HRP20201608T1 - Sinergistički pripravci koji sadrže (r)-dimiracetam (1) i (s)-dimiracetam (2) u neracemičnom omjeru - Google Patents

Sinergistički pripravci koji sadrže (r)-dimiracetam (1) i (s)-dimiracetam (2) u neracemičnom omjeru Download PDF

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HRP20201608T1
HRP20201608T1 HRP20201608TT HRP20201608T HRP20201608T1 HR P20201608 T1 HRP20201608 T1 HR P20201608T1 HR P20201608T T HRP20201608T T HR P20201608TT HR P20201608 T HRP20201608 T HR P20201608T HR P20201608 T1 HRP20201608 T1 HR P20201608T1
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Croatia
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dimiracetam
preparation
sensory neuropathy
peripheral sensory
intended
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HRP20201608TT
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Michael Scherz
Carlo Farina
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Metys Pharmaceuticals AG
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    • 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
    • A61K31/4164—1,3-Diazoles
    • A61K31/4188—1,3-Diazoles condensed with other heterocyclic ring systems, e.g. biotin, sorbinil
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    • 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
    • A61K31/407—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 other heterocyclic ring systems, e.g. ketorolac, physostigmine
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    • A61K31/7052—Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides
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    • A61K31/7072—Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides containing six-membered rings with nitrogen as a ring hetero atom containing condensed or non-condensed pyrimidines having oxo groups directly attached to the pyrimidine ring, e.g. cytidine, cytidylic acid having two oxo groups directly attached to the pyrimidine ring, e.g. uridine, uridylic acid, thymidine, zidovudine
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    • A61K31/708—Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides containing six-membered rings with nitrogen as a ring hetero atom containing condensed or non-condensed pyrimidines containing purines, e.g. adenosine, adenylic acid having oxo groups directly attached to the purine ring system, e.g. guanosine, guanylic acid
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Claims (14)

