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HRP20211968T1 - Orodisperzibilna jedinica za doziranje koja sadrži komponentu estetrola - Google Patents

Orodisperzibilna jedinica za doziranje koja sadrži komponentu estetrola Download PDF

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Publication number
HRP20211968T1
HRP20211968T1 HRP20211968TT HRP20211968T HRP20211968T1 HR P20211968 T1 HRP20211968 T1 HR P20211968T1 HR P20211968T T HRP20211968T T HR P20211968TT HR P20211968 T HRP20211968 T HR P20211968T HR P20211968 T1 HRP20211968 T1 HR P20211968T1
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Croatia
Prior art keywords
estetrol
dosage unit
granulation
combinations
granules
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HRP20211968TT
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English (en)
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Séverine Francine Isabelle Jaspart
Johannes Jan Platteeuw
Denny Johan Marijn Van Den Heuvel
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Estetra Srl
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Publication of HRP20211968T1 publication Critical patent/HRP20211968T1/hr

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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
    • 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
    • A61K9/006—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
    • A61K9/14—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
    • 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
    • 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
    • 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

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Chemical & Material Sciences (AREA)
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  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Endocrinology (AREA)
  • Physiology (AREA)
  • Nutrition Science (AREA)
  • Zoology (AREA)
  • Gynecology & Obstetrics (AREA)
  • Reproductive Health (AREA)
  • Diabetes (AREA)
  • Molecular Biology (AREA)
  • Inorganic Chemistry (AREA)
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  • Oil, Petroleum & Natural Gas (AREA)
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  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Steroid Compounds (AREA)

Claims (17)

