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HRP20170022T1 - Farmaceutski sastav koji obuhvaća derivat benzena supstituiran glukopiranozilom - Google Patents

Farmaceutski sastav koji obuhvaća derivat benzena supstituiran glukopiranozilom Download PDF

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Publication number
HRP20170022T1
HRP20170022T1 HRP20170022TT HRP20170022T HRP20170022T1 HR P20170022 T1 HRP20170022 T1 HR P20170022T1 HR P20170022T T HRP20170022T T HR P20170022TT HR P20170022 T HRP20170022 T HR P20170022T HR P20170022 T1 HRP20170022 T1 HR P20170022T1
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Croatia
Prior art keywords
pharmaceutical composition
dpp
inhibitor
glucopyranosyl
composition according
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HRP20170022TT
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Inventor
Klaus Dugi
Michael Mark
Leo Thomas
Frank Himmelsbach
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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 HRP20170022T1 publication Critical patent/HRP20170022T1/hr

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    • A61K31/7048—Compounds having saccharide radicals and heterocyclic rings having oxygen as a ring hetero atom, e.g. leucoglucosan, hesperidin, erythromycin, nystatin, digitoxin or digoxin
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    • A61K31/7028—Compounds having saccharide radicals attached to non-saccharide compounds by glycosidic linkages
    • A61K31/7034—Compounds having saccharide radicals attached to non-saccharide compounds by glycosidic linkages attached to a carbocyclic compound, e.g. phloridzin
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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
    • A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/519—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
    • A61K31/52—Purines, e.g. adenine
    • A61K31/522—Purines, e.g. adenine having oxo groups directly attached to the heterocyclic ring, e.g. hypoxanthine, guanine, acyclovir
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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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
    • A61K9/141—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
    • A61K9/145—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 compounds
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Claims (19)