1. Pripravak, naznačen time što sadrži (R)-3,6,7,7a-tetrahidro-1H-pirolo[1,5-a]imidazol-2,5-dion ((R)-dimiracetam (1)) i (S)-3,6,7,7a-tetrahidro-1H-pirolo[1,5-a]imidazol-2,5-dion ((S)-dimiracetam (2)), [image] [image] i/ili njihove farmaceutski prihvatljive solvate ili sukristale gdje je enantiomerni suvišak (ee) (R)-dimiracetama (1) jednak ili veći od 33% i manji od ili jednak 54%.
2. Pripravak u skladu s patentnim zahtjevom 1, naznačen time što omjer između (R)-dimiracetama (1) i (S)-dimiracetama (2) iznosi 2:1 do 3,3:1.
3. Pripravak u skladu s patentnim zahtjevom 1 ili 2, naznačen time što se (R)-dimiracetam (1) i/ili njegove farmaceutski prihvatljive solvate ili sukristale i (S)-dimiracetam (2) i/ili njegove farmaceutski prihvatljive solvate ili sukristale pakira odvojeno.
4. Pripravak u skladu s patentnim zahtjevom 1, naznačen time što je pripravak neracemična smjesa 3,6,7,7a-tetrahidro-1H-pirolo[1,5-a]imidazol-2,5-diona (dimiracetama) i njegovih farmaceutski prihvatljivih solvata ili sukristala, gdje neracemična smjesa sadrži (R)-dimiracetam (1) u odnosu na (S)-dimiracetam (2) u enantiomernom suvišku (ee) (R)-dimiracetama (1) jednakom ili većem od 33% i manjem od ili jednakom 54%.
5. Farmaceutski pripravak, naznačen time što sadrži pripravak u skladu s bilo kojim od prethodnih patentnih zahtjeva i farmaceutski prihvatljivi nosač.
6. Pripravak u skladu s bilo kojim od patentnih zahtjeva 1 do 4 ili farmaceutski pripravak u skladu s patentnim zahtjevom 5, naznačeni time što su namijenjeni upotrebi kao medikament.
7. Pripravak ili farmaceutski pripravak u skladu s patentnim zahtjevom 6, naznačeni time što su namijenjeni upotrebi u liječenju i/ili sprječavanju bolesti ili poremećaja, gdje se bolest, ozljedu ili poremećaj bira između periferne senzoričke neuropatije, napadaja, depresije, kognitivnog poremećaja, neuropsihijatrijskog poremećaja, poremećaja motoneurona, ili poremećaja gibanja, gdje je periferna senzorička neuropatija po mogućnosti periferna neuropatska bol, dijabetična neuropatija, postherpetična neuropatija, lumbago, bol u križima, bol uzrokovana kirurškim zahvatom, kompresivna ozljeda, ozljeda kralježnice, sindrom složene područne boli, osjeti fantomskog uda, periferna senzorička neuropatija povezana s osteoartritisom, periferna senzorička neuropatija povezana s reumatoidnim artritisom, periferna senzorička neuropatija povezana s autoimunom osteoartrozom, glavobolja, fibromialgija, periferna senzorička neuropatija izazvana terapijama protiv matičnih stanica, periferna senzorička neuropatija izazvana kemoterapijskim sredstvom, periferna senzorička neuropatija povezana s visceralnom ozljedom, periferna senzorička neuropatija povezana s osteonekrozom, periferna senzorička neuropatija povezana sa zarazom virusom ljudske imunodeficijencije, periferna neuropatska bol, ili periferna senzorička neuropatija, izazvana protuvirusnim sredstvom, poželjnije periferna senzorička neuropatija izazvana kemoterapijskim sredstvom ili periferna senzorička neuropatija izazvana protuvirusnim sredstvom.
8. Pripravak namijenjen upotrebi ili farmaceutski pripravak namijenjen upotrebi u skladu s patentnim zahtjevom 7, naznačeni time što je periferna senzorička neuropatija periferna senzorička neuropatija izazvana kemoterapijskim sredstvom, gdje se kemoterapijsko sredstvo bira iz skupine koju čine inhibitor kinaze, inhibitor proteasoma, taksan, vinka alkaloid, te sol platine, te gdje se po mogućnosti kemoterapijsko sredstvo bira između sorafeniba, sunitiniba, afatiniba, aksitiniba, vandetaniba, vemurafeniba, iksazomiba, bortezomiba, paklitaksela, docetaksela, kabazitaksela, vinkristina, vinblastina, vindezina, vinorelbina, nedaplatina, lobaplatina, pikoplatina, satraplaina, cisplatina, karboplatina i oksaliplatina i/ili protuvirusnog sredstva, gdje je protuvirusno sredstvo nukleozidni inhibitor obratne transkriptaze, te gdje se po mogućnosti protuvirusno sredstvo bira između zalcitabina, didanozina, stavudina i zidovudina.
9. Pripravak namijenjen upotrebi ili farmaceutski pripravak namijenjen upotrebi u skladu s patentnim zahtjevom 7 ili 8, naznačeni time što pripravak ili farmaceutski pripravak se upotrebljava uz najmanje jedan protutumorski lijek, gdje se po mogućnosti protutumorski lijek bira iz skupine koju čine inhibitor kinaze, inhibitor proteasoma, taksan, vinka alkaloidni i sol platine; te gdje se poželjnije protutumorski lijek bira između sorafeniba, sunitiniba, afatiniba, aksitiniba, vandetaniba, vemurafeniba, iksazomiba, bortezomiba, paklitaksela, docetaksela, kabazitaksela, vinkristina, vinblastina, vindezina, vinorelbina, nedaplatina, lobaplatina, pikoplatina, satraplaina, cisplatina, karboplatina i oksaliplatina i/ili uz najmanje jedan protuvirusni lijek, gdje se po mogućnosti protuvirusni lijek bira između nukleozida ili nukleotida, te gdje se još poželjnije protuvirusni lijek bira između zalcitabina, didanozina, stavudina i zidovudina.
10. Pripravak namijenjen upotrebi ili farmaceutski pripravak namijenjen upotrebi u skladu s bilo kojim od patentnih zahtjeva 7 do 9, naznačeni time što pripravak ili farmaceutski pripravak treba primijeniti oralno dvaput dnevno, u dozi između 10 mg i 3000 mg po primjeni, poželjnije između 20 mg i 2000 mg po primjeni, a još poželjnije između 50 mg i 1000 mg po primjeni.
11. Pripravak u skladu s bilo kojim od patentnih zahtjeva 1 do 4 ili farmaceutski pripravak u skladu s patentnim zahtjevom 5, naznačeni time što su namijenjeni upotrebi u postupku poboljšavanja učenja i pamćenja.
12. Postupak pripravljanja pripravka u skladu s bilo kojim od patentnih zahtjeva 1 do 4 ili farmaceutskog pripravka u skladu s patentnim zahtjevom 5, naznačen time što se sastoji u kombiniranju (R)-dimiracetama (1) i (S)-dimiracetama (2), ili (R)-dimiracetama (1) i racemata dimiracetama.
13. Upotreba (R)-dimiracetama (1) i/ili (S)-dimiracetama (2) i/ili racemata dimiracetama, naznačena time što su (R)-dimiracetam (1) i/ili (S)-dimiracetam (2) i/ili racemat dimiracetama namijenjeni pripravljanju pripravka u skladu s bilo kojim od patentnih zahtjeva 1 do 4 ili farmaceutskog pripravka u skladu s patentnim zahtjevom 5.
14. Neterapijska upotreba pripravka u skladu s bilo kojim od patentnih zahtjeva 1 do 4, naznačena time što je pripravak namijenjen poboljšavanju učenja i pamćenja kod zdravih subjekata.
HRP20201608TT 2017-05-31 2020-10-07 Sinergistički pripravci koji sadrže (r)-dimiracetam (1) i (s)-dimiracetam (2) u neracemičnom omjeru HRP20201608T1 (hr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP17173760 2017-05-31
EP18728356.9A EP3534898B1 (en) 2017-05-31 2018-05-30 Synergistic compositions comprising (r)-dimiracetam (1) and (s)-dimiracetam (2) in a non-racemic ratio
PCT/EP2018/064125 WO2018219977A1 (en) 2017-05-31 2018-05-30 Synergistic compositions comprising (r)-dimiracetam (1) and (s)-dimiracetam (2) in a non-racemic ratio

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HRP20201608T1 true HRP20201608T1 (hr) 2021-01-08

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US (2) US10738054B2 (hr)
EP (2) EP3534898B1 (hr)
JP (2) JP6810983B2 (hr)
KR (1) KR102269493B1 (hr)
CN (1) CN110719779B (hr)
AU (1) AU2018276382B2 (hr)
BR (1) BR112019025006A2 (hr)
CA (1) CA3061274C (hr)
CL (1) CL2019003503A1 (hr)
CO (1) CO2019013212A2 (hr)
CY (1) CY1123386T1 (hr)
DK (1) DK3534898T3 (hr)
EA (1) EA201992817A1 (hr)
EC (1) ECSP19085426A (hr)
ES (1) ES2825498T3 (hr)
GE (1) GEP20227336B (hr)
HR (1) HRP20201608T1 (hr)
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