1. Čvrsta farmaceutska orodisperzibilna jedinica za doziranje koja ima težinu između 30 i 1,000 mg, poželjno između 40 i 500 mg, navedena jedinica za doziranje se sastoji od: • 0.1-25 mas.%, poželjno 0.5-25 mas.% čestica estetrola koje sadrže najmanje 90 mas.% komponente estetrola izabrane između estetrola, estetrol estera i njihovih kombinacija; poželjno estetrol komponenta je estetrol, i • 75-99.9 mas.% jednog ili više farmaceutski prihvatljivih sastojaka; čvrsta jedinica za doziranje sadrži najmanje 100 μg komponente estetrola; pri čemu se čvrsta jedinica za doziranje može dobiti postupkom koji sadrži: • dobivanje čestica estetrola koje sadrže najmanje 90 mas.% komponente estetrola i imaju srednji promjer volumena od 2 μm) do 50 μm; poželjno od 3 μm) do 35 μm; • miješanje čestica estetrola s jednim ili više granulacijskih pomoćnih tvari radi dobivanja granulacijske mješavine; • miješanje granulacijske mješavine s granulacijskom tekućinom da se dobiju granule koje sadrže estetrol, navedena granulacijska tekućina sadrži najmanje 60 mas.% tekućeg otapala; • uklanjanje tekućeg otapala iz granula koje sadrže estetrol da se dobiju suhe granule koje sadrže estetrol; • izborno miješanje suhih granula s jednom ili više pomoćnih tvari za tabletiranje; i • formiranje suhih granula ili mješavine suhih granula i jedne ili više pomoćnih tvari za tabletiranje u čvrstu jedinicu za doziranje, pri čemu jedinica za doziranje sadrži 0.3-100 mg komponente estetrola.
2. Čvrsta jedinica za doziranje prema zahtjevu 1, naznačena time što jedinica za doziranje sadrži 50-99.9 mas.% ugljikohidrata topivih u vodi koji su izabrani između maltoze, fruktoze, saharoze, laktoze, glukoze, galaktoze, trehaloze, ksilitola, sorbitola, eritritola, maltitola, manitola , izomalta i njihove kombinacije.
3. Čvrsta jedinica za doziranje prema zahtjevu 2, naznačena time što jedinica za doziranje sadrži najmanje 20 mas.% manitola.
4. Čvrsta jedinica za doziranje prema bilo kojem od prethodnih zahtjeva, naznačena time što jedinica za doziranje sadrži 0.1-20 mas.% sredstva za dezintegraciju izabranog između modificiranog škroba, umreženog polivinilpirolidona, umrežene karmeloze i njihovih kombinacija.
5. Čvrsta jedinica za doziranje prema bilo kojem od prethodnih zahtjeva, naznačena time što navedeni farmaceutski prihvatljiv sastojak sadrži progestogen odabran iz skupine koju čine: progesteron, dezogestrel, etonogestrel, gestoden, dienogest, levonorgestrel, norgestimat, noretisteron, noretisteron-acetat (NETA), nomegestrol, nomegestrol-acetat (NOMAC), drospirenon, trimegeston, nestoron i didrogesteron.
6. Čvrsta jedinica za doziranje prema zahtjevu 5, naznačena time što je navedeni progestagen 0.05-10 mg drospirenona.
7. Čvrsta jedinica za doziranje prema bilo kojem od prethodnih zahtjeva za uporabu u medicinskom liječenju ili za uporabu u nadomjesnoj terapiji ženskih hormona, navedena uporaba sadrži sublingvalnu, bukalnu ili sublabijalnu primjenu jedinice za doziranje, poželjno navedena uporaba sadrži jednom dnevno sublingvalnu, bukalnu ili sublabijalnu primjenu jedinice za doziranje tijekom perioda od najmanje 1 tjedna.
8. Postupak ženske kontracepcije, navedeni postupak sadrži sublingvalnu, bukalnu ili sublabijalnu primjenu jedinice za doziranje prema bilo kojem od zahtjeva 1-6, poželjno navedeni postupak sadrži jednom dnevno sublingvalnu, bukalnu ili sublabijalnu primjenu jedinice za doziranje tijekom perioda od najmanje 1 tjedna.
9. Proces pripreme čvrste jedinice za doziranje zahtjevima 1 do 6, navedeni proces sadrži korake: • dobivanje čestica estetrola koje sadrže najmanje 90 mas.% komponente estetrola izabrane između estetrola, estetrol estera i njihovih kombinacija i imaju srednji promjer volumena od 2 μm do 50 μm, poželjno od 3 μm do 35 μm; • miješanje čestica estetrola s jednom ili više granulacijskih pomoćnih tvari radi dobivanja granulacijske mješavine; • miješanje granulacijske mješavine s granulacijskom tekućinom da se dobiju granule koje sadrže estetrol, poželjno u težinskom omjeru koji je u rasponu od 0.5:1 do 20:1, navedena granulacijska tekućina sadrži najmanje 60 mas.% tekućeg otapala; • uklanjanje tekućeg otapala iz granula koje sadrže estetrol, da se dobiju suhe granule koje sadrže estetrol; • izborno miješanje suhih granula s jednom ili više pomoćnih tvari za tabletiranje; poželjno su navedene pomoćne tvari odabrane između laktoze, manitola, ksilitola, mikrokristalne celuloze, škroba, kroskarmeloze natrija, polivinil pirolidona i njihovih kombinacija; i • formiranje suhih granula ili mješavine suhih granula i jedne ili više pomoćnih tvari za tabletiranje u čvrstu jedinicu za doziranje, poželjno izravnom kompresijom ili kompresijskim prešanjem.
10. Proces prema zahtjevu 9, naznačen time što granulacijska mješavina sadrži 0.1-20 mas.% sredstva za dezintegraciju izabranog između modificiranog škroba, umreženog PVP, umrežene karmeloze i njihovih kombinacija.
11. Proces prema bilo kojem od zahtjeva 9 ili 10, naznačen time što se granulacijska mješavina proizvodi kombiniranjem čestica estetrola s jednom ili više granulacijskih pomoćnih tvari u težinskom omjeru koji je u rasponu od 1: 4 do 1: 1,000.
12. Proces prema bilo kojem od zahtjeva 9-11, naznačen time što se granule koje sadrže estetrol proizvode miješanjem granulacijske mješavine s granulacijskom tekućinom u granulatoru visokog smicanja, granulatorom niskog smicanja ili granulatorom fluidiziranog sloja.
13. Proces prema bilo kojem od zahtjeva 9-12, naznačen time što granulacijska tekućina sadrži najmanje 60 mas.% polarnog otapala izabranog između vode, metanola, etanola, izo-propanola, acetona i njihovih kombinacija, poželjno izabranih između vode, etanola i njihovih kombinacija.
14. Proces prema zahtjevu 13, naznačen time što polarno otapalo sadrži najmanje 80 mas.% vode.
15. Proces prema bilo kojem od zahtjeva 9-14, naznačen time što granulacijska tekućina sadrži 0.2-50 mas.% veziva, navedeno vezivo je izabrano između derivata celuloze, škroba i derivata škroba, polivinil alkohola, polivinilpirolidona, agara, želatine, guar gume, arapske gume, alginata, polietilen glikola, glukoze, saharoze, sorbitola i njihove kombinacije, poželjno izabrano između derivata celuloze, predželatiniziranog škroba, polivinilpirolidona i njihovih kombinacija.
16. Proces prema zahtjevu 15, naznačen time što su derivati celuloze izabrani između hidroksipropil celuloze, hidroksietil celuloze, hidroksimetil celuloze, hidroksipropilmetilceluloze, metilceluloze, etilceluloze, karboksimetil celuloze i njihovih kombinacija.
17. Proces prema bilo kojem od zahtjeva 9-16, naznačen time što suhe granule koje sadrže estetrol imaju srednji promjer volumena u rasponu od 100-4,000 μm.
HRP20211968TT 2015-06-18 2016-06-17 Orodisperzibilna jedinica za doziranje koja sadrži komponentu estetrola HRP20211968T1 (hr)

