JP2021527132A - カンナビノイド組成物及びそれを使用した治療法 - Google Patents
カンナビノイド組成物及びそれを使用した治療法 Download PDFInfo
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Abstract
Description
(a)Δ9−テトラヒドロカンナビノール(THC)及び経口送達システム;及び
(b)カンナビジオール(CBD)及び経口送達システム
を含むキットを提供する。
本発明を詳細に説明する前に、本発明は、組成物、方法、及び用途などの特に例示される実施形態に限定されず、もちろん変動してもよいことが理解されるべきである。本明細書で使用される用語は、本発明の特定の実施形態を説明することのみを目的とし、制限を意図するものではないこともまた理解されるべきである。
本発明は、Δ9−テトラヒドロカンナビノール(THC)とカンナビジオール(CBD)の組み合わせ、及び経口送達システムを含む液体組成物を提供する。
・喘ぎ(イヌの場合)、不安、極度の興奮
・瞳孔の拡大、生気のない目(glossy−eyes)、及び「茫然自失」の外観
・極度の無気力状態
・よろめき、つまずき、バランスを崩したり失ったりせずに歩くことができない
・流涎及び嘔吐
・下痢(特にペットが高脂肪の食物、カンナバター、又は油を摂取した場合)
・膀胱のコントロール不能
・異常な心拍数及び血圧。
液体組成物は、経口送達システムを含む。経口送達システムは、1つ又は複数の薬学的、獣医学的及び/又は栄養補助食品的に許容可能な担体を含み、それが対象に経口投与されることを可能にする様式で、THC及びCBDを可溶化し又は懸濁させる。
・2〜6個の炭素原子を含む短鎖脂肪酸(SCFA)(カルボキシル炭素を含む);
・7〜13個の炭素原子を含む中鎖脂肪酸(MCFA)(カルボキシル炭素を含む);
・14〜22個の炭素原子を含む長鎖脂肪酸(LCFA)(カルボキシル炭素を含む);及び/又は
・例えば、23〜100個の炭素原子などの23個以上の炭素原子を含む超長鎖脂肪酸(VLCFA)(カルボキシル炭素を含む)
であってもよい。
・THCと液体担体とを含む、THC溶液を調製するステップ;
・CBDと液体担体とを含む、CBD溶液を調製するステップ;及び
THC溶液のアリコートをCBD溶液のアリコートと組み合わせて、THCとCBDの組み合わせを含む液体組成物を提供するステップ
を含む。
本発明の液体組成物を使用して、内在性カンナビノイドシステムに関連する、任意の疾患、障害又は病状が治療されてもよい。THC及びCBD療法は、以下の疾患、障害、及び病状の1つ又は複数の治療に有用であることが示されている:疼痛管理−術後、関節炎、がん、神経障害性、傷害、不安緩和、てんかん治療、胃腸の健康状態、皮膚の健康の改善−アトピー性皮膚炎、掻痒感、食欲刺激、緩和ケア、抗炎症性、緑内障の緩和、関節及び骨健康の改善、睡眠の補助、OCDをはじめとする神経系のサポート、鬱病、片頭痛、自閉症、アレルギー(例えば、接触アレルギー、食物アレルギー又はその他のアレルギー)、嘔吐及び悪心の軽減、筋肉痙攣の抑制を助ける、恐怖症の管理、行動障害の管理、認知機能障害の管理、がん増殖の減少、細菌/真菌の殺滅又は増殖遅延、血糖レベル及び脂肪酸の不均衡の減少。
(a)THC及び経口送達システムを含む液体組成物;及び
(b)CBD及び経口送達システムを含む液体組成物
を含むパートキットも開示されている。
本発明の一態様は、ケモカイン(C−Cモチーフ)リガンド5(CCL5、配列番号4に示される)、小脳変性症関連タンパク質2(CDR2、配列番号2に示される)、カンナビノイド受容体2(マクロファージ)(CNR2、配列番号3に示される)、インターロイキン8(CXCL8、配列番号1に示される)、及びアドレナリン受容体β2(ADRB2、配列番号5に示される)から選択される、1つ又は複数の遺伝子の発現を調節する方法を提供する。いくつかの実施形態では、これらの遺伝子の全ての発現が、これらの方法において調節されてもよい。
