JP2019501191A5 - - Google Patents
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- JP2019501191A5 JP2019501191A5 JP2018535283A JP2018535283A JP2019501191A5 JP 2019501191 A5 JP2019501191 A5 JP 2019501191A5 JP 2018535283 A JP2018535283 A JP 2018535283A JP 2018535283 A JP2018535283 A JP 2018535283A JP 2019501191 A5 JP2019501191 A5 JP 2019501191A5
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- JP
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- Prior art keywords
- lyophilized formulation
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- total weight
- formulation
- Prior art date
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- 239000012931 lyophilized formulation Substances 0.000 claims description 64
- 239000000203 mixture Substances 0.000 claims description 23
- 229940125904 compound 1 Drugs 0.000 claims description 22
- 238000009472 formulation Methods 0.000 claims description 21
- KRKNYBCHXYNGOX-UHFFFAOYSA-N citric acid Chemical compound OC(=O)CC(O)(C(O)=O)CC(O)=O KRKNYBCHXYNGOX-UHFFFAOYSA-N 0.000 claims description 18
- 238000000034 method Methods 0.000 claims description 16
- 239000004067 bulking agent Substances 0.000 claims description 14
- HRXKRNGNAMMEHJ-UHFFFAOYSA-K trisodium citrate Chemical compound [Na+].[Na+].[Na+].[O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O HRXKRNGNAMMEHJ-UHFFFAOYSA-K 0.000 claims description 12
- 239000013011 aqueous formulation Substances 0.000 claims description 10
- 229960004543 anhydrous citric acid Drugs 0.000 claims description 9
- 206010028980 Neoplasm Diseases 0.000 claims description 8
- 201000011510 cancer Diseases 0.000 claims description 8
- 208000032839 leukemia Diseases 0.000 claims description 8
- ODLHGICHYURWBS-LKONHMLTSA-N trappsol cyclo Chemical compound CC(O)COC[C@H]([C@H]([C@@H]([C@H]1O)O)O[C@H]2O[C@@H]([C@@H](O[C@H]3O[C@H](COCC(C)O)[C@H]([C@@H]([C@H]3O)O)O[C@H]3O[C@H](COCC(C)O)[C@H]([C@@H]([C@H]3O)O)O[C@H]3O[C@H](COCC(C)O)[C@H]([C@@H]([C@H]3O)O)O[C@H]3O[C@H](COCC(C)O)[C@H]([C@@H]([C@H]3O)O)O3)[C@H](O)[C@H]2O)COCC(O)C)O[C@@H]1O[C@H]1[C@H](O)[C@@H](O)[C@@H]3O[C@@H]1COCC(C)O ODLHGICHYURWBS-LKONHMLTSA-N 0.000 claims description 8
- 239000007864 aqueous solution Substances 0.000 claims description 7
- 239000007979 citrate buffer Substances 0.000 claims description 6
- 239000000243 solution Substances 0.000 claims description 6
- 239000000872 buffer Substances 0.000 claims description 5
- 208000031261 Acute myeloid leukaemia Diseases 0.000 claims description 4
- 229920000858 Cyclodextrin Polymers 0.000 claims description 4
- 208000033776 Myeloid Acute Leukemia Diseases 0.000 claims description 4
- 239000013543 active substance Substances 0.000 claims description 4
- WHGYBXFWUBPSRW-FOUAGVGXSA-N beta-cyclodextrin Chemical compound OC[C@H]([C@H]([C@@H]([C@H]1O)O)O[C@H]2O[C@@H]([C@@H](O[C@H]3O[C@H](CO)[C@H]([C@@H]([C@H]3O)O)O[C@H]3O[C@H](CO)[C@H]([C@@H]([C@H]3O)O)O[C@H]3O[C@H](CO)[C@H]([C@@H]([C@H]3O)O)O[C@H]3O[C@H](CO)[C@H]([C@@H]([C@H]3O)O)O3)[C@H](O)[C@H]2O)CO)O[C@@H]1O[C@H]1[C@H](O)[C@@H](O)[C@@H]3O[C@@H]1CO WHGYBXFWUBPSRW-FOUAGVGXSA-N 0.000 claims description 4
