HRP20170770T1 - Uporaba poliola za dobivanje stabilnih polimorfnih oblika rifaksimina - Google Patents

Uporaba poliola za dobivanje stabilnih polimorfnih oblika rifaksimina Download PDF

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HRP20170770T1
HRP20170770T1 HRP20170770TT HRP20170770T HRP20170770T1 HR P20170770 T1 HRP20170770 T1 HR P20170770T1 HR P20170770T T HRP20170770T T HR P20170770TT HR P20170770 T HRP20170770 T HR P20170770T HR P20170770 T1 HRP20170770 T1 HR P20170770T1
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rifaximin
water content
stabilized
compounds according
remaining water
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HRP20170770TT
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Paola Maffei
Milena Bachetti
Giuseppe Bottoni
Giuseppe Claudio Viscomi
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Alfa Wassermann S.P.A.
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    • 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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    • C07D491/00—Heterocyclic compounds containing in the condensed ring system both one or more rings having oxygen atoms as the only ring hetero atoms and one or more rings having nitrogen atoms as the only ring hetero atoms, not provided for by groups C07D451/00 - C07D459/00, C07D463/00, C07D477/00 or C07D489/00
    • C07D491/22—Heterocyclic compounds containing in the condensed ring system both one or more rings having oxygen atoms as the only ring hetero atoms and one or more rings having nitrogen atoms as the only ring hetero atoms, not provided for by groups C07D451/00 - C07D459/00, C07D463/00, C07D477/00 or C07D489/00 in which the condensed system contains four or more hetero rings
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    • 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
    • A61K31/4353—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 ortho- or peri-condensed with heterocyclic ring systems
    • A61K31/437—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 ortho- or peri-condensed with heterocyclic ring systems the heterocyclic ring system containing a five-membered ring having nitrogen as a ring hetero atom, e.g. indolizine, beta-carboline
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    • 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
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Claims (14)

1. Uporaba jednog ili više spojeva koji nose barem dvije hidroksi skupine otopljene u vodenoj otopini naznačena time da je za stabiliziranje polimorfnih oblika rifaksimina.
2. Uporaba kako je zatraženo u zahtjevu 1 jednog ili više spojeva koji su odabrani iz skupine koja sadrži poliole koji sadrže dva do sedam ugljikovih atoma i dvije do sedam hidroksi skupina, monosaharide, disaharide, polisaharide kao što je škrob, celuloza, i njihovi derivati, dekstrin i maltodekstrin, ksantan guma, di-hidroksi kiseline i poli-hidroksi kiseline.
3. Uporaba 1,2,3-propantriola kako je zatraženo u zahtjevu 1.
4. Uporaba kako je zatraženo u zahtjevu 2 poliola koji ima opću formulu H-[O-CH2-CH2]n-OH, pri čemu n može biti u rasponu između 2 i 14.
5. Uporaba 1,2-propandiola kako je zatraženo u zahtjevu 2.
6. Uporaba kako je zatraženo u zahtjevu 1 spoja za dobivanje rifaksimina u krutom stanju u polimorfnom obliku β koji ima preostali udio vode manji od 4.5 %.
7. Polimorfni oblici rifaksimina u krutom stanju naznačeni time da su stabilizirani uporabom jednog ili više spojeva prema zahtjevima 1 do 5, neovisno od preostalog udjela vode.
8. Rifaksimin polimorf β u krutom stanju, naznačen time da je stabiliziran uporabom jednog ili više spojeva prema zahtjevima 1 do 5, neovisno od preostalog udjela vode.
9. Oralni i topikalni medicinski preparati koji sadrže rifaksimin u polimorfnom obliku β naznačen time da je stabiliziran uporabom jednog ili više spojeva prema zahtjevima 1 do 5, neovisno od preostalog udjela vode zajedno s pomoćnim sredstvima dobro poznatim u stanju tehnike, kao što su razrjeđivači, ligandi, lubrikanti, sredstva za usitnjavanje, boje, arome i zaslađivači, za liječenje patoloških stanja koja trebaju antibiotsku terapiju.
10. Mikrogranule gastrootpornog rifaksimina β naznačene time da se polimorf β stabilizira s jednim ili više spojeva prema zahtjevima 1 do 5, neovisno od preostalog udjela vode.
11. Rifaksimin β u termo-zavarenim vrećicama naznačen time da se polimorf β stabilizira uporabom jednog ili više spojeva prema zahtjevima 1 do 5, neovisno od preostalog udjela vode.
12. Rifaksimin β u obliku tablete naznačen time da se polimorf β stabilizira uporabom jednog ili više spojeva kako je zatraženo u zahtjevima 1 do 5, neovisno od preostalog udjela vode.
13. Postupak za dobivanje rifaksimina u polimorfnom obliku β prema zahtjevu 8, naznačen time da se rifaksimin u krutom stanju dovodi u kontakt s vodenom otopinom jednog ili više spojeva prema zahtjevu 1 do 5, u koncentraciji od 5% do 59% (w/w), kod temperature između 30°C i 90°C, tijekom perioda vremena koji je između 1 i 24 sata, te time da, se nakon odvajanja preostalih krutih tvari, suši kod temperature od između 30 i 80°C, kod tlaka okoline ili pod vakuumom, tijekom perioda vremena koji je između 2 i 72 sata.
14. Postupak za dobivanje rifaksimina u polimorfnom obliku β prema zahtjevu 8, naznačen time da se vodena otopina poliola koja sadrži jedan ili više spojeva prema zahtjevima 1 do 5 u koncentracijama u opsegu od 5 do 50% (w/w) raspršuje na rifaksimin β u krutom stanju u aparatu s fluidiziranim slojem kod ulazne temperature između 40°C i 90°C i tako dobivena smjesa se podvrgava sušenju pod strujom zraka kod temperature između 40 i 90°C.
HRP20170770TT 2006-09-05 2017-05-23 Uporaba poliola za dobivanje stabilnih polimorfnih oblika rifaksimina HRP20170770T1 (hr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
IT001692A ITMI20061692A1 (it) 2006-09-05 2006-09-05 Uso di polioli per ottenere forme polimorfe stabili di rifaximina
EP07804680.2A EP2059232B1 (en) 2006-09-05 2007-07-31 Use of polyols to obtain stable polymorphous forms of rifaximin
PCT/IB2007/002199 WO2008029208A1 (en) 2006-09-05 2007-07-31 Use of polyols to obtain stable polymorphous forms of rifaximin

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HR20090198A HRP20090198A9 (hr) 2006-09-05 2009-04-03 Upotreba poliola za dobivanje stabilnih oblika rifaksimina
HRP20170770TT HRP20170770T1 (hr) 2006-09-05 2017-05-23 Uporaba poliola za dobivanje stabilnih polimorfnih oblika rifaksimina

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