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HRP20230709T1 - Farmaceutski pripravci za liječenje bolesti povezanih s regulatorom provodljivosti transmembrane cistične fibroze - Google Patents

Farmaceutski pripravci za liječenje bolesti povezanih s regulatorom provodljivosti transmembrane cistične fibroze Download PDF

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Publication number
HRP20230709T1
HRP20230709T1 HRP20230709TT HRP20230709T HRP20230709T1 HR P20230709 T1 HRP20230709 T1 HR P20230709T1 HR P20230709T T HRP20230709T T HR P20230709TT HR P20230709 T HRP20230709 T HR P20230709T HR P20230709 T1 HRP20230709 T1 HR P20230709T1
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Croatia
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pharmaceutical preparation
weight
spray
preparation according
dried dispersion
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HRP20230709TT
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Brian Dean Phenix
Laurent Jean-claude Bagnol
Geoffrey Glen BRODEUR
Sachin Chandran
Eleni Dokou
Lori Ann Ferris
Dragutin Knezic
Katie Lynn McCarty
Ales Medek
Sara A. Waggener
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Vertex Pharmaceuticals Incorporated
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First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=53175129&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=HRP20230709(T1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Vertex Pharmaceuticals Incorporated filed Critical Vertex Pharmaceuticals Incorporated
Publication of HRP20230709T1 publication Critical patent/HRP20230709T1/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
    • A61K9/10—Dispersions; Emulsions
    • 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
    • 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
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/40—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
    • A61K31/403—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil condensed with carbocyclic rings, e.g. carbazole
    • A61K31/404—Indoles, e.g. pindolol
    • 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
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/4427—Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems
    • A61K31/443—Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems containing a five-membered ring with oxygen as a ring hetero atom
    • 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
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/47—Quinolines; Isoquinolines
    • 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
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/47—Quinolines; Isoquinolines
    • A61K31/4709—Non-condensed quinolines and containing further heterocyclic rings
    • 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
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/47—Quinolines; Isoquinolines
    • A61K31/472—Non-condensed isoquinolines, e.g. papaverine
    • A61K31/4725—Non-condensed isoquinolines, e.g. papaverine containing further heterocyclic rings
    • A—HUMAN NECESSITIES
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    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/141—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
    • A61K9/146—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with organic macromolecular compounds
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    • 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
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    • 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
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
    • 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
    • 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
    • A61K9/2072—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
    • A61P11/00—Drugs for disorders of the respiratory system
    • 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
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07D—HETEROCYCLIC COMPOUNDS
    • C07D209/00—Heterocyclic compounds containing five-membered rings, condensed with other rings, with one nitrogen atom as the only ring hetero atom
    • C07D209/02—Heterocyclic compounds containing five-membered rings, condensed with other rings, with one nitrogen atom as the only ring hetero atom condensed with one carbocyclic ring
    • C07D209/04—Indoles; Hydrogenated indoles
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    • C07—ORGANIC CHEMISTRY
    • C07D—HETEROCYCLIC COMPOUNDS
    • C07D215/00—Heterocyclic compounds containing quinoline or hydrogenated quinoline ring systems
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    • C07—ORGANIC CHEMISTRY
    • C07D—HETEROCYCLIC COMPOUNDS
    • C07D215/00—Heterocyclic compounds containing quinoline or hydrogenated quinoline ring systems
    • C07D215/02—Heterocyclic compounds containing quinoline or hydrogenated quinoline ring systems having no bond between the ring nitrogen atom and a non-ring member or having only hydrogen atoms or carbon atoms directly attached to the ring nitrogen atom
    • C07D215/16—Heterocyclic compounds containing quinoline or hydrogenated quinoline ring systems having no bond between the ring nitrogen atom and a non-ring member or having only hydrogen atoms or carbon atoms directly attached to the ring nitrogen atom with hetero atoms or with carbon atoms having three bonds to hetero atoms with at the most one bond to halogen, e.g. ester or nitrile radicals, directly attached to ring carbon atoms
    • C07D215/48—Carbon atoms having three bonds to hetero atoms with at the most one bond to halogen
    • C07D215/54—Carbon atoms having three bonds to hetero atoms with at the most one bond to halogen attached in position 3
    • C07D215/56—Carbon atoms having three bonds to hetero atoms with at the most one bond to halogen attached in position 3 with oxygen atoms in position 4
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    • C07D405/02—Heterocyclic compounds containing both one or more hetero rings having oxygen atoms as the only ring hetero atoms, and one or more rings having nitrogen as the only ring hetero atom containing two hetero rings
    • C07D405/12—Heterocyclic compounds containing both one or more hetero rings having oxygen atoms as the only ring hetero atoms, and one or more rings having nitrogen as the only ring hetero atom containing two hetero rings linked by a chain containing hetero atoms as chain links
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2300/00—Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00

