HRP20180133T1 - Čvrsti oblici 3-(5-amino-2-metil-4-okso-4h-kinazolin-3-il) piperidin-2,6-diona, te njihovi farmaceutski pripravci i upotreba - Google Patents
Čvrsti oblici 3-(5-amino-2-metil-4-okso-4h-kinazolin-3-il) piperidin-2,6-diona, te njihovi farmaceutski pripravci i upotreba Download PDFInfo
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- HRP20180133T1 HRP20180133T1 HRP20180133TT HRP20180133T HRP20180133T1 HR P20180133 T1 HRP20180133 T1 HR P20180133T1 HR P20180133T T HRP20180133T T HR P20180133TT HR P20180133 T HRP20180133 T HR P20180133T HR P20180133 T1 HRP20180133 T1 HR P20180133T1
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- solid form
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- form according
- pharmaceutical preparation
- quinazolin
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- 239000007787 solid Substances 0.000 title claims 16
- RSNPAKAFCAAMBH-UHFFFAOYSA-N 3-(5-amino-2-methyl-4-oxoquinazolin-3-yl)piperidine-2,6-dione Chemical compound CC1=NC2=CC=CC(N)=C2C(=O)N1C1CCC(=O)NC1=O RSNPAKAFCAAMBH-UHFFFAOYSA-N 0.000 title claims 2
- 239000008194 pharmaceutical composition Substances 0.000 title 1
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 claims 10
- 208000035475 disorder Diseases 0.000 claims 8
- 239000000825 pharmaceutical preparation Substances 0.000 claims 6
- 238000000634 powder X-ray diffraction Methods 0.000 claims 3
- 201000010099 disease Diseases 0.000 claims 2
- 239000002552 dosage form Substances 0.000 claims 2
- 238000000034 method Methods 0.000 claims 2
- QCQCHGYLTSGIGX-GHXANHINSA-N 4-[[(3ar,5ar,5br,7ar,9s,11ar,11br,13as)-5a,5b,8,8,11a-pentamethyl-3a-[(5-methylpyridine-3-carbonyl)amino]-2-oxo-1-propan-2-yl-4,5,6,7,7a,9,10,11,11b,12,13,13a-dodecahydro-3h-cyclopenta[a]chrysen-9-yl]oxy]-2,2-dimethyl-4-oxobutanoic acid Chemical compound N([C@@]12CC[C@@]3(C)[C@]4(C)CC[C@H]5C(C)(C)[C@@H](OC(=O)CC(C)(C)C(O)=O)CC[C@]5(C)[C@H]4CC[C@@H]3C1=C(C(C2)=O)C(C)C)C(=O)C1=CN=CC(C)=C1 QCQCHGYLTSGIGX-GHXANHINSA-N 0.000 claims 1
- 201000001320 Atherosclerosis Diseases 0.000 claims 1
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 claims 1
- 208000029462 Immunodeficiency disease Diseases 0.000 claims 1
- 208000019693 Lung disease Diseases 0.000 claims 1
- 206010028980 Neoplasm Diseases 0.000 claims 1
- 208000002193 Pain Diseases 0.000 claims 1
- 208000030852 Parasitic disease Diseases 0.000 claims 1
- 108060008682 Tumor Necrosis Factor Proteins 0.000 claims 1
- 102000000852 Tumor Necrosis Factor-alpha Human genes 0.000 claims 1
- 208000027418 Wounds and injury Diseases 0.000 claims 1
- 239000013543 active substance Substances 0.000 claims 1
- 230000033115 angiogenesis Effects 0.000 claims 1
- 239000010425 asbestos Substances 0.000 claims 1
- 201000011510 cancer Diseases 0.000 claims 1
- 239000002775 capsule Substances 0.000 claims 1
- 208000015114 central nervous system disease Diseases 0.000 claims 1
- 230000006378 damage Effects 0.000 claims 1
- 238000000113 differential scanning calorimetry Methods 0.000 claims 1
- 239000003085 diluting agent Substances 0.000 claims 1
- 208000034737 hemoglobinopathy Diseases 0.000 claims 1
- 208000014674 injury Diseases 0.000 claims 1
- 238000001990 intravenous administration Methods 0.000 claims 1
- 208000002780 macular degeneration Diseases 0.000 claims 1
- 238000007911 parenteral administration Methods 0.000 claims 1
- 229910052895 riebeckite Inorganic materials 0.000 claims 1
- 208000017520 skin disease Diseases 0.000 claims 1
- 239000000126 substance Substances 0.000 claims 1
- 208000011580 syndromic disease Diseases 0.000 claims 1
