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HRP20200512T1 - Formulacije koje sadrže linaklotid za oralnu primjenu - Google Patents

Formulacije koje sadrže linaklotid za oralnu primjenu Download PDF

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Publication number
HRP20200512T1
HRP20200512T1 HRP20200512TT HRP20200512T HRP20200512T1 HR P20200512 T1 HRP20200512 T1 HR P20200512T1 HR P20200512T T HRP20200512T T HR P20200512TT HR P20200512 T HRP20200512 T HR P20200512T HR P20200512 T1 HRP20200512 T1 HR P20200512T1
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HR
Croatia
Prior art keywords
pharmaceutical preparation
linaclotide
constipation
leucine
preparation according
Prior art date
Application number
HRP20200512TT
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English (en)
Inventor
Angelika Fretzen
Steven Witowski
Alfredo Grossi
Hong Zhao
Mahendra Dedhiya
Yun Mo
Original Assignee
Ironwood Pharmaceuticals, Inc.
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First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=41666602&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=HRP20200512(T1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Ironwood Pharmaceuticals, Inc. filed Critical Ironwood Pharmaceuticals, Inc.
Publication of HRP20200512T1 publication Critical patent/HRP20200512T1/hr
Publication of HRP20200512T2 publication Critical patent/HRP20200512T2/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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/04—Peptides having up to 20 amino acids in a fully defined sequence; Derivatives thereof
    • A61K38/10—Peptides having 12 to 20 amino acids
    • A—HUMAN NECESSITIES
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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
    • A61K9/1605—Excipients; Inactive ingredients
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J3/00—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
    • A—HUMAN NECESSITIES
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    • A61K38/12—Cyclic peptides, e.g. bacitracins; Polymyxins; Gramicidins S, C; Tyrocidins A, B or C
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
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    • A61K9/167—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction with an outer layer or coating comprising drug; with chemically bound drugs or non-active substances on their surface
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    • A61K9/5073—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals having two or more different coatings optionally including drug-containing subcoatings
    • A61K9/5078—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals having two or more different coatings optionally including drug-containing subcoatings with drug-free core
    • A—HUMAN NECESSITIES
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    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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    • B65D81/00—Containers, packaging elements, or packages, for contents presenting particular transport or storage problems, or adapted to be used for non-packaging purposes after removal of contents
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    • B65D81/26—Adaptations for preventing deterioration or decay of contents; Applications to the container or packaging material of food preservatives, fungicides, pesticides or animal repellants with provision for draining away, or absorbing, or removing by ventilation, fluids, e.g. exuded by contents; Applications of corrosion inhibitors or desiccators
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Claims (41)

1. Farmaceutski pripravak, naznačen time, da obuhvaća farmaceutski prihvatljiv nosač, linaklotid, kation koji je odabran od Mg2+, Ca2+, Zn2+, Mn2+, K+, Na+ ili Al3+, i jedan sterično zapriječen primarni amin, pri čemu je farmaceutski pripravak jedan čvrsti sastav za oralno primjenjivanje.
2. Farmaceutski pripravak prema patentnom zahtjevu 1, naznačen time, da se navedeni Mg2+, Ca2+, Zn2+, Mn2+, K+, Na+ ili Al3+, dobivaju kao magnezijev klorid, kalcijev klorid, kalcijev fosfat, kalcijev sulfat, cinkov acetat, manganov klorid, kalijev klorid, natrijev klorid ili aluminijev klorid.
3. Farmaceutski pripravak prema patentnom zahtjevu 1 ili zahtjevu 2, naznačen time, da navedeni kation je Ca2+.
4. Farmaceutski pripravak prema patentnom zahtjevu 1, naznačen time, da navedeni kation je Ca2+, i on je dobiven kao kalcijev klorid.
5. Farmaceutski pripravak prema bilo kojem od prethodnih patentnih zahtjeva, naznačen time, da je sterično zapriječeni primarni amin jedna aminokiselina, polimerni amin, ili spoj sljedeće formule: [image] pri čemu su R1, R2 i R3 neovisno odabrani od sljedećih: H; -C(O)OH; C1-C6-alkil, opcionalno supstituiran s -CO2H, -CONH2, ili s 5-10-članim arilom ili heteroarilom; C1-C6-alkoksialkil; ili C1-C6-tioalkoksialkil, gdje bilo koja od alkilne ili arilne gornje skupine, može biti jednostruko ili višestruko supstituirana s halogenom ili -NH2, te uz uvjet da samo do dva od R1, R2 i R3, predstavljaju H.
6. Farmaceutski pripravak prema bilo kojem od patentnih zahtjeva 1 do 4, naznačen time, da sterično zapriječeni primarni amin je histidin, fenilalanin, alanin, glutaminska kiselina, aspartna kiselina, glutamin, leukin, metionin, asparagin, tirozin, treonin, izoleukin, triptofan ili valin.
7. Farmaceutski pripravak prema bilo kojem od patentnih zahtjeva 1 do 4, naznačen time, da sterično zapriječeni primarni amin je leukin.
