HRP20230210T1 - Pripravci i postupci upotrebe 2-(4-klorofenil)-n-((2-(2,6-dioksopiperidin-3-il)-1-oksoizoindolin-5-il)metil)-2,2-difluoroacetamida - Google Patents

Pripravci i postupci upotrebe 2-(4-klorofenil)-n-((2-(2,6-dioksopiperidin-3-il)-1-oksoizoindolin-5-il)metil)-2,2-difluoroacetamida Download PDF

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HRP20230210T1
HRP20230210T1 HRP20230210TT HRP20230210T HRP20230210T1 HR P20230210 T1 HRP20230210 T1 HR P20230210T1 HR P20230210T T HRP20230210T T HR P20230210TT HR P20230210 T HRP20230210 T HR P20230210T HR P20230210 T1 HRP20230210 T1 HR P20230210T1
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formulation
amount
difluoroacetamide
oxoisoindolin
chlorophenyl
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HRP20230210TT
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Tonia J. Buchholz
James Carmichael
Soraya Carrancio
Jinhong Fan
Rajan Gupta
Gang Lu
Kyle Macbeth
Emily PACE
Daniel Pierce
Michael POURDEHNAD
Yu PU
Peng Wang
Naijun WU
Sheena YAO
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Celgene Corporation
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Publication of HRP20230210T1 publication Critical patent/HRP20230210T1/hr

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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
    • 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
    • A61K31/436—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 six-membered ring having oxygen as a ring hetero atom, e.g. rapamycin
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    • C08B37/0012—Cyclodextrin [CD], e.g. cycle with 6 units (alpha), with 7 units (beta) and with 8 units (gamma), large-ring cyclodextrin or cycloamylose with 9 units or more; Derivatives thereof
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Claims (17)