- 238000002411 thermogravimetry Methods 0.000 claims 1
Classifications
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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07D—HETEROCYCLIC COMPOUNDS
- C07D401/00—Heterocyclic compounds containing two or more hetero rings, having nitrogen atoms as the only ring hetero atoms, at least one ring being a six-membered ring with only one nitrogen atom
- C07D401/02—Heterocyclic compounds containing two or more hetero rings, having nitrogen atoms as the only ring hetero atoms, at least one ring being a six-membered ring with only one nitrogen atom containing two hetero rings
- C07D401/04—Heterocyclic compounds containing two or more hetero rings, having nitrogen atoms as the only ring hetero atoms, at least one ring being a six-membered ring with only one nitrogen atom containing two hetero rings directly linked by a ring-member-to-ring-member bond
-
- 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
- A61K31/33—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
- A61K31/517—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with carbocyclic ring systems, e.g. quinazoline, perimidine
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P35/00—Antineoplastic agents
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07B—GENERAL METHODS OF ORGANIC CHEMISTRY; APPARATUS THEREFOR
- C07B2200/00—Indexing scheme relating to specific properties of organic compounds
- C07B2200/13—Crystalline forms, e.g. polymorphs
Claims (15)
1. Čvrsti oblik hidrokloridne soli 3-(5-amino-2-metil-4-okso-4H-kinazolin-3-il)piperidin-2,6-diona:
[image]
,
naznačen time što ima uzorak difrakcije rendgenskih zraka na prahu s maksimumima na otprilike 8,6, 13,1, 20,5 i 26,3 °2θ.
2. Čvrsti oblik u skladu s patentnim zahtjevom 1, naznačen time što ima uzorak difrakcije rendgenskih zraka na prahu uglavnom onakav kakav je prikazan na sljedećoj slici:
[image]
.
3. Čvrsti oblik u skladu s patentnim zahtjevom 1, naznačen time što ima uzorak difrakcije rendgenskih zraka na prahu s maksimumima na otprilike 8,6, 11,3, 13,1, 15,3, 17,3, 20,5, 22.7, 23,6, 26,3 i 31,4 °2θ.
4. Čvrsti oblik u skladu s bilo kojim od patentnih zahtjeva 1 do 3, naznačen time što ima grafički prikaz diferencijalne skenirajuće kalorimetrije koji sadrži endotermnu pojavu s početnom temperaturom na otprilike 276°C.
5. Čvrsti oblik u skladu s bilo kojim od patentnih zahtjeva 1 do 4, naznačen time što ima grafički prikaz toplinske gravimetrijske analize koji sadrži gubitak mase manji od otprilike 0,5% prilikom grijanja od otprilike 25°C do otprilike 150°C.
6. Čvrsti oblik u skladu s bilo kojim od patentnih zahtjeva 1 do 5, naznačen time što je čvrsti oblik bezvodan.
7. Čvrsti oblik u skladu s bilo kojim od patentnih zahtjeva 1 do 6, naznačen time što čvrsti oblik pokazuje povećanje mase manje od otprilike 0,5% kada se podvrgne povećanju relativne vlažnosti od otprilike 0% do otprilike 95% relativne vlažnosti.
8. Čvrsti oblik u skladu s bilo kojim od patentnih zahtjeva 1 do 7, naznačen time što je čvrsti oblik stabilan prilikom izlaganja do otprilike 40°C i otprilike 75% relativne vlažnosti u trajanju od otprilike 4 tjedna.
9. Čvrsti oblik u skladu s bilo kojim od patentnih zahtjeva 1 do 8, naznačen time što se molarni omjer između 3-(5-amino-2-metil-4-okso-4H-kinazolin-3-il)piperidin-2,6-diona i hidroklorida kreće od otprilike 0,1 do otprilike 10.
10. Farmaceutski pripravak, naznačen time što sadrži čvrsti oblik u skladu s bilo kojim od patentnih zahtjeva 1 do 9, kao i farmaceutski prihvatljivu podlogu, razrjeđivač ili pomoćnu tvar.
