JP7080230B2 - 砒素組成物 - Google Patents
砒素組成物 Download PDFInfo
- Publication number
- JP7080230B2 JP7080230B2 JP2019524985A JP2019524985A JP7080230B2 JP 7080230 B2 JP7080230 B2 JP 7080230B2 JP 2019524985 A JP2019524985 A JP 2019524985A JP 2019524985 A JP2019524985 A JP 2019524985A JP 7080230 B2 JP7080230 B2 JP 7080230B2
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- JP
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- Prior art keywords
- leukemia
- diarsenic
- composition according
- acute
- tetroxide
- Prior art date
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P35/00—Antineoplastic agents
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K33/00—Medicinal preparations containing inorganic active ingredients
- A61K33/24—Heavy metals; Compounds thereof
- A61K33/36—Arsenic; Compounds thereof
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1611—Inorganic compounds
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2009—Inorganic compounds
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/4841—Filling excipients; Inactive ingredients
- A61K9/485—Inorganic compounds
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P35/00—Antineoplastic agents
- A61P35/02—Antineoplastic agents specific for leukemia
Description
四酸化二砒素の塩の合成における様々な材料、次いで、それらの関連する量を表1に記し、参照した。乳鉢などの容器の参照は合成のスケールに関しての当業者によって理解され、スケールアップ合成のための適切なより大きいスケールの容器は前記当業者に明らかであるだろう。
これらの製造したサンプル(1aから3)を参照材料として三酸化砒素とメタ亜砒酸ナトリウムと共に特性評価し、サンプルがこれらの対照との間に明確な差異が存在し、そして上記手順が三酸化砒素をメタ亜砒酸ではない新しい種への変換を実際にもたらしたことを示す。それ故、商業的に得られるAs2O3及びメタ亜砒酸ナトリウム、サンプル1a、サンプル1b、サンプル2及びサンプル3の6サンプルをAustralian SynchrotronのPowder Diffraction BeamlineのシンクロトロンX線粉末回折により分析した。本調査の目的はサンプル1a、サンプル1b、サンプル2及びサンプル3において製造した粉末の位相集合を決定することであった。すべてのサンプルから得られたデータセットを質の高い調査員によって評価した。解析の前に粉末サンプルを乳鉢と乳棒で軽くすりつぶし、直径0.3mmのホウケイ酸塩の別々のキャピラリーに詰めた。詰められたキャピラリーをそれぞれ別々のサンプルホルダーに乗せた。
WO 2016/119019として公開されたPCT出願に開示された三酸化砒素との比較の溶解試験を行い、それ故その内容を参照により援用する。端的には、比較的高いpHにおかれた溶解性試験でさえ、20分後に三酸化砒素25%から59%しか溶解しなかった。0.1M NaOHの使用でさえ、完全な溶解には15から20分を要した。本発明の四酸化二砒素化合物は代替手段の創作により有利な方法を提供し、及び胃の糜汁中、カプセル剤の内容物の混合がより早く起こる速い溶解砒素化合物を提供する。
2gのNaCl、7mLの37%HCLを含む模擬胃溶液を調製し、それから水で約pH1.2の1Lになるまで調製した。NaHAs2O4を含むゼラチンカプセル剤を150mLの模擬胃溶液に加え、37℃で撹拌した。約1分又は1分未満で、カプセル剤の外郭が溶解し、約2分又は2分未満で、NaHAs2O4の内容物が完全に溶解した。
Claims (16)
- アルカリ金属及び/又はアルカリ土類金属の四酸化二砒素(III)と医薬的に許容可能な賦形剤とを含む、固体の経口医薬組成物。
- 前記アルカリ金属及び/又はアルカリ土類金属の四酸化二砒素(III)が式MHAs2O4(式中、Mは+1の原子価の金属である)である、請求項1に記載の組成物。
- 式MHAs2O4(式中、Mは+1の原子価のアルカリ金属である)の四酸化二砒素(III)と医薬的に許容可能な賦形剤とを含む、医薬組成物。
- 前記四酸化二砒素が式NaHAs2O4のものである、請求項1から3のいずれか一項に記載の組成物。
- 前記医薬的に許容可能な賦形剤が、乾燥剤、崩壊剤及び分散剤のうちの一つ以上である、請求項1から4のいずれか一項に記載の組成物。
- 前記乾燥剤、崩壊剤又は分散剤が重炭酸塩化合物及び/又は炭酸塩化合物である、請求項5に記載の組成物。
