MA44205B1 - Comprimé orodispersible comprenant estetrol - Google Patents

Comprimé orodispersible comprenant estetrol

Info

Publication number
MA44205B1
MA44205B1 MA44205A MA44205A MA44205B1 MA 44205 B1 MA44205 B1 MA 44205B1 MA 44205 A MA44205 A MA 44205A MA 44205 A MA44205 A MA 44205A MA 44205 B1 MA44205 B1 MA 44205B1
Authority
MA
Morocco
Prior art keywords
dosage unit
estetrol
particles
charged particles
weight
Prior art date
Application number
MA44205A
Other languages
English (en)
Other versions
MA44205A (fr
Inventor
Johannes Jan Platteeuw
Séverine Francine Isabelle Jaspart
Den Heuvel Denny Johan Marijn Van
Original Assignee
Estetra Sprl
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 Sprl filed Critical Estetra Sprl
Publication of MA44205A publication Critical patent/MA44205A/fr
Publication of MA44205B1 publication Critical patent/MA44205B1/fr

Links

Classifications

    • 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
    • A61K9/006—Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays
    • 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
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2072—Pills, 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
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2072—Pills, 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
    • A61K9/2077—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2095—Tabletting 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
    • 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)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Chemical & Material Sciences (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Zoology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Endocrinology (AREA)
  • Gynecology & Obstetrics (AREA)
  • Reproductive Health (AREA)
  • Diabetes (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

L'invention concerne une unité posologique pharmaceutique solide orodispersible ayant un poids compris entre 30 et 1 000 mg, ladite unité posologique contenant au moins 100 µg d'un composant estétrol choisi parmi l'estétrol, des esters d'estétrol et des combinaisons de ceux-ci; l'unité posologique solide pouvant être obtenue par un procédé qui comprend les étapes consistant à: fournir un liquide de charge comprenant un solvant organique; le composant estétrol et éventuellement un ou plusieurs autres ingrédients acceptables sur le plan pharmaceutique; mélanger 1 partie en poids du liquide de charge avec 0,5 à 20 parties en poids de particules porteuses pour produire des particules humides; à éliminer le solvant organique des particules humides pour produire des particules chargées; mélanger éventuellement les particules chargées avec un ou plusieurs excipients de fabrication de comprimés; et à former les particules chargées ou le mélange de particules chargées et les un ou plusieurs excipients de fabrication de comprimés en une unité posologique solide. L'unité posologique solide de la présente invention est facile à fabriquer et parfaitement adaptée à une administration sublinguale, buccale ou sublabiale.
MA44205A 2015-06-18 2016-06-17 Comprimé orodispersible comprenant estetrol MA44205B1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP15172751 2015-06-18
PCT/EP2016/064071 WO2016203009A1 (fr) 2015-06-18 2016-06-17 Comprimé orodispersible contenant de l'estétrol

Publications (2)

Publication Number Publication Date
MA44205A MA44205A (fr) 2018-04-25
MA44205B1 true MA44205B1 (fr) 2021-04-30

Family

ID=53476700

Family Applications (1)

Application Number Title Priority Date Filing Date
MA44205A MA44205B1 (fr) 2015-06-18 2016-06-17 Comprimé orodispersible comprenant estetrol

Country Status (19)

Country Link
US (1) US10894014B2 (fr)
EP (1) EP3310345B1 (fr)
JP (1) JP6866561B2 (fr)
CN (1) CN107810001A (fr)
CA (1) CA2988485A1 (fr)
CY (1) CY1124104T1 (fr)
DK (1) DK3310345T3 (fr)
ES (1) ES2877186T3 (fr)
HR (1) HRP20210668T1 (fr)
HU (1) HUE054589T2 (fr)
LT (1) LT3310345T (fr)
MA (1) MA44205B1 (fr)
MD (1) MD3310345T2 (fr)
PL (1) PL3310345T3 (fr)
PT (1) PT3310345T (fr)
RS (1) RS61812B1 (fr)
SI (1) SI3310345T1 (fr)
SM (1) SMT202100370T1 (fr)
WO (1) WO2016203009A1 (fr)