11. Farmaceutski pripravak u skladu s patentnim zahtjevom 10, naznačen time što je pripravak formuliran za oralnu, parenteralnu ili intravensku primjenu.
12. Farmaceutski pripravak u skladu s patentnim zahtjevom 10 ili 11, naznačen time što je pripravak formuliran kao jedinični oblik doziranja.
13. Farmaceutski pripravak u skladu s patentnim zahtjevom 12, naznačen time što je jedinični oblik doziranja tableta ili kapsula.
14. Čvrsti oblik u skladu s bilo kojim od patentnih zahtjeva 1 do 9 ili farmaceutski pripravak u skladu s bilo kojim od patentnih zahtjeva 10 do 13, naznačeni time što su namijenjeni upotrebi u postupku liječenja, zbrinjavanja ili sprječavanja bolesti ili poremećaja, gdje je bolest ili poremećaj rak, poremećaj povezan s angiogenezom, bol, degeneracija makule ili slični sindrom, kožna bolest, plućni poremećaj, poremećaj povezan s azbestom, parazitarna bolest, imunodeficijancijski poremećaj, poremećaj CNS-a, ozljeda CNS-a, ateroskleroza ili slični poremećaj, disfunkcionalan san ili slični poremećaj, hemoglobinopatija ili slični poremećaj ili poremećaj povezan s TNFα.
15. Čvrsti oblik ili farmaceutski pripravak namijenjeni upotrebi u skladu s patentnim zahtjevom 14, naznačeni time što se postupak sastoji u primjeni drugog aktivnog sredstva.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201161451806P | 2011-03-11 | 2011-03-11 | |
| PCT/US2012/028419 WO2012125438A1 (en) | 2011-03-11 | 2012-03-09 | Solid forms of 3-(5-amino-2methyl-4-oxo-4h-quinazolin-3-yl)-piperidine-2,6-dione, and their pharmaceutical compositions and uses |
| EP12710834.8A EP2683708B1 (en) | 2011-03-11 | 2012-03-09 | Solid forms of 3-(5-amino-2-methyl-4-oxo-4h-quinazolin-3-yl)-piperidine-2,6-dione, and their pharmaceutical compositions and uses |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| HRP20180133T1 true HRP20180133T1 (hr) | 2018-02-23 |
Family
ID=45888486
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP20180133TT HRP20180133T1 (hr) | 2011-03-11 | 2018-01-23 | Čvrsti oblici 3-(5-amino-2-metil-4-okso-4h-kinazolin-3-il) piperidin-2,6-diona, te njihovi farmaceutski pripravci i upotreba |
Country Status (34)
| Country | Link |
|---|---|
| US (5) | US8802685B2 (hr) |
| EP (2) | EP2683708B1 (hr) |
| JP (1) | JP5959543B2 (hr) |
| KR (1) | KR20140014221A (hr) |
| CN (2) | CN106083812A (hr) |
| AR (1) | AR085650A1 (hr) |
| AU (2) | AU2012229279B2 (hr) |
| BR (1) | BR112013023279A2 (hr) |
| CA (3) | CA3037184C (hr) |
| CL (1) | CL2013002593A1 (hr) |
| CO (1) | CO6821939A2 (hr) |
| CR (2) | CR20130458A (hr) |
| CY (1) | CY1119974T1 (hr) |
| DK (1) | DK2683708T3 (hr) |
| EA (1) | EA026100B1 (hr) |
| EC (1) | ECSP13012877A (hr) |
| ES (1) | ES2656855T3 (hr) |
| HR (1) | HRP20180133T1 (hr) |
| HU (1) | HUE037955T2 (hr) |
| LT (1) | LT2683708T (hr) |
| MX (1) | MX2013010360A (hr) |
| NI (1) | NI201300080A (hr) |
| NO (1) | NO2683708T3 (hr) |
| PE (1) | PE20140983A1 (hr) |
| PL (1) | PL2683708T3 (hr) |
| PT (1) | PT2683708T (hr) |
| RS (1) | RS56770B1 (hr) |
| RU (1) | RU2611007C2 (hr) |
| SG (1) | SG192946A1 (hr) |
| SI (1) | SI2683708T1 (hr) |
| TW (2) | TWI601722B (hr) |
| UA (1) | UA113512C2 (hr) |
| WO (1) | WO2012125438A1 (hr) |
