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MX369035B - Unidad de dosificacion solida de disolucion oral que contiene un componente de estetrol. - Google Patents

Unidad de dosificacion solida de disolucion oral que contiene un componente de estetrol.

Info

Publication number
MX369035B
MX369035B MX2016007595A MX2016007595A MX369035B MX 369035 B MX369035 B MX 369035B MX 2016007595 A MX2016007595 A MX 2016007595A MX 2016007595 A MX2016007595 A MX 2016007595A MX 369035 B MX369035 B MX 369035B
Authority
MX
Mexico
Prior art keywords
estetrol
dosage unit
solid dosage
orally disintegrating
estetrol component
Prior art date
Application number
MX2016007595A
Other languages
English (en)
Other versions
MX2016007595A (es
Inventor
Jan Platteeuw Johannes
Jan Tijmen Coelingh Bennink Herman
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=MX369035(B) "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 MX2016007595A publication Critical patent/MX2016007595A/es
Publication of MX369035B publication Critical patent/MX369035B/es

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)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (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 presente invención proporciona una unidad de dosificación farmacéutica sólida de disolución oral que tiene un peso de 50-1,000 mg y que contiene al menos 0.1 mg de un componente de estetrol seleccionado de estetrol, ésteres de estetrol y combinaciones de los mismos. Esta unidad de dosificación sólida comprende: • 4-95% en peso de gránulos que consisten en: - 3-80% en peso de un componente de estetrol seleccionado de estetrol, ésteres de estetrol y combinaciones de los mismos; - 20-97% en peso de alcohol de azúcar C4-C12; - 0-45% en peso de uno o más otros ingredientes farmacéuticamente aceptables; y • 5-96% en peso de uno o más excipientes farmacéuticamente aceptables. Las unidades de dosificación sólidas de la presente invención son particularmente adecuadas para administración sublingual, bucal o sublabial del componente de estetrol.
MX2016007595A 2013-12-12 2014-12-10 Unidad de dosificacion solida de disolucion oral que contiene un componente de estetrol. MX369035B (es)

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
MX2016007595A MX2016007595A (es) 2016-11-28
MX369035B true MX369035B (es) 2019-10-25

Family

ID=49759137

Family Applications (1)

Application Number Title Priority Date Filing Date
MX2016007595A MX369035B (es) 2013-12-12 2014-12-10 Unidad de dosificacion solida de disolucion oral que contiene un componente de estetrol.

Country Status (29)

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

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CN103703014A (zh) 2011-06-01 2014-04-02 埃斯特拉公司 用于产生雌四醇中间体的方法
CN103619867B (zh) 2011-06-01 2015-12-23 埃斯特拉公司 用于产生雌四醇中间体的方法
EP2383279A1 (en) 2011-07-19 2011-11-02 Pantarhei Bioscience B.V. Process for the preparation of estetrol
ME02723B (me) * 2011-08-11 2017-10-20 Estetra Sprl Upotreba estetrola kao kontraceptivnog sredstva u hitnim slučajevima
ES2877476T3 (es) 2015-06-18 2021-11-16 Estetra Sprl Comprimido orodispersable que contiene estetrol
MA44205B1 (fr) * 2015-06-18 2021-04-30 Estetra Sprl Comprimé orodispersible comprenant estetrol
CR20180042A (es) * 2015-06-18 2018-05-03 Mithra Pharmaceuticals S A Unidad de dosificación orodispersable que contiene un componente estetrol.
DK3310333T3 (da) * 2015-06-18 2020-06-02 Estetra Sprl Oralt dispergibel doseringsenhed indeholdende en estetrolkomponent
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
CN115429806A (zh) * 2018-02-07 2022-12-06 埃斯特拉有限责任公司 具有降低的心血管作用的避孕组合物
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 (en) 2023-02-02 2024-08-08 Industriale Chimica S.R.L. PROCESS FOR PREPARING (15α,16α,17β)-ESTRA-1,3,5(10)-TRIENE-3,15,16,17-TETROL (ESTETROL) MONOHYDRATE

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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
EP1260225A1 (en) 2001-05-18 2002-11-27 Pantarhei Bioscience B.V. A pharmaceutical composition for use in hormone replacement therapy
EP1390040B1 (en) * 2001-05-18 2007-01-03 Pantarhei Bioscience B.V. Pharmaceutical composition for use in hormone replacement therapy
ES2337129T3 (es) * 2001-05-23 2010-04-21 Pantarhei Bioscience B.V. Sistema de administracion de medicamento comprendiendo un estrogeno tetrahidroxilado para el uso en la anticoncepcion hormonal.
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
PT1446128E (pt) 2001-11-15 2007-03-30 Pantarhei Bioscience Bv Utilização de compostos estrogénicos combinados com compostos progestagénicos na terapia hormonal de substituição
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Also Published As

Publication number Publication date
BR112016013502A2 (pt) 2018-07-03
KR102265150B1 (ko) 2021-06-16
RS56738B1 (sr) 2018-03-30
MA39105B1 (fr) 2018-05-31
PT3079671T (pt) 2017-11-24
EA032306B1 (ru) 2019-05-31
KR20160102212A (ko) 2016-08-29
IL246082A0 (en) 2016-07-31
EP3079671B1 (en) 2017-10-25
WO2015086643A1 (en) 2015-06-18
JP2016540021A (ja) 2016-12-22
MX2016007595A (es) 2016-11-28
CL2016001411A1 (es) 2016-11-11
SG11201604741UA (en) 2016-07-28
US20160310506A1 (en) 2016-10-27
IL246082B (en) 2018-03-29
LT3079671T (lt) 2018-02-12
NO3079671T3 (es) 2018-03-24
NZ720906A (en) 2022-04-29
AU2014363599B2 (en) 2019-10-31
CN105979935A (zh) 2016-09-28
CA2932855C (en) 2022-07-19
HUE035848T2 (en) 2018-05-28
US9987287B2 (en) 2018-06-05
US9884064B2 (en) 2018-02-06
PL3079671T3 (pl) 2018-03-30
EP3079671A1 (en) 2016-10-19
CA2932855A1 (en) 2015-06-18
JP6447931B2 (ja) 2019-01-09
TN2016000230A1 (en) 2017-10-06
HRP20180129T1 (hr) 2018-02-23
BR112016013502B1 (pt) 2021-05-11
EA201691226A1 (ru) 2016-10-31
US20180117063A1 (en) 2018-05-03
AU2014363599A1 (en) 2016-06-30
ZA201603903B (en) 2018-07-25
SI3079671T1 (en) 2018-04-30
CN105979935B (zh) 2019-07-26
CY1119817T1 (el) 2018-06-27
ES2655076T3 (es) 2018-02-16
DK3079671T3 (en) 2017-12-11
MA39105A1 (fr) 2017-04-28

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