HRP20240365T1 - Farmaceutski pripravak koji sadrži derivate glukopiranozil difenilmetana, njegov farmaceutski oblik za doziranje, postupak za njihovu proizvodnju i njihove uporabe za poboljšanu regulaciju glikemije kod pacijenta - Google Patents

Farmaceutski pripravak koji sadrži derivate glukopiranozil difenilmetana, njegov farmaceutski oblik za doziranje, postupak za njihovu proizvodnju i njihove uporabe za poboljšanu regulaciju glikemije kod pacijenta Download PDF

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HRP20240365T1
HRP20240365T1 HRP20240365TT HRP20240365T HRP20240365T1 HR P20240365 T1 HRP20240365 T1 HR P20240365T1 HR P20240365T T HRP20240365T T HR P20240365TT HR P20240365 T HRP20240365 T HR P20240365T HR P20240365 T1 HRP20240365 T1 HR P20240365T1
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compound
formula
pharmaceutical preparation
preparation
specified
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Wolfram Eisenreich
Nadia S. Ladyzhynsky
Danping Li
Leon Schultz
Zeren Wang
Sreeraj Macha
Albert Barta
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Boehringer Ingelheim International Gmbh
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Application filed by Boehringer Ingelheim International Gmbh filed Critical Boehringer Ingelheim International Gmbh
Publication of HRP20240365T1 publication Critical patent/HRP20240365T1/hr

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    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
    • A61K31/425—Thiazoles
    • A61K31/429—Thiazoles condensed with heterocyclic ring systems
    • A61K31/43—Compounds containing 4-thia-1-azabicyclo [3.2.0] heptane ring systems, i.e. compounds containing a ring system of the formula, e.g. penicillins, penems
    • A61K31/431—Compounds containing 4-thia-1-azabicyclo [3.2.0] heptane ring systems, i.e. compounds containing a ring system of the formula, e.g. penicillins, penems containing further heterocyclic rings, e.g. ticarcillin, azlocillin, oxacillin
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    • A61K31/00—Medicinal preparations containing organic active ingredients
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    • A61K31/35—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom
    • A61K31/351—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom not condensed with another ring
    • A—HUMAN NECESSITIES
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    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
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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
    • A61K9/14—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
    • 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
    • A61K9/1682—Processes
    • A61K9/1694—Processes resulting in granules or microspheres of the matrix type containing more than 5% of excipient
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • 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
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    • A—HUMAN NECESSITIES
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    • A61P3/00—Drugs for disorders of the metabolism
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
    • A61P3/10—Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics

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Claims (19)