1. Formulacija koja sadrži: (2-(4-klorofenil)-N-((2-(2,6-dioksopiperidin-3-il)-1-oksoizoindolin-5-il)metil)-2,2-difluoroacetamid), ili njegov stereoizomer ili smjesa stereoizomera, farmaceutski prihvatljiva sol, tautomer, solvat, hidrat, ko-kristal, klatrat ili polimorf u količini od oko 0,01 do oko 0,15%, i hidroksipropil β-ciklodekstrin ili sulfobutil eter-beta-ciklodekstrin u količini od oko 99,1 do oko 99,99%, temeljeno na ukupnoj masi formulacije, pri čemu pojam "oko" podrazumijeva maseni postotak unutar 10%, ili 5% masenog postotka koji je obuhvaćen.
2. Formulacija prema zahtjevu 1 naznačena time što sadrži: (2-(4-klorofenil)-N-((2-(2,6-dioksopiperidin-3-il)-1-oksoizoindolin-5-il)metil)-2,2-difluoroacetamid), ili njegov stereoizomer ili smjesa stereoizomera, farmaceutski prihvatljiva sol, tautomer, solvat, hidrat, ko-kristal, klatrat ili polimorf u količini od oko 0,08 do oko 0,15%, i hidroksipropil β-ciklodekstrin ili sulfobutil eter-beta-ciklodekstrin u količini od oko 99,1 do oko 99,9%, temeljeno na ukupnoj masi formulacije.
3. Formulacija prema zahtjevu 1, naznačena time što sadrži (2-(4-klorofenil)-N-((2-(2,6-dioksopiperidin-3-il)-1-oksoizoindolin-5-il)metil)-2,2-difluoroacetamid), ili njegov stereoizomer ili smjesa stereoizomera, farmaceutski prihvatljiva sol, tautomer, solvat, hidrat, ko-kristal, klatrat ili polimorf u količini od oko 0,1 do oko 0,13%, ili pri čemu je (2-(4-klorofenil)-N-((2-(2,6-dioksopiperidin-3-il)-1-oksoizoindolin-5-il)metil)-2,2-difluoroacetamid), ili njegov stereoizomer ili smjesa stereoizomera, farmaceutski prihvatljiva sol, tautomer, solvat, hidrat, ko-kristal, klatrat ili polimorf prisutan u količini od oko 0,12% temeljeno na ukupnoj masi formulacije.
4. Formulacija prema zahtjevu 1 naznačena time što sadrži: (2-(4-klorofenil)-N-((2-(2,6-dioksopiperidin-3-il)-1-oksoizoindolin-5-il)metil)-2,2-difluoroacetamid), ili njegov stereoizomer ili smjesa stereoizomera, farmaceutski prihvatljiva sol, tautomer, solvat, hidrat, ko-kristal, klatrat ili polimorf u količini od oko 0,01 do oko 0,08%, i hidroksipropil β-ciklodekstrin u količini od oko 99,40 do oko 99,99%.
5. Formulacija prema zahtjevu 1, naznačena time što sadrži (2-(4-klorofenil)-N-((2-(2,6-dioksopiperidin-3-il)-1-oksoizoindolin-5-il)metil)-2,2-difluoroacetamid), ili njegov stereoizomer ili smjesa stereoizomera, farmaceutski prihvatljiva sol, tautomer, solvat, hidrat, ko-kristal, klatrat ili polimorf u količini od oko 0,01 do oko 0,08%, hidroksipropil β-ciklodekstrin u količini od oko 99,40% do oko 99,99%, te mravlju kiselinu od oko 0,1 do oko 0,3% temeljeno na ukupnoj masi formulacije.
6. Formulacija prema bilo kojem od zahtjeva 1 do 5 naznačena time što nadalje sadrži mravlju kiselinu u količini ne većoj od oko 0,5% temeljeno na ukupnoj masi pripravka.
7. Formulacija prema bilo kojem od zahtjeva 1 do 5, time što sadrži čvrsti oblik (2-(4-klorofenil)-N-((2-(2,6-dioksopiperidin-3-il)-1-oksoizoindolin-5-il)metil)-2,2-difluoroacetamida) ili amorfni oblik (2-(4-klorofenil)-N-((2-(2,6-dioksopiperidin-3-il)-1-oksoizoindolin-5-il)metil)-2,2-difluoroacetamida).
8. Vodena formulacija koja sadrži formulaciju prema bilo kojem od zahtjeva 1 do 5 i razrjeđivač, izborno pri čemu je razrjeđivač voda ili 1⁄2 normalna fiziološka otopina, ili pri čemu je razrjeđivač normalna fiziološka otopina.
9. Vodena formulacija prema zahtjevu 8, naznačena time što sadrži (2-(4-klorofenil)-N-((2-(2,6-dioksopiperidin-3-il)-1-oksoizoindolin-5-il)metil)-2,2-difluoroacetamid), ili njegov stereoizomer ili smjesa stereoizomera, farmaceutski prihvatljiva sol, tautomer, solvat, hidrat, ko-kristal, klatrat ili polimorf u količini od oko 0,1 do 0,3 mg/mL.
10. Vodena formulacija prema zahtjevu 8, naznačena time što vodena otopina ima pH u rasponu od oko 3,0 do oko 3,6, ili pri čemu vodena otopina ima pH u rasponu od oko 4,2 do oko 4,4.
11. Vodena formulacija prema zahtjevu 8, naznačena time što vodena otopina ima osmolalnost od oko 260-280 mOsm/kg ili pri čemu vodena otopina ima osmolalnost od oko 310-380 mOsm/kg.
12. Formulacija prema bilo kojem od zahtjeva 1 do 5 ili vodena formulacija prema zahtjevu 8 za upotrebu u postupku liječenja raka kod sisavaca.
13. Vodena formulacija za upotrebu prema zahtjevu 12, naznačena time što postupak uključuje intravensko davanje vodene formulacije.
14. Formulacija za upotrebu prema zahtjevu 12 ili vodena formulacija za upotrebu prema zahtjevu 12 ili 13, naznačena time što je rak leukemija, izborno je leukemija kronična limfocitna leukemija, kronična mijelocitna leukemija, akutna limfoblastična leukemija ili akutna mijeloična leukemija.
15. Formulacija za upotrebu prema zahtjevu 12, ili vodena formulacija za upotrebu prema zahtjevu 12 ili 13, naznačena time što dalje obuhvaća davanje terapeutski učinkovite količine još drugog aktivnog sredstva ili podržavajuće terapije, izborno pri čemu je drugo aktivno sredstvo terapijsko protutijelo koje se specifično veže na antigen raka, hematopoetski faktor rasta, citokin, sredstvo protiv raka, antibiotik, inhibitor cox-2, imunomodulacijsko sredstvo, imunosupresivno sredstvo, kortikosteroid ili farmakološki aktivni mutant ili njegov derivat.
16. Postupak za pripremu formulacije prema bilo kojem od zahtjeva 1 do 5, naznačen time što obuhvaća: otapanje (2-(4-klorofenil)-N-((2-(2,6-dioksopiperidin-3-il)-1-oksoizoindolin-5-il)metil)-2,2-difluoroacetamida) u mravljoj kiselini da se dobije predsmjesa, otapanje hidroksipropil β-ciklodekstrina u vodi da se dobije otopina, dodavanje predsmjese u otopinu da se dobije otopina lijeka.
17. Postupak prema zahtjevu 16, naznačen time što nadalje obuhvaća liofilizaciju otopine da se dobije liofilizirana formulacija.
HRP20230210TT 2017-06-30 2018-06-29 Pripravci i postupci upotrebe 2-(4-klorofenil)-n-((2-(2,6-dioksopiperidin-3-il)-1-oksoizoindolin-5-il)metil)-2,2-difluoroacetamida HRP20230210T1 (hr)

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US201762527744P 2017-06-30 2017-06-30
US201862653436P 2018-04-05 2018-04-05
US201862673064P 2018-05-17 2018-05-17
EP18823719.2A EP3644999B1 (en) 2017-06-30 2018-06-29 Compositions and methods of use of 2-(4-chlorophenyl)-n-((2-(2,6-dioxopiperidin-3-yl)-1-oxoisoindolin-5-yl) methyl) -2,2-difluoroacetamide
PCT/US2018/040286 WO2019006299A1 (en) 2017-06-30 2018-06-29 COMPOSITIONS AND METHODS FOR THE USE OF 2- (4-CHLOROPHENYL) -N - ((2- (2,6-DIOXOPIPERIDIN-3-YL) -1-OXOISOINDOLIN-5-YL) METHYL) -2,2-DIFLUOROACETAMIDE

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AU (1) AU2018294327A1 (hr)
BR (1) BR112019028101A2 (hr)
CA (1) CA3068591A1 (hr)
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PL (1) PL3644999T3 (hr)
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