HUE033508T2 - 5-azacitidin új kristályformái - Google Patents

5-azacitidin új kristályformái Download PDF

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Publication number
HUE033508T2
HUE033508T2 HUE10179540A HUE10179540A HUE033508T2 HU E033508 T2 HUE033508 T2 HU E033508T2 HU E10179540 A HUE10179540 A HU E10179540A HU E10179540 A HUE10179540 A HU E10179540A HU E033508 T2 HUE033508 T2 HU E033508T2
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HU
Hungary
Prior art keywords
azacytidine
pharmaceutical composition
crystalline
angles
use according
Prior art date
Application number
HUE10179540A
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English (en)
Inventor
Dumitru Ionescu
Peter Blumbergs
Lee Alani Selvey
Original Assignee
Celgene Int Sarl
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
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First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=32987557&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=HUE033508(T2) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Celgene Int Sarl filed Critical Celgene Int Sarl
Publication of HUE033508T2 publication Critical patent/HUE033508T2/hu

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Classifications

    • 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
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/7042—Compounds having saccharide radicals and heterocyclic rings
    • A61K31/7052—Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides
    • A61K31/706—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
    • A61K31/7064—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
    • A61K31/7068—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
    • 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
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/7042—Compounds having saccharide radicals and heterocyclic rings
    • A61K31/7052—Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides
    • A61K31/706—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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00—Drugs for disorders of the blood or the extracellular fluid
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07H—SUGARS; DERIVATIVES THEREOF; NUCLEOSIDES; NUCLEOTIDES; NUCLEIC ACIDS
    • C07H19/00—Compounds containing a hetero ring sharing one ring hetero atom with a saccharide radical; Nucleosides; Mononucleotides; Anhydro-derivatives thereof
    • C07H19/02—Compounds containing a hetero ring sharing one ring hetero atom with a saccharide radical; Nucleosides; Mononucleotides; Anhydro-derivatives thereof sharing nitrogen
    • C07H19/04—Heterocyclic radicals containing only nitrogen atoms as ring hetero atom
    • C07H19/048—Pyridine radicals
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07H—SUGARS; DERIVATIVES THEREOF; NUCLEOSIDES; NUCLEOTIDES; NUCLEIC ACIDS
    • C07H19/00—Compounds containing a hetero ring sharing one ring hetero atom with a saccharide radical; Nucleosides; Mononucleotides; Anhydro-derivatives thereof
    • C07H19/02—Compounds containing a hetero ring sharing one ring hetero atom with a saccharide radical; Nucleosides; Mononucleotides; Anhydro-derivatives thereof sharing nitrogen
    • C07H19/04—Heterocyclic radicals containing only nitrogen atoms as ring hetero atom
    • C07H19/12—Triazine radicals

Claims (9)

