JP2022066354A - 癲癇の治療におけるカンナビノイドの使用 - Google Patents
癲癇の治療におけるカンナビノイドの使用 Download PDFInfo
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Abstract
Description
計画(単剤療法としてであろうと、または併用であろうと)の適正な試行の失敗」として2009年に定義された(Kwan et al.,2009)。
CBD)が提供される。
本発明を説明するために使用される用語の幾つかの定義を下記に詳述する。
されたカンナビノイドが純度95%(w/w)以上になるようにカンナビノイドと一緒に共抽出される他のカンナビノイドおよび非カンナビノイド成分が除去される程度まで精製されたカンナビノイドと定義される。
下記の実施例で述べる拡大アクセス臨床試験(expanded access trial)に使用された既知の一定の組成を有する高度に精製された(>98%w/w)カンナビジオール抽出物の生産について述べる。
出物(中間体)を取り出し、次いで結晶化により精製してCBD(原薬)を得る。
植物抽出物である中間体を生産するためのステップの全体像は、
1)成長
2)脱炭酸
3)第一抽出(液体CO2を使用)
4)第二抽出(エタノールを使用する「脱蝋」)
5)濾過
6)蒸発
である。
中間体の植物抽出物から原薬を生産するための製造ステップは、
1)C5~C12直鎖または分岐アルカンを使用した結晶化
2)濾過
3)C5~C12直鎖または分岐アルカンからの任意選択の再結晶化
4)真空乾燥
である。
20℃の冷凍庫中に保管した。
この医薬品は、経口液剤として提供される。経口液剤の提供物は、25mg/mlまたは100mg/mlのCBDを賦形剤のゴマ油、エタノール、スクラロース、および着香料と共に含有する。これら2つの製品濃度は、広い用量範囲にわたって用量設定を可能にするために利用できる。
材料および方法
小児期に発症した重症の治療抵抗性癲癇(TRE)を有する137人の子供および若年成人のうち、27人が無緊張発作を特徴とする癲癇を患っていた。これらの対象が、大麻植物から得られた高度に精製されたカンナビジオール(CBD)抽出物でテストされた。すべての対象は、多くの場合、他の発作に加えて無緊張型発作を示した。この検討の参加
者は、CBDの拡大アクセス人道的使用プログラム(expanded access compassionate use program)の一部であった。
その全員が無緊張発作を患っている27人の子供および若年成人が、少なくとも12週間のCBDによる治療を受けた。
これらのデータは、既存のAEDに満足に応答しない高い比率の患者においてCBDが無緊張発作の回数を有意に減少させることを示している。
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Claims (21)
- 無緊張発作の治療に使用するためのカンナビジオール(CBD)。
- 前記無緊張発作が治療抵抗性である、請求項1に記載の使用のためのCBD。
- 前記無緊張発作が、レノックス・ガストー症候群、結節性硬化症、ドラベ症候群、Doose症候群、アイカルディ症候群、CDKL5、またはDup15qと関連している、請求項1または2に記載の使用のためのCBD。
- 前記無緊張発作がレノックス・ガストー症候群と関連している、請求項3に記載の使用のためのCBD。
- 1つまたは複数の附随抗癲癇薬(AED)と組み合わせて使用される、請求項1~4のいずれか一項に記載の使用のためのCBD。
- 少なくとも95%(w/w)のCBDを含む高度に精製された大麻の抽出物として存在する、請求項1~5のいずれか一項に記載の使用のためのCBD。
- 前記抽出物が0.15%未満のTHCを含む、請求項6に記載の使用のためのCBD。
- 前記抽出物が最高で1%のCBDVを更に含む、請求項6または7に記載の使用のためのCBD。
- 合成化合物として存在する、請求項1に記載の使用のためのCBD。
- 前記1つまたは複数のAEDが、クロバザム、クロナゼパム、レベチラセタム、トピラマート、スチリペントール、フェノバルビタール、ラコサミド、バルプロ酸、ゾニサミド、ペランパネル、およびホスフェニトインからなる群から選択される、請求項5に記載の使用のためのCBD。
- 前記CBDと組み合わせて使用される異なる抗癲癇薬の数が低減される、請求項1~10のいずれか一項に記載の使用のためのCBD。
- 前記CBDと組み合わせて使用される前記1つまたは複数の抗癲癇薬の用量が低減される、請求項1~11のいずれか一項に記載の使用のためのCBD。
- CBDの前記用量が5mg/kg/日を超える、請求項1~12のいずれか一項に記載の使用のためのCBD。
- 対象にカンナビジオール(CBD)を投与することを含む、無緊張発作を治療する方法。
- カンナビジオール(CBD)、溶媒、補助溶媒、甘味料、および着香料を含む、無緊張発作の治療に使用するための組成物。
- 前記溶媒がゴマ油である、請求項15に記載の組成物。
- 前記補助溶媒がエタノールである、請求項15に記載の組成物。
- 前記甘味料がスクラロースである、請求項15に記載の組成物。
- 前記着香料がイチゴ風味である、請求項15に記載の組成物。
- 前記CBDが25/mg/ml~100mg/mlの濃度で存在する、請求項15に記載の組成物。
- 25~100mg/mlの濃度のカンナビジオール(CBD)、79mg/mlの濃度のエタノール、0.5mg/mlの濃度のスクラロース、0.2mg/mlの濃度のイチゴ着香料、および1.0mlまでの適量のゴマを含む、請求項15~20のいずれか一項に記載の組成物。
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