JP7107624B2 - エダラボンの経口又は胃内投与を含む処置 - Google Patents
エダラボンの経口又は胃内投与を含む処置 Download PDFInfo
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- A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
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Description
β-シクロデキストリン又はβ-シクロデキストリンを含有するシクロデキストリンの混合物と1~5倍重量の水を混合するステップ、
エダラボン又は有機溶媒に溶かしたその溶液をシクロデキストリン溶液に加えるステップ、
粉砕又は攪拌するステップ、及び
60℃より高くない温度で水を蒸発させ、減圧により乾燥させるステップ。
β-シクロデキストリン又はβ-シクロデキストリンを含有するシクロデキストリンの混合物と1~5倍重量の水を混合するステップ、
エダラボン又は有機溶媒に溶かしたその溶液をシクロデキストリン溶液に加えるステップ、
粉砕又は攪拌するステップ、及び
60℃より高くない温度で水を蒸発させ、減圧により乾燥させるステップ。
60mgエダラボンの1回用量をもたらすためRadicut(登録商標)アンプル中に含有されたエダラボン溶液を経口と静脈内の両方でイヌに投与する試験を実施した。
単回投与、無作為化、2期のクロスオーバー試験を18人の健康な男性及び女性ヒト対象に実施した。
表3中に示す乾燥製剤1.5グラムを含有する新たに調製した100mL溶液の型で140mgエダラボン(経口)
2つのRadicut(登録商標)アンプル(溶液20ml中30mgのエダラボン)を使用して60mgエダラボン(静脈内60分)を与えた。
Claims (16)
- ヒトの神経変性疾患又は脳血管疾患の医療処置において使用するための液体状医薬組成物であって、前記液体状医薬組成物が非複合体3-メチル-1-フェニル-2-ピラゾリン-5-オン(エダラボン)の一相性水溶液であり、少なくとも75重量%の水と0.2~9mg/mLのエダラボンを含み、処置が30~300mgのエダラボン及び1日あたり体重1kgあたりで0.4~4mgのエダラボンをもたらすための10~250mLの液体状医薬組成物の経口又は胃内投与を含む、液体状医薬組成物。
- 50~200mgのエダラボンをもたらす量で投与される、請求項1に記載の液体状医薬組成物。
- 1日あたり300mgを超えないエダラボンをもたらす量で投与される、請求項1又は2に記載の液体状医薬組成物。
- 1日あたり体重1kgあたりで0.8~3.7mgのエダラボンをもたらす量で投与される、請求項1~3のいずれか一項に記載の液体状医薬組成物。
- 0.3~1mg/mLのエダラボンを含有する希釈エダラボン溶液であり、前記希釈エダラボン溶液が40~250mLの量で投与される、請求項1~4のいずれか一項に記載の液体状医薬組成物。
- 1~9mg/mLのエダラボンを含有する濃縮エダラボン溶液であり、前記濃縮エダラボン溶液が20~150mLの量で投与される、請求項1~4のいずれか一項に記載の液体状医薬組成物。
- 少なくとも85重量%の水を含有する、請求項1~6のいずれか一項に記載の液体状医薬組成物。
- 1:2~2:1のモル比で重亜硫酸アルカリ金属塩とエダラボンを含有し、前記重亜硫酸アルカリ金属塩が重亜硫酸ナトリウム、重亜硫酸カリウム、及びこれらの組合せから選択される、請求項1~7のいずれか一項に記載の液体状医薬組成物。
- 1:5~1:1の重量比でL-システインとエダラボンを含有する、請求項1~8のいずれか一項に記載の液体状医薬組成物。
- 非イオン性界面活性剤を含有しない、請求項1~9のいずれか一項に記載の液体状医薬組成物。
- 請求項1~7のいずれか一項に記載の液体状医薬組成物であって、
前記処置が、エダラボンを含む乾燥粒子状エダラボン製剤と水溶液の混合によって液体状医薬組成物を調製することを含む、液体状医薬組成物。 - 乾燥粒子状エダラボン製剤がアルカリ化剤を含む、請求項11に記載の液体状医薬組成物。
- アルカリ化剤が、アルカリ金属の酸化物及び水酸化物、アルカリ土類金属の酸化物及び水酸化物、Al(OH)3、Fe2O3、弱有機酸及び弱無機酸の塩、アルカリ性アミン、アルカリ性アミノ酸、並びにこれらの組合せから選択される、請求項12に記載の液体状医薬組成物。
- 6.0~9.0の範囲内のpHを有する、請求項11~13のいずれか一項に記載の液体状医薬組成物。
- 筋萎縮性側索硬化症(ALS)及びアルツハイマー病から選択される神経変性疾患を処置するために使用される、請求項1~14のいずれか一項に記載の液体状医薬組成物。
- 処置が少なくとも2週間の期間中少なくとも1日1回の液体状医薬組成物の経口又は胃内投与を含む、請求項1~15のいずれか一項に記載の液体状医薬組成物。
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JP2022111202A JP7415236B2 (ja) | 2017-01-17 | 2022-07-11 | エダラボンの経口又は胃内投与を含む処置 |
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Application Number | Priority Date | Filing Date | Title |
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EP17151741.0 | 2017-01-17 | ||
EP17151741 | 2017-01-17 | ||
EPPCT/EP2017/067005 | 2017-07-06 | ||
EP17180087 | 2017-07-06 | ||
PCT/EP2017/067005 WO2018133957A1 (en) | 2017-01-17 | 2017-07-06 | Medical treatment comprising enteral administration of edaravone |
EP17180087.3 | 2017-07-06 | ||