- 前記崩壊剤又は分散剤が重炭酸ナトリウム、炭酸ナトリウム、炭酸カリウム、重炭酸カリウム、炭酸カルシウム、炭酸マグネシウム、及び重炭酸マグネシウムからなる群から選ばれるか、又はそれらの組み合わせである、請求項6に記載の組成物。
- 錠剤、顆粒剤又はカプセル剤の形態である、請求項1から7いずれか一項に記載の組成物。
- 患者におけるがんの治療用の経口投与のための、請求項1から8のいずれか一項に記載の組成物。
- 前記がんが悪性血液腫瘍、固形腫瘍及びリンパ腫から選ばれる、請求項9に記載の組成物。
- 前記がんが急性リンパ芽球性白血病(ALL)、急性リンパ芽球性B細胞白血病、急性リンパ芽球T細胞白血病、急性骨髄芽球性白血病(AML)、急性前骨髄球性白血病(APL)、急性単芽球性白血病、急性赤白血病、急性巨核芽球性白血病、急性骨髄単球性白血病、急性未分化白血病、慢性骨髄性白血病、骨髄異形成症候群(MDS)及び慢性リンパ性白血病からなる群から選ばれる、請求項9または10に記載の組成物。
- 前記がんが急性前骨髄球性白血病(APL)である、請求項11に記載の組成物。
- 前記がんが多発性骨髄腫である、請求項9に記載の組成物。
- 組み合わせ治療の一部として四酸化二砒素の投与のための、請求項9から13のいずれか一項に記載の組成物。
- 請求項1から14のいずれか一項に記載の医薬組成物を製造するための、四酸化二砒素の使用。
- 治療に有効な量の砒素イオンを患者に送達するための、請求項1から14のいずれか一項に記載の組成物。
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
JP2022028046A JP7419415B2 (ja) | 2016-12-01 | 2022-02-25 | 砒素組成物 |
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
AU2016904945 | 2016-12-01 | ||
AU2016904945A AU2016904945A0 (en) | 2016-12-01 | Arsenic compositions | |
PCT/AU2017/050807 WO2018098519A1 (en) | 2016-12-01 | 2017-08-02 | Arsenic compositions |
Related Child Applications (1)
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JP2022028046A Division JP7419415B2 (ja) | 2016-12-01 | 2022-02-25 | 砒素組成物 |
Publications (2)
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JP2020500845A JP2020500845A (ja) | 2020-01-16 |
JP7080230B2 true JP7080230B2 (ja) | 2022-06-03 |
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JP2019524985A Active JP7080230B2 (ja) | 2016-12-01 | 2017-08-02 | 砒素組成物 |
JP2022028046A Active JP7419415B2 (ja) | 2016-12-01 | 2022-02-25 | 砒素組成物 |
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JP2022028046A Active JP7419415B2 (ja) | 2016-12-01 | 2022-02-25 | 砒素組成物 |
Country Status (20)
Country | Link |
---|---|
US (1) | US11241453B2 (ja) |
EP (1) | EP3548044B1 (ja) |
JP (2) | JP7080230B2 (ja) |
KR (1) | KR102487884B1 (ja) |
CN (1) | CN109952105A (ja) |
AU (1) | AU2017368444B9 (ja) |
BR (1) | BR112019007498A2 (ja) |
CA (1) | CA3041357A1 (ja) |
CL (1) | CL2019001422A1 (ja) |
DK (1) | DK3548044T3 (ja) |
ES (1) | ES2964979T3 (ja) |
IL (1) | IL265986B (ja) |
MX (1) | MX2019006107A (ja) |
NZ (1) | NZ752214A (ja) |
PE (1) | PE20191544A1 (ja) |
PL (1) | PL3548044T3 (ja) |
SG (1) | SG11201903064SA (ja) |
TW (1) | TWI808060B (ja) |
WO (1) | WO2018098519A1 (ja) |
ZA (1) | ZA201902156B (ja) |
Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JP2022069485A (ja) * | 2016-12-01 | 2022-05-11 | ユーファーマ・プロプライアタリー・リミテッド | 砒素組成物 |
Families Citing this family (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
AU2017305945B2 (en) | 2016-08-01 | 2019-11-21 | Veolia Water Solutions & Technologies Support | Process for removing silica from produced water and other wastewater streams |