1. Farmaceutski sastav, naznačen time, da obuhvaća derivat benzena supstituiran glukopiranozilom: 1-kloro-4-(β-D-glukopiranoz-1-il)-2-[4-((S)-tetrahidrofuran-3-iloksi)-benzil]-benzen, u kombinaciji s DPP IV-inhibitorom: 1-[(4-metil-kinazolin-2-il)metil]-3-metil-7-(2-butin-1-il)-8-(3-(R)-amino-piperidin-1-il)-ksantin, ili njegova farmaceutski prihvatljiva sol.
2. Farmaceutski sastav prema zahtjevu 1, naznačen time, da je sastav prikladan za kombiniranu ili istovremenu ili uzastopnu uporabu derivata benzena supstituiranog glukopiranozilom i DPP IV-inhibitora.
3. Farmaceutski sastav prema jednom od prethodnih zahtjeva, naznačen time, da su derivat benzena supstituiran glukopiranozilom i DPP IV-inhibitor prisutni u jednostrukom doznom obliku.
4. Farmaceutski sastav prema jednom od prethodnih zahtjeva, naznačen time, da su derivat benzena supstituiran glukopiranozilom i DPP IV-inhibitor prisutni u odvojenom doznom obliku.
5. Farmaceutski sastav prema jednom od prethodnih zahtjeva, naznačen time, da sadrži količinu od 5 do 50 mg derivata benzena supstituiranog glukopiranozilom.
6. Farmaceutski sastav prema zahtjevu 5, naznačen time, da sadrži količinu od 5 mg, 10 mg, 15 mg, 20 mg, 25 mg ili 50 mg derivata benzena supstituiranog glukopiranozilom.
7. Farmaceutski sastav prema jednom od prethodnih zahtjeva, naznačen time, da sadrži količinu od 0,5 do 10 mg DPP IV-inhibitora.
8. Farmaceutski sastav prema zahtjevu 7, naznačen time, da sadrži količinu od 1 mg, 2,5 mg ili 5 mg DPP IV-inhibitora.
9. Farmaceutski sastav prema zahtjevu 1, 2, 3 ili 4, naznačen time, da sadrži količinu od 5 do 50 mg derivata benzena supstituiranog glukopiranozilom i količinu od 0,5 do 10 mg DPP IV-inhibitora.
10. Farmaceutski sastav prema bilo kojem od prethodnih zahtjeva, naznačen time, da se farmaceutski sastav formulira za oralnu primjenu u čvrstom obliku.
11. Farmaceutski sastav prema bilo kojem od zahtjeva 1 do 10, naznačen time, da se upotrebljava za sljedeće: - prevencija, usporavanje njegove progresije, odgađanje ili liječenje metaboličkog poremećaja odabranog iz skupine koju čine: dijabetes melitus tipa 1, dijabetes melitus tipa 2, oslabljena tolerancija na glukozu, pogoršana glukoza u krvi natašte, hiperglikemija, reaktivna hiperglikemija, prekomjerna težina, pretilost i metabolički sindrom; ili - poboljšanje glikemijske kontrole i/ili za smanjenje glukoze u plazmi natašte, od reaktivne glukoze u plazmi i/ili od glikoziliranog hemoglobina HbA1c; ili - prevencija, usporavanje, odgađanje ili ukidanje progresije smanjene tolerancije na glukozu, pogoršane glukoze u krvi natašte, otpornosti na inzulin i/ili od metaboličkog sindroma do dijabetesa melitus tipa 2; ili - prevencija, usporavanje njegove progresije, odgađanje ili liječenje stanja ili poremećaja odabranog iz skupine koju čine: komplikacije kod dijabetesa melitus, kao što su katarakti i mikrovaskularne i makrovaskularne bolesti, kao što je nefropatija, retinopatija, neuropatija, ishemija tkiva, arterioskleroza, infarkt miokarda, moždani udar i okluzivna bolest perifernih arterija; ili - smanjenje tjelesne težine ili prevencija povećanja tjelesne težine ili olakšavanje smanjenja tjelesne težine; ili - prevencija, usporavanje, odgađanje ili liječenje degeneracije beta stanica pankreasa i/ili odstranjivanja funkcionalnosti beta stanica pankreasa i/ili za poboljšanje i/ili ponovno uspostavljanje funkcionalnosti beta stanica pankreasa i/ili ponovno uspostavljanje funkcionalnosti sekrecije inzulina pankreasa; ili - prevencija, usporavanje, odgađanje ili liječenje bolesti ili stanja, koja se pripisuju abnormalnoj akumulaciji masti u jetri; ili - održavanje i/ili poboljšanje osjetljivosti na inzulin i/ili liječenje ili prevencija hiperinzulinemije i/ili otpornosti na inzulin; za pacijenta kojemu je to potrebno.
12. Farmaceutski sastav prema zahtjevu 11, naznačen time, da se upotrebljava za poboljšanje glikemijske kontrole kod pacijenata s dijabetesom melitus tipa 2.
13. Farmaceutski sastav za uporabu prema zahtjevu 11 ili 12, naznačen time, da se derivat benzena supstituiran glukopiranozilom, primjenjuje u kombinaciji ili alternativno s DPP IV-inhibitorom.
14. Farmaceutski sastav za uporabu prema zahtjevu 11, 12 ili 13, naznačen time, da je pacijent pojedinac kojemu je dijagnosticirano jedno ili više stanja odabranih iz skupine koju čine prekomjerna težina, pretilost, organska pretilost i abdominalna pretilost.
15. Farmaceutski sastav za uporabu prema zahtjevu 11, 12 ili 13, naznačen time, da je pacijent pojedinac kod kojega se pokazuje jedno, dva ili više sljedećih stanja: (a) koncentracija glukoze u krvi natašte ili glukoze u serumu, koja je veća od 110 mg/dL, posebno je veća od 125 mg/dL; (b) reaktivna glukoza u plazmi je jednaka ili veća od 140 mg/dL; (c) vrijednost HbA1c je jednaka ili veća od 6,5%, posebno jednaka ili veća od 8,0%.
16. Farmaceutski sastav za uporabu prema zahtjevu 11, 12 ili 13, naznačen time, da je pacijent pojedinac kod kojega su prisutna jedno, dva ili više sljedećih stanja: (a) pretilost, organska pretilost i/ili abdominalna pretilost; (b) razina triglicerida u krvi ≥ 150 mg/dL; (c) razina HDL-kolesterola u krvi < 40 mg/dL kod ženskih pacijenata i < 50 mg/dL kod muških pacijenata; (d) sistolički krvni tlak ≥ 130 mm Hg i dijastolički krvni tlak ≥ 85 mm Hg; (e) razina glukoze u krvi natašte ≥ 110 mg/dL.
17. Farmaceutski sastav za uporabu prema zahtjevu 11, 12 ili 13, naznačen time, da je pacijent pojedinac kod kojega je kontraindicirana monoterapija s metforminom i/ili koji nema toleranciju protiv metformina u terapeutskim dozama.
18. Farmaceutski sastav za uporabu prema zahtjevu 11, 12 ili 13, naznačen time, da je pacijent pojedinac s nedovoljnom glikemijskom kontrolom usprkos monoterapiji sa SGLT2-inhibitorom, posebno s derivatom benzena supstituiranim glukopiranozilom prema zahtjevu 1.
19. Farmaceutski sastav za uporabu prema zahtjevu 11, 12 ili 13, naznačen time, da je pacijent pojedinac s nedovoljnom glikemijskom kontrolom usprkos monoterapiji s DPP IV-inhibitorom, posebno s DPP IV-inhibitorom prema zahtjevu 1.
HRP20170022TT 2007-08-16 2008-08-15 Farmaceutski sastav koji obuhvaća derivat benzena supstituiran glukopiranozilom HRP20170022T1 (hr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP07114459 2007-08-16
PCT/EP2008/060736 WO2009022007A1 (en) 2007-08-16 2008-08-15 Pharmaceutical composition comprising a glucopyranosyl-substituted benzene derivative
EP08787264.4A EP2187879B1 (en) 2007-08-16 2008-08-15 Pharmaceutical composition comprising a glucopyranosyl-substituted benzene derivative

