TR201808438T4 - Estetrol bileşeni içeren ağızda dağılan dozaj birimi. - Google Patents

Estetrol bileşeni içeren ağızda dağılan dozaj birimi. Download PDF

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Publication number
TR201808438T4
TR201808438T4 TR2018/08438T TR201808438T TR201808438T4 TR 201808438 T4 TR201808438 T4 TR 201808438T4 TR 2018/08438 T TR2018/08438 T TR 2018/08438T TR 201808438 T TR201808438 T TR 201808438T TR 201808438 T4 TR201808438 T4 TR 201808438T4
Authority
TR
Turkey
Prior art keywords
estetrol
dosage unit
weight
solid dosage
component
Prior art date
Application number
TR2018/08438T
Other languages
English (en)
Turkish (tr)
Inventor
Francine Isabelle Jaspart Séverine
Jan Platteeuw Johannes
Johan Marijn Van Den Heuvel Denny
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 TR201808438T4 publication Critical patent/TR201808438T4/tr

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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
    • A61K9/2009Inorganic 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)
  • Nutrition Science (AREA)
  • Physiology (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)
TR2018/08438T 2015-06-18 2016-06-17 Estetrol bileşeni içeren ağızda dağılan dozaj birimi. TR201808438T4 (tr)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
EP15172747 2015-06-18

Publications (1)

Publication Number Publication Date
TR201808438T4 true TR201808438T4 (tr) 2018-07-23

Family

ID=53442623

Family Applications (1)

Application Number Title Priority Date Filing Date
TR2018/08438T TR201808438T4 (tr) 2015-06-18 2016-06-17 Estetrol bileşeni içeren ağızda dağılan dozaj birimi.

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)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DK2714712T3 (en) 2011-06-01 2016-12-05 Estetra Sprl A process for the preparation of intermediates estetrol
SI2714710T1 (sl) 2011-06-01 2016-08-31 Estetra S.P.R.L. Postopek za proizvodnjo intermediatov estetrola
EP2383279A1 (en) 2011-07-19 2011-11-02 Pantarhei Bioscience B.V. Process for the preparation of estetrol
SI3310346T1 (sl) 2015-06-18 2021-07-30 Estetra Sprl Orodisperzibilna tableta, ki vsebuje estetrol
SMT201800232T1 (it) 2015-06-18 2018-07-17 Mithra Pharmaceuticals S A Unita' di dosaggio orodispersibile contenente un componente di estetrolo
LT3310333T (lt) * 2015-06-18 2020-06-25 Estetra Sprl Burnoje dirperguojama vaisto formą, turinti estetrolio komponentą
PT3310345T (pt) 2015-06-18 2021-05-28 Estetra Sprl Comprimido orodispersível contendo estetrol
CA3178291A1 (en) 2016-08-05 2018-04-12 Estetra Srl Method for the management of dysmenorrhea and menstrual pain
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
AU2021351921A1 (en) 2020-09-29 2023-04-06 Millicent Pharma Limited Orodispersible formulations

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