JP7017638B2 - 吸入可能な乾燥粉末シチジン類似体組成物及び癌への治療として使用する方法 - Google Patents
吸入可能な乾燥粉末シチジン類似体組成物及び癌への治療として使用する方法 Download PDFInfo
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Description
本出願は、「Inhalable dry powder5-azacytidine for treatment and prevention of lung cancer(肺癌の治療および予防のための吸入可能な乾燥粉末5-アザシチジン)」と題し、2018年2月7日に出願された、米国仮特許出願第62/627,428号に対する優先権およびその提出の恩典を主張するものであり、その明細書および特許請求の範囲は参照により本明細書に組み入れられる。
本発明は、国立衛生研究所/国立癌研究所によって授与された、助成金番号第R01 CA196590号による政府の支援によって実施された。政府は、本発明において一定の権利を有する。
適用されない。
適用されない。
適用されない。
適用されない。
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14. The Cancer Genome Atlas Research Network. Comprehensive molecular profiling of lung adenocarcinoma. Nature 2014:511:543-50.
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16. Wrangle J, Wang W, Koch A, Easwaran H, Tsai S, Juergens RA, Topalian SL, Rudin CM, Brock MV, Pardoll D, and Baylin SB. Alterations of immune response of non-small cell lung cancer with azacytidine. Oncotarget 2013;4:2067-79.
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19. Savona MR, Kokibaba K, Conkling P, Kingsley EC, Becerra C, Morris JC, Rifkin RM, Laille E, Kellerman A, Ukrainskyj SM, Dong Q, and Skikne BS. Extended dosing with CC-486 (oral azacitidine) in patients with myeloid malignancies. Am J Hematol. 2018; 93:1199-1206.
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Claims (19)
- 癌である患者へと吸入投与するための、エアロゾルにて分散するのに好適な乾燥粉末薬学的組成物であって、
前記組成物が、5-アザシチジン、ゼブラリン、5-アザ-2’-デオキシシチジン、若しくはSG-110、又はそれらの薬学的に許容される塩、溶媒和物、水和物、若しくはエステルからなる群から選択されるシチジン類似体;
ジメチルスルホキシド(DMSO);並びに
アミノ酸、糖若しくは糖アルコールまたはそれらの組合せを含む薬学的に許容される賦形剤;
を含み、
前記乾燥粉末薬学的組成物が、約1.0~約5.0μmの空気動力学的中央粒子径(MMAD)を有し、且つ約1.0μm~約3.4μmの乾燥粉末の放出された粒子サイズの分布の幾何標準偏差(GSD)を有する、乾燥粉末薬学的組成物。 - 前記賦形剤が、ロイシン、トリロイシン、イソロイシンまたはそれらの任意の組合せからなる群から選択されたアミノ酸である、請求項1に記載の組成物。
- 前記賦形剤が、糖または糖アルコールである、請求項1に記載の組成物。
- 前記糖または糖アルコールは、トレハロース、ラクトース、マンニトール、ソルビトール、ラフィノース、イノシトールおよびエリスリトールからなる群から選択される、請求項3に記載の組成物。
- 前記賦形剤が、トレハロースおよび/またはロイシンを含む、請求項1に記載の組成物。
- 前記薬学的賦形剤が、前記乾燥粉末の約99~1重量%であり、その塩、溶媒和物、水和物、およびエステルを含む前記シチジン類似体が、約0.1~20%の残留DMSOを有する、前記乾燥粉末の約1~99重量%である、請求項1に記載の組成物。
- 前記残留DMSOが、約5~15%のDMSOである、請求項6に記載の組成物。
- 約0~99w/w%の範囲のトレハロース、
約0~99w/w%の範囲のロイシン、
その塩、溶媒和物、水和物、およびエステルを含む、約0.1~50%の範囲のシチジン類似体、および
約0.1~20%の残留DMSOである、DMSOの残留物を含む、
請求項1に記載の組成物。 - 5-アザシチジン、ゼブラリン、5-アザ-2’-デオキシシチジン、若しくはSG-110、又はそれらの薬学的に許容される塩、溶媒和物、水和物、若しくはエステルからなる群から選択されるシチジン類似体を含む乾燥粉末組成物を形成する方法であって、
DMSO中に前記シチジン類似体を溶解させ、シチジン類似体DMSO溶液を形成する工程、
溶媒中に、アミノ酸、糖若しくは糖アルコールまたはそれらの組合せを含む薬学的賦形剤を溶解させる工程、
混合により、前記シチジン類似体DMSO溶液と前記溶解された賦形剤とを組み合わせる工程、
霧化することにより液滴を形成する工程、ならびに
前記液滴を蒸発させて乾燥させ、約1~5μmのMMADを有するシチジン類似体を含む粒子を形成する工程を含む、方法。 - 前記アミノ酸が、ロイシン、トリロイシンおよびイソロイシンからなる群から選択される、請求項9に記載の方法。
- 前記糖または糖アルコールが、六価アルコール、並びにトレハロース、ラクトース、マンニトール、ソルビトール、ラフィノース、イノシトールおよびエリスリトールを含む糖アルコールからなる群から選択される、請求項9に記載の方法。
- 前記薬学的賦形剤が、トレハロースおよび/またはロイシンを含む、請求項9に記載の方法。
- 前記乾燥粉末が残留DMSOを含む、請求項9に記載の方法。
- 混合はインライン混合である、請求項9に記載の方法。
- 前記薬学的賦形剤が、前記乾燥粉末の約99~1重量%であり、その塩、溶媒和物、水和物、およびエステルを含む前記シチジン類似体が、約0~20%の残留DMSOを有する、前記乾燥粉末の約1~99重量%である、請求項9に記載の方法。
- 前記残留DMSOが、約5~15%のDMSOである、請求項9に記載の方法。
- 前記乾燥粉末組成物が、
約0~99w/w%の範囲のトレハロース、
約0~99w/w%の範囲のロイシン、
その塩、溶媒和物、水和物、およびエステルを含む、約0.1~50%の範囲のシチジン類似体、ならびに
約0.1~20%の残留DMSOである、DMSOの残留物を含む、請求項9に記載の方法。 - 請求項1~8のいずれか1項に記載の乾燥粉末薬学的組成物と、乾燥粉末吸入器と、を含む、吸入投与するための薬学的キット。
- 請求項1~8のいずれか1項に記載の乾燥粉末薬学的組成物を含む、吸入投与するための容器。
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PCT/US2019/017083 WO2019157200A1 (en) | 2018-02-07 | 2019-02-07 | Inhalable dry powder cytidine analogue composition and method of use as a treatment for cancer |
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JP2012517427A (ja) | 2009-02-10 | 2012-08-02 | セルジーン インターナショナル サルル | 5−アザシチジンを用いる、非小細胞肺癌の治療方法 |
JP2014525449A (ja) | 2011-08-30 | 2014-09-29 | アステックス ファーマシューティカルズ インコーポレイテッド | デシタビン誘導体製剤 |
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