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PE20180398A1 - Unidad de dosificacion orodispersable que contiene un componente estetrol - Google Patents

Unidad de dosificacion orodispersable que contiene un componente estetrol

Info

Publication number
PE20180398A1
PE20180398A1 PE2017002731A PE2017002731A PE20180398A1 PE 20180398 A1 PE20180398 A1 PE 20180398A1 PE 2017002731 A PE2017002731 A PE 2017002731A PE 2017002731 A PE2017002731 A PE 2017002731A PE 20180398 A1 PE20180398 A1 PE 20180398A1
Authority
PE
Peru
Prior art keywords
estetrol
dosage unit
weight
component
solid
Prior art date
Application number
PE2017002731A
Other languages
English (en)
Inventor
Severine Francine Isabelle Jaspart
Johannes Jan Platteeuw
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 PE20180398A1 publication Critical patent/PE20180398A1/es

Links

Classifications

    • 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
    • A61K9/0012—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
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2009—Inorganic compounds
    • 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
    • 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
    • A61K9/2027—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • 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
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
    • 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
    • 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
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • 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
    • 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
    • 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; 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)

Abstract

La invencion proporciona una unidad de dosificacion solida orodispersable farmaceutica que tiene un peso comprendido entre 30 y 1.000 mg, consistiendo dicha unidad de dosificacion en: 0,1-25 % en peso de particulas de estetrol que contienen al menos 80 % en peso de un componente estetrol seleccionado entre estetrol, esteres de estetrol y combinaciones de los mismos; y 75-99,9 % en peso de uno o mas ingredientes farmaceuticamente aceptables; comprendiendo la unidad de dosificacion solida al menos 100 microgramo del componente estetrol; y en la que la unidad de dosificacion solida se puede obtener mediante un procedimiento que comprende la compresion de una mezcla seca de particulas de estetrol y uno o mas excipientes farmaceuticamente aceptables en una unidad de dosificacion solida. La unidad de dosificacion solida es facil de fabricar y perfectamente adecuada para su administracion sublingual, bucal o sublabial.
PE2017002731A 2015-06-18 2016-06-17 Unidad de dosificacion orodispersable que contiene un componente estetrol PE20180398A1 (es)

Applications Claiming Priority (1)

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

Publications (1)

Publication Number Publication Date
PE20180398A1 true PE20180398A1 (es) 2018-02-28

Family

ID=53442623

Family Applications (1)

Application Number Title Priority Date Filing Date
PE2017002731A PE20180398A1 (es) 2015-06-18 2016-06-17 Unidad de dosificacion orodispersable que contiene un componente estetrol

Country Status (43)

Country Link
US (3) US20160367567A1 (es)
EP (1) EP3106148B1 (es)
JP (1) JP6863547B2 (es)
KR (1) KR102664563B1 (es)
CN (2) CN107771075A (es)
AU (1) AU2016280863B2 (es)
CA (1) CA2988498C (es)
CL (1) CL2017003208A1 (es)
CO (1) CO2017012766A2 (es)
CR (1) CR20180042A (es)
CU (1) CU24523B1 (es)
CY (1) CY1120467T1 (es)
DK (1) DK3106148T3 (es)
DO (1) DOP2017000293A (es)
EA (1) EA035651B1 (es)
EC (1) ECSP17085669A (es)
ES (1) ES2671160T3 (es)
GE (2) GEAP202114677A (es)
GT (1) GT201700270A (es)
HK (1) HK1251940A1 (es)
HR (1) HRP20180889T1 (es)
HU (1) HUE037383T2 (es)
IL (1) IL256283B (es)
LT (1) LT3106148T (es)
MX (1) MX385820B (es)
MY (1) MY195019A (es)
NO (1) NO3106148T3 (es)
NZ (1) NZ737948A (es)
PE (1) PE20180398A1 (es)
PH (1) PH12017502325B1 (es)
PL (1) PL3106148T3 (es)
PT (1) PT3106148T (es)
RS (1) RS57328B1 (es)
SA (1) SA517390550B1 (es)
SG (1) SG10202010432UA (es)
SI (1) SI3106148T1 (es)
SM (1) SMT201800232T1 (es)
SV (1) SV2017005595A (es)
TN (1) TN2017000499A1 (es)
TR (1) TR201808438T4 (es)
UA (1) UA123098C2 (es)
WO (1) WO2016203011A1 (es)
ZA (1) ZA201708287B (es)

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HUE054551T2 (hu) 2015-06-18 2021-09-28 Estetra Sprl Ösztetrolt tartalmazó, szájban diszpergálódó tabletta
MA44205B1 (fr) 2015-06-18 2021-04-30 Estetra Sprl Comprimé orodispersible comprenant estetrol
SMT201800232T1 (it) 2015-06-18 2018-07-17 Mithra Pharmaceuticals S A Unita' di dosaggio orodispersibile contenente un componente di estetrolo
EP3310333B1 (en) 2015-06-18 2020-04-29 Estetra SPRL Orodispersible dosage unit containing an estetrol component
KR102712911B1 (ko) 2016-08-05 2024-10-04 에스테트라, 소시에떼 아 레스폰서빌리떼 리미떼 월경통 및 생리통의 관리방법
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