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CL2017003209A1 - Unidad de dosificación orodispersable que contiene un componente estetrol - Google Patents

Unidad de dosificación orodispersable que contiene un componente estetrol

Info

Publication number
CL2017003209A1
CL2017003209A1 CL2017003209A CL2017003209A CL2017003209A1 CL 2017003209 A1 CL2017003209 A1 CL 2017003209A1 CL 2017003209 A CL2017003209 A CL 2017003209A CL 2017003209 A CL2017003209 A CL 2017003209A CL 2017003209 A1 CL2017003209 A1 CL 2017003209A1
Authority
CL
Chile
Prior art keywords
stetrol
weight
dosing unit
solid dosage
orodispersible
Prior art date
Application number
CL2017003209A
Other languages
English (en)
Inventor
Severine Francine Isabella Jaspart
Johannes Jan Platteeuw
Den Heuvel Denny Johan Ma 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 CL2017003209A1 publication Critical patent/CL2017003209A1/es

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
    • A61K9/20—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
    • 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
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/38—Cellulose; Derivatives thereof
    • 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
    • A61K9/2013—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
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1617—Organic compounds, e.g. phospholipids, fats
    • A61K9/1623—Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Endocrinology (AREA)
  • Physiology (AREA)
  • Nutrition Science (AREA)
  • Zoology (AREA)
  • Gynecology & Obstetrics (AREA)
  • Reproductive Health (AREA)
  • Diabetes (AREA)
  • Molecular Biology (AREA)
  • Inorganic Chemistry (AREA)
  • Biophysics (AREA)
  • Biochemistry (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Steroid Compounds (AREA)

Abstract

<p>LA INVENCIÓN PROPORCIONA UNA UNIDAD DE DOSIFICACIÓN SÓLIDA ORO-DISPERSABLE FARMACÉUTICA QUE TIENE UN PESO COMPRENDIDO ENTRE 30 Y 1000 MG, CONSISTIENDO DICHA UNIDAD DE DOSIFICACIÓN EN: (A) 0,1-25 %  EN PESO DE PARTÍCULAS DE ESTETROL QUE CONTIENEN AL MENOS 80% EN PESO DE UN COMPONENTE ESTETROL SELECCIONADO ENTRE ESTETROL, ÉSTERES DE ESTETROL Y COMBINACIONES DE LOS MISMOS; Y (B) 75-99,9% EN PESO DE UNO O MÁS INGREDIENTES FARMACÉUTICAMENTE ACEPTABLES; COMPRENDIENDO LA UNIDAD DE DOSIFICACIÓN SÓLIDA QUE AL MENOS 100 UG DEL COMPONENTE ESTETROL; Y EN LA QUE LA UNIDAD DE DOSIFICACIÓN SÓLIDA SE PUEDE OBTENER A TRAVÉS DE UN PROCEDIMIENTO QUE COMPRENDE GRANULACIÓN E N HÚMEDO DE PARTÍCULAS DE ESTETROL QUE TIENEN UN PROMEDIO DE TAMAÑO DE PARTÍCULA POR VOLUMEN PESADO DE 2 UM A 50 UM. LA UNIDAD DE DOSIFICACIÓN SÓLIDA ES FÁCIL DE FABRICAR Y PERFECTAMENTE ADECUADA PARA SU ADMINISTRACIÓN SUBLINGUAL, BUCAL O SUBLABIAL.</p>
CL2017003209A 2015-06-18 2017-12-14 Unidad de dosificación orodispersable que contiene un componente estetrol CL2017003209A1 (es)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
EP15172767 2015-06-18

Publications (1)

Publication Number Publication Date
CL2017003209A1 true CL2017003209A1 (es) 2018-04-13

Family

ID=53496426

Family Applications (1)

Application Number Title Priority Date Filing Date
CL2017003209A CL2017003209A1 (es) 2015-06-18 2017-12-14 Unidad de dosificación orodispersable que contiene un componente estetrol

Country Status (42)

Country Link
US (4) US11147771B2 (es)
EP (2) EP3310333B1 (es)
JP (2) JP6866560B2 (es)
KR (2) KR102735893B1 (es)
CN (2) CN116077455A (es)
AU (4) AU2016280858B2 (es)
BR (1) BR112017027229B1 (es)
CA (1) CA2988495C (es)
CL (1) CL2017003209A1 (es)
CO (1) CO2017012670A2 (es)
CR (1) CR20180041A (es)
CU (1) CU24504B1 (es)
CY (2) CY1123006T1 (es)
DK (2) DK3701944T3 (es)
DO (1) DOP2017000294A (es)
EA (2) EA202090984A1 (es)
EC (1) ECSP17085659A (es)
ES (2) ES2800774T3 (es)
GE (1) GEP20217243B (es)
HR (2) HRP20200850T1 (es)
HU (3) HUE049232T2 (es)
IL (1) IL256282B (es)
LT (3) LT3310333T (es)
MA (1) MA45972B1 (es)
MD (1) MD3310333T2 (es)
ME (1) ME03728B (es)
MX (1) MX384904B (es)
MY (1) MY186164A (es)
NO (1) NO2022020I1 (es)
NZ (2) NZ737945A (es)
PE (2) PE20180522A1 (es)
PH (1) PH12017502326A1 (es)
PL (2) PL3701944T3 (es)
PT (2) PT3310333T (es)
RS (2) RS60252B1 (es)
SI (2) SI3701944T1 (es)
SM (2) SMT202200102T1 (es)
SV (1) SV2017005596A (es)
TN (1) TN2017000497A1 (es)
UA (1) UA123099C2 (es)
WO (1) WO2016203006A1 (es)
ZA (2) ZA201708286B (es)

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MA44205B1 (fr) 2015-06-18 2021-04-30 Estetra Sprl Comprimé orodispersible comprenant estetrol
EP3310333B1 (en) 2015-06-18 2020-04-29 Estetra SPRL Orodispersible dosage unit containing an estetrol component
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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
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