JP2020007367A5 - - Google Patents
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- Publication number
- JP2020007367A5 JP2020007367A5 JP2019172314A JP2019172314A JP2020007367A5 JP 2020007367 A5 JP2020007367 A5 JP 2020007367A5 JP 2019172314 A JP2019172314 A JP 2019172314A JP 2019172314 A JP2019172314 A JP 2019172314A JP 2020007367 A5 JP2020007367 A5 JP 2020007367A5
- Authority
- JP
- Japan
- Prior art keywords
- composition
- liposome
- cytarabine
- daunorubicin
- liposomes
- Prior art date
- Legal status (The legal status 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 status listed.)
- Pending
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- 239000000203 mixture Substances 0.000 claims 22
- 239000002502 liposome Substances 0.000 claims 19
- 229960000684 Cytarabine Drugs 0.000 claims 8
- UHDGCWIWMRVCDJ-CCXZUQQUSA-N Cytosar Chemical compound O=C1N=C(N)C=CN1[C@H]1[C@@H](O)[C@H](O)[C@@H](CO)O1 UHDGCWIWMRVCDJ-CCXZUQQUSA-N 0.000 claims 8
- STQGQHZAVUOBTE-VGBVRHCVSA-N DAUNOMYCIN Chemical compound O([C@H]1C[C@@](O)(CC=2C(O)=C3C(=O)C=4C=CC=C(C=4C(=O)C3=C(O)C=21)OC)C(C)=O)[C@H]1C[C@H](N)[C@H](O)[C@H](C)O1 STQGQHZAVUOBTE-VGBVRHCVSA-N 0.000 claims 7
- 229960000975 Daunorubicin Drugs 0.000 claims 7
- 238000004108 freeze drying Methods 0.000 claims 5
- 230000001082 cryoprotectant Effects 0.000 claims 3
- 239000002577 cryoprotective agent Substances 0.000 claims 3
- NRJAVPSFFCBXDT-HUESYALOSA-N 1,2-distearoyl-sn-glycero-3-phosphocholine Chemical compound CCCCCCCCCCCCCCCCCC(=O)OC[C@H](COP([O-])(=O)OCC[N+](C)(C)C)OC(=O)CCCCCCCCCCCCCCCCC NRJAVPSFFCBXDT-HUESYALOSA-N 0.000 claims 2
- 101710040861 DCN Proteins 0.000 claims 2
- FVJZSBGHRPJMMA-UHFFFAOYSA-N distearoyl phosphatidylglycerol Chemical compound CCCCCCCCCCCCCCCCCC(=O)OCC(COP(O)(=O)OCC(O)CO)OC(=O)CCCCCCCCCCCCCCCCC FVJZSBGHRPJMMA-UHFFFAOYSA-N 0.000 claims 2
- 239000003937 drug carrier Substances 0.000 claims 2
- 239000012528 membrane Substances 0.000 claims 2
- 201000011510 cancer Diseases 0.000 claims 1
- 239000011521 glass Substances 0.000 claims 1
- 239000008194 pharmaceutical composition Substances 0.000 claims 1
- 230000001681 protective Effects 0.000 claims 1
- 230000000717 retained Effects 0.000 claims 1
- 239000000126 substance Substances 0.000 claims 1
Claims (14)
- 凍結乾燥ゲル相リポソーム組成物であって、当該組成物は、
（ａ）ゲル相リポソーム、ここで、該リポソームの膜は、７：２：１のＤＳＰＣ：ＤＳＰＧ：ＣＨＯＬを成分として含み、かつ、該リポソームは一定比率のダウノルビシンとシタラビンと安定に会合している；及び、
（ｂ）該リポソームの外側に存在する凍結保護物質
を含み、
ここで、該リポソームが実質的に内側の凍結保護物質を含有しない、組成物。 - ダウノルビシン：シタラビンの一定の比率が１：５である、請求項１に記載の組成物。
- 前記組成物が薬学的担体中に再構成される場合、前記リポソームの平均直径が、凍結乾燥前の該組成物と比較して維持され、かつ、ダウノルビシンとシタラビンが実質的にリポソーム内に保持される、請求項１又は請求項２に記載の組成物。
- 前記組成物が再構成される場合、前記ダウノルビシン：シタラビンの比率が、凍結乾燥前の該組成物と比較して２５％以下変化する、請求項１又は請求項２に記載の組成物。
- 前記リポソームの平均直径が、凍結乾燥前に測定された該値と比較して、前記リポソーム組成物の凍結乾燥後および再構成の際、２５％以下増加する、請求項１又は請求項２に記載の組成物。
- 前記平均直径が、５℃〜２５℃の保存で少なくとも６ヶ月間維持される、請求項５に記載の組成物。
- 前記リポソーム組成物が再構成の際、ダウのルビシン及びシタラビンのそれぞれの少なくとも７５％が維持される、請求項１又は請求項２に記載の組成物。
- 平均直径が、５℃〜２５℃の保存で少なくとも６ヶ月間維持される、請求項７に記載の組成物。
