PL3701944T3 - Ulegająca rozpadowi w jamie ustnej jednostka dawkowana zawierająca składnik estetrolowy - Google Patents

Ulegająca rozpadowi w jamie ustnej jednostka dawkowana zawierająca składnik estetrolowy

Info

Publication number
PL3701944T3
PL3701944T3 PL20171407T PL20171407T PL3701944T3 PL 3701944 T3 PL3701944 T3 PL 3701944T3 PL 20171407 T PL20171407 T PL 20171407T PL 20171407 T PL20171407 T PL 20171407T PL 3701944 T3 PL3701944 T3 PL 3701944T3
Authority
PL
Poland
Prior art keywords
dosage unit
unit containing
estetrol component
orodispersible dosage
orodispersible
Prior art date
Application number
PL20171407T
Other languages
English (en)
Inventor
Séverine Francine Isabelle Jaspart
Johannes Jan Platteeuw
Denny Johan Marijn Van Den Heuvel
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 PL3701944T3 publication Critical patent/PL3701944T3/pl

Links

Classifications

    • 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
    • A61K9/20Pills, 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
    • 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
    • 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
    • A61K47/36Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • 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
    • A61K9/006Oral 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
    • A61K9/14Particulate 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
    • A61K9/20Pills, 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
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/2027Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • 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
    • A61K9/2022Organic macromolecular compounds
    • A61K9/205Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • 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
    • A61K9/2022Organic macromolecular compounds
    • A61K9/205Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2059Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
    • 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
    • A61K9/2072Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A61K9/2077Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
    • 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
    • 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)
  • 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)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Endocrinology (AREA)
  • Physiology (AREA)
  • Nutrition Science (AREA)
  • Zoology (AREA)
  • Reproductive Health (AREA)
  • Gynecology & Obstetrics (AREA)
  • Diabetes (AREA)
  • Molecular Biology (AREA)
  • Inorganic Chemistry (AREA)
  • Biophysics (AREA)
  • Biochemistry (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Steroid Compounds (AREA)
PL20171407T 2015-06-18 2016-06-17 Ulegająca rozpadowi w jamie ustnej jednostka dawkowana zawierająca składnik estetrolowy PL3701944T3 (pl)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
EP15172767 2015-06-18
EP16733341.8A EP3310333B1 (en) 2015-06-18 2016-06-17 Orodispersible dosage unit containing an estetrol component
EP20171407.8A EP3701944B1 (en) 2015-06-18 2016-06-17 Orodispersible dosage unit containing an estetrol component
PCT/EP2016/064065 WO2016203006A1 (en) 2015-06-18 2016-06-17 Orodispersible dosage unit containing an estetrol component

Publications (1)

Publication Number Publication Date
PL3701944T3 true PL3701944T3 (pl) 2022-04-04

Family

ID=53496426

Family Applications (2)

Application Number Title Priority Date Filing Date
PL20171407T PL3701944T3 (pl) 2015-06-18 2016-06-17 Ulegająca rozpadowi w jamie ustnej jednostka dawkowana zawierająca składnik estetrolowy
PL16733341T PL3310333T3 (pl) 2015-06-18 2016-06-17 Ulegająca rozpadowi w jamie ustnej jednostka dawkowana zawierająca składnik estetrolowy

Family Applications After (1)

Application Number Title Priority Date Filing Date
PL16733341T PL3310333T3 (pl) 2015-06-18 2016-06-17 Ulegająca rozpadowi w jamie ustnej jednostka dawkowana zawierająca składnik estetrolowy

Country Status (41)

Country Link
US (4) US11147771B2 (pl)
EP (2) EP3701944B1 (pl)
JP (2) JP6866560B2 (pl)
KR (2) KR102662025B1 (pl)
CN (2) CN116077455A (pl)
AU (4) AU2016280858B2 (pl)
BR (1) BR112017027229B1 (pl)
CA (1) CA2988495C (pl)
CL (1) CL2017003209A1 (pl)
CO (1) CO2017012670A2 (pl)
CR (1) CR20180041A (pl)
CU (1) CU24504B1 (pl)
CY (2) CY1123006T1 (pl)
DK (2) DK3701944T3 (pl)
DO (1) DOP2017000294A (pl)
EA (2) EA202090984A1 (pl)
EC (1) ECSP17085659A (pl)
ES (2) ES2800774T3 (pl)
GE (1) GEP20217243B (pl)
HK (1) HK1254650A1 (pl)
HR (2) HRP20211968T1 (pl)
HU (3) HUE049232T2 (pl)
IL (1) IL256282B (pl)
LT (3) LT3310333T (pl)
MA (1) MA45972B1 (pl)
MD (1) MD3310333T2 (pl)
ME (1) ME03728B (pl)
MX (1) MX2017016274A (pl)
MY (1) MY186164A (pl)
NO (1) NO2022020I1 (pl)
NZ (1) NZ737945A (pl)
PE (2) PE20231714A1 (pl)
PH (1) PH12017502326A1 (pl)
PL (2) PL3701944T3 (pl)
PT (2) PT3310333T (pl)
RS (2) RS62844B1 (pl)
SI (2) SI3310333T1 (pl)
SV (1) SV2017005596A (pl)
TN (1) TN2017000497A1 (pl)
UA (1) UA123099C2 (pl)
WO (1) WO2016203006A1 (pl)

Families Citing this family (14)

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Publication number Priority date Publication date Assignee Title
CA2835979C (en) 2011-06-01 2018-05-01 Estetra S.A. Process for the production of estetrol intermediates
PT2714710T (pt) 2011-06-01 2016-07-12 Estetra Sprl Processo para a produção de intermediários de estetrol
EP2383279A1 (en) 2011-07-19 2011-11-02 Pantarhei Bioscience B.V. Process for the preparation of estetrol
SI3310333T1 (sl) 2015-06-18 2020-08-31 Estetra Sprl Orodisperzibilna enota odmerka, ki vsebuje komponento estetrola
EP3310346B1 (en) 2015-06-18 2021-03-24 Estetra SPRL Orodispersible tablet containing estetrol
KR102664563B1 (ko) 2015-06-18 2024-05-09 에스테트라, 소시에떼 아 레스폰서빌리떼 리미떼 에스테트롤 성분을 함유하는 구강분해성 투여 단위
CA2988485A1 (en) 2015-06-18 2016-12-22 Mithra Pharmaceuticals S.A. Orodispersible tablet containing estetrol
CA3178291A1 (en) 2016-08-05 2018-04-12 Estetra Srl Method for the management of dysmenorrhea and menstrual pain
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
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CL2021001762A1 (es) * 2021-07-01 2022-01-21 Univ Pontificia Catolica Chile Uso del estetrol como tratamiento para la endometriosis

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