JP2014528402A - フィトカンナビノイドカンナビジバリン(cbdv)及びカンナビジオール(cbd)を含む医薬組成物 - Google Patents
フィトカンナビノイドカンナビジバリン(cbdv)及びカンナビジオール(cbd)を含む医薬組成物 Download PDFInfo
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- JP2014528402A JP2014528402A JP2014532465A JP2014532465A JP2014528402A JP 2014528402 A JP2014528402 A JP 2014528402A JP 2014532465 A JP2014532465 A JP 2014532465A JP 2014532465 A JP2014532465 A JP 2014532465A JP 2014528402 A JP2014528402 A JP 2014528402A
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- cbdv
- cbd
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- cannabidiol
- phytocannabinoid
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Abstract
Description
a)部分発作、及び
b)全般発作
という2つの基本的なカテゴリーにグループ分けすることができる。
精神衛生上の問題(例えば、幼少期における正常なグルタミン酸作動性シナプスの発達の抑制)、
認知障害(deficits)(例えば、学習し記憶を蓄えるための海馬中の神経回路の能力の減弱)、及び
形態上の変化(例えば、興奮毒性の結果として内側側頭葉てんかんを示す患者の海馬のCA1領域及びCA3領域中のニューロンの選択的喪失)(非特許文献20、非特許文献21)。
i)世界の人口の1%〜2%がてんかんに罹患しており
(http://www.ncbi.nlm.nih.gov/sites/ppmc/articles/PMC1808496/)、
ii)これらのうち30%は既存の治療に対して抵抗性を有しており、
iii)既存の治療法には顕著な運動の副作用も存在する
(http://en.wikipedia.org/wiki/Epilepsy)。
ペンチレンテトラゾール(PTZ)によって誘導される全般発作のモデル(非特許文献24、非特許文献25)、
ピロカルピンによって誘導される側頭葉(すなわち海馬)発作のモデル(非特許文献26)、及び
ペニシリンによって誘導される部分発作のモデル(非特許文献27)。
全般発作のPTZモデルにおけるCBDV及びCBDを含む組成物の使用
方法論:
動物:
雄性ウィスターラット(P24〜29、75g〜110g)を使用して、全般発作のPTZモデルにおけるフィトカンナビノイドCBDV及びCBDを含む組成物の複合効果を評価した。実験の前に、試験環境、ケージ、注射プロトコル及び取扱いに動物を慣らした。動物を、21℃、12時間の明暗サイクル(09時00分に明るくする)、湿度50%の部屋に収容し、飼料及び水を自由に摂取できる状態にした。
HED=動物用量(mg/kg)×(動物のKm/ヒトのKm)
ラットのKmは6であり、ヒトのKmは37である。
組成物は、カンナビノイドが本質的にCBDV及びCBD並びにより少ない量のCBCV及びCBCからなるようにカンナビノイドTHCV及びTHCを除去するための遠心分配クロマトグラフィによる更なる調製を行った、CBDVの植物性薬剤物質(BDS)を使用して調製した。このBDSは、本出願の目的との関係ではCBDV(−/−)のBDSと称する。
5個の6L容蓋付パースペクス製タンクを、タンクの間に仕切りを設けた単一のベンチ上に配置した。ラットの挙動を観察するために、その仕切り上に閉回路テレビ(CCTV)カメラを取り付けた。Sony Topica CCDカメラ(Bluecherry, USA)を、BNCケーブルを介して、Brooktreeのデジタルキャプチャカード(Bluecherry, USA)によって低ノイズPCと接続した。Zoneminder(http://www.zoneminder.com)のソフトウェアを使用して、ラットをモニタリングし、録画を開始及び終了させ、ビデオファイルを管理した。社内(In-house)Linuxスクリプトを使用して、ビデオファイルを、The Observer(Noldus Technologies)を使用する更なるオフライン解析に好適なフォーマットへとエンコードした。
或る用量範囲のPTZ(体重1kg当たり50mg〜100mg)を使用して、発作の誘導に最良の用量を決定した。結果として、腹腔内(IP、ストック溶液は、0.9%の生理食塩水中、50mg/ml)注射する85mg/kgの用量を使用して、CBDV(−/−)BDS物質をスクリーニングした。
