CA2988362C - Orodispersible tablet containing estetrol - Google Patents

Orodispersible tablet containing estetrol Download PDF

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Publication number
CA2988362C
CA2988362C CA2988362A CA2988362A CA2988362C CA 2988362 C CA2988362 C CA 2988362C CA 2988362 A CA2988362 A CA 2988362A CA 2988362 A CA2988362 A CA 2988362A CA 2988362 C CA2988362 C CA 2988362C
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CA
Canada
Prior art keywords
dosage unit
estetrol
particles
solid dosage
weight
Prior art date
Legal status (The legal status 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 status listed.)
Active
Application number
CA2988362A
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English (en)
French (fr)
Other versions
CA2988362A1 (en
Inventor
Severine Francine Isabelle Jaspart
Johannes Jan Platteeuw
Denny Johan Marijn Van Den Heuvel
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Estetra SRL
Original Assignee
Estetra SRL
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
Application filed by Estetra SRL filed Critical Estetra SRL
Publication of CA2988362A1 publication Critical patent/CA2988362A1/en
Application granted granted Critical
Publication of CA2988362C publication Critical patent/CA2988362C/en
Active legal-status Critical Current
Anticipated expiration legal-status Critical

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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
    • 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
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0053Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/006Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2013Organic compounds, e.g. phospholipids, fats
    • A61K9/2018Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2095Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing
    • 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
    • A61P5/00Drugs for disorders of the endocrine system
    • A61P5/24Drugs for disorders of the endocrine system of the sex hormones

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Endocrinology (AREA)
  • Organic Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Biophysics (AREA)
  • Zoology (AREA)
  • Molecular Biology (AREA)
  • Gynecology & Obstetrics (AREA)
  • Reproductive Health (AREA)
  • Diabetes (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
CA2988362A 2015-06-18 2016-06-20 Orodispersible tablet containing estetrol Active CA2988362C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP15172755.9 2015-06-18
EP15172755 2015-06-18
PCT/EP2016/064181 WO2016203044A1 (en) 2015-06-18 2016-06-20 Orodispersible tablet containing estetrol

Publications (2)

Publication Number Publication Date
CA2988362A1 CA2988362A1 (en) 2016-12-22
CA2988362C true CA2988362C (en) 2022-07-19

Family

ID=53476702

Family Applications (1)

Application Number Title Priority Date Filing Date
CA2988362A Active CA2988362C (en) 2015-06-18 2016-06-20 Orodispersible tablet containing estetrol

Country Status (19)

Country Link
US (1) US10888518B2 (enExample)
EP (1) EP3310346B1 (enExample)
JP (1) JP6813150B2 (enExample)
CN (1) CN107750157B (enExample)
CA (1) CA2988362C (enExample)
CY (1) CY1124052T1 (enExample)
DK (1) DK3310346T3 (enExample)
ES (1) ES2877476T3 (enExample)
HR (1) HRP20210555T1 (enExample)
HU (1) HUE054551T2 (enExample)
LT (1) LT3310346T (enExample)
MA (1) MA44206B1 (enExample)
MD (1) MD3310346T2 (enExample)
PL (1) PL3310346T3 (enExample)
PT (1) PT3310346T (enExample)
RS (1) RS61777B1 (enExample)
SI (1) SI3310346T1 (enExample)
SM (1) SMT202100350T1 (enExample)
WO (1) WO2016203044A1 (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
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
US10894014B2 (en) 2015-06-18 2021-01-19 Estetra Sprl Orodispersible tablet containing Estetrol
MD3310346T2 (ro) 2015-06-18 2021-06-30 Estetra Sprl Comprimată orodispersabilă ce conține estetrol
KR102712911B1 (ko) 2016-08-05 2024-10-04 에스테트라, 소시에떼 아 레스폰서빌리떼 리미떼 월경통 및 생리통의 관리방법
JOP20200260A1 (ar) 2018-04-19 2019-10-19 Estetra Sprl مركبات واستخداماتها للتخفيف من الأعراض المصاحبة لانقطاع الطمث
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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
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EP3310333B1 (en) 2015-06-18 2020-04-29 Estetra SPRL Orodispersible dosage unit containing an estetrol component
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UA126746C2 (uk) 2018-02-07 2023-01-18 Естетра Спрл Композиція контрацептива зі зниженими ефектами щодо серцево-судинної системи

Also Published As

Publication number Publication date
RS61777B1 (sr) 2021-06-30
DK3310346T3 (da) 2021-05-25
CY1124052T1 (el) 2022-05-27
CN107750157B (zh) 2021-07-13
HUE054551T2 (hu) 2021-09-28
US20180153801A1 (en) 2018-06-07
WO2016203044A1 (en) 2016-12-22
EP3310346A1 (en) 2018-04-25
JP6813150B2 (ja) 2021-01-13
PT3310346T (pt) 2021-04-22
CA2988362A1 (en) 2016-12-22
EP3310346B1 (en) 2021-03-24
CN107750157A (zh) 2018-03-02
SI3310346T1 (sl) 2021-07-30
JP2018517715A (ja) 2018-07-05
PL3310346T3 (pl) 2021-10-25
MD3310346T2 (ro) 2021-06-30
SMT202100350T1 (it) 2021-07-12
HK1254649A1 (en) 2019-07-26
LT3310346T (lt) 2021-06-10
US10888518B2 (en) 2021-01-12
MA44206A (fr) 2018-04-25
HRP20210555T1 (hr) 2021-05-14
MA44206B1 (fr) 2021-04-30
ES2877476T3 (es) 2021-11-16

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