- 前記リポソームのサイズ分布が、前記リポソーム組成物の凍結乾燥後および再構成の際、２５％以下変化する、請求項１又は請求項２に記載の組成物。
- 請求項１に記載の組成物を調製する方法であって、ゲル相リポソームを含む水性媒体を外部の保護物質の存在下で凍結乾燥に付すことを含み、
ここで、前記リポソームは該リポソームの膜は、７：２：１のＤＳＰＣ：ＤＳＰＧ：ＣＨＯＬを成分として含み；かつ、一定の比率のダウノルビシンとシタラビンが該リポソームと安定に会合しており；かつ、実質的に内側の凍結保護物質を含有しない、方法。 - ゲル相リポソームを含む前記水性媒体が、前記媒体のガラス転移温度（Ｔｇ）未満である温度で凍結される、請求項１０に記載の方法。
- 被験者にダウノルビシンとシタラビンを投与するための薬学的組成物を調製する方法であって、薬学的担体中で請求項１〜請求項８のいずれか１項に記載されたリポソーム組成物を再構成して再構成された組成物を得ることを含む、方法。
- 動物にダウノルビシンとシタラビンを投与する方法において使用するための請求項１２に記載の方法により調製された組成物。
- 動物の癌を治療する方法において使用するための請求項１２に記載の方法により調製された組成物。
Priority Applications (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP2021196626A JP7476161B2 (ja) | 2011-10-21 | 2021-12-03 | 凍結乾燥リポソーム |
| JP2024000732A JP2024045183A (ja) | 2011-10-21 | 2024-01-05 | 凍結乾燥リポソーム |
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201161550047P | 2011-10-21 | 2011-10-21 | |
| US61/550,047 | 2011-10-21 |
Related Parent Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2018095127A Division JP6592556B2 (ja) | 2011-10-21 | 2018-05-17 | 凍結乾燥リポソーム |
Related Child Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2021196626A Division JP7476161B2 (ja) | 2011-10-21 | 2021-12-03 | 凍結乾燥リポソーム |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| JP2020007367A JP2020007367A (ja) | 2020-01-16 |
| JP2020007367A5 true JP2020007367A5 (ja) | 2020-02-27 |
Family
ID=48141268
Family Applications (6)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2014537142A Active JP6133308B2 (ja) | 2011-10-21 | 2012-10-15 | 凍結乾燥リポソーム |
| JP2017074348A Active JP6359717B2 (ja) | 2011-10-21 | 2017-04-04 | 凍結乾燥リポソーム |
| JP2018095127A Active JP6592556B2 (ja) | 2011-10-21 | 2018-05-17 | 凍結乾燥リポソーム |
| JP2019172314A Pending JP2020007367A (ja) | 2011-10-21 | 2019-09-20 | 凍結乾燥リポソーム |
| JP2021196626A Active JP7476161B2 (ja) | 2011-10-21 | 2021-12-03 | 凍結乾燥リポソーム |
| JP2024000732A Pending JP2024045183A (ja) | 2011-10-21 | 2024-01-05 | 凍結乾燥リポソーム |
Family Applications Before (3)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2014537142A Active JP6133308B2 (ja) | 2011-10-21 | 2012-10-15 | 凍結乾燥リポソーム |
| JP2017074348A Active JP6359717B2 (ja) | 2011-10-21 | 2017-04-04 | 凍結乾燥リポソーム |
| JP2018095127A Active JP6592556B2 (ja) | 2011-10-21 | 2018-05-17 | 凍結乾燥リポソーム |
Family Applications After (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2021196626A Active JP7476161B2 (ja) | 2011-10-21 | 2021-12-03 | 凍結乾燥リポソーム |
| JP2024000732A Pending JP2024045183A (ja) | 2011-10-21 | 2024-01-05 | 凍結乾燥リポソーム |
Country Status (22)
| Country | Link |
|---|---|
| US (5) | US10028912B2 (ja) |
| EP (2) | EP2768484B1 (ja) |
| JP (6) | JP6133308B2 (ja) |
| KR (5) | KR102024836B1 (ja) |
| CN (2) | CN108853031A (ja) |
| AU (1) | AU2012326370C9 (ja) |
| BR (1) | BR112014009305B1 (ja) |
| CA (1) | CA2852777C (ja) |
| DK (1) | DK2768484T3 (ja) |
| ES (1) | ES2750368T3 (ja) |
| HK (1) | HK1201039A1 (ja) |
| HR (1) | HRP20191683T1 (ja) |
| HU (2) | HUE045978T2 (ja) |
| IL (1) | IL232161B (ja) |
| LU (1) | LUC00135I2 (ja) |
| NL (1) | NL301016I2 (ja) |