PCT/EP2018/051097 WO2018134243A1 (en) | 2017-01-17 | 2018-01-17 | Treatment comprising oral or gastric administration of edaravone |
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JP2022111202A Division JP7415236B2 (ja) | 2017-01-17 | 2022-07-11 | エダラボンの経口又は胃内投与を含む処置 |
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JP2020506959A JP2020506959A (ja) | 2020-03-05 |
JP7107624B2 true JP7107624B2 (ja) | 2022-07-27 |
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JP2019559390A Active JP7107624B2 (ja) | 2017-01-17 | 2018-01-17 | エダラボンの経口又は胃内投与を含む処置 |
JP2022111202A Active JP7415236B2 (ja) | 2017-01-17 | 2022-07-11 | エダラボンの経口又は胃内投与を含む処置 |
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Country Status (14)
Country | Link |
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US (1) | US20190328712A1 (ja) |
EP (2) | EP3785703A1 (ja) |
JP (2) | JP7107624B2 (ja) |
KR (1) | KR102550376B1 (ja) |
AU (1) | AU2018209155B2 (ja) |
BR (1) | BR112019014705A2 (ja) |
CA (1) | CA3050037A1 (ja) |
DK (1) | DK3551181T3 (ja) |
ES (1) | ES2850873T3 (ja) |
IL (1) | IL268127A (ja) |
MX (1) | MX2019008489A (ja) |
PL (1) | PL3551181T3 (ja) |
RU (1) | RU2761967C2 (ja) |
WO (1) | WO2018134243A1 (ja) |
Cited By (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JP2020525458A (ja) * | 2017-07-06 | 2020-08-27 | ツリーウェイ ティーダブリュー001 ビー.ブイ.Treeway TW001 B.V. | 酸化ストレス媒介性の神経変性障害の経口治療におけるエダラボンの使用 |
JP2022137179A (ja) * | 2017-01-17 | 2022-09-21 | ツリーウェイ ティーダブリュー001 ビー.ブイ. | エダラボンの経口又は胃内投与を含む処置 |
Families Citing this family (4)
Publication number | Priority date | Publication date | Assignee | Title |
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JP6898027B2 (ja) | 2017-01-17 | 2021-07-07 | ツリーウェイ ティーダブリュー001 ビー.ブイ.Treeway TW001 B.V. | エダラボンの腸内投与を含む医療処置 |
US11826352B2 (en) | 2018-11-02 | 2023-11-28 | Mitsubishi Tanabe Pharma Corporation | Edaravone suspension for oral administration |
AU2019369843A1 (en) | 2018-11-02 | 2021-05-27 | Mitsubishi Tanabe Pharma Corporation | Edaravone suspension for oral administration |
EP4245303A1 (en) * | 2020-11-12 | 2023-09-20 | Mitsubishi Tanabe Pharma Corporation | Pharmaceutical composition for edaravone oral administration and method for administering same |
Citations (2)
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JP2004091441A (ja) | 2002-09-04 | 2004-03-25 | Mitsubishi Pharma Corp | ピラゾロン誘導体を含有する経口投与製剤 |
WO2005075434A1 (ja) | 2004-02-09 | 2005-08-18 | Mitsubishi Pharma Corporation | 筋萎縮性側索硬化症(als)又はalsに起因する疾患の新規治療剤 |
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ES2248144T3 (es) | 2000-10-24 | 2006-03-16 | Mitsubishi Pharma Corporation | Medicamentos para tratar la esclerosis lateral amiotrofica (ela). |