| ZA (1) | ZA201306234B (hr) |
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| JP5645816B2 (ja) | 2009-05-25 | 2014-12-24 | 国立大学法人東京工業大学 | 中枢神経細胞の増殖及び分化に係る中核因子を含む医薬組成物 |
| PL2683708T3 (pl) | 2011-03-11 | 2018-03-30 | Celgene Corporation | Postacie stałe 3-(5-amino-2-metylo-4-okso-4h-chinazolin-3-ylo)-piperydyno-2,6-dionu oraz ich kompozycje farmaceutyczne i zastosowania |
| CA2867134C (en) | 2011-03-28 | 2019-05-07 | Sheila Dewitt | 2',6'-dioxo-3'-deutero-piperdin-3-yl-isoindoline compounds |
| CA2834535A1 (en) | 2011-04-29 | 2012-11-01 | Celgene Corporation | Methods for the treatment of cancer and inflammatory diseases using cereblon as a predictor |
| US9857359B2 (en) * | 2012-06-29 | 2018-01-02 | Celgene Corporation | Methods for determining drug efficacy using cereblon-associated proteins |
| US9587281B2 (en) | 2012-08-14 | 2017-03-07 | Celgene Corporation | Cereblon isoforms and their use as biomarkers for therapeutic treatment |
| WO2014039421A1 (en) | 2012-09-04 | 2014-03-13 | Celgene Corporation | Isotopologues of 3-(5-amino-2-methyl-4-oxoquinazolin-3(4h)-yl) piperidine-2-6-dione and methods of preparation thereof |
| US9694015B2 (en) | 2012-09-10 | 2017-07-04 | Celgene Corporation | Methods for the treatment of locally advanced breast cancer |
| JP6359563B2 (ja) | 2013-01-14 | 2018-07-18 | デュートルクス・リミテッド・ライアビリティ・カンパニーＤｅｕｔｅＲｘ， ＬＬＣ | ３−（５置換−４−オキソキナゾリン−３（４ｈ）−イル）−３−ジュウテロピペリジン−２，６−ジオン誘導体 |
| WO2014152833A1 (en) | 2013-03-14 | 2014-09-25 | Deuterx, Llc | 3-(substituted-4-oxo-quinazolin-3(4h)-yl)-3-deutero-piperidine-2,6-dione derivatives |
| RS56565B1 (sr) * | 2013-05-01 | 2018-02-28 | Celgene Corp | Sinteza 3-(5-amino-2-metil-4-oksohinazolin-3(4h)-il)piperidin-2,6-diona |
| EP3071211A1 (en) * | 2013-11-18 | 2016-09-28 | Instructive Color, LLC | Metastable silver nanoparticle composites with color indicating properties |
| US20150196562A1 (en) * | 2014-01-15 | 2015-07-16 | Celgene Corporation | Formulations of 3-(5-amino-2-methyl-4-oxo-4h-quinazolin-3-yl)-piperidine-2,6-dione |
| EP3827836A1 (en) | 2014-06-27 | 2021-06-02 | Celgene Corporation | Compositions and methods for inducing conformational changes in cereblon and other e3 ubiquitin ligases |
| TW201642857A (zh) | 2015-04-06 | 2016-12-16 | 西建公司 | 以組合療法治療肝細胞癌 |
| JP6727237B2 (ja) | 2015-07-02 | 2020-07-22 | セルジーン コーポレイション | 血液がん及び固形腫瘍の治療のための併用療法 |
| US9809603B1 (en) | 2015-08-18 | 2017-11-07 | Deuterx, Llc | Deuterium-enriched isoindolinonyl-piperidinonyl conjugates and oxoquinazolin-3(4H)-yl-piperidinonyl conjugates and methods of treating medical disorders using same |
| CA2996641A1 (en) * | 2015-08-27 | 2017-03-02 | Celgene Corporation | Pharmaceutical compositions comprising 3-(5-amino-2-methyl-4-oxo-4h-quinazolin-3-yl)-piperidine-2,6-dione |
| AU2016364753A1 (en) | 2015-12-02 | 2018-06-14 | Celgene Corporation | Cycling therapy using 3-(5-amino-2-methyl-4-oxo-4H-quinazolin-3-yl)-piperidine-2,6-dione |
| WO2017117118A1 (en) | 2015-12-28 | 2017-07-06 | Celgene Corporation | Compositions and methods for inducing conformational changes in cereblon and other e3 ubiquitin ligases |
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