| NO (1) | NO2019041I1 (ja) |
| PL (1) | PL2768484T3 (ja) |
| PT (1) | PT2768484T (ja) |
| RU (1) | RU2648753C2 (ja) |
| SI (1) | SI2768484T1 (ja) |
| WO (1) | WO2013059133A1 (ja) |
Families Citing this family (20)
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| CN108853031A (zh) * | 2011-10-21 | 2018-11-23 | 切拉托尔制药公司 | 冻干脂质体 |
| CN117064838A (zh) | 2014-08-28 | 2023-11-17 | 通用医疗公司 | 可注射的浆料及其制造和使用方法 |
| US11504322B2 (en) | 2014-08-28 | 2022-11-22 | The General Hospital Corporation | Injectable slurries and methods of manufacturing the same |
| US11471401B2 (en) | 2014-08-28 | 2022-10-18 | The General Hospital Corporation | Injectable slurries and methods of manufacturing the same |
| CN113679689B (zh) | 2015-07-22 | 2023-09-01 | 日东电工株式会社 | 用于纳米粒冷冻干燥物形式的组合物及方法 |
| BR112018009463A8 (pt) * | 2015-11-11 | 2019-02-26 | Celator Pharmaceuticals Inc | ensaios e métodos para selecionar um regime de tratamento para um sujeito com leucemia |
| SG10201913504XA (en) | 2016-02-26 | 2020-03-30 | Massachusetts Gen Hospital | Medical ice slurry production and delivery systems and methods |
| US11504347B1 (en) | 2016-07-22 | 2022-11-22 | Flamel Ireland Limited | Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics |
| US11602513B1 (en) | 2016-07-22 | 2023-03-14 | Flamel Ireland Limited | Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics |
| US11986451B1 (en) | 2016-07-22 | 2024-05-21 | Flamel Ireland Limited | Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics |
| UY37341A (es) | 2016-07-22 | 2017-11-30 | Flamel Ireland Ltd | Formulaciones de gamma-hidroxibutirato de liberación modificada con farmacocinética mejorada |
| US11602512B1 (en) | 2016-07-22 | 2023-03-14 | Flamel Ireland Limited | Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics |
| US20200230057A1 (en) * | 2017-07-10 | 2020-07-23 | Immunovaccine Technologies Inc. | Pharmaceutical Compositions, Methods for Preparation using Lipid Vesicle Particles of Defined Size, and Uses Thereof |
| JP2022522270A (ja) | 2019-03-01 | 2022-04-15 | フラメル アイルランド リミテッド | 食事摂取状態における改善された薬物動態を有するガンマ－ヒドロキシ酪酸塩組成物 |
| SG11202113005SA (en) * | 2019-06-28 | 2021-12-30 | Univ Texas | Method of reconstituting liposomal annamycin |
| EP4003295A1 (en) * | 2019-07-24 | 2022-06-01 | The General Hospital Corporation | Methods of creating a substance with different freezing points by encapsulation |
| US11980636B2 (en) | 2020-11-18 | 2024-05-14 | Jazz Pharmaceuticals Ireland Limited | Treatment of hematological disorders |
| US11583510B1 (en) | 2022-02-07 | 2023-02-21 | Flamel Ireland Limited | Methods of administering gamma hydroxybutyrate formulations after a high-fat meal |
| US11779557B1 (en) | 2022-02-07 | 2023-10-10 | Flamel Ireland Limited | Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics |
| CN115252563A (zh) * | 2022-06-24 | 2022-11-01 | 石药集团中奇制药技术（石家庄）有限公司 | 一种柔红霉素阿糖胞苷脂质体冻干品的制备方法 |
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-
2012
