JP2021107401A - カンナビノイドとn−アシルエタノールアミンの組み合わせ - Google Patents
カンナビノイドとn−アシルエタノールアミンの組み合わせ Download PDFInfo
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- JP2021107401A JP2021107401A JP2021057991A JP2021057991A JP2021107401A JP 2021107401 A JP2021107401 A JP 2021107401A JP 2021057991 A JP2021057991 A JP 2021057991A JP 2021057991 A JP2021057991 A JP 2021057991A JP 2021107401 A JP2021107401 A JP 2021107401A
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- acylethanolamine
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Abstract
Description
50および12.5mg/kgの投与量レベルのTHC製剤 - THCは、ゴマ油中において16.7%(ドノナビノール)の濃度で到達した。THCをエタノール:クレモフォール:生理食塩水、1:1:18の比で希釈した。100%用量で5mg / mlの濃度を達成するために、200μlを325μlのエタノール、325μlのクレモフォールと混合し、5850μlの生理食塩水で希釈した。同じ混合物を1.25mg/mlの濃度にするためにエタノール1.3ml、クレモフォール1.3mlおよび生理食塩水23.4mlで4倍に希釈した。製剤を、野外試験のために1回、およびテールピンチ試験のために再び、計2回調製した。
試験中、全グループにおいて体重(BW)の増加が観察された。BW増加は、第4Mグループで有意に減少し(p <0.01)、第1Mグループと比較して第3Mグループで増加した(p <0.05)。研究を通して到達したときのBW(+ SEM)パーセンテージ変化としてのグループ平均を図1に示す。
コントロールされていないマウスを用いた場合の平均動物速度を、オープンフィールドテストでの15分間のセッション中の各動物の合計移動距離(cm)を総移動時間(秒)で割ることによって計算した。THCは50mg/kgでコントロール(2M対1M)に比べて有意に速度を増加させたが、THCは12.5mg/kg(3M)では効果がなかった。50mg/kg(4M)のTHCと併用したPEAは速度(4M)に適度の影響しか与えなかったが、PEAは12.5mg/kg(5M)のTHCと組み合わせて速度を有意に低下させた。別の特に興味深いことに、5M群のみが、3M群ではなく、非コントロール運動の有意な低下レベルを示した。一緒になって、図2に示すデータは、カンナビノイド摂取に加えて、N-アシルエタノールアミンの同時投与が、マウスにおける制御されない動きを有意に防止または低減することができることを実証する。この能力は、カンナビノイド摂取に一般に伴うヒトにおける有害な副作用(混乱および/または方向感覚の喪失)を予防または最小化することと同等である(Metrik J. et al, J. Cogn. Psychother., 2011, pages 1-18)。
不安感の尺度であるアリーナの中心部で費やされた合計時間は、オープンフィールドテストで15分間のセッション中に評価された。THCは50mg/kg(2M)で中心部での消費時間を減少させたが、PEAとTHCを50mg/kg(4M)で併用した場合、中央で費やされた時間が増加した。図3に示すデータは、カンナビノイド摂取に加えてN-アシルエタノールアミンの同時投与が、一般にカンナビノイド摂取に関連するヒトにおける別の有害な副作用である不安感を予防または低減することができることを実証している。
テールピンチテストは、指示されたテストアイテムの投与の15分後に行った。10秒以内の圧力を尾の基部に加えた。高用量THC処置グループ(2M)で反応する潜時は、図4Aに見られるように対照と比較して高かった。高用量THCへのPEAの添加は、高用量THC(4M)の潜伏時間をさらに有意に延長した。特に興味深いことに、投与後15分で4M群のみが鎮痛効果を示し、これはN-アシルエタノールアミンとカンナビノイドとの組み合わせがほぼ即時の鎮痛効果を達成する可能性を証明する。図4Aに示すように、N-アシルエタノールアミンとカンナビノイドとの組み合わせは、投与後45日目に特に有効である。したがって、N-アシルエタノールアミンとカンナビノイドとの組み合わせは、速効性であり、疼痛の予防または最小化において非常に強力である。