- 239000003085 diluting agent Substances 0.000 claims description 4
- 208000024893 Acute lymphoblastic leukemia Diseases 0.000 claims description 2
- 208000014697 Acute lymphocytic leukaemia Diseases 0.000 claims description 2
- 208000010839 B-cell chronic lymphocytic leukemia Diseases 0.000 claims description 2
- 208000032791 BCR-ABL1 positive chronic myelogenous leukemia Diseases 0.000 claims description 2
- 208000010833 Chronic myeloid leukaemia Diseases 0.000 claims description 2
- 108090000695 Cytokines Proteins 0.000 claims description 2
- 102000004127 Cytokines Human genes 0.000 claims description 2
- FBPFZTCFMRRESA-KVTDHHQDSA-N D-Mannitol Chemical group OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KVTDHHQDSA-N 0.000 claims description 2
- 239000001116 FEMA 4028 Substances 0.000 claims description 2
- 108010002386 Interleukin-3 Proteins 0.000 claims description 2
- 102100039064 Interleukin-3 Human genes 0.000 claims description 2
- 208000031422 Lymphocytic Chronic B-Cell Leukemia Diseases 0.000 claims description 2
- 229930195725 Mannitol Natural products 0.000 claims description 2
- 208000033761 Myelogenous Chronic BCR-ABL Positive Leukemia Diseases 0.000 claims description 2
- 208000006664 Precursor Cell Lymphoblastic Leukemia-Lymphoma Diseases 0.000 claims description 2
- 239000003242 anti bacterial agent Substances 0.000 claims description 2
- 239000000427 antigen Substances 0.000 claims description 2
- 102000036639 antigens Human genes 0.000 claims description 2
- 108091007433 antigens Proteins 0.000 claims description 2
- 239000002246 antineoplastic agent Substances 0.000 claims description 2
- 235000011175 beta-cyclodextrine Nutrition 0.000 claims description 2
- 229960004853 betadex Drugs 0.000 claims description 2
- 230000003115 biocidal effect Effects 0.000 claims description 2
- 208000032852 chronic lymphocytic leukemia Diseases 0.000 claims description 2
- ALEXXDVDDISNDU-JZYPGELDSA-N cortisol 21-acetate Chemical compound C1CC2=CC(=O)CC[C@]2(C)[C@@H]2[C@@H]1[C@@H]1CC[C@@](C(=O)COC(=O)C)(O)[C@@]1(C)C[C@@H]2O ALEXXDVDDISNDU-JZYPGELDSA-N 0.000 claims description 2
- 229940111134 coxibs Drugs 0.000 claims description 2
- 239000003255 cyclooxygenase 2 inhibitor Substances 0.000 claims description 2
- 239000002955 immunomodulating agent Substances 0.000 claims description 2
- 229940121354 immunomodulator Drugs 0.000 claims description 2
- 230000002584 immunomodulator Effects 0.000 claims description 2
- 229960003444 immunosuppressant agent Drugs 0.000 claims description 2
- 230000001861 immunosuppressant effect Effects 0.000 claims description 2
- 239000003018 immunosuppressive agent Substances 0.000 claims description 2
- 239000000594 mannitol Substances 0.000 claims description 2
- 235000010355 mannitol Nutrition 0.000 claims description 2
- 229960001855 mannitol Drugs 0.000 claims description 2
- 239000000843 powder Substances 0.000 claims description 2
- 239000000651 prodrug Substances 0.000 claims description 2