8. Farmaceutski pripravak prema bilo kojem od prethodnih patentnih zahtjeva, naznačen time, da pripravak nadalje sadrži farmaceutski prihvatljivo klizno sredstvo, mazivo ili aditiv koji djeluje i kao klizno sredstvo i kao mazivo.
9. Farmaceutski pripravak prema bilo kojem od prethodnih patentnih zahtjeva, naznačen time, da pripravak nadalje sadrži jedan ili više antioksidanata, farmaceutski prihvatljivo vezivo, ili farmaceutski prihvaljivo punilo.
10. Farmaceutski pripravak prema patentnom zahtjevu 9, naznačen time, da pripravak sadrži farmaceutski prihvatljivo vezno sredstvo koje je odabrano od sljedećih: polivinilni alkohol, polivinilpirolidon (povidon), škrob, maltodekstrin ili celulozni eter.
11. Farmaceutski pripravak prema patentnom zahtjevu 10, naznačen time, da farmaceutski prihvatljivo vezno sredstvo je celulozni eter koji je odabran od metilceluloze, etilceluloze, karboksimetilceluloze, hidroksietilceluloze, hidroksietilmetilceluloze, hidroksipropilceluloze i hidroksipropilmetilceluloze.
12. Farmaceutski pripravak prema bilo kojem od patentnih zahtjeva 9 do 11, naznačen time, da pripravak sadrži farmaceutski prihvatljivo punilo i farmaceutski prihvatljivo punilo je celuloza, izomalt, manitol ili dibazični kalcijev fosfat.
13. Farmaceutski pripravak prema patentnom zahtjevu 12, naznačen time, da je celuloza odabrana od mikrofine celuloze i mikrokristalne celuloze.
14. Farmaceutski pripravak prema bilo kojem od prethodnih patentnih zahtjeva, naznačen time, da sterično zapriječen primarni amin je leukin i molarni omjer od leukina prema linaklotidu je najmanje 10:1.
15. Farmaceutski pripravak prema bilo kojem od prethodnih patentnih zahtjeva, naznačen time, da kation je Ca2+, sterično zapriječen primarni amin je leukin i molarni omjer od Ca2+ prema leukinu je najmanje 1:1.
16. Farmaceutski pripravak prema bilo kojem od prethodnih patentnih zahtjeva, naznačen time, da sljedeći molarni omjer za kation: sterično zapriječen primarni amin: linaklotid, iznosi 40-100:20-50:1.
17. Farmaceutski pripravak prema bilo kojem od prethodnih patentnih zahtjeva, naznačen time, da kation je Ca2+, sterično zapriječen primarni amin je leukin, a sljedeći molarni omjer za Ca2+: leukin: linaklotid, iznosi 60:30:1.
18. Farmaceutski pripravak prema bilo kojem od prethodnih patentnih zahtjeva, naznačen time, da: (i) produkt hidrolize ima sljedeću strukturu [image] koja sadrži manje od 2% po masi, kada se usporedbi s masom linaklotida; ili (ii) produkt oksidacije linaklotida koji ima molekularnu masu od 1542,8, sadrži manje od 2% po masi, kada se usporedbi s masom linaklotida.
19. Farmaceutski pripravak prema bilo kojem od prethodnih patentnih zahtjeva, naznačen time, da pripravak obuhvaća sljedeće: linaklotid; Ca2+; leukin; i hidroksipropilmetilcelulozu, pri čemu je linaklotid prisutan u farmaceutskom sastavu s količinom između 100 μg i 600 μg, te sljedeći molarni omjer za Ca2+: leukin: linaklotid, iznosi između 5-100:5-50:1.
20. Farmaceutski pripravak prema patentnom zahtjevu 19, naznačen time, da je Ca2+ dobiven kao CaCl2.
21. Farmaceutski pripravak prema bilo kojem od prethodnih patentnih zahtjeva, naznačen time, da pripravak obuhvaća obložena zrnca, a zrnca su obložena otopinom za oblaganje koja sadrži linaklotid.
22. Farmaceutski pripravak prema patentnom zahtjevu 21, naznačen time, da otopina za oblaganje obuhvaća sljedeće: linaklotid; Ca2+; leukin; i hidroksipropilmetilcelulozu, pri čemu je linaklotid prisutan u farmaceutskom sastavu s količinom između 100 μg i 600 μg, te sljedeći molarni omjer za Ca2+: leukin: linaklotid, iznosi 5-100:5-50:1.
23. Farmaceutski pripravak prema patentnom zahtjevu 22, naznačen time, da zrnca sadrže mikrokristalnu celulozu.
24. Postupak proizvodnje farmaceutskog pripravka koji sadrži linaklotid ili njegovu sol, naznačen time, da postupak obuhvaća sljedeće: (a) pripravljanje vodene otopine koja sadrži: (i) linaklotid ili njegovu farmaceutski prihvatljivu sol; (ii) kation koji je odabran od Mg2+, Ca2+, Zn2+, Mn2+, K+, Na+ ili Al3+, i jedan sterično zapriječen primarni amin; i (iii) prema potrebi, farmaceutski prihvatljivo vezivo; te (b) nanošenje vodene otopine na farmaceutski prihvatljivo punilo u svrhu generiranja punila koje je obloženo linaklotidom.