試験日に、CBDV(−/−)BDSを、50mg/kg、100mg/kg、200mg/kg、275mg/kg及び346mg/kgの用量で腹腔内(i.p.)注射によって投与するのと並行して、陰性対照群の役割を果たす同体積のカンナビノイドビヒクル(エタノール:クレモホル:生理食塩水(2:1:17))を動物に注射した(以下の表1.1で設定されるような規定の用量のCBDV及びCBDを与える)。それから動物を1時間観察し、その後動物に85mg/kgのPTZのIP注射を行った。陰性ビヒクル対照の実験を、カンナビノイドを投与した被験体の実験と並行して行った。PTZを投与した後、動物を観察しビデオ録画して、発作の重症度、及び幾つかの種類の発作挙動までの潜時を決定した(以下のin vivo解析を参照されたい)。動物を、発作の最後の徴候の後30分間フィルムに収め(filmed)、それからそれぞれのケージに戻した。
以下の表1.1は、CBDV(−/−)のBDSの種々の用量群におけるカンナビノイドCBDV及びCBDのそれぞれの含有量を示す。
実験手順中に動物を観察したが、全ての解析は、The Observer挙動解析ソフトウェア(Noldus, Netherlands)を使用して、録画したビデオファイルによってオフラインで行った。発作の重症度のスコア化システムを使用して、被験体が経験した発作のレベルを決定した(Pohl & Mares, 1987)。全ての動物に関して、発作の全ての徴候を詳細に記載した。
PTZの注射から第一ミオクローヌス反射(FMJ、スコア1)までの、及び動物が「強直性要素及び身体のねじれを伴う前肢間代」(スコア3.5)に到達するまでの潜時(単位:秒)を記録した。FMJは、発作活動の開始の指標であるが、90%を超える動物がスコア3.5を生じるため、より重度の発作の発生の良好なマーカーである。データを、実験群内の平均±S.E.M.として示す。
これは、以下のスコア化尺度に基づき、各実験群に関する中央値として示す。
PTZによって誘導される発作の結果として死んだ動物の実験群内における百分率。強直間代発作(スコア4及びスコア5)を発生した動物の大部分が結果的に死んだこと、及びスコア6(死)は動物が強直間代発作も経験したことを自動的に示すことに留意されたい。
発作の最初の徴候(通常はFMJ)から(生存した動物と生存しなかった動物とに分けて)発作の最後の徴候までの時間、又は被験体が死んだ場合には死ぬまでの時間(単位:秒)。これは、各実験群に関して平均±S.E.M.として示す。
潜時及び重症度の尺度に関して、全ての群に対して一元配置分散分析(ANOVA)を行って、試験物質による全体的な効果を検出した(p≦0.05を有意とみなした)。この結果を、図において「*」によって示す。
図1は発作の重症度の最大値を示し、発作の重症度の最大値に対するCBDV(−/−)のBDSの有意な効果が、275mg/kgのCBDV(−/−)のBDSという用量で観察された。
上記のデータから、CBDV(−/−)のBDSの組成物は、発作の重症度及び致死率を低減させ、発作の開始までの潜時を増大させると考えられ、このことによって、この組成物がてんかんの治療における使用のための望ましい組成物となる。
CBDV(−/−)のBDSの分析
上の実施例1において使用したCBDV(−/−)のBDSは、CBDV(+/+)のBDSの遠心分配クロマトグラフィ(CPC)を使用して得ることができる。
CBDV(+/+)のBDSの分析
以下の実施例は、CBDV(+/+)のBDSの成分の詳細を提供するために含めている。CBDV(+/+)のBDSは、亜臨界CO2抽出によって得た。CBDV(+/+)のBDSは、CBDVに加えて、カンナビノイドCBD、THCV及びTHCを相当量(各々、総カンナビノイド含有量の百分率として1重量%を超える)含む。THCは痙攣促進物質であるとされており、また、望ましくない不安症等の他の副作用に加えて顕著な向精神効果も有し得る。THCVは、てんかんにおける全般発作に特異的な抗痙攣活性を示すが、CB1アンタゴニストである。CB1アンタゴニストであるリモナバンがてんかん及び他の望ましくない効果を引き起こし得ることを示唆する証拠を踏まえると、BDSの活性に寄与することができる非カンナビノイド成分(複数も可)を保持しながら、BDSからこれらのカンナビノイドを除去することが望ましい可能性がある。
フィトカンナビノイド高含有植物の非カンナビノイドプロファイル
この比較実施例は、大量のカンナビノイドを生成するように育種された大麻植物から得られる典型的なテルペンプロファイルを示すために含めている。
「無カンナビノイド」植物の非カンナビノイドプロファイル
この比較実施例は、上の実施例4において記載されるものと異なる大麻植物のテルペンプロファイルを記載しており、ここでは比較目的で再現される(reproduced)。
全般発作のPTZモデルにおけるCBDV(+/+)のBDSの使用