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  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Pulmonology (AREA)
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  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
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  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
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Claims (30)

1. Farmaceutski pripravak, naznačen time, da sadrži: prvu sprejom osušenu disperziju i drugu sprejom osušenu disperziju, pri čemu prva sprejom osušena disperzija sadrži oko 70% po masi do oko 90% po masi amorfnog oblika od (R)-1-(2,2-difluorobenzo[d][1,3]dioksol-5-il)-N-(1-(2,3-dihidropropil)-6-fluoro-2-(1-hidroksi-2-metilpropan-2-il)-1H-indol-5-il)ciklopropankarboksamida (Spoj 1) i oko 10% po masi do oko 30% po masi polimera, i gdje druga sprejom osušena disperzija sadrži amorfni oblik od N-[2,4-bis(1,1-dimetiletil)-5-hidroksifenil]-1,4-dihidro-4-oksokinolin-3-karboksamida (Spoj 2); i pri čemu farmaceutski pripravak je tableta.
2. Farmaceutski pripravak prema patentnom zahtjevu 1, naznačen time, da polimer sadrži celulozni polimer.
3. Farmaceutski pripravak prema patentnom zahtjevu 1 ili zahtjevu 2, naznačen time, da polimer sadrži hidroksipropilmetil celulozu.
4. Farmaceutski pripravak prema patentnom zahtjevu 1, naznačen time, da druga sprejom osušena disperzija nadalje sadrži polimer.
5. Farmaceutski pripravak prema patentnom zahtjevu 4, naznačen time, da druga sprejom osušena disperzija sadrži oko 70% po masi do oko 90% po masi Spoja 2 i oko 10% po masi do oko 30% po masi polimera.
6. Farmaceutski pripravak prema bilo kojem od patentnih zahtjeva 1 do 5, naznačen time, da sadrži oko 5% po masi do oko 20% po masi prve sprejom osušene disperzije.
7. Farmaceutski pripravak prema bilo kojem od patentnih zahtjeva 1 do 6, naznačen time, da sadrži oko 15% po masi do oko 60% po masi druge sprejom osušene disperzije.
8. Farmaceutski pripravak prema bilo kojem od patentnih zahtjeva 1 do 7, naznačen time, da tableta sadrži oko 25 mg do oko 125 mg Spoja 1.
9. Farmaceutski pripravak prema bilo kojem od patentnih zahtjeva 1 do 8, naznačen time, da tableta sadrži oko 100 mg do oko 200 mg Spoja 2.
10. Farmaceutski pripravak prema bilo kojem od patentnih zahtjeva 1 do 9, naznačen time, da farmaceutski pripravak sadrži jedno ili više pomoćnih sredstava odabranih od punila, dezintegratora, lubrikanata, ili bilo koje njihove kombinacije.
11. Farmaceutski pripravak prema bilo kojem od patentnih zahtjeva 1 do 7, naznačen time, da sadrži oko 30% po masi do oko 50% po masi punila u odnosu na masu farmaceutskog pripravka.
12. Farmaceutski pripravak prema patentnom zahtjevu 11, naznačen time, da punilo sadrži mikrokristalnu celulozu.
13. Farmaceutski pripravak prema bilo kojem od patentnih zahtjeva 1 do 12, naznačen time, da sadrži oko 1% po masi do oko 10% po masi dezintegratora u odnosu na masu farmaceutskog pripravka.
14. Farmaceutski pripravak prema patentnom zahtjevu 13, naznačen time, da dezintegrator sadrži kroskarmelozu natrij.
15. Farmaceutski pripravak prema bilo kojem od patentnih zahtjeva 1 do 14, naznačen time, da sadrži oko 1% po masi lubrikanta u odnosu na masu farmaceutskog pripravka.
16. Farmaceutski pripravak prema patentnom zahtjevu 15, naznačen time, da lubrikant sadrži magnezijev stearat.
17. Farmaceutski pripravak prema bilo kojem od patentnih zahtjeva 1 do 7, naznačen time, da tableta sadrži oko 30 mg do oko 85 mg prve sprejom osušene disperzije.
18. Farmaceutski pripravak prema bilo kojem od patentnih zahtjeva 1 do 17, naznačen time, da tableta sadrži oko 150 mg do oko 250 mg druge sprejom osušene disperzije.
19. Farmaceutski pripravak prema bilo kojem od patentnih zahtjeva 1 do 18, naznačen time, da tableta sadrži oko 100 mg do oko 300 mg punila.
20. Farmaceutski pripravak prema bilo kojem od patentnih zahtjeva 1 do 19, naznačen time, da tableta sadrži oko 12 mg do oko 36 mg dezintegratora.
21. Farmaceutski pripravak prema bilo kojem od patentnih zahtjeva 1 do 20, naznačen time, da tableta sadrži oko 1 mg do oko 5 mg lubrikanta.
22. Farmaceutski pripravak prema bilo kojem od patentnih zahtjeva 1 do 21, naznačen time, da nadalje sadrži dodatno terapijsko sredstvo.
23. Farmaceutski pripravak prema patentnom zahtjevu 22, naznačen time, da dodatno terapijsko sredstvo je neki drugi CFTR korektor koji je različit od Spoja 1.
24. Farmaceutski pripravak prema patentnom zahtjevu 22, naznačen time, da dodatno terapijsko sredstvo je neki drugi CFTR potencijator koji je različit od Spoja 2.
25. Farmaceutski pripravak prema bilo kojem od prethodnih patentnih zahtjeva, naznačen time, da je za uporabu u postupku liječenja cistične fibroze kod pacijenta.
26. Farmaceutski pripravak za uporabu prema patentnom zahtjevu 25, naznačen time, da postupak obuhvaća oralno davanje farmaceutskog pripravka pacijentu.
27. Farmaceutski pripravak za uporabu prema bilo kojem patentnom zahtjevu 25 ili 26, naznačen time, da postupak nadalje obuhvaća davanje dodatnog terapijskog sredstva pacijentu.
28. Farmaceutski pripravak za uporabu prema patentnom zahtjevu 27, naznačen time, da se dodatno terapijsko sredstvo daje prije, poslije, ili istovremeno s farmaceutskim pripravkom.
29. Farmaceutski pripravak za uporabu prema bilo kojem od patentnih zahtjeva 25 do 28, naznačen time, da pacijent je homozigotan za CFTR mutaciju ΔF508.
30. Farmaceutski pripravak za uporabu prema bilo kojem od patentnih zahtjeva 25 do 28, naznačen time, da pacijent je heterozigotan za CFTR mutaciju ΔF508.
HRP20230709TT 2014-04-15 2015-04-14 Farmaceutski pripravci za liječenje bolesti povezanih s regulatorom provodljivosti transmembrane cistične fibroze HRP20230709T1 (hr)