25. Postupak prema patentnom zahtjevu 24, naznačen time, da se vodena otopina nanosi na punilo putem raspršivanja.
26. Farmaceutski pripravak prema bilo kojem od patentnih zahtjeva 1 do 23, naznačen time, da se upotrebljava u postupku liječenja pacijenta koji boluje od oštećenja crijevne peristaltike, sindroma iritabilnih crijeva, konstipacije, dispepsije, gastropareze, kronične crijevne pseudo-opstrukcije, Crohnove bolesti, ulcerativnog kolitisa, upalne bolesti crijeva, ili od bolova koji su povezani s konstipacijom.
27. Farmaceutski pripravak za uporabu prema patentnom zahtjevu 26, naznačen time, da se kod sindroma iritabilnih crijeva radi o sindromu iritabilnih crijeva s prevladavajućom konstipacijom ili se radi o periodično promjenjivom sindromu iritabilnih crijeva.
28. Farmaceutski pripravak za uporabu prema patentnom zahtjevu 27, naznačen time, da se kod navedenog sindroma iritabilnih crijeva radi o sindromu iritabilnih crijeva s prevladavajućom konstipacijom.
29. Farmaceutski pripravak za uporabu prema patentnom zahtjevu 26, naznačen time, da navedena konstipacija je kronična konstipacija, idiopatska konstipacija, post-operativni ileus ili konstipacija uzrokovana uporabom opijata.
30. Farmaceutski pripravak za uporabu prema patentnom zahtjevu 29, naznačen time, da navedena konstipacija je kronična konstipacija.
31. Farmaceutski pripravak za uporabu prema bilo kojem od patentnih zahtjeva 26 do 30, naznačen time, da farmaceutski pripravak sadrži od 50 μg do 1 mg linaklotida.
32. Farmaceutski pripravak za uporabu prema bilo kojem od patentnih zahtjeva 26 do 30, naznačen time, da farmaceutski pripravak sadrži 67,5 μg, 133 μg, 150 μg, 266 μg ili 300 μg linaklotida.
33. Farmaceutski pripravak za uporabu prema bilo kojem od patentnih zahtjeva 26 do 30, naznačen time, da farmaceutski pripravak sadrži 266 μg linaklotida.
34. Farmaceutski pripravak za uporabu prema bilo kojem od patentnih zahtjeva 26 do 30, naznačen time, da farmaceutski pripravak sadrži 133 μg linaklotida.
35. Farmaceutski pripravak za uporabu prema bilo kojem od patentnih zahtjeva 26 do 34, naznačen time, da se farmaceutski pripravak primjenjuje jednom dnevno ili dva puta dnevno.
36. Farmaceutski pripravak za uporabu prema bilo kojem od patentnih zahtjeva 26 do 35, naznačen time, da se farmaceutski pripravak primjenjuje jednom dnevno kao jedna ili dvije tablete ili kapsule.
37. Farmaceutski pripravak za uporabu prema bilo kojem od patentnih zahtjeva 26 do 36, naznačen time, da se farmaceutski pripravak primjenjuje na pacijentu u vremenskom periodu od najmanje četiri tjedna.
38. Farmaceutski pripravak za uporabu prema bilo kojem od patentnih zahtjeva 26 do 37, naznačen time, da liječenje s ovim pripravkom poboljšava barem jedan simptom koji je odabran od sljedećih: smanjenje abdominalnih bolova, povećanje broja potpuno spontanih crijevnih pokreta (CSBM – engl. complete spontaneous bowel movements) za vrijeme jednog tjedna, povećanje broja spontanih crijevnih pokreta (SBM – engl. spontaneous bowel movements) za vrijeme jednog tjedna, poboljšanje konzistencije stolice, smanjenje naprezanja, smanjenje abdominalne neugode, smanjenje nadimanja, ili smanjenje ozbiljnog simptomatskog stanja kod sindroma iritabilnih crijeva s konstipacijom (IBS-c – engl. irritable bowel syndrom with constipation).
39. Oblik jediničnog doziranja, naznačen time, da on obuhvaća farmaceutski pripravak u skladu s bilo kojim od patentnih zahtjeva 1 do 23.
40. Zabrtvljeni spremnik, naznačen time, da on obuhvaća veći broj oblika jediničnog doziranja u skladu s patentnim zahtjevom 39.
41. Uporaba farmaceutskog pripravka prema bilo kojem od patentnih zahtjeva 1 do 23, naznačena time, da služi za proizvodnju lijeka za liječenje pacijenta koji boluje od oštećenja crijevne peristaltike, sindroma iritabilnih crijeva, konstipacije, dispepsije, gastropareze, kronične crijevne pseudo-opstrukcije, Crohnove bolesti, ulcerativnog kolitisa, upalne bolesti crijeva ili od bolova koji su povezani s konstipacijom.
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