CA3211092A1 (en) * | 2021-02-26 | 2022-09-01 | Intas Pharmaceuticals Ltd. | Oral pharmaceutical composition of arsenic trioxide |
JP2022151442A (ja) * | 2021-03-26 | 2022-10-07 | 均 石井 | 白血病治療薬。 |
Citations (2)
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CN1471925A (zh) | 2002-08-02 | 2004-02-04 | 丛繁滋 | 更适于硬质肿瘤直接给药的含砷组合物、制剂及制备方法 |
WO2016119019A1 (en) | 2015-01-29 | 2016-08-04 | Eupharma Pty Ltd | Compositions containing arsenic and their use in methods of treatment |
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US2080004A (en) * | 1933-05-17 | 1937-05-11 | Frederick E Dearborn | Double salt of copper arsenite and a copper salt of an unsaturated fatty acid and process of making the same |
US3280046A (en) | 1963-03-27 | 1966-10-18 | Dow Chemical Co | Polyol ether resins and utility |
CA2307208A1 (en) | 1997-10-15 | 1999-04-22 | Polarx Biopharmaceuticals, Inc. | Compositions and methods for the treatment of primary and metastatic neoplastic diseases using arsenic compounds |
ES2399480T3 (es) | 1997-11-10 | 2013-04-01 | Memorial Sloan-Kettering Cancer Center | Procedimiento de producción de formulaciones de trióxido de arsénico |
US7521071B2 (en) | 2002-10-09 | 2009-04-21 | Versitech Limited | Formulation of oral compositions comprising arsenic trioxide and methods of use thereof |
EP1721615A1 (en) | 2005-05-09 | 2006-11-15 | Komipharm International Co., Ltd. | Pharmaceutical compositions comprising sodium or potassium arsenite for the treatment of urogenital cancer and its metastasis |
US20090246291A1 (en) * | 2008-03-27 | 2009-10-01 | Angelika Burger | Method and compositions for treatment of cancer |
CN102060722B (zh) * | 2009-05-01 | 2014-06-11 | 常州高新技术产业开发区三维工业技术研究所有限公司 | 一种含砷化合物及其制备方法和用途 |
EP2359812A1 (en) | 2010-01-18 | 2011-08-24 | Cephalon France | Oral lyophilised compositions |
CN105435228B (zh) * | 2014-08-14 | 2020-08-07 | 中国科学院上海营养与健康研究所 | 三氧化二砷的抗肿瘤新用途及抗肿瘤制剂 |
EP3981414A1 (en) | 2015-02-01 | 2022-04-13 | Syros Pharmaceuticals, Inc. | High surface-area lyophilized compositions comprising arsenic for oral administration in patients |
AU2017368444B9 (en) | 2016-12-01 | 2020-07-02 | Eupharma Pty Ltd | Arsenic compositions |
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2017
- 2017-08-02 AU AU2017368444A patent/AU2017368444B9/en active Active
- 2017-08-02 DK DK17876251.4T patent/DK3548044T3/da active
- 2017-08-02 JP JP2019524985A patent/JP7080230B2/ja active Active
- 2017-08-02 KR KR1020197013881A patent/KR102487884B1/ko active IP Right Grant
- 2017-08-02 MX MX2019006107A patent/MX2019006107A/es unknown
- 2017-08-02 US US16/465,693 patent/US11241453B2/en active Active
- 2017-08-02 SG SG11201903064SA patent/SG11201903064SA/en unknown
