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1. WO2016203006 - ORODISPERSIBLE DOSAGE UNIT CONTAINING AN ESTETROL COMPONENT

Publication Number WO/2016/203006
Publication Date 22.12.2016
International Application No. PCT/EP2016/064065
International Filing Date 17.06.2016
Chapter 2 Demand Filed 13.04.2017
IPC
A61K 9/00 2006.1
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
9Medicinal preparations characterised by special physical form
A61K 9/20 2006.1
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
9Medicinal preparations characterised by special physical form
20Pills, lozenges or tablets
A61K 31/565 2006.1
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
31Medicinal preparations containing organic active ingredients
56Compounds containing cyclopentahydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
565not substituted in position 17 beta by a carbon atom, e.g. oestrane, oestradiol
CPC
A61K 31/565
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
31Medicinal preparations containing organic active ingredients
56Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives, e.g. steroids
565not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol
A61K 9/0056
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
9Medicinal preparations characterised by special physical form
0012Galenical forms characterised by the site of application
0053Mouth and digestive tract, i.e. intraoral and peroral administration
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
A61K 9/1623
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
9Medicinal preparations characterised by special physical form
14Particulate form, e.g. powders, ; Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
16Agglomerates; Granulates; Microbeadlets ; ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
1605Excipients; Inactive ingredients
1617Organic compounds, e.g. phospholipids, fats
1623Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
A61K 9/2027
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
9Medicinal preparations characterised by special physical form
20Pills, tablets, ; discs, rods
2004Excipients; Inactive ingredients
2022Organic macromolecular compounds
2027obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
A61K 9/2054
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
9Medicinal preparations characterised by special physical form
20Pills, tablets, ; discs, rods
2004Excipients; Inactive ingredients
2022Organic macromolecular compounds
205Polysaccharides, e.g. alginate, gums; Cyclodextrin
2054Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
A61K 9/2059
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
9Medicinal preparations characterised by special physical form
20Pills, tablets, ; discs, rods
2004Excipients; Inactive ingredients
2022Organic macromolecular compounds
205Polysaccharides, e.g. alginate, gums; Cyclodextrin
2059Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
Applicants
  • MITHRA PHARMACEUTICALS S.A. [BE]/[BE]
Inventors
  • JASPART, Séverine Francine Isabelle
  • PLATTEEUW, Johannes Jan
  • VAN DEN HEUVEL, Denny Johan Marijn
Agents
  • NEDERLANDSCH OCTROOIBUREAU
Priority Data
15172767.418.06.2015EP
Publication Language English (EN)
Filing Language English (EN)
Designated States
Title
(EN) ORODISPERSIBLE DOSAGE UNIT CONTAINING AN ESTETROL COMPONENT
(FR) UNITÉ GALÉNIQUE ORODISPERSIBLE CONTENANT UN COMPOSANT ESTETROL
Abstract
(EN)
The invention provides an orodispersible solid pharmaceutical dosage unit having a weight between 30 and 1,000 mg, said dosage unit consisting of: 0.1-25 wt.% of estetrol particles containing at least 80 wt.% of an estetrol component selected from estetrol, estetrol esters and combinations thereof; and 75-99.9 wt.% of one or more pharmaceutically acceptable ingredients; the solid dosage unit comprising at least 100 μg of the estetrol component; and wherein the solid dosage unit can be obtained by a process comprising wet granulation of estetrol particles having a volume weighted average particle size of 2 μm to 50 μm. The solid dosage unit is easy to manufacture and perfectly suited for sublingual, buccal or sublabial administration.
(FR)
L'invention concerne une unité galénique pharmaceutique solide orodispersible d'un poids compris entre 30 et 1 000 mg, ladite unité galénique étant composée de: 0,1 à 25 % en poids de particules d'estetrol contenant au moins 80 % d'un composant estetrol choisi entre l'estetrol et les esters d'estetrol ou d'une combinaison de ces derniers; et 75 à 99,9 % en poids d'un ou de plusieurs ingrédients pharmaceutiquement acceptables; l'unité galénique solide comprend au moins 100 µg du composant estetrol; et l'unité galénique solide peut être obtenue par un traitement comprenant une granulation par voie humide de particules d'estetrol présentant une taille de particule pondérée en moyenne de 2 µm à 50 µm. L'unité galénique solide est facile à fabriquer et parfaitement appropriée pour une administration sublinguale, buccale ou sous-labiale.
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