  1. Sauusdiktm új kasláh tormás Sæahsdatmi tgluygostol; Iá S-syMltMtíkkrísjályos í^pÉijéiMíMitötó gyógyáytaü teytmgay myelodysplasias ssdnè* limik kfáslöst m S-sgâcltMm kiistâlyoîs (€0 Ktû.:feÊSü:gi.ràâs:sai. félkMi);jpôir^îïi|êjî4it>âtkiêà ápkttumlbán aa alltM 2i saögektiei gidiàt fdlbMZ'ô mtómumokMt
    , ös almi m síjárás smàa a gyégyássatl késKtmárp oxälkao adagctljulo 3, A 8¾ !, igöriyposit sgötigti glkgfpägferä, ahol ag Srsgaoittdóí ktlsiá- iyos fermáiáaák: (Cu Ká teügárgássai ÍMy#ítygömr#dtgöpbtt ioByegébeg a 3. ábra smmti spektrummal jellemzett,
  2. 3. Ar. S^aeitytn krisiályos fermájáí lariateïârô gyögyásaab kéaKtméav &amp;« K vagy dolgom?* pout; szsdmi gikalmarásra, ahol kristélycys fhármajá:tátsk ;CC2u Kg bosógáígissat felkelt):. maiakéi likszöpkep <Mávelsé|ökát és relativ in» tetv/ùàs énekeket mutálja;
  3. 4. A gyógyászati készítmény a/ 1-3. igcnypomok bármelyik« szerinti alkalmazásra, ahol a moaoMdratiM az alábbiak szedni .állítjuk elfe a/. 5-uaraeiiidîn kristályos tormáiét vízzel é-imkeztetjük: és a/. 5-azaeiüdin kristály*^ ionnal ai izoláljak.
  4. 5. Λ gyógyászati készítmény a 4. igénypont szerinti alkalmazásra, ahol az 1 '3. igén}pontok szépítiI S»azpiiidh| kristályos fermajának előállítására· basznak SsaæseitMtiv tóstályös ferma m Vazadíidlnl krMÉlytbrmajm II tóatálylonnájm IVikrlsiàlylkenlîa, V krisfalyifet'inäja. VI krlAályfosanáíá, VIIMsíályfefet'áj^.'¥8gy Vili kiíslálylömiájB; vagy ezek közűi kellő vágy több keveréke. o Az 5«üzaciúdin vegyes fázisú i ormait tartóin iám gyégvaszMr készítmény myelodysplasias szindrómák kezelési eljárásában történő alkalmazásra: ahol az S-aaaeiíidm vegyes :Iázi:s|fbr~ mái (Cu K« besugárzással felvett) pomóntgenditTrakciós spektruma az alábbi 30 szögéktiél mutatnak jellemző maximumokat;
    , és ahöl aa aljáfás során a gyögyásaan klssföBérAt omlisaa adagolják.
  5. 7. A gsogyá.v'öö kés<ním«ny a 6. igény pont szerinti alkalmazásra, arad az S-azadtiöín -vegyes fázisa formájának (Ca Eo feMufátliSSalîèhW> linyogl- ben a .7... ábra sxermü spskirunimal joUobizéti I, Á gyögyaáMb lésplinény a 6. vágy 7. igénypont szedői! aikatea2ísray áfeíHAig ö-aaagllldnv vögyes jlzísa föAblÄk (C'a Ka btSagidAssal Advott) por'f&amp;tgandlift'akaibi sjtektrÄä 7¾ alábbi lö szögeket, d olaelMgökát: és relatív i?f teazltls eitvkékei: nnttaijd:
    9:. lïàsiàiÿôs feriïîâjâî tartalmazó gyógyászai! rômàk .to.e!éài.ei|Msâbàa. Ä.da4ÄälawÄä^. ö-hól à-klMâlÿôglMM· (Cm Ka besugárzás·' sa! felvett) por-röntgenditTrakcids spektruma tx&amp; alábbi 20 r?.ögek«fl.tóutaij#IÍéátti€ntálMfí? mókát:
    , es ahol az epfäs semo g gyógyászati késziunényt orálisán adagoljuk,
  6. 10. A gyógyászati készítmény a 9. igénypont szerinti alkalmazásra, ahol az S-azacitkiln krls-1ály íöoóá|a: t'Co i&amp;öf teúgfeáSMI por-yőtugenblilyalíeléa spÈXmtm lényegében a é, ábra szerinti spektruammt jellemzett. Π. Λ* S-uzaettidm kristályos tonnáját tartalmazó gyógyászati készítmény a t v%f W, igénypont szerinti alkalmazási. «hoi az S-a/acttutin ktisilfyos tormája (Cu Ka dssp|uÍTZÍP*h k' \«,0 per-rémgemh tool k ,λ s^kta w«> / a abo* >é vogeket. őom tagokat rs ittam tert/itás értékeket mutatja'.
    L\ (oomuvmti kesznmem eOM t mém pontok Ménéből e ve*· eu »lkaimul u ih.>t 3' S-ázáéiiidiB ilgíáilds ittáU^it Jgy aKifjuk elő. hogy : .Aazadtklin és m arm hol oldatát Heti Ózdijuk: és a ÜoítiizáH szilárd anyagot izoláljuk..
  7. 13. A gyógyászati készítmény a 12, igénypont szerinti alkalmazásra, ahol az 5~azacitidm és mannitol oldata m SomaeHidíni és mamiitok körülbelül ki tömegarányban tartalmazza. % V' od v kno n muo o t. lu í Vv0 ik' "N ews odsv> n nn udt mák kezelési eljárásában történő alkalmazási a, ahol az eljárás során a gyógyászati készítményt orálisan adagopk. |:$. A gyógyászati készítmény a 1-4 Igénypont szerinti alkalmazásra 14.. ahol az amorf szilárd 5-azueiíídml égy állítjuk eh\ hogy: az alábbi;
    (Cu Kn besugárzással felvett) por-rOntg«nd?fT?akcios spektrumában 20 szegeknél jellemző nax vu ov\m mutató s aemmdm kiutad n nvmai mopdeoghkoh pelieülenyiiikol os DMhO közül választón oUêÂÉei atljnk;: is hmvmiUK -'lsbv-í a? ^n/aemdnu
  8. 16, A gyógyászati készítmény az előző igénypontok bármelyike szerimi alkalmazásra, ahol a gyógyászati készítmény mvábbáegy g>e>gyásza01ag eltagadható kötőanyagot« log Húszén vagy hordozót tartalma?:; vagy ahol a gyógyászati készítmény egységdó/.ks formává alakított
  9. 17, A gyógyászati készítmény a 16, igéin pont szerinti, alkalmazásra!* ahol valamennyi egy-segdózis S mg - 200 mg 5*azacitWín formát, előnyösen 100 mg S-azacuidin tormái tartalmaz,.
HUE10179540A 2003-03-17 2004-03-16 5-azacitidin új kristályformái HUE033508T2 (hu)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
US10/390,578 US6887855B2 (en) 2003-03-17 2003-03-17 Forms of 5-azacytidine