- 2017-08-02 PL PL17876251.4T patent/PL3548044T3/pl unknown
- 2017-08-02 WO PCT/AU2017/050807 patent/WO2018098519A1/en unknown
- 2017-08-02 NZ NZ752214A patent/NZ752214A/en unknown
- 2017-08-02 CA CA3041357A patent/CA3041357A1/en active Pending
- 2017-08-02 ES ES17876251T patent/ES2964979T3/es active Active
- 2017-08-02 EP EP17876251.4A patent/EP3548044B1/en active Active
- 2017-08-02 PE PE2019000939A patent/PE20191544A1/es unknown
- 2017-08-02 TW TW106126050A patent/TWI808060B/zh active
- 2017-08-02 CN CN201780069613.2A patent/CN109952105A/zh active Pending
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- 2017-08-02 BR BR112019007498A patent/BR112019007498A2/pt active Search and Examination
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- 2019-04-05 ZA ZA2019/02156A patent/ZA201902156B/en unknown
- 2019-05-27 CL CL2019001422A patent/CL2019001422A1/es unknown
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2022
- 2022-02-25 JP JP2022028046A patent/JP7419415B2/ja active Active
Patent Citations (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN1471925A (zh) | 2002-08-02 | 2004-02-04 | 丛繁滋 | 更适于硬质肿瘤直接给药的含砷组合物、制剂及制备方法 |
WO2016119019A1 (en) | 2015-01-29 | 2016-08-04 | Eupharma Pty Ltd | Compositions containing arsenic and their use in methods of treatment |
Cited By (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JP2022069485A (ja) * | 2016-12-01 | 2022-05-11 | ユーファーマ・プロプライアタリー・リミテッド | 砒素組成物 |
JP7419415B2 (ja) | 2016-12-01 | 2024-01-22 | ユーファーマ・プロプライアタリー・リミテッド | 砒素組成物 |
Also Published As
Publication number | Publication date |
---|---|
EP3548044A4 (en) | 2020-07-22 |
PE20191544A1 (es) | 2019-10-24 |
KR20190089865A (ko) | 2019-07-31 |
SG11201903064SA (en) | 2019-05-30 |
ES2964979T3 (es) | 2024-04-10 |
PL3548044T3 (pl) | 2024-03-04 |
AU2017368444B9 (en) | 2020-07-02 |
IL265986B (en) | 2022-09-01 |
AU2017368444A1 (en) | 2019-04-18 |
TW201821087A (zh) | 2018-06-16 |
ZA201902156B (en) | 2021-01-27 |
US20200016196A1 (en) | 2020-01-16 |
TWI808060B (zh) | 2023-07-11 |
IL265986A (en) | 2019-06-30 |
NZ752214A (en) | 2022-11-25 |
AU2017368444B2 (en) | 2020-04-30 |
JP7419415B2 (ja) | 2024-01-22 |
CN109952105A (zh) | 2019-06-28 |
KR102487884B1 (ko) | 2023-01-11 |
CL2019001422A1 (es) | 2019-08-02 |
EP3548044A1 (en) | 2019-10-09 |
CA3041357A1 (en) | 2018-06-07 |
JP2020500845A (ja) | 2020-01-16 |
EP3548044B1 (en) | 2023-09-20 |
US11241453B2 (en) | 2022-02-08 |
DK3548044T3 (en) | 2023-12-11 |
MX2019006107A (es) | 2019-08-21 |
JP2022069485A (ja) | 2022-05-11 |
WO2018098519A1 (en) | 2018-06-07 |
BR112019007498A2 (pt) | 2019-07-02 |
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