試験グループ - THX-TP-2.5-10 (2.5-10 mgドロナビノール(登録商標)のカプセルおよび259 mg PEAの2カプセル)。例えば、THX-TP-05 (mg ドロナビノール(登録商標)のカプセルおよび259 mg PEAの2カプセル)およびTHX-TP-10 (10 mg ドロナビノール(登録商標)のカプセルおよび259 mg PEAの2カプセル)。
コントロールグループ - プラセボ。
主要有効性エンドポイント: 主要有効性エンドポイントは、イェール全般的チック重症度尺度(YGTSS)におけるベースラインから治療期の終了までの変化である。
Claims (48)
- カンナビノイドとN-アシルエタノールアミン間のモル比が、約1:0.2〜約1:2000である、少なくとも1つのカンナビノイドまたはその塩と少なくとも1つのN-アシルエタノールアミンまたはその塩との混合物の治療有効量を含む医薬組成物。
- カンナビノイドとN-アシルエタノールアミン間のモル比が、約1:0.2〜約1:5である、請求項1に記載の医薬組成物。
- カンナビノイドとN-アシルエタノールアミン間のモル比が、約1:0.5〜約1:2である、請求項2に記載の医薬組成物。
- カンナビノイドとN-アシルエタノールアミン間のモル比が、約1:15〜約1:1800である、請求項1に記載の医薬組成物。
- カンナビノイドとN-アシルエタノールアミン間のモル比が、約1:25〜約1:450である、請求項4に記載の医薬組成物。
- カンナビノイドとN-アシルエタノールアミン間のモル比が、約1:50〜約1:100である、請求項4に記載の医薬組成物。
- 約0.5〜10mgのカンナビノイドまたはその塩を含む、請求項1から6の何れか1項に記載の医薬組成物。
- 1mg、2.5mg、5mg、7.5mgまたは10mgのカンナビノイドまたはその塩を含む、請求項7に記載の医薬組成物。
- 少なくとも1つのカンナビノイドが、テトラヒドロカンナビノール(THC)、テトラヒドロカンナビノール酸(THCA)、カンナビジオール(CBD)、カンナビノール(CBN)、カンナビゲロール(CBG)、カンナビクロメン(CBC)、カンナビシクロール(CBL)、カンナビバリン(CBV)、テトラヒドロカンナビバリン(THCV)、カンナビジバリン(CBDV)、カンナビクロムバリン(CBCV)、カンナビゲロバリン(CBGV)およびカンナビゲロールモノメチルエーテル(CBGM)、その塩および、その何れかの組み合わせ、から選択される、請求項1から8の何れか1項に記載の医薬組成物。
- 少なくとも1つのカンナビノイドが、THCまたはその塩である、請求項9に記載の医薬組成物。
- 約200〜1800mgのN-アシルエタノールアミンまたはその塩を含む、請求項1から6の何れか1項に記載の医薬組成物。
- 約250mg、500mg、750mg、1000mgまたは1500mgのN-アシルエタノールアミンまたはその塩を含む、請求項11に記載の医薬組成物。
- N-アシルエタノールアミンが、N-パルミトイルエタノールアミン(PEA)、Me-パルミトイルエタノールアミド(Me-PEA)、パルミトイルシクロヘキサミド、パルミトイルブチルアミド、パルミトイルイソプロピルアミド、オレオイルエタノールアミン(OEA)、パルミトイルイソプロピルアミド(PIA)、それらの塩および、その何れかの組み合わせ、からなる群から選択される、請求項1から6、11または12の何れか1項に記載の医薬組成物。
- N-アシルエタノールアミンが、PEAまたはその塩である、請求項13に記載の医薬組成物。
- THCまたはその塩およびPEAまたはその塩を含む混合物である、請求項1から14の何れか1項に記載の医薬組成物。
- 約0.5〜10mgのTHCまたはその塩および約200〜1800mgのPEAまたはその塩を含む混合物である、請求項15に記載の医薬組成物。
- 約2.5〜10mgのTHCまたはその塩および約250〜1000mgのPEAまたはその塩を含む混合物である、請求項16に記載の医薬組成物。
- 約2.5mg、約5mg、約7.5mg、または約10mgのTHCまたはその塩および約250mg、約500mg、約750mgまたは約1000mgのPEAまたはその塩を含む混合物である、請求項17に記載の医薬組成物。
- 医薬組成物が、全身投与のために製剤化される、請求項1から18の何れか1項に記載の医薬組成物。
- 医薬組成物が、経口、口腔粘膜、経鼻、舌下、吸入、局所、直腸、膣内、非経口、静脈内、筋肉内、または皮下投与のために製剤化される、請求項19に記載の医薬組成物。
- 医薬組成物が、経口、口腔粘膜、経鼻または舌下投与のために製剤化される、請求項20に記載の医薬組成物。
- 請求項1から21の何れか1項に記載の医薬組成物を含むまたは構成する、投薬単位。
- 少なくとも1つのカンナビノイドによる予防または治療が可能な症状を予防または治療するための方法における使用のための、請求項1から21の何れか1項に記載の医薬組成物。