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Application Number Priority Date Filing Date Title
US201461979848P 2014-04-15 2014-04-15
US201462059287P 2014-10-03 2014-10-03
EP21175519.4A EP3925607B1 (en) 2014-04-15 2015-04-14 Pharmaceutical compositions for the treatment of cystic fibrosis transmembrane conductance regulator mediated diseases

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HRP20230709TT HRP20230709T1 (hr) 2014-04-15 2015-04-14 Farmaceutski pripravci za liječenje bolesti povezanih s regulatorom provodljivosti transmembrane cistične fibroze
HRP20181194TT HRP20181194T1 (hr) 2014-04-15 2018-07-25 Farmaceutski pripravci za liječenje bolesti posredovanih transmembranskim regulatorom provodljivosti cistične fibroze
HRP20211012TT HRP20211012T1 (hr) 2014-04-15 2021-06-28 Farmaceutski pripravak za liječenje bolesti koje su posredovane regulatorom transmembranske provodljivosti cistične fibroze

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HRP20181194TT HRP20181194T1 (hr) 2014-04-15 2018-07-25 Farmaceutski pripravci za liječenje bolesti posredovanih transmembranskim regulatorom provodljivosti cistične fibroze
HRP20211012TT HRP20211012T1 (hr) 2014-04-15 2021-06-28 Farmaceutski pripravak za liječenje bolesti koje su posredovane regulatorom transmembranske provodljivosti cistične fibroze

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US (3) US10206877B2 (hr)
EP (4) EP4223294A1 (hr)
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CN (2) CN106163517B (hr)
AU (2) AU2015247850B2 (hr)
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SI (3) SI3925607T1 (hr)
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UA (1) UA124567C2 (hr)
WO (1) WO2015160787A1 (hr)
ZA (1) ZA201606418B (hr)

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