZA201603903B (en) 2018-07-25
BR112016013502A2 (pt) 2018-07-03
US9884064B2 (en) 2018-02-06

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