この比較実施例は、特許文献6(未公開)に係る特許出願において過去に提示されたものであり、ここでは代表の意味で含めている。
Claims (22)
- フィトカンナビノイドカンナビジバリン(CBDV)及びカンナビジオール(CBD)を含むか又は本質的にこれらからなる組成物。
- 1つ又は複数の賦形剤を更に含む、請求項1に記載の組成物。
- 大麻の少なくとも1つの非カンナビノイド成分を更に含む、請求項1又は2に記載の組成物。
- 前記大麻の少なくとも1つの非カンナビノイド成分がテルペンであるか又はこれを含む、請求項3に記載の組成物。
- 前記フィトカンナビノイドが、CBDV、CBD、及び1つ又は複数のカンナビクロメン型化合物を含むか又は本質的にこれらからなる、請求項1〜4のいずれか一項に記載の組成物。
- 前記1つ又は複数のカンナビクロメン型化合物が、カンナビクロメンプロピル変異体(CBCV)及び/又はカンナビクロメン(CBC)である、請求項5に記載の組成物。
- 任意の他のカンナビノイドを有しないか又はこれを実質的に有しない、請求項1〜6のいずれか一項に記載の組成物。
- 前記任意の他のカンナビノイドが、テトラヒドロカンナビバリン(THCV)及び/又はテトラヒドロカンナビノール(THC)である、請求項7に記載の組成物。
- 前記CBDV及び前記CBDが、7:1〜1:2(CBDV:CBD)の比率で存在する、請求項1〜8のいずれか一項に記載の組成物。
- 前記CBDV及び前記CBDが、5:1〜1:1(CBDV:CBD)の比率で存在する、請求項9に記載の組成物。
- 前記CBDV及び前記CBDが、4.5:1〜2:1(CBDV:CBD)の比率で存在する、請求項9又は10に記載の組成物。
- 単位投薬形態が500mg〜2000mgのCBDVを含む、請求項1〜11のいずれか一項に記載の組成物。
- 単位投薬形態が100mg〜600mgのCBDを含む、請求項1〜12のいずれか一項に記載の組成物。
- 標準抗てんかん剤(SAED)を更に含む、請求項1〜13のいずれか一項に記載の組成物。
- フィトカンナビノイドCBDV及びCBDを含むが、カンナビノイドTHCV及びTHCを実質的に有しない、抽出物又はBDS。
- 1つ又は複数の非カンナビノイド成分を更に含む、請求項15に記載の抽出物又はBDS。
- 中枢神経系の過剰興奮を特徴とする神経学的病態、痙攣又は発作の治療における使用のための、フィトカンナビノイドカンナビジバリン(CBDV)及びカンナビジオール(CBD)の組合せ。
- 前記神経学的病態がてんかんである、請求項17に記載のフィトカンナビノイドカンナビジバリン(CBDV)及びカンナビジオール(CBD)の組合せ。
- 治療対象のてんかんの種類が全般発作である、請求項18に記載のフィトカンナビノイドカンナビジバリン(CBDV)及びカンナビジオール(CBD)の組合せ。
- 標準抗てんかん剤(SAED)を更に含む、請求項17〜19のいずれか一項に記載のフィトカンナビノイドカンナビジバリン(CBDV)及びカンナビジオール(CBD)の組合せ。
- 中枢神経系の過剰興奮を特徴とする神経学的病態、痙攣又は発作の治療における使用のための薬物の生産における、フィトカンナビノイドカンナビジバリン(CBDV)及びカンナビジオール(CBD)の組合せの使用。
- 治療的有効量のフィトカンナビノイドカンナビジバリン(CBDV)及びカンナビジオール(CBD)の組合せをそれを必要とする被験体に投与することを含む、中枢神経系の過剰興奮を特徴とする神経学的病態、痙攣又は発作を治療する方法。
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
GB1116789.7 | 2011-09-29 | ||
GB1116789.7A GB2495118B (en) | 2011-09-29 | 2011-09-29 | A pharmaceutical composition comprising the phytocannabinoids cannabidivarin (CBDV) and cannabidiol (CBD) |
PCT/GB2012/052284 WO2013045891A1 (en) | 2011-09-29 | 2012-09-14 | A pharmaceutical composition comprising the phytocannabinoids cannabidivarin (cbdv) and cannabidiol (cbd) |
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JP7225104B2 (ja) | 2017-02-01 | 2023-02-20 | ジービーエス グローバル バイオファーマ,インコーポレイテッド | マスト細胞関連炎症障害又は好塩基球媒介炎症障害の治療のためのカンナビノイド含有複合混合物 |
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