- 229940002612 prodrug Drugs 0.000 claims description 2
- 230000000306 recurrent effect Effects 0.000 claims description 2
- 150000003839 salts Chemical class 0.000 claims description 2
- 239000007787 solid Substances 0.000 claims description 2
- 239000012453 solvate Substances 0.000 claims description 2
- 229940097346 sulfobutylether-beta-cyclodextrin Drugs 0.000 claims description 2
- 230000001225 therapeutic effect Effects 0.000 claims description 2
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 2
- 239000008194 pharmaceutical composition Substances 0.000 claims 11
- WQNHWIYLCRZRLR-UHFFFAOYSA-N 2-(3-hydroxy-2,5-dioxooxolan-3-yl)acetic acid Chemical compound OC(=O)CC1(O)CC(=O)OC1=O WQNHWIYLCRZRLR-UHFFFAOYSA-N 0.000 claims 5
- ZMIBIIAWFMCVFD-UHFFFAOYSA-N 2,2-difluoroacetamide Chemical compound NC(=O)C(F)F ZMIBIIAWFMCVFD-UHFFFAOYSA-N 0.000 claims 2
- -1 hydroxypropyl Chemical group 0.000 claims 2
- 125000003854 p-chlorophenyl group Chemical group [H]C1=C([H])C(*)=C([H])C([H])=C1Cl 0.000 claims 2
- PWBHUSLMHZLGRN-UHFFFAOYSA-N 2-(4-chlorophenyl)-N-[[2-(2,6-dioxopiperidin-3-yl)-1-oxo-3H-isoindol-5-yl]methyl]-2,2-difluoroacetamide Chemical compound ClC1=CC=C(C=C1)C(C(=O)NCC=1C=C2CN(C(C2=CC=1)=O)C1C(NC(CC1)=O)=O)(F)F PWBHUSLMHZLGRN-UHFFFAOYSA-N 0.000 claims 1
- 239000013078 crystal Substances 0.000 claims 1
- 239000000945 filler Substances 0.000 claims 1
- 238000001990 intravenous administration Methods 0.000 claims 1
- 230000003319 supportive effect Effects 0.000 claims 1
- DLFVBJFMPXGRIB-UHFFFAOYSA-N Acetamide Chemical compound CC(N)=O DLFVBJFMPXGRIB-UHFFFAOYSA-N 0.000 description 4
- 239000004606 Fillers/Extenders Substances 0.000 description 1
- 241000124008 Mammalia Species 0.000 description 1
- 239000007853 buffer solution Substances 0.000 description 1
- 238000011443 conventional therapy Methods 0.000 description 1
- 239000007788 liquid Substances 0.000 description 1
- 238000009120 supportive therapy Methods 0.000 description 1
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP2021068923A JP7201732B2 (ja) | 2016-01-08 | 2021-04-15 | ２－（４－クロロフェニル）－ｎ－（（２－（２，６－ジオキソピペリジン－３－イル）－１－オキソイソインドリン－５－イル）メチル）－２，２－ジフルオロアセトアミドの製剤 |
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201662276756P | 2016-01-08 | 2016-01-08 | |
| US62/276,756 | 2016-01-08 | ||
| PCT/US2017/012483 WO2017120437A1 (en) | 2016-01-08 | 2017-01-06 | Formulations of 2-(4-chlorophenyl)-n-((2-(2,6-dioxopiperidin-3-yl)-1-oxoisoindolin-5-yl)methyl)-2,2-difluoroacetamide |
Related Child Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2021068923A Division JP7201732B2 (ja) | 2016-01-08 | 2021-04-15 | ２－（４－クロロフェニル）－ｎ－（（２－（２，６－ジオキソピペリジン－３－イル）－１－オキソイソインドリン－５－イル）メチル）－２，２－ジフルオロアセトアミドの製剤 |
Publications (3)
| Publication Number | Publication Date |
|---|---|
| JP2019501191A JP2019501191A (ja) | 2019-01-17 |
| JP2019501191A5 true JP2019501191A5 (enExample) | 2020-06-25 |
| JP6871256B2 JP6871256B2 (ja) | 2021-05-12 |
Family
ID=59273934
Family Applications (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2018535283A Active JP6871256B2 (ja) | 2016-01-08 | 2017-01-06 | ２−（４−クロロフェニル）−ｎ−（（２−（２，６−ジオキソピペリジン−３−イル）−１−オキソイソインドリン−５−イル）メチル）−２，２−ジフルオロアセトアミドの製剤 |
