SMT201800232T1 - Unita' di dosaggio orodispersibile contenente un componente di estetrolo - Google Patents

Unita' di dosaggio orodispersibile contenente un componente di estetrolo

Info

Publication number
SMT201800232T1
SMT201800232T1 SM20180232T SMT201800232T SMT201800232T1 SM T201800232 T1 SMT201800232 T1 SM T201800232T1 SM 20180232 T SM20180232 T SM 20180232T SM T201800232 T SMT201800232 T SM T201800232T SM T201800232 T1 SMT201800232 T1 SM T201800232T1
Authority
SM
San Marino
Prior art keywords
dosage unit
unit containing
estetrol component
orodispersible dosage
orodispersible
Prior art date
Application number
SM20180232T
Other languages
English (en)
Italian (it)
Inventor
Johannes Jan Platteeuw
Séverine Francine Isabelle Jaspart
Den Heuvel Denny Johan Marijn Van
Original Assignee
Mithra Pharmaceuticals S A
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 Mithra Pharmaceuticals S A filed Critical Mithra Pharmaceuticals S A
Publication of SMT201800232T1 publication Critical patent/SMT201800232T1/it

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
    • 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
    • A61K9/2009Inorganic compounds
    • 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
    • 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
    • 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
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Physiology (AREA)
  • Nutrition Science (AREA)
  • Endocrinology (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Zoology (AREA)
  • Gynecology & Obstetrics (AREA)
  • Reproductive Health (AREA)
  • Diabetes (AREA)
  • Inorganic Chemistry (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
SM20180232T 2015-06-18 2016-06-17 Unita' di dosaggio orodispersibile contenente un componente di estetrolo SMT201800232T1 (it)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP15172747 2015-06-18
EP16175091.4A EP3106148B1 (en) 2015-06-18 2016-06-17 Orodispersible dosage unit containing an estetrol component

Publications (1)

Publication Number Publication Date
SMT201800232T1 true SMT201800232T1 (it) 2018-07-17

Family

ID=53442623

Family Applications (1)

Application Number Title Priority Date Filing Date
SM20180232T SMT201800232T1 (it) 2015-06-18 2016-06-17 Unita' di dosaggio orodispersibile contenente un componente di estetrolo

Country Status (43)

Country Link
US (3) US20160367567A1 (enExample)
EP (1) EP3106148B1 (enExample)
JP (1) JP6863547B2 (enExample)
KR (1) KR102664563B1 (enExample)
CN (2) CN107771075A (enExample)
AU (1) AU2016280863B2 (enExample)
CA (1) CA2988498C (enExample)
CL (1) CL2017003208A1 (enExample)
CO (1) CO2017012766A2 (enExample)
CR (1) CR20180042A (enExample)
CU (1) CU24523B1 (enExample)
CY (1) CY1120467T1 (enExample)
DK (1) DK3106148T3 (enExample)
DO (1) DOP2017000293A (enExample)
EA (1) EA035651B1 (enExample)
EC (1) ECSP17085669A (enExample)
ES (1) ES2671160T3 (enExample)
GE (1) GEP20217308B (enExample)
GT (1) GT201700270A (enExample)
HK (1) HK1251940A1 (enExample)
HR (1) HRP20180889T1 (enExample)
HU (1) HUE037383T2 (enExample)
IL (1) IL256283B (enExample)
LT (1) LT3106148T (enExample)
MX (1) MX385820B (enExample)
MY (1) MY195019A (enExample)
NO (1) NO3106148T3 (enExample)
NZ (1) NZ737948A (enExample)
PE (1) PE20180398A1 (enExample)
PH (1) PH12017502325B1 (enExample)
PL (1) PL3106148T3 (enExample)
PT (1) PT3106148T (enExample)
RS (1) RS57328B1 (enExample)
SA (1) SA517390550B1 (enExample)
SG (1) SG10202010432UA (enExample)
SI (1) SI3106148T1 (enExample)
SM (1) SMT201800232T1 (enExample)
SV (1) SV2017005595A (enExample)
TN (1) TN2017000499A1 (enExample)
TR (1) TR201808438T4 (enExample)
UA (1) UA123098C2 (enExample)
WO (1) WO2016203011A1 (enExample)
ZA (1) ZA201708287B (enExample)

Families Citing this family (12)

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Publication number Priority date Publication date Assignee Title
PL2714710T3 (pl) 2011-06-01 2017-03-31 Estetra S.P.R.L. Sposób wytwarzania estetrolowych związków pośrednich
EP2714712B1 (en) 2011-06-01 2016-08-24 Estetra S.P.R.L. 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
CA2988362C (en) 2015-06-18 2022-07-19 Mithra Pharmaceuticals S.A. Orodispersible tablet containing estetrol
JP6866561B2 (ja) * 2015-06-18 2021-04-28 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 エステトロールを含有する口腔内崩壊錠
PT3310333T (pt) * 2015-06-18 2020-06-08 Estetra Sprl Dose unitária orodispersível contendo um composto de estetrol
TN2017000499A1 (en) 2015-06-18 2019-04-12 Mithra Pharmaceuticals S A Orodispersible dosage unit containing an estetrol component
KR102712911B1 (ko) 2016-08-05 2024-10-04 에스테트라, 소시에떼 아 레스폰서빌리떼 리미떼 월경통 및 생리통의 관리방법
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
JOP20200260A1 (ar) * 2018-04-19 2019-10-19 Estetra Sprl مركبات واستخداماتها للتخفيف من الأعراض المصاحبة لانقطاع الطمث
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
WO2022069956A1 (en) 2020-09-29 2022-04-07 Millicent Pharma Limited Orodispersible formulations

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