Families Citing this family (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AU2012264602B2 (en) 2011-06-01 2017-03-09 Estetra Srl Process for the production of estetrol intermediates
WO2012164095A1 (fr) 2011-06-01 2012-12-06 Estetra S.A. Procédé pour la production d'intermédiaires d'estétrol
EP2383279A1 (fr) 2011-07-19 2011-11-02 Pantarhei Bioscience B.V. Procédé de préparation d'estetrol
US20160367567A1 (en) 2015-06-18 2016-12-22 Mithra Pharmaceuticals S.A. Orodispersible dosage unit containing an estetrol component
UA123099C2 (uk) 2015-06-18 2021-02-17 Естетра Спрл Диспергована в порожнині рота одиниця дозування, яка містить естетрольний компонент
HRP20210668T1 (hr) 2015-06-18 2021-05-28 Estetra Sprl Orodisperzibilna tableta koja sadrži estetrol
MD3310346T2 (ro) 2015-06-18 2021-06-30 Estetra Sprl Comprimată orodispersabilă ce conține estetrol
CA3178291A1 (fr) 2016-08-05 2018-04-12 Estetra Srl Methode de prise en charge de la dysmenorrhee et des douleurs menstruelles
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
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HU231240B1 (hu) 2019-09-03 2022-04-28 Richter Gedeon Nyrt. Ipari eljárás nagytisztaságú ösztetrol hatóanyag előállítására
EP4056638A4 (fr) * 2019-11-07 2022-11-30 Asahi Kasei Kabushiki Kaisha Composition de cellulose, comprimé et comprimé orodispersible
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 (fr) 2020-09-29 2022-04-07 Millicent Pharma Limited Formulations orodispersibles

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MD3310346T2 (ro) * 2015-06-18 2021-06-30 Estetra Sprl Comprimată orodispersabilă ce conține estetrol
US20160367567A1 (en) 2015-06-18 2016-12-22 Mithra Pharmaceuticals S.A. Orodispersible dosage unit containing an estetrol component
UA123099C2 (uk) 2015-06-18 2021-02-17 Естетра Спрл Диспергована в порожнині рота одиниця дозування, яка містить естетрольний компонент
HUE065350T2 (hu) 2015-06-23 2024-05-28 Laboratorios Leon Farma Sa Drospirenonalapú fogamzásgátló túlsúllyal érintett nõi beteg számára
CA3178291A1 (fr) 2016-08-05 2018-04-12 Estetra Srl Methode de prise en charge de la dysmenorrhee et des douleurs menstruelles
JP2018533542A (ja) 2016-10-28 2018-11-15 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 月経困難症および月経痛の管理のための方法
US20200046729A1 (en) 2016-08-05 2020-02-13 Estetra Sprl Methods using combined oral contraceptive compositions with reduced cardiovascular effects
CA3178181A1 (fr) 2018-02-07 2019-08-15 Estetra Srl Composition contraceptive presentant des effets cardiovasculaires reduits

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MA44205A (fr) 2018-04-25
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LT3310345T (lt) 2021-06-25
SI3310345T1 (sl) 2021-05-31
CN107810001A (zh) 2018-03-16
HUE054589T2 (hu) 2021-09-28
US20180185271A1 (en) 2018-07-05
MD3310345T2 (ro) 2021-07-31
RS61812B1 (sr) 2021-06-30
HRP20210668T1 (hr) 2021-05-28
JP2018517718A (ja) 2018-07-05
US10894014B2 (en) 2021-01-19
EP3310345B1 (fr) 2021-03-31
DK3310345T3 (da) 2021-05-25
JP6866561B2 (ja) 2021-04-28
CY1124104T1 (el) 2022-05-27
ES2877186T3 (es) 2021-11-16
EP3310345A1 (fr) 2018-04-25
CA2988485A1 (fr) 2016-12-22
WO2016203009A1 (fr) 2016-12-22
PL3310345T3 (pl) 2021-10-18

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