DK3106148T3 - Orodispergerbar doseringsenhed indeholdende en estetrolbestanddel - Google Patents
Orodispergerbar doseringsenhed indeholdende en estetrolbestanddel Download PDFInfo
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- DK3106148T3 DK3106148T3 DK16175091.4T DK16175091T DK3106148T3 DK 3106148 T3 DK3106148 T3 DK 3106148T3 DK 16175091 T DK16175091 T DK 16175091T DK 3106148 T3 DK3106148 T3 DK 3106148T3
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- 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
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- 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
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- 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
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- 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
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- 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
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- 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
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- 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
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- 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
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- 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
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- 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
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- 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
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- 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
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- 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
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- 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
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- 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
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- 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
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- Life Sciences & Earth Sciences (AREA)
- Veterinary Medicine (AREA)
- Chemical & Material Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
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- Animal Behavior & Ethology (AREA)
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Claims (19)
1. Orodispergerbar fast farmaceutisk doseringsenhed, der har en vægt på mellem 30 og 1.000 mg, fortrinsvis mellem 40 og 500 mg, hvor doseringsenheden består af: • 0,1-25 vægt-%, fortrinsvis 0,5-25 vægt-% estetrolpartikler indeholdende mindst 90 vægt-% af en estetrolbestanddel udvalgt blandt estetrol, estetrole-stere og kombinationer deraf, fortrinsvis hvor estetrolbestanddelen er estetrol; og • 75-99,9 vægt-% af en eller flere farmaceutisk acceptable bestanddele; hvor den faste doseringsenhed omfatter mindst 100 pg af estetrolbestanddelen; hvor den faste doseringsenhed kan opnås ved en fremgangsmåde omfattende: • at tilvejebringe estetrolpartikler indeholdende mindst 90 vægt-% af en estetrolbestanddel udvalgt blandt estetrol, estetrolestere og kombinationer deraf, hvor estetrolpartiklerne har en volumenmediandiameter i området fra 2 pm til 50 pm, fortrinsvis i området fra 3 pm til 35 pm; • at fremstille en tør blanding ved at blande estetrolpartiklerne med en eller flere farmaceutisk acceptable hjælpestoffer; og • at komprimere den tørre blanding til en fast doseringsenhed.
2. Fast doseringsenhed ifølge krav 1, hvor doseringsenheden indeholder 0,3-100 mg af estetrolbestanddelen.
3. Doseringsenhed ifølge et af de foregående krav, hvor doseringsenheden indeholder 50-99,5 vægt-% fyldstof udvalgt blandt maltose, fructose, sucrose, lactose, glucose, galactose, trehalose, xylitol, sorbitol, erythritol, maltitol, mannitol, isomalt, mikrokrystallinsk cellulose, calciumsalte og kombinationer deraf, fortrinsvis udvalgt blandt lactose, xylitol, sorbitol, erythritol, mannitol, mikrokrystallinsk cellulose og kombinationer deraf.
4. Doseringsenhed ifølge krav 3, hvor doseringsenheden indeholder mindst 20 vægt-% sukkeralkohol udvalgt blandt mannitol, xylitol og kombinationer deraf.
5. Doseringsenhed ifølge et af de foregående krav, hvor doseringsenheden indeholder 0,1-20 vægt-% af et opløsningsmiddel udvalgt blandt modificerede stivelser, tværbundet polyvinylpyrrolidon, tværbundet carmellose og kombinationer deraf.
6. Doseringsenhed ifølge et af de foregående krav, hvor doseringsenheden indeholder 0-60 vægt-% mikrokrystallinsk cellulose.
7. Doseringsenhed ifølge et af de foregående krav, hvor doseringsenheden indeholder 0,1-2 vægt-% smøremiddel udvalgt blandt natriumstearylfumarat, magnesiumstearat, stearinsyre, natriumlaurylsulfat, talkum, polyethylengly-col, calciumstearat og blandinger deraf.
8. Fast doseringsenhed ifølge et af de foregående krav til anvendelse ved medicinsk behandling eller til anvendelse ved kvindelig hormonsubstitutionsterapi, hvor anvendelsen omfatter sublingual, bukkal eller sublabial indgivelse af doseringsenheden.
9. Fast doseringsenhed til anvendelse ifølge krav 8, hvor anvendelsen omfatter indgivelse en gang dagligt i en periode på mindst 1 uge.
10. Fremgangsmåde til kvindelig prævention, hvilken fremgangsmåde omfatter sublingual, bukkal eller sublabial indgivelse af en doseringsenhed ifølge et af kravene 1 -7.