本発明の一態様は、炎症に関連するバイオマーカーの濃度に影響を与える方法を提供する。バイオマーカーは、顆粒球マクロファージコロニー刺激因子(GM−CSF)及びインターロイキン−15(IL−15)又はそれらの組み合わせから選択されてもよい。
この実施例は、異なる比率のTHCとCBDを含む2つの組成物のイヌへの単回経口投与を記載する。投与後に動物から血液を採取し、有害作用又は毒性の証拠について観察した。
組成−MCT油中の4.75mg/mlのTHC;製剤型−油性溶液
治験用獣医学的製品2:(IVP2):
組成−MCT油中の4.58mg/mlのCBD;製剤型−油性溶液
対照獣医学的製品(CVP):
組成−活性成分なしの中鎖トリグリセリド(MCT)油;製剤型−キャリアオイル
カンナビジオール(CBD)油及びテトラヒドロカンナビノール(THC)油、又はプラセボを11匹のイヌに単回経口投与した。
−処置2は、4匹のイヌにIVP1とIVP2を2:1の比率で投与した。
−処置3は、4匹のイヌにIVP1とIVP2を1:2の比率で投与した。
イヌは、以下の表2に示すように、個々の1日目体重に基づいて処置した。投与量は0日目に先立って計算され、実際のイヌの体重と分析証明書に基づくIVP活性成分組成とに基づいて、mg/kg体重で目標投与量を提供する。
各試験動物は、以下の臨床徴候(THC毒性に関連している)の発生について、試験期間を通して綿密にモニターした:鎮静/嗜眠、興奮/不随意運動、運動障害、眼球変化、咳嗽、流涎/唾液分泌、空嘔吐/吐き気、嘔吐、下痢、失禁、心拍数、呼吸数、体温変化、及び/又は任意のその他の異常な観察。
22ゲージの針と5mLのシリンジを使用して、各動物から各薬物濃度の試料採取時点で、約5mLの血液サンプルを採取した。
組成物は、キャリアオイル中のTHCとCBDの組み合わせを含む。THC及びCBDを既知の濃度のMCT油中で別々のストック溶液に調製し、次に各ストック溶液の一部を2:1のTHCとCBDの所定の望ましい比率で混合した。このカンナビノイドの比率は、MCT油中にある。0.9%(すなわち、約0.6%のTHCと約0.3%のCBD)、1.9%、及び2.7%のTHCとCBDの合算濃度を含む、3つの組成物を調製した。
組成物は、キャリアオイル中のTHCとCBDの組み合わせを含む。THC及びCBDを既知の濃度のMCT油中で別々のストック溶液に調製し、次に各ストック溶液の一部を1:2のTHCとCBDの所定の望ましい比率で混合した。このカンナビノイドの比率は、MCT油中にある。0.9%(すなわち、約0.3%のTHCと約0.6%のCBD)、1.9%、及び2.7%のTHCとCBDの合算濃度を含む、3つの組成物を調製した。
本実施例は、実施例1に記載された研究中に採取された血液サンプルに対して行われた遺伝子発現解析を記載する。遺伝子発現解析は、処置前、投与後1.5時間、及び投与後72時間に採取された血液サンプルに対して実施した。
本実施例は、実施例1に記載された研究中に採取された血液サンプルに対して行われたバイオマーカー解析を記載する。解析は、処置前、投与後1.5時間、及び投与後72時間に採取された血液サンプルに対して実施した。
本実施例では、可動性の障害及び/又は疼痛の徴候をもたらすいずれかの関節の変形性関節症(OA)がある、様々な犬種及び年齢の、性別でほぼバランスの取れた最大約45匹のイヌを対象とした研究について記載する。
2.処置群2(CPAT01−0.75×群−15匹)には、CannPal AUS;CPAT01混合油を0.54mg/kgの用量で1日2回、8週間にわたり、食餌上で経口投与する。
3.処置群3(CPAT01−1.5×群−15匹)には、CannPal AUS;CPAT01混合油を1.08mg/kgの用量で1日2回、8週間にわたり、食餌上で経口投与する。