1. Farmaceutski pripravak, naznačen time, da sadrži spoj 1-kloro-4-(β-D-glukopiranoz-1-il)-2-[4-((S)-tetrahidrofuran-3-iloksi)-benzil]-benzena formule (I.9), [image] pri čemu je raspodjela veličina čestica spoja formule (I.9) u navedenom pripravku 5 µm ≤ X90 ≤ 100 µm, dok se raspodjela veličina čestica odnosi na volumen i utvrđuje se metodom laserske difrakcije, i time, da navedeni spoj formule (I.9) predstavlja 1,0% do 20% od mase navedenog pripravka.
2. Farmaceutski pripravak prema patentnom zahtjevu 1, naznačen time, da spoj formule (I.9) predstavlja 2,0% do 15% od mase farmaceutskog pripravka.
3. Farmaceutski pripravak prema patentnom zahtjevu 1 ili 2, naznačen time, da raspodjela veličina čestica spoja formule (I.9) u spomenutom pripravku iznosi 10 µm ≤ X90 ≤ 100 µm, pri čemu se raspodjela veličina čestica odnosi na volumen i utvrđuje se metodom laserske difrakcije.
4. Farmaceutski pripravak prema patentnom zahtjevu 1, 2 ili 3, dok spomenuti pripravak sadrži kristalni oblik navedenog spoja formule (I.9), poželjno pri čemu je kristalni oblik spoja formule (I.9) naznačen time, da posjeduje uzorak rendgenske difrakcije na prahu koji ima maksimume na 18,84, 20,36 i 25,21 stupnjeva 2Θ (±0,1 stupanj 2Θ), pri čemu je navedeni uzorak rendgenske difrakcije na prahu (XRPD) načinjen uporabom CuKα1 radijacije.
5. Farmaceutski pripravak prema patentnom zahtjevu 4, naznačen time, da se najmanje 50% po masi, prvenstveno najmanje 80% po masi od spoja (I.9) nalazi u njegovom kristalnom obliku.
6. Farmaceutski pripravak prema bilo kojem od patentnih zahtjeva 1 do 5, naznačen time, da spomenuti pripravak sadrži dezintegrator i vezivno sredstvo, pri čemu omjer od navedenog dezintegratora prema navedenom vezivnom sredstvu iznosi između 1,5 : 3,5 i 1 : 1 (masa/masa).
7. Farmaceutski pripravak prema bilo kojem od patentnih zahtjeva 1 do 6, naznačen time, da dezintegrator u farmaceutskom pripravku je kroskarmeloza natrij.
8. Farmaceutski pripravak prema bilo kojem od patentnih zahtjeva 1 do 7, naznačen time, da vezivno sredstvo u farmaceutskom pripravku je hidroksipropil celuloza.
9. Farmaceutski pripravak prema bilo kojem od patentnih zahtjeva 1 do 8, naznačen time, da najmanje 99% čestica od navedenog vezivnog sredstva (po masi) su 250 µm ili manje.
10. Farmaceutski pripravak prema bilo kojem od patentnih zahtjeva 1 do 9, naznačen time, da se spomenuti pripravak dobiva putem vlažne granulacije visokog smicanja, pri čemu navedeni pripravak nadalje sadrži razrjeđivač, gdje se 5 - 20% (po masi) od spomenutog razrjeđivača dodaje u navedeni pripravak kao suhi dodatak nakon spomenute vlažne granulacije.
11. Farmaceutski pripravak prema bilo kojem od patentnih zahtjeva 1 do 10, naznačen time, da spomenuti pripravak sadrži: [image] ili [image] ili [image] ili [image] ili [image] ili [image] .
12. Farmaceutski pripravak prema bilo kojem od patentnih zahtjeva 1 do 11, naznačen time, da nadalje sadrži jedan ili više lubrikanata.
13. Farmaceutski pripravak prema bilo kojem od patentnih zahtjeva 1 do 12, naznačen time, da nadalje sadrži jedno ili više kliznih sredstava.
14. Farmaceutski pripravak prema bilo kojem od patentnih zahtjeva 1 do 13, naznačen time, da količina spoja formule (I.9) iznosi 1 do 25 mg, prvenstveno 1, 2,5, 5, 10 ili 25 mg.
15. Farmaceutski oblik za doziranje, naznačen time, da sadrži farmaceutski pripravak u skladu s bilo kojim od patentnih zahtjeva 1 do 14.
16. Farmaceutski oblik za doziranje prema patentnom zahtjevu 15, naznačen time, da spomenuti oblik za doziranje je čvrsti farmaceutski oblik za doziranje za oralnu primjenu, poželjno tableta, kapsula ili filmom obložena tableta.
17. Postupak vlažne granulacije, naznačen time, da je za izradu farmaceutskog oblika za doziranje koji sadrži spoj 1-kloro-4-(β-D-glukopiranoz-1-il)-2-[4-((S)-tetrahidrofuran-3-iloksi)-benzil]-benzena formule (I.9) i jednu ili više pomoćnih tvari, [image] pri čemu je raspodjela veličina čestica spoja formule (I.9) u navedenom pripravku 5 µm ≤ X90 ≤ 100 µm, dok se raspodjela veličina čestica odnosi na volumen i utvrđuje se metodom laserske difrakcije, i pritom navedeni spoj formule (I.9) predstavlja 1,0% do 20% od mase navedenog pripravka, gdje navedeni postupak obuhvaća sljedeće korake: (1) prethodno miješanje navedenog spoja formule (I.9) i