- 少なくとも1つのトゥレット障害の症状を予防または治療するための方法において使用するための、請求項23に記載の医薬組成物。
- トゥレット障害が、中度から重度トゥレット障害として分類される、請求項24に記載の医薬組成物。
- 症状がチックである、請求項24に記載の医薬組成物。
- 疼痛の予防または治療するための方法において使用するための、請求項23に記載の医薬組成物。
- 疼痛が、急性疼痛、慢性疼痛または神経因性疼痛である、請求項27に記載の医薬組成物。
- 嘔吐の予防または治療するための方法においての使用に関する、請求項23に記載の医薬組成物。
- 少なくとも1つのカンナビノイド摂取に付随する副作用を予防または治療するための方法において使用するための、請求項1から21の何れか1項に記載の医薬組成物。
- 副作用が、食欲の増加および/または体重の増加である、請求項30に記載の医薬組成物。
- 副作用が、混乱および/または方向感覚の喪失である、請求項31に記載の医薬組成物。
- 副作用が、不安感である、請求項31に記載の医薬組成物。
- 状態が、THCまたはその塩による予防または治療を受けやすく、または副作用が、THC摂取に付随される、請求項23から33の何れか1項に記載の医薬組成物。
- 医薬組成物の治療効力が、N-アシルエタノールアミンを含まない同じ医薬組成物と比較して増加する、請求項23から34の何れか1項に記載の医薬組成物。
- 医薬組成物中のカンナビノイドの必要な治療用量が、N-アシルエタノールアミンを含まない同じ医薬組成物と比較して減少する、請求項23から34の何れか1項に記載の医薬組成物。
- 少なくとも1つのカンナビノイドの副作用が、N-アシルエタノールアミンを含まない同じ医薬組成物と比較して減少する、請求項23から34の何れか1項に記載の医薬組成物。
- カンナビノイドの治療可能時間域が、N-アシルエタノールアミンを含まない同じ医薬組成物と比較して拡大される(expended)、請求項23から34の何れか1項に記載の医薬組成物。
- 少なくとも1つのカンナビノイドによる予防または治療を受けやすい状態を、それを必要とするヒト被験体において予防または治療する方法であって、投与されるカンナビノイドとN-アシルエタノールアミン間のモル比は、約1:0.2〜約1:2000の間であり、少なくとも1つのカンナビノイドまたはその塩と少なくとも1つのN-アシルエタノールアミンまたはその塩を含む医薬組成物の組み合わせの治療有効量を対象に投与する工程を含み、それによって状態を予防または治療する方法。
- トゥレット障害の症状を予防または治療することを必要とするヒト被験体において少なくとも1つのトゥレット障害の症状を予防または治療することに関する、請求項39に記載の方法。
- それを必要とするヒト被験体において疼痛の予防または治療することに関する、請求項39に記載の方法。
- 嘔吐の予防または治療することに関する、請求項39に記載の方法。
- 少なくとも1つのカンナビノイド摂取に関連する副作用を、それを必要とするヒト被験体において予防または治療する方法であって、投与されるカンナビノイドとN-アシルエタノールアミン間のモル比は、約1:0.2〜約1:2000の間であり、少なくとも1つのカンナビノイドまたはその塩と少なくとも1つのN-アシルエタノールアミンまたはその塩を含む医薬組成物の組み合わせの治療有効量を対象に投与する工程を含み、それによって少なくとも1つの副作用を予防または治療する方法。
- 状態が、THCまたはその塩による予防または治療を受けやすく、または副作用が、THC摂取に付随される、請求項39から43の何れか1項に記載の方法。
- カンナビノイドおよびN-アシルエタノールアミンが、同じ医薬組成物に含まれる、請求項39から44の何れか1項に記載の方法。
- カンナビノイドおよびN-アシルエタノールアミンの投与が繰り返される、請求項39から45の何れか1項に記載の方法。
- カンナビノイドおよびN-アシルエタノールアミンの投与が、治療前の状態と比較して、イェール全般的チック重症度尺度(YGTSS)による被験者の状態の有益な変化を達成するまで繰り返される、請求項39から46の何れか1項に記載の方法。
- カンナビノイドおよびN-アシルエタノールアミンの投与は、治療前の状態と比較して、(i)臨床全般印象尺度(CGIS)、(ii)ジル・ド・ラトゥレット障害-ライフ品質スケール(GTS-QOL)、(iii)トゥレット障害症状リスト(TSSL)、(iv)イェール-ブラウン強迫(Obsessive Compulsive)スケール(Y-BOCS)、(v)ADHD評価スケール-IV(ADHD-RS)および(vi)ハミルトン不安評価スケール(HAM-A)からなる群から選択される少なくとも1つのスケールに従って対象の状態の有益な変化を達成するまで繰り返される、請求項39から47の何れか1項に記載の方法。
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