4.処置群4(CPAT01−2.5×群−15匹)には、CannPal AUS;CPAT01混合油を1.8mg/kgの用量で1日2回、8週間にわたり、食餌上で経口投与する。
Claims (20)
- Δ9−テトラヒドロカンナビノール(THC)及びカンナビジオール(CBD)との組み合わせと、経口送達システムとを含む液体組成物。
- THC:CBDの重量比が1:1.2以上である、請求項1に記載の液体組成物。
- THC:CBDの重量比が約1:約2である、請求項2に記載の液体組成物。
- THC:CBDの重量比が1以上:1である、請求項1に記載の液体組成物。
- THC:CBDの重量比が約2:約1である、請求項4に記載の液体組成物。
- THCの濃度が最大約6.5%である、請求項1〜5のいずれか一項に記載の液体組成物。
- 前記CBDの濃度が最大約7.5%である、請求項1〜6のいずれか一項に記載の液体組成物。
- 前記経口送達システムが脂肪酸成分を含む、請求項1〜7のいずれか一項に記載の液体組成物。
- 前記経口送達システムが中鎖トリグリセリド(MCT)油を含む、請求項1〜8のいずれか一項に記載の液体組成物。
- 請求項1〜9のいずれか一項に記載の液体組成物を含む、食品。
- 請求項1〜9のいずれか一項に記載の液体組成物又は請求項10に記載の食品の有効量をそれを必要とする対象に経口的に投与するステップを含む、疼痛、炎症及び/又は不安を治療する方法。
- 請求項1〜9のいずれか一項に記載の液体組成物又は請求項10に記載の食品の有効量を対象に経口的に投与するステップを含む、対象の心拍数を制御する方法。
- 前記対象の平均心拍数が、投与後少なくとも約2時間にわたり低下する、請求項12に記載の方法。
- 疼痛、炎症及び/又は不安を治療するための薬剤の製造における、請求項1〜9のいずれか一項に記載の液体組成物又は請求項10に記載の食品の使用。
- 対象の心拍数を制御するための薬剤の製造における、請求項1〜9のいずれか一項に記載の液体組成物又は請求項10に記載の食品の使用。
- THC:CBDの重量比が1以上:1であるTHCとCBDの組み合わせに、細胞を接触させるステップを含む、ケモカイン(C−Cモチーフ)リガンド5遺伝子(CCL5、配列番号4に示される)の発現を下方制御する及び/又は小脳変性症関連タンパク質2遺伝子(CDR2、配列番号2に示される)の発現を下方制御する及び/又はカンナビノイド受容体2遺伝子(CNR2、配列番号3に示される)の発現を上方制御する及び/又はインターロイキン8遺伝子(CXCL8、配列番号1に示される)の発現を上方制御する及び/又はアドレナリン受容体β2遺伝子(ADRB2、配列番号5に示される)の発現を上方制御する方法。
- THC:CBDの重量比が1:1.2以上であるTHCとCBDの組み合わせに、細胞を接触させるステップを含む、インターロイキン8遺伝子(CXCL8、配列番号1に示される)の発現を下方制御する及び/又はケモカイン(C−Cモチーフ)リガンド5遺伝子(CCL5、配列番号4に示される)の発現を上方制御する及び/又はカンナビノイド受容体2遺伝子(CNR2、配列番号3に示される)の発現を上方制御する及び/又はアドレナリン受容体β2遺伝子(ADRB2、配列番号5に示される)の発現を上方制御する方法。
- THCとCBDの組み合わせへの前記細胞の曝露後に、CDR2を最大約70時間下方制御するステップをさらに含む、請求項17に記載の方法。
- 細胞をTHCとCBDとの組み合わせに接触させるステップを含む、顆粒球マクロファージコロニー刺激因子(GM−CSF)及びインターロイキン−15(IL−15)又はそれらの組み合わせから選択される、炎症に関連するバイオマーカーの濃度に影響を与える方法。
- 個別のパート:
(a)Δ9−テトラヒドロカンナビノール(THC)及び経口送達システム;及び
(b)カンナビジオール(CBD)及び経口送達システム
を含むキット。
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