JP2004002400A (ja) | 2002-04-23 | 2004-01-08 | Mitsubishi Pharma Corp | 軽微低体温療法を行うために用いる脳保護及び/又は脳機能正常化のための医薬 |
JP2008280253A (ja) | 2007-05-08 | 2008-11-20 | Ohara Yakuhin Kogyo Kk | エダラボン注射液 |
JP2009143902A (ja) | 2007-11-21 | 2009-07-02 | Kowa Co | エダラボンを含有する安定な水溶性製剤 |
WO2009067343A1 (en) * | 2007-11-21 | 2009-05-28 | Teikoku Pharma Usa, Inc. | Pyrazolone derivative emulsion formulations |
JP2009143922A (ja) | 2007-11-22 | 2009-07-02 | Fujiyakuhin Co Ltd | 注射剤 |
JP2009155315A (ja) | 2007-12-26 | 2009-07-16 | Fujiyakuhin Co Ltd | 注射剤 |
JP2009280561A (ja) | 2008-05-26 | 2009-12-03 | Fujiyakuhin Co Ltd | 注射剤 |
JP2010047482A (ja) * | 2008-08-19 | 2010-03-04 | Ohara Yakuhin Kogyo Kk | エダラボン注射液 |
JP2010077104A (ja) | 2008-08-29 | 2010-04-08 | Nihon Pharmaceutical Co Ltd | 3−メチル−1−フェニル−2−ピラゾリン−5−オン注射用水溶液 |
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CN101953832B (zh) | 2010-08-10 | 2012-02-15 | 南京师范大学 | β-环糊精包合依达拉奉的口服药物组合物及其制备方法 |
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EP2754440B1 (en) | 2011-09-05 | 2019-04-03 | Mitsubishi Tanabe Pharma Corporation | Medicinal agent for treating amyotrophic lateral sclerosis or preventing progression of phase of amyotrophic lateral sclerosis |
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- 2018-01-17 DK DK18701303.2T patent/DK3551181T3/da active
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Patent Citations (2)
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Cited By (4)
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JP2022137179A (ja) * | 2017-01-17 | 2022-09-21 | ツリーウェイ ティーダブリュー001 ビー.ブイ. | エダラボンの経口又は胃内投与を含む処置 |
JP7415236B2 (ja) | 2017-01-17 | 2024-01-17 | ツリーウェイ ティーダブリュー001 ビー.ブイ. | エダラボンの経口又は胃内投与を含む処置 |
JP2020525458A (ja) * | 2017-07-06 | 2020-08-27 | ツリーウェイ ティーダブリュー001 ビー.ブイ.Treeway TW001 B.V. | 酸化ストレス媒介性の神経変性障害の経口治療におけるエダラボンの使用 |
JP7277005B2 (ja) | 2017-07-06 | 2023-05-18 | ツリーウェイ ティーダブリュー001 ビー.ブイ. | 酸化ストレス媒介性の神経変性障害の経口治療におけるエダラボンの使用 |
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KR20190111929A (ko) | 2019-10-02 |
PL3551181T3 (pl) | 2021-05-31 |
IL268127A (en) | 2019-09-26 |
RU2019125848A3 (ja) | 2021-04-12 |
RU2761967C2 (ru) | 2021-12-14 |
ES2850873T3 (es) | 2021-09-01 |
AU2018209155B2 (en) | 2023-11-30 |
JP2022137179A (ja) | 2022-09-21 |
RU2019125848A (ru) | 2021-02-19 |
EP3551181B1 (en) | 2020-11-18 |
JP2020506959A (ja) | 2020-03-05 |
JP7415236B2 (ja) | 2024-01-17 |
MX2019008489A (es) | 2019-11-11 |
EP3551181A1 (en) | 2019-10-16 |
EP3785703A1 (en) | 2021-03-03 |
AU2018209155A1 (en) | 2019-08-01 |
WO2018134243A1 (en) | 2018-07-26 |
BR112019014705A2 (pt) | 2020-02-18 |
CA3050037A1 (en) | 2018-07-26 |
KR102550376B1 (ko) | 2023-07-04 |
DK3551181T3 (da) | 2020-11-30 |
US20190328712A1 (en) | 2019-10-31 |
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