| JP2021068923A Active JP7201732B2 (ja) | 2016-01-08 | 2021-04-15 | ２－（４－クロロフェニル）－ｎ－（（２－（２，６－ジオキソピペリジン－３－イル）－１－オキソイソインドリン－５－イル）メチル）－２，２－ジフルオロアセトアミドの製剤 |
Family Applications After (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2021068923A Active JP7201732B2 (ja) | 2016-01-08 | 2021-04-15 | ２－（４－クロロフェニル）－ｎ－（（２－（２，６－ジオキソピペリジン－３－イル）－１－オキソイソインドリン－５－イル）メチル）－２，２－ジフルオロアセトアミドの製剤 |
Country Status (19)
| Country | Link |
|---|---|
| US (4) | US10052315B2 (enExample) |
| EP (2) | EP4275707A3 (enExample) |
| JP (2) | JP6871256B2 (enExample) |
| KR (1) | KR20180100565A (enExample) |
| CN (2) | CN113633634A (enExample) |
| AU (2) | AU2017205167B2 (enExample) |
| BR (1) | BR112018013884A2 (enExample) |
| CA (1) | CA3010797C (enExample) |
| CL (1) | CL2018001830A1 (enExample) |
| CO (1) | CO2018008305A2 (enExample) |
| EA (1) | EA037508B1 (enExample) |
| EC (1) | ECSP18051143A (enExample) |
| ES (1) | ES2956767T3 (enExample) |
| IL (1) | IL260403B (enExample) |
| MX (1) | MX382150B (enExample) |
| SA (1) | SA518391983B1 (enExample) |
| SG (2) | SG11201805777QA (enExample) |
| WO (1) | WO2017120437A1 (enExample) |
| ZA (1) | ZA201804482B (enExample) |
Families Citing this family (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US9499514B2 (en) | 2014-07-11 | 2016-11-22 | Celgene Corporation | Antiproliferative compounds and methods of use thereof |
| US10648983B2 (en) | 2016-01-08 | 2020-05-12 | Celgene Corporation | Methods for treating cancer and the use of biomarkers as a predictor of clinical sensitivity to therapies |
| CN113633634A (zh) | 2016-01-08 | 2021-11-12 | 细胞基因公司 | 2-(4-氯苯基)-n-((2-(2,6-二氧代哌啶-3-基)-1-氧代异吲哚啉-5-基)甲基)-2,2-二氟乙酰胺的制剂 |
| IL262565B (en) * | 2016-06-06 | 2022-08-01 | Celgene Corp | Treatment of a hematologic malignancy with 2-(4-chlorophenyl)-n-((2-(2,6-dioxopiperidin-3-yl)-1-oxoisoindolin-5-yl)methyl)-2,2-difluoroacetamide |
| SMT202300068T1 (it) * | 2017-06-30 | 2023-03-17 | Celgene Corp | Composizioni e metodi d'uso di 2-(4-clorofenil)-n-((2-(2,6-diossopiperidin-3-il)-1-ossoisoindolin-5-il)metil)-2,2-difluoroacetammide |
| WO2020142422A1 (en) * | 2018-12-31 | 2020-07-09 | Celgene Corporation | Compositions and methods of use of 2-(4-chlorophenyl)-n-((2-(2,6-dioxopiperidin-3-yl)-1-oxoisoindolin-5yl) methyl)-2,2-difluoroacetamide |
| BR112022008677A2 (pt) | 2019-11-05 | 2022-07-19 | Celgene Corp | Terapia de combinação com 2-(4-clorofenil)-n-((2-(2,6-dioxopiperidina-3-il)-1-oxoisoindolin-5-il) metil)-2,2-difluoroacetamida |
| IL293481A (en) | 2019-12-06 | 2022-08-01 | Celgene Corp | Processes for preparing 2-(4-chlorophenyl)-n-((2-(2,6-dioxopiperidin-3-yl)-1-oxoisoindolin-5-yl)methyl)-2,2-difluoroacetamide |
| WO2022152821A1 (en) | 2021-01-13 | 2022-07-21 | Monte Rosa Therapeutics Ag | Isoindolinone compounds |
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| US9499514B2 (en) | 2014-07-11 | 2016-11-22 | Celgene Corporation | Antiproliferative compounds and methods of use thereof |