11. Fremgangsmåde ifølge krav 10, hvilken fremgangsmåde omfatter indgivelse en gang dagligt i en periode på mindst 1 uge.
12. Fremgangsmåde til fremstilling af en fast doseringsenhed ifølge et af kravene 1-7, hvilken fremgangsmåde omfatter de følgende trin: • at tilvejebringe estetrolpartikler indeholdende mindst 90 vægt-% af en este-trolbestanddel udvalgt blandt estetrol, estetrolestere og kombinationer deraf, hvor estetrolpartiklerne har en volumenmediandiameter i området fra 2 pm til 50 pm, fortrinsvis i området fra 3 pm til 35 pm; • at fremstille en tør blanding ved at blande 1 vægtandel af estetrolpartiklerne med 2-1.000 vægtandele af et eller flere farmaceutisk acceptable hjælpestoffer; og • at komprimere den tørre blanding til en fast doseringsenhed.
13. Fremgangsmåde ifølge krav 12, hvor fremgangsmåden ikke omfatter tilsætning af flydende opløsningsmiddel under eller efter kombineringen af estetrolpartiklerne og et ene eller de flere farmaceutisk acceptable hjælpestoffer.
14. Fremgangsmåde ifølge et af kravene 12-13, hvor den tørre blanding indeholder 50-99,5 vægt-% af et fyldstof udvalgt blandt maltose, fructose, sucrose, lactose, glucose, galactose, trehalose, xylitol, sorbitol, erythritol, malti-tol, mannitol, isomalt, mikrokrystallinsk cellulose, calciumsalte og kombinationer deraf, fortrinsvis udvalgt blandt lactose, xylitol, sorbitol, erythritol, mannitol, mikrokrystallinsk cellulose og kombinationer deraf.
15. Fremgangsmåde ifølge krav 14, hvor den tørre blanding indeholder mindst 20 vægt-% sukkeralkohol udvalgt blandt mannitol, xylitol og kombinationer deraf.
16. Fremgangsmåde ifølge et af kravene 12-15, hvor den tørre blanding indeholder 0,1-20 vægt-% af et opløsningsmiddel udvalgt blandt modificerede stivelser, tværbundet polyvinylpyrrolidon, tværbundet carmellose og kombinationer deraf.
17. Fremgangsmåde ifølge et af kravene 12-16, hvor doseringsenheden indeholder 0-60 vægt-% mikrokrystallinsk cellulose.
18. Fremgangsmåde ifølge et af kravene 12-17, hvor den tørre blanding indeholder 0,1-2 vægt-% smøremiddel udvalgt blandt natriumstearylfumarat, magnesiumstearat, stearinsyre, natriumlaurylsulfat, talkum, polyethylengly-col, calciumstearat og blandinger deraf.
19. Fremgangsmåde ifølge et af kravene 12-18, hvor den faste doseringsenhed er formet ved direkte kompression.
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EP15172747 | 2015-06-18 |
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DK3106148T3 true DK3106148T3 (da) | 2018-05-07 |
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DK16175091.4T DK3106148T3 (da) | 2015-06-18 | 2016-06-17 | Orodispergerbar doseringsenhed indeholdende en estetrolbestanddel |
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Families Citing this family (10)
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PT2714712T (pt) | 2011-06-01 | 2016-11-08 | Estetra Sprl | Processo para a produção de intermediários de estetrol |
WO2012164096A1 (en) | 2011-06-01 | 2012-12-06 | Estetra S.A. | Process for the production of estetrol intermediates |
EP2383279A1 (en) | 2011-07-19 | 2011-11-02 | Pantarhei Bioscience B.V. | Process for the preparation of estetrol |
TN2017000497A1 (en) | 2015-06-18 | 2019-04-12 | Mithra Pharmaceuticals S A | Orodispersible dosage unit containing an estetrol component |
MA44205B1 (fr) | 2015-06-18 | 2021-04-30 | Estetra Sprl | Comprimé orodispersible comprenant estetrol |
MX2017016276A (es) | 2015-06-18 | 2018-06-19 | Mithra Pharmaceuticals S A | Unidad de dosificacion orodispersable que contiene un componente estetrol. |
LT3310346T (lt) | 2015-06-18 | 2021-06-10 | Estetra Sprl | Burnoje disperguojama tabletė, turinti estetrolio |
KR20220144885A (ko) | 2016-08-05 | 2022-10-27 | 에스테트라, 소시에떼 아 레스폰서빌리떼 리미떼 | 월경통 및 생리통의 관리방법 |
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