glavnog udjela pomoćnih tvari uključujući vezivno sredstvo u miješalici kako bi se dobila predsmjesa; (2) granuliranje predsmjese iz koraka (1) pomoću dodavanja granulacijske tekućine, poželjno vode; (3) sušenje granula iz koraka (2) u sušilici s fluidiziranim slojem ili u pećnici za sušenje; (4) opcionalno suho prosijavanje osušenih granula iz koraka (3); (5) miješanje osušenih granula iz koraka (4) s preostalim pomoćnim tvarima u miješalici kako bi se dobila konačna smjesa; (6) tabletiranje konačne smjese iz koraka (5) putem njezina komprimiranja na odgovarajućoj preši za tablete u svrhu proizvodnje jezgri tableta; (7) opcionalno oblaganje filmom jezgri tableta iz koraka (6) s film oblogom.
18. Postupak izravnog komprimiranja, naznačen time, da je za izradu farmaceutskog pripravka koji sadrži spoj 1-kloro-4-(β-D-glukopiranoz-1-il)-2-[4-((S)-tetrahidrofuran-3-iloksi)-benzil]-benzena formule (I.9) i jednu ili više pomoćnih tvari, [image] pri čemu je raspodjela veličina čestica spoja formule (I.9) u navedenom pripravku 5 µm ≤ X90 ≤ 100 µm, dok se raspodjela veličina čestica odnosi na volumen i utvrđuje se metodom laserske difrakcije, i pritom navedeni spoj formule (I.9) predstavlja 1,0% do 20% od mase navedenog pripravka, gdje navedeni postupak obuhvaća sljedeće korake: (1) prethodno miješanje navedenog spoja formule (I.9) i glavnog udjela pomoćnih tvari u miješalici kako bi se dobila predsmjesa; (2) opcionalno suho prosijavanje predsmjese kroz sito kako bi se segregirale kohezivne čestice i kako bi se poboljšala uniformnost sadržaja; (3) miješanje predsmjese iz koraka (1) ili (2) u miješalici, opcionalno pomoću dodavanja preostalih pomoćnih tvari u smjesu i nastavljanje miješanja; (4) tabletiranje konačne smjese iz koraka (3) pomoću njezinog komprimiranja na prikladnoj preši za tablete u svrhu proizvodnje jezgri tableta; (5) opcionalno oblaganje filmom jezgri tableta iz koraka (4) s film oblogom.
19. Postupak suhe granulacije, naznačen time, da je za izradu farmaceutskog pripravka koji sadrži spoj 1-kloro-4-(β-D-glukopiranoz-1-il)-2-[4-((S)-tetrahidrofuran-3-iloksi)-benzil]-benzena formule (I.9) i jednu ili više pomoćnih tvari, [image] pri čemu je raspodjela veličina čestica spoja formule (I.9) u navedenom pripravku 5 µm ≤ X90 ≤ 100 µm, dok se raspodjela veličina čestica odnosi na volumen i utvrđuje se metodom laserske difrakcije, i pritom navedeni spoj formule (I.9) predstavlja 1,0% do 20% od mase navedenog pripravka, gdje navedeni postupak obuhvaća sljedeće korake: (1) miješanje spomenutog spoja formule (I.9) sa svim pomoćnim tvarima ili s dijelom pomoćnih tvari u miješalici; (2) zbijanje smjese iz koraka (1) na prikladnom valjkastom kompaktoru; (3) smanjivanje traka koje su dobivene za vrijeme koraka (2) u granule pomoću prikladnih koraka za mljevenje ili prosijavanje; (4) opcionalno miješanje granula iz koraka (3) s preostalim pomoćnim tvarima u miješalici kako bi se dobila konačna smjesa; (5) tabletiranje granula iz koraka (3) ili konačne smjese iz koraka (4) pomoću komprimiranja istih na prikladnoj preši za tablete u svrhu proizvodnje jezgri tableta; (6) opcionalno oblaganje filmom jezgri tableta iz koraka (5) s film oblogom.
HRP20240365TT 2009-02-13 2010-02-11 Farmaceutski pripravak koji sadrži derivate glukopiranozil difenilmetana, njegov farmaceutski oblik za doziranje, postupak za njihovu proizvodnju i njihove uporabe za poboljšanu regulaciju glikemije kod pacijenta HRP20240365T1 (hr)

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Application Number Priority Date Filing Date Title
US15231709P 2009-02-13 2009-02-13
US25403309P 2009-10-22 2009-10-22
EP10703652.7A EP2395968B1 (en) 2009-02-13 2010-02-11 Pharmaceutical composition comprising glucopyranosyl diphenylmethane derivatives, pharmaceutical dosage form thereof, process for their preparation and uses thereof for improved glycemic control in a patient
PCT/EP2010/051737 WO2010092126A1 (en) 2009-02-13 2010-02-11 Pharmaceutical composition comprising glucopyranosyl diphenylmethane derivatives, pharmaceutical dosage form thereof, process for their preparation and uses thereof for improved glycemic control in a patient

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KR (3) KR20170005156A (hr)
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