| CN113633634A (zh) * | 2016-01-08 | 2021-11-12 | 细胞基因公司 | 2-(4-氯苯基)-n-((2-(2,6-二氧代哌啶-3-基)-1-氧代异吲哚啉-5-基)甲基)-2,2-二氟乙酰胺的制剂 |
| KR20180099712A (ko) | 2016-01-08 | 2018-09-05 | 셀진 코포레이션 | 항증식성 화합물, 및 이의 약제학적 조성물 및 용도 |
| AU2017206039B2 (en) | 2016-01-08 | 2021-03-25 | Celgene Corporation | Solid forms of 2-(4-chlorophenyl)-N-((2-2,6-dioxopiperidin-3-yl)-1-oxoisoindolin-5-yl) methyl)-2,2-difluoroacetamide, and their pharmaceutical compositions and uses |
| JP2019011495A (ja) | 2017-06-30 | 2019-01-24 | 株式会社Ｕａｃｊ押出加工 | 熱交換器に配管部材を接続するためのアルミニウム合金製コネクタ及び該コネクタを備える熱交換器接続用配管部材、並びにこれらの製造方法 |
| WO2020142422A1 (en) | 2018-12-31 | 2020-07-09 | Celgene Corporation | Compositions and methods of use of 2-(4-chlorophenyl)-n-((2-(2,6-dioxopiperidin-3-yl)-1-oxoisoindolin-5yl) methyl)-2,2-difluoroacetamide |
| BR112022008677A2 (pt) | 2019-11-05 | 2022-07-19 | Celgene Corp | Terapia de combinação com 2-(4-clorofenil)-n-((2-(2,6-dioxopiperidina-3-il)-1-oxoisoindolin-5-il) metil)-2,2-difluoroacetamida |
-
2017
- 2017-01-06 CN CN202110818391.8A patent/CN113633634A/zh active Pending
- 2017-01-06 WO PCT/US2017/012483 patent/WO2017120437A1/en not_active Ceased
- 2017-01-06 BR BR112018013884A patent/BR112018013884A2/pt not_active Application Discontinuation
- 2017-01-06 JP JP2018535283A patent/JP6871256B2/ja active Active
- 2017-01-06 EP EP23181094.6A patent/EP4275707A3/en not_active Withdrawn
- 2017-01-06 CA CA3010797A patent/CA3010797C/en active Active
- 2017-01-06 SG SG11201805777QA patent/SG11201805777QA/en unknown
- 2017-01-06 SG SG10202007913WA patent/SG10202007913WA/en unknown
- 2017-01-06 MX MX2018008429A patent/MX382150B/es unknown
- 2017-01-06 EP EP17736406.4A patent/EP3399979B9/en active Active
- 2017-01-06 CN CN201780005873.3A patent/CN108601777B/zh active Active
- 2017-01-06 AU AU2017205167A patent/AU2017205167B2/en active Active
- 2017-01-06 KR KR1020187019190A patent/KR20180100565A/ko not_active Ceased
- 2017-01-06 US US15/400,791 patent/US10052315B2/en active Active
- 2017-01-06 EA EA201891578A patent/EA037508B1/ru unknown
- 2017-01-06 ES ES17736406T patent/ES2956767T3/es active Active
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2018
- 2018-07-03 IL IL260403A patent/IL260403B/en unknown
- 2018-07-04 ZA ZA201804482A patent/ZA201804482B/en unknown
- 2018-07-04 CL CL2018001830A patent/CL2018001830A1/es unknown
- 2018-07-05 SA SA518391983A patent/SA518391983B1/ar unknown
- 2018-07-06 EC ECSENADI201851143A patent/ECSP18051143A/es unknown
- 2018-07-19 US US16/040,450 patent/US10449187B2/en active Active
- 2018-08-08 CO CONC2018/0008305A patent/CO2018008305A2/es unknown
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2019
- 2019-09-09 US US16/565,346 patent/US11129821B2/en active Active
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2021
- 2021-04-15 JP JP2021068923A patent/JP7201732B2/ja active Active
- 2021-08-25 US US17/412,187 patent/US11883389B2/en active Active
- 2021-09-29 AU AU2021240184A patent/AU2021240184A1/en not_active Abandoned
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