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Application Number Priority Date Filing Date Title
EP15172767 2015-06-18
EP20171407.8A EP3701944B1 (en) 2015-06-18 2016-06-17 Orodispersible dosage unit containing an estetrol component

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HRP20211968T1 true HRP20211968T1 (hr) 2022-03-18

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HRP20200850TT HRP20200850T1 (hr) 2015-06-18 2020-05-26 Orodisperzibilna jedinica za doziranje koja sadrži komponentu estetrola

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Families Citing this family (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
HUE029252T2 (en) 2011-06-01 2017-02-28 Estetra Sprl Process for the preparation of intermediates of estetrol
SG195121A1 (en) 2011-06-01 2013-12-30 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
JP6866561B2 (ja) 2015-06-18 2021-04-28 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 エステトロールを含有する口腔内崩壊錠
SI3310333T1 (sl) 2015-06-18 2020-08-31 Estetra Sprl Orodisperzibilna enota odmerka, ki vsebuje komponento estetrola
US10888518B2 (en) 2015-06-18 2021-01-12 Estetra Sprl Orodispersible tablet containing estetrol
PE20180398A1 (es) 2015-06-18 2018-02-28 Mithra Pharmaceuticals S A Unidad de dosificacion orodispersable que contiene un componente estetrol
CA3178291A1 (en) 2016-08-05 2018-04-12 Estetra Srl Method for the management of dysmenorrhea and menstrual pain
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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HRP20200850T1 (hr) 2020-10-02
NZ737945A (en) 2023-06-30
KR102662025B1 (ko) 2024-05-02
ECSP17085659A (es) 2018-03-31
AU2022283615B2 (en) 2023-11-23
MD3310333T2 (ro) 2020-06-30
US11147771B2 (en) 2021-10-19
PE20180522A1 (es) 2018-03-14
RS60252B1 (sr) 2020-06-30
WO2016203006A1 (en) 2016-12-22
ES2906228T3 (es) 2022-04-13
LT3310333T (lt) 2020-06-25
NO2022020I1 (no) 2022-06-07
HUS2200027I1 (hu) 2022-07-28
US20180169022A1 (en) 2018-06-21
GEP20217243B (en) 2021-04-26
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PH12017502326A1 (en) 2018-06-25
CR20180041A (es) 2018-05-03

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