Publications (1)

Publication Number Publication Date
HUE033508T2 true HUE033508T2 (hu) 2017-12-28

Family

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Family Applications (2)

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HUE10179540A HUE033508T2 (hu) 2003-03-17 2004-03-16 5-azacitidin új kristályformái
HUE04721074A HUE030717T2 (hu) 2003-03-17 2004-03-16 5-azacitidin formák

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Country Status (11)

Country Link
US (7) US6887855B2 (hu)
EP (5) EP2258711B9 (hu)
CY (2) CY1117990T1 (hu)
DK (2) DK2258711T3 (hu)
ES (2) ES2621531T3 (hu)
HU (2) HUE033508T2 (hu)
LT (1) LT1610784T (hu)
PL (2) PL2258711T3 (hu)
PT (2) PT2258711T (hu)
SI (2) SI2258711T1 (hu)
WO (1) WO2004082619A2 (hu)

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US8513406B2 (en) 2013-08-20
LT1610784T (lt) 2016-10-25
US20130059810A1 (en) 2013-03-07
PL1610784T3 (pl) 2017-02-28
EP2258711A2 (en) 2010-12-08
US20100298253A1 (en) 2010-11-25
EP1610784B1 (en) 2016-07-06
EP2258710A1 (en) 2010-12-08
ES2621531T3 (es) 2017-07-04
US20140107058A1 (en) 2014-04-17
US8779117B2 (en) 2014-07-15
WO2004082619A2 (en) 2004-09-30
US20130059809A1 (en) 2013-03-07
US20040186065A1 (en) 2004-09-23
EP1610784A2 (en) 2006-01-04
EP2270022A1 (en) 2011-01-05
US8614313B2 (en) 2013-12-24
US20060247189A1 (en) 2006-11-02
PT2258711T (pt) 2017-03-30
WO2004082619A3 (en) 2005-05-26
EP2270023B1 (en) 2016-06-15
EP2258711A3 (en) 2011-03-30
PL2258711T3 (pl) 2017-08-31
DK2258711T3 (en) 2017-04-24
HUE030717T2 (hu) 2017-05-29
EP2258711B9 (en) 2017-12-27
EP1610784A4 (en) 2007-11-07
ES2592287T3 (es) 2016-11-29
US7772199B2 (en) 2010-08-10
US6887855B2 (en) 2005-05-03
EP2270022B1 (en) 2016-06-29
DK1610784T3 (en) 2016-09-12
US7078518B2 (en) 2006-07-18
SI2258711T1 (sl) 2017-08-31
CY1118805T1 (el) 2018-01-10
EP2258711B1 (en) 2017-01-18
CY1117990T1 (el) 2017-05-17
EP2258710B1 (en) 2016-10-19
SI1610784T1 (sl) 2017-01-31
US9192620B2 (en) 2015-11-24
US20050137150A1 (en) 2005-06-23
PT1610784T (pt) 2016-09-23

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