- 2012-10-15 CN CN201810733439.3A patent/CN108853031A/zh active Pending
- 2012-10-15 BR BR112014009305-9A patent/BR112014009305B1/pt active IP Right Grant
- 2012-10-15 ES ES12841616T patent/ES2750368T3/es active Active
- 2012-10-15 US US14/352,662 patent/US10028912B2/en active Active
- 2012-10-15 RU RU2014120475A patent/RU2648753C2/ru active
- 2012-10-15 EP EP12841616.1A patent/EP2768484B1/en not_active Revoked
- 2012-10-15 SI SI201231668T patent/SI2768484T1/sl unknown
- 2012-10-15 WO PCT/US2012/060293 patent/WO2013059133A1/en active Application Filing
- 2012-10-15 JP JP2014537142A patent/JP6133308B2/ja active Active
- 2012-10-15 PT PT128416161T patent/PT2768484T/pt unknown
- 2012-10-15 CA CA2852777A patent/CA2852777C/en active Active
- 2012-10-15 HU HUE12841616A patent/HUE045978T2/hu unknown
- 2012-10-15 KR KR1020147012039A patent/KR102024836B1/ko active IP Right Grant
- 2012-10-15 KR KR1020227034406A patent/KR20220141906A/ko not_active Application Discontinuation
- 2012-10-15 KR KR1020197027220A patent/KR102113753B1/ko active IP Right Grant
- 2012-10-15 EP EP19183846.5A patent/EP3572071A1/en active Pending
- 2012-10-15 KR KR1020207013990A patent/KR102284689B1/ko active IP Right Grant
- 2012-10-15 DK DK12841616.1T patent/DK2768484T3/da active
- 2012-10-15 AU AU2012326370A patent/AU2012326370C9/en active Active
- 2012-10-15 PL PL12841616T patent/PL2768484T3/pl unknown
- 2012-10-15 CN CN201280059606.1A patent/CN104114156A/zh active Pending
- 2012-10-15 KR KR1020217023773A patent/KR102452305B1/ko active IP Right Grant
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2014
- 2014-04-22 IL IL232161A patent/IL232161B/en active IP Right Grant
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2015
- 2015-01-27 HK HK15100906.6A patent/HK1201039A1/xx unknown
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2017
- 2017-04-04 JP JP2017074348A patent/JP6359717B2/ja active Active
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2018
- 2018-02-07 US US15/891,170 patent/US10166184B2/en active Active
- 2018-05-17 JP JP2018095127A patent/JP6592556B2/ja active Active
- 2018-11-05 US US16/181,203 patent/US10835492B2/en active Active
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2019
- 2019-09-17 HR HRP20191683 patent/HRP20191683T1/hr unknown
- 2019-09-20 JP JP2019172314A patent/JP2020007367A/ja active Pending
- 2019-10-10 HU HUS1900047 patent/HUS1900047I1/hu unknown
- 2019-10-24 LU LU00135C patent/LUC00135I2/fr unknown
- 2019-10-25 NL NL301016C patent/NL301016I2/nl unknown
- 2019-11-25 NO NO2019041C patent/NO2019041I1/no unknown
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2020
- 2020-11-13 US US17/097,530 patent/US20210169803A1/en not_active Abandoned
-
2021
- 2021-12-03 JP JP2021196626A patent/JP7476161B2/ja active Active
-
2022
- 2022-07-13 US US17/812,414 patent/US20230172855A1/en active Pending
-
2024
- 2024-01-05 JP JP2024000732A patent/JP2024045183A/ja active Pending
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