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HRP20170022T1 true HRP20170022T1 (hr) 2017-03-10

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US (1) US8551957B2 (hr)
EP (4) EP3939577A1 (hr)
JP (1) JP5595914B2 (hr)
KR (1) KR101491554B1 (hr)
CN (3) CN101784270A (hr)
AR (2) AR067970A1 (hr)
AU (1) AU2008288407B2 (hr)
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CY (2) CY1118308T1 (hr)
DK (1) DK2187879T3 (hr)
EA (1) EA018608B1 (hr)
EC (1) ECSP109977A (hr)
ES (1) ES2602748T3 (hr)
HK (2) HK1203351A1 (hr)
HR (1) HRP20170022T1 (hr)
HU (2) HUE030158T2 (hr)
IL (1) IL202886A (hr)
LT (2) LT2187879T (hr)
MA (1) MA31612B1 (hr)
ME (1) ME02573B (hr)
MX (1) MX2010001696A (hr)
MY (1) MY152037A (hr)
NL (1) NL300872I2 (hr)
NO (1) NO2017020I2 (hr)
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PE (1) PE20090938A1 (hr)
PL (1) PL2187879T3 (hr)
PT (1) PT2187879T (hr)
RS (1) RS55205B1 (hr)
SI (1) SI2187879T1 (hr)
TN (1) TN2010000073A1 (hr)
TW (2) TWI472325B (hr)
UA (1) UA100384C2 (hr)
UY (1) UY31296A1 (hr)
WO (1) WO2009022007A1 (hr)
ZA (1) ZA200909105B (hr)

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